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(12) Patent Application Publication (10) Pub. No.: US 2014/0303425 A1 Pilla Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2014/0303425 A1 Pilla Et Al US 20140303425A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0303425 A1 Pilla et al. (43) Pub. Date: Oct. 9, 2014 (54) METHOD AND APPARATUS FOR GOIR 33/48 (2006.01) ELECTROMAGNETIC TREATMENT OF A6IB 6/03 (2006.01) COGNITION AND NEUROLOGICAL INURY A6IB5/0476 (2006.01) A6IB5/00 (2006.01) (71) Applicant: IVIVI HEALTH SCIENCES, LLC, A6N2/00 (2006.01) San Francisco, CA (US) (52) U.S. Cl. CPC ................ A61N 2/02 (2013.01); A61 B 5/4836 (72) Inventors: Arthur A. Pilla, Oakland, NJ (US); (2013.01); A6 IB5/II (2013.01); A6 IB5/03 I Andre A. Dimino, Woodcliff, NJ (US); (2013.01); A61B5/746 (2013.01); A61B Sean Hagberg, San Francisco, CA (US); 5/6803 (2013.01); A61N 2/004 (2013.01); Steven M. Gluckkstern, San Francisco, GOIR 33/4806 (2013.01); A6 IB 6/037 CA (US) (2013.01); A61B5/0476 (2013.01); A61B 5/0488 (2013.01) (21) Appl. No.: 14/354,587 USPC .................................. 600/14; 600/15; 600/13 (86). PCT No.: PCT/US2O12/063576 Methods and devices for providing therapeutic electromag netic field treatment to a subject having a cognitive or neuro S371 (c)(1), logical condition or injury. Treatment devices can include (2), (4) Date: Apr. 27, 2014 headwear incorporating electromagnetic treatment delivery O O devices providing electromagnetic treatment to a user's head Related U.S. Application Data area. Such devices include protective headwear such as hel (60) Provisional application No. 61/556,068, filed on Nov. mets with electromagnetic delivery devices. Additionally, 4, 2011. embodiments of the invention provide for wearable and adjustable electromagnetic treatment devices that can be used Publication Classification to provide electromagnetic treatment to multiple areas of the user's head. Embodiments of the invention provide for (51) Int. Cl. sequential electromagnetic treatment with a single or a plu A6IN 2/02 (2006.01) rality of treatment applicators which target a single or mul A6 IB5/II (2006.01) tiple cerebral regions as determined by imaging, non-imaging A6 IB5/03 (2006.01) and physiological monitoring before, during and after elec A6 IB5/0488 (2006.01) tromagnetic treatment. M 200 Patent Application Publication Oct. 9, 2014 Sheet 1 of 32 US 2014/0303425 A1 Place EMF device in proximity to affected tissue 101 Begin treatment regime 103 Apply EMF waveform 105 Inter-treatment intervals EMF signal off 107 Completed treatment regime? 109 Yes Remove EMF device FIG. 1 Patent Application Publication Oct. 9, 2014 Sheet 2 of 32 US 2014/0303425 A1 y 200 FIG. 2 Patent Application Publication Oct. 9, 2014 Sheet 3 of 32 US 2014/0303425 A1 320 324 FIG. 3 Patent Application Publication Oct. 9, 2014 Sheet 4 of 32 US 2014/0303425 A1 y 350 353 FIG. 4A Patent Application Publication Oct. 9, 2014 Sheet 5 of 32 US 2014/0303425 A1 M 400 402 403 404 FIG. 4B Patent Application Publication Oct. 9, 2014 Sheet 6 of 32 US 2014/0303425 A1 FIG. 5 Patent Application Publication Oct. 9, 2014 Sheet 7 of 32 US 2014/0303425 A1 FIG. 6 Patent Application Publication Oct. 9, 2014 Sheet 8 of 32 US 2014/0303425 A1 700 FIG. 7 Patent Application Publication Oct. 9, 2014 Sheet 9 of 32 US 2014/0303425 A1 FIG. 8 Patent Application Publication Oct. 9, 2014 Sheet 10 of 32 US 2014/0303425 A1 FIG. 9 Patent Application Publication Oct. 9, 2014 Sheet 11 of 32 US 2014/0303425 A1 Patent Application Publication Oct. 9, 2014 Sheet 12 of 32 US 2014/0303425 A1 FIG. 11B FIG. 11D Patent Application Publication Oct. 9, 2014 Sheet 13 of 32 US 2014/0303425 A1 00Z). 90Z).ZOzL Patent Application Publication Oct. 9, 2014 Sheet 14 of 32 US 2014/0303425 A1 / Patent Application Publication Oct. 9, 2014 Sheet 15 of 32 US 2014/0303425 A1 Patent Application Publication Oct. 9, 2014 Sheet 16 of 32 US 2014/0303425 A1 Patent Application Publication Oct. 9, 2014 Sheet 17 of 32 US 2014/0303425 A1 -1600 /N-N-N-N-" FIG. 16A -1600 - - - --" FIG. 16B -1600 rto FIG. 16C Patent Application Publication Oct. 9, 2014 Sheet 18 of 32 US 2014/0303425 A1 FIG. 16E Patent Application Publication Oct. 9, 2014 Sheet 19 of 32 US 2014/0303425 A1 0.35 O.30 *P < 0.001 0.25 0.20 0.15 O. 10 0.05 N O.OO 2 Š PEMF Control PEMF+W-7 FIG. 17 Patent Application Publication Oct. 9, 2014 Sheet 20 of 32 US 2014/0303425 A1 300 2 5 O 2 O O 1 5 O 10 O 5 O N PEMF control PEMF-NAME FIG. 18 Patent Application Publication Oct. 9, 2014 Sheet 22 of 32 US 2014/0303425 A1 FIG. 20 Patent Application Publication Oct. 9, 2014 Sheet 23 of 32 US 2014/0303425 A1 FIG 21A Patent Application Publication Oct. 9, 2014 Sheet 24 of 32 US 2014/0303425 A1 FIG 21B Patent Application Publication Oct. 9, 2014 Sheet 25 of 32 US 2014/0303425 A1 N s Patent Application Publication Oct. 9, 2014 Sheet 26 of 32 US 2014/0303425 A1 FIG. 21D Patent Application Publication Oct. 9, 2014 Sheet 27 of 32 US 2014/0303425 A1 FIG. 22A Patent Application Publication Oct. 9, 2014 Sheet 28 of 32 US 2014/0303425 A1 Patent Application Publication Oct. 9, 2014 Sheet 29 of 32 US 2014/0303425 A1 Patent Application Publication Oct. 9, 2014 Sheet 30 of 32 US 2014/0303425 A1 Patent Application Publication Oct. 9, 2014 Sheet 31 of 32 US 2014/0303425 A1 62OO Y Target area computation Diagnostics module module 6102 6101 Brain trait computation 6100 module 6103 Neurological regions (e.g. Brain areas) Treatment determination module 6104 Stimulation module 6105 FIG. 25 Patent Application Publication Oct. 9, 2014 Sheet 32 of 32 US 2014/0303425 A1 Pulse 1 Pulse 2 : Patient Patient : response : response -->->ie-Die->e->->re->re-> Ta't Tb Tc To Ta Tib Tc To N-y- Time 7040 FIG. 26 US 2014/0303425 A1 Oct. 9, 2014 METHOD AND APPARATUS FOR generally to a method and apparatus for therapeutic and pro ELECTROMAGNETIC TREATMENT OF phylactic treatment of animal and human nervous system. For COGNITION AND NEUROLOGICAL INURY example, some embodiments described are devices, systems and methods for delivering electromagnetic signals and fields CROSS REFERENCE TO RELATED to individuals at risk of Suffering neurological injuries. In APPLICATIONS particular, headgear Such as helmets having electromagnetic 0001. This application claims priority to U.S. provisional treatment delivery device that can be activated by sensors are patent application 61/556,068, filed Nov. 4, 2011, and titled described. Additionally, some embodiments described pro METHOD AND APPARATUS FOR ELECTROMAG vide for delivering electromagnetic signals and fields to indi NETIC TREATMENT OF COGNITION AND NEURO viduals Suffering from a neurological injury. Specifically, LOGICAL INJURY. embodiments provide designs such as multi-coil applicator 0002 This application may also be related to any of the configured to provide therapeutic electromagnetic field treat following patent applications, each of which is herein incor ment to a single or combinations of multiple regions of a porated by reference in its entirety: U.S. patent application user's head as the therapy requires. Additionally, some Ser. No. 11/003,108, filed Dec. 3, 2004, now U.S. Pat. No. embodiments described provide for delivering electromag 7,744,524 (APPARATUS AND METHOD FOR ELEC netic signals and fields to individuals who may benefit from TROMAGNETIC TREATMENT OF PLANT. ANIMAL enhanced cognitive responses beneficial in training or task AND HUMAN TISSUE, ORGANS, CELLS AND MOL learning. Specifically, embodiments provide designs such as ECULES); U.S. patent application Ser. No. 12/771,954, applicators with a plurality of applicators placed in appropri filed Apr. 30, 2010, titled “APPARATUS AND METHOD ate head gear which may be programmed to provide electro FOR ELECTROMAGNETIC TREATMENT OF PLANT, magnetic field treatment to a single cerebral region or com ANIMAL AND HUMANTISSUE, ORGANS, CELLS AND binations of multiple regions of a user's head in the sequence MOLECULES: U.S. patent application Ser. No. 12/772, required by the task or training involved. 002, filed Apr. 30, 2010, titled “APPARATUS AND 0005. Other embodiments pertain to use of non-thermal METHOD FOR ELECTROMAGNETIC TREATMENT OF time-varying electromagnetic fields configured to accelerate PLANT. ANIMAL AND HUMAN TISSUE, ORGANS, the asymmetrical kinetics of the binding of intracellular ions CELLS AND MOLECULES”; U.S. patent application Ser. to their respective binding proteins which regulate the bio No. 12/819,956, filed Jun. 21, 2010, titled “APPARATUS chemical signaling pathways living systems employ to con AND METHOD FOR ELECTROMAGNETIC TREAT tain and reduce the inflammatory response to injury. Other MENT: U.S. patent application Ser. No. 1 1/114,666, filed embodiments pertain to the non-thermal application of repeti Apr. 26, 2005, now U.S. Pat. 7,740,574, titled “ELECTRO tive pulse bursts of sinusoidal, rectangular, chaotic or arbi MAGNETIC TREATMENT INDUCTION APPARATUS trary waveform electromagnetic fields to instantaneously AND METHOD FORUSING SAME: U.S. patent applica accelerate ion-buffer binding in signaling pathways in animal tion Ser. No. 1 1/223,073, filed Sep. 10, 2005, now U.S. Pat. and human nervous system using ultra lightweight portable No. 7,758,490, titled “INTEGRATED COIL APPARATUS coupling devices such as inductors and electrodes, driven by FOR THERAPEUTICALLY TREATING HUMAN AND miniature signal generator circuitry. ANIMAL CELLS, TISSUES AND ORGANS WITH ELEC TROMAGNETIC FIELDS AND METHOD FOR USING 0006 Another embodiment pertains to application of SAME': U.S. patent application Ser. No. 12/082,944, filed sinusoidal, rectangular, chaotic or arbitrary waveform elec Apr.
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