Leucocyte depleting filter device and method of use

• US 5,258,127 A
• Filed: 09/11/1991
• Issued: 11/02/1993
• Est. Priority Date: 07/27/1990
• Status: Expired due to Term

• Current Assignee: Pall Corporation (Danaher Corporation)
• Original Assignee: Pall Corporation (Danaher Corporation)
• Inventors: Bormann, Thomas, Matkovich, Vlado I., Gsell, Thomas C.
• Primary Examiner(s): Dawson, Robert A.
• Assistant Examiner(s): Kim, Sun U.
• Application Number:
  US07/756,567
• Time in Patent Office: 783 Days
• Field of Search: 210/691, 210/750, 210/767, 210/788, 210/805, 210/188, 210/436, 210/422, 210/512.1, 210/489, 210/492, 210/496, 210/502.1, 210/493.1, 210/497.01, 210/487 , 210/503, 210/508, 210/748, 427/40, 427/41, 427/569, 55/159, 55/185, 55/186, 55/187, 55/204, 55/178, 604/4, 604/5, 604/122, 604/126, 428/409
• US Class Current: 210/767
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 2202/0057 retained by adsorption
• CPC Class Codes: A61M 2202/025 Helium
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2202/0291 Xenon
• CPC Class Codes: A61M 2202/0439 White blood cells; Leucocytes
• CPC Class Codes: A61M 2205/7536 allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• CPC Class Codes: A61M 2206/16 Rotating swirling helical flow, e.g. by tangential inflows
• CPC Class Codes: B01D 39/1623 of synthetic origin
• CPC Class Codes: B01D 67/009 with wave-energy, particle-radiation or plasma
• CPC Class Codes: B29C 59/142 of profiled articles, e.g. hollow or tubular articles
• CPC Class Codes: B29K 2105/04 cellular or porous

Abstract

Leucocyte depletion filter assemblies decrease the leucocyte content of a biological fluid in an extracorporeal circuit. These filter assemblies are suitable for use in an extracorporeal circuit. Methods for removing leucocytes and other deleterious matter are also disclosed. The removal medium used in these assemblies and methods may be pleated structures which have been subjected to gas plasma treatment, improving the amount of leucocytes removed and increasing the amount of platelets which pass through the medium.

Claims

1. A leucocyte depletion filter assembly for removing leucocytes and other deleterious mater from a biological fluid in an extracorporeal circuit, the filter assembly comprising:

a housing having an inlet and an outlet and defining a liquid flow path between the inlet and the outlet, and

a pleated medium positioned inside the housing across the liquid flow path and including a fibrous means for decreasing the leucocyte content of the liquid, the surface of said fibrous means being modified by exposure to a gas plasma stream, wherein said fibrous means is capable of permitting the passage of red blood cells and platelets therethrough.

2. The leucocyte depletion filter assembly of claim 1 having a capacity of six liters per minute at a differential pressure less than 15 psi.

3. The leucocyte depletion filter assembly of claim 1 having a hold up volume in the range from about 70 cc to about 400 cc.

4. The leucocyte depletion filter assembly of claim 1 wherein the fibrous means has a hollow, generally cylindrical configuration.

5. The leucocyte depletion filter assembly of claim 1 wherein the fibrous means has a CWST of at least 52 dynes/cm.

6. The leucocyte depletion filter assembly of claim 1, wherein said gas plasma is generated from an inorganic gas.

7. The leucocyte depletion filter assembly of claim 1, wherein said gas plasma is generated from an organic gas.

8. The leucocyte depletion filter assembly of claim 1, wherein said gas plasma is generated from a gas selected from the group consisting of helium, argon, nitrogen, neon, nitrous oxide, nitrogen dioxide, oxygen, air, ammonia, carbon monoxide, carbon dioxide, hydrogen, chlorine, hydrogen chloride, bromine cyanide, sulfur dioxide, hydrogen sulfide, xenon, krypton, and mixtures thereof.

9. The leucocyte depletion filter assembly of claim 8, wherein said gas is oxygen.

10. The leucocyte depletion filter assembly of claim 1, wherein said pleated medium is of fibers of a synthetic resin.

11. The leucocyte depletion filter assembly of claim 10, wherein said synthetic resin is a member selected from the group consisting of polyolefin, polyesters, polysulfones, polyaramides, acrylics, polyarylene oxides, polyarylene sulfides, and polymers and copolymers made from halogenated olefins.

12. The leucocyte depletion filter assembly of claim 11, wherein said synthetic resin is a polyester.

13. The leucocyte depletion filter assembly of claim 12, wherein said polyester is polybutylene terephthalate.

14. The leucocyte depletion filter assembly of claim 13, wherein said pleated medium has been treated with an oxygen gas plasma at about 40 kilohertz, about 2 kilowatts, and about 100-150 mtorr for about 10-30 minutes.

15. The leucocyte depletion filter assembly of claim 1, wherein said plated medium has been treated with a gas plasma at about 10 to about 3000 watts, about 1 kHz to about 100 MHz, and about 0.001 to 100 torr for about 5 seconds to about 12 hours.

16. The leucocyte depletion filter assembly of claim 15, wherein said pleated medium has been treated with a gas plasma at about 500 to about 2500 watts, about 15 kHz to about 60 MHz, and about 0.01 to 1 torr for about 1 minute to about 2 hours.

17. The leucocyte depletion filter assembly of claim 16, wherein said pleated medium has been treated with a gas plasma at about 1500 to about 2500 watts, about 30 kHz to about 50 kHz, and about 0.1 to 1 torr for about 10 minutes to about 30 minutes.

18. The leucocyte depletion filter assembly for removing leucocytes and other deleterious matter from a biological fluid in an extracorporeal circuit, the filter assembly comprising:

a housing having an inlet, an outlet, and a vent and defining a liquid flow path between the inlet and the outlet;

a degassing mechanism communicating with the vent for removing gas from the biological fluid; and

a pleated fibrous medium positioned in the housing across the liquid flow path, the surface of said fibrous medium having been modified by exposure to a gas plasma stream, said fibrous medium being capable of decreasing the leucocyte consent of the biological fluid and permitting the passage of red cells and platelets therethrough.

19. The leucocyte depletion filter assembly of claim 18 having a capacity of six liters per minute at a differential pressure less than 15 psi and having a hold up volume in the range from about 70 cc to about 400 cc.

20. A leucocyte depletion filter assembly for removing leucocytes and other deleterious matter from a biological fluid in an extracorporeal circuit, the filter assembly comprising:

a generally cylindrical housing having first and second chambers, an inlet which allows tangential inflow into the first chamber, an outlet which allows outflow from the second chamber, and a vent;

a porous degassing element position end between the first and second chambers to remove gas from the biological fluid;

a liquophobic membrane covering the vent and communicating with the degassing element to allow gas but not liquid to flow through event; and

a hollow, cylindrical porous medium positioned in the second chamber and comprising a pleated fibrous medium having a CWST of 52 dynes/cm or greater, the surface of said fibrous medium having been modified by exposure to a gas plasma stream, said fibrous medium being capable of decreasing the leucocytes content of the biological fluid and permitting the passage of red cells and platelets therethrough, and the interior of the hollow pours medium communicating with the outlet.

21. A method for removing leucocytes and other deleterious matter from a biological fluid comprising:

passing the biological fluid through a pleated fibrous medium in an extracorporeal circuit, the surface of the fibrous medium having been modified by exposure to a gas plasma stream, said fibrous medium being capable of decreasing the leucocytes content of the biological fluid and permitting the passage of red cells and platelets therethrough.

22. The method of claim 21 wherein up to six liters per minute of biological fluid are placed through the fibrous medium.

23. The method of claim 21, wherein said gas plasma is generated from a gas selected from the group consisting of helium, argon, nitrogen, neon, nitrous oxide, nitrogen dioxide, oxygen, air, ammonia, carbon monoxide, carbon dioxide, hydrogen, chlorine, hydrogen chloride, bromine cyanide, sulfur dioxide, hydrogen sulfide, xenon, krypton, and mixtures thereof.

24. The method of claim 21, wherein aid pleated medium has been treated with a gas plasma at about 10 to about 3000 watts, about 1 kHz to about 100 MHz, and about 0.001 to 100 torr for about 5 seconds to about 12 hours.

25. The method of claim 21, wherein the fibrous medium comprises a synthetic resin selected from the group consisting of polyolefins, polyesters, polysulfones, polyaramides, acrylics, polyarylene oxides, polyarylene sulfides, and polymers and copolymers made from halogenated olefins.

26. The method of claim 25, wherein said polyester is polybutylene terephthalate.

27. The method of claim 26, wherein said pleated medium has been treated with an oxygen gas plasma at about 40 kilohertz, about 2 kilowatts, and about 100-150 mtorr for about 10-30 minutes.

28. A method for removing leucocytes and other deleterious matter from a biological fluid comprising:

directing biological fluid in an extracorporeal circuit through a housing;

separating gas for the biological fluid;

venting the gas for the housing;

passing the biological fluid through a fibrous means positioned within the housing, the surface of said fibrous means having been modified by exposure to a gas plasma stream, thereby decreasing the leucocyte content of the biological fluid while permitting the passage of red blood cells and platelets.

29. The method of claim 28 wherein directing the fluid through a housing comprises repeatedly circulating the biological fluid through the housing.

30. A method of treating blood in an extracorporeal circuit comprising:

directing the blood through a housing;

separating gas from the blood;

venting the gas from the housing;

passing the blood through a fibrous medium positioned within the housing, the surface of said fibrous medium having been modified by exposure to a gas plasma stream, thereby decreasing the leucocyte consent of the blood while permitting the passage of red blood cells and platelets.

31. A method for removing leucocytes and other deleterious matter from a biological fluid comprising:

directing biological fluid in an extracorporeal circuit through a pleated fibrous medium which allows platelets and red cells to pass therethrough, at a flow rate of up to six liters per minute, the surface of said fibrous medium having been modified by exposure to a gas plasma stream; and

removing a clinically or therapeutically significant amount of leucocytes from the biological fluid.

32. The method of claim 31 wherein directing the fluid through a housing comprises repeatedly circulating the biological fluid through the housing.