Abstract: A device for the percutaneous transluminal repair of septal defects is disclosed. The device comprises first and second expandable occluders fastened to each other, each occluder including a framework having a central hub with elongated struts radiating therefrom. The struts are constructed such that they have a resistance to fatigue that exceeds the maximum fatigue stresses to which the struts will be subjected over a prolonged period in vivo. As such, the device exhibits a significantly decreased likelihood of metal fatigue failures after prolonged exposure in vivo.

Abstract: A clip unit for hernia repair surgery has first and second arms joined at a hinge joint. A latch or hook locks the arms together after they are closed. A mesh material extends around the outside edges of the clip. In use, the clip is placed over a portion of the elevated peritoneum and then closed and locked. The mesh is fixed to the surrounding peritoneum. The clip and surgical method expedites hernia repair surgery and reduces trauma and medical costs.

Abstract: A suture made of bioabsorbable material is disclosed having a central body member with a plurality of lateral members extending perpendicularly therefrom and in the same general plane with the central body member, each lateral member having a plurality of barb members extending at an acute angle therefrom, allowing the lateral members to be inserted laterally into two sides of a cut in body tissue so that the two sides are joined at an incision junction at the central body member and are retained securely and non-withdrawably in the body tissue by the barb members on such lateral members. Also disclosed is a method for utilizing the suture of this invention.

Abstract: A surgical apparatus is disclosed for attaching adjacent end portions of cutaneous body tissue wherein a pair of opposed jaws have means for moving the jaws toward and away from each other. Body tissue engaging means in the form of sharp tip members extend from each jaw and toward the other so as to engage the opposed portions of cutaneous tissue when the jaws are positioned thereagainst and moved toward each other. The jaws and the tips are arranged to cause the cutaneous tissue to assume an irregular shape at the interface whereby an elongated member may be directed generally medially of the interface of the tissue to attach the opposed portions to thereby permit healing. A method of attaching adjacent end portions of cutaneous body tissue surrounding an opening utilizing the apparatus of the invention is also disclosed.

Abstract: An apparatus for suturing fascial tissue for deep puncture wounds utilizes a flexible membrane inserted into a body cavity through a trocar sheath positioned in a wound. A suture to be applied to the wound has anchors attached to each of its ends. A pair of suture-carrying needles each carry an end of the suture and its corresponding anchor. The suture-carrying needles are passed through the fascial layer surrounding the wound and are subsequently passed through the flexible membrane. The suture ends and corresponding anchor means are released from the needles. A lifting force is applied to the flexible member via a cord or shaft which extends out of the wound. The anchors are engaged by the flexible membrane as it is withdrawn out of the wound, pulling the ends of the suture out of the wound to close the opening in the fascial tissue.

Abstract: A device is proposed for inserting hemostatic material through a tissue channel and against the outside wall of a blood vessel of a patient, wherein the blood vessel wall has a puncture therein adjacent the tissue channel. The device includes a charge of hemostatic material and a hollow sheath adapted to pass through the tissue channel, the sheath having a cross sectional profile larger than the puncture. The device places the hemostatic material in the hollow sheath and advances the hemostatic material through the sheath to the outside of the vessel wall around the puncture.

Abstract: A single-use tape applicator includes a pair of sidewalls spaced laterally from one another to define a tape storage enclosure, and two posts extending between the sidewalls and spaced from one another to define a generally oval-shaped run. A closed loop of backing material is supported by the posts and is movable relative to the posts along the run. The length of the loop is substantially equal to the length of the run. A piece of tape coated on one side with an adhesive material is supported and carried on the backing material. The enclosure defines an opening through which the tape is pulled from the backing material and dispensed.

Abstract: A method of sealing the corneal incision resulting from cataract surgery is presented. The edges of the incision are maneuvered under a keratoscope until an undistorted corneal surface is obtained. Biological glue is then applied to the maneuvered incision. The seal provides for greatly reduced postoperative astigmatism.

Abstract: An apparatus and method for delivering a vessel plug into a wound or incision in a living patient are described. The apparatus includes an expandable porous mesh mounted at the distal end of an elongate catheter. The expandable mesh may be positioned within a blood vessel or a target organ and expanded. When the mesh member is in an expanded condition, the mesh can be positioned adjacent the opening within the vessel or organ and a vessel plug can be inserted into the wound. The expanded mesh prevents the advancement of the vessel plug into the vessel or target organ, thereby avoiding possible thrombosis or stenosis within the vessel at the wound or incision site. Occlusion of the blood vessel during treatment is avoided by providing the expandable mesh with a porous construction which allows blood or other body fluids to flow therethrough while the apparatus is being used within the body of the patient.

Abstract: A mechanism and applier therefor which is capable of inverted anastomosis of two lumens by an absorbable fastener. The fastener is made from two washer-like plate assemblies and a pair of introducers. Each such plate assembly has slots to receive latching prongs protruding from the other plate, and pins to impale tissue. Fastening is done through an applier that causes the pins to pierce the tissue, and causes a knife blade to cut through excess tissue. Fastening is done by attaching fastener halves. Insertion and removal of the fastener and applier optimally is done in an endoscopic procedure through a trocar or through the surgical incision in an open procedure. The system can be used such that the plates can be placed to properly set gaps between and anastomose tissue. The introducer portion will soften intraluminally and be expelled, in about 24 hours. The coupler portion will remain in place for 2-3 weeks, typically, and then fragment and be expelled with the feces.

Abstract: A method and device are provided for sealing a perforation in the wall of, for example, a blood vessel. The device is in the form of a two part closure which seals the hole by clamping the tissue surrounding the hole from both the inside and the outside of the vessel. In accordance with one exemplary embodiment, two rivet portions are provided which are bayonet or screw threadedly interlocked to clamp the vessel wall about the perforation. An alternate embodiment applies heat to couple the rivet parts as well as to cauterize the wound site. Heat may also advantageously be used to separate the rivet from its delivery system.

Abstract: An inserting device is disclosed for positioning a barbed tissue connector in tissue to close a wound. The barbed tissue connector is of a type which includes a generally rigid elongated body having a pointed leading end and a plurality of axially spaced barbs on the elongated body. The inserting device comprises a tubular body which is adapted to receive the connector therein with the pointed leading end of the connector protruding from an open leading end of the tubular body. The inserting device and the connector contained therein are positioned in tissue such that at least one of the barbs on the connector is engaging tissue, and the device is then retracted from the tissue, leaving the connector in place.

Abstract: A T-fastener installation kit includes a packaging device for loading the T-fastener into a slotted needle without requiring the hands of the surgeon to touch the sharp end of the needle. T-fasteners may be commonly used, for example, in surgical procedures in which the T-fasteners are used to secure a patient's stomach or bowel in apposition to the abdominal wall. The packaging device includes a housing having a cylindrical recess into which the "T" head of the T-fastener is loaded. The surgeon can slide the open end of the slotted needle into the cylindrical recess and over the "T" head of the T-fastener, thereby effectively loading the T-fastener into the slotted needle without requiring the surgeon to touch the sharp point of the needle.

Abstract: The present invention provides a system and a method for closing septal defects and the like. The system includes a closure device having a pair of occluding disks, each disk being formed of a membrane and an elastically deformable frame carried about the periphery of the membrane. The frame, which may be formed of a superelastic material, is capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding the membrane. A central portion of the membrane of each disk is attached to a central portion of the other membrane to define a conjoint disk. The method of the invention involves collapsing the frames of the disks, inserting the closure device into a catheter, and positioning the distal end of the catheter adjacent a septal defect. The first disk is then urged out of the distal end of the catheter to permit its frame to elastically return to a predetermined shape, pulling the membrane taut on one side of the defect.

Abstract: A closure for sealing a percutaneous puncture in an vessel, e.g., an artery, or lumen. The puncture also includes a puncture tract in which a portion of the closure is to be located. The closure comprises an elongated rigid anchor member formed of a resorbable material, a sealing member formed of a resorbable material, e.g., compressed collagen plug, and a thin resorbable material filament, e.g., a suture, connecting the anchor member and the sealing member. The anchor member is located in the interior of the vessel, with the sealing member being located in the puncture tract. An elongated reinforcing filament or ribbon, formed of a resorbable material, is incorporated in the elongated anchor member to prevent any portion of it from breaking away in the event that the anchor is loaded beyond its breaking point.

Abstract: A method is provided for closing a puncture in a wall of an artery made for the purpose of moving an elongated catheter into the artery in which an exterior guide tube is extended through the adjacent skin area through the body containing the artery, through the puncture in the wall of the artery and into the artery so as to enable the catheter to be guidingly moved through the guide tube and into the artery. The method includes the steps of withdrawing the catheter from the guide tube, extending a plug having a removable guide wire extending longitudinally therethrough into the guide tube so that the guide wire extends from the plug through the puncture, moving the guide tube outwardly so that it no longer extends within the puncture and leaves the guide wire extending through the puncture, moving the plug inwardly along the guide wire into blocking relation with the puncture, and withdrawing the guide wire from the plug so as to leave the plug sealed in blocking relation with the puncture.

Abstract: An intravascular prostheses is delivered transarterially or transvenously to occlude cardiac defects. The defects, which may include the patent ductus arteriosus, the ventricular septal defect and the atrial septal defect. The prostheses is a device having a distal occluder attached to a string and a proximal occluder connected to the string. The occluders are delivered to the heart by known methods. With the distal occluder on the distal side of the defect and the proximal occluder on the proximal side of the defect the occluders are adjusted according to the thickness of the heart structure at the defect. In one embodiment the adjustment is by moving the distal occluder over a series of knots or buttons in the string. In another embodiment the proximal occluder is connected to the distal occluder by an elastic string so that the elastic tension of the strings bring the occluders into position. A radiopaque button is placed upon the string to aid positioning the occluders.

Abstract: A system, a closure, and method of use for determining the position of a blood vessel via a percutaneous puncture and for sealing the percutaneous puncture in the blood vessel. The system includes an introducer sheath and associated positioning device, a hemostatic puncture closure, and a deployment instrument. The positioning device enables the introducer sheath to be positioned at a desired position within the vessel. The deployment instrument includes a tubular carrier storing the closure. The carrier has a distally located free end to be extended via an introducer through the puncture and its associated tract. The closure comprises a radiopaque rigid anchor, a compressed collagen plug, and a thin filament connecting the two in a pulley-like arrangement. The carrier ejects the anchor through the introducer and puncture and then draws it against the free end of the introducer.

Abstract: A device and method of closing an incision or puncture in a patient by inserting a vessel plug into the incision or puncture until the distal end of the vessel plug is adjacent to the outer lumen of the blood vessel or target organ so that the vessel plug does not obstruct the flow of fluid through the blood vessel or target organ. The precise positioning of the vessel plug in the incision or puncture is accomplished through the use of a balloon catheter or a cylindrical insertion assembly having a proximal plunger member associated therewith.

Abstract: A surgical dressing 10 for surgical closing a wound includes a pair of locating members 12, 14, the locating members 12, 14, in use, being placed on opposed sides of the wound. A manipulating means 22 interconnects the locating members 12, 14, the manipulating means 22 and the locating members 12, 14 being a one piece article and the manipulating means 22 being operable to draw the locating members 12, 14 towards each other to close the wound.

Abstract: An improved surgical stapling method and apparatus therefor is disclosed in which parallel rows of staples are inserted prior to forming an incision. When the incision is to be closed, the corresponding staples of the two rows are brought together by suitable locking pins or other techniques.

Abstract: A tissue aperture repair device which is inserted using either an openly or minimally invasive surgical procedure for at least partially covering a tissue aperture or hernial ring. The repair device includes a foldable sheet of material that is maintained with support means in an unfolded shape. The support means includes a second sheet of material attached to the circumference of the foldable sheet for forming a cavity therebetween. An elastic stiffener wire is inserted into the cavity for maintaining the device in its unfolded shape. Percutaneous insertion of the device is accomplished with the inclusion of an introducer in which the device is folded about the distal end thereof and contained within a containment sheath. The device is percutaneously inserted into the abdominal cavity of a patient, unfolded, and extended to the unfolded shape with an elastic stiffener wire also percutaneously inserted through the introducer.

Abstract: A surgical implantation device to be placed within a patient's body and seal a hernial rupture includes either a single planar member attached to a locating segment or a first planar member and second planar member, large enough to cover the opening in the abdominal fascia, that are placed on opposite sides of the fascia. In the case of a single planar member, the locating member is placed in the fascia opening and the planar member is placed interiorly of the transversalis fascia. In the case of two planar members, the first and second planar members are connected by a locating member that passes through the fascia opening. The surgical implantation device can be folded upon itself and compressed to fit with a surgical tube and inserted into the patient to the hernial site. Once the surgical tube is at the site, the surgical implantation device is forced from the tube and automatically expands so the planar members assume their flat shape and the locating member assumes its elongated shape.

Abstract: In a method for repairing a liver laceration, a plurality of bolts of biocompatible material are provided, each of the bolts being formed with anchoring means for preventing removal of the respective bolt from the liver upon insertion of the bolt therein. At least two of the bolts are driven into the liver on opposite sides of the laceration so that head portions of the two bolts remain protruding from the liver. A suture is tied around the protruding head portions of the two bolts, thereby closing the laceration and stemming a flow of blood from the laceration. The bolts may be provided with molley type sheaths which are pushed into the liver prior to insertion of the two bolts and which are expanded at least in part by the bolts to anchor the sheaths and the bolts in the liver. The sheaths, like the bolts, are made of a biocompatible, even bioabsorbable or hemostatic, material.

Abstract: A method is disclosed for accelerating the stretching of skin and the closing of open skin wounds which includes the steps of attaching a plurality of anchors, which have fasteners attached to one side of the anchors, to the surface of the skin adjacent to the wound with an adhesive whereby the anchors are spaced around the wound in a manner to allow at least one strap with a plurality of fastener receivers to be positioned across the wound and the fastener receivers to be coupled to the fasteners. At least one strap with the fastener receivers is positioned across the wound. The fasteners are coupled to a plurality of the fastener receivers which are attached to at least one strap. The tension of at least one strap is adjusted to maintain sufficient tension to stretch the skin proximate to the fasteners thereby significantly accelerating wound closure.

Abstract: Closure devices and methods of use for sealing a small, e.g., percutaneous, incisions or punctures. The closure device may take many forms an basically comprises a somewhat elongated plug having a deformable distal end portion including a free end to which a thin retraction filament is connected. The closure device is arranged to be introduced into the body of the being through the incision or puncture by an introducer so that the distal portion of the plug is located on one side of said tissue and its proximal portion is located on the other side of that tissue, with the filament extending through the incision or puncture. The filament is arranged to be grasped and pulled in the proximal direction to deform the distal portion of the plug so that it cannot pass back through the incision or puncture, whereupon the puncture or incision is sealed by the deformed distal portion of the plug.

Abstract: An improved surgical stapling method is disclosed in which parallel rows of staples are inserted prior to forming an incision. When the incision is to be closed, the corresponding staples of the two rows are brought together by suitable locking pins or other techniques.

Abstract: A sutureless closure for a skin wound or incision in which a plurality of filaments are secured between the ends of opposing adhesive tapes. A second substantially identical pair of adhesive tapes has filaments disposed therebetween with the filaments on the first and second pairs of tapes being alternately interwoven. Each of the lower tapes is adhered to skin adjacent either side of a wound. The upper tapes are adhered to the exposed surface of the lower tapes thereby stretching the filaments across the wound and drawing the wound together. In another embodiment, a pair of tapes having opposed hooks are taped onto skin adjacent opposite sides of a wound. A filament is wound between the hooks on the tapes to draw the wound together. Notches in the hooks secure the filament at each hook and permit selecting different tensions in each filament run from hook-to-hook.

Abstract: A skin closure dressing for eyelids comprising a thin backing material, a layer of adhesive on one face of the backing material, a multi-layer pad covering a portion of the face of the backing material, at least one of the layers of the multi-layer pad being an absorbent material, and an outer layer of the multi-layer pad being a non-adhesive material. The dressing is thin and narrow enough to not cause occlusion of the eye. A pair of side tabs are provided to assist in removal of the dressing.

Abstract: A visceral anchor and method for visceral wall mobilization is disclosed. The visceral anchor includes an elongated cross bar to which a suture is attached at a location substantially in the center of the cross bar. The cross bar further includes a helical spring sheath which jackets a rigid rod, the sheath extending beyond the ends of the rod to form flexible ends. An alternative embodiment includes a second suture attached to one of the ends of the cross bar. The sutures are used for orienting the anchor during insertion into and removal from a hollow viscus. The method of visceral wall mobilization includes providing a tract through the skin into a hollow intra-abdominal viscus and inserting the anchor into the viscus lumen. The sutures extend through the tract and the unattached ends remain on the outside of the body. The center suture is pulled to orient the anchor for mobilization of the visceral wall. The end suture is pulled to orient the anchor for removal.

Abstract: A device and method of closing an incision or puncture in a patient by inserting a vessel plug into the incision or puncture until the distal end of the vessel plug is adjacent to the outer lumen of the blood vessel or target organ so that the vessel plug does not obstruct the flow of fluid through the blood vessel or target organ. The precise positioning of the vessel plug in the incision or puncture is accomplished through the use of a balloon catheter or a cylindrical insertion assembly having a proximal plunger member associated therewith.

Abstract: A ventilated skin guard apparatus for protecting areas of sensitive skin is disclosed. The apparatus has two longitudinal end support members to which are connected a series of laterally placed arcuate members. Single arcuate members may be removed from the apparatus without removing the entire apparatus from the portion of the user's body having the sensitive area of skin.

Abstract: An instrument and methods of making and use for sealing a small, e.g., percutaneous, incisions or punctures. The instrument in the form of a tubular member having a plug therein. The tubular member includes a proximally located piston and a distally located portion having an open free end for introduction into the incision or puncture. The plug comprises a cord and a thin filament, with the cord being formed of a resorbable material and being folded in two to form an apex portion and a pair of wing portions extending therefrom. The filament is secured to the apex portion. The plug is located within the tubular member so that the apex portion is disposed adjacent the free end and with the wing portions and the filament extending toward the proximally located portion. The plug is then expelled partially from the tubular member so that the apex portion extends through the incision or puncture.

Abstract: A spinal needle which has the capability of sealing its opening after withdrawal. A first conventional spinal needle or cannula is used for standard diagnostic or therapeudic use. A second cannula is inserted concentrically into the first needle and includes a dural seal having an absorbable suture extending from the second cannula. A stylet is inserted into the second cannula dislodging the seal into the subarachnoid space. The cannulae are removed and the suture is pulled to set the dural seal in the spinal puncture.

Abstract: A surgical method and apparatus for opening and closing surgical wound utilizes an elastic member which is adhered across the patient's skin at the treatment site. The wound is opened by cutting through the elastic member and through the patient's skin to permit a surgical procedure to be conducted. The wound is then closed by reapproximating the patient's skin at the treatment site and by bringing the cut edges of the elastic member together and adhering a relatively inelastic sealing member over the elastic member to maintain the cut edges while the wound heals.

Abstract: A material for connecting members for soft tissues and inner organs which consists of a copolymer of N-vinylpyrrolidone and alkyl esters of acrylic and/or methacrylic acid containing in the alkyl group 2 to 8 carbon atoms at the following proportions of the components, molar percent:______________________________________ N-vinylpyrrolidone 40-90 alkyl esters of acrylic and/or methacrylic acid 10-60.

Abstract: Self-adhesive wound suture plaster with a carrier material, especially in strip form, of an elastic knitted or woven fabric, sheet or nonwoven, which is characterized in that the carrier strip extends under the action of a pulling force and, after this action of force has ended, virtually returns completely to the original length.Preferably, the carrier strip undergoes a length extension of between about 2 and 10% under the action of a pulling force of 5 N/cm, a length extension of between about 5 and 15% at 10 N/cm and a length extension of between about 15 and 30% at 20 N/cm.

Abstract: A method for performing a surgical closure of a skin incision or wound in which at least one surgical suture thread is used for holding together two opposite skin edge portions. A locking device is used for carrying out the method. The suture thread is sewn through each one of the two skin edge portions and through each one of two separate elastic members arranged at the outside of a respective one of the skin edge portions. The elastic members are made of such a material that frictional forces between the elastic members and the suture thread prevent any unintentional displacement between the suture thread and the skin edge portions after the surgical closure has been completed.

Abstract: A transcatheter occluding intracardiac defect device comprises a folding poly-urethane foam with Teflon coated wire skeleton, introducible into a long vascular sheath and automatically unfolded upon delivery in the distal to the defect cardiac chamber. A two mm string loop is attached to the center of the occluder, while the loop is closed by a 1 mm knot. A loading wire comprises a Teflon hollow wire and a double mono-filament thread which carries the occluder on the one end and is tied on the other end. An occluder-holder comprises a rhomboid poly-urethane foam with Teflon coated wire skeleton and a "rubber" piece sutured in the center. The occluder-holder is advanced over the loading wire axis and through the long sheath in the proximal to the defect cardiac chamber and is pushed against the occluder till it is securely buttoned. The distal end of the loading wire is cut and the hollow wire is pulled out over the double thread. The thread is pulled as a single strand and therefore the device is released.