Abstract: This is directed to methods and devices suited for maintaining an opening in a wall of a body organ for an extended period. More particularly devices and methods are directed maintaining patency of channels that alter gaseous flow within a lung to improve the expiration cycle of, for instance, an individual having chronic obstructive pulmonary disease.

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 plurality of structures that resiliently attract one another are provided for implanting in a patient around a body tissue structure of the patient. For example, the body tissue structure may be the esophagus, and the plurality of structures may be implanted in an annulus around the outside of the esophagus, the annulus being substantially coaxial with the esophagus. The attraction may be between annularly adjacent ones of the structures in the annulus, and it may be provided, for example, by magnets or springs. The array of structures is preferably self-limiting with respect to the smallest area that it can encompass, and this smallest area is preferably large enough to prevent the apparatus from applying excessive pressure to tissue passing through that area.

Abstract: Methods of treatment using a gastrointestinal implant device removably anchored within an animal's gastrointestinal tract. For example, the implant device includes a collapsible anchor for anchoring the device coupled to a proximal end of a flexible sleeve. The implant device can be anchored within the stomach, within the pyloric orifice, and/or distal to the pylorus and extended into the duodenum. All partially-digested food, or chyme, exiting the stomach is funneled through the device. Methods of treatment include treating obesity by one or more of: limiting the absorption of nutrients within the duodenum; delaying the mixing of chyme with digestive enzymes; alter hormonal triggers; and providing negative feedback. Alternatively or in addition, the desired result includes treating a diseases, such as diabetes, or temporarily shielding a portion of the intestine to promote healing within the intestine.

Abstract: A plurality of structures that resiliently attract one another are provided for implanting in a patient around a body tissue structure of the patient. For example, the body tissue structure may be the esophagus, and the plurality of structures may be implanted in an annulus around the outside of the esophagus, the annulus being substantially coaxial with the esophagus. The attraction may be between annularly adjacent ones of the structures in the annulus, and it may be provided, for example, by magnets or springs. The array of structures is preferably self-limiting with respect to the smallest area that it can encompass, and this smallest area is preferably large enough to prevent the apparatus from applying excessive pressure to tissue passing through that area.

Abstract: Methods and apparatus for delivering an implant device within the digestive system of an animal are presented. An delivery device includes an outer sheath, or container, for storing a proximal portion of the implant device. The outer sheath is moveable relative to the stored portion of the implant device to release the proximal portion from within the outer sheath. The delivery device also includes an inner sheath defining a lumen therein that extends distal to the outer sheath, a moveable element adapted to secure the distal end of the implant to the inner sheath, and a release mechanism coupled to the moveable element for releasing the distal end of the implant. The device also includes a atraumatic tip, or ball, coupled at its distal end to facilitate guiding the delivery device through the gastrointestinal tract.

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: 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. The catheter may also be used to diagnose urinary retention problems caused by a weak bladder or a prostatic obstruction.

Abstract: In one embodiment, an implant includes a first portion having a shape and configured to support a tissue within the body of a patient. Markings disposed on the first portion indicate a portion of the implant to be removed for resizing the first portion such that the first portion after the resizing has a shape substantially similar to the shape of the first portion before the resizing.

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: 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: The invention concerns a method for obtaining a metal implant for open porosity tissue support and/or replacement, characterized in that it comprises the following steps: (i) selecting a mould, (ii) arranging in the mould a solid metal core (7), (iii) filling the volume of the mould (1) still available with a powder of microspheres (3), (iv) consolidating the microspheres (3) with each other as well as with said at least one solid core (7) by electrical discharge sintering.

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 improved gastric bypass prosthetic (GBP) device and an improved GBP fixation device, as well as a GBP kit for the surgical treatment of obesity. In one form, a gastric bypass prosthetic (GBP) device of the invention includes a optional flexible tube extending along a central axis from a proximal end to a distal end, and having a tubular tissue fixation portion at or near said proximal end. The tissue fixation portion extends along the central axis between a proximal end and a distal end of the tissue fixation portion, and has an annular outer surface between the proximal end and the distal end of the tissue fixation portion.

Abstract: A medical graft connector or plug is made, for example, by cutting end portions of a tube of highly elastic material axially at numerous locations spaced circumferentially around the tube to produce a plurality of fingers which extend axially from each end of an uncut medial portion of the tube. The fingers are deflected radially outwardly from the medial portion and set in that condition. For a graft connector, the medial portion is coaxially connected to an end portion of a tubular graft. The connector is then installed through an aperture in the side wall of a patient's tubular body conduit, for example, by using a delivery tube in which the fingers are elastically deflected back to approximately their initial positions. When the delivery conduit is withdrawn from the connector, the fingers spring out to engage the inner and outer surfaces of the body conduit wall.

Abstract: Described are medical devices which are or can be used to form tubular medical devices, and related methods. Preferred devices include tubular grafts of biomaterial having lumen walls which present no seam edge that traverses the entire length of the lumen, illustratively including devices having lumen walls which have a discontinuous seam presenting multiple seam edges. Such a device may include a tubular structure formed by inserting a plurality of extensions of a biomaterial sheet through a plurality of corresponding apertures of the sheet.

Abstract: An arcuate nitinol splint with a rounded cross-section has two ends facing each other and spaced from each other. The splint is advanced through the mouth into the esophagus by an introducer device. By means of the device the splint is implanted completely into the wall of the esophageal sphincter to strengthen the sphincter. Materials other than Nitinol may be used.

Abstract: An endoprosthesis may be implanted in the region of an anatomical canal that is experiencing impairment. An exterior surface wall of the endoprosthesis bears projecting studs that cooperate with the wall of the anatomical canal so as to hold the endoprosthesis in position. One of the projecting studs is hollow and acts as a reservoir for a product that is active against the impairment.

Abstract: A polymeric stent, especially useful in surgical endoscopy and for the treatment of salivary gland ducts comprising; an elongated tube (1), wherein the proximal end (3) of said tube is having a funnel-like shape; and wherein said funnel further comprise at least one gorge (5a), which enables the suturing of said stent to said duct. The invention also relates to a method for implanting the polymeric stent into the lumen of a salivary gland duct.

Abstract: A ureteral drainage stent is designed to be placed in a patient's ureter and extend into a patient's bladder. An ureteral drainage stent includes a distal region for placement in the ureter and renal cavity, and a proximal region for placement in a urinary bladder and urethra. The distal region includes an elongated member with multiple lumens and the proximal region includes multiple elongated member, each defining a lumen. At least one lumen in the distal region is in liquid communication with a lumen from the proximal region. At least two of the elongated members in the proximal region are joined at their proximal ends and form a retraction structure, a structure used for removing the stent from a patient.

Abstract: Method and apparatus for limiting absorption of food products in specific parts of the digestive system is presented. A gastrointestinal implant device is anchored in the duodenum and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for attaching the device to the duodenum and an unsupported flexible sleeve to limit absorption of nutrients in the duodenum. The anchor can include a stent and/or a wave anchor and is collapsible for catheter-based delivery and removal.

Abstract: An endoluminal treatment device and method includes introducing an endoluminal device into a lumen of a patient and engaging a wall of the lumen with an implant device. The implant device can be a drug delivery device or medical device.

Abstract: A method of reducing the size of a lung by collapsing a target section of the lung includes delivering within a lung air passageway leading to the target section an intra-bronchial device. The device is deployed in a desired location and then the device is removed from the desired location. The device can be removed by gripping a portion of the device with a retractor device, which is used to draw the device proximally. Proximal movement releases anchors of the device from the passageway and the anchors can be collapsed into a removal configuration.

Abstract: A method for producing a hollow profile comprising a cross-linked, gelatinous material, the hollow profile having a polygonal cross-section and comprising a wall, which surrounds a lumen, is provided, the method comprising: a) preparing an aqueous solution of a gelatinous material; b) partially cross-linking the gelatinous material in the solution; c) applying the solution to the surface of a shaped element which defines the lumen; and d) leaving the solution to dry at least partially on the shaped element, thus forming a hollow profile comprising the cross-linked, gelatinous material.

Abstract: The invention is directed to compositions and methods for reconstructing artificial female reproductive organs. The constructs and methods of the invention can be used for ameliorating congenital malformations and disorders of female reproductive tract using tissue engineered female reproductive organs, such as the uterus, vagina, cervix, and fallopian tubes. These tissue engineered female reproductive organs can be generated by perfusing cultured cell populations derived from cells of the female reproductive tissues, such as uterine, vaginal, cervical, fallopian tube epithelial cells as well as smooth muscle cells.

Abstract: This is directed to improving the gaseous exchange in a lung of an individual and particularly, this is directed to improving the gaseous exchange in individuals having chronic obstructive pulmonary disease. It generally includes fluidly connecting the lung to an extrapleural airway such as the trachea. In one variation, a conduit is deployed to place the lung and the trachea in fluid communication which allows trapped oxygen-reduced air to pass directly out of the lung and into the trachea. Removing nonfunctional air from the lung tends to improve the gaseous exchange of oxygen into the blood and decompress hyper-inflated lungs. Sealant and biocompatible adhesives may be provided on the exterior of the conduit to prevent side flow, leaks and to otherwise prevent air from entering spaces not intended to receive air such as the pleura space.

Abstract: Methods and devices are disclosed for manipulating alignment of the foot to treat patients with flat feet, posterior tibial tendon dysfunction and metatarsophalangeal joint dysfunction. An enlargeable implant is positioned in or about the sinus tarsi and/or first metatarsal-phalangeal joint of the foot. The implant is insertable by minimally invasive means and enlarged through a catheter or needle. Enlargement of the implant alters the range of motion in the subtalar or first metatarsal-phalangeal joint and changes the alignment of the foot or toe.

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: 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: An apparatus for forming a gastric restriction comprises an applier, an expandable member, and an adhesive. The applier comprises an elongate shaft, and is dimensioned to fit in an esophagus. The applier has a conduit configured to communicate a fluid medium. The expandable member is in fluid communication with the conduit of the applier. The adhesive is positioned on at least a portion of the outer surface of the expandable member. The adhesive is configured to adhere the expanded expandable member to the inner wall of a patient's stomach. The expandable member may have a generally toroid configuration with a stoma, such that the expandable member may provide a gastric restriction when expanded and adhered to the inner wall of a patient's stomach. The expandable member may thus provide a treatment for morbid obesity by reducing food intake, by reducing stomach volume, or otherwise.

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

Abstract: A lip implant having first and second regions is described. The lip implant includes a first region formed of a liquid, solid, or a gas and a second region formed of a solid material. Also described is a lip implant having an elongated cross-section. A method for insertion of the implant is also described along with the instrumentation facilitating its insertion.

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

Abstract: A lip implant and lip instrument. The lip implant is formed of solid silicone and is shaped to be received in the lip of a patient. The lip instrument includes a pair of arms coupled together having clamping members to grasp and retain the lip implant. A method for insertion of the lip implant into the patient is further described.

Abstract: A preserved vessel isolated from a human umbilical cord or placenta and lyophilized for use as an allograft which improves blood supply to human tissue without antigenicity.

Abstract: A sheath as a lacrimal passage treatment instrument is provided. The sheath is composed of a flexible tube that is bendable and self-standable and has an outside diameter insertable into a lacrimal passage, and has both ends opened. One of the ends of the sheath has a decreasing wall thickness to form a taper, and slits are formed opposite to each other at the end.

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

Abstract: An orthopaedic implant is provided for the treatment of avascular necrosis of the bone. The orthopaedic implant includes a hollow support structure and a synthetic vascular graft. The support structure defines a passageway and includes a proximal opening and a distal opening. The synthetic vascular graft is received, at least in part, within the passageway such that a proximal end portion of the synthetic vascular graft is received through the proximal opening of the support structure and a distal end portion of the synthetic vascular graft is received through the distal opening of the support structure.

Abstract: A biologically resorbable nerve guide rail with a microporous guide tube of polymers of hydroxycarboxylic acids, where the porosity allows a metabolism through the tube wall, but prevents the passage of cells, and optionally several monofilaments of polymers of hydroxycarboxylic acids located in the guide tube, is characterized in that the inner surface of the tube and/or the surface of the monofilaments have an orientation aid for longitudinally oriented colonization with Schwann's cells.

Abstract: A polymeric stent, especially useful in surgical endoscopy and for the treatment of salivary gland ducts comprising; an elongated tube (1), wherein the proximal end (3) of said tube is having a funnel-like shape; and wherein said funnel further comprise at least one gorge (5a), which enables the suturing of said stent to said duct. The invention also relates to a method for implanting the polymeric stent into the lumen of a salivary gland duct.

Abstract: The invention relates to a process for producing an implant, with the implant possessing a textured foreign structure. A porous protein matrix is at least partially anchored in the textured foreign structure, with the porous protein matrix possessing a directional pore structure.

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: 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: Described herein is a positioning tool having an elongate portion for carrying a medical implant. Also described is a method of positioning a medical implant using an elongate positioning tool. One form of the method includes positioning a medical implant on a distal portion of an elongate positioning tool, inserting the positioning tool with the implant thereon into a body cavity, manipulating the positioning tool to position the implant into contact with tissue at an attachment location, attaching the implant to surrounding tissue at the attachment location, separating the implant from the positioning tool, and withdrawing the positioning tool from the body. In a preferred embodiment, the position of the implant is visually confirmed using an endoscope before the implant is attached to surrounding tissue. In one embodiment, the implant is a satiation device and the body cavity is the esophagus and/or stomach.

Abstract: A biodegradable common bile duct stent and the method for preparing thereof are provided. The stent is made of biodegradable polymeric material with incorporation of X-ray opaque components. The stent adapts to the anatomical shape of the CBD or it can be sutured together with the wall of the bile duct. After placing the stent in the duct, it maintains its position and does not slip. The circular tube of the stent being suitably sized and having multiple ring-shaped protruding rims at the outer wall and/or with larynx structure, leakage and outflow of the bile are thereby prevented. It can be manufactured by a conventional injection-molding or an extrusion-blowing technique. In surgical operation on the bile duct, the stent can replace the T-tube which is conventionally used to support the duct and guide bile drainage.

Abstract: A mesh (1) made of monofilament polypropylene (PPL) with surgical quality (CQ) and controlled flat memory (CM), having upper (1?) and lower (1?) layers joined by welding along almost the entire length of their edges (p). The layers have equal coaxial holes (2?, 2?) for passage of the spermatic cord of a patient, two radial slits (3?, 3?) departing from said holes and forming an angle between 9° and 120°, the zone (q) of the edges between the slits being free so as to create an upper (5?) and a lower (5?) fins that can be easily bent.

Abstract: A self-retracting body, which may have a bore, may be inserted into a biological passage. A dilating balloon may be used to expand the body toward an inner wall of the passage. The body may include an anchor that may engage the wall. The anchor may include a tip that is within the body before the body expands and extends away from the body during expansion. The body may include an opening that may receive a portion of the wall. The portion may be fixed to the body. The body may retract toward a central portion of the passage after the anchor engages the wall. The wall may be drawn toward the central passage and the diameter of the passage may be reduced. In some embodiments, a liner may be provided for the passage. In some embodiments, a baffle may be provided for the passage.

Abstract: An adjustable gel filled mammary implant includes inner and outer envelopes with the outer envelope containing about 95% of its volume filled with a silicone gel or the like. The inner envelope is attached to a bottom portion of the outer envelope and defines a volume of about 5%–10% of the volume of the outer envelope and is filled with saline. The implant also includes a self-sealing valve, filling tube and mini-reservoir for adjusting the size of the implant. A method for implanting, adjusting the size and removal of the filling tube and mini-reservoir are also disclosed.

Abstract: A tubular sleeve is provided for enabling a physician to impart a preselected shape in an implantable tubular device, such as a cardiac lead, a catheter or some other tubular structure. The sleeve may be deformed by the surgeon before or at the time of implantation to customize the shape of the tubular device to the particular anatomical structures to be encountered by the device. To retain the deformation imparted by the physician, the sleeve may be composed of a heat-sensitive shape-memory material or an elastomeric material provided with a plastically deformable rib.

Abstract: A device for insertion into a puncture in a tracheoesophageal wall includes a cylindrical body and a flexible first flange provided on an outside surface of the body. The flange has a use orientation in which it projects generally outwardly from the outside surface of the body and an insertion orientation in which it is resiliently folded toward the axis of the body. A retainer constructed of a material soluble in fluids present in the tracheoesophageal wall and esophagus retains the flange in its resiliently folded orientation.