Abstract:
Several gastrointestinal surgery procedures are effective as treatments for metabolic disorders such as obesity and diabetes. Minimally invasive procedures including intra-luminal gastrointestinal implants have been proposed to mimic the anatomical, physiological and metabolic changes achieved by these procedures. Many of these designs include long sleeve like elements that prevent contact of food with the walls of the small intestine. It is desirable to have simple delivery systems that can place these implants under endoscopic guidance. However, in order to anchor these sleeve elements safely and reliably, the inventors have previously disclosed anchoring means that anchor the sleeves at the junctions of the stomach and the intestine or the stomach and esophagus.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit under 35 U.S.C. section 119(e) of U.S. provisional patent application 61/626,658, filed Sep. 30, 2011. This application is a continuation-in-part of each of the following applications, each of which are hereby incorporated by reference in their entirety: (1) U.S. patent application Ser. No. 13/493,144, filed Jun. 11, 2012, which is a divisional of U.S. patent application Ser. No. 12/752,697, filed Apr. 1, 2010, which claims the benefit of U.S. provisional patent application 61/211,853, filed Apr. 3, 2009 (now granted as U.S. Pat. No. 8,211,186); (2) U.S. patent application Ser. No. 12/833,605, filed Jul. 9, 2010, which claims the benefit of U.S. provisional patent application 61/270,588, filed Jul. 10, 2009; (3) U.S. patent application Ser. No. 12/986,268, filed Jan. 7, 2011, which claims the benefit of U.S. provisional patent application 61/335,472, filed Jan. 7, 2010; (4) U.S. patent application Ser. No. 13/298,867, filed Nov. 17, 2011, which claims the benefit of U.S. provisional patent application 61/458,060, filed Nov. 17, 2010; and (5) U.S. patent application Ser. No. 13/360,689, filed Jan. 28, 2012, which claims the benefit of U.S. provisional patent application 61/462,156, filed Jan. 28, 2011, and U.S. provisional patent application 61/519,507, filed May 24, 2011. 
    
    
     TECHNICAL FIELD 
     This invention generally relates to implants placed within gastrointestinal systems, including the esophagus, the stomach and the intestines. In particular it relates to implant systems having components implantable and removable using endoscopic techniques for treatment of obesity, diabetes, reflux, gastroparesis and other gastrointestinal conditions. 
     BACKGROUND 
     Bariatric surgery procedures, such a sleeve gastrectomy, the Rouen-Y gastric bypass (RYGB) and the bileo-pancreatic diversion (BPD), modify food intake and/or absorption within the gastrointestinal system to effect weight loss in obese patients. These procedures affect metabolic processes within the gastrointestinal system, by either short circuiting certain natural pathways or creating different interaction between the consumed food, the digestive tract, its secretions and the neuro-hormonal system regulating food intake and metabolism. In the last few years there has been a growing clinical consensus that obese patients who undergo bariatric surgery see a remarkable resolution of their type-2 Diabetes Mellitus (T2DM) soon after the procedure. The remarkable resolution of diabetes after RYGB and BPD typically occurs too fast to be accounted for by weight loss alone, suggesting there may be a direct impact on glucose homeostasis. The mechanism of this resolution of T2DM is not well understood, and it is quite likely that multiple mechanisms are involved. 
     One of the drawbacks of bariatric surgical procedures is that they require fairly invasive surgery with potentially serious complications and long patient recovery periods. In recent years, there is an increasing amount of ongoing effort to develop minimally invasive procedures to mimic the effects of bariatric surgery using minimally invasive procedures. One such procedure involves the use of gastrointestinal implants that modify transport and absorption of food and organ secretions. For example, U.S. Pat. No. 7,476,256 describes an implant having a tubular sleeve with anchoring barbs, which offer the physician limited flexibility and are not readily removable or replaceable. Moreover, stents with active fixation means, such as barbs that deeply penetrate into surrounding tissue, may potentially cause tissue necrosis and erosion of the implants through the tissue, which can lead to complications, such as bacterial infection of the mucosal tissue or systemic infection. Also, due to the intermittent peristaltic motion within the digestive tract, implants such as stents have a tendency to migrate. 
     Gastroparesis is a chronic, symptomatic disorder of the stomach that is characterized by delayed gastric emptying in the absence of mechanical obstruction. The cause of gastroparesis is unknown, but it may be caused by a disruption of nerve signals to the intestine. The three most common etiologies are diabetes mellitus, idiopathic, and postsurgical. Other causes include medication, Parkinson&#39;s disease, collagen vascular disorders, thyroid dysfunction, liver disease, chronic renal insufficiency, and intestinal pseudo-obstruction. The prevalence of diabetic gastroparesis (DGP) appears to be higher in women than in men, for unknown reasons. 
     Diabetic gastroparesis affects about 40% of patients with type-1 diabetes and up to 30% of patients with type-2 diabetes and especially impacts those with long-standing disease. Both symptomatic and asymptomatic DGP seem to be associated with poor glycemic control by causing a mismatch between the action of insulin (or an oral hypo-glycemic drug) and the absorption of nutrients. Treatment of gastroparesis depends on the severity of the symptoms. 
     Several inventors have recently described intra-luminal implants and implant delivery tools to mimic the effect of bariatric surgery procedures such as gastric and intestinal bypass for the treatment of obesity. In particular to mimic the effects of a popular surgical procedure called the Rouen-Y Gastric bypass in which most of the stomach is excised and a lower part of the small intestine is anastamosed to a small stomach pouch, several inventors have proposed implants that anchor at the gastroesophageal junction and reroute food to the small intestine. In many instances these implants then also anchor sleeves or stented sleeves that act as bypass conduits for mimicking stomach and intestinal bypass surgeries. 
     These systems, however, have significant shortcomings in terms of clinical side effects and complications. Implants that bypass the stomach with artificial sleeve like structures or conduits do not have motility like in a surgical gastric bypass where the anastomosed section of the intestine actively propels food from the esophagus (e.g., the system described in U.S. Pat. No. 7,837,669). Hence in early clinical results using this approach patients have complained about dysphagia (difficulty swallowing) as the solid undigested food is not easily pushed forward in to the small intestine from the esophagus through these artificial passageways. Also, the delivery system contemplated to be used to perform this procedure is complicated (e.g., U.S. Patent Publication 2008/0167606). It involves placing a sleeve element into the small intestine, where the sleeve element is first delivered in a sock-like configuration and then is extended into the small intestine by unrolling it. Accurate placement with this system is difficult. 
     SUMMARY 
     According to various embodiments, the present invention provides for an apparatus and method to place and anchor an intestinal bypass sleeve within one or more of the pyloric antrum, the pylorus, the duodenum and the jejunum. The gastrointestinal implant herein disclosed can be inserted endoscopically (when the device is loaded into a delivery catheter) through the mouth, throat, stomach and intestines. The gastrointestinal implant device includes a flexible thin-walled sleeve and an expandable anchor attached to the proximal end of the sleeve; secondary anchors may also anchor other portions of the thin-walled sleeve. 
     The present invention herein disclosed (with a short bypass sleeve or no bypass sleeve) can also be used to hold open the pylorus and may help to reduce the symptoms of gastroparesis, by allowing the stomach contents to exit the stomach easier through the pylorus into the duodenum. An active pumping means may also be attached to the expandable anchor to actively pump the stomach contents from the pyloric antrum into the duodenum. 
     According to various embodiments, the delivery system includes a thin sleeve element having a proximal anchoring element attached to it and distal end that is open. A single or multi-lumen sleeve delivery catheter carries the sleeve element by being releasably attached to its distal end, but the delivery catheter does not pass through the lumen of the sleeve. A multi-lumen implant delivery catheter with a distal end in the form of a capsule that can accommodate the anchoring implant within its bore. A mechanical retention feature releasably attaches the distal end of the sleeve element to the distal end of the catheter. 
     According to various embodiments, a method of using this delivery system to deliver an implant for creating an intestinal bypass includes (1) introducing an endoscope within the stomach, (2) placing a guide wire through the lumen of the endoscope and placing it past the pylorus in to the small intestine under endoscopic and or fluoroscopic guidance, (3) withdrawing the endoscope out the patient, (4) placing the implant delivery catheter system that is pre-loaded with a sleeve delivery catheter and the sleeve element (including the proximal anchoring element) over the guide-wire in to the stomach, (5) advancing the sleeve delivery catheter which extends beyond the implant delivery catheter with the sleeve in to the small intestine so that its distal end is at the position where you want to locate the distal end of the sleeve and the capsule is correctly positioned at the pylorus under endoscopic and/or fluoroscopic guidance, (6) reintroducing the endoscope in to the stomach adjacent to the capsule at the distal end of the implant delivery catheter, (7) releasing the distal end of the sleeve by activating a release mechanism, (8) retracting the sleeve delivery catheter and the guide wire to a position proximal to the capsule, (9) deploying the intestinal side of the anchoring element with an actuator carried in one of the lumens in the implant delivery catheter, (10) deploying the stomach side of the anchoring element either with an actuator carried in one of the lumens in the implant delivery catheter or by retracting the entire implant delivery system backwards towards the mouth of the patient, and (11) withdrawing the endoscope, the guide wire and the implant delivery system out of the patient. 
     While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a cross-sectional view of a portion of the digestive tract in a human body with an intestinal bypass sleeve implanted in the duodenum from the pylorus to the ligament of Treitz. The sleeve is held in place at the pylorus by an expandable anchor that anchors on the pylorus. 
         FIG. 2  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. 
         FIG. 3  is a drawing of an expandable anchor according to exemplary embodiments of the invention. 
         FIG. 4  is a cross-sectional drawing of the pyloric antrum, pylorus, duodenal bulb and duodenum. An expandable anchor and intestinal bypass sleeve is implanted into the pylorus. 
         FIG. 5  is a drawing of an alternative embodiment of the invention herein disclosed. The expandable anchor is comprised of a hollow tubular braided structure of wire. The wire form has been shaped to conform to the shape of the pylorus and the duodenal bulb. 
         FIG. 6  is a sectional view of an alternative embodiment of an anchor and sleeve implanted into the pylorus and duodenal bulb and duodenum. 
         FIG. 7  is a drawing of an alternative embodiment of an expandable anchor. The expandable anchor is comprised of two toroidally shaped wound springs connected to a central cylinder by control arms. 
         FIG. 8  is a drawing of a flat representation of the control arms and central cylinder as in  FIG. 7  as laser cut from a piece of tubing. 
         FIG. 9  is a drawing of a heat set mandrel used for heat setting or forming the  FIG. 8  part into the final shape of expandable anchor in  FIG. 7   
         FIG. 10  is drawing of the control arms heat set to the final shape before the toroidally shaped wound springs are assembled on the control arms. 
         FIG. 11  is a drawing of an alternative embodiment of a central cylinder and control arms. 
         FIG. 12  is a drawing of the toroidally wound springs in a straight configuration, before the toroidally wrapped spring is assembled onto the control arms. 
         FIG. 13  is a drawing of alternative embodiments of toroidally wound springs. 
         FIG. 14  is a drawing of an alternative embodiment of a central cylinder and control arms. 
         FIG. 15  is a drawing of an expandable anchor and intestinal bypass sleeve. 
         FIG. 16  is a sectional view of the expandable anchor as in  FIG. 7  and intestinal bypass sleeve implanted across the pylorus. 
         FIG. 17  is a sectional view of the expandable anchor and the intestinal bypass sleeve implanted into the duodenal bulb. 
         FIG. 18  shows a drawing flat representation of an alternative embodiment of the control arms and central cylinder as laser cut from a piece of tubing. The final heat set shape will be similar to the shape in  FIG. 23 . 
         FIG. 19  shows a drawing flat representation of an alternative embodiment of the control arms and central cylinder as laser cut from a piece of tubing. The final heat set shape will be similar to the shape in  FIG. 23 . 
         FIG. 20  is a drawing flat representation of an alternative embodiment of the control arms and central cylinder as laser cut from a piece of tubing. The final heat set shape will be similar to the shape in  FIG. 23 . 
         FIG. 21  is a drawing of an alternative embodiment of an expandable anchor. The expandable anchor is comprised of two toroidally shaped wound springs connected to a central cylinder by control arms. 
         FIG. 22  is a drawing of an alternative embodiment of an expandable anchor. The expandable anchor is comprised of two toroidally shaped wound springs connected to a central cylinder by control arms. 
         FIG. 23  is a drawing of an alternative embodiment of an expandable anchor. The expandable anchor is comprised of two toroidally shaped wound springs connected to a central cylinder by control arms. 
         FIG. 24  is a drawing of an alternative embodiment of control arms. 
         FIG. 25  is a drawing of an alternative embodiment of a central cylinder. 
         FIG. 26  is a drawing showing two pieces of  FIG. 24  and  FIG. 25  assembled together with two toroidal shaped springs. 
         FIG. 27  is a drawing of alternative embodiments of a central cylinder. 
         FIG. 28  is a drawing of an expandable anchor in which the central cylinder is adjustable in length. 
         FIG. 29  is a drawing of an expandable anchor as herein disclosed in which the expandable anchor is secondarily anchored to the pylorus, duodenal bulb or pyloric antrum by secondary means. 
         FIG. 30  is a drawing of an expandable anchor in which portion of the central cylinder is soft and conformable and allows the pylorus to open close with the membrane on the central cylinder. 
         FIG. 31  is a drawing of an expandable anchor and an intestinal bypass sleeve. An optional anti-reflux valve and restrictor valve have been incorporated into the central cylinder. 
         FIG. 32  is a drawing of an over the wire delivery catheter for placing the expandable anchor and intestinal bypass sleeve within the digestive tract. 
         FIG. 33  is a drawing of a distal capsule tip for the delivery catheter as shown in  FIG. 32 . 
         FIG. 34  is a drawing of an inflatable balloon tip for the distal capsule of the delivery device as shown in  FIG. 32 . 
         FIG. 35  is a drawing of a delivery catheter for placing the expandable anchor and intestinal bypass sleeve within the digestive tract. The delivery catheter has a retainer to prevent premature deployment of the expandable anchor and to allow it to be re-sheathed to adjust the placement location within the body. 
         FIG. 36  is a drawing of a distal end of a delivery catheter and an expandable anchor and intestinal bypass sleeve. 
         FIG. 37  is a drawing of a delivery catheter for placing the expandable anchor and intestinal bypass sleeve within the digestive tract. 
         FIG. 38  is a drawing of a delivery catheter for placing the expandable anchor and intestinal bypass sleeve within the digestive tract. 
         FIG. 39  is a drawing of a delivery catheter for placing the expandable anchor and intestinal bypass sleeve within the digestive tract. 
         FIG. 40  is a drawing of an over the wire sleeve delivery catheter for placing an intestinal bypass sleeve within the intestine. 
         FIG. 41  is a drawing of a monorail sleeve delivery catheter for placing an intestinal bypass sleeve within the intestine. 
         FIG. 42  is a drawing of an over the wire sleeve delivery catheter for placing an intestinal bypass sleeve within the intestine. 
         FIG. 43  is a drawing of a delivery catheter for placing the expandable anchor and intestinal bypass sleeve within the digestive tract. 
         FIG. 44A  is a drawing of an over the wire balloon catheter that is used as a sleeve delivery catheter for placing an intestinal bypass sleeve within the intestine. 
         FIG. 44B  is a drawing of a monorail balloon catheter that is used as a sleeve delivery catheter for placing an intestinal bypass sleeve within the intestine. 
         FIG. 45A  is a drawing of the sleeve delivery catheter of  FIG. 44A  in which the intestinal bypass sleeve has been attached to the balloon catheter. 
         FIG. 45B  is a drawing of the sleeve delivery catheter of  FIG. 44A  in which the intestinal bypass sleeve has been released from the balloon catheter. 
         FIG. 45C  is a drawing of the monorail sleeve delivery catheter of  FIG. 44B  in which the intestinal bypass sleeve has been attached to the balloon catheter. 
         FIG. 46  is a drawing of a sleeve delivery catheter. 
         FIG. 47  is a drawing of a guide wire to be used for placing expandable anchors and intestinal bypass sleeves. 
         FIG. 48A  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. 
         FIG. 48B  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. A guide wire is inserted through the working channel of the endoscope. The guide wire is advanced distally in the small intestine lumen into the jejunum. 
         FIG. 49A  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. The guide wire of  FIG. 47  is back loaded into the working channel of the endoscope. The guide wire of  FIG. 47  is advanced distally in the small intestine lumen into the jejunum. 
         FIG. 49B  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. The guide wire of  FIG. 47  is left in place in the jejunum while the endoscope is withdrawn from the body. The endoscope is then reinserted into the stomach through the mouth and esophagus parallel to the guide wire, but the guide wire is not in the working channel of the endoscope. 
         FIG. 50A  is a continuation in the deployment sequence from  FIG. 49B . An expandable anchor and intestinal bypass sleeve has been loaded on to delivery catheter. The delivery catheter is advanced over the guide wire through the mouth, esophagus, Stomach and small intestine until the distal end of the sleeve reaches the desired implant location. 
         FIG. 50B  is a continuation in the deployment sequence from  FIG. 50A . The sleeve delivery catheter is actuated to release the distal end of the bypass sleeve from the catheter. The sleeve delivery catheter is then retracted to remove it partially or fully from the digestive system. The distal capsule of the delivery system then is partially retracted to deploy or release the distal end of the expandable anchor from the distal capsule. 
         FIG. 51  is a continuation in the deployment sequence from  FIG. 50B . The distal capsule of the delivery system is fully retracted to deploy or release the proximal end of the expandable anchor from the distal capsule. The expandable anchor and intestinal bypass sleeve are now in place at the intended implant location. The ball on the end of the guide wire is released. The guide wire, delivery catheter and endoscope are withdrawn from the human body. 
         FIG. 52  is a drawing of a monorail delivery catheter for placing an expandable anchor and intestinal bypass sleeve within the digestive tract. 
         FIG. 53A  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. 
         FIG. 53B  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. A guide wire is inserted through the working channel of the endoscope. The guide wire is advanced distally in the small intestine lumen into the jejunum. 
         FIG. 54A  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. The guide wire of  FIG. 47  is back loaded into the working channel of the endoscope. The guide wire of  FIG. 47  is advanced distally in the small intestine lumen into the jejunum. 
         FIG. 54B  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. The guide wire of  FIG. 47  is left in place in the jejunum while the endoscope is withdrawn from the body. The endoscope is then reinserted into the stomach through the mouth and esophagus parallel to the guide wire, but the guide wire is not in the working channel of the endoscope. 
         FIG. 55  is a continuation in the deployment sequence from  FIG. 54B . An expandable anchor and intestinal bypass sleeve has been loaded onto a monorail delivery catheter. The delivery catheter is advanced over the guide wire through the mouth, esophagus, stomach and small intestine until the distal end of the sleeve reaches the desired implant location. 
         FIG. 56A  is a continuation in the deployment sequence from  FIG. 55 . The sleeve delivery catheter is actuated to release the distal end of the bypass sleeve from the catheter. The sleeve delivery catheter is then retracted to remove it partially or fully from the digestive system. The distal capsule of the delivery system then is partially retracted to deploy or release the distal end of the expandable anchor from the distal capsule. 
         FIG. 56B  is a continuation in the deployment sequence from  FIG. 56A . The distal capsule of the delivery system is fully retracted to deploy or release the proximal end of the expandable anchor from the distal capsule. The expandable anchor and intestinal bypass sleeve are now in place at the intended implant location. The ball on the end of the guide wire is released. The guide wire, delivery catheter and endoscope are withdrawn from the human body. 
         FIG. 57  is a drawing of a catheter for removal of an expandable anchor and bypass sleeve as in  FIG. 16  from the human body. 
         FIG. 58  is a drawing of a monorail guide eyelet that may be attached to the end of the endoscope. 
         FIG. 59  is a drawing of a monorail guide eyelet that may be incorporated into the distal capsule of the expandable anchor delivery device. 
         FIG. 60  is a drawing of the expandable anchor herein disclosed implanted across a pylorus. An external band has been surgically placed with a laparoscope around the pylorus. The band around the pylorus will increase the radial compliance/stiffness of the pylorus and will provide for an increased force to cause dislodgment of the expandable anchor from within the pylorus. 
         FIG. 61  is a cross-sectional view of a portion of the digestive tract in a human body. An intestinal bypass sleeve is implanted in the duodenum from the pylorus to the ligament of Treitz. The sleeve is held in place at the pylorus by an expandable anchor that anchors on the pylorus, optional secondary expandable anchors anchor the sleeve at additional locations in the duodenum and jejunum. An expandable anchor with an anti-reflux valve is implanted at the gastroesophageal (GE) junction to help resolve gastroesophageal reflux disease (GERD). 
         FIG. 62  is a drawing of a deployment handle for a delivery catheter for expandable anchors and intestinal bypass sleeves. 
         FIG. 63  is a drawing of a deployment handle for a delivery catheter for expandable anchors and intestinal bypass sleeves. 
         FIG. 64  is a drawing of a deployment handle for a delivery catheter for expandable anchors and intestinal bypass sleeves. 
     
    
    
     While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims. 
     DETAILED DESCRIPTION 
       FIG. 1  is a sectional view of an embodiment of the invention implanted in a portion of a human digestive tract. As a person ingests food, the food enters the mouth  100 , is chewed, and then proceeds down the esophagus  101  to the lower esophageal sphincter at the gastroesophageal junction  102  and into the stomach  103 . The food mixes with enzymes in the mouth  100  and in the stomach  103 . The stomach  103  converts the food to a semi-fluid substance called chyme. The chyme enters the pyloric antrum  104  and exits the stomach  103  through the pylorus  106  and pyloric orifice  105 . The small intestine is about 21 feet long in adults. The small intestine is comprised of three sections: the duodenum  112 , jejunum  113  and ileum (not shown). The duodenum  112  is the first portion of the small intestine and is typically 10-12 inches long. The duodenum  112  is comprised of four sections: the superior, descending, horizontal and ascending. The duodenum  112  ends at the ligament of Treitz  109 . The papilla of Vater  108  is the duct that delivers bile and pancreatic enzymes to the duodenum  112 . The duodenal bulb  107  is the portion of the duodenum which is closest to the stomach  103 . As shown, an intestinal bypass sleeve  111  is implanted in the duodenum from the pyloric antrum  104  and pylorus  106  to the ligament of Treitz  109 . The intestinal bypass sleeve  111  is held in place at the pylorus  106  by an expandable anchor  110  that anchors on the pylorus  106 . 
     In various exemplary embodiments, the sleeve  111  is integrally formed with or coupled to the expandable anchor  110 . According to other exemplary embodiments, the sleeve  111  is removably or releasably coupled to the expandable anchor  110 . According to various embodiments, the bypass sleeve has a diameter of between about 10 mm and about 35 mm. According to various embodiments, the bypass sleeve has a thickness of between about 0.001 and about 0.015 inches. Exemplary structures for removably or releasably coupling or attaching the sleeve  111  to the expandable anchor  110  are disclosed for example in U.S. patent application Ser. No. 12/752,697, filed Apr. 1, 2010, entitled “Modular Gastrointestinal Prostheses,” which is incorporated herein by reference. According to various embodiments, the sleeve  111  or the expandable anchor  110  (or both) are further coupled at the pylorus  106  using one or more of the techniques described in either of U.S. patent application Ser. No. 12/752,697 or U.S. patent application Ser. No. 12/833,605, filed Jul. 9, 2010, entitled “External Anchoring Configuration for Modular Gastrointestinal Prostheses,” both of which are incorporated herein by reference. According to various embodiments of the invention, the sleeve  111  may be configured and coupled to the expandable anchor  110 , using one or more of the configurations disclosed in U.S. patent application Ser. No. 12/986,268, filed Jan. 7, 2011, entitled “Gastrointestinal Prostheses Having Partial Bypass Configurations,” which is incorporated herein by reference. 
       FIG. 2  is a sectional view of a portion of the digestive tract in a human body. As shown, an endoscope  114  has been inserted through: the mouth  100 , esophagus  101 , stomach  103  and pyloric antrum  104  to allow visualization of the pylorus  106 . Endoscopes  114  are used for diagnostic and therapeutic procedures in the gastrointestinal tract. The typical endoscope  114  is steerable by turning two rotary dials  115  to cause deflection of the working end  116  of the endoscope. The working end of the endoscope or distal end  116 , typically contains two fiber bundles for lighting  117 , a fiber bundle for imaging  118  (viewing) and a working channel  119 . The working channel  119  can also be accessed on the proximal end of the endoscope. The light fiber bundles and the image fiber bundles are plugged into a console at the plug in connector  120 . The typical endoscope has a working channel in the 2.6 to 3.2 mm diameter range. The outside diameter is typically in the 8 to 12 mm diameter range depending on whether the endoscope is for diagnostic or therapeutic purposes. 
       FIG. 3  is a drawing of an expandable anchor  110 . The expandable anchor  110  provides for an anchoring means to hold an intestinal bypass sleeve  111  within the small intestine. In exemplary embodiments, the expandable anchor  110  is designed to allow the anchor to be of a self-expanding design. A self-expanding anchor design can be compressed in diameter to allow the device to be compressed in diameter to be loaded onto a delivery catheter. The anchor  110  can then recover elastically to the original starting diameter, with the anchor diameter decreasing only a small amount due to nonelastic recovery. The anchor  110  can also be made of a plastically deformable design and require a mechanical force applied to it in the radial or longitudinal direction to accomplish the expansion of the anchor. The mechanical force can be accomplished with an inflatable balloon type device, radially expanding the anchor  110 , or it may also be accomplished by a longitudinal compression of the anchor  110  by a screw type mechanism or cable tensioning means. As shown, the anchor  110  has a proximal portion or proximal disk  144  that is comprised of 26 spring arms. 
     As shown, the anchor  110  has a distal portion (e.g., open-ended cylindrical portion)  143  that is comprised of 26 spring arms. According to various embodiments, the anchor  110  could have from 3 to 72 spring arms for the proximal disk and the open ended cylinder. 
     According to exemplary embodiments, the expandable anchor  110  is made from a nickel titanium alloys (Nitinol). Other alternative suitable alloys for manufacturing the anchor  110  are stainless steel alloys: 304, 316L, BioDur® 108 Alloy, Pyromet Alloy® CTX-909, Pyromet® Alloy CTX-3, Pyromet® Alloy 31, Pyromet® Alloy CTX-1, 21Cr-6Ni-9Mn Stainless, Pyromet® Alloy 350, 18Cr-2Ni-12Mn Stainless, Custom 630 (17Cr-4Ni) Stainless, Custom 465® Stainless, Custom 455® Stainless, Custom 450® Stainless, Carpenter 13-8 Stainless, Type 440C Stainless, cobalt chromium alloys—MP35N, Elgiloy, L605, Biodur® Carpenter CCM alloy, titanium and titanium alloys, Ti-6Al-4V/ELI and Ti-6Al-7Nb, Ti-15Mo, Tantalum, Tungsten and tungsten alloys, pure platinum, platinum-iridium alloys, platinum-nickel alloys, niobium, iridium, conichrome, gold and gold alloys. The anchor  110  may also be comprised of the following absorbable metals: pure iron and magnesium alloys. The anchor  110  may also be comprised of the following plastics: Polyetheretherketone (PEEK), polycarbonate, polyolefins, polyethylenes, polyether block amides (PEBAX), nylon 6, 6-6, 12, Polypropylene, polyesters, polyurethanes, polytetrafluoroethylene (PTFE) Poly(phenylene sulfide) (PPS), poly(butylene terephthalate) PBT, polysulfone, polyamide, polyimide, poly(p-phenylene oxide) PPO, acrylonitrile butadiene styrene (ABS), Polystyrene, Poly(methyl methacrylate) (PMMA), Polyoxymethylene (POM), Ethylene vinyl acetate, Styrene acrylonitrile resin, Polybutylene. The anchor  110  may also be comprised of the following absorbable polymeres: Polyglycolic acid (PGA), Polylactide (PLA), Poly(ε-caprolactone), Poly(dioxanone) Poly(lactide-co-glycolide). 
     The anchor  110 , according to exemplary embodiments, is laser cut from a round tubing or from a flat sheet of Nitinol and then is rolled into a cylindrical shape after laser cutting. The anchor  110 , according to exemplary embodiments, is made from a Nitinol tube of about 9 mm outside diameter by a wall thickness of 0.006 inch thick. Alternatively a starting tube outside diameter can range from about 2 mm to 16 mm. An alternative construction method is to laser cut or chemical etch the pattern from a flat sheet of Nitinol with a thickness of 0.002 inch to 0.020 inch. 
     According to various embodiment, anchor  110  has an inside diameter  139  in the range of about 2 mm to 20 mm. Anchor  110  has an expanded open end  137  in the range of about 12 mm to 60 mm. Anchor  110  has a disk-shaped feature  144  that has a diameter  145  in the range of about 12 mm to 60 mm. Anchor  110  has a central cylinder  138  that has an outside diameter in the range of 4 mm to 20 mm. Anchor  110  has a flange  141  adjacent to the large diameter open end that has a length of about 8 mm in length. According to various embodiments, this length  141  could range from a length of about 1 mm to 30 mm in length. Central cylinder section  138  can have a length  140  of about 1 mm to 30 mm and is close to the width of the pylorus  106 . The proximal disk can have a length of 1 mm to 20 mm. The proximal disk  144  can alternatively be formed in the shape of a sphere. The central cylinder  138 , in various embodiments, is made from a material having a stiffness sufficient to resist compressive forces applied by the pylorus. 
       FIG. 4  is a sectional view of the pyloric antrum  104 , pyloric aperture  105 , pylorus  106 , duodenal bulb  107  and duodenum  112 . An expandable anchor  110  and intestinal bypass sleeve  111  are implanted into the pylorus  106 . The expandable anchor  110  is shown here without a covering material to allow for better visualization of the expandable anchor  110 . In various exemplary embodiments, the expandable anchor  110  is not covered, while in other exemplary embodiments, it is covered with a polymer membrane made from a material such as silicone, flourosilicone elastomers such as Viton, polyurethane, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), polyethylene, ePTFE (expanded polytetrafluoroethylene), PFA (Perfluoroalkoxy), PVDF (Polyvinylidene Flouride, Tetrafluoroethylene), THV (Hexafluoropropylene and Vinylidene Fluoride), ETFE (Ethylenetetrafluoroethylene), ECTFE (Chloro Trifluoro Ethylene/Ethylene Copolymer) EFEP (copolymer of ethylene, tetrafluoroethylene, and hexafluoropropylene), PVF (polyvinyl fluoride) or other suitable material.  FIG. 16 , for example, shows an embodiment of the expandable anchor  110  covered with a polymer film. The expandable anchor  110  can be made from metal or plastic. The intestinal bypass sleeve  111  can vary in length from 1-2 inches in length up to several feet. In some embodiments, the sleeve bypasses the length of the duodenum up to the ligament of Treitz. The sleeve can be longer and bypass into the jejunum. The intestinal bypass sleeve  111  may be made from a thin-walled polymer material such as silicone, flourosilicone elastomers such as Viton, polyurethane, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), polyethylene, expanded polytetrafluoroethylene (ePTFE), PFA (Perfluoroalkoxy), PVDF (Polyvinylidene Flouride, Tetrafluoroethylene), THV (Hexafluoropropylene and Vinylidene Fluoride), ETFE (Ethylenetetrafluoroethylene), ECTFE (Chloro Trifluoro Ethylene/Ethylene Copolymer) EFEP (copolymer of ethylene, tetrafluoroethylene, and hexafluoropropylene), PVF (polyvinyl fluoride) or other suitable material or combinations of the listed materials. In exemplary embodiments, the wall thickness of the intestinal bypass sleeve  111  may be in the range of 0.001 inch to 0.012 inch thick. The intestinal bypass sleeve  111  may be made by extrusion, into a tubular form or a lay flat tubing, dip coated from a liquid solution, powder coated from fine particles of polymer or paste extruded and then stretched as is the case with ePTFE. 
     Tantalum radiopaque markers  361  are attached to the intestinal bypass  111  by encapsulation in a polymer  362  such as FEP. The radiopaque markers  361  can be attached to the intestinal bypass sleeve at fixed increments along the length of the bypass sleeve  111  to allow visualization of the sleeve during deployment and at patient follow-up to confirm the position of the bypass sleeve. The radiopaque markers  361  can be made of disc of tantalum. A tantalum ball bearing or sphere can be flattened to provide such a disk. 
       FIG. 5  is a drawing of an alternative embodiment of the invention herein disclosed. The expandable anchor is comprised of a hollow tubular braided structure of wire. The tubular braid can be braided in the diameter range from 10 mm in diameter up to about 70 mm in diameter. The wire diameter can range from 0.001 inch to 0.014 inch. In exemplary embodiments, the number of wire ends in the braid is 96 ends, but it can range from as few as 4 ends up to 256 ends. The wire can be made from a metal such as Nitinol, MP35N, L605, Elgiloy, stainless steel or from a plastic such as PET, PEEK or Delrin or other suitable material. The tubular wire braid is formed into a shape with a disk  360 , a central cylinder portion  363  and a cylindrical portion  359 . Wire ends are gathered into bunches  361  and welded together or a sleeve is crimped onto wires to keep the braided ends from fraying and unraveling. Alternatively, the structure could be made from a braid using a single wire end. Central cylinder  363  has a through lumen  362  that allows chyme to flow from the stomach to the duodenum. The central cylinder  363  can be rigid to hold the pylorus  106  open or it may be compliant to allow the opening and closure through lumen  362  with the pylorus  106 . 
     The length  364  of the device is typically about 50 mm but can range from about 10 mm to 100 mm. The diameter of the cylindrical portion  359  is typically about 25 mm in diameter, but can range from 10 mm to 75 mm. The diameter of the central cylinder portion is typically about 10 mm in diameter but can range from 2 mm up to 25 mm in diameter. The length of the central cylinder  363  is approximately that of the width of the pylorus  106 , but the central cylinder  363  can be slightly longer to provide a gap between central cylinder and pylorus or slightly shorter to provide for a compressive force to be applied to the pylorus. The expandable anchor is compressible in diameter and the diameter can be reduced to about 5 mm to 10 mm in diameter typically to allow the anchor to be loaded into a catheter. The expandable anchor can be covered on the outside and/or inside side with a polymer membrane covering. The membrane  365  covering the expandable anchor may be made from a thin-walled polymer material such as silicone, polyurethane, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene, polyethylene, expanded polytetrafluoroethylene (ePTFE) or other suitable material. In some embodiments, the wall thickness of the membrane covering the expandable anchor may be in the range of 0.001 inch to 0.030 inch thick. The membrane  365  may be made by extrusion, dip coating from a liquid solution, powder coated from fine particles of polymer or paste extruded and then stretched as is the case with ePTFE. The expandable anchor membrane  365  may also be cut from a flat sheet of material such as ePTFE and then bonded or sewn into a disk shape or spherical shaped structure and then attached to the expandable anchor by sewing or gluing with a polymer such as FEP. 
       FIG. 6  is a sectional view of the invention herein disclosed in  FIG. 5  implanted into the pyloric antrum  104 , pylorus  106 , duodenal bulb  107 , and duodenum  112 . An intestinal bypass sleeve  111  is attached to the anchor. 
       FIG. 7  is a drawing of an alternative embodiment of an expandable anchor. The expandable anchor provides for an anchoring means to hold an intestinal bypass sleeve  111  within the small intestine. The expandable anchor is comprised of two toroidally shaped wound springs  600  connected to a central cylinder  601  by control arms  602 . The toroidal springs  600  are prewound in a straight configuration and then the springs  600  are wound through the eyelets  604  on the end of the control arms and formed into the toroidal shape. The expandable anchor can be non-covered or it can have a polymer covering on the outside and inside as disclosed in  FIG. 16 . The spring ends are joined together at a spring joiner  614 . The spring ends may be fastened to the spring joiner  614  by mechanical means or they may be laser welded to the spring joiner  614 . The spring joiner serves two purposes, to provide for a means of spring end termination and joining of the two spring ends and also provides for an exit point for the drawstring  605  to exit the spring  600 . The drawstring  605  is fed through the central axis of the toroidal spring  600 . A drawstring  605  may be used only on the proximal disk or on both the proximal and distal disks. 
     The two ends of the drawstring  605  both exit the spring joiner  614  and are terminated at ball  606 . Pulling on the ball  606  and drawing the drawstring  605  through the spring joiner  614  causes the diameter of the spring  600  to be reduced and the control arms to bend and deflect as shown in  FIG. 15 . The drawstring  605  can also be terminated in loop  607  or with two balls  608  spaced apart. 
     The toroidal springs are further disclosed in  FIG. 12  and  FIG. 13 . The central cylinder and the control arms of the exemplary embodiment are laser cut from a piece of Nitinol tubing. In the exemplary embodiments, the expandable anchor is designed to allow the anchor to be of a self-expanding design. A self-expanding anchor design can be compressed in diameter to allow the device to be loaded onto a delivery catheter. The anchor can then recover elastically to the original starting diameter, with the anchor diameter decreasing only a small amount due to nonelastic recovery. The anchor can also be made of a plastically deformable design and require a mechanical force applied to it in the radial or longitudinal direction to accomplish the expansion of the anchor. The mechanical force can be accomplished with an inflatable balloon type device, radially expanding the anchor or it may also be accomplished by a longitudinal compression of the anchor by a screw type mechanism or cable tensioning means. As shown, the anchor has a distal disk and a proximal disk that is comprised of 14 control arms on each portion. According to various embodiments, the anchor could have from 3 to 72 control arms for the proximal disk and the distal disk. 
     According to exemplary embodiments, the central cylinder  601  and control arms  602  are made from a nickel titanium alloy (Nitinol). Springs  600  are made from MP35N LT. Other alternative suitable alloys for manufacturing the central cylinder  601 , control arms  602  and springs  600  are stainless steel alloys: 304, 316L, BioDur®108 Alloy, Pyromet Alloy® CTX-909, Pyromet® Alloy CTX-3, Pyromet® Alloy 31, Pyromet® Alloy CTX-1, 21 Cr-6Ni-9Mn Stainless, Pyromet Alloy 350, 18Cr-2Ni-12Mn Stainless, Custom 630 (17Cr-4Ni) Stainless, Custom 465® Stainless, Custom 455® Stainless, Custom 450® Stainless, Carpenter 13-8 Stainless, Type 440C Stainless, cobalt chromium alloys-MP35N, Elgiloy, L605, Biodur® Carpenter CCM alloy, titanium and titanium alloys, Ti-6Al-4V/ELI and Ti-6Al-7Nb, Ti-15Mo, Tantalum, Tungsten and tungsten alloys, pure platinum, platinum-iridium alloys, platinum-nickel alloys, niobium, iridium, conichrome, gold and gold alloys. The anchor may also be comprised of the following absorbable metals: pure Iron and magnesium alloys. The central cylinder  601 , control arms  602  and springs  600  may also be comprised of the following plastics: Polyetheretherketone (PEEK), polycarbonate, polyolefins, polyethylenes, polyether block amides (PEBAX), nylon 6, 6-6, 12, Polypropylene, polyesters, polyurethanes, polytetrafluoroethylene (PTFE) Poly(phenylene sulfide) (PPS), poly(butylene terephthalate) PBT, polysulfone, polyamide, polyimide, poly(p-phenylene oxide) PPO, acrylonitrile butadiene styrene (ABS), Polystyrene, Poly(methyl methacrylate) (PMMA), Polyoxymethylene (POM), Ethylene vinyl acetate, Styrene acrylonitrile resin, Polybutylene. The anchor, according to exemplary embodiments, is laser cut from a round tubing or from a flat sheet of Nitinol and then is rolled into a cylindrical shape after laser cutting. The anchor, according to exemplary embodiments, is made from a Nitinol tube of about 9 mm outside diameter by a wall thickness of 0.012 inch thick. Alternatively a starting tube outside diameter can range from about 2 mm to 16 mm. An alternative construction method is to laser cut or chemical etch the pattern from a flat sheet of Nitinol with a thickness of 0.002 inch to 0.020 inch. 
     According to various embodiments, the anchor has an inside diameter  610  in the range of about 2 mm to 20 mm. The anchor has disk-shaped features that have a diameter  609  in the range of about 20 mm to 66 mm. Anchor has a central cylinder  601  that has an outside diameter in the range of 4 mm to 20 mm. Central cylinder section  601  can have a length  612  of about 1 mm to 30 mm and is close to width of the pylorus  106 . The disks can have a length  611  of 1 mm to 10 mm. The proximal disk and distal disk can alternatively be formed in the shape of a cup. The central cylinder  601 , in various embodiments, is made from a material having a stiffness sufficient to resist compressive forces applied by the pylorus. The control arms  602  can radially project out through the diameter of the spring  600  and form a barb  613  on the outside diameter of the spring  600 . 
       FIG. 8  is a drawing of a flat representation of the circumference of the central cylinder  601  and control arms  602 . The control arms have round holes at the end of the arms to wind the toroidal spring through when assembling the springs  600  onto the control arms  602  to make an expandable anchor. The holes  604  at the end of the control arms  602  can be made in an alternative shape such as elliptical, rectangular or square. Alternatively the control arms  602  may have an open slot  615  to allow the spring to be snap fit into the opening on the control arms  602 . The end of the control arms  602  may also have a t-shape that could be inserted into a slot  760  laser cut into the wire of the spring  600 . The two edges of the flat representation  616  and  617  will touch when the flat representation is wrapped around a cylinder. 
       FIG. 9  is a drawing of a heat set mandrel  616  used to heat set the laser cut Nitinol tube shown in  FIG. 8  into the final shape of the central cylinder  601  and control arms  602  of  FIG. 10 . The inside diameter  617  of the heat set mandrel  616  closely approximates the outside diameter of the central cylinder  601 . A radius  618  is cut into the mandrel to force the Nitinol to bend to a gradual radius to control the strain level during shape setting of the Nitinol part into the final shape of  FIG. 10 . Laser cut tube of  FIG. 8  is inserted into the heat set mandrel of  FIG. 9 . The control arms are bend outward and then compressed longitudinally to the final location  619  on the heat set mandrel. The Nitinol laser cut tube and the heat set mandrel  616  are then heated to a temperature of 500 degree centigrade for 10 minutes and then quickly cooled to room temperature. The laser cut tube is then removed from the inside of the heat set mandrel  616  and the laser cut tube is now set to the shape in  FIG. 10 . 
       FIG. 10  is a drawing of the laser cut tube of  FIG. 8 . After it has been heat set and formed into the final shape for the expandable anchor. Control arms  602  are formed radially outward from the central cylinder  601 . The bend angle  620  of the control arms can be from −30 degrees to approximately 45 degrees. 
       FIG. 11  is a drawing of an alternative embodiment of a central cylinder and control arms. The control arms are attached to the central cylinder by a simple pin  622  and socket  623  arrangement like used in four bar linkages. The number of arms control arms can range from 3 to 72. 
       FIG. 12  is a drawing of toroidal shaped spring  600  as used in the expandable anchor of  FIG. 7 . The toroidal spring  600  is shown separately here for ease of illustration, but the spring  600  will be assembled onto the control arms  602  to form an expandable anchor as in  FIG. 7 . 
     The toroidal-shaped spring  600  may be first formed by winding a straight compression spring  600 . The compression spring  600  may be made from round wire  286 , rectangular wire  287 , square wire  288 , or elliptical wire  289 . The compression spring  600  can be wound to have a round shape  290 , rectangular shape  291 , square shape  292 , or an elliptical shape  293 . The wire may be made from Nitinol, stainless steel, Elgiloy, L605, MP35N titanium, niobium or other suitable metal. The wire is, in various embodiments, made of a solid wire but can alternatively be made of stranded or braided wire. The outer diameter or inner core of the wire may be clad or plated with gold, tantalum, platinum, iridium, or other suitable material. The wire may be co-drawn (e.g., drawn filled tube-Fort Wayne Metals) and have an outer core of a high strength material such as Nitinol, stainless steel, Elgiloy, L605, MP35N, titanium, niobium and an inner core of a high radio-opacity material such as gold, tantalum, platinum, or iridium. Alternatively, the wire is made from a plastic monofilament such as PEEK, PET or Delrin. Compression spring  624  is formed into a toroidal shape by bending spring ends towards each other and winding the spring through the holes  604  in the ends of the control arms  602  and joining spring ends at spring joiner connector  614 . A perspective view of the toroidal spring is shown in  625  (not assembled to control arms  602 ). A drawstring  605  is contained within the center of the toroidal spring  600 . The drawstring  605  is threaded through a hole in the spring joiner  614 . Drawstring  605  is terminated at spheres that can be crimped onto the end of the drawstring  605 . The spheres may be made of metal or plastic and may be attached to the drawstring  605  by crimping, welding, gluing, insert molding or other suitable means. The drawstring may be comprised of plastic or metal and may be made of a monofilament or braided cable material. When spheres  605  are withdrawn from spring joiner  614 , drawstring  605  is tensioned and the diameter of the toroidal spring and control arms  602  is reduced to the smaller diameter as in  285 . 
       FIG. 13A  is a drawing of an alternative embodiment of an expandable anchor formed in the shape of a toroidal-shaped spring  282  as previously disclosed in  FIG. 12 . The spring may have small tissue penetrating anchors  296  on the outer surface of the spring. Tissue penetrating anchor  296  may be made from, stainless steel, Elgiloy, L605, MP35N, titanium or niobium and may be crimped onto the wire or welded. Tissue penetrating anchors  296  may be an optional feature that can be added if the patient&#39;s anatomy does not have a pyloric ring that is adequate for anchoring. 
       FIG. 13B  is a drawing of an alternative embodiment of an expandable anchor formed in the shape of a toroidal-shaped spring as previously disclosed in  FIG. 12 . The toroidal-shaped spring is formed of segments where the direction of the winding of the spring is reversed to cancel out the helical twisting action of the spring. The individual segments  297 ,  298 ,  299  and  300  can be connected at joiners  301 . Alternatively the entire toroidal spring can be laser cut as one unitary piece by laser cutting the wound coil in the unformed shape as in  281  from a piece of round tubing. 
       FIG. 13C  is a drawing of an alternative embodiment of an expandable anchor formed in the shape of a toroidal-shaped spring as previously disclosed in  FIG. 12 . The spring is wound to have double helices that are 180 degrees offset from each other. 
       FIG. 14  is a drawing (a flat representation of the circumference) of an alternative embodiment of the central cylinder  601  and control arms  602  for an expandable anchor as disclosed in  FIG. 7 . The central cylinder  601  has slots  626  cut into the wall of the tubing. The slots  626  can elastically elongate and compress circumferentially as in  627  to allow the diameter of the central tube to be compressed to be loaded onto a delivery catheter and then elastically rebound to the original larger diameter when the expandable anchor is deployed through the delivery catheter. The control arms  602  have round holes  604  at the end of the arms to wind the toroidal spring through when assembling the springs  600  onto the control arms  602  to make an expandable anchor. The two edges of the flat representation  616  and  617  will touch when the flat representation is wrapped around a cylinder. 
       FIG. 15  is a drawing of an expandable anchor and an intestinal bypass sleeve  111 . Expandable anchor can be reduced in diameter by applying tension to the drawstring at the balls  608 . The diameter of the toroidal spring  600  decreases and the control arms  602  rotate from  628  to  630  as the diameter of the toroidal springs are decreased in size. 
       FIG. 16  is a sectional view of the pyloric antrum  104 , pyloric aperture  105 , pylorus  106 , duodenal bulb  107  and duodenum  112 . An expandable anchor  633  and intestinal bypass sleeve  111  is implanted into the pylorus  106 . The expandable anchor  633  is shown here in cross section to allow for better visualization of the polymer covering on the expandable anchor  633 . The expandable anchor  633  is encapsulated on the outside and inside with a polymer covering  634 . 
     In various exemplary embodiments, the expandable anchor  633  is not covered, while in other exemplary embodiments, it is covered with a polymer membrane made from a material such as silicone, flourosilicone elastomers such as Viton, polyurethane, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), polyethylene, ePTFE (expanded polytetrafluoroethylene), PFA (Perfluoroalkoxy), PVDF (Polyvinylidene Flouride, Tetrafluoroethylene), THV (Hexafluoropropylene and Vinylidene Fluoride), ETFE (Ethylenetetrafluoroethylene), ECTFE (Chloro Trifluoro Ethylene/Ethylene Copolymer) EFEP (copolymer of ethylene, tetrafluoroethylene, and hexafluoropropylene), PVF (polyvinyl fluoride). The expandable anchor  633  can be made from metal or plastic. The intestinal bypass sleeve  111  can vary in length from 1-2 inches in length up to several feet. In some embodiments, the sleeve bypasses the length of the duodenum up to the ligament of Treitz. The sleeve can be longer and bypass into the jejunum. The intestinal bypass sleeve  111  may be made from a thin-walled polymer material such as silicone, flourosilicone elastomers such as Viton, polyurethane, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), polyethylene, expanded polytetrafluoroethylene (ePTFE), PFA (Perfluoroalkoxy), PVDF (Polyvinylidene Flouride, Tetrafluoroethylene), THV (Hexafluoropropylene and Vinylidene Fluoride), ETFE (Ethylenetetrafluoroethylene), ECTFE (Chloro Trifluoro Ethylene/Ethylene Copolymer) EFEP (copolymer of ethylene, tetrafluoroethylene, and hexafluoropropylene), PVF (polyvinyl fluoride) or other suitable material or combinations of the listed a materials. The ePTFE material may be coated with another polymer material such as silicone, FEP or other suitable material to render it totally impermeable. In exemplary embodiments, the wall thickness of the intestinal bypass sleeve  111  may be in the range of 0.001 inch to 0.012 inch thick. The intestinal bypass sleeve  111  may be made by extrusion, into a tubular form or a lay flat tubing, dip coated from a liquid solution, powder coated from fine particles of polymer or paste extruded and then stretched as is the case with ePTFE. Intestinal bypass sleeve may be made porous or nonporous. Sleeve may have surface coatings to close up pores of porous membrane. Such as a surface coating of silicone, polyurethane, FEP applied to porous substrate to render it non-permeable. ePTFE is inherently hydrophobic and has some resistance to water penetration, but it may be desirable to have a higher water entry pressure or make ePTFE impermeable. Intestinal bypass sleeve may have a lubricious (or sticky) hydrophilic coating or a hydrogel added to the inner or outer surface to reduce the friction of the surface or to make it easier for food to pass through the liner or to decrease the outer surface coefficient of friction or make the sleeve stay in place better in the intestines. Intestinal bypass sleeve or expandable anchor may be used for drug delivery, delivery of peptides or other therapeutics by incorporating a drug or peptide into the polymer wall thickness of the intestinal bypass sleeve. The drug or peptide may be added directly to the surface of the intestinal liner without a polymer or covalently bonded to the polymer surface. 
     The drug or peptide may be eluted from a surface coating on the sleeve or anchor which incorporates the drug into the coating. Polymers that may be used as a coating to elute a drug include silicone, polyurethane, Polyvinyl Alcohol, Ethylene vinyl acetate, Styrene acrylonitrile, Styrene-Butadiene, Pebax® or other suitable polymer. Absorbable polymers that may be used for drug delivery include, Polyglycolic acid (PGA), Polylactide (PLA), Poly(ε-caprolactone), Poly(dioxanone) Poly(lactide-co-glycolide) or other suitable polymer. Other suitable coatings for increased biocompatibility or drug release may include human amnion, collagen Type I, II, III, IV, V, VI—Bovine, porcine, or ovine. The coating on the intestinal bypass sleeve can also take the form of a liquid that can be used to release the drug or peptide include, Vitamin D, A, C, B, E, olive oil, polyethylene glycol, vegetable oils, essential fatty acids, alpha-linolenic acid, lauric acid, linoleic acid, gamma-linolenic acid, palmitoleic acid or other suitable liquids. The drug may serve to increase satiety, to interrupt the secretion of secondary hormones or digestive enzymes, release antibacterial agents to reduce infection, to increase the fibrotic reaction of the intestinal tract, to decrease the fibrotic reaction of the intestinal tract, to target changes in the cellular composition such as decreasing the number of receptor cells in the duodenum. 
     Intestinal bypass sleeve can release cholecystokinin, gastrin, secretin, gastric inhibitory peptide, motilin, glucagon like peptide 1, bile, insulin, pancreatic enzymes, ghrelin, penicillin, amoxicillin, ampicillin, carbenicillin, cloxacillin, dicloxacillin, nafcillin, oxacillin, penicillin g, penicillin V, Piperacillin, Ticarcillin Aminoglycosides, Amikacin, Gentamicin, Kanamycin, Neomycin, NEO-RX, Netilmicin, Streptomycin, Tobramycin, Carbapenems, Ertapenem, Doripenem, DORIBAX, Emipenem-cilastatin, Meropenem, Cefadroxil, Cefazolin, Cephalexin rapymicin, taxol, Vitamin A, Vitamin C, Vitamin D, Vitamin B, Vitamin E, fatty acids, oils, vegetable oils, aspirin, somastatin, motilin, trypsinogen, chymotrypsinogen, elastase, carboxypeptidase, pancreatic lipase, amylase, enteroglucagon, gastric inhibitory polypeptide, Vasoactive intestinal peptide, PYY, Peptide Tyrosine Tyrosine, Leptin, Pancreatic polypeptide. 
       FIG. 17  is a drawing of the expandable anchor as shown in  FIG. 16  wherein the expandable anchor  633  is deployed/placed into the duodenal bulb  107  instead of across the pylorus  106 . Other alternative implant locations include the duodenum  112 , pyloric antrum  104  and the gastroesophageal (GE) junction. 
       FIG. 18  is a drawing of a flat representation of an alternate embodiment of the circumference of the laser cut central cylinder  601  and control arms  602 . The control arms have round holes  604  at the end of the arms to wind the toroidal shape spring through when assembling the springs  600  onto the control arms  602  to make an expandable anchor. The two edges of the flat representation of the circumference  616  and  617  will touch when the flat representation is wrapped around a cylinder. The expanded final shape for the laser cut part disclosed in  FIG. 18  will assume a shape similar to  FIG. 23 . An alternative embodiment of the final expandable anchor of  FIG. 18  does not incorporate the toroidal wound spring  600  into the final expandable anchor. 
       FIG. 19  is a drawing of a flat representation of an alternate embodiment of the circumference of the laser cut central cylinder  601  and control arms  602 . The control arms have round holes  604  at the end of the arms to wind the toroidal shaped spring through when assembling the springs  600  onto the control arms  602  to make an expandable anchor. The two edges of the flat representation of the circumference  616  and  617  will touch when the flat representation is wrapped around a cylinder. The expandable anchor of  FIG. 19  incorporates an expandable and compressible central cylinder by including slots cut into the circumference of the tube. This was previously disclosed in  FIG. 14 . 
     The expanded final shape for the laser cut part disclosed in  FIG. 19  will assume a shape similar to  FIG. 23 . An alternative embodiment of the final expandable anchor of  FIG. 19  does not incorporate the toroidal wound spring  600  into the final expandable anchor. 
       FIG. 20  is a drawing of a flat representation of an alternate embodiment of the circumference of the laser cut central cylinder  601  and control arms  602 . The control arms have round holes  604  at the end of the arms to wind the toroidal shaped spring through when assembling the springs  600  onto the control arms  602  to make an expandable anchor. The two edges of the flat representation of the circumference  616  and  617  will touch when the flat representation is wrapped around a cylinder. The expanded final shape for the laser cut part disclosed in  FIG. 20  will assume a shape similar to  FIG. 23 . An alternative embodiment of the final expandable anchor of  FIG. 20  does not incorporate the toroidal wound spring  600  into the final expandable anchor. 
       FIG. 21  is a drawing of an alternative embodiment of an expandable anchor. The expandable anchor provides for an anchoring means to hold an intestinal bypass sleeve  111  within the small intestine. The expandable anchor is comprised of two toroidally shaped wound springs  600  connected to a central cylinder  601  by control arms  602 . The toroidal springs  600  are prewound in a straight configuration and then the springs  600  are wound through the eyelets  604  on the end of the control arms and formed into the toroidal shape. The expandable anchor can be noncovered or it can have a polymer covering on the outside and inside as disclosed in  FIG. 16 . The spring ends are joined together at a spring joiner  614  (shown in  FIG. 7 ). The spring ends may be fastened to the spring joiner  614  by mechanical means or they may be laser welded to the spring joiner  614 . The spring joiner serves two purposes, to provide for a means of spring end termination and joining of the two spring ends and also provides for an exit point for the drawstring  605  to exit the spring  600 . The drawstring  605  (shown in  FIG. 7 ) is fed through the central axis of the toroidal spring  600 . The two ends of the drawstring  605  both exit the spring joiner  614  and are terminated at ball  606 . Pulling on the ball  606  and drawing the drawstring  605  through the spring joiner  614  causes the diameter of the spring  600  to be reduced and the control arms to bend and deflect as shown in  FIG. 15 . The drawstring  605  can also be terminated in loop  607  or with two balls spaced apart  608 . 
     The toroidal springs are further disclosed in  FIG. 12  and  FIG. 13 . The central cylinder and the control arms of the exemplary embodiment are laser cut from a piece of Nitinol tubing. In the exemplary embodiments, the expandable anchor is designed to allow the anchor to be of a self-expanding design. A self-expanding anchor design can be compressed in diameter to allow the device to be compressed in diameter to be loaded onto a delivery catheter. The anchor can then recover elastically to the original starting diameter, with the anchor diameter decreasing only a small amount due to nonelastic recovery. The anchor can also be made of a plastically deformable design and require a mechanical force applied to it in the radial or longitudinal direction to accomplish the expansion of the anchor. The mechanical force can be accomplished with an inflatable balloon type device, radially expanding the anchor or it may also be accomplished by a longitudinal compression of the anchor by a screw type mechanism or cable tensioning means. As shown, the anchor has a distal disk and a proximal disk that is comprised of 14 control arms on each portion. According to various embodiments, the anchor could have from 3 to 72 control arms for the proximal disk and the distal disk. 
     According to exemplary embodiments, the central cylinder  601 , control arms  602  and springs  600  are made from a nickel titanium alloy (Nitinol). Other alternative suitable alloys for manufacturing the central cylinder  601 , control arms  602  and springs  600  are stainless steel alloys: 304, 316L, BioDur® 108 Alloy, Pyromet Alloy® CTX-909, Pyromet® Alloy CTX-3, Pyromet® Alloy 31, Pyromet® Alloy CTX-1, 21 Cr-6Ni-9Mn Stainless, Pyromet Alloy 350, 18Cr-2Ni-12Mn Stainless, Custom 630 (17Cr-4Ni) Stainless, Custom 465® Stainless, Custom 455® Stainless, Custom 450® Stainless, Carpenter 13-8 Stainless, Type 440C Stainless, cobalt chromium alloys—MP35N, Elgiloy, L605, Biodur® Carpenter CCM alloy, Titanium and titanium alloys, Ti-6Al-4V/ELI and Ti-6Al-7Nb, Ti-15Mo, Tantalum, Tungsten and tungsten alloys, pure platinum, platinum-iridium alloys, platinum-nickel alloys, niobium, iridium, conichrome, gold and gold alloys. The anchor  110  may also be comprised of the following absorbable metals: pure iron and magnesium alloys. The central cylinder  601 , control arms  602  and springs  600  may also be comprised of the following plastics: Polyetheretherketone (PEEK), polycarbonate, polyolefins, polyethylenes, polyether block amides (PEBAX), nylon 6, 6-6, 12, Polypropylene, polyesters, polyurethanes, polytetrafluoroethylene (PTFE) Poly(phenylene sulfide) (PPS), poly(butylene terephthalate) PBT, polysulfone, polyamide, polyimide, poly(p-phenylene oxide) PPO, acrylonitrile butadiene styrene (ABS), Polystyrene, Poly(methyl methacrylate) (PMMA), Polyoxymethylene (POM), Ethylene vinyl acetate, Styrene acrylonitrile resin, Polybutylene. The anchor, according to exemplary embodiments, is laser cut from a round tubing or from a flat sheet of Nitinol and then is rolled into a cylindrical shape after laser cutting. The anchor, according to exemplary embodiments, is made from a Nitinol tube of about 9 mm outside diameter by a wall thickness of 0.012 inch thick. Alternatively a starting tube is outside diameter can range from about 2 mm to 16 mm. An alternative construction method is to laser cut or chemical etch the pattern from a flat sheet of Nitinol with a thickness of 0.002 inch to 0.020 inch. 
     According to various embodiments, the anchor has an inside diameter  610  in the range of about 2 mm to 20 mm, anchor has a disk-shaped feature and a cup that has a diameter  609  in the range of about 20 mm to 66 mm. Anchor has a central cylinder  601  that has an outside diameter in the range of 4 mm to 20 mm. Central cylinder section  601  can have a length  612  of about 1 mm to 30 mm and is close to the width of the pylorus  106 . The disks can have a length  611  of 1 mm to 10 mm. The cup shape portion can have a length of 1 mm to 50 mm. The central cylinder  601 , in various embodiments, is made from a material having a stiffness sufficient to resist compressive forces applied by the pylorus. 
       FIG. 22  is a drawing of an alternative embodiment of an expandable anchor. The expandable anchor provides for an anchoring means to hold an intestinal bypass sleeve  111  within the small intestine. The expandable anchor is comprised of two toroidally shaped wound springs  600  connected to a central cylinder  601  by control arms  602 . The toroidal springs  600  are prewound in a straight configuration and then the springs  600  are wound through the eyelets  604  on the end of the control arms and formed into the toroidal shape. The expandable anchor can be noncovered or it can have a polymer covering on the outside and inside as disclosed in  FIG. 16 . The spring ends are joined together at a spring joiner  614  (shown in  FIG. 7 ). The spring ends may be fastened to the spring joiner  614  by mechanical means or they may be laser welded to the spring joiner  614 . The spring joiner serves two purposes, to provide for a means of spring end termination and joining of the two spring ends and also provides for an exit point for the drawstring  605  to exit the spring  600 . The drawstring  605  (shown in  FIG. 7 ) is fed through the central axis of the toroidal spring  600 . The two ends of the drawstring  605  both exit the spring joiner  614  and are terminated at ball  606  (shown in  FIG. 7 ). Pulling on the ball  606  and drawing the drawstring  605  through the spring joiner  614  causes the diameter of the spring  600  to be reduced and the control arms to bend and deflect as shown in  FIG. 15 . The drawstring  605  can also be terminated in loop  607  or with two balls spaced apart  608 . 
     According to various embodiments, anchor has an inside diameter  610  in the range of about 2 mm to 20 mm, the anchor has two cup shaped features that have a diameter  609  in the range of about 20 mm to 65 mm. The cup shape portions can have a length of 3 mm to 50 mm. Anchor has a central cylinder  601  that has an outside diameter in the range of 4 to 20 mm. Central cylinder section  601  can have a length  612  of about 1 mm to 30 mm and is close to the width of the pylorus  106 . The cup shape portions can have a length of 1 mm to 50 mm. The central cylinder  601 , in various embodiments, is made from a material having a stiffness sufficient to resist compressive forces applied by the pylorus. The materials and processing of  FIG. 22  is identical to that disclosed previously in  FIG. 21 . 
       FIG. 23  is a drawing of an alternative embodiment of an expandable anchor. The expandable anchor provides for an anchoring means to hold an intestinal bypass sleeve  111  within the small intestine. The expandable anchor is comprised of two toroidally shaped wound springs  600  connected to a central cylinder  601  by control arms  602 . The toroidal springs  600  are prewound in a straight configuration and then the springs  600  are wound through the eyelets  604  on the end of the control arms and formed into the toroidal shape. The expandable anchor can be noncovered or it can have a polymer covering on the outside and inside as disclosed in  FIG. 16 . The spring ends are joined together at a spring joiner  614  (shown in  FIG. 7 ). The spring ends may be fastened to the spring joiner  614  by mechanical means or they may be laser welded to the spring joiner  614 . The spring joiner serves two purposes, to provide for a means of spring end termination and joining of the two spring ends, and also provides for an exit point for the drawstring  605  to exit the spring  600 . The drawstring  605  (shown in  FIG. 7 ) is fed through the central axis of the toroidal spring  600 . The two ends of the drawstring  605  both exit the spring joiner  614  and are terminated at ball  606  (shown in  FIG. 7 ). Pulling on the ball  606  and drawing the drawstring  605  through the spring joiner  614  causes the diameter of the spring  600  to be reduced and the control arms to bend and deflect as shown in  FIG. 15 . The drawstring  605  can also be terminated in loop  607  or with two balls spaced apart  608 . 
     According to various embodiments, the anchor has an inside diameter  610  in the range of about 2 mm to 20 mm, the anchor has two cup shaped features that have a diameter  609  in the range of about 20 mm to 65 mm. The cup shape portions can have a length of 3 mm to 50 mm. The anchor has a central cylinder  601  that has an outside diameter in the range of 4 mm to 20 mm. The central cylinder section  601  can have a length  612  of about 1 mm to 30 mm and is close to width of the pylorus  106 . The cup shape portions can have a length of 1 mm to 50 mm. The central cylinder  601 , in various embodiments, is made from a material having a stiffness sufficient to resist compressive forces applied by the pylorus. The materials and processing of  FIG. 23  is identical to that disclosed previously in  FIG. 21 . Expandable anchor in  FIG. 23  has control arms which are joined at the outer end by connectors  634 . The diamond shape pattern at connectors  634  opens and closes as the diameter of the expandable anchor changes. 
       FIG. 24  is a drawing of an alternative embodiment of control arms  635 . The control arms  635  are laser cut from a flat sheet of Nitinol. The control arms are joined together at a central ring  636 . The control arms  635  have holes  604  at the end of the arms. The diameter material and materials have been previously disclosed in  FIG. 21 . 
       FIG. 25  is a drawing of an alternative embodiment of a central cylinder  601 . The central cylinder  601  is made from a piece of metal or plastic tubing. The central cylinder has an annular groove on the outside diameter at each end to snap fit on the control arms from  FIG. 25  into the annular groove. The central cylinder can be machined or molded and can be comprised of material previously disclosed in  FIG. 7 . 
       FIG. 26  is a drawing of an expandable anchor assembly. The assembly is comprised of a control arm disk of  FIG. 24 , and a central cylinder of  FIG. 25 , assembled together with two toroidal shape springs  600 . The control arm disk central ring  636  is elastically expanded in diameter and then snapped into annular groove  637  on the central cylinder. When the control arms  635  are bent towards the central cylinder  601 , the central ring  636  rolls into the annular groove  637  and the central ring reverts and turns partially inside out as the control arms  635  deflect. 
       FIG. 27  is drawing of a central cylinder pyloric portion for use with any of the anchor embodiments herein disclosed in which the mid-portion allows for normal opening and closing of the pylorus. There is a first ring  333  and a second ring  334  which are fixed rigidly together by connector links  335 ,  338  or  337 . The central cylinder has an annular groove  637  on the outside diameter of the cylinder as previously disclosed in  FIG. 25 . 
     The connector links cross through the pyloric aperture  105  while not obstructing the pyloric aperture  105  or limiting opening or closing of the pylorus. In various embodiments, a thin polymeric membrane will be used over both rings  333  and  334  and will span the space between the two rings as disclosed in  FIG. 26 . The pylorus  106  can close by entering into the space  339  in between rings  333  and  334  to open and close. Rigid linking of rings  333  and  334  provides for a rigid structure to anchor expandable anchors to and helps to keep expandable anchor (disks) oriented in the proper orientation without canting within the pyloric antrum  104  or duodenal bulb  107 . The rigid linking also does not allow rotational movement between the two rings  333  and  334  and still allows for normal opening and closing of the pylorus. Rotational movement between  333  and  334  may cause the pyloric polymer membrane portion to close. The expandable anchors in the pyloric antrum and the duodenal bulb are tethered to the first ring  333  and second ring  334  by a polymer membrane. 
       FIG. 28  is a sectional view of the invention herein disclosed implanted into the pyloric antrum  104 , pylorus  106 , duodenal bulb  107  and duodenum  112 . The anchoring device is comprised of two disk-shaped expandable anchors  394  that are connected to a central cylinder  396  and  397 . Alternatively the disk can be constructed from a disk and toroidal springs as previously disclosed in  FIG. 14  or  FIG. 7 . The central cylinder of the device  396  and  397  in between the two anchor rings  394  can be made from plastic material such as Delrin, PEEK, high density polyethylene, polycarbonate or other suitable polymer. The central cylinder portion  396  and  397  may also be made from stainless steel, titanium or Nitinol. The fixed diameter of the pyloric portion pieces  396  and  397  of the device can be sized to provide for a full opening of the pylorus and not allow the pylorus to close normally. The length of the pyloric portion of the device  400  can be adjusted by sliding the outer cylinder  396  over inner cylinder  397  by sliding on the ratcheting mechanism. This will change the spacing between the anchor rings  394  and will allow the device to be adjusted for ring spacing in-situ. It may be desirable to change the ring spacing to accommodate differences in the pylorus  106  dimensions from patient to patient. It may also be desirable to change the length  400  of the central cylinder portion to allow the anchor ring  394  spacing to be adjusted to allow the expandable anchor to put a clamping force on to the pylorus in a longitudinal direction. The mechanism used for  398  and  399  could also be a screw thread arrangement such as a male thread on  398  and a female thread on  399 . In various embodiments, the inside diameter of the central cylinder  396  and  397  ranges from as small as 2 mm in diameter up to as large as 14 mm in diameter. The central lumen of the device has a one-way, anti-reflux valve  401 . The anti-reflux valve  401  allows for unobstructed flow in the direction of the pyloric antrum  104  to the duodenal bulb  107 , but limits flow in the reverse direction. The anti-reflux valve  401  can be constructed of a duck bill design with two flexible leaflets, or may utilize other designs such as a tri-leaflet valve or quad-leaflet valve. The anti-reflux valve may be constructed of silicone, polyurethane, polyethylene, ePTFE or other suitable polymer. The diameter of the central cylinder is fixed, but it may also be designed to allow it to be reduced in diameter during loading of the device onto a catheter. 
       FIG. 29  is a sectional view of the invention herein disclosed implanted into the pyloric antrum  104 , pylorus  106  and duodenal bulb  107  and duodenum  112 . The anchoring device is comprised of two toroidal-shaped expandable anchors  402  that are connected to a central cylinder  403 . Alternatively the disk can be constructed from a disk and toroidal springs as previously disclosed in  FIG. 14  or  FIG. 7 . The diameter of the central cylinder  403  is fixed, but it may also be elastic to allow it to be reduced in diameter during loading of the device onto a catheter. An optional needle  404 , suture, T-bar  405 , hollow helical anchor  406  or screw type anchor  407  is inserted into and/or through the tissue of the pylorus  106 , pyloric antrum  104  or duodenum  107  to provide additional anchoring and securement of the intestinal bypass sleeve  111  anchoring device to the pylorus  106  anatomy. The T-bar  405  is anchored by a tensioning member  408  and cincher  409 . 
       FIG. 30  is a sectional view of the invention herein disclosed implanted into the pyloric antrum  104 , pylorus  106 , duodenal bulb  107  and duodenum  112 . The anchoring device is comprised of two disk-shaped expandable anchors  341  and  342  as previously disclosed in this application that are connected to rings  352  and  353 . Alternatively the disk can be constructed from a disk and toroidal springs as previously disclosed in  FIG. 14  or  FIG. 7 . 
     The rings  352  and  353  are not rigidly connected to each other. Thin-walled central membrane  351  is connected to the two rings  352  and  353 . Central membrane can open and close with the pylorus. Drawstring  347  can be tensioned to collapse the diameter of the expandable anchors for removal and for loading the device onto a delivery catheter. 
       FIG. 31  is a sectional view of the invention herein disclosed implanted into the pyloric antrum  104 , pylorus  106 , duodenal bulb  107  and duodenum  112 . The anchoring device is comprised of two disk-shaped expandable anchors  341 ,  342  as previously disclosed in this application that are connected to a rigid central cylinder  344 . The disk can be constructed from a disk and toroidal springs as previously disclosed in  FIG. 14  or  FIG. 7 . 
     The lumen of the anchoring device has a one way anti-reflux valve  346  and a flow limiter  345 . Drawstring  347  can be tensioned to collapse the diameter of the expandable anchors for removal and for loading the expandable anchor onto a delivery catheter. 
       FIG. 32  is a cross-sectional drawing of a delivery catheter for the invention herein disclosed. The delivery catheter is comprised of: distal outer capsule  638 , which transitions down to a smaller diameter at the proximal outer sheath  649 , proximal pusher catheter  642 , sleeve delivery catheter outer tube  643 , sleeve delivery catheter inner tube  642 . There are four handles on the catheter: outer sheath handle  639 , proximal pusher handle  646 , sleeve delivery catheter outer tube  645  and sleeve delivery catheter inner tube  644 . The implant pusher disk  650  serves as a mechanical stop or means to hold stationery or push out the expandable anchor  648  or implant from the inside of the distal outer capsule  638 . The distal tip  652  provides for a flexible tip that will track over a guide wire. The guide wire may be inserted through the sleeve delivery catheter central lumen  651 . Expandable anchor  648  and the intestinal bypass sleeve  641  are compressed and loaded onto the delivery catheter. The intestinal bypass sleeve  641  extends out beyond the end of the distal outer capsule  638 . The sleeve delivery catheter  640  is coaxially inside the lumen of the intestinal bypass sleeve  641  and mechanically retains the intestinal bypass sleeve to the end of the sleeve delivery catheter. Capsule connector  647  joins the distal outer capsule  638  to the proximal outer sheath  649 . 
     The distal outer capsule  638  may be made from a plastic polymer such as Pebax® (polyether block amide), Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or other suitable polymer. The distal outer sheath  638  may have an inner lining made from a polymer with a low coefficient of friction such as PTFE. The distal outer capsule  638  may also have a metal re-enforcement in the wall thickness to improve the kink resistance or burst properties of the outer sheath. The metal re-enforcement may be comprised of a braided wire mesh or a coil in the wall thickness. The metal used for the braid may be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitable material. The distal outer capsule  638  length may range from 1-2 inches in length up to full length of the catheter. 
     The proximal outer sheath  649  may be made from a plastic polymer such as Pebax® (polyether block amide), Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or other suitable polymer. The proximal outer sheath  649  may have an inner lining made from a polymer with a low coefficient of friction such as PTFE. The proximal outer sheath  649  may also have a metal re-enforcement in the wall thickness to improve the kink resistance or burst properties of the outer sheath. The metal re-enforcement may be comprised of a braided wire mesh or a coil in the wall thickness. The metal used for the braid may be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitable material. 
     The proximal pusher catheter  642  may be made from a plastic polymer such as Pebax® (polyether block amide), PEEK, Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane, polyimide, PTFE, FEP or other suitable polymer. The proximal pusher catheter  642  may have an inner lining made from a polymer with a low coefficient of friction such as PTFE. The proximal pusher catheter  642  may also have a metal re-enforcement in the wall thickness to improve the kink resistance or burst properties of the outer sheath. The metal re-enforcement may be comprised of a braided wire mesh or a coil in the wall thickness. The metal used for the braid may be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitable material 
     The sleeve delivery catheter  640  may be made from a plastic polymer such as Pebax® (polyether block amide), PEEK, Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or other suitable polymer. The sleeve advancement pusher  172  may have an inner lining made from a polymer with a low coefficient of friction such as PTFE. The sleeve delivery catheter  640  may also have a metal re-enforcement in the wall thickness to improve the kink resistance or burst properties of the outer sheath. The metal re-enforcement may be comprised of a braided wire mesh or a coil in the wall thickness. The metal used for the braid may be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitable material. The sleeve delivery catheter  640  may have a hollow core to allow passage over a guide wire or it may be solid without an opening. The sleeve delivery catheter  640  may also be constructed of a simple tightly wound metal wire coil construction or it may be wound from multiple wires such as Hollow Helical Strand tube made by Fort Wayne Metals. The distal tip  652  may be molded from Pebax®, polyurethane, Hytrel, silicone or other suitable elastomer. The delivery catheter handles may be molded or machined from metal or plastic. The outer sheath handle  639  is attached to the proximal outer sheath  649 . The outer sheath handle  639  is used to hold or retract the distal outer sheath  638  and the proximal outer sheath  649  during the advancement of the delivery catheter into the human anatomy, and while deploying of the expandable anchor. 
       FIG. 33  is an alternative embodiment of the distal outer capsule  638 . The distal outer capsule has a formed tip  653  that has 6 leaflets that bend open to allow loading or deploying of the expandable anchor. The leaflets are preferably made from a plastic material such as PTFE or polyethylene. The leaflets are attached to the distal outer capsule  638  and can be made in a straight shape integral with the distal outer capsule  638  material and then heat formed into the final shape. The number of leafs can range from about 3 to 16. 
       FIG. 34  is a drawing of an alternative embodiment of a tip for the inside diameter of distal outer capsule  638 . Proximal pusher catheter  642  extends through the length of the distal capsule  638 . Proximal pusher catheter  642  is a dual lumen tubing. The first lumen  659  is for advancement or retraction of the sleeve delivery catheter, the inflation lumen  657  is for inflating and deflating the inflatable balloon tip  654  bonded at the distal end of the pusher catheter  642 . A thin wall compliant balloon tip  654  bonded onto the distal end of the proximal pusher catheter. The balloon tip  654  can be inflated or deflated through the side port  658  which is connected to the inflation lumen  657 . The balloon tip  654  is inflated with air, CO2, water or saline after the expandable anchor and intestinal bypass sleeve have been loaded into the distal outer capsule. The intestinal bypass sleeve is compressed in between the annular space  660  between the inside diameter of the distal outer capsule  638  and the balloon tip  654 . 
       FIG. 35  is a drawing of an alternative embodiment of the delivery catheter previously disclosed in  FIG. 32 . The implant pusher disk  650  as shown in  FIG. 32  has been modified to incorporate a retention mechanism  660 . Spring retainer arms  661  can engage with holes in the expandable anchor  648  central cylinder. The spring retainer arms  661  can securely hold the expandable anchor  648  and prevent the expandable anchor  648  from slipping out of the distal capsule and deploying prematurely before the expandable is in the proper implant location. The spring retainer arms  661  can also allow the distal capsule  638  to be advanced distally forward over a partially deployed expandable anchor  648  to resheath a partially deployed expandable anchor. 
       FIG. 36  is a drawing of an expandable anchor  664  and an intestinal bypass sleeve  111  attached to a retention mechanism  660  on a deployment catheter. The distal outer sheath  638  is pushed in direction  662  while maintaining tension in the direction  663  will hold the expandable anchor in position while the distal outer capsule  638  is advanced distally over the expandable anchor  664  to re-collapse it. 
       FIG. 37  is a cross-sectional drawing of a portion of a delivery catheter for the invention as previously disclosed in  FIG. 32 . The catheter is identical to that disclosed in  FIG. 32 . The expandable anchor  648  and the intestinal bypass sleeve  641  are compressed and loaded onto the delivery catheter. The sleeve delivery catheter  640  is located coaxially inside the lumen of the intestinal bypass sleeve  641  and mechanically retains the intestinal bypass sleeve to the end of the sleeve delivery catheter. The intestinal bypass sleeve  641  is wrapped in a helical direction around the sleeve delivery catheter by rotating the sleeve delivery catheter within the distal outer capsule  638 , while fixing the rotational position of distal outer capsule. This causes the intestinal bypass sleeve  641  to wrap down more compactly around the sleeve delivery catheter and reduces the delivery profile. 
       FIG. 38  is a cross-sectional drawing of a portion of a delivery catheter for the invention as previously disclosed in  FIG. 32 . The catheter is identical to that disclosed in  FIG. 32 . The expandable anchor  648  and the intestinal bypass sleeve  641  are compressed and loaded onto the delivery catheter. The sleeve delivery catheter  640  is located coaxially inside the lumen of the intestinal bypass sleeve  641  and mechanically retains the intestinal bypass sleeve to the end of the sleeve delivery catheter. The intestinal bypass sleeve  641  is loaded into the inside of the outer distal capsule  638  in an accordion fashion. 
       FIG. 39  is a drawing of an alternative embodiment of an anchor retention device  666 , distal outer capsule  638  and pusher tube  668 . During the deployment of expandable anchors on catheters without retention devices  666  the distal outer capsule  638  is pulled back in direction  669  or retracted gradually to expose the expandable anchor  665 . The pusher tube  668  is held in a fixed position. The expandable anchor  665  self expands and opens to the expanded diameter as the distal outer capsule  638  is retracted. During the retraction of the distal outer capsule  638  the expandable anchor  665  can in some instances slide forward in a distal direction  670  without further retraction of the distal outer capsule  638 . Essentially the expandable anchor  665  can self deploy without further retraction of the distal outer capsule  638 , once the distal outer capsule  638  has been partially retracted. This can lead to the expandable anchor  665  to be inadvertently deployed at the wrong implant location. In order to overcome this it is desirable to have the expandable anchor  665  remain attached to the pusher tube  668  until the distal outer capsule  638  is fully retracted. It is also desirable to have the expandable anchor  665  remain attached to the pusher tube  668  to allow the distal outer capsule  638  to be re-advanced distally  670  to cause the expandable anchor  665  to be re-collapsed and then re-sheathed so that the position of the expandable anchor in the human body can be adjusted after the start of the deployment or alternatively the expandable anchor can be removed from the body. Herein disclosed is a retention device  666  that provides for secure attachment of the expandable anchor  665  to the pusher tube  668  during distal outer capsule  638  retraction and allows for the distal outer capsule to be advanced distally  670  to sheath a partially expanded anchor  665 . The retention device  666  is formed in a cylindrical form with an hour glass shape an annular groove  672  at the central portion. The diameter of retention device  666  and the annular groove  672  is sized such that the proximal end of the expandable anchor  667  can be collapsed and the diameter reduce to allow loading inside the distal outer capsule  638 . The proximal end of the expandable anchor  667  has a larger cross section than the gap  671  between the outside diameter of  666  and the inside diameter of  638 , therefore the expandable anchor proximal end  667  cannot move proximally or distally until the distal outer capsule  638  fully retracts past the annular groove  672 . 
       FIG. 40  is a drawing of an over the wire sleeve delivery catheter for placing an intestinal bypass sleeve within the intestine. The sleeve delivery catheter is made from a piece of two lumen tubing  673 . The two lumen tubing  673  has a circular cross section. The outside diameter  679  can range from about 1 mm to 10 mm in diameter, but the diameter is about 2.3 mm in the preferred embodiment. The guide wire lumen  675  in the two lumen tubing  673  is sized to accommodate a guide wire (guide wire not shown) and can range in diameter from 0.5 mm to 2 mm. The release wire lumen  681  is sized to accommodate a release wire  677 . The release wire  677  can slide freely within the release wire lumen  681 . The length  678  of the sleeve delivery catheter can range from one to three meters in length depending upon the length of the intestinal bypass sleeve  674  length that is to be delivered with the sleeve delivery catheter. An intestinal bypass sleeve  674  is loaded over the outside diameter of the sleeve delivery catheter. The intestinal bypass sleeve  674  is secured to the sleeve delivery catheter at  683 . The release wire  677  is inserted through a hole in the side of the intestinal bypass sleeve  674 . To deploy the sleeve the release wire is pulled in direction  680  until the wire is retracted into the open position  684 . An expandable anchor would be attached to the intestinal bypass sleeve at location  682  but it is not shown. The sleeve delivery catheter can have a handle attached to the proximal end  676 . The two lumen tubing  673  is extruded from Pebax® (polyether block amide), PEEK, Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or other suitable polymer. The lumens  675  and  681  can have a liner in the lumen made from PTFE. The release wire  677  can be made from plastic such as PEEK or a metal such as stainless steel, MP35N, Nitinol or other suitable metal. The release wire  677  may be PTFE coated or siliconed coat to reduce sliding friction within the lumen  681 . 
       FIG. 41  is a drawing of a monorail sleeve delivery catheter for placing an intestinal bypass sleeve within the intestine. The sleeve delivery catheter is made from a piece of two lumen tubing  673 . The two lumen tubing  673  has a circular cross section. The outside diameter  679  can range from about 1 mm to 10 mm in diameter, but the diameter is about 2.3 mm in the preferred embodiment. The guide wire lumen  675  in the two lumen tubing  673  is sized to accommodate a guide wire (guide wire not shown) and can range in diameter from 0.5 mm to 2 mm. The release wire lumen  681  is sized to accommodate a release wire  677 . The release wire  677  can slide freely within the release wire lumen  681 . The length  678  of the sleeve delivery catheter can range from one to three meters, depending upon the length of the intestinal bypass sleeve  674 , which is the length that is to be delivered with the sleeve delivery catheter. An intestinal bypass sleeve  674  is loaded parallel to outside diameter of the sleeve delivery catheter. The intestinal bypass sleeve  674  is secured to the sleeve delivery catheter at  683 . The release wire  677  is inserted through a hole in the side of the Intestinal bypass sleeve  674 . To deploy the sleeve the release wire is pulled in direction  680  until the wire is retracted into the open position  684 . An expandable anchor would be attached to the intestinal bypass sleeve at location  682  but it is not shown. The sleeve delivery catheter can have a handle attached to the proximal end  676 . The two lumen tubing  673  can be extruded from Pebax® (polyether block amide), PEEK, Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or other suitable polymer. The lumens  675  and  681  can have a liner in the lumen made from PTFE. The release wire  677  can be made from plastic such as PEEK or a metal such as stainless steel, MP35N, Nitinol or other suitable metal. The release wire  677  may be PTFE coated or silicone coated to reduce sliding friction within the lumen  681 . 
       FIG. 42  is a drawing of an alternative embodiment of an over the wire sleeve delivery catheter for placing an intestinal bypass sleeve within the intestine. The sleeve delivery catheter is comprised of a proximal handle  692 , an outer tube  686 , an inner tube  691 , a distal tip  687 , an actuation knob  693  and a holder collar  688 . The sleeve delivery catheter has two coaxial tubes. The outer tube  686  connects to the actuation knob  693 . The inner tube  691  is connected to the proximal handle  692 . The holder collar  688  is connected to the distal end of the outer tube. The distal tip  687  is connected to the distal end of the inner tube  691 . The outer tube  686  and inner tube  691  can be made from Pebax® (polyether block amide), PEEK, Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or other suitable polymer. The inside lumen of outer tube  686  or the outside diameter of inner tube  691  can have a liner or covering of PTFE. The distal tip  687  can be made from a plastic such as Pebax® (polyether block amide), Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or other suitable polymer. The sleeve delivery catheter has a guide wire lumen  694  to allow the sleeve delivery catheter to be tracked over a guide wire. The guide wire can exit at  696  for a full over the wire catheter. Alternatively the guide wire can exit the catheter at  697  for a monorail type catheter. The distance  689  between the distal tip  687  and holder collar  688  can be increased or decreased by sliding the actuation knob  692  towards or away from the distal tip  687  to change the distance  690 . The intestinal bypass sleeve is not shown in  FIG. 42 , but it is attached to the sleeve delivery catheter as previously disclosed in  FIG. 40  in an over-the-wire means. Alternatively the intestinal bypass sleeve is attached to the sleeve delivery catheter as previously disclosed in  FIG. 41  in a monorail or parallel to the catheter means with the sleeve delivery catheter not residing within the lumen of the intestinal bypass graft. An alternative embodiment of a holder collar is disclosed in  695 . 
     Holder collars  688  and  695  are actuated and released by actuation knob  692  to mechanically secure the intestinal bypass sleeve during delivery and release the intestinal bypass sleeve from the sleeve delivery catheter at the intended implant location. 
       FIG. 43  is a drawing of a delivery catheter for placing the expandable anchor and intestinal bypass sleeve within the digestive tract. A sleeve delivery catheter as previously disclosed in  FIG. 42  is inserted through the central lumen of a delivery catheter as previously disclosed in  FIG. 32 . 
       FIG. 44A  is a drawing of a balloon catheter  121  that is used as a sleeve delivery catheter. The balloon is composed of the following elements: proximal hub  122 , catheter shaft  124 , distal balloon component  125 , radiopaque marker bands  126 , distal tip  127 , guide wire lumen  128 , inflation lumen  129 . Distal balloon component  125  can be made from silicone, silicone polyurethane copolymers, latex, nylon 12, PET (Polyethylene terephthalate) Pebax® (polyether block amide), polyurethane, polyethylene, polyester elastomer or other suitable polymer. The distal balloon component  125  can be molded into a cylindrical shape, into a dogbone or a conical shape. The distal balloon component  125  can be made compliant or non-compliant. The distal balloon component  125  can be bonded to the catheter shaft  124  with glue, heat bonding, solvent bonding, laser welding or suitable means. The catheter shaft can be made from silicone, silicone polyurethane copolymers, latex, nylon 12, PET (Polyethylene terephthalate) Pebax® (polyether block amide), polyurethane, polyethylene, polyester elastomer or other suitable polymer. Section A-A in  FIG. 3A  is a cross-section of the catheter shaft  124 . The catheter shaft  124  if shown as a dual lumen extrusion with a guide wire lumen  128  and an inflation lumen  129 . The catheter shaft  124  can also be formed from two coaxial single lumen round tubes in place of the dual lumen tubing. The balloon is inflated by attaching a syringe (not shown) to a luer fitting side port  130 . The sizing balloon accommodates a guide wire through the guide wire lumen from the distal tip  127  through the proximal hub  122 . The balloon  121  has two or more radiopaque marker bands  126  located on the catheter shaft to allow visualization of the catheter shaft and balloon position. The marker bands can be made from tantalum, gold, platinum, platinum iridium alloys or other suitable material. 
       FIG. 44B  shows a rapid exchange balloon catheter  134  that is used as a sleeve delivery catheter. The balloon is composed of the following elements: proximal luer  131 , catheter shaft  124 , distal balloon component  125 , radiopaque marker bands  126 , distal tip  127 , guide wire lumen  128 , inflation lumen  129 . The materials of construction will be similar to that of  FIG. 4A . The guide wire lumen  128  does not travel the full length of the catheter. It starts at the distal tip  127  and exits out the side of the catheter at distance shorter than the overall catheter length. The guide wire  132  is inserted into the balloon catheter to illustrate the guide wire path through the sizing balloon. The balloon catheter shaft changes section along its length from a single lumen at section B-B  133  to a dual lumen at section A-A at  124 . 
       FIG. 45A  is a drawing of the sleeve delivery catheter balloon previously disclosed in  FIG. 44A  with an intestinal bypass sleeve  800  attached to the balloon. The intestinal bypass sleeve  800  is attached to the balloon at location  801  by a release-able means. The release-able means in the preferred embodiment may be comprised of a loop of suture wrapped around the outside of the intestinal bypass sleeve at location  801 . The suture is knotted and tied to secure the intestinal bypass sleeve at location  801 . The intestinal bypass sleeve  800  may be perforated by the suture at located  801  to increase the securement force. The balloon component  125  is partially inflated to a low pressure of about one atmosphere of pressure to secure the suture and the intestinal bypass sleeve  800  at location  801 . Alternatively the sleeve is fastened to the balloon by band of plastic or an elastomer, such as a piece of heat shrink tubing, a cable tie, adhesive or by hook and loop fastener. The suture may be made of polyester, nylon, polypropylene, or other suitable polymer and may be made from a mono filament or a multifilament yarn. The intestinal bypass sleeve  800  can be arranged around the balloon catheter in a coaxial configuration as shown in section  808  or alternatively it can be arranged as shown in  FIG. 45C  section  809 . The intestinal bypass sleeve  800  is attached to the expandable anchor at location  802 . The expandable anchor would be loaded into a distal outer capsule for delivery. 
       FIG. 45B  is a drawing of the sleeve delivery catheter and intestinal bypass sleeve  800  of  FIG. 45A , the distal balloon component  125  has been inflated with air, water, saline or contrast media to a pressure high enough to expand the diameter of the balloon component  125  and to break the suture securement  803  of the intestinal bypass sleeve  800  from the distal end of the sleeve delivery balloon. The pressure required to break the suture is in the range from 2 to 15 atmospheres. After the suture or other means of securement is broken and the intestinal bypass sleeve  800  is released, the balloon is deflated and withdrawn from the intestinal bypass sleeve. 
       FIG. 45C  is a drawing of the monorail sleeve delivery catheter of  FIG. 44B  in which the intestinal bypass sleeve  806  has been attached to the balloon catheter at location  805 . The securement mechanism and release means are the same as previously disclosed in  FIG. 45A  and  FIG. 45B . The intestinal bypass sleeve  806  is not coaxial over the balloon catheter, but is delivered along side or parallel to the balloon catheter as shown in section  809 . The intestinal bypass sleeve  806  is attached to the expandable anchor at location  807 . The expandable anchor would be loaded into a distal outer capsule for delivery. 
       FIG. 46  is a drawing of a sleeve delivery catheter. Sleeve delivery catheter is comprised of an outer actuation tube  810  an inner non-actuating tube  811 . The outer actuating tube  810  can have a slot  814  cut at the distal end to secure the tab  815  at the distal end of an intestinal bypass sleeve  812 . The inner non-actuating tube  811  can have a recess  813  cut into the diameter to serve as a receptacle to hold the tab  815 . The intestinal bypass sleeve  812  is secured to the distal end of the sleeve delivery catheter by inserting the tab  815  into slot  814  and sliding the outer actuating tube  810  distally to close gap  817 . To release the intestinal bypass sleeve  812  the outer actuating tube  810  is retracted to increase the gap  817  and the tab  815  is released from slot  814 . Alternatively the intestinal bypass sleeve can have a hole  816  at the distal end and be secured to the outer actuated tube  810  by a pin which inserts through hole  816 . An actuation handle is attached to the proximal ends of outer actuation tube  810  and inner non-actuating tube  810 , a suitable design was previously disclosed in  FIG. 42 . The outer actuating tube  810  and inner non-actuating tube  811  can be made from material previously disclosed in  FIG. 42 . 
       FIG. 47  shows a guide wire to be used for placing expandable anchors and intestinal bypass sleeves. During the delivery of intestinal bypass sleeves, it is necessary to insert a guide wire two feet or more into the small intestine past the pylorus into the jejunum. It can be difficult with a conventional guide wire to advance the guide wire into the jejunum in some patients. With conventional guide wires, there is a risk that the guide wire tip may perforate through the intestinal wall if the guide wire is advanced with a large force and the guide wire does not follow the natural intestinal lumen. It is desirable to have a guide wire that can easily track several feet beyond the pylorus and have low risk of perforating the small intestine wall. It is also desirable to have the guide wire have a low profile when it is removed from a patient after an expandable anchor and intestinal bypass sleeve are placed. The guide wire is comprised of a releasable ball tip  825 , an outer coil or tube  826 , an inner tube  827 , an outer tube handle  828 , an outer tube lock  829 , an inner tube handle  827  and an inner tube lock  831 . The ball tip can range in diameter from 3 mm to 12 mm. The ball can be made from plastics such as PTFE, Nylon, polypropylene, polyethylene, PEEK or other suitable material. Alternatively, the ball can be made of a metal such as stainless steel, tantalum, titanium or other suitable material. The outer coil or tube  826  can be made of a plastic tube, a wound wire coil, a metal tube or from helical hollow stranded tube (Fort Wayne Metals). 
     According to various embodiment, the outer diameter of the outer tube  826  can range from 0.5 mm in diameter up to 4 mm in diameter. The length of the outer tube  826  can range from 1 meter to 4 meters. The inner tube  827  inserts coaxially within the inner diameter of the outer tube  826 . The outer tube handle  828  is secured and released from the outer tube  826  by lock knob  829 . The inner tube handle  830  is secured and released from the inner tube  827  by the lock knob  831 . The lock knobs  829  and  831  are threaded into the lock handles  828  and  830  and lock onto the outer tube  826  or inner tube  827  by turning the lock into the handle. The ball tip  825  is threaded onto the distal end of the inner tube  827 . A sectional view of the ball  832  shows the male threads  833  on the outside diameter of the inner tube threaded into the female threads on ball  832 . The outer tube  834  has a collar  835  on the distal end. The collar  835  has two pins  836  that engage in holes in the outside diameter of the ball  833 . The outer tube  834  and collar  835  are pushed against the ball tip  832  and rotated in a counter clockwise direction, while the inner tube  837  is rotated in a clockwise direction to unthread and detach the ball tip from the end of the guide wire. 
     An alternative ball securement or release mechanism incorporates a spring disk  839 . The spring disk  839  can be made from Nitinol or stainless steel. The proximal hub of the spring disk  839  is attached to the outer tube  840 . The distal hub of spring disk  839  is attached to the inner tube  841 . The expanded spring disk  839  fits into a cavity inside the ball tip  838 . The diameter of the spring disk  839  can be reduced to allow the spring disk to be withdrawn from the cavity inside the ball  838 . To reduce the diameter of the spring disk the outer tube  840  is retracted while the inner tube  841  is advanced. This causes the spring disk  839  to elongate and the diameter of the spring disk to reduce to the diameter of the outer tube  840 . 
     An alternative ball securement release mechanism incorporates a tension wire to secure and remotely release the ball from the guide wire tip. The ball tip  842  has a longitudinal socket bored into the diameter to allow outer tube  844  to extend into the ball diameter with a loose slip fit. The ball tip has a second hole drilled transversely through the diameter and a pin  843  is press fit into the transverse hole. Retention suture  847  is looped through the inside lumen of tube  844  around pin  843  at location  846  and back through the inside lumen of tube  844  a second time and exits tube  844  at  845 . A handle maintains the tension on the sutures  847  and  845  until the ball is detached from the guide wire. To release the ball the end of suture  847  is withdrawn from tube  844  and the other end suture  845  is drawn into outer tube  844 . The tension suture is withdrawn over pin  843  at point  846  and the ball is released. The tension suture may be comprised of a plastic suture and made from PTFE, polyester, Dyneema, nylon, polypropylene or other suitable polymer. Alternatively the retention suture  847  is comprised of metal wire, cable or braided wire and is made from stainless steel, Nitinol, MP35n, L605, Elgiloy, titanium or other suitable metal. 
       FIG. 48A  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope  701  inserted through the mouth, esophagus and stomach to the pylorus  106 . 
       FIG. 48B  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope  701  inserted through the mouth, esophagus and stomach  103  to the pylorus. A guide wire  702  is inserted through the working channel of the endoscope  701 . The guide wire is advanced distally in the small intestine lumen into the jejunum  113 . 
       FIG. 49A  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. The guide wire  702  as previously disclosed in  FIG. 47  with a ball  703  attached to the distal end is back-loaded into the working channel of the endoscope  701  prior to insertion of the endoscope. The guide wire  702  is advanced distally in the small intestine lumen into the jejunum. 
       FIG. 49B  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. The guide wire of  FIG. 47  is left in place in the jejunum while the endoscope is withdrawn from the body. The endoscope  701  is then reinserted into the stomach through the mouth and esophagus parallel to the guide wire  703 , but the guide wire  703  is not in the working channel of the endoscope. 
       FIG. 50A  is a continuation in the deployment sequence from  FIG. 49B . An expandable anchor and intestinal bypass sleeve  704  have been loaded on to the delivery catheter. The delivery catheter and intestinal bypass sleeve  704  are advanced over the guide wire  702  through the mouth, esophagus, stomach and small intestine until the distal end of the intestinal bypass sleeve  704  reaches the desired implant location. The release wire  FIG. 40  item  677  on the sleeve delivery catheter is then retracted  FIG. 40   680  to release the intestinal bypass sleeve  704  from the distal end of the sleeve delivery catheter. 
       FIG. 50B  is a continuation in the deployment sequence from  FIG. 50A . The sleeve delivery catheter distal outer capsule  706  is partially retracted proximally to deploy or release the distal end of the expandable anchor  705  from the distal outer capsule  706 . The sleeve delivery catheter is then retracted to remove it partially or fully from the digestive system. 
       FIG. 51  is a continuation in the deployment sequence from  FIG. 50B . The distal outer capsule  706  of the delivery system is fully retracted to deploy or release the proximal end of the expandable anchor  705  from the distal capsule. The expandable anchor  705  and the intestinal bypass sleeve  704  are now in place at the intended implant location. The ball  703  on the end of the guide wire  702  is now released and left to pass naturally through the digestive tract. The ball on the end of the guide wire can alternatively be made from a bio-absorbable polymer and dissolves upon release from the guide wire. The guide wire, delivery catheter, and endoscope are withdrawn from the human body. 
       FIG. 52  is a cross-sectional drawing of an alternative embodiment of a delivery catheter for the invention herein disclosed. The delivery catheter is comprised of: distal outer capsule  707 , which transitions down to a smaller diameter at the proximal outer sheath  717 , sleeve delivery catheter  715 , anchor pusher  714 , and anchor pusher disk  713 . Capsule connector  722  joins the distal outer capsule  707  to the proximal outer sheath  717 . The distal outer capsule  707  is made from dual lumen tubing. The first lumen  711  is sized to accommodate the expandable anchor and can range in diameter from 3 mm to 12 mm. The second lumen  712  is sized to accommodate the sleeve delivery catheter  715  and can range in diameter from 1 mm to 4 mm. The distal outer capsule  707  may be made from a plastic polymer such as Pebax® (polyether block amide), Hytrel (polyester elastomer), ePTFE, PTFE, FEP, nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or other suitable polymer. The distal outer capsule  707  may have an inner lining made from a polymer with a low coefficient of friction such as PTFE. The distal outer capsule  707  may also have a metal re-enforcement in the wall thickness to improve the kink resistance or burst properties of the outer sheath. The metal re-enforcement may be comprised of a braided wire mesh or a metal coil in the wall thickness. The wire used for the re-enforcement may have a round or rectangular cross section. The metal used for the braid may be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitable material. The distal outer capsule  707  length may range typically from 1-3 inches in length or alternatively up to the full length of the catheter. 
     The proximal outer sheath  717  is a dual lumen tube. The first lumen  720  is sized to accommodate the sleeve delivery catheter and may range in diameter from 1 mm to 4 mm. The second lumen  721  is sized to accommodate the anchor pusher  714  and may range in diameter from 1 to 4 mm size. The proximal outer sheath  717  may be made from a plastic polymer such as Pebax® (polyether block amide), PTFE, Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or other suitable polymer. The proximal outer sheath  717  may have an inner lining made from a polymer with a low coefficient of friction such as PTFE. The proximal outer sheath  717  may also have a metal re-enforcement in the wall thickness to improve the kink resistance or burst properties of the outer sheath. The metal re-enforcement may be comprised of a braided wire mesh or a coil in the wall thickness. The metal used for the braid may be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitable material. 
     The anchor pusher disk  713  serves as a mechanical stop or means to hold stationery or push out the expandable anchor from the inside of the distal outer capsule  711 . The anchor pusher disk  713  can be made from metal or plastic and it can incorporate the anchor retention features as previous disclosed in  FIG. 35  and  FIG. 39 . 
     The anchor pusher  714  may be made from a plastic polymer such as Pebax® (polyether block amide), PEEK, Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane, polyimide, PTFE, FEP or other suitable polymer. The anchor pusher  714  may have an inner lining made from a polymer with a low coefficient of friction such as PTFE. The anchor  714  may also have a metal re-enforcement in the wall thickness to improve the kink resistance or burst properties of the outer sheath. The metal re-enforcement may be comprised of a braided wire mesh or a coil in the wall thickness. The metal used for the braid may be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitable material. Alternatively, the anchor pusher  714  may have a solid cross section and be made from metal such as stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitable material or it may have a hollow core. 
     The sleeve delivery catheter  715  may be designed as previously disclosed in  FIG. 41 ,  FIG. 42 ,  FIG. 44A ,  FIG. 44B  or  FIG. 46 . The sleeve delivery catheter  715  may be made from a plastic polymer such as Pebax® (polyether block amide), PEEK, Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or other suitable polymer. The sleeve delivery catheter  715  may have an inner lining in lumens  720  or  721  made from a polymer with a low coefficient of friction such as PTFE. The sleeve delivery catheter  715  may also have a metal re-enforcement in the wall thickness to improve the kink resistance. 
     The guide wire may be inserted through the sleeve delivery catheter lumen  718 . Expandable anchor is compressed and loaded into the inside diameter  711  of the distal outer capsule  707 . The intestinal bypass sleeve extends out beyond the end of the distal outer capsule  707 . The sleeve delivery catheter  715  is inserted form the proximal end of lumen  720  to the distal end of lumen  720 , sleeve delivery catheter  715  then transitions from lumen  720  to lumen  712  by spanning outside the catheter across segment  723 . 
     The sleeve delivery catheter  715  is outside the lumen of the intestinal bypass sleeve and includes a feature adapted to mechanically retain the intestinal bypass sleeve to the end of the sleeve delivery catheter. 
       FIG. 53A  through  FIG. 56B  are a deployment sequence for an expandable anchor and intestinal bypass sleeve when deployed with the catheter. 
       FIG. 53A  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope  701  inserted through the mouth, esophagus and stomach to the pylorus. 
       FIG. 53B  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. A guide wire  702  is inserted through the working channel of the endoscope  701 . The guide wire is advanced distally in the small intestine lumen into the jejunum. 
       FIG. 54A  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. The guide wire  702  as previously disclosed in  FIG. 47  with a ball attached to the distal end is back loaded into the working channel of the endoscope  701  prior to insertion of the endoscope. The guide wire  702  is advanced distally in the small intestine lumen into the jejunum. 
       FIG. 54B  is a cross-sectional view of a portion of the digestive tract in a human body with an endoscope inserted through the mouth, esophagus and stomach to the pylorus. The guide wire of  FIG. 47  is left in place in the jejunum while the endoscope is withdrawn from the body. The endoscope  701  is then reinserted into the stomach through the mouth and esophagus parallel to the guide wire  702 , but the guide wire  702  is not in the working channel of the endoscope. 
       FIG. 55  is a continuation in the deployment sequence from  FIG. 54B . An expandable anchor and intestinal bypass sleeve  704  have been loaded on to a delivery catheter. The delivery catheter and intestinal bypass sleeve  704  are advanced over the guide wire  703  through the mouth, esophagus, stomach and small intestine until the distal end of the intestinal bypass sleeve  704  reaches the desired implant location. The sleeve delivery catheter  715  is parallel to (along the outside surface) of the intestinal bypass sleeve  674 . The release wire  FIG. 40  item  677  on the sleeve delivery catheter is then retracted  FIG. 40  in the direction  680  to release the intestinal bypass sleeve  704  from the distal end of the sleeve delivery catheter. The ball on the end of the guide wire is now released and left to pass naturally through the digestive tract. The ball on the end of the guide wire can alternatively be made from a bio-absorbable polymer and dissolves upon release from the guide wire. 
     The guide wire and sleeve delivery catheter are now removed from the body. 
       FIG. 56A  is a continuation in the deployment sequence from  FIG. 55A . The sleeve delivery catheter distal outer capsule  707  is partially retracted proximally to deploy or release the distal end of the expandable anchor  705  from the distal outer capsule  707 . 
       FIG. 56B  is a continuation in the deployment sequence from  FIG. 56A . The distal outer capsule  706  of the delivery system is fully retracted to deploy or release the proximal end of the expandable anchor  705  from the distal capsule. The expandable anchor  705  and the intestinal bypass sleeve  704  are now in place at the intended implant location. The delivery catheter and endoscope  701  are withdrawn from the human body. 
       FIG. 57  is a drawing of a removal catheter for removing an expandable anchor and intestinal bypass sleeve from the human body. The removal catheter is comprised of a recovery outer tube  724 , an outer tube connector  726 , proximal outer tube  725 , snare catheter  727 , and a snare loop  729 . An expandable anchor  733  as was previously disclosed in  FIG. 7  has a proximal disk  731  and a distal disk  732 . The expandable anchor  733  is shown without a polymer covering or without an intestinal bypass sleeve attached. The expandable anchor  733  is implanted in the gastrointestinal tract. To remove the expandable anchor the removal catheter is advanced through the anatomy to the implant location. The snare loop  729  is placed around the ball  730 . The snare loop  729  is drawn into the snare recovery catheter  728  to close the snare loop  729  diameter and to apply tension onto the ball  730 . The closed snare loop  729  and ball  730  is drawn inside of the recovery outer tube  724 , this causes the proximal disk  731  to contact the distal end of the recovery outer tube. The drawstring in the proximal disk  731  is tensioned with further withdrawal of the snare loop and snare recovery catheter within the proximal outer tube. The tension on the drawstring causes the proximal disk  731  to compress in diameter and the proximal end of the expandable anchor is captured  736  within the recovery outer tube  724 . Continued retraction on the snare catheter  728  and snare loop  729  would cause the distal disk  732  of the expandable anchor  723  to compress in diameter and to be pulled inside of the recovery outer tube until the entire expandable anchor  733  is re-sheathed. An alternative embodiment of the snare loop  729  is a simple hook  733  to grab a loop of suture or ball as previously disclosed. An alternative embodiment of the recovery outer tube  724  is to use an endoscope hood  734  press-fit onto the end of an endoscope  735 . The snare catheter  729  and snare recovery catheter  728  would be used through the working channel of the endoscope to grab the ball  730  and tension the draw sting to collapse the proximal disk and pull the expandable anchor into the endoscope hood. 
       FIG. 58  is a drawing of a monorail type eyelet  740  that can be used on the end of an endoscope  737 . The eyelet  740  has two lumens. Lumen  742  is sized to be a loose fit (sliding fit) on the outer diameter of the proximal outer tube  649  as shown in  FIG. 43  of a delivery catheter for an expandable anchor. Lumen  741  is sized to be a tight or friction fit on the end of an endoscope  737 . When implanting expandable anchors within the human body it is sometimes difficult to navigate the delivery catheter to the required path in the pyloric canal. It is desirable to be able to removably couple the end of the endoscope to the delivery catheter and advance the distal end of the endoscope by sliding the eyelet  740  down the proximal outer tube  739  from location  743  to  744 . With the distal end of the endoscope near the distal outer capsule the endoscope  737  steering mechanism can be used to advance the catheter through tortuous anatomy and across the pylorus. 
       FIG. 59  is a drawing of a monorail type eyelet  745  that can be attached to a distal outer capsule. The eyelet  745  has two lumens. Lumen  749  is sized to be a loose fit (sliding fit) on the outer diameter of an endoscope  737 . Eyelet  745  can be made from metal or plastic. Eyelet  745  can have a liner made from PTFE in lumen  749 . Lumen  741  is sized to be a tight or friction fit on or bonded onto a distal outer capsule. When implanting expandable anchors within the human body it is sometimes difficult to navigate the delivery catheter to the required path in the pyloric canal. It is desirable to be able to removably couple the end of the endoscope to the delivery catheter and advance the distal end of the endoscope by sliding the eyelet  745  down an endoscope  737  from location  746  to  747 . With the distal end of the endoscope near the distal outer capsule the endoscope  737  steering mechanism can be used to advance the catheter through tortuous anatomy and across the pylorus. 
       FIG. 60  is an expandable anchor  751  and an intestinal bypass sleeve  111  which is implanted across a pylorus  105  and into the duodenum  112 . An external band  750  has been laparoscopically implanted around the outside of the pylorus  105  prior to placement of the expandable anchor as was previously disclosed in co-pending U.S. patent application Ser. No. 13/298,867, filed Nov. 17, 2011. The external band  750  provides additional radial stiffness to the pyloric tissue and increases the securement force or required force to displace the expandable anchor  751  from within the pylorus  106 . 
       FIG. 61  is a cross-sectional view of a portion of the digestive tract in a human body. An intestinal bypass sleeve  111  is implanted in the duodenum  112  from the pylorus  106  to the ligament of Treitz  109 . The sleeve is held in place at the pylorus  106  by expandable anchors  410  that anchor on the pylorus  106 . Optional secondary expandable anchors  411  anchor the intestinal bypass sleeve  111  at additional locations in the duodenum  112  and jejunum  113 . An expandable anchor  412  with an anti-reflux valve is implanted at the gastroesophageal (GE) junction  102  to help resolve gastroesophageal reflux disease (GERD). Reference numbers  414 ,  415 ,  416 ,  417 ,  418  and  419  denote valve designs that have from two to seven flaps in the valve and may be used for the anti-reflux device  413 . 
       FIG. 62  is a drawing of a handle set for a delivery catheter as previously disclosed in  FIG. 52 . The handle set is comprised of a molded handle housing  752 , deployment slide  754 , slide lock  753 , proximal outer tube  717 , sleeve delivery catheter proximal end  715  and sleeve delivery lock clip  758 . The handle components can be made from plastic such as polycarbonate, ABS, PEEK, Nylon, PET, PBT or other suitable polymer or metal. The handle housing is made in a two piece clam shell configuration. The proximal outer sheath  717  is attached the deployment slide  754 . The anchor pusher  714  is fixed to the handle housing  752 . To retract the distal outer capsule  707  the slide lock  753  is removed from the handle housing  752 , the deployment slide  754  which is bonded to the proximal outer tube  717  is retracted. The anchor pusher is fixed to the handle housing, so the proximal end of the expandable anchor is stationery as the distal outer capsule retracts with the proximal outer tube to unsheath the distal end of the expandable anchor. Deployment of the expandable anchor occurs as the deployment slide is moved from position  756  to  757 . The sleeve delivery catheter can be secured to the handle housing with a snap fit feature at  758 . 
     A guide wire can be inserted through the catheter and handle set at  759 . 
       FIG. 63  is an additional view of the handle disclosed in  FIG. 62 . 
       FIG. 64  is an additional view of handle disclosed in  FIG. 62 . 
     Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.