Patent Publication Number: US-9839426-B2

Title: Jaw restraint

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 14/540,439, filed on Nov. 13, 2014, which is a continuation of U.S. patent application Ser. No. 12/956,339, filed on Nov. 30, 2010 (now abandoned). The content of this prior application is incorporated by reference herein in its entirety. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to jaw restraints for use with a jaw assembly of a surgical instrument. More particularly, the present disclosure relates to a removable jaw restraint which temporarily secures first and second jaws of a surgical instrument against movement during shipping. 
     2. Background of Related Art 
     Surgical instruments are typically transported from the manufacturer to the end user in sterile shipping packages. Some surgical instruments such as, for example, surgical stapling apparatus contain many movable parts which need to be protected during shipping. Surgical stapling instruments typically include an anvil assembly and an associated cartridge assembly which contains a plurality of staples. The staples are releasably retained within staple pockets formed within the cartridge assembly. 
     During transportation, the shipping package is often subjected to extensive handling which may result in the shipping package being bumped or shaken. This can result in movement of the staple cartridge assembly within the shipping package and possibly dislodging the staples wholly or partially from within the staple pockets. 
     Therefore, there exists a need for a jaw restraint which prevents movement of anvil and cartridge assemblies during shipping. Additionally, there exists a need for a jaw restraint which is configured to be easily disengaged from associated anvil and cartridge assemblies. There is still further need for a jaw restraint which can be secured within a shipping package to further secure the anvil assembly and cartridge assembly within the shipping package. 
     SUMMARY 
     There is disclosed a jaw restraint for releasably securing a first jaw of a tool assembly relative to a second jaw of the tool assembly to prevent movement of various components of the tool assembly during shipping. The jaw restraint generally includes a first arm for supporting a first jaw of the tool assembly and a second arm for supporting a second jaw of the tool assembly. A projection is directed inwardly between the first and second arms and is provided to be positioned within the first and second jaws of the tool assembly. A first portion connects the first arm to the projection and a second portion connects the second arm to the projection. The first and second portions are arcuate in shape and face in a first direction. The projection is also arcuate in shape and faces in a second direction generally opposite to that of the first direction. 
     The jaw restraint additionally includes a finger member extending from the first portion to facilitate biasing the first arm away from the second arm. The finger member extends in a direction opposite that of the first arm. The first arm includes a first inwardly directed lip having an enlarged distal end to prevent sideways movement of an associated anvil or cartridge assembly. 
     In a specific embodiment, the projection is formed from a flexible material. For example, the projection is formed of a polymeric material. In an alternative embodiment, the entire jaw restraint may be formed of a flexible material. In a particular embodiment, a first finger member extends from the first portion of the jaw restraint and a second finger member extends from the second portion of the jaw restraint. 
     There is also disclosed a jaw restraint for securing a first jaw of a tool assembly relative to a second jaw of the tool assembly. The jaw restraint includes a body portion having a first arm for supporting a first jaw of a tool assembly anda second arm for supporting a second jaw of the tool assembly. A projection is directed inwardly between the first and second arms. A first portion connects the first arm to the projection and a second portion connects the second arm to the projection. A finger member extends from the body portion. In a more specific embodiment, two finger members extend independently from the body portion. The two finger members are provided to be biased together in order to move the upper and lower arms away from each other. 
     There is still further disclosed a jaw restraint for use with a suture package. The jaw restraint includes a body portion having a first arm for supporting a first jaw of a tool assembly and a second arm for supporting a second jaw of the tool assembly. A projection is directed inwardly between the first and second arms and first and second portions connect the first and second arms, respectively, to the projection. A finger member extends proximally from the body portion and includes a cut out for engagement with a suture package. In one embodiment, the cut out is formed in a proximal edge of the finger member. In another embodiment, the cut out is formed in a side edge of the finger member. In still another embodiment, the cut out is formed through a generally central area of the finger member. 
     There is also disclosed a shipping package assembly having shipping package and a jaw restraint including a body portion. The body portion includes a first arm for supporting a first jaw of a tool assembly and a second arm for supporting a second jaw of the tool assembly. A projection is directed inwardly between the first and second arms and is connected to the first and second arms by respective first and second portions. A finger member extends proximally from the body portion and includes a cut out. The suture package has a projection for engagement with the cut out in the finger member in order to secure the jaw restraint to the suture package. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
       Various embodiments of the presently disclosed jaw restraint are disclosed herein with reference to the drawings, wherein: 
         FIG. 1  is a perspective view of one embodiment of a jaw restraint positioned about a tool or jaw assembly of a surgical instrument; 
         FIG. 2  is an enlarged perspective view of the jaw restraint of  FIG. 1  positioned about the jaw assembly; 
         FIG. 3  is a perspective view of the jaw restraint of  FIG. 1 ; 
         FIG. 4  is a side view of the jaw restraint of  FIG. 1 ; 
         FIG. 5  is a cross-sectional view, taken along line  5 - 5 , of  FIG. 2 ; 
         FIG. 6  is a cross-sectional view of the jaw restraint of  FIG. 1  being removed from the jaw assembly; 
         FIG. 7  is a perspective view of an alternate embodiment of a jaw restraint for use with a surgical instrument; 
         FIG. 8  is a side view of the jaw restraint of  FIG. 7  positioned about a jaw assembly; 
         FIG. 9  is a side view of the jaw restraint of  FIG. 7  being removed from the jaw assembly; 
         FIG. 10  is a perspective view of an alternate jaw restraint and loading unit of a surgical instrument positioned within a shipping package; 
         FIG. 11  is a top view of the jaw restraint and loading unit of  FIG. 10  positioned within the shipping package; 
         FIG. 12  is a cross-sectional view taken along line  12 - 12  of  FIG. 11 ; 
         FIG. 13  is a perspective view of the jaw restraint of  FIG. 10 ; 
         FIG. 14  is a side view, partially shown in section, illustrating the jaws of the loading unit being removed from the jaw restraint of  FIG. 10 ; 
         FIG. 15  is a perspective view illustrating the loading unit being removed from the shipping package; 
         FIG. 16  is a top plan view of an alternate finger member for use in a jaw restraint; and 
         FIG. 17  is a top plan view of a further alternate finger member for use in a jaw restraint. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     Embodiments of the presently disclosed jaw restraint 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. 
     Referring initially to  FIG. 1  there is disclosed one embodiment of a jaw restraint  10  for use with a surgical stapling instrument  12 . Surgical stapling instrument  12  generally includes a handle assembly  14  having an elongate member  16  extending distally from handle assembly  14 . A loading unit  18 , including a tool or jaw assembly  20 , is removably attached to a distal end  22  of elongate member  16 . Jaw assembly  20  generally includes an anvil member  26  and the cartridge assembly  28 . A jaw assembly  20  is movable from an open position to a closed position in which anvil assembly  26  and cartridge assembly  28  are in close cooperative alignment. A trigger  30  is provided on handle assembly  14  to move anvil assembly  26  from the open position to the closed position relative to cartridge assembly  28 . A rotation knob  32  is provided on elongate member  16  in order to rotate jaw assembly  20  with respect to the handle assembly  14  and relative to the tissues being operated upon. 
     Jaw restraint  10  is provided to maintain anvil assembly  26  in the open position relative to cartridge assembly  28  during shipping of loading unit  18 , in a manner described in more detail hereinbelow. By maintaining anvil assembly  26  and the open position relative to cartridge assembly  28 , jaw restraint  10  prevents shifting of, or damage to, internal components associated with anvil assembly  26  or cartridge assembly  28  due to bumping, crushing, etc. during shipment. 
     While jaw restraint  10  is described for use with surgical stapling instrument  12 , it is contemplated that jaw restraint  10  is useful with other surgical instruments having a pair of jaw members such as, for example, surgical stapling instruments including parallel jaw members, electro-surgical instruments used to join tissue, etc. 
     Referring now to  FIG. 2 , there is disclosed an enlarged view of loading unit  18  including tool assembly  20  and jaw restraint  10 . As shown, cartridge assembly  28  includes first and second longitudinally extending rows of staple containing pockets  34  and  36 . A knife slot  38  extends longitudinally through cartridge assembly  28  between first and second rows of staple containing pockets  34  and  36 . In this embodiment, the cartridge assembly  28  has three rows of staples on either side of the knife. It is contemplated herein that the disclosed jaw restraint can be used with cartridge assemblies having less than three rows of staples on either side of the knife. While not specifically shown, jaw restraint  10  is provided to maintain and stabilize anvil assembly  26  and cartridge assembly  28  in order to prevent staples (not shown) from being bumped or ejected out of the rows of staple containing pockets  34  and  36 . 
     As shown, jaw restraint  10  includes a finger member  40  to facilitate manipulation of jaw restraint  10  about anvil assembly  26  and cartridge assembly  28 . Jaw restraint  10  includes a first or upper arm  42  which is provided to engage and stabilize cartridge assembly  26  and a second or lower arm  44  which is provided to engage and stabilize cartridge assembly  28 . The first arm  42  is arcuate in shape and forms a first recess “recess  42   a ” for receiving the jaw of the tool assembly. The second arm  44  can have a similar shape and forms a second recess “recess  44   a ” for receiving the jaw of the tool assembly, where the restraint engages a surgical stapling tool, the arm for engaging the cartridge assembly has a greater depth than the other arm. 
     Referring now to  FIGS. 3 and 4 , jaw restraint  10  is at least partially formed of a generally flexible material in order to be easily removed from about anvil assembly  26  and cartridge assembly  28 . Jaw restraint  10  may be formed from a variety of materials such as polymeric copolymer materials, stainless steel, shape memory alloys, etc. Additionally, while jaw restraint  10  is illustrated as formed from generally thin rectangular material, it is also contemplated that jaw restraint  10  maybe formed from materials having other cross-sections such as, for example, tubular, solid circular, etc. 
     A resilient portion extends between the arms  42 ,  44 . Thus, jaw restraint  10  includes a resilient inwardly facing projection  46  in this embodiment provided between upper and lower arms  42  and  44 . Inwardly facing projection  46  is flexible relative to upper and lower arms  42  and  44 . Inwardly facing projection  46  functions as a hinge and is provided to bias upper and lower arms  42  and  44  into a first or closed position. Additionally, inwardly facing projection  46  is provided to extend between anvil assembly  26  and cartridge assembly  28  in order to prevent any relative movement there between during shipment. In the disclosed embodiment only one inwardly facing projection is shown, however, it is contemplated that more than one inwardly projection can be used. Upper arm  42  is connected to inwardly facing projection  46  by a first arcuate member or portion  48 . Likewise, lower arm  44  is connected to inwardly facing projection  46  by a second arcuate member or portion  50 . Wherein, the second arcuate member portion  50  has a greater depth “d” than the first arcuate member portion  48 . Inwardly facing projection  46  also has a generally arcuate shape facing generally in an opposite direction from first and second arcuate portions  48  and  50 . 
     In this embodiment, finger member  40  extends proximally from first arcuate portion  48 . In order to inhibit anvil assembly  26  and cartridge assembly  28  from sliding sideways out between upper arm  42  and lower arm  44 , upper and lower arms  42  and  44  are provided with first and second inwardly directed lips  52  and  54 . First and second inwardly directed lips  52  and  54  are provided with respective enlarged distal ends  56  and  58  to further inhibit any sideways movement of anvil assembly  26  and cartridge assembly  28  relative to jaw restraint  10 . 
     It should be noted that, the various disclosed jaw restraints and elements of the jaw restraint, such as jaw restraint  10 , may be formed as a single, integral body member or, alternatively may be formed from separate components joined together through various known methods such as, for example, welding, gluing, etc. 
     Referring now to  FIGS. 5 and 6 , and initially with respect to  FIG. 5 , the use of jaw restraint  10  to stabilize anvil assembly  26  and cartridge assembly  28  during shipment will now be described. As noted herein above, cartridge assembly  28  includes a plurality of staples  60  provided within first and second rows of staple containing pockets  34  and  36 . First and second rows of staple containing pockets  34  and  36  are formed in a plastic body portion  62  of cartridge assembly  28 . A generally U-shaped channel member  64  is provided to support body portion  62 . Anvil assembly  26  includes an upper anvil member  66  and a lower anvil plate  68  which is provided to crimp staples  60 . 
     Prior to shipment, jaw restraint  10  is positioned about anvil assembly  26  and cartridge assembly  28 . Specifically, upper arm  42  of jaw restraint  10  engages and secures anvil assembly  26  while lower arm  44  engages and secures cartridge assembly  28 . As shown, inwardly facing projection  46  extends between anvil plate  68  of anvil assembly  26  and body portion  62  of cartridge assembly  28  to thereby inhibit any movement of anvil assembly  26  relative to cartridge member  28  during shipping. 
     Additionally, first and second lips  52  and  54 , along with respective enlarged distal ends  56  and  58 , provided on upper and lower arms  42  and  44 , respectively, assist in preventing anvil assembly  26  and cartridge assembly  28  from sliding sideways in the direction of arrow A out of jaw restraint  10 . 
     Referring now to  FIG. 6 , in order to remove jaw restraint  10  from anvil assembly  26  and cartridge assembly  28 , finger member  40  is moved or squeezed in the direction of arrow B flexing or compressing inwardly facing projection  46  thereby causing upper arm  42  to move or rotate in the direction of arrow C up and away from anvil assembly  26 . This causes upper arm  42  to rotate to an open position relative to lower arm  44 . Rotation of upper arm  42  to the open position frees anvil assembly  26  from between inwardly facing projection  46  and upper arm  42 . Additionally, movement of finger member  40  in the direction of arrow B, flexes the inwardly facing projection and moves inwardly facing projection  46  slightly in the direction of arrow D to free cartridge assembly  28  from between inwardly facing projection  46  and lower arm  44 . 
     Thereafter, jaw restraint  10  may be drawn sideways in the direction of arrow E away from anvil assembly  26  and cartridge assembly  28  thereby freeing anvil assembly  26  and cartridge assembly  28  from jaw restraint  10 . It should be noted that, while jaw restraint  10  is illustrated and described as being removed sideways in the direction of arrow E relative to anvil assembly  26  and cartridge assembly  28 , jaw restraint  10  may alternatively be slid longitudinally over anvil assembly  26  and cartridge assembly  28  to slide jaw restraint  10  longitudinally off of anvil assembly  26  and cartridge assembly  28 . 
     In this manner, jaw restraint  10  firmly and robustly secures cartridge assembly  28  relative to anvil assembly  26  during shipping thereby preventing any dislodging of staples  60  from rows of staple containing pockets  34  and  36  due to bumping, shaking etc. of anvil assembly  26  and cartridge assembly  28  during shipping. 
     Referring now to  FIGS. 7-9 , and initially with regard to  FIG. 7 , there is disclosed an alternative embodiment of a jaw restraint  70 . Jaw restraint  70  is similar to jaw restraint  10  and generally includes a first or upper arm  72  and a second or lower arm  74 . An inwardly facing projection  76  is positioned between upper arm  72  and lower arm  74 . Upper arm  72  is connected to inwardly facing projection  76  by a first arcuate portion  78  and lower arm  74  is connected to inwardly facing projection  76  by a second arcuate portion  80 . In order to prevent sideways movement of a cartridge and anvil assembly such as, for example, cartridge assembly  28  and anvil assembly  26  described herein above, upper arm  72  has an inwardly facing first lip  82  terminating an enlarged distal end  84  and lower arm  74  has an inwardly facing second lip  86  terminating in an enlarged distal end  88 . 
     Jaw restraint  70  differs from jaw restraint  10  described herein above in that jaw restraint  70  includes a first finger member  90  extending proximally from first arcuate portion  78  and a second finger member  92  extending proximally from second arcuate portion  80 . The provision of first and second finger members  90  and  92  provide additional leverage to compress inwardly facing projection  76  and thus separate upper arm  72  from lower arm  74 . 
     Referring now to  FIGS. 8 and 9 , the use of jaw restraint  70  to secure and release anvil assembly  26  and cartridge assembly  28  will now be described. Referring initially to  FIG. 8 , in the shipping condition, upper arm  72  engages anvil assembly  26  and secures it against inwardly facing projection  76 . First lip  82 , including enlarged distal end  84 , inhibits sideways movement of anvil assembly  26  relative to inwardly facing projection  76 . Similarly, lower arm  74  engages cartridge assembly  28  and second lip  86  including an enlarged distal end  88  inhibit sideways movement of cartridge assembly  26  relative to inwardly facing projection  76 . As shown, in the shipping condition, first and second finger members  90  and  92  are in a static or spaced apart condition. 
     Referring now to  FIG. 9 , in order to release anvil assembly  26  and cartridge assembly  28  from jaw restraint  70 , proximal ends  94  and  96  of first and second finger members  90  and  92 , respectively, are squeezed together in the directions of arrows F and G. This compresses inwardly facing projection  76  causing upper arm  72  and lower arm  74  to move outwardly in the directions of arrows H and I to the open position. In this open position, anvil assembly  26  and cartridge assembly  28  are free to be removed from jaw restraint  70 . Similar to that described herein above with respect to jaw restraint  10 , jaw restraint  70  may now be moved sideways relative to anvil assembly  26  and cartridge assembly  28 , or may be slid longitudinally along the long axes of anvil assembly  26  and cartridge assembly  28 , to release them from jaw restraint  70 . 
     In this manner, jaw restraint  70 , incorporating pair of finger members  90  and  92 , provides additional leverage for separating upper and lower arms  72  and  74  to release anvil assembly  26  and cartridge assembly  28  from jaw restraint  70 . 
     Referring now to  FIGS. 10-15 , there is disclosed a further embodiment of a jaw restraint  100  specifically configured for use with a shipping package  102  and loading unit  18  described herein above. Referring initially to  FIGS. 10 and 11 , jaw restraint  100  generally includes an upper arm  104  and a lower arm  106  separated by an inwardly facing projection  108 . In contrast to the finger members described herein above, a cut out  110  is provided in a proximal end  112  of a finger member  114  of jaw restraint  100  to secure jaw restraint  100  to shipping package  102 . Shipping package  102  is generally in the form of a box structure  116  having a pair of support blocks  118  and  120  for releasably securing proximal body portion  24  of loading unit  18  within shipping package  102 . Box structure  116  includes an inwardly projecting finger  122  having an enlarged end  124 . Inwardly projecting finger  122  and enlarged end  124  engage cut out  110  in proximal end  112  of finger  114  to firmly secure jaw restraint  100  to box structure  116 . As shown, inwardly projecting finger  122  extends from a sidewall  126  of box structure  116 . Box structure  116  can be formed from injection molded plastic or otherwise molded plastic. Blocks  118 ,  120  can be formed during the molding process. With recesses that engage proximal body portion  24  of the loading unit  18 . 
     Shipping package  102  may additionally be provided with a removable cover  128  positioned over box structure  116  to maintain loading unit  18  in a sterile condition ( FIG. 12 ). Cover  128  may be formed from a variety of materials such as, for example, plasticized structures, Tyvek materials, etc. 
     Referring now to  FIGS. 12 and 13 , jaw restraint  100  further includes a first arcuate portion  130  connecting upper arm  104  to inwardly facing projection  108  and a second arcuate portion  132  connecting lower arm  106  to inwardly facing projection  108 . In this embodiment, finger member  114  is formed as a proximal extension of upper arm  104 . Alternatively, finger member  114  may be formed as a proximal extension of lower arm  106  or may extend proximally from either first or second arcuate portions  130  or  132 , respectively. 
     Referring now to  FIGS. 10, 14 and 15 , and initially with regard to  FIG. 10 , in use, loading unit  18  is secured within shipping package  102  and jaw restraint  100 . Specifically, anvil assembly  26  is secured between upper arm  104  and inwardly facing projection  108  and cartridge assembly  28  is secured between lower arm  106  and inwardly facing projection  108 . In this particular embodiment, jaw restraint  100  does not include the inwardly facing lips with enlarged distal ends. In order to maintain anvil assembly  26  and cartridge assembly  28  within jaw restraint  100 , proximal body portion  24  of loading unit  18  is releasably secured between blocks  118  and  120  formed in box structure  116 . Loading unit  118  is maintained in a sterile condition within shipping package  102  by cover  128 . 
     Referring now to  FIGS. 14 and 15 , in order to remove loading unit  18  from shipping package  102 , cover  128  is initially peeled off box structure  116  to expose loading unit  18 . Thereafter, proximal body portion  24  of loading unit  18  is lifted free of blocks  118  and  120  of box structure  116  and anvil assembly  26  and  28  may be pulled free from jaw restraint  100 . 
     Referring now to  FIG. 16  there is disclosed an alternate finger member  134  for use with any of the above described jaw restraints such as, for example, jaw restraint  100 . Finger member  134  includes a pair of side cutouts  136  and  138  formed in side edges  140  and  142  of finger member  134 . Side cutouts  136  and  138  are provided to cooperate with corresponding structure in a shipping package to secure jaw restraint  100  within the shipping package. More specifically, the box structure includes a pair of fingers with enlarged ends for being releasably disposed in the cut outs  136 ,  138 . 
     Referring to  FIG. 17 , there is disclosed a finger member  144  for use with any of the above described jaw restraints. In this particular embodiment, finger member  144  includes a central cut out  146  formed in finger member  144 . Central cut out  146  is provided to receive and engage an upwardly projecting member or plug  148  formed on a shipping package  150  in order to secure the associated jaw restraint within shipping package  150 . 
     It will be understood that various modifications may be made to the embodiments disclosed herein. For example, the disclosed finger members may extend proximally from the upper or lower arms or the first or second arcuate portions. Further, alternative structure may be provided on the underside of the upper and lower arms to secure the cartridge assemblies within the disclosed jaw restraint, such as, for example, adhesives, abraded surfaces, etc. Additionally, the disclosed jaw restraints may be provided with jaw or tool assembly restraining structure on only one of the upper or lower arms. Still further, the assembly retaining structure may be configured to completely encircle the respective anvil or cartridge assembly such that disclosed jaw restraint is slid longitudinally along the respective anvil cartridge assembly to release the anvil cartridge assembly from the disclosed jaw restraint. 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.