Abstract: A connector device is disclosed for establishing fluid communication between a diluent container having sidewalls and a drug vial. The connector has a piercing member having a first end and a second end and a central fluid pathway. The piercing member is mounted to the liquid container and has fluid accessing portions hermetically sealed from an outside environment. A vial receiving chamber is associated with the piercing member and is dimensioned to connect to the vial. The vial may be selectively attached to the device without piercing the closure of the vial and without breaching the hermetic seal of the fluid accessing portions of the piercing member. Means are provided for connecting the vial receiving chamber to the liquid container.

Abstract: Access recirculation in a shunt is determined quantitatively by a method in which a standard solution, such as a saline, is injected into a patient's bloodstream upstream of the shunt. At a point in the access line, a photometric measurement is conducted of the change in hematocrit (&Dgr;H) with respect to time. Electronic circuitry receives signals from the detector and compares the integrated area of &Dgr;H with respect to time of the standard solution initially flowing through the access and of the recirculated solution and provides display of access recirculation. In another aspect, access recirculation and access blood flow are quantitatively determined without injecting a solution into the bloodstream. In this aspect the extent of access recirculation and/or access blood flow is determined quantitatively by a method in which the dialyzer blood flow rate or the ultrafiltration rate (UFR) is changed and the corresponding change in concentration of a blood constituent is measured.

Abstract: A medical device assembly is adapted to isolate the heart from systemic circulation while perfusing oxygenated blood to the systemic arterial circulation during a minimally invasive bypasss procedure. An arterial catheter with an external shunt valve forms a funnel which shunts antegrade aortic blood flow from the aortic root, into a distal flow port and through an internal flow lumen in the catheter, out an intermediate flow port along the catheter proximally of the anchor, and into the systemic arterial circulation. A distal internal valve selectively occludes the shunted antegrade aortic blood flow between the distal flow port and the intermediate flow port and isolates the left heart chambers from the systemic arterial circulation. Oxygenated blood may then flow from a cardiopulmonary bypass pump, distally through the internal flow lumen, out the intermediate port.

Abstract: A first flow path is defined within a first panel that forms a part of an extracorporeal fluid circuit. A second flow path is defined within a second panel that also forms a part of the extracorporeal fluid circuit. The first and second panels are oriented in a fluid processing cartridge for mounting as an integrated unit on a fluid processing machine and for removal as an integrated unit from the fluid processing machine.

Abstract: An apparatus and system for extracorporeal treatment utilizes a hemodialysis machine capable of heating dialysis fluid to 48° C., an optional parallel plate hemodialyzer together with a sorbent-based detoxifier, a tubular heat exchanger and a high flow pump—in addition to various probes and catheters—to effect extracorporeal treatment without adverse physiological effect and without the specific need for general anesthesia. The system inheres in the combined high flow of the pump-up to 2400 ml per minute—and the high temperature—52° C.—achievable in the heat exchanger, which together provide unprecedented speed and efficiency in the administration of hyperthemia treatments. The system is also a potentiating system in the administration of heat sensitive pharmaceutically active agents and is praticularly useful in the isolated anatomic areas of a patient.

Abstract: A system and method are provided for determining the performance of a vessel, such as a hemodialysis access, which communicates blood between two locations of a patient. A conduit, such as an external dialysis circuit or an intravascular catheter, is provided in fluid communication with the vessel, and has a diversion point for diverting blood from the vessel into the conduit. The system further includes means for determining a flow rate of the diverted blood through the conduit. A first sensor in communication with the vessel generates at least one signal that is a function of a blood flow rate in the vessel downstream from the diversion point, wherein the downstream flow rate depends on the determined conduit flow rate and the performance of the vessel can be determined based on the signal. In addition, a processor can be provided in communication with the first sensor for determining a flow rate in the vessel upstream from the diversion point from the signal and the conduit flow rate.

Abstract: A device for producing a gas-supersaturated fluid is provided. The device includes a chamber having a first inlet to receive a gas and a second and a third inlets to receive a fluid; and an outlet for removal of the produced gas-supersaturated fluid. The gas is received from a gas supply that maintains pressure within the chamber at a predetermined level. An atomizer nozzle is coupled to the third inlet to create fine droplets of fluid within the chamber into which gas diffuses to create the gas-supersaturated fluid. The device also includes a first valve coupled to the outlet of the chamber and a second valve coupled to the second inlet, the third inlet and an actuator assembly to control delivery of the fluid from the piston assembly into the chamber. The fluid is delivered into the chamber through the second inlet when the second valve is open and the fluid is delivered through the third inlet when the second valve is closed.

Abstract: Apparatus for the transmission of at least first data from an electronic device (1; 1′), in particular an electromedical implant such as a cardiac pacemaker, to a monitoring arrangement (38), including at least a first interface device (6; 6′), with at least one input unit for the first data, a control device (5) connected to the first interface device (6; 6′) and a mobile radio device (7) connected to the control device at least for the transmission of the first data to the monitoring arrangement (38) by way of a telecommunication network which is at least in part in the form of a mobile radio network, wherein there is provided at least one second interface device (8) connected to the control device (5) for connecting the control device to a fixed-line telecommunication network.

Abstract: The present invention relates to a polyolefin-made holder for solutions containing vitamin D or derivatives thereof, in which the volume of polyolefin constituting a solution-holding portion of the holder is 30 cm3 or less per &mgr;mol of the vitamin D or derivatives thereof contained therein; and to a transfusion fluid container comprising the vitamin D solution holder. Use of the holder or container can minimize reduction in vitamin D content.

Abstract: The present invention relates to a plastic infusion set. Unlike the conventional ones, the infusion set of the present invention is manufactured by using a novel biodegradable polyester resin composition with superior physical properties which thus can be degraded in nature without causing an environmental contamination and can also be applied in broader fields of medical industry.

Abstract: Extracorporeal affinity adsorption treatments which are aimed at the substantial removal of two or more compounds that are etiological in the pathogenesis of diseases in man provide effective therapeutic intervention means for these diseases. The methods are particularly suitable for the treatment of atherosclerosis, cancer, degenerative and autoimmune diseases. Extracorporeal chelation and immunotherapy for atherosclerosis, extracorporeal chelation treatment with on-line regeneration or replacement of chelant, extracorporeal immunotherapy with antibody fragments, and extracorporeal immunoadsorption utilizing antibodies bound to Protein A are also disclosed.

Abstract: An apheresis system is disclosed which may include a separation chamber; a suspension flow path which communicates at one end with the separation chamber and includes a connector at the other end for connecting to a source of cellular suspension; an anticoagulant flow path which communicates at one end with the suspension flow path and includes a connector at the other end for connecting to an anticoagulant source; and a return flow path which communicates at one end with the separation chamber and communicates at the other end with a connector for connection directly to the suspension source or to the suspension flow path for returning one or more suspension components to the source. The anticoagulant flow path includes a flow restriction, such as an internal flow restriction, which limits the free flow of anticoagulants into the suspension flow path while preferably not completely stopping the flow of anticoagulant.

Abstract: A dual port vascular access assembly comprises a first access port and a second access port. The linkage is coupled between the first access port to close the second access port in the absence of an access tube in the first access port. Such port assemblies are particularly useful for implantation in patients receiving hemodialysis. By connecting the first access port to the blood withdrawal side of the system, blood withdrawal will be automatically terminated upon cessation of blood returned to due loss of the return access tube in the port assembly.

Abstract: Disclosed are novel syringes and catheters for delivering compositions which form solid masses in vivo. These syringes and catheters are particularly useful for delivering embolizing compositions intravascularly.

Abstract: An apparatus and method for blood oxygenation are provided. The apparatus includes a chamber having a first inlet to receive a gas-supersaturating fluid, e.g., physiologic saline; a second inlet to receive a gas, e.g., oxygen, from a gas supply; and an outlet coupled to a capillary assembly. An atomizer nozzle coupled to the first inlet creates within the chamber fine droplets of fluid into which the gas diffuses to create the gas-supersaturated fluid, which is removed via the outlet. The removed gas-supersaturated fluid mixes with blood within a liquid-to-liquid oxygenation assembly to form oxygenated blood for delivery to a patient. Alternately, the blood may be provided by the pump to a high pressure hollow fiber or other type membrane oxygenator within which oxygen diffuses across the membrane(s) and into the blood to form oxygenated blood, again for delivery to a patient or other site.

Abstract: A method of removing toxins from a patient's blood comprises implanting a filter device having a dialysis membrane with an exterior surface exposed to the patient's blood and a dialysate cavity exposed to an interior surface of the dialysate membrane within a blood vessel of a patient, continuously directing substantially uncontaminated or substantially decontaminated dialysate into the dialysate cavity and in diffusive communication with the patient's blood, dialysing the patient's blood with the dialysate, and continuously removing toxin contaminated dialysate from the filter device.

Abstract: A progressive filtration system for a chest drainage unit during continuous autrotransfusion comprising a gross filter for filtering incoming blood at the inlet portion of a collection chamber of a chest drainage unit and a conventional fine micron filter assembly located at the bottom portion of the collection chamber for refiltering collected blood prior to reinfusion of that blood back to the patient. The micron filter assembly includes a valve cap at the top portion of the assembly that functions as a plug to seal the top portion of the assembly and as a one way valve that permits reflux of later developing blood clots that might clog the tubing once the blood has already passed through the assembly. The valve cap is also adapted for sealing engagement with a drop tube that places the filter assembly in fluid flow communication with an outlet of the collection chamber located at the top portion of the chamber.

Abstract: A method for gas-supersaturating fluids, e.g., physiologic saline, includes providing a chamber having a first inlet to receive the fluid; a second inlet to receive a gas, e.g., oxygen, from a gas supply that maintains pressure within the chamber at a predetermined level, advantageously about 600 psi; and an outlet advantageously coupled to a capillary assembly. An atomizer nozzle coupled to the first inlet advantageously creates within the chamber fine droplets of fluid into which gas diffuses to create the gas-supersaturated fluid, which collects within the chamber below the atomizer nozzle for removal via the outlet.

Abstract: A layered fluid circuit includes first and second panel sections formed from sealed sheets of flexible material. A pattern of seals is formed in the first panel section to define a first fluid circuit. A pattern of seals is formed in the second panel section to define a second fluid circuit. The flexible sheets are aligned to place the first and second panel sections in a relationship with the first fluid circuit overlaying the second fluid circuit. The layered fluid circuit can be placed in a tray for use. Defined operating regions can be formed in one or both fluid circuits, such as an in-line clamping regions, in-line pump tubes, or in-line sensor regions, or in-line fluid holding compartments, or combinations thereof.

Abstract: Accurate measurement of hematocrit during blood recovery or plasma sequestration processes by means of algorithms to account for the presence of air or other non-blood substances in salvaged or separated blood is described. A method of automatic start-up of the hematocrit measurement circuit and a method of determining the minimum volume of blood required to obtain an accurate measurement of the hematocrit also is described.