IP Library Granted Patent US 9,433,797
Granted Patent B2
US 9,433,797 · App. 14/171,613 · Granted Sep 6, 2016

Apparatus and method for electromagnetic treatment of neurodegenerative conditions

Inventors: Arthur A. Pilla (Oakland, NJ); Andre' A. DiMino (Woodcliff Lake, NJ); Iyer Viswanathan (Santa Clara, CA); Diana Casper (New York, NY); Berish Strauch (Rye, NY)
Assignee: Rio Grande Neurosciences, Inc.
A61N2/006A61N1/36014A61N2/008A61N2/02A61N1/36025
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Quick Facts
Patent No.
US 9,433,797
App. No.
14/171,613
Granted
Sep 6, 2016
Kind
B2
Abstract

Described herein are methods of treating neurological injury and conditions, in particular neurodegenerative 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 in proximity to a target region.

Claims (89)

1. A method for treating a neurodegenerative disease or condition 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;

applying the pulsed electromagnetic field through the skull to a target cerebrofacial tissue; and

reducing a physiological response to the neurodegenerative disease 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 target cerebrofacial tissue is a head.

3. The method of claim 1 , wherein the target cerebrofacial tissue is a brain.

4. The method of claim 1 , wherein applying the pulsed electromagnetic field treats a degenerative neurological pathology.

5. The method of claim 1 , wherein pulsed electromagnetic field is applied for 1 minute to 240 minutes.

6. The method of claim 1 , wherein further comprising placing the pulsed electromagnetic field source in proximity to the cerebrofacial tissue.

7. The method of claim 1 , wherein generating the pulsed electromagnetic field comprises generating an electromagnetic field with a pulse burst envelope of mono- or bi-polar rectangular or sinusoidal pulses which induce peak electric fields between 10-8 and 10 volts per centimeter (V/cm).

8. The method of claim 1 , wherein generating the pulsed electromagnetic field comprises generating at least one burst of sinusoidal, rectangular, chaotic, or random wave shapes, having a frequency content in a range of about 0.01 Hz to about 100 MHz, having a burst duration from about 0.1 to about 100 msec, and having a burst repetition rate from about 0.01 to about 1000 bursts/second.

9. The method of claim 1 , wherein the pulsed electromagnetic field comprises about 0.01 millisecond to about 10 millisecond burst of 27.12 MHz sinusoidal waves repeating at about 1 to about 100 bursts per second.

10. The method of claim 9 , wherein the pulsed electromagnetic field has an induced electric field from about 0.001 mV/cm to about 100 mV/cm.

11. The method of claim 1 , wherein the neurodegenerative disease or condition includes Parkinson's disease.

12. The method of claim 1 , wherein applying the pulsed electromagnetic field prevents the deterioration of neurons in the cerebrofacial tissue.

13. The method of claim 1 , wherein applying the pulsed electromagnetic field increases a neuron population in the cerebrofacial tissue.

14. The method of claim 1 , wherein applying the pulsed electromagnetic field increases cytokines in the cerebrofacial tissue.

15. The method of claim 1 , wherein applying the pulsed electromagnetic field increases growth factors in the cerebrofacial tissue.

16. The method of claim 1 , wherein applying the pulsed electromagnetic field enhances blood flow in the cerebrofacial tissue.

17. A method for treating a neurodegenerative disease or condition a 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; applying the pulsed electromagnetic field through the skull to a target region affected by the neurodegenerative disease or condition; and

reducing a physiological response to the neurodegenerative disease or condition by applying the pulsed electromagnetic field,

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

18. The method of claim 17 , wherein the physiological response is inflammation.

19. The method of claim 17 , wherein the physiological response is increased intracranial pressure.

20. The method of claim 17 , further comprising

monitoring the physiological response; and

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

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

22. The method of claim 17 , wherein generating the pulsed electromagnetic field comprises a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 Hz.

23. The method of claim 17 , wherein the pulsed electromagnetic field comprises a 3 msec burst of 27.12 MHz sinusoidal waves repeating at 2 Hz.

24. The method of claim 17 , wherein the pulsed electromagnetic field comprises a 4 msec burst of 27.12 MHz sinusoidal waves repeating at 2 Hz.

25. The method of claim 17 , wherein the neurodegenerative injury or condition is Parkinson's disease or Alzheimer's disease.

26. The method of claim 17 , 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.

27. The method of claim 17 , 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.

28. The method of claim 17 , wherein the pulsed electromagnetic field comprises an ISM carrier or any other radio frequency up to 10,000 GHz, configured to modulate a rhythm of a physiological system.

29. The method of claim 28 , wherein the physiological system is the central nervous system.

30. The method of claim 17 , wherein the pulsed electromagnetic field comprises an ISM carrier or any other radio frequency up to 10,000 GHz, configured to modulate a rhythm of a brain.

31. The method of claim 17 , wherein the electromagnetic field comprises a waveform that modulates at least one biological signaling pathway.

32. The method of claim 17 , wherein the pulsed electromagnetic field comprises an ISM carrier or any other radio frequency up to 10,000 GHz, configured to modulate a sleep pattern.

33. The method of claim 17 , wherein the pulsed electromagnetic field comprises an ISM carrier or any other radio frequency up to 10,000 GHz, configured to modulate slow-wave sleep in a sleep cycle to effect the production of human growth hormone.

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

35. A method for treating a neurodegenerative injury or condition 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;

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

reducing a physiological response to the neurodegenerative 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

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

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

36. The method of claim 35 , wherein the first and second pulsed electromagnetic fields are substantially the same.

37. The method of claim 35 , 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.

38. The method of claim 35 , further comprising

monitoring the physiological response; and

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

39. The method of claim 35 , 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.

40. The method of claim 35 , 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.

41. The method of claim 35 , wherein applying the first pulsed electromagnetic field in proximity to a target region affected by the neurodegenerative injury or condition to reduce a physiological response comprises reducing a concentration of IL-1β.

42. The method of claim 35 , wherein the neurodegenerative injury or condition is Parkinson's disease or Alzheimer's disease.

43. The method of claim 35 , further comprising increasing a growth factor in the target region.

44. The method of claim 43 , wherein increasing a growth factor in the target region enhances angiogenesis.

45. The method of claim 43 , wherein increasing a growth factor in the target region enhances nervous tissue regeneration.

46. The method of claim 43 , wherein the growth factor is selected from the group consisting of FGF-2, VEGF, and BMP.

47. The method of claim 35 , wherein the target region is a brain of the patient.

48. A method for treating a neurodegenerative injury or condition 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;

externally applying the pulsed electromagnetic field through a skull to a target brain region affected by the neurodegenerative injury or condition;

modulating microglia activation in the target brain region by externally applying the pulsed electromagnetic field; and

reducing a physiological response to the neurodegenerative injury or condition by modulating microglia activation in the target brain region,

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

49. The method of claim 48 , wherein modulating microglia activation comprises reducing microglia activation in the target brain region.

50. The method of claim 48 , wherein the neurodegenerative injury or condition is Parkinson's disease or Alzheimer's disease.

51. A method of promoting neurodegenerative repair or growth following a neurodegenerative injury or condition 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;

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

reducing a physiological response to the neurodegenerative injury or condition by delivering the electromagnetic field;

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

52. The method of claim 51 , wherein generating an electromagnetic field comprises generating at least one burst of sinusoidal, rectangular, chaotic, or random waveforms, having a frequency content in a range of about 0.01 Hz to about 10,000 MHz, having a burst duration from about 0.1 to about 100 msec, at a peak amplitude of 0.001 G to about 0.1 G, and having a burst repetition rate from about 0.01 to about 100 bursts/second.

53. The method of claim 51 , further comprising delivering the electromagnetic field for a period of about 1 minute to about 240 minutes.

54. The method of claim 51 , wherein the physiological response is a cognitive deficiency.

55. The method of claim 51 , wherein the neurodegenerative injury or condition is Parkinson's disease or Alzheimer's disease.

56. The method of claim 51 , wherein the target treatment site is a brain.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 9, 2024
From: ENDONOVO THERAPEUTICS, INC.
To: SOFPULSE, INC.
Reel/Frame 067933/0673 →
LICENSE Recorded Sep 24, 2019
From: RIO GRANDE NEUROSCIENCES, INC., ASSIGNOR TO ENDONOVO THERAPEUTICS INC.
To: AAH HOLDINGS LLC
Reel/Frame 050475/0809 →
SECURITY AGREEMENT Recorded Feb 1, 2018
From: ENDONOVO THERAPEUTICS, INC.
To: STEVEN M. GLUCKSTERN
Reel/Frame 045221/0863 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2018
From: RIO GRANDE NEUROSCIENCES, INC.
To: ENDONOVO THERAPEUTICS INC.
Reel/Frame 044644/0182 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 5, 2016
From: IVIVI HEALTH SCIENCES, LLC
To: RIO GRANDE NEUROSCIENCES, INC.
Reel/Frame 037445/0365 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 28, 2015
From: IVIVI HEALTH SCIENCES, LLC
To: RIO GRANDE NEUROSCIENCES, INC.
Reel/Frame 037394/0244 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 3, 2014
From: PILLA, ARTHUR A.; DIMINO, ANDRE' A.; VISWANATHAN, IYER; CASPER, DIANA; STRAUCH, BERISH
To: IVIVI HEALTH SCIENCES, LLC
Reel/Frame 034094/0001 →
Continuity (25)
Continuation In Part 13252114 · Oct 3, 2011
Continuation In Part 13801789 · Mar 13, 2013
Continuation 12819956 · Jun 21, 2010
Continuation In Part 12772002 · Apr 30, 2010
Continuation 11003108 · Dec 3, 2004
Continuation In Part 11114666 · Apr 26, 2005
Continuation In Part 11110000 · Apr 19, 2005
Continuation In Part 11369308 · Mar 6, 2006
Continuation In Part 11369309 · Mar 6, 2006
Continuation In Part 11223073 · Sep 10, 2005
Continuation In Part 11339204 · Jan 25, 2006
Continuation In Part 11818065 · Jun 12, 2007
Continuation In Part 11903294 · Sep 20, 2007
Continuation In Part 11977043 · Oct 22, 2007
Provisional Application 61389038 · Oct 1, 2010
Provisional Application 61456310 · Nov 4, 2010
Provisional Application 60527327 · Dec 5, 2003
Provisional Application 60564887 · Apr 26, 2004
Provisional Application 60563104 · Apr 19, 2004
Provisional Application 60658967 · Mar 7, 2005
Provisional Application 60658968 · Mar 7, 2005
Provisional Application 60812841 · Jun 12, 2006
Provisional Application 60846126 · Sep 20, 2006
Provisional Application 60852927 · Oct 20, 2006
Related Publication 20140221726A1 · Aug 7, 2014