Abstract:
A gastroplasty method involves a staple line that terminates prior to reaching the gastroesophageal junction such that the bypassed portion of the stomach does not require resection. Additionally, bougies are taught that assist a physician in following the improved staple line of the present invention.

Description:
PRIORITY CLAIM TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of and claims priority to U.S. patent application Ser. No. 12/865,709, filed Feb. 28, 2011, entitled Methods And Devices For Performing Gastroplasty, which is the U.S. National Phase of and claims priority to International Patent Application No. PCT/US2009/032741, International Filing Date Jan. 30, 2009, entitled Methods And Devices For Performing Gastroplasty, which claims priority to U.S. Provisional Patent Application Ser. No. 61/025,619, filed Feb. 1, 2008 by Gagner et al., entitled Methods And Devices For Performing Gastroplasty, the contents of all of which are incorporated herein in their entireties. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates generally to improved methods and devices for anchoring a gastroenterologic sleeve within the stomach without reliance on sutures, staples, or other mechanisms that puncture the stomach wall. In addition to leaving the stomach walls free of punctures, the anchoring system of the present invention prevents movement of the sleeve in both directions, thereby preventing the sleeve from being passed through the digestive system but also from refluxing up the esophagus. 
         [0003]    According to the Center for Disease Control (CDC), sixty six percent of American are overweight, and thirty two percent are obese, presenting an overwhelming health problem. From an economic standpoint, it is estimated that more than 100 billion dollars are spent on obesity and treating its major co-morbidities. This figure does not include psychological and social costs. Many health care experts consider obesity the largest health problem facing westernized societies and considered obesity an epidemic. From a medical standpoint, obesity is the primary risk factor for type 2 diabetes and obstructive sleep apnea. It increases the chances for heart disease, pulmonary disease, infertility, osteoarthritis, cholecystitis and several major cancers, including breast and colon cancers. Despite these alarming facts, treatment options for obesity remain limited. 
         [0004]    Treatment options include dietary modification, very low-calorie liquid diets, pharmaceutical agents, counseling, exercise programs and surgery. Diet and exercise plans often fail because most individuals do not have the discipline to adhere to such plans. When diet and exercise fail, many try dietary supplements and drugs or other ingestible preparations promoted as being capable of suppressing appetite or inducing satiety. In general, these techniques for treating compulsive overeating/obesity have tended to produce only a temporary effect. The individual usually becomes discouraged and/or depressed after the initial rate of weight loss plateaus and further weight loss becomes harder to achieve. The individual then typically reverts to the previous behavior of compulsive overeating. 
         [0005]    Surgical procedures that restrict the size of the stomach and/or bypass parts of the intestine are the only remedies that provide lasting weight loss for the majority of morbidly obese individuals. Surgical procedures for morbid obesity are becoming more common based on long-term successful weight loss result. 
         [0006]    Bariatric surgery is a treatment for morbid obesity that involves alteration of a patient&#39;s digestive tract to encourage weight loss and to help maintain normal weight. Known bariatric surgery procedures include jejuno-ileal bypass, jejuno-colic shunt, biliopancreatic diversion, gastric bypass, Roux-en-Y gastric bypass, gastroplasty, gastric banding, vertical banded gastroplasty, and silastic ring gastroplasty. A more complete history of bariatric surgery can be found on the website of the American Society for Bariatric Surgery at http://www.asbs.orq, the contents of which are incorporated by reference herein in their entirety. 
         [0007]    Advances in laparoscopic surgery have allowed physicians to perform operations that previously required an invasive and painful access incision to be made. For example, in the case of a sleeve gastrectomy, a surgeon would make an abdominal incision, typically 5 cm or more in length, which provided access to the abdominal cavity. The surgeon would then suture the stomach together, forming a stoma, using a bougie as a guide along the lesser curvature of the stomach. A bougie is a relatively simple, solid tube inserted into the stomach via the esophagus. The surgeon sutures the stomach shut around the bougie, such that the stoma formed matches the size and the narrow, tubular shape of the bougie. 
         [0008]    Conducting this surgery laparoscopically minimizes trauma to the patient because the large abdominal incision is avoided. In female patients, the vagina may be used as an entry point, further minimizing trauma to the abdomen. Recovery time and the chances for infection are greatly reduced using laparoscopic surgery. 
         [0009]    However, laparoscopic surgery adds certain complications. In the case of a sleeve gastrectomy, because the suture line extends along the entire length of the stomach, a majority of the stomach is completely isolated from the digestive path. This stomach portion must be removed from the body. Hence, a sleeve gastrectomy begins with the transection of the short gastric arteries to the left diaphragmatic crus. Care must be taken to avoid damaging the spleen or its vessels. This makes removal of the unused stomach portion the most complicated aspect of a sleeve gastrectomy, whether performed laparoscopically or surgically. Laparoscopically transecting these arteries and removing the unused stomach portion is significantly more difficult than doing so surgically. In the case of a vaginal-entry laparoscopy, removing the resected stomach portion through the entry opening in the vagina can be particularly difficult, especially considering that the typical patient undergoing such a surgery as a significantly enlarged stomach. 
         [0010]    There is an apparent need for a device and method of performing a sleeve gastrectomy obviates the need for removing any portion of the stomach. If the entire stomach can be left in place, patient recovery time, procedural complexity, and patient morbidity rates will be greatly reduced. 
       SUMMARY OF THE INVENTION 
       [0011]    The present invention provides a device and method for performing a sleeve gastrectomy while obviating the need to resect the bypassed portion of the stomach. The need for resection is obviated by ending suture line a relatively short distance from the gastroesophageal junction. By leaving this small opening between the stoma and the bypassed portion of the stomach, the bypassed portion can remain in place without complication, despite the absence of food. 
         [0012]    To prevent food from passing through this opening, the suture line is angled away from the gastroesophageal junction near the top of the stomach. This is effected by the use of an embodiment of a bougie of the present invention. The bougie includes an extension that, when opened, gives the bougie a Y shape. The resulting stoma has an open top near the gastroesophageal junction but, due to the extension, it is funnel-shaped and thus directs food into the stoma instead of the bypassed stomach. Several embodiments of bougies are described herein. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1  is an elevation of a first step of the method of the present invention; 
           [0014]      FIG. 2  is an elevation of a second step of the method of the present invention; 
           [0015]      FIG. 3  is an elevation of a third step of the method of the present invention; 
           [0016]      FIG. 4  is an elevation of a fourth step of the method of the present invention; 
           [0017]      FIG. 5  is an elevation of stomach having undergone the method of the present invention; 
           [0018]      FIG. 6  is a perspective view of an embodiment of a device of the present invention; and, 
           [0019]      FIG. 7  is a perspective view of an embodiment of a device of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0020]    The present invention includes a method and devices for performing a gastroplasty procedure.  FIGS. 1-5  show a series of diagrams detailing the various steps of the method.  FIGS. 6-7  depict several embodiments of various devices. By explaining the method first, the various embodiments of devices will be more easily understood. 
         [0021]    The gastroplasty method of the present invention begins by introducing a bougie  10  into the stomach A via the esophagus B. The bougie  10  is preferably shaped to follow the lesser curve C of the stomach A. 
         [0022]    Once the bougie  10  is in place such that its distal end  12  is near the gastro-duodenal junction D, an extension  14  of the bougie  10  is splayed open as depicted in  FIG. 2 . The extension  14  opens enough such that the inner edge  15  of the bougie  10 , opposite the lesser curve C, extends away from the gastroesophageal junction E. 
         [0023]    Next, as seen in  FIG. 3 , a staple line  16  is followed along the inner edge  15  of the bougie  10  beginning at the bottom of the stomach A and working up toward the esophagus B. Optionally, suction may be applied to the stomach A, such that the stomach A collapses and is sucked against the bougie  10 , making the bougie  10  and the desired staple line  16  easier to visualize and follow. Additionally or alternatively, the bougie  10  may include a light source visible through the wall of the stomach A, thereby improving visibility. As seen in  FIG. 4 , the suture line  16  will likely include a bend  17  or angle that follows the bougie  10 . 
         [0024]      FIG. 5  shows that the suture line  16  ends prior to reaching the top of the stomach. A space  19  is left that allows some communication between the bypassed portion of the stomach F and the newly formed stoma G. After the staple line  16  is complete, the extension  14  is closed against the bougie  10  and the bougie  10  is retracted through the esophagus B. 
         [0025]    Turning now to  FIGS. 6-7 , there are shown several embodiments of bougies suitable for use with the method of the present invention. 
         [0026]      FIG. 6  shows a bougie  20  with an extension  22  and an activation device  24 . The extension  22  is biased shut but is flexible enough to be held open using the activation device  24 . 
         [0027]    The activation device  24  includes a sliding ring  26  that passes around the outside of the bougie  20  but not including the extension  22 . An extending wire  28  passes through an internal lumen of the bougie  20  and exits the bougie through a port  30  located distally of a distal end  32  of the extension  22 . The extending wire  28  is then routed proximally and attached to the sliding ring  26 . Preferably, though not shown in the figures, a second extending wire is similarly routed on an opposite side of the bougie  20  such that when pulled, and equal force is applied to both sides of the ring  26 , thereby preventing the ring from hanging up on the bougie  20 . 
         [0028]    One or preferably two (one shown) retraction wires  34  are also routed through an internal lumen of the bougie, exiting at a port  36  located proximally of the proximal end  38  of the bougie  20 . The retraction wires  34  are also connected to the sliding ring  26 . 
         [0029]    In operation, the bougie  20  is placed as desired in the stomach and the extension  22  is splayed open by pulling on the extending wire or wires  28 , thereby pulling the ring  26  down in a distal direction. The ring  26  is wedged between the extension  22  and the rest of the bougie  20 . The further the ring  26  is pulled toward the junction between the extension  22  and the bougie  20 , the greater the angle between the two becomes. 
         [0030]    When the extension  22  is splayed a desired amount, the stapling step of the procedure is accomplished. To remove the bougie  20 , the retraction wire or wires  34  are pulled, thereby pulling the sliding ring  26  in a proximal direction. The resilient nature of the extension  22  brings it flush against the bougie  20  and the bougie  20  may be removed. 
         [0031]    Turning now to  FIG. 7 , there is shown another embodiment of a bougie  40  of the present invention with an extension  42  and an activation device  44 . The extension  42  is biased open but is flexible enough to be held closed using the activation device  44 . 
         [0032]    The activation device  44  includes a sliding ring  46  that passes around the outside of the bougie  40 , including the extension  42 . An extending wire  48  passes through an internal lumen of the bougie  40  and exits the bougie through a port  50  located near or distally of a distal end  52  of the extension  42 . The extending wire  48  is then routed proximally and attached to the sliding ring  46 . Preferably, though not shown in the figures, a second extending wire is similarly routed on an opposite side of the bougie  40  such that when pulled, and equal force is applied to both sides of the ring  46 , thereby preventing the ring from hanging up on the bougie  40 . 
         [0033]    One or preferably two (one shown) retraction wires  54  are also routed through an internal lumen of the bougie, exiting at a port  56  located proximally of the proximal end  58  of the bougie  40 . The retraction wires  54  are also connected to the sliding ring  46 . 
         [0034]    In operation, the bougie  40  is placed as desired in the stomach and the extension  42  is splayed open by pulling on the extending wire or wires  48 , thereby pulling the ring  26  down in a distal direction. The ring  46  releases the extension  42  and the biased-open extension is free to splay. Depending on the how over-sized the ring  46  is compared to the bougie, the further the ring  46  is pulled toward the junction between the extension  42  and the bougie  40 , the greater the angle between the two becomes. 
         [0035]    When the extension  42  is splayed a desired amount, the stapling step of the procedure is accomplished. To remove the bougie  40 , the retraction wire or wires  54  are pulled, thereby pulling the sliding ring  46  in a proximal direction. The ring  46  collapses the extension  42  flush against the bougie  40  and the bougie  40  may be removed. Preferably the port  56  is located such that the ring  46  cannot be drawn past the proximal end of the extension  42 , such that an accidental splaying of the extension  42  during withdrawal is not possible. 
         [0036]    Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. For example, one skilled in the art will realize several embodiments bougies that include an extension and various was to deploy and retract this extension. Just a few, non-limiting examples of other devices include, but are not limited to, screw-activated devices, balloon activated devices, ratcheting devices, and the like. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.