Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F5/005—Gastric bands
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2002/045—Stomach, intestines

Definitions

• This invention generally relates to implants placed within gastrointestinal systems, including the esophagus, the stomach, and the intestines.
• it relates to implant systems having components implantable and removable using laparoscopic and endoscopic techniques for treatment of obesity, diabetes, reflux, and other gastrointestinal conditions.
• Bariatric surgery procedures such as sleeve gastrectomy, the Rouen-Y gastric bypass (RYGB), and the biliopancreatic diversion (BPD), modify food intake and/or absorption within the gastrointestinal system to effect weight loss in obese patients.
• These procedures affect metabolic processes within the gastrointestinal system, by either short-circuiting certain natural pathways or creating different interaction between the consumed food, the digestive tract, its secretions and the neuro-hormonal system regulating food intake and metabolism.
• T2DM Type-2 Diabetes Mellitus
• 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.
• active fixation means such as barbs that penetrate into the surrounding tissue
• implants due to the intermittent peristaltic motion within the digestive tract, implants such as stents have a tendency to migrate.
• the present invention is a partial gastrointestinal implant system for treating metabolic disorders, such as diabetes and obesity.
• the system includes an anchoring element (e.g., stents, rings, fabric, or elastomeric cuffs) with sleeve or graft extensions, anchored within the gastrointestinal system (e.g., the esophagus, the gastro-esophageal junction, the pyloric junction, the duodenum, the jejunum, and/or the ileum), the anchoring element including docking capability, and tubular implants (e.g., thin sleeves or stent grafts) configured to be reversibly attached to the anchoring element.
• an anchoring element e.g., stents, rings, fabric, or elastomeric cuffs
• sleeve or graft extensions anchored within the gastrointestinal system
• the anchoring element including docking capability
• tubular implants e.g., thin sleeves or stent grafts
• the system allows attachment of one or multiple tubular implants to the gastrointestinal anchoring element.
• the cross-section area of the implants can be varied or adjusted, such that systems can be created where food or secretions entering the proximal portion of the system can be selectively channeled to alternate destinations, thereby creating customized and partial bypass systems.
• the present invention is a modular intraluminal implant system for treating metabolic disorders such as obesity and diabetes, which provides far more flexible therapy alternatives than single devices to treat these disorders.
• These implant systems include components that can be selectively added or removed to mimic a variety of bariatric surgical procedures with a single basic construct.
• the fundamental building blocks of the system include anchoring implants that are placed within the Gl system or some instances around particular organs. These low-profile implants are designed for long-term performance with minimal interference with normal physiological processes. Features of these anchoring implants allow them to act as docking stations for therapy implants designed for achieving certain metabolic modification goals.
• the modular systems of the invention includes an anchoring implant portion (docking element) including an expandable structure (e.g., a low profile stent or ring or fabric/elastomeric cuff) anchored within the esophagus, the gastro-esophageal junction, the pyloric junction, the duodenum or the jejunum and may have sleeve or graft extensions.
• the stents may be balloon expandable or self-expanding and anchor against the tissue with radial force.
• the rings could be made of self-expanding nitinol and anchor to the tissue by entrapment of the tissue within the ring elements or by radial force.
• the cuffs could be either sutured or stapled or permanently or reversibly attached by other mechanical means to the tissue.
• the anchoring implant includes or is adapted to receive (e.g., endoscopically) features that enable docking functionality.
• the docking functionality of the stent, ring or cuff could take the form of magnetic elements, hooks, mating mechanical elements or structures (e.g., the stent braid or mesh or corresponding hook and loop structures) that are integral to the framework of the stent, ring or cuff or the sleeve or graft extension.
• the system also could be such that the docking functionality is not integral to the stent, ring or cuff but is introduced later by attaching other elements such as magnets, hooks, mating mechanical elements, etc. to the framework of the stent, ring, cuff or to the sleeve/graft extension of the above implants.
• Therapeutic implants such as tubular sleeves or stent grafts, are adapted to be reversibly attached to the anchoring implants. These therapeutic implants will have corresponding features (e.g., magnets, hooks, mechanical elements) to enable docking to the anchoring implants, so that the therapeutic implants can be reversibly attached to the anchoring implants.
• the tubular implants will not be in contact with tissue to minimize or prevent tissue in-growth and facilitate easy removal with endoscopic instrumentation after long-term implantation.
• the present invention includes a modular gastrointestinal implant system for treating metabolic disorders such as diabetes and obesity by creating partial internal bypasses of food and organ secretions within the gastro-intestinal tract.
• the system includes low-profile anchoring implants that are affixed within the stomach, the esophagus, the intestine (or at internal junctions of these organs) or around these organs and enable secure attachment of (i.e., act as docking elements for) other implants; and other implants whose design facilitates partial internal by-pass of food and organ secretions from one site within the gastro-intestinal tract to other sites within the gastro-intestinal tract (partial bypass elements) that are attached to these anchoring implants.
• the low-profile implant is a stent-graft or a stent with a sleeve element. In some embodiments, the low-profile implant is a fabric or elastomeric cuff. In some embodiments, the low-profile implants are stents divided into multiple channels. In some embodiments, the low-profile implants are multi- limb stent-grafts.
• the present invention is a method for treating metabolic disorders such as diabetes and obesity consisting of (a) placing low-profile implants that can be affixed within the stomach, the esophagus, the intestine or at internal junctions of these organs or around these organs and (b) securely attaching other gastro-intestinal implants that permit partial internal by-pass of food and organ secretions from one site within the gastro-intestinal tract to other sites within the gastro-intestinal tract, to these low-profile implants.
• the present invention is a method for creating a reversible treatment for metabolic disorders such as diabetes and obesity consisting of (a) placing low-profile implants that can be affixed within the stomach, the esophagus, the intestine or at internal junctions of these organs or around these organs and (b) placing other gastro-intestinal implants that permit partial internal bypass of food and organ secretions from one site within the gastro-intestinal tract to other sites within the gastro-intestinal tract, to these low-profile implants and not to the tissue so that the procedure can be reversed easily.
• the present invention is a modular system for selectively restricting passage of food and organ secretions within the gastro-intestinal tract that consists of (a) low-profile implants that are affixed within the stomach, the esophagus, the intestine or at internal junctions of these organs or around these organs and which enable secure attachment of other implants (docking elements) and (b) other gastro-intestinal implants whose design facilitates selective restriction of passage of food and organ secretions from one site within the gastrointestinal tract to other sites within the gastro-intestinal tract that are attached to these permanent implants (restrictive bypass elements).
• the structure or design feature of the implant that enables secure attachment of one or more implants to it consists of a double-braid with hollow space between the two braids.
• the present invention is a method for treating metabolic disorders such as diabetes and consisting of (a) placing low- profile implants that can be affixed within the stomach, the esophagus, the intestine or at internal junctions of these organs or around these organs and (b) securely attaching other gastro-intestinal implants that selectively restrict passage of food and organ secretions from one site within the gastro-intestinal tract to other sites within the gastro-intestinal tract, to these low-profile implants.
• the present invention is a method for creating a reversible treatment for metabolic disorders such as diabetes and obesity and gastro-esophageal reflux disease (GERD) consisting of (a) placing low-profile implants that can be affixed within the stomach, the esophagus, the intestine or at internal junctions of these organs or around these organs and (b) placing other gastro-intestinal implants that selectively restrict passage of food and organ secretions from one site within the gastro-intestinal tract to other sites within the gastro-intestinal tract, to these low-profile implants and not to the tissue so that the procedure can be reversed easily.
• GSD gastro-esophageal reflux disease
• the present invention is a modular gastrointestinal implant system for treating metabolic disorders such as diabetes and obesity by creating partial internal bypasses of food and organ secretions within the gastro-intestinal tract.
• the system includes an anchoring element configured for engaging an esophagus, the anchoring element having a docking feature; a first gastrointestinal implant having a coupling feature for engaging and coupling with the docking feature of the anchoring element and sized and shaped to extend from the esophagus to the duodenal bulb; wherein the docking feature and coupling feature are configured such that the first implant may releasably couple with the anchoring element to facilitate removal of the tubular implant; and a second gastrointestinal implant adapted to extend from the stomach or the duodenal bulb into the duodenum; wherein the first and second implants are adapted to partially overlap within the duodenal bulb.
• the present invention is a modular gastrointestinal implant system for treating metabolic disorders such as diabetes and obesity by creating partial internal bypasses of food and organ secretions within the gastro-intestinal tract.
• the system includes a first anchoring element configured for engaging an esophagus, the first anchoring element having a docking feature; a second anchoring element configured for engaging a duodenum; a first gastrointestinal implant having a proximal end including a coupling feature for engaging the docking feature of the first anchoring element and a distal end adapted to couple with the second anchoring element; wherein the docking feature and coupling feature are configured such that the first implant may releasably couple with the anchoring element to facilitate removal of the tubular implant; and a second gastrointestinal implant adapted to extend from the stomach or the duodenal bulb into the duodenum, the second implant adapted to couple with the second anchoring element; wherein the first and second implants are adapted to partially overlap within the second anchoring element.
• the present invention is a method of treating metabolic conditions such as diabetes and obesity, which method includes securing a first anchoring element to the esophagus, the first anchoring element having a docking feature; securing a second anchoring element to the duodenum; implanting a first gastrointestinal implant having a proximal end including a coupling feature for engaging the docking feature of the first anchoring element and a distal portion adapted to couple with the second anchoring element; releasably coupling the coupling feature of the first gastrointestinal implant with the docking feature of the first anchoring element and coupling the distal portion with the second anchoring element; implanting a second gastrointestinal implant adapted to extend from the stomach or the duodenal bulb into the duodenum, the second implant adapted to couple with the second anchoring element; coupling the second implant to the second anchoring element, such that the first and second implants partially overlap within the second anchoring element.
• the present invention is a gastrointestinal implant system for treating metabolic disorders such as diabetes and obesity by creating partial internal bypasses of food and organ secretions within the gastro-intestinal tract, which system includes a first gastrointestinal implant having a feature for engaging and coupling with the docking feature of the anchoring element and sized and shaped to extend from the esophagus to the duodenal bulb; and a second gastrointestinal implant adapted to extend from the stomach or the duodenal bulb into the duodenum; wherein the first and second implants are adapted to partially overlap within the duodenal bulb.
• Embodiments of the present invention describe partial bypass elements where only part of the food bypasses the stomach, such that if there is resistance to the passage of the food through the sleeve element, the food has an alternative pathway to move forward hence eliminating the chances of dysphagia.
• FIGS. 1 -4 are sectional views of a portion of the digestive tract in the body showing partial bypass systems having an external band implanted around the outside diameter of the esophagus and a first tubular implant (sleeve) implanted inside the esophagus and anchored to the external band.
• a first tubular implant extends through the stomach into the duodenal bulb and a second implant (sleeve) is implanted in the stomach antrum and extends into and/or through the duodenum.
• FIG. 5 shows an exemplary endoscope used for diagnostic and therapeutic procedures in the gastro intestinal (Gl) tract.
• FIG. 6 is a sectional view of a portion of the digestive tract in the body, with an endoscope passing through the esophagus into the stomach, and the end of the scope positioned to allow viewing of the pylorus.
• FIG. 7 is a schematic view showing a trocar and cannula operable to access the implant location of the duodenal bulb using laparoscopic techniques.
• FIG. 8 is a sectional view of a portion of the digestive tract in the body.
• An implant is implanted in the duodenal bulb.
• the implant has two interior lumens as in section A-A or the alternative section A-A that allow two tubular implants to be sleeved adjacent to each other (i.e., overlapping).
• FIG. 9 is a sectional view of a portion of the digestive tract in the body.
• a first implant is implanted in the duodenal bulb and a second implant is implanted in the esophagus.
• the implants have two interior lumens as in section A-A or the alternative section A-A that allow two tubular implants to be sleeved adjacent to each other (i.e., overlapping).
• FIGS. 10 and 1 1 are sectional views of a portion of the digestive tract in the body.
• An external anchor is positioned around the outside diameter of the esophagus and a bifurcation implant is implanted into the duodenal bulb.
• a first tubular implant (sleeve) is implanted in the esophagus and is anchored to the external anchor at a proximal portion and to the implant at a distal portion.
• a second sleeve is implanted in the stomach antrum extending into and/or through the duodenum.
• FIGS. 12 and 13 are sectional views of a portion of the digestive tract in the body.
• An external anchor is positioned around the outside of the esophagus and a first tubular implant (sleeve) is implanted in the esophagus and anchored to the external anchor.
• the first tubular implant extends through the duodenum to the ligament of Treitz.
• a second sleeve is anchored to the external anchor and extends into and/or through the stomach.
• FIGS. 14-16 are sectional views of a portion of the digestive tract in the body.
• An external anchor is implanted around the outside of the esophagus and a first tubular implant (sleeve) is implanted in the esophagus and anchored to the external anchor.
• the first tubular implant extends into the duodenum to duodenal bulb.
• a second sleeve is implanted from the esophagus into the stomach.
• a third sleeve is implanted from the pylorus or stomach antrum into or through the duodenum.
• FIGS. 17-18 are sectional views of a portion of the digestive tract in the body.
• An external anchor is positioned around the outside of the esophagus.
• a first tubular implant (sleeve) is implanted inside the esophagus and anchored to the external anchor and extends from the esophagus into the duodenum to the duodenal bulb.
• the first tubular implant has a valve (section C-C) opening that (like stoma) allows some portion of the food entering the esophagus to enter the upper portion of the stomach.
• a second sleeve is implanted from the stomach antrum into or through the duodenum.
• FIG. 19 is a sectional view of a portion of the digestive tract in the body.
• An external anchor is positioned around the outside of the esophagus.
• a bifurcated tubular implant (sleeve) is implanted on the inside of the esophagus and is anchored to the external anchor.
• a first branch of the bifurcated implant extends to an implant positioned in the duodenal bulb and a second branch extends into the stomach.
• a second tubular implant extends from the bifurcated tubular implant into the duodenum.
• FIG. 20 is a schematic view of a delivery device for implanting an internal implant.
• FIGS. 1 and 2 are sectional views of a portion of the digestive tract in a human body.
• 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 1 12, the jejunum 1 13, and the ileum (not shown).
• the duodenum 1 12 is the first portion of the small intestine and is typically 10-12 inches long.
• the duodenum 1 12 is comprised of four sections: the superior, descending, horizontal and ascending sections.
• the duodenum 1 12 ends at the ligament of Treitz 109.
• the papilla of Vater 108 is the duct that delivers bile and pancreatic enzymes to the duodenum 1 12.
• the duodenal bulb 107 is the portion of the duodenum which is closest to the stomach 103.
• an external anchoring element or band 1 10 is secured or positioned around the outside of the esophagus and a first gastrointestinal or tubular implant 1 1 1 (e.g., sleeve) is implanted inside of the esophagus and anchored magnetically through the esophageal tissue to the external band 1 10.
• a first gastrointestinal or tubular implant 1 1 1 e.g., sleeve
• magnets 135 on the anchoring element 1 10 and magnets 136 on the tubular implant 1 1 1 magnetically interact with (e.g., attraction, repulsion, or levitation) each other to anchor or secure the tubular implant 1 1 1 to the external band 1 10 in a removable or reversible configuration.
• the magnets 136 on the tubular implant 1 1 1 which magnetically interact with the magnets 135 on the anchoring element, serve as a coupling feature for the implant 1 1 1 .
• Suitable exemplary materials for the magnets include neodymium-iron-boron [Nd-Fe-B], samarium-cobalt [Sm-Co], alnico, and hard ferrite [ceramic].
• the magnets may be plated with gold or platinum or other material to make them radio- opaque or to improve the 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.
• the external band 1 10 is made from one or more elastomers (e.g., silicon, polyurethane, and ePTFE), metals, or fabrics (e.g., Dacron or a combination of polymers and textile materials).
• the gastrointestinal implant 1 1 1 extends into the duodenum 1 12 to the duodenal bulb 107.
• the sleeve 1 1 1 or the anchor mechanism 1 10 may form a restrictive stoma 262 in the esophagus (see FIGS. 1 and 2), for example, by reducing or restricting the internal diameter of the esophagus.
• a stoma is not formed.
• a second sleeve 300 or 301 is implanted from the stomach antrum 104 (or from the duodenal bulb 107) to the mid-portion of the duodenum (see, e.g. FIG.
• the two sleeves each form a D-shaped transverse section in the overlap section (e.g., the region in or near the duodenal bulb 107), such that when combined they together form a generally circular overall transverse cross-section (see, e.g., section A-A in FIGS. 1 and 2).
• the first sleeve 1 1 1 (extending between the esophagus 102 and the duodenal bulb 107) serves to bypass the stomach 103.
• the second sleeve 300 (or sleeve 301 ) allows the stomach secretions to bypass a portion (or all) of the duodenum 1 12.
• At least one of the first sleeve 1 1 1 and the second sleeve 300 are formed or shaped such that the portion of the sleeve located in the duodenal bulb has and generally holds the D- shape cross section (as shown in section A-A).
• these portions of the first sleeve and/or second sleeve 300 are not preformed or shaped, but instead are made from a material having sufficient compliance to conform to the duodenal bulb, in such a way as to have a substantially D-shape cross section.
• the anchoring mechanism 1 10 may be formed from other structures.
• Exemplary structures include a stent 500 and/or interlocking mechanical rings 501 .
• the stent 500 can be a self expanding type or a balloon expandable type.
• the rings 501 are configured such that an outer ring 141 positioned around an outer surface of the esophagus is sized and shaped to interlock with an inner ring 143a or 143b positioned around an inner surface of the esophagus.
• the anchoring mechanism 1 10 is integrally formed with the sleeve 1 1 1 , and, in other embodiments, the anchoring mechanism is structurally separate from and adapted for coupling with the sleeve 1 1 1 .
• any of the internal anchoring structures disclosed in co-pending, commonly assigned U.S. patent application 12/752,697 (incorporated herein by reference) may be used as the anchoring mechanism 1 10.
• any of the external anchoring structures disclosed in co-pending, commonly assigned U.S. patent application 12/833,605 may be used as the anchoring mechanism 1 10.
• the implants or sleeves 1 1 1 and 300 may be formed in any configuration or from any material disclosed in either of U.S. patent application 12/752,697 or U.S patent application 12/833,605.
• the implants or sleeves may be couples or anchored to the anchoring mechanism using any arrangement disclosed in either of U.S. patent application 12/752,697 or U.S patent application 12/833,605.
• FIG. 3 is an alternative embodiment of FIG. 1 where the tubular implant does not cause or form a stoma in the esophagus.
• FIG. 4 is an alternative embodiment of FIG. 2 where the tubular implant does not cause or form a stoma in the esophagus.
• FIG. 5 shows an endoscope 1 14.
• Endoscopes 1 14 are used for diagnostic and therapeutic procedures in the gastrointestinal (Gl) tract.
• the typical endoscope 1 14 is steerable by turning two rotary dials 1 15 to cause deflection of the working end 1 16 of the endoscope.
• the working end (or distal end) of the endoscope 1 16 typically contains two fiber bundles for lighting 1 17, a fiber bundle for imaging 1 18 (viewing) and a working channel 1 19.
• the working channel 1 19 can also be accessed on the proximal end of the endoscope.
• the light fiber bundles and the image fiber bundles are plugged into a console at the plug in connector 120.
• the typical endoscope has a working channel in the 2.6 mm to 3.2 mm diameter range.
• the outside diameters of the endoscopes are typically in the 8 mm to 12 mm diameter range, depending on whether the endoscope is for diagnostic or therapeutic purposes.
• FIG. 6 shows a sectional view of a portion of the digestive tract in a human body.
• an endoscope 1 14 has been inserted through: the mouth 100, esophagus 101 , stomach 103 and pyloric antrum to allow visualization of the pylorus 106.
• FIG. 7 shows a sectional view of a portion of the digestive tract in the body with a trocar 260 and cannula 261 inserted to access the implant location of the duodenal bulb, gastroesophageal junction, or other suitable location using laparoscopic techniques.
• An alternative access route is to use natural orifice surgery (e.g., access via the esophagus, stomach, belly button or vagina).
• FIG. 8 shows a sectional view of a portion of the digestive tract in the body.
• a bifurcated anchor or implant 302 is implanted in the duodenal bulb 107 or pylorus 106.
• the implant has two interior lumens or anchoring structures 307, 309, as shown in section A-A or the alternative section A-A, that may couple with or otherwise allow two tubular implants to be sleeved adjacent to each other (i.e., overlapping).
• the implant 302 is structured to have D-shaped transverse sections, as shown above for example in section A-A in FIGS. 1 and 2.
• the implant 302 is configured to couple or anchor to the duodenal bulb 107 (or pylorus 106) and serves as an anchoring location for an end of the tubular implants or sleeves.
• the anchoring mechanism 1 10 includes structures to urge or otherwise cause the overlapping portions of the first sleeve 1 1 1 and the second sleeve 300 to form a specified shape, such as the D-shape described above and shown, for example, in section A-A of FIG. 1 .
• the implant 302 further includes an area 31 1 which is located inside the implant 302 and outside the lumens 307, 309.
• the anchor or implant 302 includes a transition or seal feature covering the area 31 1 (shown for example in FIG. 8 below section A-A).
• This transition of seal feature may be shaped and configured to block or cover the area 31 1 (either partially or entirely), such that materials exiting the stomach cannot substantially bypass the sleeves coupled to either of the lumens 307, 309.
• this seal feature may be a sleeve, film or other structure made from, for example, a urethane or Goretex material.
• the area 31 1 is covered with a structure made from one or more elastomers (e.g., silicon, polyurethane, and ePTFE), metals, or fabrics (e.g., Dacron or a combination of polymers and textile materials).
• FIG. 9 shows a sectional view of a portion of the digestive tract in the body.
• a bifurcated implant 302 is implanted into the duodenal bulb 107 (or pylorus 106).
• a second bifurcation implant 303 is implanted in the esophagus 102.
• the second implant 303 is formed of any of the configurations described above with respect to the bifurcated implant 302.
• FIG. 10 is a sectional view of a portion of the digestive tract in a human body.
• a tubular implant 1 1 1 (sleeve) is implanted inside the esophagus (e.g., on the inside surface) and anchored mechanically or magnetically (as further described above) through the esophageal tissue to the external band 1 10 which is secured around the outside of the esophagus.
• the tubular implant 1 1 1 extends into the duodenum 1 12 to the duodenal bulb 107.
• the sleeve in the esophagus may form a restrictive stoma 262 in the esophagus.
• a second sleeve 300 is implanted from the stomach antrum 104 to the mid-portion of the duodenum.
• the two sleeves are inserted into a bifurcated implant 302 to anchor the sleeves and form the transition shape.
• the two sleeves each form a circular shape individually in the overlapping section.
• the two round sections of the implant form a combined round outer diameter (see, e.g., section A-A in FIG. 10).
• the overlapping ends of the sleeves 1 1 1 , 300 i.e., the distal end of the sleeve 1 1 1 and the proximal end of the sleeve 300
• the second sleeve is located from the distal stomach antrum 104 (or pylorus) to the mid- duodenum (see FIG. 10) or to the ligament of Treitz (see FIG. 1 1 ).
• the second sleeve 300 allows stomach secretions to bypass a portion of the duodenum 1 12.
• FIGS. 12 and 13 show sectional views of a portion of the digestive tract in the body.
• an external band 1 10 is implanted around the outside of the esophagus.
• a bifurcated implant is implanted inside the esophagus.
• a tubular implant 1 1 1 (sleeve) is implanted on the inside surface of the esophagus and anchored magnetically or mechanically through the esophageal tissue to the external band 1 10.
• the tubular implant 1 1 1 extends into the duodenum (e.g., to the ligament of Treitz).
• the anchor or band around the esophagus forms a restrictive stoma 262 in the esophagus.
• a second sleeve 303 is implanted from the esophagus (again, anchored to the external band 1 10 or bifurcated implant) and extends into the upper portion of the stomach near the fundus 304 (see FIG. 12) or the lower portion of the stomach near the antrum 104 (see FIG. 13).
• the two sleeves can each form a circular shape individually (see, e.g., section B-B and alternative section B-B) in the overlap section in the esophagus or alternatively the overlap portions of the sleeves can have or otherwise form D- shaped sections.
• the tubular element or sleeve 1 1 1 of the bypass system delivers food and secretions past the upper duodenum where as the rest of the food is allowed to flow into the upper duodenum where it will mix with the biliopancreatic secretions thus creating a partial duodenal bypass where controlled gastric emptying is still functional. Because of some level of biliopancreatic interaction with the food, this type of procedure is likely to result in the patient experiencing less complications such protein deficiency
• FIGS. 14-16 show sectional views of a portion of the digestive tract in the body.
• an external anchor or band 1 10 is implanted around the outside diameter of the esophagus (or alternatively a bifurcated implant is implanted inside).
• a tubular implant 1 1 1 (sleeve) is implanted on the inside surface of the esophagus and anchored magnetically or mechanically through the esophageal tissue to the external band 1 10.
• the tubular implant 1 1 1 extends from the esophagus into the duodenal bulb where a distal portion of the implant 1 1 1 couples to bifurcated implant 302.
• the anchor or band around the esophagus forms a restrictive stoma 262 in the esophagus.
• a second sleeve 303 is implanted from the esophagus (again, anchored to the external band 1 10 or bifurcated implant) and extends into the upper portion of the stomach near the fundus 304 (see FIG. 14) or the lower portion of the stomach near the antrum 104 (see FIGS. 15 and 16).
• the two sleeves can each form a circular sectional shape (see section B-B in FIG. 14) in the overlap section in the esophagus or alternatively have or otherwise form D-shaped sections.
• a third sleeve 306 is implanted from the pylorus or stomach antrum and extends into the mid-duodenum (see, e.g., FIGS. 14 and 15) or to the ligament of Treitz (see, e.g., FIG. 16).
• the two sleeves overlapping in or near the duodenum e.g., sleeve 1 1 1 and sleeve 306) can each form a circular shape (or alternatively D-shaped sections) as shown.
• the gastrointestinal system includes two stents, a first stent in the esophagus and a second stent at the pyloric junction.
• the first stent couples to and secures a proximal portion of the implant 1 1 1 and a proximal portion of the second sleeve 303.
• the second stent couples to and secures a distal portion of the implant 1 1 1 and a proximal portion of the third sleeve 306.
• the sleeve 1 1 1 includes a tubular element that bypasses a majority of the food ingested past the stomach emptying it in to the small intestine. The remainder of the food empties in to the stomach where it gets mixed with stomach enzymes and peptides such as Ghrelin released by the fundus of the stomach.
• the sleeve 306 at the pyloric junction redirects this mixture past the small intestine by means of the tubular element attached to it.
• this system can mimic both the restrictive and malabsorptive features of a stomach reduction procedure as well as reduction of exposure of peptides such as Ghrelin to the upper duodenum.
• An external anchor is positioned around the outside of the esophagus.
• a first tubular implant (sleeve) is implanted inside the esophagus and anchored to the external anchor and extends from the esophagus into the duodenum to the duodenal bulb.
• the first tubular implant has a valve (section C-C) opening that (like stoma) allows some portion of the food entering the esophagus to enter the upper portion of the stomach.
• a second sleeve is implanted from the stomach antrum into or through the duodenum.
• FIGS. 17 and 18 show sectional views of a portion of the digestive tract in the body.
• an external anchor or band is implanted around the outside of the esophagus.
• a bifurcated implant is implanted inside.
• a tubular implant 1 1 1 (sleeve) is implanted on the inside surface of the esophagus and anchored magnetically or mechanically through the esophageal tissue to the external band 1 10.
• the tubular implant 1 1 1 extends into the duodenum to the duodenal bulb.
• the band around the esophagus forms a restrictive stoma 262 in the esophagus.
• a valve 307 is constructed into the wall of the sleeve 1 1 1 .
• the valve acts as a stoma that can allow a portion of the food entering the sleeve 1 1 1 to exit the stoma opening into stomach.
• the valve 307 is any of an opening, a hole, a slit, or a mechanical valve mechanism. Exemplary structures for the valve 307 are shown in section C-C and alternative sections C-C in FIGS. 17 and 18.
• a second sleeve 306 is implanted from the pylorus or stomach antrum to the midpoint of the duodenum.
• FIG. 19 shows a sectional view of a portion of the digestive tract in the body.
• an external band is implanted around the outside diameter of the esophagus (or alternatively a bifurcated implant is implanted inside).
• a bifurcated tubular implant 310 is implanted on the inside surface of the esophagus and anchored magnetically (or mechanically) through the esophageal tissue to the external band.
• a second tubular implant 31 1 extends from the bifurcated tubular implant 310 into the duodenum 1 12 to duodenal bulb 107.
• the band around the esophagus may form an optional restrictive stoma in the esophagus.
• a third sleeve 312 is implanted from the bifurcated tubular implant in the esophagus to the lower portion of the stomach near the stomach antrum or pylorus.
• a fourth sleeve 306 is implanted from the pylorus or stomach antrum to the middle or the end of the duodenum near the ligament of Treitz.
• the two sleeves can each form a circular shape (or alternatively D shaped sections individually) in the overlap sections in the esophagus (or the duodenal bulb section).
• the tubular implant 310 is formed in a branched (e.g., Y-shaped) configuration, having a proximal end adapted for coupling or anchoring in the esophagus and a distal portion including branches or limbs (e.g., sleeve 31 1 and sleeve 312).
• the tubular implant 310 includes more than two branches (or limbs).
• FIGS. 12-19 Various embodiments of the present invention shown and described above partial bypass elements where only part of the food bypasses the stomach (e.g., FIGS. 12-19).
• there is an alternative flow path for food exiting the esophagus such that if there is resistance to the passage of the food through the bypass sleeve element, the food has an alternative pathway to move forward.
• Such a configuration may help to reduce or eliminate dysphagia or dysphagia-like symptoms in a patient.
• FIG. 20 shows a delivery catheter with an implant 1 10 loaded on to it for delivering a self-expanding internal tubular implant or stent.
• the catheter may be of an over-the-wire construction or a rapid exchange version.
• the delivery catheter is constructed with a smaller outside diameter to allow the catheter to be inserted through the working channel of the endoscope 1 14.
• 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 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 may also be constructed as follows.
• 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.
• the reinforcement may be either a braid of wire or a coil of wire.
• the wire cross section can be either 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.
• the wire diameters are typically in the .0005 inch to .010 inch diameter range.
• the outer jacket material is preferably 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.
• the guide wire will enter the central lumen of the distal end of the catheter and exit at point 188.
• the guide wire will enter the central lumen of the distal end of the catheter and exit at point 189.

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• 2011
  • 2011-01-07 EP EP11732226A patent/EP2521513A1/en not_active Withdrawn
  • 2011-01-07 AU AU2011203951A patent/AU2011203951B2/en not_active Ceased
  • 2011-01-07 IN IN5908DEN2012 patent/IN2012DN05908A/en unknown
  • 2011-01-07 WO PCT/US2011/020560 patent/WO2011085234A1/en active Application Filing

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