Method and apparatus for checking a dialyzer for the presence of a leak

Patent metadata

Field	Value
Publication number	US-11052182-B2
Application number	US-201616064197-A
Country	US
Kind code	B2
Filing date	Dec 23, 2016
Priority date	Dec 23, 2015
Publication date	Jul 6, 2021
Grant date	Jul 6, 2021

Abstract

The present invention relates to a method for checking a dialyzer for the presence of a leak in the semipermeable membrane of the dialyzer, wherein the membrane divides the inner dialyzer space into a least one blood chamber and into at least one dialyzate chamber, wherein the blood chamber is flowed through by blood in the operation of the dialyzer and is in fluid communication with a blood-side line system and the vascular system of the patient, and wherein the dialyzate chamber is flowed through by dialysis fluid in the operation of the dialyzer and is in fluid communication with a dialyzate-side line system, wherein the method comprises the following steps:
a) emptying the blood chamber or the dialyzate chamber of blood and of dialysis fluid respectively and keeping the fluid (blood or dialyzate) in the non-emptied dialyzate chamber or blood chamber; b) building up a test pressure by means of a gas, in particular by means of air, in the emptied blood chamber or in the emptied dialyzate chamber; and c) measuring the pressure drop over time in the emptied blood chamber or in the emptied dialyzate chamber or in the line system respectively in fluid communication therewith and/or measuring the pressure increase in the non-emptied blood chamber or in the non-emptied dialyzate chamber or in the line system respectively in fluid communication therewith or measuring the number of air bubbles or of a parameter correlated with the number of air bubbles in the non-emptied blood chamber or in the non-emptied dialyzate chamber or in a line system respectively in fluid communication therewith,

wherein the steps a) to c) are carried out subsequent to the blood treatment of the patient and subsequent to the disconnection of the patient from the blood-side line system.

First claim

What is claimed is:

1. A method of checking a dialyzer (D) for the presence of a leak in a semipermeable membrane of the dialyzer (D), the membrane dividing an inner dialyzer space into at least one blood chamber and into at least one dialyzate chamber, the blood chamber being flowed through by blood during operation of the dialyzer and being in fluid communication with a blood-side line system (BS) and a vascular system of a patient (P), and the dialyzate chamber being flowed through by a dialysis fluid during operation of the dialyzer and being in fluid communication with a dialyzate-side line system (DS), said method comprising the following steps:
a) emptying the blood chamber or the dialyzate chamber of blood and of dialysis fluid, respectively, and keeping the fluid (blood or dialyzate) in the non-emptied dialyzate chamber or blood chamber;
b) building up a test pressure via a gas in the emptied blood chamber or in e emptied dialyzate chamber and measuring the test pressure; and
c) measuring a pressure increase in the non-emptied blood chamber or in the non-emptied dialyzate chamber or in the line system (BS, DS), respectively, in fluid communication therewith,
the steps a) to c) being carried out subsequent to a blood treatment of the patient (P) and subsequent to disconnection of the patient (P) from the blood-side line system (BS), and
the step b) build-up of the test pressure and the measuring of the test pressure being carried out multiple times, and a continuation only being made with step c) when a drop of the measured test pressure over time does not exceed a limit value.

2. The method in accordance with claim 1 , wherein, subsequent to the carrying out of steps a) to c), no disinfection of the dialysate-side line system (DS) is carried out if no leak was detected in the membrane of the dialyzer (D).

3. The method in accordance with claim 1 , wherein the step of measuring the pressure is carried out in the dialysate chamber, in the dialyzate-side line system (DS), in the blood chamber, or in the blood-side line system (BS), or in a plurality thereof.

4. The method in accordance with claim 1 , wherein the step c) is carried out while the non-emptied chamber or the non-emptied line system (BS, DS) is closed.

5. The method in accordance with claim 1 , wherein the build-up of the test pressure in step b) is carried out via a compressor which conveys environmental air into the emptied blood chamber or dialyzate chamber or in the line system (LS, DS) in communication therewith.

6. The method in accordance with claim 1 , wherein pressure development is displayed and/or an evaluation is made based on one or more of measured values as to whether the membrane has a leak, and the result of the evaluation is displayed.

7. An apparatus for checking a dialyzer (D) for the presence of a leak in a semipermeable membrane of the dialyzer (D), said apparatus comprising:
the dialyzer (D), which is divided by the semipermeable membrane into at least one blood chamber and into at least one dialyzate chamber, including at least one blood-side line system (BS) which is in fluid communication with the blood chamber and with a vascular system of a patient (P) during a treatment, and including at least one dialyzate-side line system (DS) in fluid communication with the dialyzate chamber, blood flowing through the blood-side line system (BS) and the blood chamber, and dialysis fluid flowing through the dialyzate chamber and the dialysis fluid system (DS) during the treatment; and
a control unit, and elements which are controlled by the control unit, and are configured to carry out the method steps in accordance with claim 1 .

8. The apparatus in accordance with claim 7 , wherein the apparatus has one or more pressure sensors which are arranged indirectly or directly at the dialyzate chamber, at the dialyzate-side line system (DS), at the blood chamber, or at the blood-side line system (BS), or in a plurality thereof, and wherein the apparatus is configured to detect pressure development over time.

9. The apparatus in accordance with claim 7 , further comprising a device for emptying the blood from the blood chamber and/or for emptying the dialysis fluid from the dialyzate chamber and a device for introducing pressurized air into the blood chamber emptied of blood or into the dialyzate chamber emptied of dialysis fluid.

10. The apparatus in accordance with claim 7 , further comprising a display device configured to display pressure development and/or an evaluation unit configured to carry out an evaluation based on one or more of measured values to determine whether the membrane has a leak, and to display a result of the evaluation.

11. A dialysis device comprising at least one apparatus in accordance with claim 7 .

12. The method according to claim 1 , wherein the gas is air.

13. The apparatus according to claim 8 , wherein, based on the pressure development over time, the apparatus determines whether a leak in the semipermeable membrane is present.

14. The apparatus according to claim 9 , wherein the device for introducing pressurized air is a compressor.

15. The apparatus according to claim 9 , wherein the pressurized air is introduced into the line system (LS, DS).

Assignees

• Fresenius Medical Care Deutschland Gmbh

Inventors

• Spickermann Reiner
• Wiesen Gerhard

Classifications

• A61M2205/705

  Testing of filters for leaks · CPC title

• B01D61/28

  Apparatus therefor · CPC title

• A61M1/16

  with membranes · CPC title

• A61M2205/3331

  Pressure; Flow · CPC title

• A61M1/3652

  using gas, e.g. air · CPC title