Patent Publication Number: US-2021177401-A1

Title: Surgical Stapler with Universal Tip Reload

Description:
FIELD 
     The disclosure is directed to surgical stapling devices and, more particularly, to endoscopic surgical stapling devices. 
     BACKGROUND 
     Surgical stapling devices for performing surgical procedures endoscopically are well known. Such devices are available in a variety of different configurations, e.g., linear, curved, circular, etc., and are suitable for use in a variety of different procedures. Linear surgical stapling devices include a tool assembly having an anvil and a staple cartridge that are pivotably coupled to each other at their proximal ends between open and clamped positions. In order to better navigate the tool assembly to a surgical site endoscopically, the tool assembly may include a dissector tip that extends from a distal end of the tool assembly. Typically, the dissector tip is supported on the tool assembly and is configured to separate target tissue from body tissue to facilitate placement of the tool assembly about the target tissue. During some surgical procedures, it is desirable to have an angled dissector tip whereas in other surgical procedures it is desirable to have a linear dissector tip. 
     A continuing need exists in the art for a surgical stapling device that is better suited to access to a variety of surgical sites. 
     SUMMARY 
     One aspect of this disclosure is directed a surgical stapler including an elongate body and a tool assembly. The elongate body has a proximal portion and a distal portion. The tool assembly defines a longitudinal axis and includes a cartridge assembly, an anvil assembly, and a dissector tip. The anvil assembly has a proximal portion and a distal portion and is coupled to the cartridge assembly such that the tool assembly is moveable from an open position to a clamped position. The dissector tip includes a body having a proximal end and a distal end. The body has a thickness that decreases towards the distal end. The body is movably coupled to the anvil assembly for movement between a first configuration substantially aligned with the longitudinal axis and a second configuration defining an acute angle with the longitudinal axis. 
     In aspects of the disclosure, the dissector tip includes a tip beam having a proximal portion and a deformable distal beam portion, wherein the deformable distal beam portion is bendable between the first and second configurations. 
     In some aspects of the disclosure, the distal portion of the anvil assembly includes a bracket and the proximal portion of the tip beam is secured to the bracket. 
     In certain aspects of the disclosure, the proximal portion of the tip beam is secured to the bracket of the anvil assembly by welding or other means (mechanical snap, adhesive, pin, etc). 
     In aspects of the disclosure, the dissector tip includes a tip beam cover that is supported on the deformable distal beam portion and has an atraumatic configuration. 
     In some aspects of the disclosure, the tip beam cover is formed of a biocompatible material selected from the group consisting of polymeric materials, metals, ceramics, and elastomeric materials. 
     In certain aspects of the disclosure, the dissector tip includes a body having a proximal portion and a distal portion, wherein the proximal portion includes a hinge portion that is pivotably coupled to the distal portion of the anvil assembly. 
     In aspects of the disclosure, the distal portion of the anvil assembly includes a clevis and the hinge portion is coupled to the clevis by a clevis pin. 
     In some aspects of the disclosure, the tool assembly includes retaining structure configured to retain the dissector tip in one of the first and second configurations. 
     In certain aspects of the disclosure, the retaining structure includes a protrusion formed on one of the distal portion of the anvil assembly or the proximal portion of the dissector tip and a plurality of recesses formed on the other of the distal portion of the anvil assembly or the proximal portion of the dissector tip. 
     In one aspect of the disclosure, the dissector tip has a width that decreases towards the distal end of the dissector tip. 
     Another aspect of the disclosure is directed to a tool assembly including a cartridge assembly, an anvil assembly, and a dissector tip. The anvil assembly includes a proximal portion and a distal portion and is coupled to the cartridge assembly such that the tool assembly is moveable from an open position to a clamped position. The tool assembly defines a longitudinal axis. The dissector tip includes a body having a proximal end and a distal end and has a thickness that decreases towards the distal end. The body is movably coupled to the anvil assembly for movement between a first configuration substantially aligned with the longitudinal axis and a second configuration defining an acute angle with the longitudinal axis. 
     Another aspect of the disclosure is directed to a tool assembly defining a longitudinal axis and including a cartridge assembly, an anvil assembly, and a dissector tip. The anvil assembly includes a base portion and an anvil portion. The base portion is coupled to the cartridge assembly such that the tool assembly is moveable from an open position to a clamped position. The anvil portion is secured to the base portion and includes a plurality of staple deforming pockets. The anvil portion includes a distal portion supporting a bracket. The dissector tip includes a body having a tapered distal surface and a thickness that decreases in the distal direction. The body is movably coupled to the anvil assembly for movement between a first configuration substantially aligned with the longitudinal axis and a second configuration defining an acute angle with the longitudinal axis. The body of the dissector tip includes a tip beam having a proximal portion and a deformable distal beam portion. The proximal portion of the dissector tip is secured to the bracket of the anvil assembly and the deformable distal beam portion is bendable between the first and second configurations. 
     Other features of the disclosure will be appreciated from the following description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various aspects of the disclosed surgical stapling device are described herein below with reference to the drawings, wherein: 
         FIG. 1  is a side perspective view of exemplary aspects of the disclosed surgical stapling device including a reload assembly with a universal tip; 
         FIG. 2  is an enlarged view of the indicated area of detail shown in  FIG. 1 ; 
         FIG. 3  is a perspective bottom view of an anvil assembly of the reload assembly of the surgical stapling device shown in  FIG. 1 ; 
         FIG. 4  is an exploded, perspective view of the anvil assembly shown in  FIG. 3 ; 
         FIG. 5  is an enlarged cutaway, perspective view of a distal portion of an anvil body and tip beam of the anvil assembly shown in  FIG. 4 ; 
         FIG. 6  is a side perspective view of a tool assembly of the reload assembly shown in  FIG. 1  in a clamped position; 
         FIG. 7  is a cross-sectional view taken along section line  7 - 7  of  FIG. 6  with the anvil tip in a first position; 
         FIG. 8  is a cross-sectional view taken along section line  7 - 7  of  FIG. 6  with the anvil tip in a second position; 
         FIG. 9  is a cross-sectional view taken along section line  7 - 7  of  FIG. 6  with the anvil tip in a third position; 
         FIG. 10  is a side view of other exemplary aspects of a tool assembly of the reload assembly of the stapling device shown in  FIG. 1  with the tool assembly in the clamped position; 
         FIG. 11  is an enlarged side perspective view of a distal end of the tool assembly shown in  FIG. 10  with the tool assembly in the clamped position; 
         FIG. 12  is a side perspective, exploded view of the anvil assembly of the tool assembly shown in  FIG. 10 ; 
         FIG. 13  is an enlarged view of the distal end of the anvil base of the anvil assembly shown in  FIG. 10 ; 
         FIG. 14  is a perspective view from the proximal end of the dissector tip of the anvil assembly shown in  FIG. 11 ; 
         FIG. 15  is a cross-sectional view taken along section line  15 - 15  of  FIG. 11  with the dissector tip in a first position; and 
         FIG. 16  is a cross-sectional view taken along section line  15 - 15  of  FIG. 11  with the dissector tip in a second position. 
     
    
    
     DETAILED DESCRIPTION 
     The disclosed surgical stapling device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that the aspects of the disclosure described herein are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure. 
     In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician. In addition, the term “endoscopic” is used generally to refer to endoscopic, laparoscopic, arthroscopic, and/or any other procedure conducted through a small diameter incision or cannula. Further, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel. As used herein, the terms “parallel” and “aligned” are understood to include relative configurations that are substantially parallel, and substantially aligned, i.e., up to about + or −10 degrees from true parallel or true alignment. 
     The disclosed surgical stapling device includes a tool assembly that supports a dissector tip that is adjustable to allow a clinician to position the dissector tip in a configuration that facilitates easy access to a surgical site. Some aspects of the disclosure are directed to a dissector tip that is bendable between a first orientation in which an axis defined by dissector tip is parallel to a longitudinal axis of the tool assembly and a second position in which the axis defined by the dissector tip defines an acute angle with the longitudinal axis of the tool assembly. Other aspects of the disclosure are directed to a dissector tip that is pivotable between a first orientation in which the axis defined by the dissector tip is parallel to a longitudinal axis of the tool assembly and a second position in which the axis defined by the dissector tip defines an acute angle with the longitudinal axis of the tool assembly. 
       FIG. 1  illustrates the disclosed surgical stapling device  10  including a handle assembly  12 , an elongate body  14 , and a tool assembly  100 . Although not described in detail herein, the tool assembly  100  can form part of a reload assembly  16  that is releasably coupled to the elongate body  14  and includes a proximal body portion  16   a  and the tool assembly  100 . Alternately, the tool assembly  100  can be fixedly secured to a distal portion of the elongate body  14 . The handle assembly  12  includes a hand grip  18 , a plurality of actuator buttons  20 , and a rotation knob  22 . The rotation knob  22  facilitates rotation of the elongate body  14  and the tool assembly  100  in relation to the handle assembly  12 . The actuator buttons  20  control operation of the various functions of the stapling device  10  including approximation, firing and cutting. Although the stapling device  10  is illustrated as an electrically powered stapling device, it is envisioned that the disclosed tool assembly  100  would also be suitable for use with a manually powered surgical stapling device. U.S. Pat. No. 9,055,943 (the &#39;943 patent) discloses a surgical stapling device including a powered handle assembly and U.S. Pat. No. 6,241,139 (the &#39;139 patent) discloses a manually actuated handle assembly. The tool assembly  100  includes a cartridge assembly  112 , an anvil assembly  114 , and a dissector tip  120 . For a more detailed description of the cartridge assembly  112  of the tool assembly  100 , see, e.g., the &#39;943 and &#39;139 patents. 
       FIGS. 2-7  illustrate the anvil assembly  114  of the tool assembly  100  which defines a longitudinal axis “X” and includes a base portion  116  and an anvil portion  118 . The base portion  116  includes a proximal mounting portion  116   a  and a longitudinal rib  116   b  that extends distally from the proximal mounting portion  116   a . The proximal mounting portion  116   a  includes spaced through bores  116   c  that receive pivot members  117  ( FIG. 1 ) that pivotably couple the cartridge assembly  112  to the anvil assembly  114 . The anvil portion  118  is secured to the base portion  116  by, e.g., welding, and includes an upper surface  122 , a proximal portion  118   a , and a distal portion  118   b . The upper surface  122  of the anvil portion  118  defines a plurality of rows of staple deforming pockets  126  that are positioned on opposite sides of a knife slot  128 . The distal portion  118   b  of the anvil portion  118  includes a support plate or bracket  130 . 
     The dissector tip  120  includes a tip beam  140  and a tip beam cover  142 . The tip beam  140  includes a body having a proximal portion  144  and a deformable distal beam portion  146 . The tip beam  140  is secured to the support bracket  130  on the distal portion  118   b  of the anvil portion  118  and is formed from a substantially rigid material that can be bent and shaped to a desired configuration such as a metal. The tip beam cover  142  has an atraumatic configuration and is formed of any suitable biocompatible material including polymeric materials, metals, ceramics, elastomeric materials, etc. In certain aspects of the disclosure, the tip beam cover  142  has rounded edges  156  and a tapered distal tip  158  ( FIG. 4 ) that decreases in width in the distal direction. The tip beam cover  142  also has a thickness that decreases in the distal direction such that the cover  142  is thinnest at its distal end. The reduced thickness allows for the dissector tip  120  to more easily navigate through and dissect tissue. Other tip beam cover configurations are envisioned. 
       FIGS. 8 and 9  illustrate the distal portion of the tool assembly  100  as the dissector tip  120  is moved between a first configuration ( FIG. 8 ) in which the dissector tip  120  extends in a direction substantially parallel to the longitudinal axis “X” of the tool assembly  100  and a second configuration ( FIG. 9 ) in which the dissector tip  120  of the tool assembly  100  extends in a direction to define an acute angle Ω with the longitudinal axis “X” of the tool assembly  100 . In certain aspects of the disclosure, a distal portion  112   a  of the cartridge assembly  112  defines a tissue guide surface  160  that defines an angle θ with the longitudinal axis “X” of the tool assembly  100 . In order to move the dissector tip  120  between the first and second configurations, the tip beam  140  and the tip beam cover  142  are manually grasped by a clinician and bent or deformed in the direction of arrows “A” or “B” in  FIGS. 8 and 9 , respectively, to a desired configuration best suited to perform a certain surgical procedure e.g., in which angle Ω is from about zero to about 45 degrees. The tip beam  140  is formed of a material that will retain its deformed configuration as the dissector tip  120  is used to separate target tissue from body tissue as the tool assembly  100  is advanced endoscopically to a surgical site. 
       FIGS. 10-14  illustrate other exemplary aspects of a tool assembly  200  according to the disclosure. The tool assembly  200  includes an anvil assembly shown generally as anvil assembly  214 . The anvil assembly  214  is similar to the anvil assembly  114  but includes modifications to the dissector tip  120 . Only those modifications to the dissector tip shown generally as dissector tip  220  will be described in detail herein. 
     The anvil assembly  214  includes a base portion  216 , an anvil portion  218 , and the dissector tip  220 . The base portion  216  includes a proximal mounting portion  216   a  and a longitudinal rib  216   b  that extends distally from the proximal mounting portion  216   a  towards a distal end of the anvil portion  218 . The proximal mounting portion  216   a  includes spaced through bores  216   c  that receive pivot members  117  ( FIG. 1 ) that pivotably couple the cartridge assembly  112  ( FIG. 1 ) to the anvil assembly  214 . The anvil portion  218  is secured to the base portion  216  by, e.g., welding, and includes an upper surface  222  ( FIG. 15 ), a proximal portion  218   a , and a distal portion  218   b . The upper surface  222  of the anvil portion  118  defines a plurality of rows of staple deforming pockets (not shown) that are positioned on opposite sides of a knife slot  228  ( FIG. 13 ). The distal portion  218   b  of the anvil portion  118  includes a clevis  230  that defines spaced openings  234  that receive a clevis pin  236 . The distal portion  218   b  of the anvil portion  218  includes a distal face  238  that has a protrusion  240 . 
     The dissector tip  220  has a body including a proximal portion  220   a  and a distal portion  220   b . The proximal portion  220   a  includes a hinge portion  250  that defines a through bore  252  that receives the clevis pin  236  to pivotably secure the dissector tip  220  to the distal end portion  218   b  of the anvil portion  218 . The dissector tip  220  has a proximal face  254  that defines spaced recesses  256   a  and  256   b  that are positioned to receive the protrusion  240  on the distal face  238  of the anvil portion  218  ( FIG. 15 ). The dissector tip  220  has a tapered distal face  260  in the distal direction ( FIG. 15 ) such that the distal end of the dissector tip  220  has a height that decreases in the distal direction. In addition, the width of the dissector tip  220  may also decrease in the distal direction ( FIG. 11 .) The dissector tip  220  has a through bore  261  that extends through the tapered distal face  260 . The through bore  261  allows a clinician to lasso or grasp the dissector tip  220  with a suture to allow the clinician to more accurately move and position the tool assembly  200  within a body cavity. 
       FIGS. 15 and 16  illustrate the dissector tip  220  in a first configuration ( FIG. 15 ) and in a second configuration ( FIG. 16 ). In the first configuration ( FIG. 15 ), the dissector tip  220  defines a longitudinal axis that defines an acute angle Ω with the longitudinal axis “X” of the tool assembly  200 . As discussed above, it is envisioned that angle Ω can be substantially the same as angle θ defined by the tissue guide surface  160  of the cartridge assembly  112 . In the second configuration, the dissector tip  220  defines a longitudinal axis that is substantially parallel to the longitudinal axis “X of the tool assembly  200 . In order to move the dissector tip  220  between the first and second configurations, a clinician can apply a force to the dissector tip  220  to disengage the protrusion  240  from one of the respective spaced recesses  256   a  and  256   b  and pivot the dissector tip  220  about the clevis pin  236  to position the protrusion  240  in the other recess  256   a  or  256   b  of the dissector tip  240 . For example, when the dissector tip  220  is moved from the first configuration ( FIG. 15 ) to the second configuration ( FIG. 16 ), the clinician applies a force on the dissector tip  220  in the direction indicated by arrows “K” to pivot the dissector tip  220  about the clevis pin  236  in the direction indicated by arrow “L” to remove the protrusion  240  from the recess  256   b  and move the protrusion into the recess  256   a . Although only two configurations are shown in the figures, it is envisioned that the dissector tip  220  may be moved to multiple positions. In that respect, it is envisioned that two or more spaced recesses  256  can be provided to receive the protrusion  240  to retain the dissector tip  220  in multiple different angular positions in relation to the longitudinal axis of the tool assembly  200 . 
     Although the drawings only show retaining structure including a protrusion and a plurality of recesses, it is also envisioned that a variety of different types of retention structures can be provided to releasably retain the dissector tip in different angular positions. Further, the retaining structure can be supported on or integrally formed with either or both of the dissection tip  220  and the anvil assembly  214 . 
     Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary aspects of the disclosure. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described aspects of the disclosure. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.