Batch filtration system for preparation of sterile fluid for renal replacement therapy

• US 7,544,300 B2
• Filed: 07/07/2005
• Issued: 06/09/2009
• Est. Priority Date: 01/07/2003
• Status: Expired due to Term

• Current Assignee: Medherant Ltd.
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Brugger, James M., Burbank, Jeffrey H., Green, Brian C.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US11/160,764
• Publication Number:
  US 20070007208A1
• Time in Patent Office: 1,433 Days
• Field of Search: 210/97, 210/143, 210/645, 210/646, 210/739, 210/767, 604/6.09, 604/6.11, 604/6.13, 604/9, 604/28, 604/29, 604/30, 604/4.01, 604/5.01
• US Class Current: 210/645
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/167 Flexible packaging for solid concentrates
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1674 using UV radiation sources for sterilising the dialysate
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: C02F 1/44 by dialysis, osmosis or reverse osmosis general membrane separation processes B01D61/00, membrane modules B01D63/00, electrodialysis C02F1/4693, combination of membrane modules and bioreactors C02F3/1268

Abstract

A method and device for blood treatments that use fluids such as dialysate and replacement fluid for renal replacement therapy. In an embodiment, fluid is passed either by pump or passively by gravity feed, through a microporous sterilization filter from a fluid source to a replacement fluid container. The latter forms a batch that may be used during treatment. The advantage of forming the batch before treatment is that the rate of filtering needn'"'"'t match the rate of consumption during treatment. As a result, the sterilization filter can have a small capacity. In another embodiment, a filter is placed immediately prior to the point at which the sterile fluid is consumed by the treatment process. The latter may be used in combination with the former embodiment as a last-chance guarantee of sterility and/or that the fluid is free of air bubbles. It may also be used as the primary means of sterile-filtration.

Claims

1. A method of administering a renal replacement therapy requiring a sterile fluid, comprising:

at least one of carbon-filtering, deionizing, and ultra-filtering water to produce a source fluid;

sterile-filtering the source fluid to generate a sterile fluid;

flowing the sterile fluid into a sterile batch container;

the sterile-filtering and flowing being performed at a location and time at which a patient is to be treated;

the at least one of carbon-filtering, deionizing, and ultra-filtering being performed at the location at which the patient is to be treated; and

flowing the sterile fluid from the sterile batch container to a treatment system,

wherein at least one of the sterile-filtering and flowing the sterile fluid into a sterile batch container includes automatically controlling at least one of a flow rate of the sterile fluid and a rate of heating of the sterile fluid responsively to data representing at least one of a treatment start time and a volume of the sterile fluid required for a treatment, and

wherein the flowing the sterile fluid into a sterile batch container includes unsealing a first connector of a connector assembly of the sterile batch container, the first connector assembly being attached to a second filling port of the sterile batch container and reversibly coupling the first connector to an output port of a supply of the sterile fluid.

2. The method of claim 1, wherein the first connector assembly includes an inline sterile filter effective to isolate the contents of the sterile batch container from ingress of contaminants after the unsealing.

3. The method of claim 2, wherein the flowing the sterile fluid into a sterile batch container includes decoupling a second connector of the connector assembly, inline with the first connector, thereby leaving the inline sterile filter attached to the output port.

4. The method of claim 3, wherein the decoupling includes clamping a line of the connector assembly.