Abstract: A method for percutaneously inserting an improved pediatric intra-aortic balloon. The improvement comprises a soft tip having a self occluding lumen capable of accommodating a guide wire. A removable pull tube is disposed within the self occluding lumen to prevent occlusion of the self occluding lumen. The catheter is designed without a guide wire lumen so as to be capable of rapid inflation and deflation of the balloon. The method comprises the following steps:(a)inserting an angiographic needle into the aorta;(b) passing the guide wire through the needle into the aorta;(c) removing the needle;(d) disposing the pull tube about the proximal end of the guide wire;(e) removing the pull tube from the self occluding lumen;(f) advancing the catheter into the aorta;(g) removing the guide wire from the aorta;(h) advancing the catheter up the aortic passageway to a position appropriate for pumping.

Abstract: A needle guide ensures that an angiographic needle is inserted into a patient's femoral artery at a prescribed location, angle and direction. The needle guide includes an elongated base having a recess on one end defined by a pair of projecting fingers, and a support member on the upper surface of the base adjacent to the recess. The support member has a support surface which is inclined at a prescribed angle with respect to a locating plane defined by the base. The length of the projecting fingers help position the support surface at a spaced distance from the patient's inguinal crease, while a channel in the support surface cradles and guides the angiographic needle at the prescribed angle as it is inserted into the femoral artery. The needle guide may include a second recess defined by a pair of projecting fingers at the opposite end of the base and another support member adjacent thereto.

Abstract: A device for facilitating the insertion of balloon catheters and other devices into blood vessels, for example, the femoral artery, while presenting the minimal amount of obstruction to the flow of fluid through the vessel. The device is comprised of an introducer sheath having a hub and a short elongated section wherein when the hub abuts the patient's skin and the short elongated section is not long enough to reach the vessel. Also disclosed is a method for inserting a balloon catheter using the short introducer sheath.

Abstract: A balloon catheter assembly in which the catheter tube terminates at the entrance to the balloon chamber and in which a thin support member connects the distal end of the catheter tube to the tip at the distal end of the balloon chamber. A connecting anchor is provided at the distal end of the catheter tube. The connecting anchor has a skirt portion that is connected to the catheter tube. The support member is attached to the skirt portion.

Abstract: A guidewire delivery assist device including a cylindrical body, having a lumen extending axially therethrough from a proximal end to a distal end thereof, for receiving a guidewire, and an integral grip. The grip includes a plurality of flexible grip members extending longitudinally through at least a portion of the cylindrical body and forming a plurality of internal surface portions defining a portion of the lumen of the cylindrical body. The grip members and interior surface portions are flexibly collapsible in a radial direction of the cylindrical body and a guidewire resident in the lumen of the cylindrical body is frictionally engageable by the internal surface portions.

Abstract: A hollow, open-ended sheath is removed from a position enclosing a catheter which has been inserted through the sheath with a close tolerance and introduced into a human body thereby. A cutting blade is mounted in a deforming and guiding mechanism connected to the blade and engageable with the sheath for exerting pressure on the sheath in such a manner as to deform the sheath away from the catheter at a point immediately adjacent to the cutting blade and into contact with the cutting blade while maintaining the catheter beyond the reach of the blade. The device guides the blade for lengthwise movement relative to the sheath. The blade cuts the sheath in a lengthwise direction for removal from the catheter while the catheter remains in place.

Abstract: A balloon catheter comprises a tip having a tapered distal end, a central lumen, and a balloon membrane coaxial with and surrounding the central lumen and connected to the tip. A sheath is slidable over the balloon to form an assembly, and a guide wire is slidable through the central lumen and insertable into a blood vessel for guiding the tip, membrane and sheath to a location within the blood vessel selected for therapy. The sheath fits loosely over the balloon, whereby the sheath can be withdrawn to expose the balloon at the selected location and the balloon can then be inflated to provide therapy.

Abstract: A wrapping system for an intra-aortic balloon in which a wrapping guide is provided which restrains the proximal end of the envelope from rotating as the distal end is rotated thereby providing a uniform wrap of the envelope from its distal to its proximal end. A wrapping wire is provided for rotating the envelope distal end and the wire extends through at least a part of the catheter to which the envelope is attached. A wrapping knob is coupled to the proximal end of the wrapping wire, whose distal end can be detachably coupled to the distal end of the envelope, and the knob is constructed to permit only a predetermined number of rotations in both wrapping and unwrapping the envelope.

Abstract: A wrapping system for an intra-aortic balloon in which a wrapping guide is provided which restrains the proximal end of the envelope from rotating as the distal end is rotated thereby providing a uniform wrap of the envelope from its distal to its proximal end. A wrapping wire is provided for rotating the envelope distal end and the wire extends through at least a part of the catheter to which the envelope is attached. A wrapping knob is coupled to the proximal end of the wrapping wire, whose distal end can be detachably coupled to the distal end of the envelope, and the knob is constructed to permit only a predetermined number of rotations in both wrapping and unwrapping the envelope.

Abstract: An intra-aortic balloon adapted to be percutaneously inserted into a blood vessel in which the balloon and its support member are twisted as the balloon envelope is wrapped around its support member before insertion into the vessel to reduce the diameter of the balloon envelope. The support member is twisted as the balloon is wrapped, thereby storing energy which, urges the unwrapping of the balloon in the vessel. In one embodiment, the support member is hollow to permit a guide wire to pass there-through so that placement of the balloon within the human body may be done with greater precision and the hollow support member permits the injection of a radiopaque fluid so that the balloon can be viewed within the vessel, thereby assisting in the placement of the balloon. In another embodiment, a solid energy storage support member with a highly flexible distal portion provides an intra-aortic balloon of enhanced pliability.

Abstract: An inflatable and deflatable balloon catheter is disclosed. The inflatable chamber of the catheter is supported about an elongated support member of small diameter. One or both ends of the support member are rotatably disposed relative to the chamber wherein the chamber is adapted to being compactly twisted about the support member upon twisting, rolling or wrapping the chamber. The compactly twisted chamber has a small diameter whereby insertion of the catheter through a small incision and guiding thereof in a small body canal or passage is facilitated. A smooth-walled sheath of low friction material is disclosed for enclosing the twisted chamber to facilitate atraumatic entry of the catheter into the incision or body opening and for facilitating insertion and movement of the catheter. Balloon catheters according the present invention are advantageously used for intra-aortic balloon pumping.

Abstract: Apparatus and method for the percutaneous insertion of intra-aortic balloons into the human body wherein a sheath is provided which can be inserted into an artery through a puncture, and an intra-aortic balloon of a size sufficiently small and having sufficient flexibility is used which can be moved through the sheath into the artery. The apparatus and method includes, puncturing the skin into the artery until a needle means having a bore, introducing a guide wire into the artery through the needle means, advancing a dilator-sheath set over the wire to enlarge the puncture and to place an end of the sheath within the artery, withdrawing the dilator and guide wire and then inserting the balloon through the sheath.

Abstract: Inflatable and deflatable balloon catheters are disclosed. Catheters according to the invention have an expansion chamber that may be elongated to reduce its radial dimension without producing oblique or transverse folds or wrinkles. The inflatable chamber of the catheter is supported by an elongated support member of small diameter which has a continuously extending opening therein through which fluid is admitted to and withdrawn from the chanber. An axially movable elongating member is disposed within the expansion chamber for elongating the chamber. Axial movement of the elongating member elongates the chamber to decrease its radial dimension whereby feeding and guiding of the catheter is facilitated. In one embodiment, the support member is the gas supply tube extending into the chamber and the continuously extending opening is a helical slit running along at least part of the tube enclosed by the chamber.

Abstract: An inflatable and deflatable balloon catheter is disclosed. The inflatable chamber of the catheter is supported about an elongated support member of small diameter. One end of the support member is rotatable relative to the chamber wherein the chamber is adapted to being compactly twisted about the support member upon swiveling or rotation of the support member. The compactly twisted chamber has a small diameter whereby insertion of the catheter through a small incision and guiding thereof in a small body canal or passage is facilitated. A smooth-walled sheath of low friction material is disclosed for enclosing the twisted chamber to facilitate atraumatic entry of the catheter into the incision or body opening and for facilitating insertion and movement of the catheter. The support member is preferably made of a material which may be formed during use into a desired axial configuration by bending. Balloon catheters according to the present invention are advantageously used for intra-aortic balloon pumping.

Abstract: Apparatus and method for providing hypothermia or effecting hemostasis to prevent hemorrhaging in organs or regions of the human body and the like. In one application described herein, the apparatus provides hypothermia to the heart during, for example, cardio-pulmonary bypass. The apparatus comprises a unitary preferably disposable coolant fluid circuit, including a length of flexible tubing having a heat exchange portion and a flexible, inflatable bag through which a sterile coolant fluid passes. The inflatable bag is connected to the flexible tubing by a double lumen. The tubing is provided with appropriate fittings proximate to its juncture with the double lumen to allow introduction of coolant fluid. The heat exchanger portion of the coolant fluid circuit is located within a preferably disposable container which contains refrigeration means for reducing the temperature of the coolant fluid.

Abstract: Improved blood pumping apparatus is disclosed which includes a smooth avalvular deflatable section through which blood flows, said section mounted within a rigid avalvular airtight housing, gas being introduced and withdrawn from the housing by suitable control means, the action of the gas causing the blood chamber to inflate and deflate with consequent non-traumatic pulsatile ejection of blood from said chamber. The apparatus is simple, reliable, inexpensive and can aid the blood pumping function in many ways. For example, apparatus is disclosed to provide pulsatile flow to the blood being pumped by a heart-lung machine, or to provide pulsatile flow to the coronary arteries during coronary artery perfusion, or to be utilized as an arterio-venous fistula to decrease the afterload of the left ventricle and preserve the systemic diastolic pressure while increasing coronary perfusion.

Abstract: An assembly of bridges for retention sutures to be spaced along the length of a surgical incision, each bridge having an arched configuration so as to be spaced from the incision so that the healing of the wound is facilitated while affording a physician access to the incision. The ends of each bridge do not contact the skin but are associated with respective ones of a pair of flat mounting strips positioned on either side of the incision which distribute the pressure exerted by the bridge ends from the sutures evenly over a relatively large area.