Injectors, injector systems and injector control

• US 6,673,033 B1
• Filed: 11/22/2000
• Issued: 01/06/2004
• Est. Priority Date: 11/24/1999
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Sciulli, Francis J., Griffiths, David M., Gardner, John R., Lazzaro, Frank A., Joyce, Thomas P., Critchlow, Richard G., Dedola, Salvatore J., Nolan, William J. Jr., Spohn, Michael A.
• Primary Examiner(s): Doerrler, William C.
• Assistant Examiner(s): Zec, Filip
• Application Number:
  US09/721,427
• Time in Patent Office: 1,140 Days
• Field of Search: 604/66, 604/67, 604/123, 604/151
• US Class Current: 604/67
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

An injector for use in injecting a fluid in a medical injection procedure includes a drive mechanism to pressurize the fluid; a sensor to measure a variable that is proportional to fluid pressure (that is, a direct or indirect measurement of fluid pressure); and a pressure monitor (for example, including hardwired circuitry and/or software) in communication with the sensor and the drive mechanism to stop the injection procedure when the sensor measures a value of the variable that corresponds to a pressure hazard limit. Preferably, the pressure monitor further limits power input to the drive mechanism to a power limit once the variable reaches a value that corresponds to a power limiting pressure that is below the pressure hazard limit.

Claims

1. An injector for use in injecting a fluid in a medical injection procedure, the injector comprising:

a drive mechanism to pressurize the fluid;

a sensor to measure a variable that is proportional to fluid pressure; and

a pressure monitor in communication with the sensor and the drive mechanism to stop the injection procedure when the sensor measures a value of the variable that corresponds to a pressure hazard limit, the pressure monitor also limiting power input to the drive mechanism to a power limit once the variable reaches a value that corresponds to a power limiting pressure, the power limiting pressure being below the pressure hazard limit.

2. The injector of claim 1 wherein the drive mechanism comprises a motor and the sensor measures motor current.

3. The injector of claim 2 wherein the pressure monitor limits the motor current to a value corresponding to the power limiting pressure.

4. The injector of claim 1 wherein the power limit is predetermined for the injector.

5. The injector of claim 1 wherein the sensor measures exerted force or directly measures fluid pressure.

6. The injector of claim 1 wherein the power limit is set during operation of the injector.

7. The injector of claim 1 wherein the pressure hazard limit is set during operation of the injector.

8. The injector of claim 1 wherein feedback from the sensor is used to perform a periodic recalibration.

9. The injector of claim 1 wherein die difference between the power Iiiziiting pressure and the pressure hazard limit is sufficiently large to prevent nuisance stoppages of injection procedures.

10. The injector of claim 1, further comprising a syringe comprising a plunger operable to be driveti by the drive mechanism.

11. The injector of claim 10, further comprising:

a control unit comprising a control unit housing and control circuitry disposed within the control unit housing; and

a syringe interface module operably associated with the control unit, the syringe interface module comprising a module housing and a syringe intrface on the module housing that is adapted to connect the syringe to the module housing.

12. The injector of claim 11, further comprising a remote control in communication with the control unit.

13. An injector for use in injecting a fluid in a medical injection procedure, the injector comprising:

a drive mechanism to pressurize the fluid;

a sensor to measure a variable that is proportional to fluid pressure; and

a pressure monitor in communication with the sensor and the drive mechanism, the pressure monitor operable to limit power input to the drive mechanism to a power limit once the variable reaches a value that corresponds to a power limiting pressure and to terminate the injection procedure if the value of the variable corresponds to a pressure hazard limit, the pressure hazard limit being greater than the power limiting pressure and the power limit being set during operation of the injector.

14. The injector of claim 13 wherein the drive mechanism comprises a motor and the sensor measures motor current.

15. The injector of claim 14 wherein the pressure monitor limits the motor current to a value corresponding to the power limiting pressure.

16. The injector of claim 13 wherein the pressure hazard limit is set during operation of the injector.

17. The injector of claim 13 wherein the sensor measures exerted force or directly measures fluid pressure.

18. The injector of claim 13 wherein the difference between the power limiting pressure and the pressure hazard limit is sufficiently large to prevent nuisance terminations of injection procedures.

19. The injector of claim 13, further comprising a syringe comprising a plunger operable to be driven by the drive mechanism.

20. The injector of claim 19, further comprising:

a control unit comprising a control unit housing and control circuitry disposed within the control unit housing; and

a syringe interface module operably associated with the control unit, the syringe interface module comprising a module housing and a syringe interface on he module housing that is adapted to connect the syringe to the module housing.

21. The injector of claim 20, further comprising a remote control in communication with the control unit.

22. An injector system for use in injecting a fluid in a medical injection procedure, the injector system comprising:

a drive mechanism to pressurize the fluid;

a control mechanism to control the flow rate of the fluid and the volume of the fluid injected;

a sensor comprising a force transducer providing a measure of fluid pressure; and

a pressure monitor in communication with the sensor and the drive mechanism to stop the injection procedure when the sensor measures a pressure corresponding to a pressure hazard limit, the pressure monitor also limiting power input to the drive mechanism to a power limit when the sensor measures a pressure corresponding to a power limiting pressure, the power limiting pressure being below the pressure hazard limit.

23. The injector system of claim 22, further comprising a syringe comprising a plunger operable to be driven by the drive mechanism.

24. The injector system of claim 23, further comprising:

a control unit comprising a control unit housing and control circuitry disposed within the control unit housing; and

a syringe interface module operably associated with the control unit, the syringe interface module comprising a module housing and a syringe interface on the module housing that is adapted to connect the syringe to the module housing.

25. The injector system of claim 24, further comprising a remote control in communication with the control unit.

26. The injector system of claim 22 wherein the power limit is predetermined for the injector system.

27. The injector system of claim 22 wherein the power limit is set during operation of the injector system.

28. The injector system of claim 22 wherein the pressure hazard limit is set during operation of the injector system.

29. The injector system of claim 22 wherein the drive mechanism comprises a motor and the sensor measures motor current.

30. The injector system of claim 29 wherein the pressure monitor limits the motor current to a value corresponding to the power limiting pressure.

31. The injector system of claim 22 wherein the sensor measures exerted force or directly measures fluid pressure.

32. The injector system of claim 22 wherein the difference between the power limiting pressure and the pressure hazard limit is sufficiently large to prevent nuisance stoppage of injection procedures.

70. The injector of claim 31, further comprising a stand for supporting at least the control unit.

71. The injector of claim 70 wherein the stand further supports the at least one syringe interface module.

72. The injector of claim 70 wherein the stand is portable.

73. The injector of claim 31 wherein the at least one syringe interface module further comprises one or more switches for controlling motion of the at least one drive member.

33. An injector system for use in injecting a fluid in a medical injection procedure, the injector system comprising:

a drive mechanism to pressurize the fluid;

a control mechanism to control flow rate of the fluid and volume of the fluid injected; and

a safety system, the safety system including a sensor having a force transducer providing a measure of fluid pressure; and

a pressure monitor in communication with the sensor and the drive mechanism, the pressure monitor being adapted to override settings of the control mechanism and stop the injection procedure when the sensor measures a pressure corresponding to a pressure hazard limit, the pressure monitor also being adapted to override settings of the control mechanism to limit power input to the drive mechanism to a power limit when the sensor measures a pressure corresponding to a power limiting pressure, the power limiting pressure being below the pressure hazard limit.

34. The injector system of claim 33, further comprising a syringe comprising a plunger operable to be driven by the drive mechanism.

35. The injector system of claim 33 wherein the power limit is predetermined for the injector system.

36. The injector system of claim 33 wherein the power limit is set during operation of the injector system.

37. The injector system of claim 33 wherein the pressure hazard limit is set during operation of the injector system.

38. The injector system of claim 33 wherein the drive mechanism comprises a motor and the sensor measures motor current.

39. The injector system of claim 38 wherein the pressure monitor limits the motor current to a value corresponding to the power limiting pressure.

40. The injector system of claim 33 wherein the sensor measures exerted force or directly measures fluid pressure.

41. The injector system of claim 33 wherein the difference between the power limiting pressure and the pressure hazard limit is sufficiently large to prevent nuisance stoppages of injection procedures.

42. The injector system of claim 34, further comprising:

a control unit comprising a control unit housing and control circuitry disposed within the control unit housing; and

a syringe interface module operably associated with the control unit, the syringe interface module comprising a module housing and a syringe interface on the module housing that is adapted to connect the syringe to the module housing.

43. The injector system of claim 42, further comprising a remote control in communication with the control unit.

67. The injector of claim 36 wherein the motor is in communicative connection with the control circuitry in the control unit housing.

68. The injector of claim 67 wherein the control circuitry supplies control signals to the motor.

69. The injector of claim 67 wherein the control unit is operable to supply current to the motor.

44. A method of controlling an injector for use in a medical injection procedure, the method comprising:

measuring a variable that is proportional to fluid pressure;

limiting power input to a drive mechanism of the injector to a power limit once the variable reaches a value that corresponds to a power limiting pressure; and

terminating the injection procedure if the value of the variable corresponds to a pressure hazard limit, the pressure hazard limit being greater than the power limiting pressure.

45. The method of claim 44 wherein the drive mechanism comprises a motor and the variable is motor current.

46. The method of claim 44 wherein the variable is force exerted on a component of the injector system, the force being proportional to the fluid pressure.

47. The method of claim 44 wherein the variable is the fluid pressure.

48. The method of claim 44 wherein the difference between the power limiting pressure and the pressure hazard limit is sufficiently large to prevent nuisance terminations of injection procedures.

49. A system for performing a medical imaging procedure comprising:

an injector, the injector including a portable remote control panel;

an imaging apparatus; and

an attachment member in the vicinity of the imaging apparatus, the attachment member being adapted to support the remote control panel in the vicinity of the imaging apparatus to facilitate generally simultaneous access by the operator to both the remote control panel and the imaging apparatus while performing the medical imaging procedure.

50. The system of claim 49 wherein the imaging apparatus comprises an input device.

51. The system of claim 49 wherein the attachment member is connected to the imaging apparatus.

52. The system of claim 49 wherein the injector further comprises:

a control unit comprising a control unit housing and control circuitry disposed within the control unit housing;

a syringe interface module operably associated with the control unit, the syringe interface module comprising a module housing and a syringe interface on the module housing; and

a syringe adapted to be connected to the syringe interface.

53. The system of claim 52 wherein the portable remote control panel is in communication with the control unit.

54. An injector for use with a syringe having a plunger disposed therein, the injector comprising:

a control unit comprising a control unit housing and control circuitry disposed within the control unit housing;

at least one syringe interface module movably connected to the control unit, the at least one syringe interface module comprising a module housing, at least one syringe interface on the module housing that is adapted to connect the syringe to the module housing, a drive mechanism within the module housing and at least one drive member operably connected to the drive mechanism to control motion of the plunger, the module housing being moveable relative to the control unit housing; and

a remote control in communication with the control unit.

55. The injector of claim 54 wherein the at least one syringe interface module further comprises a power source.

56. The injector of claim 55 wherein the power source comprises a battery.

57. The injector of claim 54, further comprising a stand for supporting the control unit and the at least one syringe interface module.

58. The injector of claim 57 wherein the stand is portable.

59. The injector of claim 54 wherein the control unit housing comprises one or more devices for controlling the injector.

60. The injector of claim 54 wherein the control unit housing comprises one or more devices for controlling the injector, and some or all of the devices are also provided on the remote control.

61. The injector of claim 54 wherein the at least one syringe interface module is operable to be moved to an upright position to expel air from the syringe.

62. The injector of claim 54 wherein the at least one syringe interface module is operable to be moved to a downward position for injection of the fluid.

63. The injector of claim 54, further comprising a power source.

64. The injector of claim 63 wherein the power source is operably connected to the drive mechanism.

65. The injector of claim 54 wherein the module housing is rotatable relative to the control unit housing.

66. The injector of claim 54 wherein the drive mechanism comprises a motor operably connected to the at least one drive members.

74. The injector of claim 54 wherein the at least one syringe interface module comprises two syringe interface modules.

75. The injector of claim 74 wherein each of the two syringe interface modules comprises a drive member for controlling movement of the plunger.

76. The injector of claim 54 wherein the at least one syringe interface module is in communicative connection with the control circuitry of the control unit.

77. The injector of claim 76 wherein the at least one syringe interface module is in communicative connection with the control circuitry by means of a communication line.

78. The injector of claim 76 wherein the at least one syringe interface module is in communicative connection with the control circuitry by means of a wireless connection.

79. The injector of claim 54 wherein the drive mechanism is operably connected to the at least one drive member by means of a flexible shaft.

88. The injector of claim 59 wherein the one or more devices or controlling the injector comprises one or more switches.

89. The injector of claim 60 wherein the one or more devices for controlling the injector comprises one or more switches.

90. The injector of claim 54 wherein the remote control comprises one or more devices the programming parameters of an injection procedure.

80. An injector for use with a syringe having a plunger disposed therein, the injector comprising:

a control unit comprising a control unit housing and control circuitry disposed within the control unit housing;

a syringe interface module rotatably connected to the control unit, the syringe interface module comprising a module housing, a syringe interface on the module housing that is adapted to connect the syringe to the module housing, a motor within the module housing and a drive piston operably connected to the motor to control motion of the plunger, the module housing being rotatable relative to the control unit housing;

a power source operably connected to the motor;

a remote control in communication with the control unit; and

a support device for supporting the control unit and the syringe interface module.

81. The injector of claim 80 wherein the motor is in communicative connection with the control circuitry in the control unit housing.

82. The injector of claim 81 wherein the control circuitry supplies control signals to the motor.

83. The injector of claim 80 wherein the power source comprises a battery.

84. The injector of claim 80 wherein the control unit housing comprises one or more devices for controlling the injector.

85. The injector of claim 80 wherein the control unit housing comprises one or more devices for controlling the injector, and some or all of the devices are also provided on the remote control.

86. The injector of claim 80 wherein the syringe interface module is operable to be moved to an upright position to expel air from the syringe.

87. The injector of claim 80 wherein the syringe interface module is operable to be moved to a downward position for injection of the fluid.

91. The injector of claim 84 wherein the one or more devices for programming parameters of an injection procedure comprises one or more switches.

92. The injector of claim 84 wherein the one or more devices for controlling the injector comprises one or more switches.

93. The injector of claim 85 wherein the one or more devices for controlling the injector comprises one or more switches.

94. The injector of claim 80 wherein the remote control comprises one or more devices for programming parameters of an injection procedure.

95. The injector of claim 94 wherein the one or more devices for programming parameters of an injection procedure comprises one or more switches.

96. An injector for use with a syringe having a plunger disposed therein, the injector comprising:

a control unit comprising a control unit housing, control circuitry disposed within the control unit housing and one or more devices For controlling the injector;

a syringe interface module operably associated with the control unit and adapted to be rotated between a substantially upright position and a substantially downward position, the syringe interface module comprising a module housing, a syringe interface on the module housing that is adapted to connect the syringe to the module housing, a motor disposed within the module housing and in communication with the conirol circuitry, and a drive piston operably connected to the motor to control motion of the plunger;

a power source operably connected to the motor;

a remote control in communication with the control unit, the remote control comprising one or more devices for programming an injection procedure; and

a support device or supporting the control unit and the syringe interface module.

97. The injector of claim 96 wherein the control circuitry supplies control signals to the motor.

98. The injector of claim 96 wherein the power source comprises a battery.

99. The injector of claim 96 wherein the syringe interface module is operable to be moved to a substantially upright position to expel air from the syringe.

100. The injector of claim 96 wherein the syringe interface module is operable to he moved to a substantially downward position or injection the fluid.

101. The injector of claim 96 wherein the remote control is in communication with the motor.

102. The injector of claim 96 wherein the one or more devices on the control unit comprises one or more switches.

103. The injector of claim 96 wherein the one or more devices on the remote control comprises one or more switches.

104. The injector of claim 96 wherein some or all of the one or more devices on the control unit are also provided on the remote control.