Abstract: A surgical clip having first and second separate pieces for ligating a vessel therebetween, an applicator for applying the clip to the vessel, and a method of use thereof. The surgical clip comprises a first tube having a longitudinal slot formed through the outer wall thereof and communicating with a passage extending therethrough for receiving a second tube into the passage of the first tube and circumferentially ligating a vessel positioned in a second channel transverse to and communicating with the first passage. Tangs or projections extend from the outer wall of the first tube about the longitudinal slot thereof and into the passage of the first tube for engaging the walls about a slot in the second tube and securably positioning the second tube in the passage of the first tube. An applicator includes a main housing having a vessel channel for positioning the first tube therein.

Abstract: An oroesophageal introducer assembly for atraumatically introducing a relatively large instrument such as an echotransducer positioned on the distal end of a gastroscope for performing an echocardiographic procedure. The introducer assembly includes an outer sheath having a tapered distal end and a passageway extending therethrough for passing the large instrument therethrough. The assembly further includes a dilator extending from the tapered distal end of the outer sheath for atraumatically dilating the esophagus during introduction. The assembly further includes an introducer guide for initial oral introduction into the esophagus and stomach of the patient. The outer sheath and dilator are interconnected at the proximal ends thereof for extending the tapered distal end of the dilator from the tapered distal end of the outer sheath. The interconnected outer sheath and dilator are then introduced atraumatically into the esophagus over the introducer guide.

Abstract: A surgical cutting instrument is disclosed for percutaneously debulking tissue through an access sheath commonly used in minimally invasive laparoscopic or endoscopic surgical procedures. The cutting instrument includes a inner rotary member tube having a cutting edge at the distal end thereof for cutting and slicing tissue. The outside surface of the rotary inner cutting member tube and outer sheath annularly close about the distal ends thereof for preventing perforation of the surgical tissue bag in which the tissue is contained. The inner cutting member tube includes a hollow passageway for suctioning and aspirating tissue and fluid through the tube and into a collection chamber or out through a vacuum or suction line attached thereto. Vacuum or suction control ports are included at the proximal end of the inner cutting member tube and stationary sheath for also controlling the amount of vacuum or suction applied to the tissue.

Abstract: An improved laparoscopic medical retractor for separating body parts during a surgical procedure to thereby create or maintain a surgical cavity. The retractor comprises an interior rod having a distal end and a proximal end and an exterior tube positioned to receive the central rod, the exterior tube having a distal end and a proximal end. A plurality of straps having their distal ends are coupled to the distal end of the interior rod and have their proximal ends coupled to the distal end of the exterior tube. The straps are flexible whereby movement of the distal end of the exterior tube distally toward the distal end of the interior rod will cause the straps to assume a generally spherical configuration, the total diameter of the retracted device being less than 1.5 centimeters. Coupling means secure the interior rod and exterior tube against relative axial movement with respect to each other so that a surgeon may move the expanded retractor to enlarge a surgical cavity in which it is located.

Abstract: A closed-end catheter having a flat-surfaced valve positioned in a recess about the distal portion of the catheter for preventing retrograde flow of blood therethrough when positioned in a blood vessel of a patient. The valve catheter comprises a flexible material, cylindrical tube having a U-shaped outer wall extending longitudinally about the distal portion thereof. A flat-surfaced valve is positioned in the recess along the U-shaped distal portion and attached to the outer wall. The valve is formed by inserting a flat-surfaced rod in the U-shaped portion of the tube to stretch the outer wall. A flat-surfaced layer of flexible material is applied over the flat-surfaced rod to the stretched outer wall. The flexible material layer is cured and a longitudinal fluid aperture formed therein with the rod remaining in the passage of the U-shaped portion. The rod is then removed and a plug inserted into the passage to close the distal end of the catheter.

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 multiple lumen vascular access introducer sheath having a main lumen for introduction of another device such as a catheter therethrough and into the vascular system and a secondary lumen having a cross-sectional area significantly less than that of the main lumen for infusion of small doses of medication therethrough at a controlled rate and directly into the vascular system. The introducer sheath comprises a tubular member of an inelastic, semi-rigid plastic material such as fluorinated ethylene propylene or nylon. The main lumen extends longitudinally through the tubular member and opens at the distal and proximal ends thereof. The secondary lumen is positioned adjacent to and separated from the main lumen with a cross-sectional area approximately fifteen percent of that of the main lumen. The distal end of the tubular member is tapered with the distal end of the secondary lumen closed. The secondary lumen has a side port near the tapered distal end.

Abstract: A joint and a laminate including a nickel-titanium alloy such as nitinol and a method for preparing the surface of a nickel-titanium alloy member for bonding solder material and, electively, another similar or dissimilar member thereto. The method includes applying an aluminum paste flux to the titanium oxide coated surface of a nickel-titanium alloy member and heating the flux to its activation temperature. The flux removes and suspends the titanium oxide therein along with leaching titanium from the base alloy member surface to form a nickel-rich interface surface. The activated flux also coats the nickel-rich interface layer for protection from further oxidation. A bonding material such as a tin-silver solder is flowed onto the nickel-rich interface surface to displace the activated flux. Electively, another member is applied to the molten solder to form a joint between the two members. The residual flux is cleaned from the joint to prevent further deterioration of the base metal.

Abstract: A wire guide having a generally increasing flexible tip that is resistant to fracture. The flexible tip wire guide comprises a cylindrical wire member having a substantially uniform outer diameter main portion and a distal portion with a tapered outer surface region for gradually increasing the flexibility of the tip and a proximal concave outer surface region that extends tangentially and proximally from the tapered outer surface for increasing the fracture resistance of the decreasing outer diameter distal portion. A flexible wire coil is inserted over the distal wire portion and secured to the proximal end of the distal wire portion and the distal end of the main portion using silver solder with a uniform outer diameter for minimizing potential trauma to vessel walls. The outer diameter of the flexible wire coil is substantially equivalent to the outer diameter of the main portion of the wire guide to likewise minimize trauma to vessel walls.

Abstract: A method of and system for mounting a vascular occlusion balloon on a delivery catheter. The occlusion balloon has an interior and a neck having access to the interior and a self-sealing internal balloon valve positioned at least partially in the neck. The mounting system includes a stylet having a distal end that is insertable through the longitudinal passageway of a peel-away sheath and through the internal balloon valve and into the interior of the occlusion balloon. When the stylet is inserted in the occlusion balloon, the peel-away sheath is advanced through the valve into the interior of the balloon. The stylet is removed from the balloon and peel-away sheath, and a soft durometer, flexible tip delivery catheter inserted into the interior of the balloon through the peel-away sheath. The sheath is peeled away from the delivery catheter and out of the internal balloon valve and the interior of the balloon.

Abstract: A soft tip guiding catheter for atraumatic insertion into delicate, tortuous coronary vessels and introduction of an angioplasty balloon catheter therethrough. The guiding catheter includes a main tubular portion and a soft tubular tip with respective, matching external and internal tapers for increasing the contact area of the thermal bond. The outer and inner diameters of the main portion are uniform and match the respective outer and inner diameters of the soft tip for providing a uniform outer catheter surface and a continuous, uniform catheter passageway surface. The tapers further provide for a gradual change in durometer between the main portion and soft tip. The main portion preferably includes an inner layer of lubricous material, an outer layer of a polyether block amide, and a reinforcing braid positioned therebetween. The layers of the main portion provide a thin catheter wall with pushability, torquability, and kink resistance.

Abstract: A medical device for localizing a nonpalpable breast lesion. The device includes a tubular introducer needle and a wire guide positioned therein for inserting into a breast to the site of the lesion. The wire guide includes a distal portion having a preformed, resilient helical coil configuration for locking into position about the lesion. The distal portion includes a superelastic metallic alloy for maintaining the helical coil configuration after repeated extensions from and retractions into the needle passageway. The needle is inserted with the wire guide positioned therein into the breast to the site of the lesion and from the distal portion of the needle. The distal end of the needle includes a plurality of indentations for enhancing the ultrasound visualization thereof. As the distal portion of the wire guide emerges from the needle, the acuate distal end of the wire guide cuts into and scribes a helical path about the tissue distal to the lesion.

Abstract: A speculum for forming an ostomy in a trachea. The speculum includes a pair of opposing, pivotally interconnected elongated members and respective distal nose portions extending distally from the elongated members. The elongated members have respective proximal handle portions of which the distal nose portions extend laterally therefrom. One of the nose portions includes a tubular member with a flexible distal end that has a preformed curve and extends distally beyond the other nose portion. A cannula is inserted entirely through the passageway of the tubular member to extend distally therefrom and straighten the preformed curve of the tubular member for insertion into the trachea. The cannula and tubular member are inserted into the trachea to form an opening to the air passageway of the trachea. Proper placement is detected with formation of air bubbles in the chamber of a syringe connected to the proximal end of the cannula.

Abstract: There has been provided a catheter system which can be percutaneously implanted through a skin opening and which can be inserted for example by being pushed along a guide wire. An embodiment provides an infusion chamber which can be changed between a condition of reduced cross-section, upon being inserted, and a position of use which is expanded in relation thereto, in the implanted condition, and which is provided with expandable means which after expansion remain in the expanded condition, for shape retention purposes. The expansion means may be for example a balloon catheter which can be removed after the expansion operation. Another embodiment makes use of an infusion chamber which is of a stiff configuration.

Abstract: Heart lead removal apparatus and method are disclosed for removing a heart lead from the wall of a heart through a blood vessel leading to the heart. The apparatus comprises a flexible stylet wire with an expandable wire coil attached to the distal end for engaging the coiled structure of the heart lead. The wire coil includes first, second, and third pluralities of turns. The first plurality of turns is positioned around and about the distal end of the stylet wire for radially expanding when in the passageway of the lead to secure the stylet wire to the lead. The second plurality of turns extends proximally from the first plurality of turns and laterally from the stylet wire for engaging the lead and radially expanding the first plurality of turns. The third plurality of turns extends distally from the first plurality of turns and is attached around and about the distal end of the stylet wire for cooperating in the radial expansion of the first plurality of turns when in the passageway of the lead.

Abstract: Echogenic medical devices and methods of fabrication and of use are disclosed. The devices are adapted to be inserted into a patient. The device includes an elongated member including a material having an acoustic impedance different from that of the surrounding medium. The medium includes surrounding biological tissue or fluids surrounding the member when inserted into a passageway of the patient. The acoustic impedance of the elongated member is sufficiently different from the surrounding medium for enhancing an image produced in response to a sonic beam produced from imaging equipment. The elongated member also includes an interface layer of a high density metal of which the deposition on the base material of the member is ion beam assisted. The interface layer includes an outside surface having a plurality of particulate-type, discontinuous curved surfaces of partially spherical indentations formed therein or spheres extending therefrom.

Abstract: A system and method for producing volumetric conductive hyperthermia for the treatment of a cancerous tumor in a patient. The location and volume of the tumor are determined with the aid of a CT scanning system, and an array of probes each containing a heat-emitting element is formed by interstitial implantation in the tumor in a predetermined pattern for volumetric heating using a template for guiding the probes into parallel alignment in the tumor. The template is affixed with respect to the patient's body and with respect to the imaging plane of the CT scanning system. After implantation, the probes are connected to a manifold which is in turn connected to an external control system capable of independently controlling the probes while monitoring various analog and digital values representative of system performance.

Abstract: A rotational surgical instrument including a working head connected to a rotatable, pencil-like handle. The handle includes a casing with distal and proximal end caps, an elongated outer member extending into the casing, and a actuation link extending from the distal end cap through the casing and elongated member to the working head. An actuating mechanism is positioned distally from the distal end cap about the proximal portion of the elongated member for slidably actuating the working head between and open and closed positions. A compression spring is included in the passageway of the casing around the actuation link between the proximal end cap and the proximal end of the elongated member to return the working head to the nonactuated position. Keyed surfaces are included within the passageway of the casing and attached to the distal end of the casing and the proximal end of the elongated member for preventing rotation of the elongated member with respect to the casing and actuation link.

Abstract: A rotational pressure drive for a medical syringe to obtain, maintain, and release a desired fluid pressure within the syringe. The commercially available medical syringe includes a barrel with a plunger extending therein. Extending laterally and radially about the proximal end of the syringe barrel are several flanges. The rotational pressure drive comprises a hollow cylindrical chamber with a closed end for engaging the proximal end of the syringe plunger, and a hollow passageway extending therethrough to an open end which receives the plunger. Positioned circumferentially and longitudinally along the chamber are pluralities of internal threads with individual starts for engaging the radially extending flanges of the syringe barrel. The extended plunger is inserted into the passageway of the drive to the closed end, whereas the flanges of the syringe barrel are rotationally engaged with the starts of the internal thread pluralities for advancement into the passageway of the drive.

Abstract: A lockable wire guide control handle for grasping and manipulating a wire guide. The control handle includes an elongated member and a thumb slide positioned in a retention channel formed in the distal portion of the elongated member. The proximal portion of the elongated member is cylindrical having an enclosed passageway extending longitudinally therethrough, which is offset for passage of the wire guide therethrough. The distal portion of the elongated member includes a dovetail-shaped retention channel, the bottom surface includng an inclined slot for positioning the wire guide therein. The thumb slide includes a mating dovetail-shaped tenon positioned in the retention channel. Extending from the flat surface of the dovetail-shaped tenon is an inclined projection for fixedly positioning the wire guide in the inclined slot. The inclined slot and projection have a variable, uniform spacing therebetween for fixedly positioning various diameter wire guides therein.