Flow condition sensor assembly for patient infusion device

• US 20030167035A1
• Filed: 03/01/2002
• Published: 09/04/2003
• Est. Priority Date: 03/01/2002
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Gregory, Christopher C., Flaherty, J. Christopher, McBride, Sterling Eduard, Moroney, Richard Morgan III
• Granted Patent: US 6,830,558 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

A device for delivering fluid to a patient including an exit port assembly adapted to connect to a transcutaneous patient access tool, a flow path extending from the exit port assembly, and a flow condition sensor assembly. The sensor assembly includes a resilient diaphragm having a first surface positioned against the flow path, a chamber wall defining a sensor chamber adjacent a second surface of the diaphragm, and at least one sensor arranged to provide a threshold signal when the second surface of the diaphragm expands into the chamber in response to at least one predetermined fluid flow condition occurring in the flow path. The sensor includes a first electrode secured on the diaphragm, a second electrode positioned in a fixed location with respect to the first electrode, and an impedance meter connected between the electrodes.

Claims

1. A device for delivering fluid to a patient, comprising:

A) an exit port assembly adapted to connect to a transcutaneous patient access tool;

B) a flow path extending from the exit port assembly; and

C) a flow condition sensor assembly including

a resilient diaphragm having opposing first and second surfaces, with the first surface positioned against the flow path,

a chamber wall positioned adjacent the second surface of the diaphragm and defining a sensor chamber adjacent the second surface of the diaphragm, and

at least one sensor arranged to provide a threshold signal when the second surface of the diaphragm expands into the chamber in response to at least one predetermined fluid flow condition occurring in the flow path, the sensor including,

a first electrode secured on the diaphragm,

a second electrode positioned in a fixed location with respect to the first electrode, and

an impedance meter connected between the first and the second electrodes.

2. A device according to claim 1, wherein the predetermined fluid flow condition comprises one of an occlusion in the flow path, an inadequate flow of fluid in the flow path, and an adequate flow of fluid in the flow path.

3. A device according to claim 1, wherein the flow path includes a reservoir and a passageway providing fluid communication between the reservoir and the exit port assembly, and the flow condition sensor assembly is positioned against the passageway.

4. A device according to claim 1, wherein the second electrode is positioned on a wall of the flow path.

5. A device according to claim 1, wherein the flow condition sensor assembly further comprises at least two laminated layers and the diaphragm is positioned between two of the layers.

6. A device according to claim 5, wherein the at least two laminated layers comprise:

a first layer;

a second layer received against the first layer, the second and the first layers including at least one groove defining a passageway of the flow path, the second layer including an opening in fluid communication with the passageway, and wherein the resilient diaphragm is received on the second layer covering the opening; and

a third layer received over the diaphragm on the second layer, the third layer including the chamber wall defining the chamber over the diaphragm and in alignment with the opening of the second layer.

7. A device according to claim 6, wherein one of the second and the third layers defines a recess receiving the diaphragm, and wherein the recess has a depth about equal to a thickness of the diaphragm such that the diaphragm is secured in a substantially fluid-tight manner between the second and the third layers.

8. A device according to claim 7, wherein a length and a width of the recess are greater than a length and a width of the diaphragm.

9. A device according to claim 1, wherein the diaphragm comprises a thin, flat piece of flexible and resilient material.

10. A device according to claim 1, wherein the sensor chamber has a predetermined volume.

11. A device according to claim 1, wherein the flow condition sensor assembly includes an alarm connected to the impedance meter.

12. A device according to claim 11, wherein the alarm comprises an audible alarm.

13. A device according to claim 11, wherein the alarm comprises a visual alarm.

14. A device according to claim 1, further comprising a processor connected to the impedance meter of the sensor assembly.

15. A device according to claim 14, further comprising an alarm connected to the processor.

16. A device according to claim 15, wherein the alarm comprises an audible alarm.

17. A device according to claim 15, wherein the alarm comprises a visual alarm.

18. A device according to claim 15, wherein the processor is programmed to activate the alarm upon receiving the threshold signal from the impedance meter.

19. A device according to claim 15, wherein the processor is programmed to activate the alarm upon receiving the threshold signal from the impedance meter for more than a predetermined period.

20. A device according to claim 15, wherein the processor is programmed to activate the alarm upon receiving the threshold signal from the impedance meter for less than a predetermined period.

21. A device according to claim 14, wherein the processor is programmed to stop operation upon receiving the threshold signal from the impedance meter.

22. A device according to claim 14, wherein the processor is programmed to stop operation upon receiving the threshold signal from the impedance meter for more than a predetermined period.

23. A device according to claim 14, wherein the processor is programmed to stop operation upon receiving the threshold signal from the impedance meter for less than a predetermined period.

24. A device according to claim 14, wherein the impedance meter provides an analog signal and the processor include an analog-to-digital converter for converting the analog single to a digital signal.

25. A device according to claim 14, wherein the processor is programmed to provide a signal indicative of an undesired flow condition upon receiving the threshold signal from the impedance meter.

26. A device according to claim 14, wherein the processor is programmed to provide a signal indicative of an occluded flow condition upon receiving the threshold signal from the impedance meter for more than a predetermined period.

27. A device according to claim 14, wherein the processor is programmed to provide a signal indicative of a low flow condition upon receiving the threshold signal from the impedance meter for less than a predetermined period.

28. A device according to claim 14, wherein the processor is programmed to receive the threshold signal from the impedance meter when the device is primed.

29. A device according to claim 14, wherein the processor is programmed to determine the presence of bubbles in the flow path based upon the signal received from the impedance meter.

30. A device according to claim 1, wherein the flow path includes a reservoir containing a therapeutic fluid.

31. A device according to claim 30, wherein the therapeutic fluid is insulin.

32. A device according to claim 30, further comprising a fill port connected to the reservoir.

33. A device according to claim 30, wherein the reservoir is pressurized.

34. A device according to claim 1, wherein the exit port assembly includes a transcutaneous patient access tool.

35. A device according to claim 34, wherein the transcutaneous patient access tool comprises a needle.

36. A device according to claim 1, wherein a combined volume of the exit port assembly and the flow path is fixed and predetermined.

37. A device according to claim 1, wherein possible expansion of a combined volume of the exit port assembly and the flow path is relatively small compared with the volume of the sensor chamber.

38. A device according to claim 1, further comprising:

a dispenser for causing fluid through the flow path to the exit port assembly;

a local processor connected to the dispenser and programmed to cause fluid flow to the exit port assembly based upon flow instructions;

a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and

a housing containing the flow path, the exit port assembly, the dispenser, the local processor, and the wireless receiver, wherein the housing is free of user input components for providing flow instructions to the local processor.

39. A system including a fluid delivery device according to claim 38, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.

40. A device according to claim 1, further comprising:

a dispenser for causing fluid through the flow path to the exit port assembly;

a local processor connected to the dispenser and programmed to cause fluid flow to the exit port assembly based upon flow instructions, and further programmed to provide flow information;

a wireless transmitter connected to the local processor for transmitting the flow information from the local processor to a separate, remote control device; and

a housing containing the flow path, the exit port assembly, the dispenser, the local processor, and the wireless transmitter, wherein the housing is free of user output components for providing the flow information from the local processor to a user.

41. A system including a fluid delivery device according to claim 40 and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user output components connected to the remote processor for allowing a user to receive flow information; and

a receiver connected to the remote processor for receiving the flow information from the transmitter of the fluid delivery device.

42. A system according to claim 41, wherein the remote control device includes an alarm connected to the remote processor.

43. A device for delivering fluid to a patient, comprising:

A) an exit port assembly adapted to connect to a transcutaneous patient access tool;

B) a flow path extending from the exit port assembly; and

C) a flow condition sensor assembly including,

a resilient diaphragm having opposing first and second surfaces, with the first surface positioned against the flow path,

a chamber wall positioned adjacent the second surface of the diaphragm and defining a sensor chamber adjacent the second surface of the diaphragm, the chamber wall having a contour such that the chamber includes at least two distinct sections; and

at least one sensor positioned in each section of the chamber to provide threshold signals when the second surface of the diaphragm expands into the sections in response to predetermined fluid flow conditions occurring in the flow path.

44. A device according to claim 43, wherein the predetermined fluid flow conditions comprise at least one of an occlusion in the flow path, an inadequate flow of fluid in the flow path, and an adequate flow of fluid in the flow path.

45. A device according to claim 43, wherein the flow path includes a reservoir and the flow condition sensor assembly is positioned at an end of the reservoir.

46. A device according to claim 43, wherein the flow path includes a reservoir and a passageway providing fluid communication between the reservoir and the exit port assembly, and the flow condition sensor assembly is positioned against the passageway.

47. A device according to claim 43, wherein the sensors are responsive to one of contact, pressure, light, magnetism, strain, and density.

48. A device according to claim 43, wherein the sensor is positioned on a portions of the chamber sections furthest from the flow path and each section of the chamber has a predetermined volume.

49. A device according to claim 43, wherein the sensors each comprise a circuit having a lead positioned on the second surface of the diaphragm and a lead positioned on the chamber wall.

50. A device according to claim 43, wherein the flow condition sensor assembly further comprises at least two laminated layers and the diaphragm is positioned between two of the layers.

51. A device according to claim 50, wherein the at least two laminated layers comprise:

a first layer;

a second layer received against the first layer, the second and the first layers including at least one groove defining a passageway of the flow path, the second layer including an opening in fluid communication with the passageway, and wherein the resilient diaphragm is received on the second layer covering the opening; and

a third layer received over the diaphragm on the second layer, the third layer including the chamber wall defining the chamber over the diaphragm and in alignment with the opening of the second layer.

52. A device according to claim 51, wherein one of the second and the third layers defines a recess receiving the diaphragm, and wherein the recess has a depth about equal to a thickness of the diaphragm such that the diaphragm is secured in a substantially fluid-tight manner between the second and the third layers.

53. A device according to claim 52, wherein a length and a width of the recess are greater than a length and a width of the diaphragm.

54. A device according to claim 43, wherein the diaphragm comprises a thin, flat piece of flexible and resilient material.

55. A device according to claim 43, wherein each of the sections of the sensor chamber has a predetermined volume.

56. A device according to claim 43, wherein the flow condition sensor assembly includes an alarm connected to each of the sensors.

57. A device according to claim 56, wherein the alarm comprises an audible alarm.

58. A device according to claim 56, wherein the alarm comprises a visual alarm.

59. A device according to claim 43, further comprising a processor connected to each of the sensors of the sensor assembly.

60. A device according to claim 59, further comprising an alarm connected to the processor.

61. A device according to claim 60, wherein the alarm comprises an audible alarm.

62. A device according to claim 60, wherein the alarm comprises a visual alarm.

63. A device according to claim 60, wherein the processor is programmed to activate the alarm upon receiving the threshold signal from all of the sensors.

64. A device according to claim 60, wherein the processor is programmed to activate the alarm upon receiving the threshold signal from all of the sensors for more than a predetermined period.

65. A device according to claim 60, wherein the processor is programmed to activate the alarm upon receiving the threshold signal from only one of the sensors.

66. A device according to claim 60, wherein the processor is programmed to activate the alarm upon receiving the threshold signal from only one of the sensors for less than a predetermined period.

67. A device according to claim 59, wherein each of the sensors provides an analog signal and the processor include an analog-to-digital converter for converting the analog singles into digital signals.

68. A device according to claim 59, wherein the processor is programmed to provide a signal indicative of an occluded flow condition upon receiving the threshold signal from all of the sensors.

69. A device according to claim 59, wherein the processor is programmed to provide a signal indicative of an occluded flow condition upon receiving the threshold signal from all of the sensors for more than a predetermined period.

70. A device according to claim 59, wherein the processor is programmed to provide a signal indicative of a low flow condition upon receiving the threshold signal from only one of the sensors.

71. A device according to claim 59, wherein the processor is programmed to provide a signal indicative of a low flow condition upon receiving the threshold signal from only one of the sensors and for less than a predetermined period.

72. A device according to claim 59, wherein the processor is programmed to receive the threshold signals from the sensors when the device is primed.

73. A device according to claim 43, wherein the flow path includes a reservoir containing a therapeutic fluid.

74. A device according to claim 73, wherein the therapeutic fluid is insulin.

75. A device according to claim 73, further comprising a fill port connected to the reservoir.

76. A device according to claim 73, wherein the reservoir is pressurized.

77. A device according to claim 43, wherein the exit port assembly includes a transcutaneous patient access tool.

78. A device according to claim 77, wherein the transcutaneous patient access tool comprises a needle.

79. A device according to claim 43, wherein a combined volume of the exit port assembly and the flow path is fixed and predetermined.

80. A device according to claim 43, wherein possible expansion of a combined volume of the exit port assembly and the flow path is relatively small compared with the volume of the sensor chamber.

81. A device according to claim 43, further comprising:

a dispenser for causing fluid through the flow path to the exit port assembly;

a local processor connected to the dispenser and programmed to cause fluid flow to the exit port assembly based upon flow instructions;

a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and

a housing containing the flow path, the exit port assembly, the dispenser, the local processor, and the wireless receiver, wherein the housing is free of user input components for providing flow instructions to the local processor.

82. A system including a fluid delivery device according to claim 81, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.

83. A device according to claim 43, further comprising:

a dispenser for causing fluid through the flow path to the exit port assembly;

a local processor connected to the dispenser and programmed to cause fluid flow to the exit port assembly based upon flow instructions, and further programmed to provide flow information;

a wireless transmitter connected to the local processor for transmitting the flow information from the local processor to a separate, remote control device; and

a housing containing the flow path, the exit port assembly, the dispenser, the local processor, and the wireless transmitter, wherein the housing is free of user output components for providing the flow information from the local processor to a user.

84. A system including a fluid delivery device according to claim 83 and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user output components connected to the remote processor for allowing a user to receive flow information; and

a receiver connected to the remote processor for receiving the flow information from the transmitter of the fluid delivery device.

85. A system according to claim 83, wherein the remote control device includes an alarm connected to the remote processor.

86. A device according to claim 43, wherein the sensors each comprise:

a first electrode secured on the diaphragm;

a second electrode positioned in a fixed location with respect to the first electrode; and

an impedance meter connected between the first and the second electrodes.