Method and apparatus for electromagnetic treatment of head, cerebral and neural injury in animals and humans

• US 9,427,598 B2
• Filed: 10/03/2011
• Issued: 08/30/2016
• Est. Priority Date: 10/01/2010
• Status: Active Grant

• Current Assignee: SofPulse, Inc.
• Original Assignee: Rio Grande Neurosciences, Inc.
• Inventors: Pilla, Arthur A., Casper, Diana, Strauch, Berish
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): WILSON, KAYLEE R
• Application Number:
  US13/252,114
• Publication Number:
  US 20120116149A1
• Time in Patent Office: 1,793 Days
• Field of Search: 600/9, 600/13, 600/14, 604/20, 607/3
• US Class Current: 1/1
• 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 2/004 specially adapted for a specific therapy
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue

Abstract

Embodiments of the invention include methods of treating neurological injury and conditions, in particular, traumatic brain injury and physiological responses arising from injury or conditions. 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 1 in proximity to a target region affected by the neurological injury or condition to reduce a physiological response to the neurological injury or condition.

Claims

1. A non-invasive method for treating a traumatic neurological injury or condition in a patient in need thereof, the method comprising:

externally placing a pulsed electromagnetic device in proximity to a target region for treatment through a skull;

generating a first pulsed electromagnetic field from a pulsed electromagnetic field source, having a strength of 200 milliGauss or less wherein the pulsed electromagnetic field comprises bursts of between 5-50 MHz sinusoidal waves, wherein the bursts repeat at between 0.01 and 100 Hz;

applying the external pulsed electromagnetic field to the target region affected by the neurological injury or condition, wherein the neurological injury or condition includes traumatic brain injury (TBI); and

reducing a physiological response to the neurological injury or condition by applying the external pulsed electromagnetic field.

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

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

4. 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.

5. The method of claim 4, wherein the physiological response is increased intracranial pressure and the acceptable level is below about 20 mmHg.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

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

12. The method of claim 1, wherein the physiological system is the cardiac system.

13. The method of claim 1, wherein the physiological system is the pulmonary 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. The method of claim 1, further comprising prior to generating the pulsed electromagnetic field from the pulsed electromagnetic field source:

pre-programming a pulsed electromagnetic waveform to treat the target brain region affected by the traumatic brain injury (TBI);

placing the pulsed electromagnetic field source adjacent to the target brain region for treatment through a skull;

wherein generating the pulsed electromagnetic field from the pulsed electromagnetic field source includes the pre-programmed pulsed electromagnetic waveform.

17. A non-invasive method for treating a traumatic neurological injury or condition in a patient in need thereof, the method comprising:

externally placing a pulsed electromagnetic device in proximity to a target region for treatment through a skull;

generating a first pulsed electromagnetic field from a pulsed electromagnetic field source, having a strength of 200 milliGauss or less wherein the pulsed electromagnetic field comprises bursts of between 5-50 MHz sinusoidal waves, wherein the bursts repeat at between 0.01 and 100 Hz;

applying the first pulsed electromagnetic field in proximity to a target region affected by the neurological injury or condition, wherein the neurological injury or condition includes traumatic brain injury (TBI);

reducing a physiological response to the neurological injury or condition for a first treatment interval by applying the first pulsed electromagnetic field;

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

applying a second pulsed electromagnetic field in proximity to the target region.

18. The method of claim 17, wherein the first and second pulsed electromagnetic fields are substantially the same.

19. The method of claim 17, 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.

20. The method of claim 17, further comprising

monitoring the physiological response;

and

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

21. The method of claim 17, 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.

22. The method of claim 17, 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.

23. The method of claim 17, wherein applying the first pulsed electromagnetic field in proximity to a target region affected by the neurological injury or condition to reduce a physiological response comprises reducing a concentration of IL-Iβ

.

24. The method of claim 17, further comprising increasing a growth factor in the target region.

25. The method of claim 24, wherein increasing a growth factor in the target region enhances angiogenesis.

26. The method of claim 24, wherein increasing a growth factor in the target region enhances nervous tissue regeneration.

27. The method of claim 24, wherein the growth factor is selected from the group consisting of FGF-2, VEGF, and BMP.

28. The method of claim 17, wherein the target region is a brain of the patient.

29. The method of claim 17, wherein the inter-treatment period is greater than two hours.

30. A non-invasive method for treating a traumatic neurological injury or condition in a patient in need thereof, the method comprising:

externally placing a pulsed electromagnetic device in proximity to a target region for treatment through a skull;

pre-programming a pulsed electromagnetic waveform to treat a target brain region affected by a neurological injury or condition, wherein the neurological injury or condition includes traumatic brain injury (TBI);

placing the pulsed electromagnetic device adjacent to the target brain region;

generating a pulsed electromagnetic field from a pulsed electromagnetic field source, having a strength of 200 milliGauss or less wherein the pulsed electromagnetic field comprises bursts of between 5-50 MHz sinusoidal waves, wherein the bursts repeat at between 0.01 and 100 Hz, the pulsed electromagnetic field including the pulsed electromagnetic waveform;

applying the pulsed electromagnetic field to the target brain region affected by the traumatic brain injury; and

accelerating and increasing the binding of Ca2+ to Calmodulin in the target brain region and reducing a physiological response to the traumatic brain injury by applying the pulsed electromagnetic field.

31. A non-invasive method of promoting neurological repair or growth following a traumatic neurological injury or condition comprising:

placing a treatment coil of a self-contained, lightweight, and portable treatment apparatus externally to a target treatment site through the skull in need of repair or development, 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, having a strength of 200 milliGauss or less wherein the pulsed electromagnetic field comprises bursts of between 5-50 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 a physiological response to the neurological injury or condition by delivering the electromagnetic field, wherein the neurological injury or condition includes traumatic brain injury (TBI).

32. The method of claim 31, further comprising delivering the electromagnetic field for a period of about 1 minute to about 240 minutes.

33. The method of claim 31, wherein the physiological response is a cognitive deficiency.

34. The method of claim 31, wherein the target treatment site is a brain.