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 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: A partial-length catheter, or an extendable tube or sleeve member of the catheter, is selectively movable within the prostatic urethra to open a urine drainage passageway through and obstructed portion of the prostatic urethra or to open the external urinary sphincter muscle and thereby discharge urine from the bladder. A control element is manipulated at a position exterior of the urinary canal to selectively move the catheter or the extendable tube or sleeve member, thereby selectively controlling urine discharge.

Abstract: This invention relates to a temporary indwelling prostatic stent which provides a passage for urine through the prostatic urethra and which enable the patient to void the bladder at will. This temporary prostatic stent consists of a coiled or braided made out of metal or plastic section which spans the prostatic urethra, wings composed of memory alloy allowing an anchoring means in the bladder, and an anchoring means below the external sphincter, and a retrieval string to facilitate removal of the stent from the patient.

Abstract: Thin parylene C membranes having smooth front sides and ultrathin regions (e.g., 0.01 ?m to 5 ?m thick) interspersed with thicker regions are disclosed. The back sides of the membranes can be rough compared with the smooth front sides. The membranes can be used in vitro to grow monolayers of cells in a laboratory or in vivo as surgically implantable growth layers, such as to replace the Bruch's membrane in the eye. The application further provides an implantable cage-like apparatus for culturing cells comprising the parylene membrane.

Abstract: A medical device is disclosed, which comprises a functional unit (C) for permanent or temporary placement in the urogenital tract of a human or animal body. The functional unit has at least one electrically conducting portion. A power source (G) supplies a current to the electrically conducting portion after placement of the functional unit in the urogenital tract. In this manner, the growth of bacteria on the functional unit can be reduced.

Abstract: A gastric restrictor assembly is provided. The assembly includes a housing defining a throughbore and having a base portion, a waist portion and head portion. The assembly also includes a pin holder including a plurality of pins extending therefrom. The pin holder is configured for being lockingly received within the housing. The plurality of pins extend across the waist portion when the pin holder is received within the housing.

Abstract: Methods and apparatus described herein may utilize activation of an SMP material to install medical devices with respect to a surgical site. Activation of the SMP material may be performed with the use of a triggering force and/or a constraint applied to the SMP material. Activation using a triggering force and/or a constraint may be used to create varied activation rates in an SMP material and may be combined with temperature or other activation stimuli to create the varied activation rates.

Abstract: A collapsible gastrointestinal anchor can be characterized in various embodiments by a radial force of about 0.1 Newtons (N) or greater at a compressed diameter of 25 millimeters (mm); by an average spring rate of about 13 Newtons/meter (N/m) or greater in a range of motion between a relaxed diameter and a compressive elastic deformation diameter; or by a radial force over the range of motion of about 0.1 N or greater. Typically, the anchor can be adapted to be retained within a subject's intestine, more typically in the duodenum, or particularly in the duodenal bulb just distal to the pylorus. A gastrointestinal implant device includes the collapsible gastrointestinal anchor and a floppy sleeve. The sleeve is open at both ends and adapted to extend into a subject's intestine, the anchor being coupled to a proximal portion of the sleeve. Also include are methods of implanting the gastrointestinal implant device in a subject, and methods of treating a subject for disease.

Abstract: An array structure includes a plurality of containers arranged in a predetermined pattern. Each container of the plurality of containers has a maximum outer dimension that is less than about 1 cm, and each container of the plurality of containers has a substantially predetermined porosity.

Abstract: The present invention provides systems and methods for treating and controlling obesity and/or type II diabetes. In one aspect of the invention, an internal 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: A transvesicular drainage device configured to drain excess fluid from a variety of locations in the human body into the bladder. The device may be used to treat ascites or any fluid collection within the body of a human or of a non-human mammal.

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: A tubular tissue graft device is provided comprising a tubular member and a restrictive fiber matrix of a bioerodible polymer about a circumference of the tubular tissue. The matrix may be electrospun onto the tubular tissue. In one embodiment, the tubular tissue is from a vein, such as a saphenous vein, useful as an arterial graft, for example and without limitation, in a coronary artery bypass procedure. 5 Also provided is method of preparing a tubular graft comprising depositing a fiber matrix of a bioerodible polymer about a perimeter of a tubular tissue to produce a tubular tissue graft device. A cardiac bypass method comprising bypassing a coronary artery with a tubular tissue graft device comprising a vein and a restrictive fiber matrix of a bioerodible polymer about a circumference of the vein also is provided.

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 balloon type stent system for treatment of obesity is disclosed. An injection expansion unit and a plurality of distribution expansion units extend in a longitudinal direction of a stent unit body formed by coupling two sheets of synthetic vinyl in the shape of a cylinder. The injection expansion unit has an expansion agent injection port, and the distribution expansion units each have a distribution injection port communicating with a distribution channel. Connection ends are partially cut in the longitudinal direction such that the expansion units are divided into an integrated expansion unit and a separated expansion unit. The injection expansion unit and the distribution expansion units constituting the separated expansion unit are bent outward to form a balloon type stent unit. A tube has a length corresponding to a lumen length of the duodenum, and the tube is connected to the stent unit body by a connection wire.

Abstract: A negative pressure wound therapy apparatus that can include a wound dressing, a fluid collection device, a vacuum pump comprising a pump motor, and tubing can be powered by auxiliary power sources such as high efficiency batteries, photovoltaic panels or cells, fuel cells, combustion generators, human powered generators, or other mechanical, electrical, or chemical power sources such as hand operated dynamos or wound springs, or any combination of the foregoing. Additionally, the apparatus can include a high efficiency pressure controller for controlling the output of the vacuum pump. In some embodiments, the pressure controller can control the pump without using a processor, and can have other features such as an intermittent delay function and an anti-stall mechanism to reduce the energy consumption of the apparatus.

Abstract: In some embodiments, a stent includes an elongate member and a distal retention member. The elongate member is configured to be disposed within a ureter of a patient and has a first portion, a second portion and a plurality of beads bonded together. The plurality of beads define a plurality of spaces between the plurality of beads. The plurality of spaces are configured to allow fluid to flow from the first portion of the elongate member to the second portion of the elongate member. The distal retention member is configured to help maintain a portion of the stent within a kidney of the patient.

Abstract: The present invention relates to an anchor configured for minimally-invasive implantation and sized to remain securely positioned within at least a portion of the gastrointestinal tract of an animal. The anchor includes a radial spring formed from an elongated resilient member shaped into an annular wave pattern about a central axis. The anchor defines a central lumen and provides an outward radial force, while allowing for substantial flexure about its perimeter. The anchor is generally removable, but can include fasteners, such as barbs, to further secure it to the surrounding anatomy. In some embodiments, the anchor includes a connector coupling a fixed portion to a removable portion. Further, the anchor can be used to secure a medical device within the body, such as a flexible sleeve within the intestine.

Abstract: Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided.

Abstract: A urinary stent includes an elongate member that defines a lumen extending therethrough and that is configured to be disposed at least partially within a prostatic portion of a urethra of a patient. The elongate member includes a collapsible portion disposed at a proximal end portion of the elongate member. The collapsible portion has a first configuration in which an outer perimeter at a proximal end of the collapsible portion is substantially equal to an outer perimeter of a remaining portion of the elongate member and a second configuration in which the outer perimeter at the proximal end of the collapsible portion is smaller than the outer perimeter of the remaining portion of the elongate member.

Abstract: Devices, methods and kits are described for reducing intraocular pressure. The devices include a support that is implantable within Schlemm's canal and maintains the patency of the canal without substantially interfering with transmural fluid flow across the canal. The devices utilize the natural drainage process of the eye and can be implanted with minimal trauma to the eye. Kits include a support and an introducer for implanting the support within Schlemm's canal. Methods include implanting a support within Schlemm's canal, wherein the support is capable of maintaining the patency of the canal without substantial interference with transmural fluid flow across the canal.

Abstract: A mechanically deployable upper airway stent is disclosed along with a method of using same. The stent comprises a central tube having an inner chamber and openings on its surface. A linkage rod is housed within the central tube and is provided with branched spokes that pass through the openings. In the un-deployed state the branched spokes are contained within the central tube. Deployed spokes are preferably aligned in groupings along the central tube. The outer ends of the spokes of each grouping connect to a rib. The un-deployed stent is inserted into the nasal passageway and positioned relative to occluding anatomic structures. Upon deployment, the ribs along with web members extending between the ribs move outwardly from the central tube and press upon the tissues of the pharyngeal cavity. Spaces between the extended spokes permit the passage of air along the stent and maintain airway patency.

Abstract: A bowel extension device implantable into a body for treatment of short bowel syndrome. The bowel extension device comprises a housing and a displaceable member coupled to the housing. The bowel extension device is configured to apply a tensile force sufficient to promote bowel growth without causing damage to the bowel. In some embodiments, the bowel extension device can be completely contained with the body.

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 portable negative pressure wound therapy system includes a dressing assembly for positioning over a wound to apply a negative pressure to the wound and a canister assembly. The canister assembly includes a control unit having a vacuum source and a controller and a collection canister in communication with the dressing assembly operable to receive fluid from the wound. The collection canister has a filter assembly having a filter and a passageway between the filter and a wall of the collection canister. The collection canister also includes a canister interface having a suction port, an inlet port, and a channel. The vacuum source draws air through the suction port from the channel which draws air from the passageway connected to the channel, the air in the passageway is drawn from the collection canister through the filter, and the air in the collection canister is drawn through the inlet port.

Abstract: A hiatal hernia reduction device and method includes positioning a device having a wall that is generally configured to the normal anatomy at the gastro-esophageal region of a person without a hiatal hernia. The anatomy of the patient at the gastro-esophageal region is formed substantially to the anatomy of the normal person without a hiatal hernia.

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, distal 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 a first opening and a second opening configured for allowing fluid flow from the passage to the lumen in the first direction.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.

Abstract: The medical implant for treating pathological obesity is adapted to modify and, as an alternative, to bypass the natural food passage in the digestive tract. The implant permits an adjustable bypassing of food into the small intestine and/or into the stomach (natural digestive path). Since the ratio of this bypass is adjustable in the course of the treatment by the physician, e.g. with the aid of an endoscope, for the first time a balance between the therapeutic effect and the side-effects can be adapted individually to each patient by the use of the implant. The implant has a hollow body with first and a second tubular end portions and at least one third lateral opening having a hose-like extension. The individual at least partly closable hose-like extensions differ in their ability to allow the passage of food into the stomach.

Abstract: A modular system for therapy within a gastrointestinal system. The system includes anchoring or attachment functionality embodied in a low-profile implant technology and removable therapy components, which can be reversibly attached to these low-profile implants to accomplish various therapies. This modular design allows the physician to tailor the therapy to the patient's needs. The modular system has the potential to create conduits for diversion and/or restriction of food and organ secretions and to facilitate the treatment of metabolic disorders such as obesity and T2DM.

Abstract: Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided. The intragastric devices include an intragastric balloon comprising an initial fill gas comprising an inert gas and CO2, a valve system, and a polymeric wall having, under conditions of an in vivo gastric environment, a permeability to CO2 of more than 10 cc/m2/day, such that a rate and an amount of diffusion of CO2 from the in vivo gastric environment into a lumen of the balloon through the polymeric wall is controlled, at least in part, by a concentration of the inert gas and a concentration of CO2 in the initial fill gas, wherein the concentration of CO2 in the initial fill gas is similar to gastric pCO2.

Abstract: Apparatus (10) is provided, including a housing (26) configured to be implanted in a trachea (20) of a patient and a propeller (22), coupled to the housing. The propeller is configured to generate a positive pressure in the trachea while the propeller is in the trachea. Other embodiments are also described.

Abstract: The present invention is referred to an endoscopic implantable device for the apposition of the stomach walls for reducing the stomach internal volume, comprising a cylindrical elongated body comprising two hinged halves, each of which having a plurality of suction nozzles and a set of aligned grabbing teeth. Said suction nozzles have a fluid communication with a suction port of the endoscopic apparatus used to place said device into the patient's stomach, and the mentioned teeth of each half cooperate between each other to grab and keep the walls of the stomach together until the device is dissolved by the gastric fluids present in the stomach. The purposed invention also comprises a method for joining internal body tissue.

Abstract: This invention describes a method for determining an abnormality of metabolic function and/or a variation of metabolic function, the method including the steps of, in a processing system receiving electroencephalography (EEG) signal information (100), analysing the signal information (110), and determining the abnormality from the analysis (120). It also describes a method for managing the variation accordingly, the method including the steps of, detecting the abnormality (400), applying patient information (410), determining appropriate dose (420), and providing the required dose (430).

Abstract: The present invention relates to methods and devices that help to curb appetite and/or reduce food intake. In one embodiment, the methods and devices of the present invention include a small intestinal/duodenal insert comprising an elongated member with at least one flow reduction element that can cause the stimulation of one or more biological signals of satiety.

Abstract: The disclosure provides methods for repairing nerves and inhibiting atrophy of a muscle via a side-to side neurorraphy using a bridging element between a first epineurial window on a donor nerve and a second epineurial window on a recipient nerve.

Abstract: A medical device which defines a lumen for flowing a bodily fluid from an upstream end of the device to a downstream end thereof is disclosed. The device has a luminal wall (14) that extends between the upstream and downstream ends and defines the lumen within which the fluid flows. The wall exhibits a succession of protuberances spaced from each other along the length of the device. Each protuberance has a flank facing upstream (54) and a flank facing downstream (64), the flank facing upstream extending into the fluid flow so that a radially outermost part of the flow of fluid from the upstream to the downstream end of the device impinges on the upstream flank and is thereby caused to reverse its flow, and flow upstream from the upstream flank to the downstream flank of the next adjacent protuberance upstream, creating micro-vortices between two adjacent protuberances.

Abstract: The invention is directed to methods and devices for the reconstruction, repair, augmentation or replacement of laminarily organized luminal organs or tissue structures in a patient in need of such treatment. The device comprises a biocompatible synthetic or natural polymeric matrix shaped to conform to at least a part of the luminal organ or tissue structure with a first cell population on or in a first area and a second cell population such as a smooth muscle cell population in a second area of the polymeric matrix. The method involves grafting the device to an area in a patient in need of treatment. The polymeric matrix comprises a biocompatible and biodegradable material.

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: A surgical fastener apparatus, for securing a surgical mesh material to body tissue including a pair of anchors each having a retaining structure formed on an outer surface thereof; and a suture tether interconnecting the pair of anchors to one another. The pair of anchors have a substantially cylindrical body having a conically tapered distal end and a planar proximal end. The retaining structure includes a series of semi-circular angled projections having a planar proximal surface and a tapered distal end, wherein a center of each of the angled projections is spaced a distance from a longitudinal central axis of the body portion. The surgical fastener is made from a bioabsorbable material which reabsorbs into body tissue at an appropriate rate, such as for example, polyglycolic acid and polylactic acid.

Abstract: A ciliated stent-like system and method of operating the same.

Abstract: A medical device and method for its use in the digestive system of a mammalian patient is provided. The medical device includes a stent and a retrieval device. The stent has a magnetic element connected to an end of the stent. The retrieval device includes a magnetic member, and the retrieval device is sized to be ingested by the patient. The magnetic member is capable of being magnetically coupled to the magnetic element of the stent for removal of the stent through the natural forces of the digestive system.

Abstract: Provided are medical devices for implantation in patients having suffered the loss of or damage to at least part of their esophagus. The medical device connects the esophagus or remaining part thereof with the stomach to form a gastro-esophageal junction that promotes healing and encourages new host tissue growth while distributing the load and decreasing tension at the anastomotic site. The medical device comprises extracellular matrix shaped into a conformation that more closely approximates the geometry of the native gastro-esophageal junction than does direct attachment of the stomach to the shortened esophagus. Molds useful in manufacturing the medical device and methods of use of the device are also described herein.

Abstract: Methods and devices are disclosed for opening a passageway of a patient. The device includes a base plate for attachment to cricoid cartilage of the patient. A post extends from the base plate through the patient's skin. The post is pulled via a force to manually open the passageway.

Abstract: An elongate medical device configured for at least partial implantation or insertion into a subject. The medical device has at least one surface that contains one or more depressions, which are at least partially filled with a soluble material. Also described methods of making such devices.

Abstract: A gastroesophageal reflux disease (GERD) reduction device and method includes providing a wall that is generally configured to the anatomy at the gastroesophageal region of a normal person without reflux The device is positioned at the gastroesophageal region of the patient The anatomy of the patient at the gastro-esophageal region is formed to the anatomy of the person without reflux Additional applications include reduction of a hiatal hernia and reduction of stress through increasing the generation of at least one neuro-humoral transmitter.

Abstract: An implant device and method for inducing weight loss is provided wherein the implant device deforms the stomach wall thereby reducing the effective stomach volume without connection or access to the inner stomach. The implant device has a shape to provide for deformation of the stomach without retention within the inner stomach.

Abstract: The present invention relates generally to medical methods and systems used to restore the angle of His and treat hiatal hernias and other conditions of the lower esophagus. More particularly, the present invention relates to a method and system that allows fixation of the distal esophagus and fundus of the stomach directly to the diaphragmatic crus muscle. The present invention provides a method where the diaphragmatic crus muscle is identified and precisely located from within and through the gastrointestinal lumen followed by the placement of a translumenal anchor which connects and secures the esophagus and stomach to the diaphragmatic crus muscle. This procedure reduces the hiatal hernia, restores the normal anatomy and treats conditions associated with the lower esophagus.

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.