Random pulsed high frequency therapy

• US 20170050021A1
• Filed: 08/20/2004
• Published: 02/23/2017
• Est. Priority Date: 08/20/2004
• Status: Abandoned Application

• Current Assignee: Cosman Medical, Inc. (Boston Scientific Corporation)
• Original Assignee: Eric Richard Sr. Cosman
• Inventors: Cosman, Eric Richard Sr.
• Application Number:
  US10/922,173
• Publication Number:
  US 20170050021A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/00446 Brain
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00672 lower
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/0072 Current
• CPC Class Codes: A61B 2018/00726 Duty cycle
• CPC Class Codes: A61B 2018/00732 Frequency
• CPC Class Codes: A61B 2018/00767 Voltage
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/128 generating two or more frequencies
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 : for treatment of pain
• CPC Class Codes: A61N 1/36025 : for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia

Abstract

A method and apparatus for modifying a function of tissue can include the application of an electromagnetic signal output to tissue cells. The electromagnetic signal output can have a waveform with bursts of signal output amplitude that produces fields in the tissue during the burst on-time that can modify cell components. The on-time periods are followed by off-time periods of low signal output amplitude which produce lesser modification effects on cell components. The on-time periods have time durations that are non-predetermined and random. The rate of on-time bursts can be regular, and in one example periodic. In one example, the waveform has amplitudes during the on-time periods and durations of on-time periods that causes elevation of the temperature of tissue that exceeds the lethal temperature levels of 45 to 50° C.

Claims

1. An apparatus for altering a function of living tissue comprising:

an electrode; and

a signal generator coupled to the electrode to generate an electrical signal output to be applied to the living tissue through the electrode, the electrical signal output having an interrupted waveform having bursts of on-time periods of a high frequency carrier frequency component, the on-time periods having non-predictable and uncorrelated time durations, each of the on-time periods being followed by off-time periods, the amplitude of the electrical signal output during the off-time periods being low relative to the amplitude of the electrical signal output of the on-time period, and the bursts of the on-time periods commencing at a regular rate, such that the application of the electrical signal output to the living tissue for a sufficient treatment time will result in alteration of a function of the living tissue.

2. The apparatus of claim 1, wherein the waveform results in an average temperature in the living tissue that is below the lethal temperature range of about 45 to 50°

C.

3. The apparatus of claim 1, wherein the waveform results in an average temperature in the living tissue that is above the lethal temperature range of about 45 to 50°

C.

4. The apparatus of claim 2, wherein the waveform of the signal output results in peak heating temperatures in the living tissue to be treated during at least some of the on-time periods that are above the lethal temperature range of 45 to 50°

C.

5. The apparatus of claim 2, wherein the waveform of the signal output results in peak heating temperatures in the living tissue to be treated during the on-time periods that are below the lethal temperature range of 45 to 50°

C.

6. The apparatus of claim 1, wherein the high frequency carrier frequency component comprises at least one radiofrequency wave signal.

7. The apparatus of claim 1, wherein the high frequency carrier frequency component comprises frequency components in the physiologic stimulation frequency range.

8. The apparatus of claim 1, wherein the high frequency carrier frequency component comprises frequency components in the radiofrequency range.

9. The apparatus of claim 1, wherein the on-time periods have random time durations.

10. The apparatus of claim 1, wherein the regular rate is a periodic rate.

11. The apparatus of claim 1, wherein the regular rate is a constant rate.

31. The apparatus of claim 1, wherein the durations of the on-time periods are substantially shorter than durations of the off-time periods.

32. The apparatus of claim 1, wherein the signal amplitude of the electrical signal during the off-periods is reduced substantially relative to the signal amplitude of the electrical signal during the on-periods.

33. The apparatus of claim 1, wherein the signal amplitude of the electrical signal during the off-periods is reduced to substantially zero relative to the signal amplitude of the electrical signal during the on-periods.

34. The apparatus of claim 1, wherein the high frequency carrier frequency component comprises carrier wave oscillation frequencies.

12. (canceled)

13. A method of altering a function of tissue in a living body comprising:

applying a generated interrupted high frequency waveform having on-time bursts of a high frequency signal output of non-predictable and uncorrelated on-time durations, the high frequency signal output during the on-time bursts comprising at least one high frequency carrier frequency component, each of the on-time bursts being followed by an off-time period of a low signal output relative to the intensity of the preceding on-time period, the off-time periods having a non-predictable and uncorrelated off-time durations, the bursts commencing at a regular rate, to tissue being treated for a treatment time sufficient to result in alteration of a function of the tissue without resulting in an average temperature elevation of the tissue being treated above the lethal temperature range.

14. The method of claim 13, wherein the generated waveform includes bursts generated at a regular rate that is a constant rate.

15. The method of claim 13, wherein the generated waveform includes bursts generated at a periodic rate.

17. The method of claim 13, wherein applying included placing an electrode in proximity to a functional target of the nervous system of a patient selected from the group consisting of the spinal cord, spinal ganglia, peripheral nerves, thalamus, basal ganglia of the brain, pallidum, sub-thalamic nucleus, vagus nerve, epilogenic centers, the intervertebral disc, the prostatic nerves, and the cardiac nerves.

18. The method of claim 13, wherein the applying includes applying an electrode adapted to carry the interrupted high frequency waveforms in proximity to a functional target of the nervous system of a patient to cause the patient to experience a reduction in symptoms of a condition selected from the group consisting of epilepsy, tremor, Parkinson'"'"'s disease, spasticity, mood disorder, cardiac arrhythmia, depression, back pain, spinal pain, cancer pain, urinary disorders associated with the prostate and bladder, headache, and discogenic pain.

35. The method of claim 13, wherein the durations of the on-time periods are substantially shorter than durations of the off-time periods.

36. The method of claim 13, wherein the signal amplitude of the electrical signal during the off-periods is reduced substantially relative to the signal amplitudes of the electrical signal during the on-periods.

37. The method of claim 13, wherein the signal amplitude of the electrical signal during the off-periods is reduced to substantially zero relative to the signal amplitude of the electrical signal during the on-periods.

16. (canceled)

19. A method for modification of tissue function comprising:

applying a generated interrupted high frequency waveforms having non-predictable and uncorrelated time periods of on-time bursts of high frequency output followed by non-predictable and uncorrelated off-time periods of low output amplitude relative to the amplitude of the on-time burst, the high frequency signal output during said on-time bursts comprising at least one high frequency carrier frequency component, the rate of on-time bursts being regular, to target tissue to be treated for a treatment time sufficient to result in modification of the target tissue and heating at least a portion of the target tissue during at least a portion of the on-time bursts to temperatures that are above a lethal temperature range for tissue of about 45 to 50°

C.

20. The method of claim 19, wherein the generated waveform includes on-time bursts generated at a constant rate.

21. The method of claim 19, wherein the generated waveform includes on-time bursts generated at a periodic rate.

22. An apparatus for alteration of a function of selected tissue comprising:

a signal generator configured to generate interrupted high frequency waveforms having non-predictable and uncorrelated time periods of on-time bursts of high frequency output followed by non-predictable and uncorrelated off-time periods of low output amplitude relative to the amplitude of the on-time burst and the rate of commencing the on-time bursts being regular, the high frequency signal output during said on-time bursts comprising at least one high frequency carrier frequency component; and

an electrode coupled to the generator and being adapted to apply the interrupted high frequency waveforms to the selected tissue, wherein application of the interrupted high frequency waveforms to the selected tissue for a sufficient time alters a function of the selected tissue while inhibiting heating of the selected tissue to lethal temperatures for the selected tissue.

23. An apparatus for altering a function of tissue comprising:

an electrode adapted to apply an amplitude modulated signal to the tissue,

a signal generator adapted to connect to the electrode that generates an electromagnetic signal output with an amplitude modulated waveform having bursts of on-time periods during which a high frequency waveform is applied to the tissue, the high frequency waveform having at least one high frequency component, the bursts of on-time periods having non-predictable and uncorrelated durations and commencing at a regular rate, the amplitude of the waveform during at least some of the bursts of on-time periods being sufficient to elevate the temperature of at least a portion of the tissue to the lethal temperature range during the at least some of the bursts of on-time periods, each burst of on-time period being followed by an off-time period having a non-predictable and uncorrelated off-time duration and during which the amplitude of the waveform is lower than the amplitude of the on-time period, so that when the electromagnetic signal output is applied to the tissue through the electrode for a sufficient treatment time an alteration of a function of the tissue will occur.

24. The apparatus of claim 23, wherein the amplitude of the off-time period is approximately zero.

25. The apparatus of claim 23, wherein the temperature elevation of the tissue during the treatment time on average remains below the lethal temperature range.

26. The apparatus of claim 23, wherein the temperature elevation of at least a portion of the tissue on average exceeds the lethal temperature range for at least some of the treatment time.

27. The apparatus of claim 23, wherein the waveform has an average duty cycle that is a predetermined value, and the duty cycle values for the bursts of on-time periods and the corresponding the following off-time periods vary in a non-predictable variation around the average duty cycle, and the duty cycle values are distributed over a range of values that are non-approximate to the average duty cycle.

28. A method of altering a function of tissue, comprising:

applying an amplitude modulated electrical signal from a signal generator to the tissue through an electrode,

the amplitude modulated electrical signal having a waveform having bursts of electrical signal output for on-time periods, each of the on-time periods being followed by an off-time period of low electrical signal output relative to the electrical signal output of the on-time periods, the waveform during the bursts having at least one high frequency carrier wave oscillation frequency component, the on-time periods of the bursts having non-predictable and uncorrelated durations, and the bursts commencing at a regular rate;

electromagnetically coupling the signal generator to the electrode;

adjusting the amplitude of the signal electrical output for the on-time periods so that during at least some of the bursts the temperature of at least a portion of the tissue is elevated to the lethal temperature range; and

maintaining the application of the amplitude modulated electrical signal to the tissue for sufficient treatment time to alter a function of the tissue.

29. A system for altering a function of tissue of tissue comprising:

a signal applicator adapted to apply an electrical signal output to the tissue;

a signal generator that generates an electrical signal output including high frequency waveforms having non-predictable and uncorrelated time periods of on-time bursts of at least one high frequency carrier wave oscillation frequency component, each on-time burst being followed by an off-time period, the electrical signal output having a strength during the off-time periods being sufficiently low to have no function-altering effect on the tissue, the rate of commencement of the on-time bursts being regular, and the strength of the electrical output signal during the on-time bursts being sufficient to alter the function of the tissue when the signal is applied to the tissue for a sufficient treatment time; and

a signal coupler that couples the signal generator and the signal applicator.

30. A method for altering the function of tissue comprising:

generating an electrical signal including an interrupted high frequency waveform having non-predictable and uncorrelated time periods of on-time bursts of at least one high frequency carrier wave oscillation frequency component, each on-time burst being followed by an off-time period, the strength of the electrical signal during the off-time period being sufficiently low to have no function-altering effect on the tissue, the rate of commencement of the on-time bursts being regular, and the strength of the electrical signal during the on-time bursts being sufficient to alter the function of the tissue when the electrical signal is applied to the tissue for a sufficient treatment time; and

applying the electrical signal to the tissue for the sufficient treatment time.