Modular gastrointestinal prostheses

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DESCRIPTION

p00010Modular Gastrointestinal Prosthesis

p00011Cross reference to related request

p00012Technical field

p00013This invention relates to prosthetic implants placed within the digestive system, including the stomach, esophagus and intestines. In particular, it refers to implant systems that have implantable and removable components using endoscopic techniques, for the treatment of obesity, diabetes, reflux and other gastrointestinal conditions. WO 2007/136468 A is considered the closest prior art.

p00014Background

p00015Bariatric surgery procedures, such as tubular gastrectomy, Rouen Y gastric bypass (RYGB) and bileopancreatic deviation (BPD) are surgical procedures to modify the intake and / or absorption of food within the digestive system to achieve weight loss in obese patients. These procedures affect metabolic processes within the digestive system, short-circuiting certain natural routes or creating a different interaction between the food consumed, the digestive tract, its secretions and the neurohormonal system that regulates food intake and metabolism. In recent years, there has been a growing clinical consensus that obese diabetic patients who undergo bariatric surgery observe a remarkable resolution of their Type 2 Diabetes Mellitus (T2DM) soon after the procedure. The remarkable resolution of diabetes after RYGB and BPD usually occurs too quickly to be justified by weight loss alone, suggesting that there may be a direct impact on glucose homeostasis. The mechanism of this T2DM resolution is not well understood, and it is quite likely that multiple mechanisms are involved.

p00016One of the drawbacks of bariatric surgery procedures is that they require fairly invasive surgery, with potentially serious complications and long periods of patient recovery. In recent years, there is a growing amount of ongoing effort to develop minimally invasive procedures to mimic the effects of bariatric surgery using minimally invasive procedures. Such a procedure involves the use of gastrointestinal implants that modify the transport and absorption of food and organ secretions. For example, US Patent 7,476,256 describes an implant that has a tubular sleeve with an anchor that has spikes. Although these implants can be supplied endoscopically, the implants offer the doctor limited flexibility and are not easily removable or replaceable, since the entire implant is subject to tissue growth inwards after implantation. In addition, intraluminal stents with active fixation means, such as spikes that penetrate the surrounding tissue, can potentially cause necrosis and erosion of the implants through the tissue, which can lead to serious complications such as systemic infection.

p00017Summary

p00018In accordance with various embodiments, the present invention is a modular intraluminal implant system for treating metabolic disorders such as obesity and diabetes, which provides much more flexible therapy alternatives than individual devices for treating these disorders. These implant systems include components that can be selectively added or removed to mimic various bariatric surgery procedures with a single basic construction. The fundamental structural units of the system include anchoring implants that are placed inside the digestive system or in some cases around particular organs. These low profile implants are designed for long-term performance with minimal interference with normal physiological processes. The characteristics of these anchor implants allow them to act as assembly stations for therapy implants designed to achieve certain metabolic modification goals. Using a combination of anchoring implants with corresponding replaceable tubular elements that are assembled with them, it is possible to design therapies with particular metabolic modification goals or those that mimic currently practiced bariatric surgery procedures. This allows the physician to customize the therapy for the patient at the time of the initial procedure but also allows the flexibility to alter the therapy during the patient's lifetime, replacing individual components.

p00019According to some embodiments, the modular systems of the invention include an anchor implant part (assembly element) that includes an expandable structure (eg, an intraluminal stent

p00020or low profile elastomeric fabric ring or sleeve) anchored within the esophagus, gastroesophageal junction, pyloric junction, duodenum or jejunum and may have cuff or implant extensions. Intraluminal stents can be balloon expandable or self-expanding and anchored against tissue with radial force. The rings could be made of self-expanding Nitinol and anchored to the tissue by capturing the tissue within the ring elements or by radial force. The sleeves could be sutured or stapled or attached permanently or reversibly by other mechanical means to the fabric. The anchor implant includes or is adapted to receive (for example, endoscopically) features that allow assembly functionality. Assembly functionality

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p00029of the intraluminal stent, ring or sleeve, for example, could take the form of magnetic elements, hooks, elements or mechanical coupling structures (such as braided mesh or intraluminal stent mesh) that constitute a piece with the frame of the intraluminal stent, ring or sleeve or extension of cuff or implant. The system could also be such that the assembly functionality does not constitute a part with the intraluminal stent, ring or sleeve, but is introduced later by joining other elements such as magnets, hooks, mechanical coupling elements etc., to the frame of the intraluminal stent, ring, sleeve or to the sleeve / implant extension of the previous implants. Therapeutic implants, such as tubular sleeves or covered stents are adapted to reversibly attach to the anchor implants. These therapeutic implants will have corresponding characteristics (for example, magnets, hooks, mechanical elements) to allow assembly to the anchor implants, so that the therapeutic implants can be reversibly attached to the anchor implants. In some embodiments, the tubular implants will not be in contact with tissue to minimize or prevent the growth of tissue inwardly and facilitate simple removal with endoscopic instrumentation after long-term implantation.

p00030According to various embodiments, anchoring or assembly implants comprise intraluminal stents or covered intraluminal stents (covered stents) that promote tissue growth inwards without penetrating the tissue. Such intraluminal stents may include, for example, a self-expanding laser-cut intraluminal stent with non-penetrating struts that fit the wall of the GI tract or a self-expanding braided intraluminal stent with a Dacron-type fabric cover of suitable porosity that would promote growth. inward tissue and would help in fixation.

p00031According to various embodiments, anchoring or assembly implants comprise a double braided intraluminal stent (for example, having a spacing between braided meshes of 0.5 to 5.0 mm). This embodiment is optimized so that the outer braided mesh could be firmly anchored within the tissue, but the tissue would not grow inside the internal braided mesh, which can then be used to anchor the replaceable implant.

p00032According to various embodiments, anchoring or assembly implants are specifically designed to be constrained in certain anatomical locations. Such designs, for example, may include double-flange or dumbbell-shaped implants placed in the pyloric joint or barrel-shaped intraluminal stents placed inside the duodenal bulb.

p00033According to various embodiments, replaceable therapeutic implants that are assembled to anchor implants take the form of long tubes that can selectively channel food flow and organ secretions (eg, stomach, gallbladder, intestines and the pancreas) to various destinations within the digestive tract. This deviation and avoidance of food and organ secretions (for example, insulin and incretin from the pancreas and bile from the gallbladder) could then be controlled by adjusting the design features of the system where the implants are placed inside the GI tract. Implants may also include restrictive stoma elements or anti-reflux valves. To divert food and secretions from the first part of the intestine, for example, an anchor implant can be placed inside the duodenal bulb or in the pyloric junction. Next, a thin tube approximately 1-2 feet (30-60 cm) in length with a funnel-shaped proximal end and a rigid ring-shaped distal end can be inserted into the proximal duodenum and assembled to the permanent implant. It would be possible to later remove this by endoscopic means simply by disassembling it from the anchor implant. To restrict the passage of food, a restrictive element such as one created by a gradually narrowing tube or an intraluminal stent or a covered stent can be converted into the assembly element and reversibly attached to the assembly station.

p00034According to various embodiments, the assembly means may include elements with memory shape and mechanical super-elastic fit / disengagement, attractive / repulsive and levitation magnetic mechanisms, loop and ring fastener technologies etc. The systems can be deployed with functional assembly components or those components would be attached to the permanent implants under endoscopic visual guidance. The assembly means is designed so that the therapeutic implants can be easily deployed and firmly attached to the anchor implants. According to various embodiments, the fitting elements of the assembly system are arranged so that they do not impact the surrounding tissue, nor would they be covered later by layers of tissue. This facilitates the disengagement of the tubular sleeve elements of the intraluminal stent with simple magnetic instruments or endoscopic gripper-type instruments or catheters with funnel-shaped recovery basket or using a string-like mechanism.

p00035According to some embodiments, the anchoring element is integrated with a therapy component.

p00036A method of treating gastroesophageal reflux disease (GERD) includes placing a low profile implant inside the stomach, esophagus, intestine or in internal joints of these organs or around these organs, and firmly joining the implant with other gastrointestinal implants that allow food bypass and organ secretions from one site within the gastrointestinal tract to other sites within the gastrointestinal tract.

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p00045Although multiple embodiments are disclosed, further 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. Therefore, the drawings and detailed description should be considered illustrative and not restrictive in nature.

p00046Brief description of the drawings

p00047Figure 1 is a cross-sectional view of a part of the digestive tract in the body. An assembly element is implanted in the duodenal bulb and a tubular implant (sleeve) joins the assembly element and extends inside the duodenum to the Treitz ligament. Figure 2 is a cross-sectional view of a part of the digestive tract in the body. An endoscope is inserted into the mouth, passing through the esophagus into the stomach and the end of the endoscope is oriented to allow vision of the pylorus. Figure 3 is a drawing of a typical endoscope used for diagnostic and therapeutic procedures in the gastrointestinal (GI) tract. Figure 4A is a drawing of a sizing globe on the wire that can be used to measure the diameter of the pylorus, the duodenal bulb, the esophagus, the pyloric antrum or other light in the GI tract. Figure 4B is a drawing of a balloon of single-layered sizing that can be used to measure the diameter of the pylorus, the duodenal bulb, the esophagus, the pyloric antrum or other light in the GI tract. Figure 5 is a sectional view of a part of the digestive tract in the body. An endoscope is inserted into the GI tract to the pylorus. A sizing balloon is inserted through the instrument duct and into the duodenal bulb area. The balloon swells to measure the diameter of the duodenal bulb. Figure 6A is a drawing of an intraluminal stent that can be used as an assembly element. Figure 6B is a drawing of an intraluminal stent that can be used as an assembly element having a polymeric cover inside and outside. Figure 7 is a tubular implant that can be used to prevent the stomach, duodenum or other intestinal lumen. Figure 8 is a drawing of a delivery catheter for the assembly element and the tubular implant. Figure 9A is a cross-sectional view of a part of the digestive tract in the body. A delivery catheter with an assembly element and a tubular implant loaded in the catheter are loaded into an endoscope. The endoscope is then advanced through the esophagus, stomach and into the duodenal bulb. Figure 9B is a cross-sectional view of a part of the digestive tract in the body. A delivery catheter with an assembly element and a tubular implant loaded on it is loaded into an endoscope. The endoscope is then advanced through the esophagus, stomach and into the duodenal bulb. The outer sheath of the supply catheter is retracted to partially deploy the assembly element inside the duodenal bulb. Figure 10 is a drawing showing the assembly element fully deployed inside the duodenal bulb. The delivery catheter and endoscope have been removed to show it clearly. Figure 11 is a drawing showing the advanced endoscope and delivery catheter through the assembly element inside the duodenum to the Treitz ligament. Figure 12 is a drawing showing the advanced scope and delivery catheter through the assembly element inside the duodenum to the Treitz ligament. The outer sheath of the delivery catheter retracts to partially expose the tubular implant. Figure 13 is a drawing showing the advanced scope and delivery catheter through the assembly element inside the duodenum to the Treitz ligament. The outer sheath of the delivery catheter retracts to partially expose the tubular implant. A balloon catheter is inserted through the conduit for endoscope instruments to the partially exposed tubular implant area. The balloon swells to temporarily fix the tubular implant to the duodenum. Figure 14 is a continuation of Figure 13 where the outer sheath is further retracted to unsheathe the tubular implant to the duodenal bulb. Figure 15 is a continuation of Figure 14 where the endoscope has been removed to the duodenal bulb. The balloon in the balloon catheter is then deflated and the balloon catheter is removed to the duodenal bulb. Next, the balloon swells again to open and fix the proximal end of the tubular implant to the internal diameter of the assembly element. Figure 16 is a drawing of an alternative device and method for deploying the proximal end of the tubular element. Figure 17A is a cross-sectional view of a part of the digestive tract in the body. An assembly element is implanted in the esophagus at the gastroesophageal junction. The assembly element serves as an anti-reflux valve. Figure 17B is a cross-sectional view of a part of the digestive tract in the body. An assembly element is implanted in the esophagus at the gastroesophageal junction. The assembly element serves as a restrictive stoma. Figure 18 is a cross-sectional view of a part of the digestive tract in the body. An assembly element is implanted in the esophagus at the gastroesophageal junction. The assembly element serves as an anti-reflux valve. Figure 19A is an intraluminal stent cuff with an intraluminal stent used for

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p00056keep the cuff open. The cuff located from the duodenal bulb to the Treitz ligament. Figure 19B is an intraluminal stent cuff with an intraluminal stent used to keep the cuff open. The cuff located from the pylorus to the Treitz ligament. Figure 20 is an intraluminal stent cuff with an intraluminal stent used to keep the cuff open. The cuff is located from the stomach antrum to the Treitz ligament. Figure 21A is a sectional view of a part of the digestive tract in the body. An assembly element is implanted in the esophagus at the gastroesophageal junction. An assembly element and a tubular implant are implanted in the duodenum as well. Figure 21B is a sectional view of a part of the digestive tract in the body. An assembly element is implanted in the esophagus at the gastroesophageal junction. An assembly element and a tubular sleeve are implanted in the duodenum as well. A third implant element prevents the stomach. Figure 22A is a sectional view of a part of the digestive tract in the body. An assembly element is implanted in the esophagus at the gastroesophageal junction. A second tubular implant and assembly element is implanted from the esophageal implant to the Treitz ligament. Figure 22B is a sectional view of a part of the digestive tract in the body. An assembly element is implanted in the esophagus at the gastroesophageal junction. An assembly element and a tubular implant are implanted from the esophageal implant to the duodenal bulb. Figure 23A is a sectional view of a part of the digestive tract in the body. An assembly element and a tubular implant are implanted in the esophagus at the gastroesophageal junction. The modular implant has an anti-reflux valve. A second assembly station and a tubular implant are placed in the duodenal bulb and extend to the Treitz ligament. A third assembly station and a tubular implant connect the esophageal implant and the duodenal implant. Figure 23B is a sectional view of a part of the digestive tract in the body. An assembly element and a tubular implant are implanted in the esophagus at the gastroesophageal junction. The modular implant has an anti-reflux valve. A second assembly station and a tubular implant are placed in the pylorus and extend to the Treitz ligament. A third assembly station and a tubular implant connect the esophageal implant and the duodenal implant in the pylorus. Figure 24 is a sectional view of a part of the digestive tract in the body. An assembly element and a tubular implant are implanted in the esophagus at the gastroesophageal junction. The modular implant has an anti-reflux valve. A second assembly station and a tubular implant are placed in the pyloric antrum and extend to the Treitz ligament. A third assembly station and a tubular implant connect the esophageal implant and the duodenal implant in the pyloric antrum. Figure 25 is a drawing of a delivery catheter with an assembly element loaded on it. Figure 26 is a drawing of a delivery catheter with the endoscope inserted through the inner diameter of the supply catheter. Figure 27 is a drawing of a delivery catheter that is designed to be inserted through the endoscope instrument conduit. Figure 28 is a drawing of a delivery catheter with an assembly element and a tubular implant loaded on it. Figures 29-35 show various intraluminal stents that can be used as an assembly element. Figure 36A is a drawing of an intraluminal stent that can be used as an assembly element. Figure 36B is a drawing of an intraluminal stent that can be used as an assembly element. Figures 37-39 show assembly elements. Figure 40A is an expandable ring that can be attached to a sleeve to form a tubular implant. Figure 40B is an expandable ring that can be attached to a sleeve to form a tubular implant. Figure 40C is an expandable ring that can be attached to a sleeve to form a tubular implant. Figure 41 is a tubular implant using an expandable ring as in Figure 40A, 40B or 40C as an anchoring means. Figure 42 is a tubular implant using an expandable ring as in Figure 40A, 40B or 40C as an anchoring means. The tubular implant is placed and fixed within an assembly element. Figure 43 is a tubular implant using an expandable ring as in Figure 40A, 40B or 40C as an anchoring means. The tubular implant expands and is fixed within the assembly element. Figure 44 is a drawing of an assembly element using hook and loop to secure the tubular implant to the assembly element. Figure 45A is a drawing of a tubular implant having magnets on the wall to allow attachment to another tubular implant or an assembly element. Figure 45B is a drawing of a tubular implant that has magnets on the wall to allow attachment to another tubular implant or an assembly element, has a female receptacle to allow attachment to an assembly element or another tubular implant. Figures 46A and 46B show tubular implants. Figures 47A and 47B show tubular implants in which the sleeve has longitudinal or circumferential folds, respectively. Figures 48A and 48B show tubular implants or sleeves with a magnetic joining means. Figure 49 is a drawing of a tubular implant or sleeve with spikes to join the tissue or an element of

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p00065assembly Figure 50A is a drawing of a tubular implant or sleeve with pockets for inserting magnets to allow attachment to an assembly element or another tubular implant. Figure 50B is a drawing of a tubular implant or sleeve with hooks for joining the assembly element or another tubular implant. Figure 51A is a conical or tapered tubular assembly or implant element. Figure 51B is a tubular implant or assembly element with a stepped diameter. Figure 52 is a tubular implant having a hook and loop (velcro) attachment means for joining an assembly element or other tubular implant. Figure 53A is a balloon catheter on the wire for delivering and expanding expandable balloon intraluminal stents for an assembly element. Figure 53B is a rapid exchange balloon catheter for delivering and expanding expandable balloon intraluminal stents for an assembly element. Figure 54 shows an assembly element design with a single braided mesh design or laser cut placed at the pyloric junction. Figure 55 shows another designed assembly element where the stomach side of the assembly element is more similar to a disk. Figures 56 and 57 show assembly elements of Figure 55 and Figure 56 covered with sheets of fabric or polymer in areas where they are in contact with the fabric. Figure 58 shows a different design of the assembly element placed inside the pylorus, where two metallic elements (one on the stomach side and one on the duodenal side) are connected by a flexible sleeve element. Figure 59 depicts the assembly element of Figure 58 where the flexible sleeve element has expanded with the opening of the pyloric valve. Figure 60 represents another design of the assembly element incorporating a flexible sleeve element. Figure 61 depicts a tubular implant that can be reversibly attached to various compatible assembly elements described elsewhere, such as those shown in Figures 54 to 58. Figure 62 shows the supply of the tubular implant of Figure 61 near the assembly element of Figure 54. Figure 63 represents the assembly element and the tubular element coupled to each other at the time of release from the delivery catheter. Figure 64 shows where the tubular element is now attached to the assembly element of Figure 58. Figure 65 shows a situation in which the tubular element is attached to the assembly element of figure 58 in the stomach part of the assembly element. Figures 66-78 show schematic views of various phases of the implementation of some embodiments of the invention.

p00066Although the invention is flexible 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 that are within the scope of the invention as defined by the appended claims.

p00067Detailed description

p00068Figure 1 is a schematic sectional view of an embodiment of the invention implanted in a part of a human digestive tract. As a person ingests food, the food enters the mouth 100, is chewed, and then moves down the esophagus 101 to the lower esophageal sphincter at the gastroesophageal junction 102 and into the stomach 103. The food is mixed with Enzymes in mouth 100 and stomach 103. Stomach 103 converts food into a substance called chyme. The chyme enters pyloric antrum 104 and leaves stomach 103 through pylorus 106 and pyloric orifice 105. The small intestine is approximately 21 feet (640 cm) long in adults. The small intestine is made up of three sections. Duodenum 112, jejunum 113 and ileus (not shown). Duodenum 112 is the first part of the small intestine and is usually 10-12 inches (25-30 cm) long. The duodenum 112 consists of four sections: the upper, descending, horizontal and ascending. Duodenum 112 ends in the ligament of Treitz 109. Vater's papilla 108 is the conduit that supplies bile and pancreatic enzymes to duodenum 112. Duodenal bulb 107 is the part of the duodenum that is closest to the stomach 103.

p00069As shown in Figure 1, an assembly or anchoring element 110 is implanted in the duodenal bulb 107 and a tubular or therapy implant 111 is attached to the assembly element and extends inside the duodenum 112 to the ligament of Treitz 109. In this embodiment, magnets 135 in the assembly element 110 and magnets 136 in the tubular implant 111 are magnetically attracted to each other and thus fix the assembly element 110 to the therapy implant 111. According to various exemplary embodiments, the anchoring element 110 includes an expandable structure in the form of an intraluminal stent adapted for anchoring within the duodenal bulb and has a diameter of between about 20 and about 40 mm in its

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p00084expanded configuration not restricted. In these embodiments, the magnets 135 in the assembly or anchoring element 110 serve as an assembly feature to engage so that it can be released with the magnets 136 of the tubular implant 111.

p00085Figure 2 is a schematic view of a part of the digestive tract in a human body. An endoscope 114 has been inserted through the mouth 100, the esophagus 101, the gastroesophageal junction 102 and into the stomach 103. The endoscope 114 further extends inside the pyloric antrum 104 to allow viewing of the pylorus 106.

p00086Figure 3 is a drawing of an endoscope 114. Endoscopes 114 are commonly used for diagnostic and therapeutic procedures in the gastrointestinal (GI) tract. The typical endoscope 114 is airship by rotating two rotating dials 115 to cause the end of the working end 116 of the endoscope to be deflected. The working end of the endoscope 116 or the distal end normally contains two fiber bundles for illumination 117, a fiber bundle for imaging 118 (viewed) and a conduit for instruments 119. The conduit for instruments 119 can also be accessed at the proximal end of the endoscope. The light fiber beams and the image fiber beams are plugged into a console in the plug connector 120. The typical endoscope has a conduit for the instruments, for example, which has a diameter in the diameter range of 2 to 4 mm. It can have, for example, a conduit for instruments having a diameter in the diameter range of 2.6 to 3.2 mm. The external diameter of the endoscopes is usually in the diameter range of 8 to 12 mm depending on whether the endoscope is for diagnostic or therapeutic purposes.

p00087Figure 4A is a partial sectional view of a sizing balloon on the wire 121 that is used to measure the diameter of the pylorus 106, the duodenal bulb 107, the esophagus 102, the pyloric antrum 104 or other light in the GI tract. The sizing balloon is composed of the following elements: a proximal connector 122, a cylindrical body of the catheter 124, a distal balloon component 125, radiopaque marker bands 126, a distal tip 127, a guide wire light 128, and a light of swelling 129. The distal balloon component 125 may be made, for example, of silicone, copolymers of silicone and polyurethane, latex, nylon 12, PET (Polyethylene terephthalate) Pebax (block polyether amide), polyurethane, polyethylene, polyester elastomer or Another suitable polymer. The distal balloon component 125 can be molded in any desired shape, including for example a cylindrical shape, a dog bone shape, or a conical shape. The distal balloon component 125 may be made compatible or unsupported. The distal balloon component 125 may adhere to the cylindrical body of the catheter 124 with glue, heat adhesion, solvent adhesion, laser welding or any suitable means. The cylindrical body of the catheter can be made of silicone, copolymers of silicone and polyurethane, latex, nylon 12, PET (Polyethylene terephthalate) Pebax (block polyether amide), polyurethane, polyethylene, polyester elastomer or other suitable polymer. Section AA (shown at the top of Figure 4A) is a cross section of the cylindrical body of the catheter 124. The cylindrical body of the catheter 124 is shown as a double light extrusion with a guide wire light 128 and a swelling light 129. The cylindrical body of the catheter 124 can also be formed from two round tubes of single coaxial light instead of double light tubes. The balloon swells by attaching a syringe (not shown) to a hole on the side of a Luer 130 joint. The sizing balloon houses a guide wire through the light of the guide wire from the distal tip 127 through the proximal connector

p00088122. The sizing balloon 121 can be filled with a radiopaque dye to allow viewing and measurement of anatomy size with a fluoroscope. In the embodiment of Fig. 4A, the sizing balloon 121 has two or more radiopaque marker bands 126 located in the cylindrical body of the catheter to allow visualization of the position of the cylindrical body of the catheter and the balloon. Marker bands 126 also serve as a reference point of known fixed distance that can be measured to provide a means to calibrate and determine the diameter of the balloon with the use of the fluoroscope. The marker bands may be made of tantalum, gold, platinum, platinum and iridium alloys or other suitable material.

p00089Figure 4B is a partial sectional view of a rapid exchange sizing globe 134 that is used to measure the diameter of the pylorus 106, the duodenal bulb 107, the esophagus 102, the pyloric antrum 104 or other light in the GI tract. The sizing balloon is composed of the following elements: a proximal luer 131, a cylindrical body of the catheter 124, a distal balloon component 125, radiopaque marker bands 126, a distal tip 127, a guide wire light 128 and a light of swollen 129. The construction materials will be similar to those of the sizing globe 121 of Figure 4A. The guide wire light 128 does not travel the entire length of the catheter, begins at the distal tip 127 and exits out of the side of the catheter at a distance shorter than the overall length of the catheter. A guide wire 132 is inserted into the balloon catheter to illustrate the path of the guide wire through the sizing balloon 134. As shown in Figure 4B, the cylindrical body of the catheter with sizing balloon changes section along its length from a single light in section BB 133 to a double light in section AA in 124.

p00090Figure 5 is a schematic view of a part of the digestive tract in the body. An endoscope 114 is inserted into the GI tract to pylorus 106. A sizing balloon 121 is inserted through the conduit for instrumental 119 of the endoscope and into the area of ​​the duodenal bulb 107. The sizing balloon 121 is swollen with contrast. The diameter of the duodenal bulb 107 is measured with a fluoroscope.

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p00099Figure 6A shows various views of an intraluminal stent that can be used as an assembly or anchoring element. The intraluminal stents of this invention may be constituted, for example, by one or more of the following materials: nickel titanium (Nitinol) alloys, stainless steel alloys: 304, 316L, BioDur® 108 alloy, Pyromet Alloy® CTX-909 alloy, Pyromet® Alloy CTX-3 alloy, Pyromet® Alloy 31 alloy, Pyromet® Alloy CTX-1 alloy, 21Cr-6Ni-9Mn stainless, 21Cr-6Ni- 9Mn stainless, Pyromet Alloy 350 alloy, 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, alloy cobalt and chrome 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, Niobium, Iridium Alloys, Conichrome, gold and gold alloys. The intraluminal stent may also consist of the following absorbable materials: pure iron and magnesium alloys. The intraluminal stent may also consist of the following plastics: Polyetherketone (PEEK), polycarbonate, polyolefins, polyethylene, block polyether amide (PEBAX), nylon 6, 6-6, 12, Polypropylene, polyesters, polyurethanes, polytetrafluoroethylene (PTFE) Poly (phenylene sulfide) (PPS), poly (butylene terephthalate) PBT, polysulfone, polyamide, polyimide, poly (phenylene oxide) PPO, acrylonitrile butadiene styrene (ABS), Polystyrene, Poly (methyl methacrylate) (PMMA), Polyoxymethylene (POM), ethylene vinyl acetate, resin of styrene acrylonitrile, Polybutylene The intraluminal stent may also consist of the following absorbable polymers: Poly (PGA), Polylactide (PLA), Poly (-caprolactone), Poly (dioxanone) Poly (lactide-coglycolide). The intraluminal stent 137 according to various embodiments is laser cut from a round tube or from a flat sheet of metal. The flat representation of the circumference of the intraluminal stent is shown in item 138. The flat representation of an expanded intraluminal stent is shown in item 139. The end view of the intraluminal stent is shown in 141. Magnets 140 are attached to the intraluminal stent in the outer diameter. The magnets can be attached to the intraluminal stent using a mechanical fixator, glue, suture, welding, pressure adjustment or other suitable means. The intraluminal stent can be balloon expandable or self-expanding. The magnets may be located in the middle of the intraluminal stent or at the ends of the intraluminal stent. Suitable materials for magnets include: neodymium-iron-boron [Nd-Fe-B], samarium-cobalt [Sm-Co], alnico, and hard ferrite [ceramic] or other suitable material. In some embodiments, the magnets are encapsulated in another metal (eg, titanium) or polymer to improve corrosion resistance and biocompatibility.

p00100Figure 6B shows various views of an intraluminal stent that can be used as an assembly or anchoring element. The intraluminal stent 142 can be laser cut from a round tube or from a flat sheet of metal. The flat representation of the circumference of the intraluminal stent is shown at point 143. The flat representation of an expanded intraluminal stent is shown at the point

p00101144. The end view of the intraluminal stent is shown at 145. Permanent magnets 140 are attached to the intraluminal stent in the outer diameter. This intraluminal stent is a covered intraluminal stent. The intraluminal stent cover is not shown at points 142, 143 or 144. The cover is shown in the view of the end shown by the intraluminal stent 145. The intraluminal stent may have an outer shell 146, inner shell 147 or both. Suitable materials for the cover include but are not limited to: silicone, block polyether amide (PEBAX), polyurethanes, silicone and polyurethane copolymers, nylon 12, polyethylene terephthalate (PET), Goretex ePTFE, Kevlar, Spectra, Dyneena , polyvinyl chloride (PVC), polyethylene or polyester elastomers. The covers can be applied by immersion on the intraluminal stent or they can be made as a separate tube and then attached to the intraluminal stent using adhesives or mechanical fixators such as sutures, rivets or by thermal adhesion of the material to the intraluminal stent or other layer. The shell may also have drugs incorporated in the polymer to provide a therapeutic benefit. The cover 146 or 147 can also be of biological origin. Suitable biological materials include but are not limited to: amnion, type I, II, III, IV, V, VI collagen - bovine, porcine, sheep or placental tissue or veins or placental arteries and submucosa of the small intestine.

p00102Figure 7 is a tubular therapy implant that can be used to prevent the stomach 103, the duodenum 112 or other intestinal lights (for example, a part of or all of the jejunum). The tubular implant is made of a thin-walled tube 148 and a series of magnets 140 attached to the inside of the thin-walled tube. According to other embodiments, magnets 140 may be attached to the outside of tube 148. According to various embodiments, the magnets 140 are arranged around a circumference of the tube 148 so that the location of the magnets corresponds to corresponding magnet locations located in the anchoring or assembly element. The tubular implants of this invention may be constituted, for example, by the following materials: silicone, block polyetheramide (PEBAX), polyurethanes, silicone and polyurethane copolymers, Nylon, polyethylene terephthalate (PET), Goretex ePTFE, Kevlar, Spectra , Dyneena, polyvinyl chloride (PVC), polyethylene, polyester elastomers or other suitable materials. The length of the thin-walled tube 149 can vary from 1 inch (2.54 cm) in length to 5 feet (150 cm) in length. The thickness of the thin-walled tube will normally be in the range of 0.0001 inches (0.00025 cm) and 0.10 inches (0.25 cm). The diameter of the tubular implant will vary between normally 25 and 35 mm, but it can also vary between any point from 5 mm to 70 mm in diameter.

p00103Exemplary tubular elements for performing intraluminal gastrointestinal therapies, for example, treating metabolic disorders, which can be used with the system of the present invention include, for example, those elements disclosed in any of US Patents 4,134,405; 4,314,405; 4,315,509;

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p001124,641,653; 4,763,653; and 5,306,300, each of which is hereby incorporated by reference in its entirety.

p00113Figure 8 is a schematic view of a delivery catheter for supplying a self-expanding assembly or anchoring element 110 and tubular or therapy implant 111, in accordance with various embodiments of the invention. The supply catheter is constructed with a central light 150 large enough to allow the catheter to be loaded on the outer diameter of the endoscope 114. The supply catheter is constituted by an external catheter 151 and an internal catheter 152. To load the tubular implant onto the delivery catheter, the handle of the outer sheath 153 retracts toward the handle of the inner catheter 154 until the distance 155 (between the outer handle 153 and the inner handle 154) is relatively small. The tubular implant 111 is then compressed around the inner catheter, and the outer sheath is partially closed by advancing the handle of the outer sheath 153 away from the handle of the inner sheath 154. When the tubular implant is complete (or sufficiently) covered by the outer sheath or catheter 151, the loading process is complete for the tubular implant. The delivery catheter also has a space in the internal catheter 151 for the assembly or anchor implant 110 to be loaded. As shown in Figure 8, the anchor implant 110 is compressed around the distal part of the internal catheter 152. The handle of the outer sheath 153 is then advanced distally until it covers completely (or sufficiently) and retains the anchor implant. In one embodiment, the tubular or therapy implant 111 is compressed on the inner catheter and the outer catheter is placed on the outside (from left to right in Figure 8) of the tubular implant 111.

p00114As further shown in Figure 8, according to exemplary embodiments, an intraluminal stent retainer 159 is attached to the internal catheter. The intraluminal stent retainer 159 acts to prevent the intraluminal stent (for example, anchor or assembly implant 110) from being released from the delivery catheter prematurely during deployment. The intraluminal stent retainer is attached to the internal catheter. The intraluminal stent retainer 159 can be made of metal or plastic and can be made radiopaque from a radiopaque material such as tantalum. The intraluminal stent retainer has a complementary shape that holds the tips of the intraluminal stent and does not allow the intraluminal stent to move distally or forward until the outer sheath 151 is fully retracted to the intraluminal stent retainer 159.

p00115The catheter has a side hole 156 that allows the space between the inner and outer sheaths to be washed with saline. The outer sheath 151 and the inner sheath 152 may be made of a simple extrusion of single layer polymer such as polyethylene or PTFE. The outer sheath can also be constructed as follows. The inner diameter surface of the sheath is constructed by a thin-walled PTFE liner

p00116157. A reinforcement layer 158 is placed on the PTFE liner, the reinforcement is preferably a braided wire mesh or a wire spiral. The cross section of the wire can be round or rectangular. The preferred material for the wire is a metal such as 316 or 304 stainless steel or Nitinol or other suitable material. Wire diameters are normally in the diameter range of 0.0005 inches (0.0013 cm) to 0.010 inches (0.025 cm). The material of the outer jacket is preferably flowed back into the reinforcement layer by melting the material and making it flow into the spaces between the braided wire or the spiral wires.

p00117Figures 9A-16 show a series of steps in the implantation of the apparatus disclosed herein, in accordance with an exemplary embodiment. Figure 9A is a schematic view of a part of the digestive tract in the body. A delivery catheter with an assembly element 110 and a tubular implant 111 loaded on the catheter, are loaded onto the outside of an endoscope. The endoscope is then advanced through the esophagus, the stomach, so that a distal part is located in the pylorus or duodenal bulb. Figure 9B is a schematic view of a part of the digestive tract in the body. As shown, a delivery catheter with an assembly element 110 and a tubular implant 111 loaded onto the catheter is loaded onto an endoscope. The endoscope is then advanced through the esophagus, stomach and into the duodenal bulb. The outer sheath or catheter 151 is then retracted by moving the outer handle 153 towards the inner handle 154 to deploy the assembly or anchor element 110. Figure 10 is a schematic view of a part of the digestive tract in the body. The drawing shows the assembly element 110 fully deployed inside the duodenal bulb 107. The delivery catheter and endoscope have been removed to show it clearly.

p00118Figure 11 is a schematic view showing the delivery catheter (of Figure 9), in which the assembly element is fully deployed, further advanced inside the duodenum 112 until the distal end of the supply catheter is arranged at or near the ligament of Treitz 109. Then, as shown in Figure 12, the outer sheath 151 of the delivery catheter is retracted slightly (eg, 1-3 centimeters) to expose the distal part of the tubular implant 111. In addition, the tubular implant 111 is advanced slightly forward (for example, 1-5 centimeters), so that a sufficient amount of the distal end of the tubular implant 111 is disposed beyond the most distal part of both the inner sheath 152 as of the outer sheath 151. In some embodiments, this is achieved by using a third intermediate sleeve to apply a distal force to the tubular implant 111. In other embodiments, after deploying the anchoring element, the physician removes the patient's endoscope, loads the tubular implant with an amount

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p00133enough that it extends distally, then advances the endoscope to the appropriate locations and deploys the tubular implant 111.

p00134Next, in Figure 13, a sizing globe 121 has been inserted through the conduit for instruments 119 in the endoscope 114. The sizing globe 121 is advanced slightly (eg, 1-2 inches [2.5 -5 cm]) beyond the distal end of endoscope 114 but still inside tubular implant 111. The sizing balloon 121 is then swollen with saline solution or contrast agent to generate enough radial force to hold the tubular implant 111 in place in the duodenum 112 near the Treitz ligament 109.

p00135Next, as shown in Fig. 14, the outer sheath 151 is further retracted to expose a large part or most (for example, everything except 1-3 centimeters) of the tubular implant 111. The end of the outer sheath 151 It is now located at or near Pylorus 106. Next, as shown in Figure 15, the distal end of the endoscope 114 has been dragged back to the pyloric orifice 105 and the sizing balloon 121 has been deflated and resituated at a location near the proximal end of the tubular implant 111. The sizing balloon 121 is then swollen again to force or push the proximal end of the tubular implant 111 to come into contact with the assembly element 110, so that the magnets 140 in the tubular sleeve are now in contact with the magnets 140 in the assembly element. The magnetic attraction between the magnets 140 fixes the tubular implant 111 to the assembly element 110. The endoscope 114 is then removed and the procedure is complete.

p00136Figure 16 shows an alternative embodiment for attaching the proximal end of the tubular implant 111 to the assembly element 110. As shown, according to various embodiments, conical and tubular Nitinol 160 pliers are attached to the inner catheter near the proximal end where the tubular implant is loaded onto the delivery catheter. Nitinol 160 clamps are configured to have elastic memory in the open state. When the outer sheath 151 is fully retracted, the conical tweezers open and, in turn, push open to the proximal end of the tubular implant 111 to seat the magnets in the tubular implant 111 on the magnets in the assembly station 110.

p00137At some point during or after implantation of assembly element 110 or tubular implant 111, the practitioner may wish to remove one or both components. Either or both components can be easily removed using any of a series of techniques generally known in the art. One such technique for removing or removing the intraluminal stent or part similar to an intraluminal stent of the assembly element 110 or the tubular implant 111 involves the use of a recovery hook and a collapsible sheath or over-tube. Said exemplary system is disclosed in EP 1 832 250, which is hereby incorporated by reference in its entirety. Other withdrawal or extraction systems are disclosed, for example, in each of United States Publication 2005/0080480, United States Patent 5,474,563 and United States Patent 5,749,921, each of which is incorporated hereby as a reference in its entirety.

p00138Figure 17A is a schematic view of a part of the digestive tract in the body. An assembly element 160 is implanted in the esophagus at the gastroesophageal junction 102. The assembly element serves as an anti-reflux valve when the tube 161 is compressed flat by the pressure in the stomach 103. Figure 17B is a schematic view of a part of the digestive tract in the body. An assembly element 162 is implanted in the esophagus at the gastroesophageal junction 102. The assembly element 162 has a neck or narrow part that has an internal diameter smaller than the diameter of the native gastroesophageal junction. Because of this reduced diameter, the assembly element 162 serves as a restrictive stoma. Figure 18 is a schematic view of a part of the digestive tract in the body. An assembly element 164 is implanted in the esophagus at the gastroesophageal junction 102. A tubular implant 165 is attached to the assembly element 164. The tubular implant may have a two-valve reflux valve166, a three-valve reflux valve 167, a four-valve reflux valve 168, a five-valve reflux valve 169, a six-valve reflux valve 170 or one seven valve reflux valve.

p00139Figure 19A is a schematic view showing an alternative embodiment of the invention, in which an assembly element is not used but rather a sleeve with an intraluminal stent is used 171. An intraluminal stent is used to keep the sleeve open and anchor it. The sleeve extends from a proximal end at or near the duodenal bulb 107 to a distal end at or near the Treitz ligament 109. Those skilled in the art will understand that, in the construction of a sleeve with anterior intraluminal stent, the intraluminal stent and the sleeve could be previously mechanically joined, such as by sutures or other chemical and mechanical adhesion in which case the expansion of the intraluminal stent gives as result was the anchoring of the cuff structure with intraluminal stent over the tissue. On the other hand, the intraluminal stent could also reside freely inside the cuff at its end and, when it expands, could press the cuff against the tissue to anchor it. All intraluminal stents and delivery catheters disclosed herein can also be used to deliver and anchor a sleeve with an intraluminal stent or to deliver an intraluminal stent into a sleeve to anchor it on the surrounding tissue.

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p00148Figure 19B is an alternative embodiment of the invention in which an assembly element is not used but rather a sleeve with intraluminal stent 172 is used. An intraluminal stent is used to keep the sleeve open and anchor it. As shown, in this embodiment, the sleeve extends from a proximal end at or near the pylorus 106 to a distal end at or near the Treitz ligament 109. Those skilled in the art will understand that, in the construction of a sleeve with anterior intraluminal stent, the intraluminal stent and the sleeve could be previously mechanically joined, such as by sutures or other chemical and mechanical adhesion in which case the stent expansion intraluminal results in anchorage of the cuff structure with intraluminal stent over the tissue. On the other hand, the intraluminal stent could also reside freely inside the cuff at its end and, when it expands, could press the cuff against the tissue to anchor it. All intraluminal stents and delivery catheters disclosed herein can also be used to deliver and anchor a sleeve with an intraluminal stent or to deliver an intraluminal stent into a sleeve to anchor it in the surrounding tissue.

p00149Figure 20 is an alternative embodiment of the invention in which an assembly element is not used but rather a sleeve with intraluminal stent 172 is used. An intraluminal stent is used to keep the sleeve open and anchor it. As shown, in this embodiment, the sleeve extends from a proximal end in the pyloric antrum 104 to a distal end at or near the Treitz ligament 109. Those skilled in the art will understand that, in the construction of a sleeve with anterior intraluminal stent, the intraluminal stent and the sleeve could be previously mechanically joined, such as by sutures or other chemical and mechanical adhesion in which case the stent expansion intraluminal results in anchoring the cuff structure with intraluminal stent to the tissue. On the other hand, the intraluminal stent could also reside freely inside the cuff at its end and, when it expands, could press the cuff against the tissue to anchor it. All intraluminal stents and delivery catheters disclosed herein can also be used to deliver and anchor a sleeve with an intraluminal stent or to deliver an intraluminal stent into a sleeve to anchor it in surrounding tissue.

p00150Figure 21A shows an embodiment of the invention in which a first assembly element (or anchor) 174 or a sleeve with intraluminal stent is implanted in the gastroesophageal joint 102 and a second assembly element (or anchor) 175 or sleeve with stent intraluminal is implanted in the duodenal bulb 107. Figure 21B shows an embodiment of the invention in which a first assembly element 174 or a sleeve with intraluminal stent is implanted in the gastroesophageal junction 102, a second assembly element 175 or sleeve with intraluminal stent in the duodenal bulb 107, and A third assembly element and a tubular implant 176 are implanted to prevent the stomach from 174 to 175.

p00151Figure 22A is an alternative embodiment of the invention in which a first assembly element 178 is implanted in the gastroesophageal junction 102, a second assembly element 177 and a tubular implant are implanted extending from the assembly element 178 to a distal end in or near the T reitz ligament . Figure 22B is an alternative embodiment of the invention in which a first assembly element 178 is implanted in the gastroesophageal junction 102, a second assembly element 179 and a tubular implant are implanted from the assembly element 178 to the duodenal bulb 107 .

p00152Figure 23A is an alternative embodiment of the invention, in which a first assembly element 180, having an anti-reflux valve, is implanted in the gastroesophageal junction 102, a second assembly element 181 and a tubular implant are implanted from the bulb duodenal 107 to a location at or near the Treitz ligament. A third assembly element 182 and a tubular implant is implanted from the assembly element 180 to the assembly element 181. Figure 23B is an alternative embodiment of the invention, in which a first assembly element 180 with an anti-reflux valve is implanted in the gastroesophageal junction 102, a second assembly element 183 and a tubular implant are implanted from the pylorus 106 to the Treitz ligament. A third assembly element 184 and a tubular implant are implanted from assembly 183 to assembly element 184.

p00153Figure 24 is an alternative embodiment of the invention in which a first assembly element 185 with an anti-reflux valve is implanted in the gastroesophageal junction 102, a second assembly element 186 and a tubular implant is implanted from the pyloric antrum 104 to the Treitz ligament. A third assembly element and a tubular implant 187 are implanted from the assembly element 185 to the assembly element 186. As shown, implant 187 includes an intraluminal stent or anchoring element similar to an intraluminal stent, which is adapted for delivery in a compressed configuration and to fit the first assembly element 185 in an expanded configuration.

p00154Figure 25 is a schematic view of a delivery catheter for a self-expanding assembly element 110, in accordance with embodiments of the invention. As shown in Figure 25, the catheter is preloaded with the assembly element but not the tubular implant. The delivery catheter is constructed with a central light 150 wide enough to allow the catheter to be loaded onto the outer diameter of an endoscope. The delivery catheter is constituted by an external catheter 151 and an internal catheter 152. For loading

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p00163the tubular implant on the delivery catheter, the handle of the outer sheath 153 retracts towards the handle of the inner catheter 154 until the distance 155 is sufficiently small. Once the tubular implant is loaded on the inner catheter, the outer sheath is partially closed by advancing the handle of the outer sheath away from the handle of the inner sheath 154. The outer sheath 151 is further advanced below until the tubular implant is complete (or sufficiently) covered by the outer sheath.

p00164The delivery catheter also has a space in the internal catheter for the modular implant 110 to be loaded. Attached to the internal catheter is an intraluminal stent retainer 159. The purpose of the intraluminal stent retainer 159 is to prevent the intraluminal stent from being released from the delivery catheter prematurely during deployment. The intraluminal stent retainer is attached to the internal catheter. The intraluminal stent retainer 159 can be made of metal or plastic and can be made radiopaque from a radiopaque material such as tantalum. The intraluminal stent retainer has a complementary shape that holds the tips on the intraluminal stent and does not allow the intraluminal stent to move distally or forward until the outer sheath 151 is fully retracted to the intraluminal stent retainer 159. The catheter has a side hole 156 that allows the space between the inner and outer sheaths to be washed with saline. The outer sheath 151 and the inner sheath 152 may be made of a simple single layer polymer extrusion such as from polyethylene or PTFE. The outer sheath can also be constructed as follows. The inner diameter surface of the sheath is constructed of a thin-walled PTFE liner 157. A reinforcement layer 158 is placed on the PTFE liner, the reinforcement is preferably a braided wire mesh or a wire spiral. The cross section of the wire can be round or rectangular. The preferred material for the wire is a metal such as 316 or 304 stainless steel or Nitinol or other suitable material. Wire diameters are normally in the diameter range of 0.0005 inches (0.0013 cm) to 0.010 inches (0.025 cm). The material of the outer jacket is preferably refluxed into the reinforcement layer by melting the material and making it flow into the spaces between the braided wire or the spiral wires.

p00165Figure 26 is a schematic view showing the delivery catheter for the disclosed apparatus loaded on an endoscope. Figure 27 is a schematic view of an alternative delivery catheter for a self-expanding assembly element 110, tubular implant 111 or for both 110 and 111 in the same catheter. The supply catheter is constructed with a smaller external diameter to allow the catheter to be inserted through the conduit for endoscope instruments 114. The supply catheter is constituted by an external catheter 151 and an internal catheter 152. Attached to the catheter internally there is an intraluminal stent retainer 159. The purpose of the intraluminal stent retainer 159 is to prevent the intraluminal stent from being released from the delivery catheter prematurely during deployment. The intraluminal stent retainer is attached to the internal catheter. The intraluminal stent retainer 159 can be made of metal or plastic and can be made radiopaque from a radiopaque material such as tantalum. The intraluminal stent retainer has a complementary shape that holds the tips on the intraluminal stent and does not allow the intraluminal stent to move distally or forward until the outer sheath 151 is fully retracted to the intraluminal stent retainer 159.

p00166The catheter has a side hole 156 that allows the space between the inner and outer sheaths to be washed with saline. The outer sheath 151 and the inner sheath 152 may be made of a simple extrusion of single layer polymer such as polyethylene or PTFE. The outer sheath can also be constructed as follows. The inner diameter surface of the sheath is constructed of a thin-walled PTFE liner 157. A reinforcing layer 158 is placed on the PTFE liner, the reinforcement is preferably a braided wire mesh or a wire spiral. The cross section of the wire can be round or rectangular. The preferred material for the wire is a metal such as 316 or 304 stainless steel or Nitinol or other suitable material. Wire diameters are normally in the diameter range of 0.0005 inches (0.0013 cm) to 0.010 inches (0.025 cm). The material of the outer jacket is preferably refluxed into the reinforcement layer by melting the material and making it flow into the spaces between the braided wire or the spiral wires. The external diameter of this catheter will normally vary between 1 mm and 4 mm. The catheter can be constructed to be a catheter over the wire or a rapid exchange catheter. For a rapid exchange design, the guide wire will enter the central light of the distal end of the catheter and will exit at point 188. For a catheter design on the wire, the guide wire will enter the central light of the distal end of the catheter and will come out at point 189.

p00167Figure 28 is a schematic view of an alternative embodiment drawing of a delivery catheter for a self-expanding assembly element 110 and a tubular implant 111. As shown in Figure 28, the tubular implant is located distal to the assembly element . The delivery catheter could also be used for the delivery of an intraluminal stent construction where the sleeve and the intraluminal stent are integrated with one another in an implant. The supply catheter is constructed with a central light 150 wide enough to allow the catheter to be loaded onto the external diameter of the endoscope 114. The supply catheter is constituted by an external catheter 151 and an internal catheter 152. To load the tubular implant onto the delivery catheter, the handle of the outer sheath 153 retracts toward the handle of the inner catheter 154 until the distance 155 is sufficiently small. The outer sheath is then partially closed by advancing the handle of the outer sheath away from the handle of the inner sheath 154. Then it is made

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p00176advance further to the outer sheath 151 until the tubular implant is complete (or sufficiently) covered by the outer sheath. The delivery catheter also has a space in the internal catheter for the modular implant 110 to be loaded. Attached to the internal catheter is an intraluminal stent retainer 159. The purpose of the intraluminal stent retainer 159 is to prevent the intraluminal stent from being released from the delivery catheter prematurely during deployment. The intraluminal stent retainer is attached to the internal catheter. The intraluminal stent retainer 159 can be made of metal or plastic and can be made radiopaque from a radiopaque material such as tantalum. The intraluminal stent retainer has a complementary shape that holds the tips on the intraluminal stent and does not allow the intraluminal stent to move distally or forward until the outer sheath 151 is fully retracted to the intraluminal stent retainer 159.

p00177The catheter has a side hole 156 that allows the space between the inner and outer sheaths to be washed with saline. The outer sheath 151 and the inner sheath 152 may be made of a simple extrusion of single layer polymer such as polyethylene or PTFE. The outer sheath can also be constructed as follows. The inner diameter surface of the sheath is constructed of a thin-walled PTFE liner 157. A reinforcing layer 158 is placed on the PTFE liner, the reinforcement is preferably a braided wire mesh or a wire spiral. The cross section of the wire can be round or rectangular. The preferred material for the wire is a metal such as stainless steel 316, 304, Nitinol or other suitable material. Wire diameters are normally in the diameter range of 0.0005 inches (0.0013 cm) to 0.010 inches (0.025 cm). The material of the outer jacket is preferably refluxed into the reinforcement layer by melting the material and flowing the molten polymer into the spaces between the braided wire or the spiral wires.

p00178Figure 29 is a drawing of an intraluminal stent that can be used as an assembly element. The intraluminal stent 137 is preferably laser cut from a round metal tube or from a flat metal sheet. The flat representation of the circumference of the intraluminal stent is shown in item 138. The flat representation of an expanded intraluminal stent is shown in item 139. The end view of the intraluminal stent is shown 141. Magnets 140 are attached to the intraluminal stent in the internal diameter. The magnets can be attached to the intraluminal stent using a mechanical fixator, glue, suture, welding, pressure adjustment or other suitable means. The intraluminal stent can be balloon expandable or self-expanding. The magnets may be located in the middle of the intraluminal stent or at the ends of the intraluminal stent. Suitable materials for magnets include, for example, neodymium-iron-boron [Nd-Fe-B], samarium-cobalt [Sm-Co], alnico, and hard ferrite [ceramic] or other suitable material. The intraluminal stent may expand with a balloon or self-expand.

p00179Figure 30 is a drawing of an intraluminal stent that can be used as an assembly or anchoring element 110. The intraluminal stent can be laser cut from metal tubes or from a flat sheet of metal. The intraluminal stent may also be braided or woven from round or flat wire. As shown in Figure 30, the intraluminal stent has a double layer mesh construction and can have a separation between the two layers to allow other mechanical elements attached to the tubular implant to be mechanically engaged with the intraluminal stent without exert any anchoring force against the tissue.

p00180In the image shown, the intraluminal stent has a narrowed diameter at the midpoint of the length, this will allow the intraluminal stent to anchor more firmly in anatomical locations such as the pylorus 106. According to other embodiments, the intraluminal stent It has a cylindrical shape or other form of double layer construction as a dumbbell shape. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application. Magnets or other mechanical means for joining a tubular implant can be incorporated, as disclosed in this application. The intraluminal stent may expand with a balloon or be self-expanding. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application. Although the preferred embodiment of the anterior intraluminal stent is a double-layer mesh construction, other single-layer or multi-layer constructions that create a hollow space within the structure could also be used to allow engagement with other tubular implants. The space between the two mesh layers of the intraluminal stent also helps to prevent or minimize tissue growth towards the interior that reaches the second (i.e. internal) layer of the intraluminal stent and in the same way it reaches a tubular implant or therapy coupled to the inner layer of the intraluminal stent. Preventing or minimizing said tissue growth inwards facilitates the safe and easy removal (or replacement) of any such tubular or therapy implant.

p00181Figure 31A is a drawing of an intraluminal stent that can be used as an assembly or anchoring element. The intraluminal stent can be braided from round or flat wire. As shown in Figure 31A, the intraluminal stent is in an expanded state. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material, as previously disclosed in this application. The intraluminal stent may expand with a balloon or be self-expanding. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application. Figure 31B is a drawing of an intraluminal stent that can be used as

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p00190assembly element. The intraluminal stent can be braided from round or flat wire. As shown in Figure 31B, the intraluminal stent is in an expanded state. The intraluminal stent may include magnets 140 attached to the intraluminal stent. The magnets can be in the internal diameter, external diameter, internal or external diameter or incorporated into the wall. The magnets can be used as a means to attach a tubular implant such as 111. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application. The intraluminal stent may expand with a balloon or be self-expanding. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material, as previously disclosed in this application.

p00191Figure 32A is a drawing of an intraluminal stent that can be used as an assembly or anchoring element. The intraluminal stent can be laser cut from a round metal tube or from a flat sheet of metal. The central part of the diameter of the intraluminal stents can be adjusted to a smaller diameter to provide increased resistance to the migration of the intraluminal stent. The intraluminal stent may expand with a balloon or be self-expanding. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application. Figure 32B is a drawing of an intraluminal stent that can be used as an assembly feature. The intraluminal stent can be laser cut from a round metal tube or from a flat sheet of metal. The central part of the diameter of the intraluminal stents may conform to an hourglass shape to provide increased resistance to the migration of the intraluminal stent. As shown in Figure 32B, the intraluminal stent has rings 190 at the end of the intraluminal stent. The rings can be used to engage with an intraluminal stent retainer 159 in the inner catheter 152 to prevent premature deployment so that the sheath is fully retracted. Radiopaque markers 191 may be attached to the end of the intraluminal stent to increase the radiopacity of the intraluminal stent. A metal insert can be pressed or stamped on the rings 190. The insert can be made of a high atomic density material such as tantalum, gold, platinum or iridium. The insert can take the form of a disk or sphere and can be deformed plastically to fill the cavity of the ring. The intraluminal stent may expand with a balloon or be self-expanding. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application.

p00192Figure 33A is a drawing of an intraluminal stent that can be used as an assembly element. The intraluminal stent is preferably laser cut from a round metal tube or from a flat sheet of metal. The intraluminal stent may expand with a balloon or be self-expanding. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application. Figure 33B is a drawing of an intraluminal stent that can be used as an assembly element. The intraluminal stent is preferably laser cut from a round metal tube or from a flat sheet of metal. The intraluminal stent may expand with a balloon or be self-expanding. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application.

p00193Figure 34A is a drawing of a spiral intraluminal stent that can be used as an assembly element. The intraluminal stent is preferably made of round or flat wire. The intraluminal stent is preferably self-expanding, but may be made to be balloon expandable. The intraluminal stent can also be laser cut in a spiral from a tube. The preferred material for the intraluminal stent is Nitinol. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application. The intraluminal stent has a ring 192 at each end of the spiral. The intraluminal stent can be wound over a catheter by inserting a pin into the rings at each end of the intraluminal stent and rotating the pins in opposite directions to cause the intraluminal stent to wind over a catheter. Figure 34B is a drawing of a spiral intraluminal stent that can be used as an assembly element. The intraluminal stent is preferably made of round or flat wire. The intraluminal stent is preferably self-expanding, but may be made to be balloon expandable. The intraluminal stent can also be laser cut in a spiral from a tube. The preferred material for the intraluminal stent is Nitinol. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application. The intraluminal stent has a ring 192 at each end of the spiral. The intraluminal stent can be wound over a catheter by inserting a pin into the rings at each end of the intraluminal stent and rotating the pins in opposite directions to cause the intraluminal stent to wind over a catheter. The intraluminal stent has magnets 140 and the spiral of the intraluminal stent. The magnets can be used as a means of attachment to a tubular implant.

p00194Figure 35 is a drawing of a spiral intraluminal stent that can be used as an assembly element. The intraluminal stent is preferably made of a Nitinol metal wire or sheet. Several serial intraluminal stents adjacent to each other can be used to form the assembly element.

p00195Figure 36A is a drawing of an intraluminal stent that can be used as an assembly element. The intraluminal stent is preferably laser cut from a round metal tube or from a

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p00204flat metal sheet. The intraluminal stent is shaped in a conical shape to provide increased resistance to intraluminal stent migration and to more closely fit the anatomy. The intraluminal stent may expand with a balloon or be self-expanding. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application. Figure 36B is a drawing of an intraluminal stent that can be used as an assembly element. The intraluminal stent is preferably laser cut from a round metal tube or from a flat sheet of metal. The intraluminal stent is shaped to have a stepped diameter to provide increased resistance to intraluminal stent migration and to more closely fit the anatomy. The intraluminal stent may expand with a balloon or be self-expanding. The mesh of the intraluminal stent may be left open or it may be covered with a suitable material previously disclosed in this application.

p00205Figure 37 shows schematic views of an assembly element. The assembly element is composed of three main components: an intraluminal stent 194, a sleeve material 193 and magnets 140. The intraluminal stent can be self-expanding or balloon expandable. The sleeve can be any suitable material, as previously disclosed in this application. The magnets can be attached to the sleeve by means of adhesive or mechanical fasteners such as rivets, screws, suture or mechanical gear.

p00206Figure 38 shows schematic views of an assembly element. The assembly element is composed of four main components: an intraluminal stent 194, a sleeve material 193, radiopaque markers 196 and pockets 195. The intraluminal stent can be self-expanding or balloon expandable. The sleeve may be made of any suitable material, as previously disclosed in this application. Pockets 195 are like small sleeves that are created in sleeve material 194. Pockets 195 can be manufactured by sewing or by using a mechanical fastener. The pockets 195 form receptacles to contain magnets or other fasteners that are supplied to the pocket, so that the assembly element can be assembled on site. This design allows much larger magnetic or mechanical fasteners to be incorporated into the assembly element. A guide wire can be inserted into the pockets and the magnets or fasteners can be advanced over the guide wire into the pocket with endoscopic guidance. The sleeve may have holes 197 cut in it to allow some fluid transfer through the assembly element, if desired.

p00207Figure 39 is a drawing of an assembly element. The assembly element is composed of four main components: an intraluminal stent 194, a sleeve material 193, radiopaque markers 196 and hooks 198. The intraluminal stent can be self-expanding or balloon expandable. The sleeve may be made of any suitable material, as previously disclosed in this application. The hooks 198 are made of metal or plastic and are joined by adhesive, mechanical means or integrated in the sleeve material. The hooks serve as an assembly feature to engage with a corresponding element in a tubular implant. The sleeve may have holes 197 in it to allow some fluid transfer through the assembly element if desired.

p00208Figures 40A-40C show expandable rings that can be attached to a sleeve to form a tubular implant

p00209111. The rings can be made of metal or plastic and can be self expanding or balloon expandable. In various embodiments, the rings are made of Nitinol. The expandable rings serve as a coupling characteristic that function to engage so that tubular implant 111 can be released to an assembly characteristic in the assembly or anchoring element 110.

p00210Figure 41 is a drawing of a tubular implant. The implant is composed of sleeve material 193, expandable ring 199 and a radiopaque marker 196. The sleeve can be of any suitable material as previously disclosed in this application and the expandable ring can be of any suitable design as disclosed. in figures 40A-40C. Holes 197 can be cut in the sleeve to allow drainage through the sleeve. The expandable ring can be fixed to the sleeve by mechanical fasteners such as suture, wire, tweezers, or by adhesive or other suitable means. Figure 42 is a drawing of a tubular implant with expandable ring 199 and sleeve material 193 placed expanded and anchored to an assembly or anchoring element (such as, for example, the anchoring element shown in Figure 30). Figure 43 is a drawing of a tubular implant with expandable ring 199 and sleeve material 193 placed expanded and anchored to an assembly element. The assembly element is a modification of Figure 30. The assembly element has both layers of braided mesh or material, but is cylindrical without the hourglass shape of Figure 30. In both figures 42 and 43 the coupling characteristic of the tubular implant is configured to engage so that it can be released to the internal part of the intraluminal stent (i.e., the assembly characteristic) of the assembly or anchoring element.

p00211Figure 44 shows an assembly element composed of three main components: an intraluminal stent 194, a sleeve material 193 and a hook and loop fastener (velcro) 200 or 201. The intraluminal stent can be self-expanding or balloon expandable. The hook and loop fastener can be sewn or glued on the sleeve material. The tubular implant that attaches to the assembly element of this construction must have the hook fastener if the assembly station has the loop fastener or vice versa.

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p00220Figure 45A is a drawing of a tubular implant. The tubular implant is designed to be attached to another tubular implant or to an assembly station by means of a magnetic joining means. The tubular implant has 140 magnets embedded in the wall. Alternatively, the magnets could be located on either or both of the inner and outer walls. The magnets allow an end-to-end connection method between the components. Figure 45B shows a tubular implant with a complementary end or female component that will mate with the male component of Figure 45A.

p00221Figure 46A shows a basic sleeve that will be used as a component of an assembly station, tubular implant, or to extend a tubular implant. The sleeve has radiopaque markers 196 and may have holes in the sleeve 197 to allow some fluid flow through the sleeve if required. Figure 46B shows a basic sleeve that will be used as a component of an assembly station, tubular implant, or to extend a tubular implant. The sleeve has magnetic particles or ferromagnetic material 140 incorporated in the sleeve to allow attachment of the sleeve to a magnetic assembly station or tubular implant.

p00222Figure 47A shows a basic sleeve that will be used as a component of an assembly station, tubular implant, or to extend a tubular implant. The sleeve has magnetic particles or ferromagnetic material 140 incorporated in the sleeve to allow attachment of the sleeve to a magnetic assembly station or tubular implant. The sleeve also has longitudinal folds 202 on the surface to allow its diameter to fold more evenly and can help reduce the loaded profile. The longitudinal folds may be over the entire length or only a part of the diameter or length. Figure 47B shows a basic sleeve that will be used as a component of an assembly station, tubular implant, or to extend a tubular implant. The sleeve also has folds around the circumference 203. The circumferential folds will allow the tubular implant or sleeve to bend more easily without twisting.

p00223Figure 48A shows a tubular implant designed to be attached to another tubular implant or to an assembly station by means of a magnetic joining means. The tubular implant has magnets 140 in the outer diameter. Figure 48B shows a tubular implant designed to be attached to another tubular implant or to an assembly station by means of a magnetic joining means. The tubular implant has magnets 140 in the thickness of the wall.

p00224Figure 49 shows a tubular implant that is constructed with a sleeve material 193, and provided with hooks with spikes 204. The hook 204 has 2 spikes per hook, the hook 205 has a spike per hook, the hook 206 has no spikes, The hook 207 and 208 have different bending angles. The modular implant can be attached to an assembly element or directly to the anatomy or to another sleeve.

p00225Figure 50A shows a basic sleeve with pockets 195. The basic sleeve can be used as part of an assembly station or tubular implant. Figure 50B shows a basic sleeve with hooks 198. The sleeve can be used as part of an assembly station or tubular implant. Figure 51A is a basic sleeve with a conical diameter. The sleeve can be used as part of an assembly station or tubular implant. Figure 51B is a basic sleeve with a stepped diameter. The simple sleeve can be used as part of an assembly station or tubular implant. Figure 52 is a basic sleeve with hook and loop fastener (Velcro) in the outer diameter. The sleeve can be used as part of an assembly station or tubular implant.

p00226Figure 53A is a balloon catheter for intraluminal stent delivery for assembly elements or sleeves with intraluminal stents. The catheter is a design on the wire. Figure 53B is a balloon catheter for intraluminal stent delivery for assembly elements or sleeves with intraluminal stents. The catheter is quick exchange design.

p00227Figure 54 shows an enlarged view of the gastrointestinal anatomy of the junction between the stomach and the duodenum, including the pyloric antrum 104, the pylorus 106 and the duodenal bulb 107. A soft braided assembly or anchoring element 209 is placed in the joint pyloric (that is, it spreads through the pylorus). As shown in Figure 54, the assembly element is a variant of the element shown in Figure 42 using a single braided mesh. As shown, the assembly element 209 is shaped so as not to exert radial forces on the stomach wall or the duodenal wall for anchoring. It is retained within the pyloric junction due to its shape, which has an external diameter greater than the maximum external diameter of the pyloric orifice. As shown in Figure 54, the assembly element 209 includes a proximal part (i.e., the part located in the pyloric antrum 106), a distal part (i.e., the part located in the duodenal bulb 107, and a neck part adapted to extend through pylorus 106. According to various embodiments, the proximal and distal portions are shaped so that each has an unconstrained diameter of between about 15 and about 25 millimeters, and the neck portion has an unconstrained diameter of between about 5 and about 15 millimeters. . In some embodiments, the proportion of the diameter of the proximal part with respect to the diameter of the neck part is between about 1.2 and about 5. According to various embodiments, the neck part is formed with an unconstrained diameter smaller than a maximum diameter of the native pylorus, so that the neck part functions to restrict the flow from the stomach into the duodenum (i.e., to function as a restrictive stoma). In other embodiments, the neck portion is formed with an unconstrained diameter greater than a maximum diameter of the native pylorus, so that

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p00242the neck part does not restrict the flow from the stomach into the duodenum (i.e. through the pylorus).

p00243Figure 55 shows another assembly or anchoring element 210 that has an alternative shape. In this case, the proximal part of the anchoring element 210 (i.e., the part located on the side of the pyloric antrum) is more similar to a disk and serves as a pronounced anchor / retention flange for the device. In some embodiments, the anchoring element 210 has a maximum or unconstrained diameter slightly larger than an internal diameter of the pyloric anchor, so that the assembly element 210 exerts a slight radial force on the wall of the pyloric anchor. In other embodiments, the unconstrained form is such that the anchoring element 210 does not exert a radial force on the wall of the pyloric antrum. To minimize or prevent abrasive injury to tissue and tissue growth inwards, and to provide ease of replacement, exemplary embodiments of assembly elements 209 and 210 could be covered with flexible woven fabric or extruded nonwoven polymer material used in medical implants. Synthetics such as polyurethane, silicone, ePTFE, etc. Figures 56 and 57 show exemplary covered embodiments where the assembly element includes a cover 211.

p00244According to various embodiments, one or both of the proximal part and the distal part of the anchoring element are sized or shaped so that at least a part of the anchoring element has an unconstrained diameter greater than the diameter of the corresponding anatomical organ ( for example, the pyloric antrum or the duodenal bulb), so that, when implanted, the anchoring element exerts a radial force on the wall of the organ.

p00245Figure 58 shows a different design of the assembly element, where the assembly element 213 is now constituted by proximal (ie, stomach side) and distal (i.e., duodenal side) metallic elements connected by an element flexible sleeve (tubular) 212. Flexible element 212 could be constructed of materials such as silicone, polyurethane, ePTFE, etc., which are resistant to stomach acids, enzymes and intestinal juices. Flexible element 212 provides minimal interference to the opening and closing of the pyloric valve. Figure 58 depicts the sleeve element in a somewhat compressed state (hence the drawing showing wrinkles in sleeve 212. Figure 59 represents the same assembly element 213 where the pylorus 106 is now fully open and the sleeve member 212 is in an expanded state. Figure 60 represents another assembly element 214 where the flexible sleeve element 212 is attached to other assembly structures such as the assembly element 210 shown in Figure 55. According to various embodiments, flexible element 212 has an external diameter substantially similar to the maximum diameter of the native pylorus. The flexible element 212, for example, can have a diameter of between about 5 and about 15 millimeters. According to other embodiments, the diameter of the flexible element 212 is adjusted somewhat smaller than the maximum diameter of the pylorus, so that the flexible element 212 acts to restrict the flow from the stomach into the duodenum. According to various embodiments, the neck part is attached to the proximal and distal intraluminal stent parts by a sewing technique.

p00246Figure 61 depicts a tubular implant 215, which is a variant of the tubular implant of Figure 41. In this case, the flexible sleeve portion has a more stepped shape, as shown in the tubular implant in Figure 51B. The stepped part of the tubular implant can serve the purpose of acting as a restrictive element for the passage of food, depending on the choice of input and output dimensions. The tubular element also has anchor or coupling characteristics similar to a ring 199 attached to its proximal end similar to the tubular element of Figure 41.

p00247Figure 62 depicts the anchoring elements similar to a ring 199 of the tubular implant 215 of Figure 61 constrained in a delivery catheter 216 as it is being removed near the assembly element. Figure 63 depicts the assembly element and tubular implant 215 coupled to each other at the time of delivery of the delivery catheter. By removing the supply catheter while the tubular element is anchored in place, the anchoring elements similar to a ring are released from the supply catheter and expand to their unconstrained adjusted shape and diameter. At the time of said expansion, the digitiform projections or protrusions of the coupling feature 199 fit into the distal part of the assembly element. In these embodiments, the distal part of the assembly element is sized and shaped so that the protrusion of the coupling characteristic can extend through the openings (i.e. assembly characteristics) in the proximal part, so that the characteristic coupling 199 of the tubular implant fits the assembly or anchoring element. In addition to providing an anchoring function resisting forces directed towards the pylorus or stomach, the distal part of the assembly element 209 also provides a certain amount of structural support to the tubular implant 215, which helps resist the twisting, joining or twisting of the tubular implant

p00248Figure 64 shows the tubular implant 215 attached to the assembly element 213 using the same steps as those outlined in Figures 62 and 63. Figure 65 shows a variant of the same concept where the tubular element 215 is now attached to the stomach side of the assembly element 213. In this case, the supply catheter will have to be removed through the pylorus before activating the release of the annular element.

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p00260Although each of Figures 63-65 shows a modular system in which a tubular implant is coupled so that it can be disassembled or released with an assembly or anchoring element, in accordance with other embodiments, the tubular implant is structurally integrated with the assembly or anchoring element (for example, as shown in Figures 19-20). The tubular implant and the assembly element can be integrated using various techniques, including for example adhesive bonding, mechanical fixation, sewing and molding on a model piece. Similarly, according to some embodiments, parts of the system are modular while other parts are formed from one piece. For example, according to exemplary embodiments, the anchoring element and a tubular implant located within the duodenum are formed in one piece and the assembly element and a tubular implant located in the gastroesophageal junction and inside the stomach are modular.

p00261Figures 66-78 show schematic views of various phases of the implementation of some embodiments of the invention. Figure 66 shows the initial phase of a minimally invasive method of implanting any of the various embodiments disclosed herein. As shown, the physician has advanced (for example, endoscopically) a delivery system 300 to the pyloric antrum 104. The delivery system 300, according to some embodiments, includes an endoscope for viewing and a double catheter system for fixing the prostheses in a retracted configuration. According to some embodiments, the delivery system 300 includes each of the components shown in and described with reference to Figure 8.

p00262As shown in Figure 67, the physician has successfully guided the delivery system 300 through the pylorus 106, so that a tip of the delivery system is located within the duodenal bulb 107. Next, as shown In Figure 68, the physician has operated the delivery system 300 (for example, by retracting an external sheath or catheter), to release a distal part of the assembly or anchoring element 110 in the duodenal bulb. As shown, the physician advances the supply system 300 a sufficient distance to allow the distal part to fully expand within the duodenal bulb 107 and a neck portion of the anchoring element 110 expands within the opening of the pylorus 106 . Next, as shown in Fig. 69, the delivery system 300 is further operated to release a proximal part of the anchoring element 110 with the pyloric anchor 104. As shown, in this phase, the element anchor 110 is completely detached from the delivery system. As shown in Figure 70, the anchoring element is implanted through the pylorus 106, so that the proximal part of the anchoring element fits into the proximal surface of the pylorus and the distal part fits into the distal surface of the pylorus.

p00263Next, as shown in Figure 71, the delivery system 300, which holds the tubular element

p00264or therapy 111 in a retracted configuration, is advanced through the pylorus 106 into the duodenal bulb 107. The delivery system 300, as shown in Figure 72, is then advanced down the duodenum ( and, as desired, the jejunum), until the tip reaches the most distal implant location desired. Next, as shown in Figure 73, the physician operates the delivery system 300 (for example, by retracting an external catheter), to release a distal part of the therapy element 111 with the duodenum (or jejunum). Next, as shown in Figures 74-76, the delivery system is further retracted so that the therapy element 111 is further released from the delivery system 300. As shown in Figures 77-78, the therapy element 111 is completely released from the delivery system 300 and has been fitted into the assembly element 110.

p00265Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, although the embodiments described above refer to particular features, the scope of this invention also includes embodiments that have different combinations of features and embodiments that do not include all of the features described. Accordingly, the scope of the present invention is intended to encompass all such alternatives, modifications and variations that are within the scope of the claims, together with all equivalents thereof.