Electrophysiological Analysis System and Method

• US 20090326407A1
• Filed: 06/22/2006
• Published: 12/31/2009
• Est. Priority Date: 06/22/2005
• Status: Active Grant

• Current Assignee: Impeto Medical Incorporated
• Original Assignee: Annick Nicole Lydie Tournefier, Nicolas Boquet, Philippe Blanchard
• Inventors: Tournefier, Annick Nicole Lydie, Bocquet, Nicholas, Brunswick, Philippe
• Granted Patent: US 8,965,497 B2
• Time in Patent Office: Days
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

The invention relates to an electrophysiological analysis system which comprises a plurality of electrodes (E1-E4), power supply means (10, 30) for successively applying a substantially continuous voltage ranging approximately from 1 to 5 volts and lasting from 0.1 to 5 seconds to different slotted electrode pairs, collecting and storing means (450) for recording the variation of a current flow in the electrode pairs to which said voltage slots are applied, means (50) for enabling the current variations obtained by comparison between at least two current variations caused by supposed identical conditions and means (50) for comparing data related to the current variations recorded for several electrode pairs and enabled with reference data. Said invention can be used for chronoamperometrically detecting pathologies, pathological areas and organ dysfunctions

Claims

1. An electrophysiological examination system for the detection of pathologies, characterised in that it includes

a plurality of surface electrodes (E1-E4) designed to be positioned at distant parts of the human body,

power means (10, 30) used to apply, in succession to different electrode pairs, essentially continuous voltage pulses of between about 1 and 5 volts and with a length of between about 0.1 and 5 seconds,

acquisition and storage means (40) to record the current changes flowing in the electrode pairs as these voltage pulses are applied,

means (50) for validation of the changes in the acquired current readings by comparison between at least two current changes provoked in conditions that are assumed to be identical, and

processing means (50) for comparing the data relating to the current changes recorded for several electrode pairs and validated with reference data, and thereby to give an indication of a pathological nature.

2. The system according to claim 1, characterised in that the acquisition means (40) include means for sampling the current signal at a rate of between about 20 and 10,000 times per second.

3. The system according to claim 1 or 2, characterised in that the power means (10, 30) include means to apply, to a given electrode pair, voltage pulses of opposite sign.

4. The system according to one of claims 1 to 3, characterised in that means are provided to adjust the continuous voltage levels of the pulses.

5. The system according to claim 4, characterised in that means are provided to adjust the duration of the pulses.

6. The system according to one of claims 1 to 5, characterised in that the validation means (50) include means to compare the current changes obtained for several series of voltage pulses applied several times to the electrodes, and to validate these changes if a difference below a given threshold is observed.

7. The system according to one of claims 1 to 6, characterised in that it also includes means (50) to generate graphical representations of the current changes in the different electrode pairs, and corresponding graphical representations of the reference data.

8. The system according to one of claims 1 to 7, characterised in that the processing means (50) include means to determine the slope of the current changes at the start of each voltage pulse.

9. The system according to one of claims 1 to 8, characterised in that the processing means (50) include means to determine the time that passes between the start of the pulse and the instant at which the value of the current stabilises.

10. The system according to one of claims 1 to 9, characterised in that the acquisition means (40) and at least part of the power means (10, 30) are provided in a mobile unit (MP) that is equipped with a plurality of connectors (21, 24) for the electrodes, in that the processing means (50) are provided in a computer (PC) that is separate from the said mobile unit, and in that a communication channel (70a, 70b) is provided between the mobile unit and the computer.

11. The system according to claim 10, characterised in that the communication channel is wireless.

12. A dynamic diagnosis system, characterised in that it includes the following in combination:

server means;

a plurality of analysis systems according to one of claims 1 to 11, connected to the server means by communication channels;

means to collect data relating to the current changes measured by the analysis systems on patients whose clinical diagnoses are established beforehand, in association with data representing the said diagnoses prepared beforehand;

means for the control of algorithms provided in the server means, and executed periodically using the new collected data in order to validate pre-selected diagnosis algorithms and to identify new diagnoses.

13. The system according to claim 12, characterised in that it also includes means for the transfer to the analysis systems of the newly validated or identified algorithms, in association with pathologies or pathological predispositions that they are capable of detecting.

14. An electrophysiological examination method for the detection of pathologies, characterised in that it includes the following steps:

applying successively to a plurality of pairs of surface electrodes (E1-E4) positioned at distant parts of the human body, essentially continuous voltage pulses of between about 1 and 5 volts and with a length of between about 0.1 and 5 seconds,

recording the current changes flowing in the different electrode pairs as these voltage pulses are applied,

validation of the changes in the acquired current readings by comparison between at least two current changes provoked in conditions that are assumed to be identical, and

comparing data relating to the current changes as recorded for several electrode pairs and validated with reference data, thereby giving an indication of a pathological nature.

15. The method according to claim 14, characterised in that the recording step is executed by sampling the current signal at a rate of between about 20 and 10,000 times per second.

16. The method according to claim 14 or 15, characterised in that the step for application of the voltage pulses includes the application, to a given electrode pair, of voltage pulses of opposite sign.

17. The method according to one of claims 14 to 16, characterised in that it includes a step for adjustment of the continuous voltage levels of the pulses.

18. The method according to one of claims 14 to 17, characterised in that it includes a step for adjustment of the lengths of the pulses.

19. The method according to one of claims 14 to 18, characterised in that the validation step includes the comparison of current changes obtained for several series of voltage pulses applied several times to the electrodes, and the validation of these changes if a difference below a given threshold is observed.

20. The method according to one of claims 14 to 19, characterised in that it also includes a step that consists of generating graphical representations of the current changes for the different electrode pairs, and corresponding graphical representations of the reference data.

21. The method according to one of claims 14 to 20, characterised in that it also includes a step that consists of determining the slope of the current changes at the start of each voltage pulse.

22. The method according to one of claims 14 to 21, characterised in that it also includes a step that consists of determining the time that passes between the start of the pulse and the instant at which the value of the current stabilises.

23. A method for the detection of coronary problems, in particular by electrophysiological examination, characterised in that it includes the following steps:

(a) before the execution of any given exercise by a subject, successive application of a plurality of pairs of surface electrodes (E1-E4) positioned at least in the region of the hands and in the region of the forehead of the subject, of essentially continuous voltage pulses of between about 1 and 5 volts and with a length of between about 0.1 and 5 seconds,

(b) recording of changes in the current flowing in the different electrode pairs as these voltage pulses are applied,

(c) repetition of steps (a) and (b) after the subject has performed the said exercise,

(d) comparison of the data relating to the current changes as recorded for the electrode pairs before and after exercise,

(e) in accordance with results of step (d), provision of a predictive indication of affection or non-affection.

24. The method according to claim 23, characterised in that step (e) is implemented by comparison of the increase in the electrochemical conductance, revealed by the current changes between the moment preceding the exercise and the moment following the exercise, at least for the hand electrode pair and the forehead electrode pair, with respective thresholds.

25. An Application of the method according to either of claims 23 and 24 to the detection of diabetic problems.