Abstract: Stable microbicides comprising hydrogen peroxide, peracetic acid, acetic acid and purified water substantially free of contaminants, sequestrants or stabilizers and having anticorrosive properties for metals used in surgical and dental instruments is disclosed.

Abstract: A low prime, high heat exchange efficiency oxygenator is provided which includes an oxygenation portion and a heat exchanger portion. Disposed within the heat exchanger portion is a hollow tube heat exchanger wound bundle which includes a plurality of hollow tubes knitted into a mat, the mat wound under tension into a bundle which includes from 16 to 24 layers of the mat. The oxygenator provided permits prime volumes of 180 to 240 mLs.

Abstract: Concentrations of stock hydrogen peroxide-peracetic acid solutions can be monitored resistively. The resistivity cell electrodes have titanium surfaces which resist corrosion better than other electrode materials including platinum electrodes. Such resistivity monitoring is particularly useful to verify the concentrations of sterilant stock solutions used in machinery for cleaning and sterilizing medical and dental equipment such as dialyzer reuse machines. Over the temperature range of interest the resistivity measurement is substantially not affected by changes of temperature in the room temperature range.

Abstract: A stable, shippable microbicide solution, having improved anticorrosive properties comprising a two part system, the first part consists of a mixture of acetic acid, hydrogen peroxide, peracetic acid, and water. This is referred to for brevity as a peroxide/peracid solution. The second consists of water having dissolved therein a wetting agent which is preferably Victawet.RTM. 35B which is the sodium hydroxide reaction product of an aliphatic alcohol and phosphorous pentoxide. Three other Victawet.RTM. agents have proven operative. Alternatively, Fluorad.TM. FC95, which is a agent of potassium perfluoroalkyl sulfonates may be used. The microbicide may also be a premixed one component system containing the anticorrosive agents of the invention.

Abstract: A system for reprocessing and sterilizing a previously used catheter having at least one lumen is disclosed. The catheter is provided with a housing and enclosed within the housing. Heated sterilant is provided to the housing and the catheter. The lumen is tested during the reprocessing and sterilizing cycle for blockages and integrity. If the catheter is of a type having a balloon tip, the balloon is also tested for integrity by inflating and deflating it a plurality of times. The housing is pressurized to a level above the ambient pressure and maintained at such pressure whereby the sterility of the catheter is maintained for up to one week. Further disclosed is an apparatus for selectively coupling used catheters to a source of sterilant. The apparatus includes a housing having a tray for holding the catheter in place during reprocessing, a door for enclosing and locking the catheter within the housing, and a plurality of valves for coupling the housing to a source of sterilant.

Abstract: An oxidizing sterilant solution comprising percarboxylic acid is disclosed which contains a colorant that is color stable for a useful period in the oxidizing, sanitizing environment.

Abstract: A compact, cylindrical integrated blood heater/oxygenator in which the blood flows transversely to the axial direction of hollow heat exchange and oxygenation fibers. Blood enters a longitudinally extending central chamber of the blood heater/oxygenator, and moves radially through annular hollow heat exchange and oxygenation fiber bundles in a direction generally perpendicular to the axis of the device and generally transverse to the axial direction of the fibers. The blood proceeds toward the outer wall of the oxygenator where the temperature is adjusted and oxygenated blood is collected and passed out of the oxygenator through an exit port.

Abstract: A device (10) having a blood oxygenator (12) and heat exchanger (14) of the outside perfusion type. The blood oxygenator (12) employs a tightly packed, crisscrossing bundle of gas permeable hollow fibers (50). The heat exchanger (14) employs a bundle of polyurethane, liquid impermeable hollow tubes (96). A center divider (16) facilitates two separate compartments (30, 40) and allows control over pack densities within each compartment while allowing blood to move in a planar manner throught out the device (10).

Abstract: A device having a blood oxygenator and heat exchanger of the outside perfusion type. The blood oxygenator employs a tightly packed, crisscrossing bundle of gas permeable hollow fibers. The heat exchanger employs a bundle of polyurethane, liquid impermeable hollow tubes. A center divider facilitates two separate compartments and allows control over pack densities within each compartment while allowing blood to move in a planar manner throughout the device.

Abstract: A filter cartridge using hollow fiber tubes is provided in a housing and configuration constructed and arranged to fit most commercial filter housing systems without modification. The hollow fiber cartridge provide a multiple improvement in filtering capacity and life before requiring replacement over prior units.

Abstract: A method for non-destructive testing for approximation of oxygen transmission in hollow fiber blood oxygenators or the like is provided which method includes passing a first fluid at a predetermined temperature and volume flow rate through the hollows of the fibers and a second fluid at a second predetermined input temperature and volume flow rate across the outside of the fibers and measuring the heat rise or fall of the fluids and comparing the results with standards for a given blood oxygenator device.

Abstract: An implant device for introduction of insulin into the peritoneal cavity which permits a flexible catheter to be removed and replaced without invasive surgery. The catheter is passed through a substantially rigid percutaneous body and a distally extending catheter conduit which together form a continuous conduit from the body exterior through the peritoneal wall. A polytetrafluoroethylene polymer sleeve allows tissue ingrowth to secure the body to the epidermis. A polyethylene terephthalate portion of the sleeve provides tissue ingrowth to stabilize the implant and prevent extrusion from the dermis. The catheter is associated with the percutaneous tubular body so as to be removable and replaceable through the conduit thereformed after implantation. The catheter preferably terminates within the interior cavity of the percutaneous body and is sealed from the environment by means of a septum closure within the device cavity.

Abstract: Improvements and accessories for a septum closed T-shaped blood access device adapted for implantation into a patient. The implantable device has a stem portion extending above the skin of the patient and defining a septum closed opening into the device. The improvements include an improved septum having a groove in the side thereof encircling the septum and an elastomeric ring carried within the side groove, an improved needle assembly which provides access to the circulatory system through the septum, and a flexible cap for sealing the stem of the implantable device from the outside atmosphere which may be fitted in place or removed without the necessity of specialized tools.

Abstract: A system and process for preparation of dialysis solution from dry chemicals and water on a large scale batch basis. The required amount of water is metered into a dialysis solution tank. Water from the tank is pumped into a spray head which is positioned above a shipping drum containing predetermined amounts of chemicals. Water rains down on the chemicals dissolving and/or entraining the same and the resulting slurry is returned to the dialysate tank as a slurry by means of a pickup wand and suction source. The liquid and chemicals in the dialysis solution tank are continually cycled until all the chemicals in the drum have been removed. Typically, an additional drum containing other kinds of chemicals is then added to the dialysis solution tank in the same manner. Circulation of the solution is continued within the tank until a fully uniform solution results.

Abstract: A machine for reprocessing catheters of the type having a double lumen, one of which leads to a balloon. A used catheter is sealed within a cassette which in turn is connected by multiple ports to a cleaning side of the machine. Cleaning solution is flushed through the inside and outside of the catheter. The balloon integrity is tested by adding step wise volume additions and monitoring the pressure. The data generated is compared to a standard curve for new catheters. The cleaned, sterile catheter is then rinsed to remove all traces of sterilant. Sterile saline is alternatively flushed through the cassette and catheter. The balloon is again tested for leaks. No portion of the rinse side of the machine requires sterilizing except for the disposable tubing set and saline source. The rinsed, clean and sterile catheter is removed from the cassette for reuse.

Abstract: A system and process for preparation of dialysis concentrate solution from dry chemicals and water. The source of hemodialysis chemicals for a batch is a drum selectively filled with dry chemicals such that an inner core region therewithin is loaded with chemicals which slurry and dissolve the least readily. The required amount of water is metered into a mix tank. Water is pumped from the tank into a spray head fitted over the selectively filled drum. Water is injected onto the chemicals within the inner core region by the use of a nozzle having a narrow spray angle. The chemicals within the inner core region are preferentially dissolved or slurried before the other chemicals within the drum. The slurried and dissolved chemicals are removed from the drum by a suction wand and are entirely solubilized in the tank. Cycling of fluid continues from the drum to the tank and vice versa until all of the chemicals in the drum have been removed. Circulation of the fluid is continued until a uniform solution results.

Abstract: A dialyzer reuse machine comprising means for passing a series of liquid and gaseous fluids through the dialysate and blood compartments of the dialyzer at different flow rates according to a predetermined sequence for cleaning and disinfecting the dialyzer and means for accurately measuring the volume of the blood compartment upon completion of the dialyzer cleaning steps. Capacitive probe and load cell embodiments of the volume measuring means are disclosed. A specially designed jet pump permits a pressure leak test and dilution of stock chemicals to be performed using only tap water pressure as a source of motive force.

Abstract: A T-shaped blood access device which is adapted for implantation into a patient and which has its stem portion extending outwardly above the skin of the patient. An elastomeric septum is positioned in sealing relationship in the stem adjacent the junction with the main conduit portion. The septum is compressed between a support extension within the device stem and a pressure plate above the septum. The septum is provided with pre-formed openings therethrough to provide a resealable pathway for a needle pair. The septum may have a concave edge to facilitate sealing along the interior device edges and to accommodate laterally displaced septum material during needle insertion. A needle assembly which includes a pair of round ended needles with side openings is preferably used with the T-shaped device.

Abstract: An implantable device for providing communication between interior structures of the body and the exterior of the body, the device comprising a rigid member of biologically compatible material, including a smooth tube portion extending through the skin and a flangeless subcutaneous portion, the subcutaneous portion containing on the exterior surfaces thereof a porous tissue ingrowth media such as a collar of Dacron velour or a coating of porous titanium.

Abstract: An implant device for peritoneal dialysis which permits a flexible catheter to be removed and replaced without invasive surgery. The catheter is passed through a substantially rigid tubular percutaneous device and a flexible sleeve member which together form a continuous conduit from the body exterior through the peritoneal wall. The catheter is associated with a percutaneous tubular device so as to be removable and replaceable through the sleeve member after implantation. The catheter preferably has a relatively weak memory which gives it a tendency to maintain a compact coiled configuration near the peritoneal wall. The catheter may extend through the percutaneous device or, more preferably, terminates within the interior cavity of the percutaneous device and is sealed from the environment by means of a septum closure within the device cavity.