Electrical nerve stimulation device

• US 20080114414A1
• Filed: 07/16/2007
• Published: 05/15/2008
• Est. Priority Date: 10/17/2001
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Inventors: Karas, Michael, Woldegiorges, Bisrat, Czech, John, Moore, Gary L.
• Granted Patent: US 8,019,426 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The electrical nerve stimulation unit in accordance with the present invention generally includes a housing, an input panel, a display panel, a controller, a first channel output, a second channel output, and a power system. While the device is generally described in terms of use as a TENS unit, it must be noted that other nerve stimulation applications for the device are envisioned as well. The myriad of intelligent and proactive programmable software functions and features of the present invention are executed on the controller'"'"'s microprocessor. For instance, open lead monitoring, soft recovery implementation, compliance monitoring, and enhanced power management are all controlled and monitored through the interfacing of the processor with the various devices and hardware on the unit'"'"'s hardware platform.

Claims

1. A method of monitoring patient compliance for implementation with an electrical nerve stimulation device, the method comprising the steps of:

generating an output treatment signal to at least one output channel having at least one lead wire with an electrode for attachment to the skin tissue of a patient;

monitoring at a controller the actual delivery of the generated output treatment signal to the patient by polling the at least one output channel for an open lead condition; and

storing selected data representing patient compliance at non-volatile memory, wherein the data includes a plurality of compliance data including compliance data dependant upon sensed changes in the actual delivery of the output treatment signal to the patient.

2. The method of claim 1, further including downloading at least the compliance data at a communication port.

3. The method of claim 2, wherein the downloading of the compliance data includes downloading a patient usage timer and a device usage timer.

4. The method of claim 3, wherein the downloading of the compliance data further includes downloading a plurality of independent modality usage timers.

5. A method of using an electrical nerve stimulation device, comprising the steps of:

inputting at least one operating parameter into the nerve stimulation device at a keypad;

processing the at least one inputted operating parameter to generate an output pulse signal at an at least one output channel; and

monitoring changes in the actual delivery of the generated output signal to a user through polling of the at least one output channel.

6. The method of claim 5, further comprising storing time accumulators in non-volatile memory for use in monitoring patient compliance.

7. The method of claim 5, wherein monitoring changes in the delivery of the generated output signal further includes adjusting the output signal at the at least one output channel to a low level polling signal upon detection of an open lead condition.

8. The method of claim 7, further including setting the output signal to approximately zero upon detecting the removal of the open lead condition, and then gradually stepping up the output signal to substantially the level maintained prior to detection of the open lead condition.

9. The method of claim 6, further including downloading the time accumulators at a communication port.

10. The method of claim 9, further including uploading software to the device at a communication port, wherein the software controls, processes, and monitors operation of the device.

11. The method of claim 5, further including periodically monitoring the voltage capacity of a high voltage level power system controlling output through the at least one channel, wherein an ideal voltage capacity is substantially maintained during operation to obtain the generated output pulse signal.

12. A nerve stimulation device comprising:

at least one output channel for communicating an electrical pulse signal to a user, the at least one output channel having at least one lead wire operably connectable to the at least one output channel for communicating the electrical pulse signal;

a high voltage level power system having at least one battery source to provide power to the nerve stimulation device; and

a processor in operable communication with at least the high voltage level power system to calculate an ideal voltage level required to generate the electrical pulse signal, the processor further periodically monitoring the voltage capacity of the high voltage level power system and substantially maintaining the ideal voltage capacity during operation of the device to conserve the battery source.

13. The device of claim 12, wherein the processor maintains the ideal voltage capacity during operation by charging a capacitor in the high voltage level power system with pulses to replace pulses used to generate the electrical pulse signal.

14. A nerve stimulation device comprising:

at least one output means for communicating a generated electrical pulse signal;

power means for providing power to the nerve stimulation device, the power means having a circuit means for generating a voltage for the generated electrical pulse signal; and

control means in operable communication with at least the power means to calculate an ideal voltage level required to generate the electrical pulse signal, the control means further periodically monitoring the voltage capacity of the circuit means and substantially maintaining the ideal voltage capacity during operation of the device to conserve the battery source.

15. A method of monitoring a high voltage level circuit in a nerve stimulation device to conserve battery power, the method comprising the steps of:

processing data, including inputted treatment parameters, to calculate a required electrical treatment output;

processing the calculated electrical treatment output to further calculate an ideal voltage level needed at a high voltage circuit to obtain the required electrical output;

generating the required electrical output for communication through at least one output channel;

periodically monitoring the ideal voltage level at the high voltage circuit; and

substantially maintaining the ideal voltage level at the high voltage circuit if it measurably deviates to reduce overcharging of the high voltage circuit.

16. The method of claim 15, wherein the step of substantially maintaining the ideal voltage at the high voltage circuit includes communicating pulses to the high voltage circuit to replace pulses utilized in generating the required electrical output.

17. An electrical nerve stimulation device, comprising:

a display screen; and

a housing having

a front panel portion;

a back panel portion attachable to the front panel portion; and

a keypad panel intermediately positionable between the front panel and the second panel, the keypad panel having a display screen frame nest adapted to securely receive the display screen to facilitate alignment of the display screen within the housing.

18. The device of claim 17, wherein the display screen is a Liquid Crystal Display (LCD).

19. The device of claim 17, wherein the keypad panel is constructed of a flexible material.

20. The device of claim 19, wherein at least one of the flexible materials is selected from a group consisting of:

polymers, and polymers containing carbon.

21. The device of claim 17, wherein the keypad panel includes a plurality of keys positioned on the keypad panel for alignment with corresponding apertures in the front panel.

22. An electrical nerve stimulation device, comprising:

display means for providing visual display to a user during operation of the device; and

a housing having

a front panel portion;

a back panel portion attachable to the front panel portion; and

panel means intermediately positionable between the front panel and the second panel for securely nesting the display screen to facilitate alignment of the display screen within the housing.

23. The device of claim 22, wherein the panel means is constructed of a flexible material.

24. A method of operation for an electrical nerve stimulation device, comprising the steps of:

inputting at least one operating parameter into the nerve stimulation device;

processing the at least one inputted operating parameter to generate an output pulse signal at an at least one output channel;

monitoring changes in the delivery of the generated output signal to a user'"'"'s skin through polling of the at least one output channel;

initiating a low polling signal to replace the generated output signal upon detecting an open lead condition at the at least one channel; and

performing a soft recovery ramp up of the output signal when the open lead condition is removed such that the low polling signal is set to approximately zero and the output signal is ramped up to a level substantially equal to the output signal generated prior to the open lead condition.

25. The method of claim 24, wherein the output signal is ramped up to a level substantially equal to the output signal generated prior to the open lead condition within a predetermined period of time.

26. The method of claim 25, wherein the predetermine period of time is some time less than 3 seconds.