Method and apparatus for therapeutic apheresis

• US 20040034317A1
• Filed: 08/13/2002
• Published: 02/19/2004
• Est. Priority Date: 08/13/2002
• Status: Active Grant

• Current Assignee: Transvivo, Inc.
• Original Assignee: Transvivo, Inc.
• Inventors: Cooper, Tommy, Peters, Harold W., Gorsuch, Reynolds G., Handley, Harold H. Jr.
• Granted Patent: US 6,849,183 B2
• Time in Patent Office: Days
• US Class Current: 604/5.01
• 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

A method for carrying out therapeutic apheresis comprises separating plasma from whole blood in-vivo and removing selected disease-related components from the separated plasma. 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. A method of carrying out therapeutic apheresis comprising:

securing a triple lumen catheter having a filter device on the proximal end thereof in the superior or inferior vena cava or subclavian vein of a patient, said filter device capable of separating plasma from whole blood in-vivo at pressures and flow rates therein;

separating plasma from whole blood in-vivo and directing the separated plasma through a first lumen of said triple lumen catheter to a therapeutic apheresis selective component removal apparatus;

carrying out therapeutic apheresis by separating and removing and/or neutralizing selected disease-related components comprising toxins, antibodies, proteins, bacteria, viruses, and/or combinations of two or more thereof from the plasma, and

returning treated plasma to the patient via a second lumen of said triple lumen catheter.

2. The method of claim 1 including selectively periodically backflushing said filter device via a third lumen of said triple lumen catheter.

3. The method of claim 1 or 2 wherein said therapeutic apheresis is carried out by plasma exchange wherein at least a portion of the separated plasma is replaced with fresh plasma.

6. The method of claim 1 or 2 wherein said therapeutic apheresis is carried out by absorption.

7. The method of claim 6 comprising passing the separated plasma through an absorbent cartridge apparatus for absorbing disease-related components therefrom.

8. The method of claim 6 including substituting fresh plasma for a portion of said separated plasma.

9. The method of claim 1 or 2 wherein said therapeutic apheresis is carried out by exposing the separated plasma to one or more devices capable of removing a specific disease-related component from the separated plasma.

10. The method of claim 9 including substituting fresh plasma for a portion of said separated plasma.

11. The method of claim 1 or 2 wherein said therapeutic apheresis is carried out by directing the separated plasma through one or more chemical process systems for precipitating or neutralizing one or more disease-related components therein.

12. The method of claim 11 including substituting fresh plasma for a portion of said separated plasma.

18. Apparatus of claim 13 for carrying out a method of claim 11 wherein said selective component removal apparatus comprises one or more reactors containing compositions for reacting with disease-related components in the plasma.

4. The method of claim I or 2 wherein said therapeutic apheresis is carried out by cascade filtration.

5. The method of claim 4 including substituting fresh plasma for a portion of said separated plasma.

13. Apparatus for carrying out therapeutic apheresis comprising:

an implantable filter device comprising one or more 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 one or more of said elongated hollow tubes wherein the interior lumen of each of the fibers communicates with the interior of one or more of the 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 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 tubing for directing plasma between said catheter and the selective component removal apparatus.

14. Apparatus of claim 13 wherein said triple lumen catheter comprises a first lumen and a second lumen in fluid communication with the interior of said one or more hollow tubes and a third lumen comprising said plasma return lumen.

15. Apparatus of claim 13 for carrying out a method of claim 3 wherein said therapeutic apheresis apparatus comprises a plasma exchange assembly.

16. Apparatus of claim 13 for carrying out a method of claim 4 wherein said therapeutic apheresis apparatus comprises a multiple stage filtration assembly.

17. Apparatus of claim 13 for carrying out a method of claim 7 wherein said therapeutic apheresis apparatus comprises one or more columns or cartridges containing materials for absorbing disease-related components passing therethrough.

19. Apparatus of claim 13 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.

20. Apparatus of claim 19 including a third pump cooperating with said third tubing and in control connection with said control apparatus.

21. Apparatus of claim 19 including a source of backflush fluid cooperating with said second tubing.

22. Apparatus of claim 19 wherein said controller comprises a microprocessor-controller including software programmed for operating said apparatus.

23. Apparatus of claim 13 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 hollow tube.

24. Apparatus of claim 23 wherein the first hollow tube extends along a first axis and the second 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 hollow tube along a generally straight first row, and the second ends of said elongated microporous fibers are secured to said second hollow tube along a generally straight second row substantially parallel with said first row.

25. Apparatus of claim 24 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.

26. Apparatus of claim 25 wherein the first and second ends of said elongated microporous fibers are secured to said first and second hollow tubes, respectively, at substantially regular intervals.

27. Apparatus of claim 26 wherein said regular intervals are between about 0.1 cm and about 1.0 cm.

28. Apparatus of claim 13 or 23 wherein the length of each of said elongated microporous fibers is between about 1 cm and about 4 cm.

29. Apparatus of claim 24 wherein the length of each of said elongated microporous fibers is between about 1 cm and about 4 cm.

30. Apparatus of claim 24 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.

31. Apparatus of claim 30 wherein the length of each 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°

.

32. Apparatus of claim 13 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.

33. Apparatus of claim 32 wherein the fiber wall structure comprises a continuous change in mass density between the inner and outer surfaces of the fiber.