Assessment of sudomor function for peripheral diabetic neuropathy evaluation

• US 8,934,954 B2
• Filed: 08/23/2011
• Issued: 01/13/2015
• Est. Priority Date: 08/23/2011
• Status: Active Grant

• Current Assignee: Impeto Medical Incorporated
• Original Assignee: Impeto Medical Incorporated
• Inventors: Brunswick, Philippe, Khalfallah, Kamel, Calvet, Jean Henry
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US13/215,813
• Publication Number:
  US 20130053721A1
• Time in Patent Office: 1,239 Days
• Field of Search: 600/345, 600/346, 600/547, 600/554, 600/573
• US Class Current: 600/346
• CPC Class Codes: A61B 5/0051 by applying vibrations
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/14521 using means for promoting sweat production, e.g. heating the skin measuring sweat secretion A61B5/4266
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence

Abstract

A method for assessing sudomotor function of a patient for evaluating diabetic and autonomous neuropathy is disclosed. The method is performed in a system comprising electrodes intended to be placed on different regions of the patient body, and an adjustable DC source. The method includes applying on the electrodes DC voltage pulses of varying voltage values in order to stress sweat glands, the voltage pulses lasting given durations allowing the stabilization of electrochemical phenomena in the body, near the electrodes; collecting data representative of the current between the electrodes, and of the potential generated on the electrodes for the different DC voltages; from the data, computing results representative of the electrochemical skin conductance of the patient; reconciling the latter data with reference data obtained in the same conditions on patients identified as suffering or not from sudomotor, and identifying the patient as suffering or not from sudomotor dysfunction.

Claims

1. A method for assessing sudomotor function of a patient, with a view to diagnosing autonomic neuropathy, the method being performed in a system comprising:

an anode and a cathode, intended to be placed on different regions of the patient body;

an adjustable DC source, which is controlled in order to feed the anode with a DC current;

the method comprising the following steps;

applying DC voltage pulses of varying voltage values in order to stress sweat glands, the voltage pulses lasting given durations allowing the stabilization of electrochemical phenomena in the body in the vicinity of the electrodes;

collecting data representative of the current between the anode and the cathode, and of the potential generated on the cathode through reverse iontophoresis for the different DC voltages;

from the data, computing results representative of the electrochemical skin conductance of the patient; and

reconciling the data representative of the electrochemical skin conductance of the patient with reference data obtained in the same conditions on patients identified as suffering or not from autonomic neuropathy, and identifying the patient as suffering or not from sudomotor dysfunction.

2. The method according to claim 1, wherein the patient is identified as suffering from diabetes, and the reconciliation step allows identifying the patient as suffering or not from diabetes polyneuropathy.

3. The method according to claim 1, wherein the voltage values of the pulses are lower than 10 V.

4. The method according to claim 3, wherein the voltage values of the pulses are increased or decreased stepwise.

5. The method according to claim 1, wherein the electrodes include hands and feet electrodes.

6. The method according to claim 5, wherein the electrodes cover substantially all the surface of the hand palms and feet soles of the patient.

7. The method according to claim 1, wherein the computation step comprises the computation of electrochemical skin conductance values at given voltages, by computing the ratio between the current generated through the anode and the cathode, and the resulting voltage drop between anode and cathode.

8. The method according to claims 7, wherein the reconciling step comprises comparing the electrochemical skin conductance values of the patient at given voltages to predetermined thresholds.

9. The method according to claim 8, wherein the result of the comparison allows assessing the severity of sudomotor dysfunction.

10. The method according to claim 1, wherein the method further comprises at least one test among the following:

peripheral vibration sensation through evaluation of the vibration perception threshold, cardiac autonomic neuropathy (CAN) assessment, neuropathy assessment through Michigan neuropathy screening instrument (MNSI).

11. The method according to claim 10, wherein the computed electrochemical skin conductance values are reconciled with the at least one other measurement, as a co-indicator of sudomotor dysfunction and diabetic polyneuropathy severity.

12. The method according to claim 11, comprising determining severe sudomotor dysfunction by low feet electrochemical skin conductance values in correlation with high sensory perception threshold as assessed by vibration perception threshold evaluation.

13. The method according to claim 11, comprising determining severe peripheral neuropathy by low feet electrochemical skin conductance values in correlation with high number of abnormal CAN results.

14. The method according to claim 11, comprising determining severe peripheral neuropathy by low feet electrochemical skin conductance values in correlation with increasing symptoms and score of physical abnormalities assessed by MNSI.