Abstract:
A laparoscopic suturing device includes a handle and a shaft mounted to the handle. A toggle knob is adapted to rotate the shaft about its longitudinal axis. A pair of opposed jaws, each having a hollow structure, open and close relative to one another. A needle carrier and a needle holder are respectively slideably disposed in a lumen of a first and a second jaw. A needle has first and second pointed ends and is adapted to be press fit into the lumen of the first jaw with the first pointed end exposed and alternatively into the lumen of the second jaw with the second pointed end exposed. A spring-loaded pusher advances and retracts the needle carrier when the toggle knob is in a first position and advances and retracts the needle holder when in a second position. The tool assists a surgeon in suturing tissue captured between the jaws.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates, generally, to surgical instruments. More particularly, it relates to suturing and knot tying instruments for use during minimally invasive surgery. 
     2. Description of the Prior Art 
     Laparoscopic suturing is a challenging skill to master for surgeons performing laparoscopic surgery. It is often the rate-limiting step that prevents surgeons from performing more advanced surgical procedures in a minimally-invasive manner. Laparoscopic suturing is challenging for several reasons. First, the surgeon is operating in three dimensional space while viewing the procedure on a two dimensional screen. Second, grasping the small needle and placing the needle through tissue without wristed motion is very challenging since surgeons operate using elongated rigid shafts. Moreover, tying an appropriate knot after the suture is placed, and getting the knot secured to the appropriate tissue from a distance through small laparoscopic ports, is technically challenging. 
     Several conventional devices that assist surgeons in the performance of laparoscopic suturing are commercially available. Each of the known devices has various advantages and disadvantages, and most of these devices require the use of specific suture exclusively designed for the device. Since the suture for each of these devices is limited, the surgeon&#39;s choice of suture material is also limited. These specific sutures are also very expensive and reduce flexibility of suture available to the surgeon. Prior art sutures are also constructed with small needles attached to the end of the suture. The small needle can break during laparoscopic suturing and the small needle also limits the size of tissue that can be sutured. 
     Accordingly, there is a need for a suture assist device that works with any type of suture. 
     There is also a need for a more robust needle that is less subject to breakage than the needles heretofore known. 
     However, in view of the art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the art how the needed improvements could be provided. 
     SUMMARY OF THE INVENTION 
     The long-standing but heretofore unfulfilled need for a laparoscopic suture assist device is now met by a new, useful, and non-obvious invention. 
     The novel laparoscopic suture assist device opens widely to suture large areas of tissue. It includes a preformed needle that drives any generic suture through the tissue. The device also enables suture to be placed as a single stitch, or as a running stitch. This increases flexibility for the surgeon and decreases operative expense. The device can be used to suture multiple times throughout the surgical procedure. The device also has a unique design that allows it to open wider than the diameter of the shaft of the instrument, to maximize the area of laparoscopic suturing available to the surgeon. 
     More particularly, the novel laparoscopic suturing device includes a handle and an elongate shaft rotatably mounted to the handle. A manually controlled toggle knob is secured to the elongate shaft so that manual rotation of the toggle knob rotates the elongate shaft about its longitudinal axis. 
     A pair of opposed jaws, each having a hollow structure, open and close relative to one another. The opposing jaws are biased relative to one another so that they are separated widely from one another when in repose. A surgeon manually advances a sheath that slideably ensleeves the shaft to close the jaws and retracts the sheath to allow them to open under their inherent bias. 
     A needle holder is slideably disposed in a lumen of a first jaw and a needle carrier is slideably disposed in a lumen of a second jaw. A truncate needle has a first pointed end and a second pointed end and is adapted to be press fit into the lumen of the first jaw with the first pointed end exposed and into the lumen of the second jaw with the second pointed end exposed. 
     A spring-loaded pusher is cooperatively positioned relative to the handle and is adapted to advance and retract the needle carrier when the toggle knob is in a first position and is adapted to advance and retract the needle holder when the toggle knob is in a second position. The tool assists a surgeon in suturing tissue captured between the jaws. 
     An important object of the invention is to provide a laparoscopic assist device that can be used with any type of suture. 
     Another important object is to provide such a device having a robust needle. 
     Another object is to enable the suturing of large areas of tissue. 
     Yet another object is to enable a suture to be placed as a single stitch or as a running stitch. 
     Still another object is to provide more options to laparoscopic surgeons and to reduce the expense of operations by providing instruments with improved maneuverability, efficiency and functionality. 
     These and other important objects, advantages, and features of the invention will become clear as this description proceeds. 
     The invention accordingly comprises the features of construction, combination of elements, and arrangement of parts that will be exemplified in the disclosure set forth hereinafter and the scope of the invention will be indicated in the claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a fuller understanding of the nature and objects of the invention, reference should be made to the following detailed disclosure, taken in connection with the accompanying drawings, in which: 
         FIG. 1A  is a perspective view of a first embodiment; 
         FIG. 1B  is an enlarged perspective view of the toggle knob of the first embodiment; 
         FIG. 1C  is an enlarged perspective view of the opposed arms of the first embodiment 
         FIG. 2  is the first view of a five figure animation in perspective; 
         FIG. 3  is the second figure of said animation; 
         FIG. 4  is the third figure of said animation; 
         FIG. 5  is the fourth figure of said animation; 
         FIG. 6  is the sixth figure of said animation; 
         FIG. 7  is a perspective view of a first arm control plunger; 
         FIG. 8  is a perspective view of a plunger selector arm; 
         FIG. 9A  is a perspective, transparent view of the plunger selector arm and arm control plunger assembly; 
         FIG. 9B  is a perspective, enlarged view of the center of  FIG. 9A ; 
         FIG. 10A  is an elevational view of the novel double-pointed needle; 
         FIG. 10B  is an enlarged elevational view of the needle when press fit into the lumen of a needle carrier or holder; 
         FIG. 10C  is a perspective view of the sleeve that engages the needle when it is fully received within a needle carrier or holder; 
         FIG. 11  is an exploded side elevational view of the novel structure; 
         FIG. 12A  is the first view of a six step animation depicting the steps of tying a square knot with the novel surgical tool; 
         FIG. 12B  is the second view of said six step animation; 
         FIG. 12C  is the third view thereof; 
         FIG. 12D  is the fourth step thereof; 
         FIG. 12E  is the fifth step thereof; and 
         FIG. 12F  is the sixth step thereof. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       FIG. 1A  depicts an illustrative embodiment of the novel laparoscopic suture assist device which is denoted as a whole by the reference numeral  10 . 
     Device  10  is an eleven and a half millimeter (11.5 mm) instrument that includes nine main parts. As depicted in  FIGS. 1A ,  1 B,  1 C,  2 , and  3  those parts are handle  12 , pusher  14 , arms  16   a ,  16   b , needle carrier  18 , needle holder  20 , needle  22 , toggle knob  24 , shaft  26  and sheath  28 . 
     As will become clear as this disclosure continues, needle carrier  18  and needle holder  20  reverse roles as device  10  is used, i.e., needle  22  is carried by needle carrier  18 , inserted into needle holder  20 , and needle carrier is then withdrawn, leaving the needle in needle holder  20 . Needle holder  20  then becomes the carrier as the needle is carried to needle carrier  18  and inserted thereinto with needle holder  20  then being withdrawn. This role reversal is repeated as needed throughout a suturing procedure. 
     Needle  22  is truncate in extent and is double pointed, i.e., its opposite ends are pointed. Accordingly, a first point is exposed to a suture when needle  22  is held by needle carrier  18  and a second point is exposed when needle  22  is held by needle holder  20 . 
     Arms  16   a ,  16   b  are forced toward one another by sliding sheath  28  in a proximal to distal direction relative to shaft  26  as indicated by directional arrow  29   a  in  FIG. 1A . Suture arms  16   a ,  16   b  are formed of a flexible, resilient material so that they return under their inherent bias to their depicted position of repose upon displacement of shaft  26  in the opposite direction, as indicated by directional arrow  29   b  in  FIG. 1A . 
     Toggle knob  24  is rotatably mounted on shaft  26  so that said shaft rotates conjointly with rotation of toggle knob  24 . Finger-receiving dishes are formed in the periphery of toggle knob  24  to facilitate manual gripping thereof. 
       FIGS. 2 through 6  provide a five step animation depicting how needle  22  is transferred from needle carrier  18  to needle holder  20 . It should be understood that the same Figures can be interpreted as also disclosing the reverse procedure of transferring needle  22  from needle holder  20  to needle carrier  18 . 
     More particularly,  FIG. 2  depicts needle carrier  18  and needle holder  20  in their respective fully retracted positions within the respective lumens of hollow arms  16   a ,  16   b . Needle  22  is press fit into the distal free end of needle carrier  18 . First pointed end  22   a  of needle  22  is exposed. 
       FIG. 3  depicts needle carrier  18  after it has been slidingly displaced in a proximal to distal direction, thereby carrying needle  22  to the position depicted. The displacement means is disclosed hereinafter. 
       FIG. 4  depicts needle carrier  18  when fully extended. Pointed end  22   a  of needle  22  is now slideably received within the lumen of needle holder  20 . 
     In  FIG. 5 , needle  22 , with second pointed end  22   b  exposed, remains in the press fit grip of the lumen of needle holder  20  as needle carrier  18  is refracted by the displacement means disclosed hereinafter. 
       FIG. 6  depicts needle holder  18  fully retracted. Needle  22  remains in the grip of the lumen of needle holder  20 . 
     Needle holder  20  is displaced by the same means as needle carrier  18 . Accordingly, needle  22  can be returned to needle carrier  18 , with point  22   a  exposed, by displacement of needle holder  20 . 
     After needle  22  has been passed from needle carrier  18  to needle holder  20  as depicted in the five figure animation of  FIGS. 2-6 , the stitch is then pulled through the tissue. Needle  22  is then ready for the next maneuver. 
     A suture is located in the middle of needle  22  and it causes needle  22  to passes through tissue easily. The suture is disposed within an opening in the middle of needle  22  as depicted in  FIG. 10A . The suture may be anchored within the opening or threaded around a bar within the opening. 
     The structure depicted in  FIGS. 7-11  enables a surgeon to retract and extend needle carrier  18  and needle holder  20  independently of one another to facilitate the tying of sutures. 
       FIG. 7  depicts reduced diameter shaft  30  that is formed integrally with shaft  26 . Key  32  is formed in reduced diameter shaft  30  near the distal end thereof. As disclosed above, rotation of toggle knob  24  effects conjoint rotation of shaft  26 . More particularly, when toggle knob  24  is in a first position, key  32  is in a 12:00 position as depicted in  FIGS. 7 and 11 . When toggle knob  24  is in a second position, key  32  is in a 6:00 position as perhaps best understood in connection with  FIG. 11 . 
     Making reference now to  FIGS. 8 ,  9 A,  9 B and  11 , key  32  engages keyway  34   a  formed in first control plunger  36   a  when toggle knob  24  is in said first position and key  32  engages keyway  34   b  formed in plunger  36   b  when toggle knob  24  is rotated into its second position. Control plunger  36   a  is therefore extended and retracted conjointly with extension and retraction of shaft  26  when key  32  is in said first position and control plunger  36   b  is extended and retracted conjointly with extension and retraction of shaft  26  when key  32  is in said second position. 
     As perhaps best depicted in  FIGS. 2-6 ,  9 A and  11 , elongate flexible wire  38   a  is secured at its proximal end to the distal end of first control plunger  36   a  and elongate flexible wire  38   b  is secured at its proximal end to the distal end of second control plunger  36   b . The distal end of flexible wire  38   a  is secured to needle carrier  18  and the distal end of flexible wire  38   b  is secured to needle holder  20 . 
       FIG. 11  depicts spring  14   a . It is positioned between a proximal end of pusher  14  and the proximal end of shaft  26 . Squeezing pusher  14  like a trigger loads spring  14   a  and displaces shaft  26  in a proximal to distal direction, extending shaft  26 , and releasing the pressure on pusher  14  unloads spring  14   a  and pulls shaft  26  in a distal to proximal direction, retracting shaft  26 . Accordingly, when toggle knob  24  is in its first position, such squeezing and releasing of pusher  14  operates to push and pull (extend and retract) control plunger  36   a  and hence needle carrier  18  by means of first flexible wire  38   a . When toggle knob  24  is in its second position, such pushing and pulling of pusher  14  operates to push and pull (extend and retract) control plunger  36   b  and hence needle holder  20  by means of second flexible wire  38   b.    
     Pusher  14 , when squeezed, secures a suture, not depicted, to the center of needle  22 . Needle  22 , being pointed on both ends as at  22   a ,  22   b , allows passage through the tissue in both directions. 
     The suturing and knot tying procedure is quick and simple for surgeons and safe for patients. The steps of the procedure include loading needle  22  and suture to needle holder  20 , rotating sheath  28  and pushing it as indicated by directional arrow  29   a , inserting tool  10  inside a patient&#39;s body, retracting sheath  26  in the direction indicated by directional arrow  29   b  to open arms  16   a ,  16   b , rotating toggle knob  24  to the same side as needle  22  so that key  32  engages keyway  34   a , and activating pusher  14  by pressing on it with a trigger finger, thereby loading spring  14   a  as aforesaid, to displace needle carrier  18  in a proximal to distal direction. 
     The sheath of the proposed device is 11.5 mm in diameter and can be used on a 12-mm port, but at the tip of the device, the arms are 15 mm and cannot be inserted into body by using a 12 mm port. The arms are bigger than the 12-mm port. Therefore the sheath is used to make smaller sized arms. The two arms can be closed by sliding the sheath from back to front. Once the sheath is retracted, the suturing arms return to their original positions. 
     Needle  22  with the suture goes through the tissue and then stays on opposite arm  16   b  because it is press fit into needle holder  20 . Device  10  is then ready for the next maneuver. 
       FIG. 10C  depicts flexible and resilient sleeve  40  that is positioned at the distal end of needle carrier  18 , in the lumen thereof, as depicted in  FIG. 10B , it being understood that a similar sleeve  40  is also positioned in the lumen of needle holder  20  at its distal end. The enlarged middle  22   c  of needle  22 , depicted in  FIG. 10A , enters into the lumen of sleeve  40  and is press fit thereinto as best understood in connection with  FIG. 10B . The press fit is overcome so that needle  22  can extend from needle carrier  18  when pusher  14  is displaced as aforesaid until it reaches sleeve  40  in the lumen of needle holder  20  where it is maintained when needle carrier  18  is retracted. The same but reverse procedure delivers needle  22  from needle holder  20  to needle carrier  18 . 
     Device  10  enables a surgeon to perform suturing and knot tying procedures through extra-corporeal or intra-corporeal knot tying approaches. The tool can be used to tie square knots, a surgeon&#39;s knot, and a variety of other knots.  FIGS. 12A-12F  provide an animation for a square knot, for example. 
     It will thus be seen that the objects set forth above, and those made apparent from the foregoing disclosure, are efficiently attained and since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing disclosure or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. 
     It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention that, as a matter of language, might be said to fall therebetween.