Abstract: An apparatus for cleansing and applying therapy or prophylaxis to wounds, in which irrigant fluid containing a physiologically active material from a reservoir connected to a conformable wound dressing and wound exudate from the dressing are recirculated by a device for moving fluid through a flow path which passes through the dressing and a means for fluid cleansing and back to the dressing. A biodegradable scaffold underlies the dressing on the wound bed to promote tissue growth. The cleansing means (which may be a single-phase, e.g. micro-filtration, system or a two-phase, e.g. dialytic system) removes materials deleterious to wound healing, and the cleansed fluid, still containing materials that are beneficial in promoting wound healing, is returned to the wound bed. The dressing, an assembly comprising the dressing and scaffold, and a method of treatment using the apparatus.

Abstract: Various obesity treatment tools and methods are described herein, as well as treatments for other gastric-related diseases, e.g., GERD. Treatment includes reducing the size of the stomach pouch to limit the caloric intake as well as to provide an earlier feeling of satiety. This may be done by creating a smaller gastric pouch within the stomach directly from the interior of the stomach itself. The smaller pouches may be made through the use of individual anchoring devices, rotating probes, or volume reduction devices. A pyloroplasty procedure may also be performed to render the pyloric sphincter incompetent. A gastric bypass procedure may additionally be performed using atraumatic magnetic anastomoses devices so that sugars and fats are passed directly to the bowel while bypassing the stomach. Many of these procedures may be done in a variety of combinations. Treatment may create enforced behavioral modifications by discouraging the ingestion of high-caloric foods.

Abstract: Methods and devices for modifying the location at which bodily fluids interact with nutrients in a gastrointestinal tract having a conduit having a first end and a second end, the first end configured to divert bodily fluids from an entrance within a gastrointestinal tract to a location downstream from the entrance, and means for attaching the second end to the entrance.

Abstract: Medical devices and methods for the treatment of obesity. The medical devices generally include an attachment portion for attaching the medical devices on or adjacent the pylorus and a limitation portion for limiting the passage of stomach contents through the pylorus to delay emptying the stomach. The limitation portion may be responsive to pressure from stomach contents to substantially close or to open the passageway.

Abstract: The pyloric obesity valve includes a tubular valve body having proximal and distal ends. The valve body has an intermediate section which is between the proximal and distal ends. The proximal end is enlarged transversely relative to the intermediate section. The valve body has an inner surface and a lumen. The inner surface which is within the intermediate section has a cross-sectional area which is smaller than a cross-sectional area of the inner surface which coincides with the proximal end to resist a flow through the lumen of the valve body from the proximal end to the intermediate section.

Abstract: Various obesity treatment tools and methods are described herein, as well as treatments for other gastric-related diseases, e.g., GERD. Treatment includes reducing the size of the stomach pouch to limit the caloric intake as well as to provide an earlier feeling of satiety. This may be done by creating a smaller gastric pouch within the stomach directly from the interior of the stomach itself. The smaller pouches may be made through the use of individual anchoring devices, rotating probes, or volume reduction devices. A pyloroplasty procedure may also be performed to render the pyloric sphincter incompetent. A gastric bypass procedure may additionally be performed using atraumatic magnetic anastomoses devices so that sugars and fats are passed directly to the bowel while bypassing the stomach. Many of these procedures may be done in a variety of combinations. Treatment may create enforced behavioral modifications by discouraging the ingestion of high-caloric foods.

Abstract: Various obesity treatment tools and methods are described herein, as well as treatments for other gastric-related diseases, e.g., GERD. Treatment includes reducing the size of the stomach pouch to limit the caloric intake as well as to provide an earlier feeling of satiety. This may be done by creating a smaller gastric pouch within the stomach directly from the interior of the stomach itself. The smaller pouches may be made through the use of individual anchoring devices, rotating probes, or volume reduction devices. A pyloroplasty procedure may also be performed to render the pyloric sphincter incompetent. A gastric bypass procedure may additionally be performed using atraumatic magnetic anastomoses devices so that sugars and fats are passed directly to the bowel while bypassing the stomach. Many of these procedures may be done in a variety of combinations. Treatment may create enforced behavioral modifications by discouraging the ingestion of high-caloric foods.

Abstract: Various obesity treatment tools and methods are described herein, as well as treatments for other gastric-related diseases, e.g., GERD. Treatment includes reducing the size of the stomach pouch to limit the caloric intake as well as to provide an earlier feeling of satiety. This may be done by creating a smaller gastric pouch within the stomach directly from the interior of the stomach itself. The smaller pouches may be made through the use of individual anchoring devices, rotating probes, or volume reduction devices. A pyloroplasty procedure may also be performed to render the pyloric sphincter incompetent. A gastric bypass procedure may additionally be performed using atraumatic magnetic anastomoses devices so that sugars and fats are passed directly to the bowel while bypassing the stomach. Many of these procedures may be done in a variety of combinations. Treatment may create enforced behavioral modifications by discouraging the ingestion of high-caloric foods.

Abstract: A gastric balloon includes a scaffold structure, one or more internal inflatable compartments within the scaffold structure, and one or more inflatable bladders formed over the space-filling compartment. The gastric balloon may be deployed transesophageally using a gastroscope and is inflated in situ, preferably using a combination of liquid and gas inflation media.

Abstract: An intragastric and/or intragastrointestinal device may include a prosthesis, which may reside within the gastrointestinal tract lumen. The device may include a restrictive element that constricts or restricts the gastrointestinal tract lumen, limiting the amount of food and/or fluid an individual consumes.

Abstract: Disclosed is an esophageal stent placed in a stenosed part of the esophagus having a flexible tube to prevent the reverse flow of gastric contents from the stomach is coupled to the lower end of the esophageal stent. The flexible tube has an inside membrane and an outside membrane adhered to each other, thus having a twofold structure with at least one core longitudinally placed between the adhered inside and outside membranes while the core extends from the upper end toward the lower end of the flexible tube. Thus, the flexible tube is prevented from being inverted, and prevents the reverse flow of the gastric contents, and maximizes the operational reliability of the esophageal stent. The flexible tube does not cause a patient pain or discomfort due to frictional contact of the tube with the inner surface of the stomach when the tube moves in the stomach.

Abstract: A gastrointestinal implant device comprises a sleeve for extending into the duodenum and an artificial valve for placement at the pylorus to control flow from the stomach into the duodenal sleeve. The implant device also comprises a support structure for the valve.

Abstract: The present invention provides a modular prosthetic valve device designed as two or more device modules that may be delivered to a body lumen unassembled and then assembled into the assembled valve device in the body at least in part using a self-assembly member at or near the site of valve implantation. The device modules may include a support structure and a valve module. The valve module may be delivered in an unassembled, folded delivery configuration, and unfolded and assembled into a working configuration via the self-assembly member. In its unassembled form, the valve module may be a single-piece leaflets substructure or a plurality of valve sections. The self-assembly member has a delivery configuration and a preset configuration, and may be triggered to revert to the preset configuration to assemble the valve module.

Abstract: The invention relates to an implantable stomach prosthesis for surgically replacing or augmenting all or part of the antrum and/or pylorus of a stomach. The prosthesis controls the passage of food from the stomach to the small intestine. The prosthesis may be configured to churn ingested material and release it from the stomach through a prosthetic pyloric valve. At least one expandable member is arranged to be expanded to control the passage of food and/or to mimic the churning action of a patient's stomach. The prosthesis includes an outer support structure, a flexible inner member forming a conduit for the movement of material, and at least one expandable member located between the outer support structure and inner member. An implantable pump system is provided for inflating and deflating the expandable member(s).

Abstract: An apparatus for controlling a flow of fluid and/or other bodily matter in a lumen formed by a tissue wall of a patient's organ comprises an implantable constriction device for gently constricting (i.e. without substantially hampering the blood circulation in the tissue wall) at least one portion of the tissue wall to influence the flow in the lumen, and a stimulation device for stimulating the wall portion of the tissue wall. A control device controls the stimulation device to stimulate the wall portion, as the constriction device constricts the wall portion, to cause contraction of the wall portion constricted by the constriction device to further influence the flow in the lumen. The apparatus can be used for restricting or stopping the flow in the lumen, or for actively moving the fluid in the lumen, with a low risk of injuring the organ.

Abstract: A medical treatment device (200), for treating reflux from a stomach (201) to an oesophagus (202) and for delivering a therapeutic agent to an inner surface of the oesophagus (202), comprises a valve member (203), a lining member (204), and a support member (205). The valve member (203) is movable between a closed configuration and an open configuration, in which the valve member (203) facilitates passage of material between the oesophagus (202) and the stomach (201). The valve member (203) is biased towards the closed configuration and gradually moves over a period of 4 to 10 secs from the open configuration to the closed configuration. The support member (205) supports the device (200) relative to the oesophagus (202) and the stomach (201). The lining member (204) lines part of the inner surface of the oesophagus (202) for delivery of a therapeutic agent to the oesophagus (202).

Abstract: An endoscopic device separates ingested food from gastric fluids or gastric fluids and digestive enzymes, to treat obesity. In a particular embodiment a gastric bypass stent comprises a tubular member and two or more stent members defining a lumen. The tubular member has a substantially liquid impervious coating or covering and one or more lateral openings to permit one-way liquid flow.

Abstract: A method and apparatus for treating a patient's health condition by diverting pancreatic exocrine secretions include a flow diverter of material compatible with chronic residence within a small intestine of the patient. The flow diverter has a cover end and a discharge end. The flow diverter is sized to be placed within the small intestine with the discharge end placed distally from said cover end and with said flow diverter further sized so permit passage of chyme through the small intestine and past the flow diverter. The cover end is sized to cover a discharge papilla of the pancreatic duct. The diverter is adapted to divert at least a portion of pancreatic exocrine secretion from the papilla to the distal discharge end.

Abstract: A patient is provided with an increased sense of satiety by increasing resistance to the outflow of food from the stomach and through the intestines. Stomach emptying may be slowed with devices implantable within the gastrointestinal tract below the stomach. Implants are preferably removable and can include artificial strictures or apertures that may be adjustable or elastic to vary the rate of stomach emptying. Slowing gastric emptying may induce satiety for a longer period and may therefore reduce food consumption. Many of the embodiments include intestinal sleeves or sleeves, but they need not. The resistor concept may be applied to a simple anchor and resistor without a long sleeve.

Abstract: The invention relates to improved means for preventing eversion and subsequent obstruction of thin-walled, floppy gastrointestinal liners implanted in the digestive tract of an animal. The implantable devices include an anchor adapted for attachment within a natural body lumen and a thin-walled, floppy sleeve open at both ends and defining a lumen therebetween. A substantial length of the sleeve has material characteristics that result in the sleeve being prone to eversion in the presence of retrograde pressures. Exemplary eversion-resistant features provide an increased stiffness and/or an increased friction coefficient between the anchor and the proximal end of the sleeve to resist eversion. In some embodiments, the eversion-resistant feature includes an anti-buckling element, such as a wire coupled along the substantial length of the sleeve.

Abstract: A method and apparatus are disclosed for treating obesity includes an artificial fistula created between gastrointestinal organs such as between the stomach and the colon. The method includes selecting an implant comprising a passageway having an internal lumen with an inlet end and an outlet end. The passageway is positioned passing through a first wall of first gastrointestinal organ (for example, passing through the wall of the stomach) and a second wall of a second gastrointestinal organ (for example, passing through the wall of the large intestine) with the inlet end disposed within an interior of the first gastrointestinal organ and with the outlet disposed within an interior of the second gastrointestinal organ.

Abstract: Valve implant systems positionable within a flow passage, the systems having an inlet, an outlet, and a remotely activatable valve between the inlet and outlet, with the valves being operable to provide intermittent occlusion of the flow path. A remote field is applied to provide thermal or magnetic activation of the valves.

Abstract: The invention relates to a device for treating bladder emptying dysfunctions of a human, in which a catheter that can be inserted into the urethra is provided with a bladder emptying channel and with a balloon arrangement, which serves to seal the bladder and to hold the catheter inside the bladder lumen and which can be filled with a fluid. In addition, an automatically closing valve having an elastically held closure part is provided in a proximal end area of the catheter and is connected via a connecting channel filled with an actuating fluid to an actuating balloon placed at the distal end section of the catheter. Without the use of mechanical means, the closure part can be lead out of a sealing system solely due to a hydraulic action effected by the actuating balloon via the hydraulic pressure built up in the connecting channel at said proximal end section.

Abstract: Method and apparatus for limiting absorption of food products in specific parts of the digestive system is presented. A gastrointestinal implant device is anchored in the stomach and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for anchoring the device to the stomach and a flexible sleeve to limit absorption of nutrients in the duodenum. The anchor is collapsible for endoscopic delivery and removal.

Abstract: Disclosed is a conduit that provides a bypass around an occlusion or stenosis in a coronary artery. The conduit is a tube adapted to be positioned in the heart wall to provide a passage for blood to flow between a heart chamber and a coronary artery, at a site distal to the occlusion or stenosis. The conduit has a section of blood vessel attached to its interior lumen which preferably includes at least one naturally occurring one-way valve positioned therein. The valve prevents the backflow of blood from the coronary artery into the heart chamber.

Abstract: An esophageal valve comprising a polymeric valve body having an outer support region, at least three valve leaflets, and a main body region extending between the support region and the valve leaflets. The valve has a normally closed configuration in which the valve is closed, an antegrade open configuration in which the valve leaflets are opened in response to an antegrade force to allow flow through the valve and a retrograde open configuration in response to a retrograde force which is substantially larger than the antegrade force.

Abstract: A valve such as an esophageal valve has a normally closed configuration in which the valve is closed and an open configuration in which the valve is opened for flow through the valve. A support for the valve is adapted for mounting to a pre-deployed luminal prosthesis intermediate a proximal end and a distal end of the predeployed luminal prosthesis.

Abstract: A luminal valve for placing in a body lumen comprises at least four valve leaflets. The valve has a normally closed configuration in which the leaflets are engaged and an open configuration in which the leaflets are open. The valve may be mounted to an esophageal support.

Abstract: An esophageal valve has a central restriction to restrict flow through the valve. The valve has a proximal guide to guide antegrade flow to the restriction and a distal guide to guide retrograde flow to the restriction.

Abstract: Disclosed is a conduit that provides a bypass around an occlusion or stenosis in a coronary artery. The conduit is a tube adapted to be positioned in the heart wall to provide a passage for blood to flow between a heart chamber and a coronary artery, at a site distal to the occlusion or stenosis. The conduit has a section of blood vessel attached to its interior lumen which preferably includes at least one naturally occurring one-way valve positioned therein. The valve prevents the backflow of blood from the coronary artery into the heart chamber.

Abstract: An apparatus for cleansing and applying therapy or prophylaxis to wounds, in which irrigant fluid containing a physiologically active material from a reservoir connected to a conformable wound dressing and wound exudate from the dressing are recirculated by a device for moving fluid through a flow path which passes through the dressing and a means for fluid cleansing and back to the dressing. A biodegradable scaffold underlies the dressing on the wound bed to promote tissue growth. The cleansing means (which may be a single-phase, e.g. micro-filtration, system or a two-phase, e.g. dialytic system) removes materials deleterious to wound healing, and the cleansed fluid, still containing materials that are beneficial in promoting wound healing, is returned to the wound bed. The dressing, an assembly comprising the dressing and scaffold, and a method of treatment using the apparatus.

Abstract: Method and apparatus implementing and using techniques for controlling flow in a body lumen, including use of an implantable medical device. The device includes a membrane implantable in a body lumen and invertibly deformable between a first position and a second position. The membrane is invertible in response to the direction of fluid flow through the lumen and can be deformable by fluid flow in the body lumen.

Abstract: An anti-reflux drainage device includes an elongated member defining a lumen, and a valve disposed along the elongated member. The valve can include one or more lumens in fluid connection with the lumen of the elongated member, a socket, a shaft disposed in the socket, and a stopper connected to the shaft that occludes the second lumen when exposed to retrograde pressure. Another such device includes an elongated member and a ball valve. The ball valve can include a seat and a shoulder defined by the elongated member, and a ball disposed in the elongated member between the seat and shoulder that occludes lumen when exposed to retrograde pressure.

Abstract: An esophageal valve has a restriction to allow antegrade passage of swallowed food and controlled retrograde passage of fluid. The restriction comprises an iris having a number of folds.

Abstract: An implantable fluid management device, designed to drain excess fluid from a variety of locations in a living host into a second location within the host, such as the bladder of that host. The device may be used to treat ascites, chronic pericardial effusions, normopressure hydrocephalus, hydrocephalus, pulmonary edema, or any fluid collection within the body of a human, or a non-human mammal.

Abstract: A patient-adjustable device and surgical method for the treatment of urinary incontinence is disclosed herein. More specifically, the device is a mesh surrounded pillow which is implanted near the attachment of the urethra to the bladder, or mid to distal urethra which can be controlled by the patient. The fullness of the pillow can be controlled by the patient using two pressure-sensitive controls under the skin.

Abstract: The invention relates to an implantable stomach prosthesis for surgically replacing or augmenting all or part of the antrum and/or pylorus of a stomach. The prosthesis controls the passage of food from the stomach to the small intestine. The prosthesis may be configured to chum ingested material and release it from the stomach through a prosthetic pyloric valve. At least one expandable member is arranged to be expanded to control the passage of food and/or to mimic the churning action of a patient's stomach. The prosthesis includes an outer support structure, a flexible inner member forming a conduit for the movement of material, and at least one expandable member located between the outer support structure and inner member. An implantable pump system is provided for inflating and deflating the expandable member(s).

Abstract: A valve for use in a body lumen, where the valve includes a valve leaflet with delayed leaflet deployment relative an in vivo implant time. The valve includes a valve frame, a valve leaflet coupled to the valve frame. The valve leaflet includes a commissure that can reversibly seal for unidirectional flow of a liquid through the valve, and a biodegradable adhesive between the valve leaflet and the valve frame to hold at least the commissure of the valve leaflet in a static relationship relative the valve frame for a predetermined time once implanted in vivo.

Abstract: Microbial growth on the surface of a valve of a voice prosthesis and optionally the cartridge or ring supporting the valve, is inhibited by providing antimicrobial activity at a level sufficient to retard growth of a microbial film by dispersing an inorganic antimicrobial agent such as silver oxide or an organic antimicrobial agent such as triclosan or butyl paraben dispersed in a medical grade silicone elastomer. The valve, ring or cartridge is in contact with body fluids containing microorganisms and nutrients therefor. The antimicrobial surface can interfere with or inhibit the growth of a biofilm, bacterial layer or a yeast layer. The body of the prosthesis may also contain an antimicrobial surface as long as it is non-toxic to the tissue it contacts.

Abstract: An implantable device for use in a human and/or animal body for replacement of an organ valve. The device has an elongate main body having a first end and a second end provided with openings, and a membrane element provided with at least one opening. The device has, in a first operating state (primary form), a large ratio of length to transverse extent along an axis, and, in a second operating state (secondary form), a smaller ratio of length to transverse extent along an axis. The device is reversibly convertible from the secondary form into the primary form by application of force against elastic material forces. At least one of the two ends of the main body has an outwardly protruding anchoring portion for anchoring the device in the organ and/or a vessel.

Abstract: The present invention provides a method of modifying the lower esophagus by injecting biocompatible particles in a biocompatible carrier into a submucosal tissue site of the lower esophagus of a patient. The method may be used to treat gastroesophageal reflux disease by optimizing the closing function of the lower esophageal sphincter.

Abstract: An artificial urinary diversion system is disclosed, which consists of a first area with at least one outlet, a second area, and a third area with at least one inlet for accommodating a urinary bladder. The second area is arranged between the first area and the third area, and that the cross-sectional surfaces of the first and/or second areas which are perpendicular to the axial alignment of the urinary diversion system are smaller than the cross-sectional surface of the third area, thereby providing a shape that can be adapted to almost any patient. These artificial urinary diversion systems provide adaptable systems that can be produced without previous direct or indirect determination of the potentially available volume for the system, and that facilitate an as effective as possible determination and utilization during the surgical phase of the volume available in the patient.

Abstract: A device for placement within a body of a patient includes an elongated member and an inflatable member coupled to the elongated member. In one embodiment, the elongated member has a first end portion and a second end portion and defines a lumen. The inflatable member is coupled to the elongated member between the first end portion of the elongated member and the second end portion of the elongated member. The inflatable member is configured to be inflated with a fluid and is configured to deliver the fluid to the body of the patient when the device is placed within the body.

Abstract: The invention provides a device, assembly, and method for transoral endoscopic restoration of a gastroesophageal flap valve. The invention also provides a self-steering and self-closing tissue fixation device for tissue fixation and an invaginator device for gripping and maneuvering tissue. The restoration device includes a longitudinal member arranged for transoral placement into a stomach, a tissue shaper carried on the longitudinal member that causes stomach tissue to assume a shape related to a gastroesophageal flap, and a tissue fixation device that maintains the shaped stomach tissue in a shape approximating a gastroesophageal flap. The tissue shaper may include a mold. The device may include the invaginator device for gripping and maneuvering esophageal tissue to aid restoration of the gastroesophageal flap, and may include the tissue fixation device.

Abstract: Medical stents having valves and their methods of manufacture are disclosed. The valve may be basket-shaped and formed integral to a medical stent to prevent undesirable backflow across the valve. The valve can be formed by converting the braided wires of the stent, by providing elastomeric material onto a mold or fixture to form an elastomeric valve, or by attaching a gasket valve. The valve is normally closed but configured to allow easy opening in response to a predetermined condition.

Abstract: According to an aspect of the present invention, implantable or insertable medical devices are provided, which contain one or more polymeric regions. These polymeric regions, in turn, contain one or more polymers, at least one of which is a copolymer that includes a styrene monomer and an isobutylene monomer. Moreover, the styrene monomer content of the copolymer typically ranges from 25 to 50 mol %.

Abstract: An artificial valve is delivered percutaneously in the form of a hollow inflatable shell, which is later filled in situ with a suitable elastomer, similar to inflating a balloon. Since the shell is a flexible and mostly hollow balloon, it can be compressed and transported via a relatively small catheter. In order to inflate to the correct shape the hollow shell requires some ties between its walls. These ties are formed from a low density open cell foam or a specialized manufacturing process. The valve can combine elements with different stiffness as well as different materials. A positioning balloon can also be used in the process of placing the valve. The invention is particularly suited for cardiac valves but can be used for other artificial valves.

Abstract: Prosthetic valves for regulating fluid flow are provided. The valves have at least one leaflet that includes a plurality of pores that allow a quantity of retrograde flow to pass through the leaflet when the valve is in a closed configuration.

Abstract: Medical stents having valves and their methods of manufacture are disclosed. The valve may be basket-shaped and formed integral to a medical stent to prevent undesirable backflow across the valve. The valve can be formed by converting the braided wires of the stent, by providing elastomeric material onto a mold or fixture to form an elastomeric valve, or by attaching a gasket valve. The valve is normally closed but configured to allow easy opening in response to a predetermined condition.

Abstract: A heart valve can be replaced using minimally invasive methods which include a sutureless sewing cuff that and a fastener delivery tool that holds the cuff against the patient's tissue while delivering fasteners to attach the cuff to the tissue from the inside out. The tool stores a plurality of fasteners and is self-contained whereby a fastener is delivered and placed all from inside a vessel. The fasteners are self-forming whereby they do not need an anvil to be formed. Anchor elements are operated from outside the patient's body to cinch a prosthesis to an anchoring cuff of the valve body. The cuff is releasably mounted on the tool and the tool holds the cuff against tissue and drives the fastener through the cuff and the tissue before folding over the legs of the fastener whereby secure securement between the cuff and the tissue is assured. Fasteners are placed and formed whereby fasteners are located continuously throughout the entire circumference of the cuff.