Apparatus and method for the treatment of acute and chronic renal disease by continuous passive plasma ultrafiltration

• US 5,980,478 A
• Filed: 10/10/1997
• Issued: 11/09/1999
• Est. Priority Date: 10/10/1997
• Status: Expired due to Term

• Current Assignee: Transvivo, Inc.
• Original Assignee: Transvivo, Inc.
• Inventors: Gorsuch, Reynolds G., Venkat, Kris
• Primary Examiner(s): Stright, Ronald
• Assistant Examiner(s): Huseman, Cheryl L.
• Application Number:
  US08/949,055
• Time in Patent Office: 760 Days
• Field of Search: 604/4, 604/408, 604/7, 623/12
• US Class Current: 604/5.04
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• 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 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3479 by dialysing the filtrate
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/3673 Anticoagulant coating, e.g. Heparin coating
• CPC Class Codes: A61M 1/82 Membrane pumps, e.g. bulbs
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate

Abstract

An apparatus for treatment of acute and chronic renal disease by continuous passive plasma ultrafiltration includes a plasmapheresis element comprising a catheter and a plasmapheresis filter element secured to the end of the catheter for being implanted in a patient'"'"'s vena cava or jugular vein, a tube secured to the catheter for receiving and directing blood plasma, a one-way valve for preventing fluid flow from the tube to the catheter, and a container for receiving and collecting the blood plasma. The treatment of the patient is performed by implanting the catheter and plasmapheresis filter element in a patient'"'"'s vena cava, passing of blood plasma containing the toxins to be removed from the patient'"'"'s blood supply through the filter element and along the catheter, and collecting and discarding the collected blood plasma.

Claims

1. A method of removing toxins from a patient'"'"'s blood comprising:

implanting a catheter having a plasmapheresis filter element secured on or adjacent to an end thereof within a blood vessel of a patient;

passing a portion of blood plasma to be discarded and containing the toxins to be removed from the patient'"'"'s blood supply through said filter element and directing said blood plasma along said catheter; and

discarding said portion of blood plasma.

2. The method of claim 1, wherein the blood vessel in which said catheter and filter element are implanted is the superior vena cava.

3. The method of claim 1, including securing an end of said catheter opposite said filter element to an elongated flexible tube and directing said blood plasma to be discarded therethrough.

4. The method of claim 3, including providing a collection member and directing said blood plasma to be discarded from said tube to said collection member.

5. The method of claim 3, including providing a one-way valve cooperating with said tube for preventing blood plasma flow from said tube to said catheter.

6. The method of claim 3, including providing a variable flow valve cooperating with said tube for selectively changing the flow rate of blood plasma to be discarded therethrough.

7. The method of claim 4, including providing a variable flow valve cooperating with said tube for selectively changing the flow rate of blood plasma to be discarded therethrough.

8. The method of claim 3, including creating a vacuum within said tube and said catheter for starting and maintaining the flow of blood plasma therethrough.

9. The method of claim 4, including providing a siphon means between said tube and said collection member and using said syphon means to create a vacuum sufficient to start and maintain the flow of blood plasma through said tube to said collection member.

10. The method of claim 4, including providing a suction pump cooperating with said collection member and using said suction pump to create a vacuum sufficient to start and maintain the flow of blood plasma to said collection member.

11. The method of claim 8, including providing a vacuum release valve cooperating with said tube for selectively terminating said vacuum and stopping the flow of blood plasma in said catheter and said tube.

12. The method of claim 1, wherein said catheter is a dual lumen catheter having a first lumen for directing blood plasma to be discarded from the patient and a second lumen for directing fluid other than said blood plasma to be discarded to the patient.

13. The method of claim 12, including providing fluid source containing fluid other than said blood plasma to be discarded to be infused to the patient, and directing said fluid to the patient through said second lumen.

14. The method of claim 4, comprising continuously passing blood plasma to be discarded through said filter element, along said catheter and through said tube to said collection member.

15. The method of claim 7, comprising continuously passing blood plasma to be discarded through said filter element, along said catheter and through said tube to said collection member.

16. The method of claim 15, comprising increasing the flow rate of blood plasma to be discarded during a period of increased patient physical activity and decreasing the flow rate of blood plasma to be discarded during a period of decreased physical activity.

17. The method of claim 13, comprising continuously passing blood plasma to be discarded through said filter element and passing said blood plasma to be discarded from the patient through said first lumen of said catheter, and selectively and periodically continuously directing fluid other than said blood plasma to be discarded from said fluid source to the patient through said second lumen of said catheter.

18. The method of claim 1, comprising providing a plasmapheresis filter element having a sieving coefficient cutoff between 2×

10⁴ daltons and 4×

10⁶ daltons.

19. The method of claim 14, comprising providing a plasmapheresis filter element having a sieving coefficient cutoff between 2×

10⁴ daltons and 4×

10⁶ daltons.

20. An apparatus for removing toxins from a patient'"'"'s blood comprising:

a single lumen catheter having a plasmapheresis filter element secured on or adjacent to an end thereof, said catheter and said filter capable of implantation in a patient'"'"'s vena cava or jugular vein and for directing blood plasma to be discarded therefrom;

a flexible tube secured to said catheter for receiving and directing blood plasma to be discarded from said catheter, and a one-way valve cooperating therewith along said flexible tube for preventing fluid flow of said plasma to be discarded from returning from said tube to said catheter; and

a container cooperating with said tube for receiving and collecting blood plasma from said tube to be discarded.

21. The apparatus of claim 20, wherein said filter element comprises a hollow fiber and/or sheet membrane having a sieving coefficient cutoff of between 2×

10⁴ and 4×

10⁶ daltons.

22. The apparatus of claim 20, wherein said filter element comprises a hollow fiber and/or sheet membrane having a total outer surface area of 100-500 cm².

23. The apparatus of claim 21, wherein said filter element comprises a hollow fiber and/or sheet membrane having a total outer surface area of 100-500 cm².

24. The apparatus of claim 22 wherein the filter membrane has a flux performance of 1 to 15 ml/min/cm² /bar.

25. The apparatus of claim 23 wherein the filter membrane has a flux performance of 1 to 15 ml/min/cm² /bar.

26. The apparatus of claim 20, including a variable flow control valve cooperating with said tube.

27. The apparatus of claim 20, including a syphon device for creating a vacuum in said tube for initiating and maintaining fluid flow therethrough.

28. The apparatus of claim 20, including a vacuum pump cooperating with said tube or said container for creating a vacuum within said tube for initiating fluid flow therethrough.

29. The apparatus of claim 28, wherein said vacuum pump comprises a hand vacuum pump and one or more check valves.

30. The apparatus of claim 27, including a vacuum release valve cooperating with said tube for terminating the flow of fluid therein.

31. The apparatus of claim 28, including a vacuum release valve cooperating with said tube for terminating the flow of fluid therein.

32. An apparatus for removing toxins from a patient'"'"'s blood comprising:

a dual lumen catheter having a plasmapheresis filter element secured on or adjacent to a first end thereof, said catheter and said filter element capable of implantation in a patient'"'"'s vena cava or jugular vein, said catheter having a first lumen for directing blood plasma to be discarded from said patient and a second lumen for directing fluid other than said blood plasma to be discarded to said patient;

an infusion fluid flow directing means cooperating with said second lumen of said catheter for directing fluid other than said blood plasma to be discarded to said patient therethrough;

a flexible tube cooperating with said first lumen for directing blood plasma to be discarded from said patient therethrough and a one-way valve cooperating therewith for preventing flow of said blood plasma to be discarded back to said patient; and

a container for receiving and collecting blood plasma to be discarded from said tube.

33. The apparatus of claim 32, wherein said filter element comprises a hollow fiber and/or sheet membrane having a sieving coefficient cutoff of between 2×

10⁴ and 4×

10⁶ daltons.

34. The apparatus of claim 32, wherein said filter element comprises a hollow fiber and/or sheet membrane having a total outer surface area of 100-500 cm².

35. The apparatus of claim 33, wherein said filter element comprises a hollow fiber and/or sheet membrane having a total outer surface area of 100-500 cm².

36. The apparatus of claim 33 wherein the filter membrane has a flux performance of 1 to 15 ml/min/cm² /bar.

37. The apparatus of claim 32, including a variable flow control valve cooperating with said tube.

38. The apparatus of claim 32, including a syphon device for creating a vacuum in said tube for initiating and maintaining fluid flow therethrough.

39. The apparatus of claim 32, including a vacuum pump cooperating with said tube or said container for creating a vacuum within said tube for initiating fluid flow therethrough.

40. The apparatus of claim 39, wherein said vacuum pump comprises a hand vacuum pump and one or more check valves.

41. The apparatus of claim 38, including a vacuum release valve cooperating with said tube for terminating the flow of fluid therein.

42. The apparatus of claim 39, including a vacuum release valve cooperating with said tube for terminating the flow of fluid therein.