Method and apparatus for diagnosing and treating neural dysfunction

• US 8,560,062 B2
• Filed: 08/29/2012
• Issued: 10/15/2013
• Est. Priority Date: 08/02/2005
• Status: Active Grant

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: NeuroTherm, Inc. (Abbott Laboratories Incorporated)
• Inventors: Rittman, William J. III, Clarke, Howard Morgan
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Wieland, Robert N
• Application Number:
  US13/597,897
• Publication Number:
  US 20130190846A1
• Time in Patent Office: 412 Days
• Field of Search: 607/2, 606/32, 606/41
• 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 to a plurality of nerve locations comprising:

a radio frequency energy source having an RF output;

a plurality of electrode outputs operably coupled to the RF output, wherein each of the electrode outputs is separately and individually connectable through a corresponding electrical conductor to a probe;

a plurality of temperature sensor inputs, each of the plurality of temperature sensor inputs configured to receive temperature information from at least one temperature sensor incorporated into the corresponding probe; and

a user interface for individually selecting a plurality of user-settable temperatures, each of said plurality of temperatures associated with a corresponding one of the plurality of the electrode outputs, the device being configured such that energy delivery from the radio frequency energy source to each of the plurality of electrode outputs is regulated to simultaneously maintain each of said user-settable temperatures.

2. The device of claim 1, further comprising a plurality of probes, each of the plurality of probes coupled to a corresponding one of the plurality of electrode outputs, wherein the user-settable temperature maintained for each of the plurality of electrode outputs comprises a temperature measured by a temperature sensor at a tip of the corresponding one of the probes.

3. The device of claim 2, wherein the electrode outputs include the temperature sensor inputs.

4. The device of claim 2, further comprising a plurality of temperature displays corresponding to the plurality of temperature sensor inputs.

5. The device of claim 1, further comprising a plurality of sensor inputs configured to receive temperature information from a plurality of temperature sensors at a corresponding plurality of electrode tips.

6. The device of claim 1, further comprising a plurality of probes, each probe comprising an input, and an electrode tip, and wherein each probe input is coupled to a corresponding one of the electrode outputs.

7. The device of claim 6, wherein the probes are at least partially electrically insulated over at least part of a shaft of the probes.

8. The device of claim 6, wherein the plurality of probes are separate and not connected to one another.

9. The device of claim 1, further comprising a plurality of indicators corresponding to the plurality of electrode outputs, to indicate that a probe is receiving energy from the radio frequency energy source.

10. The device of claim 9, wherein the indicators comprise indicator lights.

11. The device of claim 1, further comprising a set temperature display to display the temperature set by the user.

12. The device of claim 11, wherein the user interface comprises a plurality of temperature controls, each temperature control corresponding to one of the plurality of electrode outputs.

13. The device of claim 11, further comprising a plurality of temperature sensor inputs, each of the plurality of temperature sensor inputs configured to receive temperature information from a temperature sensor incorporated into one of the probes.

14. The device of claim 13, further comprising a plurality of individual electrode temperature displays corresponding to the plurality of temperature sensor inputs.

15. The device of claim 1, further comprising a graphics panel configured to display at least one of the operating parameters of the device.

16. The device of claim 15, wherein the graphics panel is configured to display the temperature of a plurality of electrode tips.

17. The device of claim 15, wherein the graphics panel is configured to display both the temperature of a plurality of electrode tips, and the temperature of a plurality of electrode tips versus time.

18. The device of claim 1, wherein the RF output provides pulsed high frequency energy.

19. The device of claim 1, further comprising a reference electrode to provide a path for return current from two or more probes.

20. A system for use in delivering therapeutic treatment to a plurality of nerve locations via a plurality of probes, the system comprising:

a radio frequency energy source having an RF output;

a plurality of separate probes which are not connected to one another, each of the plurality of probes comprising an electrode tip, and a temperature sensor to provide information regarding temperature of the electrode tip;

a plurality of electrode outputs coupled to the RF output, wherein each of the electrode outputs is configured to receive temperature information from and provide radio frequency energy to a corresponding one of the probes, wherein the system is configured to regulate energy delivery from the radio frequency energy source to each of the plurality of probes to simultaneously maintain the temperature reported by the temperature sensor of each of the probes.

21. The system of claim 20, further comprising a plurality of temperature displays corresponding to the temperature information received at each of the electrode outputs.

22. The system of claim 20, further comprising a user interface for selecting a user-settable temperature individually associated with any of the electrode outputs.

23. The system of claim 20, wherein the feedback control circuitry comprises a plurality of feedback control circuits each corresponding to one of the plurality of electrode outputs.

24. The system of claim 20, further comprising a reference electrode to provide a path for return current from the plurality of probes.

25. A device for use in delivering therapeutic treatment energy to a plurality of nerve locations via a corresponding plurality of probes, 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;

a mode select interface configured to select from a plurality of settings, wherein, a therapeutic mode setting of the mode select interface is a selection of power at an RF frequency for coupling to any of the plurality of electrode outputs and a stimulate mode setting is a selection of power at a stimulate frequency, which is lower than the RF therapeutic frequency; and

a user interface for selecting a user-settable temperature associated with any of the electrode outputs for use during therapeutic mode, the device being configured such that power at the RF therapeutic frequency to each of the plurality of electrode outputs is regulated to simultaneously maintain an associated user-settable temperature of each of the plurality of electrode outputs at the probe connected to the corresponding electrode output.