Abstract: An apparatus includes a shaft, an expandable dilation member, and a bulbous tip. The shaft has a first outer cross-sectional dimension. The dilation member is positioned proximal to the distal end of the shaft. The dilation member is operable to transition between a non-expanded configuration and an expanded configuration. The dilation member is sized to pass through a passageway associated with drainage of a paranasal sinus or a Eustachian tube when the dilation member is in the non-expanded configuration. The bulbous tip is positioned at the distal end of the shaft. The bulbous tip is distal to the dilation member. The bulbous tip has a second outer cross-sectional dimension. The second outer cross-sectional dimension is larger than the first outer cross-sectional dimension. The bulbous tip is removably secured to the distal end of the shaft.

Abstract: Systems featuring two or more encapsulation devices stacked together. The encapsulation devices house cells, such as but not limited to islet cells or stem cell derived beta cells or the like. e.g., for regulating blood glucose, or other cells or spheroids that can produce and release a therapeutic agent that is useful in the body, etc. The system may feature oxygen delivery, or in some cases no exogenous oxygen is delivered and vascularization of the device can help provide oxygen and other needed nutrient to the cells. The system of the present invention may be used in conjunction with other therapies such as an artificial pancreas. Stacking the devices with blood vessel formation around and in between them may allow for a decrease in the footprint that would be needed for implantation.

Abstract: A prosthesis used for long-term treatment of Gastro-Esophageal Reflux Disease (GERD) comprising an upper thin ring mesh for incorporation in the esophageal wall with a lower tubular part to block reflux and a method where a temporary ring is placed to exert compression laterally on a thin ring supporting a tubular or slit valve to treat GERD to help the thin ring incorporate in the esophageal wall.

Abstract: An adhesive wafer for an ostomy device, the wafer comprising a skin-facing adhesive layer, a backing layer on the non-skin-facing side of the adhesive layer, and a hole for accommodating a stoma. On the central portion of the backing layer is located a release layer being configured to release a neutralizer. The neutralizer is capable of neutralizing or at least minimizing the level of skin or adhesive aggressiveness of the output.

Abstract: A method for treating tissue through a branched luminal network of a patient is provided. A pathway to a point of interest in branched luminal network of a patient is generated. An extended working channel is advanced transorally into the branched luminal network and along the pathway to the point of interest. The extended working channel may be positioned in a substantially fixed orientation at the point interest. A tool is advanced though the extended working channel to the point of interest. Tissue at the point of interest is treated.

Abstract: An implant that has a tubular interior section for implantation into a patient, an exterior section connected to the interior section and an ingrowth member that includes a three-dimensional porous structure. The three-dimensional porous structure is typically located at the inner circumference of the interior section and has desirable properties to facilitate ingrowth of tissue.

Abstract: The invention relates to a prosthesis for supporting a breast implant comprising: a reinforcement part configured to receive a curved lower portion of a breast implant, the reinforcement part having an elongation under 50N in the vertical direction of E1, a fixation part intended to be fixed to the pectoral muscle, the fixation part having an elongation under 50N in the vertical direction of E2, and a transition part connecting together the reinforcement part and the fixation part, said transition part having an elongation under 50N in the vertical direction of E3, wherein E3 is greater than E1 and greater than E2.

Abstract: A method of using an implantable mesh for repairing a tissue defect or reconstructing tissue, wherein the implantable mesh has a mesh body and at least two mesh extensions comprised of mesh extending therefrom, includes positioning the mesh body of the implantable mesh such that the mesh body extends across the tissue defect or tissue to be reconstructed and passing at least one mesh extension through tissue adjacent to the tissue defect or tissue to be reconstructed so as to anchor the implantable mesh to the tissue and resist high tension without dehiscing or migrating from the tissue defect or tissue to be reconstructed.

Abstract: Provided is a ureteral stent including a bladder portion positioned in a bladder of a patient, a kidney portion positioned in a kidney and ureteral passageway of the patient, and one or more tethers coupling the bladder portion to the kidney portion. The ureteral stent allows urine to pass around a blockage, and allows a ureter orifice connecting the ureteral passageway to the bladder to move between a compressed state and an uncompressed state to prevent or minimize urinary reflux, flank pain, blood in the urine, etc., while allowing the bladder portion to move freely in the bladder to prevent the bladder portion from irritating the trigone muscle.

Abstract: A cell composition composed of spermatogonial stem cells, Sertoli cells, Leydig cells and optionally peritubular cells, is provided, as is a culture composition, artificial testicular construct, hydrogel composition, and device containing the same. A method for using the device as a physiologically relevant in vitro model of human testicular function to screen compounds for pharmacological or toxicological activity is also provided.

Abstract: A biocompatible tissue graft is provided. The tissue graft includes an extracellular matrix patch and a means for reinforcing the patch.

Abstract: An apparatus is configured to be implanted within a biological structure. The apparatus includes an annular body, a first ring, a second ring, a first plurality of magnets, and a second plurality of magnets. The annular body is disposed about a central axis. The annular body includes an outer wall facing away from the central axis and an inner wall facing toward the central axis. The first ring extends adjacent to the inner wall of the annular body and extends annularly toward the central axis. The second ring extends between the first ring and the central axis. The second ring defines an opening disposed about the central axis. The first plurality of magnets are imbedded in the first ring and are annular disposed about the central axis. The second plurality of magnets are imbedded in the second ring and are annularly disposed about the central axis.

Abstract: The invention relates to a prosthesis for supporting a breast implant comprising: a reinforcement part configured to receive a curved lower portion of a breast implant, the reinforcement part having an elongation under 50N in the vertical direction of E1, a fixation part intended to be fixed to the pectoral muscle, the fixation part having an elongation under 50N in the vertical direction of E2, and a transition part connecting together the reinforcement part and the fixation part, said transition part having an elongation under 50N in the vertical direction of E3, wherein E3 is greater than E1 and greater than E2.

Abstract: An inventive digestive tract barrier includes a material defining dimensions of a tube sized to deploy within the digestive tract of a subject. The material or stitches that make up the barrier disintegrate in a controlled manner. The disintegration precludes the need for a surgical procedure to retrieve the barrier and allows for increased nutritional absorption after behavior modification has occurred. Through the inclusion of opening or fenestrations in the barrier, bile flow and nutrition absorption are facilitated. Disintegration is facilitated by formation of the barrier from biodegradable material, stitching non-degradable swatches with disintegrating stitching, or the use of a MEMS cutter. A digestive barrier coated on either the interior or exterior of the tube facilitates management of conditions such as obesity, colitis, and Crohn's disease.

Abstract: A device for inguinal ligament fixation includes a suspension mesh, wherein the suspension includes: a cervix and anterior vaginal wall sling; wherein a first end of the cervix and anterior vaginal wall sling is connected to a cervix or an anterior vaginal wall; two inguinal ligament suspension arms, wherein a second end of each of the two inguinal ligament suspension arms is connected to a second end of the cervix and anterior vaginal wall sling, and the two inguinal ligament suspension arms are placed in a symmetrical form; and two sacral ligament and posterior vaginal wall suspension arms, wherein a second end of each of the two sacral ligament and posterior vaginal wall suspension arms is connected to the second end of the cervix and anterior vaginal wall sling, and the two sacral ligament and posterior vaginal wall suspension arms are placed in a symmetrical form.

Abstract: An embodiment of the invention relates to an apparatus for supporting first and second blood vessels connected by an anastomosis at a fistula, the apparatus comprising: a coupler that seats on and couples to the first blood vessel; and a sleeve connected to the coupler that ensheathes a portion of the second blood vessel in the vicinity of the fistula.

Abstract: In at least one embodiment, the invention is directed to an endoluminal device comprising a stent and a sleeve. In one embodiment, the endoluminal device is implanted in a portion of the gastrointestinal tract. In some embodiments, the stent has a first region and a second region where the first and second regions provide different levels of radial force. In one embodiment, the first region is made from a plurality of first wires having a first diameter and the second region is made from a plurality of second wires having a second diameter which is smaller than the first diameter. In other embodiments, the endoluminal device has at least one engagement mechanism engaging the stent to the sleeve, the endoluminal device to a body lumen, and any combination thereof. In at least one embodiment, the endoluminal device has a wall with at least one opening therein.

Abstract: A vascular access port can include a base that can be attached to a vessel and a body extending away from the base in at least a vertical direction. A height of the body in the vertical direction can be sufficiently small such that the entire port can be implanted subcutaneously in a patient. The port can include a guidance passageway that is at least partially defined by the body and can direct an access device into a vessel of a patient when the port is attached to the vessel. In some arrangements, the guidance passageway includes a funnel region that decreases in size from a proximal end of the guidance passageway toward a distal end of the guidance passageway that defines an opening through the bottom surface of the port.

Abstract: A segmented skirted surgical mesh for use in reconstructing a soft tissue defect, the segmented skirted surgical mesh comprising: a base layer of surgical mesh, the base layer of surgical mesh comprising an outer edge; and a segmented continuous skirt of surgical mesh comprising an outer edge and an inner edge which defines a central opening, the segmented continuous skirt of surgical mesh being secured to the base layer of surgical mesh at the outer edge of the continuous skirt of surgical mesh, and the segmented continuous skirt of surgical mesh comprising a plurality of slits formed in the segmented continuous skirt of surgical mesh, wherein the plurality of slits extend outwardly from the inner edge of the segmented continuous skirt of surgical mesh, whereby to form a plurality of flaps of surgical mesh in the segmented continuous skirt of surgical mesh, such that at least one of the flaps of surgical mesh can be lifted away from the base layer of surgical mesh and secured to soft tissue without causin

Abstract: In certain systems disclosed herein, one or more of a first vascular access port and a second vascular access port can be selected by a customer. Each of the first and second vascular access ports can be implanted subcutaneously within a patient, and each can include a base configured to be attached to a vessel, a body that extends away from the base, and a guidance passageway that extends through the body and the base and includes a funnel region. A maximum height defined by the base and body of the second vascular access port can be greater than a maximum height defined by the base and body of the first vascular access port.

Abstract: An inexpensive small-sized screen printing machine having low redundancy and high production efficiency and applicable to a dual conveying-type component mounting machine. A pair of substrate supporting tables juxtaposed in a specific direction is provided. Screen printing is alternately performed by a single print executing section in a common area which can be shared by the two substrate supporting tables. In doing so, when one substrate supporting table located at a print position among the pair of substrate supporting tables starts exiting the print position, the other substrate supporting table starts entry to the print position.

Abstract: The invention relates to a neural prosthesis, a neural prosthesis for use in the treatment of severed nerves and to a method for producing a neural prosthesis. Said neural prosthesis comprises a coupling element receptacle and at least one coupling element having a first and a second coupling section, wherein the coupling element is fixed by the coupling element receptacle, and wherein the first coupling section can be arranged on a first nerve region and the second coupling section on a second nerve region so that both nerve regions can be coupled by means of the neural prosthesis.

Abstract: A gastrointestinal bypass device for directing food and liquids from an esophagus and/or a proximal portion of a stomach into an intestines is described. The device comprises a receiver, a sleeve, and a device coupling. The receiver may be configured to be positioned in the esophagus and/or the stomach. A proximal portion of the receiver may be configured to open and close to at least partially conform to an inside of the esophagus and/or a proximal portion of the stomach. The receiver may be configured to receive food and liquids from the esophagus and/or a proximal portion of the stomach into a lumen of the receiver. The sleeve may be coupled to a distal portion of the receiver. The sleeve may be configured to be positioned in the stomach and the intestines. The sleeve may have a lumen in communication with the lumen of the receiver. The sleeve may be configured to direct the food and the liquids from the receiver into the intestines.

Abstract: The invention relates to an intraluminar method of treating a reflux disease in a patient by implanting a device comprising an movement restriction device that, when implanted in a patient, fills a volume in the patient's abdomen that is close to and at least partially above the patient's cardia when the patient is in a standing position. The invention further relates to a method of restoring the location of the cardia in a patient suffering from a reflux disease and to an instrument suitable to use with intraluminar method and/or restoration method. Also disclosed are instruments treating a patient suffering hiatal hernia and providing a movement restriction device to be invaginated in the stomach fundus wall.

Abstract: A method of obtaining beta-islet cells from pancreases of rabbits and a composition for transplantation (xenografts or xenotransplants) of beta-islet cells isolated and cultured from rabbit pancreases to promote natural insulin production among people with diabetes.

Abstract: A method of positioning a main stent at a vessel bifurcation includes positioning a main guidewire in the main vessel; and advancing a stent delivery system to a position proximate the bifurcation. The stent delivery system includes a catheter with a flexible side sheath attached thereto and a main stent positioned over the catheter. The flexible side sheath is positioned to pass through the side opening in the main stent. The method also includes advancing a branch guidewire through the flexible side sheath and into the branch vessel; and subsequently, advancing the catheter over the main guidewire while advancing the flexible side sheath over the branch guidewire while viewing relative movement of a marker positioned on the flexible side sheath with respect to at least one marker positioned on the catheter.

Abstract: The invention relates to an intraluminar method of treating a reflux disease in a patient by implanting a device comprising an movement restriction device that, when implanted in a patient, fills a volume in the patient's abdomen that is close to and at least partially above the patient's cardia when the patient is in a standing position. The invention further relates to a method of restoring the location of the cardia in a patient suffering from a reflux disease and to an instrument suitable to use with intraluminar method and/or restoration method. Also disclosed are instruments treating a patient suffering hiatal hernia and providing a movement restriction device to be invaginated in the stomach fundus wall.

Abstract: Apparatus, systems, and methods for percutaneous valve replacement and/or augmentation are provided. The apparatus includes a valve having a valve frame, a valve leaflet coupled to the valve frame, and a leaflet transition member coupled to the valve leaflet. The valve leaflet and leaflet transition member can transition from a first position where the valve leaflet and leaflet frame are at least partially outside a lumen of the valve frame to a second position where the valve leaflet and the leaflet transition member are within the lumen of the valve frame.

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: A hybrid stent prosthesis including a biodegradable tubular body, a first non-biodegradable self-expanding ring coupled to a proximal end of the biodegradable body, and a second non-biodegradable self-expanding ring coupled to a distal end of the biodegradable body. The hybrid stent includes a mechanism for longitudinally compressing the tubular body to increase the radial or hoop strength thereof. The longitudinally compressing mechanism may be protruding elements coupled to and extending radially outward from the hybrid stent or elastomeric compression bands or tethers extending between the non-biodegradable rings. The compression bands may be pre-connected to both non-biodegradable rings prior to stent delivery, or may be connected to one non-biodegradable ring prior to insertion and connected to the other non-biodegradable ring in situ.

Abstract: A dual-layer hernia mesh can be configured according to a three-dimensional map of a hernia defect(s) and a hernia volume(s) of a patient. The front portion of the mesh can be configured utilizing, for example, a three dimensional map of hernia sac volumes obtained from a CT scan. The front portion of the mesh exactly fits into the hernia sac. The back portion of the hernia mesh is a sheet of mesh material that overlaps over onto the normal muscles and fascia. A “foam” collapsible mesh and/or a flat mesh with expandable hydrogel deposited in variable thickness according to the hernia defect can be utilized as a dual-layer hernia mesh for repair. The hydrogel mesh when combined with water or saline expands and fits into the hernia defect or defects. Both “foam” and hydrogel meshes adhere to the tissues of the hernia sac and then contracts over time. The hernia sac volume slowly disappears, restoring a more normal contour to the abdominal wall.

Abstract: A device for isolating tissue in the digestive tract including a biocompatible portion having a surface sized to cover the tissue to be isolated and also includes a plurality of micro-anchors attached to the biocompatible portion and extending from the surface, the micro-anchors sized to penetrate the mucosa of the tissue. A method for isolating tissue in the digestive tract in which an isolation element is delivered to a desired location in the digestive system; the isolation element having fixed thereto a plurality of micro-anchors. The method also includes attaching the isolation element to tissue at the desired location by causing the micro-anchors to penetrate the mucosa of the tissue.

Abstract: The disclosure describes methods of winding collagen fiber to make medical constructs and related collagen fiber tube and patch devices.

Abstract: Devices and methods described include a flow reduction device adapted and configured for use within the duodenum of a mammal having a spine, a first atraumatic feature, a second atraumatic feature, and a flow reduction element having a proximal end, a distal end, an interior portion, an exterior portion and a variable porosity between the proximal end and the distal end. One aspect of the device includes a spine having a proximal end and a distal end, an atraumatic feature positioned on at least one of the proximal end and the distal end of the spine, and a flow reduction element positioned along the spine and having a variable porosity along its length.

Abstract: A re-rollable membrane for wrapping around and protecting a cylindrical tissue having an injury site. The membrane includes a sheet of a porous matrix formed of cross-linked biopolymeric fibers. In one implementation, the sheet can be spirally rolled so that at least one portion overlaps another portion of the sheet and, upon absorption of a fluid, the overlapping portions adhere to each other closely so as to exclude penetration of cells. In another implementation, the sheet can be helically rolled to form a helix having a pitch of 2 mm to 40 mm and an inner diameter of 1 mm to 50 mm. Also disclosed are methods for making and using such re-rollable membranes.

Abstract: Devices and methods for gastrointestinal bypass are described. A gastrointestinal bypass device includes a gastrointestinal cuff and a gastrointestinal sleeve. The cuff may be configured to be attached in the esophagus, and may be sufficiently flexible to expand and collapse to conform with the inside of the esophagus to allow the esophagus to function substantially normally. The sleeve is configured to be coupled to the cuff, and may be made of a material that is floppy or flaccid but does not substantially expand radially.

Abstract: Methods and devices are disclosed for manipulating the airway, such as to treat obstructive sleep apnea. An implant is positioned within the body with respect to the airway. The spatial orientation of the airway is manipulated, directly or indirectly, to affect the configuration of the airway. In general, the implant is manipulated to displace the trachea in an inferior direction, resist superior displacement of the trachea and/or to alter the tracheal wall tension. The implant restrains the trachea in the manipulated configuration.

Abstract: Devices and methods for transplanting cells in a host body are described. The cell comprises a porous scaffold that allows ingrowth of vascular and connective tissues, a plug or plug system configured for placement within the porous scaffold, and a seal configured to enclose a proximal opening in the porous scaffold. The device may further comprise a cell delivery device for delivering cells into the porous scaffold. The method of cell transplantation comprises a two step process. The device is incubated in the host body to form a vascularized collagen matrix around a plug positioned within the porous scaffold. The plug is then retracted from the porous scaffold, and cells are delivered into the vascularized space created within the porous scaffold.

Abstract: This invention is a device and method for adjustably and reversibly reducing nutrient absorption from food passing through a person's gastrointestinal tract using an Adjustable Gastrointestinal Bifurcation (AGB) and a flow-control member. The Adjustable Gastrointestinal Bifurcation (AGB) includes: a first food-flow route (comprising a first branch of the AGB) through the person's gastrointestinal tract wherein there is normal absorption of nutrients from food; and a second food-flow route (comprising a second branch of the AGB) through the person's gastrointestinal tract wherein there is reduced absorption of nutrients from food. The flow-control member adjusts the types and/or amounts of food which are diverted through the second food-flow route versus the first food-flow route.

Abstract: This document provides methods and materials that can be used to replace a circumferential segment of an esophagus. For example, methods and materials that can be used to provide a tubular connection from one stump end of an esophagus to another stump end of the esophagus are provided.

Abstract: The invention relates to an intraluminar method of treating a reflux disease in a patient by implanting a device comprising an movement restriction device that, when implanted in a patient, fills a volume in the patient's abdomen that is close to and at least partially above the patient's cardia when the patient is in a standing position. The invention further relates to a method of restoring the location of the cardia in a patient suffering from a reflux disease and to an instrument suitable to use with intraluminar method and/or restoration method. Also disclosed are instruments treating a patient suffering hiatal hernia and providing a movement restriction device to be invaginated in the stomach fundus wall.

Abstract: Devices and methods for gastrointestinal bypass are described. A gastrointestinal bypass device includes a gastrointestinal cuff and a gastrointestinal sleeve. The cuff may be configured to be attached in the esophagus, and may be sufficiently flexible to expand and collapse to conform with the inside of the esophagus to allow the esophagus to function substantially normally. The sleeve is configured to be coupled to the cuff, and may be made of a material that is floppy or flaccid but does not substantially expand radially.

Abstract: A dual lumen catheter may be provided with one or more stents in a stent-deployment lumen and a wire guide disposed through a wire guide lumen. The wire guide may be directed to a target site in a patient body such as a biliary stricture. The catheter may be directed along the wire guide until it is in or adjacent the target site. A distalmost stent may be advanced out a distal side-facing aperture of the stent-deployment lumen into the target site by a pusher member that advances the stent or that holds the stent in place while the catheter is proximally withdrawn from around the stent. With the wire guide remaining substantially in place, the stent-deployment lumen can be reoriented and the steps repeated to place a second (and, if desired, subsequent) stent(s) next to—and generally parallel with—the first stent.

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 stent according to an embodiment of the invention includes an elongate body having a proximal end portion and a distal end portion. The elongate body defines a lumen and an opening in communication with the lumen between the proximal end portion and the distal end portion configured to enable the flow of fluid therethrough. The lumen is configured to have a diameter wherein the opening has a width greater than half the size of the diameter and less than the diameter of the lumen. The opening has a length at least twice the width of opening. In some embodiments, the opening is configured to laterally receive a guidewire therethrough. The elongate body can be configured to releasably couple the guidewire within the lumen of the elongate body such that the elongate body can be slidably moved along the guidewire.

Abstract: An apparatus for cleansing and promoting tissue growth in wounds, in which irrigant fluid optionally containing cell nutrients and/or other 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, a biodegradable scaffold in contact with the wound bed and a means for fluid cleansing and back to the dressing. The apparatus has means for supplying thermal energy to the fluid in the wound. 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 and a method of treatment using the apparatus.

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 that may be adjustable 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 liners or sleeves, but they need not. The resistor concept may be applied to a simple anchor and resistor without a long liner.

Abstract: A tubular body portion lining assembly adapted for insertion into a tubular body portion of a patient, the assembly including a flexible tubular liner including at least one generally circumferentially disposed attachment portion on its outer surface adapted to face the internal walls of the tubular body portion and to attach the liner thereto, and liner placing functionality adapted to place at least a portion of the tubular liner between first and second locations within the tubular body portion.

Abstract: An apparatus for preventing incontinence includes a tubular body with a first guiding element connected to a tube-shaped retaining element with a second guiding element that opens axially into a termination on a side of the retaining element. The retaining element is formed of a reversible stretchable and compressible metal grille that is air-tight and fluid-tight at the termination in a region of a transition thereof to the tubular body. A fixing device that fixes the apparatus when the apparatus is immovably implanted in a body tissue of a patient is formed of the first guiding element defining areas with axially spaced projections. In a non-extended state, the projections are formed as slits protruding out of the surface of the first guiding element and, in an axially extended state, the projections are immovably implanted in the body tissue when the first guiding element is compressed in an axial direction.

Abstract: A transorally implanted intragastric balloon or treating obesity and for weight control including a variable size balloon with one or interconnected regions acting to exert a pressure on the stomach, to provide a stomach volume occupying effect, and/or to anchor the balloon within the stomach.