Systems and methods for handling air and/or flushing fluids in a fluid circuit

• US 20030010717A1
• Filed: 07/13/2001
• Published: 01/16/2003
• Est. Priority Date: 07/13/2001
• 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., Treu, Dennis M.
• Application Number:
  US09/905,171
• Publication Number:
  US 20030010717A1
• Time in Patent Office: Days
• US Class Current: 210/650
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 1/3468 using treated filtrate as substitution fluid
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body

Abstract

Systems and methods handle air and rinsing fluid during fluid processing. The systems and methods eliminate air from a fluid processing system prior to, during, and after use. The systems and methods provide a connector assembly for establishing fluid flow from a fluid source. The connector assembly has discrete first and second passages that prevent communication between the fluid in first passage and the fluid in the second passage. Prior to system use, the connector assembly may be utilized in a priming function to remove residual air from a fluid circuit prior to use. The connector assembly may also be utilized after use to perform a rinse-back function. The rinse-back function serves to remove residual fluid from the system after use. The connector assembly can comprise two, single lumen connectors or one connector with two lumens.

Claims

1. A connector comprising

a body constructed for coupling to a fluid source,

a first fluid passage in the body,

a second fluid passage in the body that does not communicate with the first fluid passage,

a first assembly communicating with the first fluid passage and including a first fitting to releasably couple the first fluid passage to an outlet of a fluid circuit and to convey fluid only through the first fluid passage, and

a second assembly communicating only with the

second fluid passage and including a second fitting to releasably couple the second fluid passage to an inlet of the fluid circuit, whereby fluid can be circulated through the fluid source in a loop that includes the fluid circuit to collect in the fluid source air residing in the fluid circuit.

2. A connector according to claim 1,

wherein one end of the connector body is tapered to form a spike.

3. A connector according to claim 1,

wherein at least one of the first and second assemblies includes a luer fitting.

4. A connector according to claim 1,

wherein at least one of the first and second assemblies includes an in-line clamp.

5. A connector according to claim 1

wherein the first and second fittings are constructed and arranged to releasably couple the first assembly to the second assembly when the first and second fittings are disconnected, respectively, from the outlet and inlet of the fluid circuit.

6. A connector according to claim 1

further including a removable cap enclosing the body prior to use.

7. A connector according to claim 1

wherein the body includes a distal end communicating with the fluid source,

wherein the first and second fluid passages each exits the distal end, and

wherein the first fluid passage exits the distal end of the body at a higher gravity height that the second fluid passage exits the distal end.

8. A connector according to claim 1

wherein the body comprises a tubular member.

9. A connector according to claim 8

wherein the tubular member includes a distal end that is angled to form a spike.

10. A connector according to claim 8

wherein the first fluid passage exits the distal end of the tubular member at a higher gravity height than the second fluid passage.

11. A fluid processing system comprising

a fluid circuit including an inlet and an outlet, and

a connector assembly constructed for coupling to a fluid source, the connector assembly including a first fluid passage coupled to the outlet of the fluid circuit and a second fluid passage that does not communicate with the first fluid passage and is coupled to the inlet of the fluid circuit, whereby fluid can be circulated by the connector assembly through the fluid source in a loop that includes the fluid circuit to collect in the fluid source air residing in the fluid circuit.

12. A system according to claim 11

wherein the connector assembly is integrally coupled to the fluid source.

13. A system according to claim 11

wherein the connector assembly is releasably attachable to the fluid source.

14. A system according to claim 11

wherein the connector assembly includes a first connector body that includes the first fluid passage and a second connector body that is separate from the first connector body and that includes the second fluid passage.

15. A system according to claim 14

wherein at least one of the first and second connector bodies comprises a luer fitting.

16. A system according to claim 14

wherein at least one of the first and second connector bodies is tapered to form a spike.

17. A system according to claim 14

further including a removable cap enclosing at least one of the first and second connector bodies prior to use.

18. A system according to claim 11

wherein the connector assembly includes a single connector body that includes both the first and second fluid passages.

19. A system according to claim 18

further including a removable cap enclosing the single connector body prior to use.

20. A system according to claim 11

wherein at least one of the first and second fluid passages includes an in-line clamp.

21. A system according to claim 11

wherein the fluid circuit includes a blood processing element.

22. A system according to claim 11

wherein the fluid circuit includes a filter.

23. A system according to claim 22

wherein the filter comprises a hemofilter that, in use, removes toxins from blood.

24. A system according to claim 11

wherein the fluid circuit comprises at least a portion of a hemofiltration system.

25. A system according to claim 11

wherein the fluid circuit comprises at least a portion of a hemodialysis system.

26. A system according to claim 11

wherein the fluid circuit forms at least a portion of a hemodiafiltration system.

27. A system according to claim 11

wherein the fluid circuit forms at least a portion of a dialysis system.

28. A system according to claim 11

wherein the fluid circuit forms at least a portion of a peritoneal dialysis system.

30. An apparatus according to claim 29

wherein at least one of the first and second fluid passages includes an in-line clamp.

31. An apparatus according to claim 29

wherein the apparatus comprises at least a portion of a blood processing system.

32. An apparatus according to claim 29

wherein the apparatus comprises at least a portion of a hemofiltration system.

33. An apparatus according to claim 29

wherein the apparatus comprises at least a portion of a hemodialysis system.

34. An apparatus according to claim 29

wherein the apparatus forms at least a portion of a hemodiafiltration system.

35. An apparatus according to claim 29

wherein the apparatus forms at least a portion of a dialysis system.

36. An apparatus according to claim 29

wherein the apparatus forms at least a portion of a peritoneal dialysis system.

38. A system according to claim 37

wherein one end of the connector body is tapered to form a spike.

39. A system according to claim 37

further including an in-line clamp between at least one of the outlet and inlet and the respective first and second fluid passage.

40. A system according to claim 37

further including a removable cap enclosing the body prior to use.

41. A system according to claim 37

wherein the fluid circuit includes a blood processing element.

42. A system according to claim 37

wherein the fluid circuit includes a filter.

43. A system according to claim 42

wherein the filter comprises a hemofilter that, in use, removes toxins from blood.

44. A system according to claim 37

wherein the fluid circuit comprises at least a portion of a hemofiltration system.

45. A system according to claim 37

wherein the fluid circuit comprises at least a portion of a hemodialysis system.

46. A system according to claim 37

wherein the fluid circuit forms at least a portion of a hemodiafiltration system.

47. A system according to claim 37

wherein the fluid circuit forms at least a portion of a dialysis system.

48. A system according to claim 37

wherein the fluid circuit forms at least a portion of a peritoneal dialysis system.

49. A system according to claim 37

wherein the connector includes a first assembly communicating with the first fluid passage to couple the first fluid passage to the outlet and convey fluid only through the first fluid passage.

50. A system according to claim 49

wherein the first assembly includes an in-line clamp.

51. A system according to claim 49

wherein the first assembly includes a fitting releasably coupled to the outlet.

52. A system according to claim 51

wherein the fitting comprises a luer fitting.

53. A system according to claim 37

wherein the connector includes a second assembly communicating with the second fluid passage to couple the second fluid passage to the inlet and convey fluid only through the second fluid passage.

54. A system according to claim 53

wherein the second assembly includes an in-line clamp.

55. A system according to claim 53

wherein the second assembly includes a fitting releasably coupled to the inlet.

56. A system according to claim 55

wherein the fitting comprises a luer fitting.

57. A system according to claim 37

wherein the connector includes a first assembly communicating with the first fluid passage to couple the first fluid passage to the outlet and convey fluid only through the first fluid passage, and a second assembly communicating with the second fluid passage to couple the second fluid passage to the outlet and convey fluid only through the second fluid passage.

58. A system according to claim 57

wherein at least one of the first and second assemblies includes a fitting releasably coupled to the respective outlet and inlet.

59. A system according to claim 57

wherein the first assembly includes a first fitting releasably coupled to the outlet, and

wherein the second assembly includes a second fitting releasably coupled to the inlet.

60. A system according to claim 59

wherein at least one of the first and second fitting comprises a luer fitting.

61. A system according to claim 57

wherein the first and second fittings releasably couple together when disconnected from the respective outlet and inlet.

62. A system according to claim 37

wherein the first fluid passage communicates with the fluid source at a higher gravity height than the second fluid passage.

63. A system according to claim 37

wherein the body comprises a tubular member.

64. A system according to claim 63

wherein the tubular member includes a distal end that is tapered to form a spike.

65. A system according to claim 64

wherein the first fluid passage exits the distal end at a higher gravity height than the second fluid passage.

29. A fluid processing apparatus comprising

a fluid container, and

a connector assembly coupled to the fluid container, the connector assembly including a first fluid passage releasably coupled by a luer connector to an outlet of a fluid circuit and a second fluid passage that does not communicate with the first fluid passage and releasably coupled by a luer connector to a inlet of the fluid circuit, whereby fluid can be circulated by the connector assembly through the fluid container in a loop that includes the fluid circuit to collect in the fluid source air residing in the fluid circuit.

37. A fluid processing system comprising

a fluid circuit including an inlet and an outlet, and

a connector comprising a body constructed for coupling to a fluid source, a first fluid passage in the body coupled to the outlet of the fluid circuit, and a second fluid passage in the body that does not communicate with the first fluid passage and coupled to the inlet of the fluid circuit. whereby fluid can be circulated through the fluid source in a loop that includes the fluid circuit to collect in the fluid source air residing in the fluid circuit.

66. A method for priming a fluid circuit comprising the steps of

coupling a connector assembly to a fluid reservoir, the connector assembly comprising a first fluid passage and a second fluid passage,

circulating fluid in the fluid circuit through the fluid reservoir by conveying fluid into an inlet of the fluid circuit from the reservoir through the second fluid passage while conveying fluid from an outlet of the fluid circuit into the reservoir through the first fluid passage, and

during the circulation step, accumulating air residing in the fluid circuit in the fluid reservoir, thereby removing air from the fluid circuit.

67. A method according to claim 66

further including the steps of coupling the first fluid passage to the outlet of the fluid circuit and coupling the second fluid passage to the inlet of the fluid circuit.

68. A method according to claim 66

further including the steps of releasably coupling the first fluid passage to the outlet of the fluid circuit and releasably coupling the second fluid passage to the inlet of the fluid circuit.

69. A method according to claim 66

further including the step of coupling the first and second passages together after the accumulating step.

70. A method according to claim 66

wherein the circulating step includes conveying fluid into the fluid reservoir at a higher gravity height than fluid is conveyed from the fluid reservoir.

71. A method according to claim 66

wherein the connector assembly comprises a single connector body that includes both the first and second fluid passages.

72. A method according to claim 66

wherein the connector assembly includes a first connector body that includes the first fluid passage and a second connector body that includes the second fluid passage.

73. A method according to claim 66

further including the step of enclosing the connector assembly prior to use.

74. A method according to claim 66

wherein the fluid circuit includes a blood processing element.

75. A method according to claim 66

wherein the fluid circuit includes a filter.

76. A method according to claim 75

wherein the filter comprises a hemofilter that, in use, removes toxins from blood.

77. A method according to claim 66

wherein the fluid circuit comprises at least a portion of a hemofiltration system.

78. A method according to claim 66

wherein the fluid circuit comprises at least a portion of a hemodialysis system.

79. A method according to claim 66

wherein the fluid circuit forms at least a portion of a hemodiafiltration system.

80. A method according to claim 66

wherein the fluid circuit forms at least a portion of a dialysis system.

81. A method according to claim 66

wherein the fluid circuit forms at least a portion of a peritoneal dialysis system.

82. A method according to claim 66

wherein the coupling step includes inserting the connector assembly through a port tube membrane on the fluid reservoir.

83. A method according to claim 66

wherein the connector assembly comprises a tubular body.

84. A method according to claim 83

wherein the tubular body includes a distal end having a taper to form a spike.

85. A method according to claim 66

further including, after the accumulating step, coupling the inlet of the fluid circuit to a blood access site.

86. A method according to claim 66

further including, after the accumulating step, coupling the outlet of the fluid circuit to a blood access site.

87. A method for priming and flushing a fluid circuit comprising the steps of

providing a connector assembly comprising a first fluid passage releasably coupled to an outlet of the fluid circuit and a second fluid passage releasably coupled to an inlet of the fluid circuit,

coupling the connector assembly to a fluid reservoir,

priming the fluid circuit through the fluid reservoir by conveying fluid into the inlet of the fluid circuit from the reservoir through the second fluid passage while conveying fluid from the outlet of the fluid circuit into the reservoir through the first fluid passage,

after the priming step, releasing the coupling between the connector assembly and the inlet and outlet of the fluid circuit while keeping the connector assembly coupled to the fluid reservoir,

processing a selected fluid using the fluid circuit,

after the processing step, coupling the inlet of the fluid circuit to the second fluid passage, and

rinsing residue of the selected fluid from the fluid circuit by conveying fluid into the inlet of the fluid circuit from the reservoir through the second fluid passage, while conveying the selected fluid residue from the outlet of the fluid circuit in a path that bypasses the reservoir.

88. A method according to claim 87

further including the step of accumulating air residing in the fluid circuit in the fluid reservoir during the priming step, thereby removing air from the fluid circuit.

89. A method according to claim 87

wherein, during the processing step, the first and second fluid passages are coupled together in a loop.