Abstract:
A specially configured esophageal-gastric tube can be inserted into a patient&#39;s esophagus with the tip of the tube in the region of an end-to-end anaotomosis connection. The joined members are occluded upstream and downstream of the anastomosis connection. Fluid is pumped into the occluded section through the esophageal-gastric tube until a desired pressure level is attained. The anastomosis connection then is checked for leaks. The invention also includes a bougie having an end portion made of a material suitable for resisting electro-cauterization temperatures.

Description:
REFERENCE TO PROVISIONAL APPLICATION 
       [0001]    The present application claims priority to U.S. provisional application Ser. No. 60/943,501, entitled Method and Apparatus for Performing Gastric Bypass Surgery, filed Jun. 12, 2007 by Gerald Marsh and Albert N. Santilli. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The invention relates to surgical procedures and, more particularly, to a method and apparatus that can be used to perform gastric bypass surgery. 
         [0004]    2. Description of the Prior Art 
         [0005]    While the present invention has application in various types of surgical procedures, it will be described in the context of gastric bypass surgery as used for the treatment of obesity. The most common gastric bypass procedure performed today is known as the Roux-en-Y gastric bypass procedure (RYGB). In the RYGB procedure, a six-inch to eight-inch incision is made that extends from the end of the sternum to just above the navel. More recently, the RYGB has been performed laparoscopically in order to minimize trauma, healing time and risk of infection. The stomach is completely divided into two unequal portions—a small upper pouch and a large lower gastric pouch (excluded stomach). The upper pouch typically measures less than about one ounce, preferably about one-half ounce, or 15 cc, while the excluded stomach remains generally intact and continues to secrete stomach juices that flow through the intestinal tract. 
         [0006]    The small intestine is severed at a location distal of the duodenum or proximal of the jejunum. The severed end of the small intestine then is brought from the lower abdomen, behind the colon and the bypassed stomach, and joined with the upper pouch to form an end-to-end anastomosis created through a half-inch opening, also called the stoma. This rerouted segment of the small intestine is called the “Roux loop” and carries food from the upper pouch to the remainder of the intestines where the food is digested. The severed end of the segment of the duodenum that is part of the excluded stomach is connected to the Roux loop by means of an anastomotic connection. The connection is located approximately 100 cm from the stoma, and typically is made by using a stapling instrument. Prior to completion of the surgical procedure, a gastropexy commonly is performed to attach the excluded stomach to the abdominal wall or to the diaphragm, primarily to prevent the excluded stomach from being displaced within the abdominal cavity. 
         [0007]    The RYGB procedure described permits digestive juices from the bypassed stomach, pancreas and liver to join the food stream from the small upper pouch and Roux loop to begin digesting the food. The remainder of the intestinal tract is not disturbed. Due to the small size of the upper pouch, patients are forced to eat at a slower rate and are satiated much more quickly, thereby reducing their caloric intake. Moreover, because the food enters the intestines directly, certain undesirable foods such as sweets create unpleasant feelings of nausea, diarrhea, nervousness, and sweating, which in turn discourages patients from developing or maintaining unhealthy eating habits. The RYGB procedure typically demonstrates a loss of at least 50% of excess body weight; approximately 60% of the patients will be able to maintain this weight loss for at least five years. 
         [0008]    During the course of performing the RYGB procedure, it is necessary at various times to evacuate, decompress, and lavage the stomach. An important part of the procedure is to form a properly sized and shaped stoma and to create an effective anastomosis connection. Typically this is done by introducing a specially formed bougie into the gastric area through the esophagus. It also is necessary to pressure test the completed stoma in order to make certain that no leaks are present. 
         [0009]    A problem in performing the RYGB procedure is that various separate tubes and instruments must be used to accomplish the noted tasks, thereby making the procedure more complex, time-consuming, and expensive than desired. Another problem is that it can be difficult to position tubes and instruments at a proper location or position within the esophagus or gastric pouch. Yet an additional problem is that it has not been possible to adequately pressure test the completed stoma because only low pressure testing procedures have been available. Yet an additional problem is that bougies used to form the stoma and to perform the anastomosis are not very durable. As a consequence, the bougies usually are suitable for one-time use, which increases the overall cost of the procedure. Desirably, a method and apparatus would be available to conduct gastric bypass surgery that would overcome the foregoing problems. 
       SUMMARY OF THE INVENTION 
       [0010]    In response to the foregoing concerns, the present invention provides a new and improved method and apparatus especially adapted for performing gastric bypass surgery. Apparatus according to the invention includes an esophageal-gastric tube that has an elongate first tube made of a flexible material such as latex, vinyl, silicone, or similar material that defines a first, hollow passageway. The tube has a tip end, a central portion, and a tapered entrance/exit end. The tip end is provided with openings that establish fluid communication with the passageway. A first syringe can be attached to the tapered entrance/exit end. 
         [0011]    A thin, expansible balloon is disposed relatively close to the openings on the side of the openings closest to the central portion. The balloon is in fluid communication with a second, hollow passageway. The second passageway either is included as part of the wall that defines the central portion or it is part of a separate tube that is disposed within the passageway. The second passageway terminates in a branch tube that projects from the side of the first tube adjacent the entrance/exit end. A shutoff valve is disposed in the branch tube near the exposed end thereof. A second syringe is adapted to be connected to the branch tube. If desired, a number of radiographic markers can be disposed within the first tube, usually within the central portion. The markers are evenly spaced at intervals along the length of the tube. 
         [0012]    The apparatus includes a bougie that has an elongate body portion and a specially formed tip. The body portion and the tip are formed of a fairly rigid, flexible substance such as high-temperature silicone. The tip is coated with a substance such as TEFLON fluoropolymer that will resist the high electro-cauterization temperatures experienced during formation of the stoma. Apparatus according to the invention also includes a clamp for occluding a desired portion of the Roux loop. 
         [0013]    The method according to the invention includes the steps of providing a tube and positioning the tube within the esophagus with the distal end of the tube downstream of the stoma. The method includes the step of occluding the Roux loop downstream of the newly formed stoma and the end of the tube. The method includes the further step of establishing an airtight seal in the esophagus and thereafter pumping air through the tube. The pressure is increased so that a good test of the integrity of the various sutures and staples is obtained. 
         [0014]    The foregoing and other features and advantages of the invention will be apparent from a review of the following description of the invention, taken together with the attached drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0015]      FIG. 1  is a schematic view of a patient&#39;s stomach and small intestine after undergoing the RYGB procedure; 
           [0016]      FIG. 2  is a view of an esophageal-gastric tube according to the invention with two syringes and an adapter in place; 
           [0017]      FIG. 3  is a view similar to  FIG. 2  in which the syringes and the adapter have been disconnected and moved apart for purposes of clarity of illustration; 
           [0018]      FIG. 4  is an enlarged view of a tip end of the esophageal-gastric tube of  FIG. 2 ; 
           [0019]    FIG. is a schematic view of a bougie according to the invention; and 
           [0020]      FIG. 6  is a schematic view of the esophageal-gastric tube of  FIG. 2  being used during the course of performing a RYGB procedure. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0021]    The RYGB procedure is illustrated in  FIG. 1 . The patient&#39;s stomach  10  is completely divided into two unequal portions—a small upper pouch  12  and a large lower gastric pouch  14  (or excluded stomach). The upper pouch  12  typically measures less than about one ounce, preferably about one-half ounce, or 15 cc, while the larger lower pouch  14  remains generally intact and continues to secrete stomach juices that flow through the intestinal tract. 
         [0022]    The small intestine  16  is severed at a location distal of the duodenum  18  or proximal of the jejunum (not shown). A first severed end  20  of the small intestine then is brought from the lower abdomen, behind the colon and the bypassed stomach, and joined with the upper pouch  12  to form an end-to-end anastomosis  22  created through a half-inch opening, also called the stoma. This rerouted segment  24  of the small intestine is called the “Roux loop” and carries food from the upper pouch  12  to the remainder of the intestines where the food is digested. A second severed end  26  of the segment of the duodenum  18  that is attached to the lower pouch  14  of the stomach  10  is connected to the Roux loop  24  by means of an anastomotic connection indicated at  28 . The connection  28  is located approximately 100 cm from the stoma  22 , and typically is made by using a stapling instrument. 
         [0023]    A gastropexy is performed, whereby the excluded stomach  14  is connected to the abdominal wall  30  by means of a marker/connector  32 . Sutures  34  are passed through loops included as part of the marker/connector  30  and through the tissue of the adjacent pouch  14  and the abdominal wall  30 . The marker/connector  32  thus serves as a fluoroscopic marker as well as a mechanical connector between the excluded stomach  14  and the abdominal wall  30 . If it is necessary to insert an endoscope or a trochar into the excluded stomach  14 , the endoscope or trochar can be inserted through the marker/connector  30  which will serve as a target as well as a means for holding the excluded stomach  14  in place as the endoscope or trochar is inserted therethrough. 
         [0024]    Referring now to  FIGS. 2 ,  3 , and  4 , apparatus for use during the course of gastric surgery is indicated by the reference numeral  40 . The apparatus  40  includes an esophageal-gastric tube that includes an elongate first tube  42  made of latex, vinyl, silicone, or similar material that defines a first, hollow passageway  44 . The tube  42  has a tip end  46 , a central portion  48 , and a tapered entrance/exit end  50 . The tip end  46  is provided with a pair of elongated openings  51  that are disposed on opposite sides of the end  46  and which establish fluid communication with the passageway  44 . The tapered end  50  receives an adapter  52  to which a large syringe  54  (about 70 ml) can be attached by means of a luer slip connector  56 . Typically, the first tube  42  will be provided in three sizes: 22 French (7.33 mm) for gastric bypass; 22 French and 24 French (7.33 mm and 6.0 mm, respectively) for pre-induction anesthesia; and 20 French and 22 French (6.67 mm and 7.33 mm, respectively) for oral and naso-gastric lavage and evacuation. 
         [0025]    A thin, expansible balloon  58  is disposed relatively close to the openings  51  on the side of the openings  51  closest to the central portion  48 . The balloon  58  is connected to the tube  42  by means of a second, hollow passageway  60 . The second passageway  60  either is included as part of the wall that defines the central portion  48  or it is part of a separate tube that is disposed within the passageway  44 . The passageway  60  terminates in a branch tube  62  that projects from the side of the first tube  42  adjacent the entrance/exit end  50 . A shutoff valve  64  is disposed in the branch tube  62  near the exposed end thereof. A small syringe  66  (about 35 ml) is adapted to be connected to the branch tube  62  by means of a luer lock connector  68 . If desired, a number of radiographic markers  70  can be disposed within the first tube  42 , usually within the central portion  48 . The markers  70  are evenly spaced at approximately 10 cm intervals along the length of the tube  42 . 
         [0026]    Referring now to  FIG. 5 , a bougie according to the invention is indicated by the reference numeral  80 . The bougie  80  has an elongate body portion  82  and a specially formed tip  84 . The body portion  82  and the tip  84  are formed of a substance such as high-temperature silicone. The tip  84  is coated with a substance such as TEFLON fluoropolymer that will resist the high electro-cauterization temperatures experienced during formation of the stoma  22 . 
         [0027]    Referring to  FIG. 6 , the apparatus  40  according to the invention includes a clamp  90 . The clamp  90  is indicated schematically, as it can be any type of commonly available clamp suitable for occluding conduits such as the small intestine. For example, an appropriately sized bulldog clamp or an occluding forceps would be usable provided it clamped the intestine such that fluid flow was prevented. 
       Indications for Use and Features of the Apparatus  40   
       [0028]    The apparatus  40  is used for positive air-leak detection during gastric bypass surgery, eliminating the need for added procedural time and expense. The apparatus  40  provides positive intra-operative air-leak detection for both open and laparoscopic gastric bypass procedures. It permits pre-operative gastric evacuation and pre-anesthesia induction esophageal occlusion. The apparatus  40  also permits intra-operative oro-gastric lavage and can be used for x-ray determination of lumen size and catheter position. The apparatus  40  also can be used as a stent during anastomosis. 
         [0029]    The apparatus  40  features a lumen-occluding balloon  58  that is recessed to prevent back-flow during leak testing. The balloon  58  preferably is spaced about 9.0 cm behind the end of the tip  46 . The tip  46  is soft in order to decrease trauma to mucosal tissue. The tip  46  is tapered for easier passage through the stoma anastomosis  22 . The apparatus  40  preferably is made of hypoallergenic silicone construction to aid in manipulation and placement. The apparatus  40  reduces incidents of false channel and bowel perforation. The optional radiopaque markers  70 , preferably at 10 cm intervals, provide x-ray verification. The apparatus  40  also stents the bowel lumen to aid in accuracy when sizing the bypassed pouch. Because the apparatus  40  performs multiple functions such as lavage and pressure testing, there no longer is a need to use separate tubes and instruments to accomplish the previously described tasks. 
         [0030]    The bougie  80  is used for intra-operative gastric decompressions and as a stent during anastomosis. It permits intra-operative gastric lavage and may be used to determine the size of the anastomosis. 
         [0031]    The bougie  80  has a specially designed tip  84  that resists the effects of electro-cauterization that typically occurs during the course of an anastomosis procedure. Preferably the tip  84  is coated with a heat-resistant coating such as TEFLON fluoropolymer or any other suitable temperature-resistant or temperature-dissipating material. The body portion  84  of the bougie  80  is made of latex-free, high-temperature silicone to aid in manipulation and placement and in forming and sizing the anastomosis. The bougie  80  also is radiopaque for x-ray verification. Because the bougie  80  is resistant to high temperatures and will not be harmed by a single episode of electro-cauterization, it is expected that the bougie  80  can be sterilized and reused a number of times, thereby reducing the cost of a given surgical procedure. 
       Method of Operation 
       [0032]    In operation, except as noted herein, the usual open or laparoscopic procedures are used to perform the gastric bypass surgical procedure. Either before or after the patient has been anesthetized, as appropriate, the tube  42  is intubated into the esophagus such that the tip  46  is disposed within the stomach  10 , the small upper pouch  12 , or in the region of the stoma  22 , as the surgeon desires. By suitable use of the large syringe  54 , the apparatus  40  can be used for purposes of evacuation, decompression, or lavage. 
         [0033]    The method according to the invention includes the steps of positioning the tube  42  within the esophagus with the distal end of the tube  42  (the tip  46 ) downstream of the stoma  22 . The method includes the step of occluding the Roux loop  24  downstream of the newly formed stoma  22  and the tip  46  by applying the clamp  90  at a desired location. The method includes the further step of establishing an airtight seal in the esophagus by inflating the balloon  58  and thereafter pumping air through the tube  42  by use of the syringe  54 . The pressure is increased to a high level so that a good test of the integrity of the various sutures and staples is obtained. By turning the valve  64  to a shut position, air or other inflating fluid can be retained within the inflated balloon  58  so that the seal with the esophagus is maintained. Due to the simplicity and compactness of the apparatus  40 , the surgeon can manipulate the syringe  66  and the valve  64  with one hand, if necessary or desired. 
         [0034]    Although the invention has been described in its preferred form with a certain degree of particularity, it will be understood that the present disclosure of the preferred embodiments has been made only by way of example and that various changes may be resorted to without departing from the true spirit and scope of the invention as hereinafter claimed.