Abstract: A pyloric valve is provided for inhibiting the flow of chyme through the pyloric region of the gastrointestinal tract. The pyloric valve includes a blocking portion having a disc-shaped inlet and a helical flange. The helical flange may be disposed in a contracted position defining a contracted length and a contracted diameter and an extended position defining an extended length and an extended diameter, wherein the extended length is longer than the contracted length and the extended diameter is smaller than the contracted diameter. The pyloric valve may further include a sleeve that may have a beveled distal end. The pyloric valve may be constructed of silicon. Also provided are methods of inserting and removing the pyloric valve, which each include a step of manipulating the support between its contracted and extended positions. Insertion and removal systems are also provided for use with the pyloric valve.

Abstract: Devices, systems, and methods for treating gastro-esophageal reflux disease (GERD) include anti-reflux valves and retainers for securing them within the lumen of the esophagus, stomach, or a hiatal hernia. The retainers contain inflatable balloons, some of which may be enveloped by a flexible shell that is used to secure the balloon to tissue. Devices with more than one balloon, a low-profile leaf valve, and a sleeve valve are used to treat reflux in patients with a hiatal hernia. The leaf valve may also be configured for its control by constriction by gastrointestinal lumen muscle, through radial compression of the valve's flange. Bi-directional combination valves are used to treat or diagnose patients with reflux due to transient lower esophageal sphincter relaxations (TLESR). Those valves pass reflux through a channel in which gas and liquid reflux are separated.

Abstract: A pyloric valve is provided for inhibiting the flow of chyme through the pyloric region of the gastrointestinal tract. The pyloric valve includes a blocking portion having a disc-shaped inlet and a helical flange. The helical flange may be disposed in a contracted position defining a contracted length and a contracted diameter and an extended position defining an extended length and an extended diameter, wherein the extended length is longer than the contracted length and the extended diameter is smaller than the contracted diameter. The pyloric valve may further include a sleeve that may have a beveled distal end. The pyloric valve may be constructed of silicon. Also provided are methods of inserting and removing the pyloric valve, which each include a step of manipulating the support between its contracted and extended positions. Insertion and removal systems are also provided for use with the pyloric valve.

Abstract: A pyloric valve is provided for inhibiting the flow of chyme through the pyloric region of the gastrointestinal tract. The pyloric valve includes a blocking portion having at least one axially-aligned annular flange defining a central opening and a support having a rim and a support surface. The support may be disposed in a nested position wherein the support surface is disposed within the central opening and an inverted position wherein the support surface is disposed away from the central opening. The pyloric valve may further include a sleeve that may have a beveled distal end. The pyloric valve may be constructed of silicon. Also provided are methods of inserting and removing the pyloric valve, which each include a step of manipulating the support between its inverted and nested positions. Insertion and removal systems are also provided for use with the pyloric valve.

Abstract: The present invention provides systems and methods for treating and controlling obesity and/or type II diabetes. In one aspect of the invention, a device comprises a hollow sleeve sized and shaped for positioning within a duodenum of the patient, an anchor coupled to the proximal end of the sleeve and being sized and shaped to inhibit distal migration of the sleeve and a plurality of elastomeric objects coupled to the distal end of the sleeve and being sized and shaped to inhibit proximal migration of the sleeve through a pylorus of the patient. The bypass device can be placed and removed endoscopically through the patient's esophagus in a minimally invasive outpatient procedure and it is “self-anchoring” and does not require invasive tissue fixation within the patient's GI tract, thereby reducing collateral tissue damage and minimizing its impact on the digestive process.

Abstract: The present invention provides systems and methods for treating and controlling obesity and/or type II diabetes. In one aspect of the invention, a device comprises a hollow sleeve sized and shaped for positioning within a duodenum of the patient, an anchor coupled to the proximal end of the sleeve and being sized and shaped to inhibit distal migration of the sleeve and a plurality of elastomeric objects coupled to the distal end of the sleeve and being sized and shaped to inhibit proximal migration of the sleeve through a pylorus of the patient. The bypass device can be placed and removed endoscopically through the patient's esophagus in a minimally invasive outpatient procedure and it is “self-anchoring” and does not require invasive tissue fixation within the patient's GI tract, thereby reducing collateral tissue damage and minimizing its impact on the digestive process.

Abstract: The present invention provides systems and methods for treating and/or controlling obesity and type II diabetes. In one aspect of the invention, a device for treating obesity includes a flow restrictor and an anchor coupled to the flow restrictor. The flow restrictor is movable between a first or collapsed configuration sized and shaped for endoscopic advancement through the patient's esophagus and into a distal region of the stomach and a second or operative configuration sized and shaped for inhibiting a flow of chyme from the stomach to the pyloric sphincter. It is believed that this will cause the prolongation of satiety, and result in fewer meals being eaten and/or smaller meals being ingested.

Abstract: The present invention provides systems and methods for treating and controlling obesity and/or type II diabetes. In one aspect of the invention, a bypass device includes gastric and duodenal anchors coupled to each other and positioned on either side of the pylorus and a hollow sleeve designed to extend from the pylorus through at least a proximal portion of a patient's small intestine. The gastric and duodenal anchors are movable between collapsed configurations for advancement through the esophagus and an expanded configuration for inhibiting movement of the anchors through the pyloric sphincter. Thus, the bypass device can be placed and removed endoscopically through the patient's esophagus in a minimally invasive outpatient procedure and it is “self-anchoring” and does not require invasive tissue fixation within the patient's GI tract, thereby reducing collateral tissue damage and minimizing its impact on the digestive process.

Abstract: The present invention provides systems and methods for treating wounds in patients who lack the innate ability to regulate glucose (e.g., diabetic patients). In one aspect of the invention, a method includes positioning an internal bypass device within the duodenum to inhibit contact between chyme passing therethrough and an internal wall of the duodenum and maintaining the internal bypass device within the duodenum for a sufficient period of time to decrease insulin resistance and reduce a blood glucose level in the patient. The internal bypass device increases peripheral blood flow and elevates an immune system response to accelerate healing of the wound.

Abstract: The present invention provides systems and methods for treating and controlling obesity and/or type II diabetes. In one aspect of the invention, a delivery system for deploying an implant to a target region in the GI tract of a patient comprises an enclosure and an introducer. The enclosure houses at least a portion of the implant and comprises a material designed to dissolve within the patient. The introducer is coupled to the enclosure and configured for advancing the enclosure (and the implant housed therein) through an esophagus and into a stomach of the patient. In a preferred embodiment, the enclosure comprises a biocompatible material that will dissolve in less than one hour, preferably less than 30 minutes, such as gelatin or the like.