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 hollow fiber type blood oxygenator having an integrated and improved heat exchanger having a generally conical housing and core member between which a helically wrapped conduit is situated. The conduit has a plurality of parallel flutes. A housing and core member are formed with helical recessed regions which conform to the conical helix defined by the tubing or conduit. The tubing is formed with flattened opposing surfaces which mate with the corresponding recesses in the housing and core member. The mating on the flats on the tube or conduit to the corresponding flats in the recessed regions of the housing and core member allows a substantially tighter and more uniform fit which minimizes the dynamic blood priming volume.

Abstract: A system for use in peritoneal dialysis consisting of a rigid tubular implantable device, a stabilizing tool and an access set. The implantable device includes a centrally positioned, outwardly projecting cannula spike whose side openings are normally closed by a resilient sleeve member. A stabilizing tool having a broad load distributing base is locked to an upper flange of the implanted device. An access set connected to a dialysis solution system includes a septum which is penetrable by the cannula spike. Penetration simultaneously depresses the resilient cannula sleeve exposing the side openings which allows fluid flow. The access set, stabilizing tool and implant device are locked together whenever fluid is able to flow between the peritoneal cavity and the dialysis solution system.

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: 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: 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 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.

Abstract: An implantable device for providing communication between interior structures of the body and the exterior of the body, the device comprising a rigid tubular member of biologically compatible material including a transcutaneous stem portion defining a stem cavity therein and a plurality of subcutaneous arm portions in fluid communication with the stem portion. A septum closure in the stem cavity provides an interruptable seal between the stem cavity and each of the arms, permitting the arms to be separately accessed by a cannulae or needle.

Abstract: An implantable blood access device has a matte titanium finish on the exterior subcutaneous surfaces thereof providing sites for tissue ingrowth. A preferred finish is a coating of porous titanium which may be manufactured by fusing titanium powder to the device.

Abstract: Septum retaining means for an implantable tubular percutaneous device. The retaining means is a tubular stem insert having an integral pressure plate across an intermediate portion thereof. A modified septum fits into the insert below the pressure plate. Tabs extending outwardly from the upper edge of the insert cooperate with a grooved portion of a body exterior cavity in the T-stem to provide means for holding the insert in the T-stem cavity. Notches in the walls of the insert on either side of the tabs allow the wall portions containing the tabs to be flexed inwardly so as to permit the insert to be passed into and out of the T-stem. The insert is designed to permit a forceps or other crimping tool to obtain access to the tab containing insert wall portions for removal of the insert and septum.

Abstract: A proportioning system for preparing hemodialysis or hemofiltration solutions. The apparatus of the system is a specially plumbed tank containing a flexible plastic container which holds solution concentrate. Introduction of pressurized water into the tank outside the bag discharges concentrate and water through separate paths into a mixing chamber at a rate determined by the size ratio of narrow orifices in the respective paths.

Abstract: A blood pump system in which a roller pump is provided for pumping blood through a flexible tube. A low voltage D.C. motor is provided having an output shaft. An electrical control circuit is connected to the motor for applying the necessary voltage to drive the motor at a predetermined speed. Gearing means are provided connecting the motor's output shaft to drive the roller pump. Means are optically coupled to the motor for controlling the speed of the motor. Means are connected to the optically coupled means to determine the blood flow rate being pumped though the tube by the pump. Means are provided which display a digital readout of the flow rate. The roller pump is provided with an arcuate bearing surface, which carries the flexible tube, the bearing surface defining an arc of approximately 168.degree.. Lead ramps extend from each end of the bearing surface and are substantially tangent to the end of the surface from which the respective ramp extends.

Abstract: A blood pump system in which a roller pump is provided for pumping blood through a flexible tube. A low voltage D.C. motor is provided having an output shaft. An electrical control circuit is connected to the motor for applying the necessary voltage to drive the motor at a predetermined speed. Gearing means are provided connecting the motor's output shaft to drive the roller pump. Means are optically coupled to the motor for controlling the speed of the motor. Means are connected to the optically coupled means to determine the blood flow rate being pumped through the tube by the pump. Means are provided which display a digital readout of the flow rate. The roller pump is provided with an arcuate bearing surface, which carries the flexible tube, the bearing surface defining an arc of approximately 168.degree.. Lead ramps extend from each end of the bearing surface and are substantially tangent to the end of the surface from which the respective ramp extends.

Abstract: A universal dialyzer end cap which provides a connection between a kidney dialyzer and a blood tubing line. The end cap is constructed of a material which allows a firm connection to the dialyzer while at the same time is of a configuration which does not allow blood to contact the surface of the end cap when properly attached to a kidney dialyzer.

Abstract: This invention relates to an ultrasonic flow meter utilizing a conventional tubular member with an inlet and outlet. An ultrasonic transducer is located in the member to transmit and receive ultrasonic energy through liquid flowing through the member. An energizing means is connected to the transducer so that ultrasonic energy can be transmitted through the liquid in the member. Reflector means variably positionable within the member are provided for establishing a position for the reflector means which is proportional to liquid flow rate through the member and for reflecting ultrasonic energy from the transducer back to the transducer. Control means are provided for producing at least a single pulse of ultrasonic energy from the transducer to be transmitted through the liquid and for detecting an echo pulse reflected from the reflector means.

Abstract: A system for preparation of variable hemodialysate in which a controllable pump meters multiple fluid sources of dialysate concentrates and water in controlled proportion. The system includes a plurality of cylinder and piston pump assemblies linked together for simultaneous operation. Individual valves connect the separate pump assemblies to the individual fluid sources to be proportioned. A position sensor provides signals indicative of the position of the pistons throughout their stroke cycle, and with a control operates the control valves associated with the individual pump assemblies in accord with functions of piston position and preselected proportioning control inputs, so as to control the volume of fluid metered by each of the pumps during the pump stroke.

Abstract: A flow-through or fluid coupling connector assembly possessing positive locking connect and ready disconnect comprising two connector bodies; one having a male tubular member, and the other having a female tubular member for receiving the male member upon connection of the two bodies together. The male tubular member of the one connector body has resilient arm members spaced from and extending along opposite sides of the tubular member's axis with the free remote ends of the arms flaring outwardly therefrom. The arm members are each provided with an inwardly projecting flange member for locking the two connector bodies together by fitting into a recessed collar on the other connector body.

Abstract: An enclosed push button switch in which movable and fixed contact members are mounted on the switch frame, the assembly being enclosed by a protective covering which is deformable on the upper surface thereof and in contact with the movable contact member of the switch to permit operation of the same through the cover.

Abstract: An ultrasonic air and blood foam detector for use in medical procedures involving extracorporeal handling of blood. A sensor assembly is adapted for positioning about a blood drip chamber and contains ultrasonic transducer means. The blood tube downstream from the drip chamber is preferably placed through the controllable clamp. Electronic circuitry provides excitation to the ultrasonic transducer means and signals transmitted through the chamber are received, amplified and processed by a level detector which provides an output signal for actuating the clamp when a predetermined low signal level occurs, indicating excessive air or foam in the drip chamber. In the preferred embodiment, a clip-on sensor assembly having epoxy lenses is provided.

Abstract: An improved portable conductivity meter for automatically and rapidly drawing an electrolyte sample and for measuring and providing an accurate output indication of its electrical conductivity, which is independent of temperature variations of the electrolyte. A pen-like dip probe, housing an electrode pair and a thermistor in unique configuration, is designed to rapidly draw an electrolytic dialysate sample whenever the probe is immersed within the electrolyte. A high frequency AC source drives a balanced active measurement circuit, having a reference leg and a measurement leg which contains the electrode pair and the temperature compensating thermistor. The balanced circuit provides measurement and reference output signals of opposite polarity to a summing amplifier which drives a visual conductivity indicator.