Apparatuses, systems and methods for extravasation detection

• US 7,047,058 B1
• Filed: 01/30/2002
• Issued: 05/16/2006
• Est. Priority Date: 02/06/2001
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Hirschman, Alan D., Dvorsky, James E., Bouton, Chad E.
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US10/060,561
• Time in Patent Office: 1,567 Days
• Field of Search: 600/407, 600/300, 600/437, 600/431, 600/458, 600/438, 128/897, 128/898, 128/DIG.13, 604/503, 604/65, 604/66
• US Class Current: 600/407
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/0507 using microwaves or terahertz waves
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 5/007 for contrast media
• 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: G01N 22/00 Investigating or analysing materials by the use of microwaves or radio waves, i.e. electromagnetic waves with a wavelength of one millimetre or more G01N3/00 - G01N17/00, G01N24/00 take precedence
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

An apparatus for the detection of extravasation in an imaging procedure includes at least a first source of energy to supply imaging energy to tissue in the vicinity of a site and at least a first sensor to measure a signal resulting from the energy supplied to the tissue by the first imaging energy source. In preferred embodiment, the energy may be one of X-ray, gamma ray or ultrasound energy.

Claims

1. An apparatus for the detection of extravasation, comprising:

at least a first energy source adapted to supply X-ray energy or gamma ray energy to tissue in the vicinity of a site along a path of potential extravasation of fluid from a blood vessel into which fluid is injected;

at least a first sensor to measure a signal resulting from the energy supplied to the tissue by the first energy source, the signal being proportional to the X-ray energy or gamma ray energy transformed, reflected, scattered or absorbed by an extravasated fluid present in the vicinity of the site; and

an indicator to provide an indication of the occurrence of extravasation.

2. The apparatus of claim 1 wherein the at least a first energy source and the at least a first sensor are connected by a frame member to fix the geometry of the at least a first energy source and the at least a first sensor about the site so the X-ray energy from the at least a first energy source passes through tissue in the vicinity of the site to the at least a first sensor.

3. The apparatus of claim 1 wherein the indicator comprises an alarm to indicate the occurrence of extravasation.

4. The apparatus of claim 3 wherein an alarm is indicated if the energy measured at the at least a first sensor falls below a threshold value.

5. The apparatus of claim 1 wherein the first energy source and the first sensor do not contact the skin of a patient.

6. The apparatus of claim 1 wherein the first energy source and the first sensor are positioned in a manner so that the vicinity of an injection site is available for palpation and visible for visual inspection.

7. An apparatus for the detection of extravasation, comprising:

at least a first energy source adapted to supply ultrasonic energy to tissue in the vicinity of a site along a path of potential extravasation of fluid from a blood vessel into which fluid is injected;

at least a first sensor to measure a signal resulting from the energy supplied to the tissue by the first energy source, the signal being proportional to the ultrasonic energy reflected, scattered or absorbed by an extravasated fluid present in the vicinity of the site; and

an indicator to provide an indication of the occurrence of extravasation.

8. The apparatus of claim 7, wherein the indicator comprises an alarm system to indicate the occurrence of extravasation.

9. The apparatus of claim 8 wherein the occurrence of extravasation is determined by comparing the energy measured at the at least a first sensor to a threshold value.

10. The apparatus of claim 7 wherein the first energy source and the first sensor do not contact the skin of a patient.

11. The apparatus of claim 7 wherein the first energy source and the first sensor are positioned in a manner so that the vicinity of an injection site is available for palpation and visible for visual inspection.

12. A method for detecting extravasation in an injection procedure, comprising:

supplying at least one of X-ray energy, gamma ray energy or ultrasonic energy to tissue in the vicinity of a site along a path of potential extravasation of fluid from a blood vessel into which fluid is injected;

measuring a signal resulting from the energy supplied to the tissue, the measured signal being proportional to the X-ray energy, gamma ray energy or ultrasonic energy transformed, reflected, scattered or absorbed by an extravasated fluid present in the vicinity of the site; and

analyzing the measured signal to determine whether an extravasated fluid is present in the vicinity of the site.

13. The method of claim 12, further comprising:

measuring a baseline signal before beginning the injection procedure.

14. The method of claim 13, further comprising:

comparing the measured signal to the baseline signal to determine whether an extravasated fluid is present in the vicinity of the site.

15. An injection system comprising:

a powered injector; and

an extravasation detection apparatus comprising;

at least one source of energy to supply at least one of x-ray energy, gamma ray energy, or ultrasonic energy to tissue in the vicinity of a site along a path of potential extravasation of fluid from a blood vessel into which fluid is injected;

at least one sensor to measure a signal resulting from the energy supplied to the tissue in the vicinity of the site, the signal being proportional to the x-ray energy, gamma ray energy or ultrasonic energy transformed, reflected, scattered or absorbed by an extravasated fluid present in the vicinity of the site; and

an indicator to provide an indication of the occurrence of extravasation.

16. The apparatus of claim 15, wherein the indicator comprises an alarm in communication with the extravasation detection apparatus to indicate occurrence of extravasation.

17. The apparatus of claim 16 wherein the alarm indicates extravasation based upon comparing the signal to a threshold value.

18. The apparatus of claim 15 wherein the injector and the extravasation detection apparatus are in communicative connection so that an injection procedure is stopped by the injector upon detection of extravasation.

19. The injection system of claim 15 wherein the energy source and the sensor do not contact the skin of a patient.

20. The injection system of claim 15 wherein the energy source and the sensor are positioned in a manner so that the vicinity of an injection site is available for palpation and visible for visual inspection.

21. A method for detecting extravasation in an injection procedure, comprising:

supplying x-ray energy, gamma ray energy or ultrasonic energy to tissue in the vicinity of an injection site along a path of potential fluid extravasation from a blood vessel into which contrast medium is injected;

measuring a baseline signal resulting from the energy supplied to the tissue;

mixing an additive with a contrast medium;

injecting the contrast medium containing the additive through the injection site into the blood vessel;

supplying x-ray energy, gamma ray energy or ultrasonic energy to tissue in the vicinity of the injection site;

measuring a signal resulting from the energy supplied to the tissue, the measured signal being proportional to the X-ray energy, gamma ray energy or ultrasonic energy transformed, reflected, scattered or absorbed by extravasated contrast medium containing the additive present in the vicinity of the site, the additive being adapted to affect the signal;

detecting whether an extravasation has occurred by comparing the measured signal to the baseline signal to determine whether extravasated contrast medium containing the additive is present in the vicinity of the site; and

indicating that an extravasation has occurred.

22. A method of detecting extravasation of an injection medium, comprising:

supplying x-ray energy, gamma ray energy or ultrasonic energy to tissue in the vicinity of a site along a path of potential extravasation of fluid from a blood vessel into which injection medium is injected, the energy being selected so that the injection medium will reflect, scatter or absorb the energy;

measuring a signal proportional to the amount of energy reflected, scattered or absorbed;

detecting whether an extravasation has occurred by analyzing the measured signal to determine whether extravasated medium is present in the vicinity of the site; and

indicating that an extravasation has occurred.

23. The method of claim 22, further comprising:

measuring a baseline signal corresponding to a situation in which there is no extravasation.

24. The method of claim 23, further comprising:

comparing the measured signal to the baseline signal to determine whether an extravasated fluid is present in the vicinity of the site.

25. An injection system for delivering fluid to a patient during an injection procedure, the injection system comprising:

an injector; and

an extravasation detection system in communication with the injector, the extravasation detection system comprising;

an energy source adapted to supply at least one of x-ray energy, gamma ray energy, or ultrasonic energy to tissue of the patient in the vicinity of a fluid injection site;

a sensor adapted to measure a signal resulting from the energy supplied to the tissue in the vicinity of the fluid injection site, the signal being proportional to the x-ray energy, gamma ray energy or ultrasonic energy transformed reflected, scattered or absorbed by an extravasated fluid present in the vicinity of the fluid injection site; and

an alarm to provide an indication of the occurrence of extravasation;

wherein the alarm is activated when an extravasated fluid is detected by the extravasation detection system.

26. A method for detecting extravasation during a fluid injection procedure, comprising;

supplying x-ray energy, gamma ray energy or ultrasonic energy to tissue in the vicinity of a proposed fluid injection site;

measuring a baseline signal resulting from the energy supplied to the tissue;

commencing the fluid injection procedure;

supplying x-ray energy, gamma ray energy or ultrasonic energy to tissue in the vicinity of the fluid injection site;

measuring a signal resulting from the energy supplied to the tissue, the measured signal being proportional to the X-ray energy, gamma ray energy or ultrasonic energy transformed, reflected, scattered or absorbed by an extravasated fluid present in the vicinity of the site; and

comparing the measured signal to the baseline signal to determine whether an extravasated fluid is present in the vicinity of the site.

27. The method of claim 26, further comprising:

terminating the injection procedure if an extravasated fluid is present.