Apparatus and method for electromagnetic treatment of neurological injury or condition caused by a stroke

• US 9,440,089 B2
• Filed: 02/03/2014
• Issued: 09/13/2016
• Est. Priority Date: 12/05/2003
• Status: Expired due to Fees

• 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 R
• Application Number:
  US14/171,553
• Publication Number:
  US 20140213843A1
• Time in Patent Office: 953 Days
• Field of Search: 600/9, 600/13, 600/14
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• 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

Described herein are methods of treating neurological injury and conditions, in particular symptoms and complications arising from or caused by a stroke. 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 injury or condition caused by a stroke in a patient in need thereof, the method comprising:

placing a pulsed electromagnetic device comprising a pulsed electromagnetic field source external to a patient'"'"'s head and in proximity to a target region for treatment through a skull;

generating a pulsed electromagnetic field from the pulsed electromagnetic field source 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;

applying the pulsed electromagnetic field through the skull to the target region affected by the neurological injury or condition caused by the stroke; and

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

wherein the pulsed electromagnetic field has a strength of 200 milliGauss or less.

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 electromagnetic field comprises a waveform that modulates at least one biological signaling pathway.

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

14. A method for treating a neurological injury or condition caused by a stroke in a patient in need thereof, the method comprising:

placing a pulsed electromagnetic device comprising a pulsed electromagnetic field source external to a patient'"'"'s head and in proximity to a target region for treatment through a skull;

generating a first pulsed electromagnetic field from the pulsed electromagnetic field source 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;

applying the first pulsed electromagnetic field through the skull to the target region affected by the neurological injury or condition caused by the stroke for a first treatment interval;

reducing a physiological response to the neurological injury or condition 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

externally applying a second pulsed electromagnetic field in proximity to the target region through the skull,

wherein the first and second pulsed electromagnetic fields each have strengths of 200 milliGauss or less.

15. The method of claim 14, wherein the first and second pulsed electromagnetic fields are substantially the same.

16. The method of claim 14, 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.

17. The method of claim 14, further comprising monitoring the physiological response;

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

18. The method of claim 14, 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.

19. The method of claim 14, 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.

20. The method of claim 14, wherein applying the first pulsed electromagnetic field in proximity to a target region affected by the neurological injury or condition caused by the stroke to reduce a physiological response comprises reducing a concentration of IL-1β

.

21. The method of claim 14, further comprising increasing a growth factor in the target region.

22. The method of claim 21, wherein increasing a growth factor in the target region enhances angiogenesis.

23. The method of claim 21, wherein increasing a growth factor in the target region enhances nervous tissue regeneration.

24. The method of claim 21, wherein the growth factor is selected from the group consisting of FGF-2, VEGF, and BMP.

25. The method of claim 14, wherein the target region is a brain of the patient.

26. A method for treating a neurological injury or condition caused by a stroke in a patient in need thereof, the method comprising:

placing a pulsed electromagnetic device comprising a pulsed electromagnetic field source external to a patient'"'"'s head and in proximity to a target region for treatment through a skull;

generating a pulsed electromagnetic field from the pulsed electromagnetic field source 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;

applying the pulsed electromagnetic field through the skull to the target brain region affected by the neurological injury or condition caused by the stroke; and

modulating microglia activation in the target brain region and reducing a physiological response to the neurological injury or condition by applying the pulsed electromagnetic field,

wherein the pulsed electromagnetic field has a strength of 200 milliGauss or less.

27. The method of claim 26, wherein modulating microglia activation comprises reducing microglia activation in the target brain region.

28. A method of promoting neurological repair or growth following a neurological injury or condition caused by a stroke comprising:

placing a treatment coil of a self-contained, lightweight, and portable treatment apparatus externally to a target treatment site 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 wherein the 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 through a skull using the treatment coil; and

reducing a physiological response to the neurological injury or condition by delivering the electromagnetic field,

wherein the pulsed electromagnetic field has a strength of 200 milliGauss or less.

29. The method of claim 28, further comprising delivering the electromagnetic field for a period of about 1 minute to about 240 minutes.

30. The method of claim 28, wherein the physiological response is a cognitive deficiency.

31. The method of claim 28, wherein the target treatment site is a brain.