Peritoneal dialysis cycler having disinfection
Inventors
Assignees
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Publication Number
US-12433982-B2
Publication Date
2025-10-07
Expiration Date
Abstract
A peritoneal dialysis (“PD”) system includes a first volumetric balancing chamber including a first fixed volume chamber and a first diaphragm positioned and arranged to extend back and forth within the first fixed volume chamber, the first diaphragm separating a fresh PD fluid side from a used PD fluid side of the first volumetric balancing chamber; a second volumetric balancing chamber including a second fixed volume chamber and a second diaphragm positioned and arranged to extend back and forth within the second fixed volume chamber, the second diaphragm separating a fresh PD fluid side from a used PD fluid side of the second volumetric balancing chamber; and a PD fluid pump positioned and arranged to pump used PD fluid back and forth between the used PD fluid sides of the first and second volumetric balancing chamber.
Core Innovation
The invention relates to a peritoneal dialysis system designed to reduce disposables by using reusable fluid-handling components that are disinfected after treatment. The system uses two volumetric balancing chambers, each including a fixed volume chamber and a diaphragm positioned and arranged to extend back and forth within the fixed volume chamber, with the diaphragm separating a fresh PD fluid side from a used PD fluid side.
A PD fluid pump is positioned and arranged to pump used PD fluid back and forth between the used PD fluid sides of the first and second volumetric balancing chambers. This architecture supports transfer of used PD fluid between the used sides while enabling controlled fresh PD fluid delivery to and from the patient through the separated fresh sides.
The disclosure includes a sterilization sequence directed to the fresh PD fluid sides and a disinfection sequence directed to the used PD fluid sides, with heaters used for the corresponding treatment. In particular disclosed embodiments include sterilization at ≤120°C for germ deactivation and disinfection at about 65–75°C to achieve an A0 disinfection value greater than 900, together with sealed covers/ports and optional use of leftover PD fluid/water in loops, airtraps, and sensing to manage air during or after germ deactivation.
Claims Coverage
The independent claim defines a peritoneal dialysis system with two volumetric balancing chambers and a pump for used PD fluid transfer between the used sides. Additional inventive features refine the system with sterilization and disinfection loops, reusable lines and sealed covers, heater-based treatment sequences, valve-driven fresh PD fluid draw, and alternate patient drain modes.
Two volumetric balancing chambers with movable diaphragms separating fresh and used sides
A first volumetric balancing chamber including a first fixed volume chamber and a first diaphragm positioned and arranged to extend back and forth within the first fixed volume chamber, the first diaphragm separating a fresh PD fluid side from a used PD fluid side; and a second volumetric balancing chamber including a second fixed volume chamber and a second diaphragm positioned and arranged to extend back and forth within the second fixed volume chamber, the second diaphragm separating a fresh PD fluid side from a used PD fluid side.
Pump for back-and-forth transfer of used PD fluid between used sides
A PD fluid pump positioned and arranged to pump used PD fluid back and forth between the used PD fluid sides of the first and second volumetric balancing chambers.
Sterilization loop using fresh sides with reusable solution lines and sealed covers over ports
A sterilization loop using the fresh PD fluid sides of the first and second volumetric balancing chambers and including at least one reusable solution line and/or at least one sealed cover closing over patient line ports and/or drain line ports.
Disinfection loop using used sides with sealed covers over ports
A disinfection loop using the used PD fluid sides of the first and second volumetric balancing chambers and including at least one sealed cover closing over patient line ports and/or drain line ports.
Heaters for sterilization and disinfection sequences with temperature thresholds
The PD system includes a first heater configured to warm PD fluid to at least 120°C for a sterilization sequence and a second heater configured to warm PD fluid to about 65°C–75°C for a disinfection sequence.
Valve-driven draw of fresh PD fluid into a fresh side linked to pump operation
At least one valve is configured to draw fresh PD fluid into the fresh PD fluid side of the first or second volumetric balancing chamber when a PD fluid pump pumps used PD fluid out of the used PD fluid side.
Patient drain modes with optional bypass of the balancing chambers using pump accuracy
The PD system is configured to run a patient drain either by bypassing the first and second volumetric balancing chambers and relying on the PD fluid pump’s accuracy, or by operating the first and second volumetric balancing chambers.
The inventive scope centers on two fixed-volume balancing chambers with movable diaphragms that separate fresh and used PD fluid sides, combined with a pump that pumps used PD fluid back and forth between the used sides. Additional features include sterilization and disinfection loops using the respective fresh and used sides, reusable solution lines and sealed covers, heater-based sterilization and disinfection sequences with specified temperature thresholds, valve-driven fresh PD fluid draw, and alternate patient drain modes including bypassing the balancing chambers while relying on pump accuracy.
Stated Advantages
The invention is designed to reduce disposables by using reusable fluid-handling components that are disinfected after treatment.
The disclosed embodiments achieve germ deactivation and an A0 disinfection value greater than 900.
Documented Applications
Peritoneal dialysis system.
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