Method for testing dialyzer integrity prior to use

• US 5,711,883 A
• Filed: 09/27/1995
• Issued: 01/27/1998
• Est. Priority Date: 09/27/1995
• Status: Expired due to Term

• Current Assignee: Fresenius USA Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius USA Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Polaschegg, Hans D., Folden, Thomas I., Peter, Harald
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/534,375
• Time in Patent Office: 853 Days
• Field of Search: 210/85, 210/90, 210/96.2, 210/321.6, 210/321.65, 210/646, 210/739, 210/741, 210/929, 604/4-6, 73/38, 73/40, 73/866, 73/40.5 R
• US Class Current: 210/646
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/705 Testing of filters for leaks blood in dialysate A61M1/1692
• CPC Class Codes: B01D 65/102 Detection of leaks in membranes

Abstract

The present invention includes a method and apparatus for the testing the integrity of a dialyzer prior to use. The dialyzer is tested on the same hardware used for the treatment of dialysis. The dialysate and blood sides of the dialyzer are primed in the normal manner. The blood and saline lines are clamped while the venous line is vented to the atmosphere. The ultrafiltrate flow rate is increased until the blood side fluid is ultrafiltered. The dialysate side is monitored for pressure increases. If the pressure does not increase, the test fails.

Claims

1. A method for testing dialyzer integrity prior to use, comprising:

preparing a hemodialysis delivery system for hemodialysis treatment on a patient, said hemodialysis delivery system including a dialyzer;

testing said dialyzer for leaks; and

performing hemodialysis treatment on said patient, wherein said testing step is comprised of;

connecting a first end of a venous bloodline to said dialyzer;

connecting a first end of an arterial bloodline to said dialyzer;

venting said second end of said venous bloodline to the atmosphere;

clamping a second end of said arterial bloodline;

increasing flow of dialysate through the dialysate side of the dialyzer from a first flow rate to a second flow rate; and

testing the transmembrane pressure to determine if a leak in the membrane has occurred.

2. The method of claim 1, wherein the flow of dialysate through the dialysate side of the dialyzer is increased to a value greater than 3000 ml/hour.

3. The method of claim 2, wherein the transmembrane pressure is compared to a value of 300 mmHg, and further includes the step, after said testing step, of discarding the membrane if the transmembrane pressure is less than 300 mmHg.

4. The method of claim 3, further comprising the step, before said testing step, of priming the blood side compartment with saline solution.

5. The method of claim 4, further comprising the step, before said testing step, of priming the dialysate side compartment with saline solution.

6. A method for testing a dialyzer for leaks comprising the steps of:

engaging with a dialysis patient a hemodialysis delivery system having a dialysis control unit with means to test a transmembrane pressure, a dialyzer having a dialysate compartment, a blood compartment and a membrane therebetween, a venous bloodline having a first and second end, and an arterial bloodline having a first and second end;

performing hemodialysis treatment on said patient;

testing the dialyzer in the hemodialysis delivery system; and

performing hemodialysis on a second patient using the same hemodialysis delivery system if the dialyzer passes the test; and

before said testing step, priming the dialysate compartment and blood compartment with saline solution, using saline lines.

7. The method of claim 6, wherein said testing step is comprised of the steps of:

attaching the first end of the venous bloodline to the dialyzer;

attaching the first end of the arterial bloodline to the dialyzer;

clamping the bloodline and its respective saline line;

venting the venous line;

increasing ultrafiltrate flow rate; and

checking the transmembrane pressure to determine if there is a leak in the membrane.

8. The method of claim 7, wherein the transmembrane pressure is compared to a value no less than 300 mmHg, and further comprising the step, after said testing step, of discarding the membrane if the value of the transmembrane pressure is less than 300 mmHg.