Methods and apparatus for inactivating contaminants in biological fluid

• US 6,190,609 B1
• Filed: 05/18/1998
• Issued: 02/20/2001
• Est. Priority Date: 11/19/1996
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Larson, Dale N., Swallow, Michael V., Chapman, John R., Stark, Peter R. H.
• Primary Examiner(s): Thornton, Krisanne
• Application Number:
  US09/081,168
• Time in Patent Office: 1,009 Days
• Field of Search: 422/24, 422/28, 422/44, 435/283.1, 435/2, 604/4, 250/432.R
• US Class Current: 422/24
• CPC Class Codes: A61L 2/0011 using physical methods
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3683 using photoactive agents

Abstract

Apparatus and methods for treating a biological fluid with light and for inactivating contaminants in biological fluid. The biological fluid is contacted with a light source providing a high intensity light to the biological fluid. The biological fluid may include a quantity of a photochemical agent that when activated by light is operable to cause inactivation of at least some of the contaminants.

Claims

1. Apparatus for treating a biological fluid with light comprising:

a light chamber defined by at least two pair of facing, reflective walls wherein each of said pair of walls substantially defines a compound parabolic curve;

a high intensity light source disposed within said chamber; and

a fluid treatment region exterior to said light chamber, said fluid treatment region adapted to hold a quantity of biological fluid.

2. The apparatus of claim 1 wherein said apparatus is adapted to hold at least one flexible container of biological fluid within said fluid treatment region.

3. The apparatus of claim 1 wherein said light source provides a light having an intensity of at least 80 mW/cm².

4. The apparatus of claim 1 wherein said light source emits at least a portion of its light having wavelengths of between 570 and 690 nm.

5. The apparatus of claim 1 wherein said light source comprises a high pressure sodium light source.

6. The apparatus of claim 1 further comprising a sensor for measuring the amount of light contacting said biological fluid.

7. The apparatus of claim 1 further comprising a control system for ensuring that the amount of light contacting said biological fluid directly from said light source and from said reflective wall surface is at or above a selected minimum.

28. Apparatus of claim 1 wherein said light source provides light of an intensity between approximately 80-150 mW/cm².

8. A method for substantially inactivating contaminants in a biological fluid comprising:

providing a quantity of a biological fluid;

combining said biological fluid with a selected amount of a phenothiazine dye whereby the concentration of said phenothiazine dye is between approximately 2-4 μ

M; and

contacting said combination of biological fluid and phenothiazine dye with a high intensity light of greater than about 30 mW/cm².

9. The method of claim 8 wherein said phenothiazine dye comprises methylene blue.

10. The method of claim 8 wherein comprising contacting said combination for a period of time no greater than 5 minutes.

11. The method of claim 8 wherein said light source comprises a high pressure sodium light source.

12. The method of claim 8 further comprising contacting said combination with an amount of light between 35-50 J/cm².

13. The method of claim 8 wherein said biological fluid comprises blood plasma that is substantially free of red blood cells.

14. The method of claim 13 wherein after contacting, said plasma is substantially free of contaminants and comprises at least 60% of its original fibrinogen, Factor VIII and Factor XI.

29. The method of claim 9 wherein the intensity of said light is between approximately 80-150 mW/cm².

15. Apparatus for inactivating contaminants in a biological fluid comprising:

a first high intensity light source for providing light having an intensity of between approximately 80-150 mW/cm² in the wavelength range of between approximately 550-700 nm;

a second high intensity light source for providing light having an intensity of between approximately 80-150 mW/cm² in the wavelength range of between approximately 550-700 nm; and

a fluid treatment region located between said first and second light sources, wherein each of said light sources is separated from said fluid treatment region by a window which substantially transmits light in said wavelength range but does not substantially transmit selected unwanted light.

16. Apparatus of claim 15 wherein each of said light sources comprises a high pressure sodium light source.

17. Apparatus of claim 15 further comprising a sensor for monitoring the temperature within said fluid treatment region.

18. Apparatus of claim 15 further comprising a sensor for monitoring the level of useful energy contacting said biological fluid.

19. Apparatus of claim 18 further comprising a control system operably connected to said sensor and to said light sources for ensuring that the level of said useful energy contacting said biological fluid is between about 20 and 50 Joules/cm².

20. Apparatus of claim 15 further comprising a tray for holding a plastic container of said biological fluid, said tray adapted for movement into and out of said fluid treatment region.

21. Apparatus of claim 15 wherein each of said first and second light sources are housed within a light chamber.

22. Apparatus of claim 21 wherein the interior of said light chamber is comprised of a reflective material.

23. Apparatus of claim 22 wherein the interior of said chamber is defined by at least two pair of facing walls, each of said pair of walls substantially defining a compound parabolic curve.

24. Apparatus of claim 15 wherein said unwanted light comprises light in the infrared light range.

25. Apparatus of claim 24 further comprising a filter for reducing the amount of infrared light contacting said fluid.

26. Apparatus of claim 24 wherein at least a portion of said window is treated with a substance capable of reducing the amount of unwanted light contacting said fluid.

27. Apparatus of claim 24 wherein at least a portion of said window is treated by physical vapor deposition of a material that reduces the amount of unwanted light from contacting said fluid.