Dialysis machine and process for its disinfection

• US 6,379,617 B1
• Filed: 10/02/1997
• Issued: 04/30/2002
• Est. Priority Date: 10/02/1996
• Status: Expired due to Fees

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Spickermann, Reiner
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US08/942,931
• Time in Patent Office: 1,671 Days
• Field of Search: 210/645-46, 210/749, 210/753-4, 210/756, 210/758-60, 422/44-48, 422/28-31, 422/1, 422/37, 422/291-2, 604/4-5, 604/4.01, 604/5.01
• US Class Current: 422/44
• CPC Class Codes: A61L 2/183 Ozone dissolved in a liquid
• CPC Class Codes: A61L 2/186 Peroxide solutions
• CPC Class Codes: A61M 1/1674 using UV radiation sources for sterilising the dialysate
• CPC Class Codes: A61M 1/169 using chemical substances

Abstract

Dialysis machine with means for the on-line generation of at least one disinfecting agent that can be used for the disinfection of the dialysis machine as well as the process for the disinfection of a dialysis machine.

Claims

1. A system for disinfecting a medical apparatus comprising:

(a) an integrated means for chemical generation of at least one disinfecting agent;

(b) a feed mechanism in fluid communication with the chemical generation means;

(c) a medical apparatus in fluid communication with the feed mechanism; and

(d) a catalytic decomposition unit connected to the medical apparatus, which is adapted to receive or decompose the disinfecting agent.

2. The system according to claim 1 wherein the medical apparatus is a dialysis machine.

3. The system according to claim 1 wherein the disinfecting agent is selected from the group consisting of NaOCl, ozone, and mixtures thereof.

4. A system for the disinfection of a dialysis machine, comprising:

a. a NaOCl generator in fluid communication with a feed mechanism;

b. an ozone generator in fluid communication with the feed mechanism;

c. a means for combining NaOCl, or ozone, or mixtures thereof with ultrapure water, to produce a disinfecting solution for disinfecting the dialysis machine;

d. means for feeding the disinfecting solution through the dialysis machine, which is connected to the combining means;

e. a decomposition unit having an inlet in fluid communication with the dialysis machine, wherein the unit is constructed and arranged for decomposing the NaOCl and ozone in the disinfecting solution flowing from the dialysis machine into NaCl and O₂, following the disinfection of the dialysis machine; and

f. means in communication with an outlet of the decomposition unit for providing some portion of the NaCl formed by decomposition to the NaOCl generator.

5. The system of claim 4 wherein the system is located external to the dialysis machine.

6. The system of claim 4 wherein the system is integrated into the dialysis machine.

7. A medical apparatus, comprising:

a dialysis machine including a system for disinfecting the dialysis machine comprising;

a. NaOCl generator in fluid communication with a feed mechanism;

b. an ozone generator in fluid communication with the feed mechanism;

c. a means for combining NaOCl, ozone, or mixtures thereof with ultrapure water to produce a disinfecting solution for disinfecting the dialysis machine;

d. means for feeding the disinfecting solution through a dialysate flow path in the dialysis machine, wherein the feeding means is connected to the combining means;

e. means for rinsing the dialysis machine with ultrapure water following disinfection;

f. a redox electrode connected to the dialysate flow path, which is constructed and arranged for determining the amount of disinfectant in the dialysis machine;

g. a catalytic decomposition unit connected to the dialysate flow path, which is constructed and arranged for receiving the disinfecting solution and for decomposing the NaOCl and ozone in the disinfecting solution into NaCl and O₂ following disinfection; and

h. providing means connected to the catalytic decomposition unit for providing some or all of the NaCl formed in the decomposition unit to the NaOCl generator.

8. The apparatus according to claim 7 further comprising means for controlling the disinfection, catalytic decomposition and rinsing of the dialysis machine based on disinfectant levels determined by the redox electrode.

9. The apparatus according to claim 7 wherein the dialysis machine further comprises a UV photo-oxidation unit connected to the rinsing means for the production of rinse water selected from the group consisting of ultrapure water, sterile water and mixtures thereof, and wherein the dialysis machine is rinsed with the rinse water.

10. A process for disinfecting a medical apparatus which comprises chemically generating at least one disinfecting agent on-line, contacting the areas of the medical apparatus to be disinfected with the disinfecting agent, and decomposing the disinfecting agent.

11. The process according to claim 10 wherein the medical apparatus is a dialysis machine.

12. The process according to claim 10 wherein the disinfecting agent is selected from the group consisting of NaOCl, ozone and mixtures thereof.

13. The process according to claim 12 wherein the NaOCl is decomposed into NaCl and O₂ or other environmentally compatible decomposition products.

14. The process of claim 10 further comprising combining the disinfectant produced on-line with ultrapure water to form a disinfecting solution and contacting the medical apparatus with the disinfecting solution.

15. The process of claim 14 wherein the ultrapure water is formed by subjecting reverse osmosis water to UV photo-oxidation.

16. The process of claim 15 wherein the UV photo-oxidation is provided by either a low pressure mercury lamp, a high purity quartz lamp, or a combination thereof.

17. The process according to claim 10 further comprising rinsing the medical apparatus using ultrapure water, sterile water, or mixtures thereof.

18. A process for disinfecting a dialysis machine, which comprises:

a. producing NaOCl using an on-line NaOCl generator;

b. combining the NaOCl with ultrapure water to produce a disinfecting solution;

c. contacting the areas of the dialysis machine to be disinfected with the disinfecting solution;

d. catalytically decomposing the NaOCl into NaCl and O₂ after the dialysis machine has been disinfected;

e. providing NaCl to the NaOCl generator for on-line production of NaOCl;

f. determining the amount of disinfectant present in the dialysis machine using a redox electrode; and

g. rinsing the dialysis machine to remove disinfectant after disinfection.

19. The process according to claim 18 further comprising producing ozone using an on-line ozone generator and combining the ozone with the ultrapure water to form a disinfecting solution.

20. The process according to claim 18 further comprising controlling the disinfection, rinsing or catalytic decomposition processes according to the level of disinfectant determined by the redox electrode.

21. The process according to claim 18 wherein the dialysis machine is rinsed using ultrapure water, sterile water or mixtures thereof.

22. The process according to claim 18 wherein the process is carried out within the dialysis machine.

23. The process according to claim 18 wherein one or more steps are carried out external to the dialysis machine.

24. A system for disinfecting a medical apparatus comprising:

(a) an integrated means for chemical generation of at least one disinfecting agent;

(b) a feed mechanism in fluid communication with the chemical generation means;

(c) a medical apparatus in fluid communication with the feed mechanism; and

(d) means for decomposing the disinfecting agent that is in fluid connection with the medical apparatus and is constructed and arranged for accepting and decomposing the disinfecting agent after it contacts the medical apparatus,

wherein the disinfecting agent generation means provides the disinfecting agent to the medical apparatus via the feed mechanism, the disinfecting agent flows through the medical apparatus and into the decomposition means where it is decomposed.

25. The system according to claim 24 wherein the disinfecting agent is capable of being decomposed into NaCl and O₂ or other environmentally compatible decomposition products.

26. The system according to claim 25 further comprising a pipe system, or other conduction system, for providing some portion of the NaCl produced through decomposition of NaOCl to the NaOCl generator.

27. A process for disinfecting a medical apparatus which comprises chemically producing at least one disinfecting agent on-line, contacting the areas of the medical apparatus to be disinfected with the disinfecting agent, and decomposing the disinfecting agent after the medical apparatus has been contacted.

28. A system for disinfecting a medical apparatus comprising:

(a) an integrated means for chemical generation of at least one disinfecting agent;

(b) a feed mechanism in fluid communication with the chemical generation means;

(c) a medical apparatus in fluid communication with the feed mechanism;

and

(d) a redox electrode connected to the medical apparatus for determining the level of disinfecting agent remaining in the medical apparatus.

29. A process for disinfecting a medical apparatus which comprises chemically generating a disinfecting agent selected from the group consisting of NaOCl, ozone and mixtures thereof, contacting the areas of the medical apparatus to be disinfected with the disinfectant, and decomposing the NaOCl into NaCl and O₂ or other environmentally compatible decomposition products.

30. A process disinfecting a medical apparatus which comprises chemically producing at least one disinfecting agent on-line, contacting the areas of the medical apparatus to be disinfected with the disinfectant, and determining the amount of disinfectant present in the apparatus using a redox electrode.