APPARATUS AND METHOD FOR STIMULATOR ON-SKIN SHORT DETECTION

• US 20150038873A1
• Filed: 10/02/2014
• Published: 02/05/2015
• Est. Priority Date: 09/16/2010
• Status: Active Grant

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Boettcher, Bonniejean, Herb, Glenn, Kong, Xuan
• Granted Patent: US 10,004,445 B2
• Time in Patent Office: Days
• US Class Current: 600/547
• CPC Class Codes: A61B 2560/0425 Ergonomically shaped housings A61B2560/0418 takes precedence
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• 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 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/6828 Leg

Abstract

A device for measuring sural nerve conduction velocity and amplitude, the device comprising:

• • a housing;
  • stimulation means mounted to the housing for electrically stimulating a human sural nerve;
  • a biosensor releasably mounted to the housing, the biosensor comprising a plurality of electrodes for detecting a sural nerve response evoked by the stimulation means;
  • acquisition means mounted to the housing and electrically connected to the biosensor for electrically acquiring the sural nerve response detected by the biosensor;
  • detection means mounted to the housing and electrically connected to the stimulation means and the acquisition means for detecting shorting or shunt of the stimulation current on the surface of the skin;
  • processing means mounted to the housing and electrically connected to the acquisition means for digitizing, processing and storing the acquired sural nerve response;
  • calculation means mounted to the housing and electrically connected to the processing means for calculating the conduction velocity and amplitude of the processed sural nerve response; and
  • display means mounted to the housing for displaying the sural nerve conduction velocity and amplitude;
  • wherein the stimulation means and the biosensor are designed to be placed on a patient'"'"'s anatomy, in the vicinity of a sural nerve, by manipulating the housing.

Claims

1. A device for measuring sural nerve conduction velocity and amplitude, the device comprising:

a housing;

stimulation means mounted to the housing for electrically stimulating a human sural nerve;

a biosensor releasably mounted to the housing, the biosensor comprising a plurality of electrodes for detecting a sural nerve response evoked by the stimulation means;

acquisition means mounted to the housing and electrically connected to the biosensor for electrically acquiring the sural nerve response detected by the biosensor;

detection means mounted to the housing and electrically connected to the stimulation means and the acquisition means for detecting shorting or shunt of the stimulation current on the surface of the skin;

processing means mounted to the housing and electrically connected to the acquisition means for digitizing, processing and storing the acquired sural nerve response;

calculation means mounted to the housing and electrically connected to the processing means for calculating the conduction velocity and amplitude of the processed sural nerve response; and

display means mounted to the housing for displaying the sural nerve conduction velocity and amplitude;

wherein the stimulation means and the biosensor are designed to be placed on a patient'"'"'s anatomy, in the vicinity of a sural nerve, by manipulating the housing.

2. A device according to claim 1 wherein the detection means utilizes the size of a stimulus artifact recorded by the acquisition means to determine the likelihood of shorting or shunt of the stimulation current on the surface of the skin.

3. A device according to claim 1 wherein the stimulation means comprises anode and cathode probes, and further wherein the detection means utilizes the voltage difference between the anode and cathode probes of the stimulation means to determine the likelihood of shorting or shunt of the stimulation current on the surface of the skin.

4. A device according to claim 1 wherein the detection means utilizes the time constant of the decaying rate of a stimulus artifact recorded by the acquisition means to determine the likelihood of shorting or shunt of the stimulation current on the surface of the skin.

5. A device according to claim 1 wherein the stimulation means comprises anode and cathode probes, and further wherein the detection means utilizes a combination of the voltage difference between the anode and cathode probes of the stimulation means and the size and decaying rate of a stimulus artifact recorded by the acquisition means to determine the likelihood of shorting or shunt of the stimulation current on the surface of the skin.

6. A device according to claim 1 wherein the display means display an error message if the detection means determines that there is a shorting or shunt of the stimulation current on the skin.

7. A method for measuring nerve conduction attributes, the method comprising:

positioning a nerve conduction testing device on the surface of the skin of a patient so that the nerve conduction testing device is positioned to electrically stimulate a nerve and a biosensor is positioned to detect a nerve response evoked by the nerve conduction testing device;

detecting the likelihood of shorting or shunting of the stimulation current on the surface of the skin;

using the nerve conduction testing device to electrically stimulate a nerve and to acquire the nerve response detected by the biosensor; and

processing the acquired nerve response to determine the conduction attributes of the processed nerve response.

8. A method according to claim 7 wherein the nerve conduction testing device comprises anode and cathode stimulation probes, and further wherein the likelihood of shorting or shunting of the stimulation current is determined by monitoring (1) the magnitude of a stimulus artifact waveform, and (2) the voltage difference between the anode probe and the cathode probe of the nerve conduction testing device.

9. A method according to claim 7 wherein if a shorting or shunting of the stimulation current is detected, an error message is displayed and no further electrical stimulation is delivered.

10. A method according to claim 8 wherein the intensity of the stimulation current used to determine the likelihood of shorting or shunting is less than the intensity of the stimulation current normally used in nerve conduction testing.