Abstract:
A method for stapling tissue using the steps of providing a surgical stapling device having a handle with a longitudinal axis extending between a proximal end and a distal end having an end effector disposed thereon, which is substantially perpendicular to the longitudinal axis. The end effector comprising a staple cartridge housing a plurality of staples, the end effector having an open position and a closed position. The device also has an elongated trigger having a distal end and a proximal end, wherein the distal end of the trigger is pivotably attached to the handle. The trigger has an open position wherein the proximal end of the trigger is spaced apart from the handle, and a closed position wherein the proximal end of the trigger is closely adjacent the handle. Lastly, the device has an actuator for ejecting the plurality of staples from the cartridge towards the anvil, the actuator is a rotatable knob mounted onto the distal end of the handle. The method further involves the step of moving the end effector to its closed position by moving the trigger towards the handle. The method also involves the step of ejecting the plurality of staples from the cartridge by rotating the knob.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention has application in conventional open surgical instrumentation as well application in robotic-assisted surgery. The present invention has even further relation to linear staples and staplers.  
       BACKGROUND OF THE INVENTION  
       [0002]     Surgical staplers are frequently used in surgical procedures for suturing body tissues such as, for example, intestinal and gastric walls. Such devices typically include a staple holder, or cartridge, which is disposed on one side of the tissue to be fastened and an anvil assembly on the other side of the tissue. During the surgical procedure, the staples are driven from the cartridge by some type of actuator so that the ends of the staples pass through the tissue and then are bent inwardly by the anvil so as to produce an array of finished fasteners in the tissue. During the typical suturing process, pusher members associated with the cartridge are controllably advanced by the operating mechanism of the instrument in a manner to urge the staples out of the cartridge, through the tissue and forcibly against the anvil.  
         [0003]     One such frequently used type of surgical stapler is the open linear stapler, which is a device that enables the surgeon to simultaneously place one or more rows of surgical staples in body tissue or organs. By way of example, a typical procedure is a pneumectomy, which is a removal of a portion of the patient&#39;s lungs. The linear stapler can be used several times during this procedure, including for the occlusion of the pulmonary artery prior to its resection. For this later use, the surgeon first clamps the jaws of the stapler across the artery then forms the staple and before reopening the stapler jaws, cuts the artery with a scalpel using the edge of the staple jaws as a guide.  
         [0004]     An example of an open linear stapler is disclosed in U.S. Pat. No. 5,706,998 issued to Plyley et al. A surgical stapler is described having a supporting frame including a stationary jaw having an anvil, a movable jaw, a replaceable staple cartridge carried by the movable jaw, a mechanism for approximating the cartridge relative to the anvil, and a mechanism for firing the device so as to crimp the staples against the anvil in a manner to enable the surgeon to substantially simultaneously place one or more rows of surgical staples in organs or tissues. The device includes interrelated, cooperating first and second locking mechanisms for positively preventing re-firing if the staple cartridge is spent and for providing a tactile sensation to the surgeon to indicate that a spent staple cartridge is present within the instrument. One of the drawbacks to this design is the large amount of force required for the surgeon to fire the staples using the firing mechanism. Having an open linear stapler with a large amount of force required for the surgeon to fire the staples limits the number of surgeons that can actually use the device because of the strength required to actuate the firing mechanism. Another drawback of this design is the fact that no cutting means, or knife, is available to use after the staples have been fired.  
         [0005]     Another example of an open linear stapler is disclosed in U.S. Pat. No. 3,692,224 issued to Astafiev et al. A surgical stapling apparatus is described including a support housing having an open longitudinal cavity wherein slidable rods of the staple housing and pusher are accommodated. The staple housing has a head provided with a socket in which a magazine with staples in entirely inserted. The staple housing and the pusher are provided with screw drives to axially shift them relative to the support housing. The apparatus also includes a limit strip capable of retaining the magazine when it is completely pushed into the socket and holding the tissue being sutured. The limit strip interacts with the nut of the drive of the staple housing whereby the drive of the pusher is blocked with the drive of the staple housing in such a manner that a predetermined sequence of actions is provided during the operation of the apparatus. In accordance with this sequence, the staple housing can move only after the magazine is completely pushed into the socket of the staple housing and the pusher can displace only after the staple housing has defined for a maximal suturing gap between the working surface of the magazine and the die. One of the drawbacks of this design is the inability to grasp the tissue and secure it prior to firing the staples. Without being able to secure the tissue, if a surgeon slips firing the device, he or she may misplace the staples from their intended position. Another drawback of this design is the fact that no cutting means, or knife, is available to use after the staples have been fired.  
         [0006]     The prior art open linear staplers all exhibit one or more drawbacks that have thus far limited their usefulness to the surgeon using these open linear staplers. What is needed therefore is an open linear stapler that has a low actuation force required to fire the staples and an integrated knife, which also cuts with this low actuation force.  
       SUMMARY OF THE INVENTION  
       [0007]     The present invention provides method for stapling tissue using the steps of providing a surgical stapling device having a handle with a longitudinal axis extending between a proximal end and a distal end having an end effector disposed thereon, which is substantially perpendicular to the longitudinal axis. The end effector comprising a staple cartridge housing a plurality of staples, the end effector having an open position and a closed position. The device also has an elongated trigger having a distal end and a proximal end, wherein the distal end of the trigger is pivotably attached to the handle. The trigger has an open position wherein the proximal end of the trigger is spaced apart from the handle, and a closed position wherein the proximal end of the trigger is closely adjacent the handle. Lastly, the device has an actuator for ejecting the plurality of staples from the cartridge towards the anvil, the actuator is a rotatable knob mounted onto the distal end of the handle. The method further involves the step of moving the end effector to its closed position by moving the trigger towards the handle. The method also involves the step of ejecting the plurality of staples from the cartridge by rotating the knob.  
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0008]     The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which:  
         [0009]      FIG. 1  illustrates an isometric view of the linear stapler of the present invention in its open position.  
         [0010]      FIG. 2  illustrates an isometric view of the end effector of the linear stapler of the present invention.  
         [0011]      FIG. 3  illustrates an isometric view of the linear stapler of the present invention in its open and pre-stapled position with the outer handle shrouding removed to expose inner components.  
         [0012]      FIG. 4  illustrates an isometric view of the linear stapler of the present invention in its closed and pre-stapled position with the outer handle shrouding of the invention is removed to expose inner components.  
         [0013]      FIG. 5  illustrates a close-up isometric view of proximal internal components of the linear stapler of the present invention showing the linear stapler in its open and post-stapled position.  
         [0014]      FIG. 6  illustrates a close-up isometric view of proximal internal components of the linear stapler of the present invention showing the linear stapler in its closed and post-stapled position.  
         [0015]      FIG. 7  illustrates an isometric view of internal components of the linear stapler of the present invention showing the linear stapler in its closed and stapled position.  
         [0016]      FIG. 8  illustrates a side view of internal components of the linear stapler of the present invention showing the safety mechanism through which the firing bars cannot be advanced until the trigger is closed.  
         [0017]      FIG. 9  illustrates a side view of internal components of the linear stapler of the present invention showing the safety mechanism through which the trigger cannot be opened while firing.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0018]     As used herein, the term “proximal” refers to a location on the linear stapler closest to the clinician using the device and thus furthest from the patient on which the device is used. Conversely, the term “distal” refers to a location farthest from the clinician and closest to the patient.  
         [0019]     As illustrated in  FIG. 1 , linear stapler  2  comprises of frame assembly  4 , closure assembly  20 , firing assembly  50 , and a U-shaped end effector  70 . Frame assembly  4  includes first hook  5  and second hook  6 . First hook  5  and second hook  6 , which can be made of, but is not limited to, stainless steel, play an integral role in connecting end effector  60  to frame assembly  4 , which will be described in more detail later. Frame assembly  4  further includes handle outer shrouding  8 . Handle outer shrouding  8 , which can be used to grip and maneuver linear stapler  2 , includes left handle shrouding  10  and right handle shrouding  11  (not shown but opposite of left handle shrouding  10 ). Right handle shrouding  11  and left handle shrouding  10  are preferably made of a polymer such as, for example, polycarbonate. Right handle shrouding  11  can be coupled to left handle shrouding  10  by gluing or any other suitable attachment means suitable to those skilled in the art to form handle outer shrouding  8  of frame assembly  4 .  
         [0020]     Referring to  FIG. 2 , end effector  70 , which is located at the proximal end of linear stapler  2 , includes cartridge  72  and anvil  74 . The cartridge  72  has a tissue contacting surface  75  which displays a plurality of staple- containing slots  76  in vertical rows. Cartridge  72  further includes an opening  73  therethrough located at its top end and an integrated knife  78  therein. Integrated knife  78  can be actuated by the firing assembly  50 , which will be described in more detail later, to cut the tissue between the rows of staples formed therearound. Staples (not shown) are fired from the cartridge  72  against the staple-forming surface of the anvil  74  (not shown), which faces the tissue-contacting surface  75  of the cartridge  72 . End effector  70  further includes end effector pin  80 , which is preferably made of, but is not limited to, stainless steel. End effector pin  80  can be slid through opening  73  of cartridge  72  and screwed into a circular screw slot located at the top end of anvil  74  (not shown) to help secure the frame assembly  4 , the cartridge  72  and the anvil  74  and will be described in more detail later.  
         [0021]     As illustrated in  FIG. 1 , linear stapler  2  comprises of frame assembly  4 , closure assembly  20  ( FIG. 8 ), firing assembly  50  ( FIG. 5 ), and a U-shaped end effector  70 . Frame assembly  4  includes first hook  5  and second hook  6 . First hook  5  and second hook  6 , which can be made of, but is not limited to, stainless steel, play an integral role in connecting end effector  70  to frame assembly  4 , which will be described in more detail later. Frame assembly  4  further includes handle outer shrouding  8 . Handle outer shrouding  8 , which can be used to grip and maneuver linear stapler  2 , includes left handle shrouding  10  and right handle shrouding  11 . Right handle shrouding  11  and left handle shrouding  10  are preferably made of a polymer such as, for example, polycarbonate. Right handle shrouding  11  can be coupled to left handle shrouding  10  by gluing or any other suitable attachment means suitable to those skilled in the art to form handle outer shrouding  8  of frame assembly  4 .  
         [0022]     Referring to  FIG. 2 , end effector  70 , which is located at the proximal end of linear stapler  2  ( FIG. 1 ), includes cartridge  72  and anvil  74 . The cartridge  72  has a tissue contacting surface  75  which displays a plurality of staple- containing slots  76  in vertical rows. Cartridge  72  further includes an opening  73  therethrough located at its top end and an integrated knife  78  therein. Integrated knife  78  can be actuated by the firing assembly  50  ( FIG. 5 ), which will be described in more detail later, to cut the tissue between the rows of staples formed therearound. Staples (not shown) are fired from the cartridge  72  against the staple-forming surface of the anvil  74  (not shown), which faces the tissue-contacting surface  75  of the cartridge  72 . End effector  70  further includes end effector pin  80 , which is preferably made of, but is not limited to, stainless steel. End effector pin  80  can be slid through opening  73  of cartridge  72  and screwed into a circular screw slot located at the top end of anvil  74  (not shown) to help secure the frame assembly  4 , the cartridge  72  and the anvil  74  and will be described in more detail later.  
         [0023]     As illustrated in  FIGS. 8-9 , closure assembly  20  includes trigger  22 , first linkage system  28 , second linkage system  38 , closure assembly pin  41 , first closure plate  51  ( FIG. 7 ), and second closure plate  52  ( FIG. 7 ). Trigger  22  includes a trigger shrouding  23 , a first frame wing  24 , and a second frame wing  26  (not shown but opposite first frame wing  24 ). Trigger shrouding  23 , which can be made of, but is not limited to a polymer such as, for example, polycarbonate, has a first sidewall and second sidewall. First frame wing  24 , which can be made of, but is not limited to, stainless steel, extends downward from the distal end of first side of trigger shrouding  23 . Similarly, second frame wing  26 , which can be made of, but is not limited to, stainless steel, extends downward from the distal end of second side of trigger shrouding  23 . Trigger  22  further includes first linkage plate  25  and second linkage plate  27  (not shown but opposite first linkage plate  25 ). First linkage plate  25 , which can be made of but is not limited stainless steel, extends downward from the first sidewall of trigger shrouding  23  between its proximal and distal ends. First linkage plate  25  has a slot therein which plays an integral role in connecting first linkage system  28  and second linkage system  38  to trigger shrouding  23  and will be described in more detail later. Second linkage plate  27 , which can be made of but is not limited stainless steel, extends downward from the second sidewall of trigger shrouding  23  between its proximal and distal ends. Second linkage plate  27  has a slot therein which plays an integral role in connecting first linkage system  28  and second linkage system  38  to trigger shrouding  23  and will be described in more detail later. First linkage system  28 , which can be made of, but is not limited to, a polymer such as, for example, ultem, has a proximal end and a distal end. At the distal end of first linkage system  28  is lock surface  30 , and first linkage system pin  34 . At the proximal end of first linkage system  28  is first closure assembly pin opening  36 . Second linkage system  38 , which can be made of, but is not limited to, a polymer such as, for example, ultem, has a proximal end and a distal end. At the distal end of second linkage system  38  is second closure assembly pin opening  40 . At the proximal end of second linkage system  38  is second linkage system pin  42 . Second linkage system pin  42  plays an integral role in connecting frame assembly  4  to trigger  22  and will be described in more detail later. First linkage system  28  is assembled to second linkage system  38  such that first closure assembly pin opening  36  is aligned with second closure assembly pin opening  40  thereby allowing closure assembly pin  41  to be inserted therethrough. Trigger  22  is then assembled to first linkage system  28  and second linkage system  38  such that closure assembly pin  41  resides in both slots of first linkage plate  25  and second linkage plate  27 .  
         [0024]     As shown in  FIGS. 3-7 , firing mechanism  50  includes first closure plate  51 , second closure plate  52 , first firing bar  54 , second firing bar  55 , first spacer  56 , second spacer  57 , knife bar  58 , screw block  60 , drive screw  62 , and stapling knob  64 . First closure plate  51  and second closure plate  52 , which can be made of, but is not limited to, stainless steel, play an integral role in both closure mechanism  20  and firing mechanism  40  and will be described in more detail later. Attached to the proximal end of first closure plate  51  and second closure plate  52  is screw block  60 . Screw block  60 , which can be made of, but is not limited to, a polymer such as, for example, ultem, includes drive screw  62  passing therethrough. Drive screw  62 , which has a proximal and distal end, can be made of, but is not limited, to a polymer such as, for example, ultem. Attached to the proximal end of drive screw  62 , via a slip fit or any other suitable attachment means known to those skilled in the art, is stabling knob  64 . Stapling knob  64 , which can be made of, but is not limited to, a polymer such as, for example, polycarbonate, can be used by the surgeon to fire staples from linear stapler  2  at a much smaller force to fire than conventional stapling mechanisms. The distal end of drive screw  62  is attached to the proximal end of knife bar  58  via a rotatable coupling or other known art. Knife bar  58 , which has proximal and distal end, can be made of, but is not limited to, a polymer such as, for example, ultem. The distal end of knife bar  58  is attached integrated knife  78  and will be described in more detail later. Knife bar  58  further includes two side walls. Attached to one side wall of knife bar  58  is first firing bar  54 , which can be made of, but is not limited to stainless steel. Attached to the opposite side of knife bar  58  is second firing bar  55 , which can be made of, but is not limited to, stainless steel. Attached to the outside of first firing bar  54  is first spacer  56 . Similarly, attached to the outside of second firing bar  55  is second spacer  57 . First spacer  56 , which can be made of, but is not limited to, a polymer such as, for example, polycarbonate, has an outside wall. Second spacer  57 , which can be made of, but is not limited to, a polymer such as, fore example, polycarbonate, has an outside wall. The outside wall of first spacer  56  slidably situated adjacent to first closure plate  51 . Similarly, the outside wall of second spacer  57  slidably situated adjacent to second closure plate  52 .  
         [0025]     Referring now to  FIGS. 3-7 , firing assembly  50  is assembled to frame assembly  4  as follows; 
    the outside of first closure plate  51  is slidably situated adjacent to the inside of first hook  5 ; and     the outside of second closure plate  52  is slidably situated adjacent to the inside of second hook  6 .    
 
         [0028]     Now closure assembly  20  is assembled to frame assembly  4  ( FIG. 4 ) and firing assembly  50  as follows; 
    first linkage system pin  34  of first linkage system  28  is attached to the opening of wing of first closure plate  51  of firing assembly  50  and the opening of wing of second closure plate  52  of firing assembly  50  respectively; and     second linkage system pin  42  of second linkage system  38  is attached to the opening of wing of first hook  5  of frame assembly  4  ( FIG. 4 ) and the opening of wing of second hook  6  of frame assembly  4  ( FIG. 4 ) respectively.    
 
         [0031]     Finally, frame assembly  4  ( FIG. 4 ) including closure assembly  20  and firing assembly  50  is assembled to end effector  70  as follows; 
    the distal end of knife bar  58  is attached to the proximal end of integrated knife  78  ( FIG. 2 ) in cartridge  72  ( FIG. 2 );     the distal end of first firing bar  54  is adjacent to the proximal end of cartridge  72  ( FIG. 2 ) such that it pushes one side of staples out into anvil  74  ( FIG. 2 ) when actuated;     the distal end of second firing bar  55  is adjacent to the proximal end of cartridge  72  ( FIG. 2 ) such that it pushes one side of staples out into anvil  74  ( FIG. 2 ) when actuated;     the distal end of first closure plate  51  is attached to the side of cartridge  72  ( FIG. 2 ) and the distal end of second closure plate  52  is attached to the opposite side of cartridge  72  ( FIG. 2 ) such that when closure mechanism  20  is closed by actuating trigger  22  first closure plate  51  and second closure plate  52  move distally moving cartridge  72  ( FIG. 2 ) distally as well; and     stationary slot pin  67  connects first hook to second hook such that stationary slot pin  67  extends through the slots of the closure plates, spacer plates and the firing bar.    
 
         [0037]     In an actual surgical procedure utilizing the device of the present invention, after gaining access to the surgical site through, the surgeon inserts linear stapler  2  through the access way to the surgical site such that the tissue to be stapled is placed between the staple cartridge  72  and anvil  74  of the end effector  70 . As the closure trigger  22  is actuated and the linkage system is closed, first linkage system  28  is moved forward thereby moving the closure plates  51  &amp;  52  forward compressing the target tissue between the anvil  74  and cartridge  72 . As the closure plates  51  &amp;  52  are moved forward, the stapling mechanism is moved forward within the frame of the device. At this point the staple knob  64  at the proximal end of the device is rotated. As the stapling knob  64  is rotated the drive screw  62  is rotated and translates distally through the screw block  60 . The distal end of the drive screw  62  pushes the knife bar  58  forward thereby pushing the firing bars  54  &amp;  55  forward and forming the staples as well as pushing the knife forward and dividing the tissue at the midline of the staples. The staples and knife are timed as to allow for the majority of the staple forming operation to occur before the knife divides the tissue.  
         [0038]     Lastly, it is preferred that device disclosed above be sterilized. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam.  
         [0039]     While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. For example, as would be apparent to those skilled in the art, the disclosures herein have equal application in robotic-assisted surgery. In addition, it should be understood that every structure described above has a function and such structure can be referred to as a means for performing that function. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.