Fiber assembly for in vivo plasma separation

• US 5,735,809 A
• Filed: 12/05/1996
• Issued: 04/07/1998
• Est. Priority Date: 12/05/1996
• Status: Expired due to Fees

• Current Assignee: Matria Healthcare, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Matria Healthcare, Inc. (Abbott Laboratories Incorporated)
• Inventors: Gorsuch, Reynolds
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/764,631
• Time in Patent Office: 488 Days
• Field of Search: 604/6, 604/53, 604/52, 604/4, 604/282
• US Class Current: 604/6.04
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: B01D 63/021 Manufacturing thereof
• CPC Class Codes: B01D 63/024 with a single potted end

Abstract

An improved plasma extraction element for being implanted in a blood vessel for carrying out in vivo plasma separation comprises an elongated catheter having a fan-like assembly of elongated hollow microporous polymeric fibers loops spaced apart along the outer catheter surface. According to the invention the catheter is made from a plurality of elongated arc-shaped segments, a helically wrapped elongated polymer ribbon, a flexible polymer sheet and a plurality of polymer washers.

Claims

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

an elongated hollow catheter having a circumferential fan-like assembly of elongated microporous hollow polymeric fiber loops spaced apart circumferentially and axially, each fiber loop extending substantially radially from the outer surface of said elongated catheter with the interior of each said hollow fiber communicating with the lumen of said catheter, and wherein said catheter comprises a plurality of elongated arc-shaped segments joined axially along said lumen, each of said segments having a plurality of said elongated fiber loops extending radially therefrom.

2. A fiber assembly of claim 1 wherein said fan-like assembly of fiber loops comprises one or more helical rows of said fiber loops extending along the length of said elongated hollow catheter.

3. A fiber assembly of claim 2 wherein each of said arc-shaped segments comprises a single helical row of said fiber loops.

4. A fiber assembly of claim 1 wherein each said fiber loop comprises a pair of substantially straight, elongated, legs having an integral hollow loop extending between said legs at the distal end thereof.

5. A fiber assembly of claim 2 wherein each said fiber loop comprises a pair of substantially straight, elongated, legs having an integral hollow loop extending between said legs at the distal end thereof.

6. A fiber assembly of claim 1 wherein a radial centerline of adjacent fiber loops are separated circumferentially between 2°

and 10°

.

7. A fiber assembly of claim 1 wherein the radial centerline of adjacent fiber loops are separated circumferentially between 4°

and 8°

.

8. A fiber assembly of claim 1 comprising four of said segments, each segment covering a circumferential arc of approximately 90°

, each segment having between 10 and 20 of said fiber loops thereon.

9. A fiber assembly of claim 2 comprising four of said arc-shaped segments, each segment covering a circumferential arc of approximately 90°

, and each of said helical rows having between 10 and 20 of said fiber loops therein.

10. A fiber assembly of claim 3 comprising four of said arc-shaped segments, each segment covering a circumferential arc of approximately 90°

, and each of said helical rows having between 10 and 20 of said fiber loops therein and wherein each said helical row of fibers covers an arc of approximately 90°

.

11. A fiber assembly of claim 1 having between about 4 and about 8 of said fiber loops per centimeter of catheter length.

12. A fiber assembly of claim 2 having between about 4 and about 8 of said fiber loops per centimeter of catheter length.

13. A fiber assembly of claim 1 comprising four of said segments, each said segment having 16 of said fiber loops thereon and wherein the centers of adjacent fiber loops are separated circumferentially approximately 6°

.

14. A fiber assembly of claim 13 wherein the length of each of said fiber loops is between about 4 mm and about 8 mm.

15. A fiber assembly of claim 10 wherein each said fiber loop comprises a pair of substantially straight, elongated, legs having an integral hollow loop extending between said legs at the distal end thereof.

16. A fiber assembly of claim 1 wherein said fiber loops are substantially circumferentially coterminous.

17. A fiber assembly of claim 15 wherein said fiber loops are substantially circumferentially coterminous.

18. A fiber assembly of claim 1 wherein the diameter of said assembly is between 10 and 20 mm.

19. A fiber assembly of claim 1 wherein the diameter of said assembly is between 15 mm and 17 mm.

20. A fiber assembly of claim 15 wherein the diameter of said assembly is between 15 mm and 17 mm.

21. A fiber assembly of claim 1 wherein the length of said assembly is between 2 cm and 4 cm, and wherein said hollow fiber loops are generally uniformly spaced along said length.

22. A fiber assembly of claim 15 wherein the length of said assembly is between 2 cm and 4 cm, and wherein said hollow fiber loops are generally uniformly spaced along said length.

23. A fiber assembly of claim 1 wherein said fibers comprise a polymeric membrane having a transmembrane flux of at least 40 ml/min/cm² (H₂ O)/bar.

24. A fiber assembly of claim 1 wherein said catheter comprises polyurethane.

25. A fiber assembly of claim 2 wherein said legs are substantially parallel.

26. A method of preparing a fiber assembly of claim 1 comprising casting each of said plurality of elongated axial segments in a centrifugal mold using a plastic, with first ends of said elongated hollow fiber loops embedded in said plastic and second distal ends extending outwardly therefrom, removing the casts of said elongated segments from said mold and cutting said casting to expose the embedded ends of said hollow fiber loops, rotating each said segment axially to form a fan-like row of said fiber loops, and joining a plurality of said segments to form said elongated hollow catheter.

27. A fiber assembly for being implanted in a blood vessel for carrying out in vivo plasma separation comprising an elongated polymer ribbon helically wrapped to form an elongated hollow catheter and having a plurality of elongated hollow microporous polymeric fiber loops extending outwardly therefrom, each of said hollow fiber loops comprising first and second elongated hollow legs joined by an integral hollow loop at the distal end thereof and wherein the hollow interior of each leg of said fiber loop communicates with the lumen of said catheter.

28. A fiber assembly of claim 27 wherein said polymer ribbon is formed along an elongated axis and wherein said first and second legs of each fiber loop are substantially parallel to one another along the elongated axis of said ribbon.

29. A fiber assembly of claim 28 wherein said first and second fiber legs of each said fiber loop are spaced apart and whereby said polymer ribbon is helically wrapped around a cylindrical surface at a pitch to form an acute angle greater than about 30°

between the elongated axis of said ribbon and the radius of the cylinder.

30. The fiber assembly of claim 29 wherein said acute angle is greater than about 45°

and whereby the profile of the first and second legs of each fiber loop along the axis of said catheter do not overlay.

31. A fiber assembly of claim 30 wherein said hollow fiber loops are substantially uniformly spaced along said elongated ribbon at between about 1.5 mm and about 3.5 mm.

32. A fiber assembly of claim 28 wherein the thickness of said ribbon is between about 0.5 mm and about 2.0 mm.

33. A fiber assembly of claim 28 wherein the length of said hollow fibers is substantially uniform and between about 4 mm and about 8 mm between said catheter and said distal end.

34. A fiber assembly of claim 31 wherein the length of said hollow fibers is substantially uniform and between about 4 mm and about 8 mm between said catheter and said distal end.

35. A fiber assembly of claim 30 wherein said hollow fiber loops are substantially uniformly spaced along said elongated ribbon at between about 2.0 mm and about 2.5 mm, wherein the thickness of said ribbon is approximately 1 mm and wherein the length of said hollow fibers between said ribbon and said distal fiber end is approximately 6 mm.

36. A fiber assembly of claim 27 wherein said ribbon comprises polyurethane, and wherein said hollow fiber loops comprise a polymeric membrane having a transmembrane flux of at least 40 ml/min/cm² (H₂ O/bar.

37. A fiber assembly of claim 27 wherein said first and second legs are substantially perpendicular to the catheter surface.

38. A fiber assembly of claim 37 wherein said legs are substantially centered between edges of said ribbon.

39. A fiber assembly of claim 38 wherein said catheter is formed along an axis and said first and second legs of each fiber loop are substantially parallel to one another along a plane substantially normal to said axis.

40. A fiber assembly of claim 39 wherein each of said substantially parallel rows lie along a different plane substantially normal to said axis.

41. A fiber assembly of claim 40 wherein the distance between said rows is between about 1.0 mm and about 3.0 mm.

42. A fiber assembly of claim 31 wherein the length of said catheter is between about 8.0 mm and about 20 mm.

43. A fiber assembly of claim 41 wherein the ratio of the length of said catheter to the spacing between said rows is between about 10:

1 and about 5;

1, respectively.

44. A fiber assembly of claim 43 having between about 4 and about 8 of said fiber loops per row.

45. A fiber assembly for being implanted in a blood vessel for carrying out in vivo plasma separation comprising:

an elongated hollow catheter having a circumferential fan-like assembly of elongated microporous hollow polymeric fiber loops spaced apart circumferentially and axially, each fiber loop extending substantially radially from the outer surface of said elongated catheter with the interior of each said hollow fiber communicating with the lumen of said catheter, and wherein said catheter comprises a flexible polymer sheet having a plurality of rows of said hollow polymeric fiber loops extending from a first surface thereof and wherein the interior of said hollow fiber loops are exposed on a second opposite surface of said sheet, wherein said sheet is wrapped around a mandrel to form said catheter having said elongated fiber loops extending radially therefrom.

46. A fiber assembly of claim 45 wherein said sheet and said catheter has a length of between about 8 mm and about 20 mm.

47. A fiber assembly of claim 46 having between about 5 and about 12 rows of fiber loops.

48. A fiber assembly of claim 47 wherein each row contains between about 4 and about 8 fiber loops.

49. A fiber assembly of claim 48 wherein said rows of fiber loops are substantially parallel and said fiber loops in adjacent rows are offset from one another along the axis of said catheter.

50. A fiber assembly of claim 49 wherein the ratio of the length of said catheter to the spacing between rows of fiber loops is between about 10:

1 and about 5;

1, respectively.

51. A fiber assembly for being implanted in a blood vessel for carrying out in vivo plasma separator comprising:

a plurality of annular segments aligned along a common axis and joined therealong to form an elongated catheter, each said segment comprising a polymer washer having a first side and an opposite second side, and a plurality of elongated hollow microporous polymeric fiber loops secured to said first and second sides of said washer and extending radially from the outer peripheral edge thereof, said fiber loops being separated from one another circumferentially around the periphery of said washer, said catheter having a lumen extending axially along the center of said segments.

52. A fiber assembly of claim 51 wherein each of said segments comprise first fiber loops secured along a first side of a washer and second fiber loops secured along a second side thereof, and wherein first and second fiber loops alternate circumferentially around said assembly.

53. A fiber assembly of claim 51 wherein said fiber loops are substantially circumferentially coterminous.

54. A fiber assembly of claim 52 wherein said fiber loops are substantially circumferentially coterminous.

55. A fiber assembly of claim 51 having eight fiber loops per washer.

56. A fiber assembly of claim 55 comprising eight of said segments.

57. A fiber assembly of claim 51 wherein the diameter of said assembly is between 10 mm and 20 mm.

58. A fiber assembly of claim 53 wherein the diameter of said assembly is between 15 mm and 17 mm.

59. A fiber assembly of claim 54 having eight fiber loops per washer and wherein the diameter of said assembly is approximately 16 mm.

60. A fiber assembly of claim 51 wherein said fiber loops are generally uniformly spaced around said assembly.

61. A fiber assembly of claim 59 wherein the diameter of said washers is approximately 4 mm.