Apparatus and method for inactivating viral contaminants in body fluids

• US 6,800,432 B1
• Filed: 09/29/2000
• Issued: 10/05/2004
• Est. Priority Date: 12/06/1994
• Status: Expired due to Fees

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Foley, John, Bratten, William, Wolf, Ludwig Jr.
• Primary Examiner(s): Marx, Irene
• Application Number:
  US09/675,511
• Time in Patent Office: 1,467 Days
• Field of Search: 435/2, 435/238
• US Class Current: 435/2
• CPC Class Codes: A61L 2/0011 using physical methods
• CPC Class Codes: A61L 2/0082 using chemical substances
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: C12M 37/00 Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination C12M23/38 takes precedence; filtration in general and filters per se B01D24/00-B01D41/00; autoclaves B01J3/04; treatment of microorganisms with electrical or wave energy C12N13/00
• CPC Class Codes: C12N 7/04 Inactivation or attenuation; Producing viral sub-units

Abstract

A method and apparatus for inactivating viruses in a body fluid. A mixture including a therapeutically effective amount of methylene blue and an amount of a body fluid is formed in a container under sterile conditions and then the container is irradiated with a light field of a suitable intensity and wavelength for activating the methylene blue for a time sufficient to inactivate viruses in the mixture. The mixture is maintained in a substantially static state within the container.

Claims

1. A method for inactivating viruses in a blood or blood component, the method comprising the steps of:

initially storing an amount of methylene blue and an amount of the blood or blood component in separate sterile containers, each container having an inner surface made of a non-polyvinyl chloride, plastic material and the container in which the blood or blood component is stored includes portions that are made of a polyvinyl chloride material;

forming a mixture by adding at least a portion of the amount of the methylene blue to the amount of the blood or blood component wherein the portion of methylene blue is a virucidally effective amount of the methylene blue and further wherein the mixture formed is within one of the containers in which the methylene blue or blood or blood component is initially stored under sterile conditions; and

irradiating the mixture with a light field of a suitable intensity and wavelength for activating the methylene blue for a time sufficient to inactivate viruses in the mixture, while maintaining the mixture under a substantially no flow condition within the container in which the mixture is formed.

2. The method of claim 1 wherein the blood component is selected from the group consisting of:

plasma, red blood cells, white blood cells, and platelets.

3. The method of claim 1 further comprising the step of:

adding the methylene blue to the container in which the blood or blood component is already stored.

4. The method of claim 1 further comprising the step of:

adding the blood or blood component to the container that contains methylene blue.

5. The method of claim 1 further comprising the step of:

transporting the mixture in the container in which the mixture is formed on a conveyor past at least two light sources.

6. The method of claim 1 wherein the light field is generated by at least one array of light emitting diodes.

7. The method of claim 1 wherein the mixture is irradiated by the light field for a cumulative period of at least five minutes.

8. A method for inactivating viruses in a blood or blood component, the method comprising the steps of:

initially storing an amount of methylene blue having a pH of less than 7.0 in a container that includes an interior and at least one port extending from the container that provides controlled access to the interior, the container is constructed of a plastic material and includes an inner surface made of a non-polyvinyl chloride, plastic material;

forming a mixture by adding at least a portion of the amount of the methylene blue to an amount of the blood or blood component, by use of the port, wherein the portion of methylene blue is a virucidally effective amount of the methylene blue and further wherein the mixture formed is within either the container or in a second container that initially housed the blood or blood components; and

irradiating the mixture with a light field of a suitable intensity and wavelength for activating the methylene blue for a time sufficient to inactivate viruses in the mixture, while maintaining the mixture under a substantially no flow condition within the container in which the mixture is formed.

9. The method of claim 8 wherein the blood component is selected from the group consisting of:

plasma, red blood cells, white blood cells, and platelets.

10. The method of claim 8 further comprising the step of:

adding the methylene blue to the second container in which the blood or blood component is housed.

11. The method of claim 8 wherein the container in which the mixture is formed includes a polyvinyl chloride material.

12. The method of claim 8, wherein the light field is generated by at least one array of light emitting diodes.

13. The method of claim 8 wherein the mixture is irradiated by the light field for a cumulative period of at least five minutes.

14. A method for inactivating viruses in a blood or blood component, the method comprising the steps of:

initially storing an amount of methylene blue in a container that includes an interior and at least one port extending from the container that provides controlled access to the interior, the container is constructed of a plastic material and includes an inner surface made of a non-polyvinyl chloride, plastic material;

forming a mixture bv adding at least a portion of the amount of the methylene blue to an amount of the blood or blood component, by use of the port, wherein the portion of methylene blue is a virucidally effective amount of the methylene blue and further wherein the mixture formed is within either the container or in a second container that initially housed the blood or blood component;

irradiating the mixture with a light field of a suitable intensity and wavelength for activating the methylene blue for a time sufficient to inactivate viruses in the mixture, while maintaining the mixture under a substantially no flow condition within the container in which the mixture is formed;

wherein the container in which the mixture is formed does not include any polyvinyl chloride plastic.

15. A method for inactivating viruses in a blood or blood component, the method comprising the steps of:

initially storing an amount of methylene blue in a container that includes an interior and at least one port extending from the container that provides controlled access to the interior, the container is constructed of a plastic material and includes an inner surface made of a non-polyvinyl chloride, plastic material;

forming a mixture by adding the blood or blood component to the container that contains methylene blue, by use of the port, wherein the portion of methylene blue is a virucidally effective amount of the methylene blue; and

irradiating the mixture with a light field of a suitable intensity and wavelength for activating the methylene blue for a time sufficient to inactivate viruses in the mixture, while maintaining the mixture under a substantially no flow condition within the container in which the mixture is formed.

16. A method for inactivating viruses in a blood or blood component, the method comprising the steps of:

initially storing an amount of methylene blue in a container that includes an interior and at least one port extending from the container that provides controlled access to the interior, the container is constructed of a plastic material and includes an inner surface made of a non-polyvinyl chloride, plastic material;

forming a mixture by adding at least a portion of the amount of the methylene blue to an amount of the blood or blood component, by use of the port, wherein the portion of methylene blue is a virucidally effective amount of the methylene blue and further wherein the mixture formed is within either the container or in a second container that initially housed the blood or blood component; and

irradiating the mixture with a light field of a suitable intensity and wavelength for activating the methylene blue for a time sufficient to inactivate viruses in the mixture, while maintaining the mixture under a substantially no flow condition within the container in which the mixture is formed;

wherein the container in which the mixture is formed comprises at least an inner surface made of a non-polyvinyl chloride material.

17. A method for inactivating viruses in a blood or blood component the method comprising the steps of:

initially storing an amount of methylene blue in a container that includes an interior and at least one port extending from the container that provides controlled access to the interior, the container is constructed of a plastic material and includes an inner surface made of a non-polyvinyl chloride, plastic material;

forming a mixture by adding at least a portion of the amount of the methylene blue to an amount of the blood or blood component, by use of the port, wherein the portion of methylene blue is a virucidally effective amount of the methylene blue and further wherein the mixture formed is within either the container or in a second container that initially housed the blood or blood component;

transporting the mixture in the container in which the mixture is formed on a conveyor past at least two light sources; and

irradiating the mixture with a light field of a suitable intensity and wavelength for activating the methylene blue for a time sufficient to inactivate viruses in the mixture, while maintaining the mixture under a substantially no flow condition within the container in which the mixture is formed.

18. A method for inactivating viruses in a blood or blood component, the method comprising the steps of:

initially storing an amount of methylene blue in a container that includes an interior and at least one port extending from the container that provides controlled access to the interior, the container is constructed of a plastic material and includes an inner surface made of a non-polyvinyl chloride, plastic material;

forming a mixture by adding at least a portion of the amount of the methylene blue to an amount of the blood or blood component, by use of the port, wherein the portion of methylene blue is a virucidally effective amount of the methylene blue and further wherein the mixture formed is within either the container or in a second container that initially housed the blood or blood component;

allowing excess methylene blue to leach into the container in which the blood or blood component is stored after mixture with the methylene blue; and

irradiating the mixture with a light field of a suitable intensity and wavelength for activating the methylene blue for a time sufficient to inactivate viruses in the mixture, while maintaining the mixture under a substantially no flow condition within the container in which the mixture is formed.