Abstract:
A procedure wherein an elongate, at least partially flexible tie member is partially wound about tissues to be closed at a surgical site. Opposite ends of the flexible tie element are entrained by a twisting instrument which has a distal end juxtaposed to the surgical site. The twisting instrument extends out of the patient so that a proximal end of the instrument is manipulable by a surgeon. The surgeon rotates the instrument about a longitudinal axis, thereby twisting the tie member multiple turns about itself. Where the tie member is a wire, the twisting effectively locks the tie member at the surgical site. The tie member may then be severed by a cutters so that the tissues are closed.

Description:
BACKGROUND OF THE INVENTION 
     This invention relates to a method for forming a surgical closure. This invention also relates to a device for use in the method. More specifically, this invention relates to a surgical instrument and an associated method for forming a closure in organic tissues of a patient in a minimally invasive endoscopic operation. The invention is useful in laparoscopic, arthroscopic, thoracoscopic, etc., procedures. 
     Minimally invasive surgical procedures such as laparoscopy, arthroscopy, thoracoscopy, etc., use endoscopes (laparoscopes, arthroscopes . . .) for enabling visual observation of a surgical site below the patient&#39;s skin surface. These minimally invasive operations generally entail the placement of one or more cannulas in the patient&#39;s skin. The cannulas penetrate to the surgical site and various instruments are inserted through the cannulas to perform an operation on organic tissues which remain mostly covered by the skin surfaces of the patient. 
     A continuing problem in such minimally invasive operations is the formation of surgical closures inside the body. The suturing of an incision, the closure of a wound or the ligating of a tube inside the body through endoscopic cannulas is a difficult and tedious task. Various methods have been proposed for simplifying and facilitating the formation of sutures. U.S. Pat. No. 5,037,433, for example, discloses a method for performing a surgical operation on internal body tissues of a patient which comprises the steps of inserting a tubular endoscope member through an aperture in the patient&#39;s body, using the endoscope to visually locate the internal body tissues inside the patient&#39;s body, and upon locating the surgical site, pushing an elongate flexible rod member in a distal direction through a biopsy channel in the tubular endoscope member to eject a needle disposed in a straightened configuration inside the channel at a distal end of the tubular endoscope member. In this method, the needle has a spring bias construction tending to automatically bend the needle into an arcuate configuration, and the needle further has a proximal end attached to a suture. Upon ejection of the needle from the endoscope biopsy channel, the needle is passed in the arcuate configuration through the internal body tissues. After passing of the needle through the internal body tissues, the suture is closed, whereupon the tubular endoscope member is withdrawn or removed from the patient&#39;s body though the introduction aperture. 
     Other recently proposed methods entail the tying of sutures outside the body and sliding the suture ties down through a cannula to the surgical site inside the patient. 
     Nevertheless, despite these recent proposals, no method has been generally adopted by surgeons who regularly perform minimally invasive surgical operations. 
     OBJECTS OF THE INVENTION 
     An object of the present invention is to provide an instrument and/or an associated method for forming a surgical closure inside a patient through a small opening in the skin surface of the patient. 
     Another object of the present invention is to provide such an instrument and associated closure method which is easy to use. 
     A further object of the present invention is to provide such an instrument and associated method which result in a reliable closure. 
     These and other objects of the present invention will be apparent from the drawings and descriptions herein. 
     SUMMARY OF THE INVENTION 
     These objects are attained in a procedure wherein an elongate, at least partially flexible tie member is partially wound about tissues to be closed at a surgical site. Opposite ends of the flexible tie element are entrained by a twisting instrument which has a distal end juxtaposed to the surgical site. The twisting instrument extends out of the patient so that a proximal end of the instrument is manipulable by a surgeon. The surgeon rotates the instrument about a longitudinal axis, thereby twisting the tie member multiple turns about itself. 
     Where the tie member is a wire, the twisting effectively locks the tie member at the surgical site. The tie member may then be severed by a cutters so that the tissues are closed. 
     Where the tie member is a suture, the suture may be locked after the twisting operation by placing a clamp or clip on the twisted portion of the suture. The clamp or clip may be a welded clip as disclosed in U.S. Pat. No. 5,383,883, the disclosure of which is hereby incorporated by reference. The locking of the suture may additionally or alternatively be effectuated through the application of glue. A glue gun or ejector may be used to apply a drop of glue to the twisted part of the suture prior to the severing of the suture. Alternatively, the glue may be dried on the suture and subsequently activated by a heating instrument. 
     In one embodiment of the present invention, the twisting instrument has a pair of pivoting jaws at a distal end. The jaws are provided with a passageway for the tie member. The instrument is inserted into the patient and the jaws opened and subsequently closed about the tissues (e.g., a blood vessel or duct). After the closure of the jaws inside the patient, an end of the tie member is threaded from one jaw to another and gripped by the second jaw. The jaws are then opened and pulled away from the surgical site. The tie member slides out of the first jaw during the opening of the jaws and during the withdrawal of the instrument from the surgical site. Thus, a loop is formed about the tissues to be closed. The instrument is then turned about its longitudinal axis, thereby twisting the tie member between the jaws and the target tissues of the patient. Where the tie member is a wire, the twisting effectively locks the tie member at the surgical site. Where the tie member is a suture, the suture is locked after the twisting operation by an additional procedural step such as placing a clamp or clip and/or gluing. After locking, the tie member is severed by a cutters so that the tissues are closed. 
     Other types of twisting devices may be used to perform a surgical closure operation in accordance with the present invention. For example, an elongate tube provided at a distal end with a pair of eyelets, or a pair of hooks, may be used for twisting a wire or suture after the wire or suture has been partially wound around tissues to be closed. This winding can be accomplished with elongate forceps-type instruments commonly used in minimally invasive endoscopic operations. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a schematic side elevational view of a laparoscopic or arthroscopic instrument in accordance with the present invention. 
     FIG. 2 is a partial schematic view, partially broken away, of a patient undergoing a laparoscopic closure operation utilizing the instrument of FIG.  1 . 
     FIGS. 3A-3F are respective schematic perspective views showing additional successive steps in the operation depicted in FIG.  2 . 
     FIG. 4 is a schematic perspective view, similar to FIG. 3E, showing an alternative step in the laparoscopic operation illustrated in FIGS.  2  and  3 A- 3 F. 
     FIG. 5 is a schematic perspective view, similar to FIG. 3E, showing another alternative step in the laparoscopic operation illustrated in FIGS.  2  and  3 A- 3 F. 
     FIGS. 6A-6D are schematic sectional views of a patient undergoing a laparoscopic closure operation in accordance with the present invention, utilizing a different instrument. 
     FIG. 7 is a schematic side elevational view of another laparoscopic or arthroscopic instrument in accordance with the present invention. 
     FIG. 8 is a partial perspective view of one end of the instrument of FIG.  7 . 
     FIG. 9 is a partial perspective view similar to FIG. 8, showing a modified design for the instrument of FIG.  7 . 
     FIG. 10 is a partial perspective view similar to FIG. 8, showing a further alternative design for the instrument of FIG.  7 . 
     FIG. 11 is a schematic side elevational view showing the instrument of FIGS. 7 and 8,  9 , or  10  inserted through a cannula to perform a laparoscopic or arthroscopic closure operation. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     As illustrated in FIG. 1, a surgical instrument  10  for use in performing surgical closures in minimally invasive endoscopic-type procedures such as laparoscopic or arthroscopic surgery includes an elongate shaft  12  provided at a distal end with a pair of pivotably mounted jaws  14  and  16 . At least one jaw  14  is provided with a passageway  18  through which extends an at least partially flexible tie member  20  such as a wire. The other jaw  16  is provided with an opening  22  which serves to grip a free end of wire  20  upon a pushing of wire  20  through passageway  18 . The gripping action may be accomplished by a friction fit of wire  20  in opening  22 . Alternatively, jaw  16  may be provided with an active gripping element such as a clamp actuatable from a proximal end  24  of instrument  10 . A pair of pivotably mounted handgrips  26  and  28  extending from proximal end  24  of instrument  10  are operatively coupled to jaws  14  and  16  for alternately opening and closing the jaws. 
     As illustrated in FIG. 2, instrument  10  is inserted into a patient PT through a cannula  30  which traverses a skin surface SUR of the patient and extends into a natural or artificially generated cavity CAV to a surgical site SS. Upon insertion of a distal end portion of instrument  10  through cannula  30 , handgrips  26  and  28  are actuated to open jaws  14  and  16 , as shown in FIG.  2 . Further steps in the laparoscopic procedure are depicted in FIGS. 3A-3F. First, handgrips  26  and  28  are operated to close jaws  14  and  16  about tissues  32  to be closed. In the example of FIGS.  2  and  3 A- 3 F, these tissues  32  take the form of a tube (e.g., a cystic duct) or a blood vessel. 
     Upon the closure of jaws  14  and  16 , closure wire  20  is pushed through passageway  18  and into opening  22 , whereupon the free or distal end of wire  20  is gripped by jaw  16 . In the event that a suture rather than wire  20  is used as the closure or tie member, jaw  16  is provided with a gripper, such as clamping jaws (not illustrated). This gripper is attached to a tensile element or rod (not shown) which extends back to the proximal end of instrument  10 . The tensile element or rod is pulled to draw the free end of the suture out of jaw  14  and into jaw  16 . 
     After the extension of closure or tie wire  20  from jaw  14  to jaw  16 , handgrips  26  and  28  are again actuated to open jaws  14  and  16 , as illustrated in FIG.  3 B. At that juncture, the entire instrument  10  is drawn in a proximal direction, as indicated by an arrow  34  in FIG. 3C, so that a loop  36  is formed in wire  20 , the loop being partially wound about tube or duct  32 . Upon the formation of loop  36 , instrument  10  is rotated about its longitudinal axis, as indicated by an arrow  38  in FIG.  3 D. This rotation twists closure or tie wire  20  about itself, as indicated at  40 . 
     As illustrated in FIG. 3E, a laparoscopic scissors or clipper instrument  42  is inserted into the patient&#39;s cavity CAV via another laparoscopic trocar sleeve or cannula (not shown). After the formation of twists  40  in wire  20 , scissors or clipper instrument  42  is operated to sever the wire  20  (FIG.  3 F). Twists  40  are permanent deformations of wire  20  and serve to lock the wire in a closure about tube or duct  32 . 
     FIG. 4 shows a variation of the operation of FIGS.  2  and  3 A- 3 F where a suture  44  is used instead of a wire  20  to close tube or duct  32 . A clip or clamp  46  made of biocompatible material is placed about suture  44  to lock the suture after a twisting thereof pursuant to the step shown in FIG.  3 D. Clip or clamp  46  may closed or locked by ultrasonic welding or convention heating, as disclosed in U.S. Pat. No. 5,383,883, the disclosure of which is hereby incorporated by reference. Other types of clips are also possible, including, for instance, hook and loop type fastening elements. 
     FIG. 5 depicts an alternative locking technique to the procedure of FIG. 4 where suture  44  is used to close tube or duct  32 . Instead of or in addition to clip  46 , a drop of biocompatible adhesive  48  is applied to the twisted suture via a laparoscopic or arthroscopic glue gun  50 . After glue drop  48  dries, scissors or clipper instrument  42  is used to sever the suture on a side of the dried glue drop  48  opposite tube or duct  32 . 
     In an alternative non-illustrated procedure, the suture is coated with a layer of glue which can be activated or set by the application of heat, radiation, ultrasonic vibrations, or other form of energy,. An instrument applies the energy after the twisting of the suture at the surgical site as described above or below. 
     In a variation of the above procedure utilizing a different twisting instrument  52  (FIGS.  6 C and  6 D), a laparoscopic forceps  54  is partially inserted into an abdominal cavity ABC through a laparoscopic trocar sleeve or cannula  56 , as shown in FIG.  6 A. Jaws  58  at the distal end of forceps instrument  54  grip a suture needle  60  to which a suture or wire  62  is attached. Forceps  54  (or another forceps inserted through a different cannula) is manipulated to insert needle  60  through internal organic tissues TI at a surgical site SIS so that suture or wire  62  extends through the tissues and partially surrounds a wound or incision WN to be closed, as illustrated in FIG.  6 B. Opposite ends of suture or wire  62  extend out of the patient through sleeve or cannula  56 . Instrument  52  (FIG. 6C) is then used to entrain the opposite ends of suture or wire  62 . More particularly, instrument  52  includes an elongate shaft  64  provided at one end with a flange  66  in turn formed with a pair of apertures  68  and  70  through which the ends of suture or wire  62  are passed, as shown in FIG.  6 C. After the threading of the ends of suture or wire  62  through apertures  68  and  70 , instrument  52  is inserted partially into the patient through sleeve or cannula  56 , as illustrated in FIG.  6 D. Then, instrument shaft  64  is rotated about its longitudinal axis, as indicated by an arrow  72  in FIG. 6D, to form a series of twists  74  in suture or wire  62  at wound or incision WN. The twists  74  are locked as described above with reference to FIGS. 3F,  4  and  5 , and then severed by a scissors or cutter instrument  76 . 
     FIG. 7 shows a twisting instrument  78  comprising a tube  80  which may have a slightly conical form. Tube  80  is open at opposite ends and is provided at a smaller end with a formation  82  (FIG. 8) for entraining two ends of a suture or wire. Formation  82  comprises a crosspiece  84  which divides the shaft opening into two portions  86  and  88 . Alternatively, suture entrainment is accomplished by a pair of hooks  90  and  92 , shown in FIG. 9, or a pair of eyelets  94  and  96 , shown in FIG.  10 . 
     FIG. 11 illustrates the use of instrument  78 . Tube  80 , with opposite ends  100  and  102  of a suture or wire (not separately designated) entrained by formation  82  (FIG.  8 ), hooks  90  and  92  (FIG.  9 ), or eyelets  94  and  96  (FIG.  10 ), is inserted through a sleeve or cannula  98 . Tube  80  is then rotated about its longitudinal axis to form a series of twists  104  in the suture or wire. 
     It is to be understood that the laparoscopic procedures detailed herein are merely exemplary of minimally invasive operations conducted under visual observation mediated by one or other type of endoscopic instrument.