Electrotherapy stimulation device having electrode peel off detection capabilities

• US 20040015212A1
• Filed: 05/31/2002
• Published: 01/22/2004
• Est. Priority Date: 05/31/2002
• Status: Abandoned Application

• Current Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Original Assignee: EMPI Corporation (Enovis Corp.)
• Inventors: Huber, Hartley H., Lucke, Lori E.
• Application Number:
  US10/160,959
• Publication Number:
  US 20040015212A1
• Time in Patent Office: Days
• US Class Current: 607/72
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/3603 Control systems

Abstract

Improved operating features for an electrotherapy device are provided by the use of a peel off detection system which monitors device operation and provides necessary corrective action where appropriate. More specifically, the electrotherapy device monitors the connection characteristics of the electrodes, in order to determine if acceptable connections are being maintained to the patient. In order to monitor these connections, a baseline signal measurement is made when the system is first started. Subsequent measurements are then compared to this baseline measurement, to insure that the magnitude stays within an acceptable range. If the measurement shows a non-acceptable connection condition, the electrotherapy device is shut down and appropriate warning signals are provided to the user. Where multiple output channels are used, isolation circuits are included in the feedback network in order to insure no signal coupling exists.

Claims

1. An electrotherapy device for use in providing a stimulation signal to a patient and monitoring the device'"'"'s connection characteristics so as to avoid undesirable conditions, the electrotherapy device comprising:

a stimulation signal generator having a therapy signal output attachable to the patient, the stimulation signal generator capable of producing a pulsed stimulation signal in response to a control signal, the pulsed stimulation signal having on and off periods;

a controller attached to the stimulation signal generator, the controller capable of generating the control signal so as to control the characteristics of the pulsed signal; and

a feedback connection operatively coupling the therapy signal output to the controller, wherein the controller can determine connection quality by sampling the pulsed signal during the on periods.

2. The electrotherapy device of claim 1 wherein the feedback connection is coupled to an A/D input of the controller.

3. The electrotherapy device of claim 1 wherein the connection quality is determined by comparing the sampled pulsed signal with an initialization sample, the initialization sample obtained by sampling the pulsed signal during initiation of the therapy.

4. The electrotherapy device of claim 1 wherein the stimulation signal generator includes a transformer for generating the stimulation signal in response to the control signal.

5. The electrotherapy device of claim 3 wherein the initiation of therapy includes a ramp up time prior to sampling.

6. The electrotherapy device of claim 1 further comprising:

a second stimulation signal generator attachable to the patient and connected to the controller, the second stimulation signal generator having a second therapy signal output also attachable to the patient, the second stimulation signal generator capable of producing a second pulsed stimulation signal in response to a second control signal from the controller, the second pulsed stimulation signal having on and off periods; and

a second feedback connection operatively coupling the second therapy signal output to the controller, wherein the controller can determine connection quality by sampling the pulsed signal during the on periods

7. The therapy device of claim 6 wherein the feedback connection comprises an isolation circuit attached to the therapy signal output so as to provide isolation between the therapy signal output and the second therapy signal output, the isolation circuit having an output attached to the controller.

8. The therapy device of claim 6 wherein the feedback connection comprises an isolation circuit attached to the second therapy signal output so as to provide isolation between the therapy signal output and the second therapy signal output, the isolation circuit having an output attached to the controller.

9. The electrotherapy device of claim 6 wherein the isolation circuit includes an optocoupler driver attached to the therapy signal output and an optocoupler attached to the optocoupler driver, the output of the optocoupler forming the output of the isolation circuit.

10. The electrotherapy device of claim 6 wherein the controller coordinates the sampling of the therapy signal and the second therapy signal such that sampling is only done during on periods.

11. The electrotherapy device of claim 6 wherein the connection quality for the second therapy signal generator is determined by comparing the sampled pulsed signal with an initialization sample, the initialization sample obtained by sampling the pulsed signal during initiation of the therapy.

12. The electrotherapy device of claim 6 wherein the connection quality is determined by comparing the sampled pulsed signal with an initialization sample, the initialization sample obtained by sampling the pulsed signal during initiation of the therapy.

13. A multi channel therapy device for providing a plurality of stimulation signals to a patient and for monitoring those signals to insure that undesirable conditions are avoided:

a controller for coordinating the operation of the therapy device;

a first therapy signal generator attached to the controller for producing a first therapy signal at a first therapy signal output;

a second therapy signal generator attached to the controller for producing a second therapy signal at a second therapy signal output;

an isolation circuit connecting the first therapy output to the controller while also providing electrical isolation between the first therapy output and the second therapy output;

a feedback connection attaching the second therapy signal output to the controller; and

wherein the controller will monitor the first therapy output and the second therapy output to insure that undesirable conditions are avoided.

14. The multi channel therapy device of claim 13 wherein the isolation includes an optocoupler driver and an optocoupler, wherein the magnitude of the first therapy signal is first translated to a current, and then an isolated voltage is transmitted to the controller through the optocoupler.

15. The multi channel therapy device of claim 13 further comprising an A/D converter for monitoring the therapy signals.

16. The multi channel therapy device of claim 15 wherein the controller will monitor the first and second therapy signal by generating a baseline measurement for each therapy signal and then comparing the first therapy signal and the second therapy signal with the respective baseline signal.

17. A method for providing peel off detection during the operation of an electrotherapy device, comprising:

initially attaching a plurality of electrodes to a patient, each electrode attached to the electrotherapy device;

powering up the electrotherapy device causing the creation of a plurality of initial stimulation pulses;

sampling the initial stimulation pulses to create a baseline stimulation pulse measurement and subsequently storing a baseline magnitude value representative of the magnitude of the baseline stimulation pulse measurement;

continuing to operate the electrotherapy device, thus creating a plurality of therapy pulses to provide a desired treatment to a patient;

sampling the therapy pulses to create a normal operating pulse measurement and storing a magnitude value representative of the magnitude of the therapy pulse;

comparing the magnitude value with the baseline magnitude value to determine a difference value; and

evaluating the difference value to determine if it is within a predetermined range, and if it is not within the predetermined range, shutting down the operation of the electrotherapy device.

18. The method of claim 17 wherein the electrotherapy device is a constant current device.

19. The method of claim 18 wherein the baseline stimulation pulse measurement and the normal operating pulse measurement are measurements of voltage levels.