Method and arrangement for integrity-testing of a tube-set for use in a cycler for peritoneal dialysis

• US 6,327,895 B1
• Filed: 12/21/1999
• Issued: 12/11/2001
• Est. Priority Date: 07/09/1997
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Thell, Bengt-Olov, Jeppsson, Jan-Bertil
• Primary Examiner(s): Larkin, Daniel S.
• Assistant Examiner(s): Garber, Charles D.
• Application Number:
  US09/446,486
• Time in Patent Office: 721 Days
• Field of Search: 73/37, 73/40, 73/405.R, 73/46, 73/491, 73/495, 604/29
• US Class Current: 73/40
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities

Abstract

Methods and apparatus are disclosed for testing the integrity of a tube set used in a cycler for peritoneal dialysis comprising a closable housing for at least a portion of the tube set and an air pump for subjecting the housing to an underpressure or an overpressure, and clamps for clamping portions of the tube set passing into the housing. The method includes subjecting the housing to a first overpressure with the clamps closed whereby a first pressure leakage is observed, subjecting the housing to a second overpressure with the clamps open whereby a second pressure leakage is observed, and comparing the first and second pressure leakages so that action can be taken based upon that comparison.

Claims

1. A method for testing the integrity of a tube set used in a cycler for peritoneal dialysis comprising a closable housing for at least a portion of said tube set and pressure means for subjecting said housing to an underpressure or an overpressure, and including clamps for clamping portions of said tube set passing into said housing, said tube set containing air and said method comprising

subjecting said housing to a first overpressure with said clamps closed, whereby a first pressure leakage can be observed,

subjecting said housing to a second overpressure with said clamps open, whereby a second pressure leakage can be observed, and

comparing said first and second pressure leakages, whereby action can be taken based upon said comparison.

2. The method of claim 1 wherein said first and second overpressures are substantially the same, and wherein said comparing of said first and second pressure leakages determines whether said difference or ratio between said first and second pressure leakages exceeds a predetermined value, whereby action can be taken if said predetermined value is exceeded.

3. The method of claim 1 wherein said observing of said first and second pressure leakages comprises monitoring said pressure leakage with a pressure sensor, whereby said pressure leakage comprises a pressure drop over a predetermined time period or until a predetermined pressure drop is obtained within a predetermined time period.

4. The method of claim 1 wherein said subjecting of said housing to said first and second overpressure comprises connecting an air pump to the lower portion of said housing, and including monitoring the entry of liquid into said air pump.

5. The method of claim 1 including monitoring the presence of liquid in the lower portion of said housing by means of a liquid sensor disposed in said housing.

6. Apparatus for testing the integrity of a tube set used in a cycler for peritoneal dialysis comprising a closable housing for at least a portion of said tube set, said apparatus comprising:

pressure means for subjecting said housing to an overpressure or an underpressure,

clamps for clamping portions of said tube set passing into said housing, whereby when said housing is subjected to a first overpressure with said clamps closed a first pressure leakage can be observed and when said housing is subjected to a second overpressure with said clamps open a second pressure leakage can be observed, and

control means for comparing said first and second pressure leakages, whereby action can be taken based on said comparison.

7. The apparatus of claim 6 wherein said first and second overpressures are substantially the same, and wherein said control means compares said first and second pressure leakages to determine if the difference or ratio between said first and second pressure leakages exceeds a predetermined value, whereby action can be taken if said predetermined value is exceeded.

8. The apparatus of claim 6 wherein said pressure means comprises a pressure sensor for monitoring said pressure leakage, whereby said pressure leakage comprises a pressure drop over a predetermined time period or until a predetermined pressure drop is obtained within a predetermined time period.

9. The apparatus of claim 6 wherein said pressures means comprises an air pump connected to the lower portion of said housing, whereby the entry of liquid into said air pump can be monitored.

10. The apparatus of claim 6 including a liquid sensor disposed in said housing for monitoring the presence of liquid in a lower portion of said housing.