Last-chance quality check and/or air/pathogen filter for infusion systems

• US 20050209547A1
• Filed: 06/05/2003
• Published: 09/22/2005
• Est. Priority Date: 06/06/2002
• Status: Abandoned Application

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Brugger, James M., Burbank, Jeffrey H.
• Application Number:
  US10/513,693
• Publication Number:
  US 20050209547A1
• Time in Patent Office: Days
• US Class Current: 604/5.10
• CPC Class Codes: A61L 2/0017 Filtration
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/3401 Cassettes therefor
• CPC Class Codes: A61M 1/3455 Substitution fluids
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 1/3465 using dialysate as substitution fluid
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: B01D 61/32 Controlling or regulating

Abstract

Blood treatment system and method for high rate hemofiltration ensures against pyrogenic patient reaction by providing various mechanisms for filtering replacement fluid to remove endotoxins and other safety features including detecting incorrect fluid administration.

Claims

1. A method for performing hemofiltration, comprising the steps of:

providing at least one container of fluid that is regulatory-cleared for infusion into patients;

connecting said at least one container to at least one filter effective to ensure a concentration of endotoxins in said fluid passing therethrough is below 0.03 EU/ml;

administering to a patient a blood treatment including a step of infusing said fluid into said patient after filtering said fluid by means of said at least one filter.

2. A method as in claim 1, further comprising performing said treatment within a regulatory regime in which a standard for regulatory clearance is such that said fluid may contain more than 0.03 Eu/ml.

3. A method as in claim 1, wherein said step of administering includes drawing said fluid from said at least one container and passing it through said at least one filter, whereby said fluid is filtered as it is consumed by said treatment.

4. A method as in claim 1, wherein said at least one filter is located immediately upstream of a flow junction at which said fluid is injected into a venous line returning blood into said patient.

5. A method as in claim 1, wherein said at least one filter is effective to reduce a concentration of endotoxins in said fluid such as to deliver no more than 5 EU/hr per Kg of patient weight of fluid upon filtration thereof at a defined rate of infusion into said patient.

6. A method as in claim 1, wherein at least one container is at least two containers and said at least one filter is at least one filter for each of said containers, each said filtering being connected inline in a respective flow line connected to each of said at least two containers, whereby fluid from each container is filtered by its own filter.

7. A method as in claim 1, wherein:

said at least one filter is at least two;

said step of administering includes drawing said fluid from said at least one container and passing it through at least one of said at least two filters, whereby said fluid is filtered as it is consumed by said treatment; and

at least another of said at least two filters is located upstream of a flow junction at which said fluid is injected into a venous line returning blood into said patient such that said fluid is double-filtered before entering said patient'"'"'s body.

8. A method as in claim 7, wherein said at least another of said at least two filters is located immediately upstream of said flow junction at which said fluid is injected into said venous line.

9. A method for performing hemofiltration, comprising the steps of:

providing at least one container of fluid that is regulatory-cleared for a defined rate of infusion into patients;

connecting said at least one container to at least one filter effective to reduce a concentration of endotoxins in said fluid to a rate below that of said fluid in said container;

administering to a patient a blood treatment including a step of infusing said fluid into said patient at said defined rate after filtering said fluid by means of said at least one filter.

10. A method as in claim 9, further comprising performing said treatment within a regulatory regime in which a standard for regulatory clearance for said defined rate of infusion is such that said fluid may contain more than 0.03 EU/ml.

11. A method as in claim 9, wherein said step of administering includes drawing said fluid from said at least one container and passing it through said at least one filter, whereby said fluid is filtered as it is consumed by said treatment.

12. A method as in claim 9, wherein said at least one filter is located immediately upstream of a flow junction at which said fluid is injected into a venous line returning blood into said patient.

13. A method as in claim 9, wherein said at least one filter is effective to reduce a concentration of endotoxins in said fluid to such as to deliver to a patient no more than 5 EU/hr per Kg. of patient weight of fluid upon filtration thereof at said defined rate of infusion.

14. A method as in claim 9, wherein at least one container is at least two containers and said at least one filter is at least one filter for each of said containers, each said filtering being connected inline in a respective flow line connected to each of said at least two containers, whereby fluid from each container is filtered by its own filter.

15. A method as in claim 9, wherein:

said at least one filter is at least two;

said step of administering includes drawing said fluid from said at least one container and passing it through at least one of said at least two filters, whereby said fluid is filtered as it is consumed by said treatment; and

at least another of said at least two filters is located upstream of a flow junction at which said fluid is injected into a venous line returning blood into said patient such that said fluid is double-filtered before entering said patient'"'"'s body.

16. A method as in claim 15, wherein said at least another of said at least two filters is located immediately upstream of said flow junction at which said fluid is injected into said venous line.

17. A method as in claim 9, wherein said at least one filter is effective to reduce a concentration of endotoxins in said fluid to a rate below 0.03 EU/ml.

18. A method for performing hemofiltration, comprising the steps of:

providing at least one container of fluid for infusion into patients;

connecting said at least one container to at least one filter effective to ensure a concentration of endotoxins in said fluid passing therethrough is below both 0.03 EU/ml and such as to deliver no more than 5 EU/hr per Kg of patient weight at a defined rate of infusion into a patient;

administering to a patient a blood treatment including a step of infusing said fluid into said patient.

19. A method as in claim 18, further comprising performing said treatment within a regulatory regime in which a standard for regulatory clearance for said defined rate of infusion is such that said fluid may contain more than 0.03 EU/ml.

20. A method as in claim 18, wherein said step of administering includes drawing said fluid from said at least one container and passing it through said at least one filter, whereby said fluid is filtered as it is consumed by said treatment.

21. A method as in claim 18, wherein said at least one filter is located immediately upstream of a flow junction at which said fluid is injected into a venous line returning blood into said patient.

22. A method as in claim 18, wherein said at least one filter is effective to reduce a concentration of endotoxins in said fluid to a rate such as to deliver to said patient no more than 5 EU/hr. per Kg. of patient weight of fluid upon filtration thereof at said defined rate of infusion into said patient.

23. A method as in claim 18, wherein at least one container is at least two containers and said at least one filter is at least one filter for each of said containers, each said filtering being connected inline in a respective flow line connected to each of said at least two containers, whereby fluid from each container is filtered by its own filter.

24. A method as in claim 18, wherein:

said at least one filter is at least two;

said step of administering includes drawing said fluid from said at least one container and passing it through at least one of said at least two filters, whereby said fluid is filtered as it is consumed by said treatment; and

at least another of said at least two filters is located upstream of a flow junction at which said fluid is injected into a venous line returning blood into said patient such that said fluid is double-filtered before entering said patient'"'"'s body.

25. A method as in claim 24, wherein said at least another of said at least two filters is located immediately upstream of said flow junction at which said fluid is injected into said venous line.

26. A method as in claim 18, wherein said at least one filter is effective to reduce a concentration of endotoxins in said fluid to a rate below 0.03 EU/ml.

27. A method for performing hemofiltration, comprising the steps of:

filtering a replacement fluid to ensure against a presence of endotoxins, in a filtered fluid resulting from said step of filtering, at a concentration no higher than 0.03 EU/ml;

drawing a waste fluid from a patient;

infusing said filtered fluid into said patient;

said step of filtering including filtering with a media having a pore size that is ineffective to block endotoxins, but made of a material that is effective to adsorb endotoxins.

28. A method as in claim 27, further comprising performing said treatment within a regulatory regime in which a standard for regulatory clearance for said defined rate of infusion is such that said fluid may contain more than 0.03 EU/ml.

29. A method as in claim 27, wherein said step of administering includes drawing said fluid from said at least one container and passing it through said at least one filter, whereby said fluid is filtered as it is consumed by said treatment.

30. A method as in claim 27, wherein said at least one filter is located immediately upstream of a flow junction at which said fluid is injected into a venous line returning blood into said patient.

31. A method as in claim 27, wherein said at least one filter is effective to reduce a concentration of endotoxins in said fluid to a rate such as to deliver to said patient no more than 5 EU/hr per Kg. of patient weight of fluid upon filtration thereof at said defined rate of infusion into said patient.

32. A method as in claim 27, wherein at least one container is at least two containers and said at least one filter is at least one filter for each of said containers, each said filtering being connected inline in a respective flow line connected to each of said at least two containers, whereby fluid from each container is filtered by its own filter.

33. A method as in claim 27, wherein:

said at least one filter is at least two;

said step of administering includes drawing said fluid from said at least one container and passing it through at least one of said at least two filters, whereby said fluid is filtered as it is consumed by said treatment; and

at least another of said at least two filters is located upstream of a flow junction at which said fluid is injected into a venous line returning blood into said patient such that said fluid is double-filtered before entering said patient'"'"'s body.

34. A method as in claim 33, wherein said at least another of said at least two filters is located immediately upstream of said flow junction at which said fluid is injected into said venous line.

35. A method as in claim 27, wherein said at least one filter is effective to reduce a concentration of endotoxins in said fluid to a rate below 0.03 EU/ml.

36. A device for performing hemofiltration, comprising:

at least one container of fluid for infusion into patients;

connected to said at least one container, at least one filter effective to ensure a concentration of endotoxins in said fluid passing therethrough is below both 0.03 EU/ml and such as to deliver no more than 5 EU/hr per Kg of patient weight at a defined rate of infusion into a patient;

a hemofiltration system including at least one pump for pumping blood from and back to said patient;

a fluid circuit for conveying said blood, said fluid circuit connecting an outlet of said filter with a return flow of blood, whereby replacement fluid having a low level of pyrogens in infused into said patient.

37. A device as in claim 36, wherein said at least one filter is at least two, each of which is incorporated in an inline configuration in a respective arm of a manifold.

38. A device as in claim 36, wherein said at least one filter includes a membrane of charged nylon.

39. A device as in claim 36, wherein said at least one filter includes filter medium being such that an endotoxin load of a filtrate thereof is obtained by a combination of mechanical blocking due to small pore size and adsorption, whereby a pressure drop of said medium is lower than would be required if the medium relied on pore size alone to reduce the endotoxin load to said concentration.

40. A disposable fluid circuit for infusion, comprising:

a line for receiving an infusible fluid;

a pumping portion for engagement with a peristaltic pump;

an inline filter downstream of said pumping portion and immediately prior to a connector to a patient access configured to filter an infusate prior to contact with a patient blood stream;

said inline filter having properties to one of degass and reduce a rate of endotoxins of said infusate.

41. A fluid circuit as in claim 40, wherein said fluid circuit includes a blood filter or dialyzer and said inline filter is located immediately upstream of a junction for diluting blood.

42. A fluid circuit as in claim 41, wherein said inline filter is configured to reduce a rate of endotoxins to 3 EU/ml. or less.

43. A fluid circuit as in claim 40, further comprising a portion for engagement with an air sensor downstream of said inline filter.

44. A fluid circuit as in claim 43, wherein said inline filter is configured to reduce a rate of endotoxins to 3 EU/ml. or less.

45. A fluid circuit as in claim 40, further comprising fluid property detection sensor.

46. A fluid circuit as in claim 45, wherein said fluid property detection device includes a conductivity detector.

48. A fluid circuit as in claim 46, wherein said inline sensor includes at least a portion of a conductivity cell.

47. A disposable fluid circuit for infusion, comprising:

a line for receiving an infusible fluid;

a pumping portion for engagement with a peristaltic pump;

an inline sensor effective to detect a property of an infusate prior to contact with a patient blood stream.

49. A fluid circuit as in claim 47, wherein said inline sensor is integrated within the housing of an inline filter that is arranged to filter said infusate.

50. A disposable fluid circuit for renal replacement therapy and connectable with a blood treatment machine, comprising:

a blood line connectable to a blood filter having properties appropriate for treatment by hemofiltration or dialysis;

said blood line having arterial and venous portions connectable to a patient access;

a replacement fluid line connected to said venous portion of said blood line for diluting blood;

a connection for an inline component in said replacement fluid line located immediately upstream of a junction joining said replacement fluid line and said venous portion;

said inline component including at least one of an inline filter effective to block pyrogens and/or air and a fluid property sensor connectable to a controller or alarm.

51. A fluid circuit as in claim 50, wherein said inline component includes a sterile filter permanently connected to said connection.

52. A fluid circuit as in claim 51, wherein said inline component includes an inline filter with media capable of reducing a rate of endotoxins to less than 3 EU/ml.

53. A fluid circuit as in claim 52, wherein said inline filter is permanently connected to said replacement fluid line.

54. A fluid circuit as in claim 53, wherein said inline filter includes media capable of blocking gas bubbles.

55. A fluid circuit as in claim 54, further comprising a cartridge for supporting said replacement fluid line, said blood line, and said inline filter, said cartridge engaging with said blood treatment machine to orient it with respect thereto.

56. A fluid circuit as in claim 55, wherein said inline filter is operable in a selected orientation and said cartridge orients said inline filter when said cartridge is engaged with said blood treatment machine.

57. A fluid circuit as in claim 56, wherein said inline filter includes media capable of reducing a rate of endotoxins to less than 3 EU/ml.

58. A fluid circuit as in claim 54, further comprising a portion for engagement with an air detector downstream of said inline filter.

59. A fluid circuit as in claim 54, further comprising a cartridge for supporting said replacement fluid line, said blood line, and said inline filter, said cartridge engaging with said blood treatment machine to orient it with respect thereto.

60. A fluid circuit as in claim 55, wherein said inline filter is operable in a selected orientation and said cartridge orients said inline filter when said cartridge is engaged with said blood treatment machine.

61. A fluid circuit as in claim 50, wherein said blood treatment machine is a hemofiltration machine.

62. A fluid circuit as in claim 61, wherein said inline component includes an inline filter with media capable of reducing a rate of endotoxins to less than 3 EU/ml.

63. A fluid circuit as in claim 50, wherein said blood line is permanently connected to said blood filter.

64. A fluid circuit as in claim 50, further comprising a connection connectable to a source of sterile replacement fluid and wherein said inline component includes an inline filter with media capable of reducing a rate of endotoxins to less than 3 EU/ml.

65. A device for batch preparation of replacement fluid retrofittable to a blood treatment machine, comprising:

a disposable fluid circuit including a replacement fluid container with a first input line having a connector for an inline sterile filter and an inlet connectable to a source of replacement fluid to be filtered by said sterile filter;

a peristaltic pump actuator;

said first input line having a pumping portion engageable with said peristaltic pump actuator;

said replacement fluid container having a first outlet connectable to a replacement fluid connector of a blood treatment machine that consumes replacement fluid in performing renal replacement therapy.

66. A device as in claim 65, further comprising an insulated housing for supporting said replacement fluid container.

67. A device as in claim 66, further comprising a heater for warming said replacement fluid container.

68. A device as in claim 67, further comprising a controller configured to regulate a temperature of said replacement fluid container.

69. A device as in claim 65, further comprising a control valve and a controller configured to shut said control valve after a quantity of replacement fluid is filtered by said filter.

70. A device as in claim 65, further comprising a heater to heat filtered replacement fluid and a controller configured to control said pump and said heater responsively to a scheduled treatment time.

71. A device as in claim 65, wherein said controller is configured to filter said replacement fluid at a time such that a batch of replacement fluid is filtered, stored in said replacement fluid container, and heated to a specified temperature immediately prior to said scheduled treatment time.

72. A device as in claim 65, wherein said controller is configured to filter said replacement fluid and maintain a temperature thereof until a time for consumption by said blood treatment machine.

73. A tubing set for preparation of replacement fluid by sterile filtering, comprising:

a sterile replacement fluid container with an inlet line connected to a filter and a connector for drawing replacement fluid from a source;

an outlet port for drawing filtered replacement fluid from said replacement fluid container;

at least one recirculation port to flow sterile replacement fluid in a recirculating flow through said replacement fluid container to purge air from said outlet line, said recirculation port and a connection between them provided by a blood treatment circuit.

74. A set as in claim 73, wherein said filter contains media capable of reducing a rate of endotoxins to less than 3 EU/ml.

75. A set as in claim 73, wherein said outlet port is connected to an outlet line having connector.

76. A set as in claim 73, wherein said at least one is at least two ports.