Electrical nerve stimulation device

• US 20030074037A1
• Filed: 10/17/2002
• Published: 04/17/2003
• Est. Priority Date: 10/17/2001
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: Rehabilicare, Inc. (Compeq Technology Company Limited)
• Inventors: Karas, Michael, Woldegiorges, Bisrat, Czech, John, Moore, Gary L.
• Granted Patent: US 7,254,444 B2
• Time in Patent Office: Days
• US Class Current: 607/63
• 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; 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.

2. The device of claim 1, wherein the processor periodically scans the at least one channel during the open lead condition with the low polling level signal to detect whether the open lead condition has been removed.

3. The device of claim 2, wherein the low polling level comprises a low current signal of less than 10 milliamps.

4. The device of claim 1, wherein the processor performs an automatic shut down of the power for the device if an open lead condition is not removed after a predetermined time period.

5. The device of claim 1, further comprising non-volatile memory in operable communication with the processor for storing data.

6. The device of claim 5, 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.

7. The device of claim 6, wherein the operating parameter data for the device includes pulse cycle, pulse width, and operation mode settings from a recent treatment session.

8. The device of claim 5, wherein the non-volatile memory is capable of storing compliance monitoring data processed by the processor.

9. The device of claim 8, wherein stored compliance monitoring data includes a plurality of time accumulators into which active time data is accumulated.

10. The device of claim 9, wherein the plurality of time accumulators include a patient usage timer, a device usage timer, and a modality usage timer.

11. The device of claim 1, further including a high voltage level power system in operable communication with the processor, wherein the processor controls charging of the high voltage level power system to an ideal voltage level not substantially above that necessary to obtain the generated electrical pulse signal.

12. The device of claim 1, wherein the open lead condition is caused by events selected from a group consisting of:

disengagement of an end of the lead wire from the user, and disengagement of the at least one lead wire from the at least one output channel.

13. The device of claim 1, wherein the processor further performs a soft recovery ramp up of the pulse signal upon removal of the open lead condition.

14. The device of claim 13, 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.

15. The device of claim 1, further comprising a communication port adapted to provide uploading and downloading communication with the processor.

16. The device of claim 15, wherein the communication port is a serial communication port adapted to receive a serial cable in operable communication with an external computing device.

17. The device of claim 1, including at least one recessed output channel jack providing intermediate connectability for attachment of the at least one lead wire to the at least one output channel.

18. The device of claim 17, wherein the recessed output channel jack is surface-mounted to a circuit board of the nerve stimulation device.

19. The device of claim 1, further comprising a keypad housed within the nerve stimulation device, the keypad having

a plurality of input keys;

and

a display frame nest for securing a display screen within the nerve stimulation device.

20. An electrotherapy compliance monitoring system for incorporation with an electrical nerve stimulation device for monitoring patient compliance, the system comprising:

at least one output channel adapted to communicate a generated electrical output;

a processor in operable communication with the at least one channel, the processor including software for sensing changes in delivery of the generated electrical output at the at least one output channel; and

non-volatile memory capable of storing selected data regarding patient compliance, the selected data including data dependant upon sensed changes of the delivery to the patient of the generated output caused by an open lead condition.

21. The system of claim 20, further including a communications port adapted to at least provide access to the data stored in the non-volatile memory.

22. The system of claim 20, wherein non-volatile memory stores parameters selected from a group consisting of:

mode, rate, cycle, and timer.

23. The system of claim 20, wherein the stored data includes a plurality of time accumulators including a patient usage timer and a device usage timer.

24. The system of claim 23, wherein the time accumulators further include a plurality of independent modality usage timers.

25. The system of claim 20, wherein the stored data includes a plurality of time accumulators including a patient usage timer, a device usage timer, and a plurality of independent modality usage timers.

26. The system of claim 21, wherein the communications port is adapted to allow for selective resetting of the stored data.

27. An electrotherapy compliance monitoring system for incorporation with an electrical nerve stimulation device, the compliance monitoring system comprising:

at least one channel means for outputting a generated treatment signal;

processing means in operable communication with the at least one channel for sensing changes in delivery to the patient of the generated treatment signal and monitoring other operating parameters of the electrical nerve stimulation device; and

memory means for storing selected data regarding patient compliance including data dependant upon sensed changes in delivery to the patient of the generated treatment signal caused by an open lead condition.

28. 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.

29. The method of claim 28, further including downloading at least the compliance data at a communication port.

30. The method of claim 29, wherein the downloading of the compliance data includes downloading a patient usage timer and a device usage timer.

31. The method of claim 30, wherein the downloading of the compliance data further includes downloading a plurality of independent modality usage timers.

32. An electrical nerve stimulation device, comprising:

a housing having

a front panel portion;

a back panel portion attachable to the front panel portion;

at least one recessed lead wire connector defined by a recess in the back panel relative to an overlapping of a proximate portion of the front panel;

a controller programmed to control and process circuitry and data in treating a user with an electrical pulse signal; and

at least one output channel for communicating the electrical pulse signal to the user, the at least one output channel having at least one lead wire attachable to the at least one recessed lead wire connector of the housing such that the at least one recessed lead wire connector provides protection from inadvertent disengagement of the at least one lead wire.

33. The device of claim 32, wherein the at least one recessed lead wire connector includes at least one connector line, with the at least one connector line providing communication between the at least one recessed lead wire connector and the controller.

34. The device of claim 33, wherein the at least one recessed lead wire connector is surface mountable to the controller.

35. The device of claim 32, wherein the recessed lead wire connector is positionable for attachment of the at least one lead wire through a recess aperture of the back panel portion.

36. An electrical nerve stimulation device, comprising:

a housing having

a front panel portion;

a back panel portion attachable to the front panel portion;

at least one recessed connector means for providing operable communication between a lead wire and the device to reduce inadvertent disengagement of the lead wire;

control means for programmable control over input and output circuitry and data in treating a user with an electrical pulse signal; and

at least one output means for communicating the electrical pulse signal to the user through the lead wire.

37. 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.

38. The device of claim 37, wherein the control means further performs a soft recovery ramp up of the pulse signal upon detecting removal of the open lead condition.

39. The device of claim 37, wherein the control means monitors the low level polling signal to detect the removal of the open lead condition.

40. The device of claim 39, wherein the low level polling signal is a current pulse of less than 10 milliamps.

41. The device of claim 38, 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.

42. The device of claim 41, wherein the predetermined period for the soft recovery ramp up is some time less than 3 seconds.

43. The device of claim 37, wherein the control means initiates a shut down sequence after a predetermined period if the open lead condition has not been removed.

44. The device of claim 43, wherein the predetermined period for initiating the shut down sequence is some time less than 60 seconds.

45. The device of claim 43, wherein the control means stores a plurality of parameters prior to initiation of the shut down sequence.

46. 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.

47. The method of claim 46, further comprising storing time accumulators in non-volatile memory for use in monitoring patient compliance.

48. The method of claim 46, 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.

49. The method of claim 48, 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.

50. The method of claim 47, further including downloading the time accumulators at a communication port.

51. The method of claim 50, further including uploading software to the device at a communication port, wherein the software controls, processes, and monitors operation of the device.

52. The method of claim 46, 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.

53. 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.

54. The device of claim 53, 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.

55. 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.

56. 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.

57. The method of claim 56, 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.

58. 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.

59. The device of claim 58, wherein the display screen is a Liquid Crystal Display (LCD).

60. The device of claim 58, wherein the keypad panel is constructed of a flexible material.

61. The device of claim 60, wherein at least one of the flexible materials is selected from a group consisting of:

polymers, and polymers containing carbon.

62. The device of claim 58, wherein the keypad panel includes a plurality of keys positioned on the keypad panel for alignment with corresponding apertures in the front panel.

63. 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.

64. The device of claim 63, wherein the panel means is constructed of a flexible material.

65. 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 connected to the at least one output channel for communicating the electrical pulse signal; and

a processor performing open lead monitoring of the at least one channel by detecting an 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 at the time when the open lead disruption is removed.

66. The device of claim 65, wherein the low polling level signal is some level lower than 10 milliamps.

67. The device of claim 65, wherein the soft recovery ramp up sets the pulse signal to approximately zero before ramping up of the pulse signal.

68. The device of claim 65, wherein the soft recovery ramp up initiates at the time when the open lead disruption is removed and is complete in less than 3 seconds at which time the electrical pulse signal will substantially reach the level maintained prior to the open lead disruption.

69. 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.

70. The method of claim 69, 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.

71. The method of claim 70, wherein the predetermine period of time is some time less than 3 seconds.

72. A nerve stimulation device comprising:

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

control means for performing open lead monitoring of the at least one output means by detecting an 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.

73. The device of claim 72, 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.

74. The device of claim 73, wherein the soft recovery ramp up completes ramping up the pulse signal in some time less than 3 seconds.