Automated cleaning method for dialyzers

• US 4,444,596 A
• Filed: 05/03/1982
• Issued: 04/24/1984
• Est. Priority Date: 03/03/1980
• Status: Expired due to Fees

• Current Assignee: Andrew S. Huson, Norman Gortz, Robert M. Macintyre
• Original Assignee: Andrew S. Huson, Norman Gortz, Robert M. Macintyre
• Inventors: Gortz, Norman, MacIntyre, Robert M., Huson, Andrew S.
• Primary Examiner(s): Lindsay, Jr., Robert L.
• Application Number:
  US06/373,873
• Time in Patent Office: 722 Days
• Field of Search: 210/321.3, 210/140, 210/96.2, 210/85, 210/90, 210/646, 210/791, 134/18, 134/22.1, 134/22.11, 134/22.12, 134/22.16, 134/26, 134/56 R, 134/57 R, 134/58 R, 134/113, 134/171
• US Class Current: 134/18
• 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: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: B01D 2321/40 Automatic control of cleaning processes
• CPC Class Codes: B01D 65/022 Membrane sterilisation

Abstract

A fully automated method and apparatus for cleaning and disinfecting blood dialyzers for reuse having multiple stations simultaneously capable of cleaning a plurality of dialyzers. The dialyzer, the station cleaning the dialyzer, and the patient are identified and the identifications are stored in memory. A predetermined sequence of cleaning procedures tailored to the type of dialyzer to be cleaned are provided. The cleaning procedures are automatically machined sequenced, and the sequence is selectively controlled in response to automatic test procedures measuring indicia of dialyzer reusability. The tests performed on the dialyzer include a blood presence test, a pressure leakage test, and an ultrafiltration rate test. If it is determined that the dialyzer is not reusable, it is either cleaned further to make it reusable or machine sequencing of subsequent cleaning procedures is inhibited.

Claims

1. A method of cleaning dialyzers having blood and dialysate sides comprising:

identifying the particular dialyzer to be cleaned;

identifying the particular patient who used a particular dialyzer in a treatment;

storing the dialyzer and patient identification in a memory at the time of cleaning;

storing a predetermined sequence of cleaning procedures designed to clean said dialyzers and to measure indicia of reusability of a dialyzer being cleaned;

automatically machine sequencing said procedures;

selectively controlling the sequencing of said procedures subsequent to a test procedure in response to the dialyzers measured indicia of reusability.

6. The method of claims 1 or 4 wherein said controlling comprises automatically machine sequencing additional cleaning steps if said measured indicia do not meet any of said predetermined criteria.

7. The method of claims 1 or 4 wherein one of said test procedures is a procedure for measuring the level of blood components remaining in an effluent obtained from rinsing the blood side of the dialyzer.

8. The method of claim 7 wherein said level of blood components is determined by measuring the concentration of hemoglobin present in said effluent.

9. The method of claims 1 or 4 wherein one of said test procedures is a procedure for measuring the pressure leakage from the blood side of said dialyzer.

10. The method of claim 9 wherein said pressure leakage is determined by pressurizing said blood side and measuring the pressure drop from the blood side in a ten second period.

11. The method of claims 1 or 4 wherein one of said test procedures is a procedure for determining the ultrafiltration rate of a fluid through a membrane between the dialysate and blood sides of the dialyzer over a period of time.

12. The method of claim 11 wherein said ultrafiltration rate is determined by filling said blood side with a fluid, pressuring said blood side and measuring the rate of ultrafiltration of said fluid through said membrane.

13. The method of claim 6, wherein one of said test procedures is a procedure for measuring the level of blood components remaining in an effluent obtained from rinsing the blood side of the dialyzer.

14. The method of claims 1, 2, or 3, wherein said identifying and storing steps include reading a coded label with a photo-optical data reading input device.

15. The method of claim 14 wherein said input device is a wand.

16. The method of claims 1, 2, or 3, further comprising:

inhibiting said automatic machine sequencing if said identifications have not been stored.

2. A method of cleaning dialyzers having blood and dialysate sides comprising:

identifying the particular dialyzer to be cleaned;

identifying the particular patient who used a particular dialyzer in a treatment;

storing the dialyzer and patient identification in a memory at the time of cleaning;

storing a predetermined sequence of cleaning procedures, said procedures including a plurality of test procedures which measure indicia of reusability of a dialyzer being cleaned;

automatically machine sequencing said procedures;

predetermining a set of reusability criteria adapted for each test procedure;

automatically inhibiting said cleaning sequence if said measured indicia do not meet any of said predetermined criteria.

3. A method of cleaning dialyzers comprising:

providing a plurality of stations capable of simultaneously cleaning multiple dialyzers;

identifying the particular dialyzer to be cleaned;

identifying the particular patient who used a particular dialyzer in a treatment;

storing the dialyzer and patient identification in a memory at the time of cleaning;

identifying the particular station which cleans a particular dialyzer;

storing said station identification to provide for determining which of said plurality of stations cleaned a particular dialyzer;

storing a predetermined sequence of cleaning procedures;

automatically machine sequencing said cleaning procedures;

monitoring during cleaning whether said dialyzer is reusable;

selectively controlling the sequencing of the procedures in said predetermined sequence in response to said monitoring.

4. A method of cleaning dialyzers having blood and dialysate sides comprising:

storing a predetermined sequence of cleaning procedures, said procedures including a plurality of test procedures which measure indicia of reusability of a dialyzer being cleaned;

automatically machine sequencing said cleaning procedures;

predetermining a set of reusability criteria adapted for each test procedure; and

selectively controlling the sequencing of cleaning procedures subsequent to each test procedure in response to the dialyzers measured indicia of reusability.

5. The method of claim 4 wherein said controlling comprises automatically inhibiting said cleaning sequence if said measured indicia do not meet any of said predetermined criteria.

17. A method for cleaning dialyzers having blood and dialysate sides comprising:

predetermining a plurality of cleaning procedures, each of said procedures being specifically different for each different type of dialyzer to be cleaned;

identifying the type of dialyzer to be cleaned;

selecting the appropriate cleaning procedure for the identified type of dialyzer to be cleaned; and

automatically machine sequencing said appropriate cleaning procedure for the identified dialyzer.

18. The method of claim 17, wherein said predetermined cleaning procedures include predetermined dialyzer cleaning steps, predetermined dialyzer testing steps, and predetermined reusability criteria for said dialyzer testing steps.

19. The method of claim 18, wherein said identifying step comprises reading a coded label with a photo-optical data reading wand.

20. The method of claim 18 further comprising:

sensing to determine whether the type of dialyzer has been identified; and

inhibiting said automatic machine sequence if said identification has not been made.

21. The method of claim 17 wherein one of said adapted cleaning procedures is adapted to a hollow fiber type dialyzer and another of said adapted cleaning procedures is adapted to both parallel plate and coil type dialyzers.

22. The method of claim 20 further comprising:

predetermining a sequence of first cleaning procedures common to all types of dialyzers and automatically sequencing said first common cleaning procedures.

23. The method of claim 22 further comprising:

predetermining a sequence of second cleaning procedures common to all types of dialyzers and automatically sequencing said second common cleaning procedures.

24. The method of claim 23 wherein the sequencing of said adapted cleaning procedure occurs between the sequencing of said first and second common cleaning procedures.

25. A method for cleaning dialyzers having blood and dialysate sides, comprising:

providing a plurality of different cleaning procedures, each said cleaning procedure being adapted to a particular type of dialyzer and including predetermined cleaning steps, predetermined testing steps to determine dialyzer reusability, and predetermined reusability criteria;

identifying the type of dialyzer to be cleaned; and

automatically machine sequencing the particular predetermined cleaning procedure adapted to said identified type of dialyzer.