Electrical nerve stimulation device

• US 7,254,444 B2
• Filed: 10/17/2002
• Issued: 08/07/2007
• 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.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/273,392
• Publication Number:
  US 20030074037A1
• Time in Patent Office: 1,755 Days
• Field of Search: 607/46, 607/48, 607/49, 607 72- 74, 715/708
• 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 nerve stimulation device comprising:

at least one output channel capable of communicating a generated electrical pulse signal to a user, the at least one output channel being operably coupled to at least one lead wire for delivering the generated electrical pulse signal;

a processor performing open lead monitoring for the at least one output channel to sense changes in the delivery to the user of the generated electrical pulse, and adjusting the electrical pulse signal to a low polling level signal upon detecting an open lead condition; and

non-volatile memory in operable communication with the processor for storing data, wherein the non-volatile memory includes EEPROM memory capable of storing operating parameter data for the device prior to power shut down of the device.

2. The device of claim 1, wherein the operating parameter data for the device includes pulse cycle, pulse width, and operation mode settings from a recent treatment session.

3. A nerve stimulation device comprising

at least one output channel capable of communicating a generated electrical pulse signal to a user, the at least one output channel being operably coupled to at least one lead wire for delivering the generated electrical pulse signal;

a processor performing open lead monitoring for the at least one output channel to sense changes in the delivery to the user of the generated electrical pulse, and adjusting the electrical pulse signal to a low polling level signal upon detecting an open lead condition; and

non-volatile memory in operable communication with the processor for storing data, wherein the non-volatile memory is capable of storing compliance monitoring data processed by the processor.

4. The device of claim 3, wherein stored compliance monitoring data includes a plurality of time accumulators into which active time data is accumulated.

5. The device of claim 4, wherein the plurality of time accumulators include a patient usage timer, a device usage timer, and a modality usage timer.

6. A nerve stimulation device comprising:

at least one output channel capable of communicating a generated electrical pulse signal to a user, the at least one output channel being operably coupled to at least one lead wire for delivering the generated electrical pulse signal; and

a processor performing open lead monitoring for the at least one output channel to sense changes in the delivery to the user of the generated electrical pulse, and adjusting the electrical pulse signal to a low polling level signal upon detecting an open lead condition, wherein the processor further performs a soft recovery ramp up of the pulse signal upon removal of the open lead condition.

7. The device of claim 6, wherein the soft recovery ramp up initiates at the time when the open lead condition is removed such that the low level polling signal is set to approximately zero and ramped up over a period of less than 3 seconds to substantially the pulse signal level maintained prior to the open lead condition.

8. A nerve stimulation device, comprising:

output means for communicating an electrical pulse signal to a user, the output means having at least one wire means attachable to the output means for communicating the electrical pulse signal to the user'"'"'s skin tissue; and

control means for monitoring the output means for an open lead condition, and adjusting the electrical pulse signal to a low level polling signal upon detecting the open lead condition, wherein the control means further performs a soft recovery ramp up of the pulse signal upon detecting removal of the open lead condition.

9. The device of claim 8, wherein the soft recovery ramp resets the pulse signal to approximately zero, and then performs a gradual increase of the pulse signal over a predetermined period until the pulse signal reaches a level substantially the same as before the detection of the open lead condition.

10. The device of claim 9, wherein the predetermined period for the soft recovery ramp up is some time less than 3 seconds.

11. A nerve stimulation device comprising:

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

control means for performing open lead monitoring of the at least one output means by detecting open lead disruption in the delivery of the pulse signal to the user, adjusting the electrical pulse signal to a low polling level signal upon detecting the disruption, and performing a soft recovery ramp up of the pulse signal when the open lead disruption is removed,

wherein the soft recovery ramp up performed by the control means includes setting the pulse signal to approximately zero and then ramping up the pulse signal to substantially the level of the pulse signal being delivered to the user just prior to detection of the open lead disruption.

12. The device of claim 11, wherein the soft recovery ramp up completes ramping up the pulse signal in some time less than 3 seconds.