Process for determining the operability of the structural components in the dialysis section of a dialyzer of a hemodialysis apparatus and apparatus for executing this process

• US 5,580,460 A
• Filed: 07/11/1995
• Issued: 12/03/1996
• Est. Priority Date: 11/27/1992
• Status: Expired due to Term

• Current Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Inventors: Polaschegg, Hans-Dietrich
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/501,162
• Time in Patent Office: 511 Days
• Field of Search: 210/90, 210/143, 210/321.71, 210/433.1, 210/434, 210/646, 210/741, 210/790, 210/929, 210/138, 604/4-6
• US Class Current: 210/646
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1617 using measurements made during a temporary variation of a characteristic of the fresh dialysis fluid
• CPC Class Codes: A61M 1/1635 with volume chamber balancing devices between used and fresh dialysis fluid
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/702 automatically during use

Abstract

A method and apparatus for monitoring the operability of components in a hemodialysis apparatus during dialysis treatment. The dialyzer is isolated from the dialyzing liquid circuit for a time interval during dialysis treatment. During the isolation time interval, the dialyzing liquid circuit pressure is measured and monitored to detect deviations from a mean dialyzate operating pressure. The isolation is repeated periodically, with the time period between isolation intervals dependent upon the ultrafiltration coefficient of the dialyzer. This method may be performed automatically by a microprocessor in the hemodialysis apparatus.

Claims

1. A method for monitoring the operability of components in a hemodialysis apparatus which comprises a dialyzer and a dialyzing liquid circuit, comprising:

isolating said dialyzer from said dialyzing liquid circuit for a predetermined time interval T during dialysis treatment so that dialyzing liquid within said dialyzing liquid circuit bypasses said dialyzer, said dialyzing liquid having a mean dialyzate operating pressure;

measuring pressure in said dialyzing liquid circuit during said time interval T; and

monitoring said pressure to detect a deviation from said mean dialyzate operating pressure while continuing to allow said pressure to freely fluctuate.

2. The method of claim 1, wherein said time interval T is approximately 20 seconds.

3. The method of claim 1, wherein said isolating step is performed by closing an isolation valve and opening a bypass valve so that dialyzing liquid flows through a bypass line.

4. The method of claim 1, wherein said isolating step is repeated after a time period Δ

t, wherein Δ

t is defined as

space="preserve" listing-type="equation">Δ

t=(Δ

UF/P*(60/UFC)),

wherein Δ

UF is the maximum ultrafiltration error of said dialyzer, P is the transmembrane pressure of said dialyzer, and UFC is the ultrafiltration coefficient (ml/h-mmHg) of said dialyzer.

5. The method of claim 1, further comprising:

displaying said measured pressure for visual observation.

6. The method of claim 1, further comprising:

switching said dialyzer into said dialyzing liquid circuit after said monitoring step if said deviation is not detected.

7. The method of claim 6, wherein said switching step is performed by opening an isolation valve and closing a bypass valve so that dialyzing liquid flows through said dialyzer.

8. The method of claim 1, further comprising:

switching said dialyzer to a safe state after said monitoring step if said deviation is detected.

9. The method of claim 1, wherein said isolating, measuring, and monitoring steps are performed automatically by said hemodialysis apparatus.

10. The method of claim 1, wherein said measuring step is performed using a pressure transducer.

11. An apparatus for monitoring the operability of components in a hemodialysis apparatus which comprises a system having a dialyzer and a dialyzing liquid circuit, comprising:

means for isolating said dialyzer from said dialyzing circuit for a predetermined time interval T during dialysis treatment so that dialyzing liquid within said dialyzing liquid circuit bypasses said dialyzer, said dialyzing liquid having a mean dialyzate operating pressure;

a pressure transducer operable for measuring pressure in said dialyzing liquid circuit during said time interval T;

means for monitoring said measured pressure to detect a deviation from said mean dialyzate operating pressure;

control means for actuating said means for isolating, and for controlling operation of said pressure transducer and said means for monitoring at a selected time during dialysis treatment; and

means responsive to said detecting to change the operating state of the system.

12. The apparatus of claim 11, wherein said control means comprises a microprocessor.

13. The apparatus of claim 11, further comprising:

means for displaying said measured pressure.

14. The apparatus of claim 11, further comprising:

means for switching said dialyzer into said dialyzing liquid circuit.

15. The apparatus of claim 14, wherein said means for switching comprises an isolation valve and a bypass valve.

16. A method for monitoring the operability of a component in a hemodialysis apparatus which comprises a chamber in a dialyzing liquid circuit having first and second chamber sections, said first chamber section receiving dialyzing liquid during first working cycles of said chamber and said second chamber section receiving dialyzing liquid during second working cycles of said chamber, said method comprising:

measuring and averaging the pressure in said first chamber section during one of said first working cycles to obtain an average individual working cycle pressure for said first chamber section;

measuring and averaging the pressure in said second chamber section during one of said second working cycles obtain an average individual working cycle pressure for said second chamber section;

obtaining a plurality of said average individual working cycle pressures for said first chamber section and averaging said plurality of said average individual working cycle pressures for said first chamber section to obtain an average composite working cycle pressure for said first chamber section;

obtaining a plurality of said average individual working cycle pressures for said second chamber section and averaging said plurality of said average individual working cycle pressures for said second chamber section to obtain an average composite working cycle pressure for said second chamber section;

comparing said average composite working cycle pressure for said first chamber section and said average composite working cycle pressure for said second chamber section to obtain a difference value; and

generating an alarm if said difference value exceeds a threshold value.

17. The method of claim 16, further comprising:

determining said threshold value based upon an ultrafiltration coefficient of said dialyzer.

18. An apparatus for monitoring the operability of a component in a hemodialysis apparatus which comprises a chamber in a dialyzing liquid circuit having first and second chamber sections, said first chamber section receiving dialyzing liquid during first working cycles of said chamber and said second chamber section receiving dialyzing liquid during second working cycles of said chamber, said apparatus comprising:

means for measuring the pressure in said first chamber section during one of said first working cycles to thereby produce a first pressure signal;

means for measuring the pressure in said second chamber section during one of said second working cycles to thereby produce a second pressure signal; and

electronic control means, wherein said electronic control means comprises,

first input means for receiving said first pressure signal and for generating an average individual first pressure signal for said one first working cycle,

second input means for receiving said second pressure signal and for generating an average individual second pressure signal for said one second working cycle,

averaging means for averaging said average individual first pressure signals for a plurality of said first working cycles to generate an average first pressure signal, and for averaging said average individual second pressure signals for a plurality of said second working cycles to generate an average second pressure signal,

comparing means for comparing said average composite first pressure signal and said average composite second pressure signal to generate a difference value, and

generating means for generating an alarm signal if said difference value exceeds a threshold value.

19. Apparatus according to claim 18, wherein said electronic control means comprises a microprocessor.

20. Apparatus according to claim 18, wherein said means for measuring the pressure in said first chamber section comprises a pressure transducer.

21. Apparatus according to claim 18, wherein said means for measuring the pressure in said second chamber section comprises a pressure transducer.