Last-chance quality check and/or air/pathogen filter for infusion systems

• US 8,192,387 B2
• Filed: 02/29/2008
• Issued: 06/05/2012
• Est. Priority Date: 06/06/2002
• Status: Expired due to Fees

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Brugger, James M., Burbank, Jeffrey H.
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Wiest, Philip R
• Application Number:
  US12/040,748
• Publication Number:
  US 20080203023A1
• Time in Patent Office: 1,558 Days
• Field of Search: 210/646, 210/321.79, 2103218-3219, 210/433.1, 210/500.23, 210/650, 422/44, 604/4.01
• US Class Current: 604/6.09
• CPC Class Codes: A61L 2/0017 Filtration
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/3401 Cassettes therefor
• CPC Class Codes: A61M 1/3455 Substitution fluids
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• 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 2205/75 with filters
• CPC Class Codes: B01D 61/32 Controlling or regulating

Abstract

Blood treatment system and method for high rate hemofiltration ensures against pyrogenic patient reaction by providing various mechanisms for filtering replacement fluid to remove endotoxins and other safety features including detecting incorrect fluid administration.

Claims

1. A method for supplying sterile fluid to a blood treatment machine, the blood treatment machine consuming said sterile fluid in performing a specified blood treatment on a patient, the fluid being required to be sterile, including an endotoxin level below 0.03 EU/ml, as consumed by the treatment process according to specified requirements of the specified blood treatment, the method comprising:

providing a container of sterile fluid with an endotoxin level below 0.03 EU/ml, the fluid in the container thereby being suitable, without further sterilization, for use by the blood treatment machine in performing the specified blood treatment;

connecting a connector of a fluid line of the blood treatment machine to the container, the connector being such that sterile fluid flowing through the connector is susceptible to contamination by said connecting; and

,

flowing the sterile fluid from the container through the connector and then through a filter in said fluid line to the blood treatment machine, said filter being effective to remove any contamination generated by said connecting such that in the event of a touch contamination resulting from the connecting, the fluid flowing into the blood treatment machine is restored to an endotoxin level below 0.03 EU/ml.

2. The method of claim 1, wherein the filter is effective to reduce a concentration of endotoxins in the fluid supplied to the blood treatment machine so as to deliver no more than 5 EU/hr per kg of patient weight of fluid upon filtration thereof at a defined rate of infusion into the patient.

3. The method of claim 1, wherein the specified blood treatment includes one of hemofiltration and hemodiafiltration.

4. The method of claim 1, wherein the filter includes a membrane of charged nylon.

5. The method of claim 1, wherein said container comprises a bag of sterile fluid and said connector comprises a spike.

6. A method for supplying sterile fluid to a blood treatment machine that consumes fluid in a process of performing a specified blood treatment, said fluid consumed being required to be sterile, and have a concentration of endotoxins below 0.03 EU/ml, for said specified blood treatment, the method comprising:

providing at least one container, the at least one container containing sterile fluid that does not require further sterilization in order to render it suitable for the specified blood treatment;

manually making a connection between the blood treatment machine and the at least one container such that the sterile fluid flowing from the at least one container is susceptible to touch contamination; and

flowing fluid from the at least one container through at least one filter to the blood treatment machine,

wherein the at least one filter is adapted to remove the touch contamination, which results from making the connection, from fluid conveyed through the at least one filter, thereby restoring the fluid from the at least one container to a sterile condition including an endotoxin level below 0.03 EU/ml for use in the specified blood treatment.

7. The method of claim 6, wherein the at least one container is at least two containers, and the at least one filter is at least one filter for each of the containers, each filter being connected inline in a respective branch of a fluid line connected to each of said at least two containers, whereby fluid from each container is filtered by its own filter.

8. The method of claim 6, wherein the at least one container is at least two containers, and the at least one filter is a single common filter, a respective branch of a fluid line for each container being connected to an inlet of the common filter, whereby fluid from each container is filtered by the common filter.

9. The method of claim 6, wherein the at least one filter is effective to reduce a concentration of endotoxins in the fluid supplied to the blood treatment machine so as to deliver no more than 5 EU/hr per kg of patient weight of fluid upon filtration thereof at a defined rate of infusion into the patient.

10. The method of claim 6, wherein the specified blood treatment includes one of hemofiltration and hemodiafiltration.

11. The method of claim 6, wherein the at least one filter includes a membrane of charged nylon.

12. A method of performing a specified blood treatment on a patient, the method comprising the steps of:

providing a blood treatment machine that consumes sterile fluid in performing the specified blood treatment on the patient, the sterile fluid being required to have an endotoxin concentration below a specified threshold according to requirements of the specified blood treatment, the blood treatment machine having a fluid line with a connector for receiving sterile fluid;

providing a container of fluid, the fluid in said container having an endotoxin concentration below said specified threshold so as to be sufficiently sterile for use by the blood treatment machine in performing the specified blood treatment without any further sterilization;

providing a filter in the fluid line between the connector and the blood treatment machine;

attaching said connector to the container such that the fluid line connects the container of fluid to the blood treatment machine, the attaching being such that the fluid is susceptible to touch contamination, whereby the endotoxin concentration of the fluid exceeds the specified threshold;

flowing the fluid from the container through the filter to the blood treatment machine; and

performing the specified blood treatment on the patient using the blood treatment machine, whereby fluid from the container is consumed by the blood treatment machine,

wherein contamination, caused by said attaching, of the fluid flowing to the blood treatment machine from the container is removed by flowing the fluid through the filter such that the fluid consumed by the blood treatment machine is restored to the specified threshold.

13. The method of claim 12, wherein the filter is effective to ensure a concentration of endotoxins in the fluid supplied to the blood treatment machine is below 0.03 EU/ml.

14. The method of claim 12, wherein the filter is effective to reduce a concentration of endotoxins in the fluid supplied to the blood treatment machine so as to deliver no more than 5 EU/hr per kg of patient weight of fluid upon filtration thereof at a defined rate of infusion into the patient.

15. The method of claim 12, wherein the specified blood treatment includes one of hemofiltration and hemodiafiltration.

16. The method of claim 12, wherein said requirements of the specified blood treatment include the sterile fluid having a concentration of endotoxins below 0.03 EU/ml.