Fluid circuits, systems, and processes for extracorporeal blood processing

• US 7,214,312 B2
• Filed: 08/27/2003
• Issued: 05/08/2007
• Est. Priority Date: 07/12/2001
• Status: Expired due to Term

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Brugger, James M., Treu, Dennis M., Burbank, Jeffrey H.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US10/650,935
• Publication Number:
  US 20040069709A1
• Time in Patent Office: 1,350 Days
• Field of Search: 210/85, 210/86, 210/87, 210/90, 210/97, 210/194, 210/195.1, 210/232, 210/252, 210/253, 210/257.1, 210/258, 210/321.6, 210/416.1, 210/646, 210/195.2, 604/4.01, 604/6.09, 604/6.11
• US Class Current: 210/195.2
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3441 Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3444 in which the collected ultra-filtrate expels an equal volume of substitution fluid from a reservoir
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 1/3465 using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/705 Testing of filters for leaks
• CPC Class Codes: B01D 61/145 Ultrafiltration
• CPC Class Codes: B01D 61/18 Apparatus therefor
• CPC Class Codes: C02F 1/444 by ultrafiltration or microfiltration

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.

Claims

1. 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 and having at least one patient access port connected to said replacement fluid container to define a recirculating path;

a port on a non-blood side of said filter or dialyzer 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.

2. A fluid circuit as in claim 1, wherein said replacement fluid circuit is connected to said blood circuit, said patient access port is connected to said replacement fluid container by at least one access line, and said recirculating path is defined by at least a portion of each of said blood circuit, said access line, and said replacement fluid container and said replacement fluid circuit.

3. A fluid circuit as in claim 2, wherein said access line includes two tubes making a parallel connection between said blood circuit and said replacement fluid container.

4. A fluid circuit as in claim 1, wherein said replacement fluid circuit includes an inline component including at least one of an inline filter effective to block pyrogens and/or air and a fluid property sensor connectable to a controller or alarm.

5. A fluid circuit as in claim 4, wherein said inline component is located immediately upstream of a junction with said blood circuit.

6. A fluid circuit as in claim 5, wherein said inline component includes filter effective to reduce endotoxins to a rate of less than 3 EUs/ml.

7. A fluid circuit as in claim 1, wherein said recirculating path includes an access needle.

8. A fluid circuit as in claim 7, wherein said access needle forms part of a connector connecting said replacement fluid container via said access line to said blood circuit, said connector having a portion that automatically seals said access line when disconnected to make said access needle available for accessing the blood flow of a patient in preparation for treatment.

9. A fluid circuit as in claim 1, wherein said replacement fluid container has ports forming part of said recirculating path, said ports being arranged to prevent short-circuit flow therebetween, whereby bubbles may settle out of said recirculating flow into said replacement fluid container.

10. A fluid circuit as in claim 9, wherein said replacement fluid container is at least 5 liters in volume.

11. A fluid circuit for a blood treatment system, comprising:

a blood circuit connected to a sterile container by a replacement fluid circuit;

a non-blood circuit;

a blood filter or dialyzer connecting said blood circuit with said non-blood circuit;

said blood filter or dialyzer having a membrane with a blood side and a non-blood side;

said membrane blood side being in fluid communication with said blood circuit;

said membrane non-blood side being in fluid communication with said non-blood circuit;

said blood circuit including venous and arterial lines, each connected to said sterile container by releasable connectors configured for connection to a patient access device;

said blood circuit, said non-blood circuit, said non-blood side of said blood filter or dialyzer, and said sterile container being entirely hermetically isolated from an outside of said fluid circuit except by a flow path through a membrane of said filter or dialyzer, permanently connected, and free of releasable connectors such that fluid may be added to an interior of said sterile container only through said membrane, through said venous and arterial lines only after a seal of said releasable connectors is broken;

said releasable connectors being pre-connected when said fluid circuit is sterilized so that said sterile container may be filled by pumping fluid through said membrane without a possibility of touch contamination until a disconnection of said releasable connectors is made to connect said releasable connectors to a patient access.

12. A fluid circuit for a blood treatment system, comprising:

a blood circuit connected to a sterile container by a replacement fluid Circuit;

a non-blood circuit;

a blood filter or dialyzer connecting said blood circuit with said non-blood circuit;

said blood filter or dialyzer having a membrane with a blood side and a non-blood side;

said membrane blood side being in fluid communication with said blood circuit;

said membrane non-blood side being in fluid communication with said non-blood circuit;

said blood circuit including venous and arterial lines being releasably connected to said sterile container by at least one connector that is configured for connection to a patient access device;

said blood circuit, said non-blood circuit, said non-blood side of said blood filter or dialyzer, and said sterile container being entirely hermetically isolated from an outside of said fluid circuit except by a flow path through a membrane of said filter or dialyzer, permanently connected, and free of releasable connectors such that fluid may be added to an interior of said sterile container only through said membrane, through said venous and arterial lines only after a seal of said at least one connector is broken;

said at least one connector being pre-connected when said fluid circuit is sterilized so that sterile container may be filled by pumping fluid through said membrane without a possibility of touch contamination until a disconnection of said at least one connector is made to connect said at least one connector to a patient access.

14. A fluid circuit as in claim 12, wherein said access port includes a patient access device.

13. A fluid circuit, comprising:

a dialyzer with a membrane having blood and dialysate sides separated by a membrane;

said dialyzer being connected to a blood circuit on said blood side and a dialysate circuit on said dialysate side;

a sterile container being connected to the blood circuit;

at least one patient access port of the blood circuit connected to the sterile container to define by a replacement fluid circuit recirculating path,

a port on a non-blood side of the dialyzer connectable to a source of dialysate;

said recirculating path being entirely hermetically isolated from an outside of the fluid circuit except by a flow path through a membrane of the dialyzer from the non-blood side to the blood side such that dialysate fluid may be added to the sterile container only through said dialyzer membrane and stored therein;

wherein a flow through the recirculating path may be established without making any connections or disconnections breaking the hermetic seal.

15. A circuit as in claim 13, wherein said access device includes a dual lumen access needle.