Apparatus for therapeutic apheresis

• US 7,267,771 B2
• Filed: 12/10/2004
• Issued: 09/11/2007
• Est. Priority Date: 08/13/2002
• Status: Expired due to Fees

• Current Assignee: Transvivo, Inc.
• Original Assignee: Transvivo, Inc.
• Inventors: Cooper, Tommy, Peters, Harold W., Gorsuch, Reynolds G., Handley, Harold H. Jr.
• Primary Examiner(s): Menon; Krishnan S.
• Application Number:
  US11/009,226
• Publication Number:
  US 20050155932A1
• Time in Patent Office: 1,005 Days
• Field of Search: None
• US Class Current: 210/321.88
• 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 1/1684 Checking the module characteristics before reuse
• CPC Class Codes: A61M 1/1688 with recirculation of the sterilising fluid
• 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 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3431 upstream of the filter
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers

Abstract

Apparatus for carrying out therapeutic apheresis includes a filter device for being implanted in a blood vessel for carrying out in-vivo plasma separation having one or more elongated hollow tubes and a plurality of elongated hollow microporous fibers capable of separating plasma from whole blood at pressure and blood flow within a patient'"'"'s vein, a multiple lumen catheter secured to the proximal end of the filter device having one or more lumens in fluid communication with the interior of said one or more hollow tubes and a plasma return lumen, and therapeutic apheresis apparatus for removing and/or separating selected disease-related components from the separated plasma and means for directing plasma between said catheter and the selective component removal apparatus.

Claims

1. Apparatus for carrying out therapeutic apheresis comprising:

an implantable filter device comprising a plurality of elongated hollow tubes and a plurality of elongated microporous fibers capable of separating plasma from whole blood in-vivo, each fiber having an interior lumen extending along the length thereof and having a first and second end secured to different ones of said elongated hollow tubes wherein the interior lumen of each of the fibers communicates with the interior of two of said elongated hollow tubes;

a triple lumen catheter secured to the proximal end of the filter device having one or more lumens in fluid communication with the interior of said elongated hollow tubes and a plasma return lumen; and

therapeutic apheresis apparatus for removing and/or separating selected disease-related components from the separated plasma and tubing for directing plasma between said catheter and the selective component removal apparatus.

2. Apparatus of claim 1 wherein said triple lumen catheter comprises a first lumen and a second lumen in fluid communication with the interior of said elongated hollow tubes and a third lumen comprising said plasma return lumen.

3. Apparatus of claim 1 wherein said therapeutic apheresis apparatus comprises a plasma exchange assembly.

4. Apparatus of claim 1 wherein said therapeutic apheresis apparatus comprises a multiple stage filtration assembly.

5. Apparatus of claim 1 wherein said therapeutic apheresis apparatus comprises one or more columns or cartridges containing materials for absorbing disease-related components passing therethrough.

6. Apparatus of claim 1 wherein said selective component removal apparatus comprises one or more reactors containing compositions for reacting with disease-related components in the plasma.

7. Apparatus of claim 1 including:

a fluid control assembly comprising first tubing in fluid communication with said first lumen of said catheter and a first fluid pump cooperating therewith for directing plasma from said filter device, second tubing in fluid communication with said second lumen of said catheter and a second pump cooperating therewith for directing backflush fluid into said filter device, and third tubing in fluid communication with said third lumen of said catheter for directing plasma from the therapeutic apheresis apparatus to a patient; and

control apparatus operatively communicating with said first and second pumps for controlling the operation thereof, respectively.

8. Apparatus of claim 7 including a third pump cooperating with said third tubing and in control connection with said control apparatus.

9. Apparatus of claim 7 including a source of backflush fluid cooperating with said second tubing.

10. Apparatus of claim 7 wherein said control apparatus comprises a microprocessor-controller including software programmed for operating one or more of said pumps.

11. Apparatus of claim 8 wherein said control apparatus comprises a microprocessor-controller including software programmed for operating one or more of said pumps.

12. Apparatus of claim 9 wherein said control apparatus comprises a microprocessor-controller including software programmed for operating one or more of said pumps.

13. Apparatus of claim 1 wherein said filter device comprises first and second elongated hollow tubes extending substantially parallel along the length thereof, and wherein a first end of each of said elongated microporous fibers is secured to a first hollow tube and a second end of each of said fibers is secured to a second hollow tube whereby the interior fiber lumen of each fiber communicates with the interior of a first and a second elongated hollow tube.

14. Apparatus of claim 13 wherein the first elongated hollow tube extends along a first axis and the second elongated hollow tube extends along a second axis substantially parallel with said first axis, and wherein the first ends of said elongated microporous fibers are secured to said first elongated hollow tube along a generally straight first row, and the second ends of said elongated microporous fibers are secured to said second elongated hollow tube along a generally straight second row substantially parallel with said first row.

15. Apparatus of claim 14 wherein each of said fibers are generally bowed along its length between said first and second ends to form an arch spaced apart from said elongated hollow tubes and forming a passageway therebetween.

16. Apparatus of claim 13 wherein the first and second ends of said elongated microporous fibers are secured to said first and second elongated hollow tubes, respectively, at substantially regular intervals.

17. Apparatus of claim 14 wherein said regular intervals are between about 0.1 cm and about 1.0 cm.

18. Apparatus of claim 1 wherein the length of each of said elongated microporous fibers is between about 1 cm and about 4 cm.

19. Apparatus of claim 13 wherein the length of each of said elongated microporous fibers is between about 1 cm and about 4 cm.

20. Apparatus of claim 14 wherein the length of each of said elongated microporous fibers is between about 1 cm and about 4 cm.

21. Apparatus of claim 14 wherein the first end of each elongated microporous fiber is offset longitudinally from the second end of each said fiber along the length of said elongated hollow tubes whereby a straight line extending through the first and second end of a fiber forms an acute angle with one of said axes.

22. Apparatus of claim 21 wherein the length of each elongated hollow tube is between about 10 cm and about 25 cm, wherein the length of each elongated microporous fiber is between about 1 mm and about 4 mm, wherein the space between adjacent fibers is between about 0.1 cm and about 0.3 cm, and wherein said acute angle is between about 45°

and about 85°

.

23. Apparatus of claim 1 wherein the fiber wall morphology of the elongated microporous fibers is asymmetrical between the inner wall surface extending along the interior fiber lumen and the outer wall surface, said 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, said higher mass density zone having a smaller average nominal pore size than the average nominal pore size of the lower mass density zone.

24. Apparatus of claim 23 wherein the fiber wall structure comprises a continuous change in mass density between the inner and outer surfaces of the fiber.

25. Apparatus of claim 7 including a container cooperating with said therapeutic apheresis apparatus for receiving effluent therefrom.

26. Apparatus of claim 25 including fourth tubing in fluid communication with said container and said therapeutic apheresis apparatus.

27. Apparatus of claim 26 including an effluent pump cooperating with said fourth tubing for pumping effluent from said therapeutic apheresis apparatus to said container.

28. Apparatus of claim 27 including control connection between said control apparatus and said effluent pump.

29. Apparatus of claim 28 wherein said control apparatus comprises a program for directing operation of said apparatus.

30. Apparatus of claim 28 wherein said control apparatus comprises a program for controlling operation of one or more of said pumps.

31. Apparatus of claim 28 wherein said control apparatus comprises a microprocessor-controller including a program for controlling operation of one or more of said pumps.

32. Apparatus of claim 23 having a lower mass density zone characterized by a nominal average pore diameter of between about 1 μ

m and about 60 μ

m.

33. Apparatus of claim 23 having a higher mass density zone characterized by a nominal average pore diameter of between about 0.3 μ

m and about 1 μ

m.

34. Apparatus of claim 32 having a higher mass density zone characterized by a nominal average pore diameter of between about 0.3 μ

m and about 1 μ

m.

35. Apparatus of claim 34 wherein the nominal average pore diameter in said lower mass density zone is between about 2 μ

m and about 6 μ

m.

36. Apparatus of claim 35 wherein the nominal average pore diameter in said higher mass density zone is between about 0.4 μ

m and about 0.8 μ

m.

37. Apparatus of claim 34 having one or more intermediate mass density zones having a nominal average pore diameter of between about 0.8 μ

m and about 2 μ

m.

38. Apparatus of claim 35 having two intermediate mass density zones, a first intermediate zone having a nominal average pore diameter of between about 0.8 μ

m and about 1.2 μ

m and a second intermediate zone having a nominal average pore diameter of between about 1.2 μ

m and about 2 μ

m.

39. Apparatus of claim 23 wherein said fibers comprise a polysulfone fiber.

40. Apparatus of claim 21 wherein the fiber wall structure comprises a continuous change in mass density from said outer wall surface to said inner wall surface and comprises a continuum of voids bounded by solid frames, said fiber wall having an asymmetrical pore size and asymmetrical mass density between said inner wall surface and the outer wall surface.

41. Apparatus of claim 40 wherein said fibers comprise a polysulfone fiber.