FLUID, CIRCUITS, SYSTEMS, AND PROCESSES FOR EXTRACORPOREAL BLOOD PROCESSING

• US 20070185430A1
• Filed: 04/03/2007
• Published: 08/09/2007
• Est. Priority Date: 07/12/2001
• Status: Active Grant

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Treu, Dennis, Burbank, Jeffrey, BRUGGER, JAMES
• Granted Patent: US 7,419,597 B2
• Time in Patent Office: Days
• US Class Current: 604/6.90
• 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

1-29. -29. (canceled)

30. 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:

connecting a source of electrolytically-balanced fluid to the liquid fluid circuit;

ensuring sterility of the electrolytically-balanced fluid by passing the same through the membrane to produce sterile fluid and storing the sterile fluid in a reservoir;

warming and maintaining a temperature of the sterile fluid until a treatment time;

recirculating the sterile fluid through the reservoir during a first phase of priming to permit gas to be purged from the sterile fluid and prime a first portion of the fluid circuit;

priming a further portion of the fluid circuit.

31. A method as in claim 30, wherein the priming a further portion is executed after the recirculating.

32. A method as in claim 30, further comprising conveying blood from a patient through the blood fluid circuit during a treatment cycle and removing waste from the blood from the blood circuit through the membrane to the liquid fluid circuit.

33. A method as in claim 30, further comprising using the sterile fluid from reservoir in the process of performing a blood waste removing process on a patient.

34. A method as in claim 30, wherein the ensuring sterility includes ensuring a rate of endotoxins below a predetermined level by filtering with a membrane with a pore size effective to limit endotoxins.

35. A method as in claim 34, wherein the predetermined level is 3 EUs/ml. or less.

36. A method as in claim 33, wherein the adding is performed substantially simultaneously with the removing.

37. A method as in claim 30, further comprising vibrating the reservoir to aid in the removal of gas.

38. A method as in claim 30 wherein the pumping the electrolytically-balanced fluid from the source includes operating a blood in a first direction and the conveying blood includes operating the blood pump in a second direction opposite the first.

39. 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:

at a predetermined time prior to a treatment time, automatically preparing a batch of replacement fluid by filtering unfiltered replacement fluid with the membrane and storing filtered replacement fluid, resulting from the preparing, in a reservoir;

initiating priming the fluid circuit with the 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 warming the filtered replacement fluid responsively to a predetermined time before the treatment time;

initiating treating responsively to an indication of a completion of the priming.

40. A method as in claim 39, wherein the indication of a completion of the priming includes a change in a level of air in the fluid circuit.

41. A method as in claim 39, wherein the warming includes maintaining a predetermined temperature of the filtered replacement fluid.

42. A method as in claim 39, further comprising measuring a pressure of the filtered or the unfiltered replacement fluid upstream of a filter and generating an alarm when the pressure falls below a predetermined level or changes faster than predetermined rate.

43. A method as in claim 39, further comprising insulating the filtered replacement fluid.

44. A method as in claim 39, wherein the treating includes passing blood through the blood fluid circuit such that filtrate passes through the same membrane to the liquid fluid circuit such that a same membrane is used to generate sterile replacement fluid and treat a patient.

45. A method for performing a blood treatment, comprising;

providing a fluid circuit with a blood circuit and a non-blood circuit connected by a filter component having a porous membrane that separates the blood and non-blood circuits;

the non-blood circuit including at least one connector and at least one pumping portion;

the blood circuit having two access lines, each with line connectors being connected to the container to form a closed circuit;

a single-chamber container, the two access line connectors being connected to the container to form a closed circuit;

the blood circuit and container being hermetically isolated from an outside of the blood circuit and container except by a flow path through the porous membrane;

sterilizing the fluid circuit, including the hermetically isolated blood circuit and container and providing it at a treatment site;

flowing a treatment fluid through the non-blood circuit at least one connector into the container to fill it;

disconnecting the two access line connectors from the container and connecting them to a patient access.