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

• US 7,749,393 B2
• Filed: 05/01/2009
• Issued: 07/06/2010
• Est. Priority Date: 01/07/2003
• Status: Expired due to Term

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• 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:
  US12/434,246
• Publication Number:
  US 20090211975A1
• Time in Patent Office: 431 Days
• Field of Search: 210/645, 210/646, 210/650, 210/739, 210/746, 210/767, 210/232, 210/252, 210/257.1, 210/258, 210/321.6, 604/4.01, 604/5.01, 604/6.09, 604/6.11, 604/6.13, 604/9, 604/28, 604/29, 604/30
• US Class Current: 210/767
• 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 providing fluid to a blood treatment system for performing a blood treatment, the method comprising:

delivering a sterile batch container to a treatment location for the blood treatment, the sterile batch container containing, as delivered, a concentrate solution sealed therein and being sealed in part by a connector assembly attached to a first port of the sterile batch container, the connector assembly having a first connector and an inline filter, the inline filter being arranged between the first port and the first connector and being an anti-pyrogenic filter with a pore size effective to block contaminants such that the concentrate solution is isolated at least by the inline filter from contaminants outside the sterile batch container;

unsealing the first connector of the connector assembly;

reversibly coupling the first connector of the connector assembly to a supply of purified water, said purified water being sufficiently pure and sterile for infusion into a living animal;

flowing the purified water from the supply through the inline filter into the sterile batch container so as to dilute the concentrate solution therein with the filtered purified water to form a sterile fluid and such that the inline filter prevents any touch contamination from reaching the contents of the sterile batch container;

clamping the connector assembly with a non-reopenable tubing clamp arranged between the first connector and the inline filter;

disconnecting the connector assembly from the sterile batch container so as to leave the connector assembly, including the inline filter, attached to the supply of purified water such that at least one of the non-reopenable tubing clamp and the inline filter isolates the supply of purified water from contaminants;

reversibly coupling the sterile batch container to the blood treatment system;

flowing sterile fluid from the sterile batch container through the first port to the blood treatment system at a rate at which the sterile fluid is consumed by a blood treatment process; and

leaving the connector assembly attached to the supply of purified water for an interval of time to isolate the supply of purified water from contamination during said interval and thereafter detaching the connector assembly from the supply of purified water and immediately coupling a first connector of a connector assembly of another sterile batch container to the supply of purified water, the interval including a time interval between successive blood treatment processes provided to a patient;

wherein the unsealing the first connector, the reversibly coupling the first connector, the flowing the purified water, the clamping, the disconnecting, the reversibly coupling the sterile batch container, and the flowing sterile fluid all occur at a same treatment location as the blood treatment.

2. The method of claim 1, further comprising, prior to the unsealing the first connector,

coupling a second connector assembly to a supply of concentrate solution, the second connector assembly being attached to a second port of the sterile batch container;

flowing concentrate solution from the supply of concentrate solution into the sterile batch container by way of the second port;

removing the second connector assembly; and

permanently sealing the second port.

3. A method of providing fluid to a blood treatment system for performing a blood treatment, the method comprising:

reversibly coupling a first connector of a connector assembly to a supply of purified water, the connector assembly being attached to a first port of a sterile batch container and having an inline filter arranged between the first port and the first connector, the purified water being sufficiently pure and sterile for infusion into a living animal;

flowing purified water from the supply through the inline filter so as to filter the purified water thereby removing any touch contamination caused by the reversibly coupling and flowing the filtered purified water into the sterile batch container;

disconnecting the connector assembly from the sterile batch container;

reversibly coupling the sterile batch container to the blood treatment system; and

flowing contents of the sterile batch container through the first port to the blood treatment system as a blood treatment is performed and at a rate at which sterile fluid is consumed by the blood treatment.

4. The method of claim 3, wherein the disconnecting the connector assembly includes decoupling the connector assembly from the sterile batch container and leaving the connector assembly attached to the supply of purified water for an interval of time to isolate the supply of purified water from contamination during said interval and thereafter detaching the connector assembly and immediately coupling a first connector of a connector assembly of another sterile batch container to the supply of purified water.

5. The method of claim 3, further comprising, before the reversibly coupling a first connector, deionizing and ultra-filtering water to produce the supply of purified water.

6. The method of claim 5, wherein the deionizing and ultra-filtering includes deionizing and ultra-filtering water at a same treatment location as the blood treatment is performed.

7. The method of claim 3, wherein the sterile batch container has a concentrate solution contained therein and the flowing the filtered purified water includes diluting the concentrate solution with the filtered purified water in the sterile batch container to form sterile dialysate.

8. The method of claim 3, further comprising, prior to the reversibly coupling a first connector,

delivering the sterile batch container to a treatment location for the blood treatment, the sterile batch container containing, as delivered, a concentrate solution completely sealed therein,

wherein the sterile batch container is delivered with the connector assembly attached to the first port and with the first connector sealed such that the concentrate solution is isolated from contamination by both the sealed first connector and the inline filter.

9. The method of claim 3, further comprising, before the reversibly coupling a first connector,

coupling a second connector assembly to a supply of concentrate solution, the second connector assembly being attached to a second port of the sterile batch container;

flowing concentrate solution from the supply of concentrate solution into the sterile batch container by way of the second port;

removing the second connector assembly; and

permanently sealing the second port.

10. The method of claim 3, further comprising, after the flowing purified water and before the disconnecting the connector assembly,

removing a sample of the contents of the sterile batch container through a third connector of a third connector assembly;

testing conductivity of the sample of the contents;

replacing the sterile batch container with a new sterile batch container and repeating the reversibly coupling a first connector and the flowing purified water when the tested conductivity is lower than a predetermined range; and

repeating the flowing purified water when the tested conductivity is higher than a predetermined range.

11. The method of claim 10, wherein the third connector assembly includes a check valve effective to prevent backflow or contamination from reaching the sterile batch container through the first port.

12. The method of claim 3, wherein the inline filter is an anti-pyrogenic filter constructed such that the contents of the sterile batch container are isolated from ingress of contaminants.

13. The method of claim 3, wherein the blood treatment is a renal replacement therapy for a patient, the blood treatment system is one of a hemofiltration machine, a hemodiafiltration machine, and a hemodialysis machine, and the sterile fluid is replacement fluid for the patient.