Abstract:
Method and apparatus for treatment of morbid obesity by placement of a series of flow reduction elements in the small intestine to induce satiety are disclosed. The flow reduction elements restrict the movement of partially digested food and reduce the flow rate through the small intestine which causes the emptying of the stomach and the duodenum to occur slower. The flow reduction elements are attached to an elongated tube and are constructed from various shapes and configurations. The flow reduction elements may be inflated with fluid or may be constructed from self-expandable materials. The device is anchored in the antrum of the stomach with an anchoring member. The transoral gastric device can be inserted with a delivery catheter through the working lumen of an endoscope or alongside an endoscope and may be removed with the aid of an endoscope if desired.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 14/101,241, filed Dec. 9, 2013, titled “METHOD AND APPARATUS FOR REDUCING OBESITY,” now U.S. Patent Application Publication No. 2014-0100513, which is a continuation of U.S. patent application Ser. No. 13/086,250, filed Apr. 13, 2011, titled “METHOD AND APPARATUS FOR REDUCING OBESITY,” now U.S. Pat. No. 8,623,095, which is a continuation of U.S. patent application Ser. No. 10/999,410, filed Nov. 30, 2004, titled “METHOD AND APPARATUS FOR REDUCING OBESITY,” now U.S. Pat. No. 7,931,693, which claims the benefit under 35 U.S.C. 119 of U.S. Provisional Patent Application No. 60/547,630, filed Feb. 26, 2004, and titled “METHOD AND APPARATUS FOR REDUCING OBESITY.” These applications are herein incorporated by reference in their entirety. 
     
    
     INCORPORATION BY REFERENCE 
       [0002]    All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. 
       BACKGROUND OF THE INVENTION 
       [0003]    1. Field of the Invention 
         [0004]    The present invention relates to the medical treatment of obesity in humans, and more particularly to apparatus and methods for curbing the appetite of persons being treated for obesity. 
         [0005]    2. Description of the Related Art 
         [0006]    Extreme obesity is a major health concern in the United States and other countries. Its complications may include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, venous disease, multiple orthopedic problems and pulmonary insufficiency with markedly decreased life expectancy. Medical management including dietary, psychotherapy, medications and behavioral modification techniques have not yielded exceptional results in multiple trials. Despite the declaration of obesity as a major health problem, the Centers for Disease Control reports that obesity contributes to about 400,000 deaths annually, just behind tobacco (435,000) and ahead of alcohol (85,000), car accidents (43,000) and guns (29,000). Obesity and its complications now account for an estimated 9 percent of U.S. health spending. 
         [0007]    Non-surgical approaches for the treatment of obesity include voluntary dieting which is often unsuccessful since most persons do not possess sufficient willpower to limit the intake of food. In addition to behavioral modification, several surgical techniques have been tried which induce malabsorption by reducing the absorptive surface of the small intestine or modify the stomach to reduce a patients desire to eat. Gastric reduction surgeries in which the stomach&#39;s volume is reduced had limited early success but often the stomach&#39;s size stretches over time so these patients did not exhibit real weight for a sustained period of time. Other surgical approaches combine gastric volume reduction by either partition or bypass with a reduction in the absorptive surface of the small intestine. These procedures may be both hazardous to perform in morbidly obese patients and often create numerous life-threatening postoperative complications. Such procedures typically are invasive, require a long recuperation time and subject the patient to undue pain and discomfort. Also, such operative procedures are often difficult to reverse. These procedures are also expensive and place a large burden on the national health care system. 
         [0008]    Other endoscopic approaches include implantation of gastric balloons that prevent overeating by occupying volume within the stomach. This fills a portion of the stomach and provides the patient with a feeling of fullness, thereby reducing food intake. Many problems are associated with the gastric balloon device, including poor patient tolerance and complications due to rupture, migration, and pressure trauma to the gastrointestinal tract. Some sham-controlled studies have failed to show that the gastric balloon was superior to diet alone in achieving weight reduction. 
         [0009]    Other devices are designed to attempt to limit the absorption of nutrients in the duodenum by funneling the food through a tube so that the digestive process bypasses portions of the small intestine entirely. By interrupting the intermixing of the digestive fluids and/or limiting the residence period within the stomach, it is believed that the food materials will not fully digest into particles small enough to be absorbed by the body. However these devices have not been evaluated clinically. 
         [0010]    Having made the above critical observations, the present invention further recognizes a need for a transoral endoscopic device that mediates physiologic weight loss that is easily inserted into and removed from the gastrointestinal tract, well tolerated by the patient, does not migrate, does not adversely obstruct the lumen, and does not cause tissue injury. 
       BRIEF SUMMARY OF THE INVENTION 
       [0011]    The present invention provides a method and apparatus for treatment of morbid obesity by placement of a series of flow reduction elements in the small intestine to induce satiety. The flow reduction elements are attached along an elongated member which may or may not have a central lumen inside. This elongated member is used to position the flow reduction elements in the small intestine. The length and diameter of the flow reduction section can be selected by the physician to adjust the amount of weight reduction to the patients needs. 
         [0012]    The central tube has an anchoring member attached near the proximal end that secures the proximal end in the antrum of the stomach. The anchoring member is sized so that it will not pass through the pyloric valve and so that it secures the central tube and the attached flow reduction elements in proper position in the small intestine. In one embodiment, the anchoring member is constructed of one or more inflatable balloons that when inflated are larger than the pylorus. The anchoring balloons can be deflated for delivery into the stomach and removed through the working lumen or alongside an endoscope. In another embodiment the anchoring member is an expandable umbrella-like skeleton frame that is attached to the flexible tube. The large end of the umbrella faces the pylorus and the frame can be collapsed for delivery and recovery. 
         [0013]    The flow reduction elements can have various shapes and may be attached at various points along the central tube. The flow reduction elements may be inflated with fluid through a fluid connection with the central tube or may be constructed from self-expandable material such as a foam or spring structure. The space occupying flow reduction elements may also be filled or impregnated with pharmacologics, biochemicals, alimentary lipids, alimentary peptides or metabolic substances that release into the small intestine to further provide feelings of satiety. 
         [0014]    The transoral gastric device can be inserted with a delivery catheter through the working lumen of an endoscope or alongside an endoscope and may be removed with the aid of an endoscope if desired. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein: 
           [0016]      FIG. 1  is a general drawing of the stomach and adjacent parts of the alimentary canal. 
           [0017]      FIG. 2  is a perspective view of a duodenal/small intestinal insert in accordance with the present invention positioned inside the stomach and small intestine. 
           [0018]      FIG. 3  is a partial section view of a central tube illustrating attached flow reduction elements and central lumen. 
           [0019]      FIG. 4  is a partial section view of a central tube illustrating eccentrically attached flow reduction elements and central lumen. 
           [0020]      FIG. 5  is a perspective view of an alternative embodiment showing an elongated member and illustrating attached flow reduction elements. 
           [0021]      FIG. 6  is a section view of the central tube inside of the pylorus and small intestine. 
           [0022]      FIG. 7  is a perspective section view of a central tube and an anchoring member. 
           [0023]      FIG. 8  is a perspective view of an alternative embodiment of a central tube and an anchoring member. 
           [0024]      FIG. 9 a    is a section view of alternative embodiment of the current invention. 
           [0025]      FIG. 9 b    is a section view of alternative embodiment of the current invention shown in a collapsed configuration. 
       
    
    
     DETAILED DESCRIPTION 
       [0026]      FIG. 1  shows the human stomach and small intestine. Important features are the esophagus  2 , stomach  4 , antrum  7 , pylorus  8 , pyloric valve  11 , duodenum  10 , jejunum  12  and ampulla of Vater  13 . The esophagus  2  terminates at the nose or mouth at its superior end and at the stomach  4  at its inferior end. The stomach  4  encloses a chamber which is characterized, in part, by the esophageal-gastric juncture  6 , which is an opening from the esophagus  2  at one end, and the antrum-pyloric juncture  5  which is a passageway between the antrum  7  through the pylorus  8  to the duodenum  10  at the other end. Specifically, the pylorus  8  controls discharge from the stomach  4  by a sphincter muscle, the pyloric valve  11 , which enables the pylorus  8  to open wide enough to pass an object which is approximately one cubic centimeter or less. Gastric contents, after passing into the duodenum  10 , continue on into the jejunum  12  and on into the ileum (not shown). The duodenum  10 , jejunum  12  and ileum make up what is known as the small intestine. However these individual portions of the alimentary canal are sometimes individually referred to as the small intestine. In the context of this invention the small intestine refers to all or part of the duodenum, jejunum and ileum. The ampulla of Vater  13  is shown as a small protrusion on the medial wall. Bile and pancreatic fluids enter the duodenum  10  at this point to further aid digestion. 
         [0027]    The duodenum  10  comprises the first nine to ten inches of the small intestine and is the only portion of the small intestine which is attached to the back wall of the abdominal cavity (retroperitoneum). The remainder of the small intestine is not attached to the body, but merely folds freely in a sack called the mesentery, which is contained within the peritoneum. The digestive process starts when food materials are mixed with saliva and enzymes in the mouth. The digestive process continues in the stomach  4 , where the food is combined with acids and additional enzymes to liquefy the food. This food resides in the stomach  4 , for a short time and then it passes into the duodenum  10  to be intermixed with bile and pancreatic juice, which make the nutrients contained therein available for absorption by the villi and microvilli of the small intestine or by other absorptive organs of the body. 
         [0028]    The present invention understands that if the passage of partially digested food as described is partially blocked and the flow rate through the small intestine is reduced, then the emptying of the stomach and the duodenum will occur slower. This in turn will create a feeling of satiety and will decrease the consumption of food by an obese patient. 
         [0029]    Additionally, because a large amount of the nutritional absorption occurs in the small intestine, if the amount of absorptive surface area of the walls of the small intestine is restricted or blocked, thus interrupting or reducing the intermixing of the digestive fluids, the partially digested food materials are not readily absorbed by the small intestine or other absorptive organs of the body. The partially digested food materials are then passed to the large intestine for elimination from the body with limited caloric absorption by the body. 
         [0030]    Furthermore, the present invention understands that if the physical characteristics of the device and/or a reduction of flow rate of food breakdown products through the small intestine results in distension of the small intestine, or increases the contact time between the small intestine and the partially digested food then this distention or increased contact time may activate osmoreceptors that may release hormones and neurotransmitters such as cholecystokinins (CCK) and neural signals that may induce satiety. 
         [0031]      FIG. 2  shows an exemplary non-limiting small intestinal insert  20  made in accordance with the present invention in position in the stomach and small intestine. The insert has a proximal portion  30  and a distal portion  40 . The insert has a central tube  50  that extends between the proximal portion  30  and the distal portion  40 . A series of flow reduction elements  200  can be attached to the distal portion of the central tube and may be sized to fit inside the small intestine. However, the area of the central tube  50  near the ampulla of Vater  13  has no flow reduction elements  200  to prevent blockage of the ampulla of Vater. The central tube preferably has an anchoring member  100  attached near a proximal end  52  of the central tube  50 , with the anchoring member  100  securing the proximal end  52  of the central tube  50  in the antrum  7  of the stomach. The anchoring member  100  is sized so that it will not pass through the pylorus  8 , so that it can maintain the flow reduction elements  200  in proper position in the small intestine. In one embodiment, the anchoring member can be established by one or more inflatable balloons  102  that when inflated are larger than the pylorus  8 . The inflatable balloons  102  can be deflated for delivery into the stomach and then inflated inside the stomach. The inflatable balloons  102  can also be later deflated for removal using endoscopic techniques. 
         [0032]      FIG. 3  shows the central tube  50  with the flow reduction elements  200  attached. The central tube  50  can be flexible and constructed of polymeric material that can be easily formed or extruded and delivered with the aid of an endoscope by known techniques. A central tube  50  that is soft and flexible will contour to the anatomy of the gastrointestinal tract and provide less irritation of the stomach lining. The central tube  50  can be made from polymers such as nylon, polyolefins, polyurethane, silicone or polyvinyl chloride (PVC). The central tube polymer needs to be compatible with the chemical environment of the gastrointestinal tract and should provide enough structural integrity to prevent migration of the flow reduction elements in response to peristaltic action in the bowel. If desired, however, the central tube  50  can deploy to a fixed configuration so that once properly positioned it will maintain a steady position despite peristaltic movement of the stomach and small intestine. For example, the fixed configuration could be the shape that the duodenum  10  and jejunum  12  naturally assume in the abdomen. 
         [0033]    The length of the central tube  50  can be established depending on the therapeutic result desired and the patient&#39;s anatomy. For example, the central tube  50  and the attached flow reduction elements  200  may extend into a portion of or through the entire duodenum  10 . On some patients the central tube  50  and the attached flow reduction elements  200  may extend past the duodenum  10  and into the jejunum  12 . It is anticipated that several lengths might be used by a physician to treat the various body types and metabolic demands. For example, if a patient is 20% overweight, the physician might select a length of central tube  50  with its attached flow reduction elements  200  that permits absorption of only 80% of the nutritional potential of a typical daily intake of calories. The reduction of caloric intake over time will lead to weight loss. 
         [0034]      FIG. 3  shows a central tube  50  with an outer wall  54  and an inner wall  56  that define an interior space  58 . The interior space  58  forms an inner lumen  59  that may be continuous from the proximal end  52  to just short of the distal end  53  of the central tube  50 . The distal end  53  of the central tube  50  is sealed at a point  55  so that fluid introduced into the central tube  50  does not leak out distally into the small intestine. In some embodiments a valve  90  can be located substantially at the proximal end of the inner lumen  59 . The valve  90  may be a self sealing valve that has a septum  92  that can be accessed by a needle or blunt tip tube for introduction of fluid into the inner lumen  59 . The valve  90  also can be accessed so that the fluid inside the inner lumen  59  of the central tube  50  can be aspirated for removal. It is to be understood that the valve type is not limited to a septum type valve only, and that other types of mechanical valves may also be used in place of the septum valve described. 
         [0035]    As shown in  FIG. 3  and as mentioned above, one or more flow reduction elements  200  can be attached to the central tube  50 . In some embodiments the diameter of each flow reduction element  200  can be concentric with the axis of the central tube  50 . Each flow reduction element  200  has an outer wall  210 , an inner wall  212 , and an inner space  214  is established inside the inner wall  212 . At or near its proximally-oriented surface  220  and also at or near its distally-oriented surface  222 , each flow reduction element  200  can be attached to the central tube  50  with the inner space  214  of the flow reduction element  200  in fluid communication with the lumen  59  of the central tube  50 , such that the inner space  214  surrounds the outer wall  54  of the central tube  50 . Each flow reduction element  200  may be attached to the central tube  50  by adhesives, heat bonding, mechanical restraint or other suitable methods. 
         [0036]    As shown in  FIG. 3 , the central tube  50  can be formed with plural inlet/exit ports  216  that are located inside respective flow reduction elements  200 . More specifically, each port  216  is formed completely through the central tube wall  51  to establish a pathway for fluid communication between the inner lumen  59  of the central tube  50  and the inner space  214  of the respective flow reduction element  200 . Consequently, the inner lumen  59  of the central tube  50  may be used to introduce fluid into the inner spaces  214  of the flow reduction elements  200  and to inflate the flow reduction elements  200  from a collapsed configuration, in which insertion and removal of the flow reduction elements  200  is facilitated, to an inflated configuration shown in  FIG. 3 , in which resistance to food passage is increased to induce satiety. Thus, the flow reduction element or elements  200  in this embodiment act as balloons that can be deflated and collapsed around the central tube  50  for introduction into the small intestine and then inflated to the desired diameter once in position. 
         [0037]    Each flow reduction element or elements  200  can either be elastic balloons or inelastic balloons. When an elastic balloon material is used to establish a flow reduction element  200 , the flow reduction element  200  inflates to a diameter that is dependent on the volume of fluid introduced into the inner space of the flow reduction element. This embodiment permits adjustment of the balloon size as determined by the physician. If the balloon is too small, for instance, additional fluid could be introduced to enlarge the balloon diameter. Alternatively, if the balloon is too large, additional fluid could be removed to shrink the balloon diameter. It is understood that an alternate embodiment consisting of an inelastic balloon inflates to a diameter that is independent of the volume of fluid introduced into the inner space of the sphere. The diameter of this type of balloon is fixed when manufactured and does not permit in situ adjustment of the balloon size. However, this type of balloon prevents possible over inflation and rupture if too much fluid is introduced into the balloon. 
         [0038]    The flow reduction elements  200  shown in  FIG. 3  have the shape of a round sphere. However, other shapes are contemplated and any shape that effectively functions to inhibit the passage of partially digested food into the small intestine is acceptable. It is understood that the ability of the small intestinal insert  20  to remain within the small intestine can be affected by the shape, orientation and tautness of the flow reduction elements  200 . For example alternate shapes such as ovoid, elliptical, elongated ellipse and even irregular non-geometrical shapes are potentially feasible. 
         [0039]      FIG. 4  illustrates an alternative embodiment of the present invention in which one or more flow reduction elements  300  are eccentrically attached to a central tube  350 . In this embodiment the axis or diameter of the flow reduction element or elements  300  is not concentric with the axis of the central tube. The outer wall  302  of the flow reduction element is attached to the side of an outer wall  354  of the central tube  350 . An inner space  314  of each flow reduction element  300  is eccentric relative to the axis of the central tube  350  and is in fluid communication with an inner lumen  359  of the central tube  350  through a respective opening  316 . As was the case with the embodiment shown in  FIG. 3 , in the embodiment shown in  FIG. 4  the inner lumen  359  can be used to introduce and remove fluid into the inner space  314  of the flow reduction element  300  to move the flow reduction element  300  between inflated and collapsed configurations. 
         [0040]    In this context the flow reduction elements  300  can be inflated with a fluid, either liquid or gas. Preferably the gas is air, nitrogen or carbon dioxide and the liquid is preferably water or water mixed with other solutions. It is important for the physician to monitor the flow reduction element  300  location in the small intestine and the diameter of the flow reduction element relative to the diameter of the small intestine. The flow reduction element can be inflated with a radiopaque fluid that is visible on X-ray. If the flow reduction element containing the radiopaque fluid is visible on x-ray, the physician can non-invasively visualize the flow reduction element size from outside the patient&#39;s body. This knowledge enables the physician to adjust the size of the flow reduction element by injecting additional fluid into the flow reduction element through the inner lumen  59  as required. Likewise radiopaque marker bands  218  as shown in  FIGS. 3 and 4  can be placed around the central tubes  50  and  350  respectfully to facilitate visualization of the central tube&#39;s location in the small intestine. The radiopaque marker bands  218  can be placed at predetermined intervals so that the distance inside the small intestine can be used as depth markers and can be measured from outside the body. 
         [0041]      FIG. 5  shows an alternative embodiment with a central shaft  450  around which first flow reduction elements  400  are concentrically attached and second flow reduction elements  410  are eccentrically attached. The element  400  can be attached to the central shaft  450  in any manner as described previously. The flow reduction elements  400  are made from material that can be folded or collapsed to a first volume suitable for insertion with the aid of an endoscope and then self expand to a second volume suitable for restricting the flow of partially digested food according to the present invention. The flow reduction elements can be made from materials such as sponge, foam, hydrogels or springs. These materials can be compacted into a small volume and then self expand to a pre-determined shape and volume when unrestricted. The central shaft  450  can be solid and without an inner lumen or inner space. Because the flow reduction elements self expand, the need for an inflation system is eliminated and this embodiment represents a simple mechanical design. The flow reduction elements are attached mechanically, by heat fusing, adhesives or other suitable methods as known in the art. 
         [0042]    The surface of the flow reduction element  415  and outside walls of the central tube  452  may be filled or coated with slow release medicaments, enzymes, cofactors, pharmacologics, biochemicals, alimentary lipids, alimentary peptides or metabolic substances. These substances are designed to release over time into the intestine to modify the biochemical processes or trigger alternative receptor sites that in turn will alter the digestive process. 
         [0043]      FIG. 6  shows the central tube  50  in the antrum  7 , pylorus  8  and the duodenum  10 ; consisting of three parts, the duodenal bulb  10 A, the vertical duodenum  10 B, and the horizontal duodenum  10 C. The flow reduction elements have been removed from  FIG. 6  for clarity. The central tube  50  is shown traversing the pyloric valve  11 . It is important that the diameter of the central tube not obstruct the pyloric valve opening so that the valve can still function normally. The central tube diameter should be in the range of 5 to 7 French. Distal to the pylorus  8  and immediately after entering the duodenum  10  the central tube  50  can assume a sharp bend of radius β between the duodenal bulb  10 A and the vertical duodenum  10 B, and a sharp bend of radius α between the vertical duodenum  10 B and horizontal duodenum  10 C. Preferably the radius β and the radius α may be between 45° and 110°. More preferably, the radius β and the radius α may be between 60° and 100° such that the central tube  50  bends to follow the inner lumen of the duodenum  10  at this these locations. It is advantageous that the central tube  50  be flexible enough to conform to this sharp angulation to avoid kinking. In another embodiment the central tube  50  can be pre-formed with a configuration that conforms to the duodenal angulations prior to insertion in the body and is constrained in a straight configuration by a stiffening rod  110  placed down the inner lumen  59  of the central tube  50  as shown. This stiffening rod  110  is placed into a separate lumen designed to house this stiffening rod or imbedded in the wall of the central tube  50 . Upon insertion into the patient with the aid of an endoscope, when the central tube  50  reaches the location of the sharp bends in the duodenum  10 , the stiffening rod  110  is withdrawn, thereby allowing the central tube  50  to assume the pre-formed shape. In another embodiment, the central tube  50  may have a shape memory alloy wire imbedded inside the central tube wall  51  or residing in the inner lumen  59 . This shape memory alloy wire has a pre-set bend configuration with a radius β and a radius α that matches the bend configuration of the duodenum and is positioned in the central tube  50  at the corresponding location. Upon insertion into the patient with the aid of an endoscope, when the central tube  50  reaches the location of the sharp bend in the duodenum  10  and the shape memory alloy wire reaches a pre-set transition temperature equal to the temperature of the small intestine or 37° Fahrenheit, the wire assumes the programmed shape and forces the central tube  50  and the central tube wall  51  to assume the same shape. In another embodiment, the central tube  50  may have a spring embedded inside the central tube wall  51  or inner lumen  59 . This spring could be pre-shaped to the anatomy of the wall of the small intestine. The spring is held straight during delivery and conforms to the small intestine anatomy after release. The shape enables the device to remain in place. 
         [0044]    Turning to various anchoring members  100  that can be used, as shown in  FIG. 7 , the central tube  50  has an anchoring member  100  attached near the proximal end  52 . The anchoring member  100  can be established by one or more inflatable balloons  102 . These balloons  102  can be eccentrically attached to the central tube at point  104  near the proximal end  52  of the central tube  50 . These balloons can be formed in many shapes and are not limited to the spherical shape shown. The central tube can be formed with an opening  116  for each respective balloon  102  so that a pathway for fluid communication is established between the inner lumen  59  of the central tube  50  and the inner space of each balloon  106 . The inner lumen  59  is used to introduce fluid into the inner space of the balloon  106  and inflate the balloon  102  from a first volume in a collapsed state to a second volume or inflated state. 
         [0045]    When the anchoring member  100  is fully inflated, it secures the proximal end of the central tube  52  in the antrum of the stomach. The inflatable balloons  102  have a combined cross sectional diameter greater than the diameter of the pyloric valve  11  to prevent migration across the pylorus. The inflatable balloons  102  can be inflated and deflated by adding or removing fluid from the central tube inner lumen  59 . The inflatable balloons  102  may be connected to the same central tube inner lumen  59  as flow reduction elements  200  and  300  as shown in  FIGS. 3 and 4 , and can be inflated simultaneously and deflated simultaneously. However, the central tube  50  may have more than one inner lumen so that the inflatable balloons  102  and individual flow reduction elements  200  and  300  may be inflated and deflated independently from each other. 
         [0046]      FIG. 8  illustrates another embodiment of the anchoring member  100  deployed in the antrum  7 . A central tube  50  is attached to an inverted umbrella skeleton  160 . This skeleton  160  has a ring  162  that surrounds the central tube  150  and is supported by three struts  164 ,  165  and  166 . These struts are joined together at the central tube  50  at point  167  and attached to the ring  162  at points  170 ,  171  and  172 . Although three struts are illustrated in  FIG. 8 , it is possible to construct the anchoring member  100  with one or more struts. The ring  162  is made from flexible plastic material or flexible wire and has a diameter significantly larger than the diameter of the pyloric valve  11 . The umbrella skeleton  160  is collapsed around the central tube  50  for insertion into the stomach with the aid of an endoscope. As the device is released from the endoscope, the umbrella skeleton  160  springs out and assumes a configuration shown in  FIG. 8 . The struts  164 ,  165  and  166  may be made from plastic, metal or from plastic covered metal. The edge of the ring which is in contact with the antrum walls  163 , may be constructed to assist in securing the umbrella ring  162  to the walls of the antrum. The surface may be roughened to increase surface friction or the wall may have protrusions or barbs that physically attach to the stomach lining. 
         [0047]      FIG. 9  illustrates another embodiment of the current invention.  FIG. 9 a    depicts a duodenal/small intestinal insert  500  with a proximal portion  502  and a distal portion  504  shown in an expanded state. In this embodiment, a central shaft  506  is attached to an expandable sleeve  508  at the sleeve distal end  510  near the distal portion  504  of the duodenal/small intestinal insert. The opposite end of the central shaft  506  is attached to a toroid anchoring member  520 . The anchoring member  520  is attached at the central shaft  506  with two connecting struts  521  and  522 . More than two connecting struts may be employed to securely attach the toroid anchoring member  520  to the central shaft  506 . The anchoring member  520  is shaped like a funnel that is designed to seat in the Pylorus without obstructing its function. The central shaft  506  may be pre-formed to have a configuration that conforms to the anatomy of the duodenum  10  shown in  FIG. 6 . A central shaft  506  so described would also force the expandable sleeve  508  to assume the configuration of the shaft  506 . The central shaft  506  may be constructed out of wire, spring, shape memory alloys, hollow steel tubing or plastic polymers. The expandable sleeve is comprised of at least one flow reduction element  530  and a connecting tube  532 . The flow reduction element  530  can be formed using springs or polymer materials. The flow reduction element  530  maybe formed from a spring and then covered with a flexible polymer to prevent partially digested food from entering the flow reduction element  530 . The flow reduction element  530  can be formed with a preset curved shape which can be straightened out for insertion with the aid of an endoscope. The flow reduction element  530  diameter is sized to the small intestine diameter.  FIG. 9 b    illustrates the connecting tube  532 , anchoring member  520  and the flow reduction element  530  in a collapsed configuration for insertion into the small intestine. In this configuration the connecting tube  532  and the expandable sleeve  508  have been drawn toward the proximal end of the central shaft  506 . The connecting tube  532  also covers the collapsed anchoring member  520 . This movement of the connecting tube  532  relative to the central shaft  506  occurs because the flow reduction element  530  is collapsed in response to a force A applied to the connecting tube  532 . It is anticipated that the connecting tube  532  can be pulled toward the proximal portion  502  of the central shaft to collapse the insert for insertion into the small intestine with the aid of an endoscope. Once in position, the force A is removed, the connecting tube  532  returns toward the distal portion  504  of the insert which releases the anchoring member  520  from its constraint and allows the expandable sleeve  508  to expand to its original diameter. 
         [0048]    This invention has been described and specific examples of the invention have been portrayed. The use of those specifics is not intended to limit the invention in anyway. Additionally, to the extent that there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is my intent that this patent will cover those variations as well.