Electrophysiological analysis system and method

• US 8,965,497 B2
• Filed: 06/22/2006
• Issued: 02/24/2015
• Est. Priority Date: 06/22/2005
• Status: Active Grant

• Current Assignee: Impeto Medical Incorporated
• Original Assignee: Impeto Medical Incorporated
• Inventors: Tournefier, Annick Nicole Lydie, Brunswick, Philippe, Bocquet, Nicolas
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US11/922,812
• Publication Number:
  US 20090326407A1
• Time in Patent Office: 3,169 Days
• Field of Search: 600/300, 600/547, 600/548, 324/600, 324/612, 324/613, 324/691, 324/692
• 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 detection of pathologies, comprising:

a plurality of surface electrodes designed to be positioned in direct skin-to-electrode contact with distant parts of a human body where each surface electrode of the plurality of surface electrodes has a significant area ranging from 1 square centimeter to 15 square centimeters,

a power supply operable to be selectively electrically coupled in succession to form sets of electrode pairs of the plurality of electrodes to apply continuous DC voltage pulses ranging from 1 to 5 volts with a duration ranging from 0.1 to 5 seconds to the sets of electrode pairs, wherein the applied DC voltage pulses are adapted to induce electrochemical changes in the human body including production of chloride ions which affects current flowing in the sets of electrode pairs when the electrophysiological examination system is in use,

an acquisition and storage circuit to record current changes flowing in the several sets of electrode pairs as the continuous DC voltage pulses are applied, the acquisition and storage circuit having a sampling circuit configured to sample current signals at a rate ranging from 20 to 10,000 times per second, and

a processor configured to compare at least two current changes to validate the changes in the recorded current readings by comparison between at least two current changes provoked in conditions that are assumed to be identical, the processor configured to compare data relating to the recorded and validated current changes with reference data, and thereby produce an output indicative of a pathological nature.

2. The system according to claim 1, wherein the power supply includes a switching circuit to apply, to a given electrode pair, voltage pulses of opposite sign.

3. The system according to claim 1, wherein the power supply is programmable to adjust voltage levels of the pulses.

4. The system according to claim 3, wherein the power supply is programmable to adjust the duration of the pulses.

5. The system according to claim 1, wherein the processing device is operably configured to compare 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.

6. The system according to claim 1, further comprising an output device operably configured to generate graphical representations of the current changes in the several sets of electrode pairs, and corresponding graphical representations of the reference data.

7. The system according to claim 1, wherein the processing device is operably configured to determine a slope of current changes at a start of each voltage pulse.

8. The system according to claim 1, wherein the processing device is operably configured to determine a time that passes between a start of the pulse and an instant at which the value of a current stabilises.

9. The system according to claim 1, wherein the acquisition and storage circuit and at least part of the power supply are provided in a mobile unit that is equipped with a plurality of connectors for the electrodes, and wherein the processing device comprises a computer that is separate from the mobile unit, and wherein a communication channel is provided between the mobile unit and the computer.

10. The system according to claim 9, wherein the communication channel is wireless.

11. The system according to claim 1, further comprising:

a server;

a network of multiple ones of the electrophysiological examination system set forth in claim 1 where the multiple electrophysiological examination systems are separated from each other and have a mobile connection to the server by communication channels;

the server being programmed to collect data relating to the current changes measured by the acquisition and storage circuit on patients whose clinical diagnoses are established beforehand, in association with data representing the said diagnoses prepared beforehand; and

the server being programmed to control algorithms provided in the server, and to execute the algorithms periodically using newly collected data in order to validate pre-selected diagnosis algorithms and to identify new diagnoses.

12. The system according to claim 11, wherein the communication channels are two way, thereby enabling transfer of newly validated ones of the pre-selected diagnosis algorithms to the multiple electrophysiological examination systems, in association with pathologies or pathological predispositions that the multiple electrophysiological examination systems are capable of detecting.

13. An electrophysiological examination system for detection of pathologies in a patient comprising:

a plurality of surface electrodes each adapted to be positioned in direct contact with a skin surface of the patient when the electrophysiological examination system is in use, each surface electrode of the plurality of surface electrodes having a significant area of at least 1 square centimeter,

a DC power supply operably and selectively electrically coupled in succession to several sets of electrode pairs of the plurality of electrodes to apply pulses of continuous DC voltage ranging from 1 to 5 volts and having a duration ranging from 0.1 to 5 seconds to the electrode pairs, wherein the several sets of electrode pairs include a first pair of electrodes including a first electrode positioned at a distant body part of the patient from a second electrode of the first pair of electrodes,

an acquisition and storage circuit to record current changes flowing in the several sets of electrode pairs as the pulses of continuous DC voltage are applied, and

a processing device configured to compare changes in the recorded current readings between at least two current changes provoked in conditions that are assumed to be identical, and the processing device operably configured to compare data relating to the recorded and validated current changes with reference data, and thereby produce a signal indicative of a pathological nature.

14. The system according to claim 13, wherein the significant area of the plurality of surface electrodes covers palm surfaces and sole surfaces of the patient when the plurality of electrodes are positioned in direct contact with hands and feet of the patient.

15. The system according to claim 14, wherein the first electrode is adapted to be positioned in direct contact with one of the hands of the patient and the second electrode is adapted to be positioned in direct contact with one of the feet of the patient.

16. The system according to claim 14, wherein the several sets of electrode pairs include a second pair of electrodes and wherein the first pair of electrodes are adapted to be positioned in direct contact with the hands of the patient and the second pair of electrodes are adapted to be positioned in direct contact with the feet of the patient.

17. The system according to claim 13, wherein the plurality of surface electrodes are adapted to be positioned in direct contact with at least two body parts chosen from a group of:

left and right hands of the patient, left and right feet of the patient, and a forehead of the patient.

18. The system according to claim 13, wherein the pulses of continuous DC voltage, that the DC power supply is configured to apply to the plurality of surface electrodes, exhibit a square waveform.

19. The system according to claim 13, wherein the acquisition and storage circuit is configured to record current changes flowing in the several sets of electrode pairs over a total time period having a duration that is less than 1 minute.

20. The system according to claim 13, wherein the plurality of surface electrodes are reusable.