Abstract: Tubular bundles are potted in a housing, such as in an oxygenator or a pheresis unit. Spacer material is placed into the housing to cover the first ends of the tubular elements. A layer of potting material is placed into the housing covering the spacer material, and then solidified in place to seal between each of the tubular elements and the housing. The spacer material is then removed from the housing to expose the first ends of the tubular elements. In the oxygenator, at least some of the tubes are gas exchange tubes having an interior lumen and a tube wall which is permeable for oxygen and carbon dioxide flow through the tube wall. The potting separates the housing into manifold chambers communicating with the interior of the tubes and a blood flow chamber sealed from the manifold chambers. Blood flows over the exterior surface of the tubes. Other tubes may be heat transfer tubes, such as for carrying a heat transfer fluid to control the temperature of the blood.

Abstract: A blood handling system has a first blood handling apparatus mounted on a second blood handling apparatus with a mounting apparatus. The mounting apparatus has two primary components: a retention sleeve attached to a stem that protrudes from the lower portion of the first blood handling apparatus; and a slotted plate that is attached to a stem on the second blood handling apparatus. The retention sleeve has a track for receiving the slotted plate and a flexible tab, with a protruding tooth, that securely engages the slotted plate in a locked position. If it becomes necessary to disconnect the first blood handling apparatus from the second blood handling apparatus during surgery, the tab may be easily moved into an unlocked position, allowing the disk to slide freely out of the track so that the units can be easily separated from each other.

Abstract: A multilayer hollow fiber body useful, for example, in a blood oxygenator. The multilayer hollow fiber body comprises a single hollow fiber mat arranged in the form of a body comprising a plurality of hollow fiber plies. The mat comprises a plurality of generally parallel hollow fibers disposed at regular intervals, and a plurality of connecting fibers holding the connecting fibers. The mat is repeatedly folded over on itself along fold lines, each of which is at an oblique angle to the hollow fibers, to form a multilayer hollow fiber body in which the hollow fibers of any ply of the multilayer hollow fiber body are disposed so as to cross the hollow fibers of an adjacent successive ply of the multilayer hollow fiber body. Also disclosed is a method of making the multilayer hollow fiber body.

Abstract: An integral blood oxygenator and heat exchanger device for oxygenating and heating or cooling a patient's blood during heart bypass surgery. The device preferably includes a pleated blood filter disposed within a gap formed between the opposite ends of the blood oxygenating medium. A blood inlet manifold closely receives a tubular heat exchanging barrier and directs blood flow around the barrier to a blood outlet slot. The blood oxygenating medium covers the blood outlet slot so that blood must flow through the blood oxygenating medium before reaching the blood filter. A vent port and bypass port may be provided in the gap formed by the opposite ends of the blood oxygenating medium upstream of the blood filter.

Abstract: A novel integral cardiotomy/venous blood reservoir, blood oxygenator and heat exchanging device, method of making a blood oxygenating and heat exchanging device and an extracorporeal circulatory support circuit. The reservoir includes a novel blood defoaming and filtering chamber closely receiving filtering and defoaming media. The blood oxygenating and heat exchanging device includes thermal formed housing portions, and a heat exchanging barrier, blood oxygenating medium and/or filtering medium, which are sealed by potting compound at one time. The oxygenating medium comprises a hollow fiber type medium, with its ends left open to be sealingly mounted in a gas path by a novel mounting bracket.

Abstract: A multilayer hollow fiber body useful, for example, in a blood oxygenator. The multilayer hollow fiber body comprises a single hollow fiber mat arranged in the form of a body comprising a plurality of hollow fiber plies. The mat comprises a plurality of generally parallel hollow fibers disposed at regular intervals, and a plurality of connecting fibers holding the connecting fibers. The mat is repeatedly folded over on itself along fold lines, each of which is at an oblique angle to the hollow fibers, to form a multilayer hollow fiber body in which the hollow fibers of any ply of the multilayer hollow fiber body are disposed so as to cross the hollow fibers of an adjacent successive ply of the multilayer hollow fiber body. Also disclosed is a method of making the multilayer hollow fiber body.

Abstract: A novel integral cardiotomy/venous blood reservoir, blood oxygenator and heat exchanging device, method of making a blood oxygenating and heat exchanging device and an extracorporeal circulatory support circuit. The reservoir includes a novel blood defoaming and filtering chamber closely receiving filtering and defoaming media. The blood oxygenating and heat exchanging device includes thermal formed housing portions, and a heat exchanging barrier, blood oxygenating medium and/or filtering medium, which are sealed by potting compound at one time. The oxygenating medium comprises a hollow fiber type medium, with its ends left open to be sealingly mounted in a gas path by a novel mounting bracket.

Abstract: A novel integral cardiotomy/venous blood reservoir, blood oxygenator and heat exchanging device, method of making a blood oxygenating and heat exchanging device and an extracorporeal circulatory support circuit. The reservoir includes a novel blood defoaming and filtering chamber closely receiving filtering and defoaming media. The blood oxygenating and heat exchanging device includes thermal formed housing portions, and a heat exchanging barrier, blood oxygenating medium and/or filtering medium, which are sealed by potting compound at one time. The oxygenating medium comprises a hollow fiber type medium, with its ends left open to be sealingly mounted in a gas path by a novel mounting bracket.

Abstract: A membrane oxygenator is disclosed. The oxygenator has a housing, gas and blood inlets and outlets, and a transfer membrane mechanism for transferring oxygen to blood. The oxygenator has a device for increasing its efficiency. The device maintains the total pressure of the oxygenating gas at each point within gas flow paths near yet below the total pressure of the blood opposite the transfer membrane mechanism generally throughout the oxygenator. The mechanism restricts the flow of oxygenating gas exiting through a oxygenating gas outlet with approximately the pressure of blood exiting through a blood outlet by providing a pressurization fluid with approximately the pressure of the blood exiting through the blood outlet. In a preferred embodiment, the oxygenating gas outlet is situated within the hollow portion of the housing.

Abstract: A mounting assembly for holding a heat exchanger particularly of the type used in administering cardioplegia during heart surgery. The mounting assembly both mounts the heat exchanger and provides heatexchanging fluid (e.g., water) to the heat exchanger. The mounting assembly also includes a valve and sealing mechanism which are simultaneously operated to ensure that the valve is not opened until after the heat exchanger is properly sealed. The sealing mechanism includes an expandable seal that is designed to hold the heat exchanger on the mounting assembly.

Abstract: A membrane blood oxygenator having a mechanism for automatically maintaining the total pressure of the oxygenating gas near yet below that of the blood across the membrane is described. This includes a valve for restricting the flow of oxygenating gas exiting the oxygenator with the pressure of the blood exiting the oxygenator. A tubing communicates the pressure of the exiting blood to the valve to activate the valve.

Abstract: The present invention concerns a novel process for collecting and storing platelets. The process enables the platelets to be removed from a patient prior to surgery, stored in a quiescent environment, and returned to the patient at the end of the surgery.

Abstract: A cardioplegia administration set including a heat exchanger, a bubble trap, a three-end connector, a normally-closed, pressure-responsive valve and interconnecting tubing. A first tubing means having an inlet adapted to be connected to a source of cardioplegia solution and an outlet connected to an inlet of the three-end connector interconnects inlets and outlets of the heat exchanger and the bubble trap therebetween so that a solution passageway is established from the source of cardioplegia solution through the heat exchanger and the bubble trap to an end of the three-end connector adapted to connect to an injection catheter. A second tubing means has an inlet connected to a recirculation outlet of the three-end connector and an outlet adapted to be connected to the source of cardioplegia solution so that a solution passageway is established from the three-end connector through the normally-closed valve back to the source of cardioplegia solution when the valve is open.

Abstract: A mass transfer device (60) includes a hollow fiber bundle (10) comprising a generally cylindrical core (14) having opposed ends, a plurality of layers of hollow fiber (12) that have been wound around the core, and binding means (48a, 48b, 48c), such as double-sided pressure-sensitive tape that have been wound around the layers of hollow fiber in a plurality of longitudinally spaced locations along the core and intermediate the opposite ends of the core for providing longitudinally spaced support means for the hollow fiber bundle. The hollow fiber bundle is enclosed in a housing (62) having an inner wall (80) which defines a generally circular opening for receiving the hollow fiber bundle except that the inner wall adjust a fluid outlet manifold (74) includes an expansion volume (82) for the hollow fibers that are adjacent that fluid outlet manifold. A screen (88) is provided adjacent the fluid outlet manifold to prevent the fibers from migrating too far into the outlet and to provide a controlled expansion.

Abstract: A combination fluid path and mount for a heat exchanger of the type used to cool or heat blood or solution for cardioplegia by transferring heat between the blood or solution and a heat-exchanging fluid. The heat exchanger has an inner surface defining a passageway in which heat-exchanging fluid circulates. The combination comprises a body of generally flexible-resilient material having a periphery adapted to be received in the passageway of the heat exchanger. A bracket is provided for mounting the body on a support. The body has heat-exchanging fluid inlet and outlet passageways, each opening through the periphery for circulating the heat-exchanging fluid to the passageway of the heat exchanger. A fixing-sealing mechanism is provided for removably fixing the heat exchanger to the body and sealing between the body and the inner surface of the heat exchanger.

Abstract: A system is provided for collecting platelets. Whole blood is removed from a patient 10 and directed to a hemoconcentrator 22 having a blood inlet 24, a blood outlet 26, a blood passage communicating with the blood inlet and blood outlet, an ultrafiltrate outlet 28 and a membrane separating the blood passage from the ultrafiltrate outlet. The blood is passed through the blood passage of the hemoconcentrator while a negative pressure is adapted to the ultrafiltrate outlet. In this manner, the platelets concentrate on the membrane wall. After a selected period of time, the application of the negative pressure is terminated to the ultrafiltrate outlet, and the concentrated platelets from the hemoconcentrator are flushed and directed to a platelet collection container 44. In one embodiment, the flushing solution comprises the patient's blood that is directed via the blood inlet through the blood passage while in another embodiment, the patient's blood is diverted and a saline solution is used as the flush.

Abstract: A heat exchanger (38) is provided which may be used in a mass transfer device (20), such asn an oxygenator or a dialyzer. The heat exchanger comprises a core (40) formed of a corrugated metal having a high thermal conductivity. Each of the corrugations of the core comprises substantially parallel side walls (70, 72). A first fluid, such as blood, is introduced onto the outside of the core. A second fluid, such as water, is introduced into the inside of the core. The first and second fluids will be in heat exchange relationship with each other and the flow of the fluids is substantially uniform resulting from the substantially parallel side walls of the corrugations. The core is formed by providing a flexible metalhose, annealing the flexible metal hose, compressing the annealed hose and expanding the compressed hose to a length that is substantially less than its original length but greater than its length during compression.

Abstract: A hollow fiber separation device such as an oxygenator for blood which comprises a core having a bundle of hollow tubular fibers circumferentially wrapped around the core for separation of materials. A housing encloses the bundle and first and second manifold systems respectively provide separated flow through the bundle in contact with exterior surfaces of the hollow fibers and the bores of the hollow fibers in first and second flow paths. A space extends longitudinally through the bundle exposing open ends of the fibers at opposed sides of the space, regions of the bundle are adjacent to the space being potted to prevent leakage around to the fibers. The second manifold system includes an inlet and outlet conduit, each being in flow communication with the space. Partition means in the space isolates fluid flow between the inlet conduit in one of the opposed sides from fluid flow between the outlet conduit in the other of opposed sides.

Abstract: A mass transfer device (60) includes a hollow fiber bundle (10) comprising a generally cylindrical core (14) having opposed ends, a plurality of layers of hollow fiber (12) that have been wound around the core, and binding means (48a, 48b, 48c) such as double- sided pressure-sensitive tape that have been wound around the layers of hollow fiber in a plurality of longitudinally spaced locations along the core and intermediate the opposite ends of the core for providing longitudinally spaced support means for the hollow fiber bundle. The hollow fiber bundle is enclosed in a housing (62) having an inner wall (80) which defines a generally circular opening for receiving the hollow fiber bundle except that the inner wall adjacent a fluid outlet manifold (74) includes an expansion volume (82) for the hollow fibers that are adjacent that fluid outlet manifold.

Abstract: A system is disclosed for priming an ultrafiltration unit (10) connected to a blood source, without requiring a pump in the blood line. An ultrafiltration unit (10) is provided having an ultrafiltration membrane which separates a blood compartment from an ultrafiltrate compartment, a blood inlet port (12), a blood outlet port (14), a second inlet port (16) communicating with the ultrafiltrate compartment, and an ultrafiltrate outlet port (18). A feedback tube (38) connects the blood outlet port (14) to the second input port (16). Priming solution (36) is introduced to the blood inlet port (12) and a vacuum is applied to the ultrafiltrate outlet port (18). The priming solution (36) is drawn through the blood compartment, through the ultrafiltrate compartment, out the ultrafiltrate outlet port, and to drain.