In-line infiltration detection apparatus and method

• US 4,959,050 A
• Filed: 09/26/1988
• Issued: 09/25/1990
• Est. Priority Date: 09/26/1988
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Bobo, Donald E. Jr.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/249,065
• Time in Patent Office: 729 Days
• Field of Search: 604/50, 604/65-67, 604/118, 604/245, 604/246, 128/DIG. 12, 128/DIG. 13, 128/748, 128/681
• US Class Current: 604/505
• 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: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

The present invention provides a stand-alone, in-line device and method for detecting whether a fluid is being properly supplied to a patient, including means for delivering a test pulse of the fluid through conduit means to the patient with the test pulse being distinguishable from the normal delivery pattern and with the test pulse creating a pressure wave response in the conduit means. The device and method also includes means for determining the area between a baseline and at least a portion of a pressure versus time curve representing the pressure wave response, and means responsive to the magnitude of the area for detecting whether the fluid is being improperly supplied by the conduit means to the patient. Preferably, the device and method also includes means for diverting and accumulating a predetermined volume of the upstream flow from the infusion source for use as the test pulse.

Claims

1. An apparatus for detecting whether a fluid is being properly supplied to a patient through conduit means by a flow controller which is located upstream from the detection apparatus and which infuses fluid in a normal delivery pattern at any of a plurality of selected infusion rates through conduit means to the patient, comprising:

(a) means for diverting and accumulating a predetermined volume of the upstream flow from the flow controller for use as a test pulse;

(b) means for delivering the test pulse of the fluid through the conduit means to the patient with the test pulse being distinguishable from the normal delivery pattern and with the test pulse creating a pressure wave response in the conduit means;

(c) means for determining the area between a baseline and at least a portion of a pressure versus time curve representing the pressure wave response; and

(d) means responsive to the magnitude of said area for detecting if the fluid is being improperly supplied by the conduit means to the patient.

2. A detection device for detecting whether a fluid is being properly supplied to a patient through conduit means by a flow controller, the flow controller being of the type that infuses fluid in a normal delivery pattern at any of a plurality of selected infusion rates, wherein:

said detection device is located between said flow controller and the patient and operates independently of said flow controller, and said detection device comprises (a) means for diverting at least a portion of the fluid flowing from the flow controller through the conduit means prior to delivery of a fluid test pulse, (b) means for delivering said test pulse through the conduit means to the patient, said test pulse being distinguishable from the normal delivery pattern of the flow controller and said test pulse creating a pressure wave response in the conduit means, (c) means for determining the area between a base line and at least a portion of a pressure versus time curve representing the pressure wave response, and (d) means responsive to the magnitude of said area for detecting if the fluid is being improperly supplied by the conduit means to the patient.

3. An apparatus according to claim 2, wherein the pressure wave response has a peak value of pressure and a leading portion and a trailing portion on opposite sides of the peak value and said determining means determines the area from an initial point on the leading portion side of the peak value to a truncation point with the truncation point being on a portion of said curve corresponding to the trailing portion of the pressure wave response.

4. An apparatus according to claim 3, wherein said truncation point is essentially outside the noise range.

5. An apparatus according to claim 3, wherein said determining means establishes the truncation point as a percent of the peak value.

6. An apparatus according to claim 3, wherein said truncation point is at a time at which the pressure is no more than about 30 percent of the peak value.

7. An apparatus according to claim 3, wherein said truncation point is at a time at which the pressure is no less than about 70 percent of the peak value.

8. An apparatus according to claim 3, wherein said truncation point is at a time at which the pressure is between about 30 percent to about 70 percent of the peak value.

9. An apparatus according to claim 3, wherein said truncation point is at a time at which the pressure is about 50 percent of the peak value.

10. An apparatus according to claim 3, wherein the initial point is essentially at the beginning of the point on said curve corresponding to the beginning of the pressure wave response.

11. An apparatus according to claim 3, wherein said test pulse delivery means delivers the fluid in an altered pattern, said altered pattern including a test pulse and leading and trailing separating regions on opposite sides of the test pulse, each of which provides a different flow rate of fluid than the adjacent portions of the test pulse.

12. An apparatus according to claim 11, wherein said altered pattern includes at least three test pulses delivered in rapid succession and leading and trailing separating regions on opposite sides of each test pulse.

13. An apparatus according to claim 12, wherein said determining means establishes the truncation point as the first to occur of a percent of peak value and said trailing separating region.

14. An apparatus according to claim 12, wherein the detecting means includes means for comparing the area of each test pulse to determine the relative change in area between each successive test pulse, said change being indicative of a fluid being improperly supplied by the conduit means to the patent, thereby making the triple rate pulse essentially self-normalizing.

15. An apparatus according to claim 11, wherein the test pulse provides a greater flow rate of fluid than the normal delivery pattern and the separating regions are valleys each of which provide a lesser flow rate of fluid than said adjacent portions of the test pulse.

16. An apparatus according to claim 11, wherein the detecting means includes means for dividing said area by a divisor which is a function of the difference between the flow rate during at least one of the valleys and the test pulse to provide a quotient and means for comparing the quotient to a threshold.

17. An apparatus according to claim 2, including means for establishing the baseline as essentially constant for the determination of said area.

18. An apparatus according to claim 2, including means for determining the baseline for use in the determination of said area as a function of the pressure in the conduit means when the pressure wave response is not present.

19. An apparatus according to claim 2, including first means responsive to the pressure of the fluid in the conduit means during the normal delivery pattern to ascertain if pressure conditions in the conduit means are suitable for detecting whether the fluid is being improperly supplied by the conduit means to the patient.

20. An apparatus according to claim 19, wherein said first means includes means for comparing a function of the pressure of the fluid in the conduit means during the normal delivery pattern to a threshold to ascertain if pressure conditions in the conduit means are suitable for detecting if fluid is being improperly supplied by the conduit means to the patient.

21. An apparatus according to claim 20, wherein said function of the pressure equals Bl+K(B2) where Bl is the baseline pressure at an instant prior to the test pulse, K is a constant and B2 is the rms value of a plurality of segments of the baseline pressure prior to the test pulse and with at least one of said segments being prior to said instant.

22. An apparatus according to claim 2, including means for establishing the baseline including means for averaging the pressure in the conduit means during at least a portion of the time that the pressure wave response is not present.

23. An apparatus according to claim 2, including means for establishing the baseline including means for sampling the pressure in the delivery system during at least a portion of the time that the pressure wave response is not present to provide a plurality of samples, means for averaging said samples and means for excluding from said average at least the portion of any of said samples that exceeds a threshold.

24. An apparatus according to claim 2, wherein said detecting means includes means for normalizing said area and comparing the normalized area to a threshold.

25. An apparatus according to claim 2, wherein the pressure wave response has a peak value of pressure and a leading portion and a trailing portion on opposite sides of the peak value and said determining means determines the area from an initial point on the leading portion side of the peak value to about the peak value of pressure.

26. An apparatus according to claim 25, wherein the area between the initial point and about the peak value is a front end area and the determining means also determines a truncated area between the initial point and a truncation point with the truncation point being on a portion of said curve corresponding to the trailing portion of the pressure wave response and said detecting means is responsive to said front end area and said truncated area to detect if the fluid is being improperly supplied by the conduit means to the patient.

35. A detection device according to claim 2 or 27, further comprising means for accumulating a predetermined volume of said fluid for use as the test pulse.

36. A detection device according to claim 2 or 27, further comprising means for providing reduced fluid flow or no fluid flow prior to delivery of said test pulse to permit the baseline to stabilize prior to delivery of said test pulse.

37. A detection device according to claim 2 or 27, wherein said diverting means diverts substantially all of the fluid flowing from the flow controller prior to delivering a test pulse.

38. A detection device according to claim 2 or 27, wherein said diverting means diverts said fluid flowing from the flow controller prior to and during delivery of said test pulse.

39. A detection device according to claim 36, wherein said diverting means diverts said fluid flowing from the flow controller prior to and during delivery of said test pulse.

40. A detection device according to claim 2 or 27, wherein said test pulse delivery means alters the normal delivery pattern by delivering a test pulse at an increased flow rate and providing a period of reduced or no flow prior to and following delivery of said test pulse.

27. A detection device for detecting whether a fluid is being properly supplied to a patient through conduit means by a flow controller, the flow controller being of the type that infuses fluid in a normal delivery pattern at any of a plurality of selected infusion rates, wherein:

said detection device is located between said flow controller and the patient and operates independently of said flow controller, and said detection device comprises (a) means for diverting at least a portion of the fluid flowing from the flow controller through the conduit means prior to delivery of a fluid test pulse, (b) means for delivering said test pulse through the conduit means to the patient, said test pulse being distinguishable from the normal delivery pattern of the flow controller and said test pulse creating a pressure wave response in the conduit means, and (c) means responsive to the pressure wave response in the conduit means for detecting if the fluid is being improperly supplied by the conduit means to the patient.

28. An apparatus according to claim 27, further comprising means responsive to the selected flow rate of the flow controller for controlling the flow rate of the fluid provided during the test pulse, whereby said controlling means decreases the ratio of test pulse flow rate to selected flow rate for increased selected flow rates, and said detecting means includes means responsive to the rate of change of the pressure wave response in the conduit means for detecting whether the fluid is being improperly supplied by the conduit means to the patient.

29. An apparatus according to claim 27, wherein said test pulse delivery means includes means for selectively initiating a test pulse on demand.

30. An apparatus according to claim 27, wherein said detecting means includes means responsive to the rate of change of at least a portion of the pressure wave response in the conduit means for detecting whether the fluid is being improperly supplied by the conduit means to the patient.

31. An apparatus according to claim 27, wherein said detecting means detects the improper supply of the fluid when the pressure change of at least a portion of the pressure wave response exceeds a predetermined magnitude.

32. An apparatus according to claim 27, wherein said detecting means includes a pressure transducer for providing a pressure signal which is related to the pressure in the conduit means, means for sampling said pressure signal at least during a sample time which occurs at least partially during the pressure wave response to provide a plurality of digital samples and means responsive to the samples obtained during said sample time for detecting whether the fluid is being improperly supplied by the conduit means to the patient.

33. An apparatus according to claim 27, wherein said detecting means is responsive at all infusion rates of the infusion device to the change in pressure of the same portion of the pressure wave response during a predetermined period for detecting if the fluid is being improperly supplied to the patient.

34. An apparatus according to claim 27, further comprising means responsive to the detecting means for indicating that the fluid is not being properly supplied to the patient by the conduit means.

41. An apparatus for detecting whether a fluid is being properly supplied to a patient by conduit means from a flow controller which is located upstream from the detection apparatus and which infuses fluid in a normal delivery pattern at any of a plurality of selected infusion rates through conduit means to the patient, comprising:

(a) means for diverting and accumulating a predetermined volume of the upstream flow from the flow controller for use as a test pulse;

(b) means for delivering said test pulse of the fluid through the conduit means to the patient with the test pulse being distinguishable from the normal delivery pattern, said test pulse creating a pressure wave response in the conduit means; and

(c) means responsive to the pressure wave response in the conduit means for detecting whether the fluid is being improperly supplied by the conduit means to the patient.

42. An apparatus according to claim 41, wherein the test pulse is delivered at an increased flow rate greater than the flow rate during normal delivery pattern, and the test pulse delivery means includes means for delivering a reduced flow rate of fluid or no flow of fluid adjacent the test pulse.

43. An apparatus according to claim 42, wherein said delivery means provides reduced flow or no flow on opposite sides of the test pulse, with said reduced flow rate being less than the flow rate during the normal delivery pattern.

44. A method for detecting whether a fluid is being properly supplied to a patient by conduit means from a flow controller which infuses fluid in a normal delivery pattern at any of a plurality of selected infusion rates through conduit means to the patient, comprising the steps of:

(a) diverting and accumulating a predetermined amount of the upstream flow from the flow controller for use as a test pulse of fluid;

(b) delivering said test pulse through the conduit means to the patient from a point downstream from the flow controller, with the test pulse being distinguishable from the normal delivery pattern and with the test pulse creating a pressure wave response in the conduit means; and

(c) monitoring at least a portion of the pressure wave response in the conduit means to detect whether the fluid is being improperly supplied by the conduit means to the patient.

45. A method for detecting whether a fluid is being improperly supplied to a patient by conduit means from a flow controller which infuses fluid in a normal delivery pattern at any of a plurality of selected infusion rates through conduit means to the patient, comprising:

(a) diverting and accumulating a predetermined volume of the upstream flow from the flow controller for use as a test pulse;

(b) delivering said test pulse through the conduit means to the patient, with the test pulse being distinguishable from the normal delivery pattern and with the test pulse creating a pressure wave response in the conduit means;

(c) determining the area between a base line and at least a portion of a pressure versus time curve representing the pressure wave response; and

(d)using the magnitude of said area to detect whether the fluid is being improperly supplied by the conduit means to the patient.

46. A method for detecting whether a fluid is being improperly supplied to a patient by conduit means from a flow controller which infuses fluid in a normal delivery pattern at any of a plurality of selected infusion rates through conduit means to the patient, comprising the steps of:

(a) diverting at least a portion of the upstream flow of fluid from the flow controller prior to delivery of a fluid test pulse;

(b) delivering said test pulse through the conduit means to the patient at a point downstream from the flow controller, said test pulse being distinguishable from the normal delivery pattern of the flow controller and said test pulse creating a pressure wave response in the conduit means; and

(c) monitoring at least a portion of the pressure wave response in the conduit means to detect whether the fluid is being improperly supplied by the conduit means to the patient.

48. A method according to claim 46 or 47, further comprising the step of accumulating a predetermined volume of said fluid for use as the test pulse.

49. A method according to claim 46 or 47, further comprising the step of providing reduced fluid flow or no fluid flow prior to delivery of said test pulse to permit the base line to stabilize prior to delivery of said test pulse.

50. A method according to claim 46 or 47, wherein said diverting step diverts substantially all of the fluid flowing from the flow controller prior to delivering a test pulse.

51. A method according to claim 46 or 47, wherein said diverting step diverts said fluid flowing from the flow controller prior to and during delivery of said test pulse.

52. A method according to claim 50, wherein said diverting step diverts said fluid flowing from the flow controller prior to and during delivery of said test pulse.

53. A method according to claim 46 or 47, wherein said test pulse delivery step alters the normal delivery pattern by delivering a test pulse at an increased flow rate and providing a period of reduced or no flow prior to and following delivery of said test pulse.

47. A method for detecting whether a fluid is being improperly supplied to a patient by conduit means from a flow controller which infuses fluid in a normal delivery pattern at any of a plurality of selected infusion rates through conduit means to the patient, comprising the steps of:

(a) diverting at least a portion of the upstream flow of fluid from the flow controller prior to delivery of a fluid test pulse;

(b) delivering said test pulse through the conduit means to the patient at a point downstream from the flow controller, said test pulse being distinguishable from the normal delivery pattern of the flow controller and said test pulse creating a pressure wave response in the conduit means;

(c) determining the area between a base line and at least a portion of a pressure versus time curve representing the pressure wave response; and

(d) monitoring the magnitude of said area to detect whether the fluid is being improperly supplied by the conduit means to the patient.