Apparatus and method for in vivo plasma separation

• US 4,950,224 A
• Filed: 08/05/1988
• Issued: 08/21/1990
• Est. Priority Date: 08/05/1988
• Status: Expired due to Fees

• Current Assignee: HFG Healthco-4 LLC (Apollo Global Management, Inc.)
• Original Assignee: Healthdyne, Inc. (Abbott Laboratories)
• Inventors: Gorsuch, Reynolds G. F., Atkin, John
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Doley, Kathleen A.
• Application Number:
  US07/229,007
• Time in Patent Office: 746 Days
• Field of Search: 604/4, 604/5, 604/6, 604/7, 604/8, 604/52, 604/53, 604/405, 604/406, 604/27, 604/20, 210/645, 210/646, 120/200.25
• US Class Current: 604/6.04
• CPC Class Codes: A61B 5/14528 invasively
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61M 1/1643 with weighing of fresh and used dialysis fluid
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3406 Physical characteristics of the filtrate, e.g. urea
• CPC Class Codes: A61M 1/3479 by dialysing the filtrate
• CPC Class Codes: A61M 1/3486 Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
• CPC Class Codes: A61M 2202/0042 filtrate, i.e. the fluid passing through the filter
• CPC Class Codes: A61M 2202/046 Low-density lipoprotein
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 with microprocessors or computers

Abstract

An apparatus for the continuous in vivo separation of plasma from other blood components comprising a bundle of microporous hollow fibers inserted into the vena cava. The fibers are sized to permit diffusion of plasma through the fiber pores but not cellular or other larger blood components. The fibers are in fluid communication with a dual lumen catheter which removes plasma from the hollow fibers to a treatment system and returns treated plasma to the bloodstream. The apparatus can be incorporated into an ambulatory plasma separator system for providing continuous plasma treatment while the user is mobile.

Claims

1. An apparatus for continuous in vivo plasma separation, comprising:

at least one elongated microporous fiber having a hollow interior, said fiber being dimensioned to be received within a blood vessel without significantly obstructing fluid flow through said blood vessel, the pore size of said fiber being sufficient to allow plasma to diffuse through said pores into said hollow interior of said fiber but not sufficient to allow cellular components larger than plasma to diffuse therethrough; and

said hollow interior of said elongated fiber being in fluid communication with a means for conducting plasma comprising a first discrete hollow tube which connects to one end of the fiber and permits passage of plasma from said hollow interior of said fiber and a second discrete hollow tube which returns plasma to said blood vessel such that plasma being removed from said fiber is kept separated from plasma being returned to the blood vessel.

2. The apparatus of claim 1 wherein said fiber is composed of a polymeric material.

3. The apparatus of claim 2 wherein said polymeric material is polypropylene.

4. The apparatus of claim 3 wherein said fiber has a pore size of from about 0.1 to 1.0 μ

m.

5. The apparatus of claim 3 wherein said fiber has a pore size of from about 0.2 to 0.8 μ

m.

6. The apparatus of claim 3 wherein said fiber has a pore size of from about 0.4 to 0.6 μ

m.

7. The apparatus of claim 1, wherein said at least one elongated microporous hollow fiber comprises a plurality of elongated microporous hollow fibers, said plurality of fibers being dimensioned to be received within a blood vessel without significantly obstructing fluid flow through said blood vessel.

8. The apparatus of claim 2, wherein said second tube includes means returning the plasma to said blood vessel downstream from said fibers within the blood vessel, such that said returned plasma does not immmediately diffuse back into said fibers.

9. The apparatus of claim 8, wherein said pair of tubes comprise a dual lumen catheter.

10. The apparatus of claim 9, wherein said tubes are disposed substantially parallel to one another.

11. The apparatus of claim 9, wherein said tubes are disposed co-axially relative to one another, such that the inner passage defines a central lumen and the outer passage defines an outer lumen.

12. The apparatus of claim 11, wherein said central lumen returns plasma from said plasma receiving means to said blood vessel through an opening in said central lumen which extends downstream in said fluid flow from said fibers, whereby said returned plasma is not immediately diffused back into said fibers.

13. The apparatus of claim 7, further comprising a connector means for placing said fibers in fluid communication with said pair of tubes comprising a header.

14. The apparatus of claim 1, further comprising a removable sheath which surrounds said fibers to facilitate insertions of said fiber into said blood vessel, said sheath being removable from said fiber within the blood vessel to expose said fiber to fluid.

15. The apparatus of claim 14, further comprising a flexible elongated guide wire removably disposed within said sheath for facilitating insertion of said fiber into said blood vessel.

16. The apparatus of claim 1, further comprising a treatment system in fluid communication with said fiber, whereby selected subcomponents of said plasma removed from said blood vessel are treated and the treated plasma returned to said blood vessel.

17. The apparatus of claim 16, further comprising means for admixing said treated plasma with an amount of fluid prior to returning said plasma to the blood vessel.

18. The apparatus of claim 17, wherein the amount of said fluid admixed with said treated plasma is sufficient to approximate the volume of plasma removed from said blood vessel prior to treatment by said plasma receiving means, whereby the volume of fluid in the body is kept approximately constant.

19. The apparatus of claim 18, wherein said fluid comprises saline.

20. The apparatus of claim 1, further comprising a pumping means for motivatng diffusion of said plasma through said fiber into said hollow interior of said fibers.

21. The apparatus of claim 20, wherein said pumping means comprises means for generating a negative pressure within said hollow interiors of said fiber.

22. The apparatus of claim 21, wherein said negative pressure generating means comprises a vacuum pump, such that said pump creates a pressure drop across said microporous fiber facilitating the passage of plasma through said fiber into said hollow interior of said fibers.

23. A method for continuous in vivo plasma separation, comprising the steps of:

(a) implanting in a blood vessel at least one elongated microporous fiber having a hollow interior, said elongated fiber being dimensioned to be received within a blood vessel without significantly obstructing fluid flow through said blood vessel, the pore size of said elongated microporous fiber being sufficient to allow plasma to diffuse through said pores into said hollow interior of said fiber but not sufficient to allow cellular components larger than plasma to diffuse therethrough;

(b) placing said hollow interior of said elongated fiber in fluid communications with a means for conducting plasma comprising a first discrete hollow tube which connects to one end of the fiber and permits passage of plasma from said hollow interior of said fiber, and a second discrete tube which returns plasma to said blood vessel such that plasma being removed from said fiber is kept separated from plasma being returned to the blood vessel;

(c) removing plasma from said blood vessel;

(d) treating said plasma to remove or treat selected subcomponents of said plasma; and

(e) re-infusing said plasma into said blood vessel.

24. The method of claim 23, further comprising the step of admixing a volume of replacement fluid with said treated plasma to re-infusion into said blood vessel.

25. The method of claim 23, wherein said blood vessel is the vena cava.

26. The method of claim 25, wherein said blood vessel is the superior vena cava.