Abstract: A method for non-surgically treating an internal nasal valve of a patient comprising, injecting a working device into the internal nasal valve of the patient, wherein the injected working device in the nasal tissue causes an alteration of an internal or external nasal valve. A device introduced by injection into the nose, allowing for structural support or filling of defects in the nose, and causing a change in external shape of the nose. The device and inserts and implants described also have use in cosmetic applications relating to the facial tissue.

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 device to provide body fluid flow control in the form of a valve to be located within a duct or passageway. The device is controlled through pressure above a preselected threshold. Bulk resilience about a passageway in a valve body provides the mechanism for controlled flow. One-way valve operation may be provided through a flap or through a pressure differential on the valve body depending upon the direction of flow. A frame structure positioned within a resilient seal includes longitudinally elongated elements which may be of spring material, malleable material or heat recoverable material so as to accomplish an initial insertion state and an expanded anchoring state. A valve support transitions between the resilient seal portion and the valve body to insure that the states do not change the threshold opening pressure. Insertion devices may be employed to position and actuate a change of state of the frame in the body duct or passageway.

Abstract: A stent includes a cylindrical main body contractible and expandable in a circumferential direction, a cover member coated on inner and/or outer circumference of the main body, and an inverse current preventing member for preventing food or fluid from reversely flowing. The inverse current preventing member is disposed in the main body and includes a fixing layer defining a passage having a diameter capable of allowing food and fluid to pass, the fixing layer being fixed in the main body and a valve layer extending from the fixing layer to a distal end of the main body.

Abstract: A prosthetic orthopaedic head has a fluid chamber defined therein. A fluid filter is positioned in the fluid chamber. In response to a load being exerted on the prosthetic head, synovial fluid is advanced through a filter thereby removing debris from the synovial fluid. A method of operating a prosthesis is also disclosed.

Abstract: Disclosed is a pressure sensitive prosthesis that includes a tubular member having a passageway extending therethrough and a sleeve attached about one end of the tubular member. The sleeve functions as a one-way valve to permit fluid flowing through the sleeve lumen in a first direction and under a first pressure, while collapsing in response to fluid flowing in a second direction when the pressure thereof exceeds that of the first direction or pressure. One aspect of the invention includes an esophageal anti-reflux expandable prosthesis wherein the sleeve is adapted to invert back through the tubular stent frame to permit belching or vomiting (fluid or materials under a third, significantly higher pressure). Another aspect of the invention includes a tubular drainage stent, such as a biliary or urethral stent in which the sleeve opens to permit passage of fluids, then collapses to prevent retrograde flow.

Abstract: A device for inducing weight loss in a patient includes a tubular prosthesis self-expandable from a collapsed position in which the prosthesis has a first diameter to an expanded position in which the prosthesis has a second, larger, diameter. In a method for inducing weight loss, the prosthesis is placed in the collapsed position and inserted into a stomach of a patient. The prosthesis is allowed to self-expand from the collapsed position to the expanded position and into contact with the walls of the stomach, where it induces feelings of satiety and/or inhibits modulation of satiety-controlling factors such as Ghrelin.

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: A ureteral stent is configured for improved patient comfort and aftercare. The stent can have one or more of the following features: a distal portion with a somewhat flattened, non-circular cross-section that provides reduced irritation and elimination of urine reflux; a proximal portion with a helical coil shape that allows self-anchoring of the stent below the kidney; and a portion along the body of the stent having a coil shape that allows self-adjustment of the stent with ureteral movement.

Abstract: An implantable stomach prosthesis is provided 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: A device to provide body fluid flow control in the form of a valve to be located within a duct or passageway. The device is controlled through pressure above a preselected threshold. Bulk resilience about a passageway in a valve body provides the mechanism for controlled flow. One-way valve operation may be provided through a flap or through a pressure differential on the valve body depending upon the direction of flow. A frame structure positioned within a resilient seal includes longitudinally elongate elements which may be of spring material, malleable material or heat recoverable material so as to accomplish an initial insertion state and an expanded anchoring state. A valve support transitions between the resilient seal portion and the valve body to insure that the states do not change the threshold opening pressure. Insertion devices may be employed to position and actuate a change of state of the frame in the body duct or passageway.

Abstract: An externally worn tracheal valve has a valve assembly supporting a flexible, resilient lightweight diaphragm centrally thereof. The diaphragm is folded towards the trachea so that air expelled from the trachea will tend to unfold the diaphragm to an extended position to close the valve. During normal breathing the diaphragm remains at least partially folded and the valve remains open. During voice exhalation, the diaphragm extends to close the valve. During high pressure coughing exhalation, the diaphragm may evert, opening the valve to release excessive pressure.

Abstract: A grafted network including one or more graft segments for use in coronary bypass procedures and which are configured to operably transport bypass blood flow from a singular supply location to one or more delivery locations in the grafted network is provided in combination with one or more multiple channel blood flow connectors for directing such bypass blood flow in the grafted network to one or more vascular members requiring restorative blood flow thereto. The grafted network also preferably includes one or more devices for operably maintaining the grafted network under relatively high internal fluid pressure so as to continuously supply selective vascular members with adequate bypass blood flow.

Abstract: A flow control device includes a sealing component that can be positioned within a bronchial lumen. The sealing component can comprise two or more overlapping segments that are movable relative to one another such that the segments collectively form a seal that can expand and contract in size to fit within and seal bronchial lumens of various sizes.

Abstract: A system for repairing an intervertebral disc by delivering and curing a biomaterial in situ within the disc. The system includes both a device, having an insertable balloon and related lumen, controls and adapters, as well as an in situ curable biomaterial (and related biomaterial delivery means). The system can allow the doctor to determine a suitable endpoint for biomaterial delivery, by controlling distraction and/or biomaterial delivery pressure, and in turn, to deliver a desired quantity of biomaterial to the balloon in order to achieve improved polymer cure and implant characteristics. Also provided is a related method for repairing an intervertebral disc by using such a system to deliver and cure the biomaterial in situ. The system can be used to implant a prosthetic total disc, or a prosthetic disc nucleus in a manner that leaves the surrounding disc tissue substantially intact.

Abstract: Disclosed are esophageal anti-reflux valve prostheses, and tools and procedures for peroral implantation and extraction of the prostheses. The prostheses disclosed have a semipermeable membrane to allow retrograde passage of gas, magnets disposed at a distal end of the sleeve to facilitate closure, and an outwardly bendable array of spikes that are longitudinally aligned for peroral insertion and lockable into a radially outwardly deployed configuration to keep the prosthesis from dislocating implantation. The implantation tool has inner and outer concentric tubes, the inner tube releasably threadably connected to the prosthesis, the outer tube reverse threaded with the inner tube to advance a distal headpiece to engage, deploy and lock the spikes into the deployed configuration. A vacuum assist can be used to help impact the lumen wall on the spikes.

Abstract: Disclosed is a valve implanting device comprising a collapsible frame, inner and outer guide wires removably connected to the collapsible frame, and a plurality of valve flaps attached to the collapsible frame. The collapsible frame is inserted into a patient's femoral vein or artery, guided to a deployment position using the guide wires, expanded using the guide wires, and stabilized using the guide wires to manipulate fixating hubs on the collapsible frame. The collapsible frame includes a central hub, a plurality of spokes, fixating hubs, gripping members, and a plurality of valve flaps.

Abstract: The valve mounting system of the invention incorporates a hard cartridge with a grove on its outer, distal surface and a slot communicating distal from the end of the cartridge with the grove and a specially configured elastomeric valve attached to an outer band with a short tab. The band is positioned with the tab aligned with the slot and is stretched and is slid proximally over the cartridge until the tap enters the slot and the band snaps into the seats in the groove. The width of the slot is the same as the width of the tab providing exact alignment of the valve element with the seat provided in the cartridge. The tab can be disposed at an angle to the seat to preload the valve element against the seat.

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: In one embodiment, the invention is directed to a ureteral stent adapted for placement within a patient's urinary tract to facilitate drainage from the patient's kidney to the patient's bladder. The ureteral stent includes an elongated portion, a retention portion and a mesh or coil portion. The elongated portion has first and second ends, defines an elongated portion of a lumen extending between the first and second ends, and has a length sufficient to extend within the ureter from the patient's kidney to the patient's bladder. The retention portion extends from the first end of the elongated portion, defines a retention portion of the lumen and at least one through aperture for providing fluid communication between the lumen and the kidney. The retention portion is adapted for placement substantially within the kidney and for retaining the placement of the stent within the kidney.

Abstract: A method of flowing blood from a heart chamber to a coronary vessel includes providing a conduit with a first end and second end, providing the conduit within a heart wall such that the first end of the conduit is open towards the heart chamber and the second end is open towards the blood vessel, and during diastole, restricting a flow of blood from the coronary vessel to the heart chamber via the natural valve.

Abstract: A device for generating an artificial constriction in the gastrointestinal tract comprises a band (1), which can be placed annularly about a particular portion (2) of the gastrointestinal tract, and, by means of a piston-cylinder unit (8), the size of the passageway opening (19) of the portion (2) of the gastrointestinal tract encompassed by the band (1) is variable, and the band (1), in the proximity of its first end (4), is connected with the cylinder (6) of the piston-cylinder unit (8). The band (1) is connected in the proximity of its second end (5) with the piston (7) of this piston-cylinder unit (8).

Abstract: Medical devices for implantation in a body vessel are provided. Each medical device comprises a main body, a valve, and a vessel engaging member. The vessel engaging member is disposed on an outer surface of the main body. Kits including a plurality of vessel engaging members for use with one or more valve members are also provided. The vessel engaging members have varying radial dimensions, allowing assembly of medical devices having varying radial dimensions. Methods of treating a patient using medical devices according to the invention are also provided.

Abstract: With an object of providing an artificial sphincter for which repeated shape changes are possible, and for which the quantity of shape change is sufficient so as to be used as a substitute for a large natural sphincter, an artificial sphincter 11 that opens and closes, as required, either the anus of a living body or part of the intestine 19 led outside the body is provided, wherein this artificial sphincter 11 comprises a pair of shape memory alloy elements 13 that change reversibly between two opposite shapes upon changes in temperature and hinges 15 that link the shape memory alloy elements 1 together in a cylindrical shape.

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: 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: 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 device for inducing weight loss in a patient includes a tubular prosthesis positionable at the gastro-esophageal junction region, preferably below the z-line. In a method for inducing weight loss, the prosthesis is placed such that an opening at its proximal end receives masticated food from the esophagus, and such that the masticated food passes through the pouch and into the stomach via an opening in its distal end.

Abstract: An intra-bronchial device placed and anchored in an air passageway of a patient to collapse a lung portion associated with the air passageway. The device includes a support structure, an obstructing member carried by the support structure that reduces ventilation to the lung portion by preventing air from being inhaled into the lung portion, and at least one anchor carried by the support structure that anchors the obstruction device within the air passageway. The anchor may engage the air passageway wall by piercing or friction, include a stop dimensioned for limiting the piercing of the air passageway wall, and may be releasable from the air passageway for removal of the intra-bronchial device. The anchors may be carried by a peripheral portion of the support structure, or by a central portion of the support structure. The obstructing member may be a one-way valve.

Abstract: A prosthetic device is described that is positionable within the gastro-esophageal junction region of a patient. The prosthetic device includes a proximal opening and a distal orifice that is adjustable in size prior to and/or following implantation. During use, the prosthetic device is attached to tissue of the gastro-esophageal junction region of the patient, with the device positioned such that food ingested by the patient passes from the esophagus through the proximal opening into the interior of the prosthetic device, and eventually exits the prosthetic device via the distal opening.

Abstract: A lung-assist apparatus includes a tubular housing, a tubular nozzle therein, and a first valve disposed between the housing and nozzle. The housing is implanted across a bifurcation such that the nozzle extends from a first branch communicating with a healthy region of a lung towards a main passage, and terminates proximate a lateral opening in the housing that is disposed within a second branch communicating with a damaged region of the lung. During inhalation, the first valve opens to allow air flow into the first branch, and closes during exhalation to force air through the nozzle, thereby inducing a vacuum for drawing air from the damaged region. A second valve in the second branch opens during exhalation to draw air from the diseased region, and closes during inhalation to prevent air from being drawn into the damaged region.

Abstract: The invention relates to a generally tubular prosthesis (1) for controlling the direction of flow in a duct (O) of a living organism. Said prosthesis consists of a biocompatible, elastically deformable material and comprises an annular proximal fixing part (1a) in a section (H) of the duct (O) with a greater diameter; and a distal part (1b) whose wall is designed in such a way that it can collapse on itself in the event that an overpressure is exerted on its outer surface. The diameter of said annular proximal fixing part (1a) is substantially equal to that of said section (H) of the duct (O) with a greater diameter and its resistance to crushing is significantly greater than that of the distal part (1b) of the prosthesis (1), so that the annular proximal part (1a) can retain the prosthesis (1) in the duct (O) of the living organism.

Abstract: The present invention provides a device for causing weight loss in obese patients comprising an implant that creates an intestinal bypass between a first region of intestine and a second region of intestine. In one embodiment, the implant comprises an adjustable opening to adjust the fraction of food material passing through the intestinal bypass. Also disclosed is a method for causing weight loss in obese patients comprising the steps of surgically creating an intestinal bypass with an adjustable opening, calculating an expected weight loss and an expected electrolyte balance in the patient, periodically monitoring the patient's weight loss and electrolyte balance and adjusting the size of the adjustable opening if necessary.

Abstract: The present invention relates to noval design of mechanical valve prostheses and manufacturing methods. A series of prosthetic valves with novel design and a unique manufacturing approach are disclosed. These devices possess unique designs and are made of nanostructurely engineered biomaterial. In addition, a novel manufacturing approach will be used to produce these devices because the convention technique is incapable of fabricating the devices due to the small size, design requirements and material properties restrain. Furthermore, it provides the convenience and thus low cost in manufacturing. The devices are particularly but not exclusively useful in human circulation system to restore the normal functions.

Abstract: An implantable digestive organ is provided for the transport of materials through the digestive tract and in one particular application to an artificial large bowel for replacing all or part of a colon or large bowel. The prosthetic organ of one embodiment includes an outer support structure, an expandable member or members located within the outer support structure, and a flexible inner member forming a conduit for the passage of material. The flexible inner member is located within the outer member and the expandable member or members are located between the inner member and the outer support structure. The expandable members are expanded and contracted, or inflated and deflated to provide a pumping action that pumps the material through the organ. The prosthesis may also include valves or sphincters at the entrance and/or exit points of the organ where material moves into and out of the prosthesis.

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: 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 invertably 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: A satiation device is described which includes a sheath or liner extending from the proximal or middle stomach to the distal antrum. Food ingested by the patient passes through the sheath or liner, thereby minimizing contact between the ingested food and the stomach. It is believed that over time, reduced contact between food and the stomach will result in decreased Ghrelin production by the patient and a consequent decrease in appetite. In some embodiments, the satiation device may also include a proximal pouch and/or a distal bypass tube.

Abstract: Disclosed is a pressure sensitive prosthesis (10) that includes a tubular member (11) having a passageway (12) extending therethrough and a sleeve (13) attached about one end of the tubular member. The sleeve functions as a one-way valve to permit fluid flowing through the sleeve lumen (15) in a first direction (17) and under a first pressure, while collapsing in response to fluid flowing in a second direction 18 where the pressure that exceeds that of the first direction or pressure. One aspect of the invention includes an esophageal anti-reflux expandable prosthesis wherein the sleeve is adapted to invert back through the tubular stent frame to permit belching or vomiting (fluid or materials under a third, significantly higher pressure). Another aspect of the invention includes a tubular drainage stent (60), such as a biliary or urethral stent in which the sleeve opens to permit passage of fluids, then collapses to prevent retrograde flow.

Abstract: In an artificial endosphincter (1) for the urethra, comprising a retaining part (2) and a valve (10) which can be manually actuated by pressure from the outside, the retaining part (2) is formed as self-expanding stent. This permits gentle, simple and safe positioning as well as reliable and simple handling of the artificial endosphincter (1).

Abstract: An anti-reflux stent includes an extended inner sleeve, a stent surrounding at least a portion of the inner sleeve and a coating that bonds the stent to the inner sleeve whereby the extended inner sleeve can have a cross-sectional thickness that varies along the length of the inner sleeve. The inner sleeve is made of a material having a thickness and/or flexibility such that the distal end not surrounded by the stent collapses under gastric pressure to prevent the contents of the stomach from flowing into an esophagus. Food and liquid can pass through an inner lumen of the inner sleeve to enter a stomach when desired.

Abstract: An apparatus for distributing a liquid in a patient's body comprises an implantable pump adapted to pump the liquid and an implantable valve device adapted to direct the liquid pumped by the pump. A first ceramic valve member of the valve device includes a first plane surface and a second ceramic valve member of the valve device includes a second plane surface facing and touching the first plane surface. The second valve member is displaceable relative to the first valve member between different positions, wherein the valve members include different liquid channels. The valve device is operable to displace the second valve member to hydraulically connect the pump to at least one of the liquid channels in at least one of the positions.

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 device for inducing weight loss in a patient includes a tubular prosthesis self-expandable from a collapsed position in which the prosthesis has a first diameter to an expanded position in which the prosthesis has a second, larger, diameter. In a method for inducing weight loss, the prosthesis is placed in the collapsed position and inserted into a stomach of a patient. The prosthesis is allowed to self-expand from the collapsed position to the expanded position and into contact with the walls of the stomach, where it induces feelings of satiety and/or inhibits modulation of satiety-controlling factors such as Ghrelin.

Abstract: A bladder access device is disclosed that incorporates a load port and a valve connected to each other by way of a series of tubes. The valve is a four piece elliptical ring closed by a locking mechanism. The inner major axis portion of the elliptical ring has two inflatable cuffs. When fluid is injected into a self sealing and leakproof load port, the fluid flows through the series of tubes into the inflatable cuffs of the valve thus expanding them. This allows the elliptical ring to be placed around a patient's bladder and upon inflation of the inflatable cuffs, the valve closes onto the bladder allowing for continence. During this state of inflation, access can be made to the bladder by compressing the valve with two fingers. The valve closes automatically when released. The present device can be used as a closure control valve for other internal organs as well.

Abstract: Disclosed is a conduit that provides a bypass around a stenosis or occlusion in a coronary artery. The conduit is adapted to be positioned in the myocardium to provide a passage for blood to flow from a heart chamber to a coronary artery, at a site distal to the blockage or stenosis in the coronary artery. The conduit has a one-way valve positioned therein to prevent the backflow of blood from the coronary artery into the heart chamber.

Abstract: A device to provide body fluid flow control in the form of a valve to be located within a duct or passageway. The device is controlled through pressure above a preselected threshold. Bulk resilience about a passageway in a valve body provides the mechanism for controlled flow. One-way valve operation may be provided through a flap or through a pressure differential on the valve body depending upon the direction of flow. A frame structure positioned within a resilient seal includes longitudinally elongate elements which may be of spring material, malleable material or heat recoverable material so as to accomplish an initial insertion state and an expanded anchoring state. A valve support transitions between the resilient seal portion and the valve body to insure that the states do not change the threshold opening pressure. Insertion devices may be employed to position and actuate a change of state of the frame in the body duct or passageway.

Abstract: A device to provide body fluid flow control in the form of a valve to be located within a duct or passageway. The device is controlled through pressure above a preselected threshold. Bulk resilience about a passageway in a valve body provides the mechanism for controlled flow. One-way valve operation may be provided through a flap or through a pressure differential on the valve body depending upon the direction of flow. A frame structure positioned within a resilient seal includes longitudinally elongate elements which may be of spring material, malleable material or heat recoverable material so as to accomplish an initial insertion state and an expanded anchoring state. A valve support transitions between the resilient seal portion and the valve body to insure that the states do not change the threshold opening pressure. Insertion devices may be employed to position and actuate a change of state of the frame in the body duct or passageway.

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 invertably 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: Disclosed is an instrument, valve prosthesis and procedure for the minimally invasive implantation of a sutureless anti-reflux valve in a patient for the treatment of gastroesophageal reflux disease. Self-anchoring or stapleable one-way anti-reflux valve prostheses are provided, which may be implanted proximate a patient's gastroesophageal junction without open or laparoscopic surgery. An instrument for the peroral insertion, positioning and fixing of the valve prosthesis to the tissue of the esophagus is described for the implantation of either the self-anchoring or stapleable prosthesis.