Automated peritoneal dialysis system and process with in-line sterilization of dialysate

An automated peritoneal dialysis system for performing continuous peritoneal dialysis of the type which includes a fluid circuit for delivering sterile dialysate to the peritoneal cavity of a patient and removing spent dialysate from the patient;

• and a system controller for controlling the flow of dialysate during said fill and drain of dialysate wherein said system comprises:
• a generally continuous supply of unsterilized dialysate for supplying large volumes of dialysate on demand;
• an inflow line segment included in said fluid circuit for delivering dialysate from said supply to the patient;
• an outflow line segment included in said fluid circuit for connection to the patient's peritoneal cavity to drain spent dialysate from the peritoneal cavity;
• an in-line sterilization filter assembly disposed in said inflow line segment for realtime sterilization of said unsterilized dialysate during flow of said dialysate in said inflow line segment and prior to patient delivery;
• said sterilization filter assembly including an inlet port connected in said inflow line segment for receiving unsterilized dialysate, a sterilization filter medium through which said dialysate passes for producing sterilized dialysate, and an outlet port connected in said inflow line segment through which sterilized dialysate flows for delivery to the patient during the peritoneal dialysis;
• a filter test component operatively associated with said sterilization filter assembly for conducting a realtime integrity test on said filter assembly to test for a filter failure condition which would allow contaminants into said dialysate prior to patient delivery, wherein said system controller is operative to control said filter test component to test said sterilization filter assembly after said dialysate has passed through said filter assembly and before said dialysate is delivered to the patient during the peritoneal dialysis;
• and
• a test sensor in communication with said testing component for detecting said failure condition;
• whereby large volumes of sterilized dialysate are available on demand in realtime during the peritoneal dialysis process to provide a high rate of dialysate exchange during repeated dialysate fill and drain cycles until a desired weight of fluid waste is removed from the patient.

An automated peritoneal dialysis system for performing continuous peritoneal dialysis of the type which includes a fluid circuit for delivering sterile dialysate to a patient's peritoneal cavity and removing used dialysate from the patient;

• and a system controller for controlling said filling and draining to achieve an effective dialysis, wherein said system comprises:
• a steady supply of a large volume dialysate effective for dialysis available on demand;
• an inflow line segment included in said fluid circuit for connection to the patient to deliver dialysate from said supply;
• an outflow line segment included in said fluid circuit for connection to the patient to drain spent dialysate from the peritoneal cavity;
• a sterilization unit included in said inflow line segment which includes:
• a primary in-line sterilization filter assembly disposed in said inflow line segment for real-time sterilization of said dialysate during flow of said dialysate in said inflow line segment prior to patient delivery;
• a secondary in-line sterilization filter assembly disposed in said inflow line segment for real-time sterilization of said dialysate during flow of said dialysate in said inflow line segment prior to patient delivery;
• said primary sterilization filter assembly unit including an inlet port connected in said inflow line segment for receiving said dialysate from said supply, a sterilization filter medium through which said dialysate passes for producing sterilized dialysate, and an outlet port connected in said inflow line segment through which sterilized dialysate flows;
• a delivery vessel included in said inflow line connected to said outlet port of said primary sterilization filter assembly for accumulating said dialysate;
• said secondary filter assembly having an inlet port connected to said delivery vessel for receiving said accumulated dialysate, a sterilization filter medium for sterilizing said dialysate, and an outlet port for delivering dialysate to the patient;
• and
• a filter test component operatively associated with said primary and secondary sterilization filter assemblies for conducting a real-time integrity test on said filter assemblies to test for a filter failure condition which would allow contaminants into said dialysate while said dialysate is accumulated and prior to patient delivery;
• whereby filling and draining of the peritoneal cavity with dialysate may be repeated by the system controller as needed using a realtime supply of sterilized dialysate ready on demand providing a high rate of dialysate exchange.

An automated peritoneal dialysis process for performing continuous peritoneal dialysis of the type which includes providing a supply of sterile dialysate to fill the patient's peritoneal cavity and removing spent dialysate from the patient's cavity, said process comprising the steps of:

• (a) providing a generally continuous supply of large volumes of unsterilized dialysate;
• (b) passing said unsterilized dialysate from said supply through an in-line sterilization filter assembly to produce sterilized dialysate in realtime during the process prior to delivery to the patient's peritoneal cavity;
• (c) accumulating said sterilized dialysate in a delivery vessel prior to delivery to the patient;
• (d) subjecting said in-line filter assembly to a realtime filter integrity test during the process to test for a filter failure that would allow contaminants into said dialysate prior to patient delivery;
• (e) delivering said sterile dialysate from said delivery vessel to the patient's peritoneal cavity after said filter integrity test is passed;
• and
• (f) repeating steps (a) through (e) until a desired volume of dialysate is exchanged.

In a continuous, cyclic peritoneal dialysis process, an in-line, realtime dialysis fluid sterilization process to produce a sterilized dialysate comprising:

• preparing an unsterilized osmotic dialysate effective for dialysis;
• passing said dialysate through at least one in-line sterilization filter assembly connected in an inflow line to the patient in realtime during the process prior to delivery to the patient;
• and
• testing said sterilization filter assembly in realtime during the process after said passing step for a filter failure condition prior to delivering said dialysate to the peritoneal cavity of the patient.