Abstract:
The present invention generally provides for correcting an imbalance between caloric intake and caloric expenditure in patients, as well as for treating co-morbidities often associated therewith, which is non-invasive or minimally invasive and which may be reversible. More specifically, the present invention provides systems which cause metabolic improvement in a patient by controlling the amount of bile available for food breakdown or by controlling the effective absorption time and area by delivering bile to selected locations in the intestinal tract. These methods and devices fall under three general categories: bile diversion systems, bile manipulation systems, and surgical methods.

Description:
REFERENCE TO RELATED APPLICATIONS 
       [0001]    This non-provisional application claims the benefit of U.S. Provisional Application Ser. No. 61/256,221 entitled: “Bile Manipuliation System and Methods”, filed on Oct. 29, 2009. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates to methods and systems for manipulation of bile within the body in order to affect a metabolic improvement. 
         [0003]    Obesity is a disease in which excess body fat accumulates due to an imbalance between caloric intake and caloric expenditure. Obese patients often suffer from serious health issues, or co-morbidities, such as diabetes, heart disease, asthma, hypertension and many others. Many studies have shown a direct correlation between obesity and these co-morbid conditions, resulting in a finding that obesity substantially reduces life expectancy. For many obese patients, the desire to eat and presence of hunger are major factors that contribute to their caloric imbalance. 
         [0004]    Amongst the most common co-morbidities is Type II diabetes. The most common form of diabetes, Type II, occurs in approximately 3-5% of Americans under 50 years of age, and increases to 10-15% in those over 50. More than 90% of the diabetics in the United States are Type II diabetics. Sometimes called age-onset or adult-onset diabetes, this form of diabetes occurs most often in people who are overweight and who do not exercise. It is also more common in people of Native American, Hispanic, and African-American descent. People who have migrated to Western cultures from East India, Japan, and Australian Aboriginal cultures also are more likely to develop Type II diabetes than those who remain in their original countries. Type II is considered a milder form of diabetes because of its slow onset (sometimes developing over the course of several years) and because it usually can be controlled with diet and oral medication. The consequences of uncontrolled and untreated Type II diabetes, however, are the just as serious as those for Type I. This form is also called noninsulin-dependent diabetes, a term that is somewhat misleading. Many people with Type II diabetes can control the condition with diet and oral medications, however, insulin injections are sometimes necessary if treatment with diet and oral medication is not working. 
         [0005]    Many obese patients require some sort of intervention to overcome their obesity and to treat their accompanying co-morbidities. Behavior and lifestyle modification are often the first measures to be taken. This includes reducing caloric intake as well as increasing exercise to increase caloric expenditure. If these measures are not sufficient enough to achieve the weight loss desired by the patient, pharmaceuticals are often introduced that will suppress appetite as well as boost metabolism. Many of these pharmacological approaches result in negative side effects, which may include increased sweating, tachycardia and hypertension. 
         [0006]    The patient&#39;s last option would be surgical intervention. Currently, one of the most common bariatric surgeries is gastric bypass with a Roux en-Y. Gastric bypass with a Roux en-Y is a procedure that is both restrictive and malabsorptive in nature. A small pouch is first created in the stomach, by way of surgical stapling, greatly restricting the amount of food that can be ingested. Next, the small intestine is transected, the distal portion is anastomosed to the stomach and the proximal portion is anastomosed back to the small intestine further downstream. This limits the amount of time that the ingested food and its nutrients can be absorbed by the body. While this procedure is very effective in creating weight loss, there are many side effects associated with it, such as nutritional deficiencies and sometimes even death. 
         [0007]    Other approaches such as the jejunoileal bypass and biliopancreatic diversion offer excellent results in terms of rapid and long term weight loss. However, specific complications associated with these procedures include a myriad of iatrogenic nutritive deficiencies such as vitamin A deficiency, osteoporosis and protein-calorie malnutrition. 
         [0008]    Additional drawbacks to these surgical procedures are that they are often extremely invasive such as through rerouting of larger portions of the gastrointestinal tract and these procedures require general anesthesia thereby increasing the risk for morbidly obese patients. Furthermore, these procedures are generally considered irreversible. 
         [0009]    What is needed therefore are means for correcting an imbalance between caloric intake and caloric expenditure in patients, as well as a means for treating co-morbidities often associated therewith, which is non-invasive or minimally invasive and which may be reversible. 
       SUMMARY OF THE INVENTION 
       [0010]    The present invention generally provides means for correcting an imbalance between caloric intake and caloric expenditure in patients, as well as a means for treating co-morbidities often associated therewith, which is non-invasive or minimally invasive and which may be reversible. More specifically, the present invention provides systems which cause metabolic improvement in a patient by controlling the amount of bile available for food breakdown or by controlling the effective absorption time and area by delivering bile to selected locations in the intestinal tract. The system may also provide the benefits of controlling the amount of bile available as signalling molecules for thyroid hormone receptors in order to control a patient&#39;s energy expenditure, as well as controlling the amount of bile available for glucagon-like peptide 1 (GLP-1) in order to control appetite, and manage Type II diabetes by controlling insulin release from the pancreas. Numerous methods and devices are disclosed herein for accomplishing these effects. These methods and devices fall under three general categories: bile diversion systems, bile manipulation systems, and surgical methods. The surgical methods disclosed fall under three general categories: bile diversion, bile exclusion, and bile acceleration. 
         [0011]    Numerous bile diversion systems are disclosed herein. In general, these systems provide an inlet to some or all of the bile that exits the common bile duct, such that the bile is diverted to a more distal location in the body, such as in the gastrointestinal (GI) tract, to limit or prevent nutrient absorption in the body, and may optionally serve as a way for fixing a bile manipulation system within the GI tract. Three main bile diversion system types are disclosed. They include malabsorptive catheter systems, stents, and diversion valves, all of which will be discussed in greater detail later herein. 
         [0012]    The bile manipulation systems disclosed herein generally serve as a means to prevent bile from interacting with food content in the GI tract. Two main bile manipulation system types are disclosed. They include thermal bile deactivating catheters and chemical bile deactivating catheters, both of which will be discussed in greater detail later herein. 
         [0013]    Two main surgical methods for correcting an imbalance between caloric intake and caloric expenditure are disclosed herein. They include direct shunting of the common bile duct and connecting proximal and distal portions of the small intestine to speed delivery of bile and/or chyme to distal regions of the GI tract, both of which will be discussed in greater detail later herein. These surgical methods are minimally invasive when compared to known procedures and are fully reversible. 
         [0014]    As may be appreciated, any of the aforementioned devices and methods disclosed herein may be practiced either alone or in combination with any of the other disclosed devices and methods, where practical, without departing from the scope of the present invention, to achieve the desired effect of correcting an imbalance between caloric intake and caloric expenditure to enable excess weight loss, which is non-invasive or minimally invasive, and may be reversible in nature. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which: 
           [0016]      FIG. 1  is a schematic partially transparent view of a clipped catheter system placed in the Ampulla of Vater. 
           [0017]      FIG. 2  is a schematic partially transparent view of a self-expanding stent placed in the Ampulla of Vater. 
           [0018]      FIG. 3  is a schematic partially transparent view of a self-expanding stent having a diversion valve placed in the Ampulla of Vater. 
           [0019]      FIG. 4  is a schematic partially transparent view of a therapeutic system connected to the bile inlet of the duodenum through a transhepatic catheter. 
           [0020]      FIG. 5  is a schematic partially transparent view of a therapeutic system connected to the bile inlet of the duodenum through a transhepatic catheter having a subcutaneous fill port. 
           [0021]      FIG. 6  is a schematic partially transparent view of a therapeutic system and associated reservoir, pumping system and control system connected to the bile inlet of the duodenum through a transhepatic catheter having a subcutaneous fill port. 
           [0022]      FIG. 7  is a schematic partially transparent view of a Y-connection between the bile inlet of the duodenum and a catheter. 
           [0023]      FIG. 8  is a schematic partially transparent view of a catheter which extends into an impermeable length of tubing extending to the bile inlet of the duodenum. 
           [0024]      FIG. 9  is a schematic partially transparent view of a catheter with a one-way check valve, which extends into an impermeable length of tubing extending to the bile inlet of the duodenum. 
           [0025]      FIG. 10  is a schematic partially transparent view of a catheter which extends into an impermeable length of tubing extending into the bile inlet of the duodenum, and having inlet features therein. 
           [0026]      FIG. 11  is a schematic partially transparent view of a bile pumping system to accelerate an intestinal braking effect in combination with a gastric band. 
           [0027]      FIG. 12  is schematic partially transparent view of a catheter system for thermally deactivating a portion of the bile passing therethrough. 
           [0028]      FIG. 13  is schematic partially transparent view of a forked catheter system for chemically deactivating a portion of the bile passing therethrough. 
           [0029]      FIG. 14  is a schematic view of a direct diversion of the common bile duct by means of shunting and/or surgical bypass. 
           [0030]      FIG. 15  is a schematic partially transparent view of an extraluminal catheter delivered distally in the small intestine by connecting proximal and distal portions of the small intestine. 
           [0031]      FIG. 16  is a schematic partially transparent view of an extraluminal catheter delivered distally in the small intestine by connecting proximal and distal portions of the small intestine in an alternative manner. 
           [0032]      FIG. 17  is a schematic partially transparent view of a stent and catheter system exiting the common bile duct at the Sphincter of Oddi, then travelling through the small intestine to the jejunum where it exits and travels subcutaneously along the abdominal wall into the systemic vein. 
           [0033]      FIG. 18  is a schematic partially transparent view of a stent and dual catheter system exiting the common bile duct at the Sphincter of Oddi for diverting bile and pancreatic secretions separately. 
           [0034]      FIG. 19  is a schematic partially transparent view of a stent and catheter system exiting the common bile duct through the cystic duct and gall bladder into the jejunum. 
           [0035]      FIG. 20  is a schematic partially transparent view of a catheter anchored within the gall bladder by a coil, and passing through the common bile duct into the duodenum. 
           [0036]      FIG. 21  is a schematic view detailing a procedure for cutting the common bile duct before it joins the duodenum and reattaching it at a distal location. 
           [0037]      FIG. 22  is a schematic view detailing a procedure for cutting the tissue surrounding the Sphincter of Oddi and transplanting that cut tissue patch at a distal location. 
           [0038]      FIG. 23  is schematic partially transparent view of a catheter anchored within the common bile duct for diverting bile to a distal location in the small intestine. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0039]    Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention. 
         [0040]    Numerous bile diversion systems are disclosed herein. In general, these systems provide an inlet to some or all of the bile that exits the common bile duct, such that the bile is diverted to a more distal location in the body, such as in the GI tract, to limit or prevent nutrient absorption in the body, and may optionally serve as a way for fixing a bile manipulation system within the GI tract. Three main bile diversion system types are disclosed. They include catheter systems, stents, and diversion valves, all of which will be discussed in greater detail later herein. 
         [0041]      FIG. 1  is a schematic partially transparent view of clipped catheter system  100  placed in Ampulla of Vater  102  and secured therein at Sphincter of Oddi  104  using clip  106 . In this embodiment, catheter  100  extends through the lumen of the duodenum and diverts biliary and pancreatic secretions approximately 125-175 cm distally from the Ligament of Treitz. Further, catheter  100  can be divided into two regions along its length, where each region is composed of a different absorbable material. The more proximal region of catheter  100  as best seen in the enlarged detail may be constructed from a material with a slower degradation rate than that of the distal region of catheter  100 . Accordingly, the area of GI tract available for absorption of nutrients from food content would increase over time as catheter  100  degraded from its distal end to its proximal end. Examples of acceptable absorbable materials include polylactic acid/polylactide (PLA), polydimethylsiloxane (PDMS), polyglycolide/polyglycolic acid (PGA), and the like. Each of these materials absorbs in the body over time and has a different degradation rate generally ranging from several days to several months. Additionally, catheter  100  and/or clip  106  may further elute a therapeutic substance such as an antibiotic, a bile deactivating agent, an intestinal brake inducing agent, a hunger suppressing agent, or the like to further enhance the effectiveness of system  100 . 
         [0042]      FIG. 2  is a schematic partially transparent view of self-expanding stent  200  placed in Ampulla of Vater  102 . In this embodiment, stent  200  may be deployed endoscopically into Ampulla of Vater  102  by attaching it to a flexible, impermeable length of tubing  202  that extends down the intestinal lumen for a variable length. The purpose of tubing  202  is to shunt or divert biliary and pancreatic secretions away from the duodenum and proximal small intestine where they would normally mix with the contents thereof and be at least partially absorbed into the bloodstream. Due to the normal peristalsis of the GI tract, the biliary and pancreatic secretions within tubing  202  would be pumped therethrough. In certain embodiments, the tubing may be constructed from absorbable materials including polylactic acid/polylactide (PLA), polydimethylsiloxane (PDMS), polyglycolide/polyglycolic acid (PGA), and the like, and may further elute a therapeutic substance such as an antibiotic, a bile deactivating agent, an intestinal brake inducing agent, a hunger suppressing agent, or the like to further enhance the effectiveness of the system. Additionally, it may be desirous to anchor stent  200  within the Ampulla of Vater  102  via suturing, surface features on stent  200  or other known means. 
         [0043]      FIG. 3  is a schematic partially transparent view of self-expanding stent  200  having diversion valve  302  placed in Ampulla of Vater  102 . In this embodiment, sensors  300  are provided at separate locations in the GI tract of a patient. Sensors  300  actively communicate with controller  304  to selectively control the position of valve  302 . In this embodiment, valve  302  is a two position valve which is selectively controlled to permit flow of the biliary and pancreatic secretions to relatively proximal and relatively distal locations in the GI tract away from the duodenum and proximal small intestine where they would normally mix with the contents thereof and be at least partially absorbed into the bloodstream. In certain embodiments, controller  304  may comprise a portacath or transhepatic catheter through which a saline solution or the like may be injected or withdrawn to control the position of valve  302 . In certain other embodiments, controller  304  may comprise an electronic controller. 
         [0044]      FIG. 4  is a schematic partially transparent view of therapeutic system  400  connected to the bile inlet of duodenum  404  through transhepatic catheter  406 . In this embodiment, transhepatic catheter  406  passes through liver  408  and enters common bile duct  402  near hepatic ducts  410 . Catheter  406  extends past gall bladder  418  and associated cystic duct  412 , as well as pancreas  416  and associated pancreatic duct  414 . As with previous embodiments, a self-expanding stent  200  is placed in Ampulla of Vater  102 , and a flexible, impermeable length of tubing  202  extends down the intestinal lumen for a variable length. The purpose of tubing  202  is to shunt or divert biliary and/or pancreatic secretions away from the duodenum and proximal small intestine where they would normally mix with the contents thereof and be at least partially absorbed into the bloodstream. In this embodiment, a therapeutic substance such as an antibiotic, a bile deactivating agent, an intestinal brake inducing agent, a hunger suppressing agent, or the like may be supplied by catheter  406  to further enhance the effectiveness of system  400 . 
         [0045]      FIG. 5  is a schematic partially transparent view of therapeutic system  500  connected to the bile inlet of duodenum  404  through transhepatic catheter  406  having subcutaneous fill port  502 . In the embodiment of  FIG. 5 , subcutaneous fill port  502  is provided as a way to provide a therapeutic substance to catheter  406 . The therapeutic substance may, for example, comprise an antibiotic, a bile deactivating agent, an intestinal brake inducing agent, a hunger suppressing agent, or the like to further enhance the effectiveness of system  500 . Additionally, tubing  202  is provided in a configuration that eliminates the need for stent  200 ; details of which are provided later herein with respect to  FIG. 8 . 
         [0046]      FIG. 6  is a schematic partially transparent view of therapeutic system  600  and associated reservoir  602 , pumping system  604  and control system  606  connected to the bile inlet of duodenum  404  through a transhepatic catheter  406  having a subcutaneous fill port  502 . In this embodiment, therapeutic substance is provided to reservoir  602  by subcutaneous fill port  502 . The therapeutic substance within reservoir  602  is then pumped into catheter  406  via pumping system  604  as determined by control system  606 . As with previous embodiments, the therapeutic substance may, for example, comprise an antibiotic, a bile deactivating agent, an intestinal brake inducing agent, a hunger suppressing agent, or the like to further enhance the effectiveness of system  600 . 
         [0047]      FIG. 7  is a schematic partially transparent view of Y-connection  700  between the bile inlet of duodenum  404  and transhepatic catheter  406 . In this embodiment, there is no need for a stent to secure Y-connection  700  in Ampulla of Vater  102 . Instead, Y-connection is supported by catheter  406 , and is further sized and shaped to allow limited passage thereby of a portion of the biliary and pancreatic secretions in common bile duct  402 . In this way, the risk of blockage of common bile duct  402  is greatly reduced, yet the advantages of delivery of the biliary and pancreatic secretions to relatively proximal and relatively distal locations in the GI tract away from the duodenum and proximal small intestine are realized. 
         [0048]      FIG. 8  is a schematic partially transparent view of transhepatic catheter  406  which extends into an impermeable length of tubing  202  extending to the bile inlet of duodenum  404 . The purpose of tubing  202  is to shunt or divert biliary and pancreatic secretions away from the duodenum and proximal small intestine where they would normally mix with the contents thereof and be at least partially absorbed into the bloodstream. In this embodiment, tubing  202  is provided in a configuration that eliminates the need for a separate stent to hold it in place. In this manner, the bile inlet of the duodenum  404  remains unaffected, whereas if a stent were used, it may be prone to tissue thickening as it grew to cover the stent. Further, in this configuration, the bile inlet of the duodenum  404  is maintained opened to prevent a build up of biliary and pancreatic secretions which may increase the risk of a blockage or infection, and further allows for a continuous shunting or diversion of biliary and pancreatic secretions away from the duodenum and proximal small intestine. 
         [0049]      FIG. 9  is a schematic partially transparent view of transhepatic catheter  406  with a one-way check valve  900 , which extends into an impermeable length of tubing  202  extending to the bile inlet of duodenum  404 . As with previous embodiments, the purpose of tubing  202  is to shunt or divert biliary and pancreatic secretions away from the duodenum and proximal small intestine where they would normally mix with the contents thereof and be at least partially absorbed into the bloodstream. In this embodiment, check valve  900  is functional to prevent backflow from the GI tract into common bile duct  402 , thereby reducing the risk of infection or blockage in common bile duct  402 . Check valve  900  may be formed from very thin materials, such as a polyester having a thickness of less than one-thousandth of an inch, and as low as about two ten-thousandths of an inch or thinner. Thus, check valve  900  may be designed to accommodate flow of biliary and pancreatic secretions into the GI tract when the biliary and pancreatic secretions flow under very low pressure, but to still prevent backflow from the GI tract. Transhepatic catheter  406  may have walls that are thicker than the walls of check valve  900  to provide durability for catheter  406  while still designing check valve  900  to allow low pressure flow. 
         [0050]      FIG. 10  is a schematic partially transparent view of transhepatic catheter  406  which extends into an impermeable length of tubing  202  extending into the bile inlet of duodenum  404 , and having inlet features  1000  therein. In this embodiment, inlet features  1000  comprise a series of finger-like protrusions attached at their respective bases to the interior of tubing  202  and unattached at their distal ends, although numerous other configurations are envisioned. Inlet features  1000  are functional to prevent backflow from the GI tract into common bile duct  402 , thereby reducing the risk of infection or blockage in common bile duct  402 . 
         [0051]    Although embodiments of transhepatic catheters are discussed, these embodiments could also be useful with a catheter that is not installed transhepatically. As a non-limiting example, a catheter that is not installed transhepatically could also provide a therapeutic substance, connect to fill port  502 , support Y-connection  700 , extend into a length of tubing  202 , contain check valve  900 , or contain inlet features  1000 . 
         [0052]      FIG. 11  is a schematic partially transparent view of bile pumping system  1100  to accelerate an intestinal braking effect in combination with gastric band  1102 . In this embodiment, gastric band  1102  is connected to fill port  1104  via tubing  1106 . This allows fluid to be added or withdrawn to change the interior diameter of gastric band  1102 . Additionally, a mechanism  1108  is connected by tubing  1112  between gastric band  1102  and fill port  1104  via a T-fitting  1110  positioned along tubing  1106 . Extending from mechanism  1108  is tube  1114  which is placed in Ampulla of Vater  102  by stent  200 . Mechanism  1108  can serve many functions, such as being a fluid reservoir, a check valve system, a pre-programmed controller, and/or may be functional to move fluid in either or both directions along tubing  1112  and/or tubing  1114  separately or in concert. In certain other embodiments, gastric band  1102  may be operable to provide pressure signals to mechanism  1108  representative of the act of swallowing food, which would in turn enable mechanism  1108  to operate as a logic controller for the operation of the various components of system  1100 . In this manner, mechanism  1108  can dynamically change the interior diameter of gastric band  1102  and/or provide fluid into the bile inlet of the duodenum  404  in order to cause flushing or pumping of biliary and pancreatic secretions more rapidly down the GI tract. The provided fluid may comprise, for example, a bile deactivating agent, an intestinal brake inducing agent, an antibiotic agent, a hunger suppressing agent, or the like to further enhance the effectiveness of the system. In alternative embodiments, a stent and extension tube system as in  FIG. 2  may be used as a means to shunt or divert the provided fluid and biliary and pancreatic secretions away from the duodenum and proximal small intestine where they would normally mix with the contents thereof and be at least partially absorbed into the bloodstream. Thus, the provided fluid may be directed to the jejunum or the ileum, distally to the ampulla of Vater. Alternately, the provided fluid may be directed proximally to the ampulla of Vater. 
         [0053]    Although not explicitly shown or discussed previously herein with respect to the bile diversion systems of  FIGS. 1-11 , it is anticipated that bile diversion to distal intestinal locations may limit the ability of bile to lower the pH level of chyme in proximal intestinal locations. Accordingly, the need may exist for pH balancing to accompany these bile diversion systems. Exemplary pH balancing devices include catheter systems formed of semi-permeable pH membranes, components which elute pH balancing substances, and the like. Such pH balancing devices would act to balance the pH levels of the chyme within the GI tract to the appropriate levels in order to prevent tissue damage within the GI tract due to overly acidic chyme. 
         [0054]    As may be appreciated, numerous modifications to the systems disclosed in  FIGS. 1-11  may be realized without departing from the scope of the present invention. For example, catheter  406  and/or tubing  202  may have indicia thereon to aid in determining their proper length during implantation. In other instances, catheter  406  may be installed surgically in common bile duct  402  and exit out through the lumen into the peritoneal space, then be reinserted into the desired distal GI tract location, thereby eliminating the need for peristalsis to pump the biliary and pancreatic secretions through tubing  202 . Further, it should be understood that by rerouting the biliary and pancreatic secretions to distal locations in the GI tract, they are prevented from coming into contact with ingesta and chyme in the small intestine until they are far enough along in the GI tract that they cannot be or can only be minimally absorbed. It should also be understood that by shunting a small amount of undigested intestinal contents and/or biliary and pancreatic secretions to distal locations in the GI tract sooner than would be possible through natural biological processes, the patient may experience greater feelings of satiation, as well as prolonged feelings of satiation. 
         [0055]    The bile manipulation systems disclosed herein generally serve as a way to prevent bile from interacting with food content in the GI tract, thereby preventing or limiting digestion and absorption of nutrients into the body. Two main bile manipulation system types are disclosed. They include thermal bile deactivating catheters and chemical bile deactivating catheters, both of which will be discussed in greater detail later herein. 
         [0056]      FIG. 12  is schematic partially transparent view of a catheter system for thermally deactivating a portion of the biliary and pancreatic secretions passing therethrough. In the embodiment of detail A of  FIG. 12 , forked catheter  1200  has an inlet lumen  1202  that is divided into a first branch  1204  and a second branch  1206  at its distal end which later reconnects at an outlet  1208  catheter. In this manner, secretions passing through catheter  1200  are divided between branch  1204  and branch  1206 . Within branch  1206  resides a heating coil  1210  which is controlled by a controller  1212 . In certain embodiments, controller  1212  may be a logic controller which uses sensed parameters to determine the operating characteristics of heating coil  1210 . As secretions pass through branch  1206 , heating coil  1210  (or other means for deactivating at least a portion of the digestive enzymes in an amount of secretions, as described below) is operable to impart thermal energy to the secretions to raise the temperature to a point where the digestive enzymes within the secretions are deactivated. The secretions passing through branch  1204  are left unaffected. In this manner, when the secretions of branches  1204  and  1206  are recombined at outlet  1208 , the overall potency of the bile is decreased, thus decreasing its ability to aid in the digestion and absorption of nutrients in the body. In the embodiment of detail B of  FIG. 12 , catheter  1214  does not include the forked configuration of catheter  1200  of detail A. Instead, secretions enter catheter  1214  through inlet  1216  and passes over heating coil  1220  before exiting at outlet  1218 . Heating coil  1220  is controlled by controller  1222  and may be operated such that it is pulsed on and off to create an alternating deactivated and unaffected secretions stream exiting from outlet  1218 . In this manner, the average potency of the secretions exiting outlet  1218  is decreased, thus decreasing its ability to aid in the digestion and absorption of nutrients in the body. 
         [0057]      FIG. 13  is schematic partially transparent view of forked catheter system  1300  for chemically deactivating a portion of the biliary and pancreatic secretions passing therethrough. Forked catheter  1300  has an inlet  1302  that is divided into a first branch  1304  and a second branch  1306  which later reconnect at an outlet  1308 . In this manner, secretions passing through catheter  1300  are divided between branch  1304  and branch  1306 . Connected to branch  1306  via tube  1310  is reservoir  1312 . In certain embodiments, a logic controller which uses sensed parameters to determine the operating characteristics of a pump connected to reservoir  1312  may be employed to selectively supply a biliary and pancreatic secretion neutralizing agent to the secretion stream flowing through branch  1306 . In this manner, as secretions pass through branch  1306 , the supplied secretion neutralizing agent deactivates the digestive enzymes within the secretions. The secretions passing through branch  1304  are left unaffected. In this manner, when the secretions of branches  1304  and  1306  are recombined at outlet  1308 , the overall potency of the secretions is decreased, thus decreasing its ability to aid in the digestion and absorption of nutrients in the body. In certain embodiments, a valve means may be included in tube  1310  which may also be controlled by the logic controller outlined above. Further, certain embodiments may also include a therapeutic eluting stent. As with previous embodiments, the therapeutic substance being eluted may comprise, for example, a pH balancing fluid, a biliary and pancreatic secretion deactivating agent, an intestinal brake inducing agent, an antibiotic agent, a hunger suppressing agent, or the like to further enhance the effectiveness of the system. 
         [0058]    Two main surgical methods for correcting an imbalance between caloric intake and caloric expenditure are disclosed herein. They include direct shunting of the common bile duct and connecting proximal and distal portions of the small intestine to speed delivery of bile and/or chyme to distal regions of the GI tract, both of which will be discussed in greater detail later herein. These surgical methods are minimally invasive when compared to known procedures and are fully reversible. 
         [0059]      FIG. 14  is a schematic view of a direct diversion of common bile duct  402  by means of shunting and/or surgical bypass. Detail A of  FIG. 14  illustrates an unaffected GI tract having an esophagus  1400 , stomach  1402 , duodenum  404 , small intestine  1404 , large intestine  1406 , gall bladder  418 , and common bile duct  402 . In detail B of  FIG. 14 , a distal portion of small intestine  1404  is brought into fluid communication with common bile duct  402  at location  1408 , via shunting and/or surgical bypass. This may be accomplished, for example, by a side-to-side anastomosis of common bile duct  402  and small intestine  1404 . In this manner, at least a portion of the biliary and pancreatic secretions within common bile duct  402  are channelled away from duodenum  404  and proximal portions of small intestine  1404  where they would normally mix with the contents thereof and be at least partially absorbed into the bloodstream. In certain embodiments, a direct diversion of the Papilla of Vater by means of shunting or surgical bypass external to the GI tract may be employed as a means to allow bile, chyme and the like to flow directly to the ileum which would creating an intestinal braking effect. 
         [0060]      FIG. 15  is a schematic partially transparent view of extraluminal catheter  406  delivered distally in small intestine  1404  by connecting proximal and distal portions of small intestine  1404 . In one embodiment, the proximal portion of small intestine  1404  may comprise the duodenum  404  while the distal portion of small intestine  1404  may comprise a middle portion of the ileum. In this embodiment, the proximal and distal portions of small intestine  1404  may be stapled or sutured together by fasteners  1502 , leaving an opening  1500  which is large enough for tubing  202  and a small amount of chyme to pass therethrough. In this manner, the biliary and pancreatic secretions within common bile duct  402  are channelled away from duodenum  404  and proximal portions of small intestine  1404  where they would normally mix with the contents thereof and be at least partially absorbed into the bloodstream, and the chyme passing through opening  1500  may aid is speeding the initiation of an intestinal brake in the GI tract. This further allows for the biliary and pancreatic secretions within common bile duct  402  to be directly channelled to the ileum which would create an intestinal braking effect. As with previous embodiments of the present invention, it is anticipated that bile diversion may limit the ability of bile to lower the pH level of chyme in proximal intestinal locations. Accordingly, the need may exist for pH balancing to accompany such systems. Examples of such pH balancing devices include catheter systems formed of semi-permeable pH membranes or components which elute pH balancing substances. Such pH balancing would act to balance the pH levels of the chyme within the GI tract to the appropriate levels in order to prevent tissue damage within the GI tract due to overly acidic chyme. 
         [0061]      FIG. 16  is a schematic partially transparent view of an extraluminal catheter  406  delivered distally in small intestine  1404  by connecting proximal and distal portions of small intestine  1404  in an alternative manner. In this embodiment, the proximal and distal portions of small intestine  1404  may be stapled or sutured together by fasteners  1502 , leaving an opening  1500  which is large enough for only tubing  202  to pass therethrough. In this manner, the biliary and pancreatic secretions within common bile duct  402  are channelled away from duodenum  404  and proximal portions of small intestine  1404  where they would normally mix with the contents thereof and be at least partially absorbed into the bloodstream, while chyme must still pass through the length of small intestine  1404 . As with previous embodiments of the present invention, it is anticipated that bile diversion may limit the ability of bile to lower the pH level of chyme in proximal intestinal locations. Accordingly, the need may exist for pH balancing means to accompany such systems. Examples of such pH balancing means include catheter systems formed of semi-permeable pH membranes or components which elute pH balancing substances. Such pH balancing means would act to balance the pH levels of the chyme within the GI tract to the appropriate levels in order to prevent tissue damage within the GI tract due to overly acidic chyme. 
         [0062]      FIG. 17  is a schematic partially transparent view of stent  200  and catheter  100  system exiting common bile duct  402  at Sphincter of Oddi  104 , then travelling through the small intestine to the jejunum where it exits and travels subcutaneously along abdominal wall  1700  into the systemic vein  1702 . Alternately, catheter  100  system could travel into the thoracic duct. The purpose of this procedure is to divert at least a portion of the bile from common bile duct  402  to systemic vein  1702  or the thoracic duct. This procedure may be accomplished via a conventional endoscopic retrograde cholangiopancreatography (ERCP). It should be noted that the jejunum may be affixed to abdominal wall  1700 , in order to prevent leakage where catheter  100  exits the jejunum and enters abdominal wall  1700 . Additionally, as with other embodiments disclosed herein, a pumping system (not shown) or valve (not shown) may be further included to compensate for pressure differentials and to prevent backflow through catheter  100  into common bile duct  402 . 
         [0063]      FIG. 18  is a schematic partially transparent view of stent  200  and dual catheter system  1800  exiting common bile duct  402  into the small intestine at Sphincter of Oddi  104 , for diverting bile and pancreatic secretions separately. In one embodiment, first catheter  1802  is positioned such that it diverts only bile, while second catheter  1804  is positioned such that it diverts only pancreatic secretions. In the embodiment shown in  FIG. 18 , first catheter  1802  is longer than second catheter  1804 , however, it should be understood that any desirable lengths may be chosen for these catheters at the discretion of the attending physician, so as to enable the desired metabolic improvement in the patient. As may be appreciated, catheter  1804  may be absent in certain embodiments of the invention, leaving the pancreatic secretions to flow normally without diversion. 
         [0064]      FIG. 19  is a schematic partially transparent view of stent  200  and catheter  100  exiting common bile duct  402  through cystic duct  412  and gall bladder  418  into the jejunum. In one embodiment, an anastomosis of gall bladder  418  and jejunum may be performed. In another embodiment, gall bladder  418  and jejunum may simply be fenestrated to allow passage of catheter  100  therethrough. In certain embodiments, catheter  100  may also be fixated at its distal end and/or at the cholecysto-jejunostomy location in order to maintain its position and allow bile to freely flow therethrough. As may be appreciated, in addition to the jejunum location disclosed in  FIG. 18 , various other locations in the body may be realized for the diverted bile as have been disclosed herein with respect to other embodiments, without departing from the scope of the present invention. Further, catheter  100  can be fenestrated in its location within gall bladder  418  in order to allow the free flow of bile to and from gall bladder  418 , in case catheter  100  were to completely obstruct cystic duct  412 . 
         [0065]      FIG. 20  is a schematic partially transparent view of catheter  100  anchored within gall bladder  418  by coil  2000 , and passing through common bile duct  402  into duodenum  404 . Coil  2000  may, for example, be implanted by passing it through duodenum  404 , past Sphincter of Oddi  104 , through common bile duct  402 , into cystic duct  412 , arriving in gall bladder  418 , where it may be expanded and deployed to serve as an anchor for catheter  100 . 
         [0066]      FIG. 21  is a schematic view detailing a procedure for cutting common bile duct  402  at location  2100 , before it joins duodenum  404 , and reattaching it at a distal location  2102 . In this particular embodiment, distal location  2102  is the ileum, however, as with the other embodiments disclosed herein, alternate locations are contemplated. Additionally, as with other embodiments disclosed herein, a pumping system (not shown) or valve (not shown) may be further included to compensate for pressure differentials and to prevent backflow through common bile duct  402 . 
         [0067]      FIG. 22  is a schematic view detailing a procedure for cutting the tissue surrounding Sphincter of Oddi  104  and transplanting that patch of tissue at distal location  2202 . In this particular embodiment, distal location  2202  is the ileum, however, as with the other embodiments disclosed herein, alternate locations are contemplated. Additionally, as with other embodiments discloses herein, a pumping system (not shown) or valve (not shown) may be further included to compensate for pressure differentials and to prevent backflow through common bile duct  402 . 
         [0068]      FIG. 23  is schematic partially transparent view of catheter  100  anchored within common bile duct  402  for diverting bile to a distal location  2300  in small intestine  1404 . In this particular embodiment, distal location  2300  is the ileum, however, as with the other embodiments disclosed herein, alternate locations are contemplated. Additionally, as with other embodiments discloses herein, a pumping system (not shown) or valve (not shown) may be further included to compensate for pressure differentials and to prevent backflow through catheter  100  into common bile duct  402 . 
         [0069]    One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.