HEMOFILTRATION SYSTEM

• US 20010016699A1
• Filed: 02/14/1997
• Published: 08/23/2001
• Est. Priority Date: 02/14/1997
• Status: Abandoned Application

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: BRUGGER, JAMES M., BURBANK, JEFFREY H., FINCH, CHARLES D. Jr.
• Application Number:
  US08/800,881
• Publication Number:
  US 20010016699A1
• Time in Patent Office: Days
• US Class Current: 604/4.01
• CPC Class Codes: A61M 1/3448 by mechanically linked pumps in both ultra-filtrate and substitution flow line
• CPC Class Codes: A61M 1/3451 the difference in weight between both ultra-filtrate and substitution reservoir being used as control signal
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A hemofiltration system and method is provided that allows for high flow rate, accurate determination of net fluid withdrawal from or addition to a patient, and simple and reliable home operation. A removable, disposable assembly includes a filter housing and pump member including one or more fluid conduits mounted against the pump member. When the disposable filter/pump member assembly is attached to the treatment system, a pump roller mechanism associated with the system actuates the conduits mounted against the pump member. A disposable waste receptacle and fluid replacement (infusate) reservoir can be provided as an integral part of the disposable filter/pump member assembly.

Claims

1. A method of clearing a patient'"'"'s blood of uremic toxins, comprising:

subjecting a patient in need of renal therapy to a protocol involving continuously removing blood from a patient at a blood flow rate of at least 300 ml/min, at least partially clearing the blood of uremic toxins to create cleared blood, and continuously returning the cleared blood to the patient; and

repeating the protocol at least 4 times in one week.

2. A method as in

claim 1

, comprising subjecting the patient to a protocol involving renal therapy at a blood flow rate of at least 400 ml/min, and repeating the protocol at least 4 times in one week.

3. A method as in

claim 1

, comprising subjecting the patient to a protocol involving renal therapy at a blood flow rate of at least 500 ml/min, and repeating the protocol at least 4 times in one week.

4. A method as in

claim 1

, comprising subjecting the patient to a protocol involving renal therapy at a blood flow rate of at least 600 ml/min, and repeating the protocol at least 4 times in one week.

5. A method as in

claim 1

, comprising accessing a patient'"'"'s vascular system through a subcutaneous port, removing the blood from the patient, at least partially clearing the blood of uremic toxins to create cleared blood, and returning the cleared blood to the patient subcutaneously.

6. A method as in

claim 1

, the protocol involving allowing uremic toxins in the patient'"'"'s blood to reach no more than about 80% of the maximum level compared to thrice-weekly therapy levels, and treating the patient'"'"'s blood to reduce uremic toxins in the blood to a level no less than about 20% minimum level.

7. A method as in

claim 1

, the protocol involving subjecting the patient to hemofiltration.

8. A method as in

claim 7

, comprising subjecting the patient to hemofiltration using a hemofiltration system including a disposable infusate reservoir containing from about 4 to about 18 liters infusate.

9. A method as in

claim 1

, comprising subjecting the patient to a protocol using a system including:

a filter having a first side and a second side;

an input conduit in fluid communication with the first side of the filter and fluidly connectable to a patient'"'"'s blood stream;

a return conduit in fluid communication with the first side of the filter for returning cleared blood to the patient'"'"'s blood stream;

a waste receptacle;

a waste conduit fluidly connecting the waste receptacle to the second side of the filter;

a reservoir containing from about 4 to about 25 liters of infusate;

an infusate conduit fluidly connecting the reservoir to the return conduit.

10. A method as in

claim 9

, wherein the reservoir, contains from about 4 to about 18 liters infusate.

11. A method as in

claim 9

, wherein the filter, input conduit, return conduit, waste receptacle, waste conduit, and infusate reservoir together comprise a self-contained, disposable unit packaged together and operable in combination with a pump and a controller by making no more than two fluid connections within the unit including fluidly connecting the input conduit and the return conduit to a patient'"'"'s blood stream.

12. A method as in

claim 1

, the protocol involving clearing a patient'"'"'s blood of uremic toxins via hemofiltration at an effective clearance rate of at least 100 ml/min.

84. A method as in

claim 1

, comprising repeating the protocol at least five times in one week.

85. A method as in

claim 1

, comprising repeating the protocol at least six times in one week.

86. A method as in

claim 2

, comprising repeating the protocol at least five times in one week.

87. A method as in

claim 2

, comprising repeating the protocol at least six times in one week.

88. A method as in

claim 3

, comprising repeating the protocol at least five times in one week.

89. A method as in

claim 3

, comprising repeating the protocol at least six times in one week.

90. A method as in

claim 4

, comprising repeating the protocol at least five times in one week.

91. A method as in

claim 4

, comprising repeating the protocol at least six times in one week.

92. A method as in

claim 8

, wherein the disposable infusate reservoir contains from about 9 to about 13 liters infusate.

93. A method as in

claim 8

, wherein the disposable infusate reservoir contains from about 10 to about 12 liters infusate.

94. A method as in

claim 9

, wherein the reservoir contains from about 9 to about 13 liters infusate.

13. A method comprising clearing a patient'"'"'s blood of uremic toxins via hemofiltration at an effective clearance rate of at least 100 ml/min

14. A method as in

claim 13

, comprising:

subjecting a patient in need of renal therapy to a protocol involving allowing uremic toxins in the patient'"'"'s blood to reach no more than about 80% of the maximum level compared to those levels encountered in thrice-weekly therapy, treating the patient'"'"'s blood to reduce uremic toxins in the blood to a level no less than about 20% of the maximum level compared to those levels encountered in thrice-weekly therapy; and

repeating the protocol at least four times in one week.

15. A method as in

claim 13

, comprising clearing the patient'"'"'s blood of uremic toxins via a system including:

a filter having a first side in fluid communication with a source of a patient'"'"'s blood and a second side in fluid communication with a waste receptacle; and

a reservoir containing from about 4 to about 25 liters of infusate fluidly connectable to the patient'"'"'s blood stream.

16. A method as in

claim 15

, wherein the reservoir contains from about 4 to about 18 liters infusate.

17. A method as in

claim 13

, comprising clearing the patient'"'"'s blood of uremic toxins via a system including:

a filter having a first side and a second side;

an input conduit in fluid communication with the first side of the filter and fluidly connectable to a patient'"'"'s blood stream;

a return conduit in fluid communication with the first side of the filter for returning cleared blood to the patient'"'"'s blood stream;

a waste receptacle;

a waste conduit fluidly connecting the waste receptacle to the second side of the filter;

a reservoir containing from about 4 to about 25 liters of infusate;

an infusate conduit fluidly connecting the reservoir to the return conduit.

18. A method as in

claim 17

, wherein the reservoir contains from about 4 to about 18 liters infusate.

19. A method as in

claim 17

, wherein the filter, input conduit, return conduit, waste receptacle, waste conduit, reservoir, and infusate conduit together comprise a self-contained, disposable unit packaged together and operable in combination with a pump and a controller by making no more than two fluid connections within the unit including fluidly connecting the input conduit and the return conduit to a patient'"'"'s blood stream.

95. A method as in

claim 15

, wherein the reservoir contains from about 9 to about 13 liters infusate.

96. A method as in

claim 17

, wherein the reservoir contains from about 9 to about 13 liters infusate.

20. A method comprising:

subjecting a patient in need of renal therapy to a protocol involving allowing uremic toxins in the patient'"'"'s blood to reach no more than about 80% of the maximum level compared to thrice-weekly therapy levels, treating the patient'"'"'s blood to reduce uremic toxins in the blood to a level no less than about 20% of the maximum level compared to thrice-weekly therapy levels; and

repeating the protocol at least 4 times in one week.

21. A method as in

claim 20

, comprising subjecting the patient to the protocol using a self-contained system including

a filter having a first side in fluid communication with a source of a patient'"'"'s blood and a second side in fluid communication with a waste receptacle;

and

a reservoir containing from about 4 to about 25 liters of infusate fluidly connectable to the patient'"'"'s blood stream.

22. A method as in

claim 21

, wherein the reservoir contains from about 4 to about 18 liters infusate.

23. A method as in

claim 20

, comprising subjecting a patient to the protocol using a system including:

a filter having a first side and a second side;

an input conduit in fluid communication with the first side of the filter and fluidly connectable to a patient'"'"'s blood stream;

a return conduit in fluid communication with the first side of the filter for returning cleared blood to the patient'"'"'s blood stream;

a waste receptacle;

a waste conduit fluidly connecting the waste receptacle to the second side of the filter;

a reservoir containing from about 4 to about 25 liters of infusate;

an infusate conduit fluidly connecting the reservoir to the return conduit.

24. A method as in

claim 23

, wherein the reservoir contains from about 4 to about 18 liters infusate.

25. A method as in

claim 23

, wherein the filter, input conduit, return conduit, waste receptacle, waste conduit, reservoir, and infusate conduit together comprise a self-contained, disposable unit packaged together and operable in combination with a pump and a controller by making no more than two fluid connections within the unit including fluidly connecting the input conduit and the return conduit to a patient'"'"'s blood stream.

97. A method as in

claim 23

, wherein the reservoir contains from about 9 to about 13 liters infusate.

26. A self-contained system for clearing a patient'"'"'s blood of uremic toxins, comprising:

a filter having a first side fluidly connectable to a source of a patient'"'"'s blood and a second side fluidly connectable to a waste receptacle; and

a reservoir containing from about 4 to about 25 liters of infusate fluidly connectable to the patient'"'"'s blood stream.

27. A system as in

claim 26

, wherein the reservoir contains from about 4 to about 18 liters infusate.

28. A system as in

claim 26

, comprising:

a filter having a first side and a second side;

an input conduit in fluid communication with the first side of the filter and fluidly connectable to a patient'"'"'s blood stream;

a return conduit in fluid communication with the first side of the filter for returning cleared blood to the patient'"'"'s blood stream;

a waste receptacle;

a waste conduit fluidly connecting the waste receptacle to the second side of the filter;

a reservoir containing from about 4 to about 25 liters of infusate;

an infusate conduit fluidly connecting the reservoir to the return conduit.

29. A system as in

claim 28

, the reservoir containing from about 4 to about 18 liters infusate.

30. A system as in

claim 28

, wherein the filter, input conduit, return conduit, waste receptacle, waste conduit, reservoir, and infusate conduit reservoir together comprise a self-contained, disposable unit packaged together and operable in combination with a pump and a controller by making no more than two fluid connections within the unit including fluidly connecting the input conduit and the return conduit to a patient'"'"'s blood stream.

98. A method as in

claim 26

, wherein the reservoir contains from about 9 to about 13 liters infusate.

99. A method as in

claim 28

, wherein the reservoir contains from about 9 to about 13 liters infusate.

31. A system for clearing a patient'"'"'s blood of uremic toxins, comprising:

a filter having a first side and a second side;

an input conduit in fluid communication with the first side of the filter and fluidly connectable to a patient'"'"'s blood stream;

a return conduit in fluid communication with the first side of the filter for returning cleared blood to the patient'"'"'s blood stream;

a waste receptacle;

a waste conduit fluidly connecting the waste receptacle to the second side of the filter;

a reservoir containing from about 4 to about 25 liters of infusate; and

an infusate conduit fluidly connecting the reservoir to the return conduit.

32. A system as in

claim 31

, the reservoir containing from about 4 to about 18 liters infusate.

33. A system as in

claim 31

, wherein the filter, the input conduit, the return conduit, waste receptacle, the waste conduit, the infusate reservoir, and the reservoir together comprise a self-contained, disposable unit packaged together and operable in combination with a pump and a controller by making no more than two fluid connections within the unit including fluidly connecting the input conduit and the return conduit to a patient'"'"'s blood stream.

34. A system as in

claim 33

, wherein the self-contained unit further comprises a pump member surface that mates with a pump in a treatment controller when the unit is attached to the treatment controller and at least two conduits of the input conduit, the waste conduit, the infusate conduit, and the return conduit are arranged proximate the pump member surface such that when the unit is attached to the treatment controller the at least two conduits are actuable by the pump.

39. A system as in

claim 34

, the fluid conduit containing a physiological fluid.

100. A method as in

claim 31

, wherein the reservoir contains from about 9 to about 13 liters infusate.

35. A system comprising:

a peristaltic pump;

a fluid conduit passing through the pump and having a portion upstream of the pump; and

a valve in the portion of the fluid conduit upstream of the pump.

36. A system as in

claim 35

, wherein the valve is movable between a first position creating a first degree of resistance to fluid flow past the valve and a second position creating a second degree of resistance to fluid flow past the valve greater than the first degree of resistance.

37. A system as in

claim 36

, wherein the valve is operably linked to a controller responsive to a flow sensor.

38. A system as in

claim 35

, the fluid conduit constructed and arranged to receive a physiological fluid.

40. A method comprising:

adjusting the rate of fluid flow through a peristaltic pump by adjusting the resistance to fluid flow upstream of the pump.

41. A method as in

claim 40

, the adjusting step involving moving a valve, of a fluid conduit supplying fluid to the peristaltic pump, towards a closed position.

42. A method as in

claim 40

, comprising adjusting the rate of flow of a physiological fluid through the peristaltic pump.

43. A method comprising:

establishing a flow of fluid through a peristaltic pump from a source of the fluid; and

changing the rate of flow of the fluid through the peristaltic pump while the pump operates at a constant speed and the source of fluid remains constant.

44. A method as in

claim 43

, involving establishing a flow of physiological fluid through the peristaltic pump and changing the rate of flow of the physiological fluid.

45. A method as in

claim 43

, the changing step involving adjusting the resistance to fluid flow upstream of the pump.

46. A method as in

claim 45

, involving adjusting the resistance to fluid flow by moving a valve of a fluid conduit supplying the pump towards a closed position.

47. A method comprising:

controlling an amount of a replacement fluid added from a reservoir to a blood stream of a patient in response to a signal generated from comparison of (a) a total amount of an accumulated waste product removed from the blood stream and the replacement fluid in the reservoir with (b) one of the amount of the accumulated waste product and the replacement fluid in the reservoir.

48. A method as in

claim 47

, comprising:

accumulating a waste product removed from a blood stream of a patient;

adding a replacement fluid to the blood stream from a reservoir of replacement fluid;

monitoring a total amount of the accumulated waste product plus the replacement fluid in the reservoir;

monitoring an amount of at least one of the accumulated waste product and the replacement fluid in the reservoir;

comparing the total amount of the accumulated waste product and the replacement fluid in the reservoir with the at least one of the accumulated waste product and the replacement fluid in the reservoir to generate a signal; and

controlling an amount of replacement fluid added to the blood stream in response to the signal.

49. A system comprising:

a blood treatment device having an input fluidly connectable to a source of blood drawn from a patient in need of renal treatment and an output fluidly connectable to a receptacle of blood waste product;

a first scale adapted to determine a first value that is a total amount of the content of the receptacle of blood waste product plus an amount of blood replacement fluid in a reservoir;

a second scale adapted to determine a second value that is at least one of the content of the receptacle of blood waste product and the amount of blood replacement fluid in the reservoir;

a microprocessor capable of generating a signal indicative of a comparison of the first value and the second value; and

a controller capable of controlling delivery of blood replacement fluid to the patient'"'"'s blood stream in response to the signal.

50. A system as in

claim 49

, wherein the fluid treatment device is a filter housing.

51. A system as in

claim 49

, wherein the fluid treatment device is a filter.

52. A system as in

claim 49

, wherein the fluid treatment device is removably securable to a housing of the microprocessor.

53. A system as in

claim 49

, further comprising a first fluid pump having an inlet fluidly connectable to the source of blood and an outlet fluidly connectable to the blood treatment device.

54. A system as in

claim 53

, wherein the fluid treatment device is removably securable to the fluid pump.

55. A system as in

claim 53

, wherein the fluid treatment device is attached to the fluid pump.

56. A system as in

claim 55

, wherein the fluid treatment device is removably securable to a housing of the microprocessor.

57. A system as in

claim 49

, further comprising a second fluid pump having an inlet fluidly connectable to the blood treatment device and an outlet fluidly connectable to the waste product receptacle.

58. A system as in

claim 57

, wherein the first and second fluid pumps are driven by a single driving mechanism.

59. A system as in

claim 58

, wherein each of the first and second fluid pumps comprises a fluid pathway addressed by a common peristaltic pump apparatus.

60. A system as in

claim 57

, further comprising a third fluid pump having an inlet fluidly connectable to the reservoir of blood replacement fluid and an outlet fluidly connectable to the patient'"'"'s blood stream.

61. A system as in

claim 60

, wherein each of the first and third fluid pumps comprises a fluid pathway addressed by a common peristaltic pump apparatus.

62. A system as in

claim 60

, wherein each of the second and third fluid pumps comprises a fluid pathway addressed by a common peristaltic pump apparatus.

63. A system as in

claim 60

, wherein each of the first, second, and third fluid pumps comprises a fluid pathway addressed by a common peristaltic pump apparatus.

64. A system comprising:

a peristaltic pump including a fluid conduit and a rotatable actuator that urges fluid flow within the conduits upon rotation, the first conduit connected to a source of physiological fluid.

65. A system as in

claim 64

, wherein the peristaltic pump is a multi-conduit peristaltic pump including a second fluid conduit, wherein the rotatable actuator urges fluid flow within the conduit and the second conduit upon rotation, both conduits being connected to a physiological fluid source.

66. A method comprising:

urging simultaneously the flow of first and second physiological fluids within first and second conduits, respectively, via actuation of a single fluid pump actuator.

67. A method as in

claim 66

comprising urging the flow of the first and second physiological fluids via actuation of a peristaltic pump.

68. A fluid pump constructed and arranged for use with a blood treatment system, the treatment system including a blood treatment device, a withdrawal conduit arranged to supply a source of blood from a patient in need of renal treatment to the treatment device, a return conduit arranged to return treated blood from the treatment device to the patient, a waste product conduit arranged to deliver waste product removed from the blood by the treatment device to a waste outlet, and a replacement fluid conduit arranged to deliver a replacement fluid to the patient,

wherein the fluid pump is constructed and arranged to urge fluid to flow within at least two of the withdrawal conduit, the return conduit, the waste product conduit, and the replacement fluid conduit.

69. A fluid pump as in

claim 68

, constructed and arranged to urge fluid to flow within at least three of the withdrawal conduit, the return conduit, the waste product conduit, and the replacement fluid conduit.

70. A fluid pump as in

claim 68

, constructed and arranged to urge fluid to flow within each of the withdrawal conduit, the waste product conduit, and the replacement fluid conduit.

71. A fluid pump as in

claim 68

comprising a race and a peristaltic roller member, constructed to receive between the race and roller member the at least two conduits.

72. An assembly for use with a blood treatment system that is removably attachable to the system, comprising:

a blood filter housing having an inlet and a first outlet and a second outlet;

a pump member having a surface that mates with a pump in the treatment system when the assembly is attached to the treatment system;

a withdrawal conduit in fluid communication with the filter housing inlet and fluidly connectable to a source of blood from a patient in need of renal treatment;

a return conduit in fluid communication with the first filter housing outlet and fluidly connectable to a conduit for returning treated blood to the patient; and

a waste product conduit in fluid communication with the second filter housing outlet,

at least two of the withdrawal conduit, the return conduit, and the waste product conduit being arranged proximate the pump member surface such that, when the assembly is attached to the treatment system, the at least two conduits are actuable by the pump.

73. An assembly as in

claim 72

, constructed and arranged such that when the assembly is attached to the treatment system, at least two of the withdrawal conduit, the return conduit, the waste product conduit, and a replacement fluid conduit arranged to deliver a replacement fluid to the patient are actuable by the pump.

74. An assembly as in

claim 73

, wherein at least two of the withdrawal conduit, the return conduit, the waste product conduit, and the replacement fluid conduit pass between a the pump member surface and a pump roller assembly of the pump when the assembly is attached to the treatment system.

75. An assembly as in

claim 72

, wherein the assembly is provided in combination with instructions for a single use followed by disposal.

76. An assembly as in

claim 72

, wherein the assembly is readily attachable and detachable by a patient from a housing containing a microprocessor for controlling actuation of the pump.

77. An assembly as in

claim 76

, wherein the a waste product conduit is fluidly connectable to a waste product container and the replacement fluid conduit is fluidly connectable to a replacement fluid reservoir.

78. A blood treatment system assembly as in

claim 77

, wherein the a waste product conduit is fluidly connectable to a waste product container and the replacement fluid conduit is fluidly connectable to a replacement fluid reservoir that forms an integral unit with the waste product container.

79. A blood treatment system assembly as in

claim 77

, wherein the a waste product conduit is fluidly connectable to a waste product container and the replacement fluid conduit is fluidly connectable to a replacement fluid reservoir that forms a single, disposable unit with the waste product container.

80. A system comprising:

a conduit fluidly connectable to a patient'"'"'s vascular system; and

an ultrasonic sensor responsive to fluid flow in the conduit and including an output for delivering a signal indicative of fluid flow rate in the conduit.

81. A system as in

claim 80

, further comprising an alarm responsive to the signal delivered by the ultrasonic sensor, arranged to be activated when the fluid flow rate.

82. A system as in

claim 81

, wherein the alarm is activated when the fluid flow rate drops below a predetermined rate.

83. A system for clearing a patient'"'"'s blood of uremic toxins, comprising:

a subcutaneous port providing fluid communication with a patient'"'"'s vascular system;

a filter having a first side and a second side;

an input conduit in fluid communication with the first side of the filter and fluidly connectable to the subcutaneous port;

a return conduit in fluid communication with the first side of the filter for returning cleared blood to the patient'"'"'s blood stream;

a waste receptacle;

a waste conduit fluidly connecting the waste receptacle to the second side of the filter;

a reservoir containing from about 4 to about 25 liters of infusate; and

an infusate conduit fluidly connecting the reservoir to the return conduit,

wherein the system is constructed and arranged to continuously clear the blood of uremic toxins to create cleared blood at a blood flow rate of at least 300 ml/min.