Extracorporeal pathogen reduction system

• US 7,470,245 B2
• Filed: 06/22/2005
• Issued: 12/30/2008
• Est. Priority Date: 02/02/2000
• Status: Expired due to Fees

• Current Assignee: Xepmed Incorporated
• Original Assignee: Xepmed Incorporated
• Inventors: Chang, Yu-An, Tu, Hosheng, Lin, Hun-Chi
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US11/158,814
• Publication Number:
  US 20050274672A1
• Time in Patent Office: 1,287 Days
• Field of Search: 604/4.01, 604/5.01, 604/5.02, 604/5.04, 604/6.01, 604/6.04, 604/6.08, 604/6.09, 210/645
• US Class Current: 604/6.09
• CPC Class Codes: A61M 1/26 and internal elements which are moving
• CPC Class Codes: A61M 1/262 rotating
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3683 using photoactive agents
• CPC Class Codes: B01D 2321/2058 by vibration of the membrane, e.g. with an actuator
• CPC Class Codes: B01D 2321/24 Magnetic effects
• CPC Class Codes: B01D 61/145 Ultrafiltration
• CPC Class Codes: B01D 63/087 Single membrane modules
• CPC Class Codes: B01D 65/08 Prevention of membrane fouling or of concentration polarisation

Abstract

The invention relates to an apparatus system and methods for treatment of virus-infected or pathogen-loaded human blood components separated from normal components comprising a separation apparatus and treatment apparatus system that inactivate pathogens in an extracorporeal blood system.

Claims

1. A method of extracorporeally treating a patient with a pathogen burden comprising:

(a) filtering the patient'"'"'s blood through a blood filtration apparatus configured for separating a plasma constituent from the blood, wherein the blood filtration apparatus comprises a chamber having a hollow interior enclosed by a first plate, a second plate, and a flexible seal element between the first plate and the second plate, wherein the first plate is either essentially parallel to or at an acute angle to the second plate so as to form a chamber gap for the hollow interior;

means for directing blood into the chamber gap;

a non-rotational drive structure;

said second plate comprising the filter membrane means for separating plasma constituent from the blood, wherein the second plate is detachably coupled to said non-rotational drive structure that controls the second plate in an orbital motion in reference to a center axis of the first plate;

a collecting means;

means for directing the plasma constituent passing through said filter membrane means to said collecting means; and

means for directing from the chamber gap a remaining constituent of the blood out of the chamber;

(b) passing the plasma constituent through a pathogen-reduction means for reducing the pathogen burden in the plasma constituent;

(c) returning cellular components of the patient'"'"'s blood back to said patient; and

(d) returning the treated plasma back to said patient.

2. The method of claim 1, wherein the pathogen burden is from a pathogen source of mutated viruses.

3. The method of claim 1, wherein the blood filtration apparatus is operated at a collection rate of at least 27 ml/sec/cm².

4. The method of claim 1, further comprising a step of purifying said plasma constituent, wherein the purifying step removes unwanted solids from the plasma constituent.

5. The method of claim 1, wherein the pathogen-reduction means comprises at least one photosensitizer being added into the plasma constituent and a step of photosensitized inactivation with an effective amount of radiation to the plasma constituent.

6. The method of claim 5, wherein the photosensitizer is selected from a group consisting of vitamin B2, vitamin K1, vitamin K2, vitamin K5, vitamin K6, vitamin K7, vitamin K-S(II), vitamin L, and alloxazine compounds.

7. The method of claim 5, wherein the effective amount of radiation is at least 1 Joule per ml of plasma constituent for a period at least 1 second of radiation time.

8. The method of claim 1, wherein the pathogen-reduction means comprises an organic solvent being added into the plasma constituent in an amount and for a period of time sufficient to inactivate said pathogen, wherein the organic solvent is selected from a group consisting of ethers, alcohols, volatile chlorinated hydrocarbons, acetone and chloroform.

9. The method of claim 1, wherein the pathogen-reduction means comprises cyclodextrin being added into the plasma constituent in an amount and for a period of time sufficient to inactivate said pathogen, wherein the cyclodextrin is selected from a group consisting of an α

-cyclodextrin, a β

-cyclodextrin, a γ

-cyclodextrin and a derivative thereof.

10. The method of claim 9, wherein the pathogen-reduction means further comprises cladribine being added into the plasma constituent in an amount and for a period of time sufficient to inactivate said pathogen.

11. The method of claim 1, wherein the pathogen is selected from a group consisting of HBV, HCV, HAV, HIV-1, HIV-2, HHV-6, HSV-1, HSV-2, CMV, EBV, rotavirus, adenoviruses, respiratory syncytial virus, parvovirus B19, Ebola virus, Varicella-zoster virus, poliovirus, Dengue virus, Haemophilus influenza, measles virus, mumps virus, influenza viruses, bovine viral diarrhea virus, vesicular stomatitis virus, West Nile virus, canine parvovirus, porcine parvovirus, aspergillus app, candida spp, Gram positive bacteria, Gram negative bacteria, Pseudomonas aerogenosa, Clamydia pneumoniae, E. coli, S. epidermidis, S. aureus, B. cereus, Mycobacterium tuberculosis, and parasites.

12. A method of treating a patient with acute infections, sepsis, acute enterovirus infection or fulminant hepatitis comprising:

(a) filtering the patient'"'"'s blood though a blood filtration apparatus configured for separating a plasma constituent from the blood, wherein the blood filtration apparatus comprises a chamber having a hollow interior enclosed by a first plate, a second plate, and a flexible seal element between the first plate and the second plate, wherein the first plate is either essentially parallel to or at an acute angle to the second plate so as to form a chamber gap for the hollow interior;

means for directing blood into the chamber gap;

a non-rotational drive structure;

said second plate comprising the filter membrane means for separating plasma constituent from the blood, wherein the second plate is detachably coupled to said non-rotational drive structure that controls the second plate in an orbital motion in reference to a center axis of the first plate;

a collecting means;

means for directing the plasma constituent passing through Mid filter membrane means to said collecting means; and

means for directing from the chamber gap a remaining constituent of the blood out of the chamber;

(b) passing the plasma constituent trough pathogen-reduction means for reducing the pathogen burden in the plasma constituent; and

(c) returning cellular components and the cleaned plasma of the patient'"'"'s blood back to said patient.

13. The method of claim 12, further comprising a step of removing unwanted solids from the plasma constituent before the passing step.

14. The method of claim 13, wherein the removing step is carried out by centrifugation, membrane filtering, or an adsorption process.

15. A method of treating a patient with an acute phase biodefense disease comprising:

(a) filtering the patient'"'"'s blood through a blood filtration apparatus configured for separating a plasma constituent from the blood, wherein the blood filtration apparatus comprises a chamber having a hollow interior enclosed by a first plate, a second plate, and a flexible seal element between the first plate and the second plate, wherein the first plate is either essentially parallel to or at an acute angle to the second plate so as to form a chamber gap for the hollow interior;

means for directing blood into the chamber gap;

a non-rotational drive structure;

said second plate comprising the filter membrane means for separating plasma constituent from the blood, wherein the second plate is detachably coupled to said non-rotational drive structure that controls the second plate in an orbital motion in reference to a center axis of the first plate;

a collecting means;

means for directing the plasma constituent passing through said filter membrane means to said collecting means; and

means for directing from the chamber gap a remaining constituent of the blood out of the chamber;

(b) passing the plasma constituent through pathogen-reduction means for reducing the pathogen burden in the plasma constituent; and

(c) returning cellular components and cleaned plasma of the patient'"'"'s blood back to said patient.

16. The method of claim 15, further comprising a step of removing hemoglobin or particles from the plasma constituent before the passing step.

17. The method of claim 15, wherein the biodefense disease is selected from a group consisting of severe acute respiratory syndrome, seasonal flu, avian flu, anthrax, and Pandemic flu.