Abstract:
A surgical instrument, a snap-on guide and method capable of being used for closure of fascia and other laparoscopic procedures that use large operative ports or trocars and is intended to help prevent post-operative hernia defects and is also used to stop acute bleeding from the abdominal wall. The instrument shaft with the needle tip is attached to a hand piece allowing the operator to control the retractable grasping surface. The needle guide directly applies onto the shaft of a trocar and it slides down to the level of the subcutaneous tissue helping the operator to place the needle. Once the suture is passed through the abdominal wall, it is released then the needle is re-inserted through the opposite “guide port”. The suture creates an intra-abdominal loop of suture outside the abdomen. Suture ends will be tied, allowing closure of the fascial defect within the abdominal wall.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
         [0001]    Not Applicable  
         STATMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
         [0002]    Not Applicable  
         DESCRIPTION OF ATTACHED APPENDIX  
         [0003]    Not Applicable  
         BACKGROUND OF THE INVENTION  
         [0004]    This invention relates generally to the field of laparascopic surgery and more specifically to a surgical fascia closure instrument, guide and method.  
           [0005]    1. Field of the Invention  
           [0006]    The present invention relates to improvements in the procedure for suturing tissue during laparoscopic surgery. More particularly, the invention relates to a method of suturing which utilizes a modified laparoscopic grasper and a guide. An alternative embodiment of the laparoscopic grasper has an interchangeable shaft configuration.  
           [0007]    2. Description of the Related Art  
           [0008]    An endoscopic/laparoscopy procedure involves making small surgical incisions in a patient&#39;s body for the insertion of trocar tubes thereby creating access ports into the patient&#39;s body. Thereafter, various types of endoscopic/laparoscopic instruments are inserted through these access ports and the appropriate surgical procedures are carried out.  
           [0009]    After the surgical procedure is performed, the trocar tubes are usually removed and the incisions sutured closed by using both a needle and grasper for penetrating the tissue and handling the suture. This procedure for closure is frequently a time-consuming procedure requiring the identification of the fascia and closure of each fascial site with suture from an external point.  
           [0010]    The necessity for closing these port sites in laparoscopic surgery is critical since suturing the incisions improperly can lead to bowel herniation through the port sites as well as the possibility of omental trapping if the fascial sites are not properly closed. Incisional hernias have occurred in both laparoscopic-assisted vaginal hysterectomies and laparoscopic cholecystectomies as well as other advanced laparoscopic procedures.  
           [0011]    Thus there is a need for an endoscopic/laparoscopic instrument, a guide and method which will significantly reduce the operating time and is better able to give the surgeon direct visualization of the fascial and peritoneal closing. Additionally, there is a need for a surgical instrument which allows the surgeon to control bleeding sites by rapidly putting sutures around blood vessels of the abdominal wall without the need to remove trocar tubes already in the wound.  
           [0012]    U.S. Pat. No. 6,183,485 issued to Rodger D. Thomason on Feb. 6, 2001  
           [0013]    This patent is directed to a suturing means and method using a laparoscopic surgical instrument and a guide. The laparoscopic surgical instrument comprises a modified laparoscopic grasper wherein forceps jaws at the tip are manipulated by means of handles extending from a tubular housing with an enclosed reciprocating actuating rod connected with the handlers. The laparoscopic surgical instrument of this patent has the tip of the forceps jaws modified to have either a knife-, chisel-, or cone-shaped tip when the jaws are in the closed position. The guide is used for directing the surgical instrument to accurately pierce the tissue and carry the suture to the predetermined area of the body. To place the guide within the body opening, the removal of the operating trocar tubes are necessary.  
           [0014]    With the present invention, the suture guide is applied to the shaft of a trocar at the beginning of the surgery and slides down to the level of the subcutaneous tissue. Within the needle guide, there are two guide ports which orient the needle at selected angles to allow the needle to pass through the abdominal wall. Suturing can start immediately without frustration The surgeon simply passes the suture through the tissue, then picks up the suture for tying or passing through the tissue to create another stitch for wound closure. The present invention allows introduction of suture through large, 10 mm or greater operative ports or trocars.  
           [0015]    Additionally, the technique for using the present invention is easily learned; and the several embodiments set forth herein generally reduce the time and frustration associated with intra-abdominal suturing. These advantages are enhanced by use of the guide disclosed herein.  
         BRIEF SUMMARY OF THE INVENTION  
         [0016]    It is an object of the present invention to provide a surgical instrument, a guide and a method for the closure of a surgical incision under direct camera vision of the surgeon.  
           [0017]    A further object of the invention is to provide a laparoscopic instrument, a guide and a method that allows for the rapid control of bleeding vessels in the outer or the abdominal wall that may occur with the placement of laparoscopy trocars.  
           [0018]    Still another object of the invention to provide a guide that will attach onto the trocar tube and eliminates trocar removal from the incision, therefore causes less trauma and allows the surgeon to start the facia closure procedure immidately.  
           [0019]    Another object of the invention is to provide a laparoscopic instrument that easily disassembles by hands only for providing easy access to all the components for cleaning and sterilization prior to surgery.  
           [0020]    It is another object of the invention to provide an improved guide to accurately and consistently restrain the position and angle of insertion of a laparoscopic instrument to provide for proper placement and retrieval of suture material at a predetermined location within the body.  
           [0021]    Accordingly, it is an objective of the present invention to provide a method associated with an improved surgical instrument and an improved guide that better suits the needs of a surgeon when suturing closed a surgical incision.  
           [0022]    These and other objects of and advantages of the present invention will be apparent from a review of the following specification and accompanying drawings.  
           [0023]    Other objects and advantages of the present invention will become apparent from the following descriptions, taken in connection with the accompanying drawings, wherein, by way of illustration and example, an embodiment of the present invention is disclosed.  
           [0024]    The present invention is directed to a suturing means and method using an improved probe guide and an improved laparoscopic surgical instrument which permits a surgeon to pass suture without trauma through tissue while retaining the function of grasping the suture.  
           [0025]    The laparoscopic surgical instrument comprises a modified laparoscopic grasper wherein grasping surfaces close to the tip are manipulated by means of handles extending from a tubular housing with an enclosed reciprocating actuating rod connected with the handles.  
           [0026]    The invention includes a snap on suture probe guide delivering guided access to appropriate tissue layers for suturing. In a preferred embodiment, the probe guide is attached on to the operating trocar which remains in the wound during a laparoscopic tissue closure procedure.  
           [0027]    The drawings constitute a part of this specification and include exemplary embodiments to the invention, which may be embodied in various forms. It is to be understood that in some instances various aspects of the invention may be shown exaggerated or enlarged to facilitate an understanding of the invention.  
       
    
    
     BRIEF DESCRIPTION OF DRAWINGS  
       [0028]    The above, as well as other, advantages of the present invention will become readily apparent to those skilled in the art from the following detailed description of the preferred embodiments when considered in light of the accompanying drawings in which:  
         [0029]    [0029]FIG. 1 a . is a side elevational view of a laparoscopic instrument of the present invention  
         [0030]    [0030]FIG. 1 b . is an exploded side elevational view of the laparoscopic instrument of FIG. 1 a.    
         [0031]    [0031]FIG. 2. is a side elevational partial view of the tip of the laparoscopic instrument showing in closed condition  
         [0032]    [0032]FIG. 3. is a side elevational sectional view of the tip of the laparoscopic instrument showing in closed condition  
         [0033]    [0033]FIG. 4. is a side elevational partial view of the tip of the laparoscopic instrument showing in open condition  
         [0034]    [0034]FIG. 5. is a side elevational broken view of the tip of the laparoscopic instrument showing in open condition  
         [0035]    [0035]FIG. 6. is an isometric view of the tip of the laparoscopic instrument showing in open condition  
         [0036]    [0036]FIG. 7. is a dimetric view of the tip of the laparoscopic instrument showing in open condition  
         [0037]    [0037]FIG. 8 a . is a diagrammatic sketch, partly broken away, of the surgical instrument in the closed position passing suture through tissue.  
         [0038]    [0038]FIG. 8 b . is a diagrammatic sketch, partly broken away, of the surgical instrument in the open position for dropping the suture.  
         [0039]    [0039]FIG. 8 c . is a diagrammatic sketch, partly broken away, of the surgical instrument in the closed position passing suture through tissue at the other side of the incision and picking up suture.  
         [0040]    [0040]FIG. 8 d . is a diagrammatic sketch, partly broken away, of the surgical instrument pulling suture through muscle fascia and peritoneum.  
         [0041]    [0041]FIG. 8 e . is a diagrammatic sketch, partly broken away, of the suture tied below the skin to complete closure.  
         [0042]    [0042]FIG. 9 a . is a side elevational view of an alternative embodiment to the laparoscopic instrument of the present invention.  
         [0043]    [0043]FIG. 9 b . is a perspective view of the forceps jaws in open and in closed position according to one embodiment of the invention.  
         [0044]    [0044]FIG. 9 c . is an isometric view of another alternative embodiment to the laparoscopic instrument of the present invention showing in closed position.  
         [0045]    [0045]FIG. 9 d . is a perspective detail view, of the forceps tip in closed position according to one embodiment of the invention.  
         [0046]    [0046]FIG. 9 e . is a perspective detail view, of the forceps tip in open position according to one embodiment of the invention.  
         [0047]    [0047]FIG. 9 f . is an isometric view of another alternative embodiment to the laparoscopic instrument of the present invention showing in open position.  
         [0048]    [0048]FIG. 10 a . is a diagrammatic sketch showing the guide of the present invention attached on the operating trocar within the wound to be closed receiving the tip of the surgical instrument received within a passageway carrying suture material.  
         [0049]    [0049]FIG. 10 b . is a diagrammatic sketch showing the guide with the surgical instrument releasing the suture material.  
         [0050]    [0050]FIG. 10 c . is a diagrammatic sketch showing the guide with the surgical instrument being received in an opposite and adjacent passageway of the guide retrieving the suture material.  
         [0051]    [0051]FIG. 10 d . is a diagrammatic sketch showing the guide with the surgical instrument pulling suture through muscle fascia and peritoneum.  
         [0052]    [0052]FIG. 10 e . is a diagrammatic sketch showing the operating trocar with the guide and the surgical instrument has been removed from the body and the loop of suture is ready for wound closure.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0053]    Detailed descriptions of the preferred embodiment are provided herein. It is to be understood, however, that the present invention may be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but rather as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present invention in virtually any appropriately detailed system, structure or manner.  
         [0054]    Referring now to the drawings wherein like reference numerals refer to like and corresponding parts throughout, the laparoscopic instrument is generally indicated by numeral  20 .  
         [0055]    Referring now to FIGS. 1 a  and  1   b  , where grasping surface  35  is fixed and grasping surface  36  is moving back and forth when actuating rod  37  is reciprocated by a surgeon manipulating the instrument handle  22  and  23  providing a driving for driving grasping surface  36  to be in closed contact with fixed grasping surface  36  for carrying suture. Detachable means  21  comprise an elongated tube  23  concentrically sharing an axis with the actuating rod  37  having having grasping surfaces  35  and  36  engaged at a distal third of the outer shaft  23 .  
         [0056]    As shown in FIG. 1 b  , the laparoscopic instrument  20  can be easily disassembled for sterilization prior to surgery by separating handle  22  from detachable means  21  by loosening the knurled screws  28  on fixed handle housing  22 ,and other knurled screw  27  at thumbring  25  and unlatching connecting ball  32  from rotating piece  26  which thereby frees actuating rod  37  and tube  23  from handle housing  22 . By loosening thumb screw  27 , thumbring  25  can be disassembled from fixed handle housing  22  that allows for cleaning of the inside of the handle-housing area. When disassembled, the parts may be flushed, washed, and dried according to hospital procedures for stainless steel surgical instruments.  
         [0057]    With the above-described arrangement, it will be seen that the surgeon is able to selectively operate the handle  22  and thumbring  23  to independently open and close the movable grasping surface  36  in relationship to fixed grasping surface  35  for grasping, carrying, or releasing suture during a laparoscopic operation. To open grasping surface  36 , the surgeon moves movable thumbring  25  connected to rotating piece  26  forward toward the distal end of tube  23 . As shown in FIGS. 2, 3,  4  and  5  the grasping surfaces  35  and  36  are separate from needle tip  33 . The tip  33  operates as a sharp needle point that pierce through soft tissue while grasping surface  35  and  36  simultaneously grips and passes the suture. FIG. 4. shows the surgical instrument  20  in the open position. FIG. 5. shows a sectional side elevational view of the instrument and it also explains how the inner part  24  with the grasping surface  36  at the end moves inside the outer tube  23 , FIGS. 2. and  3 . shows the same instrument in a closed position.  
         [0058]    [0058]FIGS. 8 a . through  8   e . are diagrammatic representations of one example of using the method and laparoscopic instrument  20  of the present invention grasping and passing suture through soft tissue for closure of an incision  62 . In FIG. 8 a . the surgeon grasps the suture material  50  with grasping surfaces  35  and  36  and inserts instrument  20  carrying suture material  50  through the muscle fascia  60  and peritoneum  61  until the tip  33  and grasping surface  35  and  36  is seen through the peritoneum by direct camera vision. Subsequently, the surgeon releases the suture  50  by opening the moving grasping surface  36  located on the end of the moving inner part  24  and withdrawing the instrument  20  out of incision  62  as shown in FIG.  8   b . In FIG. 8 c . the surgeon then takes instrument  20  and inserts the tip  33  through the muscle fascia  60  and peritoneum  61  opposite the first point of insertion, grasping the suture  50  with gripping surface  35  and  36  and pulling the suture  50  carried and held by grasping surface  35  and  36  outside incision  62  as shown by FIG. 8 d . whereupon suture  50  is tied below the skin to complete closure of incision  62  as shown by FIG. 8 e.    
         [0059]    As shown in FIGS. 9 a . through  9   f ., additional alternative embodiments of the present invention provide additional advantages for both specific and general applications.  
         [0060]    [0060]FIG. 9 b . shows an interchangeable grasping forcep shaft  80  with serrated jaws  81  forming a sharp, cone shaped needle tip in a fully closed position. The shaft  80  is connected to the handle  22  and thumbring  25  by tightening knurled screw  27  and  28 . The interchangeable grasper shaft  80  has two identical jaws  81  at the tip. Both jaws  81  are are retractable by an inner actuating rod  84  allowing to pierce tissue and carry suture in the same time. A pin  83  serves as a pivot point for the moving jaws  81 . The exceedingly sharp needle tip formed by the jaws  81  provides easy penetration of tissue layers. The option to be able to retract both jaws, allows the surgeon to manipulate the suture easier.  
         [0061]    As shown on FIG. 9 c , the novel configuration of the shaft  100  provides an alternative embodiment to that shown in FIGS. 1 a . and  1   b . The shaft  101  is fix and engaged to handle  22 . An actuating rod  105  with a needle tip  102  at its end connected to handle  22  and thumbring  25 , moves inside the outer tube defining a suture gripping area  106  (shown in FIG. 9 d .) between grasping surface  104  and the paralell end of the outer tube  101 . The advantage of this alternative is, there is no need to rotate the instrument for suture pick up because the gripping surface is concentrically located on the instrument shaft allowing suture grasping in 360 degrees.  
         [0062]    [0062]FIG. 9 c . shows the above alternative embodiment in a closed position and the detail view of the closed tip in FIG. 9 d.    
         [0063]    [0063]FIG. 9 f . shows the above alternative embodiment in an open position and the detail view of the open tip in FIG. 9 e.    
         [0064]    Materials used to construct the devices set forth herein include surgical stainless steel and other alloys.  
         [0065]    The present invention has been found to facilitate many camera-viewed laparoscopic procedures. By varying the diameter, length and curvature of the shaft, many procedures may be improved compared to previously-existing methods. Laparoscopic port closure and the identification and retraction of ureters during lympadenectomy also advantageously implement the present invention. The same is likewise true for retraction of kidneys and other structures during laparoscopic nephrectomy.  
         [0066]    Intra-abdominal suturing, whether by closing of peritoneum or intra-abdominal knot-tying, has benefited from use of the present invention as has laparoscopic port closure (as for the urological uses listed above). In general surgery, the present invention has been found to be advantageously used with respect to laparoscopic port closures and temporary fixations of hernia mesh.  
         [0067]    It is contemplated that many other surgical procedures will advantageously use the present inventive methods, guide and instruments as described herein.  
         [0068]    These features and their advantages in use will be more particularly appreciated when reviewing the following method of the present invention used to pass suture through soft tissues during endoscopic/laparoscopic surgery for which the instrument  20  of this invention is provided. In application the surgical instrument  20  is to be grasped by a skilled laparoscopic surgeon and placed for closure of punctured vessels in the muscular surface or for closure of the fascia.  
         [0069]    As shown in FIGS.  11 - 17 , a specially adapted guide  70  can be used in the suturing procedure discussed above, and its application is demonstrated in FIGS. 10 a - 10   f . The guide  70  provides the surgeon a device and methodology for accurately and precisely positioning and removing the suture material  50  in or from the patient&#39;s body where desired.  
         [0070]    The guide  70  has a longitudinal axis x shown in FIG. 17 and is generally symmetrical about its x axis. Its extended lip also serves as a gripping area for the surgeon with a radially disposed surface  120  which further assists the surgeon in gripping and holding the guide  70 . The gripping surface  120  may be smooth or roughened for easy finger contact.  
         [0071]    The surface at the proximal end exposes the two passageways  132  through the guide  70 . The passageways  132  are parallel to each other, and each forms an angle alpha of approximately 20 .degree. with the longitudinal axis x. The two passageways  132  starts at the same surface and runs in an opposite direction from each other. The diameter of the passageways  132  are sized to receive the surgical instrument to be used.  
         [0072]    The guide  70  has an opening running parallel to the longitudinal axis x. The open side allows the surgeon to attach the guide  70  onto the trocar  40 . In use, the guide  70  snaps onto the shaft of the trocar  40  still in the wound, and its extending lip  136  is adjacent to the wound to be sutured. The shaft of the trocar  40  is concentric with the center opening of the guide  70 , and it clips into the center opening of the guide by two extruded locking surface  128  parallel to the longitudinal axis x. The cutout  130  in the guide  70  serves as a stress relief and makes the guide more flexible while attaching onto the trocar  40 , allowing the operator to complete the snap-on attachment of the guide  70  and the trocar  40  with ease. The two extruded locking surface than keeps the guide  70  in place in order to complete skin closure. The lip  136  prevents the guide  70  from sliding further down on the trocar  40  shaft into the wound and, therefore, should be sized to be of a greater diameter than that of the open wound to be sutured.  
         [0073]    A distal portion  126  of the guide  70  is slightly tapered . Tapering allows for greater ease of insertion while the guide  70  slides into the wound between the trocar  40  and surrounding tissue until it stops at the subcutaneous tissue by the lip portion  136 .  
         [0074]    The entire guide  70  can be integrally formed out of high-density polyethylene or other comparable material which is durable and medically inert and can serve as a disposable or a reusable product.  
         [0075]    As can be seen in FIGS. 10 a - 10   f , the guide  70  greatly assists in the procedure described above for FIGS. 8 a - 8   e . More particularly, the guide  70  is attached on the trocar which is already going through the skin incision, muscle, fascia, and peritoneum so that the trocar  40  appears in the view of the laparoscope. The guide  70  is oriented so that the passageways  132  in the guide  70  are in the required position to complete skin closure.  
         [0076]    The fascia closure instrument  20  (or  80  or  100 ) is inserted with suture in its grasp through the correctly positioned passageway in the guide  70  and observed to exit through the peritoneum by laparoscopic view.  
         [0077]    The suture is then released and the instrument  20  (or  80  or  100 ) withdrawn from the guide  70 . The instrument  20  is placed in the first passageway  132  of the guide and watched by laparoscopic view to exit through the peritoneum.  
         [0078]    The suture is withdrawn through the hole made by the instrument  20 . The trocar  40  with the guide  70  on its shaft is then withdrawn from the incision  62  completely. The suture is then tied by standard techniques, thus ensuring the fascia and peritoneum in a mass closure under the skin.  
         [0079]    As can be seen by inspection of the Figures, particularly FIGS. 9 a - 9   f  some surgical instruments that do maintain a linear configuration could use the guide  70  with its straight passages.  
         [0080]    Alternative embodiment to the suture guide shown in FIGS.  18 - 19 .  
         [0081]    The overall length of the guide shaft  124  may vary, but it does not depend upon the patient&#39;s anatomy. The guide clips onto the trocar  40  shaft which is placed in the wound at the beginning of the laparoscopic surgery. Therefore the guide shaft  124  can be eliminated completely leaving the extended lip portion  136  as an alternative guide  160  to the original suture guide  70  of the present invention as shown on FIG.18.  
         [0082]    As shown on FIG. 19., the alternative embodiment  160  of the suture guide  70  can be placed on the shaft of the operating trocar  40  before the first surgical incision is performed assuring that when the laparoscopic surgery is complete, the suture guide will be available immediately to begin tissue closure.  
         [0083]    Additionally, the alternative suture guide  160  can be sterilized and packaged together with the operating trocars by healthcare manufacturers, offering great economical and surgical advantages.  
         [0084]    There has been described and illustrated herein an improved laparoscopic instrument, a guide, and a surgical method. While particular embodiments of the invention have been described, it is not intended that the invention be limited exactly thereto, as it is intended that the invention be as broad in scope as the art will permit. The foregoing description and drawings will suggest other embodiments and variations within the scope of the claims to those skilled in the art, all of which are intended to be included in the spirit of the invention as herein set forth.  
         [0085]    While the invention has been described in connection with a preferred embodiment, it is not intended to limit the scope of the invention to the particular form set forth, but on the contrary, it is intended to cover such alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims.