Method and apparatus for patient fluid management

• US 7,481,936 B2
• Filed: 03/11/2005
• Issued: 01/27/2009
• Est. Priority Date: 10/17/2001
• Status: Expired due to Fees

• Current Assignee: Transvivo, Inc.
• Original Assignee: Transvivo, Inc.
• Inventors: Handley, Harold H., Peters, Harold W., Gorsuch, Reynolds G.
• Primary Examiner(s): Menon; Krishnan S
• Application Number:
  US11/078,016
• Publication Number:
  US 20050215936A1
• Time in Patent Office: 1,418 Days
• Field of Search: None
• US Class Current: 210/645
• 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 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3406 Physical characteristics of the filtrate, e.g. urea
• CPC Class Codes: A61M 1/3431 upstream of the filter
• CPC Class Codes: A61M 1/3472 with treatment of the filtrate
• CPC Class Codes: A61M 1/3479 by dialysing the filtrate
• CPC Class Codes: A61M 1/3486 Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: B01D 2313/10 Specific supply elements
• CPC Class Codes: B01D 63/02 Hollow fibre modules
• CPC Class Codes: B01D 63/024 with a single potted end
• CPC Class Codes: B01D 63/0241 being U-shaped
• CPC Class Codes: B01D 63/034 Lumen open in more than two directions

Abstract

Patient fluid management is carried out by separating plasma from whole blood in vivo via an implantable filter device comprising one or more elongated hollow tubes and a plurality of elongated microporous fibers having an interior lumen extending along the length thereof, each fiber having a first and second end secured to the one or more elongated hollow tubes by passing plasma through the fiber wall from the outer wall surface to the inner wall surface and to the interior fiber lumen, directing the separated plasma to an ultrafiltration apparatus having a sieving coefficient cutoff between about 1×10⁴ and about 6×10⁴ daltons, separating plasma water and selected plasma components, from the separated plasma, and directing the treated plasma to the patient.

Claims

1. Apparatus for carrying out patient fluid management comprising:

an implantable filter device comprising a plurality of elongated hollow tubes and a plurality of elongated microporous fibers having an interior lumen extending along the length thereof, each fiber 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 hollow tubes, and wherein each of the elongated microporous fibers have an asymmetrical fiber wall morphology 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 in the lower mass density zone and wherein said fibers are configured to separate plasma from whole blood in-vivo by passing plasma through said fiber wall from the outer wall surface to the inner wall surface and to said interior lumen thereof;

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

ultrafiltration apparatus having a sieving coefficient cutoff between about 1×

10⁴ and about 6×

10⁴ daltons and configured to separate plasma water and selected plasma components having molecular weights below the sieving coefficient cutoff point from the separated plasma, and tubing for directing plasma between said catheter and the ultrafiltration apparatus.

2. Apparatus of claim 1 wherein said multiple 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.

3. 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 ultrafiltration apparatus to a patient; and

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

4. Apparatus of claim 3 including a third pump cooperating with said third tubing and in control connection with said control apparatus.

5. Apparatus of claim 3 including a source of backflush fluid cooperating with said second tubing.

6. Apparatus of claim 3 wherein said control apparatus comprises a microprocessor-controller including software programmed for operating said apparatus.

7. A filter device of claim 1 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 one or more elongated hollow tubes and forming a passageway therebetween.

8. A filter device of claim 7 wherein said elongated microporous fibers comprise first and second fibers, said first fibers forming a first arch of spaced fibers extending over a first portion of said device, said second fibers forming a second arch extending over a second portion of said device, opposite the first portion, said first and second arches spaced apart from said one or more elongated hollow tubes to form passageways therebetween.

9. A filter device of claim 1 wherein the first and second ends of said elongated microporous fibers are secured to said one or more hollow tubes, respectively, at substantially regular intervals.

10. A filter device of claim 1 wherein the length of each of said elongated microporous fibers is between about 1 cm and about 4 cm.

11. A filter device of claim 1 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 one or more 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.

12. A filter device of claim 1 wherein the space between adjacent fibers is between about 0.1 cm and about 1.0 cm.

13. A filter device of claim 1 wherein the length of said one or more hollow tubes is between about 10 cm and about 25 cm.

14. Apparatus of claim 1 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.

15. Apparatus of claim 3 including a container cooperating with said ultrafiltration apparatus for receiving effluent therefrom.

16. Apparatus of claim 15 including fourth tubing in fluid communication with said container and said ultrafiltration apparatus.

17. Apparatus of claim 16 including an effluent pump cooperating with said fourth tubing for pumping effluent from said ultrafiltration apparatus to said container.

18. Apparatus of claim 3 including a source of fresh plasma in fluid communication with said ultrafiltration apparatus and/or said third tubing.

19. Apparatus of claim 3 wherein said ultrafiltration apparatus has a sieving coefficient cutoff below the molecular weight of albumin.

20. Apparatus of claim 3 wherein said filter device has a sieving coefficient cutoff above the ultrafiltration sieving coefficient cutoff and below about 5×

10⁶ daltons.

21. Apparatus of claim 3 wherein said filter device has a sieving coefficient cutoff between about 6×

10⁴ daltons and about 2×

10⁵ daltons.

22. 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.

23. Apparatus of claim 14 wherein said filter device has a sieving coefficient cutoff above the ultrafiltration sieving coefficient cutoff and below about 5×

10⁶ daltons.

24. Apparatus of claim 20 wherein said ultrafiltration apparatus has a sieving coefficient cutoff below the molecular weight of albumin.

25. Apparatus of claim 22 wherein said ultrafiltration apparatus has a sieving coefficient cutoff below the molecular weight of albumin.

26. A filter device of claim 1 comprising one or more first elongated hollow tubes and one or more 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.

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

m and about 60 μ

m.

36. Apparatus of claim 1 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.

37. Apparatus of claim 35 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.

38. Apparatus of claim 37 wherein the nominal average pore diameter in said lower mass density zone is between about 2 μ

m and about 6 μ

m.

39. Apparatus of claim 38 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.

40. Apparatus of claim 37 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.

41. Apparatus of claim 38 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.

42. Apparatus of claim 1 wherein said fibers comprise a polysulfone fiber.

43. Apparatus of claim 14 wherein said fibers comprise a polysulfone fiber.

44. Apparatus of claim 22 wherein said fibers comprise a polysulfone fiber.

27. A method of patient fluid management and/or treating patient fluid overload comprising:

separating plasma from whole blood in-vivo using a filter device comprising a plurality of elongated hollow tubes and a plurality of elongated microporous fibers having an interior lumen extending along the length thereof, each fiber 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 the hollow tubes, and wherein the fiber wall morphology of each 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 in the lower mass density zone, and passing plasma through said fiber wall from the outer wall surface to the inner wall surface and to said interior lumen thereof;

directing the separated plasma to an ultrafiltration apparatus having a sieving coefficient cutoff between about 1×

10⁴ and about 6×

10⁴ daltons and separating plasma water and selected plasma components having molecular weights at or below the sieving coefficient cutoff from said separated plasma; and

returning the treated plasma to the patient.

28. A method of claim 27 comprising separating plasma water and plasma components having a molecular weight below the molecular weight of albumin from said separated plasma.

29. A method of claim 27 wherein said filter apparatus comprises a triple lumen catheter having said filter device on the proximal end thereof, and wherein separated plasma is directed from said filter device to said ultrafiltration apparatus through a first lumen of said triple lumen catheter and returned to the patient through a second lumen thereof.

30. A method of claim 29 including periodically backflushing said filter device via a third lumen of said triple lumen catheter.

31. A method of claim 27 including directing fresh plasma to the patient.

32. A method of patient fluid management and/or treating patient fluid overload comprising:

securing a plasma filter apparatus comprising a filter device in a blood vessel of a patient, said filter device comprising a plurality of elongated hollow tubes and a plurality of elongated microporous fibers having an interior lumen extending along the length thereof, each fiber 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 the hollow tubes, and wherein the fiber wall morphology of each 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 in the lower mass density zone;

separating plasma from whole blood in-vivo by passing plasma through said fiber wall from the outer wall surface to the inner wall surface;

directing the separated plasma to an ultrafiltration apparatus having a sieving coefficient cutoff between about 1×

10⁴ and about 6×

10⁴ daltons and separating plasma water and selected plasma components having molecular weights at or below the sieving coefficient cutoff from said separated plasma; and

returning the treated plasma to the patient.

33. A method of claim 32 wherein said filter apparatus comprises a triple lumen catheter having said filter device on the proximal end thereof, and wherein separated plasma is directed from said filter device to said ultrafiltration apparatus through a first lumen of said triple lumen catheter and returned to the patient through a second lumen thereof.

34. A method of claim 33 including periodically backflushing said filter device via a third lumen of said triple lumen catheter.