Extravasation detection technique

• US RE38,879 E1
• Filed: 09/07/2001
• Issued: 11/15/2005
• Est. Priority Date: 01/14/1994
• Status: Expired due to Term

• Current Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Original Assignee: E-Z-EM Incorporated (Bracco SPA)
• Inventors: Goodman, Jack, Zimmet, Arthur
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US09/948,277
• Time in Patent Office: 1,530 Days
• Field of Search: 600/547, 600/372, 600/382, 600/384, 600/386, 600/393, 600/396, 600/506, 604/503, 604/506, 604/507, 604/508, 604 65- 67, 604/245, 340/573, 128/DIG.13
• US Class Current: 600/547
• CPC Class Codes: N/A

Abstract

The technique for detecting extravasation during the injection of fluid into a patient involves the establishment of a baseline representing impedance at the zone of the injection prior to the injection starting. Extravasation is signaled when at least two characteristics appear. First is that the impedance varies from the baseline more than a predetermined amount in more than a predetermined number of discreet time slots called epochs herein. Second is that, the rate of change of the impedance, which is called the slope herein, is consistently greater than a predetermined amount.

Claims

1. The method of detecting extravasation that may occur when a needle is inserted into a patient for the purpose of delivering fluid into the patient'"'"'s vascular system comprising the steps of:

prior to the delivery of fluid, establishing an impedance baseline for patient tissue impedance near the tip of the needle;

determining an impedance slope value based on deviations from said baseline for each of a plurality of time based epochs during the delivery of fluid, and

signaling extravasation when said slope values are outside a first predetermined threshold with a consistency that meets a predetermined consistency criterion.

2. The method of claim 1 wherein:

said predetermined consistency criterion includes the combination of (a) a first predetermined number of out of threshold slopes, and (b) a second predetermined number of consecutive out of threshold slopes subsequent to the infusion of a predetermined volume of said fluid.

3. The method of claim 2 wherein said first predetermined number is of consecutive out of threshold slopes.

4. The method of claim 2 wherein said first predetermined number is inversely proportional to the rate at which fluid is delivered.

5. The method of claim 2 wherein said first predetermined number is greater than said second predetermined number.

6. The method of claim 2 wherein said step of determining a slope value comprises determining a best fit slope value over a predetermined number of epochs adjacent to the epoch for which said slope value is determined.

7. The method of claim 2 wherein said second predetermined number of out of threshold slopes commences after said first predetermined number of out of threshold slopes is determined.

8. The method of claim 2 wherein:

a sliding window of a plurality of epochs is employed to provide a base for the slope value determination, each slope value determination being based on a set of epochs that include epochs on which the preceding slope value determination was made.

9. The method of claim 1 wherein said step of determining a slope value comprises determining a best fit slope value over a predetermined number of epochs adjacent to the epoch for which said slope value is determined.

10. The method of claim 1 wherein:

a sliding window of a plurality of epochs is employed to provide a base for the slope value determination, each slope value determination being based on a set of epochs that include epochs on which the preceding slope value determination was made.

11. The method of claim 1 further comprising the steps of:

establishing said impedance baseline based on a first sliding window of epochs to provide an epoch impedance baseline,

establishing a noise exclusion gate around said epoch impedance baseline, and

during the delivery of fluid, providing a count of the number of consecutive epoch impedance averages which lie outside said gate,

said step of signaling extravasation further requiring that said count of consecutive epoch impedance averages outside said gate exceeds a first value.

12. The method of claim 11 further comprising the steps of:

prior to said step of establishing an epoch impedance baseline, determining that there are a predetermined number of successive epochs each of which have an impedance average within a predetermined window.

13. The method of detecting extravasation that may occur when a needle is inserted into a patient for the purpose of introducing fluid into the patient'"'"'s vascular system comprising the steps of:

prior to the delivery of fluid, establishing an epoch impedance baseline for patient tissue impedance near the tip of the needle based on a first sliding window of epochs,

establishing a noise exclusion gate around said epoch impedance baseline,

during the delivery of fluid, counting the number of consecutive impedance averages outside of said gate to provide a first count,

establishing a second sliding window of epochs,

determining an impedance slope for epoch impedance values over each of said second sliding windows of epochs,

counting the number of consecutive ones of said impedance slopes having a value outside of a predetermined range to provide a second count,

counting the total number of said impedance slopes having a value outside of said predetermined range to provide a third count,

signaling extravasation when (a) said first count is greater than a first predetermined number, (b) said second count is greater than a second predetermined number, and (c) said third count is greater than a third predetermined number.

14. The method of claim 13 further comprising the steps of:

counting the number of consecutive ones of said impedance slopes adjacent to said third predetermined count having a value outside of said predetermined range to provide a fourth count, and

wherein said step of signaling extravasation further requires that said fourth count be greater than a fourth predetermined number.

15. The method of claim 14 further comprising the steps of:

counting the number of consecutive ones of said impedance slopes having a value inside of said predetermined range, and

resetting to said steps of counting to provide said first count.

16. The method of claim 14 wherein said first predetermined number is a count of consecutive averages outside said noise exclusion gate and wherein said first count is reset to zero when an epoch average falls within said noise exclusion gate.

17. The method of claim 13 further comprising the steps of:

counting the number of consecutive ones of said impedance slopes having a value inside of said predetermined range, and

resetting to said steps of counting to provide said first count.

18. The method of claim 17 wherein said first predetermined number is a count of consecutive averages outside said noise exclusion gate and wherein said first count is reset to zero when an epoch average falls within said noise exclusion gate.

19. The method of claim 13 wherein said second and third predetermined numbers are inversely proportional to the rate at which fluid is delivered.

20. The method of claim 19 wherein said third predetermined number is greater than said second predetermined number.

21. The method of claim 13 wherein said second sliding windows include epochs that contribute to said first count.

22. The method of claim 13 wherein said first predetermined number is a count of consecutive averages outside said noise exclusion gate and wherein said first count is reset to zero when an epoch average falls within said noise exclusion gate.

23. A non-invasive method of detecting extravasation when fluid is delivered into a patient'"'"'s vascular system, comprising:

a) providing first and second electrodes;

the electrodes being separated from each other to encompass the vicinity around an end of a channel inserted in the patient'"'"'s vascular system for delivering fluid into the vascular system;

b) the first and second electrodes defining a measuring zone;

the measuring zone being sized to detect extravasation in the measuring zone;

c) providing third and fourth electrodes to induce a signal between the first and second electrodes;

said signal being a function of tissue impedance in the measuring zone; and

d) ascertaining if an extravasation has occurred by measuring changes in impedance within the measuring zone.

24. The method of claim 23, further comprising the step of energizing the third and fourth electrodes to induce the signal between the first and second electrodes.

25. The method of claim 24, further comprising the step of positioning a hydrogel material between the patient'"'"'s skin and the electrodes.

26. The method of claim 23, further comprising the step of energizing the third and fourth electrodes with a current in the micro ampere range at a frequency of about 20 kilo-hertz.

27. The method of claim 23, further comprising the step of applying a hydrogel material on the electrodes.

28. The method of claim 23, further comprising the step of affixing the electrodes to the patient'"'"'s skin.

29. The method of claim 23, further comprising the step of positioning the first and second electrodes between the third and fourth electrodes.

30. The method of claim 23, further comprising the step of deploying the first, second, third and fourth electrodes along a base, said base adapted to be affixed to the skin of a patient.

31. The method of claim 23, further comprising the step of providing, for each of the electrodes, a coupling region adapted for connection to a clip having electrical contacts.

32. A non-invasive method of detecting extravasation when fluid is delivered into a patient'"'"'s vascular system, comprising:

a) providing first and second electrodes and third and fourth electrodes, said first and second electrodes being spaced from one another on either side of a center line, said first and second electrodes defining a measuring zone, said measuring zone being shaped and dimensioned to encompass within said zone an end of a channel inserted in a patient'"'"'s vascular system for delivering fluid into the vascular system, said zone being sized to detect extravasation in the measuring zone and long enough to facilitate placement of the end of the channel within the measurement zone;

each of said third and fourth electrodes being outward, relative to said center line,

b) energizing said third and fourth electrodes to provide a field which induces a signal in said first and second electrodes that is a function of tissue impedance in said measuring zone, and

c) ascertaining if an extravasation has occurred by measuring changes in impedance within the measuring zone.

33. The method of claim 32, further comprising the step of energizing the third and fourth electrodes to induce the signal between the first and second electrodes.

34. The method of claim 33, further comprising the step of positioning a hdyrogel material between the patient'"'"'s skin and the electrodes.

35. The method of claim 32, further comprising the step of energizing the third and fourth electrodes with a current in the micro ampere range at a frequency of about 1 kilo-hertz to 20 kilo-hertz.

36. The method of claim 32, further comprising the step of applying a hydrogel material on the electrodes.

37. The method of claim 32, further comprising the step of affixing the electrodes to the patient'"'"'s skin.

38. The method of claims 32, further comprising the step of positioning the first and second electrodes between the third and fourth electrodes.

39. The method of claims 32, further comprising the step of deploying the first, second, third and fourth electrodes along a base, said base adapted to be affixed to the skin of a patient.

40. The method of claims 32, further comprising the step of providing, for each of the electrodes, a coupling region adapted for connection to a clip having electrical contacts.

41. A non-invasive method of detecting extravasation when fluid is delivered into a patient'"'"'s vascular system, comprising:

a) providing first and second electrodes;

the electrodes being separated from each other to encompass the vicinity around an end of a channel inserted in the patient'"'"'s vascular system for delivering fluid into the vascular system;

b) the first and second electrodes defining a measuring zone;

the measuring zone being sized to detect extravasation in the measuring zone;

c) providing third and fourth electrodes to induce a signal between the first and second electrodes;

said signal being a function of tissue impedance in the measuring zone;

d) ascertaining if an extravasation has occurred by measuring changes in impedance within the measuring zone; and

e) wherein the first, second, third and fourth electrodes are substantially the same length.

42. A non-invasive method of detecting extravasation when fluid is delivered into a patient'"'"'s vascular system, comprising:

providing first and second electrodes;

the electrodes being separated from each other to encompass the vicinity around an end of a channel inserted in the patient'"'"'s vascular system for delivering fluid into the vascular system;

a) the first and second electrodes defining a measuring zone;

the measuring zone being sized to detect extravasation in the measuring zone;

b) providing third and fourth electrodes to induce a signal between the first and second electrodes;

said signal being a function of tissue impedance in the measuring zone;

c) ascertaining if an extravasation has occurred by measuring changes in impedance within the measuring zone; and

d) wherein the first, second, third and fourth electrodes are about 3 inches in length and about 3/16^th of an inch wide.

43. A non-invasive method of detecting extravasation when fluid is delivered into a patient'"'"'s vascular system, comprising:

a) providing first and second electrodes;

the electrodes being separated from each other to encompass the vicinity around an end of a channel inserted in the patient'"'"'s vascular system for delivering fluid into the vascular system;

b) the first and second electrodes defining a measuring zone;

the measuring zone being sized to detect extravasation in the measuring zone;

c) providing third and fourth electrodes to induce a signal between the first and second electrodes;

said signal being a function of tissue impedance in the measuring zone;

d) ascertaining if an extravasation has occurred by measuring changes in impedance within the measuring zone; and

e) wherein the first, second, third and fourth electrodes are silver/silver chloride strips.

44. A non-invasive method of detecting extravasation when fluid is delivered into a patient'"'"'s vascular system, comprising:

a) providing first and second electrodes;

the electrodes being separated from each other to encompass the vicinity around an end of a channel inserted in the patient'"'"'s vascular system for delivering fluid into the vascular system;

b) the first and second electrodes defining a measuring zone;

the measuring zone being sized to detect extravasation in the measuring zone;

c) providing third and fourth electrodes to induce a signal between the first and second electrodes;

said signal being a function of tissue impedance in the measuring zone;

d) ascertaining if an extravasation has occurred by measuring changes in impedance within the measuring zone; and

e) wherein the first and second electrodes are parallel relative to each other.

45. A non-invasive method of detecting extravasation when fluid is delivered into a patient'"'"'s vascular system, comprising:

a) providing first and second electrodes;

the electrodes being separated from each other to encompass the vicinity around an end of a channel inserted in the patient'"'"'s vascular system for delivering fluid into the vascular system;

b) the first and second electrodes defining a measuring zone;

the measuring zone being sized to detect extravasation in the measuring zone;

c) providing third and fourth electrodes to induce a signal between the first and second electrodes;

said signal being a function of tissue impedance in the measuring zone;

d) ascertaining if an extravasation has occurred by measuring changes in impedance within the measuring zone; and

e) wherein the fourth and fifth electrodes are parallel to each other.