Abstract:
A surgical device to perform open, endoscopic and/or laparoscopic surgical operations. The surgical device includes a handle assembly and at least one disposable loading unit. The handle assembly includes a casing forming a housing, a stationary handle element, and a handle element movable by way of an actuating movement. The at least one disposable loading unit may be reversibly mounted at least partially inside the casing, and includes an actuation mechanism.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a National Stage Application of PCT International Application No. PCT/FR2014/052926 (filed on Nov. 17, 2014), under 35 U.S.C. §371, which claims priority to French Patent Application No. 13 61249 (filed on Nov. 18, 2013), which are each hereby incorporated by reference in their respective entireties. 
     
    
     TECHNICAL FIELD 
       [0002]    The invention relates to a surgical device, and more particularly a device intended to perform open, endoscopic and/or laparoscopic surgical operations. 
       BACKGROUND 
       [0003]    Numerous surgical techniques are known from the prior art equally well in open surgery and in endoscopic and laparoscopic surgery. Typically, in a surgical procedure, each operative step performed by the surgeon requires the use of a different surgical tool. Indeed, during a procedure, the surgeon may be required to use a plurality of different tools, for example to fit clips or staples of different sizes and shapes, and very regularly in large numbers. Each of these instruments or applicators must be sterilized. Such practices increase the procedure time, the complexity and overall cost associated with these procedures. 
         [0004]    A number of prior art documents have proposed providing a surgical device capable of receiving refills of a type of surgical tool, particularly reloadable surgical clip applicators or reloadable staplers, in order to reduce at least partially the overall cost of these procedures. 
         [0005]    The document EP 0 760 230 A1 describes a surgical stapler comprising an actuating handle assembly and a disposable loading unit containing a plurality of staples, and an anvil fitted to be adjacent to the staple cartridge and movable being an open position and a closed position. 
         [0006]    The document U.S. Pat. No. 6,869,435 B2 describes a surgical instrument suitable for applying surgical fasteners during a surgical procedure. The instrument comprises a functional shaft with functional components, and a removable fastener cartridge equipped with a fastener application mechanism. 
         [0007]    Though comprising disposable loading units enabling reuse of the shaft or handle during a surgical operation, the devices of the prior art very often exhibit malfunctions thus invalidating the reusable nature thereof. Indeed, for such reloadable devices, the complementarity of the mechanisms between that comprised in the handle (or shaft) and that comprised in the tool engaging in the handle must be such that, once the tool is engaged in the handle, the device must be operational immediately and in complete safety. 
         [0008]    A first aim according to the invention is that of proposing an ergonomic surgical device, that is simple to manufacture and operate, easy to use, and suitable for reducing the time of a surgical procedure. 
         [0009]    A further aim according to the invention is that of proposing a suitable device suitable for accomplishing a plurality of different tasks, and notably capable of stapling, applying surgical clips, dissecting, clamping or making an incision. 
         [0010]    A further aim according to the invention is that of proposing a surgical device suitable for reducing the overall cost of a surgical procedure. 
         [0011]    A final aim according to the invention is that of proposing a surgical device addressing the drawbacks of the devices of the prior art. 
       SUMMARY 
       [0012]    A first aim of the invention relates to a surgical device comprising:
       a handle assembly comprising a casing forming a housing, a stationary handle element, and a movable handle element that can be moved by means of an actuating movement;   at least one disposable loading unit suitable for being mounted at least partially in a reversible manner inside said casing forming a housing, said disposable loading unit comprising an actuation mechanism;       
 
         [0015]    said device being characterized in that said casing forming a housing supports:
       a first actuation shaft mounted to make a longitudinal movement inside the housing in response to the movement of the movable handle element;   a transmission element mounted to actuate a longitudinal movement of a second actuation shaft mounted inside said casing forming a housing in response to the longitudinal movement of the first actuation shaft;   a main actuation sled and a secondary actuation sled mounted to at least partially receive said at least one disposable loading unit, said actuation sleds being secured respectively to the actuation shafts in order to activate the actuation mechanism of the disposable loading unit in response to the longitudinal movements thereof.       
 
         [0019]    The drive shafts comprise a toothed rack, the transmission element engaging with each of said racks. 
         [0020]    Advantageously, the secondary actuation sled is contained in the main actuation sled and is suitable for moving longitudinally by means of a guiding element. 
         [0021]    Preferably, the housing further supports a retraction element connected at the proximal end thereof to the first actuation shaft and at the distal end thereof to a fixed support element. 
         [0022]    Advantageously, the drive shafts and the actuation sleds each form a single preformed part respectively. 
         [0023]    The disposable loading unit preferentially comprises a fastening element engaging at least partially with the proximal part of the body of the disposable loading unit. 
         [0024]    The casing forming a housing advantageously comprises an unlocking element, said unlocking element comprising a portion in the form of a projection extending at least partially into the casing in order to engage by locking with the edge of a locking element. 
         [0025]    A further aim relates to a kit comprising a surgical device according to the invention, and a plurality of disposable loading units in the form of surgical clip applicators each comprising at least one linear row of surgical clips. 
         [0026]    A further aim relates to a kit comprising a device according to the invention and a plurality of disposable loading units preferably selected in the group formed by:
       surgical clip applicators;   staplers;   incision tools, notably incision blades.       
 
     
    
     
       DRAWINGS 
         [0030]      FIG. 1  is a perspective representation of an embodiment of the surgical device according to the invention wherein a disposable loading unit  40  is functionally engaged in the distal part of the casing  10  forming a housing. The arrow “C” illustrates the actuation stroke of the movable handle  13 . 
           [0031]      FIG. 2 a    is a perspective view of the cross-section of the handle assembly  30  of the surgical device. 
           [0032]      FIG. 2 b    is a side cross-section view of the handle assembly  30  of the surface device according to the invention. 
           [0033]      FIG. 3 a    is a perspective representation of the actuation mechanism supported in the housing  10  of the handle assembly  30 . 
           [0034]      FIG. 3 b    is an exploded view representation of the actuation mechanism in  FIG. 3   a.    
           [0035]      FIG. 4 a    is a perspective view of a disposable loading unit  40  suitable for being functionally engaged with the handle assembly  30  of the surgical device according to the invention. 
           [0036]      FIG. 4 b    is an exploded view representation of the disposable loading unit  40  in  FIG. 4   a.    
           [0037]      FIG. 5  is a perspective representation of the engagement mechanism of a disposable loading unit  40  on the handle assembly  30  of the surgical device according to the invention. The arrow “A” shows a longitudinal translational movement in the proximal direction of the disposable loading unit  40 ; the arrow “B” shows a rotational movement of the disposable loading unit  40 . 
       
    
    
     DESCRIPTION 
       [0038]    The term “proximal” refers to the end of the device (or apparatus) closest to the operator; the term “distal” refers to the end of the device (or apparatus) furthest from the operator. 
         [0039]    Preferred embodiments of the multifunctional surgical device will now be described in detail with reference to the figures. It will be understood that a number of modifications may be made to the embodiments disclosed hereinafter. The description should not be understood to be a restriction of the invention, but merely as exemplifications of preferred embodiments. Obviously, a person skilled in the art can envisage further modifications. 
         [0040]    With reference to  FIGS. 1, 2   a  and  2   b , the handle assembly  30  comprises a stationary handle element  11  and a movable handle element  13 , and also comprises a casing  10  forming a housing which preferably consists of molded casing half-sections  10   a  and  10   b , which form the stationary handle element  11  and a shaft portion  12  of the handle assembly  30 . The handle assembly  30  comprises an opening  31  suitable for receiving a portion of a disposable loading unit  40 , as will be described in more detail hereinafter. The movable handle element  13  is supported in a pivoting manner between the casing half-sections  10   a  and  10   b  around the pivot  15  ( FIG. 2 a   ). A stress element (not shown in the figures), which is preferably a torsion spring, stresses the movable handle  13  away from the stationary handle  11 . In the shaft portion  12  are supported two drive shafts  16   a ,  16   b  each comprising a toothed rack  160   a ,  160   b . A transmission element  17  ( FIG. 2 b   ) engages with each of the two racks  160   a ,  160   b  of the drive shafts  16   a ,  16   b  and is pivotally mounted about a pivot  17   c . More particularly, the transmission element  17  consists of a notched wheel portion  17   a  suitable for engaging with the rack  160   a  of the first drive shaft, and a second notched wheel portion  17   b  suitable for engaging with the rack  160   b  of the second drive shaft  16   b . The rotational axis of both notched wheel portions  17   a ,  17   b  is situated at the pivot  17   c.    
         [0041]    The movable handle  13  can pivot to move the first actuation shaft  16   a  forward linearly in the distal direction and actuate the transmission element  17  in contact with the toothed rack  160   a  of said first actuation shaft  16   a . The rotation of the transmission element  17  enables the movement of the second actuation shaft  16   b  linearly in the proximal direction. 
         [0042]    The retraction mechanism which comprises a retraction element  18  may be advantageously connected to the proximal end of the first actuation shaft  16   a  by a traction spring  18 . In addition, the traction spring  18  is connected to a fixed support element  19 , such that said spring  18  is configured to make a longitudinal translational movement in the distal or proximal direction. 
         [0043]    With reference to  FIGS. 3 a  and 3 b   , the first drive shaft  16   a  is connected to a main actuation sled  20   a  comprising at the distal end an opening  201   a  engaging with the proximal part of the disposable loading unit  40  as described in detail further in the description. The second drive shaft  16   b  is in turn connected to the secondary actuation sled  20   b  by means of a guiding element  25 . The actuation sled  20   b  comprises at the distal end thereof an opening  201   b  engaging with the proximal part of the disposable loading unit  40 . In one preferred embodiment, the opening  201   b  of the secondary actuation sled  20   b  is smaller in diameter than that of the main actuation sled  20   a.    
         [0044]    As illustrated more clearly in  FIG. 3 b   , the secondary actuation sled  20   b  is contained in the actuation sled  20   a , and is suitable for moving longitudinally by means of a guide rail  25  suitable for moving in a sliding manner the guiding part  26  on the guide rail  25 . 
         [0045]    In one preferred embodiment, the drive shafts  16   a ,  16   b  and the actuation sleds  20   b ,  20   a  each respectively form a single preformed part by molding ( FIG. 3 b   ). 
         [0046]    With reference to the embodiments in  FIGS. 3 a  and 3 b   , a fastening mechanism of the disposable loading unit  40  extends into the casing  10  of the handle assembly  30 . The fastening mechanism comprises a first actuation sled  20   a  having a rectangular cross-section which is supported in a sliding manner with the first drive shaft  16   a , and a secondary actuation sled  20   b  having a rectangular cross-section supported in a sliding manner at the second drive shaft  16   b . The two distal openings  201   a ,  201   b  of the actuation sleds  20   a ,  20   b  having a substantially circular shape, and further comprise two additional recesses situated on either side of the opening enabling the passage of the proximal end of the disposable loading unit  40  at the proximal part  45  thereof. 
         [0047]    With reference to the embodiments in  FIGS. 1, 2 and 3 , the casing  10  contains, inter alia, the first drive shaft  16   a , the first actuation sled  20   a , the second drive shaft  16   b  and the secondary actuation sled  20   b , and the transmission element  17  and the traction element  18 ; this represents an advantageous embodiment. 
         [0048]    With reference to  FIG. 4 , the disposable loading unit  40  comprises a proximal portion  45  suitable for engaging releasably with the distal end of the handle assembly  30  ( FIG. 1 ). An actuation mechanism (not shown in the figure) comprised in the body  41  of the disposable loading unit  40  is configured to actuate the tool assembly  44 . The proximal portion  45  of the loading unit includes a first pair of hooks  450  and a second pair of hooks  451  suitable for fastening the disposable loading unit  40  on the handle assembly  30 , at the distal end of the shaft portion  12  of the casing  10 , as will be described in more detail hereinafter. The disposable loading unit  40  further comprises a locking element  46  consisting preferably of molded half-sections  46   a  and  46   b  suitable for locking and aligning the mounting assembly comprised in the body of the loading unit. The proximal end of the locking element  46  comprises an edge  46   c  suitable for engaging with the unlocking element  14  by locking. More particularly, the unlocking element comprises a portion in the form of a projection  14   a  situated in the recess  10  of the device engaging with the edge  46   c  of the locking element. 
         [0049]    In one advantageous embodiment, the disposable loading unit  40  comprises a fastening element  42  engaging at least partially with the proximal part of the body  41  of the disposable loading unit, and “surrounding” at least partially the locking element  46 . The fastening element makes it possible to retain the alignment of the assembly of constituent parts of the body  41 , and more particularly the assembly of the actuation mechanism comprised in said body  41 . Indeed, in order to function correctly, the assembly of constituent parts of the loading unit  40  must be perfectly aligned with respect to one another, with tolerances of only a few tenths of millimeter, in order to actuate the overall device. 
         [0050]    With reference to  FIGS. 4 and 5 , to use an embodiment of the surgical device according to the invention, a disposable loading unit  40  is first fastened to the distal end of the handle assembly  30 . To fasten the disposable loading unit  40  to the handle assembly  30 , the proximal portion  45  of the loading unit is inserted into the opening  30   a  of the handle assembly  30 , the first pair of hooks  450  is made slide longitudinally in the distal end of the casing  10  in the direct shown by the arrow “A” in  FIG. 5 , such that the first pair of hoods  450  is engaged in a first phase through the first actuation sled  20   a  via to the distal opening  201   a , then in a second phase through the second actuation sled  20   b  via the distal opening  201   b . When the first pair of hooks  450  is engaged in the actuation sled  20   b , the second pair of hooks  451  is engaged through the actuation sled  20   a  via the distal opening  201   a . Simultaneously, the proximal end of the locking element  46  engages with the unlocking elements  14  by locking. 
         [0051]    Once the two pairs of hooks  450 ,  451  are engaged, the disposable loading unit  40  is made rotate in the direction shown by the arrow “B” in  FIG. 5  to engage the pairs of hooks  450 ,  451  with the inner shoulders of the distal ends of the actuation sleds  20   a ,  20   b . It should be noted that, when the disposable loading unit is made rotate, an audible click sound is produced indicating that the disposable loading unit  40  is fastened correctly to the housing  10 . 
         [0052]    When the disposable loading unit  40  is fastened to the casing  10 , the tool  45  can be used and positioned to dispense a plurality of clips. For this purpose, the movable handle  13  is moved in the direction shown by the arrow “C” in  FIG. 1  against the stress of the torsion spring to make the first actuation shaft  16   a  move forward linearly in the distal direction and to move the second actuation shaft  16   b  forward linearly in the proximal direction by means of the transmission element  17 . 
         [0053]    The movement of the actuation shafts  16   a ,  16   b  induces the movement of the respective actuation sleds  20   a ,  20   b  thereof. The disposable loading unit  40  being fastened to the handle  30 , the movement of the actuation sled  20   b  induces therewith the movement in the proximal direction of the first pair of hooks  450  which is rigidly connected to a first plate (not shown in the figures). The first plate thus moves longitudinally in the proximal direction until it engages with a clip “n−1” stored in the body  43  of the movable loading unit  40 . Simultaneously, the movement of the actuation sled  20   a  induces therewith the movement in the distal direction of the second pair of hooks  451  which is in turn rigidly connected to a second plate (not shown in the figures) suitable for moving a clip “n” in the distal direction, i.e. toward the tool assembly  44 . Furthermore, associated with the movement of the pair of hooks  451 , a third plate (not shown in the figures) is actuated in the distal direction toward the tool assembly  44  enabling the actuation thereof, notably making it possible in the case of a clip applicator to close the jaws of the tool assembly around the clip “n”. 
         [0054]    Advantageously, the disposable loading unit  40  further comprises a securing element  43  situated at least partially on the body  41  of the loading unit to retain the alignment of the clips comprised in the body  41  before the use of the device, notably when the device is transported or stored. During the use of the device  1 , the securing element  43  must be removed to activate the various clip dispensing mechanisms. 
         [0055]    With reference once again to  FIG. 1 , the invalidated or locked disposable loading unit  40  can be removed from the casing  10  by applying a pressure to the unlocking element  14 , then by rotating the disposable loading unit  40  in the opposite direction of the direct shown by the arrow “B” in  FIG. 5  to disengage the pairs of hooks  450 ,  451  on the inner shoulders of the actuation sleds  20   a ,  20   b . After rotation, the disposable loading unit  40  can be made slide in the opposite direction to that shown by the arrow “A” in order to detach the casing  10  from the disposable loading unit  40 . Subsequently, additional disposable loading units can be fastened to the distal end of the casing  10 , as described above, to perform the same operation, i.e. dispensing clips, or to perform further tasks, for example stapling tissue, an incision, a section operation. 
         [0056]    The device according to the invention thus comprises a simplified mechanism reducing tooling and assembly requirements considerably, while offering very good operational reliability, at least cost. In order to function correctly, the device according to the invention requires small general tolerances. By way of illustration, the general tolerances relating to the sizing of the clips are as follows: ±0.30 mm on all the plane faces of the clip, ±0.4 mm for the height, ±0.40 mm width of the clip between the jaws of a tool assembly. 
         [0057]    The disposable loading unit  40  may comprise at least one linear row of at most thirty clips, preferably at most twenty clips. These clips are used to ligate blood vessels, notably arteries, or before sectioning same or assembling organic or synthetic tissue. The clips may be absorbable or non-absorbable, in the latter case, the clips are preferably made of titanium and substantially U-shaped. Furthermore, the length of the linear row of surgical clips or staples may be modified to meet the needs of a specific surgical procedure. 
         [0058]    Obviously, a number of modifications may be made to the embodiments described above. For example, the device according to the invention does not necessarily apply only surgical clips (or surgical fasteners) but may also apply staples, for example for the ablation of all or part of an organ and/or to make it possible to carry out anastomosis. As such, the device may be used with disposable loading units designed to apply linear rows of staples and may be used to activate disposable loading units containing individual staples. 
         [0059]    The device according to the invention may also support in the housing thereof a disposable loading unit wherein the distal end part supports a blade configured to make incisions, for example an incision in stapled body tissue. 
       LIST OF REFERENCE SYMBOLS 
       [0060]      
         [0000]    
       
         
               
               
               
             
           
               
                   
                   
               
             
             
               
                   
                  1 
                 Device 
               
               
                   
                  10 
                 Casing 
               
               
                   
                  11 
                 Stationary handle element 
               
               
                   
                  12 
                 Shaft portion 
               
               
                   
                  13 
                 Movable handle element 
               
               
                   
                  14 
                 Unlocking element 
               
               
                   
                  15 
                 Pivot 
               
               
                   
                  16a 
                 First actuation shaft 
               
               
                   
                  16b 
                 Second actuation shaft 
               
               
                   
                  17 
                 Transmission element 
               
               
                   
                  18 
                 Traction element 
               
               
                   
                  19 
                 Support element 
               
               
                   
                  20a 
                 Main actuation sled 
               
               
                   
                  20b 
                 Secondary actuation sled 
               
               
                   
                  25 
                 Guide rail 
               
               
                   
                  26 
                 Guiding part 
               
               
                   
                  30 
                 Handle assembly 
               
               
                   
                  31 
                 Opening 
               
               
                   
                  40 
                 Disposable loading unit 
               
               
                   
                  41 
                 Body 
               
               
                   
                  42 
                 Fastening element 
               
               
                   
                  43 
                 Securing element 
               
               
                   
                  44 
                 Tool assembly 
               
               
                   
                  45 
                 Proximal portion 
               
               
                   
                  46 (46a, 46b) 
                 Locking element 
               
               
                   
                  46c 
                 Peripheral edge of locking element 
               
               
                   
                 160a, 160b 
                 Toothed racks 
               
               
                   
                 201a, 201b 
                 Distal openings 
               
               
                   
                 450 
                 Lower dental canal 
               
               
                   
                 451 
                 Horizontal partition