Abstract: A catheter system for use in minimally invasive cardiac surgical procedures. The catheter system diminishes certain trauma generally associated with invasive cardiac procedures while providing aortic occlusion, extracorporeal circulation, cardiac arrest, and cardiac venting. The catheter system provides a minimally invasive and simplified system that performs total cardiopulmonary bypass with ease of insertion, improved whole body profusion, and shortened recovery periods. The catheters are refined, with reduced diameters and specialized functions for maximum control of each aspect of cardiopulmonary bypass.

Abstract: An aortic knife which provides multi-sided incisions within an aorta for effectuating improved aortotomies. The aortic knife includes a handle and multiple blades radiating from the handle. The handle is sized and configured to maximize grip and surgical manipulation thereof. The multiple blades radiate outwardly and proximally from a distal sharpened point. A substantially cruciate, or cross-shaped, incision results from four sharpened blades extending from the distal sharpened point. Alternatively, the multi-bladed configuration of the aortic knife may comprise three, five, or six or more blades. The blades form equal angles in radiation outwardly and proximally from the distal sharpened point. The method of the invention requires obtaining an appropriately sized aortic knife which is stabbed into a portion of an aorta. An anvil of an aortic punch is then inserted into the incision in the aorta without the stretching necessitated by the conventional single linear incision.

Abstract: The present invention is directed to new and useful methods and apparatus for isolating and immobilizing tissue for improved presentation in a surgical site, preferably in coronary bypass on a beating heart. At the same time, the present invention also helps avert ischemic damage to tissues downstream. A surgical stabilizer in accordance with the present invention offers physical manipulation of a surgical site, which improves the surgeon's sewing, grasping, and visualizing abilities at the site, and in turn, may increase the confidence and patency of the graft. The stabilizer is used to compress or to suction a region of the heart just below a stenotic coronary artery. The surgeon may selectively articulate the tissue by spreading it apart or pushing it together, as per his or her preference, or per the requirements of the surgical situation. The surgeon may lock in place the handle via a ratchet mechanism to hold the specific open or closed articulation of the surgical stabilizer.

Abstract: Methods and apparatuses for salvaging blood from a patient are disclosed. A blood salvaging and/or blood processing circuit coupled to a cardiopulmonary bypass circuit, cardiotomy circuit, or directly to the patient comprises a hemocentrator for removing water, fluids, and low molecular weight solutes by ultrafiltration and a sorbent-containing plasma separator for removing a selected solute, such as heparin. A combination device for salvaging blood comprises a closed plasma chamber containing a plasma chamber solution, a hollow fiber plasma-separating membrane for receiving blood and permitting plasma to be transported therethrough into the plasma chamber solution and for refiltering the treated plasma back into the blood circuit, a selective sorbent for contacting the selected solute in the plasma and binding the selected solute, and an ultrafiltration membrane for removing water, fluids, and low molecular weight components from the plasma.

Abstract: The present invention is directed to new and useful methods and apparatus for improving access to the heart during cardiac surgery, while avoiding damage to the phrenic nerves. The present invention comprises a heart elevation apparatus which is soft and substantially cylindrical, with substantially flat anterior and posterior surfaces. Upon inflation, the anterior surface stabilizes the positioning of the heart and prevents the heart from falling off of the apparatus. The flat posterior surface facilitates positioning of the apparatus on the chest wall. An insulation pad on the posterior surface serves to insulate the phrenic nerves from the frigid bathes commonly employed in cardiac surgical procedures, and also protects the nerves from any compressive forces exerted during the surgery.

Abstract: A vascular occluder clip including a resiliently-biased pair of clamping elements extending transversely to longitudinally-extending members. Gripping loops or pads are provided for grasping by the user and compression of the members against the biasing force to separate the clamping elements. The gripping loops or pads extend from the longitudinal members on the opposite side thereof from the clamping elements.

Abstract: Pressure relief valve apparatus is disclosed for shunting fluids under conditions of overpressure, thereby preventing further increases in the pressure within a fluid delivery system. A presently preferred embodiment of the apparatus of the invention is formed of two components, a valve body member and a valve tube member. The valve body member is provided with first and second connector elements for use in connecting the pressure relief valve into a medical fluid delivery circuit. It is also provided with first and second bores passing through the first and second connector elements, respectively, and exiting at respective first and second exit ports on the side of the valve body member. A valve seat comprising a raised annular ridge around the circumference of the valve body member separates the first and second exit ports.

Abstract: The present invention is directed to a new and useful apparatus and method for absorbing and collecting blood and other fluids which accumulate in a patient during surgical procedures. An absorbent portion is connected to a suction source. When the absorbent portion is placed in contact with the fluid to be collected, the fluid is absorbed by the absorbent portion. Operation of the suction source provides a vacuum which draws the fluid away from the absorbent portion and out of the body. The fluid can be drawn into a receptacle for later cleansing and reuse. A flexible backing plate is attached to the absorbent portion. Channels formed a long the backing plate direct the vacuum evenly across the absorbent portion of the device such that fluid is drawn evenly from the absorbent portion. Suction tubing connects the absorbent portion to the suction source. The absorbent portion and attached backing plate can be folded to fit into small areas.

Abstract: This invention relates to balloon catheters for use in infusing a solution into a body passageway, and their methods of use and manufacture. Each catheter contains at least one lumen through which a solution flows into the body. The balloons of each catheter are secured to the proximal end of the catheter, and each have a plurality of protuberances projecting outwardly from the outer surface of the balloons for the purpose of firmly gripping the walls of the body passageway so as to secure placement of the catheter within the passageway. A malleable wire assists in retaining the catheter in position within the body passageway. A double balloon catheter allows sealing of the body passageway to be accomplished separately from securely gripping the walls.

Abstract: A polycationic system for the removal of polyanions from a fluid medium is formed by, first, activating a biocompatible hydroxylated support with an organic sulfonyl chloride, such as p-toluene-sulfonyl chloride, in the presence of a dialkylamino pyridine activation catalyst, such as 4-dimethylamino-pyridine (DMAP). The activated support is then reacted with a polymer having a polyamide backbone with pendent alkyl amine groups, such as poly-L-lysine (PLL), to form C--N bonds between an activated carbon from the hydroxylated polymer and an amine group from the polymeric polyamide. Finally, any unreacted activated sites on the hydroxylated polymer are capped or removed with an effective amount of capping agent such as a mercapto (--SH), hydroxy (--OH) or amino (--NH.sub.2) containing compound which reacts with the unreacted activated sites. The pendent alkyl amines on the polyamide backbone exist, at the appropriate pH, as polycations.

Abstract: Methods and apparatus are disclosed for variably controlling the ratio of blood to cardioplegia solution to be administered to a patient. A presently preferred embodiment of the apparatus of the invention comprises a multilumen tubing member having a blood supply lumen and three cardioplegia supply lumens, each having approximately the same tubing wall thickness, but having different inside diameters so that causing flow through different combinations of the cardioplegia lumens will result in different ratios of blood to cardioplegia. The four tubes comprising the multilumen tubing member are advantageously connected by web members, thereby facilitating use with a roller pump and minimizing the tangle of tubes.

Abstract: A disposible visualization wand for removal of bodily fluids from a graft, wound or other target site on a patient. The wand includes a barrel having a fan tip outlet, and a inlet end secured to a filter for removing contaminants from a gas stream feed for the wand. Also included is a liquid feed into the wand, for moisturizing the gas stream and preventing dehydration of the patient's tissue at the target site.

Abstract: This invention relates to a stylet for use with a retrograde cardioplegia catheter and its methods of use. The stylet includes a stylet rod, a handle on the proximal end of the stylet rod and a predetermined curve in the distal end of the stylet rod. The handle has a thumb rest on the proximal end and a one or two finger loops extending outward from the handle. An obturator is located on the distal end of the predetermined curve to impede blood flow through a tip of the cardioplegia catheter during insertion of the catheter. The invention also contemplates methods for using the stylet.

Abstract: A system and method of achieving both convective and diffusive transport of plasma across a membrane accompanied by the selective removal of plasma components using sorbents followed by reinfusion of the purified plasma in a blood circulation system is achieved by pumping blood through a filter comprising a bundle of "U" shaped hollow fibers immersed in a closed plasma chamber containing sorbents in an electrolyte solution. As blood flows through the entry arm, due to positive transmembrane pressure difference, plasma filtration into the plasma chamber occurs. The entering plasma causes an increase in the chamber pressure but does not exceed the pressure in the entry arm. The increase in chamber pressure exceeds the pressure in the exit arm of filter where the transmembrane pressure difference is negative and the direction of filtration reverses causing reverse filtration/reinfusion of plasma from the chamber into the blood in the exit arm.

Abstract: A three-way double stopcock and associated tubing is disclosed with which to connect both a cardioplegia solution source and a pressure monitor for the solution selectively and alternatively to either an antegrade cardioplegia catheter or a retrograde cardioplegia catheter. The stopcock includes a hollow valve body with three solution infusion ports communicating to the interior thereof in a coplanar arrangement at a first longitudinal point on the valve body. Three cardioplegia pressure monitoring ports also communicate through the valve body to the interior thereof at a second longitudinal position distinct from the first. Mounted in the valve body is a cylindrical valve core selectively rotatable about the longitudinal axis thereof between a first position in which the cardioplegia solution source and the pressure monitor are coupled to the antegrade cannula and a second position in which the cardioplegia solution source and the pressure monitor are coupled to the retrograde catheter.

Abstract: This invention relates to a retrograde cardioplegia catheter and its method of use. The catheter contains two lumens, an infusion lumen through which the cardioplegic solution flows and a pressure sensing lumen for monitoring the fluid pressure at the point where the solution exits the catheter. A slightly tapered, self-filling balloon is secured to the distal end of the catheter. Also, located at the distal end of the catheter is a soft, rounded tip to prevent damage to the sensitive intimal tissues of the coronary sinus. A stylet having a predetermined curve at the distal end and a handle at the proximal end is removably located within the infusion lumen. The predetermined curve at one end of the stylet enables the cardioplegia catheter to be inserted quickly and accurately within the coronary sinus through a very small incision made in the right atrium. After the catheter is securerd in place, the stylet is withdrawn.

Abstract: A cannula adapted for antegrade administration of cardioplegic solutions during surgical procedures on the heart. The cannula includes a flow lumen having a smooth interior surface to reduce hemolysis when blood is passed therethrough during reperfusion. Structures are included to allow the wall of the vessel, generally the aortic root, to be readily pierced so that fluid may pass through the flow lumen of the cannula into the heart. A suture flange is provided to secure the cannula to the heart. A pressure lumen is provided to communicate the pressure within the heart to a location where it can be monitored. A vent line is also provided to allow a surgeon to readily vent fluids out of the heart.

Abstract: An improved venous cannula and obturator for interconnecting the superior and the inferior vena cava to the venous return line of a heart-lung machine. The cannula includes a pair of resilient, divergent hollow branches. The branches are of unequal length. The longer branch is to be received within the inferior vena cava and the shorter branch is to be received in the superior vena cava. The open branch ends are thus longitudinally staggered when the branches are clamped together by the obturator to facilitate insertion of the branch ends through a single incision within the atrium and ultimate disposition of the branches in the superior and inferior vena cavae. The obturator includes an elongated rod with a hub having a pair of axial legs to be received within the branches of the cannula. The obturator is provided to be slidably received with minimal frictional resistance within the interior lumen of the cannula and the cannula branches.

Abstract: A venous return catheter is provided having a first diameter distal portion suitable for insertion in a vena cava, a second, larger diameter proximal portion, and a transition portion forming a smooth transition between the first and second diameter portions. Drainage openings are provided in both the proximal and distal catheter portions. The catheter is of unitary construction, having a smooth bore through its entire length. It is also constructed from a soft, resilient material, but is reinforced with a harder, stiffer material in the region of the proximal drainage openings. The catheter may also be provided with wire reinforcement. The catheter is manufactured by a dip-molding process utilizing a male mandrel as a form.