Apparatus and method for electromagnetic treatment of neurological pain

• US 9,415,233 B2
• Filed: 02/03/2014
• Issued: 08/16/2016
• Est. Priority Date: 12/05/2003
• Status: Active Grant

• Current Assignee: SofPulse, Inc.
• Original Assignee: Rio Grande Neurosciences, Inc.
• Inventors: Pilla, Arthur A., DiMino, Andre' A., Viswanathan, Iyer, Casper, Diana, Strauch, Berish
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Wilson, Kaylee
• Application Number:
  US14/171,644
• Publication Number:
  US 20140213844A1
• Time in Patent Office: 925 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia

Abstract

Described herein are methods of treating neurological injury and conditions, in particular neurological pain. These treatment methods can include the steps of generating a pulsed electromagnetic field from a pulsed electromagnetic field source and applying the pulsed electromagnetic field in proximity to a target region.

Claims

1. A method for treating a neurological pain in a patient in need thereof, the method comprising:

generating a pulsed electromagnetic field from a portable pulsed electromagnetic field source, the pulsed electromagnetic field having a peak amplitude of less than 200 milliGauss and wherein the pulsed electromagnetic field comprises bursts of between 15-40 MHz sinusoidal waves, wherein the bursts repeat at between 0.01 and 100 Hz;

externally applying the pulsed electromagnetic field through a skull to a target region affected by the neurological pain; and

reducing the neurological pain or a physiological response to the neurological pain by externally applying the pulsed electromagnetic field.

2. The method of claim 1, wherein reducing a physiological response by applying the pulsed electromagnetic field includes reducing inflammation in the target region.

3. The method of claim 1, wherein the physiological response is neuronal degeneration.

4. The method of claim 1, wherein the physiological response is inflammation.

5. The method of claim 1, wherein the physiological response is increased intracranial pressure.

6. The method of claim 1, further comprising

monitoring the physiological response;

and

continuing to apply the pulsed electromagnetic field until an acceptable level of the physiological response is reached.

7. The method of claim 6, wherein the physiological response is increased intracranial pressure and the acceptable level is below about 20 mmHg.

8. The method of claim 1, wherein generating the pulsed electromagnetic field comprises a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 Hz.

9. The method of claim 1, wherein the pulsed electromagnetic field comprises a 3 msec burst of 27.12 MHz sinusoidal waves repeating at 2 Hz.

10. The method of claim 1, wherein the pulsed electromagnetic field comprises a 4 msec burst of 27.12 MHz sinusoidal waves repeating at 2 Hz.

11. The method of claim 1, wherein the pulsed electromagnetic field comprises about a 1 msec to about a 10 msec burst of 27.12 MHz sinusoidal waves repeating at about 1 Hz to about 10 Hz.

12. The method of claim 1, wherein the pulsed electromagnetic field comprises an ISM carrier frequency modulated at about a 1 msec to about a 10 msec burst repeating at about 1 Hz to about 10 Hz.

13. The method of claim 1, wherein the physiological system is the central nervous system.

14. The method of claim 1, wherein the electromagnetic field comprises a waveform that modulates at least one biological signaling pathway.

15. The method of claim 1, wherein the target region is a brain of the patient.

16. A method for treating a neurological pain in a patient in need thereof, the method comprising:

generating a first pulsed electromagnetic field from a pulsed electromagnetic field source, the first pulsed electromagnetic field having a peak amplitude of less than 200 milliGauss and wherein the pulsed electromagnetic field comprises bursts of between 15-40 MHz sinusoidal waves, wherein the bursts repeat at between 0.01 and 100 Hz;

externally applying the first pulsed electromagnetic field through a skull to a target region affected by the neurological pain for a first treatment interval;

reducing the neurological pain or a physiological response to the neurological pain by externally applying the first pulsed electromagnetic field;

discontinuing the application of the first pulsed electromagnetic field for an inter-treatment period greater than zero; and

externally applying a second pulsed electromagnetic field to the target region wherein the second pulsed electromagnetic field has a peak amplitude of less than 200 milliGauss and wherein the pulsed electromagnetic field comprises bursts of between 15-40 MHz sinusoidal waves, wherein the bursts repeat at between 0.01 and 100 Hz.

17. The method of claim 16, wherein reducing a physiological response by applying the first pulsed electromagnetic field includes reducing inflammation in the target region.

18. The method of claim 16, wherein the physiological response is neuronal degeneration.

19. The method of claim 16, wherein the first and second pulsed electromagnetic fields are substantially the same.

20. The method of claim 16, further comprising

monitoring the physiological response;

and

modifying the first pulsed electromagnetic field to the second pulsed electromagnetic field in response to the monitoring step.

21. The method of claim 16, further comprising

monitoring the physiological response;

and

discontinuing treatment once an acceptable level of the physiological response is reached.

22. The method of claim 16, further comprising attenuating inflammatory cytokines and growth factors at the target region by applying the first pulsed electromagnetic field or the second pulsed electromagnetic field to the target region.

23. The method of claim 16, further comprising accelerating the healing of the target region by applying the first pulsed electromagnetic field or the second pulsed electromagnetic field to the target region.

24. The method of claim 16, wherein applying the first pulsed electromagnetic field in proximity to a target region affected by the neurological pain to reduce a physiological response comprises reducing a concentration of IL-1β

.

25. The method of claim 16, further comprising increasing a growth factor in the target region.

26. The method of claim 25, wherein increasing a growth factor in the target region enhances angiogenesis.

27. The method of claim 25, wherein increasing a growth factor in the target region enhances nervous tissue regeneration.

28. The method of claim 25, wherein the growth factor is selected from the group consisting of FGF-2, VEGF, and BMP.

29. The method of claim 16, wherein the target region is a brain of the patient.

30. A method for treating a neurological pain in a patient in need thereof, the method comprising:

generating a pulsed electromagnetic field from a pulsed electromagnetic field source, the pulsed electromagnetic field having a peak amplitude of less than 200 milliGauss and wherein the pulsed electromagnetic field comprises bursts of between 15-40 MHz sinusoidal waves, wherein the bursts repeat at between 0.01 and 100 Hz;

externally applying the pulsed electromagnetic field through a skull to a target brain region affected by the neurological pain; and

modulating microglia activation in the target brain region and reducing the neurological pain or a physiological response to the neurological pain by externally applying the pulsed electromagnetic field.

31. The method of claim 30, wherein reducing a physiological response by applying the pulsed electromagnetic field includes reducing inflammation in the target region.

32. The method of claim 30, wherein the physiological response is neuronal degeneration.

33. The method of claim 30, wherein modulating microglia activation comprises reducing microglia activation in the target brain region.

34. A method of promoting neurological repair or growth to treat a neurological pain comprising:

placing a treatment coil of a self-contained, lightweight, and portable treatment apparatus externally through a skull to a target treatment site in need of treatment, wherein the treatment apparatus comprises a conformable coil having one or more turns of wire and a control circuit;

generating an electromagnetic field using the treatment coil, the electromagnetic field having a peak amplitude of less than 200 milliGauss and wherein the pulsed electromagnetic field comprises bursts of between 15-40 MHz sinusoidal waves, wherein the bursts repeat at between 0.01 and 100 Hz;

delivering the electromagnetic field to the target treatment site using the treatment coil; and

reducing the neurological pain or a physiological response to the neurological pain by delivering the electromagnetic field.

35. The method of claim 34, wherein reducing a physiological response by delivering the electromagnetic field to the target treatment site includes reducing inflammation in the target treatment site.

36. The method of claim 34, wherein the physiological response is neuronal degeneration.

37. The method of claim 34, further comprising delivering the electromagnetic field for a period of about 1 minute to about 240 minutes.

38. The method of claim 34, wherein the target treatment site is a brain.