One of the drawbacks of bariatric surgical procedures is that they require fairly invasive surgery with potentially serious complications and long patient recovery periods. In recent years, there is an increasing amount of ongoing effort to develop minimally invasive procedures to mimic the effects of bariatric surgery using minimally invasive procedures. One such procedure involves the use of gastrointestinal implants that modify transport and absorption of food and organ secretions. For example, U.S. Patent 7,476,256 describes an implant having a tubular sleeve with an anchor having barbs. While these implants may be delivered endoscopically, the implants offer the physician limited flexibility and are not readily removable or replaceable, since the entire implant is subject to tissue in-growth after implantation. Moreover, stents with active fixation means, such as barbs that penetrate into the surrounding tissue, may potentially cause tissue necrosis and erosion of the implants through the tissue, which can lead to serious complications, such as systemic infection. Also, due to the intermittent peristaltic motion within the digestive tract, implants such as stents have a tendency to migrate. The document US 2008/0221597 A1 discloses a device for fixating a gastrointestinal device by a band of material being wrapped around the gastrointestinal tract in such a way that it is integrated into the stomach tissue. The document US 2005/0197714 A1 shows another example of a system for regulating absorption and caloric intake by an elongated tube fixed in the stomach by a clamping structure. The document US 2009/0093767 A1 as well as the document US 2005/0096673 A1 disclose devices and methods for retaining a medical implant within a body cavity.
According to various embodiments, the present invention as defined by claim 1 is a gastrointestinal implant system for treating metabolic disorders, such as diabetes and obesity. The system includes a tubular implant adapted for placement within at least a portion of the duodenum, the tubular implant having a securing feature and an external band configured for implantation around at least one of a pylorus, and the duodenum, the external band having a coupling feature for removably engaging and coupling with the securing feature of the tubular implant without penetrating the duodenum or pylorus, such that the tubular implant resists migration within the gastrointestinal tract, wherein the external band has an implanted inner diameter generally equal to a corresponding outer diameter of the duodenum or pylorus, and the securing feature and coupling feature are configured such that the tubular implant is releasably coupled to the external band to facilitate removal of the tubular implant, wherein the securing feature and the coupling feature are each magnetic structures adapted for magnetically coupling the tubular implant to the external band, wherein the securing feature and the coupling feature are configured to secure the tubular implant to the external band by magnetic attraction.
According to various examples useful for understanding the present invention, a modular gastrointestinal implant system is presented for treating metabolic conditions, such as diabetes and obesity. The system includes an external implant configured for affixing around at least a portion of a duodenum or pylorus, the external implant having a docking feature, and a therapeutic implant adapted for placement within a gastrointestinal tract, the therapeutic implant having a securing feature adapted to removably couple with the docking feature without penetrating the gastrointestinal tract, such that the therapeutic implant resists migration within the gastrointestinal tract, wherein the external band has a diameter generally equal to the diameter of the duodenum or pylorus.
According to other examples useful for understanding the present invention, a method is presented of treating metabolic conditions, such as diabetes and obesity. The method includes placing an external implant around at least a portion of the duodenum, the external implant having a docking feature and the external implant having an inner diameter generally equal to an outer diameter of the corresponding portion of the esophagus, implanting, using a minimally-invasive technique, an internal tubular implant having a securing feature to a location within the duodenum corresponding to the location of the external implant, and causing the securing feature to removably couple with the docking feature without penetrating the duodenum.
According to various examples useful for understanding the invention, a modular system is illustrated for creating internal bypass of food and organ secretions within the gastrointestinal tract that includes low-profile implants that are affixed around the stomach, the esophagus, the intestine or externally around junctions of these organs, and gastrointestinal implants that permit internal by-pass of food and organ secretions from one site within the gastrointestinal tract to other sites within the gastrointestinal tract that have complementary design features to the external implant that enables secure placement within the gastrointestinal tract.
According to various examples useful for understanding the invention, a modular system is illustrated for creating a completely reversible internal bypass of food and organ secretions within the gastrointestinal tract that includes low-profile implants that are affixed around the stomach, the esophagus, the intestine or externally around junctions of these organs and which enable secure attachment of other implants within the gastrointestinal tract, and gastrointestinal implants that permit internal by-pass of food and organ secretions from one site within the gastrointestinal tract to other sites within the gastrointestinal tract that have complementary design features to the external implant that enables secure placement within the gastrointestinal tract.
According to various examples useful for understanding the invention, a modular system is illustrated for treating gastro-esophageal reflux disease (GERD) that includes low-profile implants that are affixed around the stomach, the esophagus, the intestine or externally around junctions of these organs and which enable secure attachment of other implants within the gastrointestinal tract, and an internal tubular implant of a design that normally permits only one-way passage of food from the esophagus to the stomach and that can be secured within the gastrointestinal tract by the external low-profile implant.
According to various examples useful for understanding the invention, a method is illustrated for creating a reversible treatment for metabolic disorders, such as diabetes and obesity, and for the treatment of gastro-esophageal reflux disease (GERD), including placing low-profile implants that can be affixed around the stomach, the esophagus, the intestine or externally around junctions of these organs and which enable secure attachment of other implants within the gastrointestinal tract, and placing other gastrointestinal implants that permit internal by-pass of food and organ secretions from one site within the gastrointestinal tract to other sites within the gastrointestinal tract, which do not directly anchor to the tissue but are securely held by the external implant so that the procedure can be reversed easily.
According to various examples useful for understanding the invention, a method of treating metabolic disorders is illustrated, such as obesity and diabetes, by placing a permanently band like structure around the esophagus, the stomach, the intestine or externally around junctions of these organs, and endoscopically placing a long tubular sleeve within the GI tract with expandable elements at its ends, those expandable elements having design functionality that enables it to be reversibly secured in position by the external band.
According to various examples useful for understanding the invention, a method is illustrated for creating a gastrointestinal bypass, the method including delivering a band like structure at appropriate locations around the gastrointestinal tract, such as the esophagus, the stomach, the duodenal bulb, the pyloric junction, the gastro-esophageal junction, etc.; and delivering a tubular sleeve with expandable ring shaped elements at its ends, those rings having outward indentations that enable it to be reversibly secured in position by the external band.
According to various examples useful for understanding the invention, as a second mode of anchoring, stabilizing, or preventing migration, the external band is coupled to an anatomical feature (e.g., a ligament) external to the tissue of the esophagus, stomach, pylorus, or intestine. In some examples useful for understanding the invention, the external band is intertwined with, interlocked with or threaded between the anatomical feature and the tissue. According to one example useful for understanding the invention, the external band is coupled to the hepatoduodenal ligament. This second mode of anchoring enables the use of external bands that do not rely on excessive compressive force to keep the implant in place, since excessive compressive forces can cause tissue necrosis and erosion.
While multiple embodiments are disclosed, still other embodiments of the present invention as defined by the appended claims 1-10 will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention as defined by the appended claims 1-10. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
FIG. 19 shows the system of FIG. 18, where the endoscope has been withdrawn to the duodenal bulb. The balloon on the balloon catheter is then deflated and the balloon catheter is withdrawn to the duodenal bulb. The balloon is then reinflated to open up and secure the proximal end of the tubular implant to the inside diameter of the docking element.
FIG. 21 is a sectional view of a portion of the digestive tract in the body. An external anchoring device is implanted around the stomach about 5 cm (a couple of inches) below the gastro-esophageal junction. The external anchoring device can serve as a restrictive means and can form a pouch-like restrictive segment at the top of the stomach. An internal tubular implant is implanted from the external anchoring device at the stomach to the ligament of Treitz.
FIGS. 28-31 show sectional views of various examples of an external anchoring device implanted around the duodenal bulb. An internal tubular implant is implanted from the duodenal bulb to the ligament of Treitz. The internal tubular implant one of more expandable rings or stents to anchor the device inside of the duodenal bulb.
FIGS. 34, 37, 38 show various examples of an internal tubular implant sleeve. FIGS. 35, 36, 39 show an internal tubular implant sleeve according to various embodiments of the invention.
FIGS. 50-51 show various examples of a delivery device for an internal tubular implant.
While the invention defined by claim 1 is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
FIG. 1 is a schematic, sectional view of a portion of a human digestive tract. As a person ingests food, the food enters the mouth 100, is chewed, and then proceeds down the esophagus 101 to the lower esophageal sphincter at the gastro-esophageal junction 102 and into the stomach 103. The food mixes with enzymes in the mouth 100 and in the stomach 103. The stomach 103 converts the food to a semi-fluid substance called chyme. The chyme enters the pyloric antrum 104 and exits the stomach 103 through the pylorus 106 and pyloric orifice 105. The small intestine is about (21 feet) long in adults and is comprised of three sections: the duodenum 112, the jejunum 113 and the ileum (not shown). The duodenum 112 is the first portion of the small intestine and is typically 25 - 30 cm (10-12 inches) long. The duodenum 112 is comprised of four sections: the superior, descending, horizontal and ascending. The duodenum 112 ends at the ligament of Treitz 109. The papilla of Vater 108 is the duct that delivers bile and pancreatic enzymes to the duodenum 112. The duodenal bulb 107 is the portion of the duodenum which is closest to the stomach 103.
FIG. 2 shows an external band that may be used to provide for an external anchoring device to secure the internal tubular implant. The band 250, according to various embodiments, is made from one or more elastomers (e.g., silicone, polyurethane, and ePTFE), metals or fabrics (e.g., Dacron or a combination of polymers and textile materials). The band can be made flexible with varying degrees of longitudinal elasticity. According to various embodiments, the external band includes magnets 135 located on the inside surface, outside surface, or embedded in the middle of the band. Suitable materials for the magnets include, for example: neodymium-iron-boron [Nd-Fe-B], samarium-cobalt [Sm-Co], alnico, and hard ferrite [ceramic] or other suitable material. The magnets may be plated with gold or platinum or other material to make them radio-opaque or to improve corrosion resistance. The magnets may be encapsulated within a metal casing such as titanium or stainless steel to improve the corrosion resistance and the biocompatibility. As shown in FIG. 2, the magnets 135 are shaped as bars, which may have a length generally similar to the width of the band 250. According to various embodiments, the band is placed around the intended implant location (e.g., the duodenal bulb, esophagus, or stomach). The band, according to various embodiments, is wrapped around the implant location like a belt. As shown, for example, in FIG. 2, one end of the band 250 has a loop 252 and the other end has a button 251. The band is enclosed around the duodenal bulb or other implant location, the loop 252 is snapped over the button 251 to secure the band closed. The magnetic poles of the magnet are aligned such that the all the north poles are aligned to the inside or outside of the band. The magnets on the inside tubular implant are assembled to the device, so the poles are the opposite magnetic polarity, and the outside band and the inside tubular implanted will attract to each other when one device is sleeved inside the other.
FIG. 8 shows an internal tubular implant that can be used to bypass the stomach 103, duodenum 112 or other intestinal lumen. The tubular implant is made of a thin wall tube 148 and a series of magnets 140 attached to the inside of the thin wall tube. The tubular implants, according to various embodiments, are made from one or more of the following materials: silicone, polyether block amides (PEBAX), polyurethanes, silicone polyurethane copolymers, Nylon, polyethylene terphalate (PET), ePTFE, Kevlar, Spectra, Dyneena, polyvinyl chloride (PVC), polyethylene, polyester elastomers or other suitable materials. The thin wall tube length, according to various embodiments, may range from about 2.5 cm (1 inch) in length up to about 150 cm (5 feet) in length. The thickness of the thin walled tube will typically be in the range of from about 0.00025 cm (0.0001 inch) thick up to about 25 cm (0.10 inch) thick. The diameter of the tubular implant will typically range from about 25 mm to about 35 mm, with a maximum range anticipated of from about 5 mm to about 70 mm in diameter.
Next, as shown in FIG. 16, the outer sheath 151 on the delivery catheter is retracted about 5 cm (a couple of inches) to expose the tubular implant 111.
Next, as shown in FIG. 17, a sizing balloon 121 is inserted through the working channel 119 on endoscope 114. The sizing balloon 121 is advanced about 2.5 cm (one inch) beyond the distal end of the endoscope 114 but still inside of the tubular implant 111. The sizing balloon 121 is then inflated with saline or contrast agent. The inflated sizing balloon 121 will hold the tubular implant 111 in place in the duodenum 112 or jejunum 113 (e.g., near the ligament of Treitz 109).
FIG. 20 is an alternative embodiment showing a means to seat the proximal end of the internal tubular implant 111 to the outer band 110. A nitinol conical / tubular shaped forceps 160 are attached to the inner catheter near the proximal end of where the tubal implant is loaded on the delivery catheter. The nitinol forceps 160 have an elastic memory in the open state. When the outer sheath 151 is fully retracted, the conical forceps open and, in turn, open the proximal end of the tubular implant 111 and seats the magnets 140 on the tubular implant 111 to the magnets 140 on the outer band 111.
FIG. 27 is a sectional view of a portion of the digestive tract in a human body. An external band 110 is implanted around the duodenal bulb 107 and an internal tubular implant 111 is attached to the external band 110 and extended into the duodenum 112 or the jejunum 113 (e.g., to the ligament of Treitz 109). As shown, magnets 135 on the external band 110 and magnets 136 on the internal tubular implant 111 are magnetically repelled and secure the internal tubular implant 111 to the external band implant 110. Stent 263 (with magnets attached) is attached to internal tubular implant 111. In some examples, the stent 263 has an expanded outer diameter of generally equal to an inner diameter of the corresponding implant location of the gastrointestinal tract. According to some examples, the expanded outer diameter of the stent is within about ten percent, about five percent, or about two percent of the inner diameter of the corresponding implant location of the gastrointestinal tract.
FIGS. 28-31 show various examples of an external band 264 and an internal implant 111 configured for removably or reversibly coupling with each other. As shown, in each of these examples, the internal implant includes a portion including a feature or a structure adapted to mechanically couple with a corresponding (e.g., mating) feature or structure of the external band 264. In each case, the coupling is accomplished through or across a gastrointestinal organ or tissue (e.g., across the duodenum, the pylorus, or the gastric antrum), but without penetrating such tissue. In some examples, the external band 264 and the internal implant 111 are not in direct mechanical contact, but instead engage or couple with each other with intervening gastrointestinal tissue.
FIG. 29 is a sectional view of a portion of the digestive tract in a human body. An external band 264 is implanted around the duodenal bulb 107 and an internal tubular implant 111 is coupled to the external band and extended into the duodenum 112 or the jejunum 113 (e.g., to the ligament of Treitz 109). As shown, diameter interference with the external band 264 and internal implant 110 secure the implant 110 within the gastrointestinal system and limit longitudinal movement without exerting too much radial force. The tubular implant 111 includes an attached expandable ring or stent 265.
FIG. 30 is a sectional view of a portion of the digestive tract in a human body. An external band 264 is implanted around the duodenal bulb 107 and an internal tubular implant 111 is attached to the external band 264 and extended into the duodenum 112 or the jejunum 113 (e.g., to the ligament of Treitz 109). As shown, diameter interference with the external band 264 and internal implant 111 limit longitudinal movement without exerting too much radial force. Expandable ring/stent 265 is attached to internal tubular implant 111. According to exemplary examples, the external band 264 (of FIGS. 28-30) includes a portion or portions having a final, implanted inner diameter smaller than an outer diameter of a corresponding securing portion (e.g., the ring or stent 265) of the internal implant, such that, upon implantation, the external band 264 mates with, couples with, or otherwise interacts with the internal tubular implant 111 to prevent or resist longitudinal movement or migration of the tubular implant. Likewise, according to various examples, the ring of stent 265 has an expanded outer diameter of generally equal to an inner diameter of the corresponding implant location of the gastrointestinal tract. According to some examples, the expanded outer diameter of the stent is within about ten percent, about five percent, or about two percent of the inner diameter of the corresponding implant location of the gastrointestinal tract.
FIGS. 32-33 show various embodiments of an internal tubular implant. The tubular implant is designed to attach to another tubular implant or to an external band by a magnetic attachment means. In the embodiment of FIG. 32, the tubular implant has magnets 140 on the outside diameter. In the embodiment of FIG. 33, the tubular implant has magnets 140 in the wall thickness. In various embodiments, the magnets 140 are adapted for coupling the tubular implant to an external band, a docking element or another internal implant.
FIG. 34 shows various examples of a simple sleeve used as a component of an internal tubular implant, or for extending a tubular implant. In the example of FIG. 34, the sleeve has radio-opaque markers 196 and may have holes in the sleeve 197 to allow some fluid flow through the sleeve, if required. FIGS. 35-36 shows various embodiments of a simple sleeve used as a component of an internal tubular implant, or for extending a tubular implant. In the embodiment of FIG. 35, the sleeve has magnetic particles or ferromagnetic material 140 incorporated into the sleeve to allow attachment of the sleeve to a magnetic docking station or tubular implant. In the embodiment of FIG. 36, the sleeve has magnetic particles or ferromagnetic material 140 incorporated into the sleeve to allow attachment of the sleeve to a magnetic docking station or tubular implant. In various embodiments, the sleeve also has longitudinal pleats 202 in the surface to allow it to collapse in diameter more uniformly and may help to reduce the loaded profile. The longitudinal pleats maybe be over the entire length or just apportion of the diameter or length. In the example of FIG. 37, the sleeve has pleats around the circumference 203. These circumferential pleats will allow the tubular implant or sleeve to bend easier without kinking.
FIG. 38 is a simple sleeve with a conical diameter. The simple sleeve may be used as part of a docking station or tubular implant.
FIG. 39 is a simple sleeve with a stepped diameter. The simple sleeve may be used as part of a docking station or tubular implant.
FIG. 40 is a stent that can be used to couple with an external band 110. The stent may incorporate magnets to allow magnetic attract or repulsion to an external band. As shown, magnets 136 are associated with the stent and are configured to interact with magnets 135 associated with the external band 110. According to various embodiments, the stent is integrated with or otherwise adapted to couple with an internal implant. For example, the stent may serve as a docking element for a sleeve portion of the tubular implant.
FIG. 42B shows a stent that can be used as a part of an internal implant. According to various embodiments, the stent is laser cut from round metal tubing or from a flat sheet of metal. The central portion of the stent's diameter may be shaped into an hour glass shape to provide increased resistance to stent migration. The stent has hoops 190 at the end of the stent. The hoops may be used to interlock with a stent retainer 159 on the inner catheter 152 to prevent premature deployment before the sheath is fully retracted. Radiopaque markers 191 can be attached to the end of the stent to increase the radio-opacity of the stent. A metal insert may be pressed / swaged into the hoops 190. The insert may be made from a high atomic density material, such as tantalum, gold, platinum or iridium. The insert may take the form of a disk or sphere and may be plastically deformed to fill the hoop cavity. The stent may be balloon expanded or self expanding. The mesh of the stent may be left open or it may be covered with a suitable material previously disclosed in this application. According to various embodiments, the stent of FIGS. 42A or 42B includes a narrow central portion adapted to generally fit within an align with the pylorus.
FIG. 47A shows a stent that can used as a part of an internal implant. The stents can be comprised of one or more of the following materials: Nickel titanium alloys (Nitinol), Stainless steel alloys: 304, 316L, BioDur® 108 Alloy, Pyromet Alloy® CTX-909, Pyromet® Alloy CTX-3, Pyromet® Alloy 31, Pyromet® Alloy CTX-1, 21 Cr-6Ni-9Mn Stainless, 21 Cr- 6Ni-9Mn Stainless, Pyromet Alloy 350, 18Cr-2Ni-12Mn Stainless, Custom 630 (17Cr-4Ni) Stainless, Custom 465® Stainless, Custom 455® Stainless, Custom 450® Stainless, Carpenter 13-8 Stainless, Type 440C Stainless, Cobalt chromium alloysMP35N, Elgiloy, L605, Biodur® Carpenter CCM alloy, titanium and titanium alloys, Ti-6A14V/ELI and Ti-6A1-7Nb, Ti-15Mo tantalum, tungsten and tungsten alloys, pure platinum, platinum-Iridium alloys, platinum-nickel alloys, niobium, iridium, Conichrome, gold and gold alloys. The stent may also be comprised of one or more of the following absorbable metals: pure iron and magnesium alloys. The stent may also be comprised of the following plastics: polyetheretherketone (PEEK), polycarbonate, polyolefins, polyethylenes, polyether block amides (PEBAX), nylon 6, 6-6, 12, polypropylene, polyesters, polyurethanes, polytetrafluoroethylene (PTFE) poly(phenylene sulfide) (PPS), poly(butylene terephthalate) PBT, polysulfone, polyamide, polyimide, poly(p-phenylene oxide) PPO, acrylonitrile butadiene styrene (ABS), polystyrene, poly(methyl methacrylate) (PMMA), polyoxymethylene (POM), ethylene vinyl acetate, styrene acrylonitrile resin, polybutylene. The stent may also be comprised of the following absorbable polymers: polyglycolic acid (PGA), polylactide (PLA), poly(e-caprolactone), poly(dioxanone) poly(lactide-coglycolide).
According to various embodiments, the stent 137 stent is laser cut from a round tubing or from a flat sheet of metal. The flat representation of the stent circumference is shown in item 138. The flat representation of an expanded stent is shown in item 139. The end view of the stent is shown 141. Magnets 140 are attached to the stent on the outside diameter. The magnets 140 may be attached to the stent by use of a mechanical fastener, glue, suture, welding, snap fit or other suitable means. The stent can be either balloon expandable or self expanding. The magnets may be located in middle of the stent or at the ends of the stent. Suitable materials for the magnets include: neodymium-iron-boron [Nd-Fe-B], samarium-cobalt [Sm-Co], alnico, and hard ferrite [ceramic] or other suitable material.
FIG. 47B shows a stent that can used as a part of an internal implant. Stent 142 may be laser cut from a round tubing or from a flat sheet of metal. The flat representation of the stent circumference is shown in item 143. The flat representation of an expanded stent is shown in item 144. The end view of the stent is shown 145. Permanent magnets 140 are attached to the stent on the outside diameter. This stent is a covered stent. The stent covering is not shown on items 142, 143 or 144. The covering are shown on the end view which shows stent 145. Stent may have an outside covering 146, inside covering 147 or both. Suitable materials for the covering include, but are not limited to: silicone, polyether block amides (PEBAX), polyurethanes, silicone polyurethane copolymers, nylon 12, polyethylene terphalate (PET), ePTFE, Kevlar, Spectra, Dyneena, polyvinyl chloride (PVC), polyethylene or polyester elastomers. The coverings may be dip coated onto the stent or they may be made as a separate tube and then attached to the stent by adhesives or mechanical fasteners, such as suture, rivets, or by thermal bonding of the material to the stent or another layer. The covering may also have drugs incorporated into the polymer to provide for a therapeutic benefit. The covering 146 or 147 may also be of biologic origin. Suitable biologic materials include, but are not limited to: Amnion, Collagen Type I, H, HI, IV, V, VI - Bovine, porcine, ovine, placental tissue or placental veins or arteries and small intestinal sub- mucosa.
To load the tubular implant onto the delivery catheter the outer sheath handle 153 is retracted towards the inner catheter handle 154 until distance is a small as possible. The outer sheath is then partially closed by advancing the outer sheath handle 153 away from the inner sheath handle 154. Continue advancing the outer sheath 151, when the tubular implant is completely covered by the outer sheath 151, the loading process is complete for the tubular implant. The delivery catheter also has a space on the inner catheter for the modular implant to be loaded. Attached to the inner catheter is a stent retainer 159. The purpose of the stent retainer 159 is to prevent the stent from releasing from the delivery catheter prematurely during deployment. The stent retainer 159 is fastened to the inner catheter. The stent retainer 159 can be made from metal or plastic and can be made radio-opaque by making it from a radio-opaque material such as tantalum. The stent retainer 159 has a complementary shape that holds the tips on the stent and does not allow the stent to move distally or forward until the outer sheath 151 is fully retracted to the stent retainer 159. The catheter has a side port 156 which allows the space between the inner and outer sheaths to be flushed with saline. The outer sheath 151 and inner sheath 152 may be made from a simple single layer polymer extrusion, such as from polyethylene or PTFE. The outer sheath 151 may also be constructed in the following manner. The sheath inner diameter surface is constructed of a thin wall PTFE liner 157. A layer of reinforcement 158 is placed over the PTFE liner 157. According to various embodiments, the reinforcement is either a braid of wire or a coil of wire. The wire cross-section can be either round or rectangular. In some embodiments, the wire is made from a metal such as 316, 304 stainless steel, Nitinol, or other suitable material. The wire diameters are typically in the 0.0012 to 0.025 cm (.0005 inch to .010 inch) diameter range. The outer jacket material may be reflowed into the reinforcement layer by melting the material and flowing the melted polymer into the spaces in between the braided wire or the coiled wires.
FIG. 51 shows an alternative embodiment of a delivery catheter for a self expanding internal tubular implant or for both 110 and 111 on the same catheter. The delivery catheter is constructed with a smaller outside diameter to allow the catheter to be inserted through the working channel of the endoscope 114. The delivery catheter consists of an outer catheter 151 and an inner catheter 152. Attached to the inner catheter is a stent retainer 159. The purpose of the stent retainer 159 is to prevent the stent from releasing from the delivery catheter prematurely during deployment. The stent retainer 159 is fastened to the inner catheter. The stent retainer 159 can be made from metal or plastic and can be made radio-opaque by making from it from a radio-opaque material such as tantalum. The stent retainer has a complementary shape that holds the tips on the stent and does not allow the stent to move distally or forward until the outer sheath 151 is fully retracted to the stent retainer 159. The catheter has a side port 156 which allows the space between the inner and outer sheaths to be flushed with saline. The outer sheath 151 and inner sheath 152 may be made from made from a simple single layer polymer extrusion such as from polyethylene or PTFE. The outer sheath 151 may also be constructed in the following manner. The sheath inner diameter surface is constructed of a thin wall PTFE liner 157. A layer of reinforcement 158 is placed over the PTFE liner 157, the reinforcement may be either a braid of wire or a coil of wire. The wire cross-section can be either round or rectangular. According to various embodiments, the wire is made from a metal such as 316 or 304 stainless steel or Nitinol or other suitable material. The wire diameters are typically in the 0.0012 to 0.025 cm (.0005 inch to .010 inch) diameter range. The outer jacket material may be reflowed into the reinforcement layer by melting the material and flowing it into the spaces in between the braided wire or the coil wires. The outside diameter of this catheter will range typically from 1 mm to 4 mm. The catheter can be constructed to be an over the wire catheter or a rapid exchange catheter. For a rapid exchange design, the guidewire will enter the central lumen of the distal end of the catheter and exit at point 188. For an over the wire catheter design, the guidewire will enter the central lumen of the distal end of the catheter and exit at point 189.
Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention as defined by the appended claims 1-10. For example, while the embodiments described above refer to particular features, the scope of this invention as defined by the appended claims 1-10 also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims.
wherein the securing feature and coupling feature are configured such that the tubular implant (111) is releasably coupled to the external band (110) to facilitate removal of the tubular implant (111), wherein the securing feature and the coupling feature are each magnetic structures (135, 136, 140) adapted for magnetically coupling the tubular implant (111) to the external band (110), characterized in that the securing feature and the coupling feature are configured to secure the tubular implant (111) to the external band (110) by magnetic attraction.
The gastrointestinal implant system of claim 1 wherein the securing feature and the coupling feature are configured to secure the tubular implant (111) to the external band (110) by mechanical coupling.
The gastrointestinal implant system of claim 2 wherein a diameter of the coupling feature of the external band (110) is mechanically adjustable.
The gastrointestinal implant system of claim 2 wherein a diameter of the coupling feature of the external band (110) is adjustable using an inflatable member.
The gastrointestinal implant system of claim 1 wherein the tubular implant (111) extends within the duodenum (112) such that a distal end of the tubular implant (111) is located at or near the ligament of Treitz (109).
The gastrointestinal implant system of claim 1 wherein the coupling feature is a stent.
The gastrointestinal implant system of claim 1 wherein the coupling feature is a metal band.
The gastrointestinal implant system of claim 1 wherein the coupling feature is a fabric or elastomeric band.
The gastrointestinal implant system of claim 1 wherein the securing feature and the coupling feature are mechanical elements adapted to couple without penetrating the gastrointestinal tract.
The gastrointestinal implant system of claim 1 wherein the tubular implant (111) includes a long tubular element adapted to function as a conduit for food and organ secretions.
Inventor name: BELHE, KEDAR R.
Inventor name: THOMPSON, PAUL J.