Abstract: A dual-filled twin bag, a packaging including the twin bag, and a method for forming the packaged twin bags are provided. Each of two bags, a solution bag (10) and a drain bag (12) for a system used for a peritoneal dialysis procedure, are filled, at least partially, with a solution (14). A tubing set (16) connects the two filled bags (10, 12) and may also be filled with solution (14) which is added to the bags (10, 12) and the tubing set (16) during the manufacturing process. The tubing set (16) is sandwiched between the solution bag (10) and the drain bag (12) and subsequently packaged in an overpouch (24). The method for forming the package including the bags filled with solution is simplified and the overall package size is reduced due to the sandwiched tubing set (16) between the solution bags (10, 12) and the provision of solution in both bags (10, 12).

Abstract: A system and method is provided which substantially eliminates the effect of air entrapped in tubing for delivering a liquid from a container. The inner diameter of the tubing is selected such that the gravitational force of the liquid from the container is greater than the surface tension of the liquid. A release agent may be used as a coating layer on the interior wall in addition to or alternatively from an expanded diameter.

Abstract: An apparatus (31) and a method are disclosed for performing an operation upon multiple webs (51,53), including the feeding of multiple webs (51,53), the provision of a carrier (65) for assisting in moving the webs (51,53) along a predetermined path (83), the performance of an operation (69) upon the webs, the insertion of a carrier (65) between the webs (51,53), and the provision of a sealing device (71) for sealing the webs together to form a sealed portion (75) to cooperate with the carrier (65) for assisting in moving the webs (51,53). The carriers (65) are mounted on a conveyor (83) and each carrier (65) pushes against the sealed portion (75) to pull the webs (51,53), and the packages (41) formed therefrom in the direction of conveyor travel. The preferred carrier (65) has a shaped head on the end of a flat plastic blade.

Abstract: A system and a method are provided to effect solution exchange particularly for a patient requiring peritoneal dialysis. The system includes a device (1) that is portable and particularly adaptable for patients requiring a night time exchange or an additional exchange. The device (1) includes an operator-touch control panel (10) operatively connected to a pouch (26) with an incorporated heater (12). The pouch (26) holds a solution bag (18) and may be selectively opened and closed by a cover (28). A drain tray (30) holds a drain bag (20) and has a scale (14) incorporated therein. The pouch (26) is connected to the control panel (10) by an upper arm (38), and the drain tray (30) is connected to the control panel (10) by a lower arm (42). The device (1) may be collapsed by releasing the upper arm (38) and the lower arm (42) such that the system (1) lays in a substantially flat arrangement when not in use.

Abstract: The present invention provides a dialysis solution that contains amino acids for treating and/or preventing malnutrition in a peritoneal dialysis patient. The amino acid composition is optimized to minimize metabolic acidosis while normalizing amino acid plasma profiles.

Abstract: A flexible fluid junction that links three or more fluid ducts is provided. The junction includes a pair of flexible webs with at least three tubes or fluid ducts disposed between the flexible webs. The outer periphery of the webs is sealed together and around the tubes to define a chamber. An end of each tube terminates inside the chamber so that fluid may flow from each tube through the chamber. Still further, a method of manufacturing a flexible fluid junction and a method of using a flexible fluid junction are also provided.

Abstract: A connector assembly and disinfectant system is provided for any system requiring a connection, such as during a peritoneal dialysis procedure. The connector assembly includes a transfer set connector and a disposable connector. The transfer set connector and disposable connector each include a member that join to create a fluid path. The disposable connector contains a housing that includes a ring partially saturated with disinfectant for bathing the transfer set member near the opening of the fluid path when a connection is made. The ring forms an opening through which the transfer set member passes. At disconnection, the transfer set member passes through a section of the ring having wiping properties to wipe the member dry.

Abstract: An improved system and method for providing sterile connections. To this end, a device is provided comprising a body, a chamber defined, at least in part, by a portion of the body, the chamber including an interior having a solid sterilizing agent that can sublimate at ambient conditions, and a member that defines., in part, the chamber and is so constructed and arranged to allow the solid sterilizing agent to release in a rate controlled manner through the member.

Abstract: A system and a method are provided for packaging components required for conducting a dialysis procedure. To this end, a rigid container is designed such that other necessary components required for conducting a dialysis procedure may be contained therein prior to use. The rigid container is designed with a lid having a port in the lid such that a drainage line may be connected to the port and the rigid container may be used as a drainage container. The rigid container is constructed from a rigid material such that rigid containers may be stacked during transport and storage of the same. The rigid container may also be re-used for subsequent dialysis procedures.

Abstract: The present invention provides a dialysis solution that contains amino acids for treating and/or preventing malnutrition in a peritoneal dialysis patient. The amino acid composition is optimized to minimize metabolic acidosis while normalizing amino acid plasma profiles.

Abstract: An apparatus (31) and a method are disclosed for temporarily separating multiple webs (51,53) while performing an operation (123,125,133) thereon, including the feeding of multiple webs (51,53), the provision of a retractable web separator (68) for temporarily separating the webs, the performance of an operation (123,125,133)) upon the webs, the provision of a gripping device (65) for gripping the webs and assisting in moving the webs (51,53) along a predetermined path (83), and the provision of a sealing device (71) for sealing the webs together to form a package seal (73). The retractable separators (68) are mounted on a conveyor (83) and each separator (68) in turn temporarily separates the webs (51,53), for insertion of a port (45), fitting or the like, whereupon the separator (68) may be retracted and the port (45) may be sealed into the packages (41) being manufactured. The preferred separator (68) has a shaped head (170) on the end of a reciprocating shaft (158).

Abstract: The present invention provides a dialysis solution that contains amino acids for treating and/or preventing malnutrition in a peritoneal dialysis patient. The amino acid composition is optimized to minimize metabolic acidosis while normalizing amino acid plasma profiles.

Abstract: There is disclosed a method and apparatus for automatically conducting peritoneal equilibration testing. The method involves removing a sample of overnight dwell fluid from a patient in an amount sufficient to determine the concentration of a metabolite in the drain fluid. The concentration of the metabolite in the sample is then detected and the overnight dwell fluid is drained and weighed. A known weight of dialysate fluid is instilled into a patient and thereafter there are periodically withdrawn samples of the dialysate fluid and the concentration of metabolite in each sample is determined. The ratio of metabolite concentration of each of the periodically drawn samples to metabolite concentration for the overnight dwell fluid is determined. The patient is then drained after a predetermined dwell time and the volume of drained dialysate is determined. The mass transfer area coefficient of the patient's peritoneal membrane is then obtained as a function of the measured variables.

Abstract: Disclosed are methods that achieve i) site-directed delivery, ii) in situ amplification, and iii) sustained expression of an exogenous gene product within renal glomeruli. An exogenous gene, E. coli .beta.-galactosidase, was introduced into cultured rat mesangial cells using a replication-defective retrovirus, and stable infectants were administered to a rat kidney via the renal artery. In the injected kidney, the engineered, cultured mesangial cells populated 40% of glomeruli site-specifically. The gene product was detected throughout a 14-week period of observation. In an alternative method, engineered, cultured mesangial cells were injected into a kidney subjected to an antibody that induces mesangiolysis followed by mesangial regeneration. Under these conditions, expression of .beta.-galactosidase was dramatically amplified in situ, and high level expression continued for at least 8 weeks.

Abstract: A tubing has members located on the inside surface of a tubing. The flow through the tubing is completely occluded when the tubing is clamped due to the members filling channels around the clamped site. Reduced clamping pressure is required to fully occlude the flow through the tubing. The tubing undergoes less deformation upon clamping and returns to its pre-clamped form upon recovery.

Abstract: An improved on-line real time hemodialysis monitoring system for hemodialysis treatment. The hemodialysis monitoring system quantitates the rate and amount of a constituent, such as urea, removed during the hemodialysis treatment by measuring the constituent concentrations as a function of time in the spent dialysate effluent from a hemodialysis machine. A quantity of the spent dialysate effluent is removed from the dialysate effluent waste line periodically for testing. A urea concentration time profile can be analyzed to determined the urea removal, KT/V, URR, SRI and normalized protein catabolic rate (nPCR) indices. The hemodialysis monitoring system preferably can obtain a dialysate sample equilibrated with the blood prior to the start of a hemodialysis treatment. The hemodialysis monitoring system includes a two pool analysis for taking into account the constituent concentration differences in the extracellular and intracellular spaces in the hemodialysis patient during the hemodialysis treatment.

Abstract: An additive system for a polyvinyl chloride formulation for improved processability while maintaining thermal stability of the formulation, and having a low-water-blush haze and low extractability in an aqueous media, the additive system including a primary stabilizer which is a Lewis acid metal compound selected from the group consisting of organo-tin compounds and organo-zinc compounds, a secondary stabilizer selected from the group consisting of epoxide compounds having less than approximately 5.2 oxirane groups per molecule; and, an external lubricant for lubrication of the PVC formulation, wherein a critical ratio of the primary stabilizer to the secondary stabilizer maximizes thermolytic color stability while limiting generation of excessive build-up, plate-out, dark particles during the processing of the polyvinyl chloride formulation.

Abstract: The present invention provides an improved peritoneal dialysis method and system. The system comprises a single catheter that is placed in the patient, a source of dialysate, and a diatyzer in fluid communication with the source of dialysate and the catheter. The system includes a single fluid pump in fluid communication with the source of dialysate and the catheter. The single pump is capable of pumping the dialysate into and out of the patient and back to the source of dialysate. The method includes the steps of placing a single catheter in a peritoneum of the patient, providing a source of dialysate, coupling the source of dialysate in fluid communication with the catheter on a single fluid circuit, pumping the dialysate from the source of dialysate into and out of the peritoneum using a single pump in the single fluid circuit.

Abstract: A method is provided for creating a plastic component constructed, at least in part, from polychlorotrifluoroethylene, having improved properties. The method creates a component from a composition that has polychlorotrifluoroethylene, heats the component to a temperature that is greater than the melting point of the composition, and rapidly quenches the component in a cold medium.

Abstract: Pumping mechanisms for performing peritoneal dialysis and the like employ a pumping mechanism comprising a diaphragm that operate in response to applied fluid pressure. Flexible tubing is attached to the pumping mechanism for carrying liquid to and from the patient's peritoneal cavity. An actuating station for pumping mechanism receives the pumping mechanism and attached tubing. A pressure transfer element conveys fluid pressure to the diaphragm for moving liquid through the cassette. An occluder element contacts and crimps closed the tubing attached to the cassette. A first reservoir inflates with positive fluid pressure for contacting the pressure transfer element to hold it in operative contact against the diaphragm. A second reservoir inflates with positive fluid pressure for contacting the occluding element to hold it away from crimping contact with the tubing. At least one of the first and second reservoirs also transports fluid pressure to the pressure transfer element for conveyance to the diaphragm.