Method and apparatus for sterilizing a heat sensitive fluid

• US 6,818,179 B1
• Filed: 04/15/2002
• Issued: 11/16/2004
• Est. Priority Date: 03/30/1999
• Status: Expired due to Fees

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Dunkley, Michael John, Wilkinson, Eric, Hammond, Richard J., Edgson, Raymond Anthony
• Primary Examiner(s): JASTRZAB, KRISANNE MARIE
• Application Number:
  US09/937,738
• Time in Patent Office: 946 Days
• Field of Search: 422/38, 422/41, 422/1, 422/307, 422/308, 210/143, 210/149, 426/521, 426/522, 994/83
• US Class Current: 422/38
• CPC Class Codes: A61L 2/0023 Heat
• CPC Class Codes: A61L 2/04 Heat A61L2/08 takes precedence

Abstract

Methods and apparatus for sterilizing heat sensitive fluids are provided. The methods include providing a first heat sensitive fluid component, providing a second fluid component, heating the second fluid component to a temperature greater than a predetermined sterilizing temperature, mixing the first heat sensitive fluid component with the heated second fluid component to heat the first heat sensitive fluid components and provide a mixed fluid at a temperature at least up to the predetermined sterilizing temperature, and maintaining the mixed fluid at that temperature for a predetermined sterilizing period. Apparatus for carrying out this method is also provided.

Claims

1. A method for sterilizing a heat sensitive fluid in a medical solution comprising providing a first heat sensitive fluid component, providing a second fluid component, heating said second fluid component to a first temperature, said first temperature being greater than a predetermined sterilizing temperature, mixing said first heat sensitive fluid component with said heated second fluid component, whereby said first heat sensitive fluid component is heated and said heated second fluid component is cooled, and a mixed fluid is provided at a second temperature, said second temperature being at least said predetermined sterilizing temperature, and maintaining said mixed fluid at said second temperature for a predetermined sterilizing period, whereby a predetermined sterilizing dose is obtained for delivery to a recipient.

2. The method of claim 1 including controlling said heating of said second fluid component to said first temperature to ensure that said mixed fluid reaches said second temperature.

3. The method of claim 1 including cooling said mixed fluid.

4. The method of claim 1 wherein said first heat sensitive fluid component comprises a component selected from the group consisting of glucose and a glucose polymer.

5. The method of claim 1 wherein said second fluid component comprises water.

6. The method of claim 5 wherein said second fluid component includes electrolytes.

7. The method of claim 6 wherein said electrolytes are selected from the group consisting of sodium chloride, calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate, and sodium lactate.

8. The method of claim 1 including preheating said first heat sensitive fluid component.

9. The method of claim 1 including maintaining said first heat sensitive fluid component and said second fluid component under a predetermined pressure sufficient to prevent boiling of said first heat sensitive fluid component and said second fluid component.

10. The method of claim 9 wherein said providing of said first heat sensitive fluid component and providing of said second fluid component comprises providing flows of said fluid components.

11. The method of claim 10 wherein said flow of said first heat sensitive fluid component comprises a first flow rate and said flow of said second fluid component comprises a second flow rate, said second flow rate being greater than said first flow rate.

12. The method of claim 10 including determining said first and second flow rates by means of a weighing device or a flow meter, and maintaining said first heat sensitive fluid component and said second fluid component at said predetermined pressure by means of a pump.

13. The method of claim 10 wherein said heat sensitive fluid component comprises a complex fluid comprising a plurality of first fluid components including said first heat sensitive fluid component, and including sequentially sterilizing said plurality of first fluid components.

14. The method of claim 13 including providing a plurality of sources of concentrate fluid components for each of said plurality of first fluid components, providing a source of said second fluid component, said second fluid component comprising water, pumping one of said plurality of sources of said concentrate fluid components so as to increase the pressure thereof, pumping said water so as to increase the pressure thereof, and repeating said method for each of said plurality of first fluid components.

15. The method of claim 14 including preheating each of said plurality of first fluid components before said mixing with said heated second fluid component.

16. The method of claim 15 wherein said preheating comprises heat exchanging each of said plurality of said first fluid components with said predetermined sterilized dose.

17. The method of claim 16 wherein said preheating comprises initially heating said second fluid component by heat exchange with said predetermined sterilized dose, and further preheating said second fluid component to said first temperature by means of a separate heater.

18. The method of claim 17 wherein said separate heater comprises an electric heater.

19. The method of claim 18 including controlling said further preheating of said second fluid component by means of a temperature sensor downstream of said maintaining of said mixed fluid at said second temperature, whereby said second temperature is maintained at said at least said predetermined sterilizing temperature.

20. The method of claim 1 including dissolving at least one powdered substance in said second fluid component to provide at least one of said first heat sensitive fluid components and said second fluid component.

21. The method of claim 1 including providing a third heat sensitive fluid component, and mixing said first heat sensitive fluid component and said third heat sensitive fluid component with said heated second fluid component.

22. The method of claim 21 wherein said third heat sensitive fluid component comprises water and at least one amino acid.

23. Apparatus for sterilizing a heat sensitive fluid in a medical solution comprising a first vessel containing a first heat sensitive fluid component, a second vessel containing a second fluid component, a first heater for heating said second fluid component to a first temperature, said first temperature being greater than a predetermined sterilizing temperature, mixing means for mixing said first heat sensitive fluid component with said second fluid component to obtain a mixed fluid at a second temperature at least equal to said predetermined sterilizing temperature, and residence means for maintaining said mixed fluid at said second temperature for a predetermined sterilizing period, whereby a sterilized fluid is provided for delivery to a recipient.

24. The apparatus of claim 23 including a controller for controlling said first heater to obtain said first temperature.

25. The apparatus of claim 23 including a cooler for cooling said mixed fluid.

26. The apparatus of claim 23 wherein said first heat sensitive fluid component comprises a component selected from the group consisting of glucose and a glucose polymer.

27. The apparatus of claim 23 wherein said second fluid component comprises water.

28. The apparatus of claim 27 wherein said second fluid component includes an electrolyte.

29. The apparatus of claim 28 wherein said electrolyte is selected from the group consisting of sodium chloride, calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate and sodium lactate.

30. The apparatus of claim 23 including a preheater for preheating said first heat sensitive fluid component.

31. The apparatus of claim 23 including pressurizing means for maintaining said first heat sensitive fluid component and said second fluid component at a predetermined pressure to prevent said first heat sensitive fluid component and said second fluid component from boiling.

32. The apparatus of claim 23 wherein said first heat sensitive fluid component and said second fluid component comprise fluid flows.

33. The apparatus of claim 32 wherein said fluid flow of said first heat sensitive fluid component has a first flow rate and said fluid flow of said second fluid component has a second flow rate, said second flow rate being greater than said first flow rate.

34. The apparatus of claim 33 including flow rate determining means for determining said first and second flow rates, said pressurizing means comprising a pump.

35. The apparatus of claim 34 wherein said flow rate determining means comprises a weighing device or a flow meter.

36. The apparatus of claim 32 wherein said first heat sensitive fluid component comprises a plurality of first fluid components including said first heat sensitive fluid component, and including means for sequentially sterilizing each of said plurality of first fluid components and said second fluid component.

37. The apparatus of claim 36 wherein said means for sequentially sterilizing includes supply means for supplying said plurality of first fluid components, said first vessel comprising a plurality of containers for concentrates of said plurality of first fluid components, said second vessel comprising an inlet for said second fluid component, a concentrate pump for pumping one of said plurality of first fluid components from one of said plurality of containers whereby the pressure of said one of said first fluid components is increased, a water pump for pumping said second fluid component, said second fluid component comprising water, whereby the pressure of said second fluid component is increased, said heater comprising a water heater for heating said second fluid component to said first temperature, said mixing means comprising a mixer for mixing said one of said plurality of first fluid components and said heated second fluid component to provide said mixed fluid, said residence means comprising means for maintaining said mixed fluid at said first temperature for a predetermined sterilizing period to provide a sterilized dose for delivery to a recipient, and including control means for controlling and repeating said sequential sterilizing of each of said plurality of first fluid components to provide a final sterilized complex fluid.

38. The apparatus of claim 37 including preheating means for preheating said one of said plurality of first fluid components.

39. The apparatus of claim 38 including a heat exchanger for recovering heat from said sterilized dose.

40. The apparatus of claim 39 wherein said heat exchanger preheats said second fluid component by heat exchange with said sterilized dose, and including a heater for heating said second fluid component to said first temperature.

41. The apparatus of claim 40 including a temperature sensor downstream of said residence means for controlling said heater, whereby said first temperature comprises a temperature at least sufficient to constitute said sterilizing temperature.

42. The apparatus of claim 23 wherein at least one of said first and second vessels includes at least one powdered substance for dissolution in water to provide at least one of said first and second fluids.

43. The apparatus of claim 23 including a third vessel for containing a third heat sensitive fluid component.

44. The apparatus of claim 43 wherein said third heat sensitive fluid component comprises water and at least one amino acid.