Apparatus and method for detecting fluid extravasation

• US 9,289,550 B1
• Filed: 03/20/2006
• Issued: 03/22/2016
• Est. Priority Date: 02/06/2001
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Dvorsky, James E., Bouton, Chad E., Hirschman, Alan D.
• Primary Examiner(s): Le, Long V
• Assistant Examiner(s): Bor, Helene
• Application Number:
  US11/385,448
• Time in Patent Office: 3,655 Days
• US Class Current: 1/1
• 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 of an injection fluid infused into a tissue during an imaging procedure is disclosed. The apparatus includes at least a first source of energy to supply an X-ray or gamma ray imaging energy to tissue in the vicinity of a site and at least a first sensor to measure an energy signal resulting from the energy supplied to the tissue by the first imaging energy source, and circuitry configured to compare the energy signal detected by the first sensor to a baseline measurement and provide an alert that extravasation is occurring.

Claims

1. An apparatus for detecting extravasation of an injection fluid infused into tissue, comprising:

a first energy source emitting an energy, wherein the first energy source comprises a source of X-ray energy or gamma ray energy;

a first sensor and at least a second sensor,

wherein the first sensor detecting a resultant emitted energy after transmission, transformation, scattering, attenuation or absorption of the emitted energy supplied to the tissue by the first energy source, wherein a level of energy detected by the first sensor is related to extravasation, and

wherein the at least a second sensor detecting the resultant emitted energy after transmission, transformation, scattering, attenuation or absorption of the emitted energy supplied to the tissue by the first energy source, wherein the level of energy detected by the second sensor is related to extravasation; and

circuitry configured to compare the level of energy detected by the first sensor and the at least a second sensor to a baseline measurement, wherein the circuitry detects extravasation in real time with fluid injection when a threshold value of change in activity from the baseline measurement is detected in the level of energy detected by the at least a first sensor or the threshold value of change in activity from the baseline measurement is detected in the level of energy detected by the at least a second sensor and provides an alert that extravasation is occurring.

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

3. The apparatus of claim 1 wherein the first energy source, the first sensor, and the at least a second sensor do not contact the skin of a patient.

4. The apparatus of claim 1, wherein the energy is selected to reflect, scatter or absorb when transmitted through the tissue or the injection medium.

5. The apparatus of claim 1 wherein the at least a second sensor is capable of detecting high-energy photons.

6. The apparatus of claim 1 wherein the at least a second sensor is a high-energy photonic detector, photo multiplier tube, solid-state detector or gamma ray detector.

7. The apparatus of claim 1, further including an imaging apparatus to obtain an image of a region of interest.

8. A method for detecting extravasation, comprising:

injecting at least an injection medium into a patient at a site;

emitting a first energy from a first energy source comprising a source of X-ray energy or gamma ray energy to tissue in a vicinity of the site;

measuring a first energy signal with a first sensor based on the first energy supplied to the tissue, wherein the first energy signal is related to a first energy reflected, scattered or absorbed by an extravasated fluid;

measuring an at least a second energy signal with an at least a second sensor based on the first energy supplied to the tissue, wherein the at least a second energy signal is related to the first energy reflected, scattered or absorbed by the extravasated fluid; and

comparing the first energy signal and the at least a second energy signal to a baseline measurement to detect extravasation in real time with injection of the injection medium.

9. The method of claim 8 further including supplying imaging energy from an imaging energy source to a region of interest of the patient to create an image.

10. The method of claim 9 in which the first energy and the imaging energy are substantially the same type.

11. The method of claim 8 wherein the injection includes an injection medium that transforms, reflects, scatters or absorbs the first energy supplied to the tissue.

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

a first energy source to supply a first energy to tissue in a vicinity of a first site, wherein the first energy comprises x-ray energy or gamma ray energy;

at least a first sensor to measure a resultant first energy signal resulting from the first energy supplied to the tissue by the first energy source at a first time;

at least a second sensor to measure a resultant second energy signal resulting from the first energy supplied to the tissue by the first energy source at the first time; and

circuitry configured to compare the resultant first energy signal and the resultant second energy signal to a baseline measurement, wherein the circuitry detects extravasation in real time with introduction of a fluid when a threshold value of change in activity from the baseline measurement is detected in the level of the resultant first energy signal detected by the first sensor or the threshold value of change in activity from the baseline measurement is detected in the level of the resultant second energy signal detected by the at least a second sensor and provides an alert that extravasation is occurring,

wherein the resultant first energy signal is related to a first energy reflected, scattered or absorbed by an extravasated fluid; and

wherein the resultant second energy signal is related to the first energy reflected, scattered or absorbed by the extravasated fluid.