Patent Publication Number: US-2019192161-A1

Title: Surgical stapling device with lockout system for preventing actuation in the absence of an installed staple cartridge

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation application claiming priority under 35 U.S.C. § 120 to U.S. patent application Ser. No. 14/746,305, entitled SURGICAL STAPLING DEVICE WITH LOCKOUT SYSTEM FOR PREVENTING ACTUATION IN THE ABSENCE OF AN INSTALLED STAPLE CARTRIDGE, filed Jun. 22, 2015, now U.S. Patent Application Publication No. 2015/0289874, which is a continuation application claiming priority under 35 U.S.C. § 120 to U.S. patent application Ser. No. 13/429,647, entitled SURGICAL STAPLING DEVICE WITH LOCKOUT SYSTEM FOR PREVENTING ACTUATION IN THE ABSENCE OF AN INSTALLED STAPLE CARTRIDGE, filed Mar. 26, 2012, which issued on Jul. 14, 2015 as U.S. Pat. No. 9,078,653, the entire disclosures of which are hereby incorporated by reference herein. 
    
    
     BACKGROUND 
     The present invention relates to surgical instruments and, in various embodiments, to surgical cutting and stapling instruments and staple cartridges therefor that are designed to cut and staple tissue. 
     SUMMARY 
     In accordance with at least one general form, there is provided a surgical stapling instrument that includes an end effector that has an elongate channel that is configured to operably support a surgical staple cartridge therein. An anvil is movably supported on the elongate channel between an open position and closed positions in response to an application of opening and closing motions applied thereto. An anvil lock member cooperates with the anvil to retain the anvil in an open position when a staple cartridge has not been installed in the elongate channel and prevents the anvil from moving to a closed position until the staple cartridge has been seated within the elongate channel. 
     In accordance with at least one other general form, there is provided a surgical stapling instrument that includes a handle and an elongate shaft assembly that is operably coupled to the handle. A closure system is operably supported by the handle for generating closing and opening motions in response to actuation of a closure trigger operably supported by the handle. The instrument further includes an elongate channel that is coupled to the elongate shaft assembly. The instrument also includes an anvil that has an anvil mounting portion that is movably supported on the elongate channel between an open position and closed positions in response to applications of opening and closing motions transmitted thereto through the elongate shaft assembly. An anvil lock member is operably supported by the elongate shaft assembly for movable engagement with the anvil mounting portion. A surgical staple cartridge is configured to be seated within the elongate channel and cooperates with the anvil mounting portion such that when the surgical staple cartridge has not been seated within the elongate channel, the anvil lock member cooperates with the anvil mounting portion to retain the anvil in the open position. In addition, when the surgical staple cartridge is seated within the elongate channel, the staple cartridge moves the anvil mounting portion to a position wherein the anvil may be closed upon application of the closure motions thereto. 
     In accordance with still another general form, there is provided a surgical staple cartridge for use with a surgical stapling instrument including an end effector with an anvil that is supported in an open position until moved to an actuatable position wherein the anvil is movable to closed positions in response to a closing motion applied thereto by a closure system. In at least one form, the surgical staple cartridge comprises a cartridge body that is sized to be removably seated within a portion of the end effector such that a portion of the cartridge body contacts the anvil to move the anvil from the open position to the actuatable position when seated within the end effector. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein: 
         FIG. 1  is a perspective view of a surgical stapling instrument embodiment; 
         FIG. 2  is an exploded assembly view of the surgical stapling instrument of  FIG. 1 ; 
         FIG. 3  is an exploded assembly view of a portion of an articulation assembly embodiment; 
         FIG. 4  is a partial exploded perspective view of a portion of the handle; 
         FIG. 5  is a side view of the handle with a handle case removed; 
         FIG. 6  is a partial exploded perspective view of an end effector and anvil lock embodiment; 
         FIG. 6A  is a partial exploded perspective view of another end effector and anvil lock member embodiment; 
         FIG. 7  is a perspective view of an anvil lock member embodiment; 
         FIG. 7A  is a perspective view of an anvil lock member embodiment of  FIG. 6A ; 
         FIG. 8  is a side elevational view of an end effector embodiment in an open position; 
         FIG. 9  is a top view of the end effector of  FIG. 8 ; 
         FIG. 10  is a bottom view of the end effector depicted in  FIGS. 8 and 9 ; 
         FIG. 11  is a partial bottom perspective view of an anvil embodiment; 
         FIG. 12  is a perspective view of a pivot mount embodiment; 
         FIG. 13  is a bottom perspective view of the pivot mount embodiment of  FIG. 12 ; 
         FIG. 14  is a perspective view of a proximal end portion of a surgical staple cartridge embodiment; 
         FIG. 15  is a side elevational view of the surgical staple cartridge embodiment depicted in  FIG. 14 ; 
         FIG. 16  is a side view of an end effector embodiment prior to seating a staple cartridge in the elongate channel; 
         FIG. 17  is a cross-sectional view of the end effector depicted in  FIG. 16 ; 
         FIG. 18  is a side view of an end effector embodiment of  FIGS. 16 and 17  with the anvil in the open position and wherein a surgical staple cartridge is being inserted into the elongate channel; 
         FIG. 19  is a cross-sectional view of the end effector of  FIG. 18 ; 
         FIG. 20  is a side view of the end effector of  FIGS. 16-19  with the staple cartridge embodiment seated within the elongate channel; 
         FIG. 21  is a cross-sectional view of the end effector of  FIG. 20 ; 
         FIG. 22  is a side elevational view of the end effector of  FIGS. 16-22  clamping tissue; 
         FIG. 23  is a cross-sectional view of the end effector of  FIG. 22 ; 
         FIG. 24  is a side elevational view of the end effector of  FIGS. 16-23  in a fully clamped position ready to fire; 
         FIG. 25  is a cross-sectional view of the end effector of  FIG. 24 ; 
         FIG. 26  is an exploded assembly view of another surgical stapling instrument embodiment; 
         FIG. 27  is a perspective view of another pivot mount embodiment; 
         FIG. 28  is a bottom perspective view of the pivot mount embodiment of  FIG. 27 ; 
         FIG. 29  is a partial exploded perspective view of an end effector and another anvil lock member embodiment; 
         FIG. 30  is a perspective view of another anvil lock member embodiment; 
         FIG. 31  is a partial side elevational view of a proximal end portion of another surgical staple cartridge embodiment; 
         FIG. 32  is a perspective view of a proximal end portion of the surgical staple cartridge embodiment of  FIG. 31 ; 
         FIG. 33  is a side view of another end effector embodiment prior to seating a staple cartridge in the elongate channel; 
         FIG. 34  is a cross-sectional view of the end effector depicted in  FIG. 33 ; 
         FIG. 35  is a side view of an end effector embodiment of  FIGS. 33 and 34  with the anvil in the open position and wherein a surgical staple cartridge is being inserted into the elongate channel; 
         FIG. 36  is a cross-sectional view of the end effector of  FIG. 35 ; 
         FIG. 37  is a side view of the end effector of  FIGS. 33-36  with the staple cartridge embodiment seated within the elongate channel; 
         FIG. 38  is a cross-sectional view of the end effector of  FIG. 37 ; 
         FIG. 39  is a side elevational view of the end effector of  FIGS. 33-38  clamping tissue; 
         FIG. 40  is a cross-sectional view of the end effector of  FIG. 39 ; 
         FIG. 41  is a side elevational view of the end effector of  FIGS. 33-40  in a fully clamped position ready to fire; and 
         FIG. 42  is a cross-sectional view of the end effector of  FIG. 41 . 
     
    
    
     DETAILED DESCRIPTION 
     Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the various embodiments of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention. 
     Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment”, or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment”, or “in an embodiment”, or the like, in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation. Such modifications and variations are intended to be included within the scope of the present invention. 
     The terms “proximal” and “distal” are used herein with reference to a clinician manipulating the handle portion of the surgical instrument. The term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “up”, and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute. 
     Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the person of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein can be used in numerous surgical procedures and applications including, for example, in connection with open surgical procedures. As the present Detailed Description proceeds, those of ordinary skill in the art will further appreciate that the various instruments disclosed herein can be inserted into a body in any way, such as through a natural orifice, through an incision or puncture hole formed in tissue, etc. The working portions or end effector portions of the instruments can be inserted directly into a patient&#39;s body or can be inserted through an access device that has a working channel through which the end effector and elongate shaft of a surgical instrument can be advanced. 
     Turning to the Drawings wherein like numerals denote like components throughout the several views,  FIGS. 1 and 2  depict a surgical stapling device  10  that is capable of practicing the unique benefits of various embodiments disclosed herein. An exemplary surgical device that has features with which embodiments of the present invention may be effectively employed is disclosed in U.S. Pat. No. 5,704,534, entitled ARTICULATION ASSEMBLY FOR SURGICAL INSTRUMENTS, issued Jun. 6, 1998, the entire disclosure of which is herein incorporated by reference. Various other exemplary surgical stapling device embodiments are described in greater detail in the following U.S. Patents which are each herein incorporated by reference in their respective entireties: U.S. Pat. No. 6,964,363, entitled SURGICAL STAPLING INSTRUMENT HAVING ARTICULATION JOINT SUPPORT PLATES FOR SUPPORTING A FIRING BAR, issued Nov. 15, 2005; U.S. Pat. No. 7,000,818, entitled SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING MOTIONS, issued Feb. 21, 2006; U.S. Pat. No. 7,044,352, entitled SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING, issued May 16, 2006; U.S. Pat. No. 7,111,769, entitled SURGICAL INSTRUMENT INCORPORATING AN ARTICULATION MECHANISM HAVING ROTATION ABOUT THE LONGITUDINAL AXIS, issued Sep. 26, 2006; and U.S. Pat. No. 7,143,923, entitled SURGICAL STAPLING INSTRUMENT HAVING A FIRING LOCKOUT FOR AN UNCLOSED ANVIL, issued Dec. 5, 2006. 
     Referring again to  FIGS. 1 and 2 , the depicted surgical stapling device  10  includes a handle  20  that is operably connected to an implement portion  22 , the latter further comprising an elongate shaft assembly  30  that is operably coupled to an end effector  200 . The handle  20  includes a pistol grip  24  toward which a closure trigger  152  is pivotally drawn by the clinician to cause clamping, or closing of an anvil  220  toward an elongate channel  210  of the end effector  200 . A firing trigger  102  is farther outboard of the closure trigger  152  and is pivotally drawn by the clinician to cause the stapling and severing of clamped tissue in the end effector  200 . 
     For example, closure trigger  152  is actuated first. Once the clinician is satisfied with the positioning of the end effector  200 , the clinician may draw back the closure trigger  152  to its fully closed, locked position proximate to the pistol grip  24 . Then, the firing trigger  102  is actuated. The firing trigger  102  springedly returns when the clinician removes pressure. A release button  120  when depressed on the proximal end of the handle  20  releases the locked closure trigger  152 . 
     Articulation System 
     The depicted embodiment include an articulation assembly  62  that is configured to facilitate articulation of the end effector  200  about the elongate axis A-A of the device  10 . Various embodiments, however, may also be effectively employed in connection with non-articulatable surgical stapling devices. As can be seen in  FIG. 2 , for example, the elongate shaft assembly  30  includes a proximal closure tube segment  151  that is operably supported by a nozzle  60  that is supported on the handle  20 . The handle  20  may be formed from two handle cases  21 ,  23  that operably contain firing and closure systems  100 ,  150 . A proximal end portion  153  of the proximal closure tube segment  151  is rotatably supported by the handle  20  to facilitate its selective rotation about the elongate axis A-A. See  FIG. 1 . As can also be seen in  FIGS. 1 and 2 , in at least one embodiment, a distal end portion  157  of the proximal closure tube segment  151  is coupled to a flexible neck assembly  70 . The flexible neck assembly  70  has first and second flexible neck portions,  72  and  74 , which receive first and second elongate flexible transmission band assemblies  83 ,  85 . The first and second transmission band assemblies  83 ,  85  have exterior reinforcement band portions  86 ,  87 , respectively, extending distally from the structural portions of the bands. Each exterior reinforcement band portion  86 ,  87  has a plurality of attachment lugs  88  for securing first and second interior articulation bands  89 ,  90 . See  FIG. 2 . The transmission band assemblies  83 ,  85  may be, for example, composed of a plastic, especially a glass fiber-reinforced amorphous polyamide, sold commercially under the trade name Grivory GV-6H by EMS-American Grilon. In contrast, it may be desired that the interior articulation bands  89 ,  90  of the transmission band assemblies  83 ,  85  be composed of a metal, advantageously full hard 301 stainless steel or its equivalent. The attachment lugs  88  on the exterior reinforcement band portions  86 ,  87  of the transmission bands  83 ,  85  are received into and secured within a plurality of lug holes  91  on the corresponding interior articulation band  89 ,  90 . At the distal end of the first and second interior articulation band assemblies  89 ,  90  there are first and second connectors  92 ,  93 . The articulation assembly further comprises distal articulation bands  96  and  97  that are configured to hookingly engage the first and second connectors  92 ,  93 , respectively. The articulation bands  96  and  97  have receptacles  98 ,  99  to couple the bands  96 ,  97  to the end effector  200  as will be discussed in further detail below. 
     In at least one form, the flexible neck assembly  70  is preferably composed of a rigid thermoplastic polyurethane sold commercially as ISOPLAST grade  2510  by the Dow Chemical Company. As can be seen in  FIG. 3 , the flexible neck assembly  70  has first and second flexible neck portions  72 ,  74 . These neck portions  72 ,  74  are separated by a central longitudinal rib  73 . See  FIG. 6 . The neck portions  72 ,  74  each have a plurality of neck ribs  75  configured essentially as semi-circular disks. The flexible neck portions  72 ,  74  together generally form a cylindrical configuration. A side slot  76  extends through each of the neck ribs  75  to provide a passage through the first and second flexible neck portions  72 ,  74  for receiving the interior articulation bands  89 ,  90  and exterior reinforcement band portions  86 ,  87  of the flexible band assemblies  83 ,  85 . In a similar fashion, the central longitudinal rib  73  separating the first and second flexible neck portions  72 ,  74  has a central longitudinal slot for providing a passage to receive the stapler actuating members. Extending proximally from the first and second flexible neck portions  72 ,  74  are first and second support guide surfaces  77 ,  78  for supporting the reciprocating movement of the interior articulation bands  89 ,  90  and the exterior reinforcement portions  86 ,  87  of the flexible transmission band assemblies  83 ,  85 . Extending from the distal end of the flexible neck portions  72 ,  74  is a channel guide  79  for guiding the movement of the stapler actuating members into a staple cartridge  300  of the end effector  200  as will be further discussed below. 
     In at least one form, when the first and second transmission band assemblies  83 ,  85  are brought into contact with each other during assembly of the instrument  10 , they form an elongate cylinder which has a longitudinal cavity through it that is concentrically positioned between the band assemblies  83 ,  85  for the passage of a firing rod  110 . The proximal ends of the first and second bands have first and second gear racks  94 ,  95  which, as will be discussed below, meshingly engage an articulation assembly  62 . 
     Upon rotation of the articulation assembly  62 , one of the first and second flexible transmission band assemblies is moved forwardly and the other band assembly is moved rearwardly. In response to the reciprocating movement of the band assemblies  83 ,  85  within the first and second flexible neck portions  72 ,  74  of the flexible neck assembly  70 , the flexible neck assembly  70  bends to provide articulation. As can be seen in  FIG. 5 , an articulation assembly  62  includes an actuator  63 , an articulation body  64  and the nozzle  60 . Rotational movement of the actuator  63  causes corresponding rotation of the articulation body  64  within the nozzle  60 . The first and second elongate transmission band assemblies  83 ,  85 , consequently reciprocate axially in opposite directions parallel to the longitudinal axis A-A of the endoscopic shaft  30  of the stapling device  10  to cause the remote articulation of the end effector  200  through the flexible neck assembly  70 . The articulation body  64  further includes a drive gear  65  thereon. As can be seen in  FIG. 4 , the drive gear  65  has a flared opening  66  through it, and a lower pivot  67 . Within the flared opening  66  of the drive gear  65 , there is a firing rod orifice  68  for receiving the firing rod  110  enabling the firing of staples into the clamped tissue in response to pivotal rotation of the firing trigger  102 . The drive gear  65  is supported for meshing engagement with the first and second drive racks  94 ,  95  on the flexible elongate transmission band assemblies  83 ,  85  to effect the desired reciprocating movement of the band assemblies  83 ,  85 . 
     As can be seen in  FIG. 5 , the nozzle  60  of the articulation assembly  62  has a nozzle body  61 . The nozzle body  61  has an axial bore  69  extending through it for receiving the drive gear  65  of the articulation body  64 . The bore  69  provides a continuous opening axially from the frame into the elongate endoscopic shaft  30  and therefore the firing rod  110  and other operative components of the stapling device  10  can communicate with the end effector  200 . Further details relating to the articulation assembly  62  may be found in U.S. Pat. No. 5,704,534, which has been previously herein incorporated by reference. 
     Closure System 
     As will be discussed in further detail below, the end effector  200  comprises an elongate channel  210  that is configured to operably receive a surgical staple cartridge  300 . An anvil  220  is movably supported relative to the elongate channel  210  and is moved from an open position ( FIGS. 16 and 17 ) to closed positions wherein tissue may be cut and stapled ( FIGS. 24 and 25 ). The movement of the anvil  220  between open and closed positions is at least partially controlled by a closure system, generally designated as  150 , which, as indicated above, is controlled by the closure trigger  152 . The closure system  150  includes the proximal closure tube segment  151  that operably houses the articulation band assemblies  83 ,  85  in the manner discussed above and which is non-movably coupled to the flexible neck assembly  70 . 
     In various forms, the proximal closure tube segment  151  includes a proximal end portion  153  that axially extends through the bore  69  in the nozzle  60 . The proximal closure tube segment  151  has elongate axial slots  155  therethrough to permit the articulation body  64  to extend therethrough. See  FIG. 2 . The slots  155  enable the articulation body  64  to rotate about articulation axis B-B relative to the proximal closure tube segment  151  while facilitating the axial movement of the proximal closure tube segment  151  along axis A-A relative to articulation body  64 . The transmission bands  83 ,  85  function as a frame upon which the proximal closure tube segment  151  can axially move. The proximal end  153  of the proximal closure tube segment  151  is rotatably coupled to a closure yoke  154  that is supported within the handle  20  for reciprocating motion therein. See  FIGS. 4 and 5 . 
     The closure trigger  152  has a handle section  156 , a gear segment section  158  and an intermediate section  160 . See  FIG. 5 . A bore extends through the intermediate section  160 . A cylindrical support member  162  extending from the second handle housing  23  passes through the bore for pivotably mounting the closure trigger  152  on the handle portion  20 . A proximal end  98  of the closure yoke  154  has a gear rack  164  that is engaged by the gear segment section  158  of the closure trigger  152 . When the closure trigger  152  is moved toward the pistol grip  24  of the handle portion  20 , the closure yoke  154  and, hence, the proximal closure tube segment  151  move distally, compressing a spring  166  that biases the closure yoke  152  proximally. 
     In at least one form, the closure system  150  further includes a distal closure tube segment  170  that is non-movably coupled to the channel guide portion  79  of the flex neck assembly  70  by attachment tabs  72 ,  74 . See  FIGS. 9 and 10 . The distal closure tube segment  170  has an opening  176  therein that is adapted to interface with an upstanding tab  224  formed on the anvil  220  as will be discussed in further detail below. Thus, axial movement of the proximal closure tube segment  151  results in axial movement of the flex neck assembly  70 , as well as the distal closure tube segment  170 . For example, distal movement of the proximal closure tube segment  151  effects pivotal translation movement of the anvil  220  distally and toward the elongate channel  210  of the end effector  200  and proximal movement effects opening of the anvil  220  as will be discussed in further detail below. 
     Firing System 
     In at least one form, the surgical instrument  10  further includes a firing system, generally designated as  100 , for applying firing motions to the firing rod  110  in response to actuation of the firing trigger  102 . In at least one form, the firing system  100  further includes a drive member  104  that has first and second gear racks  105 ,  106  thereon. A first notch  109  is provided on the drive member  105  intermediate the first and second gear racks  105 ,  106 . During return movement of the firing trigger  102 , a tooth  112  on the firing trigger  102  engages with the first notch  109  for returning the drive member  104  to its initial position after staple firing. A second notch  114  is located at a proximal end of the firing rod  110  for locking the firing rod  110  to an upper latch arm  122  of the release button  120  in its unfired position. The firing system  150  further includes first and second integral pinion gears  111 ,  113 . The first integral pinion gear  111  is engaged with a drive rack  115  provided on the firing rod  110 . The second integral pinion gear  113  is engaged with the first gear rack  105  on the drive member  104 . The first integral pinion gear  111  has a first diameter and the second integral pinion gear  113  has a second diameter which is smaller than the first diameter. 
     In various embodiments, the firing trigger  102  is provided with a gear segment section  103 . The gear segment section  103  engages the second gear rack  106  on the drive member  104  such that motion of the firing trigger  102  causes the drive member  104  to move back and forth between first and second drive positions. In order to prevent staple firing before tissue clamping has occurred, the upper latch arm  122  on the release button  120  is engaged with the second notch  114  on the drive rack  115  such that the firing rod  110  is locked in its proximal-most position. When the upper latch arm  122  falls into a recess in the closure yoke, the upper latch arm  122  disengages with the second notch  114  to permit distal movement of the firing rod  110 . Because the first gear rack  105  on the drive member  104  and the drive rack  115  on the firing rod  110  are engaged, movement of the firing trigger  102  causes the firing rod  110  to reciprocate between a first reciprocating position and a second reciprocating position. Further details concerning various aspects of the firing system  150  may be gleaned from reference to U.S. Pat. No. 7,000,818 which has been herein incorporated by reference in its entirety. 
     As can be seen in  FIG. 3 , various embodiments, the distal end  117  of the firing rod  110  is rotatably received within a firing bar mounting yoke  118 . The firing bar mounting yoke  118  has a slot  119  for hookingly receiving a hook  132  formed on a proximal end of a knife bar  130 . In addition, as shown in  FIG. 3 , a support bar  140  is supported for axial movement between the first and second support guide surfaces  77 ,  78  of the flex neck assembly  70 . The support bar  140  has a slot  142  that is configured to permit the knife bar  130  to slidably pass therethrough. The metal knife bar  130  has a tissue cutting edge  134  formed on its distal end and is configured to operably interface with a wedge sled operably supported within a surgical staple cartridge  300 . 
     End Effector 
     As discussed above, in at least one form, an end effector  200  includes an elongate channel  210  that is configured to operably support a surgical staple cartridge  300  therein. As shown in  FIGS. 2 and 6 , the elongate channel  210  has a proximal end portion that includes two spaced mounting tabs  212  that are configured to be engaged by the hooks  998 ,  99  on the distal ends of the articulation bands  96 ,  97 . Thus, the reciprocating motions of the articulation bands  96 ,  97  cause the elongate channel  210  to articulate relative to the flex neck assembly  70 . As further indicated above, the end effector  200  also includes an anvil  220 . In at least one form, the anvil  220  is fabricated from, for example, 416 Stainless Steel Hardened and Tempered RC35 Min (or similar material) and has a staple-forming undersurface  222  thereon that is configured for confronting engagement with the staple cartridge  300  when mounted in the elongate channel  210 . The anvil  220  is formed with a proximally extending mounting portion  223  that includes two trunnion walls  226 ,  228  that each has a trunnion  30  protruding therefrom. See  FIG. 11 . In addition, formed on the underside  232  of the mounting portion  223  is a downwardly protruding pivot tab  234  that has a slot  236  extending therethrough that is configured to receive and support the knife bar  130  as it is axially advanced through the end effector  200  during cutting and stapling. In addition, the anvil opening tab  224  is formed on the mounting portion  223  such that it can operably interface with the opening  176  in the distal closure tube segment  170  as will be further discussed below. As can be seen in  FIGS. 16-25 , the anvil trunnions  230  are configured to be movably received in corresponding trunnion slots  214  formed in the proximal end of the elongate channel  210 . Each trunnion slot  214  has an arcuate segment  216  that communicates with a locking notch  218 . 
     To facilitate pivotal travel of the anvil mounting portion  223  relative to the elongate channel  210 , various embodiments include a pivot mount  240 . As can be in  FIGS. 12 and 13 , one form of a pivot mount  240  has a body portion  242  that is configured to be attached to the elongate channel  210 . For example, the body portion  242  may be formed with two opposed attachment tabs  243  that are configured to retainingly engage tab openings  211  ( FIG. 6 ) formed in the elongate channel  210 . In addition, the pivot mount  240  has a proximally extending foot portion  244  that has a retainer lug  245  protruding therefrom that is configured to be received in a corresponding opening  211  in the elongate channel  210 . See  FIG. 17 . The pivot mount  240  may be fabricated from, for example, Vectra A435 Liquid Crystal Polymer—natural or similar materials. As can be further seen in  FIGS. 12 and 13 , the body portion  242  has an upstanding central portion  246  that has a slot  247  extending therethrough for axially receiving the knife bar  130 . The central portion  246  provides lateral support to the knife bar  130  as it is driven through tissue clamped within the end effector  200 . Various embodiments of the pivot mount  240  further include rocker surfaces  248  formed on each side of the central portion  246  for pivotally receiving the trunnion walls  226 ,  228  of the anvil  220  thereon. 
     Anvil Lockout System 
     Various embodiments include a unique and novel anvil lockout system  250  that prevents closure of the anvil  220  when a staple cartridge  300  has not been properly installed in the elongate channel  210 . Referring to  FIGS. 6 and 7 , for example, an embodiment of an anvil lockout system  250  includes a movable anvil lock member  260  that is movable in response to contact by a portion or portions of a staple cartridge  300  as will be discussed in further detail below. In at least one form, the anvil lock member  260  comprises a body portion  262  that has a distally protruding central support tab  264  formed thereon. A slot  266  extends through body portion  262  and the central support tab  264  to enable the knife bar  130  to pass therethrough. The body portion  262  further includes proximally extending mounting bar  268  that is configured to be slidably received within a corresponding mounting opening  270  in the channel guide  79  of the flex neck assembly  70 . In addition, a biasing member in the form of, for example, a coil spring  269  is supported within the opening  270  to bias the anvil lock member  260  in the distal direction “DD”. See  FIG. 16 . When the anvil  220  is mounted to the elongate channel  210 , the trunnions  230  are received within their corresponding trunnion slots  214  in the elongate channel  210 , the central support tab  264  of the anvil lock member  260  is received between the trunnion walls  226 ,  228  to further provide support to the anvil  220 . The body portion  262  of the anvil lock member  260  is further formed with two cam surfaces  263  configured to engage the proximal end surfaces  227 ,  229  of the trunnion walls  226 ,  228 . See  FIGS. 6 and 7 . Various embodiments of the anvil lock member may be fabricated from, for example, Vectra A435 Liquid Crystal Polymer—natural or similar materials. 
       FIGS. 6A and 7A  illustrate an alternative anvil lock member  260 ′ that is movable in response to contact by a portion or portions of a staple cartridge  300 . In at least one form, the anvil lock member  260 ′ comprises a body portion  262  that has a distally protruding central support tab  264  formed thereon. A slot  266  extends through body portion  262  and the central support tab  264  to enable the knife bar  130  to pass therethrough. The body portion  262  further includes proximally extending mounting bar  268 ′ that is configured to be slidably and retainably received within a corresponding mounting opening  270 ′ in the channel guide  79 ′ of the flex neck assembly  70 ′. In addition, a biasing member in the form of, for example, a coil spring  269  is supported within the opening  270 ′ to bias the anvil lock member  260 ′ in the distal direction “DD”. The anvil lock member  260 ′ otherwise operates in the same manner as anvil lock member  260 . When the anvil  220  is mounted to the elongate channel  210 , the trunnions  230  are received within their corresponding trunnion slots  214  in the elongate channel  210 , the central support tab  264  of the anvil lock member  260 ′ is received between the trunnion walls  226 ,  228  to further provide support to the anvil  220 . The body portion  262  of the anvil lock member  260  is further formed with two cam surfaces  263  configured to engage the proximal end surfaces  227 ,  229  of the trunnion walls  226 ,  228 . The distal closure tube segment  170 ′ operates in the same manner as the distal closure tube segment  170  described above. 
     Surgical Staple Cartridge 
     Various embodiments include a unique and novel surgical staple cartridge  300  that is configured to interact with the anvil lockout system  250  when installed in the elongate channel  210 . As can be seen in  FIGS. 14 and 15 , in at least one form, the surgical staple cartridge  300  includes a cartridge body  302  that may be fabricated from, for example, Vectra A435, 20% PTFE/15% GF—natural. The cartridge body  302  is sized and shaped to be received within the elongate channel  210 . In at least one form, the cartridge body  302  is configured to be seated in the elongate channel  210  such that is removably retained therein. The cartridge body  302  may be formed with a centrally disposed slot  304  therein for receiving the knife bar  130 . On each side of the slot  304 , there is provided rows  306 ,  308 ,  310  of staple openings  312  that are configured to support a surgical staple therein. In the depicted embodiment, three rows  306 ,  308 ,  310  are provided on each side of the slot  304 . The surgical staples may be supported on staple drivers that are movably supported within the staple openings  312 . Also supported within the staple cartridge body  302  is a wedge sled that is configured for axial movement through the cartridge body  302  when contacted by the cutting bar. The wedge sled is configured with wedge-shaped driving members that contact the staple drivers and drive the drivers and their corresponding staples toward the closed anvil as the wedge sled is driven distally through the cartridge body  302 . Examples of staple driver arrangements and wedge sled arrangements that may be employed are described in further detail in U.S. Pat. No. 7,669,746, the entire disclosure which is herein incorporated by reference. In various embodiments, to facilitate installation of the wedge sled and drivers in the cartridge body  302 , metal cartridge pans  314 ,  316  may be attached to the cartridge body  302  as shown in  FIGS. 14 and 15 . The cartridge pans  314  and  316  serve to retain the wedge sled and drivers within the cartridge body  302 . 
     In various embodiments, the cartridge body  302  additionally has at least one release member formed thereon that protrudes in the proximal direction. In the embodiment depicted in  FIG. 14 , two release members  320  are formed on the proximal end  319  of the cartridge  300 . The release members  320  each have a wedge shape that defines a sloped pivot surface  321  that are configured to pivotally support a portion of the anvil mounting portion  223  thereon. 
     Installation of a Staple Cartridge 
     An understanding of the operation of a anvil lockout system may be gleaned from reference to  FIGS. 16-25 .  FIGS. 16 and 17  illustrate the position of the anvil  220  relative to the elongate channel  210  prior to installing a staple cartridge  300 . When in that “unloaded” and open position, the anvil lock member  260  is biased in the distal direction by spring  269  such that the cam surfaces  263  on the anvil lock member  260  are in contact with the end surfaces  227 ,  229  of the trunnion walls  226 ,  228 . The anvil lock member  260  pushes the anvil mounting portion  223  in the distal direction “DD” such that the trunnions  230  are seated in their respective locking notch  218 . The cam surfaces  263  on the anvil lock member  260 , in cooperation with the end wall surfaces  227 ,  229 , also serve to pivot and retain the anvil in the open position as shown in  FIGS. 16 and 17 . As can be seen in  FIG. 16 , when in that position, the trunnion walls  226 ,  228  are supported on the rocker surfaces  248  on the pivot mount  240 . When in that position, the surgeon cannot close the anvil  220  by actuating the closure trigger  152  to advance the distal closure tube  170 . Because the closure tube segments cannot be advanced distally to close the anvil  220 , the closure trigger  152  cannot be actuated to its fully closed position whereby the firing trigger  102  may be actuated. Thus, when no cartridge  300  is present, the end effector  200  may not be actuated. 
       FIGS. 18 and 19  illustrate the initial insertion of the staple cartridge  300  into the elongate channel  210 .  FIGS. 20 and 21  illustrate the end effector  200  after the staple cartridge  300  has been fully seated in the elongate channel  210 . As can be seen in  FIG. 20  for example, when the cartridge  300  has been fully seated, the release members  320  on the cartridge  300  engage the trunnion walls  226 ,  228  and serve to move the anvil mounting portion  223  in a proximal direction “PD” such that the trunnion walls  226 ,  228  now pivotally rest on the release members  320 . As can be seen in  FIG. 21 , when in that position, the anvil mounting portion  223  has moved proximally such that the trunnions  230  are moved out of their respective locking notches  218  and into the bottom of the arcuate slot segment  216  into an “actuatable” position whereby the anvil  220  may be pivoted closed by actuating the closure trigger  152 . 
     When the device  10  is in the starting position and the staple cartridge  300  has been loaded into the elongate channel as described above, both of the triggers  152 ,  102  are forward and the anvil  220  has been moved to the actuatable position, such as would be typical after inserting the loaded end effector  200  through a trocar or other opening into a body cavity. The instrument  10  is then manipulated by the clinician such that tissue “T” to be stapled and severed is positioned between the staple cartridge  300  and the anvil  200 , as depicted in  FIGS. 22 and 23 . As discussed above, movement of the closure trigger  152  toward the pistol grip  24  causes the proximal closure tube segment  151 , the flex neck assembly  70  and the distal closure tube segment  170  to move distally. As the distal closure tube segment  170  moves distally, it contacts a closure ledge  221  on the anvil  220 . Pressure from the tissue captured between the anvil  220  and the staple cartridge  300  serves to move the anvil  220  such that the trunnions  230  are positioned to move within the arcuate trunnion slot segments  216 . The surgeon may pivot the anvil  220  relative to the staple cartridge  300  to manipulate and capture the desired tissue “T” in the end effector  200 . As the distal closure tube segment  170  contacts the closure ledge  221 , the anvil  220  is pivoted towards a clamped position. The retracted knife bar  130  does not impede the selective opening and closing of the anvil  220 . 
     Once the desired tissue “T” has been positioned between the anvil  220  and the cartridge  300 , the clinician moves the closure trigger  152  proximally until positioned directly adjacent to the pistol grip  24 , locking the handle  20  into the closed and clamped position. As can be seen in  FIG. 25 , when in the fully clamped position, the anvil trunnions  230  are located in the upper end of the arcuate slot portion  216  and the anvil tab  224  is received within the opening  176  in the distal closure tube segment  170 . After tissue clamping has occurred, the clinician moves the firing trigger  102  proximally causing the knife bar  130  to move distally into the end effector  200 . In particular, the knife bar  130  moves through the slot  236  in the pivot tab portion  234  of the anvil  220  and into the slot  304  in the cartridge body  302  to contact the wedge sled operably positioned within the staple cartridge  300 . As the knife bar  130  is driven distally, it cuts the tissue T and drives the wedge sled distally which causes the staples to be sequentially fired into forming contact with the staple-forming undersurface  222  of the anvil  220 . The clinician continues moving the firing trigger  102  until brought proximal to the closure trigger  152  and pistol grip  24 . Thereby, all of the ends of the staples are bent over as a result of their engagement with the anvil  220 . The cutting edge  132  has traversed completely through the tissue T. The process is complete by releasing the firing trigger  102  and by then depressing the release button  120  while simultaneously squeezing the closure trigger  152 . Such action results in the movement of the distal closure tube segment  170  in the proximal direction “D”. As the anvil tab  224  is engaged by the opening  176  in the distal closure tube segment  170  it causes the anvil to pivot open. The end surfaces  227 ,  229  again contact the pusher surfaces  263  on the anvil lock member  260  to pivot the anvil to the open position shown in  FIGS. 20 and 21  to enable the spent cartridge  300  to be removed from the elongate channel  210 . 
       FIGS. 26-42  illustrate an alternative surgical stapling instrument  10 ′ that is similar in construction and operation to surgical stapling instrument  10  except for the differences discussed below. This embodiment, for example, employs the pivot mount  240 ′ illustrated in  FIGS. 29 and 30 . As can be seen in  FIGS. 27 and 28  one form of a pivot mount  240 ′ has a body portion  242 ′ that is configured to be attached to the elongate channel  210 . For example, the body portion  242 ′ may be formed with two opposed attachment tabs  243 ′ that are configured to retainingly engage tab openings  211  ( FIG. 26 ) formed in the elongate channel  210 . In addition, the pivot mount  240 ′ has a proximally extending foot portion  244 ′ that has a slot  247 ′ extending therethrough for axially receiving the knife bar  130 . Various embodiments of the pivot mount  240 ′ further include rocker surfaces  248 ′ formed on the body portion  242 ′ for pivotally receiving the trunnion walls  226 ,  228  of the anvil  220  thereon. 
     This embodiment also includes an anvil lockout system  250 ′ that prevents closure of the anvil  220  when a staple cartridge  300 ′ has not been properly installed in the elongate channel  210 . Referring to  FIGS. 29 and 30 , for example, an embodiment of an anvil lockout system  250 ′ includes an anvil lock member  400  that is configured to contact the anvil mounting portion  223  as will be discussed in further detail below. In at least one form, the anvil lock member  400  comprises a leaf spring  402  that has a slot  404  therein for accommodating the knife bar  130 . The leaf spring  402  is configured for attachment to the channel guide  79 ″ of the flex neck assembly  70 ″. 
     As can be seen in  FIGS. 31 and 32 , in at least one form, the surgical staple cartridge  300 ′ includes a cartridge body  302 ′ that is similar to the surgical staple cartridge  300  described above, except for the differences discussed below.  FIG. 29  depicts a wedge sled  360  that is supported within the cartridge body  302 ′ in the manner described above. In this embodiment, the proximal end portion  303  of the cartridge body  302 ′ is configured to contact a portion of the anvil mounting portion  223  and urge the anvil  220  proximally when the cartridge body  302 ′ is seated within the elongate channel  210 . 
     An understanding of the operation of a anvil lockout system  250 ′ may be gleaned from reference to  FIGS. 33-43 .  FIGS. 33 and 34  illustrate the position of the anvil  220  relative to the elongate channel  210  prior to installing a staple cartridge  300 ′. When in that “unloaded” position, the anvil lock member  400  has engaged the upper surface of the anvil support portion  223  such that the anvil  220  is pivoted to the open position on the rocker surfaces  248 ′ on the pivot mount  140 ′. When in that position, the trunnions  230  are seated in their respective locking notch  218 . When in that position, the surgeon cannot close the anvil  220  by actuating the closure trigger  152  to advance the distal closure tube  170 ′. Because the closure tube segments cannot be advanced distally to close the anvil  220 , the closure trigger  152  cannot be actuated to its fully closed position whereby the firing trigger  102  may be actuated. Thus, when no cartridge  300 ′ is present, the end effector  200  may not be actuated. 
       FIGS. 35 and 36  illustrate the initial insertion of the staple cartridge  300 ′ into the elongate channel  210 .  FIGS. 37 and 38  illustrate the end effector  200  after the staple cartridge  300 ′ has been fully seated in the elongate channel  210 . As can be seen in  FIG. 37  for example, when the cartridge  300 ′ has been fully seated, the proximal end portion  303  on the cartridge  300 ′ engages the trunnion walls  226 ,  228  and serves to move the anvil mounting portion  223  in a proximal direction “PD” such that the trunnions are moved out of their respective locking notch  218  and into an actuatable position the bottom of the arcuate slot segment  216 . The anvil  220  is now in position to be pivoted closed by actuating the closure trigger  152 . 
     When the device  10 ′ is in the starting position and the staple cartridge  300 ′ has been loaded into the elongate channel  210  as described above, both of the triggers  152 ,  102  are forward and the anvil  220  is open and in the actuatable position, such as would be typical after inserting the loaded end effector  200  through a trocar or other opening into a body cavity. The instrument  10 ′ is then manipulated by the clinician such that tissue “T” to be stapled and severed is positioned between the staple cartridge  300 ′ and the anvil  220 , as depicted in  FIGS. 39 and 40 . As discussed above, movement of the closure trigger  152  toward the pistol grip  24  causes the proximal closure tube segment  151 , the flex neck assembly  70 ″ and the distal closure tube segment  170 ″ to move distally. As the distal closure tube segment  170 ′ moves distally, it contacts a closure ledge  221  on the anvil  220 . Pressure from the tissue captured between the anvil  220  and the staple cartridge  300 ′ serves to move the anvil  220  such that the trunnions  230  are positioned to move within the arcuate trunnion slot segments  216 . The surgeon may pivot the anvil  220  relative to the staple cartridge to manipulate and capture the desired tissue “T” in the end effector  200 . As the distal closure tube segment  170 ″ contacts the closure ledge  221 , the anvil  220  is pivoted towards a clamped position. The retracted knife bar  130  does not impede the selective opening and closing of the anvil  220 . 
     Once the desired tissue “T” has been positioned between the anvil  220  and the cartridge  300 ′, the clinician moves the closure trigger  152  proximally until positioned directly adjacent to the pistol grip  24 , locking the handle  20  into the closed and clamped position. As can be seen in  FIG. 42 , when in the fully clamped position, the anvil trunnions  230  are located in the upper end of the arcuate slot portion  216  and the anvil tab  224  is received within the opening  176  in the distal closure tube segment  170 ″. After tissue clamping has occurred, the clinician moves the firing trigger  102  proximally causing the knife bar  130  to move distally into the end effector  200 . In particular, the knife bar  130  moves through the slot  236  in the pivot tab portion  234  of the anvil  220  and into the slot  304  in the cartridge body  302 ′ to contact the wedge sled  360  operably positioned in therein. As the knife bar  130  is driven distally, it cuts the tissue T and drives the wedge sled  360  distally which causes the staples to be sequentially fired into forming contact with the staple-forming undersurface  222  of the anvil  220 . The clinician continues moving the firing trigger  102  until brought proximal to the closure trigger  152  and pistol grip  24 . Thereby, all of the ends of the staples are bent over as a result of their engagement with the anvil  220 . The cutting edge  132  has traversed completely through the tissue T. The process is complete by releasing the firing trigger  102  and by then depressing the release button  120  while simultaneously squeezing the closure trigger  152 . Such action results in the movement of the distal closure tube segment  170 ″ in the proximal direction “D”. As the anvil tab  224  is engaged by the opening  176  in the distal closure tube segment  170 ″, it causes the anvil  220  to pivot open. The anvil lock member  400  applies a biasing force to the upper surface of the trunnion walls of the anvil mounting portion  223  and serves to pivot the anvil to the open position shown in  FIGS. 33 and 34  to enable the spent cartridge  300 ′ to be removed from the elongate channel  210 . 
     The various unique and novel features of the above-described embodiments serve to prevent the end effector from being closed when a surgical staple cartridge is not present or has not been properly seated within the elongate channel. When the anvil is in the locked position wherein the anvil trunnions are retained in their respective locking notches, the anvil is retained in the open position. When in the open position, the end effector cannot be inadvertently inserted through a trocar. Because a full closure stroke is prevented, the firing system cannot be actuated. Thus, even if the clinician attempts to actuate the firing trigger, the device will not fire. Various embodiments also provide the clinician with feedback indicating that a cartridge is either not present or has not been properly installed in the elongate channel. 
     The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application. 
     Preferably, the invention described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. 
     Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. 
     While this invention has been described as having exemplary designs, the present invention may be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.