Abstract: A system and method for increasing gas concentration in blood which has use as a generalized extracorporeal system and method to treat hypoxemic blood from a patient by mixing the blood with an oxygen supersaturated solution to generate hyperoxemic blood to be infused back to the patient. The extracorporeal system comprises an extracorporeal tubing through which blood from the patient is circulated, a blood pump for withdrawing blood from and delivering blood to the patient, at least one channel for delivering oxygen-supersaturated fluid and a mixing region for introducing supersaturated fluid without bubble formation. By infusing the oxygen-supersaturated fluid into the hypoxemic or normoxemic blood from the patient, hyperoxemic blood is thereby produced. The hyperoxemic blood is then returned to a central vein, right heart or artery of the patient with the blood pump at approximately the same volume delivery rate as blood volume withdrawal rate.

Abstract: A hemofiltration system is provided in which ultrafiltrate is purified by reverse osmosis for reinfusion. Non-sterile infusate concentrate is dialyzed into the purified ultrafiltrate and combined with cleared blood which is returned to the patient. In another system, a hemofilter is used to sterilize essentially pure, non-sterile water for dilution of sterile infusate concentrate, then the hemofilter is used to filter blood, the infusate concentrate being combined with cleared blood for return to the patient.

Abstract: A lancet device, a tip for a lancet device and method of using the lancet device. The lancet device has a body portion for firing the lancet and a tip portion. The tip for a lancet device includes a front assembly which includes a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element, a slot is disposed in one of the sidewall portion and the lancet stop element, and at least one following element extending into the slot, wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element. The method includes adjusting a set depth of penetration of the needle by moving the at least one following element, disposing the distal end of the lancet device against a surface of skin, and triggering the firing mechanism to cause the needle to penetrate the surface of the skin to the set depth, wherein the puncture allows a blood sample to be taken.

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: 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: Disclosed herein is a low profile catheter valve comprising a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port.

Abstract: A therapeutic product formed from a high concentration of white blood cells having a high degree of cell viability. The white blood cells are sequestered from their normal population presence in whole blood by placing the blood into a container and preventing coagulation of the blood, separating the blood into two components, one of which is extremely rich in white blood cells through the use of a reagent and centrifugation, sequestering the white cell concentration, and freezing the white cells.

Abstract: A self-contained pack assembly includes all of the disposable components of an extracorporeal support circuit for cardiac bypass surgery. The pack assembly comprises a blood reservoir, a blood oxygenator, and a carrier for mounting the blood reservoir and blood oxygenator. One or more trays may be releasably attached to the carrier to serve as storage containers for coiled tubing used in the support circuit. Pre-made connections can also be formed between the tubing and the blood reservoir and blood and oxygenator as may be desired.

Abstract: Plastic compositions, medical containers and methods for providing such compositions and containers are disclosed. The plastic compositions and the medical containers made thereof include a plastic resin, Vitamin E and a plasticizer. The plastic resin may be polymeric material such as polyvinyl chloride or polyolefin.

Abstract: The present invention relates to an impermeable flexible multicompartment bag for medical use for sterile solutions, and to a method for the preparation of such bags. Impermeable flexible multicompartment bags for medical use for sterile solutions for perfusions, consisting of two welded sheets of a composite material wherein the sheets forming the inner wall of the bag consist of a polypropylene and are bonded to an outer layer of a thermoplastic polymer by means of a polyolefin layer, characterized in that the sheets facing the contents of the bags which are made of a homophase copolymer of propylene are immediately welded in the intercompartment region and in the peripheral region such that the weld forming the intercompartment region can be ruptured with a force in the range of from 10 to 30 N while the weld in the peripheral region cannot be ruptured.

Abstract: An atrial isolator comprising two tubular members, two lumens, drainage ports, and expandable occluders. The expandable occluders are adapted to engage an opening of the superior vena cava into the right atrium or the inferior vena cava and right tricuspid valve into the right atrium. The second tubular member is inserted into the lumen of the first tubular member to provide a displacement between the first expandable occluder and the second expandable occluder which is adjustable. A cardioplegia port is located between the two expandable occluders and in communication with a cardioplegic lumen. Methods of using such an atrial isolator are also disclosed, particularly to provide circulatory isolation of the heart and coronary blood vessels, and cardioplegia delivery.

Abstract: A method for selective perfusion of fluids through blood vessels is controlled by the pressure in the blood vessels. A tubing line open at the proximal end for the perfusion of fluids through a tissue region is introduced into a patient's blood vessel in which perfusion is to be performed. The vessel is sealed off from the line in the area of its proximal end, and fluid is pumped into the vessel. The method is characterized in that a specific set value for the internal pressure of the vessel is measured, and the perfused flow of fluid is regulated during pumping in such a way that the set value for the internal pressure of the vessel is kept as closely as possible.

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: A bendable shape-retaining cannula and methods of use. The bendable shape-retaining cannula comprises a tubular member having a proximal region, a distal region adapted to enter a blood vessel or heart chamber, a lumen therebetween, and a flexible region positioned proximal the distal region. A suture flange may be disposed about the cannula distal the flexible region. The flexible region can be bent and retains its bent configuration until a positive force is applied.

Abstract: An apparatus for delivering fluid materials into and out of the inner ear via the round window membrane. A fluid transfer conduit is provided which includes one or more passageways therethrough which may have a semipermeable membrane associated therewith to control fluid flow. Attached to the conduit is an inflatable bladder sized for insertion within the round window niche. When inflated, the bladder engages the internal side wall of the niche, thereby securing the bladder and part of the conduit within the niche. The conduit can then transfer fluids to and from the niche and the fluid-permeable round window membrane therein. Bladder inflation may be achieved through one of the passageways within the conduit which can deliver an inflation fluid into the bladder. Also, the conduit may include an elongate conductive diagnostic member for transferring electrical potentials to and from the inner ear.

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: A catheter having an elongate shaft including a proximal and a distal end. The shaft includes a conductor. An electrode is disposed at the distal end of the shaft and is connected to the conductor. The electrode has a generally annular, cross-sectional shape. The annular shape defines an opening within the electrode. An insulator surrounds the conductor. In accordance with the method of the present invention, a crater wound can be formed through the endocardium and into the myocardium of a patient's heart. Collateral damage to the myocardium can be made by infusing pressurized fluid into the crater wound.

Abstract: An obturator prevents the tips or flaps of a duck-bill valve from self-adhering during storage or during sterilization procedures. The obturator holds the tips apart until the end-user is ready to use the valve. The duck-bill valve is used as an air outlet valve in blood reservoirs.

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.