Non-invasive brain water monitoring device for cerebral edema and cerebral autoregulation monitoring system and method

• US 10,499,838 B2
• Filed: 04/23/2016
• Issued: 12/10/2019
• Est. Priority Date: 04/24/2015
• Status: Active Grant

• Current Assignee: Drexel University
• Original Assignee: Drexel University
• Inventors: Izzetoglu, Meltem, Du, Juan, Ben Dor, Baruch
• Primary Examiner(s): McCrosky, David J.
• Assistant Examiner(s): Shah, Jay B
• Application Number:
  US15/136,899
• Publication Number:
  US 20160310054A1
• Time in Patent Office: 1,326 Days
• Field of Search: None
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/14553 specially adapted for cerebral tissue
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6833 Adhesive patches

Abstract

A system, device and methods for quantitatively monitoring and evaluating changes in water and hemoglobin content in the brain in a non-invasive manner are provided. The system may be used for real-time detection and monitoring of brain edema and/or for an assessment of cerebral autoregulation.

Claims

1. A portable, point-of-care, near-infrared-based imaging device for quantitatively monitoring and evaluating changes in water and hemoglobin content in a patient'"'"'s brain, comprising:

a pair of separate and identical probes, one of said probes being adapted for non-invasive placement against a left side of a forehead of a patient and the other one of said probes being adapted for separate non-invasive placement against a right side of the forehead of the patient, each of said probes having a light emitting diode (LED) light source mounted thereon for separately and sequentially irradiating light at three different pre-determined wavelengths between 600 and 1100 nm, each of said probes having a pair of photo detectors mounted thereon at different predetermined distances from said light source for measuring an amount of light reflected during irradiation of light at each wavelength, and each of said probes having a temperature sensor mounted thereon; and

at least one electronic processing unit for receiving measurements from said probes of light reflected for each of the wavelengths and temperature and for using the measurements to determine a change in water content, a change in oxygenated hemoglobin, and a change of deoxygenated hemoglobin separately for each of the right and left hemispheres of the patient'"'"'s brain;

wherein each of said probes includes a flexible circuit board able to flex to match a contour of a patient'"'"'s forehead, a cushioning material covering the flexible circuit board, and an adhesive for securing the probe in a non-invasive manner on the patient'"'"'s forehead;

wherein the three different predetermined wavelengths include a wavelength of 730 nm for use in determining changes in deoxygenated hemoglobin content, a wavelength of 850 nm for use in determining changes in oxygenated hemoglobin content, and a wavelength of 940 or 960 nm for use in determining changes in water content;

wherein said at least one electronic processing unit is configured to control operation of the light sources such that light is emitted at only one wavelength at a time and such that light is emitted at each of the three wavelenghts in a sequential manner;

wherein said at least one electronic processing unit is configured to apply a modified Beer-Lambert law (MBLL) algorithm to determine relative changes in water, deoxygenated hemoglobin, and oxygenated hemoglobin over time based on changes of optical density detected for each of the three wavelengths;

wherein information of temperature, wavelength of light, light source to photo detector spacing, left and right hemisphere measurements and oxygen saturation is utilized by said algorithm to adjust the determination of relative changes in water, deoxygenated hemoglobin, and oxygenated hemoglobin; and

wherein said at least one electronic processing unit is configured to automatically identify re-positioning movements of the patient'"'"'s head based on changes in water content, changes in oxygenated hemoglobin content, and changes in deoxygenated hemoglobin content that exceed a pre-determined threshold within a pre-determined amount of time.

2. A method of quantitatively monitoring and evaluating changes in water and hemoglobin contents in a patient'"'"'s brain, comprising the steps of:

using the portable, point-of-care, near-infrared-based imaging device according to claim 1 by securing a first probe of the device in a non-invasive manner on a left forehead of a patient and separately securing a second probe of the device on a right forehead of the patient;

electronically controlling at least one light source mounted on each one of the probes to separately and sequentially irradiate light at three different pre-determined wavelengths between 600 and 1100 nm;

electronically controlling at least one photo detector mounted on each one of the probes at a predetermined distance from said at least one light source to measure an amount of light reflected detected by the at least one photo detector for each wavelength;

measuring temperature with a temperature sensor mounted on each one of the probes;

applying an algorithm with at least one electronic processing unit in communication with the probes to measurements of light reflection for each of the wavelengths and temperature; and

determining and displaying on a display a change in water content, a change in oxygenated hemoglobin, and a change of deoxygenated hemoglobin separately for each of the right and left hemispheres of the patient'"'"'s brain;

wherein the three different predetermined wavelengths include a wavelength of 730 nm for use in determining changes in deoxygenated hemoglobin content, a wavelength of 850 nm for use in determining changes in oxygenated hemoglobin content, and a wavelength of 940 nm for use in determining changes in water content;

wherein said step of controlling the at least one light source includes causing the at least one light source to sequentially emit light only at a wavelength of 730 nm for a pre-determined period of time, to emit light only at a wavelength of 850 nm for a pre-determined period of time, and to emit light only at a wavelength of 940 nm for a pre-determined period of time followed by a period of no light emission before repeating the sequence;

wherein said algorithm applying step includes application of a modified Beer-Lambert law (MBLL) algorithm to determine relative changes in water, deoxygenated hemoglobin, and oxygenated hemoglobin over time based on changes of optical density detected for each of the three wavelengths, said algorithm applying step including the use of information of temperature, wavelength of light, light source to photo detector spacing, left and right hemisphere measurements, and oxygen saturation to adjust the determination of relative changes in water, deoxygenated hemoglobin, and oxygenated hemoglobin; and

wherein said algorithm applying step includes automatically identifying re-positioning movements of the patient'"'"'s head based on changes in water content, changes in oxygenated hemoglobin content, and changes in deoxygenated hemoglobin content that exceed a pre-determined threshold within a pre-determined amount of time.