Abstract: The present invention includes a method and apparatus for adhering tissue to one another. In an embodiment of the present invention the two tissues to be joined, for example the lower esophagus and the fundus of the stomach, are first placed adjacent to one another. Next a first restraint is placed near the outside surface of one of the tissues and a second restraint is placed near the outside surface of the other tissue. An irritant is then placed between the two adjacent tissues. The restraints, and consequently the tissue surfaces, are then drawn together. As the touching irritated tissue surfaces heal they will become bonded to one another and their need for the mechanical fastening of the restraints, to secure them together, will be diminished.

Abstract: Endoluminally delivered tissue patches and related systems and methods for delivering the tissue patches for treating lesions of the alimentary tract are disclosed. A tissue patch includes a tissue implant imbedded in a substrate to form a first layer and a second layer of substrate on a top surface and a bottom surface of the tissue implant. A predetermined thickness of the first layer is different from a predetermined thickness of the second layer. A tissue patch may include a tissue implant imbedded in a substrate formed of a plurality of sections capable of being folded into a contracted state for endoluminal delivery to the lesion. A system for delivering a tissue implant includes a catheter having an expandable member at a distal end portion, a carrier placed around the expandable member, and the carrier configured to expand from a contracted state to an expanded state and to receive the tissue implant.

Abstract: Endoluminally delivered tissue patches and related systems and methods for delivering the tissue patches for treating lesions of the alimentary tract are disclosed. A tissue patch includes a substrate, a tissue implant attached to the substrate, and a protective liner covering at least a portion of the tissue implant. A method includes providing a tissue patch having a tissue implant attached to a substrate and a protective liner covering at least a portion of the tissue implant. The tissue patch is formed into a contracted state and inserted into a lumen containing the lesion. The tissue patch then is positioned in the vicinity of the lesion. After removing the protective liner to reveal the tissue implant, the tissue implant is placed in the lesion.

Abstract: A method and device for performing endoluminal fundoplication are described. A device is inserted in the patient's stomach through the esophagus, including an unit adapted to grasp and pull a portion of the gastroesophageal junction into the stomach, and an unit adapted to move a portion of the fundus towards the esophagus. The device also can place fasteners to hold the gastric wall and the esophageal wall secured together, thus forming a valve between esophagus and stomach. An adhesive compound can be used to stabilize the juncture of the two walls.

Abstract: A biocompatible fastener particularly well-suited for use in fundoplication procedures. In a preferred embodiment, the fastener is designed to break within the span of approximately three to six months after implantation and comprises a male portion and a female portion. The male portion includes a first base member, the first base member being generally flat and oval. A pair of male members are mounted on the bottom surface of the first base member, each male member comprising a cylindrical post extending downwardly from the bottom surface of the first base member and a conical head disposed at the bottom end of the post. The female portion includes a second base member, the second base member being generally flat and oval. A pair of sleeves are mounted on the top surface of the second base member and extend upwardly therefrom. Each sleeve defines a bore adapted to receive a head from a corresponding male member and has an inner flange formed thereon.

Abstract: A method and device for performing endoluminal fundoplication are described. A device is inserted in the patient's stomach through the esophagus, including an unit adapted to grasp and pull a portion of the gastroesophageal junction into the stomach, and an unit adapted to move a portion of the fundus towards the esophagus. The device also can place fasteners to hold the gastric wall and the esophageal wall secured together, thus forming a valve between esophagus and stomach. An adhesive compound can be used to stabilize the juncture of the two walls.

Abstract: A device is disclosed for introducing a flexible elongated element through at least two portions of a subject. In an embodiment, the device includes a proximal end and a distal end, as well as an advancement unit for longitudinally advancing the flexible elongated element toward the distal end such that a proximal end of the elongated element may pass from the distal end of said device with sufficient force to pass through the portions of the subject. The device also includes a securing unit for variably adjusting a securing force applied by the flexible elongated element to secure together the portions of the subject.

Abstract: An impermanent biocompatible fastener comprises a male portion and a female portion. The male portion includes a base member and a pair of male members. The male members extend downwardly from the base member, each male member comprising a post and a head disposed at the bottom end of the post. The female portion includes a base member and a pair of sleeves. The sleeves extend upwardly from the base member, each sleeve defining a bore adapted to receive a head from a corresponding male member and having an inner flange. The flange extends into the bore and is engageable with the head once the head has been inserted past the flange to inhibit withdrawal of the head from the bore. Except for a biodegradable outer coating on each of the two heads, the fastener is made entirely of a non-bioabsorbable material.

Abstract: A miniaturized x-ray apparatus for delivering x-rays to a selected site within a body cavity includes a catheter having at least one lumen and an x-ray transparent window at a distal end thereof; an x-ray source in the lumen adjacent said x-ray transparent window; a movable x-ray shield positioned to direct x-rays from the source through the x-ray transparent window to the selected site.

Abstract: A miniaturized x-ray apparatus for delivering x-rays to a selected site within a body cavity includes a catheter having at least one lumen and an x-ray transparent window at a distal end thereof; an x-ray source in the lumen adjacent said x-ray transparent window; a movable x-ray shield positioned to direct x-rays from the source through the x-ray transparent window to the selected site.

Abstract: A biocompatible fastener particularly well-suited for use in fundoplication procedures. In a preferred embodiment, the fastener is designed to break within the span of approximately three to six months after implantation and comprises a male portion and a female portion. The male portion includes a first base member, the first base member being generally flat and oval. A pair of male members are mounted on the bottom surface of the first base member, each male member comprising a cylindrical post extending downwardly from the bottom surface of the first base member and a conical head disposed at the bottom end of the post. The female portion includes a second base member, the second base member being generally flat and oval. A pair of sleeves are mounted on the top surface of the second base member and extend upwardly therefrom. Each sleeve defines a bore adapted to receive a head from a corresponding male member and has an inner flange formed thereon.

Abstract: An endoscope having a guide wire with an x-ray transparent window allows x-rays from an x-ray source to pass therethrough to reach the desired site. Preferably, the guide wire and x-ray catheter, which contains the x-ray source, have positioning flags or markers to aid alignment of the x-ray source with the x-ray transparent window of the guide wire.

Abstract: The present invention includes a method and apparatus for adhering tissue to one another. In an embodiment of the present invention the two tissues to be joined, for example the lower esophagus and the fundus of the stomach, are first placed adjacent to one another. Next a first restraint is placed near the outside surface of one of the tissues and a second restraint is placed near the outside surface of the other tissue. An irritant is then placed between the two adjacent tissues. The restraints, and consequently the tissue surfaces, are then drawn together. As the touching irritated tissue surfaces heal they will become bonded to one another and their need for the mechanical fastening of the restraints, to secure them together, will be diminished.

Abstract: Method and apparatus for repairing the lower esophageal sphincter is provided. The method includes placing the lower esophagus and the fundus adjacent to one another, placing a restraint near a surface of the lower esophagus, placing a second restraint near a surface of the fundus, and then drawing them together to secure the fundus to the lower esophagus. The apparatus includes a pointed carrier containing a first anchor and a second anchor, the second anchor containing a sclerosing agent.

Abstract: An endoscopic stapler includes a stapling head which is removably locatable on the distal end of an endoscope. The stapling head includes a stationary part which houses a removable staple cartridge and a movable part which includes an anvil for receiving and bending the ends of staples fired from the stationary part. The staple cartridge preferably houses two semi-circular rows of staples which are staggered relative to each other. The movable part is coupled to the stationary part by a threaded shaft which engages a worm gear in the stationary part and a first rotatable control wire is coupled to the worm gear. A substantially semi-circular firing cam is located proximal of the staple cartridge in the stationary part. The firing cam has an interior splined surface which is engaged by a spline gear coupled to a second rotatable control wire. In one embodiment, a knife is coupled to the firing cam so that tissue is cut subsequent to stapling.

Abstract: An endoscopic stapler includes a stapling head which is removably locatable on the distal end of an endoscope. The stapling head includes a stationary part which houses a removable staple cartridge and a movable part which includes an anvil for receiving and bending the ends of staples fired from the stationary part. The staple cartridge preferably houses two semi-circular rows of staples which are staggered relative to each other. The movable part is coupled to the stationary part by a threaded shaft which engages a worm gear in the stationary part and a first rotatable control wire is coupled to the worm gear. A substantially semi-circular firing cam is located proximal of the staple cartridge in the stationary part. The firing cam has an interior splined surface which is engaged by a spline gear coupled to a second rotatable control wire. In one embodiment, a knife is coupled to the firing cam so that tissue is cut subsequent to stapling.

Abstract: A medical device for causing the hemostasis of a blood vessel located along the gastrointestinal tract. The medical device comprises a tissue-penetrating device having a pair of hollow jaws, and a clip that is insertable into the tissue-penetrating device. Methods for causing the hemostasis of a blood vessel located along the gastrointestinal tract by using the medical device of the present invention are also provided.