Abstract:
Methods and devices reroute chyme to induce intestinal brake in order to improve the effectiveness of bariatric surgical procedures and to improve comorbidity resolution. A bowel is manipulated to provide a shortened path for chyme to travel to the ileum. These methods and devices of rerouting chyme to induce intestinal brake may comprise one or more of a surgical procedure, an implanted device, or a combination of an implant with an improved surgical procedure.

Description:
PRIORITY 
       [0001]    This application claims priority to U.S. Provisional Patent Application Ser. No. 61/348,267, entitled “Methods and Devices for the Rerouting of Chyme to Induct Intestinal Brake,” filed May 26, 2010, the disclosure of which is incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to methods and devices for the rerouting of chyme to induce intestinal brake. 
       BACKGROUND OF THE INVENTION 
       [0003]    Obesity is the accumulation of excess body fat on a person to the extent it may have an adverse effect on health and is a leading, preventable cause of death worldwide. Adverse health effects due to obesity, which are a consequence of the mechanical or metabolic effects of obesity, range from mild to acute and often include development of comorbidities. These comorbidities include cardiovascular disease, diabetes and degenerative diseases of the cartilaginous tissue between the vertebral bones of the spine and other weight bearing joints. Treatment for mild cases includes dietary and physical exercise and severe cases require surgery. Bariatric surgery is a term encompassing all of the surgical treatments for morbid obesity. Every year there are more morbid obese and those who do seek bariatric surgery are heavier. 
         [0004]    Meal digestion and absorption are time-intensive processes and bariatric procedures effectively reduce stomach volume and or bowel length and operate to promote earlier satiation, a perception colloquially referred to as ‘feeling full’. Inducing this feeling results in loss of desire to continue eating and a resulting reduction in caloric intake. Chyme is a semi-fluid mass of mechanically and chemically digested food which is produced by the stomach and expelled into the duodenum where it begins the journey through the gastrointestinal (GI) tract. To optimize digestion and absorption, transit of the meal through the GI tract is regulated by a complex integration of signals from the small intestine in response to nutrient sensing in the bowel or gut. Satiation results from signals originating in the stomach caused by distension and signals generated by the jejunal brake and ileal brake. Activation of the distal part of the gut, the so called ileal brake, leads to reduction in hunger and food intake. Collectively, the jejunal brake response and ileal brake response are referred to as intestinal brake. 
         [0005]    Intestinal brake has been shown to initiate satiation more quickly and is theorized to play an important role in the effectiveness of bariatric surgical procedures such as Roux-en-Y gastric bypass (RYGB) and has shown both excess weight loss (EWL) and comorbidity resolution. Bariatric procedures such as Ileal Transposition have been developed based on the concept of delivery of substances with rich nutrient/caloric content to the ileum in order to trigger the intestinal brake response and have been shown to be effective in numerous animal models. Food reaching the ileum contributes to L-cell stimulation and production of glucagon-like peptide-1 (GLP-1) hormones that signal satiety leading to the cessation of hunger and a corresponding loss of desire to eat. Transposition of the terminal ileum to the duodenum provides GLP-1 whenever glucose is ingested. The presence of fat or glucose in the duodenum or the ileum has shown to increase GLP-1. Also known as the “ileal-brake” hormone, GLP-1 slows down or stops emptying of the stomach and slows motility of the small bowel thus promoting earlier satiation and increasing the effectiveness of bariatric procedures. 
         [0006]    Accordingly, there remains a need for methods and devices of rerouting chyme to induce intestinal brake in order to improve the effectiveness of bariatric surgical procedures and to improve comorbidity resolution. 
     
    
     
       DESCRIPTION OF THE FIGURES 
         [0007]      FIG. 1  is a view of a portion of a bowel prior to being bunched. 
           [0008]      FIG. 2  is a schematic view of the bowel after it is bunched along the suture. 
           [0009]      FIG. 3  is a side view of a segment of small bowel prior to intussusception. 
           [0010]      FIG. 4  is a cutaway, side view of a portion of intussuscepted bowel. 
           [0011]      FIG. 5  is a side view of a portion of intussuscepted bowel. 
           [0012]      FIG. 6  is a schematic, partially transparent view of an overtube inserted a bowel prior to being bunched. 
           [0013]      FIG. 7  is a schematic, partially transparent view of the bowel partially bunched. 
           [0014]      FIG. 8  is a schematic, partially transparent view of the bunched bowel. 
           [0015]      FIG. 9  shows a partial section of bowel having a tube disposed therein. 
           [0016]      FIG. 10   a  is a schematic view of a portion of small bowel prior to performance of an ileum brake surgical procedure. 
           [0017]      FIG. 10   b  is a schematic view of an ileum brake formed by an anastomosis of the ileum to the upper jejunum. 
           [0018]      FIG. 11   a  is a perspective view of a pair of puck anastomosis staples. 
           [0019]      FIG. 11   b  is a cut away view of the pair of puck anastomosis staples. 
           [0020]      FIG. 11   c  is a front view of an anvil. 
           [0021]      FIG. 12  shows a pair of puck anastomosis staples having internal positive and negative magnets. 
           [0022]      FIG. 13  is a cut away view of a gastrointestinal tract after placement of gastric trocar and placement of a pair of puck anastomosis staples. 
           [0023]      FIG. 14  is a schematic view of a gastrointestinal tract including a gastric trocar seal and two of a pair of puck anastomosis staples. 
           [0024]      FIG. 15  is a side view of a section of bowel following implantation of the cartridge upper half. 
           [0025]      FIG. 16  is a schematic view of a gastrointestinal tract including a gastric trocar seal and where the jejunum is mobilized and two pairs of puck anastomosis staplers are aligned. 
           [0026]      FIG. 17  is a schematic view of a gastrointestinal tract including a gastric trocar seal and where circular compression anastomoses are formed using a laparoscopic firing device between the mobilized jejunum and the ileum and jejunum. 
           [0027]      FIG. 18  is a schematic view of a gastrointestinal tract including a gastric trocar seal where circular anastomoses connect and the ileum and jejunum via a jejunum leg. 
           [0028]      FIG. 19  is a schematic view of a gastrointestinal tract where a gastric sleeve has been created and circular anastomoses connect the ileum and jejunum via jejunum leg. 
           [0029]      FIG. 20  is a schematic view of a hybrid bypass variant using the methods and devices of the present invention. 
           [0030]      FIG. 21  is a schematic view of a hybrid “Y” variant without malabsorption. 
           [0031]      FIG. 22  is a schematic view of a hybrid “Y” variant with some malabsorption. 
           [0032]      FIG. 23  is a schematic view of an intact pyloric sphincter bypass hybrid where a gastric sleeve has been created and circular anastomoses and 2 connect the ileum proximal the pyloric sphincter. 
           [0033]      FIG. 24  is a schematic view of a gastrointestinal tract having a valve implant device. 
           [0034]      FIGS. 25   a  and  25   b  are a schematic view of the valve implant device and a schematic cross sectional view of the valve implant device. 
           [0035]      FIG. 26   a  is a schematic view of a gastrointestinal tract having a shunt device positioned at a proximal position. 
           [0036]      FIG. 26   b  is a schematic view of a gastrointestinal tract having a shunt device positioned at the stomach. 
           [0037]      FIGS. 27   a  and  27   b  are a schematic view of the shunt device and a schematic cross sectional view of the shunt device. 
           [0038]      FIGS. 28   a - d  are schematic views of ileal pouches formed on the proximal portion of the ileum. 
           [0039]      FIG. 29   a  is a cut away view of an ileal pouch containing a chyme reservoir formed via an ileal pouch on a portion of the ileum. 
           [0040]      FIG. 29   b  is a cross sectional view of a power pack/transmitter coupled to an abdominal wall. 
           [0041]      FIG. 29   c  is the power pack/transmitter worn externally on a belt. 
           [0042]      FIG. 30  is a schematic view of the chyme reservoir undergoing peristaltic response. 
           [0043]      FIG. 31  is a schematic view of a gastrointestinal tract following the creation of a recirculation loop. 
           [0044]      FIG. 32  is a schematic view of a gastrointestinal tract following the creation of more than one recirculation loop. 
           [0045]      FIG. 33  is a schematic view of a section of bowel following the implantation of an inflatable shunt anchor. 
           [0046]      FIG. 34  is a schematic view of a gastrointestinal tract following the performance of the hybrid band procedure. 
           [0047]      FIG. 35   a  is a view of the valve of the hybrid band procedure. 
           [0048]      FIG. 35   b  is a view of the valve of the hybrid band procedure in an opened state. 
           [0049]      FIG. 35   c  is a sequential view of the valve of the hybrid band procedure as it closes. 
           [0050]      FIG. 36  is a graphic representation of the relationship between the pressure applied to the valve with respect to time. 
           [0051]      FIG. 37   a  is the sphincter dilation after one minute. 
           [0052]      FIG. 37   b  is the sphincter dilation after five minutes. 
           [0053]      FIG. 37   c  is the sphincter dilation after ten minutes. 
           [0054]      FIG. 38  is a schematic view of a gastrointestinal tract showing anastomosis variants of the hybrid band procedure. 
           [0055]      FIG. 39  is a schematic view of a gastrointestinal tract with the tethered gastric band in fluid communication with a second gastric band. 
           [0056]      FIG. 40   a  is a perspective view of a valve. 
           [0057]      FIG. 40   b  is a schematic view of a gastrointestinal tract with the tethered gastric band. 
           [0058]      FIG. 41  is a schematic view of a gastrointestinal tract including a shunt including a storage area. 
           [0059]      FIG. 42  is a schematic view of a gastrointestinal tract including a shunt. 
           [0060]      FIG. 43   a  is a schematic view of a gastrointestinal tract including a coiled shunt tube. 
           [0061]      FIG. 43   b  is a perspective view of a one way valve and a cut away view of the one way valve. 
           [0062]      FIG. 43   c  is a perspective view of an alternative embodiment of a one way valve after placement in a bowel. 
           [0063]      FIG. 44  is a cross sectional view of a laproscopically delivered lumen port. 
           [0064]      FIG. 45  is a schematic view of a gastrointestinal tract including an intraluminal shunt with one exit and one target region. 
           [0065]      FIG. 46  is a schematic view of a gastrointestinal tract including an intraluminal shunt with multiple exits and target regions. 
           [0066]      FIG. 47  is a schematic view of a shunt including stent segments. 
           [0067]      FIG. 48  is perspective view of one of the stent segments. 
           [0068]      FIG. 49  is a schematic view of a section of bowel following the implantation of an inflatable shunt anchor. 
           [0069]      FIG. 50  is a schematic view of a gastrointestinal tract including a dynamically adjustable belly ball. 
       
    
    
     DETAILED DESCRIPTION 
       [0070]    The following description contains embodiments of methods and devices for rerouting chyme in order to induce intestinal brake and facilitate desired weight loss effects. The chyme is rich in caloric and nutrient content and delivery of the chyme to the ileum triggers the intestinal brake response. Inducing intestinal brake by bunching a section of small bowel shortens the distance chyme has to travel through the small bowel. 
         [0071]    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. 
         [0072]    Referring to the Figures, wherein like numerals indicate like or corresponding parts throughout the several views, a segment of a small bowel is shown as  10  in  FIG. 1 . The bunching of the bowel  10  is achieved by using a suture  20  passed through an outer layer  15  of the bowel  10  using a needle  30 . Preferably, as in  FIG. 1 , needle  30  is used to pass the suture  20  through the outer layer  15  of the bowel  10  in an alternating fashion. As shown in  FIG. 2  the ends of suture  20  are drawn together into a knot  40  forming a tight loop causing the bowel  10  to bunch along the suture  20 . It is contemplated for suture  20  placement to be accomplished using known surgical techniques or the bunching could be created non-invasively using a flexible endoscope outfitted with a stitching device. It is further contemplated that multiple strands of suture could be used to tailor the bunching of the bowel  10  to create even bunching along the bowel. It is also contemplated that multiple lines of suture may be made. It may be appreciated that other soft tissue clamping devices could be used in place of the suture  20 . Examples which may be used to pull the bunch together include staples, clips, clamps or t-tags with sutures attached. 
         [0073]    An alternative technique for bunching the bowel  10  involves in-vaginating part of the small intestine into and adjacent section of intestine using a technique referred to as intussusception as shown in  FIGS. 3-5 .  FIG. 3  shows a plurality of mesenteric veins  50  attached to the segment of small bowel  10  prior to intussusception. Turning to  FIG. 4 , a portion of intussuscepted bowel  60  is created by causing a portion of bowel to roll over upon itself circumferentially. This may be done repeatedly in discrete lengths to eliminate extensive entrainment of the mesentery. Each portion of intussuscepted bowel  60  is secured using a suture  70  passed through the outer layer  15  of the bowel  10  as shown in  FIG. 5 . 
         [0074]    Combining several of the portions of intussuscepted bowel  60  into a string or series provides an effectively shorter path for the chyme  75  to follow as it passes through the bowel toward the ileum. The result is that the chyme  75 , which is nutrient and calorie rich, activates the intestinal brake and leads to reduction in hunger and food intake. 
         [0075]      FIGS. 6-8 , refer to an alternate technique for bunching the bowel.  FIG. 6  is a schematic, partially transparent view of the bowel  10 . In this embodiment, a tube  80 , such as an over tube for an endoscope  90 , is advanced longitudinally distal from the endoscope and positioned into the bowel  10 . Preferably, the tube  80  includes a suction means  100  at a distal end of the tube  80 . Activation of the suction means  100  causes the bowel  10  proximate the distal end of the tube  80  to adhere to the distal end of the tube  80  and bunching of the bowel  10  occurs as the tube is retracted as shown in  FIGS. 7 and 8 . The bunching is then secured using sutures. The suction means  100  may be used to aid the suturing process. It may be appreciated that other soft tissue clamping devices could be used in place of the suture  20 . Examples of devices which may be used to pull the bunch together include staples, clips, clamps or t-tags with sutures attached. Non-limiting disclosures of devices and methods for securing bunched tissue can be found in U.S. Pat. No. 5,242,457 to Akopov et al., U.S. Pat. No. 5,484,451 to Akopov et al., U.S. Pat. No. 4,703,887 to Clanton et al., U.S. Pat. No. 5,188,636 to Fedotov, U.S. Pat. No. 5,484,451 to Akopov et al., U.S. Pat. No. 5,573,543 to Akopov et al., and U.S. Pat. No. 4,665,917 to Akopov et al. are hereby incorporated by reference in its entirety. 
         [0076]      FIG. 9  shows a partial section of bowel  10  having a tube  110  disposed therein. Preferably, the tube  110  is a vacuum tube which includes a series of circumferential ridges  112  and valleys  114  and suction holes  116  placed advantageously along the length of the tube  110 . As shown in  FIG. 9  a preferred placement for the suction holes  116  would be in the valleys to draw the tissue about the tubing. The tube  110  could then be secured to the bowel  110  using the needle  30  and suture (not shown). A stitch is formed by passing the needle  30  parallel to the center axis of the tube  110  near the circumference of the tube such that it pierces the bowel  110  tissue which has been drawn in between the valleys  114  and the ridges  112  by the suction holes  116 . It may be appreciated that soft tissue clamping devices could be used to secure the bowel  10  to the tube  110  in place of the suture (not shown). Examples which may be used to secure the bowel  10  to the tube  110  include staples, clips, clamps or t-tags with sutures attached. 
         [0077]    The bunching effect of this procedure provides an effectively shorter path for the chyme  75  to follow as it passes through the bowel toward the ileum. The result is that the chyme  75 , which is nutrient and calorie rich, activates intestinal brake in the distal part of the gut and leads to loss of hunger and an associated reduction in food intake. This procedure, which may be performed endoscopically, enables the proven weight loss effects of an ileal transposition procedure without transecting the bowel lumen thus reducing the surgical risk. Further, bunching of the bowel  10  as described results in less anatomical change when compared to a traditional ileal transposition and has the added benefit of being reversible. 
         [0078]    In an alternative embodiment, intestinal brake is induced through bowel lumen size reduction. Chyme transit through the intestine is impacted by reducing the diameter of the bowel lumen locally. In this particular embodiment, a longitudinal firing of a linear cutter across the lumen will result in minor reduction of the lumen diameter. Alternatively, an end to end anastomosis will result in a similar reduction in local lumen size. Both methods slow chyme transit allowing increased duration of release of satiation signal hormones such as peptide YY (PYY) and GLP-1 which inhibit gastric secretion. Preferably, a laparoscopic device is used to create the smaller lumen. For example a small endoscopic stapler may be used to create a very small controllable plication in the lumen. 
         [0079]      FIGS. 10   a - 10   b  show creation of an ileum brake by formation of an anastomosis using an open otomy providing increased satiety through recirculation of digestive nutrients.  FIG. 10   a  is a schematic view of a portion of small bowel  10  prior to performance of an ileum brake surgical procedure. The small bowel  10  of  FIG. 10   a  includes an opening  12  in an ileal region  16  of the small bowel  10  proximal the pylorus (not shown) and a distal opening  14  in an upper jejunal region  18 . Chyme (not shown) from the stomach enters the small bowel  10  through the opening  12  and passes through and exits the small bowel  10  through the distal opening  14 . In  FIG. 10   b , an ileum brake formed by an anastomosis of the ileum  16  to the upper jejunum  18  is shown. The anastomosis of the ileum  16  to the upper jejunum  18  to creates a small fistula  118 . It may be appreciated that the fistula  118  may be formed using a balloon or wire stent. The fistula  118  allows a small portion of chyme exiting the stomach into the ileum  16  to be diverted to the upper jejunum  18  while the bulk of chyme is processed as normal. As may be appreciated that the ileum brake diverts food which would have a malabsorption aspect proportional to the size of the opening. The diverted portion is not subject to nutrient extraction due to bypassing the bowel  10  which effectively decreases caloric uptake and enables the ileum to signal satiety sooner. In a preferred embodiment, the anastomosis procedure is performed using circular staples. 
         [0080]      FIGS. 11-23  show schematic views of novel devices and new laparoscopic hybrid access port gastric sleeve/bypass procedures to achieve a metabolic impact. Gastric sleeving appears to have some of the short term effects of standard of gastric bypass procedures such as the Roux-en-Y. Effects such as an almost immediate post surgical resolution of type II diabetes and very fast sustainable weight loss. However, older similar gastric modifications would suggest that it will not be durable in the long term. As may be appreciated the present invention does present a much simpler and quicker procedure and can be accomplished entirely laparoscopically. There is a need to create a restrictive component only to limit the caloric intake with apparently some non-understood impact to the metabolic level of the body. Additional components such as metabolic changes would better assure the durability of the procedure is more akin to the Roux-en-Y. As may be appreciated, contemplated metabolic changes include malabsorption or transporting fatty acids to the ileum to induce the ileal brake phenomena. Further, the present invention may also be used to enable other bariatric procedures such as a mini gastric bypass (MGB) procedure. Conventional open otomy methods take on average from twelve to thirty six minutes for some surgeons to perform just the gastro jejunal (G-J) anastomosis. The complexity of the procedure is at the edge of most surgeons and it is rarely purely laparoscopic. 
         [0081]    The present invention is an alternative to an open otomy and permits creation of an ileum brake with minimally invasive surgical intervention. Further, the procedure of the present invention creates the ileum brake without having to mobilize an ileum section. Benefits of the method of the present invention include simplified procedure steps compared to the Roux-Y gastric bypass but with similar potential durability to Roux-Y. The procedure is a completely laparoscopic procedure using a single incision site using an umbilicus approach. The procedure requires significantly shorter operating time and offers the benefits of potentially less pain and healing time. Both restrictive and metabolic impacts are provided without the malabsorption problems often associated with the Roux-Y and there is no need for vitamin supplements. Although the total procedure is multi-quadrant, the surgical challenges are limited due to only working in one quadrant at a time. The procedure avoids performing an anastomoses procedure on a stricture and the staple lines are more durable since not firing through another staple line. The procedure removes a piece of jejunum to make simple shunt. There is no gastric wound to close due to trans-gastric steps since the sleeve removes the penetrated section. 
         [0082]      FIG. 11   a  shows a pair of puck anastomosis staples  120 . The individual pucks of the pair of puck anastomosis staples  120  include a cartridge upper half  130  which carries staples  132  and a lower half  140  which carries an anvil  142  and a blade  144  as shown in  FIG. 11   b . As may be appreciated, it is contemplated that the anvil  142  may be implantable or removable. The anvil  142  may have alternate forms such as having a segmented circumference, as shown in  FIG. 11   c , to avoid stricture of the stomach or other tissue. It may be appreciated that each of the cartridge upper half  130  has a negative magnetic polarity on the head side  122  and each of the lower half  140  has a negative magnetic polarity on the head side  122  to permit positioning using a magnetic laparoscopic positioner  150  as will be described. The pair of puck anastomosis staples  120  may include absorbable or non-absorbable anastomic rings with the primary function remaining to form an anastomosis. Further, the anastomic rings may be implantable. 
         [0083]      FIG. 12  shows a pair of puck anastomosis staples  120  having internal positive  124  and negative  126  magnets imbedded in mating sides  128  opposite the head side of the cartridge upper half  130  and the lower half  140 . The internal positive  124  and negative  126  magnets serve to rotate the cartridge upper half  130  and the lower half  140  as will be described. In a preferred embodiment the internal positive  124  and negative  126  magnets are rare earth magnets. However, the internal positive  124  and negative  126  magnets may have alternate forms and it should be understood that the aforementioned rare earth magnets are a non-limiting example and other types of magnets are contemplated without changing or altering the scope of the present invention. 
         [0084]    The method for performing the hybrid lap gastric sleeve procedure of the present invention will now be described with reference to  FIGS. 13-24 . According to a preferred embodiment, the first step includes making a single incision at the umbilicus. Then a flexible retractor (not shown) for a later attached 4-port, single port seal system (not shown) is inserted and secured. In a preferred embodiment, the 4-port system has three 5 mm ports and one 12 mm port. Preferably, the single port seal includes a removable cap. 
         [0085]    Referring to  FIG. 13 , with the cap of the single port seal system removed, two pairs of the puck anastomosis stapler (two anvil pucks A, B and two cartridge pucks a, b) are inserted into the stomach  5  and a gastric trocar  160  with a dilating iris seal is then positioned as shown. The single port seal cap is then installed and the abdomen is insulfated. In a preferred embodiment, a flexible sleeve gastric trocar retractor is held within the 12 mm deployment shaft and is inserted through the 12 mm port while a 5 mm camera in one of the other 5 mm ports is used for guidance. The flexible sleeve gastric trocar retractor shaft punctures the gastric wall and the flexible retractor is then installed in the gastric wall when the deployment plunger is pressed. 
         [0086]    Through the use of two 5 mm graspers, the gastric trocar seal cap is acquired and attached to the gastric trocar, preventing escape of gastric contents into the abdomen. An alternate embodiment uses an insert tool that holds only the flexible retractor ring having the gastric trocar seal cap already installed on the retractor so that no gastric contents are spilled during insertion. The iris seal of the gastric trocar is opened laparoscopically by one of the graspers and the two pairs of puck anastomosis staples  120  are inserted into the stomach and the iris is then closed. 
         [0087]      FIG. 14  shows a schematic view of a gastrointestinal tract including a gastric trocar seal  160  and two of a pair of puck anastomosis staplers  120 . As shown in  FIG. 14  the individual pucks A, B and a, b of the pair of puck anastomosis staplers  120  are positioned by a magnetic laparoscopic positioner  150 . In a preferred embodiment, the pair of puck anastomosis staplers  120  are designed to cut off blood supply to the joining tissue through the magnetic attraction of the individual pucks. Over time the magnetic attraction of the individual pucks causes the tissue to be joined together around the edges resulting in necrosis of the tissue in the center of the puck. The necrotic tissue and the magnetically joined pucks dislodge from the joint area forming a passageway. By this time the anastomosis is completely healed around the edges and the passageway allows food to pass from one side to another. Once dislodged the pucks pass through the GI tract. 
         [0088]    In a preferred embodiment, the magnetic laparoscopic positioner  150  is a 5 mm size; however, other sizes are contemplated. In a preferred embodiment, the magnetic laparoscopic positioner  150  has an electromagnetic head  152  that can be switched in polarity to prevent confusing the lower half  140  which carries the anvil  142  and the cartridge upper half  130 . In a preferred embodiment, each of the lower halves  140  which carry the anvil  142  have a positive polarity on the head side  122  and the cartridge upper halves  130  have a negative polarity on the head side  122 . The magnetic laparoscopic positioner  150  therefore only attracts one or the other cap components depending on the selected polarity of the manipulator. 
         [0089]      FIG. 15  shows a section of bowel  10  following implantation of the cartridge upper half  130 . The cartridge upper half  130  has a negative polarity on the head side  122 . When the cartridge upper half  130  is properly positioned, a first holding wafer  170  is inserted through the 12 mm port and is magnetically attached to the cartridge upper half  130  through the jejunum wall. Similarly, a second holding wafer  170  is used to position the lower half  140 . Each individual puck of the pair of puck anastomosis staplers  120  is positioned and held in place in a similar fashion. Alternately, the holding wafer  170  may be placed on the abdominal wall  4  as shown in  FIG. 15 . It is contemplated that each holding wafer  170  includes a means to locate and position the cartridge upper half  130  and the lower half  140  in order to facilitate following the procedure steps. In a preferred embodiment the means to facilitate includes a light source. It is further contemplated that the light source is color coded. The color coding facilitates identification of each holding wafer  170  which is associated with a particular individual puck of the pair of puck anastomosis staplers  120 . Further, it is contemplated that the light is a light emitting diode (LED) and the light may flash to aid in locating each holding wafer  170 . 
         [0090]      FIG. 16  is a schematic view of a gastrointestinal tract including the gastric trocar seal  160  and where the jejunum  180  is mobilized and the two pairs of puck anastomosis staplers A, B and a, b are aligned. Once all four puck anastomosis staplers A, B and a, b are properly positioned the jejunum  180  forms a loop and the puck anastomosis staplers A, B and a, b are mated as shown in  FIG. 16 . Internal positive  124  and negative  126  magnets are imbedded in mating sides  128  of the cartridge upper half  130  and the lower half  140 . The internal positive  124  and negative  126  magnets serve to rotate the cartridge upper half  130  and the lower half  140  within the jejunum  180  to properly orient the cartridge upper half  130  and the lower half  140  when they are adjacent. In a preferred embodiment the internal positive  124  and negative  126  magnets are rare earth magnets. However, as may be appreciated, the internal positive  124  and negative  126  magnets may have alternate forms. 
         [0091]      FIG. 17  is a schematic view of a gastrointestinal tract including the gastric trocar seal  160  and where circular compression anastomoses  195  are formed using a laparoscopic firing device  190  between the mobilized jejunum  180  and the ileum  16  and jejunum  18 . As shown in  FIG. 17 , the laparoscopic firing device  190  is exchanged with one of the graspers. It is contemplated that the laparoscopic firing device  190  is merely a larger grasper that cradles the cartridge upper half  130  and the lower half  140  through the jejunum walls. The laparoscopic firing device  190  may have alternate forms such as a four bar linkage or a 12 mm cantilever beam device. The laparoscopic firing device  190  operates to crush the cartridge upper half  130  into the lower half  140  of the pair of puck anastomosis staplers  120 . The blade  144  is passed from the cartridge upper half  130  to the lower half  140  at the same time as creating the circular compression anastomosis  195 . In a preferred embodiment, the pair of puck anastomosis staplers  120  include covers which are stapled through and create an absorbable buttress for the staple lines. Preferably the covers are made of Vycril to create better strength staple lines as they act as a buttress after deployment. However, the covers may be made of any suitable material. 
         [0092]      FIG. 18  is a schematic view of a gastrointestinal (GI) tract including the gastric trocar seal  160  and where circular anastomoses  195  connect and the ileum  16  and jejunum  18  via a jejunum leg  181 . Once the pair of puck anastomosis staplers  120  are fired the jejunum now has two full diameter compression anastomoses  195 , one near the pyloric sphincter (upper anastomosis  195  in  FIG. 18 ) and one near the ileum (lower anastomosis  195  in  FIG. 18 ). The cartridge upper half  130  and the lower half  140  of the pair of puck anastomosis staplers  120  are moved back up the intestinal track to the gastric trocar seal  160  using magnetic laparoscopic positioner  150  and removed. An alternative embodiment would be to have a filament tether attached to the cartridge upper half  130  and the lower half  140  when inserted. Removal would merely require the gastric trocar iris be opened and the filament pulled to quickly remove the halves. Another alternative embodiment would be to only remove the anvil parts and leave the cartridge upper half  130  and the lower half  140  in the bowel  10  since after being fired they are merely crushed donuts of plastic and would normally pass through the GI tract. Using a laparoscopic linear cutter the jejunal loop  180  is transected and sealed at  182 . The transected jejunal loop  180  is then removed from the abdomen through the gastric trocar seal  160 . 
         [0093]    An alternative device to anastomose a bowel is to use a circular stapler with a flexible shaft such as one manufactured by Power Medical, Inc. An exemplary embodiment utilizes this type of stapler by inserting circular staple heads into the intestinal tract by placing them into the mouth and down the esophagus. Accordingly a surgeon can then follow by placing the staples into the intestines transorally and utilizing the heads to anastomose portions of the intestines. It is also helpful to mark each anvil with a colored tag, or to have a colored filament or string proceeding from the anvil to the mouth so that the surgeon can identify a particular anvil of a number of anvils placed within the intestinal tract. A non-limiting disclosure of a surgical procedure utilizing the flexible-shaft circular staples can be found in U.S. Pat. No. 6,543,456 to Freeman, and is hereby incorporated by reference in its entirety. Using a laparoscopic linear cutter the jejunal loop  180  is transected and sealed  182 . The transected jejunal loop  180  is then removed from the abdomen through the gastric trocar seal  160 . 
         [0094]    Turning to  FIG. 19 , a schematic view of a gastrointestinal tract where a gastric sleeve  200  has been created and circular anastomoses  195  connect the ileum  16  and jejunum  18  via jejunual leg  181 . As previously described with reference to  FIGS. 17 and 18 , the laparoscopic linear cutter used to transect the jejunal loop  180  is then used to create a gastric sleeve  200  and a stomach specimen  205 . Once separated, the gastric trocar seal  160  is removed from the stomach specimen  205  and both are removed through the opened head of the single port abdomen trocar. 
         [0095]      FIG. 20  is a schematic view of a hybrid bypass variant using the methods and devices of the present invention. As previously described with reference to  FIGS. 16-18 , application of the circular anastomoses procedure as disclosed forms anastomoses  1  and  2 . As previously described with reference to  FIGS. 17 and 18 , the laparoscopic linear cutter is used to transect the jejunal loop  180  and the transections are sealed at  1   a  and  4   a . Similarly the laparoscopic linear cutter is used to remove the stomach by cutting and sealing at  2   a - 3   a  and  5   a - 6   a . The transected jejunal loop  180  is then removed from the abdomen through the opened head of the single port abdomen trocar as previously described. 
         [0096]      FIG. 21  is a schematic view of a hybrid Y variant without malabsorption where a gastric sleeve  200  has been created and circular anastomoses  1  and  2  connect the ileum  16  and jejunum  18  via jejunum leg  181  using the methods and devices of the present invention. As previously described with reference to  FIGS. 16-18 , application of the circular anastomoses procedure as disclosed forms anastomoses  1  and  2 . As previously described with reference to  FIGS. 17 and 18 , the laparoscopic linear cutter used to transect the jejunal loop  180  and the transections are sealed at  1   a  and  2   a . The laparoscopic linear cutter is then used to create a gastric sleeve  200  and a stomach specimen  205  by cutting and sealing at  3   a - 7   a . Once separated, the gastric trocar is removed from the stomach specimen  205  and both are removed from the abdomen through the opened head of the single port abdomen trocar as previously described. 
         [0097]      FIG. 22  is a schematic view of a hybrid Y variant with some malabsorption where a gastric sleeve  200  has been created and circular anastomoses  1  and  2  connect the lower ileum  16  and jejunum  18  via jejunum leg  181  using the methods and devices of the present invention. As previously described with reference to  FIGS. 16-18 , application of the circular anastomoses procedure as disclosed forms anastomoses  1  and  2 . As previously described with reference to  FIGS. 17 and 18 , the laparoscopic linear cutter used to transect the jejunal loop  180  and the transections are sealed at  1   a  and  2   a . The laparoscopic linear cutter is then used to create a gastric sleeve  200  and a stomach specimen (of the type shown in  FIG. 21 ) by cutting and sealing at  3   a - 7   a . Once separated, the gastric trocar is removed from the stomach specimen  205  and both are removed from the abdomen through the opened head of the single port abdomen trocar as previously described. 
         [0098]      FIG. 23  is a schematic view of an intact Pyloric sphincter bypass hybrid where a gastric sleeve  200  has been created and circular anastomoses  1  and  2  connect the ileum  16  proximal the pyloric sphincter and jejunum  18  via jejunum leg  181  using the methods and devices of the present invention. As previously described with reference to  FIGS. 16-18 , application of the circular anastomoses procedure as disclosed forms anastomoses  1  and  2 . As previously described with reference to  FIGS. 17 and 18 , the laparoscopic linear cutter used to transect the jejunal loop  180  and the transections are sealed at  1   a  and  2   a . The laparoscopic linear cutter is then used to create a gastric sleeve  200  and a stomach specimen  205  by cutting and sealing at  3   a - 7   a . In addition ileum  16  proximal the pyloric sphincter is cut and sealed at 8 m. Once separated, the gastric trocar is removed from the stomach specimen  205  and both are removed from the abdomen through the opened head of the single port abdomen trocar as previously described. 
         [0099]    In order to prevent a stricture in the lumen at the site of the compression anastomoses  195 , an absorbable stent or non-absorbable stent may be subsequently placed in the lumen at the site of the newly created anastomosis. A non-limiting disclosure of an absorbable stent can be found in U.S. Pat. No. 7,452,363 to Ortiz, which is hereby incorporated by reference in its entirety. A non-limiting disclosure of a non-absorbable stent can be found in U.S. Pat. No. 7,115,136, to Park et al., which is hereby incorporated by reference in its entirety. A non-limiting disclosure of an applier can be found in U.S. Pat. No. 7,309,341 to Ortiz et al., which is hereby incorporated by reference in its entirety. 
         [0100]      FIG. 24  shows a schematic view of a gastrointestinal tract having a valve implant device  210  positioned at a proximal position  220 . Chyme flow is indicated by arrows. The valve implant device  210  is an implantable device for bridging or linking the proximal portion of the gastrointestinal tract to the ileum and provides a solution for one-way redirection of nutrients directly to the ileum. Preferably, the proximal position  220  is at the stomach  5 , duodenum  16  or proximal jejunum  215 . The location may be based on patient needs such as body mass index (BMI) or selection based on an appropriate delay of the onset of satiety from start of a meal. The portion of the duodenum  16  just past the ampulla of vater may be preferred over the stomach  5  for pH compatibility reasons. Similarly, the proximal jejunum  215  may be preferred over both the stomach  5  and the duodenum  16  because of available length to reach the ileum whose distal end is constrained by the attachment of the colon to the abdominal cavity. Bridge locations may have other placements with the primary function remaining to: (a) provide nutrients which are present in the proximal intestinal tract to the ileum to trigger the ileal brake and (b) to provide these nutrients to the ileum soon after eating, i.e. earlier than would be expected during the course of a meal to activate physiologic processes related to satiety. 
         [0101]      FIGS. 25   a  and  25   b  show a schematic view of the valve implant device  210  and a schematic cross sectional view of the valve implant device  210 . In this embodiment, the valve implant device  210  uses a male and female connection to snap together and clamp into the lumen. The valve implant device  210  includes a male valve housing  212  and a one way valve  214  disposed adjacent the male valve housing  212 . A female valve housing  216  couples with the male valve housing  212 . The male valve housing  212  and the female valve housing  216  cooperate to compress a first tissue wall  218  and a second tissue wall  219  and form a tissue compression zone  217 . The valve implant device  210  may incorporate a filter cover over the proximal inlet to the bridge conduit to prevent occlusion with food-stuff. In an alternative embodiment, the valve implant device  210  may be an absorbable or non-absorbable style stent, which would allow insertion in a small diameter and deployment to a large engagement diameter. 
         [0102]    The valve implant device  210  may include a liner  235 , as shown in  FIGS. 27   a  and  27   b , made of synthetic materials including: polyurethane, ePTFE, polyethylene terphthalane, or similar. One suitable high molecular weight polyethylene is sold under the brand name Spectra. A suitable PET material is commercially available under the brand name Dacron. Alternatively, liner  235  can be formed from a sheet of material which is either itself impervious to blood flow, or covered with a coating which renders the material impervious. In still other embodiments liner  235  is a film, sheet or tube of biocompatible material such as ePTFE. Further, the valve implant device  210  may be formed or made entirely or in part from biological materials such as pericardial tissue. There is a wide range of biologically based valves made of natural valves or composed of biological materials such as pericardial tissue. Furthermore, in accordance with another preferred embodiment of the present invention, the valve implant device  210  is provided with radio-opaque material, so as to help tracking the valve device operation in vivo. The valve implant device  210  may have alternate forms and placements within the GI tract without departing from the scope of the present invention. 
         [0103]      FIG. 26   a  shows a schematic view of a gastrointestinal tract having a shunt device  230  positioned at a proximal position  220 . Chyme flow is indicated by arrows. In this embodiment, the shunt device  230  bridges or links the proximal portion of the gastrointestinal tract to the ileum. Preferably, the proximal position  220  is at the stomach  5 , duodenum  16  or proximal jejunum  215 . The shunt device  230  is shown placed with the proximal position  220  at the stomach  5  in  FIG. 26   b . As may be appreciated, location selection may be based on patient needs such as body mass index (BMI) or selection based on an appropriate delay of the onset of satiety from start of a meal. The portion of the duodenum  16  just past the ampulla of vater may be more preferred over the stomach  5  for pH compatibility reasons. Similarly, the proximal jejunum  215  may be preferred over both the stomach  5  and the duodenum  16  because of available length to reach the ileum whose distal end is constrained by the attachment of the colon to the abdominal cavity. Bridge locations may have other placements with the primary function remaining to: (a) provide nutrients which are present in the proximal intestinal tract to the ileum to trigger the ileal brake and (b) to provide these nutrients to the ileum soon after eating, i.e. earlier than would be expected during the course of a meal to activate physiologic processes related to satiety. Further, the inclusion of a one way valve provides a solution for one-way redirection of nutrients directly to the ileum. Details of such valves are disclosed herein with respect to  FIGS. 43   b  and  43   c.    
         [0104]      FIG. 27   a  and shows a schematic view of the shunt device  230  and  FIG. 27   b  shows a schematic cross sectional view of the shunt device  230 . The shunt device  230  is a one-way valve implant device incorporating a conduit section which provides compression to tissue so as to facilitate the joining of these tissues via a lumen. The shunt device  230  includes walls  236  forming the conduit section are preferable formed of a pliable material. The walls  236  are of interwoven wire surrounding a liner  235 . The interwoven wire is a flexible wire mesh which allows the shunt device  230  to fixture itself to the lumen. A woven shape memory version of such a device and an associated applier may be found in U.S. Pat. No. 7,115,136 and in U.S. Pat. No. 7,309,341, respectively. Alternatively, a non-shape memory alloy version of this device may be utilized, wherein the stent may yield under the application load and then sutured into place. 
         [0105]    A one way valve  232  is disposed adjacent the liner  235 . The shunt device  230  includes compression portions  238  for coupling the shunt device  230  to a first tissue wall  218  and a second tissue wall  219  as indicated by arrows. Preferably the shunt device  230  permits in-growth of adjacent tissue after placement. Further, the shunt device  230  includes a filter cover over the proximal inlet  239  to prevent occlusion with food-stuff. The shunt device  230  may be formed of synthetic materials including: polyurethane, ePTFE, polyethylene terphthalane, or similar materials. Similarly, the shunt device  230  may be formed entirely or in part from biological materials such as pericardial tissue. 
         [0106]    Methods of the present invention allow a physician to treat obesity by selecting the delay of the onset of satiety from the start of meal with appropriate proximal placement of the valve implant device  210  or the shunt device  230 . These devices can be utilized or placed laproscopically providing both short-term weight loss and sustained long-term excess weight loss. The devices herein may also be effective in treating type-2 diabetes. Further, the devices can be used alone or adjunctively and synergistically with current bariatric procedures such as gastric banding. It is to be appreciated that removing the bridge and adjacent tissue renders the procedure at least somewhat reversible. 
         [0107]      FIGS. 28   a - d  show schematic views of ileal pouches formed on the proximal portion of the ileum  250 . Creation of an ileum or juxtaposed chyme reservoir makes an available chyme source that can be used to provide chyme to the ileum and thereby induce intestinal brake when eating starts. The intent is to increase the time that the intestine holds chyme between eating. Once eating commences the chyme would move deeper into the ileum to have the L-cells secrete GLP-1 thus inducing intestinal brake. In a first embodiment, rerouting chyme involves creating the ileal pouch to contain the chyme reservoir by connecting folds of the ileum  250 . In this embodiment the ileum remains together with input from jejunum and emptying through the cecum. Various pouch configurations are contemplated such as a J-pouch  241  as in  FIG. 28   a  which has a pouch length of between fifteen to twenty centimeters, a lateral pouch  242  as in FIG.  28   b  having a pouch length of between ten to twelve centimeters, an S-pouch  243  as in  FIG. 28   c  having a pouch length between twelve to fifteen centimeters and a W-pouch  244  as in  FIG. 28   d  having a pouch length between twelve to fifteen centimeters. However, as, the pouch may be of any suitable configuration or dimension and it should be understood that the aforementioned pouch configurations and dimensions are non-limiting examples and other configurations are contemplated without changing or altering the scope of the present invention. 
         [0108]    In the pouch procedure, a stoma is created in a section of the ileum to form an anastomosis to the remaining rectal stump. Such pouches could be created by firing an Endocutter intralumenally across adjoining layers of intestinal wall. In a preferred embodiment, an endocutter is inserted into the bowel through an enterotomy and the intestine segmented. After the intestinal segment is anastomosed, the enterotomy may be closed by another firing of a linear cutter across the enterotomy or may be closed by use of a suture. Similar pouches could be created in the duodenum or jejunum due to the presence of L-cells and other cells that may trigger satiation signals. It is further contemplated that satiating signals involve endocannabinoid receptors. As shown in  FIG. 28   d , the pouch can be made up of several side to side anastomoses while leaving the lumens mainly disconnected from each other. The chyme would still move through using peristalsis action without getting hung up in a giant pouch. The benefit is that the chyme is allowed to proceed quickly through the GI tract through the side holes. As may be appreciated, pouch placement could be done anywhere along the GI tract which results in effectively shortening the traverse of the bowel without departing from the scope of the present invention. The complete or partial evacuation of the reservoir may be accelerated by stimulating the muscle walls of the ileum/jejunum or activating a pump action along the bowel. 
         [0109]      FIG. 29   a  shows a cut away view of a chyme reservoir  255  formed via an ileal pouch  240  on a portion of the ileum  18 . In this particular embodiment, fat or glucose reaching the ileum  18  contributes to L-cell stimulation and production of the GLP-1 hormone that signals satiety. Creation of the ileum or juxtaposed chyme reservoir  255  makes available a source of fat or glucose that is used to trigger production of the GLP-1 hormone when eating starts. In a first embodiment, rerouting chyme involves creating the ileal pouch  240  to contain the chyme reservoir  255  by connecting folds of the ileum  18 . Various pouch configurations are contemplated such as described with reference to  FIGS. 28   a - d . As shown in  FIG. 29   a , the ileal pouch  240  is created by performing a side to side anastomosis of a portion of the ileum, or in a preferred embodiment, a transplanted portion of another segment of bowel to this location. This anastomosis may be performed by a firing of a linear cutter without a knife. Subsequently, the enterotomy used to perform the side to side anastomosis is closed by another firing of a linear cutter or may be closed by sutures. 
         [0110]    Still referring to  FIG. 29   a , a sensor  260  in communication with the stomach  5  detects the pH of the stomach. The sensor  260  uses a change in pH to identify when the stomach  5  is being filled. Alternatively, it is contemplated that the sensor  260  is in communication with the proximal duodenum and uses a change in pH to identify when the stomach  5  is being filled. A change in pH is normally associated with meal consumption or the commencement of eating or anticipation of eating. 
         [0111]      FIG. 29   b  shows a cross sectional view of a power pack/transmitter  280  coupled to an abdominal wall  275 . Communications means  265  couples the power pack/transmitter  280  to sensor  260  and the means to activate peristaltic response  270 . The sensor  260  detects the change in pH and generates an output signal which is communicated to the power pack/transmitter  280  via the communications means  265 . The power pack/transmitter  280  initiates peristaltic response of the ileal pouch  240  and the chyme reservoir  255  by activating the means to activate peristaltic response  270  via communications means  265 . 
         [0112]    In one embodiment the sensor  260  and means to activate peristaltic response  270  are in wireless communication with the power pack/transmitter  280  which is worn externally on a belt  285  as shown in  FIG. 29   c . The power pack/transmitter  280  may have alternate forms and placements, with the primary function remaining to signal the means to activate peristaltic response  270 . 
         [0113]    An exemplary embodiment contemplates the sensor  260  is an internal pH measuring device. The pH measuring device may be swallowable such as the iPill available from Phillips of Amsterdam, the Netherlands, or the SMARTpill available from the Smartpill Corporation of Buffalo, N.Y. In the preferred embodiment the internal pH measuring device is implanted in the stomach  5  rather than swallowed. In an alternate embodiment, the sensor  260  is implanted on the exterior of the stomach  5  with a sensing probe extending through the stomach wall into the stomach interior. A serosal to serosal tissue fold can be used to hold the sensor probe in place within the stomach. In an alternate embodiment, a pH sensor may be swallowed prior to a meal to act as a trigger for the chyme pouch. 
         [0114]      FIG. 30  is a schematic view of the chyme reservoir undergoing peristaltic response. The means to activate peristaltic response  270  activates peristaltic response at the ileal pouch  240 , pushing the contents of the chyme reservoir  255  out of the ileal pouch  240  and leading to stimulation of the L-Cells to produce GLP-1 and a resulting satiation. The partial or complete evacuation of the chyme reservoir  255  may be accelerated by stimulating the muscle walls of the ileum/jejunum either concurrently or in sequence either before or after the means to activate peristaltic response  270  is activated. Further, two or more pouches may be used. The outlet flow of chyme from a first pouch could be controlled as needed such as, for example, by a valve. The valve may be controlled using embodiments as described herein. 
         [0115]      FIG. 31  shows a schematic view of a gastrointestinal tract following the creation of a recirculation loop  290 . In this particular embodiment, looping the small bowel  10  recirculates digestive nutrients to induce the intestinal brake for increased satiety. Looping the small bowel  10  by moving the ileum  18  proximally with respect to its original position results in nutrients inducing the intestinal brake earlier and leads to quicker satiation. The rerouting of chyme exposes the ileum  18  to nutrients for a longer period of time and satiety is prolonged. The loop can be made using principles outlined in United States Patent Application Publication number US2006/0271075 to Bilotti et al, hereby incorporated herein by reference in its entirety. 
         [0116]      FIG. 32  shows a schematic view of a gastrointestinal tract following the creation of more than one recirculation loop  290 . In this alternative embodiment, multiple recirculation loops  290  within the small bowel  10  are formed. The recirculation loop  290  is formed in the duodenal region  295 , in the jejunal region  300  and in the ileal region  302  of the small bowel  10  as shown in  FIG. 32 . More than one recirculation loop  290  can be used and alternate placements are contemplated with the primary function remaining to recirculate digestive nutrients to induce the intestinal brake for increased satiety. In an alternative embodiment, a one way valve is provided in the recirculation loop  290  in order allow chyme to move distally in order to produce the ileal brake without the undesired flow of chyme in the proximal direction. 
         [0117]      FIG. 33  shows a schematic view of a section of bowel  10  following the implantation of an inflatable shunt anchor  310 . The inflatable shunt anchor  310  uses inflatable portions  312  to fix the inflatable shunt anchor  310  to the walls of the bowel  10 . In this embodiment it is contemplated that the inflatable shunt anchor  310  includes a one way valve. In an alternative embodiment, one such one-way valve may be a prosthetic flapper valve which is inserted endoscopically and stitched into place by an endoscopic stitching device or passing a needle endoscopically and using endoscopic graspers to stitch the device into place. In an alternate embodiment, an elastomeric, flexible duckbill valve may be implanted and similarly attached by suture or stapling. This valve could be compliant with the bowel, avoiding interference with peristalsis. Such a valve could also be placed endoscopically. In another alternative embodiment, an anatomical flapper valve made by folding lumen wall tissue in upon itself could be used. Further, the anatomical flapper valve is made biologically compatible by taking a harvested portion of intestine or blood vessel and intussuscepting the vessel such that a flapper valve is created. An anastomosis joins the ends of the biologically compatible anatomical flapper valve to the target portions of lumen ensures biocompatibility, particularly if the tissue is autologous tissue. Suture or t-tags could be used to hold the tissue in place until the serosa to serosa contact surface could heal together. 
         [0118]      FIG. 34  is a schematic view of a gastrointestinal tract following the performance of a hybrid band procedure. The hybrid band procedure implants a valve  315  in the location of a single anastomosis between the proximal duodenum and the ileum. In a preferred embodiment, the valve  315  is implanted in conjunction with the performance of the jejunum loop as described with reference to  FIGS. 16-23 . The hybrid band procedure is a reversible metabolic impacting procedure as reversal requires only removal of the valve  315  and closure of both otomies. Further, the valve  315  could be tied to a tethered gastric band  320  via a communications means  325  and used in conjunction with the tethered gastric band  320  to improve the effects of a gastric band intervention which will be described. After the patient starts eating the stomach begins to expand and contract and pressure is exerted on the tethered gastric band  320 . The tethered gastric band  320  senses this pressure and applies pressure to the valve  315  is via communications means  325 . The valve  315  remains open for a predetermined duration as described then the pressure is bled off and the valve  315  closes leaving the remainder of the digestive process unchanged. 
         [0119]      FIG. 35   a  is a view of the valve  315  of the hybrid band procedure. In this embodiment, the valve  315  is an iris type valve including a body  316  having a port  318 . The body  316  supports a plurality of leaves  317  which cooperate to form a sphincter of variable size for permitting material such as chyme to pass. In a preferred embodiment the port  318  is in fluid communication with the tethered gastric band  320  via communications means  325 . As shown in  FIG. 35   b , a pressure applied to port  318  causes each of the leaves  317  to pivot about a hinge point  319  thus dilating the sphincter. Conversely, as is shown in reference to  FIG. 35   c , a reduction of the pressure applied to port  318  allows the iris to close as will be described in greater detail herein. 
         [0120]      FIG. 36  is a graphic representation of the relationship between the pressure applied to the valve with respect to time. The valve  315  opens for a short period of time after the patient starts eating and then closes for the rest of the meal and does not reset to open again before a minimum of several hours passes. In a preferred embodiment the duration the valve  315  is open is 5 minutes. Alternately, as shown in  FIGS. 37   a - c  the valve  315  slowly closes over a ten minute period with  FIG. 37   a  showing the sphincter dilation after one minute,  FIG. 37   b  showing the sphincter dilation after five minutes and  FIG. 37   c  showing the sphincter dilation after ten minutes. This would also allow some food through to the ileum quickly then leave the rest of the digestive tract undisturbed. The valve  315  may be open for other durations of time without departing from the scope of the present invention. 
         [0121]    It is contemplated that the position of the valve  315  can be adjusted to suit particular patient requirements. In one embodiment, the valve  315  is positioned to exit the stomach in the fundus area to accommodate a patient who consumes a high calorie diet in liquid form. The valve  315  would regulate digestion by allowing chyme to exit to the lower GI tract to prevent absorption and to stimulate metabolic affects. Placement of the valve  315  may include alternate positions with the primary function remaining as regulating chyme to prevent absorption. 
         [0122]      FIG. 38  is a schematic view of a gastrointestinal tract showing anastomosis variants of the hybrid band procedure. In a first embodiment, an anastomosis in the upper sleeve section rather than the jejunum just distal to the pyloric sphincter is indicated at  1  in  FIG. 38 . In a second embodiment, a jejunum to jejunum anastomosis is mid-length to just above the ileum is shown at  2  in  FIG. 38 . In a third embodiment, a mid jejunum to CBC bile duct is indicated at  3  in  FIG. 38 . Further, an anastomosis device may be passed trans-orally as indicated at  4  in  FIG. 38  in conjunction with any of the preceding embodiments. It is further contemplated to use the pair of puck anastomosis staples discussed previously. 
         [0123]      FIG. 39  is a schematic view of a gastrointestinal tract with the tethered gastric band  320  in fluid communication with a second gastric band  330 . In this particular embodiment the tethered gastric band  320  discussed above could be used in fluid communication with the second gastric band  330  which is wrapped around a duodenal-jejunal anastomosis site  335 . The placement of the second gastric band  330  is shown in greater detail in  FIG. 40   b . The fluid communication is provided by a communications means  350  and regulated by a modified one-way valve  340 . Communications means  350  includes a member  351  connecting the modified one-way valve  340  to the second gastric band  330  and a member  352  connecting the modified one-way valve  340  to the tethered gastric band  320 . This arrangement would allow rapid flow in the direction from the tethered gastric band  320  to the second gastric band  330  such that peristaltic pressure would begin to transfer fluid from the tethered gastric band  320  to the second gastric band  330 . The peristaltic pressure may be, for example, due to the swallowing of food content at the beginning of food consumption. Some food content would have the opportunity to pass through the pylorus before enough fluid passed through to the second gastric band  330  to occlude the anastomosis, thereby forcing all subsequent chyme to pass through the normal channel. The modified one-way valve  340  permits a controlled passage of pressure from the second gastric band  330  toward the tethered gastric band  320 . Over time, the modified one-way valve  340  would allow the elasticity of the second gastric band  330  to push the fluid back to the tethered gastric band  320 , opening the anastomosis again for the next meal. In a preferred embodiment the modified one-way valve  340  may be a duckbill valve  341  as shown in  FIG. 40   a . It is contemplated that the diameters of the member  351  and the member  352  may be adjusted in order to tailor fluid communication between the tethered gastric band  320  and the second gastric band  330  through the modified one-way valve  340 . 
         [0124]      FIGS. 41-44  show alternative embodiments of extraluminal shunts. In these embodiments, an extraluminal shunt is used to direct nutrients from the upper GI tract to desired locations in the lower GI tract. These embodiments use the extraluminal shunt which exits the bowel lumen at the proximal gut and re-enters the bowel lumen in the lower GI tract, preferably the ileum. 
         [0125]      FIG. 41  is a schematic view of a gastrointestinal tract  1  including a shunt  360  including a storage area  365 . The shunt  360  including establishes fluid communication between the duodenum  16  and the ileum  18 . A first portion  361  provides fluid communication between the duodenum  16  and the storage area  365 . A second portion  362  provides fluid communication between the storage area  365  and the ileum  18 . In a preferred embodiment the storage area  365  is divided into two chambers, an upper chamber  366  and a lower chamber  367 . 
         [0126]    The shunt  360  may include a buffer substance that is eluded into the chyme as it passes through the shunt  360  to permit ileal brake induction without damage to the proximal bowel due to acidic pH of the chyme. The chyme entering the shunt  360  from the proximal bowel with a low pH will exit the shunt  360  at the desired location at a neutral pH in order to initiate the ileal brake. It is contemplated that the buffer substance could be resupplied to the extraluminal shunt by a fill port. Further, the buffer substance could simply saturate the internal lining of the shunt as an alternative to elution as a mechanism of buffering. In one embodiment, such a buffer substance could be calcium carbonate. 
         [0127]    The upper chamber  366  acts as a reservoir for a portion of mechanically and chemically broken down food or chyme received from the duodenum  16  through the first portion  361 . When large amounts of food are consumed the shunt  360  carries the bulk of it away and prevents absorption while slowly releasing it into the distal ileum  18  at a controlled rate. Further, it is contemplated that a pump may be included to ensure the chyme passes through the shunt  360  without clogging. The stored chyme would remain in the upper chamber until the initiation of the next meal, at which time; it would be transferred to the lower chamber  367  through the second portion  362  and to the ileum  18  at a controlled rate. In one embodiment, initiation of chyme transfer between the upper chamber  366  and the lower chamber  367  is accomplished using a chamber release trigger. The chamber release trigger could be set via exogenous mechanisms such as telemetric means or by an implanted mechanism. It is contemplated that the beginning of a meal be used as an initiation point for the chamber release trigger. An alternative embodiment contemplates using a valve-like or pump-like release mechanism as used in other implantable devices. 
         [0128]    The presence of chyme in the ileum  18  activates the intestinal brake response and leads to reduction in hunger and food intake. The remainder of the chyme passes through the gastrointestinal tract  1  as indicted by the arrows on  FIG. 41 . The upper chamber  366  will then be empty and ready to store new chyme from the duodenum  16  to be release at the start of the next meal. An advantage of the present embodiment is the utilization of a more natural stimulator of the ileal brake response as an alternative to electronic or mechanical stimulations. In one embodiment, it is contemplated that the shunt  360  could be made of biocompatible materials. 
         [0129]      FIG. 42  is a schematic view of a gastrointestinal tract  1  including a shunt  370 . In this embodiment, the shunt  370  includes a bypass  371  and a reservoir  372  which have been realized in a biologically compatible fashion by constructing the bypass  371  and reservoir  372  from autologous tissue. Preferably, the shunt  370  is constructed from a segment of jejunum. The segment of jejunum is moved from its original location with mesentery still attached and reconstructed to form the bypass  371  and reservoir  372 . The distal end of the apparatus may be reduced in diameter by using a smaller vessel  373  attached to the ileum  18 . In a preferred embodiment the vessel  373  is a necked down portion of jejunum or other intestine. Alternatively the vessel  373  is formed using a harvested portion of another vessel such as, for example, a saphenous vein. 
         [0130]    The shunt  370  may include a buffer substance that is eluded into the chyme as it passes through the shunt  370  to permit ileal brake induction without damage to the proximal bowel due to acidic chyme. The chyme entering the shunt  370  from the proximal bowel with a low pH will exit the shunt  370  at the desired location at a neutral pH in order to initiate the ileal brake. It is contemplated that the buffer substance could be resupplied to the extraluminal shunt by a fill port. Further, the buffer substance could simply saturate the internal lining of the shunt as an alternative to elution as a mechanism of buffering. In one embodiment, such a buffer substance could be calcium carbonate. 
         [0131]      FIG. 43   a  is a schematic view of a gastrointestinal tract  1  including a coiled shunt tube  380 . In this embodiment, the coiled shunt tube  380  provides a flexible path between the proximal and distal gut. Advantageously, the flexible nature of the coiled shunt tube  380  would help prevent excess stress on the tissue attachment points due to body movement. The length of the coiled shunt tube  380  provides a reservoir effect as described above with respect to the embodiments of  FIGS. 41 and 42 . Further, the coiled shunt tube  380  includes a one way valve as described herein. The valve may placed at any suitable point in the coiled shunt tube  380 . 
         [0132]      FIG. 43   b  is a perspective view of a one way valve  400  and a cut away view of the one way valve  400 . The one way valve  400  includes a valve body  405  having a proximal end  401  and a distal end  402 . A first suture tab  410  and a second suture tab  410  project from the proximal end  401  of the valve body  405 . The valve body  405  houses a flapper  415  which only permits flow through the valve body  405  from the proximal end  401  to the distal end  402  as indicated by the arrows. 
         [0133]      FIG. 43   c  shows a perspective view of an alternative embodiment of a one way valve  420  after placement in a bowel  10 . In this embodiment, the one way valve  420  includes a valve body  425  having a proximal end  421  and a distal end  422 . A first suture tab  430  and a second suture tab  430  project from the proximal end  421  of the valve body  425 . The one way valve  420  includes a valve portion  435 . Fluid pressure acting on the valve portion  430  permits flow from the proximal end  421  to the distal end  422  through the valve body  425 . Preferably the valve portion  430  is formed of a pliable material such as, for example, rubber. 
         [0134]    Another embodiment of an extraluminal shunt includes a pumping system. The pump with the extraluminal shunt transfers nutrients to the ileum at a desired rate due to the pump. The result is that earlier ileal brake inducement is made possible. The pump allows for the delivery of nutrients to the ileum according to a predetermined beneficial schedule. This provides a less invasive alternative to ileal transposition. 
         [0135]    In a preferred embodiment, the pumping system includes at least four subsystems: a shunt subsystem, pump subsystem, a sensing subsystem and a power generation and storage subsystem. It is contemplated that the shunt subsystem be any of the embodiments disclosed herein. It is further contemplated that the pump subsystem is comprised of any implantable or external pumping means such as, for example, single or multiple fluid pumps, piezoelectric actuated pumps, osmotic pumps or MEMS pumps. The sensing subsystem may be based on any suitable sensing or measuring means such as, for example, displacement, pressure, pH or glucose. 
         [0136]    A temperature based sensing means may be triggered if the temperature of the stomach contents is above or below a threshold. Alternately, the sensor may trigger if a patient drinks a sequence of hot and/or cold drinks before eating. One contemplated displacement sensing means includes, for example, a piezofilm secured to the fundal region of the stomach either intragastrically or on the serosal layer. The piezofilm generates an electric current when flexed thus signalling or measuring gastric motility or gastric pressure. As may be appreciated, this film can be attached to other upper GI members such as duodenum, jejunum or even subcutaneously to provide for user actuation. Pressure may be intra gastric or outside the body as applied by the patient via an external or subcutaneous device. 
         [0137]    It is contemplated that displacement sensing means includes motion detection. In one embodiment the, motion may be detected by an accelerometer, gravitometer, inclinometer or other suitable motion measuring device. Motion detection may occur during various time periods such as, for example, during the day with motion detection inactive at night. 
         [0138]    The power subsystem may a wearable power source. Non-limiting disclosures of a wearable power source can be found in U.S. patent application Ser. No. 11/958,638, filed Dec. 18, 2007, entitled Wearable Elements For Implantable Restriction Systems, in U.S. patent application Ser. No. 12/027,820, filed Feb. 7, 2008, entitled Powering Implantable Restriction Systems Using Kinetic Motion, in U.S. patent application Ser. No. 12/027,817, filed Feb. 7, 2008, entitled Powering Implantable Restriction Systems Using Temperature, and in U.S. patent application Ser. No. 12/027,784, filed Feb. 7, 2008, entitled Powering Implantable Restriction Systems Using Light, which are hereby incorporated by reference in their entirety. 
         [0139]      FIG. 44  is a cross sectional view of a laproscopically delivered lumen port  450 . In this embodiment, the lumen port  450  provides a direct physical connection between a subcutaneous port directly to the interior of a lumen such as an ileum or duodenum. The direct physical connection is similar to the gastric band described herein. The lumen port  450  includes a tube  455  defining a lumen  460 . The tube  455  may be an extraluminal shunt as described herein. A seal  465  surrounds the tube  455  and is held in place by a guide retainer  475  which couples with a retainer  480  to surround seal  465  and secure it in position. A ring  485  is disposed about the tube  455  and the guide retainer  475 . A valve  490  is disposed within the tube  455  to permit fluid communication in one direction through tube  455 . It is contemplated that valve  490  may be any of the embodiments disclosed herein. The lumen port  450  may be made of any suitable material with out departing from the scope of the present invention. It is further contemplated that a portion or all of the lumen port  450  is conductive. 
         [0140]    In a preferred embodiment the seal  465  is made of an elastomeric material. Further, a sealing means  495  such as a tissue sealant may be disposed between the seal  465  and the lumen wall  470 . Further it is contemplated that the lumen port  450  is surrounded at the tissue contact interface by a material which may be quickly endothelialized. It is contemplated that such materials include hernia mesh materials or functionalized keratin sheets. Such a material would encourage tissue growth up to the boundary of the implant device to prevent thrombosis. 
         [0141]    The lumen port  450  can be laproscopically delivered and provides a means to deploy therapies such as, for example, a targeted therapy to stimulate GLP-1 or administering a liquid or gel application via endoscopic delivery. It is further contemplated that the therapy includes delivery of modified cells to the ileum or duodenum. The lumen port  450  provides a means to sense internal conditions such as sensing hormonal response. Further, the lumen port  450  provides a lumen to lumen connection such as the duodenum to ileum for more direct immediate physical communication in order to stimulate GLP-1. 
         [0142]    It is further contemplated that the lumen port  450  be used to provide an exposed external port. Such a port would provide a direct connection to a transdermal patch. Further, the port could be connected to an implantable infusion pump system that regulates delivery of a substance to the area being stimulated. The lumen port  450  may have other placements without departing from the scope of the present invention. 
         [0143]    In one embodiment, the lumen port  450  has on-board sensing and an electrical connection to the subcutaneous port to permit the transmission of information. Contemplated transmission means include wireless and optical means. Further, the lumen port includes an electrode configuration or an array of electrodes that can be connected to an electrical stimulation device. In another embodiment the lumen port  450  system includes an electromagnetic coil around the tube  455 , and the coil could be energized from a distance from the port either internal or external to the body. The coil could be tuned to a specific resonant frequency to achieve the desired stimulation signal. 
         [0144]    Additionally, it is contemplated that the connection can be associated with a reservoir and pump to feed into the lumen access. The connection can be internal or external and the reservoir can be a disposable or refillable type. The pump may be an automatic or manual type as disclosed herein. 
         [0145]      FIG. 45  is a schematic view of a gastrointestinal tract  1  including an intraluminal shunt  500  with one exit  520  and one target region  515 . In this embodiment, the intraluminal shunt  500  includes a proximal end  510  and a distal end  520 . The intraluminal shunt  500  provides a path through the bowel  10  for chyme from the proximal end  510  to a desired target location  515  or locations near the distal end  520  in the distal bowel  10 . The intraluminal shunt  500  prohibits nutrient absorption of the chyme by the bowel as the chyme passes through the shunt  500 . This shielding effect provides chyme that is more nutrient rich to the distal bowel  10 , which is more likely to stimulate the intestinal brake. Further, a one way valve  511  may be disposed on the shunt  500  between the proximal end  510  and the distal end  520 . Further, any optional subsystem may be placed between the proximal end  510  and the distal end  520  such as, for example, pumps or sensors as described herein. 
         [0146]      FIG. 46  is a schematic view of a gastrointestinal tract  1  including an intraluminal shunt  500  with multiple exits  520  and target regions  515 . 
         [0147]      FIG. 47  is a schematic view of a shunt  550  including stent segments  560 . In this embodiment, the stent segments  560  are advantageously constructed to amplify peristalsis such that each contraction of the stomach will result in a further excursion of the chyme along the shunt  550  than would normally be experienced in the intestine. 
         [0148]      FIG. 48  shows perspective view of one of the stent segments  560 . The stent segments  560  are progressively necked down to an aperture  565  so as volume of the segment is reduced by peristalsis; chyme must accelerate to move through the aperture similar to a nozzle effect. It is contemplated that the proximal end of the segment  561  would be fixed to the wall of the shunt  550  for stability using an anchor. Further, each of the stent segments  560  may also include a one way valve to prevent backflow of chyme. In a representative embodiment, the one way valve would be a flapper valve  566 . 
         [0149]    In a preferred embodiment, the anchor for the shunt may be a laser cut or woven wire stent which is fastened to the lumen wall by suture, t-tags or by tissue overgrowth in the case of an expanding stent. Further, barbs on the stent may serve to fasten the stent to the wall of the intestine. The anchor may have other forms without departing from the scope of the present invention. It is contemplated that the inflatable shunt anchor described with respect to  FIG. 33  is used to anchor the shunt  550  as described herein. The shunt may be sized so as to conduct all or a portion of the intestinal content (chyme) to the distal region. Further, the internal surface of the shunt may be coated with a lubricious material such as a hydro gel to facilitate quicker passage of the content to the distal gut. 
         [0150]      FIG. 49  is a schematic view of a section of bowel  10  following the implantation of an inflatable shunt anchor  700 . The inflatable shunt anchor  700  is anchored to the intestinal wall by inserting a tube  705  through the pylorus  2  and then inflating balloons  710  on both sides of the pylorus  2 , preventing forward or reverse motion of the inflatable shunt anchor  700  with respect to the pylorus  2 . Further, the entire assembly may be substantially flexible such that it flexes with pyloric contractions, but preferably always remains larger than the pyloric opening. It is contemplated that the inflatable shunt anchor  700  may also be advantageously anchored with a stent fixed to the bowel wall by barbs, suture or t-tags. Further, it is contemplated that the inflatable shunt anchor  700  may include a one way valve  715  as described herein. 
         [0151]      FIG. 50  is a schematic view of a gastrointestinal tract  1  including a dynamically adjustable belly ball  600 . In this embodiment, the presence or anticipation of food in the stomach  5  causes certain physiological changes such as, for example, a lowering of pH, that are sensed by a sensor  610  attached to the belly ball  600 . The sensor  610  is in communication with ball expansion motor  620 , which in turn causes the ball to expand. The sensor  610  is also in communication with a pump  630  which is in fluid communication with the ileal brake accelerator tube  640  which has a proximal end  645  and a distal end  650  located in the ileum  18 . Sensor  610  also causes the pump  630  in the belly ball  600  to advance a portion of the chyme contained in the stomach  5  through the proximal end  645  and directly to the ileum  18 . It is further contemplated that between meals, the pump  630  could continue to meter chyme input to the ileum on a slow continual or periodic basis in order to maintain and prolong satiety. The chyme may be drawn from a cache of chyme held in the belly ball  600 . The chyme may be stored in other forms and placements without departing from the scope of the present invention. Further, the shape of the ball  600  could be non-spherical so that it maintains orientation, and its expansion could be asymmetric to tailor the expansion effects to various targeted regions of the stomach. 
         [0152]    In an alternate embodiment, the stent segments as disclosed herein include a means to accelerate the action of the body&#39;s ileal brake mechanism to achieve a complete solution for causing early onset of satiation and prolonged satiety. It is contemplated that the means to accelerate the action of the body&#39;s ileal brake mechanism include the stent segments as described herein. 
         [0153]    Alternate embodiments could involve pumping something other than the raw chyme to the ileum. A first alternate embodiment includes pumping biologics that are produced in vivo by filtering, processing, or converting the chyme within the belly ball  600  to create the substance that is pumped, or pumping a substance from a closed, refillable reservoir within the belly ball  600 . Refilling of the reservoir may be accomplished while the reservoir is in vivo such as, for example, through the esophagus. It is contemplated that processing may be accomplished using a lab-on-a-chip. Further, the substance may include a biologic or therapeutic substance. 
         [0154]    Further, it is contemplated that one or more of many input signals within the body could be used to control the pump  630  and expansion of the ball  600 . In one alternate embodiment, the portion of the tube  640  that passes through the pyloric sphincter  2  could made rigid enough that it would not be crushed or pinched off when the sphincter is closed, or it may be made flexible enough that it would normally be pinched off when the sphincter is closed, and only open when the sphincter is open, or when pressure from the pump forces it open. Power for the devices in the belly ball  600  could be stored and recharged periodically, or could be provided by energy converted from its surroundings. The power may be provided by a wearable power source. 
         [0155]    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.