Magnetic pulse treatment device (MPTD) for pain treatment

Abstract

To introduce an epoch-making device for a person suffering from a foot pain, especially, peripheral neuropathy.SOLUTION: A main feature of a magnetic pulse treatment device for pain treatment is a novel automatic alignment applicator with which the entire foot is simultaneously treated and adjustment and size adjustment are unnecessary. In the system, a segmented solenoid is used and the foot is placed directly on a coherent core magnetic flux of the solenoid, so that a sufficiently large and strong treatment zone can be achieved. A dosage of 2,500 ΣΔBT for the entire foot can be achieved within an hour. Extremely low voltage is used and almost no heat is generated, and therefore, this device is suitable for use at home.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims the benefit of and priority to U.S. Patent Application No. 18 / 432,044, entitled "MPTD for the Treatment of Pain," filed February 4, 2024, the entirety of which is incorporated herein by reference. This application is a continuation of and claims the benefit of and priority to U.S. Patent Application No. 18 / 905,994, entitled "MPTD for the Treatment of Pain," filed October 3, 2024, the entirety of which is incorporated herein by reference.

[0002] Origin of the invention The motivation for this invention stems from the inventor's personal experience with debilitating foot pain caused by idiopathic peripheral neuropathy.

[0003] Desperate because prescription medications were not relieving his pain, he traveled to Asia several years ago to receive treatment using a high-power magnetic pulse therapy device (hereafter referred to as "MPTD"), even though it was not yet FDA-approved for use in the U.S. These treatments were highly effective, completely reducing his pain, although ongoing maintenance periods were still required.

[0004] Realizing that CPAP machines are essentially hospital ventilators specifically tailored to treat sleep apnea at home, he wondered if perhaps he could use the same simplification principles to adapt the MPTD to be clinically effective, yet safe and convenient for use at home.

[0005] This invention is the culmination of extensive research with thousands of hours and hundreds of prototypes in its pursuit. The inventor, with a 50-year background in electrical engineering and computer science, embarked on a mission to develop a better MPTD that could provide pain relief to millions of people suffering from similar pain. This invention introduces a groundbreaking device that combines clinical-level effectiveness, simplicity, safety, economy, and suitability for self-administration at home.

[0006] Background Art of the Invention More than 1 million Americans suffer from severe neuropathic pain in the feet. More than one-third of people with diabetes suffer from chronic pain due to diabetic peripheral neuropathy (DPN). An estimated 20 million Americans suffer from plantar fasciitis.

[0007] Despite the well-documented analgesic effects of MPTDs, their adoption for pain relief remains limited. As explained in detail in the Prior Art section of this application, this limited adoption is primarily due to the inherent technical challenges and limitations associated with existing MPTDs. Currently, no commercially available MPTDs meet both FDA approval for the treatment of foot pain and the necessary safety requirements for self-administration and home use. Unfortunately, this has led to a proliferation of unauthorized devices (ranging from counterfeit devices to devices with significant design flaws), often promoted through clandestine channels. This proliferation highlights the persistent unmet need for safe and effective MPTDs for pain management, with an emphasis on self-administration and home use.

[0008] Technical Field The present invention is a medical device for treating pain and other conditions. It can treat any type of pain, but is particularly suited to treating pain resulting from diabetic neuropathy (DN or DPN), peripheral neuropathy (PN), or chemotherapy-induced peripheral neuropathy (CIPN).

[0009] The present invention uses dynamic magnetic fields (magnetic pulses) generated by an electric pulse coil to treat humans or animals, with the magnetic field itself providing the therapeutic effect. This type of MPTD is commonly referred to by various names, including magnetic therapy (C61N), repetitive magnetic pulse stimulation (RPMS), magnetic peripheral nerve stimulation (mPNS), transcranial magnetic stimulation (TMS), pulsed electromagnetic fields (PEMF), pulsed electromagnetic transduction (PEMT), electromagnetic field therapy (EMF), magnetic pulse stimulation (MPS), and transcutaneous magnetic stimulation (TCMS).

[0010] Background technology Magnetic pulse therapy devices (MPTDs) used to treat pain have a history dating back approximately 40 years. One of the earliest published studies was by Polson in 1982 (POLSON, MJR, BARKER, AT & FREESTON, IL Stimulation of nerve trunks with time-varying magnetic fields. Med. Biol. Eng. Comput. 20, 243-244 (1982)). Hundreds of thousands of studies have demonstrated that repetitive electromagnetic pulses can safely reduce or eliminate pain. Outside the United States, MPTDs have been used clinically for pain relief for at least 20 years.

[0011] The FDA has approved the use of MPTDs for the treatment of chronic neuropathic pain and other indications.

[0012] Powerful, repeated magnetic pulses can produce significant and long-lasting analgesic or anti-pain effects, even when medications are ineffective. Studies show that this analgesia is effective in the majority of cases, reducing pain intensity by 50% to 100%. Effects often last for weeks or months, and in some cases, some of the pain relief may be permanent. There are no known side effects from repeated administration of magnetic pulses.

[0013] Some patients with diabetic peripheral neuropathy (a condition often characterized by both pain and numbness) report partial recovery of sensation in previously numb areas after MPTD therapy.

[0014] The exact biological mechanisms by which MPTDs relieve pain are not well understood.

[0015] 2. Description of Related Art Magnetic Pulse Parameters for Efficacy Most studies show medical efficacy in treating pain with magnetic pulses having a magnetic flux density of at least 10 millitesla (B >= 10 mT), but more consistent and demonstrable results are obtained with magnetic flux densities of at least 25 mT (B >= 25 mT).

[0016] It is unclear whether magnetic pulses with intensities less than 1 mT have any medical benefit (except for the placebo effect). It is unclear why magnetic pulses weaker than 1 mT (B<1 mT) have generally shown no medical benefit.

[0017] Medical efficacy appears to derive from dosage, which is the total change in magnetic flux delivered (ΣΔB). High-power systems offer the advantage of faster efficacy, but do not improve overall efficacy. This is likely because high-power systems deliver the required dose quickly, whereas low-power systems take over 100 hours to deliver the same dose as a single 20-minute high-power session.

[0018] In a clinical setting, a typical treatment protocol involves 15,000ΣΔB T ~75,000ΣΔB T This means that a typical treatment session will administer 1,000 to 50,000 pulses of 1.5T (1,500mT) magnetic flux density (calculation: 1,000 pulses x 1.5T = 1,500ΣΔB T , 50,000 pulses × 1.5T = 75,000ΣΔB TTypically, 5 to 10 treatment sessions are required in the first month. At these power levels, pain relief generally occurs within 5 to 10 sessions and may be evident in as little as one session.

[0019] Research generally shows that the rise time of the pulse is very important. A steeper rise time (ΔB / dt or dB / dt) of the magnetic flux is clearly superior to a sine wave. A square wave is often considered ideal, but other shapes such as a triangle have also shown effectiveness. It is generally understood that ΔB / dt is the second most important parameter after ΔB, and thus a square wave with steep rising and falling edges appears to be optimal.

[0020] Although pulse durations (tp) of approximately 250 μS are widely accepted as optimal for pain treatment, MPTDs produce pulses ranging from 10 to 500 μS. Very long pulse durations (tp > 100 mS) appear to be ineffective and may even be harmful. Very short pulses (tp < 10 μS) appear to be less effective.

[0021] Magnetic pulses generate an electrical charge within the cells being treated. Leaving a charge in the cells is considered bad. The best-known method for achieving a net zero cellular charge is to use a symmetrical bipolar pulse that returns to zero. The ideal pulse is 125 μS followed immediately by a 125 μS pulse of the opposite polarity. Some regulatory agencies mandate bipolar pulses.

[0022] Pulse frequencies vary widely among magnetic pulse therapies. Frequencies above 100 Hz are discouraged by both regulations and the International Commission on Non-Ionizing Radiation Protection (ICNRP) recommendations. This is because high frequencies (kHz and MHz) can cause heating within the treated appendage and have been shown to potentially cause DNA damage in some circumstances. For the relief of neuropathic pain, frequencies between 1 Hz and 100 Hz are most common.

[0023] Some companies selling non-FDA-approved MPTDs claim that certain frequencies are "tuned" to specific ailments: for example, 10-15 Hz for acne treatment, 2-8 Hz for Alzheimer's disease, 5 Hz for constipation, and 6 Hz for erectile dysfunction. Alternatively, Schumann resonances are sometimes promoted for dubious (snake-oil) medicinal properties. U.S. Patent 6,701,185 ('185) makes some pretty bold speculations in this regard. There is absolutely no scientific evidence to support these claims, and there are no FDA-approved indications for MPTD therapy.

[0024] Most clinical systems currently in use are high-power MPTDs with a magnetic flux density of approximately 1,500 ± 500 mT, generating 125 μS + 125 μS dipole pulses at frequencies between 1 PPS and 200 PPS.

[0025] Magnetic pulse formation and challenges A magnetic pulse is generated by passing electricity through a coil. The magnetic output of a coil can be simply expressed as the product of the number of turns (N) of the coil winding and the amperage (A). Thus, the number of turns and the amperage of the coil are positive and negative.

[0026] The problem is that the coil has inductance (L), which prevents changes in the amperage flowing through it. Thus, adding more turns increases the inductance, making it increasingly difficult to send amperage pulses through the coil. A typical MPTD coil may have 12 to 24 turns. This number of turns provides enough inductance to strongly prevent enough amperage from passing through it. To get enough amperage through the coil requires a very high voltage (acting as pressure), typically 500 to 1,000 volts.

[0027] The goal of fast flux rise time (ΔB / dt) favors coils with fewer turns and lower inductance, which is why MPTDs are biased towards high amperage designs.

[0028] Generating a magnetic pulse with a clinical-strength high-power MPTD typically requires 500–1,000 volts and 1,000–10,000 amps, and the coil is typically constructed with very thick wire, such as #2–#8 AWG. Such power levels are instantly lethal and are extremely difficult to comply with mandatory medical safety regulations, such as IEC 60601. This is why high-power MPTDs are only suitable for controlled clinical environments under expert supervision. It is also why these systems are expensive, large, and heavy.

[0029] Core Flux MPTDs generally use applicators that use coils that are placed flush with the treatment area and use non-core magnetic flux (as shown in Figure PA14 of Information Disclosure Statement #2). Non-core magnetic flux is magnetic flux that emanates from the edges, sides, and periphery of the coil. When the coil is simply a circle or loop, nearly all of the magnetic flux is non-core. This type of magnetic flux is chaotic, disperses quickly, and quickly assumes random directions. This is sometimes referred to as "incoherent" magnetic flux.

[0030] In contrast, core flux is the magnetic flux passing through the area enclosed by the coil. In the case of a single coil, the coil is nearly infinitely thin. If the coil is long enough to form a cylindrical shape (commonly called a "solenoid"), the entire core within the solenoid becomes nearly entirely core flux. Thus, the only practical way to create core flux is with a solenoid of some length (as shown in Figure PA15 of Information Disclosure Statement #2).

[0031] The main characteristics that distinguish core and non-core flux are:

[0032] 1. Spatial Distribution: Within the coil, the magnetic flux lines are concentrated, but outside the core, the magnetic flux lines are more dispersed and spread out. This means that the core flux density is higher (more powerful). Core flux is less affected by distance from the coil than non-core flux.

[0033] 2. Magnetic field uniformity: The magnetic field is generally very uniform within the core. The field quickly becomes non-uniform outside the core. This means that the core flux has few interference patterns and no hot spots or voids.

[0034] 3. Magnetic field coherence length: The coherence length (the spatial extent to which magnetic field components are correlated) is greater and longer for core flux due to the stronger, more organized magnetic field. Non-core flux is weaker and more dispersed and random. Magnetic field coherence length and uniformity are important properties because solenoids can be formed from multiple axially aligned but independent coils.

[0035] 4. Magnetic Field Coupling: The magnetic field lines of core flux are tightly coupled and interact strongly, while the magnetic field lines of non-core flux are weakly coupled and interact less. This coupling is important because it is the means by which the magnetic flux from one coil can combine with the magnetic flux from another coil to form a combined flux that can be denser than either coil while still maintaining high coherence.

[0036] 5. Dispersion: Core flux has much less dispersion of magnetic flux. Non-core flux disperses quickly and widely in all directions, often very randomly and rapidly. Core flux is confined within the core of the coil, so it is concentrated and bounded and does not disperse.

[0037] Unfortunately, nearly all clinical applicators currently in use primarily use uncored magnetic flux because of the ease of manufacture and the ability to reduce the applicator to a simple circular coil.

[0038] prior art High-power (1,500mT) MPTD Nearly all currently used clinical magnetic pulse therapy devices (MPTDs) and all systems currently approved by the FDA for pain treatment are high-output MPTDs that generally emit pulses with a magnetic flux density (B) of 500 mT to 3,000 mT (500 mT < B < 3,000 mT). The intensity of MPTD devices used in clinics is typically 1,500 mT (1.5 T). The main reasons for preferring high output are as follows.

[0039] 1) Hit-and-miss coverage. Most applicators require skillful operation by technicians to uniformly cover the treatment target area. Nevertheless, the applicators are inconsistent and will cover the treatment target area in a "hit-and-miss" manner. The higher the output, the larger the size of the applicator that can be used, resulting in fewer "misses".

[0040] 2) Penetration and compensation. Magnetic flux rapidly decreases with distance, especially the non-core magnetic flux from around the coil. High-output MPTDs of 300 mT to 1,500 mT can exhibit a magnetic field density of only 15 mT to 75 mT at a distance of 25 to 40 mm from the center of the applicator (see FIGS. 3E and 3F of U.S. Patent No. 11,305,130). The effective treatment area is a circle with a diameter of about 2 inches (50 mm) and becomes smaller when deeper penetration is required.

[0041] 3) Non-coherent magnetic flux. Most applicators are of the "pack type" and apply non-core magnetic flux from the outer periphery of the coil. This type of magnetic flux has low coherence and is more randomly oriented, so it is essentially less effective. At high output levels, brute force is used to provide sufficient magnetic flux to compensate for the random magnetic flux. Higher output is required to compensate for low-quality magnetic flux.

[0042] 4) Over-therapy concept. While multiple studies demonstrate that magnetic pulses above 25 mT can produce medical benefits, using excessive powers poses little harm, with no known side effects. Higher powers are used to compensate for deficiencies in application and applicator design. Pure brute force overcomes many inherent deficiencies in the design, application, and delivery of magnetic pulse therapy.

[0043] 5) Speed. Clinics need to treat and discharge patients quickly, often within 10-20 minutes. Higher-power devices deliver doses faster. Patients also get faster results.

[0044] The use of higher power means that a larger dose (ΣΔB) is delivered during a treatment session, with the goal being to deliver a specific dose quickly. High power therefore allows for faster treatment of patients, addressing irregular coverage, compensating for poor quality magnetic flux, and better filling gaps. High-power MPTD systems are practical in clinical settings where high costs are amortized over a large number of patients during the day.

[0045] High-power systems are not suitable for home self-administration. High-power MPTDs use instantly lethal internal voltages of greater than 500 (V >= 500) and amperages of greater than 500 (A >= 500). Voltages exceeding 1,000 volts and amperages of 1,000 to 10,000 amperes are not uncommon (instantaneous power of approximately 1 megawatt).

[0046] Regulatory compliance for medical devices necessarily means conformance to the IEC 60601 standard. Designing to the safety levels required by IEC 60601 is extremely challenging, as it requires extensive insulation, air gaps, fault monitoring, and operating methods. Complicating this is that most MPTDs have pluggable applicator cables and may employ liquid cooling of the electronics or applicator.

[0047] It is highly unlikely that a high-power MPTD will ever be approved for home use or self-administration, and as such, high-power MPTD therapy will always be limited to clinical settings requiring trained personnel to administer the therapy.

[0048] High-power MPTDs are necessarily complex, heavy (often around 50 pounds), large (requiring dollies for movement), and very expensive (rentals in some cases were as high as $5,000 per month).

[0049] Good examples of high-power MPTDs include the Neuralace Medical Axon Therapy (www.neuralacemedical.com) and the MagVenture R30.

[0050] High Power Applicator High power MPTD applicators are typically connected via thick cables to an energization control unit that contains a source of high voltage and high amperage pulses.

[0051] High-power MPTD applicators may operate at power levels that can momentarily approach megawatts. Both voltage and amperage may exceed 1,000 (V >= 1,000, A >= 1,000). In some implementations, amperage may approach 10,000 amperes. This generates significant heat within the applicator. Typically, the applicator reaches its maximum safe operating temperature after 10–15 minutes of use. This may require liquid cooling or replacement of the high-power applicator with a pre-cooled applicator stored in a nearby cooler. Replacing the applicator requires unplugging the heavy-duty power cable, which exposes potentially lethal voltage and amperage connectors, necessitating additional safety precautions. High-power applicators are expensive, often costing thousands of dollars. Applicators are often immersed in a cooler to rapidly cool them, making them susceptible to water ingress and thermal stress. Therefore, applicator lifespans are limited.

[0052] High-power MPTDs must be adjusted for each patient by titrating the power level until muscle movement is elicited by the magnetic pulses during a treatment session. The goal is to use the highest power level acceptable for maximum efficacy and minimum treatment time. This power calibration process is subjective and requires training and careful observation.

[0053] High-power MPTD applicators are most typically coils attached to a handle, so the applicator can be placed anywhere but can also be accidentally dropped or unintentionally operated.

[0054] High-power MPTDs can have outputs exceeding 2 Tesla (>2T), which exceeds the safe levels adjacent to pacemakers (which can be 1 Tesla) or insulin pumps, posing a safety risk and making these devices contraindicated for people who use these devices. This is problematic because many people who use insulin pumps suffer from painful diabetic peripheral neuropathy (DPN). For reference, high-power MPTDs can destroy credit cards and nearby small electronic devices.

[0055] High power applicators are rarely approved for home use by the general public due to the inherent dangers, cost, and complexity of application.

[0056] Medium power MPTD (1mT~100mT) Moderate-power magnetic pulses above 1 millitesla (B>=1mT) are clearly beginning to be useful from a medical perspective. While there is evidence of therapeutic benefit from magnetic pulses as low as 1mT, pulses in the 10mT-50mT range have been widely studied and generally produce measurable, verifiable, and repeatable medical effects (e.g., pain relief). This may be the most studied range of all magnetic pulse power ranges.

[0057] Mid-power systems are inherently much slower than high-power MPTDs; it can take over 100 hours for a mid-power MPTD to deliver the equivalent dose of a 20-minute clinical session using a high-power system.

[0058] Therefore, clinics dedicated to providing good patient outcomes are not interested in medium-power systems because they are impractical and generally ineffective within the time constraints available for treatment. Clinics need to treat patients and discharge them quickly, and the higher cost of high-power MPTDs is more than offset by the savings in staff labor.

[0059] Thus, an unfortunate reality exists in the realm of mid-power MPTD devices. The primary market appears to be companies selling devices through clandestine channels that lack the necessary regulatory approvals. This approach sometimes results in unsubstantiated, "quack-like" medical claims that exploit the desperation of people suffering from severe chronic pain (see "Specific Frequencies" previously discussed in paragraph

[0023] ). Many of these devices range from ineffective counterfeit products to devices with horrific design flaws.

[0060] Medium-power MPTDs generally come in two configurations, neither of which is well suited for pain treatment:

[0061] 1) A scaled-down version of a high-power MPTD, or

[0062] 2) A scaled-up version of the low-power MPTD.

[0063] Scaled-down high-power MPTD to medium-power MPTD Scaled-down versions of high-power MPTDs suffer from the same problems as the high-power systems they are derived from: they still use lethal voltages and amperage, are cumbersome, somewhat expensive, and typically contain a coil within the applicator that is connected to electronics by a thick cable. Treatment requires careful and meticulous manipulation of the applicator. Effectiveness is inconsistent, and doses are often inadequate.

[0064] Scaled-down high-power MPTDs still have difficulty complying with mandatory regulatory standards such as IEC 60601 due to their lethal voltage and current values. These systems are, after all, just cheap high-power systems. There is no fundamental difference.

[0065] Scaled-down versions of high-power MPTDs have never been FDA-approved for home use by the general public, and in most cases are not FDA-approved for any medical condition. Because safety testing is often lacking and they cannot meet regulatory requirements, these MPTDs are generally not suitable for use in clinics.

[0066] A prime example of a scaled-down high-power system is Curatronic's Curatron MPTD. The FDA has taken action against this company. To this day, the company continues to sell mid-power MPTDs to consumers in defiance of the FDA, evidence of the long-standing demand for this category of product.

[0067] Low-power MPTD scaled up from mid-power MPTD Another configuration of medium-power MPTDs is the scaled-up low-power MPTD. Scaled-up low-power MPTDs typically operate at extremely low voltage (ELV) and may be battery-powered. These MPTDs use simple devices such as charged capacitors and MOSFETs to energize a modest-sized coil. To claim medium-power strength, these MPTDs typically require very small coil sizes, most around 1 inch (25 mm) in diameter. Such devices can indeed generate 20 mT magnetic pulses, but only a few millimeters deep within this very small area.

[0068] There are three fundamental problems with scaled-up low-power MPTDs:

[0069] 1) These MPTDs have a small treatment area (often 1 inch), requiring frequent repositioning of the applicator.

[0070] 2) The dose (ΣΔB) is so small that the applicator must be left in one place for a long time (sometimes more than an hour).

[0071] 3) The penetration of these MPTDs is low and they cannot adequately reach nerve bundles at a depth of 10–20 mm.

[0072] Scaled-up microtesla MPTDs are not FDA-cleared for any medical condition.

[0073] An example of a scaled-up low-power MPTD is the Micro-Pulse ICES® system.

[0074] Low power MPTD (μT=<1mT) There are many low-power magnetic pulse therapy devices (MPTDs) that emit magnetic pulses in the microtesla range (<1mT). Generating magnetic pulses with magnetic flux densities in the microtesla range is cheap and simple; all it takes is a AAA battery and a wire wrapped around a pencil.

[0075] A typical low-power MPTD includes a pulse generator operating at a convenient low voltage connected to one or more coil assemblies formed into the shape of a puck, cable, loop, mat, chair, or beautiful Spirograph artwork. Some of these low-power MPTDs include aesthetically pleasing touchscreen displays and can cost thousands of dollars.

[0076] The amount of magnetic flux delivered by low-power MPTDs is negligible. For example, Swiss Bionic's iMRS system provides mats that are reported to deliver a magnetic flux density of 0.009–0.065 mT (0.000009–0.000065 T).

[0077] Despite marketing claims, studies have not demonstrated that low-power magnetic pulse therapy devices (MPTDs) provide analgesic effects to relieve pain. Any perceived benefits are likely due primarily to the placebo effect. While generally considered harmless, low-power MPTDs are not FDA-cleared for any medical indication. As a result, marketing must refrain from making medical claims and adhere to FDA policy, which classifies these devices as "general wellness" products, similar to crystal or aromatherapy.

[0078] An example of a low-power MPTD is the iMRS Prime from Swiss Bionic Solution.

[0079] Non-core magnetic flux applicator Applicator design is an essential part of any MPTD, and applicator design is both an art and a science. The applicator's role is to ensure that the magnetic pulse is applied to the entire treatment area. Applicator design always faces a trade-off between size and power delivery. The larger the applicator, the higher the power required, otherwise a weaker pulse will be delivered. Different applicator shapes result in different shapes of the applied magnetic flux field.

[0080] Existing applicators make less than optimal use of the magnetic flux generated by the coil and primarily utilize non-core magnetic flux. Because the applicator attempts to deliver the magnetic pulse with the highest intensity over the widest possible area, the applicator coil is typically coplanar (parallel) with the area to be treated. This means that most of the magnetic flux is non-core. Non-core magnetic flux applicators generally have a coplanar coil arrangement, as described in U.S. Patent No. 6,701,185 ('185) and shown in Figure PA22 of Information Disclosure Statement #2. Foot therapy devices such as those shown in PA22 are not known to exist outside of the present invention; this is merely an illustration of how coplanar coils may be arranged within such a therapy applicator.

[0081] Because non-core flux decreases rapidly with distance (roughly proportional to the square or cube of the distance), a 1,500 mT applicator using non-core flux may only have an intensity of 25 mT at a distance or depth of 25 mm. Some areas may receive 1,500 mT, while other nearby areas may receive only 25 mT. (See Figures 3D, 3E, and 3F of U.S. Pat. No. 11,305,130 and the web citation in Information Disclosure Statement #1 for coverage degradation.) Of course, applicator geometry and powering electrical pulse parameters make a big difference. Non-core flux is also somewhat random (incoherent), and therefore less effective at any given intensity. Also, with a coplanar coil applicator, half of the flux is completely lost on the other side of the applicator.

[0082] Non-core magnetic flux-based applicators typically have highly variable magnetic flux levels from one area to another nearby area. A 25 mm difference in distance can result in a 4:1 to even 10:1 difference in treatment intensity. Even moving the applicator systematically across the area typically results in a haphazard application. Some applicators have irregular coverage patterns that can be shaped like donuts (loops), curves (ropes), or polka dots (U.S. Patent No. 6,701,185).

[0083] Most applicators use non-core magnetic flux, which makes them inefficient and prevents uniform application of the dose. A trained technician must manipulate the applicator to achieve the most complete and uniform coverage possible, which is labor-intensive.

[0084] Puck-type applicator One of the most commonly used high-power MPTD applicators is the puck type, which has a rigid, shrouded coil attached to a handle and connected to the electronics via an essential thick cable (further described in Figures PA17A and PA17B of Information Disclosure Statement #2).

[0085] Despite the high power (typically 1,000-2,000 mT), the coverage area is very small, perhaps only 2 inches in diameter (see Figures 3D, 3E, and 3F of U.S. Pat. No. 11,305,130), or an 8-inch diameter donut with a 3-inch uncovered hole in the center. Other coil shapes, such as racetrack or figure-eight, also exist, each with its own unique coverage pattern.

[0086] The technician systematically and methodically moves the puck along a prescribed coverage path at an appropriate speed to deliver a prescribed magnetic pulse dose (ΣΔB) to treat an area such as the foot. The technician may need to continually adjust the parameters of the treatment protocol during the session.

[0087] Puck applicators are particularly susceptible to overheating, which can damage the pack, injure the patient, or cause a fire. Safety circuits and, in some cases, liquid cooling are required to prevent thermal runaway. Typically, packs overheat in less than a single treatment, so they are replaced with spare packs kept in an ice chest.

[0088] Although manually operated pack applicators are versatile, they can be difficult to use to evenly and consistently treat irregular areas such as the feet.

[0089] Loop Applicator The loop applicator consists of a coil formed into a circular loop, with the ends of the loop meeting in a T-shape where they meet the required heavy cable that connects to the controller. The loop can be worn around the neck, knee, foot, etc. (Shown in Figures PA18A, PA18B, and PA18C of Information Disclosure Statement #2.)

[0090] There is a misconception about loops. Many people mistakenly believe that there is a lot of magnetic flux throughout the core of the loop, possibly flowing from one side of the perimeter to the other and everywhere in between. Magnetic field measurements show that the magnetic flux is generally confined to within 25-50mm of the loop itself, with most of it being within about 10-20mm (such as if a pool noodle were to wrap around the loop and the magnetic flux were within the pool noodle). There is very little magnetic flux in the core of the loop. A typical loop produces very little core flux.

[0091] Loop applicators are rarely (if ever) used in high-power machines because they are prone to thermal runaway at high power outputs, there is no reliable way to monitor the temperature of the entire loop, and it is much more difficult to apply a uniform dose to a specific area than with a puck applicator.

[0092] The primary use for loop applicators is in medium and low power MPTDs where individuals like the idea of simply hanging the loop and leaving it in one place.

[0093] Dual Loop and Butterfly Applicators Some applicators have two loops attached to a single power cable, conveniently hanging one on each leg, as shown in Figure PA21 of Disclosure Statement #2. In a dual loop system, the magnetic flux is necessarily half the strength of a single loop of the same size, simply because the dual loop spreads the same magnetic flux over a larger area.

[0094] While convenient, dual loops are significantly less effective at treating the toes, heels, and plantar surfaces of the feet due to distance issues and because the loops do not generate the bubble of magnetic flux most users imagine. It is a natural human bias to mistakenly imagine a bubble covering the entire foot, when in fact the range is closer to a "pool noodle" of magnetic flux covering the loop. Because the strength of non-core magnetic flux falls off as the square (or cube) of distance, effective flux density is limited to a distance of 25-50 mm.

[0095] A variation of the Dual Loop is where the larger loop can be folded over to form what is called a Butterfly Loop (shown in Disclosure Statement #2, Figures PA19A, PA19B, and PA19C). This allows treatment of both sides of the leg, arm, shoulder, etc. All of the mismatches and irregularities of a simple loop are present.

[0096] Dual loop and butterfly applicators are rarely used in high-power systems for the same reasons that traditional loop applicators are not used: the risk of thermal runaway and the difficulty of applying a uniform dose over an area.

[0097] Helmholtz applicator The Helmholtz applicator positions two coils at specific locations, parallel to each other and to the treatment area.

[0098] Helmholtz applicators attempt to establish a coherent magnetic flux and have met with some success. However, this type of applicator fails for several reasons. To create a coherent magnetic flux, the spacing between two Helmholtz coils must be maintained at half the coil diameter. This requires either a very large coil diameter or a very small treatment area. To bridge the distance between coils of a useful size, very high power is required to achieve a reasonable magnetic field strength. High power comes with lethal voltages, heavy cables, and heat problems.

[0099] Helmholtz applicators are generally similar to loop applicators and therefore suffer from many of the same problems and limitations.

[0100] As a result, Helmholtz coil applicators are rarely (if ever) used in high-power systems. This type of applicator is typically used in medium- or low-power systems. In medium- and low-power systems, the large area within the applicator and limited power result in low dose delivery rates, making Helmholtz applicators medically ineffective for pain treatment.

[0101] Rope-type applicator The rope applicator is a long wire with each end connected separately to a controller. The rope is then wrapped around the leg, thigh, arm, or neck (shown in Figure PA20 of Information Disclosure Statement #2).

[0102] The rope emits magnetic flux in the same way that a garden hose sprays water everywhere. The magnetic flux density from the rope tends to be low, making it difficult to treat the ends of appendages such as toes. Where the rope turns back, the magnetic flux cancels out. Where the rope crosses, a checkerboard interference pattern forms. Power to the rope must be kept low to prevent thermal runaway. Also, because half of the rope goes from the controller to the treatment area, about half of the magnetic flux is simply wasted in the air along this path.

[0103] Ropes are very difficult (almost impossible) to drive with high power systems due to their unpredictable inductance. When the rope is straight, it has very little inductance and appears as a short circuit. When it is tightly wound, it has high inductance and may have very low power or very slow pulse rise times.

[0104] There's a good reason why rope-style applicators aren't common.

[0105] Mat & Chair Applicator Mat and chair applicators have one or more coils embedded in a cushioned mat or chair cushion. Their purpose is to cover very large areas, such as the whole body. Mat applicators usually contain multiple coils wired in series or parallel, or a combination thereof. Because of the need to cover such a large area, the coils are often quite large, perhaps around 250 mm in diameter. In some cases, the mat is divided into "channels" or regions, each with its own set of coils and connecting wires to electronics.

[0106] Essentially, this is an expansion of U.S. Patent No. 6,701,185 ('185), which is described in more detail later in this disclosure. Companies selling this type of applicator lead customers to assume that the entire area within the mat is immersed in magnetic flux, which is a logical assumption to the uninitiated. Magnetic field measurements often reveal Swiss cheese or polka dot coverage with hot spots and very large gaps, and large variations in overall magnetic flux density.

[0107] A common mistake in the design of these mats is to orient all loops in the mat with their windings and polarities in the same direction. As a result, when multiple loops are close together and energized simultaneously, they simply cancel each other out. This is addressed to some extent in patent WO 2022 / 261172 A1. However, a bigger problem is that the magnetic flux density of MPTDs using mats is typically in the range of 1% to 3% of what a puck or loop applicator would produce in the same electronics package, slowing down the dispensing of sufficient doses.

[0108] Due to inherent problems with thermal runaway and inconsistent coverage, mat and chair applicators are necessarily used with low-power MPTDs. The expense of high-power systems is wasted when all of the power is distributed over a very large area and there is no way to predict where the magnetic pulse will actually land. While the concept of sitting on a mat and receiving magnetic pulse therapy is appealing to consumers, the FDA has never found a mat medically effective for treating pain. More simply, mat and chair applicators are not optimized for treating appendages such as the foot.

[0109] Shoe last applicator U.S. Patent No. 9,550,067 ('067) is a proprietary high-power MPTD and associated applicator. The applicator's single coil is formed into the shape of a shoe from very large #2 to #6 AWG wire. The '067 applicator essentially wraps a single giant coil around the foot. The result is a heavy, inflexible, and possibly dangerous applicator.

[0110] The shoe-shaped coil has a significant advantage because it ensures consistent application of magnetic pulses to the foot (which is perhaps the most responsive part of the human body to magnetic pulse pain treatment). This is the beginning of a good concept for maximizing magnetic flux to the foot and applying magnetic pulses consistently. However, in practice, the '067 device does not work.

[0111] The applicator disclosed in '067 is based on a high-power MPTD, which generates significant heat. The large amount of heat generated, combined with the thick foam rubber lining padding (col. 2, line 61), results in highly insulated shoes that present a fire hazard. Worse yet, because many patients with nerve damage to the feet (e.g., peripheral neuropathy) cannot sense temperature, their feet can literally heat up without them even realizing it.

[0112] Access to the applicator disclosed in the '067 patent is highly problematic: the applicator lacks an obvious opening, is padded with insulating foam, is heavy with the weight of the sizable #2-#6 AWG coils, is immobilized by the connecting cable, and is not easily maneuverable in feet that are tender to the touch due to neuropathy.

[0113] A high-power single-coil applicator in the shape of a shoe is conceptually a step in the right direction, but not feasible.

[0114] Sandal-type applicator U.S. Patent No. 9,849,302 ('302) is a dedicated high-power MPTD that includes an applicator designed to apply magnetic pulses to the foot. The invention discloses three precisely positioned coils in a coplanar structure resembling a sandal.

[0115] The '302 is definitely a high-power MPTD, stating that "the peak current in the coil can be as low as 500 amperes or as high as 10,000 amperes, and the peak pulse voltage to achieve these high-power levels of current is between 500 volts and 10,000 volts" (col. 3, line 59). The coil in the '302 device is constructed of #6 to #12 AWG wire (col. 7, line 60), or inconsistently #2 to #8 AWG wire (col. 5, line 32), which are typical sizes for high-power MPTDs.

[0116] The '302 patent states that the coil typically contains 10 to 30 turns of wire up to #2 AWG. Because #2 AWG wire is approximately 1 / 4 inch in diameter (including insulation rated for up to 10,000 volts), the coil may be 2 to 6 inches tall and quite heavy. The '302 patent suggests using Velcro straps to secure the three coils in place, but this seems unlikely given the bulk, weight, and pull of the thick connecting cables. Even if completed, the "sandal" may not resemble anything depicted in Figure 6. This would be extremely inconvenient, and it would be difficult to "put on" such a bulky and heavy coil on a patient.

[0117] The '302 patent explains that a rubber or other liner must be used to minimize the number of different sizes required. The possibility of foot burns from sandals remains.

[0118] Recognizing the thermal issues inherent in the design, the '302 patent proposes forming the coil conductor into a tubular shape with gas or water passing through it to provide cooling. Forming the coil conductor into a tubular shape presents additional problems. The large diameter of a tubular conductor necessarily reduces the number of turns possible in the available space. Fewer turns generates less overall magnetic flux, requiring more amperage to compensate, generating more heat. Achieving this within the form factor of a sneaker is difficult, even ignoring the extreme complexity of constructing a coil from a water-filled, insulating tube that can carry up to 10,000 volts. The '302 patent does not suggest how this might be possible.

[0119] Furthermore, the '302 patent discloses that three coils can be operated serially (to be precise). The disclosed advantage is that the inductance of each of the three coils is lower than that of a single coil, resulting in higher amperage. Unfortunately, however, such an arrangement triples the amperage, and the triple wiring of the cable connecting the applicator and pulse generator and operating the three large, thick molded coils remains problematic. Presumably, monitoring and management of thermal risks from three separate coils is magnified as well.

[0120] There is another, even more troubling aspect to the '302 patent disclosure: the magnetic flux cancellation effect of the three coplanar coils in close proximity. The actual reason for separately powering the coils in the sandal design is that they must be energized separately because they would partially cancel each other if energized simultaneously. For these three coplanar coils, there is no combination of coil polarities that does not result in magnetic flux cancellation. The proposed (correct) three-coil arrangement does not take this cancellation effect into account, which would otherwise be the real reason for needing to energize the coils separately and sequentially.

[0121] The '302 patent alleges that placing a generally flat, straight wire in the bottom of the sandal minimizes heating. The science behind this novel claim is questionable.

[0122] Therefore, the '302 sandal applicator has heat issues, ingress and egress issues, and uneven coverage of magnetic flux, making it simply impossible to fabricate a sandal as shown. The toes protrude from the applicator, the tibial nerve in the medial ankle is not close to any of the coils, and only one side of the heel is treated. This invention may be more of an idea than something that can actually be fabricated.

[0123] The '302 patent is deficient in many respects, demonstrating that it is not feasible. The '302 patent again demonstrates that a shoe or sandal-configured applicator is a difficult problem to solve.

[0124] Integrated Applicator While US Patent No. 10,589,117 ('117) alleviates many of the problems of the '067 and '302 disclosures, it introduces several new problems.

[0125] The device disclosed in '117 integrates the applicator into the same housing as the energized electronics, thereby eliminating the connecting cable harness. It also has an applicator that is a solid shelf on which the foot can rest either above or below, as opposed to the enclosed sneaker of the '067 and '302 devices.

[0126] The use of shelves potentially overcomes the thermal runaway and foot insertion problems inherent in the '067 and '302 designs. In these respects, the '117 device is superior to the '067 and '302 devices.

[0127] However, the device disclosed in '117 is not without significant limitations. It still utilizes high power, which generates significant heat (typical of all high-power MPTDs). The '117 device appears to anticipate and address this issue by proposing an 80% reduction in power levels to 300 mT, which represents approximately 20% of the typical power levels of high-power MPTDs. The power reduction is likely an effort to control temperature.

[0128] The '117 device has an applicator consisting of a single coplanar coil formed in the shape of a shelf. The patient's foot can be placed on the shelf to treat the plantar and toes, or the patient's foot can be placed below the shelf to treat the toes and top of the foot. The '117 disclosure suggests that the patient can treat other parts of the foot, but does not fully disclose what bending is required to achieve this. However, to achieve this, treating the plantar and top of the foot necessarily requires multiple steps, repositioning the foot and adding additional treatment time.

[0129] The '117 patent provides numerous advancements and once again highlights the need for MPTDs for treating nerve pain in the foot. However, the '117 device remains suitable only for clinical use, and delivering a uniform dose to the required location remains problematic. Thus, a long-standing need remains unmet, and the challenge of a truly superior applicator for the foot remains unsolved.

[0130] Coplanar Multiple Applicator US Patent No. 6,701,185 ('185) speculates enthusiastically about the medical benefits of magnetic pulses, most of which remain unrealized after more than 20 years.

[0131] Where '185 advances the technology is in its use of multiple coils arranged coplanarly within a flexible wrap. '185's MPTD describes a wrap containing 3 to 32 small, always overlapping, coplanar coils that can be selectively steered. The '185 patent correctly points out that multiple coils can generate a larger magnetic field than a single coil. While the coil arrangement remains coplanar, the coils are not axially aligned, do not together form a solenoid, and do not use core flux. Coplanar coils do not seamlessly create some kind of blanket effect.

[0132] The first drawback of the '185 patent is that by arranging the coils in a coplanar, overlapping pattern, the magnetic field is not uniform as suggested. Rather, it resembles a polka dot pattern with irregularly shaped voids and hot spots. When the coil segments overlap and have the same polarity, they produce an enhanced magnetic field. When the coils are parallel and have opposite polarities, they tend to cancel each other out. This problem is addressed to some extent in patent WO 2022 / 261172 A1. Magnetic fields can be concentrated or dispersed, and the '185 appears to unintentionally do a little of both by overlapping the coils.

[0133] Two important features of the present invention are completely absent from the '185 patent disclosure.

[0134] The first drawback of the '185 device is that the minimum voltage stated is 200 volts. The inventor appears unaware that the device could potentially take advantage of lower voltages by arranging multiple coils.

[0135] A second drawback of the '185 device is that it only contemplates coplanar coil placement (i.e., the coils are not axially aligned with one another). While a coplanar placement accomplishes the stated goals of wide overall area coverage and selective treatment area selection, it does not use the coils in a manner that achieves the high flux density or uniform coverage that an axially aligned placement would achieve. Such coplanar coil configurations typically do not deliver a significant amount of core flux.

[0136] Brief Description of the Prior Art 1) There remains a long-standing unmet need for MPTDs that can safely and effectively treat foot pain.

[0137] 2) High-power MPTDs have medical potential. They have been clinically proven to be effective in pain relief. However, they use lethal voltages and currents, are expensive and complex, are prone to thermal runaway, and require skilled operation by trained technicians in clinical settings.

[0138] 3) Medium- and low-power MPTDs have not been clinically proven to be effective in treating foot pain. Due to their low magnetic flux density and small applicator size, they are not believed to be able to provide adequate dosage levels in a reasonable manner.

[0139] 4) There are many styles of applicators. None are optimal for the foot or similar appendages. Dedicated applicators designed for the foot are impossible to build, thermally hazardous, difficult to use, and in any case are only suitable for use in clinical settings. Manually operated applicators do not deliver a uniform dose even with careful manipulation.

[0140] 5) Existing applicators do not take advantage of the highly uniform, coherent, and powerful core magnetic flux.

[0141] 6) No MPTD uses an applicator in the form of a solenoid formed by multiple axially aligned coils, with the treatment region within the solenoid.

[0142] 7) There are no MPTDs suitable for self-application at home that have the medical efficacy to treat foot pain by delivering the required dose to the entire foot.

[0143] Summary of the Invention The present invention discloses a magnetic pulse therapy device (MPTD) 20 that consistently delivers medically effective amounts of magnetic pulses (ΣΔB) for pain relief, and is inherently safe, easy to use, and suitable for self-application at home.

[0144] This is accomplished using a novel applicator 10 that easily inserts and removes the foot 11. The applicator consistently and precisely positions the foot within the core of a solenoid 15. The solenoid 15 is functionally formed by multiple axially aligned low-voltage coils 13 that collectively generate a large core magnetic flux 90 large enough and strong enough to treat the entire foot simultaneously. The design is inherently safe and reliable, does not use high voltages, is free from the possibility of thermal runaway, does not require skilled operation of the applicator, and is convenient enough for frequent use to deliver a therapeutically effective dose.

[0145] For clarity and brevity, this description uses the terms "appendage," "paw," "foot," "legs," "hand," "hands," "arm," and "leg" interchangeably. The selection of one term over another is not intended to limit the scope of the disclosed magnetic pulse therapy device (MPTD). Rather, the MPTD is designed to be applicable to any appendage suitable for receiving magnetic pulse therapy, regardless of the particular nomenclature used.

[0146] Object of the invention With respect to MPTD, these objectives of the present invention have been established.

[0147] 1) It has medical efficacy in treating pain.

[0148] 2) be able to meet regulatory requirements for self-administration at home;

[0149] 3) It is suitable for home use and is simple and convenient.

[0150] The present invention achieves all of these goals in a highly novel way by integrating a unique applicator and a unique method for generating and delivering a powerful magnetic flux throughout a volume large enough to treat the entire foot or both feet simultaneously.

[0151] explanation Achieving medical outcomes Medical effectiveness depends primarily on the delivery of a medically effective dose of magnetic flux (ΣΔB). The inability of mid- and low-power MPTDs to deliver sufficient doses is the primary reason for their ineffectiveness. Quantification of the dose is necessary to establish that the present invention can deliver doses equivalent to high-power machines.

[0152] Leading Asian hospitals using high-power MPTDs for the treatment of neuropathic pain employ various monthly maintenance treatment protocols ranging from 10,000 to 50,000 magnetic pulses with an average applied magnetic flux strength of 1.5 T (1,500 mT). Thus, the monthly dose is 15,000 ΣΔB. T ~75,000ΣΔB T The range is (calculation: 10,000Δ×1.5B T =15,000ΣΔB T , 50,000Δ×1.5B T =75,000ΣΔB T ).

[0153] Note 1:ΣΔB Tis in tesla, the implicit default unit, and so can be expressed simply as ΣΔB.

[0154] Note 2: It is sometimes tempting to mistakenly apply a percentage to the dose, claiming that each pulse on a high-power system only treats a portion of the foot. This temptation is incorrect. The correct approach is to determine the total cumulative dose applied to the entire foot. ΣΔB T It is immaterial whether the doses are applied gradually or simultaneously.

[0155] The daily dose is calculated by dividing the monthly dose by 30 days, which is 500ΣΔB T ~2,500ΣΔB T For MPTD to have any medical effect, the entire foot must be treated with this dose.

[0156] Actuation solenoid A solenoid 15 most typically consists of a single winding of wire around a core of a meaningful, purposeful length. A coil 13 usually has multiple turns of wire wound as tightly as possible to form a circle of as short a length as possible. For purposes of this invention, an "actuated solenoid" 15 (sometimes referred to herein simply as a "solenoid" for brevity) refers to a series of axially aligned coils 13 that, when energized simultaneously, create a core magnetic flux along the length of the coils 15, similar to a typical solenoid, thereby collectively operating as a solenoid. (Such solenoids are sometimes technically referred to as "segmented solenoids," but this term is not used herein except as a summary used to most concisely explain the invention.) To accomplish this, the coils 13 may be tightly wound or may actually be short solenoids themselves, having a meaningful, purposeful length (these coils 13 are technically short solenoids, but are referred to herein as "coils").

[0157] A laboratory prototype demonstrated that one 25 mm long coil13, energized with 24 Volts DC extremely low voltage (ELV), could generate a magnetic pulse with an average intensity of 30 mT using readily available automotive / industrial electronics.

[0158] Therefore, the daily dose is 2,500ΣΔB T At least 75,000 pulses would be required to reach this target. At a high pulse rate of 25 PPS (pulses per second), it would take nearly an hour to treat just the area within this 25mm coil. (Calculation: 2,500TΣΔB T ÷ 30 mT ÷ 25 PPS = 55.5 minutes). This also quantifies why medium and low output MPTDs are so ineffective in treating pain: they are slow and do not cover a large area.

[0159] The breakthrough was the realization that a sufficiently large actuating solenoid 15 can be formed from multiple axially aligned, independent coils 13 (this concept is conceptually and theoretically illustrated in Figure PA15 of Information Disclosure Statement #2). Because of its high coherence and long coherence length, core flux essentially builds up with other core fluxes. Stacking coils 13 thus creates an additive effect for the coils; that is, the coils reinforce each other's strength and collectively act like a conventional solenoid. The average magnetic flux density within the length of the solenoid 15 has been measured to be approximately 50% higher than the average for each individual coil 13. The overall magnetic flux density across these coils 13 is remarkably uniform 91-96 throughout the length of the solenoid 15 because the flux builds up into a true core flux. Importantly, the strength of a solenoid 15 formed in this manner can be increased simply by adding additional coils 13. Strength increases in direct proportion to the number of coils 13.

[0160] After building hundreds of prototypes, it was established that it was possible to construct an actuation solenoid 15 from a suitable number of independent, axially aligned coils 13, each individually powered with 24 volts. Laboratory testing confirmed that the magnetic flux from the individual coils 13 did, in fact, form a strong, coherent core flux throughout the entire length of the actuation solenoid 15.

[0161] A test fixture was constructed consisting of six axially aligned coils 13 sized and shaped to treat the entire forefoot, including the big toe 67, dorsal surface 62, and plantar surface 61 down to the medial ankle 63. This test fixture allowed for highly accurate and repeatable measurements of magnetic flux density from the big toe (position = 0 mm) to the medial ankle (position = 150 mm) and beyond, and at a penetration depth of 10 mm from both the plantar 61 and dorsal 62 surfaces.

[0162] The coils 13 were selectively and collectively energized, and the results are shown in graph FIG. 9A and table 9B (which show the same information). "Coil 1" 91 through "Coil 6" 96 indicate that each coil was energized individually. "All Coils" 90 and "All 6 Coils Energized Simultaneously" indicate that all coils were energized simultaneously.

[0163] The magnetic flux density was extremely uniform 90, coherent, and stronger than any of the individual coils 91-96 across the entire forepaw (Figures 9A and 9B). Penetration into the paw was deeper than necessary (typically 25 mm or more), with consistent coverage along both the plantar and dorsal aspects.

[0164] Most importantly, the present invention can achieve dose levels comparable to high-power MPTDs. 90 Because the entire foot is treated simultaneously, 500 ΣΔB is achieved in 10-55 minutes for the entire foot. T ~2,500ΣΔB T A consistent and uniform daily dose of

[0165] Thermal images showed no temperature rise at all when the test fixture was operated continuously for very long periods of time. The use of multiple axially aligned low voltage coils to form the solenoid also solves the problem of thermal runaway.

[0166] Known MPTDs do not allow the entire foot to be safely treated simultaneously, nor are they able to be treated uniformly as demonstrated in this test.

[0167] Applicator The applicator design is even more critical for the MPTD of the present invention than for most MPTDs because of the need to axially align multiple coils 13 to form an actuating solenoid 15 and position feet 11 within the core of solenoid 15.

[0168] With the applicator 10 of the present invention, the patient simply inserts the foot 11 into the applicator (FIG. 1). There are no straps or adjustments, no moving parts, no need to reposition the foot, one size fits all, and the entire foot is treated simultaneously, from the big toe 67 to the heel 68 to the ankle 69 (FIG. 6B). The patient can remove their foot at any time. The low-voltage coil arrangement does not generate heat, so there is no risk of burns and no icebox or liquid cooling.

[0169] The interior of the preferred applicator is shaped like a high-top sneaker, chukka boot, or desert boot, but the back (heel) region 14, 68 is completely open, resembling an open-back boot (FIGS. 3A and 5A). The toe region 12, 67 is open for ease of cleaning and increased comfort. The interior ("treatment zone") extends from the hallux (big toe) 67 to the heel 67 and down to the inner ankle 63 (FIG. 6A).

[0170] The foot can be easily slid into the applicator 10. Upon insertion, either the dorsal aspect 62 or medial ankle 63 of the foot rests against the inner top surface 64 of the applicator (FIG. 6A). At this point, the foot is perfectly centered and aligned. In this position, three key treatment areas rich in nerve endings—the plantar aspect 61, the dorsal aspect 62, and the medial ankle 63—are all in close proximity to the coil 13 (FIG. 6B). The simple act of inserting the foot until it rests ensures consistent, repeatable, and near-perfect alignment within the applicator 10.

[0171] The applicator can be configured to treat only the forefoot. In this configuration, the proximal applicator half 12 is not required. All of the principles and advantages of the present invention apply equally to the forefoot configuration.

[0172] The applicator can be optimized for hand treatment. This configuration is similar to the forepaw-only version, except that the height of the applicator's internal treatment chamber is reduced to approximate the height of the hand. All of the principles and advantages of the present invention apply equally to the hand configuration.

[0173] Removing a foot (or hand) is as easy as pulling it off - there are no straps, fasteners, adjustments or moving parts.

[0174] Coils and solenoids The exterior of the applicator 10 positions, holds, and forms axially aligned coils 13 (FIGS. 1, 6B, 7A, and 7B). The axially aligned coils 13 begin at the distal end 12. The next coil proceeds to the proximal end 14 of the applicator 10. The axially aligned coils 13 are positioned sufficiently close to each other and similar enough in shape to form an actuation solenoid 15 (evidenced 90 in FIGS. 7A, 7B, and 9A, 9B). Positioning the coils near the foot is beneficial, but not required, for proper operation, since the magnetic flux density is highest closest to the coils (FIG. 6A).

[0175] The number of coils is flexible; more coils provide greater magnetic flux density (strength), while fewer coils are more economical. Figure 7A shows an applicator 10 with a total of 22 coils 13 (11 of which surround the front legs), and Figure 7B shows an applicator with a total of 14 coils 13 (7 of which surround the front legs). The length of each coil can be varied; shorter coils concentrate power, while longer coils spread the magnetic flux evenly across the width. Typically, a section of the applicator, such as the front legs, is approximately 150 mm long, with seven coils each approximately 20 mm long (calculation: 150 mm ÷ 7 coils ≈ 20 mm).

[0176] Along the distal (forefoot) portion of the applicator 12, the coils preferably have larger circumferences as they are stacked (or continued) away from the distal end 12. Consequently, coils with larger circumferences have lower magnetic flux densities. This can be compensated for by gradually shortening the coils as they move away from the distal end 12. Another way to compensate is to use larger diameter wire (smaller AWG), which allows for more turns and more current, creating a higher magnetic flux density. However, this is not actually preferred because maintaining a higher magnetic flux density at the nerve endings of the toes 67 is beneficial, and the nerve-rich inner ankle 63 already has multiple coils passing nearby from the proximal end 14 of the applicator 10.

[0177] The distal portion 12 of the applicator has horizontal stepped ledges onto which the coil is wound (FIG. 6A). These stepped ledges 66 hold the coil 13 in place; without them, the coil would tilt and slide down the sloped surface along the dorsal surface 62.

[0178] The applicator 65 has a standoff-like support at the bottom, allowing weight placed on the bottom of the applicator to be transferred to the surface below without crushing the coil 13 or wearing away the insulation (FIGS. 6A and 6B). A diagram showing the relationship of the coil 13 to the stepped ledge 66 and bottom standoff support is shown in FIG. 6B.

[0179] At the proximal end 14 of the applicator, the coils follow an altered path (FIGS. 6B and 7B). These proximal coils pass under the bottom (plantar) of the foot 61, then vertically over or near the ankle 69, then form around the medial ankle 63, return near the opposite ankle, and then vertically return to the plantar 61 (shown diagrammatically in FIG. 6B). "U"-shaped clips 18 are molded into the applicator over or near the ankle to facilitate the transition of the coils 13 through the necessary vertical to horizontal turns. These clips 18 are clearly shown in FIGS. 1 and 7B. All of the proximal coils pass around the medial ankle 63. This is beneficial because a large and important nerve bundle also passes through this area, allowing for a little "extra" treatment.

[0180] In practice, it has been found that the applicator assembly 10 is best constructed in two halves, one for the distal end and one for the proximal end, which can be snapped or screwed together.

[0181] housing The applicator 10 is housed in a small enclosure 24 (FIGS. 3A and 3B) that encloses the applicator 10, coil 13, and most of the electronics, eliminating the need for heavy interconnecting cables. The entire MPTD fits into a 6" x 6" x 12" housing (excluding a small external power pack).

[0182] The housing 24 is preferably constructed as a distal / proximal clamshell. In this manner, the two halves of the applicator are also clamped together. The clamshell and applicator 10 are aligned by studs, lugs, or beams molded into the plastic that makes up the applicator halves. This also greatly reduces the need for fasteners. A flange can also be added to the applicator to attach and secure it to the outer housing. One such mounting flange is shown near the inner ankle of the applicator in FIGS. 1 and 19.

[0183] Both feet at the same time The ability to treat both feet simultaneously is particularly attractive. This can be achieved in two ways using the present invention.

[0184] 1) Two applicators can be used per foot (Figure 2). The two applicators 20, 21 can be positioned at the distance and angle that the patient finds most comfortable. Another advantage is that each such applicator can be equipped with its own power pack, and for a medical-grade power pack, it is cheaper to have two small applicators than a larger applicator with twice the power output. It also simplifies compliance with IEC 60601 regulations.

[0185] Although the housings 20, 21 are separate, the two applicators function as one MPTD. The two separately housed applicators can communicate using Bluetooth, with one applicator 20 being the primary and the other applicator 21 being the secondary. The secondary applicator 21 receives its operating parameters from the primary unit via Bluetooth, so no display or buttons are required. In the preferred embodiment, a Raspberry "Pico W" CPU with built-in Bluetooth is used.

[0186] 2) The second method is to place two applicators 10 in a single housing 50 (FIGS. 5A and 5B). In a clinical environment, this method is advantageous because it is easier for the patient to understand and, if there are multiple treatment bays, there is one physical device for each.

[0187] Another advantage of placing two applicators 10 within a single housing 50 is that the coils 13 of both applicators can be wired in series or parallel 121 to share the same electronics board (FIG. 12). Sharing an electronics board splits power but provides some economy. Whether each applicator within a housing is wired to its own electronics board or shares an electronics board is a trade-off between price and performance. Either configuration utilizes the principles and advantages of the present invention.

[0188] summary As can be seen, the multiple axially aligned coils 13 create a large amount of core magnetic flux within the applicator 10 that automatically aligns the foot, allowing a sufficient dose of magnetic pulses 90 to be delivered to the entire foot (or both feet) to achieve clinical levels of pain relief analgesia within a reasonable time.

[0189] This new approach addresses a long-standing need for a simple and effective method of pain relief using magnetic pulses that can be safely and reliably self-administered in the home or clinical setting. [Brief explanation of the drawings]

[0190] [Figure 1] A perspective view of the present invention with a foot 11 inserted into a magnetic pulse therapy device (MPTD) with the housing (not shown) removed. This shows a preferred embodiment in which there are eight coils 13 at the distal (toe) end 12 of the device and seven coils 13 at the heel portion 14 of the device, for a total of 15 coils. The coils are wrapped around an applicator structure 10 forming a solenoid air coil 15. [Figure 2] The MPTD 20 is shown inserted into the patient's left foot 11. Also shown is a second (optional) MPTD 21 that can be attached to the patient's other foot (right foot). The patient 22 is seated during treatment. [Figure 3A] The MPTD is shown as seen from the proximal end (heel) 14 of the device, revealing an opening 31 through the housing that allows the foot to be inserted into the applicator. [Figure 3B] 3A is shown looking at the distal end (big toe / big toe) 12 of the device. The toe and cleaning opening 12 are shown. [Figure 4] The MPTD is shown with the patient's foot 11 inserted. The display and control knobs 23 for operating the device are also shown. [Figure 5A] 1 is a perspective view from the proximal end (heel and insert) 14 of the invention, showing two applicators 10, one for each foot. An opening 31 is evident, allowing the foot to be inserted through the housing into the applicator. [Figure 5B] FIG. 5B is a perspective view of the same device shown in FIG. 5A, viewed from the distal end (big toe / big toe) 12 of the device. [Figure 6A] A cross-sectional view of the applicator 10 showing the foot 11 fully inserted. The dorsal (left) side 14 is open for easy insertion. The plantar (bottom) surface 61, dorsal (top) surface 62, and medial ankle 63 of the foot are all adjacent to the top 64 and bottom 65 surfaces of the applicator. A stepped shelf 66 that supports the coil is located above the dorsal surface 62. [Figure 6B] This shows the same cross section as Figure 6A, with the addition of dotted lines indicating the optimal location of coils 13. These coils will be the same on the back of the applicator and in the cutout area. The number of coils is consistent with the preferred embodiment: eight coils surrounding the dorsal surface 62 and seven coils at the proximal end 14. [Figure 7A] 7B and 7C are perspective views of an applicator assembly 10 configured with 11 coils along the distal (bump / toe) end 12 and 11 coils along the proximal (heel) end 14 of the applicator structure 10. The overall size of the applicator is the same as that shown in FIG. 7B and elsewhere. [Figure 7B] 7B and other figures. [Figure 8] Shown are three loop applicators arranged on foot 11 in axial alignment, close together and adapted to form an actuating solenoid when energized, also known as a "stacked ring" configuration. [Figure 9A]This graph shows magnetic field measurements of magnetic flux density for a six-coil, 150 mm long, forefoot-shaped test fixture. Each of the six graph lines ("Coil 1" 91 through "Coil 6" 96) represents the magnetic flux density recorded in 10 mm increments (from the distal end 12 to the proximal end 14) for each of the six axially aligned coils, with Coil 1 positioned closest to the toe 16 and Coil 6 positioned closest to the medial ankle 17. The graph line labeled "All six coils energized simultaneously" 90 represents the magnetic flux density recorded in 10 mm increments (from the distal end / bone / tip of the toe) when all six coils were energized simultaneously. All measurements are in milliteslas (mT). Measurements were taken beyond the end of the test fixture, so the chart extends to 170 mm, even though the fixture was only 150 mm long. Most notably, all coils 90 deliver a magnetic flux entity of 35 mT±15% from the toes to the inside of the ankle. [Figure 9B] 9B is a table of magnetic field measurements displayed on the chart shown in FIG. 9A. Values are in milliteslas (mT). [Figure 10] This is an electrical diagram showing the connection of a 16 coil system where all 16 coils share a common bridge (also known as a "driver") 101. Each of the 16 coils can be individually controlled by a respective bridge circuit 102 (boxes 1-16) under the control of the CPU. The "polarity" line 104 controls the output polarity of the bridge circuit 105, as indicated by a "+", while the "common" driver 101 has essentially the opposite polarity, as indicated by a "-". The "enable" line 105 enables the selected circuit for the duration of the enable pulse. [Figure 11]This is a schematic diagram of a preferred embodiment with 15 coils. This coil configuration is called "multi-tap" because the coil connections resemble a multi-tap transformer. The odd-numbered coils 16, 102 (coil 1, coil 3, coil 5, etc.) are wound in the opposite direction from the even-numbered coils 17, 102 (coil 2, coil 4, coil 6, etc.) with reverse spirals. The odd-numbered (boxes 1, 3, 5, etc.) bridges ("drivers") have essentially the opposite polarity to the even-numbered (boxes 2, 4, 6, etc.) bridges due to NOT gates. The alternating bridge polarity and alternating coil winding direction ensure that all axially aligned coils have the same magnetic polarity. Important: Coil 16 is shown dotted to indicate that it is not (and should not be) provided. [Figure 12] Similar to Figure 11, except that each coil 13 has multiple windings. Each coil in Figure 12 is shown with three windings, such as a two applicator system with one [[ ]] winding for the right applicator, a second [[ ]] winding for the left applicator, and a third [[ ]] winding for the self-test function. This illustrates that the present invention can be configured in a variety of alternative embodiments. [Figure 13] The logical function of the bridge 102 shown in Figures 10-12 is shown in boxes numbered 1-16 or "common" 101. This shows a typical bridge circuit and is intended to show typical functionality, but is not intended to limit the design to this functionality. This shows a component such as the BTS7960B, showing that only two simple controls (enable 106 (INH) and polarity 104 (IN)) are required to achieve the complete bridge function. DETAILED DESCRIPTION OF THE INVENTION

[0191] The present invention is a magnetic pulse therapy device (MPTD) designed to deliver therapeutic pulses to an appendage, such as the foot 11 (FIGS. 1 and 2). This is accomplished by wrapping a plurality of axially aligned coils 13 (FIG. 11) around an applicator 10 (FIGS. 7A and 7B). The applicator 10 contacts both the plantar (bottom) surface 61 of the foot and the instep (top) surface 62 or the medial (medial) ankle 63 (FIG. 6A). The coils surround the inserted appendage 11 (FIG. 6B). The coils are connected to and energized by a series of half bridges 102 (hereinafter simply referred to as "bridges") (FIGS. 10, 11, 12). The half bridges 102 are each designated 102 in FIG. 13 and are operatively connected to a microcontroller (CPU) 103. The coil 13, applicator 10, and electronics (not shown, located on the top of the foot) are contained within a housing 20, 50 (FIGS. 3A and 3B).

[0192] The patient's foot 11 is inserted into the applicator 10 from the proximal end (heel) 14 (FIG. 3A) distally (toes first) until it contacts either the top of the foot 62 or the mid-ankle 63 (FIG. 6A). It does not matter which surface of the foot contacts the applicator 10 first. In either case, upon full insertion (FIG. 4), the foot contacts the applicator along two surfaces, the bottom 65 and the top 64, as shown in FIG. 6A. In this position, the ankles 63, 69 are automatically centered laterally by the curvature of the applicator opening 31 at the medial ankle 63. The foot can be quickly removed at any time by simply pulling it out. There are no straps or retainers.

[0193] 1 shows a preferred embodiment of the applicator 10 with the housing removed and a foot 11 inserted. In the preferred embodiment, there are eight coils along the distal (dorsal) end 12 and seven coils along the proximal (heel) end 14, for a total of fifteen coils. Alternate embodiments can have any number of coils (three or more) as needed to achieve the desired field strength.

[0194] Alternatively, the MPTD may have two (or more) applicators 10 arranged in a single housing 50 (FIGS. 5A and 5B) or separate housings 24 (FIG. 2) to treat both feet simultaneously. The basic principles of the present invention remain the same in all such configurations.

[0195] The MPTD can be used to treat the hand as well as other parts of the appendage, such as a portion of the arm or leg that is inserted into the core of the solenoid 15 .

[0196] Applicator and Winding A cross section of the applicator is shown in FIG. 6A. The proximal end 14 of the applicator (left side of FIG. 6A) is completely open (FIG. 3A), allowing unrestricted entry and exit of the foot 11. The bottom of the applicator 65 is generally flat, and the top surface of the applicator 64 is preferably contoured similarly to the instep 62 of a typical foot, curving upward from the toes 67 to the mid (medial) ankle 63 of a typical foot, as shown in FIG. 6A. Generally, the width and height of the top surface are large enough to accommodate the largest size foot required (typically a US shoe size 13, representing the 95th percentile). A perfect shape or size or a snug fit on the foot is not critical for the applicator to function.

[0197] Coil 13 is wound around applicator 10, thus surrounding foot 11 (FIG. 6B). When inserted, foot 11 is necessarily adjacent to coil 13 (FIGS. 1 and 6A), and coil 13 surrounds foot 11 (FIGS. 1 and 6B). An important aspect of the present invention is that because foot 11 is surrounded by multiple coils 13, it is within the core of operating solenoid 15 and is therefore treated primarily by the core flux (shown in FIG. PA16 of Information Disclosure Statement #2).

[0198] The exterior of the applicator 10 has a series of steps, or stepped shelves 66, on the dorsal (top) surface 64 (FIG. 6A). The stepped shelves 66 prevent the coil 13 from sliding down toward the toes 67, as would occur if the top surface 64 did not have these stepped shelves or other retainers. The stepped shelves 66 are preferably not too wide so that the coil 13 remains close to the instep surface 62 of the foot. The more stepped shelves 66 there are, the better they can conform to the contours of the dorsal surface 62. A preferred embodiment including eight stepped shelves 66 works well (FIG. 1). The bottom exterior of the applicator may also have guides 65 or channels that can support the applicator at its base to prevent the foot from crushing the coil 13 as it passes underneath (FIG. 6A).

[0199] While it is convenient for the number of stepped shelves 66 to match the number of coils 13, this is not required; coils 13 may be wound across multiple stepped shelves 66, or multiple coils 13 may be wound on a single shelf 66. In preferred embodiments, a coil length of 15 mm to 20 mm has been found to be convenient. In alternative embodiments, the number of coils 13 may be different, with the appropriate coil length being the length of the distal portion 12 of the applicator 10 (approximately 150 mm) divided by the desired number of coils 10. Eight coils are shown on the back in FIGS. 6B and 1, eleven coils are shown on the back in FIGS. 7A and 7B, and six coils were used in the test fixture in FIGS. 9A and 9B.

[0200] Once all of the coils 10 are wound, they are connected to electronics (not shown) housed on the back 12 of the applicator 10. The applicator 10, with its coils 13 and electronics, is then slid into and encased by the outer housing 24, 50 (FIGS. 3A and 3B).

[0201] If there are proximal coils 13, they are wound similarly, except that they pass near or over the ankle 69, then around and in front of the inner ankle 63, return to the opposite ankle 69, and then under the plantar 61 (Figures 6B, 7A, and 7B).

[0202] Solenoid and core flux For optimum performance, it is important that all of the coils 13 are reasonably close to, and generally axially aligned. To the extent possible, each coil should have approximately the same peripheral profile, particularly along the bottom 65 and sides. The coils 13 will, of course, be generally parallel to one another, but will not be perfectly aligned along the top due to the stepped shelf 66.

[0203] All coils 13 must be energized with the same "logical" rotation so that the magnetic flux from each coil has the same polarity. (A "logical" rotation in a multi-tap configuration means that the connecting leads of adjacent coils 13 are reversed, or each coil 13 is physically wound in the opposite direction from its neighbors, so that all coils 13 produce magnetic flux of the same polarity.) In this way, the core flux from each individual coil 13 merges with the core flux from its neighbors to form a single, operating solenoid. Due to the high magnetic field coherence and magnetic field coherence length inherent in core flux, multiple closely spaced, axially aligned coils 13 form a single ("operable") solenoid 15 that generates core flux from the toe 67 to the ankle 63 or heel 69. (Figures PA15 and PA16 in Information Disclosure Statement #2 visualize the scientific behavior of core flux merging with core flux from adjacent individual coils 13.)

[0204] To verify that an active solenoid is present and that core flux is being created (as is the purpose of this invention), all coils 13 in the solenoid are energized simultaneously. Measurements of magnetic field strength are then taken along the length of the solenoid 15. These magnetic field strengths can then be visualized by graphing them, as was done in Figure 9A. The fewer "valleys" present between the coils 13 in the graph, the higher the quality of the core flux and the more uniform the magnetic field within the core of the solenoid 15. As the coils become farther apart, or as the coils 13 become too dissimilar around their circumferences, or as insufficient current flows through the coils 13, the more imperfections in the solenoid increase, forming valleys in the graph. Whether the overall trend is upward or downward, especially at the center of the coils 13, is not important. Increasing valleys between the coils 13 indicate increasing solenoid imperfections. At some point, perhaps when the magnetic field strength between the coils 13 is only 50% of that at the center of the coils 13, it can be concluded that the solenoid 15 is no longer functioning; this threshold has some bearing on applicator functionality.

[0205] BEST MODE FOR CARRYING OUT THE INVENTION The following is a description of how to construct a preferred embodiment of the present invention. The level of detail provided is intended to be sufficient for one "of ordinary skill in the art" to construct a functioning device. Required skills are 3D CAD and 3D printing to form the applicator 10, basic wiring to form the coil 13, electrical engineering for the electronics, CAD and 3D printing for the housing, and a minimum ability to program a microcontroller CPU.

[0206] 1) Form the applicator: A large human foot 11 is scanned to form the interior of the applicator 10. In the CAD system, a transverse cross-section is created along a line from the hallux 67 to the calcaneal tuberosity (from the big toe to the center of the heel 68) of the scanned foot, and the remainder of the scan is discarded. This cross-section is extruded from left to right to form the required width of the interior of the applicator 10 (typically 120 mm). The toe 67 portion is extruded beyond the distal end 12 of the applicator and truncated to form an opening. The proximal face 14 (heel 68 and back of the ankle) is extended beyond the length of the applicator and truncated at the proximal end (heel) 14. The plantar (bottom) face 61 is extruded beyond the floor of the applicator 10 and truncated at the required floor 65 of the applicator. Sides and contours are added to the top and bottom. At this point, the CAD should have an interior shell with open distal and proximal ends 12 and 14. The shell is expanded from the bottom of the applicator 65 to accommodate a variety of foot sizes and shapes. An expansion factor of +3% to +5% has proven to be suitable. The shell is truncated distally 12, proximally 14, and at the top to accommodate the maximum desired applicator size 10.

[0207] Along the dorsal surface 64, stepped shelves 66 are constructed to support the coils 13. In a preferred embodiment, there are eight stepped shelves 66 (FIG. 6A). A slot or support is added under the plantar surface 65 to support the weight of the foot and allow the wire to pass underneath (FIG. 6B). A clip or hook 18 is added near the heel so that the wire runs vertically from the bottom 65 to the heel 68 and then around the medial ankle 63. A preferred embodiment is shown in FIG. 1, with eight coils in the distal (dorsal) half 12 of the applicator 10 and seven coils around the proximal half (heel portion) 14 (FIGS. 1 and 6B).

[0208] Add the retaining clip 18 shown in Figure 1 at or above the heel 69 to allow the coil 13 wire to bend toward the inner ankle 63. Add the necessary mounting flanges 19 or holes to attach the applicator 10 shell to the housing 24 and to mount the printed circuit board for the electronics on the back 64. The applicator in the CAD system should look like Figure 1.

[0209] Export the CAD file and print it using a 3D printer. The recommended 3D printing orientation is with the proximal end 14 of the applicator 10 portion on the build plate.

[0210] 2) Form a coil. The number of coils 13 required depends primarily on the power required for the device. The more coils 13 there are, the greater the power, in a linear relationship. The preferred embodiment has 15 coils, 8 in the distal portion 12 and 7 in the proximal portion 14 of the applicator 10 (FIGS. 1 and 6B).

[0211] The coils 13 are formed from #20 AWG magnet wire. At the distal end 12, the coils 13 are wound as shown in FIG. 6B. At the distal end 12, the wire of each coil 13 wraps under the plantar surface 65 and wraps around a stepped shelf 66 above the top of the foot 64. At the proximal end 14, the wire wraps under the plantar surface 65, then vertically up to the clip 18 near the heel 69, around the medial ankle 63, up to the opposite clip 18, and back vertically under the plantar surface 65. Each coil 13 is wrapped 32 times (the number of wraps can be optimized but is not required for operation). The finished result will resemble FIGS. 1 and 6B. 3) Assemble the electronics:

[0212] A 15 coil 13 system requires a total of 16 bridges 102. Coils 16 should not be installed, otherwise electricity will flow back if the coils are selectively activated. (Additional coils 16 can be added if all coils 13 are energized simultaneously.) A suitable bridge is the BTS7960B, but there are several suitable alternatives.

[0213] Coils 13 are connected to bridge 102 as shown in Figure 11. Because this schematic uses a multi-tap solenoid configuration, the even numbered coils 17 are connected with opposite polarity, as shown in Figure 11. This is necessary to ensure that the flux polarities of all coils add in the same direction.

[0214] The INH control lines 106 of the bridges 102 are logic level compatible and can be wired directly to GPIO lines of the CPU 103 (Figure 11). In the preferred embodiment, it is desirable to be able to selectively activate individual coils 13, so each bridge 102 should be connected to its own GPIO so that it can be controlled independently. If independent control is not required, all INH lines 106 can be tied together and a single GPIO line used, although if this is done it is recommended that a buffer redrive this signal to avoid overloading the GPIO.

[0215] The IN lines 104 of all odd-numbered bridges are connected together and then connected to a GPIO on the CPU assigned to control the polarity (Figure 11). The IN lines of all even-numbered bridges are connected to the output of a NOT gate and then the input of this gate is connected to the polarity line 104 (Figure 11). This ensures that the polarity of adjacent bridges 102 is always opposite.

[0216] Use a 24V DC power supply such as a Mean Well GSM90A24 medical-grade power supply rated at 90 watts. The output of this power supply is connected to a constant current ("cc") regulator set at 3 amps. The output of the current regulator is connected to a 30mF capacitor. The capacitor is connected to the high side of all bridges 104, shown as "VS" in Figure 13.

[0217] 4) CPU and software The Raspberry RP2040 CPU is a good choice for CPU103 because it contains many IO lines and built-in PIO functionality with DMA support, allowing for complex and precise pulse timing.

[0218] A GPIO line on the CPU 103 controls the polarity (IN) 104, and the GPIO line enables the bridge via the INH line (Figure 11). The CPU is fast enough that pulse timing could be done through a timing loop, but it is preferable to do it through the RP2040's PIOs, which are specially designed to provide very accurate timing with a resolution of 8nS.

[0219] The software is very simple: set the polarity GPIO line 104 (connected to IN), turn on the GPIO enable line (INH) 106 associated with the bridge 102, wait, toggle the polarity GPIO line (IN), wait, turn off the GPIO enable (INH) line 106. This generates one dipole pulse. Repeat for each pulse required. The recommended pulse timing is 125 μS per polarity.

[0220] This type of code is obvious to anyone familiar with microcontroller software. The proper code was written in less than an hour using AI.

[0221] 5) Outer housing: The housing 24 will look like Figures 3A and 3B. The external shape is purely cosmetic and not critical to the function of the invention. It must secure the internal applicator 10 and electronics and provide openings 31 for 1) a power connector, 2) a foot 11 for insertion and removal from the proximal end 14 of the applicator 11, 3) an applicator toe opening 12 (if required), 3) a power connector, and 4) any necessary controls or buttons 23 (start / stop button and possibly a display).

[0222] The housing 24 can be designed in CAD and printed on a 3D printer, and how to do this will be well understood by CAD designers with experience in 3D printing.

[0223] Alternative Embodiments While the preferred embodiment is most preferred, alternative embodiments may be advantageous for different purposes.

[0224] The number of coils 13 does not affect the principles of the present invention. The benefits of the present invention can be achieved with as few as three coils 13, and increasing the number of coils 13 increases the treatment power in a roughly linear relationship. An example of a 22-coil applicator with a 60% or higher output is shown in FIG. 7A. In clinical models requiring greater output, the number of coils 13 can be significantly greater, even to 50 or more. Therefore, the selection of the number of coils 13 is a trade-off between economy and performance.

[0225] A generally preferred arrangement for coil 13 is to conventionally wind the coil as individual coils positioned side-by-side, as shown in Figures 1, 6B, 7A, and 7B.

[0226] Many alternative coil winding and layout styles are possible while still maintaining the principles and advantages of the present invention, examples of which include, but are not limited to:

[0227] 1) Parallel Wound Coils: Multiple individual coils are wound with the wires parallel to each other throughout the entire winding. Each coil remains separate at the ends.

[0228] 2) Layered coil: Multiple coils are wound in layers, rather than side by side.

[0229] 3) Elongated Coil / Motor Winding Style: A normally circular coil is elongated, usually to fit the length of the solenoid, and each winding is typically rotated slightly along the axis of the solenoid's core, so that the coil forms something similar to a ball of string, or in some sense a bundle of string. This variation is often used for motor windings.

[0230] 4) Loosely spaced bobbin coils: The windings of each coil are not directly adjacent, but are spaced apart to some extent, usually spanning a significant portion of the solenoid's length, and most typically spiraling up and down from end to end. While generally a suboptimal winding style, it may be beneficial in certain pulse applications.

[0231] 5) Vertical Coil: Typically, the treatment zone exists with the coil surrounding the applicator, with a portion of the appendage to be treated within the enclosed area. However, it is also possible for the appendage to be inserted into the core from the side of the solenoid. In this configuration, coils in the approximate center of the solenoid are spaced far enough apart that the appendage can pass between them, or the appendage is an island, with straight-moving traffic bypassing the island and then continuing straight on, with the coils curved around the appendage's opening. This can be somewhat similar to a Helmholtz coil, except that multiple coils on both sides have an additive effect, increasing the magnetic flux density. Thus, despite the side openings, the performance is still similar to a solenoid.

[0232] 5) Hybrid Coil: A "logical coil" is wound as multiple physical windings resembling a coil (Figure 12). Despite the multiple windings, it is considered a single "coil" for purposes of this specification. A successful application of this would be to place one winding on the left applicator and a second winding on the right applicator, with both windings wired in parallel or series and sharing the same bridge. Such a hybrid coil could economically treat both feet simultaneously without requiring twice the electronics.

[0233] In a preferred embodiment, the coils 13 are wired in a multi-tap configuration (FIG. 11), but they can be connected in a shared leg fashion (FIG. 10) if they are primarily used selectively and not all energized simultaneously. Alternatively, each coil 13 can have its own pair of bridges 102 (even-numbered coils are omitted in FIG. 11). Alternatively, the coils 13 can be wired in series or parallel 121, as shown in the "hybrid coil" previously described and in FIG. 12. Alternative coil configurations, arrangements, and wiring can all utilize the principles and advantages of the present invention.

[0234] Previously, alternative embodiments have been described that highlight how the principles and advantages of the present invention can be incorporated in a dual applicator 50 configuration. Two such alternative embodiments include:

[0235] 1) Two single-foot applicators 20 (Figure 2).

[0236] 2) Two applicators 10 in a single housing 50 (FIGS. 5A and 5B).

[0237] The structure of the applicator 10 itself has alternative embodiments. One possible arrangement is shown in FIG. 8, where three (or more) loop-type (individually operable) applicators 81 are slid onto the foot, having the same polarity, operatively forming a solenoid. Alternatively, multiple axially aligned coils could be sewn to a cuff and slid onto the arm or leg. While these alternative embodiments lack some of the benefits of the preferred embodiment with an integrated housing featuring automatic, perfect alignment, they may offer economy or convenience while retaining the benefits of core flux, the added benefits of additional axially aligned coils, the ability to achieve strong flux using safe low voltages, and a large treatment volume.

[0238] High power systems can also benefit from the present invention by using a foot applicator 10 that allows for easy insertion and removal of the foot, self-aligns the inserted foot 11, and distributes power evenly over a very large treatment area by using multiple coils 13 that have much lower inductance than a single long coil.

[0239] The principles and advantages of the present invention are independent of the particular choice of voltage. The preferred embodiment uses 24 volts because this currently represents the best combination of low-cost, readily available components and sufficient performance. Voltages below 120 volts DC are still considered ELV for medical device purposes, with 36 or 48 volts being considered the best choices.

[0240] Regardless of what alternative embodiments are realized, the present invention advances magnetic pulse therapy by introducing an MPTD that includes a convenient and reliable applicator 10, produces medically effective levels of highly coherent and powerful magnetic flux, can be powered using safe low voltages, and can be self-administered at home, allowing millions of people suffering from severe chronic pain to benefit from this invention.

Claims

1. 1. A magnetic pulse therapy device, the device comprising: an applicator having a cavity accessible through a proximal opening, the proximal opening configured to receive a human foot; three or more coils arranged in a multi-tap configuration around the applicator; an electronic controller operable to provide electrical pulses through the three or more coils; Device.

2. The device of claim 1 , wherein the applicator is tapered at a distal end.

3. The device of claim 1 , further comprising an outer housing that encloses at least a portion of the applicator and at least a portion of the electronic controller while maintaining the opening.

4. The device of claim 1 , wherein the shape of the applicator positions the person's foot within the core of the three or more coils.

5. The device of claim 1 , wherein the proximal opening allows for attachment and detachment without the need for manual grasping, manipulation, or assistance.

6. 10. The method of claim 1 further comprising: providing a second magnetic pulse therapy device communicatively coupled, physically coupled, or both, to the device of claim 1; 10. The device of claim 1, wherein the combined devices form a dual applicator system capable of treating two separate feet of a person simultaneously.

7. 10. The device of claim 1, wherein the three or more coils simultaneously deliver multiple magnetic pulses to the heel, the ankle, or both.

8. 10. The apparatus of claim 1, wherein the pulses supplied to the three or more coils of the multi-tap configuration are very low voltage, nominally not exceeding 50V AC or 120V DC.

9. 10. The apparatus of claim 1, wherein the plurality of coils comprises alternative coil winding configurations selected from the group consisting of parallel wound coils, layered coils, elongated coils, loose and coarse bobbin coils, vertical coils, hybrid coils, stacked rings, and Helmholtz coils.

10. 1. A magnetic pulse therapy device, the device comprising: an applicator having a cavity and an opening located proximal to the cavity for receiving a human foot; a plurality of three or more coils circumferentially arranged around the applicator; an electronic controller operable to apply electrical pulses through the plurality of three or more coils; an outer housing enclosing at least a portion of the applicator and at least a portion of the electronic controller while maintaining the opening; Device.

11. The device of claim 10 , wherein the applicator is tapered at a distal end.

12. 11. The device of claim 10, wherein the shape of the applicator when the person's foot is fully inserted aligns the inserted foot within a treatment zone.

13. 11. The device of claim 10, wherein the opening allows for attachment and detachment without the need for manual grasping, manipulation, or assistance.

14. 11. The method of claim 10, further comprising: providing a second, replica magnetic pulse therapy device communicatively coupled, physically coupled, or both, to the first device of claim 10; 11. The device of claim 10, wherein the combined device forms a dual applicator system capable of treating two separate feet of a person simultaneously.

15. 11. The device of claim 10, wherein the three or more coils simultaneously deliver multiple magnetic pulses to the heel, the ankle, or both.

16. 11. The apparatus of claim 10, wherein the electrical pulses supplied to the plurality of three or more coils are very low voltage, nominally not exceeding 50V AC or 120V DC.

17. 11. The apparatus of claim 10, wherein the plurality of three or more coils comprises an alternative coil winding configuration selected from the group consisting of a parallel wound coil, a layered coil, an elongated coil, a loose and coarse bobbin coil, a vertical coil, a hybrid coil, a stacked ring, and a Helmholtz coil.

18. 1. A magnetic pulse therapy device, the device comprising: a shoe-shaped enclosure having a cavity accessible through an opening; an actuation solenoid disposed around the exterior of the shoe-shaped enclosure; means for connecting an electronic circuit to said actuation solenoid; an outer housing enclosing at least a portion of the enclosure and at least a portion of the electronic circuitry while maintaining the opening; the enclosure is configured to receive a foot through the opening to allow the foot to move in and out; the opening allows for attachment and detachment without the need for manual grasping, manipulation, or assistance; Device.

19. 20. The device of claim 18, further comprising an electronic circuit that provides power to the actuation solenoid.

20. 20. The device of claim 19, wherein the actuation solenoid delivers multiple magnetic pulses simultaneously to the heel, the ankle, or both.

21. 21. The apparatus of claim 20, wherein the electrical pulses supplied to the actuation solenoid are very low voltage, nominally not exceeding 50V AC or 120V DC.

22. 20. The device of claim 18, wherein the shape of the enclosure when the foot is fully inserted aligns the inserted foot within a treatment zone.

23. 20. The method of claim 18, further comprising: providing a second magnetic pulse therapy device communicatively coupled, physically coupled, or both, to the device of claim 18; 20. The device of claim 18, wherein the combined device forms a dual applicator system capable of treating two separate feet of a person simultaneously.

24. 20. The apparatus of claim 18, wherein the actuation solenoid comprises an alternative coil winding configuration selected from the group consisting of a parallel wound coil, a layered coil, an elongated coil, a loose and coarse bobbin coil, a vertical coil, a hybrid coil, a stacked ring, and a Helmholtz coil.

25. 1. A magnetic pulse therapy device, the device comprising: an actuation solenoid comprised of three or more coils, the actuation solenoid having a core shaped to accommodate a foot portion, the foot portion being capable of being inserted and removed from the core of the actuation solenoid without the need for manual grasping, manipulation, or assistance; means for connecting an electronic circuit to the three or more coils forming the actuation solenoid; Device.

26. 26. The apparatus of claim 25, wherein the three or more coils are wired in a multi-tap configuration.

27. 26. The apparatus of claim 25, wherein the pulses supplied to the actuation solenoid are very low voltage, nominally not exceeding 50V AC or 120V DC.

28. 26. The method of claim 25 further comprising: providing a second, replica magnetic pulse therapy device communicatively coupled, physically coupled, or both, to the device of claim 25; 26. The device of claim 25, wherein the combined device forms a dual applicator system capable of treating two separate feet simultaneously.

29. 26. The device of claim 25, wherein the applicator is tapered at a distal end.

30. When energized, one or more coils in addition to the three or more coils (a) along a path beginning at the plantar surface of the base of the heel, such as the calcaneus, of the foot, proceeding along the medial border, passing anteriorly through the medial malleolus, crossing dorsally and continuing posteriorly to the lateral malleolus, and returning to the heel; (b) along a path beginning under the heel, passing over, beside, or near the ankle, around the inner ankle, to the opposite side of the ankle, then down under the foot and back to the heel; (c) along the region between the medial ankle and the proximal half of the plantar surface of the foot; or (d) along the proximal half of the plantar surface of the foot and the dorsal medial aspect of the ankle joint; 26. The device of claim 25, wherein the device is positioned to deliver a magnetic pulse to a region represented by at least one of the paths, or a combination thereof.

31. 1. A magnetic pulse therapy device (MPTD), comprising: (a) at least three coils; (b) a drive circuit configured to energize the at least three coils; and (c) an applicator; each coil includes at least one annular winding, each annular winding including a plurality of turns, at least some of the turns circumferentially surrounding the treatment chamber; The applicator comprises: (i) the treatment chamber configured to accommodate a treatment target, (i) the treatment object includes a portion of a hand or foot having a longitudinal length of at least 50 mm; (ii) the interior of the treatment chamber is (A) the average height of the treatment chamber is at least 20% less than the average width measured at the center width and along a longitudinal length of at least 50 mm; or (B) the treatment chamber is shaped and contoured to meet at least one or a combination of the following criteria: the volume of space within the treatment chamber is at least 15% less than the volume of a cylinder having a diameter equal to the width of the treatment chamber, measured over a longitudinal length of at least 50 mm; (2) a treatment zone defined as an area within the treatment chamber that receives magnetic flux generated by the at least three coils when energized by the drive circuit; (3) a proximal access opening configured to facilitate insertion and removal of the treatment target from the treatment chamber; (4) A configuration that does not require any of the following functional actions to be performed: (1) inserting the treatment object into the treatment chamber; (2) positioning the treatment object within the treatment zone; or (3) removing the treatment object from the treatment zone or the treatment chamber: wrapping, bending, conforming, deforming, shaping, sizing, cored, padded, expanding, or pushing. Device.

32. 32. The magnetic pulse therapy device (MPTD) of claim 31 , wherein the proximal access opening is configured to allow the treatment subject to be inserted into and removed from the treatment chamber without the use of hands or assistance from another person, using only limb movement associated with the treatment subject.

33. 32. The magnetic pulse therapy device (MPTD) of claim 31 , wherein the applicator has one or more engagement points, and when the treatment target is inserted into the treatment chamber and the one or more engagement points come into contact with a limb associated with the treatment target, at least a portion of the treatment target enters the treatment zone.

34. 32. The magnetic pulse therapy device (MPTD) of claim 31, further comprising a rigid housing that encloses at least a portion of the treatment chamber and at least a portion of the at least three coils and allows the treatment subject access to the proximal access opening.

35. 32. The magnetic pulse therapy device (MPTD) of claim 31, further comprising a support that transfers the weight of the applicator to the surface below and prevents damage to the windings.

36. 32. The magnetic pulse therapy device (MPTD) of claim 31, further comprising a second MPTD, wherein the MPTD of claim 31 and the second MPTD are configured to communicate with each other and coordinate operation to treat both a left hand and a right hand, or both a left foot and a right foot, simultaneously.

37. 32. The magnetic pulse therapy device (MPTD) of claim 31, wherein the applicator is configured for the left foot or left hand and further includes a second applicator for a corresponding right foot or right hand.

38. 32. The magnetic pulse therapy device (MPTD) of claim 31, wherein at least three or more of the at least three coils are configured in a multi-tap configuration.

39. 32. The magnetic pulse therapy device (MPTD) of claim 31, wherein the longitudinal length of the treatment zone is at least 50 mm.

40. 32. The magnetic pulse therapy device (MPTD) of claim 31, wherein the treatment target comprises a portion of a hand or foot, the portion having a longitudinal length of at least 100 mm, and the longitudinal length of the treatment zone is also at least 100 mm.

41. The treatment target is a foot, and at least a portion of the winding, when energized, generates a magnetic pulse: (a) along a path beginning at the plantar surface of the base of the calcaneus, such as the heel, of the treated foot, proceeding along the medial border, passing anteriorly through the medial malleolus, crossing dorsally and continuing posteriorly to the lateral malleolus, and returning to the heel; (b) along a path beginning under the treated heel, passing over, beside, or near the ankle, around the medial ankle, to the opposite side of the ankle, then down under the foot and back to the heel. (c) along the region between the medial ankle of the subject and the proximal half of the plantar surface of the subject; or (d) along the proximal half of the plantar surface of the treated foot and the dorsal medial aspect of the ankle joint; 41. The magnetic pulse therapy device (MPTD) of claim 40, positioned to deliver magnetic pulses to a region represented by at least one of the paths, or a combination thereof.

42. (a) at least a portion of the at least one toroidal winding is constructed from wire having a diameter of 18 AWG or less; 41. The magnetic pulse therapy device (MPTD) of claim 40, wherein (b) the drive circuit configured to energize the coil provides a nominal voltage of 120 volts or less.

43. 43. The magnetic pulse therapy device (MPTD) of claim 42, wherein some of the turns positioned distally relative to other turns have a circumference at least 35 mm smaller than the distal turns.

44. The treatment zone comprises: (a) along a longitudinal path across the central width of the treatment chamber for a longitudinal length of at least 50 mm; (b) at a distance of at least 10 mm from any interior surface of the treatment chamber; (c) when energizing various combinations of coils including at least one coil, the combinations being different for each measurement point; and 43. The magnetic pulse therapy device (MPTD) of claim 42, wherein (d) the device maintains a measured magnetic flux density of at least 1 mT within 1 millisecond of energizing the coil combination.

45. 45. A magnetic pulse therapy device (MPTD) as described in claim 44, wherein the treatment zone has a magnetic flux density of at least 10 mT measured as described in claim 44.

46. 1. A magnetic pulse therapy device (MPTD), comprising: (a) an applicator having a treatment zone including at least three coils; (b) a drive circuit configured to energize the at least three coils; Each coil includes at least one winding, each winding including a plurality of turns; and (1) at least three of the coils include a plurality of annular turns circumferentially surrounding the treatment zone; (2) the treatment zone has a longitudinal length, measured from the most distal annular turn to the most proximal annular turn, of at least 75 mm; (3) the treatment zone is shaped to accommodate a treatment target, the treatment target being a human hand or foot, and the treatment zone has a longitudinal length of at least 75 mm; (4) the overall height of the treatment zone is less than its overall width measured over each 75 mm longitudinal length, the overall height being calculated as the sum of the maximum heights of each turn circumferentially surrounding the treatment zone, and the overall width being calculated as the sum of the maximum widths of each turn circumferentially surrounding the treatment zone; and (5) The treatment zone generates a magnetic field of at least 1 mT magnetic flux density within 1 millisecond of energizing some combination of three or more coils at a distance of at least 10 mm from all current-carrying windings, measured along at least 75 mm of a longitudinal length within the treatment zone, the combination of current-carrying coils being different at each measurement point. Device.

47. (a) at least a portion of at least one toroidal winding is constructed from wire having a diameter of 18 AWG or less; 47. The magnetic pulse therapy device (MPTD) of claim 46, wherein (b) the drive circuit energizes at least one coil with a nominal voltage of less than 50 volts.

48. further comprising an assembly including the applicator and the housing; (a) the assembly defines a treatment chamber shaped and sized to contain the treatment target within the treatment zone; (b) the assembly includes an opening that facilitates insertion and removal of the treatment object into and from the treatment chamber; (c) the assembly contains, positions, holds, or forms at least a portion of the toroidal winding; 47. The magnetic pulse therapy device (MPTD) of claim 46, wherein (d) the assembly surrounds at least a portion of the annular winding.

49. 49. The magnetic pulse therapy device (MPTD) of claim 48, wherein the subject can insert and remove the assembly and the treatment zone without using hands or assistance from anyone other than the person receiving treatment, using only limb movements related to the subject.

50. 49. The magnetic pulse therapy device (MPTD) of claim 48, wherein no functional wrapping, bending, conforming, deforming, shaping, sizing, cored, padded, expanding, or pushing actions are required to perform any of the following tasks: (1) inserting the treatment object into the treatment chamber; (2) positioning the treatment object within the treatment zone; or (3) removing the treatment object from the treatment zone or the treatment chamber.

51. 49. The magnetic pulse therapy device (MPTD) of claim 48, wherein the treatment zone has a magnetic field with a magnetic flux strength of at least 5 mT within 1 millisecond of energizing some combination of three or more coils, measured at a distance of at least 10 mm from all windings along at least 75 mm of longitudinal length within the treatment zone, and wherein the combination of energized coils can vary from measurement point to measurement point.

52. (a) at least five of the at least three coils each include at least one annular winding, each annular winding including a plurality of turns circumferentially surrounding the treatment zone; (b) the longitudinal length of the treatment zone is at least 100 mm; (c) The magnetic pulse therapy device (MPTD) of claim 48, wherein the treatment target is a portion of a human hand or foot having a longitudinal length of at least 100 mm.

53. 1. A magnetic pulse therapy device (MPTD), comprising: (a) at least one applicator assembly; (b) at least one coil; (c) a drive circuit or cable; (d) a housing; The at least one applicator assembly comprises: (i) a treatment chamber sized and shaped to accommodate a treatment subject, the treatment subject comprising a portion of a hand or foot having a longitudinal length of at least 75 mm; (ii) the interior of the treatment chamber is (1) the average height of the treatment chamber, measured at the center width of the treatment chamber, is at least 20% less than the average width of the treatment chamber measured along at least 75 mm of the longitudinal length of the treatment chamber; or (2) the volume of space within the treatment chamber is at least 15% less than the volume of a cylinder having a diameter equal to the width of the treatment chamber, measured along at least 75 mm of the longitudinal length of the treatment chamber; (iii) a proximal access opening to the treatment chamber, which allows the treatment object to be inserted into and removed from the treatment chamber without using hands or assistance from another person, using only limb movements relative to the treatment object; (iv) comprising structural features configured to contain, orient, hold, support, form, or position at least some of the turns relative to the treatment chamber; Each coil includes at least one winding, each winding including multiple turns; (i) at least a portion of at least one coil is constructed from wire having a diameter of 18 AWG or less; (ii) at least a portion of the turns, referred to as annular turns, circumferentially surround the treatment chamber, thereby forming a treatment zone defined as the area circumferentially surrounded by at least a portion of the annular turns within the treatment chamber; (iii) the annular winding is (1) the annular turns are, on average, closer to the interior surface of the treatment chamber than if they were individually molded into a circle or collectively molded into a cylinder, measured as the average distance along the length of the turns from the annular turns to the interior surface of the treatment chamber; (2) the volume between the inner surface of the treatment chamber and the space enclosed by the annular winding is at least 10% smaller than the volume between the inner surface of the treatment chamber and a cylinder having a diameter equal to the width of the treatment chamber; (3) some annular turns located distally from other annular turns have a circumference at least 35 mm smaller than the circumference of the annular turns located proximally; or (4) the circumference of at least a portion of the annular winding exhibits one or more of the following characteristics: the circumference is less than π times the width of the interior of the treatment chamber at its widest point; and (c) the drive circuit is connected to the coil and configured to energize the coil, or the cable allows the coil to be connected to a drive circuit; (d) the housing (i) surrounding at least a portion of the applicator assembly; (ii) surrounding at least a portion of the plurality of windings; and (iii) configured to allow the treatment target to be inserted into the treatment zone; Device.

54. 54. The magnetic pulse therapy device (MPTD) of claim 53, further comprising one or more engagement points, wherein when the treatment target is inserted into the treatment chamber and the engagement points come into contact with a limb associated with the treatment target, the treatment target is aligned to overlap a portion of the treatment zone.

55. 54. The magnetic pulse therapy device (MPTD) of claim 53, further comprising two applicator assemblies and at least two coils, one applicator assembly and coil configured for the left hand or left foot and the other applicator assembly and coil configured for the right hand or right foot, the housing adapted to accommodate insertion of a treatment subject into each treatment zone.

56. The treatment zone comprises: (i) across its longitudinal length, equal to the lesser of (A) the length of the current-carrying coil or (B) 75 mm; (ii) along the central width of both the plantar and dorsal surfaces of the treatment chamber; (iii) at a distance of at least 10 mm from the measurement surface; (iv) energizing the one or more coils and changing the coil combination for each measurement point; and 54. A magnetic pulse therapy device (MPTD) as described in claim 53, wherein (v) the combination of coils has a magnetic flux density of at least 1 mT measured within 1 millisecond of energizing the combination of coils.

57. 54. The magnetic pulse therapy device (MPTD) of claim 53, wherein the treatment chamber includes a surface on which the treatment subject is placed, the surface being supported to prevent damage to the windings.

58. 54. The magnetic pulse therapy device (MPTD) of claim 53, wherein the device includes at least three coils, each coil including at least one winding, each winding including multiple turns, and the drive circuitry applies a nominal voltage of less than 50 volts to at least some of the coils.

59. (a) the treatment target is a portion of a human foot including at least a portion from the phalanges to the tarsal region; (b) at least some of the turns, when energized, (i) along a path beginning at the plantar surface of the base of the heel, such as the calcaneus, of the target heel, proceeding along the medial border, passing anteriorly through the medial malleolus, traversing the dorsum and continuing posteriorly to the lateral malleolus, and returning to the heel; (ii) along a path beginning under the treated heel, passing over, beside, or near the ankle, around the medial ankle, to the opposite side of the ankle, then down under the foot and back to the heel; (iii) along the region between the medial ankle of the treated foot and the proximal half of the plantar surface of the treated foot; or (iv) along the proximal half of the plantar surface of the treated foot and the dorsal medial aspect of the ankle joint; 54. The magnetic pulse therapy device (MPTD) of claim 53, positioned to deliver magnetic pulses to at least a portion of an area represented by at least one or a combination of the paths.

60. 1. A magnetic pulse therapy device (MPTD), comprising: (a) at least one actuation solenoid; (b) a drive circuit; (c) an applicator; and (d) a proximal access opening; (e) an enclosure; and (f) a treatment chamber, structure, proximal access opening, and enclosure; (g) at least one actuation solenoid, coil, winding, drive circuit, and applicator; (a) the at least one actuation solenoid comprises: (i) at least one coil configured to be energized by the drive circuit, each coil including at least one winding having a plurality of turns; (ii) a solenoid core length of at least 50 mm; (b) the drive circuit is configured to energize the at least one coil; (c) the applicator comprises: (i) a treatment chamber sized and shaped to accommodate a treatment object, the treatment object being a portion of a hand or foot, the portion having a longitudinal dimension of at least 75 mm; (ii) a structure configured to house, position, support, hold, or form at least some of the turns of the at least one actuation solenoid, wherein at least some of the turns comprising the at least one actuation solenoid circumferentially surround the treatment chamber, thereby forming a treatment zone defined as the area within the core of the at least one actuation solenoid and within the treatment chamber; (d) the proximal access opening to the treatment chamber, which allows the treatment object to be inserted into and removed from the treatment chamber without using hands or assistance from another person, but only with movement of the limbs associated with the treatment object; (e) the enclosure encloses the at least one actuation solenoid and at least a portion of the applicator and provides the subject with access to the proximal access opening; (f) the treatment chamber, structure, proximal access opening, and enclosure are configured to have one or more engagement points, such that when the treatment subject is inserted into the treatment chamber and an engagement point contacts an extremity associated with the treatment subject, at least a portion of the treatment subject is within the treatment zone; (g) the at least one actuation solenoid, coil, winding, drive circuit, and applicator are configured such that the treatment zone: (i) across its longitudinal length, equal to the lesser of (A) the total length of the current-carrying coil, or (B) 50 mm; (ii) along the central width of both the plantar and dorsal surfaces of the treatment chamber; (iii) at a distance of at least 10 mm from the measurement surface; (iv) the combination changes for each measurement point when one or more coils constituting at least one actuation solenoid are energized; and (v) configured to have a magnetic flux density of at least 1 mT measured within 1 millisecond of energizing the coil combination; Device.

Images