Abstract:
A minimally invasive method of performing surgical procedures in the peritoneum is provided. The method includes providing a non-lumened flexible visualization scope, a flexible gastric pressurization tube, and at least one additional flexible manipulating instrument, wherein the scope, tube and the instruments are all discrete from each other and all smaller than 2 mm in diameter. The tools are extended into the esophagus and transgastrically through holes defined by incisions or instrument piercing in the stomach wall into the peritoneum, where they are used to visualize, insufflate and perform a peritoneal surgical procedure. Upon removal of the instruments, the holes are substantially self-sealing, and do not require surgical closure. Optionally, a biocompatible glue can be dispensed at the holes to facilitate closure.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    This invention relates broadly to surgery. More particularly, this invention relates to methods of performing minimally invasive surgical procedures. 
         [0003]    2. State of the Art 
         [0004]    Throughout most of the history of surgery, general surgical procedures, i.e., surgical procedures performed within the abdomen, were performed open. That is, the abdominal cavity was surgically opened to expose the internal organs and provide direct access to the surgeons performing the surgical procedure. However, the trauma to the patient from the procedure can present significant issues for the patient, including extended recovery time. Moreover, there is the danger of complication as prolonged exposure of surgical wounds to the open environment heightens the chance of infections even in presumably sterile settings. 
         [0005]    In the last few decades minimally invasive surgery has become possible and more and more important. A minimally invasive surgery is one in which the instruments enter the body through the skin or through a body cavity or anatomical opening with the smallest damage possible to these structures. Other than through the instrument passages, the body is not opened to the environment. 
         [0006]    Minimally invasive surgery results in less operative trauma for the patient. It is also less expensive, reduces hospitalization time, causes less pain and scarring, and reduces the incidence of complications related to the surgical trauma, speeding the recovery. However, even in minimally invasive procedures, holes are made in the body that are of such significant dimension that they need to be closed after instrument removal. 
         [0007]    For example, in a peritoneal laparoscopic procedure from outside the body, multiple holes will initially be made in the abdominal wall. These holes provide access for a visualization scope, a pressurization pathway to insufflate the abdomen, and two or manipulating instruments (e.g., graspers, forceps, scalpels, staplers, suturing devices, irrigators, cauterization devices, etc.) to be inserted into the abdomen. Given the sizes of the holes, the holes will need to be sutured or stapled closed at the conclusion of the procedure. 
         [0008]    U.S. Pat. No. 5,458,131 to Wilk teaches an intra-abdominal method for performing peritoneal procedures. In such procedures, a flexible endoscope is extended through the esophagus and passed through an incised hole in the stomach wall into the peritoneum. Other flexible and steerable manipulating instruments are similarly passed through the lumen of the endoscope and other incised holes in the stomach wall or through an incised perforation in another natural body cavity. The endoscope includes a lumen that may be used for insufflation of the peritoneum or for passage of additional instruments. Such endoscopes are typically on the order of 9 mm to 15 mm, with lumen diameters of 2 mm to 5 mm. The instruments used therethrough are typically sized for close fit through the lumen of the endoscope. Upon completion of the surgery, after the instruments are withdrawn, the incised holes in each of the body cavities are surgically closed. U.S. Pat. No. 5,458,131 to Wilk teaches closure of the holes via ligation using O-rings. 
         [0009]    The advantages of such minimally invasive surgery includes minimizing the trauma of access to internal organs and decreasing the time of the surgical procedure. By avoiding a long incision through the muscular abdominal wall, many post-operative problems are eliminated. Furthermore, the patient is provided with reduced anesthetic as the procedure is shortened and the trauma is decreased. The need for strong post-operative pain medications is drastically reduced so that the drowsiness, fatigue and unsteadiness they cause are virtually eliminated, and it is possible to return to normal activities in a fraction of the time necessary after regular surgery. 
         [0010]    It is anticipated that further reducing trauma to the body during surgical procedures and reducing the time of a surgical procedure will provide better surgical outcomes and decreased recovery times. 
       SUMMARY OF THE INVENTION 
       [0011]    It is therefore an object of the invention to provide minimally invasive methods of performing surgical procedures in the peritoneum which are less invasive than currently performed minimally invasive methods. 
         [0012]    It is another object of the invention to provide a minimally invasive method of performing surgical procedures in the peritoneum that reduces the extent of the internal incisions, particularly at the gastric wall, and thus reduces trauma to internal organs. 
         [0013]    It is a further object of the invention to provide a minimally invasive method of performing surgical procedures in the peritoneum that does not necessitate surgical repair of holes upon withdrawal of the instruments. 
         [0014]    In accord with these objects, which will be discussed in detail below, a minimally invasive method of performing surgical procedures in the peritoneum is provided. The method includes providing a non-lumened flexible visualization scope, a flexible gastric insufflation tube, and at least one additional flexible manipulating instrument, wherein the scope, tube and the instruments (collectively, ‘the surgical tools’) are all discrete from each other. The surgical tools do not exceed 2 mm in diameter, and are all preferably steerable or otherwise guidable without being extended through an endoscope. The tools are extended into the esophagus and transgastrically through incisions or piercings in the stomach wall into the peritoneum, where they are used to visualize, insufflate and perform a peritoneal surgical or diagnostic procedure. By way of example, such procedure may include cauterizing a site of abdominal bleeding, ablation of tumors, or local delivery of therapeutic agents. At the conclusion of the procedure, the tools are withdrawn. In view of the small dimension of each of the tools (significantly smaller than the incision required for the flexible lumened endoscope passed through the stomach wall in prior art transgastric peritoneal procedures), the holes are substantially self-sealing, and do not require surgical closure, as the holes will close on their own. Optionally, a biocompatible glue can be dispensed at the holes to facilitate closure. Such glue can be released from a discrete instrument or from portion of one or more of the tools upon removal of the tools from their respective holes. 
         [0015]    Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1 through 5  schematically illustrate a first embodiment of a method of a transgastric peritoneal surgical procedure. 
           [0017]      FIG. 6  is a distal end view of an exemplar tissue manipulating instrument having glue releasing capability. 
           [0018]      FIG. 7  are broken side elevations of the distal ends of embodiments of instruments in an instrument set for carrying out a second embodiment of the invention. 
           [0019]      FIG. 8  is a schematic illustration of instruments and methods for carrying out a third embodiment of the invention. 
           [0020]      FIG. 9  is a schematic illustration of instruments and methods for carrying out a fourth embodiment of the invention. 
           [0021]      FIG. 10  is a schematic illustration of instruments and methods for carrying out a fifth embodiment of the invention. 
           [0022]      FIGS. 11 through 15  are schematic illustrations of instruments and methods for carrying out a sixth embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0023]    Turning now to  FIGS. 1 through 5 , a first embodiment of performing an transgastric peritoneal surgical procedure on a mammal and preferably a human according to the invention is shown. Referring to  FIG. 1 , in carrying out the method, a flexible steerable visualization scope  10 , a flexible steerable insufflation tube  12  for insufflating the peritoneal space  14  and a flexible steerable endoknife (needle knife)  16  are inserted through the esophagus  18  and into the stomach  20 . Exemplar instruments having suitable dimensions for carrying out the invention include the following: the visualization scope  10  can be a 1.8 mm CCD camera available from Medigus Ltd. of Israel, and the insufflation tube  12  can be a Cragg-McNamara 4 Fr or 5 Fr Valved Infusion Catheter available from ev3, Inc. (Neurovascular Division) of Irvine, Calif. While these commercially available devices are not steerable, modified versions of these devices may incorporate the steering technology used in commercially available endoscopes. Endoscope steering technology includes the use of pull wires to cause the distal end of the endoscope to bend in a desired direction. The endoknife may be a Needle Knife KD-10Q-1.A, available from Olympus America Inc, Melville, N.Y., having a diameter suitable for a 2.0 mm diameter endoscope working channel. The scope  10 , tube  12  and the endoknife  16  all include elongate tubular bodies, and preferably the portions of such devices that are insertable into the intragastric cavity do not exceed 2 mm in diameter. More particularly, the distal ends of the scope  10 , tube  12  and the endoknife  16  are all preferably 2 mm or smaller in diameter. These instruments have a length in the range of about 100 cm to about 300 cm with a preferred range of about 150 cm to 250 cm. The length of the instrument that extends across the gastric wall and into the peritoneal space is in the range of 25 cm to 100 cm. Referring to  FIGS. 2 and 3 , under visualization of the scope  10 , the cutting tip  22  of the endoknife  16  is used to incise a first small hole  24  in the gastrointestinal wall  26  (preferably in the wall of the stomach  20 ). The incision  24  preferably does not exceed 2 mm in diameter. The insufflation tube  12  is maneuvered through the first hole  24  and into the peritoneal space  14  in the abdomen. The endoknife  16  is then moved to a second location and used to incise a second small hole at  28  (not exceeding 2 mm in diameter) for passing a manipulating instrument  30  (e.g., grasper, forceps, scalpel, cauterization device) into the peritoneal space  14 . The process may be repeated for any additional instrument that may be required during the procedure. At any time during the procedure, the endoknife  16  is utilized to incise a hole  32  to insert the scope  10  into the peritoneal space  14 . In addition, the endoknife  16  may incise a hole  34  ( FIG. 5 ) for itself and then be passed through into the peritoneal space  14  for use in carrying out a procedure within the peritoneal space. Preferably none of the holes created in the gastrointestinal wall are larger than 2 mm in diameter. 
         [0024]    Referring to  FIG. 4 , after the insufflation tube  12  is within the peritoneal space  14 , insufflation fluid is passed through the insufflation tube to expand the peritoneal space. Then, under observation of the scope  10 , the manipulating instruments  16 ,  30  are actuated to operate on tissue  36  and perform a surgical procedure within the peritoneal space. Such procedures include obtaining a tissue sample, removal of a tumor or local delivery of a therapeutic agent. Referring to  FIG. 5 , once the procedure is complete, the instruments  10 ,  12 ,  16 ,  30  are removed from the peritoneal space, and withdrawn through the stomach  20  and esophagus  18 . In view of the small diameter of each of the instruments that is passed through the gastrointestinal wall  26 , the holes  24 ,  28 ,  32 ,  34  will self-seal quickly on their own. 
         [0025]    If closure assistance is required or optionally desired for the holes, given the small diameter of the holes, such assistance can be provided via an adhesive (as opposed to mechanical devices that must penetrate pierce or tissue on opposite sides of the hole). In accord with one embodiment of the invention, a dedicated instrument or one or more of the previously identified instrument types is provided with a channel or small diameter lumen from which a tissue adhesive can be dispensed. It is appreciated that hole closure via an adhesive and without tissue penetration is significantly less time consuming and the system for dispensing an adhesive is significantly less complex than that required to manipulate tissue and to dispense staples, clips, ligating bands, etc. 
         [0026]    For example, turning to  FIG. 6 , a distal end of a forceps device  30   a  is shown with a first lumen  40  for the forceps jaws  42 ,  44  and a second lumen  46  through which adhesive  48  can be dispensed. The adhesive  48  can be contained in a reservoir  50  near the distal end  52  of the device  30  and pushed out with an advancing shovel  54  attached to a wire longitudinally actuated from the proximal end of the instrument. A frangible membrane may be provided over the distal end of the second lumen reservoir  50  and automatically removed under pressure as the shovel  54  is distally advanced to release the adhesive  48 . 
         [0027]    Turning now to  FIG. 7 , a set  100  of instruments is shown for carrying out another embodiment of a method according to the invention. Each instrument in the set  100  is provided with a tissue piercing end that can pierce the tissue of the gastrointestinal wall without prior incision with an endoknife. Visual scope  110  includes a chisel-cut tissue piercing hood  111 . The hood  111  is preferably retractable relative to the distal end of the scope to provided unencumbered visualization of the peritoneum after passage through the gastrointestinal wall. Insufflation tube  112  includes an angle-cut tissue piercing end  113 . Endoknife  116  has a sharp cutting end  122 . Graspers  130   a  and biopsy forceps  130   b  are each provided with retractable hoods,  131   a ,  131   b , respectively, similar to hood  111 , but which can also operate as jaw release and jaw closure means. Thus, each of the instruments  110 ,  112 ,  131   a ,  131   b  can be forced directly through the gastrointestinal wall and into the peritoneal space without previously defining a hole for passage therethrough with the endoknife  116 . It is appreciated that other tissue piercing means can be provided to the individual instruments in the set. 
         [0028]    In view of the above, it is a goal of the invention to operate intragastrically and within the peritoneal space without necessitating incision of one or more large holes for passage of endoscopes or other relatively large instruments that have been previously required for such surgery. The prior use of endoscope in such surgery includes scopes substantially larger than 2 mm in diameter and defining one or more lumen for the passage of instruments. Nevertheless, as described hereinafter, it is appreciated that the surgery of the invention may be facilitated with the use of an endoscope larger than 2 mm in diameter passed through the esophagus and into the stomach, but not through the gastrointestinal wall. 
         [0029]    Referring now to  FIG. 8 , another embodiment of a method according to the invention is shown. The instruments  210 ,  212 ,  216 ,  230   a ,  230   b  (collectively  200 ) for passage into the peritoneal space  14  are retained about the periphery in a predetermined radial proximity relative to substantially larger endoscope  250 . Such relationship is maintained using, for example, a spacer  252   a . The spacer  252   a  preferably maintains a relative distance between the instruments  200  that are to be passed into the peritoneal space  14 . Moreover, the spacer  252   a  (and several spacers  252   b  may be provided along the length of the larger endoscope  250 ) increases the effective longitudinal stiffness of the instruments  200  as they are forced through the gastrointestinal wall  26  and provides increased stability as they are actuated. The instruments  200  may be moved longitudinally relative to the spacer(s)  252   a ,  252   b  to operate within the peritoneal space  14 . In addition, the larger endoscope  250  provides visualization of the gastrointestinal space, e.g., stomach  20 , even after a smaller endoscope  210  (2 mm or less in diameter) is passed into the peritoneal space. Optionally, the endoknife  216  can be passed through the lumen  254  of the endoscope  250 , which provides stable guidance to the endoknife as the endoknife incises holes for the other instruments  200 . Different instruments can also be extended through lumen  254 . While endoscope  250  remains within the stomach cavity, or elsewhere in the intragastric cavity, a small scope not exceeding 2 mm in diameter (not shown) will extend transgastrically into the peritoneum  14  as previously described for visualization of the peritoneal procedure. 
         [0030]    Turning now to  FIG. 9 , another embodiment of a method of the invention in which a standard gastrointestinal endoscope  350  is inserted into the stomach  20 . The endoscope  350  includes a peripheral longitudinal channel  352  that at least partially retains an instrument  330  relative to the endoscope. The instrument can be moved longitudinally within the sheath  352  and the distal of the instrument can be inserted through the gastrointestinal wall  26  and into the peritoneal space  14  under observation of the optics  356  of the endoscope  350 . The lumen  354  of endoscope  350  can be used for passage and guidance of an endoknife that incises a hole  358  for the instrument, or for other instruments. Additional instruments (not shown) can be inserted into the peritoneal space  14  coupled to other sheaths of the endoscope or in a manner discretely from the endoscope. While endoscope  350  remains within the stomach cavity, or elsewhere in the intragastric cavity, a small scope not exceeding 2 mm in diameter (not shown) will extend transgastrically into the peritoneum  14  as previously described for visualization of the peritoneal procedure. 
         [0031]    Referring now to  FIG. 10 , another embodiment of a method of the invention in which a standard gastrointestinal endoscope is inserted into the stomach is provided. An instrument  430  is coupled to the distal end of the endoscope  450  with a cuff  452  that retains the distal end of the instrument  430  relative to the endoscope. The instrument  430  can be moved longitudinally within the cuff  452  and the distal of the instrument  430  can be inserted through the gastrointestinal wall  26  and into the peritoneal space  14  under observation of the optics  456  of the endoscope  450 . The lumen  454  of endoscope  450  can be used for passage and guidance of an endoknife  416  that incises a hole  458  for the instrument  430 , or for another instrument. Additional instruments (not shown) can be inserted into the peritoneal space  14  coupled to other cuffs attached to the endoscope or in a manner discretely from the endoscope. While endoscope  450  remains within the stomach cavity, or elsewhere in the intragastric cavity, a small scope not exceeding 2 mm in diameter (not shown) will extend transgastrically into the peritoneum  14  as previously described for visualization of the peritoneal procedure. 
         [0032]    Turning now to  FIGS. 11 through 15 , another method according to the invention is shown. An endoscope  550  with a lumen  554  is extended through the esophagus and passed into the stomach. An endoknife  516  may be inserted through the lumen of the endoscope, with the endoscope  550  providing visualization and facilitating stabilization of the instrument  516 . Instruments, e.g., scope  510 , insufflation tube, and forceps  530  for operating or facilitating the operation within the peritoneal space  14  are also passed through the esophagus and into the stomach and through incisions  570 ,  572  made with the endoknife  516 . Once all the necessary instruments for performing the peritoneal procedure are within the peritoneal space, the larger endoscope  550  can be removed from the gastric cavity and esophagus. Alternatively, the endoscope  550  can be left within the stomach to provide visualization of the gastric wall from within the gastric cavity. Once the peritoneal procedure is complete, the instruments are withdrawn from the patient&#39;s body. 
         [0033]    There have been described and illustrated herein several embodiments of instruments for performing transgastric peritoneal surgery and methods of performing such surgical procedures. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while a particular order to the insertion of various instruments has been disclosed, it will be appreciated that the instruments may be inserted in an order other than as described. In addition, while particular types of peritoneal procedures have been described, it will be understood that other procedures can be performed as well. Also, while particular tissue manipulating instruments have been described, it will be recognized that other tissue manipulating instruments can be inserted transgastrically into the peritoneal space for performing the procedures. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.