Abstract: A perfusion shunt apparatus and methods are described for isolating and selectively perfusing a segment of a patient's cardiovascular system and for directing circulatory flow around the isolated segment. An aortic perfusion shunt apparatus is configured for deployment within a patient's aortic arch and methods are described for isolating the aortic arch vessels from the aortic lumen, for selectively perfusing the arch vessels with a fluid and for directing blood flow within the aortic lumen through a shunt past the isolated arch vessels. The perfusion shunt apparatus may be mounted on a catheter or cannula for percutaneous introduction or for direct insertion into a circulatory vessel, such as the aorta.

Abstract: The present invention provides an aortic catheter having an upstream occlusion member positioned in the ascending aorta between the coronary arteries and the brachiocephalic artery and a downstream anchoring member positioned in the descending aorta, downstream of the aortic arch. The upstream occlusion member may be an inflatable balloon or a selectively deployable external catheter valve. The downstream anchoring member may be a larger inflatable balloon or other anchoring structure that provides sufficient friction to prevent migration of the balloon catheter in the upstream or downstream direction. In addition, an arch perfusion lumen, a corporeal perfusion lumen and a cardioplegia lumen are provided for performing selective perfusion and cardioplegic arrest.

Abstract: The present invention discloses a multi-access cannula for use in a variety of surgical procedures, particularly for use in the course of performing conventional open-chest and peripheral access cardiopulmonary bypass (CPB). The multi-access cannula is capable of being inserted through a single puncture site with a percutaneous tip. At the appropriate depth of insertion, a closure seal may be engaged at the point of entry to secure the positioning of the cannula and prevent leakage of blood from the incision. Once the cannula is at the appropriate position the cannula provides a multiplicity of procedural options for the surgeon. For example, when approaching through the ascending aorta, the multi-access cannula enables the simultaneous passage of various fluids and multiple catheters or instruments in opposing directions within the lumen of the aortic arch through a single insertion site.

Abstract: A low-profile steerable dilatation catheter for angioplasty procedures which has an inflated balloon on the distal end with little or no tendency to wrap on itself when the catheter is advanced through a patient's vascular system. The catheter comprises an elongated tubular member which is longitudinally relatively flexible but diametrically relatively rigid, a guide extension secured to the distal end of the elongated tubular member, and an inflatable balloon secured on the proximal end thereof to the distal end of the elongated tubular member and on the distal end directly or indirectly to the guide member or the tubular member and an elongated flexible member such as a helical coil secured to the guide extension distally of the balloon. The elongated tubular member is preferably a hypotube of stainless steel or nitinol.

Abstract: A dilatation catheter having a balloon with an inflated length than can be adjusted according to the length of stenosis to be dilated. In one embodiment an exterior sheath having an expandable distal tip is employed about a elongated balloon which can be longitudinally adjusted so as to expose a length of balloon which provides a working balloon length required to dilate the stenosis. In another embodiment, the balloon has independently inflatable chambers. In yet another embodiment, the balloon has longitudinal tubular sections which expand sequentially higher pressures. Other means are also described.

Abstract: A low-profile steerable dilatation catheter for angioplasty procedures which has an inflated balloon on the distal end with little or no tendency to wrap on itself when the catheter is advanced through a patient's vascular system. The catheter comprises an elongated tubular member which is longitudinally relatively flexible but diametrically relatively rigid, a guide extension secured to the distal end of the elongated tubular member, and an inflatable balloon secured on the proximal end thereof to the distal end of the elongated tubular member and on the distal end directly or indirectly to the guide member or the tubular member and an elongated flexible member such as a helical coil secured to the guide extension distally of the balloon. The elongated tubular member is preferably a hypotube of stainless steel or nitinol.

Abstract: A perfusion-type dilatation catheter with perfusion ports in the wall of the catheter shaft wherein the proximal edges of the perfusion ports have depressions extending into a guidewire receiving inner lumen which passes through the catheter shaft. The depressed proximal edges prevent excursions of guidewires through the perfusion ports as the guidewire is passed through the guidewire receiving inner lumen. The perfusion ports may be conveniently made by forming holes into the wall of the catheter shaft, inserting shaping pins into the holes, heating the wall of the catheter shaft to make it readily deformable and then rotating the shaping pins proximally along the longitudinal axis of the catheter shaft so that the rotated shaping pins form depressions along the proximal edges of the perfusion ports which extend into the guidewire receiving inner lumen within the catheter shaft.

Abstract: Self-venting balloon dilatation catheter having an elongate flexible tubular member having at least one lumen therein extending longitudinally thereof. A balloon is carried by the flexible tubular member and is in communication with the lumen. A fitting is carried by the tubular member for inflating the balloon with a balloon inflation medium. A plurality of small passages are formed which permit air to escape from the interior of the balloon but inhibit the passage of the balloon inflation medium from the balloon.

Abstract: Tandem balloon dilatation catheter assembly having a flexible elongate member with proximal and distal ends. The flexible elongate member is provided with at least first and second lumens extending therethrough. First and second balloons are carried by the distal extremity of the flexible elongate member and are spaced apart longitudinally thereof. The first balloon has a diameter which is less than the diameter of the second balloon. The first balloon is disposed distally of the second balloon. Communication is established between the interior of the first balloon and the first lumen and between the interior of the second balloon and the second lumen.

Abstract: A low-profile steerable dilatation catheter for angioplasty procedures which has an inflated balloon on the distal end with little or no tendency to wrap on itself when the catheter is advanced through a patient's vascular system. The catheter comprises an elongated tubular member which is longitudinally relatively flexible but diametrically relatively rigid, a guide extension secured to the distal end of the elongated tubular member, and an inflatable balloon secured on the proximal end thereof to the distal end of the elongated tubular member and on the distal end directly or indirectly to the guide member or the tubular member and an elongated flexible member such as a helical coil secured to the guide extension distally of the balloon. The elongated tubular member is preferably a hypotube of stainless steel or nitinol.

Abstract: Self-venting balloon dilatation catheter having an elongate flexible tubular member having at least one lumen therein extending longitudinally thereof. A balloon is carried by the flexible tubular member and is in communication with the lumen. A fitting is carried by the tubular member for inflating the balloon with a balloon inflating medium. A plurality of small passages are formed which permit air to escape from the interior of the balloon but inhibit the passage of the balloon inflation medium from the balloon.

Abstract: Floppy guide wire comprising an elongate flexible element formed of a metallic material. The element has a cylindrical proximal portion, a tapered intermediate portion and a flattened distal portion. A coil formed of a substantially radiopaque material is secured to said element and is generally concentric with the element. The coil extends beyond a rounded metallic protrusion is carried by the distal extremity of the coil and is spaced from the distal extremity of the flexible elongate element. A safety wire is disposed within the coil and is secured to the protrusion and to the flexible elongate element.

Abstract: Hemostatic valve and method for positioning a plurality of elongated elements such as dilatation catheters and guide wires in the cardiovascular system. The hemostatic valve has two or more separately sealable access ports through which the elongated elements can be inserted and manipulated independently of each other.

Abstract: Tool and method for bending of shaping the tips of angioplasty guide wires. The tool has two relatively rigid body sections joined together by a relatively flexible hinge, with a flexible tube extending across the hinge for holding the tip of the wire to be bent. The body sections are folded together about the hinge to bend the wire, and the flexible tube tends to form a kink in the wire which helps the wire to retain the shape to which it is bent. Stops limit the movement of the body sections and prevent overbending of the wire.

Abstract: Steerable dilatation catheter assembly having an adapter with at least one arm. A guide wire having proximal and distal ends is provided with the proximal end extending through the adapter. A flexible tubular member has one end secured to the adapter and extends over the guide wire and has a balloon carried by a distal portion thereof. The distal extremity of the balloon is bonded to the guide wire to form a liquid-tight seal between the guide wire and the balloon. A flexible tip is secured to the guide wire. A rotation limiter secured to the guide wire and carried by the arm for rotating the guide wire through a number of turns less than a predetermined number of turns.

Abstract: Steerable balloon dilatation catheter assembly having dye injection and pressure measurement capabilities and comprising an elongate flexible tubular member having first and second lumens extending therethrough and a balloon carried by the distal portion of the tubular member and having its interior in communication with the second lumen. A guide wire extends through the first lumen and has a coil carried by the distal portion thereof and extending beyond the distal extremity of the tubular member. A device is coupled to the guide wire facilitating at least limited rotation of the distal extremity of the guide wire. A first fitting is coupled to the second lumen and is adapted to receive a liquid for inflating and deflating the balloon. A second fitting is in communication with the first lumen. The first lumen and the guide wire being sized so that dye injections and/or pressure measurements can be made through the second fitting.

Abstract: Adjustable rotation limiter device for use with a steerable balloon type dilatation catheter of the type having a flexible core wire extending therethrough and an adapter adapted to be secured to the proximal extremity of a dilatation catheter. The adapter has at least a first arm with a fitting thereon. A sealing is disposed within the fitting. A thumb screw having a first knob carrying a threaded axially extending member is threaded into the fitting and is adapted to engage the seal whereby when a core wire extends through the fitting, the seal, and the thumb screw, the rotation of the thumb screw in one direction will cause sealing engagement between the seal and the core wire. A torque knob having a second knob carrying an axially extending member is threaded into said thumb screw. A rotation limiter is carried by one of the knobs and has a portion thereof extending over the other of the knobs which serves to limit the rotational movement of the second knob with respect to the first knob.

Abstract: Low profile dilation catheter and method of manufacturing the same for use in percutaneous transluminal coronary angioplasty. The catheter has an inflatable balloon for dilating stenotic lesions, and an integral guide wire by which the catheter can be steered into the artery system.

Abstract: Guide wire and method for insertion and use of a catheter. The guide wire has a shaft of substantially smaller diameter than the luminal opening, with a flexible coil at one end of the shaft. The guide wire is inserted into the cardiovascular system, and the catheter is advanced along the guide wire to the desired position, with the flexible coil outside the distal end of the catheter. An annular passageway is formed between the shaft and the wall of the luminal opening, and fluids are passed through this passageway while the guide wire is within the catheter. A marker of radio opaque material is provided at the distal end of the guide wire so that the position of the wire can be accurately determined even though the wire itself may be too small to be visible with a fluoroscope.