Method and apparatus for diagnosing and treating neural dysfunction

• US 7,574,257 B2
• Filed: 08/02/2006
• Issued: 08/11/2009
• Est. Priority Date: 08/02/2005
• Status: Active Grant

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories Incorporated), RF Medical Devices, Inc. (Abbott Laboratories Incorporated), Precision Medical Instruments, Inc.
• Original Assignee: NeuroTherm, Inc. (Abbott Laboratories Incorporated)
• Inventors: Rittman, William J. III
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/498,446
• Publication Number:
  US 20070032835A1
• Time in Patent Office: 1,105 Days
• Field of Search: 600 16- 18, 600508-528, 607 2- 7, 606/32, 606/34, 606/41, 606/49
• 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 performing nerve modification procedures comprising:

a device connected to at least two non-connected, separate probes each having electrodes, wherein temperature sensors are incorporated into tip portions of each of said probes;

a radio frequency energy source integrated in said device, wherein energy from said energy source is independently and simultaneously delivered to each said probe;

a feedback control circuit integrated for each probe to regulate energy delivery to each said probe so as to maintain a user settable temperature for each probe, said circuit comprising a control element and a switch, said control element opening and closing said switch based on whether the user settable temperature has been reached; and

a user interface connected to said device, said user interface having a display for selecting the user settable temperature for each probe, and said display showing actual temperatures of said probes.

2. A device in accordance with claim 1, wherein said probes are at least partially electrically insulated over at least part of a shaft of said probes.

3. A device in accordance with claim 1, wherein said energy source delivers low frequency (1-1000 Hz) stimulation pulses.

4. A device in accordance with claim 1, wherein said user interface further comprises at least one display configured to display a graphic representation of the temperature of each probe tip, and/or time versus temperature of each of the said probes.

5. A device in accordance with claim 4, wherein said user interface displays EMG signals that are recorded from each of the probes.

6. A device in accordance with claim 5, wherein the user interface delivers audible representations of the EMG signal.

7. A device in accordance with claim 4, wherein the user interface records and displays user selectable sensory stimulation thresholds from each of said probes.

8. A system for performing nerve modification procedures comprising:

an energy source for generating at least one of a high frequency energy and a low frequency stimulation pulse;

a plurality of non-connected, separate probes each having electrodes connected to said energy source for transmitting energy to a patient, said probes being simultaneously powered by said energy source and independently controlled;

a temperature feedback circuit incorporated in said energy source for each said probe, said feedback circuit including a plurality of temperature sensors incorporated into corresponding probes, and means for monitoring the temperature of said probes to control temperature at said probes to match a selected set temperature, said means for monitoring including a control element and a switch to be set in an open or closed position; and

a user interface for selectively energizing said probes, and enabling said simultaneous and independent control of said probes, and wherein said user interface includes a mean for setting and displaying set temperatures for each of the probes, and means for displaying measured temperatures of said probes in comparison to the selected set temperatures, and energy output options including at least one of EMG measuring, high frequency energy delivery, and low frequency stimulation pulses.

9. A system, as claimed in claim 8, wherein:

said low frequency stimulation pulses are delivered at a frequency of between about 1 to 1,000 Hz.

10. A system, as claimed in claim 8, wherein:

said user interface further comprises at least one display configured to show a graphic representation of temperatures of said probes, and/or time versus temperature for each of said probes.

11. A system, as claimed in claim 8, wherein:

said user interface further includes a showing of recorded EMG signals.

12. A system, as claimed in claim 8, wherein:

said user interface includes audible representations of EMC signals.

13. A system, as claimed in claim 8, wherein:

said user interface records and displays user selectable sensory stimulation thresholds from each of said plurality of probes.

14. A method of controlling a plurality of probes each having electrodes that deliver energy to a targeted area, said method comprising the steps of:

providing an energy source configurable in respective modes to deliver high frequency energy and low frequency stimulation pulses;

providing a plurality of non-connected, separate probes each having electrodes connected to said energy source;

providing a user interface for selecting a mode of said energy source and for selectively controlling energy delivered and for recording measurements of temperature at said probes;

delivering energy through said probes, wherein each of said probes are independently and selectively controlled by a feedback control circuit for each probe;

delivering over a period of time and at selected sequences, the high frequency energy and the low frequency stimulation pulses, and wherein said high frequency energy delivered is simultaneous and is independently controlled for each of said probes;

displaying set temperatures selected by the user and respective measured probe temperatures; and

controlling the delivered energy to disrupt the delivery of energy if the measured probe temperatures reach the corresponding set temperatures.

15. A method, as claimed in claim 14, wherein:

the energy source is delivered to a patient for treatment.

16. A method, as claimed in claim 14, wherein:

the energy source is configurable as an EMG measuring circuit for treatment of a patient.

17. A method for performing nerve modification procedures comprising:

providing an energy source selectively configurable in respective modes to deliver high frequency energy for treatment of target nerves and low frequency pulses for observing stimulation of the target nerves;

providing a plurality of non-connected, separate probes each having electrodes connected to the energy source;

providing a feedback control circuit for each probe to regulate energy delivery to each said probe so as to maintain a user settable temperature for each probe, each control circuit including a control element and a switch that is activatable by the control element to connect and disconnect a corresponding probe from receiving energy from the energy source;

providing a user interface for selecting a mode of said energy source and for selectively controlling energy delivered and for recording measurements of temperature at said probes;

delivering energy through said probes, wherein each of said probes are independently and selectively controlled by their corresponding feedback control circuit;

delivering over a period of time and at selected sequences, the high frequency energy and the low frequency pulses, and wherein said high frequency energy delivered by said electrodes is probes simultaneous; and

displaying on the user interface the temperature of each of said probes.