Extravasation detector using microwave radiometry

• US 5,954,668 A
• Filed: 06/14/1996
• Issued: 09/21/1999
• Est. Priority Date: 06/14/1996
• Status: Expired due to Fees

• Current Assignee: Medrad Incorporated (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Uber, Arthur E. III, Griffiths, David M.
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US08/663,710
• Time in Patent Office: 1,194 Days
• Field of Search: 128/713, 128/736, 128/DIG. 12-13, 73/346, 604/49-50, 604/52, 374/122, 374/148
• US Class Current: 600/549
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

A microwave antenna senses the temperature of tissue into which a fluid is to be injected. The fluid is injected by a needle or other vascular entry device connected to a fluid injector by a connector tube. The fluid temperature is measured by a temperature sensor attached to the connector tube. An alarm processor determines whether an extravasation occurs by comparing a temperature discrimination function derived from tissue temperature taken at different times with a calculated threshold value. The threshold value is calculated from the tissue temperature and the fluid temperature. The threshold value is recalculated and updated continuously during the fluid injection.

Claims

1. Apparatus for detecting extravasations in tissue injected with fluid from a fluid injector, comprising:

a fluid temperature sensor for sensing the temperature of fluid present in a connector tube which transmits fluid to a patient, and generating a fluid temperature signal in response thereto;

a tissue temperature sensor for sensing the temperature of tissue proximate the site of injection and generating a tissue temperature signal in response thereto; and

a processor adaptable to periodically receive said tissue temperature signal and said fluid temperature signal, said processor having an alarm circuit for declaring the occurrence of an extravasation and a threshold calculation circuit for periodically calculating at least one threshold value as a function of said tissue temperature signal and said fluid temperature signal, said processor activating said alarm circuit as a function of said tissue temperature signal, said fluid temperature signal, and said at least one threshold value during the fluid injection.

2. The apparatus of claim 1 wherein said fluid temperature sensor is an in-line sensor mounted in said connector tube.

3. The apparatus of claim 1 wherein said fluid temperature sensor is a microwave antenna and a radiometer coupled to said microwave antenna.

4. The apparatus of claim 1 wherein said fluid temperature sensor is a thermistor having a clip attaching said thermistor to said connector tube.

5. The apparatus of claim 1 wherein said fluid temperature sensor is a thermocouple disposed adjacent said connector tube.

6. The apparatus of claim 1 wherein said tissue temperature sensor is a microwave antenna and a radiometer coupled to said microwave antenna.

7. The apparatus of claim 1, wherein said processor further comprises:

a circuit for deriving at least first and second tissue temperatures from said tissue temperature signal at different times;

a circuit for deriving a fluid temperature from said fluid temperature signal;

a memory for storing said first and second tissue temperatures and said fluid temperature;

a temperature discrimination function circuit for calculating a temperature discrimination function as a function of said first and second tissue temperatures; and

a comparison circuit for comparing said temperature discrimination function with said at least one threshold, said comparison circuit activating said alarm circuit to declare an extravasation when the value of said temperature discrimination function exceeds said at least one threshold.

8. The apparatus of claim 7, wherein said threshold calculation circuit calculates a first, positive threshold as a function of said second tissue temperature and said fluid temperature, said threshold calculation circuit further calculating a second, negative threshold as a function of said second tissue temperature and said fluid temperature, said comparison circuit activating said alarm circuit when either the value of said temperature discrimination function exceeds said first threshold or when the value of said temperature discrimination function is less than said second negative threshold.

9. The apparatus of claim 7, wherein said temperature discrimination function circuit periodically calculates the temperature discrimination function as the difference between said fluid tissue temperature and each of a plurality of sequentially determined second tissue temperatures.

10. The apparatus of claim 7, wherein said first tissue temperature is a tissue temperature at the beginning of fluid injection, said second tissue temperature being a current tissue temperature.

11. The apparatus of claim 7, wherein said second tissue temperature corresponds to a current time, said first tissue temperature being taken and stored by said memory for a time which is a predetermined interval earlier than said current time.

12. The apparatus of claim 7, and further comprising means for entering at least one patient parameter, said memory storing said at least one patient parameter, said threshold calculation circuit calculating said threshold as a function of said at least one patient parameter.

13. The apparatus of claim 12, wherein said at least one patient parameter is selected from the group consisting of age, vein condition, vein size, vein depth, health of the patient, obesity, type of vascular entry device being employed, vascular insertion difficulty and needle positioning confidence.

14. The apparatus of claim 12, wherein said means for entering said at least one patient parameter is adaptable to receive a plurality of different patient parameters, said memory adaptable to store said plurality of patient parameters, said threshold calculation circuit calculating said threshold as a function of said plurality of patient parameters.

15. The apparatus of claim 12, and further comprising means for receiving a fluid flow rate for the fluid to be injected, said threshold calculation circuit calculating said threshold as a function of said fluid flow rate.

16. The apparatus of claim 1 wherein said processor further comprises a threshold circuit capable of taking initial tissue and fluid temperatures and calculating a threshold value based on said initial tissue and fluid temperatures, said processor further comprising a discrimination circuit capable of calculating a temperature discrimination function based on said initial tissue temperature and a current tissue temperature, said discrimination circuit further activating said alarm circuit if said temperature discrimination function exceeds said initial threshold value.

17. The apparatus of claim 16 wherein said threshold circuit further includes a circuit for determining updated fluid and tissue temperatures and

a circuit for calculating an updated threshold value, said discrimination circuit further including a circuit for calculating an updated temperature discrimination function and

a circuit for activating said alarm circuit if said updated temperature discrimination function exceeds said updated threshold value.

18. The apparatus of claim 1 wherein said processor further comprises a warning circuit which compares the difference of said fluid temperature and said tissue temperature with a minimal difference threshold to warn that no extravasation detection is possible.

19. A fluid temperature sensor for use with an extravasation detector having a fluid needle, a fluid connector tube having fluid, and a connector having an interior sidewall connecting said tube to said needle, said fluid temperature sensor comprising:

an electrical temperature transducer; and

a thermally conductive insert adapted to extend through said connector and said interior sidewall, said thermally conductive insert adaptable to be in contact with said fluid in said connector tube to provide a temperature conductive path, and said thermally conductive insert coupled to said thermoelectric transducer.

20. The fluid temperature sensor of claim 19 wherein said transducer is a thermistor.

21. The fluid temperature sensor of claim 19 wherein said transducer is a thermocouple.

22. A fluid injection system comprising:

a fluid injector head capable of initiating and stopping fluid flow;

a connector tube coupled to said fluid injector, said tube forming a path for transmitting fluid from said fluid injector to tissue containing a vessel into which fluid is intended to be injected;

a fluid temperature sensor located on said connector tube, said temperature sensor producing a fluid temperature signal representing the temperature of said fluid in said connector tube;

a tissue temperature sensor for generating a tissue temperature signal as a function of the temperature of said tissue; and

an alarm circuit coupled to said tissue temperature sensor and said fluid temperature sensor, said alarm circuit having a temperature discrimination function circuit capable of calculating a temperature discrimination function from said tissue temperature, a threshold circuit capable of comparing at least a first threshold value with said temperature discrimination function, said threshold circuit calculating said first threshold value at different time intervals during said fluid flow.

23. The fluid injection system of claim 22 wherein said tissue temperature sensor further comprises:

an antenna disposed to receive microwave radiation from said tissue; and

a radiometer coupled to said antenna, said radiometer capable of producing said tissue temperature signal.

24. The fluid injection system of claim 22, wherein said temperature sensor is attached to a clip, said clip attaching said temperature sensor to said tube connector.

25. The fluid injection system of claim 23 wherein said fluid temperature sensor comprises an antenna located on said connector tube and a radiometer coupled to said antenna for generating said fluid temperature signal.

26. The fluid injection system of claim 25, further comprising a multiplexor, an output of said multiplexor coupled to said radiometer, a first input of said multiplexor coupled to said antenna located on said connector tube, and a second input of said multiplexor coupled to said antenna located near said tissue, said multiplexor selectively being sending said signals from said temperature sensor and said antenna located near said tissue to said radiometer.

27. The fluid injection system of claim 22, wherein said fluid temperature sensor is an electrical temperature transducer.

28. The fluid injection system of claim 27, wherein said transducer is a thermistor.

29. The fluid injection system of claim 27, wherein said transducer is a thermocouple.

30. The fluid injection system of claim 27, wherein said transducer is imbedded in a disposable plastic piece mounted to said connector tube.

31. The fluid injection system of claim 27, wherein said fluid temperature sensor comprises a housing mounted to said connector tube and defining a fluid path therethrough for fluid to be injected, said housing having an exterior and an interior adjoining said fluid path, a heat conductor disposed in said housing and providing a heat conductive path from said interior to said exterior, said transducer affixed to said heat conductor.

32. The fluid injection system of claim 22, wherein said alarm circuit further comprises a processor and a memory, said memory capable of holding instructions for said processor.

33. The fluid injection system of claim 22 wherein said alarm circuit is capable of controlling said fluid injector to stop fluid flow when said temperature discrimination function exceeds said first threshold value.

34. The fluid injection system of claim 22 wherein said first threshold value is calculated by said processor as a function of said temperature of said tissue and said temperature of said fluid.

35. The fluid injection system of claim 34, and further comprising means for entering at least one patient parameter and storing said at least one patient parameter, and wherein said first threshold value is calculated by said processor as a function of said at least one patient parameter.

36. The fluid injection system of claim 35, wherein said at least one patient parameter is selected from the group consisting of age, vein condition, vein size, vein depth, health of the patient, obesity, type of vascular entry device being employed, vascular insertion difficulty and needle positioning confidence.

37. The fluid injection system of claim 35, wherein said means for entering said at least one patient parameter is adaptable to receive and store a plurality of different patient parameters, and wherein said first threshold value is calculated by said processor as a function of said plurality of patient parameters.

38. The fluid injection system of claim 22 wherein said alarm circuit further comprises a second circuit capable of comparing said temperature discrimination function with a second negative threshold value, said second circuit calculating said second negative threshold value at different time intervals during said fluid flow.

39. The fluid injection system of claim 22 wherein said alarm circuit is capable of controlling said fluid injector head to stop fluid flow when said temperature discrimination function is less than said second negative threshold value.

40. A method for detecting extravasations in tissue injected with fluid from a fluid injector, comprising the steps of:

periodically sensing the temperature of fluid present in a connector tube transmitting fluid to a patient, and generating a fluid temperature signal in response thereto;

periodically sensing the temperature of tissue proximate the site of injection and generating a tissue temperature signal in response thereto;

receiving the fluid temperature signal and the tissue temperature signal;

storing a fluid temperature and a tissue temperature derived from the received signals; and

declaring the occurrence of an extravasation as a function of said tissue temperature signal and said fluid temperature signal during the fluid injection.

41. The method of claim 40 and further comprising the steps of:

determining initial tissue and fluid temperatures;

calculating at least one initial threshold value as a function of said initial tissue and fluid temperatures;

calculating a temperature discrimination function based on said initial tissue temperature; and

activating an alarm if said temperature discrimination function exceeds said initial threshold value.

42. The method of claim 41, and further comprising the steps of:

determining updated fluid and tissue temperatures;

calculating an updated threshold value as a function of said updated fluid and tissue temperatures;

calculating an updated temperature discrimination function; and

activating said alarm if said updated temperature discrimination function exceeds said updated threshold value.

43. The method of claim 41 further comprising the steps of:

comparing the difference between said fluid temperature and said tissue temperature to a minimal difference threshold;

warning that no extravasation detection may occur if said minimal difference threshold exceeds said difference.

44. A method of detecting an extravasation in fluid injected into a tissue by a fluid injector which generates fluid flow through a connector tube, the method comprising the steps of:

measuring a first tissue temperature;

measuring a first fluid temperature;

calculating a first threshold value as a function of said first tissue temperature and said first fluid temperature;

measuring a second tissue temperature at a time after said step of measuring said first tissue temperature;

calculating a temperature discrimination function from said first and second tissue temperatures;

comparing said first threshold value with said temperature discrimination function;

generating an alarm signal if said temperature discrimination function exceeds said threshold value;

measuring a second fluid temperature and a third tissue temperature;

calculating an updated temperature discrimination function from said third tissue temperature;

calculating an updated first threshold value as a function of said second fluid temperature and said third tissue temperature;

comparing said updated first threshold value with said updated temperature discrimination function; and

generating an alarm signal if said updated temperature discrimination function exceeds said updated first threshold value.

45. The method of claim 44, further comprising the steps of:

disposing an antenna near a tissue;

coupling said antenna to a radiometer capable of producing a signal representing the tissue temperature;

attaching a temperature sensor to said connector tube;

coupling an alarm processor to said radiometer and said temperature sensor; and

performing said steps of comparing, calculating, and generating said alarm signal.

46. The method of claim 44 further comprising the steps of:

calculating a second threshold value as a function of said first tissue temperature and said first fluid temperature;

comparing said second threshold value with said temperature discrimination function;

generating an alarm signal if said second threshold value exceeds said temperature discrimination function;

calculating an updated second threshold value as a function of said second fluid temperature and said third tissue temperature;

comparing said updated second threshold value with said updated temperature discrimination function; and

generating an alarm signal if said updated second threshold value exceeds said updated temperature discrimination function.

47. The method of claim 44 wherein said step of calculating an updated temperature discrimination function further comprises selecting the second and third tissue temperatures such that a predetermined constant interval of time is between them.

48. Apparatus for detecting an extravasation in tissue injected with fluid from a fluid injector, the fluid transmitted through a connector tube, the apparatus comprising:

a tissue temperature sensor for sensing the temperature of the tissue proximate the injection and generating a tissue temperature signal in response thereto;

a fluid temperature controller for controlling the temperature of the fluid; and

a processor adaptable to receive said tissue temperature signal and a fluid temperature signal generated from the temperature of the fluid, said processor having an alarm circuit for declaring the occurrence of an extravasation as a function of said tissue temperature signal and said fluid temperature signal, said processor coupled to said fluid temperature controller to control said temperature of said fluid in said connector tube so that a minimum difference exists between said tissue temperature and said fluid temperature.

49. The apparatus of claim 48, wherein said fluid controller further comprises a temperature sensor for sensing fluid temperature and generating said fluid temperature signal.

50. The apparatus of claim 49, wherein said fluid temperature sensor is a microwave antenna and a radiometer coupled to said microwave antenna, and wherein said fluid controller further comprises a microwave transmitter coupled to said microwave antenna.

51. The apparatus of claim 49, wherein said temperature sensor is a thermistor, and wherein said fluid controller further comprises a heating element coupled to said thermistor.

52. The apparatus of claim 49, wherein said temperature sensor is a metal foil heating element, and wherein said fluid controller further comprises a heating element coupled to said metal foil heating element.

53. The apparatus of claim 48, wherein said fluid temperature controller is located on said connector tube.

54. The apparatus of claim 53, wherein said fluid controller is a block of thermally conductive material.

55. The apparatus of claim 54, wherein said material is aluminum.

56. The apparatus of claim 54, wherein said fluid controller further comprises a heating device attached to said block of thermally conductive material.

57. The apparatus of claim 54, wherein said fluid controller further comprises a cooling device attached to said block of thermally conductive material.

58. A method of detecting an extravasation in fluid injected into a tissue by a fluid injector which generates fluid flow through a connector tube, the method comprising the steps of:

measuring a tissue temperature;

measuring a fluid temperature;

controlling said fluid temperature so the difference between said tissue temperature and said fluid temperature is sufficient to permit extravasation detection; and

declaring the occurrence of an extravasation as a function of said tissue temperature and said fluid temperature.

59. A method of detecting extravasations in tissue injected with fluid from a fluid injector, comprising the following steps:

periodically sensing the temperature of fluid present in a connector tube transmitting fluid to a patient, and generating a fluid temperature signal in response thereto;

periodically sensing the temperature of tissue proximate the site of injection, and generating a tissue temperature signal in response thereto;

receiving the fluid temperature signal and the tissue temperature signal;

storing a fluid temperature and a tissue temperature derived from the received signals;

determining the initial tissue and fluid temperatures;

calculating at least one initial threshold value as a function of the initial tissue and fluid temperatures;

calculating a temperature discrimination function based on the initial tissue temperature; and

activating an alarm declaring the occurrence of an extravasation if the temperature discrimination function exceeds the at least one initial threshold value.