Method and apparatus for diagnosing and treating neural dysfunction

• US 8,265,747 B2
• Filed: 07/19/2011
• Issued: 09/11/2012
• Est. Priority Date: 08/02/2005
• Status: Active Grant

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories)
• Original Assignee: NeuroTherm, Inc. (Abbott Laboratories)
• Inventors: Rittman, William J. III, Clarke, Howard Morgan
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): WIELAND, ROBERT N
• Application Number:
  US13/185,646
• Publication Number:
  US 20120029592A1
• Time in Patent Office: 420 Days
• Field of Search: 607/2, 607/102, 606/34, 606/41, 606/32, 600/509
• US Class Current: 607/2
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 5/00 Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

A method and apparatus for diagnosing and treating neural dysfunction is disclosed. This device has the capability of delivering the therapeutic electrical energy to more than one treatment electrode simultaneously. In another exemplary embodiment, this device can perform EMG testing both before and after the therapeutic energy has been delivered, to assess whether the target nerve was successfully treated. In another embodiment, the device has the capability to record and store sensory stimulation thresholds both before and after treatment is described, which allows the clinician to accurately determine whether the target nerve has been desensitized. Energy control may achieved by simultaneously comparing the tip temperature of each treatment electrode to a set temperature selected by the operator, and regulating the therapeutic energy output to maintain the set temperature. In another embodiment, EMG, stimulation thresholds, and graphs of temperature versus time can be conveniently displayed on a two-dimensional graphics display.

Claims

1. A device for use in delivering therapeutic treatment energy to a plurality of nerve locations via a corresponding plurality of probes, the device configured to selectively produce power at a stimulate frequency in a stimulate mode, and at an RF therapeutic frequency in a therapeutic mode, the device comprising:

a plurality of electrode outputs, wherein each of the electrode outputs is adapted to receive temperature information from and provide RF energy to one of the probes; and

a mode select interface configured to select from a plurality of settings, wherein,

in a stimulate mode setting of the mode select interface, power at a stimulate frequency, which is lower than the RF therapeutic frequency, is selectively coupled to a single one of the plurality of electrode outputs, and

in a therapeutic mode setting of the mode select interface, power at an RF frequency is coupled to any of the plurality of electrode outputs.

2. The device for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 1, further comprising an indicator display to indicate, in the stimulate mode, which electrode output is the single one of the plurality of electrode outputs coupled to the power source.

3. The device for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 2, wherein the mode select interface comprises a plurality of buttons corresponding to the plurality of electrode outputs, and the indicator display comprises a plurality of indicator lights.

4. The device for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 1, wherein the mode select interface comprises a selector having at least a stimulate mode position and a therapeutic mode position.

5. The device for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 1, further comprising:

a plurality of probes each coupled to one of the electrode outputs;

a graphics output screen, the graphics output screen having;

a plurality of pre-stimulation display areas configured to display a pre-stimulation sensory threshold for each of the probes at one of the nerve locations, and

a plurality of post-stimulation display areas configured to display a post-stimulation sensory threshold for each of the probes at one of the nerve locations.

6. The device for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 5:

wherein the plurality of pre-stimulation display areas each comprise a pre-stimulation bar graph, and

wherein the plurality of post-stimulation display areas each comprise a post-stimulation bar graph.

7. The device for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 1, wherein the stimulate frequency is a sensory frequency.

8. The device for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 1, wherein the stimulate frequency is a muscle motor frequency.

9. The device for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 1, the device further comprising a plurality of temperature displays associated with a plurality of probes coupled to the plurality of the electrode outputs, each of the plurality of temperature displays configured to indicate the temperature of its corresponding probe.

10. The device for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 9, the device further comprising a graphical display capable of displaying a time vs temperature graph for at least one of the probes.

11. A system for use in delivering therapeutic treatment energy to nerve locations, the system configured to selectively produce power at a stimulate frequency in a stimulate mode, and at an RF therapeutic frequency in a therapeutic mode, the system comprising:

an RF energy source having an RF output;

at least one electrode output adapted to receive temperature information from and provide RF energy to a probe attached thereto; and

a user interface providing a mode select interface configured to select from a plurality of settings, wherein,

in a stimulate mode setting of the mode select interface, power at a stimulate frequency, which is lower than the RF therapeutic frequency, is selectively coupled to a single one of the at least one electrode output, and

in a therapeutic mode setting of the mode select interface, power at an RF frequency is coupled to one or more of the at least one electrode output,

and the user interface further providing a sensory stimulation graph for use in the stimulation mode to display a line, the length of which indicates a stimulation sensory threshold and a display for use in the therapeutic mode for actual temperatures reported to the at least one electrode output.

12. The system for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 11 further comprising a log button user activatable in the stimulation mode to identify a stimulation sensory threshold for saving.

13. The system for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 12 wherein the saved stimulation sensory threshold is displayed on the sensory stimulation graph with a length corresponding to the threshold.

14. The system for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 11, wherein the stimulate frequency is a sensory frequency.

15. The system for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 11, wherein the stimulate frequency is a muscle motor frequency.

16. The system for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 11, the system further comprising a graphical display capable of displaying a time vs temperature graph for temperature information received at the at least one electrode output.

17. A system for use in delivering therapeutic treatment energy to nerve locations, the system configured to selectively produce power at a stimulate frequency in a stimulate mode, and at an RF therapeutic frequency in a therapeutic mode, the system comprising:

an RF energy source having an RF output;

at least one electrode output adapted to receive temperature information from and provide RF energy to a probe attached thereto;

a log button for use in a stimulation mode activatable to identify a stimulation sensory threshold for saving;

and

a user interface providing a mode select interface configured to select from a plurality of settings, wherein,

in a setting for the stimulate mode, power at a stimulate frequency, which is lower than the RF therapeutic frequency, is selectively coupled to a single one of the at least one electrode output, and

in a therapeutic mode setting of the mode select interface, power at an RF frequency is coupled to one or more of the at least one of electrode output,

and the user interface further providing a display for the saved stimulation sensory threshold and a display for use in the therapeutic mode for actual temperatures reported to the at least one electrode output.

18. The system for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 17 wherein the saved stimulation sensory threshold is displayed on the display for the saved stimulation sensory threshold with a length corresponding to the threshold.

19. The system for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 17, wherein the stimulate frequency is a sensory frequency.

20. The system for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 17, wherein the stimulate frequency is a muscle motor frequency.

21. The system for use in delivering therapeutic treatment energy to a plurality of nerve locations of claim 17, wherein the display for use in the therapeutic mode includes a graphical display capable of displaying a time vs temperature graph for temperature information received at the at least one electrode output.