Microporous membrane sheet plasma extraction catheter

• US 5,968,004 A
• Filed: 09/23/1997
• Issued: 10/19/1999
• Est. Priority Date: 09/23/1997
• Status: Expired due to Fees

• Current Assignee: Matria Healthcare, Inc. (Abbott Laboratories)
• Original Assignee: Matria Healthcare, Inc. (Abbott Laboratories)
• Inventors: Gorsuch, Reynolds G.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Huseman, Cheryl L.
• Application Number:
  US08/935,399
• Time in Patent Office: 756 Days
• Field of Search: 601/62, 424/424, 210/644, 210/195.2, 210/321.6, 604/4
• US Class Current: 604/6.04
• CPC Class Codes: A61M 1/1631 having non-tubular membranes, e.g. sheets
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/3472 with treatment of the filtrate
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence

Abstract

An assembly for being implanted in a blood vessel for carrying out in vivo plasma separation incorporates a plasma extraction capsule formed of a microporous polymeric membrane sheet having a pore size capable of allowing diffusion of plasma, the capsule having one or more interior plasma flow channels and a catheter secured to the capsule and having at least one lumen in fluid communication with the one or more interior capsule channels.

Claims

1. An assembly for being implanted in a blood vessel for carrying out in vivo plasma separation comprising:

a plasma extraction capsule comprising a plurality of panels or lobes formed of a microporous polymeric membrane sheet having a pore size capable of allowing plasma to diffuse therethrough, said capsule having one or more plasma flow channels therein, and a catheter secured to said capsule and comprising at least one lumen in fluid communication with said one or more plasma flow channels.

2. An assembly of claim 1, wherein said catheter extends along at least a portion of the interior of said capsule.

3. An assembly of claim 2, wherein said catheter is a dual lumen catheter having a first passageway in fluid communication with the interior of said capsule for directing plasma therefrom and a second passageway having a port for communicating with a blood vessel for returning plasma thereto.

4. An assembly of claim 1, including a header secured to said catheter and said membrane sheet.

5. An assembly of claim 1 wherein said capsule comprises a corrugated tube having a plurality of lobes formed by said membrane set.

6. An assembly of claim 5, wherein said corrugated tube comprises grooves and ridges formed along said membrane sheet.

7. An assembly of claim 5, wherein said corrugated tube comprises a plurality of elongated membrane sheets each sheet joined to an adjacent sheet.

8. An assembly of claim 7, wherein a portion of said catheter extends along the interior of said capsule and wherein each of said elongated membrane sheets is secured to said catheter.

9. An assembly of claim 8, wherein said corrugated tube comprises a plurality of lobes and wherein said catheter portion extending along the interior of said capsule includes a plurality of ports each in fluid communication with one of said lobes.

10. An assembly of claim 9, wherein said catheter is a dual lumen catheter having a first passageway in fluid communication with the interior of said capsule for directing plasma therefrom and a second passageway having a port for communicating with a blood vessel for returning plasma thereto.

11. An assembly of claim 9, wherein each of said elongated membrane sheets have a first edge joined to the first edge of an adjacent elongated membrane sheet to form an elongated ridge, and a second edge secured along said catheter to form an elongated groove, and wherein said lobes are elongated lobes formed by said elongated ridges and grooves.

12. An assembly of claim 1, comprising a plurality of panels each panel comprising an envelope formed of opposite segments of said microporous polymeric membrane sheet said assembly having a fluid directing member secured between said opposite segments forming said plasma flow channel.

13. An assembly of claim 12, wherein said envelope comprises a folded polymeric membrane sheet and wherein the edges of said sheet are joined to enclose said capsule.

14. An assembly of claim 12, wherein said panels extend radially from said catheter.

15. An assembly of claim 14, wherein the opposite segments lie along substantially parallel planes extending radially from said catheter.

16. An assembly of claim 14, wherein said capsule comprises pairs of panels each panel of a pair extending from said catheter opposite the other panel of said pair.

17. An assembly of claim 15, wherein said capsule comprises pairs of panels each panel of a pair extending from said catheter opposite the other panel of said pair.

18. An assembly of claim 12, wherein each of said panels is elongated along a different axis extending radially from said catheter.

19. An assembly of claim 12, including a plurality of elongated microporous hollow polymeric fiber loops secured in fluid communication with one or more of said plurality of panels.

20. An assembly of claim 19, wherein each of said fiber loops has a pair of ends secured adjacent to a panel and wherein the hollow interior of each said fiber is in fluid communication with the plasma flow channel of said panel.

21. An assembly of claim 14, including a plurality of elongated microporous hollow polymeric fiber loops secured in fluid communication with one or more of said plurality of panels.

22. An assembly of claim 21, wherein each of said fiber loops has a pair of ends secured adjacent to a panel and wherein the hollow interior of each said fiber is in fluid communication with the plasma flow channel of said capsule.

23. An assembly of claim 19, wherein said plurality of fiber loops are spaced substantially uniformly along said panels.

24. An assembly of claim 21, wherein said plurality of fiber loops are spaced substantially uniformly along said panels.

25. An assembly of claim 23, wherein each of said panels is elongated along a different axis extending radially from said catheter.

26. An assembly of claim 25, wherein the fiber loops extending from each panel extend substantially normal to the radial axis of each said panel, respectively.

27. An assembly of claim 26, wherein said plurality of fiber loops are secured along the elongated axis of each respective panel.

28. An assembly of claim 1, comprising a plurality of said capsules, each capsule having a different cross-sectional diameter.

29. An assembly of claim 28, compromising a first cylindrical capsule having a first diameter for being transplanted in a first blood vessel and second cylindrical capsule having a second diameter for being transplanted in a second blood vessel.

30. An assembly of claim 29, wherein said first and second capsules extend along a common axis.

31. An assembly of claim 1, wherein said pore size of said membrane sheet is between 0.001μ

and 1μ

.

32. An assembly of claim 1, wherein said membrane sheet has a transmembrane flux of between 4 and 260 ml/min/cm² (water @ 25°

C.)/bar.

33. A method of forming a plasma extraction device for in vivo separation of plasma from blood comprising:

forming a plurality of plasma extraction lobes or panels using a plurality of membrane sheets having a pore size between 0.001μ and

1μ

, folding each of said sheets and joining the adjacent edges of each said folded sheet to form generally flat lobes or panels, and securing each of said lobes or panels along a catheter.