Abstract:
A surgical stapling instrument for performing a vascular anastomosis procedure comprises an elongated body  10  and a needle  12  having a hook  12   b  for penetrating and everting the edges  56, 58  of tissue to be joined. The needle  12  is slidable in the body  10  between an extended position as shown and a retracted position wherein the hook is engaged with the end  10   a  of the body. A stapling mechanism includes a slidable pusher  40  for driving a staple  36  longitudinally of the body  10  against the inside of the hook  12   b  for deformation of the staple into penetrating engagement with the everted tissue edges  56, 58.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to surgical stapling instruments, and in particular to instruments for performing a vascular anastomosis procedure.  
         BACKGROUND OF THE INVENTION  
         [0002]    The term “anastomosis” covers a variety of procedures in which blood vessels such as veins and arteries, or other tubular members, such as part of the colon, intestines, stomach etc., are joined or reconnected. These vessels may be joined in a variety of relative orientations, including end-to-end and end-to-side and side-to side.  
           [0003]    Recent advances made in the field of microsurgery and beating heart surgery have led to the development of alternatives to conventional suturing processes for joining vessels in order to accommodate the minute size of the vessels and in particular towards achieving a rapid anastomosis during beating heart (off-pump) coronary artery bypass surgery.  
           [0004]    An alternative to suturing is the use of surgical clips which are applied along the junction between the vessels or tissue portions which are to be joined, and the clips perform a holding function similar to that of sutures. Two such non-penetrating clips are shown in U.S. Pat. Nos. 4,586,503 and 4,733,664.  
           [0005]    The former patent discloses a surgical micro clip composed of plastically deformable metal or plastic material having minimal spring back when crimped. The clip has a pair of parallel curved legs joined by a bridge at one end and terminating in round tips at the other end. The clip grips the edges of the everted tissue and joins them by crimping the legs together.  
           [0006]    The latter patent discloses a vascular surgical clip comprising a plastically deformable body portion, a tang for deforming the body, and the neck connecting the tang to the body. The body is designed to deform upon application to the tang of a predetermined tensile force, and the neck is designed to break upon application of a force in excess of the predetermined force to the tang.  
           [0007]    As described in the above patents, the non-penetrating clips are applied over opposed edges of the vessels, the edges being first everted, or turned outward, to form flanges that are gripped between the jaws of the clips. A disadvantage of the above non-penetrating clip is the necessity to apply these clips to the outside of the everted tissues. The anastomosed vessels being repaired need to be returned to the intended function as quickly as possible, particularly where critical blood flow is involved.  
           [0008]    The need therefore, exists for an instrument for rapidly applying surgical staples from either within the lumen or from outside the site of the anastomosis.  
         SUMMARY OF THE INVENTION  
         [0009]    Accordingly, the present invention provides a surgical stapling instrument for stapling edges of tissue to be joined, the instrument comprising an elongated body and, carried by the body, a rigid member having a hooked end for penetrating the edges of tissue to be joined and stapling means for applying a staple to the edges held by the hooked end of the rigid member.  
           [0010]    The invention also provides a device which accomplishes the same result with folds in tissue, i.e. rather than stapling two edges of tissue, an unbroken area of tissue may be folded and the folds stapled together in the same manner.  
           [0011]    Preferably the stapling means comprises means for driving a staple longitudinally of the body against the inside of the hooked end of the needle for deformation of the staple into penetrating engagement with the everted edges.  
           [0012]    The present invention may be used to perform a variety of vascular anastomosis including peripheral vascular surgical anastomosis, arterial venous fistula formation for dialysis, and coronary artery bypass anastomosis. More particularly, the present invention may be used to perform a coronary artery bypass anastomosis utilising a number of approaches including an open-chest approach (with and without cardiopulmonary bypass), a closed-chest approach under direct viewing and/or indirect thorascopic viewing (with and without cardiopulmonary bypass).  
           [0013]    In an embodiment of the invention the instrument includes an elongated body with a handle at one end (herein referred to as the rear end) and which terminates at the other (front) end in a vascular staple delivery mechanism and a tissue grasping needle having a sharp hooked end. The elongated body portion includes two manually slidable members, the first to extend and retract the needle relative to the front end of the body and the second to deliver a staple which is deformed around an anvil on the inside of the hooked end of the needle. The staple is advanced by a spring biased pusher member coupled to the second slider.  
           [0014]    Upon approximation of one of the tissue walls to be anastomosed by a suitable vascular forceps, the needle is extended so that the sharp hooked end of the needle is advanced free of the front end of the body so that, by manipulation by the user, it can penetrate and hook the tissue wall. When one tissue wall has been hooked, the forceps are used to approximate the other tissue wall which is then also hooked by the extended needle. The needle is configured so that when the tissue wall has been hooked it is inclined to slide back towards the narrow hooked end. The width of the hooked end is optimally equivalent to the combined wall thicknesses of the tissue walls being anastomosed. The needle is then retracted so that the hooked end grasping the tissue walls engages the front end of the body for stability during the subsequent staple delivery.  
           [0015]    Once the tissue to be anastomosed has been grasped and approximated against the front end of the body the pusher member is advanced forwardly along a track in which a staple from a stack of 20 or more is positioned. The pusher member advances the staple along the track until the staple legs engage the inside edge of the hooked end of the needle. As the staple is further advanced the legs are deformed inward and toward each other by the anvil through the hole in the tissue walls created by the needle. Once the staple is deployed the pusher member returns so that its front end is positioned proximal to the staple stack.  
           [0016]    The needle slider is then advanced so as to move the needle and stapled tissue away from the front end of the body to allow the needle to be unhooked from the stapled tissue.  
           [0017]    In a further aspect the invention provides a method of stapling the edges of tissue to be joined, comprising the steps of:  
           [0018]    a) penetrating the edges of tissue to be joined with a rigid member having a hooked end; and  
           [0019]    b) applying a staple to the edges held by the hooked end of the rigid member. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0020]    The embodiment of the invention will now be described, by way of example, with reference to the accompanying drawings, in which:  
         [0021]    [0021]FIGS. 1A to  1 C are, respectively, a side view, a top plan view and an opposite side view of an instrument for applying a surgical staple to a blood vessel during a microsurgical anastomosis procedure;  
         [0022]    [0022]FIGS. 2A to  2 C are longitudinal sectional views of the instrument, similar to those of FIGS. 1A to  1 C, with the needle extended in preparation for penetrating and grasping the edges of tissue to be anastomosed;  
         [0023]    [0023]FIGS. 3A to  3 C are longitudinal sectional views of the instrument, similar to those of FIGS. 2A to  2 C, with the needle retracted after having penetrated and grasped the edges of the tissue;  
         [0024]    [0024]FIGS. 4A to  4 C are longitudinal sectional views of the instrument, similar to those of FIGS. 2A to  2 C, showing a staple driven forwardly into the hook of the needle just prior to closing the staple onto the tissue;  
         [0025]    [0025]FIG. 4D is an enlarged detailed view of the circled part of FIG. 4C;  
         [0026]    [0026]FIGS. 5A to  5 C are longitudinal sectional views of the instrument, similar to those of FIGS. 2A to  2 C, just after closure of the staple;  
         [0027]    [0027]FIG. 5D is an enlarged detailed view of the circled part of FIG. 5C;  
         [0028]    [0028]FIG. 5E is an enlarged detailed view of the circled part of FIG. 5D;  
         [0029]    [0029]FIG. 5F is an enlarged cross-section taken on the line A-A of FIG. 5D;  
         [0030]    [0030]FIGS. 6A to  6 C are longitudinal sectional views of the instrument, similar to those of FIGS. 2A to  2 C, with the needle extended once again to release the stapled tissue;  
         [0031]    [0031]FIG. 6D is an enlarged detailed view of the circled part of FIG. 6C;  
         [0032]    [0032]FIG. 7 is a schematic side view of the tip of the instrument during the creation of a pleat in tissue; and  
         [0033]    [0033]FIG. 8 is a sectional side view of the pleat when created by the instrument.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0034]    Referring now to the drawings, an instrument for applying a surgical staple to a blood vessel during a microsurgical anastomosis procedure comprises an elongated hollow body  10  having a front “business” end  10   a  and a rear handle end  10   b . A needle  12  is mounted within the body  10  and has a straight body portion  12   a  and a hooked front end  12   b  (hereinafter referred to simply as a hook), the hook  12   b  terminating in a sharp outwardly inclined tip  12   c.    
         [0035]    The body portion  12   a  of the needle is parallel to the longitudinal axis of the body  10  and is slidable longitudinally of the body  10  between an extended position, FIGS. 2 and 6, wherein the hook  12   b  is free of the front end  10   a  of the body  10  and a retracted position, FIGS. 1, 3,  4  and  5 , wherein the opposite sides  12   b   1  and  12   b   2  of the hook are engaged with the front end  10   a  of the body.  
         [0036]    The needle  12  is actuated between its extended and retracted positions by a thumb-operated slider  14  mounted on the outside of the body  10  and fixed to the rear end of the needle portion  12   a  through a longitudinal slot  16  (FIG. 1A) in the body. In its extended position the needle  12  is able to penetrate and evert tissue walls to be anastomosed, while in its retracted position the needle allows a staple to be delivered to the everted tissue walls, as will be described.  
         [0037]    The slider  14  also operates a needle lock  18  via a push rod  20  which is slidable longitudinally of the body  10  in a bearing  22 . The needle lock comprises a U-shaped member  18  which embraces the front end  10   a  of the body  10  and whose opposite arms  18   a ,  18   b  are pivoted to the front end of the push rod  20  for rotation about an axis  24  normal to the axis of the body  10 . The arms  18   a ,  18   b  also slide in respective bearings  26  which are mounted on opposite sides of the front end  10   a  of the body  10  for rotation about an axis  28  parallel to the axis  24 .  
         [0038]    When the needle  12  is fully retracted (FIGS. 1, 3,  4  and  5 ) the base  18   c  of the U-shaped member  18  engages in a groove  30  in the front end  10   a  of the body  10  just behind the needle tip  12   c.    
         [0039]    This maintains the inside edge of the side  12   b   1  of the hook in alignment with one edge  32   a  of a narrow staple guide slot  32  in the body  10 , the straight portion  12   a  of the needle extending along the opposite edge  32   b  of the guide slot. As will be described, this provides continuous guidance for a staple along the guide slot  32 , out of the front end  10   a  of the body  10  and between the opposite sides  12   b   1  and  12   b   2  of the hook fully to the curved base  12   b   3  of the hook.  
         [0040]    When the slider  14  is pushed forwardly to extend the needle  12 , the push rod  20  pushes the pivot axis  24  forwardly so that the U-shaped member  18  rotates and slides in the bearings  26  so that it is lifted out of the groove  30  to allow free forward movement of the tip  12   c  of the needle, FIGS. 2 and 6.  
         [0041]    A stack  34  of staples  36  are accommodated in the body  10 , the stack  34  being pressed laterally towards the guide slot  32  by a leaf spring  38  so that the lowermost staple in the stack (as seen in FIG. 2B) is aligned with the staple guide slot  32  with its legs pointing forward (FIG. 2C).  
         [0042]    Staples are contained in a removable cartridge-like housing. When the contents of the cartridge have been exhausted, the empty cartridge is ejected from the device and replaced with a new cartridge pre-loaded with the desired quantity of staples.  
         [0043]    A staple pusher  40  is slidable in the guide slot  32  behind the staple  36 , so that, when the needle  12  is fully retracted, by sliding the pusher  40  forwardly the staple  36  currently aligned with the slot  32  is pushed forwardly along the slot, toward the forward end  10   a  of the body  10 , between the opposite sides  12   b   1  and  12   b   2  of the hook  12   b  and finally up against the curved base  12   b   3  of the hook. The pusher  40  is actuated by a further thumb-operated slider  42  mounted on the outside of the body  10  and fixed to the rear end of the pusher  40  through a further longitudinal slot  44  (FIG. 1C) in the body.  
         [0044]    The slider  42  is coupled to the rear end  10   b  of the body  10  by a tension spring  46  which biases the pusher  40  towards the rear end  10   b . Therefore, the user has to push against the bias of the spring  46  when advancing the pusher  40 . However, a ratchet  48  engaged by a ratchet spring  50  fixed to the slider  42  ensures that the pusher  40  cannot inadvertently return towards the rear end  10   b  of the body  10  until a full forward stroke of the pusher  40  has been completed, at which point the ratchet spring disengages from the front end  48   a  of the ratchet  48  (FIG. 5B) to allow return of the pusher.  
         [0045]    Except at the curved base  12   b   3  of the hook  12   b  the needle  12  has a generally C-shaped cross-section along its full length. This defines a channel  52  along the inside edge of the needle  12 . When the needle  12  is fully retracted and a staple  36  is pushed forwardly by the pusher  40  as described, within the body  10  the staple is guided towards the hook  12   b  by sliding along the slot  32  with one leg of the staple engaging in the channel  52  in the straight portion  12   a  of the needle and the other leg of the staple engaging the edge  32   a  of the slot. When the staple  36  leaves the front end  10   a  of the body  10  the leg previously engaging the edge  32   a  of the slot  32  now enters and slides along the channel  52  in the side  12   b   1  of the hook which is held in alignment with the edge  32   a  by the needle lock  18 . At the same time the other leg of the staple  36  continues along the channel  52  in the side  12   b   2  of the hook (FIGS. 5E and 5F).  
         [0046]    At the curved base  12   b   3  of the hook  12   b  the inside edge of the needle has an anvil bump  54 , FIG. 5E. As a staple  36  is driven up against the base  12   b   3  of the hook by the pusher  40 , the legs of the staple are deformed so that they close to penetrate the everted tissue walls held by the hook  12   b  (FIG. 5D).  
         [0047]    In use of the instrument, one of the tissue walls  56  to be anastomosed is grasped by a suitable vascular forceps. Then the needle  12  is extended so that the needle lock  18  is rotated out of the groove  30  and the hook  12   b  is advanced free of the front end  10   a  of the body  10  (FIG. 2) so that, by manipulation by the user, it can penetrate and hook the tissue wall  56 . When one tissue wall has been hooked, the forceps are used to grasp the other tissue wall  58  which is then also hooked by the extended needle.  
         [0048]    The needle is manipulated so that the hooked tissue flaps slide toward the curved base. The needle  12  is then retracted so that the hook  12   b  engages the front end  10   a  of the body  10  and the needle lock  18  rotates back into the groove  30 , FIG. 3. It will be noted that retraction of the needle automatically everts the tissue walls  56 ,  58 . The front end  10   a  of the body  10  has a V-shaped slot  60  which guides the side  12   b   1  of the hook to its final position in alignment with the edge  32   a  of the slot  32 .  
         [0049]    Now the pusher  40  is advanced forwardly to drive the lowermost staple  36  in the stack  34  along the track  32  until the staple legs engage the channel  52  in the inside edges of the opposite sides  12   b   1  and  12   b   2  of the hook  12   b , FIG. 4. As the staple is further advanced its legs are deformed inward and toward each other by the anvil bump  54  so that the legs of the staple pass through the holes in the tissue walls  56 ,  58  created by the needle  12 , FIG. 5. Once the staple is deployed the pusher  40  returns so that its front end is once more positioned behind the staple stack  34  ready for a future deployment.  
         [0050]    The needle slider  14  is then advanced so as to move the needle hook  12   b  and stapled tissue away from the front end  10  of the body  10  to allow the needle  12  to be unhooked from the stapled tissue, FIG. 6.  
         [0051]    The staple is made from a biocompatible material such as titanium or stainless steel. Specialist materials such as nitinol (memory metal) may also be used. Typically the material used will be ductile, easily formed, and will have minimum spring back. Preferably, the staple will be generally U-shaped with a curved base and straight sides, the sides being angled outward with respect to its centre-line. When loaded in the cartridge, the legs are compressed inwards until approximately parallel with the centre-line. This outward bias on the legs ensures they remain stacked tightly in position within the cartridge and prevents inadvertent forward movement of the staple when advancing along guide slot  32 .  
         [0052]    While the staple legs are preferably pointed as shown, pointed ends are not necessarily required as the tissue grasping needle will already have punctured the tissue when the staple is deployed.  
         [0053]    In another embodiment an adjustment feature is added to the device which allows the user to vary the forward movement of the staple pusher  40 . it can be seen that advancing the pusher beyond its normal stop will close the staple further. This has advantage where the user finds that the factory setting is insufficient to form a tight anastomosis. The device can then be adjusted to allow the staple pusher  40  advance further thereby closing the staple more tightly and providing a better quality anastomosis.  
         [0054]    In another application the device may be used to create folds or pleats in tissue. An example of this is the creation of folds at the gastro-oesophagal junction as a possible cure of gastro-oesophagal reflux disease (GERD). In this instance, as illustrated in FIG. 7, the needle  12  is displaced forward from the front end  10   a  of the stapler and is used to penetrate a pair of convex tissue folds  70  defining a concave fold  72  between them. A staple  36  is then applied onto the needle  12  in the manner described previously, and the staple deformed as shown in FIG. 8 to capture the concave fold  72 .  
         [0055]    The invention is not limited to the embodiment described herein which may be modified or varied without departing from the scope of the invention.