Apparatus and method for in-vivo plasmapheresis using periodic backflush containing anticoagulant

• US 8,070,706 B2
• Filed: 01/13/2009
• Issued: 12/06/2011
• Est. Priority Date: 01/04/2001
• Status: Expired due to Fees

• Current Assignee: Transvivo, Inc.
• Original Assignee: Transvivo, Inc.
• Inventors: Gorsuch, Reynolds G., Cooper, Tommy Gene, Handley, Harold H. Jr., Peters, Harold W.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US12/353,209
• Publication Number:
  US 20090118660A1
• Time in Patent Office: 1,057 Days
• Field of Search: 604/4.01, 604/5.01, 604/5.04, 604/6.04, 604/6.09, 604/6.16, 604/7, 604/8, 604/9, 604/21, 604/27, 604/28, 604/264, 422/44, 210/600, 210/634, 210/644, 210/645, 210/646, 210/500.1, 210/651, 210/195.2, 210/200, 210/203, 210/500.21, 210/650, 210/433.1, 210/500.23
• 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

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, directing backflush fluid into the fibers at a pressure and interval sufficient to cleanse the fiber pores, after which plasma diffusion is resumed. The backflush fluid, preferably a normal saline solution, may contain an anticoagulant such as heparin, citrate or NO donor in suitable concentration for systemic anti-coagulation or for treating the fiber for thromboresistance.

Claims

1. A method for carrying out plasmapheresis, comprising:

providing a filter device comprising a plurality of elongated hollow microporous fibers;

diffusing plasma and toxins from a patient'"'"'s blood through the wall of the fibers into the hollow interior thereof; and

periodically interrupting the diffusion of plasma and toxins and backflushing the fibers by directing a backflush fluid containing an amount of anticoagulant at least sufficient to provide fiber thromboresistance through a catheter into the fibers at a pressure and for an interval sufficient to substantially clear the pores of the filter, and after the interval, resuming the diffusion of plasma.

2. The method of claim 1, comprising using a backflush fluid comprising a saline solution containing heparin.

3. The method of claim 2, wherein the NO donor is in a concentration sufficient to provide local anticoagulation and insufficient to provide systemic anticoagulation.

4. The method of claim 2, wherein the NO donor comprises at least one member selected from the group consisting of a N-nitrosimine, nitrosothiol, organic nitrate, organic nitrite, oximine, sydnonimine, C-nitroso compound, furoxan, benzofuroxan, N-hydroxyguanidine, and diazeniumdiolate.

5. The method of claim 1, comprising backflushing at a pressure of between about 15 and about 100 mg Hg for an interval of between about 5 and about 50 seconds.

6. The method of claim 1, for inducing systemic anticoagulation comprising using a single bolus of backflush fluid containing heparin.

7. The method of claim 1, for maintaining systemic anticoagulation comprising using a backflush fluid containing more than about 150 IU heparin per ml.

8. The method of claim 1, wherein toxin-containing plasma from the fibers is directed to plasma treatment apparatus through a second lumen of the catheter.

9. The method of claim 8, wherein plasma from plasma treatment apparatus is directed to a third lumen of the catheter and returned to the patient.

10. The method of claim 1, wherein the anticoagulant comprises sodium citrate.

11. The method of claim 10, comprising using a backflush fluid comprising a saline solution having a sodium citrate concentration of at least 0.1 mol/liter.

12. The method of claim 11, wherein the sodium citrate concentration is sufficient to provide local anticoagulation and insufficient to provide systemic anticoagulation in a human patient.

13. The method of claim 11, wherein the sodium citrate concentration is sufficient to provide systemic anticoagulation in a human patient.

14. The method of claim 1, wherein the anticoagulant comprises a NO donor.

15. The method of claim 1, wherein the backflush fluid contains patient medication.

16. A method for carrying out plasmapheresis, comprising:

providing a filter device, the filter device comprising one or more elongated hollow tubes and a plurality of elongated microporous fibers capable of separating plasma from whole blood, each fiber having an interior lumen extending along the length thereof and having a first and second end secured to one or more of the elongated hollow tubes wherein the interior lumen of each of the fibers communicates with the interior of the one or more hollow tubes;

providing a catheter in fluid communication with the hollow interior of the fibers, and diffusing plasma and toxins from a patient'"'"'s blood through the wall of the fibers into the hollow interior thereof; and

periodically interrupting the diffusion of plasma and toxins and backflushing the fibers by directing a backflush fluid containing an amount of anticoagulant at least sufficient to provide fiber thromboresistance through the catheter into the fibers at a pressure and for an interval sufficient to substantially clear the pores of the filter, and after the interval, resuming the diffusion of plasma.

17. The method of claim 16, wherein the anticoagulant comprises at least one member selected from the group consisting of heparin, citrate, and a NO donor.

18. The method of claim 17, wherein a concentration of the anticoagulant is sufficient to provide local anticoagulation.

19. The method of claim 18, wherein a concentration of the anticoagulant is insufficient to provide systemic anticoagulation in a human patient.

20. A method for carrying out plasmapheresis comprising:

providing a filter device, the filter device comprising one or more elongated hollow tubes and a plurality of elongated microporous fibers having an interior lumen extending along the length thereof, each fiber having a first and second end secured to the one or more elongated hollow tubes, wherein the interior lumen of each of the fibers communicates with the interior of the one or more hollow tubes, and wherein each of the elongated microporous fibers have an asymmetrical fiber wall morphology between the inner wall surface extending along the interior fiber lumen and the outer wall surface, the fiber wall having a higher mass density zone adjacent to the outer wall surface and a lower mass density zone adjacent to the inner wall surface, the higher mass density zone having a smaller average nominal pore size than the average nominal pore size in the lower mass density zone and wherein the fibers are configured to separate plasma from whole blood by passing plasma through the fiber wall from the outer wall surface to the inner wall surface and to the interior lumen thereof;

providing a catheter in fluid communication with the hollow interior of the fibers, and diffusing plasma and toxins from a patient'"'"'s blood through the wall of the fibers into the hollow interior thereof; and

periodically interrupting the diffusion of plasma and toxins and backflushing the fibers by directing a backflush fluid containing an amount of anticoagulant at least sufficient to provide fiber thromboresistance through the catheter into the fibers at a pressure and for an interval sufficient to substantially clear the pores of the filter, and after the interval, resuming the diffusion of plasma.

21. The method of claim 20, wherein the anticoagulant comprises at least one member selected from the group consisting of heparin, citrate, and a NO donor.

22. The method of claim 21, wherein a concentration of the anticoagulant is sufficient to provide local anticoagulation.

23. The method of claim 21, wherein a concentration of the anticoagulant is insufficient to provide systemic anticoagulation in a human patient.