Method for assessment of cerebrovascular regulation

• US 10,244,978 B2
• Filed: 06/24/2016
• Issued: 04/02/2019
• Est. Priority Date: 10/19/2015
• Status: Active Grant

• Current Assignee: Brain Check Medical, LLC
• Original Assignee: Brain Check Medical, LLC
• Inventors: Borgos, John A., Richmond, Isabelle
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US15/191,738
• Publication Number:
  US 20170105671A1
• Time in Patent Office: 1,012 Days
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/02108 from analysis of pulse wave characteristics
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/031 Intracranial pressure
• 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 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/6814 Head

Abstract

A system device and method are presented for determining if cerebral blood flow autoregulation functionality has been compromised in a patient. The system includes sensors for detecting and measuring at least two physiological parameters such as oxygenation and blood pressure. The system analyzes these measurements and presents them as waveforms. Episodes of interest in each waveform are determined and compared. Any time lag between the occurrence of episodes of interest in each waveform is established and accounted for. Where there is correspondence between episodes of interest in each waveform then impairment of cerebral blood flow autoregulation is likely.

Claims

1. A system for detecting and diagnosing potential dysfunction of cerebral autoregulation (CAR) comprising:

a headset, the headset containing;

an oximetry sensor, the oximetry sensor configured to detect and measure cerebral oxygen concentration and provide cerebral oxygen concentration measurements over a period of time in the form of cerebral oxygen concentration signals; and

a pressure sensor, the pressure sensor configured to detect and measure arterial blood pressure and provide arterial blood pressure measurements over the period of time in the form of arterial blood pressure signals,

the headset is configured such that when placed on a patient'"'"'s head the oximetry sensor is positioned over the patient'"'"'s forehead and the pressure sensor is positioned over a region of the patient'"'"'s head corresponding to the location of the patient'"'"'s superficial temporal artery;

the headset in communication with;

a signal processor, the signal processor configured to receive cerebral oxygen concentration signals and arterial blood pressure signals and generate a cross-correlation result representative of lead time between the cerebral oxygen concentration signals and the arterial blood pressure signals;

to identify and define a cerebral oxygen concentration waveform based on the cerebral oxygen concentration signals and an arterial blood pressure waveform based on the arterial blood pressure signals, wherein each waveform comprises a beginning minimum value, a rising segment, a maximum value and a decreasing segment, the rising segment being an episode of interest; and

to determine a dysfunction of CAR when the cross-correlation result indicates a similarity of pattern between episodes of interest in the waveforms; and

a display, the display configured to display the cerebral oxygen concentration waveform and the arterial blood pressure waveform, the display also configured to display the cross-correlation result and the dysfunction of CAR.

2. The system of claim 1, wherein normal CAR function is displayed when the cross-correlation result indicates no similarity of pattern between episodes of interest in the waveforms.

3. The system of claim 2 wherein the cross-correlation function is defined as the sum of the products of the pressure measurements and time delayed oximetry measurements over a period corresponding to each episode of interest.

4. The system of claim 2 wherein the oximetry sensor comprises an array of near infrared spectroscopy optical elements.

5. The system of claim 2 wherein the pressure sensor comprises an applanation tonometry pressure sensor.

6. The system of claim 2 wherein the oximetry sensor and the pressure sensor are in wireless communication with the signal processor.

7. The system of claim 2 wherein the signal processor comprises at least one bandpass filter through which at least one of the cerebral oxygen concentration signals and arterial blood pressure signals are passed before the signal processor generates the cross-correlation result.

8. A system for detecting dysfunction of cerebral autoregulation (CAR) comprising:

a headset, the headset containing;

an oximetry sensor, the oximetry sensor configured to detect and measure cerebral oxygen concentration and provide cerebral oxygen concentration measurements over a period of time in the form of cerebral oxygen concentration signals; and

a pressure sensor, the pressure sensor configured to detect and measure arterial blood pressure and provide arterial blood pressure measurements over the period of time in the form of arterial blood pressure signals,

the headset is configured such that when placed on a patient'"'"'s head the oximetry sensor is positioned over the patient'"'"'s forehead and the pressure sensor is positioned over a region of the patient'"'"'s head corresponding to the location of the patient'"'"'s superficial temporal artery;

the headset in communication with;

a signal processor, the signal processor configured to receive cerebral oxygen concentration signals and arterial blood pressure signals, identify and define a series of Episodes of Interest (EOI) in a series of arterial blood pressure signal waveforms, each waveform comprising a beginning minimum value, a rising segment, a maximum value and a decreasing segment, the rising segment being an EOI, and for each EOI generate a result representative of lead time between the cerebral oxygen concentration signal and the arterial blood pressure signal to produce a series of EOI lead time results; and

a display, the display configured to display the series of EOI lead time results during the measurement period of time.

9. The system of claim 8, wherein the EOI lead time results are determined using a cross correlation function over each separate EOI to obtain optimal lead time estimates for each of the EOIs.

10. The system of claim 8, wherein the series of EOI lead times is determined by calculating the lead time between the beginning minimum value of the arterial blood pressure EOI and the beginning minimum value of the closest cerebral oxygen EOI.