Apparatus and methods for inductive field therapy

Abstract

Methods and apparatuses performing magnetic therapy (e.g., microtesla magnetic therapy, MMT). These methods and apparatuses may be useful for, but are not limited to, reducing or eliminating inflammation, and / or for treating an inflammatory disorder by applying a modulated time-varying magnetic field in which one or more pulse parameters (such as burst width and / or burst duration) are increased or decreased in a stepwise manner within a defined range to produce a significant decrease in inflammation. In particular, described herein are headsets that may securely and comfortably center a magnetic coil in a transverse plane around the patient's head at a distance from the head.

Description

APPARATUS AND METHODS FOR INDUCTIVE FIELDTHERAPYCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 708,733, titled “APPARATUS FOR INDUCTIVE FIELD THERAPY,” filed on October 17, 2024, herein incorporated by reference in its entirety.BACKGROUND

[0002] Inductive field therapy, including pulsed electromagnetic field (PEMF) therapy, is a non-invasive technique that uses electromagnetic fields to stimulate healing and cellular function. This therapy has gained attention for its potential to treat various medical conditions. The treatment involves the application of electromagnetic pulses. In some cases it may be particularly beneficial to apply inductive field therapy to conditions related to the head, e.g., to reduce inflammation, alleviate pain, and enhance the healing of damaged tissues.

[0003] The exact mechanisms by which PEMF therapy works are still being studied, but early research shows promising results for its potential in treating a range of conditions. While clinical evidence is still growing, and more large-scale studies are needed, PEMF therapy is increasingly being integrated into alternative and complementary medicine practices for head and brain health. The treatment is typically painless, and patients can often undergo it in outpatient settings, making it a convenient option for those seeking nonpharmaceutical interventions.

[0004] For example, reactive oxygen species (ROS) play vital roles in many cellular signaling pathways under both physiological and pathological conditions. ROS are a series of highly active radicals, ions and molecules that have a single unpaired electron in their outer shell, including free oxygen radicals, such as superoxide anion, hydroxyl radical, and single oxygen, and non-radical ROS, for instance, hydrogen peroxide, organic hydroperoxides, and hypochloric acid. The intracellular ROS levels are dependent on the dynamic balance between ROS generation and elimination. ROS at low levels can act as second messengers and activate signaling cascades in response to gene expression, cell proliferation, apoptosis, and other intracellular pathways. On the other hand, excessive ROS could attack membrane phospholipids, impair mitochondrial function, and damage proteins, lipids, DNA, RNA, and sugar to disrupt normal cellular processes.- 1 -SG Docket No.: 14852-702.600

[0005] To date, there is no clear understanding of the effect of magnetic fields on ROS levels. Published literature provides conflicting evidence that magnetic fields, e.g., static magnetic fields (SMFs), extremely low frequency electromagnetic fields (ELF-EMFs), and radio frequency electromagnetic radiations (RF-EMRs) may increase ROS levels in multiple types of human, mouse, and rat cells, as well as in various mice and rat tissues. However some reports show no change ROS levels due to such magnetic fields.

[0006] What is needed are methods and apparatuses for robustly and repeatably manipulating ROS, and mitochondrial ROS in particular, in order to treat disorders such as inflammation, including but not limited to neuroinflammation, particularly in the head (and brain). The methods and apparatuses described herein may address these needs.SUMMARY OF THE DISCLOSURE

[0007] Described herein are methods and apparatuses for applying inductive field therapy (e.g., magnetic therapy, or microtesla magnetic therapy, MMT) to a patient, including (but not limited to) a patient’s head. In some cases, these methods may be used for reducing or eliminating inflammation, and / or for treating an inflammatory disorder by applying a modulated time-varying magnetic field in which one or more pulse parameters, such as burst width and / or burst duration, are modulated during the treatment period within a defined range to cause a significant decrease in inflammation. The methods and apparatuses described herein may alternatively or additionally generate mitophagy (mitochondrial recycling) and mitochondrial biogenesis, which may be as important if not more important than the antiinflammatory effects and may underlie the anti-inflammatory effects.

[0008] In general, these methods and apparatuses may include one or more headpiece and / or base unit (controller) configured to apply inductive field therapy appropriate to specifically modulate ROS. These methods and apparatuses may be configured to limit the application of a treatment (e.g., a dose) to no more than once per 24 hours or longer (e.g., no more than once per 30 hours, once per 36 hours, once per 48 hours, once per 72 hours, once per 96 hours, etc. including any time between 24 hours and 72 hours).

[0009] The methods and apparatuses described herein may modulate mitochondrial biology, e.g., by modulating the release of ROS with a controlled range that may maximize the efficacy to reduce inflammation, which may be detected by a reduction in pro- inflammatory molecules (e.g., IL-lb and TNFa). Surprisingly, the enhanced efficacy and reliability resulting from these treatments are specific to the ranges and parameters described herein, as outside of these ranges the decrease in inflammation is not seen or is greatly diminished and / or highly variable.- 2 -SG Docket No.: 14852-702.600

[0010] For example, described herein are methods, including methods of treating inflammation and / or methods of treating an inflammatory disorder, and apparatuses (including systems and devices) for performing these methods that include one or more headpieces. The headpiece may be configured to securely and comfortably center the applicator coil around a subject’s head in a predetermined location.

[0011] For example, descried herein are apparatuses for applying a dose of a timevarying magnetic field, wherein the apparatus (e.g., system) comprises: a headset comprising one or more magnetic field applicators configured to apply a magnetic field; a signal generator coupled to the one or more magnetic field applicators to apply a dose of a timevarying magnetic field during a treatment period; and a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses, wherein the modulated pulse train is modulated by automatically varying one or more pulse parameter to decrease the level of one or more inflammatory molecules.

[0012] In general, the headset of any of these apparatuses may include a plurality of fins. The headset of any of these apparatuses may include a coil enclosure, and a headset inner shell adjacent to the coil enclosure. The fins may also or alternatively be referred to as projections, fingers, digits, etc. All or some of the individual fins of the plurality of fins may comprise a flexure retainer, a flexure, and a flexure tip. The flexure retainer may attach to the headset inner shell. The flexure tip may be configured to rest against a patient’s head. The flexure of each of the plurality of fins may be coupled at an angle of between 10 and 50 degrees relative to the inner shell. For example, each fin may be configured to extend at an angle, e.g., of between about 10 degrees to 45 degrees, 15 degrees to 40 degrees, 15 degrees to 30 degrees, etc., relative to the inner diameter, e.g. relative to a tangent line drawn from the attachment point, e.g., flexure, along the inner diameter of the inner shell.

[0013] The fins described herein may generally be configured to deflect to create a light pressure against the patient’s head. The fins may be deflected by one or more (or a combination of) the material forming the fin and / or the flexure attachment coupling the fin to the inner shell.

[0014] Any of these apparatuses may include a console coupled to the signal generator. In some cases the signal generator may be integrated with the console. For example, the console may include a housing and the housing may at least partially enclose the signal generator. In any of these apparatuses the signal generator may be configured to apply a dose as described herein.- 3 -SG Docket No.: 14852-702.600

[0015] The headsets described herein may further comprise a strap (also referred to herein as a back strap). In some example the strap extends in the plane (e.g., transverse plane) of the headset. The strap may be elastic or non-elastic. For example, the strap may be part of the inner shell, extending across the opening formed in the inner shell to help secure the fins in contact with the subject’s head within the inside of the headset. In some examples the strap may be a rigid backstop. In some cases the strap may include a cushion region (e.g., a strap cushion) to cushion and prevent movement of the head relative to the headset. The strap cushion may be, e.g., a low-durometer material, such as a silicone material. For example the strap may attach as a chord across the inner shell. The plurality of fins and the strap may therefore cooperate to secure a patient’s head within the headset so that the patient’s head is centered within the headset. The strap may come in different sizes in order to better ensure that the patient’s head is centered front-to-back. For example, the strap may be small, medium or large, and may have differing lengths of the strap itself. The strap may be removably attached, e.g., may be swapped out by removing a flexure retainer assembly which may include the flexure retainer, the fingers, the tips, the strap, and the strap cushion. This assembly can be easily snapped in and out of the headset.

[0016] The flexure tip may comprise an elastic element that encompasses a distal end region of each fin of the plurality of fins. The headset may comprise a headset outer shell that comprises a headset printed circuit board and a cable exit gland.

[0017] The console may comprise one or more connectors and an electric or power socket. In some examples the console is connected to the headset via the connector. The connector may connect to a main or primary printed circuit board of the console and the electric or power socket connects to a power supply of the console.

[0018] For example, a system for applying a dose of a time-varying magnetic field may include: a headset comprising one or more magnetic field applicators configured to apply a magnetic field, wherein the headset comprises a plurality of fins, a coil enclosure, and a headset inner shell adjacent to the coil enclosure; a signal generator coupled to the one or more magnetic field applicators to apply a dose of a time-varying magnetic field during a treatment period; and a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses, wherein the modulated pulse train is modulated by one or more of: varying a pulse burst width during the treatment period between 1 msec and 50 msec in a stepwise manner; and / or varying a burst repetition rate during the treatment period between 0.1 Hz and about 100 Hz in a stepwise manner.- 4 -SG Docket No.: 14852-702.600

[0019] As mentioned, each fin of the plurality of fins may comprise a flexure retainer, a flexure, and / or a flexure tip. The flexure retainer may attach to the headset inner shell. In some examples the headset comprises a headset outer shell that comprises a headset printed circuit board of the controller and a cable gland. Any of these apparatuses may include a console configured to couple to the headset. For example, the apparatus may include one or more coaxial connectors (e.g., a BNC connector) and an electric or power socket. The console may be connected to the headset via the connector. In some cases the connector may connect to a main or primary printed circuit board of the console and the electric or power socket connects to a power supply of the console.

[0020] Also described herein are apparatuses comprising: one or more magnetic field applicators configured to apply a magnetic field, wherein the one or more magnetic field applicators comprises a headset, wherein the headset further comprises a plurality of fins, a coil enclosure, and a headset inner shell adj acent to the coil enclosure; a signal generator coupled to the one or more magnetic field applicators to apply a dose of a time-varying magnetic field during a treatment period; and a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses, wherein the modulated pulse train is modulated by automatically varying one or more pulse parameter to decrease the level of one or more inflammatory molecules.

[0021] Any of these apparatuses may include a console, wherein the console comprises a connector (including, but not limited to, a coaxial connector such as a BNC connector) further wherein the console is configured to connect to the headset via the connector. Any of these apparatuses may include a cover for the headset, a cover for the console, and / or a protective foam layer. The cover for the console may comprise a thermoformed foam.

[0022] For example, an apparatus may include: one or more magnetic field applicators configured to apply a magnetic field, wherein the one or more magnetic field applicators comprises a headset, wherein the headset further comprises a plurality of fins, a coil enclosure, and a headset inner shell adjacent to the coil enclosure; a signal generator coupled to the one or more magnetic field applicators to apply a dose of a time-varying magnetic field during a treatment period; and a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses, wherein the modulated pulse train is modulated by one or more of: varying a pulse burst width during the treatment period between 1 msec and 50 msec in a stepwise manner; and / or varying a burst repetition rate during the treatment period between 0.1 Hz and about 100 Hz in a stepwise manner. Any of- 5 -SG Docket No.: 14852-702.600these apparatuses may include a protective assembly comprises a cover for the headset, a cover for the console, and a protective foam layer. The cover for the console may comprise a thermoformed foam.

[0023] Any of the apparatuses (including systems and / or devices) described herein may be systems for applying magnetic therapy (e.g., microtesla magnetic therapy) and may include: an applicator (e.g. a headset) comprising one or more magnetic field applicators configured to apply a magnetic field; a signal generator coupled to the one or more magnetic field applicators to apply a dose of a time-varying magnetic field during a treatment period; and a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses from the magnetic field applicators, wherein the modulated pulse train is modulated by automatically varying one or more pulse parameter over the course of the modulated pulse train.

[0024] Any of the apparatuses described herein may include a detection circuit. The detection circuit may provide feedback control for the application of the therapy. For example, any of these apparatuses may include a detection circuit in communication with the controller and configured to detect reflected power and / or the ratio of forward to reverse power applied from the headset.

[0025] The detection circuit may comprise a filter-detector-coupler (FDC) circuit. The controller may be configured to control or adjust the modulated pulse train based on the reflected power and / or the ratio of forward to reverse power. The controller may be configured to adjust an amplitude of the modulated pulse train based on the reflected power and / or the ratio of forward to reverse power.

[0026] In any of these apparatuses, the controller may be configured to confirm a subject is wearing the headset based on an amplitude of the modulated pulse train based on the reflected power and / or the ratio of forward to reverse power. Alternatively or additionally, the controller is configured to track compliance (e.g., that the subject is using / wearing the apparatus and receiving therapy). The controller may be configured to allow the application of the modulated pulse train after confirming that the subject is wearing the headset, and / or may prevent the application of energy until the headset is worn, or worn properly (as detected by the detection circuitry).

[0027] As mentioned, the headset may be configured as described above. In some cases the headset may comprise a plurality of fins, a coil enclosure, and a headset inner shell adjacent to the coil enclosure. In some cases each fin of the plurality of fins comprises a flexure retainer, a flexure, and a flexure tip. The flexure retainer may be configured to - 6 -SG Docket No.: 14852-702.600removably attach and / or detach to the headset inner shell. In some cases the flexure tip is configured to rest against a patient’s head. The flexure of each of the plurality of fins may be coupled at an angle of between 10 and 45 degrees relative to the inner shell. Any of these apparatuses may include a console coupled to the signal generator.

[0028] Also described herein are methods, e.g., method of treating a subject (e.g., a patient), using any of these apparatuses to apply magnetic therapy. These methods may include instructing the subject to wear (and / or how to wear) the applicator, detecting / confirming that the user is wearing the headset, detecting and / or confirming compliance, etc. The method may also include applying a modulated time-varying magnetic field to a region of the subject’s body from the applicator worn on the subject’s body, wherein the dose is applied for a duration period, and wherein the applicator emits a magnetic field driven by a modulated pulse train comprising a plurality of burst of pulses, wherein the modulated pulse train is modulated by varying one or more pulse parameter.

[0029] Any of these methods may include preventing the application of a subsequent dose for greater than 24 hours (e.g., in some cases to decrease the level of one or more inflammatory molecules). The modulated pulse train may be modulated by varying one or more pulse parameter selected from the group of: pulse burst width and burst repetition rate. The pulse burst width during the treatment period may be increased or decreased by between about 1 msec and 100 msec in a stepwise manner during the treatment. The pulse repetition rate during the treatment period may be increased or decreased by between about 0.1 Hz and about 100 Hz in a stepwise manner.

[0030] In any of these methods, varying the pulse burst width during the treatment period may comprise increasing or decreasing the pulse burst width by between about 5-50 msec every 1-10 minutes of the duration period. In any of these methods or apparatuses, varying the pulse burst width during the treatment period may comprise increasing or decreasing the pulse burst width by between about 10-50 msec every approximately 3-10 minutes of the duration period.

[0031] In any of these methods or apparatuses, varying the burst repetition rate may comprise increasing or decreasing the burst repetition rate by between about 0.1-100 Hz every approximately 1-10 minutes of the duration period. In any of these methods or apparatuses, varying the burst repetition rate may comprise increasing or decreasing the burst repetition rate by between about 10-100 Hz every approximately 3-10 minutes of the duration period. In any of these methods or apparatuses, the modulated pulse train may be modulated by varying both a pulse burst width and a burst repetition rate during the treatment period. The dose period may be between about 1 minute and about 65 minutes (e.g., between about - 7 -SG Docket No.: 14852-702.60030 minutes and about 60 minutes, between about 1 minute and 45 minutes, between about 5 minutes and 60 minutes, between about 10 minutes and 60 minutes, between about 45 minute and about 60 minutes, etc.). In any of these methods and apparatuses, the dose period may be between about 450 minutes and about 30 minutes.

[0032] In any of these methods or apparatuses, the plurality of burst of pulses may have a frequency of greater than 45 MHz. The plurality of bursts of pulses may have a frequency of about 27.452 MHz.

[0033] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0034] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0035] FIG. 1 schematically illustrates one example of a possible molecular pathway for the low energy magnetic field treatment described herein, including modulation of mitochondrial ROS.

[0036] FIG. 2 schematically illustrates an example of a noninvasive MMT device that is configured to target inflammatory brain disorders with low energy magnetic field treatment as described herein.

[0037] FIG. 3 shows an example of a noninvasive MMT device including a headset and base (e.g., console).

[0038] FIG. 4 shows an exploded view of a portion of a noninvasive MMT device similar to that shown in FIG. 3.

[0039] FIGS. 5A-5C show views of the headset of the noninvasive MMT device similar to that shown in FIG. 3. FIG. 5 A shows an exploded view. FIG. 5B shows a front view and FIG. 5C shows a top perspective view.

[0040] FIG. 6 shows an example of a cord (e.g., power / data cord) coupling the headset to the console.

[0041] FIG. 7 shows a partial perspective view of a headset similar to that shown in FIG.3.

[0042] FIG. 8 shows a top view of the headset similar to that shown in FIG. 3, worn on a model.- 8 -SG Docket No.: 14852-702.600

[0043] FIG. 9 shows a top perspective view of the apparatus, showing the headset and console.

[0044] FIG. 10 shows a partially transparent view of the headset, similar to the headset of FIG. 3.

[0045] FIG. 11 shows one example of a PCBA that may be included as part of the apparatus described herein.

[0046] FIG. 12 is a top view of a console as described herein.

[0047] FIG. 13 is a perspective the console of FIG. 12.

[0048] FIGS. 14 and 15 illustrate examples of connectors (e.g., BNC connectors) coupling the headset to the source of power and pulsed modulation.

[0049] FIG. 16 shows a view of an inside of a console as described herein.

[0050] FIG. 17 shows a partially transparent view of a console as described herein.

[0051] FIGS. 18, 19 and 20 illustrate examples of PCBAs comprising part of the controllers for the apparatuses described herein.

[0052] FIG. 21 is another example of a portion of a console as described herein.

[0053] FIG. 22A shows another example of a noninvasive MMT device including a headset and base. FIG. 22B shows an example of the inner region of the headset, including the strap and fins. The inner region of the headset may be removably inserted and / or removed from the outer region.

[0054] FIG. 23 shows one example of a protective case at least partially enclosing a noninvasive MMT device including a headset and base.

[0055] FIGS. 24A-24D illustrate one example of a method of wearing a headset as described herein.

[0056] FIGS. 25A-25C show an example of a noninvasive magnetic therapy (e.g., MMT) device similar to that shown in FIGS. 3. and 5A-5C.

[0057] FIG. 26 schematically illustrates one example of a detection circuit (e.g., a filter- detector-coupler FDC circuit) that may be included with any of the magnetic therapy apparatuses described herein.

[0058] FIG. 27 schematically illustrates one example of a coupler circuit that may be used with any of the apparatuses described herein (including as part of an FDC circuit such as that shown in FIG. 26).

[0059] FIG. 28 schematically illustrates one example of a forward detector circuit that may be used with any of the apparatuses described herein (including as part of an FDC circuit such as that shown in FIG. 26).- 9 -SG Docket No.: 14852-702.600

[0060] FIG. 29 schematically illustrates one example of a reverse detector circuit that may be used with any of the apparatuses described herein (including as part of an FDC circuit such as that shown in FIG. 26).

[0061] FIG. 30 schematically illustrates one example of a phase detector circuit that may be used with any of the apparatuses described herein (including as part of an FDC circuit such as that shown in FIG. 26).

[0062] FIG. 31 show a table illustrating measured input reflection coefficient (“SI 1”) data measured using a magnetic therapy apparatus as described herein.

[0063] FIGS. 32A-32B are graphs showing examples of measured percent reflection and phase measured for different loads (e.g., heads, models) from an example of a magnetic therapy apparatus as described herein.

[0064] FIG. 33 is a table illustrating input reflection coefficient (Si l) data from different sizes of heads (or head models).DETAILED DESCRIPTION

[0065] Described herein are apparatuses (and method of using them to reduce inflammation) comprising a non-invasive, wearable applicator that is configured to apply energy applied by a pulsed magnetic field over time (e.g., during a continuous treatment period) in a manner that is configured to reduce inflammation in a dose-dependent manner. These apparatuses and methods are configured to deliver a pulsed, low-energy magnetic field within a specific and effective range of parameter values, outside of which the reduction either does not occur at all or is substantially diminished. These apparatuses and methods may result in a significantly more reliable (e.g., less variable) reduction in inflammation as compared with other techniques, including other PEMF techniques. The pulsed magnetic field treatments described herein may be referred to as microtesla magnetic therapy (MMT) and the apparatuses configured to deliver this energy may be referred to as MMT applicators. In some cases MMT may be referred to (or may include) as low energy inductive field therapy (LEIT).

[0066] These methods and apparatuses may modulate the production of inflammatory molecules (e.g., cytokines) in the tissue or cells, such as, but not limited to pro-inflammatory proteins, including but not limited to interleukin 1 beta (II- lb) and Tumor necrosis factor (TNFa). Other pro-inflammatory molecules may include inflammatory cytokines such as IL- 6, IL-8, IL- 12, IFN-y, IL- 18, and IL- la. These effects may be due, at least in part, to a change in the level of reactive oxygen species (ROS), which may modulate inflammation, when applying a time varying magnetic field as described herein. Thus, the methods and - 10 -SG Docket No.: 14852-702.600apparatuses described herein may significantly decrease the level of pro-inflammatory molecules by the application of low-energy, time-varying magnetic fields.

[0067] In general, the methods and apparatuses described herein vary an applied timevarying magnetic field that is applied to a tissue or cells to reduce inflammation in the tissue / cells. The reduction in inflammation achieved may include be observed as a significant decrease in pro-inflammatory molecules (e.g., Tl-lb, TNFa, etc.), which may be assayed directly or indirectly from the tissue / cells. For example, these methods and apparatuses may result in a reduction in pro-inflammatory molecules of greater than 10% (e.g., greater than 15%, greater than 20%, greater than 25%, greater than 30%, greater than 35%, greater than 40%, greater than 45%, greater than 50%, greater than 55%, greater than 60%, etc. This reduction may be relative to baseline tissue / cells, and / or relative to an inflammatory response of the tissue / cell, including, but not limited to, relative to the inflammatory response following a challenge to the tissue / cells by an inflammatory agent.

[0068] As used herein, varying the time-varying magnetic field may include varying one, or in some cases more than one, pulse parameter (e.g., pulse width, burst width, pulse frequency, pulse amplitude, etc.). In some examples these methods and apparatuses may vary both burst width and pulse frequency during the treatment period. A traditional time-varying magnetic field may be applied at a constant repetition rate (also referred to as burst frequency, e.g., the frequency of pulses and / or bursts of pulses), such as, e.g., 1 Hz, and a constant burst width, e.g., 40 msec, during a treatment period. In contrast, these methods and apparatuses may vary parameters, such as the burst width and the repetition rate, resulting in significantly greater reduction in inflammation as compared with tissue / cells treated by the application of magnetic field energy using a traditional time-varying magnetic field. For example the burst width during a treatment period may be varied between 1 msec and 100 msec (e.g., between about 1 msec and 50 sec, between about 1 msec and about 80 msec, between about 1 msec and about 60 msec, between about 1 msec and about 40 msec, between about 1 msec and about 20 msec, between about 1 msec and 10 msec, between about 1.5 msec and 10 msec, between about 1.5 msec and 8 msec, between about 1.5 msec and 6 msec, etc.) at a repetition rate of between about 2 mHz and about 20 mHz (e.g., about every 1 min, every 2 min, every 3 min, every 4 min, every 5 minutes, etc.).

[0069] For example, the apparatus or method may vary the burst width and / or burst repetition rate during a treatment period. A treatment period may be the duration of treatment from the start of the application of the pulsed magnetic field energy to the stop of the application of pulsed magnetic field energy, after which the pulsed magnetic field energy is no longer applied. The treatment period may be from about 5 minutes or longer, e.g., about 6 - 11 -SG Docket No.: 14852-702.600minutes or longer, about 7 minutes or longer, about 8 minutes or longer, about 9 minutes or longer, about 10 minutes or longer, about 12 minutes or longer, about 13 minutes or longer, about 15 minutes or longer, about 17 minutes or longer about 20 minutes or longer, about 25 minutes or longer, about 30 minutes or longer, about 35 minutes or longer about 40 minutes or longer, about 1 hour longer, about 1.5 hours or longer, about 2 hours or longer, about 2.5 hours or longer, about 3 hours or longer, etc., including between about 5 minutes and 4 hours, about 5 minutes and 3 hours, between about 5 minutes and 2 hours, between about 5 minutes and 1 hour, about 5 minutes and 50 minutes, about 5 minutes and 45 minutes, about 5 minutes and 40 minutes, about 5 minutes and 35 minutes, about 5 minutes and 30 minutes, about 5 minutes and 25 minutes, about 5 minutes and 20 minutes, about 5 minutes and 15 minutes, about 5 minutes and, etc. In some cases the treatment period may be between about 10-50 minutes.

[0070] In any of these methods and apparatuses, the burst width may vary during the treatment period. The burst width may be varied in a continuous manner or in a discrete manner. As mentioned, the burst width may be varied between about 1 msec and about 200 msec. In some cases the burst width may be varied between about 10 msec and 200 msec in a stepwise manner, e.g., increasing or decreasing by x msec (where x is about 1 msec, about 2 msec, about 3 msec, about 5 msec, about 10 msec, about 15 msec, about 20 msec, about 25 msec, about 30 msec, about 40 msec, about 50 msec, about 60 msec, about 70 msec, about 80 msec, etc.) every y seconds / minutes during the treatment period (e.g., every 1 second, every 2 seconds, every 5 seconds, every 10 seconds, every 30 seconds, every 1 minute, every 1.5 minutes, every 2 minutes, every 2.5 minutes, every 3 minutes, every 5 minute, etc.). For example, the pulse width may be increased or decreased by between about 5-50 msec every 1-10 minutes.

[0071] In any of these methods and apparatuses, the burst repetition rate (burst frequency) may be varied during the treatment period. The burst repetition rate may be varied in a continuous manner or a discrete manner. For example, the burst repetition rate may be varied between about 0.1 Hz and about 100 Hz. In some cases the burst repetition rate may be varied between 0.1 Hz and about 100 Hz in a stepwise manner, e.g., increasing or decreasing by x Hz (where x is about 1 Hz, about 2 Hz, about 3 Hz, about 4 Hz, about 5 Hz, about 7 Hz, about 10 Hz, about 15 Hz, about 20 Hz, about 25 Hz, about 30 Hz, about 35 Hz, about 40 Hz, about 45 Hz, about 50 Hz, about 55 Hz, about 60 Hz, about 65 Hz, about 70 Hz, about 80 Hz, about 90 Hz, about 100 Hz, etc.) every y seconds / minutes during the treatment period (e.g., every 1 second, every 2 seconds, every 5 seconds, every 10 seconds, every 30 seconds, every 1 minute, every 1.5 minutes, every 2 minutes, every 2.5 minutes, every 3 minutes, every 5- 12 -SG Docket No.: 14852-702.600minute, etc.). For example, the burst repetition rate may be increased or decreased by between about 0.1-100 Hz every 1-10 minutes.

[0072] In some examples, both the burst width and the burst repetition rate may be varied, either independently of each other or concurrently. For example, the burst width and the burst repetition rate may be independently varied, including changing during the treatment period at different times, and by different amounts / percentages. Alternatively in some cases the burst repetition rate and burst width may be changed during the treatment period at the same time.

[0073] Any of these methods and apparatuses may also limit the application of the dose of energy so that additional doses are not applied more often than every 36 to 72 hours. For example, the treatment periods may be limited to being repeated only after a 30-36 hour delay or quiescent period or refractory period or a 70-72 hour delay or quiescent period or refractory period. This is consistent with the theory that the effect is mediated by ROS that may be released at a relatively low, protective level during or after the treatment period in which the time varying magnetic field is varied as descried herein, but additional applied magnetic fields may result in an excess of ROS that cannot be readily processed by the tissue / cells.

[0074] Without being bound by any particular theory of operation, these results may be the result of modulation of mitochondrial response for ROS. This is schematically illustrated in FIG. 1, illustrating mitohormesis, in which the application of the MMT results in a stressdefense transcription that, at appropriate levels reduces inflammation, reduces cell death and increases the lifespan of the organism. This may help explain the dose sensitivity seen in these results for the first time, in which either too little or too much pulsed electromagnetic (e.g., pulsed magnetic field) energy, as well as the dramatic improvements seen when varying the rate that energy is applied by a pulsed magnetic field over time, e.g., varying the timevarying magnetic field including varying one, or in some cases more than one, pulse parameter such as (but not limited to) the pulse width (e.g., between 1.5 msec or more, e.g., between 1.5 msec and 10 msec), and / or burst frequency.

[0075] In general, the magnetic therapy (e.g., microtesla magnetic therapy, MMT) methods and apparatuses described herein are sufficiently low energy that they are subthreshold for triggering a neuromuscular contraction response. Thus, they do not trigger contraction of muscle fibers and / or sensory neurons. This may advantageously allow application of therapeutic MMT energy to be applied and specifically modulated as described herein with a high degree of patient tolerance, while retaining efficacy. In addition the energy- 13 -SG Docket No.: 14852-702.600applied by the therapy is non-thermal and does not result in direct ablation or destruction of tissue or cells based on the applied electromagnetic (e.g., magnetic field) energy.

[0076] In general, any appropriate apparatus may be used to apply the low energy magnetic fields described herein and may include control circuitry for modulating one or more stimulation parameters (e.g., burst width, burst repetition rate, quiescent period, etc.). For example, an apparatus as described herein may include one or more magnetic field generating devices, which may be coupled or coupled to an energy source (e.g., battery, wall power, etc.), the magnetic field generating device may be optimized to apply the energies described herein. The magnetic field generating device (magnetic field pulse generator) may be controlled by a dedicated controller and / or may be controlled by a separate controller. The apparatus may also include one or more applicators (emitters). For example, the applicator may generally be part of a magnetic treatment device that may be part of an applicator for being held against or near (including adjacent to) the tissue to be treated. An applicator may be configured to include one or more magnetic field delivery components, e.g., coils, which are configured to apply the controlled magnetic fields described herein. In some cases the applicator(s) may be configured to be held against the body of the patient, including against the skin of the body for non-invasive energy application. The applicator(s) may be adapted to apply energy to any or more body part, including the head, face, neck, shoulder, arms, hands, wrists, chest, back, buttocks, stomach, groin, leg, thigh, angle, foot, etc.

[0077] These applicators and the magnetic field generators may be configured to deliver pulsed magnetic fields using a carrier signal that is derived from a 27.12 MHz continuous sine (or square) wave. Any appropriate carrier frequency may be used (e.g., having a puling frequency of greater than 1 MHz, greater than 5 MHz, greater than 10 MHz, greater than 20 MHz, greater than 25 MHz, etc.). The individual pulses may be monopolar or bipolar. The pulses may be transmitted as bursts of carrier pulses having a earner frequency, and the bursts of pulses may have a burst width of between about 1 msec and about 100 msec (e.g., between about 1.5 msec and 50 msec, between about 1.5 msec and 25 msec, between about 1.5 msec and 12 msec, between about 1.5 and 10 msec, between about 1.5 msec and 8 msec, etc.). In some, non-limiting, examples the pulsed magnetic field generator may delivery pulse burst envelopes of mono- or bi -polar rectangular or sinusoidal pulses. The resulting pulsed magnetic field may induce a peak electric fields between 10 '’ and 1 volts per centimeter (V / cm).

[0078] Thus, the pulse magnetic fields described herein may be applied by a pulsed EMF generator and emitter / applicator (e.g. coil, including but not limited to a Helmholtz coil) that- 14 -SG Docket No.: 14852-702.600is pulsing a train of pulses in bursts having a fixed or varying, and in particular, stepwise varying, burst duration. The individual pulses may be at any appropriate frequency.

[0079] For example, FIG. 2 illustrates one example of an apparatus configured to apply a low energy magnetic field to tissue / cells in which the time-varying magnetic field is modulated by increasing or decreasing the pulse width every 1-10 minutes during a treatment period and / or changing the burst repetition rate by increasing or decreasing the pulse burst rate every 1-10 minutes during the treatment period. The apparatus may be configured to limit the application of the treatment so that there is a quiescent period of at least 24 hours between consecutive treatment periods.

[0080] For example, the controller of the apparatus may be configured to vary the timevarying magnetic field by increasing or decreasing the pulse width by between about 5-50 msec every 1-10 minutes during a treatment period (lasting between 1-180 minutes or more, e.g., lasting between 1-60 minutes, between 1-45 minutes, between 1-30 minutes, between 1- 20 minutes, between 1-15 minutes, etc.). In some examples the controller of the apparatus may be configured to vary the burst repetition rate by increasing or decreasing the pulse burst rate every 1-10 minutes during the treatment period by between about 0.1-100 Hz (e.g., by about 10 Hz, by about 15 Hz, by about 20 Hz, by about 25 Hz, by about 30 Hz, by about 40 Hz, etc.). In some cases the burst rate may be limited to between about 0.1 Hz and 500 Hz (e.g., between 1 Hz and 400 Hz, between 2 Hz and 300 Hz, between 5 Hz and 250 Hz, between 10 Hz and 200 Hz, etc.).

[0081] In FIG. 2 the apparatus includes an applicator 1005 integrated into a wearable (e.g., headset) 1006. The applicator may include one or more coils for delivering a magnetic field. The magnetic field is configured as a headset in this example and may include a frame holding the applicator coils. Any appropriate applicator may be used. The applicator may be integrated into a garment or other wearable apparatus, or it may be configured as a device to be held against the body for the treatment duration. In FIG. 2, the apparatus also includes a base 1007 having a housing that may enclose the control circuity, including a magnetic field generator and control circuitry configured to control operation of the apparatus, as described herein. The applicator may be connected to the magnetic field generator by one or more cables or wires, as shown in FIG. 2. In some examples the applicator may be integrated with the base and control circuitry (and / or power source or power control circuitry).

[0082] FIG. 3 shows another example of a noninvasive MMT device including a headset 220 and console 102. The console 102 may include a controller (e.g., control circuitry) and / or a pulse generator (not visible within he console in this example). The headset 101 is coupled via the cable 103 and one or more connectors 104. In the example shown in FIG. 4, the - 15 -SG Docket No.: 14852-702.600apparatus (e.g., system 200) includes a console 202 (or base), and a headset for delivery of electromagnetic fields as described here. The headset in this example includes a plurality of fins 206 extending from the loop, hoop, circle, etc. that are enclosed over the one or more coils to form the core of the applicator (e.g., coil enclosure 205). The headset also includes an inner insert or other member, such as a strap 207. The coil enclosure 205 forms an opening that may be oval, circular, etc.

[0083] FIGS. 5A-5C illustrate different view of one example of a headset including an inner elastic 307 forming part of the headset from which the plurality of fins 406 configured to project from the inside of the headset (e.g., the inner surface of the coil enclosure 305); in FIG. 5A the fins 306 form a part of an elastic (e.g., elastomeric) inner region 307. In some cases the inner region may be integrally formed (including the fins) as shown in FIGS. 5A- 5C, or may be separately formed and coupled together. In FIG. 5C the headset includes a strap 507 extending within the inner (e.g., circular, or oval) opening thorough the wearable portion. The headset in FIG. 6 shows the attachment of the headset to the controller via a cable 408, and also include a strap 507 and fins 506. The headset also includes an enclosure 205 extending the perimeter of the headset.

[0084] In general, the fins of each headset may be divided up into at least two regions a left side and a right side, which may be minor images of each other. When worn, the fins may comfortable and easily secure the headset over the head so that the coil (not visible) within the coil enclosure 705 of the inner shell 720 may be centered over the head in a predefined manner to deliver the dose of energy as described herein. This is illustrated in FIG. 8, showing a model of a head 810 over which the headset 800 is positioned. The fins 806 may center and hold the apparatus (e.g., the loop) centered over the head. The headset may also include one or more straps 807 that form a chord across the inner diameter of the headset and may help securely hold the headset in position during use. As shown in FIG. 7, the fins are one type of support projection (e.g., finger, fin, support, stmt, etc.) that may be used in any of these apparatuses and that project inward (e.g., radially inward) from the coil enclosure (or any intermediate structure between the coil enclosure and fins) to support the coil enclosure and therefore the coil applicator, at a fixed position around the head. The support projections 506 may be flexible and / or deformable themselves, and / or may be mounted by a flexible or deformable connector 728, which may be referred to herein as a flexure attachment, to the inner surface of the rest of the headset (applicator), including from an inner surface of the coil enclosure, as shown in FIG. 7. Thus, the support projections may be collectively referred to as deformable and / or deflectable, e.g., elastically deflectable from an initial angle (e.g., between 50 to 20 degrees) relative to a tangent to the coil enclosure. In- 16 -SG Docket No.: 14852-702.600any of these apparatuses the support projection may be curved (e.g., in a continuous curve) as shown in FIG. 7.

[0085] FIG. 9 shows another example of a noninvasive MMT device including a headset and base. In this example, the headset for the system in FIG. 9 includes a coil enclosure 905, a plurality of fins 906 extending from an inner shell portion 920 and one or more strap chords 907 extending across the inner shell portion. Any of these straps may include a cushion (e.g., strap cushion 917). Finally, the apparatus includes a base configured as a console 910. Another example of a headset is shown in FIG. 10. In this example the headset includes an inner shell 1004, from which a plurality of fins extend, each fin (“flexure”) 1003 including a flexure retainer 1001 (e.g., flexible attachment) coupling it to the inner shells so that it is biased to be at an initial angle (e.g., approximately 40 degrees from a tangent to the inner surface). The fins in this example each comprise flexure body 1003 and a flexure tip 1002. The headset include a coil housing (the outer portion of which is shown removed in FIG. 10) enclosing a coil 1008 extending around the headset so that, when worn, by head fits into the opening and the skull and brain are within the transverse plane formed by the ring of the coil enclosure to apply the magnetic field through the brain, he apparatus also includes an outer shell region 1005 forming a housing having an outer shell enclosing circuitry (e.g., headset circuitry such a headset PCBA 1006). The headset may also include a cable connector 1009 and a strain relief clamp 1007. FIG. 11 shows one example of a printed circuit board (PCB) 1100 to be held within this headset region. The PCB shown in FIG. 11 may control, for example, tuning of the magnetic field emitted by the apparatus.

[0086] FIGS. 12 and 13 show section and perspective views, respectively, of a console for use with any of the headsets described herein. The headset includes support projections (e.g., fins 1212), that are flexibly connected to the ring-shaped coil enclosure. In this example the noninvasive MMT device has a base including a connector 1204, 1304 (e.g., BNC connector) for the console 1202, 1302. FIGS. 14 and 15 illustrate other examples of connectors 1404, 1504 (e.g., BNC connectors) that may be use as described herein. The console may be configured to include a housing that may enclose the controller, pulse generator and other circuitry. The console 1202, 1302 may include one or more plugs or connectors for power 1313, data (in / out), etc.). The console housing may also include vents 1355 for cooling (or passing sounds, e.g., alerts, status indicators, etc.). In FIG. 16, the console 1602 is shown with the cover removed from the bottom 1602’ of the console, the bottom portion of the console includes a connector (e.g., BNC connection 1604).

[0087] FIG. 17 is a partially transparent view through the console 1700. In this example, the apparatus includes an external connector 1708. The console includes multiple layers of- 17 -SG Docket No.: 14852-702.600PCBs 1707. The apparatus also includes power supply 1702, and may include one or more displays or display components, such as an LED light pipe 1703, LED(s) 705, etc. The console lid 1701 may fit over a console base 1712 and may enclose the supports or bulkheads for the IEC 1709, and / or USB ports 1710. The housing may be a shield, and / or on or more additional shields (e.g., an RF shield over the amplifier) 1711 may be included within the housing. In any of these apparatuses, the console 1700 may include one or more controls, such as but not limited to a start, stop, pause (e.g., treatment pause) button 1704, etc. In some cases the same control (e.g., button, knob, lever, toggle, etc.) may be used for multiple functions, such as starting the dose, stopping the dose, pausing the dose, etc.). The console may include a power (e.g., power on / off) button 1706. The console may include one or more outputs (e.g., indicators, displays, etc., such as one or more LEDs. The output may include circuitry for controlling the output, such as an LED printed circuit board 1705, within the housing.

[0088] Examples of control circuitry (which may include a memory and one or more processors) are shown in FIGS. 18 and 19. FIG. 18 shows two different sizes of a main PCB 1800, 1800’ with a connector 1804, 1804’. FIG. 19 shows another example of a PCB 1900 that may form part of the control circuitry. The PCB shown in FIG. 19 may be useful, for example, to control the user interface components (e.g., LED, input(s), etc.). These PCBs may fit within the console (and in some case one or more may fit into the headset), as shown in FIG. 20 and 21. In FIG. 20 the main PCB 2000 (e.g., controlling power and RF energy) fits into the base of the headset 2020. The console may also include shielding (e.g., custom RF shielding 2100) for all or a portion of the console and apparatus; in the example shown in FIG. 21 the custom shielding may protect and cover the power amplifier.

[0089] FIG. 22A shows another example of a noninvasive MMT device including a headset 2220 and base 2202 (e.g., console). The headset is connected by a cable or connector 2203 to the base / console 2220 via a connector 2204. The headset in this example is similar to that shown above and includes a plurality of fins 2206 and a strap chord 2207. FIG. 22B shows an image of the inner region of the headset removed from the outer region, showing the finer regions of the headset, including the strap and projections.

[0090] Any of these apparatuses may include a cover 2314 or case, as shown in FIG. 23. In this example, the case includes a compartment for the console 2302 that may be lined (e.g., with a foam 2316, such as a thermoformed foam). The case may also include a container or compartment 2301’ for the headset 2301. In this example the container / compartment for the headset may also fold over and act as a cover for the compartment holding the base, or an- 18 -SG Docket No.: 14852-702.600intermediate cover 2318 (e.g. a protective foam layer) may be included. The protective case shown in FIG. 23 is just one example and other configurations may be used.

[0091] FIGS. 24A-24D illustrate one example of a method of applying a headset as described herein, including placing the headset over the top of the patient’s head (FIG. 24 A), so that the anterior fins may first engage with the patient’s head and gently deform as the headset is rotated over the patient’s head 2450, 2450’. The halodike headset may be positioned as desired. Finally, the apparatus may be operated (e.g., turned on) by actuating one or more controls on the console (FIG. 24D). FIGS. 25A-25C illustrate one example of an apparatus including a headset 2570 (shown in FIG. 25 A), and console 2580 or base unit (shown in FIG. 25B). The headset includes a back strap 2507, rear housing 2505, fins 2506 (e.g., fingers, projections, etc.), and cable 2503 with connector 2504. FIG. 25C shows a top view of the console and base. The console 2580 includes an outer cover having a control 2581 (e.g. power button), one or more indicators 2583 (e.g., time remaining indicator lights), one or more inputs 2585 (e.g., start button) and a connector (e.g., BNC connector) 2587 for coupling to the headset. FIGS. 25C shows the headset 2570 connected to the base (e.g., the console) 2580 by a wired connection. In some cases the apparatus may not include a separate console / base, but may integrate the controller, pulse generator, etc. into the headset.Control Systems

[0092] Any of the apparatuses and methods described herein may include one or more control sub-systems for controlling the energy applied, and / or the dosing. For example, any of these apparatuses may be configured to reduce noise, and in particular the harmonics associated with the carrier frequency, e.g., in some cases the 27.12 frequency. Any of these apparatuses may also or alternatively include feedback to control or adjust the applied energy based on feedback, including feedback from one or more of: forward, reflected or phase between the forward and reverse power levels. In some cases the apparatus may be configured (using the forward, reflected and / or phase between forward and reflected power, or other sensors or inputs) to determine a size and / or identity of the patient and may control and / or adjust the applied energy accordingly. The applied energy may be controlled by turning the power on, e.g., locking the apparatus to prevent the application of energy until and / or unless it is confirmed that the user is the correct user. The applied energy may be adjusted by scaling the energy applied based (e.g., increasing the power, treatment duration, etc.).

[0093] In general, any of these apparatuses may include a Filter-Detector-Coupler (FDC) circuit. An FDC may enhance the functionality to the generator, such as a 27.12MHz RF generator that may be part of the apparatus (e.g., the console portion of an apparatus). The - 19 -SG Docket No.: 14852-702.600FDC may be configured to filter to reduce harmonics of the carrier (e.g., the main 27.12MHz) RF signal. The FDC may be configured to include a coupling function configured to sample forward and / or reflected power levels from the generator, and / or may include a power detection function to convert sampled forward and reflected RF signals to a lower frequency (such as DC). Any of these FDCs may include a phase detector (e.g., a phase detection function) configured to quantify the phase difference between the forward and reflected power.

[0094] For example, FIG. 26 schematically illustrates one example of a filter-detector- coupler (FDC) circuit that may be included. In general, the FDC may include a filter 2603 that filters input from the generator 2601. In some cases the filtering is achieved by using a 5thorder LC low-pass filter with a cutoff frequency above 27.12MHz and below the first harmonic of 27.12MHz (e.g., 54.24MHz). Different filter orders and filter topologies may be used. Any of these apparatuses (e.g., including an FDC) may include a coupler 2605. The coupler may be configured as a directional coupler capable of discriminating between forward and reflected signals. The directivity of the coupler (a measure of isolation between forward and reverse sampled signals and may be 20dB or better. FIG. 27 shows one, nonlimiting, example of a coupler circuit that may be used as part of any of these apparatuses (e.g., as all or part of the coupler 2605). The coupler may sample the forward and reflected power levels. For example, a coupler may include a Low Pass Filter (LPF) Section to attenuate high-frequency signals (e.g., formed of inductors and capacitors configured in an alternating series of inductors and shunt capacitors to ground), a power supply filter region to smooth and decouple the power supply, and a coupler section that splits the signal into forward and reverse paths for monitoring, which may include a directional coupler (e.g., CPU, and outputs: RF_Fwd, RF_Rev).

[0095] For example, the coupler may couple to an attenuator / splitter 2607, 2607' (in FIG. 26, two attenuator / splitters are shown) and through them to a forward detector (e.g., forward power detector 2611) and the phase detector 2609, and / or the reverse detector (e.g., reflected power detector 2613) and phase detector 2609. Detector circuitry may convert the forward magnitude, reflected magnitude and phase between fwd / rev signals to a DC output.

[0096] Power detection may be achieved using an RF detector integrated circuit (IC) that consists of a rectifier / filter or some other means of converting an RF signal into a proportional low frequency (e.g. DC) signal. For example, FIG. 28 shows an example of a forward detector circuit that may be included as all or portion of the forward detector 2611. Similarly, FIG. 29 shows an example of a reverse (reflected) detector circuit that may be included as all or portion of the reverse (e.g., reflection) detector 2613.- 20 -SG Docket No.: 14852-702.600

[0097] These apparatuses may also include a phase detector 2609 configured to detect phase between the forward and reflected power levels. The phase detection function may be determined by a phase detector circuit such as a mixer and low-pass filter that converts a sample of the forward and reverse RF signals into a low frequency (e.g. DC) signal that is proportional to the phase difference between the two signals. FIG. 30 shows one example of a phase detector circuit that may be included as at least part of the phase detector 2609.

[0098] By reducing harmonics of the main 27.12MHz signal, the apparatus, e.g., in some examples the FDC included as part of the apparatus, may reduce electromagnetic radiation that exceeds a threshold, such as an industry standard threshold. The FDC may also provide measurements of the magnitude of the forward / reflected RF signal, as well as the phase difference between the two signals. The controller may use all or some of this data to stabilize the output power of the system over time, and / or to determine the loading status of the headpiece of the device. For example, when the headpiece is worn on the subject’s head, the reverse / forward power ratio is typically very low (i.e. there is a small amount of reflection) which can be measured by the apparatus (e.g., by the FDC). Conversely, if the headpiece is removed its impedance typically no longer matches to the generator and the reverse / forward power ratio increases. This difference can be detected by the FDC any of these apparatuses may use this power ratio (or change thereof) to trigger system tasks such as displaying a user warning or error. Similarly, the power ratio (forward / reverse phase change, etc.), which may be detected by measuring a change in phase between the reverse and forward power, may be used to control the apparatus.

[0099] For example an FDC circuit of an apparatus (or comparable circuit for detecting a change in the forward / reverse power) may be used to determine when the headband is being worn by the subject. In some cases just the reflected signal may be used, and may indicate that the device is being worn, and therefore control the application of power so that power is only able to turn on when the device is being worn or is automatically turned off when the device is not in use.

[0100] Any of these apparatuses may determine one or more subject characteristics based on the reflected power and / or the ratio of forward to reverse power. For example, the apparatus may include an FDC circuit that is configured to determine an estimate of the subject’s head size. As shown in FIGS. 31-33. In general, the transmission of energy (RF energy) from the generator to the coil and out of the coil to the subject (e.g., patient) may not be a perfect match, but it may have sufficient energy to determine when a shift in the energy / ratio of forward and reverse / reflected energy to indicate that the patient has a small- 21 -SG Docket No.: 14852-702.600vs. large head. In general, the amplitude and / or shift in signal (phase) may indicate a reflected signal and / or phase offset indicative of the patient, and specifically, the patient’s brain.

[0101] Thus, in any of these apparatuses the apparatus (e.g., controller) may be configured to control and / or adjust the applied energy based on the reflected signal and / or phase offset. This may be detected in some cases using an FDC circuit or components of the FDC circuit (e.g., a filter, and / or detector. For example, the reflected signal and / or phase may be used to indicate patient size and / or when the headpiece is being worn (e.g., based on the difference from the signal in air vs. worn on the head).

[0102] FIG. 31 shows an example of a table illustrating measured input reflection coefficient (“SH”), for a system such as those illustrated in the examples above (e.g., FIGS. 3-25C). The input reflection coefficient is one way to detect reflect signal and / or phase. For example, Si l (input reflection coefficient) may measure how much of an input signal, e.g., from the console, and the controller with the console) is reflected back from the applicator (e.g., headset), typically due to an impedance mismatch. This may help to quantify the reflected signal, e.g., the return loss (which may be measured in decibels). A low SI 1 value (closer to zero) indicates a good impedance match and less reflected power, while a high value signifies significant reflection.

[0103] In the table of FIG. 31 examples of different loads (air, male head, female head, and various sized models, e.g., saline tanks) are shown with the respective measured SI 1 components and FDC outputs. FIG. 32A is a graph showing the percent reflection (% reflection), measured with a vector network analyzer (VNA) vs. the rev / forward ratio of the detector signal for each of these different test loads. FIG. 32B is a graph showing examples of SI 1 phase measured (by VNA) vs. the phase detector output, in mV (and corrected for amplitude differences). These graphs illustrate that forward and reverse energy detectors can be used to accurately track input reflection coefficient (Si l) changes due to loading of the headpiece. For example, air vs. head may be readily differentiated by the controller based on the input reflection coefficient data (e.g., based on the difference in magnitude and / or phase of reflected and forward energy). In any of these apparatuses and methods, smaller changes in input reflection coefficient (Si l) may be detectable when worn on different user’s head.Thus, in general, these methods and apparatuses may include determining (using the forward and reflected power, e.g., phase and / or magnitude) the size of the subject’s head and / or the fit and may adjust the apparatus to modify output based on the detected / derived size. Any of these apparatuses may be configured to dynamically adjust the output (applied energy) based on size of head as determined by the reflected signal (e.g., by the forward and / or reverse- 22 -SG Docket No.: 14852-702.600power, e.g., phase and / or magnitude). For example, the table shown in FIG. 33 illustrates the relative relationship between head size and Si l.

[0104] In general, these apparatuses may detect and / or confirm compliance with a treatment, and / or that the treatment is being applied (or will be applied) to the correct subject (e.g., patient), e.g., the right person is receiving the therapy. The applied power (e.g., the amplitude of the applied power) can be personalized to a particular subject. For example, the apparatus can automatically or semi-automatically measure the reflected (or forward and reverse) energy and / or gain to determine a correct dose.

[0105] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Furthermore, it should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0106] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like. For example, any of the methods described herein may be performed, at least in part, by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the processes(s) of the method.

[0107] While various embodiments have been described and / or illustrated herein in the context of fully functional computing systems, one or more of these example embodiments may be distributed as a program product in a variety of forms, regardless of the particular type of computer-readable media used to actually cany out the distribution. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include script, batch, or other executable files that may be stored on a computer-readable storage medium or in a computing system. In some embodiments, these software modules may configure a computing system to perform one or more of the example embodiments disclosed herein.- 23 -SG Docket No.: 14852-702.600

[0108] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained within the modules described herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.

[0109] The term “memory” or “memory device,” as used herein, generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices comprise, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk drives, caches, variations or combinations of one or more of the same, or any other suitable storage memory.

[0110] In addition, the term “processor” or “physical processor,” as used herein, generally refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the above-described memory device. Examples of physical processors comprise, without limitation, microprocessors, microcontrollers, Central Processing Units (CPUs), Field-Programmable Gate Arrays (FPGAs) that implement softcore processors, Application-Specific Integrated Circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor.

[0111] Although illustrated as separate elements, the method steps described and / or illustrated herein may represent portions of a single application. In addition, in some embodiments one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as the method step.

[0112] In addition, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules recited herein may transform a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.- 24 -SG Docket No.: 14852-702.600

[0113] The term “computer-readable medium,” as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media comprise, without limitation, transmission-type media, such as carrier waves, and non-transitory-type media, such as magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical-storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash media), and other distribution systems.

[0114] A person of ordinary skill in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of the steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed.

[0115] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps in addition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.

[0116] The processor as described herein can be configured to perform one or more steps of any method disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods as disclosed herein.

[0117] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.- 25 -SG Docket No.: 14852-702.600

[0118] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0119] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under”, or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0120] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0121] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive and may be expressed as “consisting of’ or alternatively “consisting essentially of” the various components, steps, sub-components or sub-steps.

[0122] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” - 26 -SG Docket No.: 14852-702.600or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0123] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0124] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have - 27 -SG Docket No.: 14852-702.600been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.- 28 -SG Docket No.: 14852-702.600

Claims

CLAIMSWhat is claimed is:

1. A system for applying a dose of a time-varying magnetic field, wherein the system comprises: a headset comprising one or more magnetic field applicators configured to apply a magnetic field, wherein the headset comprises a coil enclosure enclosing a magnetic applicator coil and forming an opening therethrough, and a plurality of deflectable fins extending into the opening and configured to hold the headset around a head; a signal generator coupled to the one or more magnetic field applicators to deliver a dose of a time-varying magnetic field to the magnetic applicator coil during a treatment period; and a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses, wherein the modulated pulse train is modulated by automatically varying one or more pulse parameter over the course of the modulated pulse train.

2. A system for applying a dose of a time-varying magnetic field, wherein the system comprises: a headset comprising one or more magnetic field applicators configured to apply a magnetic field; a signal generator coupled to the one or more magnetic field applicators to apply a dose of a time-varying magnetic field during a treatment period; and a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses, wherein the modulated pulse train is modulated by automatically varying one or more pulse parameter over the course of the modulated pulse train.

3. The system of claim 2, wherein the headset further comprises a plurality of fins, a coil enclosure, and a headset inner shell adjacent to the coil enclosure.- 29 -SG Docket No.: 14852-702.6004. The system of claim 1 or 3, wherein each fin of the plurality of fins comprises a flexure retainer, a flexure, and a flexure tip.

5. The system of claim 4, wherein the flexure retainer is configured to removably attach and / or detach to the headset inner shell.

6. The system of claim 4, wherein the flexure tip is configured to rest against a patient’s head.

7. The system of claim 4, wherein the flexure of each of the plurality of fins is coupled at an angle of between 10 and 45 degrees relative to the inner shell.

8. The system of any of claims 1-7, further comprising a console coupled to the signal generator.

9. The system of any of claims 1-8, wherein the headset further comprises a strap.

10. The system of claim 9, wherein the strap attaches as a chord across the inner shell.

11. The system of claim 9, wherein the plurality of fins and the strap cooperate to secure a patient’s head within the headset so that the patient’s head is centered within the headset.

12. The system of claim 4, wherein the flexure tips comprise a strap that encompasses a distal end region of each fin of the plurality of fins.

13. The system of any of claims 1-12, wherein the headset comprises a headset outer shell that comprises a headset printed circuit board and a cable gland.

14. The system of claim 13, wherein the console comprises a connector and an electric or power socket.

15. The system of claim 14, wherein the console is connected to the headset via the coaxial connector.

16. The system of claim 14, wherein the coaxial connector connects to a main or primary printed circuit board of the console and the electric or power socket connects to a power supply of the console.- 30 -SG Docket No.: 14852-702.60017. A system for applying a dose of a time-varying magnetic field, wherein the system comprises: a headset comprising one or more magnetic field applicators configured to apply a magnetic field, wherein the headset comprises a plurality of fins, a coil enclosure, and a headset inner shell adjacent to the coil enclosure; a signal generator coupled to the one or more magnetic field applicators to apply a dose of a time-vary ing magnetic field during a treatment period; and a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses, wherein the modulated pulse train is modulated by one or more of: varying a pulse burst width during the treatment period between 1 msec and 50 msec in a stepwise manner; and / or varying a burst repetition rate during the treatment period between 0.1 Hz and 100 Hz in a stepwise manner.

18. The system of claim 17, wherein each fin of the plurality of fins comprises a flexure retainer, a flexure, and a flexure tip.

19. The system of claim 18, wherein the flexure retainer attaches to the headset inner shell.

20. The system of claim 17, wherein the headset comprises a headset outer shell that comprises a headset printed circuit board of the controller and a cable gland.

21. The system of claim 17, further comprising a console configured to couple to the headset.

22. The system of claim 21, further comprising a connector and an electric or power socket.

23. The system of claim 21, wherein the console is connected to the headset via the connector.

24. The system of claim 22, wherein the connector connects to a main or primary printed circuit board of the console and the electric or power socket connects to a power supply of the console.- 31 -SG Docket No.: 14852-702.60025. An apparatus, the apparatus comprising: one or more magnetic field applicators configured to apply a magnetic field, wherein the one or more magnetic field applicators comprises a headset, wherein the headset further comprises a plurality of fins, a coil enclosure, and a headset inner shell adjacent to the coil enclosure; a signal generator coupled to the one or more magnetic field applicators to apply a dose of a time-vary ing magnetic field during a treatment period; and a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses, wherein the modulated pulse train is modulated by automatically varying one or more pulse parameter.

26. The apparatus of claim 25, further comprising a console, wherein the console comprises a connector, further wherein the console is configured to connect to the headset via the connector.

27. The apparatus of claim 25, further comprising a cover for the headset, a cover for the console, and a protective foam layer.

28. The apparatus of claim 27, wherein the cover for the console comprises a thermoformed foam.

29. An apparatus, the apparatus comprising: one or more magnetic field applicators configured to apply a magnetic field, wherein the one or more magnetic field applicators comprises a headset, wherein the headset further comprises a plurality of fins, a coil enclosure, and a headset inner shell adjacent to the coil enclosure; a signal generator coupled to the one or more magnetic field applicators to apply a dose of a time-varying magnetic field during a treatment period; and a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses, wherein the modulated pulse train is modulated by one or more of:- 32 -SG Docket No.: 14852-702.600varying a pulse burst width during the treatment period between 1 msec and 50 msec in a stepwise manner; and / or varying a burst repetition rate during the treatment period between 0.1 Hz and 100 Hz in a stepwise manner.

30. The apparatus of claim 29, further comprising protective assembly comprises a cover for the headset, a cover for the console, and a protective foam layer.

31. The apparatus of claim 30, wherein the cover for the console comprises a thermoformed foam.

32. A system for applying magnetic therapy, the system comprising: a headset comprising one or more magnetic field applicators configured to apply a magnetic field; a signal generator coupled to the one or more magnetic field applicators to apply a dose of a time-varying magnetic field during a treatment period; a controller comprising one or more processors and control circuity coupled to the signal generator and configured to drive the signal generator to emit a modulated pulse train comprising a plurality of burst of pulses from the magnetic field applicators, wherein the modulated pulse train is modulated by automatically varying one or more pulse parameter over the course of the modulated pulse train; and a detection circuit in communication with the controller and configured to detect reflected power and / or the ratio of forward to reverse power applied from the headset.

33. The system of claim 32, wherein the detection circuit comprises a filter-detector- coupler (FDC) circuit.

34. The system of any of claims 32-33, wherein the controller is configured to control or adjust the modulated pulse train based on the reflected power and / or the ratio of forward to reverse power.

35. The system of any of claims 32-34, wherein the controller is configured to adjust an amplitude of the modulated pulse train based on the reflected power and / or the ratio of forward to reverse power.- 33 -SG Docket No.: 14852-702.60036. The system of any of claims 32-35, wherein the controller is configured to confirm a subject is wearing the headset based on an amplitude of the modulated pulse train based on the reflected power and / or the ratio of forward to reverse power.

37. The system of claim 36, wherein the controller is configured to track compliance.

38. The system of claim 36, wherein the controller is configured to allow the application of the modulated pulse train after confirming that the subject is wearing the headset.

39. The system of any of claims 32-38, wherein the headset further comprises a plurality of fins, a coil enclosure, and a headset inner shell adjacent to the coil enclosure.

40. The system of claim 39, wherein each fin of the plurality of fins comprises a flexure retainer, a flexure, and a flexure tip.

41. The system of claim 40, wherein the flexure retainer is configured to removably attach and / or detach to the headset inner shell.

42. The system of claim 40, wherein the flexure tip is configured to rest against a patient’s head.

43. The system of claim 40, wherein the flexure of each of the plurality of fins is coupled at an angle of between 10 and 45 degrees relative to the inner shell.

44. The system of any of claims 32-43, further comprising a console coupled to the signal generator.- 34 -SG Docket No.: 14852-702.600

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