Fluid circuits, systems, and processes for extracorporeal blood processing
AssigneeNxStage Medical, Inc.
InventorsJames M. Brugger, Jeffrey H. Burbank, Dennis M. Treu
Life of this patent
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Abstract
A sterilized fluid management kit for use in renal replacement therapy isolates a replacement fluid container from touch contamination and provides for sterilization of replacement fluid by filtering using an installed filter that is hermetically connected to the replacement fluid container. A method is described where replacement fluid is automatically generated before treatment.
Claims43
A sterilized fluid management kit for use in renal replacement therapy, comprising:
- a filter with a membrane, a replacement fluid container, and a filtrate container;
- a filtrate circuit connected to said filter, said filtrate circuit having a connector for connection to a source of fluid;
- said membrane having a pore size effective to reduce pyrogenic material to a level safe for infusion;
- a blood circuit with venous and arterial blood lines and a blood side of said filter and terminated with connectors for connection to a patient access;
- said venous blood line having a branch terminated by a connection to said replacement fluid container;
- said blood circuit being entirely sealed and presterilized except for fluid communication, through a membrane of said filter, with said filtrate circuit such that raw fluid may be pumped through said membrane into said replacement fluid container with no opportunity for coming into contact with a non-purified surface after passing through said membrane;
- whereby sterility of replacement fluid placed in said replacement fluid is assured.
The kit of claim permitting said to enable fluid to be directed to engageable with a pump actuator for
The kit of claim 21, wherein a second one of the plurality of tubes is a blood return line.
The kit of claim 22, wherein a third one of the plurality of tubes is a replacement fluid line or waste line.
The kit of claim 19, further including a connector, and wherein a second end of at least one of the plurality of tubes is releasably connected to the purified replacement fluid reservoir by the connector.
The kit of claim 24, wherein the connector is adapted to releasably couple to a vascular access device.
The kit of claim 24, wherein the connector is a Luer connector.
The kit of claim 19, further including a sterilized cap, and wherein the sterilized cap removably seals the second end of the replacement fluid container tube.
A method for performing renal replacement therapy with a treatment device that employs a fluid circuit with liquid and blood fluid circuits separated by a membrane, the membrane having a pore size effective to block the passage of pyrogenic material, the method comprising the steps of:
- connecting a source of electrolytically-balanced fluid to the liquid fluid circuit;
- ensuring sterility of said electrolytically-balanced fluid by passing the same through said membrane to produce sterile fluid and storing said sterile fluid in a reservoir;
- warming and maintaining a temperature of said sterile fluid until a treatment time;
- recirculating said sterile fluid through said reservoir during a first phase of priming to permit gas to be purged from said sterile fluid and prime a first portion of said fluid circuit;
- priming a further portion of said fluid circuit.
A method for performing renal replacement therapy with a treatment device that employs a fluid circuit with fluid and blood circuits separated by a membrane, the membrane having a pore size effective to block the passage of pyrogenic material, the method comprising the steps of:
- at a predetermined time prior to a treatment time, automatically preparing a batch of replacement fluid by filtering unfiltered replacement fluid with said membrane and storing filtered replacement fluid, resulting from said step of preparing, in a reservoir;
- initiating a step of priming said fluid circuit with said filtered replacement fluid responsively to a signal indicating one of a passage of an interval of time, a mass of filtered replacement fluid, and a mass of unfiltered replacement fluid;
- initiating a step of warming said filtered replacement fluid responsively to a predetermined time before said treatment time;
- initiating a step of treating responsively to an indication of a completion of said step of priming.
A fluid circuit for a blood treatment system, comprising:
- a blood filter or dialyzer with a blood circuit and a replacement fluid container with a replacement fluid circuit connected to said blood circuit for diluting blood;
- said blood circuit communicating with a blood side of said blood filter or dialyzer having and having at least one patient access port connected to said replacement fluid container to define a recirculation path;
- a port on a non-blood side of said filter connectable to a source of replacement fluid;
- said recirculating path being entirely hermetically isolated from an outside of said fluid circuit except by a flow path through a membrane of said filter or dialyzer from said non-blood side to said blood side such that replacement fluid may be added to said replacement fluid container through said filter or dialyzer membrane and stored therein and a flow through said recirculating path may be established without making any connections or disconnections breaking said hermetic seal.
A dialysis fluid circuit, comprising:
- a connection for a source of dialysate connectable to a dialysate side of a dialyzer;
- a blood circuit connected to a blood side of said dilayzer;
- said blood circuit being connected to a replacement fluid container to form a circuit leading through said filter to said replacement filter container while otherwise hermetically sealing said replacement fluid container from an external environment whereby dialysate may be sterile filtered by passing from said dialysate side to said blood side of said dialyzer and stored in said replacement fluid container for use in treatment at which time said dialyzer is free for use for dialysis.
Dependencies are inferred from the claim text.