Method and apparatus for leak detection in a fluid line

• US 6,572,576 B2
• Filed: 07/07/2001
• Issued: 06/03/2003
• Est. Priority Date: 07/07/2001
• Status: Expired due to Term

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Brugger, James M., Treu, Dennis M., Burbank, Jeffrey H.
• Primary Examiner(s): Doerrler, William C.
• Assistant Examiner(s): Zec, Filip
• Application Number:
  US09/900,362
• Publication Number:
  US 20030009123A1
• Time in Patent Office: 696 Days
• Field of Search: 604/4.01, 604/122, 604/149, 604/118, 210/90, 210/646, 210/739, 210/741
• US Class Current: 604/4.01
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor

Abstract

One of the most significant safety concerns in the automation of extracorporeal blood treatments such as dialysis is the risk of blood leakage. Such systems draw blood at such a high rate that a loss of integrity in the blood circuit can be catastrophic. The most reliable leak detection method known is the detection of infiltrated air in a blood line, but this only works in blood lines under negative pressure. According to the invention, a leak detector for return lines is provided by periodically generating a negative pressure, which may be brief or at a 50% duty cycle, in the blood return line to draw air into it and thereby reveal the leaks using an air sensor. Although the return line is ordinarily under positive pressure, during the negative pressure cycle, the blood return line draws air through any leaks or disconnects. If air is detected, the system is shut down and an alarm generated.

Claims

1. A leak detector comprising:

at least one actuator controlled by a controller, said at least one actuator being configured to control pressure in a blood circuit, said controller configured to control flow in said blood circuit and detect a loss of integrity in said blood circuit, by;

delivering blood to a patient through the blood circuit during first time including applying a positive gauge pressure to said circuit;

applying a negative pressure to said blood circuit during second time;

detecting a presence of air in said blood circuit during at least a portion of said second time or after said second times, such that air infiltrating said blood circuit during said second time as a result of said negative pressure and a presence of a leak is detected.

2. A detector as in claim 1, wherein said controller is further configured to wait passage of a predetermined volume of blood into said patient prior to applying said negative pressure.

3. A detector as in claim 1, wherein said controller is further configured such that said applying a negative pressure includes reversing a direction of flow of blood in said blood circuit.

4. A detector as in claim 1, wherein said controller is further configured such that said applying a negative pressure includes switching a valve to cause blood to flow in a reverse direction through said blood circuit.

5. A detector as in claim 1, wherein said controller is further configured such that said applying a negative pressure includes changing a volume of a portion of said blood circuit.

6. A detector as in claim 1, wherein said controller is further configured such that said detecting includes detecting air bubbles in blood.

7. A detector as in claim 1, wherein said controller is further configured such that:

said applying includes reversing a direction of flow of blood in said blood circuit;

said detecting includes detecting air with an air sensor located to detect air at a specified position in said blood circuit; and

a duration of said second time is at least long enough to insure that blood will ultimately flow from a terminus of said blood circuit to said specified position, whereby leakage of blood in said blood circuit at least between said specified position and said terminus is assured.

8. A leak detector, comprising:

a mechanism operative to reverse flow in a blood circuit configured to return blood to a patient such that a negative pressure is generated in said blood circuit;

an air sensor positioned with respect to said blood circuit to detect air drawn into said blood circuit in the event of a loss of integrity in said blood circuit;

a controller connected to control said mechanism such that said negative pressure is of sufficient magnitude and duration as to insure that blood at a remote end of said blood circuit connected to said patient is drawn to point where it is detectable by said air sensor.

9. A leak detector as in claim 8, wherein said mechanism includes a four-way valve.

10. A leak detector as in claim 8, wherein said mechanism includes a controller configured to reverse said flow iteratively after successive displacements of a predetermined volume of blood.

11. A leak detector as in claim 10, wherein said predetermined volume corresponds to no more than a maximum tolerable volume of blood that can be lost without injury to a patient.

12. A leak detector as in claim 8, wherein said mechanism connects said blood circuit with a therapeutic process to which blood circulated through said blood circuit is subjected.

13. A leak detector connectable to a blood processing machine that has an access blood circuit connectable to a patient to remove blood from, and deliver blood to, said patient;

a process blood circuit including a treatment component for treating blood circulated through said process blood circuit, said leak detector comprising;

a reversible conveyance connected to move blood through said process and access blood circuits;

an air detector in said access circuit;

a controller configured to reverse said conveyance periodically to draw air into any leaks in said blood circuit and to control said conveyance such that said air is moved to said air detector, whereby a leak in said access blood circuit may be detected.

14. A detector as in claim 13, wherein said controller is configured to reverse said conveyance such that a volume of blood at least as great as a volume of said access blood circuit between said air detector and a remote terminus of said access blood circuit.

15. A detector as in claim 13, wherein said conveyance has a four-way valve and is configured to reverse by switching said four-way valve.

16. A detector as in claim 13, wherein said air detector detects air bubbles in fluid.

17. A detector as in claim 13, wherein said controller is configured such that said conveyance is reversed sufficiently frequently that no more than a minimum safe quantity of blood is lost due to a leak before said leak is detected.

18. A leak detector connectable to a device operative to control a flow of blood through a blood circuit, said leak detector including a controller programmed to implement a method of detecting a leak in a fluid circuit supplying fluid to a patient, comprising the steps of:

delivering fluid to a patient through a circuit during a first time;

applying a negative pressure to said blood circuit during a second time;

detecting a presence of air in said fluid circuit during at least a portion of said second time or after said second time such that air infiltrating said fluid circuit during said second time as a result of said negative pressure is detected.

19. A detector as in claim 18, wherein said method includes waiting for the passage of a predetermined volume of fluid into said patient prior to applying said negative pressure.

20. A detector as in claim 18, wherein said step of applying a negative pressure includes reversing a direction of flow of fluid in said fluid circuit.

21. A detector as in claim 18, wherein said step of applying a negative pressure includes switching a valve to cause fluid to flow in a reverse direction through said fluid circuit.

22. A detector as in claim 18, wherein said step of applying a negative pressure includes changing a volume of a portion of said fluid circuit.

23. A detector as in claim 18, wherein said step of detecting includes detecting air bubbles in fluid.

24. A detector as in claim 18, wherein:

said step of applying includes reversing a direction of flow of fluid in said fluid circuit;

said step of detecting includes detecting air with an air sensor located to detect air at a specified position in said fluid circuit; and

a duration of said second time is at least long as required to cause said fluid to flow from a terminus of said fluid circuit to said specified position.

25. A tubing set for a leak detecting blood treatment device, comprising:

draw and return lines connectable to at least one access of a patient for the draft and return of blood;

at least a body of a four-way valve with four ports, at least two of which are sealingly connected to said draw and return lines respectively;

arterial and venous lines connectable to a blood processing machine, said arterial and venous lines being connected, respectively, to two others of said four ports.

26. A leak detection device connectable to a fluid infusion or treatment system, comprising:

a support for a fluid circuit configured to convey fluid between a source and an outlet for connection to a patient;

at least an actuator operative to control a portion of said fluid circuit such that a negative pressure can be selectively generated in an outlet portion of said fluid circuit at selected times;

a controller connected to control said actuator and configured to generate a negative pressure in said outlet portion automatically and repeatedly during the course of a treatment of said patient such that a predefined volume of fluid is displaced in a reverse direction;

said controller being further configured to control said actuator such that, at other times, a positive pressure is permitted in said outlet portion.

27. A device as in claim 26, wherein said actuator is configured to control a four-way valve portion of said fluid circuit.

28. A device as in claim 27, wherein said fluid is blood.

29. A device as in claim 26, wherein said actuator is configured to control a four-way valve portion of said fluid circuit that changes a direction of flow in said portion of said fluid circuit and at least another portion of said fluid circuit such that a continuous reverse flow between said patient and said outlet portion is generated when said negative pressure is generated.

30. A device as in claim 29, wherein said fluid is blood.

31. A device as in claim 26, wherein said fluid is blood.

32. A device as in claim 26, wherein:

said source includes an air sensor and a source fluid circuit leading to said air sensor, said source fluid circuit being one of connected and connectable to said source;

said controller is configured such that said predefined volume of fluid is sufficient to insure that air infiltrating at said terminus of said outlet portion reaches a point of detectablility by said air sensor.

33. A device as in claim 32, wherein said fluid is blood.

34. A device as in claim 26, wherein said controller is configured such that said negative pressure in said outlet portion is generated with such regularity that no more than a predetermined volume of said fluid is conveyed through said outlet portion before said negative pressure is again generated.

35. A device as in claim 34, wherein said fluid is blood.

36. A device as in claim 26, further comprising an air sensor positioned to detect air in said fluid circuit when said fluid flows in reverse responsively to said controller.

37. A device as in claim 36, wherein said fluid is blood.

38. A device as in claim 36, wherein said controller is configured such that said predefined volume of fluid is sufficient to insure that air infiltrating at said terminus of said outlet portion reaches a point of being detectable by said air sensor.

39. A device as in claim 38, wherein said fluid is blood.

40. A device as in claim 38, further comprising at least one of a fluid flow halting actuator configured to halt flow in said fluid circuit and an alarm, said controller being configured to actuate said at least one a of a fluid flow halting actuator configured to halt flow in said fluid circuit and an alarm responsively to a signal from said air sensor.

41. A device as in claim 40, wherein said fluid is blood.

42. A leak detector comprising:

a controller configured to detect a leak in a fluid infusion or treatment system that includes a source of fluid to be pumped into a patient;

the controller drawing from said source and conveying said fluid from said source to said patient during a first time and automatically regularly generating a negative pressure such that said fluid is drawn in a reverse direction away from said patient creating a reverse flow of said fluid and one detecting a presence and a flow of air into said fluid infusion system.

43. A detector as in claim 42, further comprising a sensor connected to said controller to detect a presence of air in said reverse flow.

44. A detector as in claim 42, wherein said fluid includes blood.

45. A detector as in claim 42 wherein said controller is configured to one of generate an alarm signal and halt a flow of fluid responsively to detecting said one of a presence and a flow.

46. A detector as in claim 45, wherein said fluid is blood.

47. A detector as in claim 42, wherein said controller generates said negative pressure by controlling a flow reversing actuator.

48. A detector as in claim 47, wherein said fluid is blood.

49. A detector as in claim 42, wherein said source of fluid is said patient'"'"'s blood supply and said reverse flow is such that blood is drawn from said patient.

50. A detector as in claim 42, wherein each instance of said reverse flow results in a displacement of said fluid sufficient to transport air infiltrating a supply access to said patient to point of detectability by a nearest air sensor to said patient.

51. A detector as in claim 50, wherein said fluid is blood.

52. A detector as in claim 42, wherein said negative pressure is generated with such regularity that no more than a predetermined volume of said fluid is conveyed to said patient before said negative pressure is again generated.

53. A detector as in claim 52, wherein said fluid is blood.

54. A leak detector for a sterile contiguous fluid line for infusing a patient, the fluid line including a draw line connectable to at least one patient access and a return line connectable to said at least one patient access, said detector comprising:

a portion adapted to be interoperable with a pump actuator such that fluid may be conveyed therethrough;

a filter, or filter connectors to permit connection to a filter, to complete a closed fluid circuit joining said draw and return lines;

at least a wetted portion of a device configured to generate a negative pressure in said return line, whereby a flow through said return line may be reversed.

55. A detector line as in claim 54, wherein said device configured to generate a negative pressure is further configured to reverse a flow in both said return line and said draw line.

56. A detector as in claim 54, wherein said device configured to generate a negative pressure in said return line includes at least a portion of a four-way valve.

57. A leak detecting replacement kit for infusing a patient, the replacement kit including a blood line with a draw line connectable to at least one patient blood access, a return line connectable to said at least one patient blood access, a portion adapted to be interoperable with a pump actuator such that fluid may be conveyed therethrough, a filter, or filter connectors to permit connection to a filter, to complete a closed fluid circuit joining said draw and return lines;

instructions for using said blood line providing for the installation of said adapted to be interoperable with a pump actuator into a location such that it becomes interoperable with a reversible pump.

58. A leak detecting replacement kit for infusing a patient, comprising:

a blood line including;

a draw line connectable to at least one patient blood access;

a return line connectable to said at least one patient blood access;

a portion adapted to be interoperable with a flow reversing actuator;

a filter, or filter connectors to permit connection to a filter, to complete a closed fluid circuit joining said draw and return lines;

instructions for using said blood line providing for the installation of said portion adapted to be interoperable with flow reversing actuator into a device with a flow reversing actuator.

59. A kit as in claim 58, wherein said portion adapted to be interoperable with a flow reversing actuator is a wetted portion of a four-way valve.

60. A leak detector for an infusion device for delivering a fluid to a patient, the device including a circuit including a pump, a source end and a delivery end joined by said pump, comprising:

a mechanism to reverse flow at least at said delivery end;

an air detector in said circuit;

said mechanism being controlled such that said mechanism is actuated to reverse said flow automatically and regularly and, at each instance of reversing said flow, to displace enough fluid to transport air infiltrating said circuit at said delivery end to said air detector.

61. A detector as in claim 60, wherein said mechanism is a drive configured to reverse said pump.

62. A leak detector with at least one actuator and a controller programmed to implement a method of detecting a loss of integrity in a liquid circuit, comprising the steps of:

conveying liquid through a circuit during first time;

said step of conveying including applying a positive gauge pressure to said circuit;

regularly applying a negative pressure to said circuit during second time;

detecting a presence of air in said liquid circuit during at least a portion of said second time or after said second time, such that air infiltrating said circuit during said second time, as a result of said negative pressure and a presence of a leak, is detected.

63. A detector as in claim 62, further comprising waiting for the passage of a predetermined volume of liquid through said circuit prior to applying said negative pressure.

64. A detector as in claim 62, wherein the step of applying a negative pressure includes reversing a direction of flow of liquid in said circuit.

65. A detector as in claim 62, wherein said step of applying a negative pressure includes switching a valve to cause liquid to flow in a reverse direction through said circuit.

66. A detector as in claim 62, wherein said step of applying a negative pressure includes changing a volume of a portion of said circuit.

67. A detector as in claim 62, wherein said step of detecting includes detecting air bubbles.

68. A detector as in claim 62, wherein said step of detecting includes detecting air bubbles with an ultrasonic sensor.

69. A detector as in claim 62, wherein:

said step of applying includes reversing a direction of flow of liquid in said circuit;

said step of detecting includes detecting air with an air sensor located to detect air at a specified position in said circuit; and

a duration of said second time at least long enough to cause liquid to flow from a terminus of said circuit to said specified position, whereby leakage of liquid from any point in said circuit between said specified position and said terminus is assured.

70. A leak detector for an infusion device that includes a circuit connectable to a patient to deliver fluid to a patient, comprising:

a reversible conveyance connected to move fluid through said circuit;

an air detector in said circuit;

a controller configured to reverse said conveyance regularly and periodically to draw air into any leaks in said circuit and move said air to said air detector, whereby a leak in said circuit may be detected.

71. A device as in claim 70, wherein said controller is configured to reverse said conveyance such that a volume of fluid sufficient to insure detection of infiltration of air by said air detector.

72. A detector as in claim 70, wherein said conveyance has a four-way valve and is configured to reverse by switching said four-way valve.

73. A detector as in claim 70, wherein said air detector detects air bubbles in said fluid.

74. A detector as in claim 70, wherein said air detector detects air bubbles in said fluid using an acoustical signal.

75. A leak detector for a blood processing machine with a draw circuit and a return circuit connected, respectively, to supply blood from a patient to, and return blood to said patient from, a blood processing device, comprising:

a reversible conveyance connected in said draw and return circuits to drive blood therethrough;

a controller connected to control said reversible conveyance such that said reversible conveyance is regularly reversed each time a predefined volume of blood is passed through said return circuit;

at least one air sensor in at least one of said draw and return circuits;

said controller being configured such that a volume of blood displaced in reverse each time said reversible conveyance is reversed, is at least sufficient to transport fluid from a terminal end of said return circuit up to a point of being detectable by said at least one air sensor.

76. A leak detector as in claim 75, wherein said air sensor detects bubbles in blood.

77. A leak detector as in claim 75, wherein said air sensor is an ultrasonic air sensor.

78. A leak detector as in claim 75, wherein said reversible conveyance includes a four-way valve and a pump.

79. A leak detector as in claim 75, wherein said reversible conveyance includes a reversible pump.

80. A leak detector as in claim 75, wherein said predefined volume is a maximum safe volume of blood said patient may lose due to leaks in said leak detector.

81. A leak detector for a blood processing machine that includes a draw circuit and a return circuit connected, respectively, to supply blood from a patient to, and return blood to said patient from, a blood processing device, comprising:

a reversible conveyance connected in said draw and return circuits to drive blood therethrough;

a controller connected to control said reversible conveyance such that said reversible conveyance is regularly reversed;

at least one air sensor in said circuit;

said controller being configured such that a volume of blood displaced in reverse each time said reversible conveyance is reversed is sufficient to insure blood from a terminal end of said return circuit is drawn at least to said at least one air sensor.

82. A leak detector as in claim 81, wherein said air sensor detects bubbles in blood.

83. A leak detector as in claim 81, wherein said air sensor is an ultrasonic air sensor.

84. A leak detector as in claim 81, wherein said reversible conveyance includes a four-way valve and a pump.

85. A leak detector as in claim 81, wherein said reversible conveyance includes a reversible pump.

86. A device for detecting leaks and connectable to a blood processing system having an air sensor adapted to detect blood in a blood circuit, said blood circuit having draw and return lines:

a conduit connectable to said return line;

a fluid conveyance connectable to said return line and said conduit and configured to connect said return line to a patient return access;

said conveyance being adapted to selectively and generate a reverse flow in said conduit and convey said reverse flow to said draw line;

a final control configured to control said conveyance to generate said reverse flow repeatedly during a treatment cycle of said blood processing leak detector.

87. A leak detector for a blood processing machine that includes an access blood circuit connectable to a patient to remove blood from, and deliver blood to, said patient and a a process blood circuit including a treatment component adapted to treat blood circulated through said process blood circuit, comprising:

a conveyance connected to move blood through said process and access blood circuits configured to generate a negative pressure in a return portion of said access blood circuit;

an detector configured to detect infiltration of air in said return portion;

a controller configured to generate said negative pressure in said conveyance repeatedly during a treatment cycle to draw air into said access circuit.

88. A detector as in claim 87, wherein said detector includes an acoustic sensor configured to detect an audio signature of air infiltrating a said portion.

89. A detector as in claim 88, wherein said sensor is a hydrophone.