Abstract: An exchanger and method for manufacturing the same are disclosed. In one embodiment, the exchanger crimps a hollow fiber bundle along a length of a cylindrical case in at least two radial positions. At least one crimp is between an inlet port and an outlet port of a blood conduit. Preferably, the cylindrical case has two portions with different radii so that when the two portions are mated to enclose the hollow fiber bundle, crimping is achieved. In this way, shunting of blood is avoided by being forced to pass a crimped position between the inlet and outlet ports to more evenly distribute the blood among the fibers of the bundle. In another embodiment, a method for making an exchanger includes filling a chamber, integral to the exchanger, with uncured potting material. The exchanger is spun to distribute the uncured potting material about open ends of an encasement. After curing, a portion of the potting material and the hollow fiber bundle are trimmed away.

Abstract: A device (10) for removal of gas bubbles and dissolves gasses from fluids delivered into a patient during medical procedures is disclosed. A housing (20) having a number of gas permeable hollow fibers (50) passing therethrough is provided. The infused fluid is introduced through the interior lumens of the hollow fibers (50), and entrained or dissolved gasses are drawn through the fiber walls to the outer or shell side of the fibers. A vacuum may be drawn on the housing through a vent (32) to enhance gas removal. A passage (70) is optionally provided through the device to allow a tool or other device to be passed therethrough.

Abstract: Improvements to integrated blood pump/oxygenator having a rotating hollow fiber bundle assembly that both oxygenates and pumps blood are provided. An inner member arranged along a central axis of the device accelerates blood entering the fiber bundle to reduce microbubble generation and blood trauma. Shearing loads imposed on the fiber elements of the fiber bundle are reduced by the addition of a reinforcement structure, while the gas flow path is configured to reduce flooding and loss of oxygenation efficiency due to occasional rupture of fiber elements.

Abstract: A hollow fiber membrane oxygenator of external blood circulation type has a housing and a lot of porous hollow fiber membranes for gas transfer housed in the housing. In the oxygenator, blood flows along the outer side of the hollow fiber membranes, whereas oxygen-containing gas flows along the inner side thereof. An outer surface or outer layer of the hollow fiber membrane as a blood-contacting portion is coated with synthetic polymer mainly formed of alkoxyalkyl(meta)acrylate containing a C(1-4)alkoxy group and a C(1-4)alkyl group. An intermediate layer and inner layer of the hollow fiber membranes contain substantially no synthetic polymer.

Abstract: A composition for cleaning and decontaminating medical devices such as dialyzers. A per-compound oxidant, for example, hydrogen peroxide (H2O2) and/or peracetic acid, is mixed with a buffer such as dipotassium hydrogen phosphate. The pH of the composition is between about 5-11. The composition effectively cleans the device, can achieve high level disinfection and sterilization of the device and is non-corrosive to plastics and adhesives used in the device.

Abstract: A coupling is connectable to an access of a blood compartment. The compartment has at least one inner surface intended to be coated with at least one molecular layer of a substance soluble in an aqueous solution and capable of increasing biocompatibility. A determined quantity of the substance is deposited inside the coupling in a form such that the substance is capable of undergoing, substantially without deterioration, an irradiation capable of sterilizing the coupling.

Abstract: An integrated blood pump/oxygenator having a rotating hollow fiber bundle assembly that both oxygenates and pumps blood is provided that includes a plurality of partitions disposed within or about the fiber bundle assembly to lengthen the flow path of blood passing through the fiber bundle. Alternatively, or in addition, blood flow paths may be lengthened and oxygenation improved by providing internal recirculation paths within the pump/oxygenator, which also advantageously may be used to reduce blood trauma caused by stagnation nearing moving parts and heat build-up.

Abstract: An integrated blood pump, oxygenator and heat exchanger is provided having a rotating hollow fiber bundle assembly. A plurality of vanes arranged along a central shaft of the device increase pressure near the center of the fiber bundle to develop sufficient pressure head to pump the blood through the heat exchanger. In alternative embodiments, the heat exchanger comprises a pleated metal wall, a bundle of non-permeable hollow fibers, or a coiled tub disposed between the rotating hollow fiber bundle and an interior wall of the housing.

Abstract: Process for producing hydrophobic polyolefinic membranes for gas exchange via thermally induced liquid-liquid phase separation is disclosed. A solution of at least one polyolefin in a solvent system, of a compound A and a compound B having a viscosity less than 60 mPa s, is extruded to form a shaped object. The compound A is a solvent and compound B preferably a non-solvent of the polymer, and the boiling point of compound A is at least 50° C. higher than that of compound B. After the shaped object leaves the die, at least one surface thereof is subjected to an atmosphere promoting evaporation of compound B, and the shaped object is subsequently cooled until the phase separation and solidification of the high-polymer-content phase take place.

Abstract: A coating for microporous hollow fiber membrane blood oxygenators increases the resistance of the fibers to passage of blood plasma through the micropores. The coating comprises alkoxysilane/alkylsilane copolymer, preferably aminoalkylsiloxane.

Abstract: An integrated blood oxygenation and pump system suitable for use in a sterile field having a low priming volume is provided in which a blood oxygenator portion of the system includes an active element, separate from the pump, that disrupts the development of laminar flow and stagnation zones in the fiber bundle employed for gas exchange. The integrated system enables the pump and oxygenator to be used independently of one another or be rapidly reconfigured to provide both pumping action and blood oxygenation.

Abstract: Improvements to integrated blood pump/oxygenator having a rotating hollow fiber bundle assembly that both oxygenates and pumps blood are provided. A plurality of vanes arranged along a central shaft of the device increase pressure near the center of the fiber bundle to prevent microbubble generation and blood trauma. Shearing loads imposed on the fiber elements of the fiber bundle are reduced by the addition of a reinforcement structure, while the gas flow path is configured to minimize flooding and loss of oxygenation efficiency due to occasional rupture of fiber elements. Blood trauma may be further reduced by contouring the vanes and other components of the device.

Abstract: An artificial gut (100) comprises a first hollow fiber (203) having an inner surface (215) that is lined with at least a portion of a layer of one or more of a plurality of biological components (205) that typically line a mammalian gut. Further, a second hollow fiber (201) is adjacent the first hollow fiber. The layer of one or more of the plurality of biological components can consist essentially of enterocytes. The enterocyte-lined inner surface is perfused with a feeding solution containing nutrients, and the enterocytes absorb, process, and transport the nutrients across the wall of the first hollow fiber. The nutrients eventually diffuse into the second hollow fiber. A perfusate selected from the group consisting of culture medium, blood, and plasma, can perfuse an inner surface of the second hollow fiber, whereby the perfusate is nourished by the nutrients.

Abstract: An improved cardiopulmonary bypass system which consolidates and miniaturizes the entire CPB circuit on an integrated panel or box-type structure capable of being positioned within (or closely adjacent to) the sterile surgical field.

Abstract: An oxygenator of hollow fiber membrane type of the present invention includes a cylindrical core; a cylindrical hollow fiber membrane bundle consisting of a plurality of gas-exchange hollow fiber membranes wound on an outer surface of the cylindrical core; a housing accommodating the cylindrical hollow fiber membrane bundle; a gas inlet portion and a gas outlet portion both communicating with the interior of the hollow fiber membrane; and a blood inlet portion and a blood outlet portion communicating with the outside of the hollow fiber membrane and the interior of the housing. The hollow fiber membranes of the cylindrical hollow fiber membrane bundle wound on cylindrical core are multi-layered on the outer surface thereof. Each hollow fiber membrane layer has cross portions of the hollow fiber membranes in the neighborhood of the center of the cylindrical core in a longitudinal direction thereof.

Abstract: This invention deals with a composite membrane comprising a thermoplastic matrix and fibrous reinforcing construct for use in constructing membrane blood oxygenators. The surface of the composite membrane can be chemically activated to incorporate functional groups to provide certain desirable properties to increase the utility of the membrane and extend its use to chromatographic applications and incorporation in dialysis units.

Abstract: The present invention is to a process for blood oxygenation using a microporous fiber membrane. The use of the hollow fiber allows improvements in plasma break through results. The oxygenator includes a housing and microporous membrane cartridge. The cartridge comprises a microporous hollow fiber membrane having a wall thickness greater than 30 microns and having a bubble point of ≧150 psig.

Abstract: The invention relates to an oxygenator membrane based on organically modified silicic-acid polycondensates into a process for preparation thereof. The oxygenator membrane is obtainable by processing a viscous to resinous liquid by conventional methods to form a membrane, drying this membrane, if desired, and subjecting it to curing induced thermally and/or radiatively and/or chemically. The viscous to resinous liquid is obtained by hydrolytic polycondensation of one or more compounds of the general formula I and/or II and/or III and/or IV and/or of precondensates derived from these compound by hydrolytic condensation and, if desired, of one or more compounds of the general formula V, and, if desired, by addition of one or more monomers and/or oligomers which are capable of undergoing addition copolymerization and/or (poly)addition reaction and/or of one or more curing catalysts.

Abstract: Microorganisms are destroyed and enzymes can be inactivated in liquids, such as juices for example, by continuously flowing the liquid and continuously flowing pressurized dense CO2 along flow paths which are separated by membrane having minute pores at which the flows contact each other in a nondispersive manner. Pressures in the two flow paths are equalized and the dense CO2 flow is continuously recirculated without depressurization. Contact between the flows can be maximized by using a plurality of parallel hollow fiber porous membranes with one of the flows being directed into the hollow fibers and the other of the flows being directed along exterior surfaces of the fibers. The process does not adversely affect properties of the liquid, such as taste, aroma and nutritional content, as heating of the liquid to a high temperature is unnecessary.

Abstract: A membrane oxygenator may receive a supply of pressurized oxygen and a supply of pressurized fluid, such as water or blood. In one example, a plurality of tubular membranes are disposed in a housing, where the pressurized fluid is delivered into the tubular membranes and where the pressurized oxygen is delivered into the area surrounding the tubular membranes. The oxygen diffuses through the membranes of the oxygenator to produce an oxygenated fluid. Advantageously, the oxygenated fluid is oxygen-saturated and delivered to a high pressure vessel where it may be stored until it is delivered to a patient.

Abstract: The need for a venous reservoir in a heart-lung machine is obviated by using a vacuum-purged negative-pressure air filter in the venous return line ahead of the main blood pump. The purging vacuum for the venous air filter can also be used to purge air from the cardiotomy reservoir if a backflow-preventing valve is used on the venous air filter.

Abstract: A cell containing sample is separated into a cell containing portion and a substantially cell depleted portion, by mixing the sample with particles to produce a cell containing network, and separating the network from the remaining substantially cell depleted portion within a plurality of confining walls, wherein at least one of the walls is flexible. While in some aspects the separation is performed employing a magnetic force, in other aspects the separation is performed using two forces, wherein one force is a magnetic force and the other force is a mechanical force. It is contemplated that whole blood may be used as the sample, and that the cell-containing portion largely comprises a network of inter-linked red blood cells. It is especially contemplated that separation involves antiligands, preferably primary antibodies that bind to a ligand such as antigen on or in red blood cell membranes, and secondary antibodies that bind to the primary antibodies.

Abstract: An apparatus and method for removing entrained gases from a liquid by directing a liquid flow adjacent a substantially hydrophobic microporous membrane material and providing a negative pressure to one side of the membrane material to draw undissolved gas bubbles out of the liquid and through the membrane walls.

Abstract: An apparatus and a method for making a transfer device comprising a tube bundle. The transfer device is suitable for use as a heat exchanger in a blood cardioplegia circuit, for example. The apparatus axially winds a flexible tube around a winding core. The apparatus includes a winding core, a core rotating means, a tube bobbin, and a tube shuttle to guide the tube around the core. A shuttle rotating means rotates the tube shuttle around the core. The method of making the transfer device includes providing a winding core, winding a tube from end to end around the winding core, fitting the wound bundle into a housing, sealing the first and second ends of the housing using a potting material, cutting the ends of the bundle to expose a lumen within the tubes, and attaching a first end cap and a second end cap.

Abstract: A test sample card has a well formed in the card body for receiving a fluid sample containing a microbiological agent or microorganism and a reagent. The test sample card has a membrane in the form of a tape covering the sample well to form a closed reaction chamber of the fluid sample and reagent and provide a barrier between the fluid sample and the atmosphere. The tape is made from polymethylpentene. The high oxygen permeable and transmissible characteristics of the tape promotes a reaction between the reagent and the microorganism. The increased growth rate exhibited by the microorganism, as compared to prior art tapes, substantially reduces the time needed to complete the test detection such as using transmittance optical analysis, for example confirm of the identity of the microbiological agent or the susceptibility of the microorganism to antibiotic agents.

Abstract: A customized pump, filtration, oxygenation and/or debubbler apparatus includes a first pump module, a filtration module, an oxygenation module, a debubbler module and/or a second pump module. Each module is formed of stackable support members with filtration, oxygenation and/or degassing membranes interposed therebetween.

Abstract: Improvements to integrated blood pump/oxygenator having a rotating hollow fiber bundle assembly that both oxygenates and pumps blood are provided. A plurality of vanes arranged along a central shaft of the device increase pressure near the center of the fiber bundle to prevent microbubble generation and blood trauma. Shearing loads imposed on the fiber elements of the fiber bundle are reduced by the addition of a reinforcement structure, while the gas flow path is configured to minimize flooding and loss of oxygenation efficiency due to occasional rupture of fiber elements. Blood trauma may be further reduced by contouring the vanes and other components of the device.

Abstract: A combination mass transfer and pump apparatus, which in a single step actively mixes a first mass and a second mass and simultaneously pumps one of the first mass and the second mass through the apparatus. The combination mass transfer and pump apparatus substantially comprises a housing and at least one distributor element having a plurality of selectively fluid-permeable membrane elements wherein the at least one distributor element is agitated within the second mass such that the first mass diffuses across the selectively fluid-permeable membrane elements, mixing with the second mass, and in the same step the second mass is pumped through the housing.

Abstract: A compact blood oxygenator has a minimal priming volume and is particularly advantageous for pediatric cardiac surgery. A generally rectangular housing has longitudinally spaced and interspersed heat exchanger conduit groups and oxygenator fiber bundles. The conduits and oxygenator fibers extend transversely across the interior of the housing in criss-cross fashion. Cured potting compound and flanges on the interior surfaces of the housing define hermetically sealed heat transfer fluid, blood and gas mixture flow paths. The inlet and outlet ends of the heat exchanger conduits communicate with first and second chambers formed on opposite sides of the housing. The inlet and outlet ends of the oxygenator fibers communicate with third and fourth chambers on the other opposite sides of the housing.

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: Waterless temperature control of blood in a blood oxygenator is achieved by providing a non-disposable heater/cooler with a temperature-controlled surface that can be intimately mated with a heat-conducting surface of a disposable blood heat exchanger associated with the oxygenator. Blood flows in a shallow path past the heat-conducting surface so that substantially all of the blood will assume the temperature of the heat-conducting surface as it flows past that surface.

Abstract: An apparatus for the treatment of blood or plasma by extracorporeal circulation includes a compartment for the circulation of blood. The compartment is provided with two accesses and has at least one inner surface intended to be coated, after sterilization, with at least one molecular layer of a substance soluble in an aqueous solution. The aqueous solution is capable of increasing the bicompatibility of the inner surface of the compartment. A determined quantity of the substance is deposited inside the blood compartment, at one of the accesses, in a form such that the substance is capable of undergoing, substantially without deterioration, an irradiation capable of sterilizing the apparatus.

Abstract: A heat exchanger is provided which may be used in an integrated blood oxygenator and heat exchanger. The heat exchanger has a plurality of wave shaped sinusoidal channels on one or both sides. The heat exchanger has a cap attached at the upper end. The heat exchanger is disposed within a housing. The bottom end of the heat exchanger is bonded to the bottom end of the housing, and the upper end of the heat exchanger with the cap attached is spaced apart from the upper end of the housing. A liquid inlet and outlet are in fluid communication with the inner surface of the heat exchanger. A blood inlet and outlet are in fluid communication with the outer surface of the heat exchanger. The heat exchanger may be used with a blood oxygenating chamber. The blood oxygenating chamber contains a plurality of permeable hollow fibers which oxygenate blood flowing through the blood oxygenating chamber. The blood oxygenating chamber is in fluid communication with the outer surface of the heat exchanger and the blood outlet.

Abstract: A portable perfusion/oxygenation module includes respiratory gas driven dual positive displacement pumps coupled to a stacked membrane oxygenator unit for perfusion fluid oxygenation, a valving manifold to control perfusate flow-direction coupled to an organ chamber designed to enable easy installation of organ and maintenance of intra and extra organ fluid pressure. All of the components and oxygen cylinders are fitted into an insulated chest capable of sustaining perfusion and oxygenation for 24 hours. The perfusion/oxygenation apparatus requires no electrical power, is compact with the total weight including the perfusion fluids and organ weighing less than 50 pounds. With low cumulative weight and the extremely low flow rate of gas required to pump the perfusate, the oxygen supply is capable of sustaining pumping operation for 24 hours without gas cylinder change.

Abstract: A gas exchange apparatus for use as a artificial lung incorporates a hollow fiber module for bundling a plurality of thin-walled hollow silicone fibers. The fibers are wound in the form of a twilled pattern so as to form an internal perfusion passage and an external perfusion passage. A housing encloses the hollow fiber module. The housing incorporates a first inlet and outlet formed on the housing for communication of gas or liquid with the internal perfusion passage, and a second inlet and outlet formed for communication of gas or liquid with the external perfusion passage.

Abstract: A contactor for degassing liquids includes a perforated core, a plurality of microporous hollow fibers, and a shell. The fibers surround the core and have two ends. A tube sheet affixes the ends of the fibers. A baffle is located between the tube sheets. The hollow fibers are closed at the baffle. The shell encloses the fibers, tube sheets, and the baffle. The system for degassing liquids includes a source of liquid containing a gas, a source of vacuum, and the contactor.

Abstract: Pulsatile cardiopulmonary flow closely approximating a natural heartbeat is generated in a heart-lung machine by using a proportioning valve to partly convey blood in the machine's cardiopulmonary circuit to the arterial supply line, and to partly recycle that blood into the cardiopulmonary circuit upstream of the arterial pump. The relative proportions of conveying and recycling are varied in accordance with a waveform approximating the waveform of a human heartbeat.

Abstract: The process, particularly useful in blood oxygenators, whereby a differential velocity between a fluid and a diffusing surface of hollow tubes by a rotating member such that the boundary layer is perturbed enhancing the coefficient of mass and thermal transfer. The differential velocity is achieved by rotating hollow tubes containing one fluid in a second fluid, or by apposing a rotating member to the surface of the stationary hollow tubes.

Abstract: A method for improving priming of an integrated oxygenator and heat exchanger which includes pretreating the integrated hollow fiber oxygenator and heat exchanger device with a surfactant. Pretreating the device coats the interior surfaces of the integrated hollow fiber oxygenator and heat exchanger with the surfactant, which facilitates the removal of entrapped air. An integrated hollow fiber oxygenator and heat exchanger having a surfactant coating on the interior surfaces is provided which subsequently allows for more efficient priming with an aqueous priming media.

Abstract: A simple, self-supporting cardiotomy filter/defoamer is formed by a 20 .mu.m cylindrical spray spun hollow plastic filter cartridge impregnated with an anti-foaming agent.

Abstract: The process, particularly useful in blood oxygenators, whereby a differential velocity between a fluid and a diffusing surface of hollow tubes by a rotating member such that the boundary layer is perturbed enhancing the coefficient of mass and thermal transfer. The differential velocity is achieved by rotating hollow tubes containing one fluid in a second fluid, or by apposing a rotating member to the surface of the stationary hollow tubes.

Abstract: Apparatus for processing fluids, in particular blood, includes a housing having an fluid inlet port and a fluid outlet port, with the housing being formed by an outer tube, an intermediate tube set within the outer tube for forming a first chamber therebetween, and an inner tube set within the intermediate for forming a second chamber therebetween. Disposed within the chambers are a plurality of hollow fiber membranes for suitably conducting heat exchange fluid and gas. The first and second chambers are so interconnected to one another and the inlet port and outlet ports are so disposed as to effect a fluid flow path through the chambers in longitudinal direction of the tubes.

Abstract: An improved sealant for a biocard or other sample holder is provided. The sealant achieves low weight, good tensile strength, and high oxygen permeability while avoiding excessive fluid evaporation, speeding incubation times.

Abstract: Containers for medical use comprising a storage portion formed of a soft polyvinyl chloride resin containing a vinyl chloride resin and diundecyl pthalate (DUP) as a plasticizer wherein the sheet exhibits an oxygen permeability of about 9.0.times.10.sup.-10 to 22.0.times.10.sup.-10 cc.cm/cm2.sec.cmHg/22.degree. C. and a carbon dioxide permeability of about 6.0.times.10.sup.-9 to 19.0.times.10.sup.-9 cc.cm/cm2.sec.cmHg/22.degree. C. The containers are suitable for the storage of blood, especially the cellular components of blood. The invention also provides processes for making such containers as well as methods for storing blood cells using such containers.

Abstract: An extracorporeal blood oxygenation system comprising an integrated blood pump/heat exchanger/membrane oxygenator assembly which is mountable upon, and engageable with, a separate motor/drive assembly. The blood pump of the system incorporates a novel axial/centrifugal impeller assembly. An optional blood reservoir may be incorporated into the system to receive and contain venous return and/or surgical site blood. Also, an optional arterial filter may be incorporated into the system for filtering the oxygenated blood before the blood is returned to the patient. The pump/heat exchanger/membrane oxygenator component is preferably constructed such that heat exchange fluid which is being infused into the heat exchanger will pass through and/or in contact with a portion of the membrane oxygenator so as to further maintain the temperature of blood as it passes through the membrane oxygenator.

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 blood oxygenator having a housing with an outer walled portion and a top portion and bottom portion. Blood is introduced through the bottom portion of the housing to be oxygenated by a fiber bundle having blood and oxygen flow. A blood outlet manifold in the upper portion of the housing is connected to a blood outlet on one end having a conical passage. The blood outlet manifold includes a reservoir with an increasing volume toward the conical passage and is sloped upwardly to enhance gaseous microemboli disentrainment. The wall of the housing decreases in dimension upwardly toward the blood outlet manifold, while the introduction of blood to the fibers is in a lesser ratio to the area adjacent the outlet manifold.

Abstract: The structure has a core which may be a strand or braid, as well as a sheath surrounding the core and defining the exchange surface. Preferred applications are for biomedical equipment such as blood oxygenators and blood purification equipment.

Abstract: An apparatus 10 and method for delivering a high partial pressure of a gas into a liquid. The apparatus has a gas transfer device 12 with a housing 14 that includes upstream 16 and downstream 18 regions, between which there is located a gas-liquid contacting region 20 with contacting members 22, such as hollow microporous fibers. A reservoir 36 of gas supplies the gas at a high pressure (P) to a flask 38 of gas-depleted liquid and to the gas transfer device 12. The reservoir 36 of gas provides hydrostatic pressure for urging the liquid through the contacting members 22 and propelling the gas around the contacting members 22 so that the gas does not diffuse across the contacting members 22. The gas-enriched liquid is then ducted to a high resistance delivery channel 44 for administration to a site of interest without effervescence, bubble formation, or significant disruption of laminar flow.

Abstract: A mass transfer device including a hollow fiber bundle wound on a core for radially outward flow of a first fluid. The core has an axis extending from one end to the other. The hollow fiber bundle has packing fractions which increase radially outward of the core's axis for a major portion of the bundle. Methods for making such mass transfer device.