Patent Publication Number: US-8985428-B2

Title: Indicator for surgical stapler

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 12/953,603 filed Nov. 24, 2010, now U.S. Pat. No. 8,714,430, which claims benefit of U.S. Provisional Application No. 61/291,453 filed Dec. 31, 2009, and the disclosures of each of the above-identified applications are hereby incorporated by reference in their entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to a surgical stapling apparatus and, more specifically, to a surgical stapling apparatus having a mechanism for indicating to a surgeon the condition of the stapler. 
     Background of Related Art 
     Surgical stapling instruments used for applying parallel rows of staples through compressed living tissue are well known in the art, and are commonly used, for example, for closure of tissue or organs prior to trans-section, prior to resection, or in anastomoses, and for occlusion of organs in thoracic and abdominal procedures. 
     Typically, such surgical stapling instruments include an anvil assembly, a cartridge assembly for supporting an array of surgical staples, an approximation mechanism for approximating the anvil and cartridge assemblies, an alignment pin assembly for capturing tissue between the cartridge and anvil assemblies and for maintaining alignment between the cartridge and anvil assemblies during approximation and firing, and a firing mechanism for ejecting the surgical staples from the cartridge assembly. The approximation mechanism and the firing mechanism generally include distinct actuators for effecting approximation and firing of the staples. 
     A continuing need exists for a surgical stapling instrument which provides a clinician with visual indication of the stage of actuation of the surgical stapler. 
     SUMMARY 
     A surgical stapler configured for visually indicating to a user the stage of operation of the stapler is provided. In one aspect, the surgical stapler includes a body, a stapling assembly positioned on a distal portion of the body and including a cartridge assembly and an anvil assembly. A thrust bar is slidably disposed within the body and configured to advance distally from a retracted position to a first advanced position during approximation of the cartridge assembly towards the anvil assembly and advance further to a second advanced position to cause the release of staples from the cartridge assembly. An indicator member is connected to the thrust bar and configured to provide visual indication to a user upon complete approximation of the cartridge assembly and upon release of staples from the cartridge assembly. 
     In one embodiment, the distal end of the thrust bar may be configured for operable engagement with the stapling assembly to cause the ejection of staples from the cartridge assembly during the release of staples from the cartridge assembly. The body can include at least one window for viewing the indicator member. The indicator member may further be configured to indicate the stapler is ready to be approximated. In some embodiments, the indicator member is slidably mounted within the body. In other embodiments, the indicator member is rotatably mounted within the body. The indicator member may include a first symbol to indicate completion of the approximation stroke and a second symbol to indicate the release of staples from the cartridge assembly. 
     In one embodiment, the indicator member is rotatably mounted to the thrust bar. In some embodiments, the body may include a rack operably connected to the thrust bar. The rack may include a base, a pair of link members and a pair of toothed extensions operably engaged with the indicator members. Advancement of the thrust bar may cause rotation of the indicator member. 
     In one embodiment, an indicator member is slidable along with the thrust bar. 
     In another aspect, the present disclosure provides a surgical stapler comprising a body, a stapling assembly positioned on a distal portion of the body and including a cartridge assembly and an anvil assembly. A thrust bar is slidably disposed within the body and configured to advance distally from a retracted position to a first advanced position. An indicator member is configured to provide visual indication to a user upon at least one of complete approximation of the cartridge assembly and release of staples from the cartridge assembly. A rack is operably connected to the thrust bar and has a pair of toothed extensions, the toothed extensions being operably engaged with the indicator member and advancement of the thrust bar causes rotation of the indicator member. 
     In some embodiments, the indicator member is rotatable about an axis perpendicular to the longitudinal axis of the thrust bar. In some embodiments, the indicator member includes a first symbol to indicate complete approximation of the cartridge assembly and a second symbol to indicate release of staples from the cartridge assembly. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Embodiments of the presently disclosed surgical stapling apparatus are described herein with reference to the drawings, wherein: 
         FIG. 1  is a perspective view of an embodiment of a surgical stapler in accordance with the present disclosure; 
         FIG. 2  is a perspective view of a portion of the surgical stapler of  FIG. 1  showing the indicator mounted within the surgical stapler; 
         FIG. 3  is a perspective view of the indicator of  FIG. 2 ; 
         FIG. 4  is a side view of the surgical stapler of  FIG. 1  in a pre-clamped (unapproximated) condition and with an alignment pin having been manually advanced; 
         FIG. 5  is an enlarged view of the indicated area of detail of  FIG. 4 , showing no symbol in the window; 
         FIG. 6  is a side view of the surgical stapler of  FIG. 1  in a clamped (approximated) condition; 
         FIG. 7  is an enlarged view of the indicated area of detail of  FIG. 6  showing a clamp symbol; 
         FIG. 8  is a side view of the surgical stapler of  FIG. 1  in a fired condition; 
         FIG. 9  is an enlarged view of the indicated area of detail of  FIG. 8  showing a stapled (fired) symbol; 
         FIG. 10  is a perspective view of portion of the stapler of the present disclosure of an alternate embodiment showing an alternate indicator on a surgical stapler; 
         FIG. 11  is a side view of a surgical stapler including the indicator mechanism of  FIG. 10 ; 
         FIG. 12  is a side view of an indicator member of the indicator mechanism of  FIG. 10 ; 
         FIG. 13  is an enlarged view of the indicated area of detail of  FIG. 11  showing a pre-clamp symbol; 
         FIG. 14  is an enlarged view of the indicated area of detail of  FIG. 11  showing a clamp symbol; and 
         FIG. 15  is an enlarged view of the indicated area of detail of  FIG. 11  showing a stapled (fired) symbol. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the presently disclosed surgical stapler will now be described in detail with reference to the drawings, wherein like reference numerals designate corresponding elements in each of the several views. Throughout this description, the term “proximal” will refer to the portion of the instrument closer to the operator and the term “distal” will refer to the portion of the instrument further from the operator. 
     With reference to  FIG. 1 , a surgical stapling device according to an embodiment of the present disclosure is shown generally as surgical stapler  10 . Surgical stapler  10  includes a body  12  defining a stationary handle  14 , a pivotable trigger  16 , an elongated central body portion  18 , a cartridge assembly  20  and an anvil assembly  22 . A thumb button  24  is slidably positioned on each side of body  12 . Thumb buttons  24  are movable distally to manually advance an alignment pin  38  ( FIG. 4 ) from alignment pin assembly  21  into engagement with anvil assembly  22  to capture tissue between anvil assembly  22  and cartridge assembly  20 . A release button  150  of a release mechanism (not shown) is positioned on the proximal end of body  12  and is depressible to allow cartridge assembly  20  to return from an approximated position disposed adjacent to anvil assembly  22  to an unapproximated position spaced from anvil assembly  22  (as shown). 
     With continued reference to  FIG. 1 , body  12  is formed from a pair of molded half-sections  12   a ,  12   b . In one embodiment, half-sections  12   a ,  12   b  are formed of plastic, although half-sections  12   a ,  12   b  may be formed of other materials, including metal. A cutout or window  13  is formed in each of half-sections  12   a ,  12   b . Windows  13  may include a clear cover (not shown) to prevent debris from entering body  12 . As will be discussed in further detail below, windows  13  are configured to align with an operably positioned indicator member mounted within body  12 . 
     The internal structure and function of surgical stapler  10  will now be described to the extent necessary to fully disclose the aspects of the present disclosure. A more detailed discussion of the internal structure and function of the surgical stapler is disclosed U.S. Pat. No. 6,817,508 (the &#39;508 patent), the entire contents of which are incorporated by reference herein. Although described with reference to surgical stapler  10 , the aspects of present disclosure may be modified for use with any device having a multi-stage firing sequence. Also, the term surgical stapling as used herein includes application of two part fasteners. 
     Referring now to  FIG. 2 , surgical stapler  10  includes a pair of clamp slide members  66   a ,  66   b  and a thrust bar  70 . Clamp slide members  66   a ,  66   b  and thrust bar  70  are slidably supported between frame members  28   a ,  28   b  of surgical stapler  10  for movement between retracted and advanced positions in response to movement of trigger  16  through an approximation stroke and a stapling (staple firing) stroke. As will be discussed in further detail below, thrust bar  70  advances distally during the approximation stroke and advances further distally during the stapling (staple firing) stroke. Cartridge assembly  20  is operably supported at a distal end (not shown) of clamp slide members  66   a ,  66   b  such that advancement of clamp slide members  66   a ,  66   b  effects advancement of cartridge assembly  20 . Cartridge assembly  20  is operably connected at a distal end (not shown) of thrust bar  70  such that advancement during the stapling stroke effects ejection of staples from cartridge assembly  20  into contact with anvil pockets on anvil assembly  20 . Thrust bar  70  includes a flange  70   a  formed in a proximal end thereof. Flange  70   a  is configured to be operably engaged by indicator member  73 . 
     Turning now to  FIG. 3 , indicator member  73  includes a base  75  and a pair of extensions or wings  77   a ,  77   b . Base  75  is configured for operable engagement with flange  70   a  of thrust bar  70 . In one embodiment, and as shown, base  75  includes an opening or slot  75   a  configured to be received about flange  70   a . Indicator member  73  may, however, be operably engaged with thrust bar  70  in other suitable manners, including using adhesives and/or mechanical fasteners. In another embodiment, indicator member  73  is integrally formed with thrust bar  70 . Extensions  77   a ,  77   b  extend radially outwardly from base  75  and are configured to slide along respective frame members  28   a ,  28   b  during advancement of thrust bar  70 . Extensions  77   a ,  77   b  are mirror images of one another with each including a clamp symbol “C” and a staple symbol “S” on their outer arcuate surfaces. Symbols “C”, “S” may be pictures or icons, as shown, or may include one or more numbers, one or more letters, one or more colors, or any combination thereof or other indicia. Symbols “C”, “S” are horizontally aligned on each of extensions  77   a ,  77   b , and as will be discussed below, are located to be viewed through window  13  formed in each of half sections  12   a ,  12   b . Although shown including only two symbols, extensions  77   a ,  77   b  may be modified, i.e., lengthened, to include a third, pre-clamped symbol (not shown). 
     The operation of surgical stapler  10  and indicator member  73  will now be described with reference to  FIGS. 4-9 . Referring initially to  FIGS. 4 and 5 , surgical stapler  10  is shown in a first or pre-clamped (unapproximated) condition. As shown, an alignment pin  38  has been manually advanced using thumb buttons  24 ; however, alignment pin  38  may instead be automatically advanced during the approximation stroke of trigger  16 . In the first or pre-clamped condition, neither indicator member  73  nor either of symbols “C”, “S” formed thereon are visible through window  13  of half sections  12   a ,  12   b . As discussed above, in an alternative embodiment, extensions  77   a ,  77   b  are lengthened and include a third, pre-clamped symbol which is horizontally aligned with symbols “C”, “S” and would be visible through window  13  when surgical stapler  10  is in a pre-clamped condition. In another embodiment, symbols “C”, “S” are formed on half-sections  12   a ,  12   b  and extensions  77   a ,  77   b  include an arrow (not shown). In this manner, advancement of indicator member  73  causes sequential alignment of the arrow with a respective symbol “C”, “S” during the clamping and stapling operations of surgical stapler  10 . 
       FIGS. 6 and 7  illustrate surgical stapling device  10  during the approximation stroke of trigger  16 . As illustrated, trigger  16  is moved towards stationary handle  14 , in the direction indicated by arrow “A”, to advance clamp slides  66   a ,  66   b  ( FIG. 2 ) from a retracted position towards the advanced or approximated position, as described in detail in the &#39;508 patent. As clamp slides  66   a ,  66   b  are advanced, thrust bar  70  ( FIG. 2 ) is simultaneously advanced. As discussed above, advancement of thrust bar  70  causes advancement of indicator member  73 . Indicator member  73  and window  13  formed in each of half sections  12   a ,  12   b  are arranged such that upon completion of the approximation stroke, clamp symbol “C” is completely visible through window  13 . In this manner, a clinician receives visual indication that the clamping stage is complete and that surgical stapler  10  is in a clamped condition. If, during the approximation stroke, the surgical stapler  10  is not fully approximated, clamp symbol “C” would not be visible or would only be partially visible through windows  13 . Anything less than a completely visible clamp symbol “C” would visually indicate to the clinician that surgical stapler  10  is not properly approximated. 
     As described in detail in the &#39;508 patent, after the approximation stroke of trigger  16  is completed, trigger  16  returns to a non-compressed position upon its release to ready surgical stapler  10  for the stapling stroke. Prior to the stapling stroke, tissue (not shown) is captured between cartridge assembly  20  and anvil assembly  22 . Alignment pin  38  ( FIG. 4 ) maintains or captures the tissue between cartridge assembly  20  and anvil assembly  22 . 
       FIGS. 8 and 9  illustrate surgical stapler  10  after trigger  16  has been moved through the stapling stroke, as indicated by arrow “B”. During the stapling stroke, thrust bar  70  ( FIG. 2 ) continues to distally advance within body  12 . As noted above, advancement of thrust bar  70  causes advancement of indicator member  73 . Upon completion of the stapling stroke, indicator member  73  has advanced to a position which staple symbol “S” is completely visible through window  13  of half-sections  12   a ,  12   b . As discussed above with regard to the approximation stroke, if following the stapling stroke, staple symbols “S” are not completely visible through windows  13 , the clinician is provided with visual indication that the staples of surgical stapler  10  have not been properly fired. 
     With continued reference to  FIG. 8 , upon completion of the stapling stroke, release button  150  is depressed and a spring (not shown) returns thrust bar  70  ( FIG. 2 ) and clamp slide members  66   a ,  66   b  ( FIG. 2 ) proximally to the initial or pre-clamped position. In one embodiment, and as shown, in the pre-clamped position, indicator member  73  is not visible through windows  13 . In another embodiment, in the pre-clamped position, a pre-clamped symbol (not shown) is visible. In either instance, surgical stapler  10  is ready for reloading and use. 
     Turning now to  FIGS. 10-12 , an alternate embodiment of a surgical stapler in accordance with the present disclosure is shown generally as surgical stapler  310 . Surgical stapler  310  is substantially similar to surgical stapler  10 , and will only be described as relates to the differences therebetween. 
     Surgical stapler  310  includes an indicator mechanism  373  configured to provide visual indication to a user of the current condition of surgical stapler  310 . Indicator mechanism  373  includes a base  375  and a pair of link members  377   a ,  377   b . Base  375  includes a slot  375   a  configured to be received about flange  370   a  of thrust bar  370 ; however, base  375  may be attached with thrust bar  370  in any suitable manner, including adhesive and mechanical connections. Alternatively, indicator mechanism  373  can be integrally formed with thrust bar  370 . Link members  377   a ,  377   b  extend proximally from base  375  and are configured to slide along frame members  328   a ,  328   b  as thrust bar  370  is advanced through an approximation stroke and a stapling stroke. Link members  377   a ,  377   b  may be integrally formed with base  375 , or instead, may be attached thereto in any suitable manner. Ends of link members  377   a ,  377   b  each include toothed extension or rack  379   a ,  379   b . Toothed extensions  379   a ,  379   b  may be integrally formed with respective link members  377   a ,  377   b , or instead, may be attached thereto in any suitable manner. As will be discussed in further detail below, toothed extensions  379   a ,  379   b  are configured to operably engage indicator members  383   a ,  383   b.    
     With continued reference to  FIG. 10 , indicator mechanism  373  includes indicator members  383   a ,  383   b  operably mounted on a distal end of frame members  328   a ,  328   b . As shown, indicator members  383   a ,  383   b  include pinion members rotatably supported on pinion holders  329   a ,  329   b . In one embodiment, and as shown, pinion holders  329   a ,  329   b  are securely mounted to proximal ends of respective frame members  328   a ,  328   b  using rivets; however any suitable fastening means may be used. In alternate embodiments, pinion holders  329   a ,  329   b  are integrally formed with frame members  328   a ,  328   b  and may be positioned in other locations along body  12 . 
     Turning now to  FIG. 12 , indicator member  383   b  is shown. Indicator members  383   a ,  383   b  are substantially similar and include an axle  385  defining a longitudinal axis “X” and a toothed gear  387 . Axles  385  of indicator members  383   a ,  383   b  are perpendicular to the longitudinal axis of the thrust bar and are configured such that indicator members  383   a ,  383   b  are rotatably received by respective pinion holders  329   a ,  329   b . Toothed gears  387  are configured to engage toothed extensions  379   a ,  379   b  formed on link members  377   a ,  377   b , respectively. Each of indicator members  383   a ,  383   b  include a pre-clamp symbol “P” ( FIG. 13 ), a clamp symbol “C” ( FIG. 14 ) and a staple symbol “S” ( FIG. 15 ). Symbols “P”, “C”, “S” can be arranged about indicator member  383   b  in a clockwise configuration while symbols “P”, “C”, “S” arranged about indicator members  383   a  in a counter-clockwise configuration. Other symbols or indicia are also contemplated. 
     Surgical stapler  310  includes a body  312  including a pair of windows  313 . Windows  313  are configured to align with indicator members  383   a ,  383   b  such that each symbols “P”, “C”, “S” may be sequentially viewed during firing of surgical stapler  310 . The mirror image configuration of symbols “P”, “C”, “S” are such that the same symbol is viewed in both of windows  13  during use of surgical stapler  310 . 
     Surgical stapler  310  and indicator mechanism  373  operate in a substantially similar manner to surgical stapler  10  described herein above. Prior to an approximation stroke, pre-clamp symbols “P” of indicator members  383   a ,  383   b  are visible through windows  313 . During the approximation stroke, thrust bar  370  is advanced distally causing the advancement of base  375 , link members  377   a ,  377   b , and toothed extension  379   a ,  379   b  (collectively, rack  377 ). Advancement of toothed extensions  379   a ,  379   b  cause rotation of respective indicator members  383   a ,  383   b . Following the approximation stroke, clamp symbols “C” are visible through windows  313 . Release of trigger  16  permits trigger  16  to return to a non-compressed condition to permit the stapling stroke. During the stapling stroke, thrust bar  370  is advanced further distally, thereby causing the advancement of base  375 , link members  377   a ,  377   b , and toothed extension  379   a ,  379   b , and the rotation of respective indicator members  383   a ,  383   b . Following the stapling stroke, staple symbols “S” on indicator members  383   a ,  383   b  are visible through windows  313 . If at any time during the stapling process surgical stapler  310  is not in desired stage or condition, one of symbols “P”, “C”, “S” will not be completely visible through window  313 , thereby providing a clinician with visual indication that surgical stapler  310  is not in such stage. 
     It will be understood that various modifications may be made to the embodiments disclosed herein. For example, the components of the surgical stapling device can be formed of any material suitable for surgical use and having the required strength characteristics. The stapling device could contain two part fasteners. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.