Apparatus and method for in-vivo plasmapheresis using periodic backflush

• US 6,659,973 B2
• Filed: 01/04/2001
• Issued: 12/09/2003
• Est. Priority Date: 01/04/2001
• Status: Expired due to Fees

• Current Assignee: Transvivo, Inc.
• Original Assignee: Transvivo, Inc.
• Inventors: Cooper, Tommy, Gorsuch, Reynolds G.
• Primary Examiner(s): Lazarus, Ira S.
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US09/754,773
• Publication Number:
  US 20020087109A1
• Time in Patent Office: 1,069 Days
• Field of Search: 604/6.11, 604/6.09, 604/6.01, 604/5.01, 604/4.01, 604/5.04, 604/28, 604/29, 607/6
• US Class Current: 604/6.04
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• CPC Class Codes: A61M 1/1688 with recirculation of the sterilising fluid
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 2205/7554 with means for unclogging or regenerating filters
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

Apparatus and method for in-vivo plasmapheresis utilizing a plurality of elongated hollow microporous filter fibers periodically interrupt diffusion of blood plasma from a patient, and, for a selected time, backflush fluid into the fibers at a pressure and interval sufficient to cleanse the fiber pores, after which plasma diffusion is resumed.

Claims

1. Apparatus for carrying out in-vivo plasmapheresis comprising:

a filter assembly for being implanted in a blood vessel comprising a plurality of elongated hollow microporous membrane fibers for diffusing plasma therethrough and a header in fluid communication with the interior of said hollow fibers;

a multiple lumen catheter in fluid communication with said header comprising a first lumen in fluid communication with the interior of said fibers for directing backflush fluid through said header into the interior of said hollow fibers, a second lumen in fluid communication with the interior of said fibers for directing plasma from said filter assembly, and a third lumen for returning plasma to the blood vessel; and

a pump in fluid communication with said first lumen for periodically pumping backflush fluid into the interior of said fibers and through the membrane thereof.

2. Apparatus of claim 1 including a source of backflush fluid in fluid communication with said pump and said first lumen.

3. Apparatus of claim 1 including a microprocessor/controller operatively connected to said pump.

4. Apparatus of claim 3 wherein said microprocessor/controller and said pump cooperate to direct said backflush fluid into said microporous membrane fibers for a duration and at a flow rate sufficient to backflush and substantially cleanse the membrane pores.

5. Apparatus of claim 4 wherein said microprocessor/controller and said pump cooperate to direct said backflush fluid into said microporous membrane fibers at a pressure sufficient to substantially cleanse the membrane pores.

6. Apparatus of claim 1 wherein said pump in fluid communication with said first lumen is a first pump, said apparatus including a second pump in fluid communication with said second lumen for pumping plasma from said filter to plasma treatment apparatus.

7. Apparatus of claim 6 including a third pump in fluid communication with said third lumen for pumping plasma from plasma treatment apparatus to the blood vessel.

8. Apparatus of claim 7 including a microprocessor/controller operatively connected to said first, second and third pumps.

9. Apparatus of claim 8 wherein said microprocessor/controller and said first pump cooperate to direct said backflush fluid into said microporous membrane fibers for a duration and at a flow rate sufficient to backflush and substantially cleanse the membrane pores.

10. Apparatus of claim 9 wherein said microprocessor/controller and said first pump cooperate to direct said backflush fluid into said microporous membrane fibers at a pressure sufficient to substantially cleanse the membrane pores.

11. Apparatus of claim 6, 7, 8 or 9 including a pump and conduit cooperating therewith for pumping separated plasma components from plasma treatment apparatus to a container.

17. Apparatus of claim 1 or 12 wherein said fibers have a sieving coefficient cutoff of between 2×

10⁴ and 4×

10⁶ Daltons.

18. Apparatus of claim 1 or 12 wherein said fibers comprise a fiber wall having a plurality of zones between the inner and outer wall surfaces, each of said zones having a mass density different than the mass density of an adjacent zone, said fiber wall characterized by having a lower mass density zone at the inner wall surface and a higher mass density zone at the outer wall surface.

19. A membrane of claim 18 wherein said membrane fiber wall has two mass density zones.

20. A membrane of claim 18 wherein said membrane fiber wall has three mass density zones.

21. A membrane of claim 18 wherein membrane fiber wall has four or more mass density zones.

22. A membrane of claim 18 wherein each of said zones is characterized by a different average nominal pore size.

23. A membrane of claim 22 capable of in-vivo plasmapheresis wherein said lower mass density zone is characterized by a nominal average pore diameter of between about 1 μ

m and about 60 μ

m.

24. A membrane of claim 22 wherein said higher mass density zone is characterized by a nominal average pore diameter of between about 0.3 μ

m and about 1 μ

m.

25. A membrane of claim 23 wherein said higher mass density zone is characterized by a nominal average pore diameter of between about 0.3 μ

m and about 1 μ

m.

26. A membrane of claim 18 characterized by having the capability of extracting at least 0.75 (ml/min)(cm²×

mmHg) of blood plasma at trans-membrane pressures of between about 5 and about 20 mmHg.

12. Apparatus for carrying out in-vivo plasmapheresis comprising:

a filter for being planted in a patient'"'"'s blood vessel comprising a plurality of elongated hollow microporous fibers having an interior lumen and a fiber wall having a pore size capable of allowing plasma to diffuse therethrough;

a multiple lumen catheter in fluid communication with the interior fiber lumen including a first lumen for directing backflush fluid into said fiber lumen and a second lumen for directing plasma from said fiber lumen; and

means for periodically pumping backflush fluid into said first fiber lumen at a pressure and duration sufficient to backflush and cleanse the pores of the fiber walls.

13. Apparatus of claim 12 wherein said means for pumping backflush fluid comprise one or more positive displacement pumps cooperating with said catheter.

14. Apparatus of claim 12 wherein said one or more pumps is capable of pumping the backflush fluid at a pressure of between about 15 and about 100 mg Hg for a duration of between about 5 and about 50 seconds.

15. Apparatus of claim 13 wherein said one or more pumps is capable of pumping said backflush fluid at a rate of between about 5 and about 45 ml/minute.

16. Apparatus of claim 12, 13, 14 or 15 wherein said catheter includes a third lumen for returning plasma to the patient'"'"'s blood vessel.

27. Apparatus of claim 12 wherein said means for pumping backflush fluid is one or more first pumps cooperating with said first lumen for pumping said backflush fluid therethrough, and wherein said apparatus includes one or more second pumps cooperating with said second lumen for pumping plasma from said fibers therethrough.

28. Apparatus of claim 27 including one or more third pumps cooperating with said third lumen for pumping plasma therethrough.

29. Apparatus of claim 28 including plasma treatment apparatus for removing toxins from the plasma diffused through the fibers.

30. Apparatus of claim 29 including a pump and conduit cooperating therewith for pumping separated plasma components from plasma treatment apparatus to a container.

31. A method of carrying out in-vivo plasmapheresis comprising:

implanting a filter device within a blood vessel of a patient, said filter device comprising a plurality of elongated hollow microporous fibers;

providing a multiple lumen catheter in fluid communication with the hollow interior of said fibers; and

diffusing plasma and toxins from the patient'"'"'s blood through the wall of said fibers into the hollow interior thereof, and therefrom through a second lumen of said catheter;

periodically interrupting said diffusion of plasma and toxins and thereafter directing a fluid through a first lumen of said catheter into said fibers and backflushing said fibers with said fluid at a pressure and for an interval sufficient to substantially cleanse the pores of said filter, and after said interval, resuming said diffusion of plasma.

32. A method of claim 31 wherein the fluid is backflushed at a pressure of between about 15 and about 100 mg Hg for an interval of between about 5 and about 50 seconds.

33. A method of claim 31 or 32 wherein said backflush fluid comprises saline solution.

34. A method of claim 31 or 32 wherein said fluid is backflushed by pumping said fluid into the hollow interior of said fibers.

35. A method of claim 34 wherein said fluid is pumped into said fibers at a pressure of between about 15 and about 100 mg Hg.

36. A method of claim 34 wherein said fluid is pumped into said fiber for an interval of between about 5 and about 50 seconds.

37. A method of claim 31 including a plasma treatment apparatus, and wherein toxin-containing plasma from said fibers is directed to said plasma treatment apparatus through said second lumen of said catheter.

38. A method of claim 37 wherein plasma from said plasma treatment apparatus is directed to a third lumen of said catheter and returned to said patient.

39. A method of claim 35 wherein said fluid is pumped into said fiber for an interval of between about 5 and about 50 seconds.