Abstract:
A system for stapling tissue comprises a flexible endoscope and an operative head including a pair of opposed, curved tissue clamping jaws sized to pass through an esophagus, the jaws being moveable with respect to one another between an open tissue receiving configuration and a closed tissue clamping configuration, a first one of the curved jaws including a stapling mechanism and a second one of the jaws including a staple forming anvil surface, the stapling mechanism including staple slots through which staples are fired arranged in a row extending from a proximal end of the first jaw to a distal end thereof in combination with a control handle which, when the operative head is in an operative position within one of a patient&#39;s stomach and esophagus, remains outside the patient, the control handle including a first actuator for moving the jaws relative to one another and a second actuator for operating the stapling mechanism.

Description:
[0001]     This application is a Continuation of U.S. patent application Ser. No. 10/855,908, entitled “Apparatus and Method for Resectioning Gastro-esophageal Tissue” filed May 27, 2004 which is a divisional application of U.S. patent application Ser. No. 10/062,760 filed Jan. 31, 2002 which claims benefit of U.S. Provisional Patent Application Ser. No. 60/265,469 filed on Jan. 31, 2001. The entire disclosures of these prior applications are considered part of the disclosure of the accompanying application and is hereby expressly incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to endoscopic devices for performing localized resections of gastro-esophageal lesions.  
       BACKGROUND OF THE INVENTION  
       [0003]     Endoscopic surgical stapling apparatus are known in the art and are utilized to provide a variety of surgical procedures. For example, U.S. Pat. No. 5,040,715 to Green, et al. discloses an endoscopic stapling device configured to be inserted through a small entrance wound in the abdominal cavity to place rows of staples in body tissue. This device has a limited range of motion in that the stapling assembly at the distal end of the instrument can only be rotated about the central axis of the instrument.  
         [0004]     An endoscopic stapling apparatus purporting to have a greater range of motion is disclosed in U.S. Pat. No. 5,326,013 to Green et al. This device has an articulating stapling assembly mounted for pivotal movement about an axis extending transverse to the central axis of the instrument. An endoscopic stapling device designed to be inserted through a small incision in a body wall and purporting to have an increased range of motion is described in U.S. Pat. No. 5,389,098 to Tsuruta et al. A stapling assembly of this device curves away from a central axis of the instrument to a 90 degree angle so that it can more easily reach tissue spaced from the central axis. This device incises tissue clamped within the stapling assembly and places staggered lines of staples on both sides of the incision.  
       SUMMARY OF THE INVENTION  
       [0005]     The present invention is directed to a system for stapling tissue comprising a flexible endoscope and an operative head including a pair of opposed, curved tissue clamping jaws sized to pass through an esophagus, the jaws being moveable with respect to one another between an open tissue receiving configuration and a closed tissue clamping configuration, a first one of the curved jaws including a stapling mechanism and a second one of the jaws including a staple forming anvil surface, the stapling mechanism including staple slots through which staples are fired arranged in a row extending from a proximal end of the first jaw to a distal end thereof in combination with a control handle which, when the operative head is in an operative position within one of a patient&#39;s stomach and esophagus, remains outside the patient, the control handle including a first actuator for moving the jaws relative to one another and a second actuator for operating the stapling mechanism. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0006]      FIG. 1  shows a perspective view of a system according to an illustrative embodiment of the present invention along with a partially cross-sectional view of a patient showing a target portion of tissue to be resected;  
         [0007]      FIG. 2   a  shows the system of  FIG. 1  inserted into the patient&#39;s body via the mouth;  
         [0008]      FIG. 2   b  shows a display of the image of a stapling apparatus of the system of  FIG. 1  provided to a user;  
         [0009]      FIG. 2   c  shows a cross-sectional view of the patient&#39;s esophagus with the stapling apparatus of  FIG. 3  in position adjacent to the target portion of tissue;  
         [0010]      FIG. 3  shows a perspective view of the system of  FIG. 1  with jaws of the stapling apparatus open;  
         [0011]      FIG. 4  shows a partially cross-sectional view of a proximal end of the stapling apparatus of  FIG. 3  showing control cables for operating the jaws configured as when the jaws are open;  
         [0012]      FIG. 5  shows a perspective view of the system of  FIG. 1  with jaws of the stapling apparatus closed with a lower actuator lever on a control handle being actuated;  
         [0013]      FIG. 6  shows a partially cross-sectional view of the control handle of the system of  FIG. 5  showing a coupling between control cables for operating the jaws and the lower actuator lever on the control handle;  
         [0014]      FIG. 7  shows a partially cross-sectional view of a proximal end of the stapling apparatus of  FIG. 5  showing control cables for operating a stapling pusher of the stapling apparatus configured as when the lower actuator lever is actuated;  
         [0015]      FIG. 8  shows a perspective view of the system of  FIG. 1  with jaws of the stapling apparatus closed with an upper actuator lever on the control handle being actuated;  
         [0016]      FIG. 9  shows a partially cross-sectional view of a portion of the control handle of the system of  FIG. 8  showing a coupling between control cables for operating the jaws and the upper actuator lever on the control handle;  
         [0017]      FIG. 10  shows a partially cross-sectional view of a proximal end of the stapling apparatus of  FIG. 5  showing control cables for operating a stapling pusher of the stapling apparatus configured as when the upper actuator lever is actuated;  
         [0018]      FIG. 11  shows a partially cross-sectional view of a stapling assembly of the system of  FIG. 1  grasping esophageal tissue;  
         [0019]      FIG. 12  shows a partially cross-sectional view of the stapling assembly of the system of  FIG. 1  illustrating a mechanism for grossly approximating the jaws of the stapling assembly;  
         [0020]      FIG. 13  shows a partially cross-sectional view of the stapling assembly illustrating a mechanism for finely approximating the jaws in an initial position;  
         [0021]      FIG. 14  shows a perspective view of an I-beam member of the fine approximation mechanism of  FIG. 13 ;  
         [0022]      FIG. 15  shows a partially cross-sectional view of the stapling assembly with the fine approximation mechanism in a partially advanced position;  
         [0023]      FIG. 16  shows a perspective view of the stapling assembly with a C-shaped clamp member thereof in an initial position;  
         [0024]      FIG. 17  shows a perspective view of the C-shaped clamp member of  FIG. 16  rotated 180 degree removed from the jaws;  
         [0025]      FIG. 18  shows a cross-sectional view of the stapling assembly with the C-shaped clamp member in a partially advanced position;  
         [0026]      FIG. 19  shows an alternate embodiment of the system according to the present invention with a lateral endoscope receiving lumen;  
         [0027]      FIG. 20  shows the system of  FIG. 19  with an endoscope received therein;  
         [0028]      FIG. 21  shows a system in accord with the present invention positioned within the stomach to perform a procedure for the treatment of reflux; and  
         [0029]      FIG. 22  shows a system in accord with the present invention positioned within the stomach to perform a stomach reduction procedure. 
     
    
     DETAILED DESCRIPTION  
       [0030]     A detailed description of illustrative embodiments of the present invention is provided in conjunction with the attached drawings. In the descriptions of the various embodiments and the corresponding drawings, like reference numerals refer to like elements.  
         [0031]     A method and apparatus for resectioning anastomized lumenal tissue is disclosed in U.S. Pat. No. 5,868,760 to McGuckin et al., the disclosure of which is hereby incorporated by reference in its entirety. The disclosed apparatus includes a flexible tubular body and a distal operating capsule that may be inserted through either a naturally occurring body orifice or a surgical incision and guided to an operative site endoscopically or using radiologic imaging guidance. In use the target tissue is stapled, cut and captured within the operating capsule for removal from the body. The healthy tissue is thereby anastomized by surgical staples.  
         [0032]      FIG. 1  shows a system for resecting esophageal tissue according to an illustrative embodiment of the present invention. A surgical stapling apparatus, designated generally by the reference numeral  10 , is utilized in conjunction with an endoscope  20  for providing remote vision of an operative area and to assist in guiding the stapling apparatus  10  to the operative area. An endoscopic grasping device  30  extends through a lumen in the endoscope  20  for use at the surgical site as would be understood by those of skill in the art. Those skilled in the art will further understand that, while the illustrative embodiments are described in conjunction with visual observation of the operative site via the endoscope  20 , these procedures may also be visualized through the use of Magnetic Resonance Imaging (MRI). In this case, components of the system and the instruments utilized therewith, such as the grasping device  30 , would be constructed from non-ferrous material such as titanium, as would be understood by those of skill in the art.  
         [0033]     As shown in  FIG. 1 , the stapling apparatus  10  includes a proximal handle portion  12 , an elongated flexible body portion  14  extending from the handle portion  12  and a generally C-shaped stapling assembly  16  operatively associated with a distal end of the flexible body portion  14 . The flexible body portion  14  and the stapling assembly  16  are preferably dimensioned and configured to traverse the natural curvature of the esophagus. As shown in  FIGS. 2   b  and  2   c  and described in detail below, the stapling assembly  16  includes a pair of opposable jaws  17  defined by a staple carrying portion  40  and a staple forming portion  50 . Those skilled in the art will understand that, although the jaws  17  are described herein as rotating relative to one another between the open and closed positions, that these jaws  17  may be coupled by a mechanism which allows them to move linearly with respect to one another or in any other manner so long as they move between a first position in which the jaws  17  are separated from one another to receive tissue and a second position in which the jaws  17  are clamped together to hold tissue tightly therebetween for stapling.  
         [0034]     Furthermore, those skilled in the art will understand that the system may operate with any of a variety of commercially available medical endoscopes which may include, for example, a proximal handle portion  22 , an elongated flexible body portion  24  through which one or more interior lumena extend for accommodating, for example, a fiber optic bundle or other image transmission structure, a working channel for the grasping device  30 , etc. Those skilled in the art will understand that the fiber optic bundle (or other image transmitting structure) allows a user to remotely visually monitor a field of view at the distal end of the endoscope (e.g., an operative site S within the esophagus E). As would be further understood by those of skill in the art, the tissue grasping device  30  may include a handle portion  32 , an elongated flexible body portion  34  and a pair of opposable jaws  36 , which consists of first and second opposable jaws  36   a  and  36   b.    
         [0035]     In use as shown in  FIGS. 2   a - 2   c , the surgical stapling apparatus  10  and the flexible endoscope  20  are introduced into a patient&#39;s mouth and advanced into the esophagus to the operative site S under visual guidance from the endoscope  20 . Once at the site S, the operator maneuvers the stapling assembly  16  into a desired position relative to the tissue to be resected. Those skilled in the art will understand that the stapling assembly  16  may be coupled to the handle portion  22  by a cable steering system (not shown) substantially as included in commercially available endoscopes to allow the remote maneuvering and positioning of the stapling assembly  16 . The jaws  17  of the stapling assembly  16  are then opened to a tissue receiving position as shown in  FIG. 3  and the grasping device  30  is advanced from the distal end of the endoscope  20 . The jaws  36   a  and  36   b  are rotated away from one another by manipulation of the grasper handle portion  32  and the tissue T to be resected is grasped by closing the jaws  36   a ,  36   b . The grasping device  30  is then withdrawn into the working channel of the endoscope  20  to pull the tissue T into position between the jaws  17  of the stapling assembly  16  and the jaws  17  are closed to clamp the tissue T in place between the staple carrying portion  40  and the staple forming portion  50 . Those skilled in the art will understand that the tissue T is preferably drawn between the jaws  17  so that a margin of healthy tissue is positioned between the staple carrying portion  40  and the staple forming portion  50  to ensure that all of the diseased or damaged tissue T is removed. Those skilled in the art will understand that this may be visually confirmed through the use of a vision system  55  of the endoscope as shown in  FIG. 2   b.    
         [0036]     As shown in  FIG. 2   c , once the tissue T has been properly positioned between the jaws  17 , the jaws  17  are grossly approximated and are then finely approximated using a translating clamping member  60 , illustrated in detail in  FIGS. 16-18 . As shown in  FIGS. 3, 4  and  12 , an illustrative embodiment of the system according to the present invention includes an actuation cable  44  to facilitate gross approximation of the jaws  17  via actuation of an actuator knob  38 . The actuation cable  44  may be secured to the one of the jaws  17  including, for example, the staple carrying portion  40  by a member  75 , which may, for example be a spindle, capstan or other member around which cable  44  loops. The cable  44  is operatively coupled to the other jaw  17  including the staple forming portion  50  by a member  85 , which is substantially similar to the member  75  and around which the cable  44  passes to change direction to generate the clamping force to draw the jaws  17  together. Furthermore, an overhanging flange  98  at a proximal end of the staple carrying portion  40  acts as a tissue shield preventing the target tissue T from entering into the joint between the jaws  17 .  
         [0037]     As shown in  FIGS. 3-7 , to actuate the clamping member  60  to finely approximate the jaws  17 , the lower clamping handle  12   a  is actuated in the direction of the arrow in  FIG. 5  to cause the integral gear rack  62   a  to turn pinion gear  62   b  which rotates elongated drive cable  64 . As shown in  FIG. 7 , the drive cable  64  is coupled to a drive screw  63  interacting with a geared surface  65  so that rotation of the drive cable  64  rotates the drive screw  63  moving the clamping member  60  distally as shown in  FIG. 18 . This finely approximates the jaws  17  of the stapling assembly  16  whereby a tissue contacting surface of the staple carrying portion  40  and a tissue contacting surface of the staple forming portion  50  are brought into cooperative alignment, tightly clamping the tissue therebetween. Those skilled in the art will understand that alternative sources of power (e.g., electrical, hydraulic, pneumatic, etc.) may be applied to drive the jaws  17  and to drive all other mechanisms of the stapling assembly  16 .  
         [0038]     As shown in  FIG. 8 , once the jaws  17  have been brought into cooperative alignment with one another, the stapling assembly  16  may be actuated to fire staples through the clamped tissue while simultaneously cutting away the tissue T from the stapled and anastamized tissue. The user actuates the stapling assembly  16  to drive staples through the margin of healthy tissue in one or more arcuate bands located radially outward of a line of tissue cutting. Alternatively, those skilled in the art will understand that the stapling operation may be separated from the tissue cutting operation so that no tissue is cut until the entire stapling operation has been successfully concluded.  
         [0039]     Specifically, as shown in  FIGS. 8-10 , the operator drives an I-beam member  70  through the stapling assembly  16  by operating the clamping handle  12   b  in the direction of the arrow in  FIG. 8 , causing gear rack  72   a  to rotate pinion gear  72   b  which rotates a staple driving drive cable  74  as shown in  FIG. 9 . The drive cable extends through the flexible body portion  14  to a linear drive screw  76  which drives a flexible pusher  80  coupled to the I-beam member  70  as shown in  FIG. 10 .  
         [0040]     As shown in  FIGS. 11, 13 ,  14  and  15 , the I-beam member  70  includes upper and lower beam portions  82   a ,  82   b , respectively, connected by a central web portion  84 . A leading edge  84 a of the central web portion  84  may preferably define a cutting blade for incising tissue as the I-beam member  70  is moved distally as described below. As shown in  FIG. 11 , an arcuate channel  90  within which the central web portion  84  travels, is defined in the opposing jaws  17  radially inward of the arcuate lines of staple carrying slots (not shown). Those skilled in the art will understand that the staple slots may be arranged in any number of rows, for example, from one to five such rows may be included and the slots of these rows may be staggered so that to ensure that the opening created by the resection is completely sealed.  
         [0041]     As described above, actuation of the lower handle  12   a  causes the C-shaped clamp member  60  to move along an arc the length of the curved stapling assembly  16  to finely approximate the jaws  17  toward one another. As shown in  FIGS. 13, 14  and  15 , the clamp member  60  includes a body portion  112  from which depend upper and lower clamping beams  114   a  and  114   b , respectively, for urging the jaws  17  toward one another.  
         [0042]     In addition, as shown in  FIGS. 16 and 17 , in one embodiment of the invention, the body  112  includes a radially depending driving stem  115  having a sloped leading edge configured to extend through an arcuate slot  116  formed in the staple carrying portion  40  for sequentially contacting each of a plurality of staple pushers  118 . The staple pushers  118  are positioned so that, when contacted by the driving stem  115 , each staple pusher  118  is driven through a corresponding one of the staple slots to drive a staple housed therein from the slot out of the staple carrying portion  40 , through both thicknesses of the folded portion of tissue clamped between the jaws  17  and against the staple forming surface  50   a  of the staple forming portion  50  to couple the two thicknesses of tissue to one another. In this embodiment, the clamping member  60  further includes an integral cutting blade  130  for forming an arcuate incision substantially concentric with and radially within an inner one of the arcs of staple slots. Furthermore, the cutting blade  130  is preferably positioned so that it trails the leading edge  115  so that tissue is stapled before it is cut.  
         [0043]     As shown in  FIG. 15 , according to a further embodiment of the invention, actuation of the upper actuation handle  12   b  causes the I-beam member  70  to move through the stapling assembly  16  to sequentially fire arcuate rows of staples while simultaneously cutting tissue away from the esophagus radially within the rows of staples. When the I-beam member  70  is driven by the pusher  80 , the sloped leading edge of the upper beam portion  82   a  contacts sequentially each of a plurality of staple pushers  118  to drive them through their respective staple slots to drive the staples housed therein from each slot out of the staple carrying portion  40 , through both thicknesses of the folded portion of tissue clamped between the jaws  17  and into the staple forming pockets  122  formed in the staple forming surface  50   a  of the staple forming portion  50  to couple the two thicknesses of tissue to one another. As the leading edge  84   a  of the central web portion  84  is proximal to the sloped leading edge, the incision trails the stapling action so that only tissue within the arc that has previously been stapled is severed.  
         [0044]     As shown in  FIGS. 19 and 20 , according to a further embodiment of the invention, a stapling assembly  16 ′ according to the present invention may include an endoscope receiving lumen  140  through which the endoscope  20  may be slidably inserted. This allows an operator to use to steering and vision capability of the endoscope  20  to locate the operative site S. Once the distal end of the endoscope  20  is positioned adjacent to the site S, the stapling assembly  16 ′ may be slid along the endoscope  20  to the operative site S and the steering capability of the distal end of the endoscope  20  may be employed to achieve a desired position and orientation of the stapling assembly  16 ′ relative to the tissue T. Other than the endoscope receiving lumen  140 , the construction of the rest of the system of  FIGS. 19 and 20  may be substantially in accord with that of any of the previously described embodiments.  
         [0045]     Furthermore, as shown in  FIGS. 21 and 22 , the system according to the present invention may also be used to perform resections within the stomach. For example, the stapling apparatus  10  may be used to correct gastro-esophageal reflux (“GERD”) or to perform a stomach reduction procedure. Specifically, as shown in  FIG. 21 , a system according to the invention may be inserted through the esophagus into a patient&#39;s stomach and the operator may position the jaws  17  under visual control via the endoscope  20  adjacent to a junction between the esophagus and the stomach. The operator then uses the steering capability of the endoscope  20 , received within the endoscope lumen  140  to direct the jaws  17  toward a portion of stomach tissue to be fastened to the esophagus. Specifically, the operator grasps a portion of the stomach using the grasping device  30  and urges the tissue T toward the esophagus to create a fold of tissue with an outside surface of the stomach tissue adjacent to or in contact with an outer surface of the esophagus. This fold is then clamped by the jaws  17  and stapled together to reduce the diameter of the opening from the esophagus to the stomach. The tissue radially within the stapled tissue is then resected.  
         [0046]     Similarly as shown in  FIG. 22 , to perform a stomach reduction, an operator inserts a system according to the present invention into the stomach via the esophagus as described above in regard to  FIG. 21  and locates a portion of tissue to be folded over on itself to reduce the size of the stomach. This tissue T is grasped by the grasping device  30  and drawn between the jaws  17  which clamp the tissue T together folded onto itself and staples the fold together. Those skilled in the art will understand that, for a stomach reduction procedure, the folded tissue radially within the staples may, if desired, be left in place without resection so that the operation may be reversed at a later date. Thus, for such a stomach reduction procedure where the folded, stapled tissue will be left in place within the stomach, the stapling apparatus  10  need not include a tissue cutting mechanism. Rather, the stapling apparatus  10  need only include structure for approximating the jaws  17  and for driving staples through the gripped fold of tissue. In this case, the C-shaped clamp member  60  would be constructed without the cutting blade  130 .  
         [0047]     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.