Abstract: The invention provides a thermoplastic polyurethane elastomer which contains a blend of polyurethane resins and is suitable for use in the form of tubing. The blend has a tensile strength of more than 7000 psi and an ultimate elongation greater than 200%. The blend contains about 50% to about 80% by weight of an elastomeric polyurethane resin having a hardness in the range of about 60 to 70 Shore D units. The blend additionally contains about 20% to about 50% of a relatively rigid polyurethane resin having a hardness of about 10 units more than the elastomeric resin. The invention also provides methods for using and methods for manufacturing tubing fabricated from the thermoplastic polyurethane elastomer. Preferred extrusion conditions are described.

Abstract: A securing collar is used in combination with two tubular flow connectors to prevent the inadvertent disconnection of I.V. tubing sets. The securing collar includes a housing supported by one of the connectors, a radial flange extending from the housing, a tubular collar having a outwardly splayed end, at least two notches that separates the splayed collar into at least two elongated segments, a transition portion on the exterior of the collar, and a sliding annular locking ring. The locking ring slides on the collar from the proximal end over the transition portion to the distal segments so that the annular locking ring forces the splayed and segmented distal portions radially inward to grip the second connector.

Abstract: A solution pumping system is disclosed which is embodied as a disposable pump cassette including a self-contained positive displacement pump, and an associated pump driver including a reciprocable pump piston for driving the pump of the cassette. This system is particularly suited for use in compounding in preparation of parenteral solutions for administration to patients. In order to promote high liquid output with minimum peak pumping pressures, the controls of the system operate to provide a "square" pumping pressure waveform, thus optimizing performance of the system. This is achieved by selectively varying the velocity of the pump piston during its operation.

Abstract: A self-threading securing apparatus is used in combination with two tubular flow connectors to prevent the inadvertent disconnection of I.V. tubing sets. The securing apparatus includes a hollow shroud surrounding an extending cannula. The inner surface of the shroud includes interior threads for self-threading engagement with the resilient rolled-over exterior surface portion of the reseal connector.

Abstract: This invention pertains to a reseal member made of a resilient material used for sealing a fluid access port. The reseal member is inserted into the fluid access port and prevents fluids from passing therethrough. The reseal member is provided with a slit or recess, or both, that allows a user to exert-minimal force to insert a blunt cannula into the reseal member to create a passage to pass fluids through the reseal member. Upon withdrawal of the blunt cannula, the reseal forms a generally fluid-tight seal so that fluids cannot pass through the reseal.

Abstract: A reseal member having a preferentially weakened central portion, and a method of its manufacture through the application of ultrasonic energy. The reseal is for use with an associated blunt cannula. The reseal comprises a central region and a peripheral region. The central region has a predetermined thickness and includes, in the direction of thickness, a weakened portion extending at least partially therethrough. The upper and lower surface portions of the reseal are continuous and unbroken. A method of forming the weakened central portion includes the steps of positioning the reseal member in an ultrasonic energy generating device, placing the member in compression, and imparting a predetermined amount of ultrasonic energy, in the form of vibrational energy, into the reseal member. The present reseal member can be used for solution vials and containers, tubing set Y-sites, and similar applications.

Abstract: An irrigation solution re-circulating system comprises a reservoir of irrigation solution, a solution supply line for joining the reservoir in fluid communication with a surgery site for delivering a controlled volume, pressure, and temperature of the irrigation solution to the surgery site, and a return line for further joining the surgery site in fluid communication with the reservoir. A pump, which is preferably non-hemolyzing, is connected to the return line for returning a controlled volume of the irrigation solution from the surgery site to the reservoir. The system further comprises at least one filter connected to the return line for removing contaminants from the irrigation solution prior to return to the reservoir to permit re-circulation of the solution without impairing endoscopic visualization of the surgery site, while providing solution for expanding the surgery site to permit performance of the attendant surgical procedure.

Abstract: A multiple configuration adapter assembly is provided for a prefilled emergency syringe and includes a cylindrical sheath, a removable sharp needle assembly and a luer extension assembly.

Abstract: A flexible container for medical solutions is provided that includes first and second film sheets sealed together along multiple sides so as to form a pouch having an open end. An end port member is located between and sealed to the first and second film sheets near the open end of the pouch to enclose the interior of the container. The end port member has at least one integrally-formed access port for fluid communication between the exterior and the interior of the flexible container. A portion of the first and second film sheets extend beyond the end port member and are sealed together along the edges of the extended portions so as to form a protective cover for the access ports. The protective cover is detachable.

Abstract: A reverse osmosis device for purifying water from a source comprising a housing having an inlet for passage of water from the source, a first outlet for passage of purified water from the housing and a second outlet for passage of waste water remaining after purification. A first reverse osmosis multilayer assembly is disposed within the housing in fluid communication with the inlet for purification of at least a first portion of the water from the source. Water treatment chemicals can be positioned in a core about which the first reserve osmosis multilayer assembly is wound. The treatment chemicals are in fluid communication with the first reverse osmosis multilayer assembly to receive the first purified portion of water and for removal of at least chemical contaminants therefrom. A second reverse osmosis multilayer assembly is also wound on the core and is in fluid communication with the water treatment chemicals to receive the chemically purified water for purification of at least a second portion thereof.

Abstract: In an apparatus for testing pneumatic flow resistance of a test component, such as an air filter useful in a system for admixing parenteral solutions, a pneumatic bridge has two branches connected, via a filter, a flow restrictor, and a flowmeter, to a source of gas under regulated pressure. Each branch comprises two arms with a centerpoint. The bridge has a pressure transducer connected between the centerpoints and arranged to detect pressure imbalances in the bridge. Each arm comprises a flow restrictor, namely a needle valve, which is calibrated via a vernier head. The valves are adjustable to balance the bridge. In one arm, in which the needle valve can be fully opened, the test component is connectible to constitute a flow restrictor. The transducer produces an output displayed via a digital voltmeter, which may be calibrated.

Abstract: An improved head is provided for an apparatus which places a stopper in the opening of a filled container. The head has a sleeve which includes an inflatable bladder for receiving the end of the filled container and for temporarily sealing the periphery of the container around the opening. A housing is disposed over the sleeve. The housing has a top surface and defines an access passage which communicates between the top surface and the inside of the sleeve. The stopper is subsequently inserted into the container through the access passage. The housing defines a chamber around the access passage, and the chamber communicates with the access passage. A conduit projects from the housing top surface in communication with the chamber, and vacuum can be drawn through the conduit.

Abstract: A method of testing a pumping system including a pump cassette effects pressurization of the system, with subsequent monitoring of any pressure loss in the system. This is achieved by closing any inlets and outlets of the cassette, and thereafter over-pressurizing the cassette beyond its normal operating range. Pressure measurements are taken before and after a specified time interval, with any significant pressure loss indicating system leakage. In the preferred practice, the diaphragm of the pump cassette is first subjected to cold flow, or "creep", thereby minimizing the influence of cold flow of the diaphragm on subsequent pressure measurement.

Abstract: The present invention relates to a sterile form, filled and sealed flexible solution container and an attached port assembly that allows for the sterile dispensing of the solution.

Abstract: Packaging of highly toxic materials entails incorporating safety improvement so as not to endanger patients and health care workers. Such safety improvements include the use of suitable sealing members between the glass vials and the protective covering therefor and various means to ensure that vials of highly toxic materials can not be inadvertently interconnected to single treatment I.V. bags, for instance, by making the connecting means on the vials and the single treatment diluent bags incompatible with one another.

Abstract: A stopper assembly for sealing the open end of a container and usable with a blunt entry device includes an elastomeric stopper having an annular flange portion, a hollow plug portion, and a thin diaphragm portion, the flange portion covering and abutting the open end of the container, the plug portion depending from the inner circumference of the flange portion and sealingly engaging the interior of the open end of the container, and the diaphragm portion spanning the center portion of the annular flange portion. A metal ferrule for securing the stopper to the container has an annular top portion and an annular skirt portion for engagement with the exterior of the container.

Abstract: A luer adapter assembly for a prefilled emergency syringe includes a cylindrical sheath which extends coaxially with the syringe needle. The sheath can be integrally molded with the injector housing or is attached to the syringe injector housing by spin welding or sonic welding. The sheath is joined to the housing so that an annular clearance space for the removable luer adapter assembly is maintained between the tapered hub and the sheath. A removable cap on a threaded lock on the adapter extension is removed by twisting the cap in a first direction. The whole adapter assembly is removed from the tapered hub by twisting the cap in a second direction which is the same direction as the threads of the threaded lock.

Abstract: The present invention relates to a compression load cell used to monitor pressure in a diapragm cassette pumping system. A plunger is axially slidable in a linear bearing and has a first end in contact with the cassette and the second end in contact with the load cell. The force signals have a direct relationship with the pressure in the cassette.

Abstract: The present invention relates to a fluid transfer tubing set assembly including a disposable pumping component, tubing component, a tray component for organizing the tubing, a handle component for the pumping component and a packing box which facilitates easy and proper assembly.

Abstract: Medical drug formulation and delivery system includes a reverse osmosis device for purifying water from a source comprising a housing having an inlet for passage of water from the source, a first outlet for passage of purified water from the housing and a second outlet for passage of waste water remaining after purification. A first reverse osmosis multilayer assembly is disposed within the housing in fluid communication with the inlet for purification of at least a first portion of the water from the source. Water treatment chemicals can be positioned in a core about which the first reserve osmosis multilayer assembly is wound. The treatment chemicals are in fluid communication with the first reverse osmosis multilayer assembly to receive the first purified portion of water and for removal of at least chemical contaminants therefrom.