Single container preparation of peritoneal dialysis fluid

Inventors

Hobot, Christopher M • MEYER, Thomas E

Assignees

Mozarc Medical US LLC

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Publication Number

US-12329893-B2

Patent

Publication Date

2025-06-17

Expiration Date


Abstract

The invention relates to systems and methods for generation and use of peritoneal dialysis fluid. The peritoneal dialysis fluid is generated by dissolving solids or diluting concentrated liquids in a single container having all components of the final peritoneal dialysis fluid.

Core Innovation

The invention provides a system for generating a peritoneal dialysis fluid by reconstituting dialysis fluid in a single dialysate container. The dialysate container initially contains solid material or a concentrated liquid, and a water source is used to supply water into the container to generate the peritoneal dialysis fluid. A recirculation line is provided with an inlet and an outlet fluidly connected to the dialysate container, enabling recirculation of the mixture within the system.

A control system is programmed to pump a predetermined volume or a predetermined mass of water into the dialysate container to generate the peritoneal dialysis fluid. The control system uses sensor-based solute concentration determination and dissolution completion monitoring to verify the resulting peritoneal dialysis fluid quality. The disclosure includes examples of dialysate constituents such as sodium chloride, calcium chloride, magnesium chloride, sodium lactate, sodium bicarbonate, and an osmotic agent.

The disclosed system further includes selectable water purification modules and mixing and sterilization elements used in the preparation and handling of the reconstituted peritoneal dialysis fluid. Purification components include sorbent cartridges with ion exchange and activated carbon, reverse osmosis, electrodialysis, nanofilters, and microbial or particulate filters. The system also describes a venturi-tube mixing element with suction ports, as well as sterilization modules such as ultrafiltration, UV light, microbial filters, heat sterilization, or flash pasteurization, and connection to a cycler for infusion.

Claims Coverage

The provided independent claims cover a peritoneal dialysis fluid generation system in which water is pumped into a single dialysate container containing solid material or a concentrated liquid, with a recirculation line and a control system programmed to pump a predetermined volume or predetermined mass of water. Across the independent claims, the core coverage is focused on the container-based reconstitution architecture and the predetermined water dosing by the control system, with additional dependent claim inventive features specifying purification, mixing, solute/concentrate constituents, sensing, and optional cycler and sterilization functionality.

Single dialysate container with reconstitution feed

A dialysate container initially contains solid material or a concentrated liquid, and the control system is programmed to pump a predetermined volume or a predetermined mass of water into the dialysate container to generate a peritoneal dialysis fluid.

Recirculation line for container-connected mixing

A recirculation line has an inlet and an outlet fluidly connected to the dialysate container for recirculation of the mixture used to generate the peritoneal dialysis fluid.

Predetermined water dosing into the dialysate container

A control system is programmed to pump a predetermined volume or a predetermined mass of water into the dialysate container to generate a peritoneal dialysis fluid.

Concentration determination from sensor data

At least one sensor provides data to the control system, and the control system determines a concentration of at least one solute in the peritoneal dialysis fluid based on the sensor data.

The independent-claim coverage centers on generating peritoneal dialysis fluid by pumping predetermined water quantity or mass into a dialysate container initially holding solid material or a concentrated liquid, and on using a recirculation line fluidly connected to the container, with dependent features further narrowing the system through sensor-based concentration determination and other subsystem selections.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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