Abstract:
A surgical instrument for fastening tissue with a staple. The instrument includes a cartridge adapted for containing the staple. The cartridge includes a mechanism adapted to selectively advance the staple toward a forward end of the cartridge so the ends of the staple protrude from the cartridge and to selectively close the staple. The cartridge includes a mount connected to the cartridge and adapted for mounting the cartridge to an end of an endoscope. The cartridge includes a linkage connected to the cartridge for actuating the mechanism to advance and close the staple and a remote actuator connected to the linkage a predetermined distance from the cartridge for actuating the mechanism from a position remote from the cartridge.

Description:
BACKGROUND  
       [0001]    This invention generally relates generally to surgical instruments and more particularly to staplers used in endoscopic procedures. 
         [0002]    A variety of designs have been commercialized or proposed for instruments having an end effector for engaging tissue during surgery and applying a fastener to the tissue. Such instruments typically have a handle for actuating the instrument. The instrument may also include parts that pivot and/or rotate to facilitate using the instrument in various orientations. 
         [0003]    Some conventional endoscopic instruments include an operable end effector such as a staple applying cartridge for engaging the tissue in a certain way. In some of these conventional endoscopic instruments, the end effectors mount on a rigid, straight shaft of the instrument so the end effectors extend from the end of the shaft generally parallel to the shaft. Depending on the surgical procedure being performed, it is sometimes desirable to provide an end effector assembly that can be easily bent relative to the longitudinal axis of the shaft. These movements permit the surgeon to engage the tissue more easily in some situations. For example, when a staple is applied to certain hollow internal organs such the stomach, a rigid shaft cannot be used without making incisions in the patient to access the stomach. A flexible delivery system would enable the stapler to be introduced into the stomach of the patient through the esophagus. In spite of the fact that some procedures require the instrument be flexible to reach a particular area inside the patient where the procedure is being performed, most conventional endoscopic stapling devices have rigid shafts. As a result the complexity and duration of the surgical procedures may be increased, thereby increasing recover times and complications. 
       BRIEF SUMMARY  
       [0004]    The present invention relates to a surgical instrument for fastening tissue with a staple. The staple is deformable from an open configuration in which tissue is initially engaged by ends of the staple to a fastened configuration in which the ends of the staple are moved toward each other so the staple closes around the tissue thereby fastening the tissue. The instrument comprises a cartridge adapted for containing the staple. The cartridge includes a mechanism adapted to selectively advance the staple toward a forward end of the cartridge so the ends of the staple protrude from the cartridge and to selectively close the staple. The instrument further includes a mount connected to the cartridge and adapted for mounting the cartridge to an end of an endoscope laterally offset from a tip of the endoscope so tissue can be viewed through the endoscope when fastened. In addition, the instrument comprises a linkage connected to the cartridge for actuating the mechanism to advance and close the staple and a remote actuator connected to the linkage a predetermined distance from the cartridge for actuating the mechanism from a position remote from the cartridge. 
         [0005]    In another aspect of the present invention, a surgical instrument comprises a cartridge adapted for containing the staple. The cartridge includes a mechanism adapted to selectively advance the staple toward a forward end of the cartridge so the ends of the staple protrude from the cartridge and to selectively close the staple. The instrument also includes a flexible shaft connected to the cartridge for positioning the cartridge in the patient. Still further, the instrument includes a linkage connected to the cartridge and extending along the shaft for actuating the mechanism to advance and close the staple. The instrument comprises a remote actuator connected to the linkage a predetermined distance from the cartridge for actuating the mechanism from a position remote from the cartridge. 
         [0006]    Other aspects of the present invention will be in part apparent and in part pointed out hereinafter. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0007]      FIG. 1  is a side elevation of a endoscopic surgical stapler in partial section of a first embodiment of the present invention; 
           [0008]      FIG. 2  is a front elevation of an undeformed staple used in a stapler of the first embodiment; 
           [0009]      FIG. 3  is a front elevation of the staple of  FIG. 2  after being deformed; 
           [0010]      FIG. 4  is a schematic perspective of a series of staples and a portion of a cartridge of a stapler; and 
           [0011]      FIG. 5  is a perspective of a stapler of a second embodiment of the present invention. 
       
    
    
       [0012]    Corresponding reference characters indicate corresponding parts throughout the several views of the drawings. 
       DETAILED DESCRIPTION  
       [0013]    Referring now to the drawings and in particular  FIG. 1 , one embodiment of an endoscopic surgical stapler is designated in its entirety by the reference numeral  20 . The stapler  20  is a surgical instrument including a staple cartridge (generally designated by  22 ) mounted on a flexible shaft (generally designated by  24 ) at a working end (generally designated by  26 ) of the stapler. A manipulator handle (generally designated by  28 ) is attached to the shaft  24  opposite the cartridge  22  for manipulating the cartridge into position and actuating the cartridge to apply a staple once the cartridge is in position. The cartridge  22  is adapted to hold a supply of staples, each staple generally designated by  30 , ( FIG. 2 ) and to individually apply the staple to tissue (not shown). 
         [0014]    Usually, the staples  30  are applied to hold two portions of tissue together, but if desired the staples  30  may be used to attach a non-tissue element (e.g., a medical implant or surgical mesh) to one or more portions of tissue. Although the staple  30  may be made from other suitable materials without departing from the scope of the present invention, in some embodiments the staple is made from titanium, stainless steel, or other metals used in surgical applications. In appropriate applications, the staple  30  may be made from non-metallic materials, including synthetic polymers. Each staple  30  has a transverse member or crown  32  having opposite end portions  34  joined by a central portion  36 . Prior to being deformed in use, the central portion  36  of the staple  30  is vertically offset from the end portions  34 . Each crown end portion  34  joins an upper end of a leg  38  oriented generally perpendicular to the crown  32  having an angled lower end surface providing a piercing point  40 . 
         [0015]    The staples  30  are advanced by the cartridge  22  ( FIG. 1 ) and applied to tissue. The stapler  20  is manipulated so the cartridge  22  is positioned adjacent the tissue to be stapled. The cartridge  22  is advanced farther to push the piercing points  40  of one staple  30  extending from the cartridge into the tissue so the points penetrate the tissue. The staple legs  38  may be advanced into the tissue to a predetermined depth depending on design parameters. In some applications, it may be desirable to advance the legs  38  into the tissue until the staple crown  32  engages the tissue and/or auxiliary element being stapled to the tissue. Once the legs  38  are advanced to the desired depth, the stapler  20  is actuated to deform the staple crown  32  so the staple legs  38  assume a generally closed configuration as illustrated in  FIG. 3 . In one embodiment, the pointed ends  40  of the staple leg  38  overlap as shown in  FIG. 3 . 
         [0016]    In one embodiment of the cartridge  22 , the staples  30  are stored in a side-by-side serial arrangement as illustrated in  FIG. 4 . The staples  30  are oriented so the staple legs  30  point generally downward and perpendicular to a longitudinal direction  42 . The staples  30  are biased toward the forward end  26  of the stapler  20  by a helical compression spring  44  that forces an engaging member  46  against a last staple at a back end of the series of staples. 
         [0017]      FIG. 4  schematically illustrates movement of staples  30  in the cartridge  22  ( FIG. 1 ). When the stapler  20  is actuated to apply a staple  30 , a lead staple at the front end of the series is pushed down an angled path (as schematically illustrated by arrow  50 ) and pivots about 90 degrees to the position generally indicated for the staple  30 B. In this position, the staple legs  30  point forward. The staple  30 B is pivoted by a guide track (not shown) and staple former  52  (partially shown). This causes the staple  30 B to advance toward the forward end of the stapler  20  where the points  40  of the staple legs  30  penetrate the tissue. As the staple  30 B advances farther, the staple crown  32  is bent around an anvil  54  so the staple legs overlap in a fastened configuration as illustrated in  FIG. 4 . 
         [0018]    As shown in  FIG. 1 , the staples  30  are stored in the cartridge  22  adjacent the forward end  26  of the stapler  20 . The cartridge  22  also has a generally circular transverse cross section. The diameter of the cartridge  22  is generally constant and between about 3 millimeter and about 15 millimeter. The cartridge  22  tapers at its forward end to a non-circular, flattened configuration as shown in  FIG. 1 . The cartridge  22  is mounted on the flexible shaft  24 . In one embodiment, this shaft  24  is flexible along its entire length. The handle  28  includes a rotational control knob  60  for rotating the shaft  24  and cartridge  22  relative to the handle. In addition, the manipulator handle  28  includes a pivoting grip or trigger lever  62  that actuates the cartridge to advance the staple  30  and to apply it to tissue. 
         [0019]    The cartridge  22  is removable from the forward end  26  of the stapler  20  so that when all of the staples  30  initially supplied in the cartridge have been applied to tissue, the empty cartridge may be removed from the stapler, and a new cartridge full of staples may be installed on the stapler. 
         [0020]    The staples  30  are advanced in the cartridge  22  and applied to tissue by squeezing a trigger lever  62  on the manipulator handle  28 . The trigger lever  62  is pivotally mounted on the handle  28  for pivotal movement in the rearward direction and in the forward direction as indicated by the double-headed arrow  64  in  FIG. 1 . The handle  28  also includes a grip  66  for receipt in the palm of the hand while the fingers of the hand extend around the trigger lever  62  to squeeze the trigger lever rearward toward the handle grip. 
         [0021]    The components of the manipulator handle  28  may be fabricated from suitable materials. It is presently contemplated that some of the components, such as the knob  60 , the trigger lever  62  and handle grip  66  may be fabricated from synthetic polymers, such as polycarbonate or nylon. It is also envisioned that suitable alternative materials may be used. For some of the other components, especially components that transfer internal forces and moments, metal materials (e.g., steel or stainless steel) may be used. 
         [0022]    The flexible shaft  24  includes an outer flexible tube  70  as shown in  FIG. 1 . The rearward end of the tube  70  is connected to the rotational control knob  60  so the tube rotates with the control knob. In a presently contemplated embodiment, the tube  70  has a generally circular transverse cross section, an inner diameter of between about 1 millimeter and about 13 millimeter, and an outer diameter of between about 1.5 millimeter and about 15 millimeter. Further, the tube  70  has a length of between about 10 inches and about 100 inches. It is envisioned that the tube  70  may be coiled stainless steel or a synthetic polymer. 
         [0023]    A flexible cable or linkage  72  extends through the tube  70 . As will be explained in greater detail below, the cable  72  is operatively connected to the lever  62  and the cartridge  22  so that a staple  30  is advanced forward in the cartridge and applied to tissue with each squeeze of the lever. 
         [0024]    Thus, as will be appreciated by those skilled in the art, the shaft  24  may be advanced into a patient. Once the cartridge  22  has been advanced to a position adjacent the tissue to be fastened, the cartridge may be rotated into an desired orientation by turning the knob  60 . Once the cartridge  22  is oriented as desired, the trigger  62  is pulled to advance and apply a staple  30  to adjacent tissue. 
         [0025]    Configuration and operation of the cartridge  22  is identical to that described in U.S. Pat. No. 5,588,581, which is hereby incorporated by reference in its entirety. Accordingly, the configuration and operation of the cartridge will not be described in detail. Likewise the internal configuration and operation of the control knob and lever  60 ,  62 , respectively, are described in detail in U.S. Pat. No. 5,588,581 and will not be described further. As those skilled in the art will appreciate, the precise connections of the control knob and lever  60 ,  62  to the tube  70  and cable  72  may vary without departing from the scope of the present invention. 
         [0026]    In another embodiment of the present invention shown in  FIG. 5 , a cartridge  100  similar to that described above is mounted laterally adjacent a tip  102  of a conventional flexible endoscope, generally designated by  104 , by means of a visually transparent cap  106  having an interference fit with the tip. An actuation cable  110  extends rearward beside the endoscope  104 . The cable  110  includes a grip (not shown) at its end opposite the cartridge  100  for pulling the cable to actuate the cartridge advancing a staple  30  and applying it to tissue. 
         [0027]    As will be further appreciated by those skilled in the art, the cartridges  22 ,  100  described above allow a surgeon to perform a method of approximating mucosa in a hollow body organ. The cartridge is positioned adjacent the tissue, and the cartridge is actuated to advance a staple  30  into position so its points  40  extend from the cartridge. In one embodiment, it is envisioned that the staple  30  may be partially deformed so the points  40  are slightly angled toward each other. The surgeon advances the cartridge, sticking one of the points into the mucosal tissue near one edge of the wound. The device is manipulated, such as with a remote steering device or in the case of the second embodiment by manipulating the endoscope, so that the opposite side of the wound is engaged by the opposite staple tip  40 . The cartridge is then fully actuated to complete the staple formation. In so doing, the two edges of the wound are drawn together and into a position in which the wound is closed so healing can occur. 
         [0028]    Mucosa in a hollow body organ may be approximated using another method. An flexible endoscope is placed in the hollow body organ, such as a stomach. For example, the endoscope is inserted through the esophagus and into the stomach. A guide wire is placed into the jejunum, using conventional guide wire techniques, and the endoscope is removed from the patient. A cartridge  22  is inserted into the patient, using the guide wire as an insertion guide. The endoscope is inserted into the patient following the shaft  24  of the stapler  20 , and the guide wire is withdrawn. A conventional tissue grasping end effector or grasper is inserted through a working channel of the endoscope into the patient. The grasper is used to close the tissue near the inner edges of the mucosal wound to bring the edges into close approximation. Then the cartridge  22  is positioned over the approximated mucosal tissue edges. The trigger  62  of the stapler  20  is actuated to advance a staple  30  from the cartridge  22  and into the approximated edges. The trigger  62  is further actuated to close the staple  30 , closing the wound and allowing healing to proceed. 
         [0029]    Another method of using the device includes closing a full thickness wound such as a gastrotomy. The stapler may work in conjunction with an end effector intended for grasping or manipulating tissue, such as a grasper extending through a working channel of a conventional endoscope. The grasper extends from the end of the endoscope generally parallel to the stapler  100 . In alternate embodiments, the tissue manipulating device may be a singe needle device formed as a corkscrew or a two needle device having curved needles extending in generally opposite directions. The tissue manipulating device is advanced and activated to engage the tissue near the full thickness wound. In one embodiment, the device is inserted into the wound so it engages both sides of the wound, fully through the thickness of the wound. The two edges are manipulated to bring the two edges close together. The cartridge  100  is actuated so a staple is deployed to secure the edges of the wound together. A plurality of staples  30  may be applied in this way to provide closure to the wound and to allow healing to proceed. 
         [0030]    As will be appreciated by those skilled in the art, the devices described above permit a surgeon to complete mucosal resections and closures within the esophagus, stomach and colon. Further, wounds in the stomach may be repaired using a stapling device without making an incision. Tissue in the digestive tract may be approximated or remodeled without making an incision. Still further, tissue may be repaired in the abdominal cavity by making an incision in the gastric wall rather than in the abdominal wall. In addition, the offset cap attachment provided in the device  100  of the second embodiment allows visual confirmation of staple placement through the corresponding endoscope. 
         [0031]    When introducing elements of the present invention or the preferred embodiment(s) thereof, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. 
         [0032]    As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.