MONITORING OF ACUTE STROKE PATIENTS

• US 20110201950A1
• Filed: 10/07/2009
• Published: 08/18/2011
• Est. Priority Date: 10/07/2008
• Status: Abandoned Application

• Current Assignee: Orsan Medical Technologies, Ltd.
• Original Assignee: Orsan Medical Technologies, Ltd.
• Inventors: Poupko, Ben Zion, Rappaport, Alon, Ben-Ari, Shlomi
• Application Number:
  US13/122,965
• Publication Number:
  US 20110201950A1
• Time in Patent Office: Days
• US Class Current: 600/506
• CPC Class Codes: A61B 2505/01 Emergency care
• 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 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61B 5/7242 using integration
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

A method of monitoring an acute stroke patient, comprising:

• a) obtaining signals of impedance plethysmography (IPG), photoplethysmography (PPG) or both, in the patient, at least once an hour, for at least six hours;
• b) processing the one or more signals to obtain one or more measures of cerebral hemodynamics of the patient;
• c) applying a rule about alerting or not alerting medical personnel based on any of values, amount of change, and direction and rate of change of the measures.

Claims

1. A method of monitoring an acute stroke patient, comprising:

a) obtaining signals of impedance plethysmography (IPG) and photoplethysmography (PPG) in the patient, at least once an hour, for at least six hours;

b) applying a same or substantially same algorithm to the IPG and PPG signals to obtain first and second measures, respectively, of cerebral hemodynamics of the patient;

c) finding a measure based on comparing the first and second measures; and

d) applying a rule about alerting or not alerting medical personnel based on any of values, amount of change, and direction and rate of change of the measure based on comparing the first and second measures;

wherein the first and second measures each use an effective rise time of a cardiac cycle of the respective signal, or each use an integral of the respective signal over an effective rise time.

2. A method according to claim 1, wherein measuring and applying the rule are done automatically without human intervention.

3. A method according to claim 1, also including performing medical tests or treatment or both, in response to the alerting of medical personnel.

4. A method according to claim 1, wherein the patient is an ischemic stroke patient.

5. A method according to claim 1, wherein the patient is a sub-arachnoid hemorrhage (SAH) patient.

6. A method according to claim 1, wherein the measures comprise an estimate of one or more of global, hemispheric and regional measures of cerebral blood flow (CBF), of cerebral blood volume (CBV), of mean transit time (MTT), and of time to peak (TTP), and mathematical functions of the foregoing parameters singly or in any combination.

7. A method according to claim 1, wherein the signals comprise at least a first signal obtained from a measurement primarily of the left side of the head, and a second signal obtained from a measurement primarily on the right side of the head that is substantially a mirror image of the first measurement, and processing comprises comparing the first and second signals.

8. A method according to claim 1, wherein the one or more signals comprise at least one signal obtained from an impedance measurement made substantially symmetrically or anti-symmetrically with respect to a bilateral symmetry plane of the patient'"'"'s head.

10. A method according to claim 1, wherein the effective rise time interval begins when the signal first reaches a fixed percentage of the full range of the signal, above a minimum value of the signal.

11. A method according to claim 1, wherein the effective rise time interval ends when the signal first reaches a fixed percentage of the full range of the signal, below a maximum value of the signal.

12. A method according to claim 1, wherein the effective rise time interval ends at a maximum slope of the signal, or at a first inflection point of the signal with positive third derivative, or at a first local maximum of the signal, after the beginning of the effective rise time interval.

13. A method according to claim 1, wherein processing the one or more signals comprises finding an integral of the signal over the effective rise time interval.

14. A method according to claim 13, wherein processing the one or more signals comprises comparing the integral of said signal over the effective rise time interval to an integral of said signal over an effective fall time interval of a cardiac cycle, or over a whole cardiac cycle.

15. A method according to claim 1, wherein processing the one or more signals comprises finding a curvature of the signal during the effective rise time interval.

16. A method according to claim 1, wherein processing comprises normalizing a signal to obtain a measure that does not depend on a degree of amplification of the signal.

17. A method according to claim 1, wherein processing comprises normalizing a time interval to a cardiac cycle period.

18. A method according to claim 1, also including obtaining an electrocardiogram (ECG) signal of the patient, wherein processing comprises using the ECG signal to calibrate the timing of a feature of an IPG or PPG signal in a cardiac cycle.

19. A method according to claim 1, wherein the measures comprise an estimate of cerebral blood flow, and medical personnel are alerted when the estimate of cerebral blood flow falls by a predetermined relative amount that is at least 10% of an initial value of the estimate of cerebral blood flow.

20. A method according to claim 19, wherein the predetermined relative amount is not more than 30% of an initial value of the estimate of cerebral blood flow.

21. A method according to claim 1, wherein the measures comprise an estimate of cerebral blood flow, and medical personnel are alerted when the estimate of cerebral blood flow increases by a predetermined relative or absolute amount.

22. A method according to claim 1, wherein the one or more signals comprise a signal obtained from a measurement made primarily of one side of the head, and processing comprises using at least said signal to find a measure that is an estimate of a hemispheric or regional cerebral hemodynamic parameter on the same side of the head, or on the opposite side of the head.

23. A method according to claim 22, wherein the hemispheric or regional cerebral hemodynamic parameter is on a side of the head in which clinical evidence indicates a stroke occurred.

25. A method according to claim 1, wherein a first one of the signals is obtained from a measurement made substantially symmetrically on the head with respect to the bilateral symmetry plane, and a second one of the signals is obtained from a measurement made primarily on one side of the head.

26. A method according to claim 1, wherein the signals are both obtained from measurements made primarily on a same side of the head.

28. A method of evaluating patients suspected of suffering from an acute stroke, the method comprising:

a) processing the signals of impedance plethysmography (IPG), photoplethysmography (PPG) or both, obtained from the patient, to obtain one or more measures of cerebral hemodynamics of the patient;

b) utilizing at least said measures to evaluate whether the patient suffered from an ischemic stroke for which the patient would be likely to benefit from thrombolytic therapy; and

c) monitoring the patient according to the method of any of the preceding claims, following (b).

30. A method according to claim 1, wherein processing the one or more signals comprises finding an average second derivative of the signal during the effective rise time interval.

9. (canceled)

24. (canceled)

27. (canceled)

29. A system for monitoring an acute stroke patient, comprising:

a) an electric current source;

b) at least two sensors adapted to be placed on the patient'"'"'s head, including at least one sensor comprising an IPG electrode structure adapted to pass current from the current source through the head to measure impedance, and at least one sensor comprising a PPG sensor powered by the current source;

c) a controller adapted to receive waveforms of IPG and PPG signals from the sensors, process the IPG and PPG waveforms using a same or substantially same algorithm to obtain a measure of effective rise interval of a cardiac cycle of the waveform, or an integral of the waveform over the effective rise interval of a cardiac cycle of the waveform, compare the effective rise time or integral over effective rise time for the IPG and PPG signals to obtain one or more measures of cerebral hemodynamics of the patient, and apply a rule to decide when to issue a medical alert based on the measures; and

d) an alert device, activated by the controller when the controller issues a medical alert, which alerts medical personnel when it is activated.

31. (canceled)