Abstract:
A loading unit having a shipping safety device is provided for use with a surgical instrument. The loading unit includes a body portion, a movable operative device disposed in the body portion and an actuator associated with the body portion and operable to move the movable operative device. A locking member movably mounted in the body portion and movable in response to movement of the actuator. The locking member is movable between a first locked position and a second unlocked position. The removable safety device generally includes a base, a blocking member projecting from the base and engageable with the movable operative device and a lockout member projecting from the base and engageable with the locking member. Flexible arms extend from the base and engage the body portion of the loading unit. The removable safety device is locked to the body portion when the locking member is in the first locked position and is unlocked for removal from the body portion when the locking member it is in the second unlocked position.

Description:
BACKGROUND 
       [0001]    1. Technical Field 
         [0002]    The present disclosure relates to a shipping safety device for use with a surgical instrument. More particularly, the present disclosure relates to a shipping wedge having a lockout member and a single use loading unit or “SULU” having a lockout mechanism for use with the surgical instrument. 
         [0003]    2. Background of Related Art 
         [0004]    In an effort to reduce trauma and recovery time, many surgical procedures are performed through small openings in the skin, such as an incision or a natural body orifice. Generally, such procedures are referred to as “endoscopic,” unless performed on the patient&#39;s abdomen, in which case the procedure is referred to as “laparoscopic.” Throughout the present disclosure, the term “minimally invasive” should be understood to encompass both endoscopic and laparoscopic procedures. 
         [0005]    During the course of minimally invasive surgical procedures, a surgical fastener applying apparatus is often employed to connect adjacent sections of tissue. Many varieties of such apparatus are known in the art, some of which are specifically adapted for use in particular surgical procedures including, but not limited to, end-to-end anastomosis, circular end-to-end anastomosis, open gastrointestinal anastomosis, endoscopic gastrointestinal anastomosis, and transverse anastomosis. Examples of suitable surgical fastener applying apparatus are disclosed in U.S. Pat. Nos. 5,915,616; 6,202,914; 5,865,361; and 5,964,394. Typically, these surgical fastener applying apparatus include a first member that is movable relative to a second member such that target tissue is positionable therebetween to facilitate grasping and/or clamping of the target tissue. 
         [0006]    Linear surgical fastener applying apparatus generally include two elongated jaw members, one of which includes a surgical fastener cartridge housing a plurality of surgical fasteners that are arranged in two or more linear rows, and the other of which includes an anvil component with a plurality of fastener forming pockets that are configured and dimensioned to receive and form the surgical fasteners upon ejection of the fasteners from the surgical fastener cartridge. The surgical fastener applying apparatus may also include a knife that is movable between the linear rows of surgical fasteners such that the tissue being joined and/or sealed is simultaneously, or sequentially, cut upon actuation of the surgical fastener applying apparatus. Given this capability, surgical fastener applying apparatus of the linear variety are commonly used during surgical procedures to simultaneously seal and cut target tissue, e.g., a patient&#39;s vasculature, organs, or the like. 
         [0007]    Some surgical fastener applying apparatus are provided in two parts, a reusable handle or actuator section and a removable or replaceable single use loading unit or “SULU”. The SULU includes the staple containing cartridge, anvil and a knife blade for cutting stapled tissue. 
         [0008]    Safety devices may be provided to prevent movement of the knife blade during shipment and/or prior to use. In some instances, the safety devices can be removed from the SULU prior to the SULU being assembled to the reusable handle. Therefore, there exists a need for a shipping safety device and SULU having locking structure which prevents removal of the shipping safety device from the SULU prior to assembly with a reusable handle. 
       SUMMARY 
       [0009]    There is disclosed a shipping wedge for use with a surgical instrument having body portion. The shipping wedge includes a base, a blocking member depending from the base and engagable with a movable operative member of the surgical instrument and a locking member also depending from the base and engageable with a lockout mechanism of the surgical instrument. Flexible arms project from the base and are shaped to cooperate with the body portion of the surgical instrument. 
         [0010]    In certain embodiments, the locking member includes an enlarged flange in the form of a circular disc. A downward extension connects the circular disc to the base. The blocking member is a distally facing hook engageable with the movable operative member of the surgical instrument. 
         [0011]    In certain embodiments, the flexible arms are a first flexible arm and a second flexible arm depending from opposed sides of the base and engageable with a body portion of the surgical instrument. The first and second flexible arms are longitudinally spaced along the base. 
         [0012]    An alignment unit is located at a distal end of the base and includes a pair of distally projecting, flexible arms for aligning the blocking member with corresponding structure on the surgical instrument. 
         [0013]    In one embodiment, the shipping wedge further includes second and third flexible arms depending from opposed sides of the base and longitudinally spaced from the first and second flexible arms. 
         [0014]    A grasping frame is provided and extends from a side of the base opposite of the locking member. An indicia plate is located between the grasping frame and the base for display of various modes of informational indicia. In a specific embodiment, a flexible thumb tab extends from a proximal end of the grasping frame. 
         [0015]    In one embodiment, the shipping wedge is foamed from a polymeric material while in an alternative embodiment, the shipping wedge is formed from a metallic material. 
         [0016]    In a particular embodiment, the shipping wedge is formed as a monolithic structure. 
         [0017]    There is also disclosed a surgical instrument having a lockout mechanism, including a body portion, an actuator movably mounted on the body portion. A lockout mechanism, including a locking plate, is movably mounted to the body portion. The instrument includes a loading lock having a locking member, the locking plate being engageable with the locking member of the loading lock, the locking plate being movable in response to movement of the actuator between a locked position preventing removal of the loading lock from the body portion to an unlocked position allowing removal of the loading lock from the body portion, the loading lock having flexible arms shaped to cooperate with the body portion of the instrument. 
         [0018]    In a specific embodiment, the locking plate includes a keyhole slot engageable with the shipping safety device. The keyhole slot includes a first narrower locking portion and a second enlarged unlocking portion. 
         [0019]    The locking plate is operatively connected to the actuator by an extension rod and is biased to the locked position by a biasing spring mounted in the body portion. 
         [0020]    In certain embodiments, the body portion has a knife member and the loading lock has a hook insertable through a hole defined in the body portion and arranged to block movement of the knife member. 
         [0021]    There is further disclosed a loading unit having a removable shipping safety device. The loading unit generally includes a body portion, a movable operative device disposed in the body portion and an actuator associated with the body portion and operable to move the movable operative device. A locking member movably mounted in the body portion and movable in response to movement of the actuator. The locking member is movable between a first locked position and a second unlocked position. 
         [0022]    The removable shipping safety device generally includes a base, a blocking member projecting from the base and engageable with the movable operative device and a lockout member projecting from the base and engageable with the locking member. The removable safety device is locked to the body portion when the locking member is in the first locked position and is unlocked for removal from the body portion when the locking member it is in the second unlocked position. 
         [0023]    In a particular embodiment, the locking member includes a keyhole slot engageable with the lockout member of the removable safety device such that the removable safety device is locked to the body portion when the lockout member is in a keyway in the locking member and is unlocked from the body portion when the lockout member is in a hole formed in the locking member. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0024]    An embodiment of the presently disclosed shipping wedge with lockout is disclosed herein with reference to the drawings, wherein: 
           [0025]      FIG. 1  is a perspective view of an embodiment of a shipping wedge with lockout (“shipping wedge”) installed on a Single Use Loading Unit (“SULU”); 
           [0026]      FIG. 3  is a perspective view of the shipping wedge; 
           [0027]      FIG. 4  is a side plan view of the shipping wedge; 
           [0028]      FIG. 5  is a top plan view of the shipping wedge; 
           [0029]      FIG. 6  is a bottom plan view of the shipping wedge; 
           [0030]      FIG. 7  is an end view taken along line  7 - 7  of  FIG. 4 ; 
           [0031]      FIG. 8  is an opposite end view taken along line  8 - 8  of  FIG. 4 ; 
           [0032]      FIG. 9  is a cross-sectional view taken along line  9 - 9  of  FIG. 4 ; 
           [0033]      FIG. 10  is a cross-sectional view taken along line  10 - 10  of  FIG. 4 ; 
           [0034]      FIG. 11  is a cross-sectional view taken along line  11 - 11  of  FIG. 4 ; 
           [0035]      FIG. 12  is a perspective view illustrating a distal end of the shipping wedge during initial installation into the SULU; 
           [0036]      FIG. 13  a perspective view similar to  FIG. 12  illustrating further installation of the shipping wedge into the SULU; 
           [0037]      FIG. 14  is a perspective view of a proximal end of the shipping wedge positioned adjacent the SULU; 
           [0038]      FIG. 15  is a perspective view of the SULU with a cover tube removed; 
           [0039]      FIG. 16  is an enlarged perspective view of the SULU illustrating a locking mechanism in an unlocked position on the SULU; 
           [0040]      FIG. 17  is a cross-sectional view taken along line  17 - 17  of  FIG. 16  with the shipping wedge installed through the locking mechanism; 
           [0041]      FIG. 18  is a perspective view similar to  FIG. 15  with the locking mechanism in a locked position; 
           [0042]      FIG. 19  is an enlarged perspective view similar to  FIG. 16  with the locking mechanism in the locked position; 
           [0043]      FIG. 20  is a cross-sectional view taken along line  20 - 20  of  FIG. 19  with the shipping wedge in the locked condition; 
           [0044]      FIG. 21  is a cross-sectional view of the shipping wedge installed on the SULU and in the locked condition; and 
           [0045]      FIG. 22  is an enlarged area of detail view of  FIG. 21  illustrating a distal shipping hook engaged with the SULU and blocking a knife blade of the SULU. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0046]    An embodiment of the presently disclosed shipping wedge with lockout will now be described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views. As is common in the art, the term ‘proximal” refers to that part or component closer to the user or operator, i.e. surgeon or physician, while the term “distal” refers to that part or component further away from the user. 
         [0047]    Referring initially to  FIG. 1 , there is disclosed a surgical stapling instrument  10  according to an embodiment of the present disclosure. The instrument has a Loading Unit  12 , e.g. a “SULU”, and a shipping wedge or loading lock  10 . The loading unit  12  is provided as a self contained, replaceable device which is removably attachable to the surgical stapling instrument in order to allow for multiple uses of the surgical stapling instrument. Loading unit  12  generally includes an elongate tubular member  14  having a staple cartridge  16  mounted to a distal end  18  of elongate tubular member  14 . An anvil member  20  extends from and is affixed to distal end  18  of elongate tubular member  14 . Staple cartridge  16  is movable from an open position spaced from anvil member  20  to a closed position in close cooperative alignment with anvil member  20  to clamp tissue therebetween. Specifically, a proximal end  22  of staple cartridge  16  is movably mounted to distal end  18  of elongate tubular member  14 . Staple cartridge  16  is movable between the open and closed position in response to operation of an actuator (not shown) associated with the surgical stapling instrument. 
         [0048]    Staple cartridge  16  includes pluralities of rows of staple containing pockets  24 . Staples (not shown) contained in rows of staple containing pockets  24  are ejected out of staple cartridge  16 , through tissue, and crimped against anvil member  20  in response to operation of an actuator such as a movable handle trigger. In order to accommodate a knife blade to sever the stapled tissue, staple cartridge  16  includes a longitudinal knife slot  26  extending between plurality of rows of staple containing pockets  24 . Knife slot  26  allows for passage of the knife blade (see  FIGS. 21 and 22 ) through the stapled tissue. When installed on loading unit  12 , shipping wedge  10  prevents movement of the knife blade through knife slot  26  in a manner described hereinbelow. 
         [0049]    A connector assembly  28  extends from a proximal end  30  of elongate tubular member  14  and is provided to allow loading unit  12  to be operatively connected to the surgical stapling instrument. 
         [0050]    Referring now to  FIG. 2 , loading unit  12  includes a body portion  32  having a cover tube  34  overlying body portion  32 . A hole  36  is provided through cover tube  34  and functions with a locking plate  38 , movably mounted on body portion  32 , to form part of a locking mechanism  40  which prevents removal of shipping wedge  10  from elongate tubular member  14  prior to installation of loading unit  12  on a surgical stapling instrument. Locking mechanism  40  additionally includes a biasing or compression spring  42  to bias locking plate  38  proximally relative to body portion  32 . An extension rod  44  abuts locking plate  38  and extends along body portion  32  from an actuator  46  on body portion  32 . Specifically, a proximal end  48  of extension rod  44  engages actuator  46  while a distal end  50  of extension rod  44  engages a proximal edge  52  of locking plate  38 . Movement of actuator  46  distally drives extension rod  44  and locking plate  38  distally along body portion  32  against the bias of compression spring  42 . 
         [0051]    Locking plate  38  includes a key hole slot  54  having a distal longitudinal keyway  56  and a proximal hole  58 . Shipping wedge  10  includes a proximal locking pin  60  which is insertable through hole  36  in cover tube  34  and into key hole slot  54  in locking plate  38 . Engagement of key way  56  of locking plate  38  with proximal locking pin  60  secures shipping wedge  10  against loading unit  12  until loading unit  12  has been properly installed into a surgical stapling instrument or until actuator  46  has been manually moved in a manner described in more detail hereinbelow. Shipping wedge or loading lock  10  additionally includes a distal hook  62  which is insertable through a hole  64  formed through distal end  18  of elongate tubular member  14  and serves to block movement of a knife  17  (see  FIG. 17 ) through knife slot  26  in staple cartridge  16  when shipping wedge  10  is installed on loading unit  12 . 
         [0052]    Referring now to  FIGS. 3-11 , and initially with regard to  FIGS. 3-6 , the details of shipping wedge  10  will now be described. Shipping wedge  10  includes a generally elongate rectangular base  66  having a distal end  68 , a proximal end  70 , an upper surface  72  and a lower surface  74 . Proximal locking pin  60  projects from lower surface  74  at proximal end  70  of base  66  while distal hook  62  projects from lower surface  74  at distal end  72  of base  66 . With specific reference to  FIGS. 3 and 4 , proximal locking pin  60  includes a downward extension  76  extending from lower surface of  74  of base  66 . Downward extension  76  terminates in an enlarged, circular locking flange  78 . Distal hook  62  also has a downward extension  80  which terminates in a distally projecting lip  82 . Locking flange  78  is positionable through hole  36  in cover tube  34  and hole  58  in key hole slot  54  of locking plate  38  while distally projecting lip  82  is insertable into hole  64  in elongate tubular member  14  (see also  FIG. 2 ). 
         [0053]    In order to initially position distal hook  62  relative to hole  64  in elongate tubular member  14  ( FIG. 2 ), shipping wedge  10  includes a distally projecting, semi-cylindrical alignment unit  84 . Alignment unit  84  includes a semi-cylindrical proximal portion  86  and a pair of distally extending alignment arms  88  and  90  extending distally from proximal portion  86 . Proximal portion  86  and alignment arms  88  and  90  are relatively flexible so as to engage elongate tubular member  14  in snap fit fashion. 
         [0054]    Referring to  FIGS. 3-6 , in order to further secure shipping wedge  10  on elongate tubular member  14  in snap fit fashion, shipping wedge  10  includes flexible arms  92 ,  94 ,  96  and  98  projecting downwardly from base  66 . The flexible arms are shaped to cooperate with the cover tube and body portion. Flexible arms  92 ,  94 ,  96  and  98  are arcuate in shape and spaced longitudinally along base  66 . For example, flexible arcuate arms  92  and  94  are longitudinally spaced along one side of base  66  while flexible arcuate arms  96  and  98  are spaced distally along an opposed side of base  66 . In addition, flexible arcuate arms  92  and  94  are staggered longitudinally relative to flexible arcuate arms  96  and  98 . 
         [0055]    Shipping wedge  10  additionally includes a grasping frame  100  to facilitate manipulation of shipping wedge  10  onto elongate tubular member  14 . Grasping frame  100  generally includes an arcuate distal portion  102 , a central portion  104  and a proximal portion  106 . Distal portion  102  extends from a distal end  108  of central portion  104  to distal end  68  of base  66 . Likewise, proximal portion  106  extends from a proximal end  110  of central portion  104  to proximal end  70  of base  66 . A thumb tab  112  extends proximally from proximal end  110  of central portion  104  to facilitate removal of shipping wedge  10  from elongate tubular member  14  in a manner described in more detail hereinbelow. An indicia plate  114  is provided between base  66  and grasping frame  100  and serves to strengthen or stiffen shipping wedge  10  as well as provide space for text and symbol indicia  116  and  118 , respectively, on opposed sides  120  and  122  of indicia plate  114 . Thumb tab  112  of shipping wedge  10  includes a flexible arm  124  terminating in an enlarged end  126 . A central raised rib  128  is provided on central portion  104  of grasping frame  100 . 
         [0056]    As best shown in  FIG. 7 , distal hook  62  projects downwardly through semicylindrical alignment unit  84  and between distally extending alignment arms  88  and  90 . As best seen in  FIG. 8 , proximal locking pin  60 , including circular locking flange  78 , projects downwardly into the space defined by the flexible arcuate arms  94  and  98 . 
         [0057]    Shipping wedge  10  may be formed from a variety of relatively flexible materials such as, for example, polymeric materials, metallic materials, etc. Forming shipping wedge  10  from flexible materials allows alignment arms  88  and  90  of distally projecting alignment unit  84 , as well as flexible arcuate arms  92 ,  94 ,  96  and  98 , to flex outwardly around loading unit  12  to allow shipping wedge  10  to be attached to loading unit  12  in snap fit fashion. Similarly, the flexible nature of the materials forming shipping wedge  10  allows thumb tab  112  to flex slightly to facilitate removal of shipping wedge  10  from loading unit  12 . As noted herein above, shipping wedge  10  includes base  66  which, in conjunction with grasping frame  100  and indicia plate  114 , provides sufficient rigidity to shipping wedge  10  in order to prevent undue flexing and inadvertent dislodgement of shipping wedge  10  from loading unit  12 . 
         [0058]    The elements of shipping wedge  10  may be formed from a variety of separate components which are then welded, glued or otherwise assembled or, with specific reference to  FIGS. 9-11 , shipping wedge  10  maybe formed intergrally as one single, monolithic molded or machined unit. For example, as shown in  FIG. 9 , flexible arcuate arm  94  is illustrated integral with indicia plate  114  and grasping frame  100  while in  FIG. 10 , flexible arcuate arm  92  is illustrated integral with indicia plate  114  and grasping frame  100 . As best shown in  FIG. 11 , distally projecting alignment unit  84  is illustrated as being formed integral with indicia plate  114  and grasping frame  110 . 
         [0059]    Referring now to  FIGS. 2 ,  3  and  12 - 22 , the use of shipping wedge  10  in conjunction with lockout mechanism  40  on loading unit  12  will now be described. Referring initially to  FIGS. 12 and 13 , in order to assemble shipping wedge  10  to loading unit  12 , shipping wedge  10  is initially positioned adjacent loading unit  12  such that alignment arms  88  and  90  surround anvil  20  and distal hook  62  of shipping wedge  10  is positioned over hole  64  in anvil  20 . Shipping wedge or loading lock  10  is then manipulated such that distally projecting lip  82  of distal hook  62  enters hole  64  ( FIG. 13 ). Thereafter, with reference to  FIGS. 12-14 , proximal end  70  of base  66  is pivoted downwardly in the direction of arrow A, causing flexible arcuate arms  92 ,  94 ,  96  and  98  to engage and flex around cover tube  34  of loading unit  12 . As noted herein above, flexible arcuate arms  92 ,  94 ,  96  and  98  are provided to secure shipping wedge  10  against loading unit  12  and prevent shipping wedge  10  from inadvertently falling off loading unit  12 . With specific reference to  FIG. 14 , in this condition, proximal locking pin  60  of shipping wedge  10  is positioned adjacent hole  36  in cover tube  34 . 
         [0060]    Referring to  FIGS. 15 and 16 , during the initial or factory installation of shipping wedge  10  to loading unit  14 , locking mechanism  40  is artificially manipulated into an unlocked condition by advancing actuator  46  distally in the direction of arrow B. Movement of actuator  46  distally drives extension rod  44  and locking plate  38  distally relative to body portion  32  of elongate tubular member  14  and against the bias of compression spring  42 . As specifically shown in  FIG. 16 , when locking plate  38  is in the distal most position relative to body portion  32  of elongate tubular member  14 , hole  58  of key hole slot  54  in locking plate  38  is positioned directly above a depression  130  formed in body portion  32  of elongate tubular member  14 . As further best shown in  FIG. 16 , locking plate  38  includes a distal arm  132  which engages a proximal end  134  of compression spring  42 . Compression spring  42  is constrained within a spring trough  136  formed in body portion  32 . A distal end  138  of compression spring  42  abuts a distal end  140  of spring trough  136 . 
         [0061]    With specific reference now to  FIG. 17 , once shipping wedge  10  has been fully manipulated in the direction of the arrow A to bring flexible arcuate arms  92 ,  94 ,  96  and  98  into engagement with cover tube  34  ( FIG. 14 ), proximal locking pin  60  of shipping wedge  10  is seated in depression  130  in body portion  32  of elongate tubular member  14  such that circular locking flange  78  of proximal locking pin  60  is within depression  130  and downward extension  76  of proximal locking pin  60  is positioned within hole  58  of key hole slot  54  in locking plate  38 . In this position, locking plate  38  is in the distal most or unlocked condition enabling proximal locking pin  60  of shipping wedge  10  to be inserted and subsequently removed through keyhole slot  54  of locking plate  38 . 
         [0062]    Referring now to  FIGS. 18 and 19 , in order to move locking plate  38  into a locked condition distal pressure is removed from actuator  46  allowing lockout mechanism  40 , including extension rod  44  and lockout plate  38  to move proximally in the direction of arrow C against the bias of compression spring  42 . As specifically shown in  FIG. 19 , when locking plate  38  is in a proximal most position, narrower width keyway  56  of keyhole slot  54  is located over depression  130  formed a body portion  32  of elongate tubular member  14 . 
         [0063]    With reference to  FIG. 20 , it can be seen that with locking plate  38  of lockout mechanism  40  in a proximal or a locked position, downward extension  76  of proximal locking pin  60  is positioned within keyway  56  of keyhole slot  54 . Circular locking flange  78  of proximal locking pin  60 , being larger in diameter than the width of keyway  56  in keyhole slot  54 , prevents removal of proximal locking pin  60  out of depression  130  formed in body portion  32 . This prevents shipping wedge  10  from being removed from body portion  32  and, in turn, loading unit  14  when locking mechanism  40 , and specifically locking plate  38 , is in the distal most or locked condition. In this manner, locking mechanism  40  completely prevents removal of shipping wedge  10  from loading unit  12  until such time as locking mechanism  40  has been moved to the unlocked condition either artificially during initial assembly of shipping wedge  10  to loading unit  12  or, more importantly, during movement of actuator  46  distally by installation of loading unit  12  fully into a surgical stapling instrument. 
         [0064]    Referring finally to  FIGS. 21 and 22 , and as noted herein above, shipping wedge  10 , and in particular distal hook  62  of shipping wedge  10 , is provided to prevent inadvertent and premature movement or advancement of a knife blade  142  included in loading unit  12  distally within elongate tubular member  14 . As best shown in  FIG. 22 , with distal hook  62  positioned through hole  64  in elongate tubular member  14 , a proximal end  144  of distal hook  62  blocks distal movement of knife blade  142  by engagement with a distal end  146  of knife blade  142 . 
         [0065]    It will be understood that various modifications may be made to the embodiments disclosed herein. For example, the locking pin on the shipping wedge or loading lock may have alternative shapes, such as, for example T-shaped, etc. Further, the locking pin may be engaged by an edge of the locking plate. Additionally, the distal hook of the shipping wedge or loading lock may engage alternate components on the SULU such as, for example, driving bars for ejecting the staples, etc. The loading unit shown in  FIG. 1  has a staple cartridge and an anvil. However, surgical instruments having staple cartridges that are removable and replaceable are also contemplated. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.