Abstract:
A system of catheters, guidewires filaments, loops and laparoscopic instruments to simplify the placement of the anastomosis device to connect a stomach pouch to the small intestine in bariatric surgery, the surgical reduction of stomach size to treat morbid obesity.

Description:
[0001]     This application claims the benefit of Provisional application No. 60/669,900, filed Apr. 11, 2005, the entire content of which is hereby incorporated by reference in this application. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     The present invention provides a kit and method for the transoral passage and transgastric positioning of the anvil for the End-to-End Anastomotic (EEA) device in bariatric surgery.  
         [0003]     Biatric surgery is the surgical reduction of stomach size to treat morbid obesity. Referred to as the Roux-en-Y procedure, this gastric bypass procedure promotes early satiety and malabsorption of food that is ingested. A small pouch is created from the stomach, about the size of an egg. The small intestine is divided and reconnected into a Y consisting of two limbs and a common channel to bypass the majority of the stomach as well as a portion of the small intestine. The pancreo-biliary limb is the proximal small bowel, which is maintained attached to the stomach and the duodenum and serves to drain bile, digestive enzymes, and gastric secretions. The food limb or roux limb is attached to and drains the small gastric pouch through a gastroenteral anastomosis. At the junction of these two limbs, the food mixes with the digestive juices and then proceeds along the common channel towards the colon.  
         [0004]     Until recently, gastric by-pass has been performed as an open, single incision surgical procedure. However, laparoscopic gastric bypass techniques have been developed. The laparoscopically performed procedure is performed through a series of smaller incisions in the abdominal area. The result is decreased pain, faster recovery and more rapid return to normal activity and work.  
         [0005]     Many surgeons create the anastomosis between the gastric pouch and the jejunum, the gastroenteral anastomosis by using the circular EEA stapler. One method of creating this anastomosis is to pass the anvil of the EEA transorally, down the esophagus and across the gastric pouch so that the tip of the anvil protrudes from the gastric wall. The anvil tip is then attached to a post emanating from the EEA hand piece, which has been introduced into the jejunum. After the anvil and hand piece are attached and brought into proximity to each other, the device is fired creating a circular stapled anastomosis. The most common method of passing the anvil involves attaching it to a nasogastric tube (NGT), which is then passed transorally down the esophagus and into the gastric pouch. A small opening is made surgically in the gastric pouch and the NGT is passed through this opening and then used to pull the anvil through the mouth, down the esophagus, and into position across the gastric pouch wall. Positioning the EEA anvil in this manner can be tedious and time-consuming causing many surgeons to abandon this approach.  
       BRIEF DESCRIPTION OF THE INVENTION  
       [0006]     The invention provides a kit and method for facilitating and simplifying anvil passage and placement. In an embodiment of the invention, a large caliber introducer is passed transorally into the gastric pouch. The introducer has a central lumen large enough to accommodate, e.g., a catheter knife assembly which may then in turn be used to form a small hole through an appropriate area of the gastric pouch wall. The catheter of the catheter knife assembly is adapted to be positioned across the gastric wall after the incision is made. Next, a filament is introduced through the catheter and into the peritoneal space where it is grasped by the surgeon. The introducer and catheter knife assembly may then be removed and the anvil secured to the filament for being fed transorally to the incision/perforation in the gastric pouch, through which it may extend for engagement with the EEA handpiece.  
         [0007]     Thus, the invention may be embodied in a method for the passage and positioning of an anvil component of an end-to-end anastomotic device comprising: providing an introducer comprising a tube having distal and proximal ends; disposing said introducer to pass through a natural orifice to a first target wall segment of a first biological dust or organ in which the introducer is disposed; viewing an outer surface of the target wall segment and visually determining a location of said introducer with said first biological duct or organ; advancing a catheter knife assembly through said introducer to said first target wall segment; using said catheter knife assembly to form an opening through said first target wall segment; advancing the catheter knife assembly through said first target wall segment; threading a filament through the catheter of said catheter knife assembly; removing said catheter and said introducer while retaining said filament extending through said first target wall segment; securing said anvil component to a proximal end of said filament; and pulling a distal end of said filament so as to guide said anvil through said natural orifice and to said opening to align said anvil in surrounding relation to said opening.  
         [0008]     In an example embodiment, the method may further comprise inserting a second, handheld component of said anastomotic device to extend through an opening in a second target wall segment in a second biological duct or organ to be attached to said first target wall segment; aligning and attaching said first and second components and actuating said anastomotic device to form an anastomosis between said first and second target wall segments and withdrawing said anastomotic device.  
         [0009]     The invention may also be embodied in a kit for placement of one part of a two part anastomotic device comprising: an introducer; a catheter knife assembly for placement through said introducer; and a filament for threading through said catheter of said catheter knife assembly.  
         [0010]     Modifications may be made to the components to further simplify or facilitate the procedure. For example, a fiber optic light may be added to the introducer for transilluminating the gastric pouch to guide and determine placement of its tip for passage of the catheter knife assembly. A second alternative is to make the catheter of large enough diameter to accommodate the filament without removal of the knife itself. This would save a step in the procedure. Finally, the inner catheter could be used in the absence of an introducer tube by introducing it through an introducer in the form of a gastroscope, so that the procedure could be performed under direct visualization. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]      FIG. 1  is a schematic view of a proximally transected stomach with small intestine severed in accordance with a gastric bypass procedure;  
         [0012]      FIG. 2  is a view similar to  FIG. 1  illustrating the reconnection of a proximal limb of the small intestine downstream;  
         [0013]      FIG. 3  is a schematic illustration of an introducer disposed in a gastric pouch as a first step in a method embodying the invention;  
         [0014]      FIG. 4  illustrates a needle knife forming an opening in the gastric pouch in an embodiment of the invention;  
         [0015]      FIG. 5  depicts the advancement of the needle knife catheter through the formed opening;  
         [0016]      FIG. 6  illustrates the disposition of a filament through the catheter, after removal of the needle knife from the catheter in this example embodiment;  
         [0017]      FIG. 7  is a view of the gastric pouch from another angle, illustrating the threaded filament with introducer and catheter knife assembly removed;  
         [0018]      FIG. 8  is a schematic illustration showing an anvil attached to the proximal end of the threaded filament;  
         [0019]      FIG. 9  is a view similar to  FIG. 7  illustrating the threading of the anvil to the target wall segment;  
         [0020]      FIG. 10  illustrates the second component of the anastomotic device positioned for attachment to the first component or anvil;  
         [0021]      FIG. 11  is a view similar to  FIG. 10  illustrating the components attached and ready for EEA device actuation;  
         [0022]      FIG. 12  is an illustration of the formed anastomosis;  
         [0023]      FIG. 13  is a view of the gastrointestinal configuration at the conclusion of the procedure.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0024]     The kit and method of the invention will be described hereinbelow in connection with a gastric bypass, or Roux-en-Y procedure, it being understood that gastric bypass is just one procedure in which the kit of the invention may be used to advantage.  
         [0025]     As mentioned above, laparoscopic gastric bypass is now a well-established procedure for the surgical management of morbid obesity. As a first step in the bypass procedure, the stomach  10  is proximally transected as at  12  with a linear stapler to create a small gastric pouch  14  having a volume of about 15 to 30 ml. The small intestine is then reconfigured into a Y.  
         [0026]     As illustrated, the small intestine is severed as at  16  to create the first limb  18  of the reconfigured small intestine. This proximal portion  18  of the small intestine remains attached to the stomach and duodenum. This limb is sometimes called the pancreo-biliary conduit or limb  18 . It serves to drain bile, digestive enzymes and gastric secretions to facilitate digestion downstream. The distal end of the first limb is sutured to the downstream segment of small intestine as at  20  to join the internal passages of the respective limbs. The food limb, sometimes referred to as the Roux limb  22  is to be attached to drain the proximal gastric pouch  14 . It is the attachment of the Roux limb  22  to the gastric pouch  14  which is the primary subject of this invention. Many surgeons create the gastroenteral anastomosis, the junction between the gastric pouch and the Roux limb, using a circular EEA stapler. The EEA stapler is comprised of an anvil segment  24  and a handheld stapler  26 . The anvil segment  24  must be disposed to extend through the gastric pouch wall and the hand held segment is disposed through the free end  28  of the Roux limb  22  as illustrated in  FIGS. 10-11 . The present invention thus relates in particular to a kit for more easily placing the anvil  24  to extend through the gastric pouch  14  at a determined location for ultimate attachment to the handheld EEA device  26 .  
         [0027]     The anvil must be placed in the gastric pouch transorally. Meanwhile the gastric pouch is very small and the anvil must be properly disposed with respect to the pouch wall to provide the desired connection to the Roux limb. To facilitate anvil placement, the invention provides a kit including an introducer  30 , a catheter knife assembly  40  and a filament  50  such as a looped wire for threading the anvil  24  to a target portion  32  of the gastric pouch wall  34 .  
         [0028]     The introducer  30  is a small gauge catheter that is introduced through the esophagus  36 . In an exemplary embodiment, the introducer catheter has an outside diameter of about 12 mm (36 French) and ends in a tapered, narrowed tip  38 . In accordance with an exemplary method embodying the invention, the introducer is disposed through the esophagus, inserted into the gastric pouch  14  and urged against the wall  34  of the gastric pouch so that the surgeon can endoscopically visualize and determine a location of the introducer tip  38  from within the peritoneal cavity, outside the gastric pouch. As an alternative, a fiber optic element(s) can be disposed to illuminate the tip of the introducer so that the illuminated tip can be identified from the outside of the gastric pouch. As an alternative to providing a catheter introducer, an endoscope having a passage for receiving a catheter knife assembly, as described hereinbelow, may be adopted. However, an introducer catheter having a relatively pointed tip is preferred to localize the target site for the anvil and to reduce the cost associated with the procedure.  
         [0029]     Once the introducer has been disposed to identify and align with a target portion  32  of the gastric pouch, a catheter knife assembly  40 , such as a needle tipped catheter, is inserted or threaded through the introducer  30 . The needle tipped catheter is used to form a small opening  42  in the wall  34  of the gastric pouch. In an exemplary embodiment a cautery needle tipped catheter is used but the cautery function may be considered optional and, therefore, may be omitted without departing from the invention. The tip of the catheter body  44  is advanced through the opening  42  in the gastric wall into the peritoneal space. The needle tip  46  may thereafter be removed from the catheter body  44  and a filament  50  for threading the anvil  24  disposed through the catheter body  44  in its stead. In an example embodiment a double looped wire is provided as the filament  50 .  
         [0030]     The introducer  30  and catheter body  44  may then be removed and the proximal end  52  of the filament  50 , which is disposed outside the patient&#39;s mouth, may be secured to the tip  54  of the anvil  24 . By pulling the filament  50  from the peritoneal cavity, with suitable endoscopic instruments or manually, the anvil  24  is pulled into position ( FIGS. 8 and 9 ) and the feed filament  50  can be removed. The anvil will then be disposed through the opening  42  in the gastric pouch wall and disposed for attachment to the EEA hand piece  26 . The EEA may then be closed and fired to create the circular anastomosis  54  and the EEA is removed. The result is a reconfigured small intestine and minuscule gastric pouch to complete the gastric bypass procedure.  
         [0031]     As will be appreciated, the kit provided in accordance with the invention facilitates directing the anvil to a target portion of the gastric pouch wall and thereafter enables rapid feed and alignment of the anvil to facilitate the rapid formation of the anastomosis to the Roux limb.  
         [0032]     In  FIGS. 3-9  and  10 - 12 , the portion of the stomach below the staple line has been omitted. It is to be understood that the gastric pouch may be severed and separated from the remainder of the stomach adjacent the staple line or the gastric pouch may remain attached to the remainder of the stomach without modifying the procedure for anvil placement described herein.  
         [0033]     Although in the illustrated embodiment, the needle  46  of the needle tipped catheter  40  is removed in advance of feeding the looped wire filament  50 , it is to be understood that as an alternative, a needle tipped catheter may be provided that is large enough to accommodate the looped wire through a conduit thereof, so that the removal of the needle tip  46  may not be necessary to accomplish the method of the invention.  
         [0034]     While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.