Apparatus and method for in vivo hemodialysis

• US 6,561,996 B1
• Filed: 05/19/1998
• Issued: 05/13/2003
• Est. Priority Date: 05/19/1998
• Status: Expired due to Fees

• Current Assignee: Transvivo, Inc.
• Original Assignee: Transvivo, Inc.
• Inventors: Gorsuch, Reynolds G.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/081,883
• Time in Patent Office: 1,820 Days
• Field of Search: 604/4, 604/5, 604/6, 604/27-29, 604/890.1, 604/891.1, 604/892.1, 604/48, 604/507-508, 604/540, 604/4.01, 604/6.09, 604/5-1-, 604/6.16, 604/39.41, 604/43, 604/44, 623/11, 623/12, 422/44, 422/48, 128/DIG.13, 128/898-899
• US Class Current: 604/6.09
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/3417 using distinct filters for dialysis and ultra-filtration
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure

Abstract

A method of removing toxins from a patient'"'"'s blood comprises implanting a filter device having a dialysis membrane with an exterior surface exposed to the patient'"'"'s blood and a dialysate cavity exposed to an interior surface of the dialysate membrane within a blood vessel of a patient, continuously directing substantially uncontaminated or substantially decontaminated dialysate into the dialysate cavity and in diffusive communication with the patient'"'"'s blood, dialysing the patient'"'"'s blood with the dialysate, and continuously removing toxin contaminated dialysate from the filter device.

Claims

1. A method of removing toxins from a patient'"'"'s blood without removing blood or blood plasma from a patient, said method comprising:

implanting a filter device within a blood vessel of a patient, said filter device comprising a dialysis membrane having an exterior surface for being exposed to the patient'"'"'s blood and a dialysate cavity exposed to an interior surface of said dialysis membrane, continuously directing substantially uncontaminated or substantially decontaminated dialysate into said dialysate cavity and in diffusive communication with the patient'"'"'s blood, dialyzing the patient'"'"'s blood with said dialysate by diffusing toxins in the patient'"'"'s blood into said dialysate, and continuously removing toxin contaminated dialysate from said filter device without removing blood or blood plasma from the patient.

2. A method of claim 1 including providing a multiple lumen catheter in fluid communication with said dialysate cavity for directing said dialysate thereto and therefrom.

3. A method of claim 2 wherein said filter device includes an ultrafiltration membrane having an exterior surface for being exposed to said patient'"'"'s blood and an ultrafiltration cavity exposed to an interior surface of said ultrafiltration membrane.

4. A method of claim 3 wherein said catheter comprises a first and second lumen each in fluid communication with said dialysate cavity,and a third lumen in fluid communication with said ultrafiltration cavity for directing ultrafiltrate therefrom.

5. A method of claim 4 including selectively pumping ultrafiltrate from said ultrafiltration cavity.

6. A method of claim 1 wherein said filter device includes an ultrafiltration membrane having an exterior surface for being exposed to said patient'"'"'s blood and an ultrafiltration cavity exposed to an interior surface of said ultrafiltration membrane.

7. A method of claim 1 including recovering said toxin contaminated dialysate from said filter device, absorbing toxins from said contaminated dialysate to produce substantially decontaminated dialysate, and directing said substantially decontaminated dialysate filter device.

8. A method of claim 1 wherein dialysate is directed into said filter device using gravity feed.

9. A method of claim 8 wherein contaminated dialysate is siphoned gravitationally from said filter device.

10. A method of claim 8 including selectively pumping contaminated dialysate from said filter device.

11. A method of claim 1 wherein dialysate is pumped into the dialysate cavity of said filter device from a dialysate supply source.

12. A method of claim 11 wherein contaminated dialysate is pumped from said filter device.

13. A method of claim 12 including using a microprocessor controller for controlling the flow of dialysate to and from said filter device.

14. A method of claim 13 including sensing the pressure of dialysate pumped to and from said filter device and controlling the flow of dialysate in response to the sensed dialysate pressure.

15. A method of claim 14 including sensing the blood urea nitrogen level of the dialysate removed from the filter device.

16. A method of claim 12 wherein said filter device includes an ultrafiltration membrane having an exterior surface for being exposed to said patient'"'"'s blood and an ultrafiltration cavity exposed to an interior surface of said ultrafiltration membrane, including selectively pumping ultrafiltrate from said ultrafiltration cavity and using a microprocessor controller for controlling said pumping.

17. A method of claim 1 including filtering toxins from dialysate directed to said dialysate cavity.

18. A method of claim 1 including filtering bacteria from dialysate directed to and from said filter device.

19. A method of claim 18 including sensing the blood urea nitrogen level of the dialysate removed from the filter device.

20. A method of claim 1 including sensing the blood urea nitrogen level of the dialysate removed from the filter device.

21. A method of claim 1 wherein said substantially uncontaminated or substantially decontaminated dialysate is gravitationally fed to said filter device.

22. A method of claim 1 wherein said toxin contaminated dialysate is removed from said filter device by siphoning.

23. A method of claim 22 wherein said siphoning is carried out by providing an outflow tubing having a one-way valve.

24. A method of claim 23 including providing manual vacuum in said outflow tubing.

25. A method of claim 1 wherein said dialysis membrane has a low flux dialyser cut-off of about 5×

10³ daltons and a high flux cut-off of about 5×

10⁴ daltons.

26. A method of claim 1 or 25 wherein said dialysis membrane comprises one or more microporous membrane sheets.

27. A method of claim 1 or 25 wherein said dialysis membrane comprises a plurality of elongated hollow microporous membrane filters.

68. An apparatus of claim 27 wherein said filter device comprises a dual lumen catheter segment having a first lumen for directing dialysate to said capsules and as second lumen for receiving dialysate from said capsules, and wherein said capsules extend radially from said catheter segment.

28. Apparatus for removing toxins from a patient'"'"'s blood comprising:

a filter device for being implanted in a patient'"'"'s blood vessel comprising a dialysis membrane having an exterior surface for being exposed to a patient'"'"'s blood and a dialysate cavity exposed to an interior surface of said dialysis membrane for receiving dialysate fluid directed thereto from a dialysate supply source and whereby said dialysate fluid is in direct diffusive communication with a patient'"'"'s blood,

a multiple lumen catheter secured to said filter device and in fluid communication with said dialysate cavity and having a first lumen for directing fresh dialysate thereto from a dialysate supply source and a second lumen for directing toxin contaminated dialysate, therefrom, and

a dialysate supply source in fluid communication with said catheter capable of continuously supplying fresh dialysate to said dialysate cavity.

29. An apparatus of claim 28 including a first dialysate pump cooperating with said first lumen and a second dialysate pump cooperating with said second lumen.

30. An apparatus of claim 29 including a microprocessor-controller cooperating with said first and second dialysis pumps for controlling the operation of said pumps.

31. An apparatus of claim 30 including one or more pressure transducers cooperating with said multiple lumen catheter for sensing the flow rate of dialysate fluid therein and communicating with said microprocessor-controller.

32. An apparatus of claim 31 comprising one or more first pressure transducers cooperating with said first lumen and one or more second pressure transducers cooperating with said second lumen.

33. An apparatus of claim 30 including a blood toxin sensor cooperating with said second lumen for sensing the concentration of toxins in the dialysate directed from said filter device, and wherein said sensor is in communication with said microprocessor-controller.

34. An apparatus of claim 28 wherein said filter device includes an ultrafiltration membrane having an exterior surface for being exposed to a patient'"'"'s blood and an ultrafiltration cavity exposed to an interior surface of said ultrafiltration membrane.

35. An apparatus of claim 34 wherein said multiple lumen catheter comprises a third lumen for directing ultrafiltrate from said ultrafiltration cavity and an ultrafiltration pump cooperating with said third lumen.

36. An apparatus of claim 34 including a microprocessor-controller cooperating with said first and second dialysate pumps and said ultrafiltration pump for controlling the operation of said pumps.

37. An apparatus of claim 36 including one or more pressure transducers cooperating with said multiple lumen catheter and in communication with said microprocessor-controller.

38. An apparatus of claim 37 comprising one or more first pressure transducers cooperating with said first lumen, one or more second pressure transducers cooperating with said second lumen and one or more third pressure transducers cooperating with said third lumen, wherein said transducers are in flow rate sensing communication with said respective lumens.

39. An apparatus of claim 35 including a receptacle for cooperating with said third lumen for receiving ultrafiltrate.

40. An apparatus of claim 34 wherein said ultrafiltration membrane has a cut-off of about 5.8×

10⁴ daltons.

41. An apparatus of claim 28 including a toxin absorption device cooperating with said dialysate supply source for substantially filtering toxins directed to said filter device.

42. An apparatus of claim 28 wherein said second lumen directs dialysate fluid from said filter device to said dialysate supply source, and wherein said apparatus includes a toxin absorption device cooperating with said first lumen for substantially filtering toxins from dialysate directed to said filter device from said dialysate supply source.

43. An apparatus of claim 28 wherein said dialysate supply source comprises substantially toxin free dialysate and wherein said apparatus includes a receptacle cooperating with said second lumen for receiving said toxin containing dialysate.

44. An apparatus of claim 43 including a tube in communication with said second lumen of said catheter for directing toxin containing dialysate to said receptacle, and a one-way valve cooperating with said tube for preventing fluid flow from said tube to said catheter.

45. An apparatus of claim 44 including a vacuum pump cooperating with said tube or said receptacle for creating a vacuum in said tube for initiating fluid flow therethrough.

46. An apparatus of claim 45 wherein said vacuum pump comprises a hand vacuum pump and one or more check valves.

47. An apparatus of claim 43 including a flow control valve cooperating with said tube.

48. An apparatus of claim 43 including a siphon device for creating a vacuum in said tube for initiating and maintaining fluid flow therethrough.

49. An apparatus of claim 28 wherein said filter device comprises a first dialysate cavity exposed to an interior surface of a first portion of said dialysis membrane and a second dialysate cavity exposed to an interior surface of a second portion of said dialysis membrane, and a partition separating said first and second dialysate cavities.

50. An apparatus of claim 49 wherein said first lumen of said multiple lumen catheter is in fluid communication with said first dialysate cavity, and said second lumen of said multiple lumen catheter is in fluid communication with said second dialysate cavity.

51. An apparatus of claim 50 wherein said filter member includes a third cavity having an inlet port communicating with said multiple lumen catheter and an outlet port communicating with the exterior of said filter device.

52. An apparatus of claim 51 wherein said multiple lumen catheter includes a third lumen communicating with said inlet port of said third cavity.

53. As apparatus of claim 50 wherein said first dialysate cavity is in fluid communication with said second dialysate cavity.

54. An apparatus of claim 49 wherein said first dialysate cavity is in fluid communication with said second dialysate cavity.

55. An apparatus of claim 49 wherein said filter device comprises a first elongated assembly having a first cross-sectional dimension and a second elongated assembly having a cross-sectional dimension.

56. An apparatus of claim 55 wherein said dialysis membrane comprises a first portion enveloping said first elongated assembly and a second portion enveloping said second elongated assembly.

57. An apparatus of claim 56 wherein said first and second elongated assemblies are substantially coaxial.

58. An apparatus of claim 57 wherein said first and second elongated assemblies are substantially cylindrical and wherein said first and said second dialysate cavities are substantially semi-cylindrical and extend along opposite sides of said first and second elongated assemblies, respectively.

59. An apparatus of claim 28 wherein said filter device comprises a plurality of elongated dialysis membrane fibers having a hollow interior defining said dialysate cavity.

60. An apparatus of claim 28 wherein said filter device comprises a corrugated tube formed by one or more sheets of said dialysis membrane.

61. An apparatus of claim 60 wherein said corrugated tube comprises grooves and ridges formed along said dialysis membranes sheet.

62. An apparatus of claim 61 wherein said grooves and ridges form a plurality of lobes.

63. An apparatus of claim 59 wherein said plurality of fibers comprises a bundle of substantially parallel fibers.

64. An apparatus of claim 63 wherein said filter device comprises a plurality of helically wound bundles.

65. An apparatus of claim 59 wherein said filter device comprises:

a dual lumen catheter segment having a first lumen for directing dialysate to said dialysate membrane fibers and a second lumen for receiving dialysate from said dialysate membrane fibers.

66. An apparatus of claim 28 wherein said fiber device comprises a cylindrical tube formed by one or more sheets of said dialysis membrane.

67. An apparatus of claim 66 wherein said filter device comprises a plurality of capsules, each capsule comprising an envelope formed of panels of said dialysis membrane sheets.

69. An apparatus of claim 28 wherein said dialysate supply source is a gravity feed supply source.

70. An apparatus of claim 28 wherein said dialysis membrane has a low flux dialyser cut-off of about 5×

10³ and a high flux cut-off of about 5×

10⁴ daltons.

71. An apparatus of claims 28, 56, 58, 59, 66, 62, 70 or 40 wherein said dialysis membrane comprises a microporous membrane.

72. An apparatus of claim 71 wherein said dialysis membrane comprises one or more microporous membrane sheets.

73. An apparatus of claim 71 wherein said dialysis membrane comprises a plurality of elongated hollow microporous membrane fibers.

74. An apparatus of claim 71 wherein said microporous membrane comprises a combination of one or more microporous membrane sheets and a plurality of elongated hollow microporous membrane fibers.