Method and apparatus for cleaning a dialysate circuit downstream of a dialyzer

• US 5,603,902 A
• Filed: 05/31/1995
• Issued: 02/18/1997
• Est. Priority Date: 07/16/1993
• Status: Expired due to Term

• Current Assignee: Gambro Renal Products, Inc. (Baxter International Inc.)
• Original Assignee: COBE Laboratories Incorporated (Terumo Corporation)
• Inventors: Wood, Archie T., Maltais, Jo-Ann B., Hovland, Roy S.
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/454,951
• Time in Patent Office: 629 Days
• Field of Search: 210/85, 210/87, 210/91, 210/94, 210/143, 210/136, 210/636, 210/645, 210/646, 210/321.69, 604/4, 422/28, 422/116, 422/117, 134/22.1, 134/22.11, 134/22.12, 134/22.13, 134/22.14, 134/104.1, 134/166 C, 134/168 C, 137/240, 137/238, 137/511, 137/512
• US Class Current: 210/321.71
• CPC Class Codes: A61M 1/168 Sterilisation or cleaning before or after use
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• CPC Class Codes: A61M 1/1684 Checking the module characteristics before reuse
• CPC Class Codes: A61M 1/169 using chemical substances
• CPC Class Codes: Y10T 137/4259 With separate material addition

Abstract

A method and apparatus for cleaning of a dialysate circuit located downstream of the dialyzer in a dialysis machine is described. The method comprises injecting a cleaning agent into the dialysis machine at a point between the dialyzer inlet port and the downstream dialysate circuit in an amount sufficient to substantially reduce the deposit in said downstream dialysate circuit; permitting flow of the agent towards the downstream dialysate circuit; and substantially preventing flow of the agent toward the dialyzer inlet port. The injection adaptor apparatus comprises an injection connector downstream of a backflow prevention valve, and two flanking tubing connectors. The apparatus is inserted at a point downstream of the dialyzer inlet port, and cleaning agent is injected into the injection connector. An adaptor to facilitate handling of cleaning agent during manual agent injection is also described. Additionally, an automated agent injection apparatus is described.

Claims

1. An apparatus for reducing deposits in a portion of a dialysate circuit located downstream of a membrane fluid treatment device in a dialysis machine while not contaminating a portion of the dialysate circuit located upstream of the membrane fluid treatment device, said apparatus comprising:

a first tubing connector selectively connectable and disconnectable with a bypass block connector of the dialysate circuit;

a backflow prevention valve in fluid communication with the first tubing connector;

an injection connector in fluid communication with the backflow prevention valve and adapted for fluid communication with a source of fluid; and

a second tubing connector selectively connectable and disconnectable with the dialysate circuit in fluid communication with the injection connector;

wherein said backflow prevention valve is oriented to allow flow only in a direction from the first connector to the second connector.

2. The apparatus of claim 1, wherein the membrane fluid treatment device is a hemodiafiltration dialyzer.

3. The apparatus of claim 1, wherein the membrane fluid treatment device is a blood dialyzer.

4. The apparatus of claim 1, wherein the injection connector is an injection port.

5. The apparatus of claim 4, further comprising:

a syringe in fluid communication with the injection port.

6. The apparatus of claim 5, wherein said fluid communication between said syringe and injection port comprises a needle.

7. The apparatus of claim 1, wherein the injection connector is a tee connector.

8. The apparatus of claim 7, further comprising:

a tubing having a first and a second end, said second end being in fluid communication with the tee connector;

a container containing a cleaning agent and comprising an opening, said opening being in fluid communication with the first end of the tubing; and

a pump for pumping the agent through the tubing from the container to the injection connector.

9. The apparatus of claim 8, wherein the tubing further contains a flow sensor.

10. The apparatus of claim 8, further comprising a backflow prevention valve located in the pump or tubing.

11. The apparatus of claim 8, wherein the container further comprises:

an internal tube that is in contact with said agent and in fluid communication with the opening of the container; and

an air inlet valve.

12. The apparatus of claim 8, further comprising:

a container adaptor through which the first end of the tubing communicates with the container opening.

13. The apparatus of claim 1, wherein the first tubing connector comprises a female connector and the second tubing connector comprises a male connector.

14. The apparatus of claim 1, wherein the backflow prevention valve comprises a check valve.

15. The apparatus of claim 14, wherein the backflow prevention valve comprises a plurality of check valves.

16. The apparatus of claim 1, wherein the fluid communication between the back flow prevention valve and the first tubing connector, between the injection connector and the backflow prevention valve and between the second tubing connector and the injection connector comprise silicone tubing.

17. The apparatus of claim 1, wherein a sensor is disposed in the downstream dialysate circuit.

18. The apparatus of claim 17, wherein the sensor is an optical sensor.

19. The apparatus of claim 18, wherein the sensor is a blood leak detector.