System and method for coordinated focused ultrasound and magnetic stimulation for therapeutic applications

Abstract

Systems and methods are provided for controlling a treatment device to treat pain of a patient by coordinating timing and delivery of magnetic stimulation and ultrasonic stimulation from the treatment device to the patient. A processor configured to access the memory and control operation of the treatment device.

Description

SYSTEM AND METHOD FOR COORDINATED FOCUSED ULTRASOUND AND MAGNETIC STIMULATION FOR THERAPEUTIC APPLICATIONSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is based on and claims the benefit of U.S. Provisional Patent Application No. 63 / 694,970, filed on September 16, 2024, the entire contents of which is hereby incorporated by reference, for any and all purposes.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0002] This invention was made with government support under 5R01MH111875-04 awarded by the National Institutes of Health. The government has certain rights in the invention.BACKGROUND

[0003] The present disclosure relates generally to systems and methods for therapeutic applications for pain reduction or relief. More particularly, systems and methods are provided for coordinated use of focused ultrasound and magnetic stimulation.

[0004] Sciatica is one of the main indications in the United States for spinal cord stimulation (SCS), and SCS often may produce large clinical effect sizes for this indication. Sciatica falls into many categories, but most commonly is described as leg / back pain with radiculopathy or lumbosacral radiculopathy. This encompasses a variety of conditions, such as disc herniation with radiating pain, spinal cord stenosis, persistent pain after trauma, and radiating leg / back pain to name a few. For patients with radicular pain, this often manifests as high levels of axial radiating to the buttock and leg, commonly known as sciatica. Prevalence estimates for lumbosacral radiculopathy range from 3 to 5% of the general population, and this number will likely continue to increase as our population ages.

[0005] As with most forms of neuropathic pain, it is thought that central and peripheral sensitization plays a large role in the development of lumbosacral radiculopathy. An initial or persistent injury or trauma leads to lowered firing thresholds in peripheral nociceptors and ascending sensory pathways, leading to baseline firing of nociceptors. This process involves the release of analgesic substances, including serotonin, prostaglandin, protons, ATP, and bradykinin. In addition, lowered thresholds of NMDA receptor neurons in the spinal cord and brain areextensively documented. Even when active compression or impingement is removed, as in the case of spinal surgery, many patients persist in having similar symptoms, which is termed failed back surgery syndrome. Likewise, for surgery with spinal cord stenosis, many patients may have unchanged sensory symptoms even after symptoms of weakness improve.

[0006] Thus, many forms of non-surgical treatment have been tried for neuropathic pain in general, including oral medications, targeted blocks with local anesthetics and steroids, and neuromodulation, which broadly encompasses the use of energy to modify neural circuits and pain pathways. In general, most therapies for sciatica provide a limited magnitude and duration of relief.

[0007] One technology that has been more successful for reducing pain associated with sciatica is spinal cord stimulation (SCS). Notably, SCS implantation requires major surgery with many complications, including epidural abscess, infected implant, epidural hematoma, lead migration, and lead fracture.

[0008] Over time, patient preference and concerns for safety have driven the development of less invasive devices and procedures. Dorsal root ganglion (DRG) stimulation has been used successfully in various conditions, including sciatica, CRPS, phantom limb pain, and postsurgical pain. Unfortunately, DRG stimulation uses a small, implanted device to deliver electrical pulses to the dorsal root ganglion. Thus, while less complex than SCS implantation, implantation of the stimulation device for DRG stimulation is still a complex surgical procedure.

[0009] Thus, there is a continuing need for new systems and methods for addressing and treating pain, such as associated with sciatica, preferably, with less risk, side effects, and / or intervention.SUMMARY

[0010] The present disclosure overcomes the aforementioned drawbacks by providing systems and methods for therapeutic ultrasound delivered by magnetic stimulation systems.

[0011] In accordance with one aspect of the disclosure, a stimulation system is provided for delivering therapeutic treatment to a patient. The system includes a treatment device having at least one coil configured to generate both a magnetic field and ultrasound pulses, a power source configured to deliver power to the treatment device to energize the at least one coil, and a processor configured to coordinate timing and delivery of magnetic stimulation and ultrasonic stimulation by the at least one coil to treat a patient using the treatment device.

[0012] In accordance with another aspect of the disclosure, an apparatus is provided including a memory having instructions for controlling a treatment device to treat pain of a patient by coordinating timing and delivery of magnetic stimulation and ultrasonic stimulation from the treatment device to the patient. The system also includes a processor configured to access the memory and control operation of the treatment device.

[0013] In accordance with yet another aspect of the disclosure, a method is provided for controlling a system to configure treatment. The method includes activating a processor to coordinate operation of at least one coil configured to generate both magnetic fields and ultrasound pulses, generating pulse commands that define timing, amplitude, and sequence of stimulation pulses for both magnetic fields and ultrasound pulses from the at least one coil, and synchronizing magnetic field generation with ultrasound pulse production through the at least one coil to perform multimodal therapeutic stimulation.

[0014] The foregoing and other aspects and advantages of the present disclosure will appear from the following description. In the description, reference is made to the accompanying drawings that form a part hereof, and in which there is shown by way of illustration one or more embodiment. These embodiments do not necessarily represent the full scope of the invention, however, and reference is therefore made to the claims and herein for interpreting the scope of the invention. Like reference numerals will be used to refer to like parts from Figure to Figure in the following description.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Various objects, features, and advantages of the disclosed subject matter can be more fully appreciated with reference to the following detailed description of the disclosed subject matter when considered in connection with the following drawings, in which like reference numerals identify like elements.

[0016] Fig. l is a schematic illustration of a system in accordance with the present disclosure.

[0017] Fig. 2 a block diagram of a stimulation system, according to aspects of the present disclosure.

[0018] Fig. 3 is a non-limiting example of a pulse diagram in accordance with the present disclosure.

[0019] Fig. 4 is an illustration of a coil system that may be used in accordance with the present disclosure.

[0020] Fig. 5A is a schematic illustration of a stimulation system for use on the hand or wrist, in accordance with the present disclosure.

[0021] Fig. 5B is a graph of action potential accompanying the illustration of Fig. 5 A.

[0022] Fig. 6A is an illustration of electrode and stimulation placement relative to the radial nerve for wrist or hand stimulation in accordance with the present disclosure.

[0023] Fig. 6B is an image of a stimulation system to detect the radial nerve in accordance with the present disclosure deployed to the hand.

[0024] Fig. 6C is another image of a stimulation system showing placement of a microcoil in accordance with the present disclosure.

[0025] Fig. 6D is yet another image of a stimulation system showing placement of the microcoil in accordance with the present disclosure.

[0026] Fig. 6E is a graph showing readings taken using the system illustrated in Figs. 6A-6D.

[0027] Fig. 6F is a graph showing further readings taken using the system illustrated in Figs. 6A- 6D.

[0028] Fig. 6G is a graph showing microcoil stimulation with different recordings from the SNUFF of the same subject.

[0029] Fig. 6H is a graph showing microcoil stimulation with recording from the SNUFF of different subjects.

[0030] Fig. 7 is a block diagram of a computerized system that may have the processor system or other components of Figs. 1 and / or Fig. 2 integrated therewith.DESCRIPTION

[0031] The present disclosure provides systems and methods for non-invasive stimulation that yield similar effect sizes as implantable devices. Without the need for complex surgical procedures, the systems and methods of the present disclosure are available to patients earlier in the course of a patient’s chronic leg / back pain, radiculopathy, peripheral neuropathy, or CRPS, rather than being a therapy of last resort, like traditional, invasive DRG stimulation and SCS. In one non-limiting example the present disclosure provides systems and methods for non-invasive DRG stimulation. Even when not administered continuously (as is implantable DRG stimulation),the systems and methods of the present disclosure are able to achieve dramatic reductions in pain syndromes when administered with frequency in the clinic or as a home device.

[0032] As will be described, the systems and methods of the present disclosure may be realized in any of a variety of implementations. Transcutaneous electrical spinal cord stimulation can be utilized, recognizing limitations caused by activation of skin nociceptors and attenuation of current by tissue impedance. Additionally or alternatively, focused ultrasound (FUS) can be used for neuromodulation and has many advantages of transcutaneous electrical stimulation alone, including its spatial resolution and depth penetration. By combining FUS with another stimulation modality, the need to control against thermal injury and narrow delivery windows, while still achieving sufficient neuromodulation, can be realized. Trans-spinal magnetic stimulation (TMS or TSMS) may be used with FUS. A single three-minute low intensity focused ultrasound (LIFU) modulatory treatment of the dorsal root ganglion (DRG) can limit anti-nociceptive responses in small and large animal models for days to weeks. While promising, other spinal cord regions typically used for pain treatment (i.e., dorsal columns in spinal cord stimulation) remain difficult to target due to the proximity of bone and neural structures in the spine. TSMS may be used to penetrate tissue deeply, particularly, when coupled with effective coil design.

[0033] Referring to Fig. 1, a system 100 is provided that uses electromagnetic pulses to non- invasively deliver a pulsed magnetic field that can depolarize neurons either in the central nervous system or in the peripheral nervous system. The system 100 can be used with any of a variety of coils, including a micro-coil, such as will be described. Though not required, the system 100 of the present disclosure can use a magnetic field produced by a much smaller coil through the use of Flex techniques, miniaturization, and a ceramic A12O3 core.

[0034] The stimulation system 100 may provide therapeutic treatment to a patient 101 through multimodal neuromodulation. The stimulation system 100 may include an ultrasound system 102 connected to a treatment device 104 having a first coil 106 and a second coil 108. The stimulation system 100 may coordinate the timing and delivery of both ultrasound stimulation and magnetic stimulation through the treatment device 104.

[0035] In some cases, the first coil 106 and the second coil 108 may be arranged as circular ribbons connected in series to create focused stimulation patterns. As will be described, the coils 106, 108 may be formed in a figure-8 arrangement. The treatment device 104 may generate both magneticfields and ultrasonic waves for therapeutic applications, or may just detect ultrasonic signals generated by the coils 106, 108 in the treatment device 104.

[0036] The stimulation system 100 may include a processor board 110 connected to a processor system 112 for controlling system operations. The processor board 110 may manage the coordination between magnetic and ultrasonic stimulation modalities. In some cases, the processor system 112 may execute control algorithms that account for different propagation speeds of sound waves versus electromagnetic fields. The processor board 110 may control a power bridge 114 through gate driver commands 116 and may receive fault output 118 for system monitoring. In one, non-limiting implementation, the power bridge 114 may utilize up to 25 paralleled lower- current IGBTs per H-bridge leg rather than fewer high-current IGBT modules for cost effectiveness. This parallel configuration may provide improved current handling capabilities while reducing component costs compared to high-current IGBT modules.

[0037] The stimulation system 100 may include a capacitor bank 120 and a resonant cap bank 122 connected to the power bridge 114. The capacitor bank 120 may store energy for generating high- current pulses, while the resonant cap bank 122 may work in conjunction with the coil inductance to create resonant operation. In some cases, the resonant cap bank 122 may be connected in series with the first coil 106 and the second coil 108 to cancel the inductance of the coils. In one, nonlimiting example, this resonant mode operation may allow the stimulation system 100 to achieve currents up to lOkA peak by reducing the impedance at the resonant frequency. The resonant configuration may enable the generation of high-amplitude current pulses with lower voltage requirements compared to non-resonant operation.

[0038] The processor board 110 may manage the coordination between magnetic and ultrasonic stimulation modalities. In some cases, the processor system 112 may execute control algorithms that account for different propagation speeds of sound waves versus electromagnetic fields. The processor board 110 may control the power bridge 114 through gate driver commands 116 and may receive fault output 118 for system monitoring. In one, non-limiting example, the power bridge 114 may utilize up to 25 paralleled lower-current IGBTs per H-bridge leg rather than fewer high-current IGBT modules. This parallel configuration may provide improved current handling capabilities while reducing component costs compared to high-current IGBT modules.

[0039] Thus, the stimulation system 100 may incorporate multiple safety measures to protect both the patient 101 and components of the system 100 during operation. These safety measures mayinclude safety interlocks that prevent simultaneous charging, discharging, and pulse generation operations. Hard-wired protections may be implemented to ensure fail-safe operation even in the event of software malfunctions or component failures. The fault output 118 may provide real-time monitoring of system conditions and may trigger protective actions when abnormal conditions are detected. In some cases, discharge resistors may be connected across high-voltage capacitors to ensure safe voltage bleed-off over time. Software error protection may include pulse time limits and dead-time generators to prevent damaging conditions. Per-IGBT overcurrent protection may monitor individual IGBT currents and may disable switches when predetermined current thresholds are exceeded, protecting the power bridge 114 from overcurrent damage.

[0040] The stimulation system 100 may include a cooling unit 124 that provides thermal management for system components during operation. The cooling unit 124 may be connected to the treatment device 104 through a cooling connection 126 to maintain optimal operating temperatures. In some cases, the cooling unit 124 may circulate coolant through the first coil 106 and the second coil 108 to maintain desired temperature during high-current pulse generation. The cooling connection 126 may comprise fluid lines that transport coolant between the cooling unit 124 and the coils. Temperature sensors 128 may be positioned at various locations throughout the stimulation system 100 to monitor thermal conditions and provide real-time temperature feedback to the processor system 112 to enable thermal protection and control algorithms.

[0041] The temperature sensors 128 may monitor both coil surface temperatures and / or core temperatures to provide comprehensive thermal monitoring. In some cases, the processor system 112 may execute thermal protection algorithms that limit pulse parameters when temperature thresholds are approached. The processor system 112 may receive feedback from the thermocouplers to perform transient thermal calculations and monitoring to ensure temperature rise during current pulses remains below, as one non-limiting example, 20°C. In one non-limiting example, 4 thermocouples may be used per coil. The cooling unit 124 may adjust cooling flow rates based on thermal feedback from the temperature sensors 128 and or commands from the processor system 112. The thermal monitoring system may prevent tissue damage and component degradation by maintaining safe operating temperatures throughout treatment sessions.

[0042] To achieve this monitoring and / or other system coordinating and control, the processor system 112 may be connected, for example, through the processor board 110, to a variety of input / output (I / O) components. For example, an analog I / O 130 may provide analog signalprocessing capabilities for the stimulation system 100 and interface with various analog sensors and control signals throughout the system. In addition, digital I / O 132 and digital I / O 134 may handle digital communication and control functions within the stimulation system 100. In some cases, the digital I / O 132 may manage safety interlock signals, while the digital I / O 134 may handle system status and monitoring functions. The digital I / O components 132, 134 may communicate with the processor board 110 and, thereby, to the processor system 112, to coordinate system operations and safety functions.

[0043] The system 100 may include a signal attenuator 136 to process voltage signals from the coils to provide safe monitoring levels for the processor system 112 by scaling down high-voltage signals to levels compatible with monitoring circuits. The output to the analog I / O 130 is a signal, Vcoii 138, that represents the voltage across the first coil 106 and the second coil 108 during operation and may be monitored to determine coil current and power delivery. The analog I / O 130 may communicate a signal, Vcc140, that enables the processor system 112 to monitor the coil voltages. Another signal attenuator 142 may be coupled to receive capacitor bank voltage signals for monitoring purposes and enable safe monitoring of high-voltage capacitor conditions. The attenuator 142 communicates a signal, Vcaps 144, that represent the voltage across the capacitor bank 120 and may be monitored to determine energy storage levels and charging status. In addition, another signal, gate driver monitoring signal 146, may provide oversight of the power bridge 114 operation and IGBT status by detecting fault conditions in individual IGBTs and communicating fault information to the processor system 112 via the processor board 110. In some cases, the gate driver monitoring 146 may monitor gate drive signals, IGBT temperatures, and current levels to ensure safe operation.

[0044] A power supply 148 may provide electrical power to various system components by converting AC line power to appropriate DC voltage levels for system operation. A charge controller 150 may manage the charging process for energy storage components by regulating charging current and voltage to ensure safe and efficient capacitor charging. A cap bank 152 may provide filter any remaining AC components and / or provide any additional energy storage capacity for the stimulation system 100.

[0045] Under direction of the processor system 112, a waveform generator 154 may create the timing and control signals for stimulation pulses and generate pulse commands 156 that define the timing, amplitude, and sequence of stimulation pulses. In some cases, the waveform generator154 may coordinate the timing between magnetic and ultrasonic stimulation modalities. The pulse commands 156 may specify pulse parameters such as frequency, duration, and amplitude for both magnetic and ultrasonic stimulation.

[0046] As one non-limiting example, the stimulation system 100 may operate at frequencies of 10kHz or greater, up to 40kHz, rather than traditional frequencies of 40-100Hz. In this way, a control signal 158 may be used to enable charge / discharge controls, fault monitoring and may provide system-level control and safety oversight by preventing unsafe operating conditions and coordinating charging, discharging, and pulse generation operations to ensure they remain mutually exclusive.

[0047] In one non-limiting example, the above-described system was constructed to include a high-frequency TSMS coil (such as the figure-8 coil described below) driven by a HF-TSMS drive system that included several components: a) a capacitor bank charged by the high-voltage supply that stores the energy needed to generate a single pulse or pulse train, as the AC line cannot support ms range multi-kA pulses; b) an H-Bridge that switches the bulk capacitor bank voltage across the coil to produce the current pulses; c) an NI PXIe-1071 software programmed in Lab View that generates two trains of square waveforms - one for the top and one for the bottom transistors of the H-Bridge, respectively - with a 100 ps period and with a 180° shift, so that the upper bridge and lower bridges are never open simultaneously, thus avoiding a catastrophic shoot-through in the H-bridge.

[0048] Square-wave voltage pulses were applied directly to the coil resulting in a set of rounded sawtooth current pulses, with the shape set by the L / R time constant of the coil’s inductance and resistance. To ensure signal integrity, all high-voltage components within the system were isolated and insulated, mitigating interference and preserving signal quality. Furthermore, optical fiberbased connections were used for all control signals, such as those responsible for enabling or disabling each gate driver, thereby eliminating the risk of electrical interference.

[0049] That is, the stimulation system 100 may include optical fiber-based connections for all control signals to eliminate electrical interference and ensure signal integrity. The optical fiber connections may isolate control circuits from high-voltage and high-current sections of the stimulation system 100 and carry gate driver enable signals, fault detection signals, and system status information. The optical isolation may prevent ground loops and electrical noise from affecting sensitive control circuits. The processor board 110 may communicate with varioussystem components through the optical fiber connections to maintain signal integrity during high- power pulse generation. The optical fiber-based control system may enhance system reliability and reduce electromagnetic interference that could affect stimulation precision.

[0050] During testing, given the low impedance of the coil, a wave of approximately 300V can generate 2kA. During one test, the current rises linearly for 50ps, while the square-wave voltages remain approximately constant. The system was reprogrammed to allow for ON / OFF resting cycles. The coils and the driving hardware operated in a resonant mode - using a capacitor bank in series with the coil to cancel its inductance - that allows for currents up to lOkA peak.

[0051] Multiple safety measures were implemented in the system to prevent direct exposure to high currents and voltages for users. These measures include several safety interlocks and hardwired protections. Additionally, a protection circuitry, based on a fault system that prevents pulse generation, discharge resistors for the capacitors, software error protection, and other measures, were designed to prevent uncontrolled high currents and damaging shoot-throughs. For instance, to safeguard the IGBTs from over-currents, two boards were included for each IGBT. If the current of any IGBT exceeded a pre-determined threshold, this was reported back to the corresponding gate driver, and the switch is disabled. Furthermore, transient thermal calculations were conducted for every major conductor in the system to ensure that the temperature rise during a current pulse always remained lower than 20°C.

[0052] Referring to Fig. 2, a stimulation system 200 that may further implement the systems of Fig. 1 or may provide an alternative implementation for therapeutic neuromodulation is illustrated. The system 200 leverages audio pulses generated by magnetic coils as an advantageous feature rather than an undesirable byproduct as they have been traditionally viewed by TMS and other such systems. The stimulation system 200 may include a processor 202 that coordinates system operations and manages the integration of multiple stimulation modalities. The processor 202 may execute control algorithms that synchronize magnetic field generation with ultrasonic wave production to achieve enhanced therapeutic effects. In some cases, the processor 202 may implement pulse sequence programming that accounts for different propagation speeds of sound waves versus electromagnetic fields, with programmed delays between low-intensity focused ultrasound (LIFU) and magnetic stimulation pulses. The processor 202 may calculate timing delays based on the approximately 1,500 m / s propagation speed of ultrasonic waves compared to the near-instantaneous propagation of electromagnetic fields.

[0053] The stimulation system 200 may include a pulse generator 204 connected to the processor 202 for creating precisely timed electrical signals that drive the therapeutic stimulation process. The pulse generator 204 may produce positive and negative voltage signals with specific timing characteristics designed to optimize both magnetic and ultrasonic stimulation effects. In some cases, the pulse generator 204 may generate square-wave voltage pulses that are applied directly to downstream coil components. The pulse generator 204 may operate under control of the processor 202 to create complex pulse sequences that coordinate magnetic field generation with ultrasonic wave production. The timing precision of the pulse generator 204 may enable the stimulation system 200 to exploit the natural acoustic emissions from magnetic coils as a therapeutic advantage rather than treating such emissions as unwanted noise.

[0054] An amplifier array 206 may be coupled to the pulse generator 204 to provide signal amplification capabilities for driving high-power stimulation components. The amplifier array 206 may include multiple amplifiers connected in parallel to achieve the current levels needed for effective therapeutic stimulation. In some cases, the amplifier array 206 may amplify the voltage signals from the pulse generator 204 to power levels suitable for generating strong magnetic fields and corresponding acoustic emissions. The amplifier array 206 may distribute amplified signals to downstream stimulation components, while maintaining signal integrity and timing precision. The parallel configuration of amplifiers within the amplifier array 206 may provide redundancy and enhanced current handling capabilities compared to single amplifier implementations.

[0055] The stimulation system 200 may incorporate a stimulation system 208 that receives amplified signals from the amplifier array 206 and converts electrical energy into therapeutic stimulation modalities. The stimulation system 208 may integrate magnetic field generation with ultrasonic wave production through coordinated operation of electromagnetic components. Coils 210 within the stimulation system 208 may generate both magnetic fields B and ultrasonic pulses or waves P when energized by the amplified electrical signals. The coil 210 may produce magnetic fields B for direct electromagnetic stimulation of neural tissue while simultaneously generating acoustic pressure waves P that propagate through tissue at the ultrasound velocity VSOund of 1,500 m / s. The dual -mode operation of the coil 210 may enable multimodal therapeutic stimulation from a single transducer element, where the acoustic emissions traditionally considered undesirable become an integral part of the therapeutic mechanism.

[0056] An input / output display 212 may be connected to the processor 202 to provide user interface capabilities for system control and monitoring functions. The I / O display 212 may enable clinicians to configure stimulation parameters, monitor system status, and observe real-time feedback during therapeutic treatments. In some cases, the input output display 212 may present information about both magnetic field strength and ultrasonic pressure levels generated by the coil 210. The I / O display 212 may provide visual feedback regarding the coordination between electromagnetic and acoustic stimulation modalities. The processor 202 may communicate system status information to the input output display 212 to enable comprehensive monitoring of the dualmode stimulation process.

[0057] The stimulation system 200 may include a first thermometer 214 and a second thermometer 216 positioned to monitor temperature conditions during system operation and provide thermal feedback to prevent overheating of system components. The first thermometer 214 may monitor temperature at a first location within the stimulation system 208, while the second thermometer 216 may monitor temperature at a second location to provide comprehensive thermal monitoring. In some cases, the first thermometer 214 may monitor coil surface temperature, while the second thermometer 216 may monitor core temperature or ambient conditions. The processor 202 may receive temperature data from both the first thermometer 214 and the second thermometer 216 to implement thermal protection algorithms. The multi-temperature monitoring approach may enable precise thermal management during high-power operation when the coil 210 generates both magnetic fields B and acoustic waves P simultaneously.

[0058] An ultrasound transducer 218 may be positioned to detect ultrasonic waves generated by the stimulation system 208 and provide feedback regarding the acoustic component of the therapeutic stimulation. The ultrasound transducer 218 may capture the acoustic waves P produced by the coil 210 during magnetic field generation, enabling real-time monitoring of the ultrasonic stimulation component. In some cases, the ultrasound transducer 218 may provide feedback signals to the processor 202 for closed-loop control of the acoustic stimulation parameters. The ultrasound transducer 218 may enable the stimulation system 200 to monitor and optimize the acoustic emissions that were traditionally considered undesirable byproducts of magnetic coil operation. The processor 202 may use feedback from the ultrasound transducer 218 to adjust pulse parameters and timing sequences to enhance the therapeutic effectiveness of the combined magnetic and ultrasonic stimulation approach. Additionally, the transducer 218 may beused to generate further ultrasound pulses that are designed to intersect with the pulses generated by the coil 210, for example, at a therapeutic target.

[0059] Referring to Fig. 3, the stimulation system 200 of Fig. 2 may operate using specifically designed pulse sequences. One, non-limiting example of a pulse sequence is provided in Fig. 3. In one, non-limiting example, square-wave voltage pulses applied directly to the coil, resulting in rounded sawtooth current pulses shaped by the L / R time constant of the coil inductance and resistance characteristics. The L / R time constant may determine the current rise time and waveform characteristics when square-wave voltages are applied to the coil. In some cases, the rounded sawtooth current pulses may provide optimal conditions for generating both strong magnetic fields B and corresponding acoustic pulses P . The current waveform shape may influence both the electromagnetic stimulation characteristics and the acoustic emission properties of the coil 210. The processor 202 may account for the L / R time constant when calculating pulse timing sequences to ensure proper coordination between magnetic and ultrasonic stimulation effects.

[0060] The voltage characteristics and waveform properties of the coil system may demonstrate resonant behavior during pulse operation. The graph of Fig. 3 may illustrate voltage measurements over time with a characteristic resonant peak indicated by curve 300. The first pulse train 302 may operate at a higher frequency followed by a delay interval 304, and then a second pulse train 306 at a lower frequency may be applied. In some cases, the first pulse train 302 may show multiple oscillations of consistent amplitude, while the second pulse train 306 may exhibit increasing amplitude with a maximum peak. In one, non-limiting example, the voltage measurements 300 may range from -2.0kV to 2.4kV over a time period from 0.0ms to 1.0ms, demonstrating the high- voltage operation capabilities of the coil system. The resonant behavior may result from the interaction between the coil inductance and the resonant capacitor bank, creating conditions for enhanced current amplitude at specific frequencies.

[0061] With continued reference to Fig. 3, the waveform characteristics may demonstrate the coordinated timing between different stimulation modalities within the treatment system. The delay interval 304 between pulse trains 302, 306 may yield different propagation speeds of electromagnetic and acoustic energy, enabling synchronized delivery of therapeutic stimulation to target tissues. In some cases, the increasing amplitude pattern in the first pulse train 302 may be crated due to energy accumulation in the resonant circuit during the initial pulse sequence 302.Notably, in this pulse sequence of Fig. 3, a peak resonant response 308 occurs during a third pulse train 310, demonstrating the effectiveness of the resonant circuit design in achieving high- amplitude stimulation pulses.

[0062] Referring to Fig. 4, the treatment device described above may incorporate a magnetic field coil implemented as a figure-8 ribbon design 400 with two circular ribbons 402, 404. In one nonlimiting example, the ribbons may be made of 25mm diameter each connected in series. This figure-8 configuration may allow for more focal stimulation compared to rectangular-shaped figure-8 designs by concentrating the magnetic field at the intersection point between the two circular sections. The circular ribbon geometry may provide enhanced field focusing characteristics while maintaining structural integrity during high-current operation. In some cases, the series connection of the two circular ribbons may cause current flowing through the coils to sum constructively at the center of the figure-8 shape, creating a concentrated stimulation zone. In one, non-limiting example, each coil may have a diameter of 25mm to realize a combine length in series of 50 mm. In one, non-limiting example, the average resistance and inductance [mean±SD] of the coils 402, 404 were [10.21±0.26] mQ and [4.43±0.13] pH, respectively. These values are just examples. The specific size may be selected to optimize the balance between field penetration depth and spatial resolution for therapeutic applications targeting neural structures.

[0063] The coil construction may utilize copper strips wrapped to form the ribbon structure rather than conventional wire materials. The copper strips may provide lower resistance characteristics compared to traditional wire windings while enabling the formation of the specialized ribbon geometry. In some cases, the copper strips may be formed into the circular ribbon configuration through precision winding techniques that maintain consistent spacing and electrical properties throughout the coil structure. The ribbon construction approach may allow for higher current densities and improved thermal dissipation compared to conventional wire-based coil designs. The copper strip material may be selected for optimal electrical conductivity and mechanical properties suitable for the high-current pulse applications of the stimulation system.

[0064] In one, non-limiting example, the coil may be manufactured using Flex circuit technology with eight-layered miniaturized construction comprising flexible sheets with copper parallel lines bonded to polyimide substrate. The Flex circuit approach may enable precise control of conductor geometry and spacing while providing mechanical flexibility for coil formation. In some cases, the eight-layered construction may allow for multiple parallel current paths that reduce overall coilresistance and improve current handling capabilities. The copper parallel lines may be photolithographically defined on the polyimide substrate to achieve precise dimensional control and consistent electrical characteristics. The polyimide substrate may provide electrical insulation between layers while maintaining flexibility for the coil winding process. The Flex circuit technology may enable the creation of complex coil geometries that would be difficult to achieve with conventional wire winding techniques.

[0065] The coil may be placed inside a 3D-printed housing 406 and electrically and thermally insulated with epoxy material to provide mechanical protection and electrical isolation. The 3D- printed mold may be designed to precisely accommodate the figure-8 ribbon geometry while providing structural support during operation. In some cases, the mold material may be selected for thermal stability and mechanical strength to withstand the forces generated during high-current pulse operation. The epoxy insulation may provide both electrical isolation and thermal management by encapsulating the coil structure and preventing electrical breakdown between conductors. The epoxy material may be selected for appropriate dielectric strength and thermal conductivity characteristics to maintain safe operation while enabling heat dissipation from the coil during pulse generation.

[0066] In one, non-limiting example, the system may incorporate a ceramic A12O3 core that improves stimulation strength and cooling performance within the coil structure. The ceramic A12O3 core may provide enhanced magnetic permeability characteristics that concentrate and focus the magnetic field generated by the coil windings. In some cases, the ceramic core may also serve as a thermal management component by conducting heat away from the copper conductors during high-current operation. The A12O3 material may be selected for optimal magnetic properties, thermal conductivity, and mechanical stability under the operating conditions of the stimulation system. The ceramic core may be precisely machined or formed to fit within the figure-8 ribbon geometry while maximizing the magnetic coupling between the coil windings and the target tissue region. The combination of the ceramic A12O3 core with the ribbon coil design may enable enhanced field strength and improved thermal management compared to air-core coil configurations.

[0067] With this context and referring again to Fig. 1, operation of the treatment device 104 may provide an integrated magnetic and ultrasound system configuration that combines both magnetic stimulation and low-intensity focused ultrasound (LIFU) capabilities in a single multimodalsystem. The treatment device 104 may generate a magnetic field through the coordinated operation of the first coil 106 and the second coil 108, which may, as a non-limiting example, be arranged in the figure-8 configuration. The magnetic field may penetrate tissue to reach target neural structures while simultaneously producing ultrasonic waves as part of the integrated therapeutic approach. In some cases, the treatment device 104 may coordinate the timing and intensity of both magnetic and ultrasonic stimulation modalities to achieve enhanced therapeutic effects compared to single-modality approaches. The processor system 112 may control the generation of the magnetic field through precise timing of current pulses delivered to the first coil 106 and the second coil 108. The integrated system configuration may enable the treatment device 104 to leverage both electromagnetic and acoustic energy for comprehensive neural stimulation.

[0068] In one, non-limiting clinical example, as illustrated in Fig. 1, the coil design may target specific anatomical locations including the dorsal root ganglion at L5 level and thoracic dorsal columns at T9 / T10 level for therapeutic intervention. The positioning of the first coil 106 and the second coil 108 may be designed to direct the magnetic field toward these specific neural targets while maintaining appropriate field strength and spatial resolution. In some cases, the L5 dorsal root ganglion may be targeted for treatment of peripheral neuropathic pain conditions, while the T9 / T10 thoracic dorsal columns may be targeted for broader spinal cord stimulation applications. The treatment device 104 may be positioned externally on the patient 101 at locations corresponding to the underlying target anatomy, enabling non-invasive access to deep neural structures. The magnetic field generated by the coil configuration may penetrate through skin, muscle, and bone tissue to reach the targeted neural structures at depths appropriate for therapeutic stimulation. The processor board 110 may execute positioning algorithms that account for individual patient anatomy and optimize the magnetic field distribution for specific target locations.

[0069] While spinal cord stimulation (SCS) and / or dorsal root ganglia (DRG) are advantageous clinical applications of the systems and methods described herein, many other clinical applications are also advantageous. For example, referring to Figs. 5A and 5B, other anatomical areas, such as the hand or wrist, or other areas, such as the leg or angle or neck, are also applicable. The electromagnetic field interactions with neural tissue may be precisely controlled through the coordinated operation of the first coil and the second coil within the treatment device. The magnetic field may induce electrical currents in the target neural tissue through electromagneticinduction principles, creating localized depolarization of neural membranes. In some cases, the field strength and spatial distribution of the magnetic field may be optimized to selectively activate specific neural fiber types while minimizing activation of surrounding non-target tissues. The treatment device may generate field gradients that focus stimulation energy at the intersection point of the figure-8 coil configuration, creating a concentrated stimulation zone at the target anatomical location. The processor system may monitor and adjust the magnetic field characteristics in realtime based on feedback from the temperature sensors and other system monitoring components. The electromagnetic field interactions may be enhanced through the coordinated application of ultrasonic energy from the ultrasound system , creating synergistic effects that improve stimulation efficacy while reducing the power requirements for individual modalities.

[0070] More particularly, referring to Fig. 5A, the systems described above were applied to the hand / wrist. As illustrated, the coil 500 was positioned to stimulate a branch of the radial nerve. In particular, the coil 500 was positioned to have the stimulation area and recording site 502 shown on the left arm. A sensorial action potential was delivered as a long pulse (600 ps) seen at the recording site 502. As shown in Fig. 5B, Results showed maximum induced electric field, estimated as the 99.9th percentile, on the radial nerve of 45 V / m.

[0071] Referring now to Figs. 6A-6H, experimental configurations and recorded responses from peripheral nerve stimulation studies demonstrated the effectiveness of magnetic stimulation approaches in generating neural responses through controlled testing methodologies. The experimental setup incorporated precise electrode placement strategies that enable comparative analysis between conventional electrical stimulation and magnetic coil stimulation techniques. Fig. 6A illustrates the positioning of recording electrodes relative to the radial nerve, establishing standardized measurement locations for consistent data collection across multiple test subjects. The electrode placement methodology may ensure optimal signal capture while minimizing interference from surrounding tissue structures. In some cases, the recording electrode positions may be selected based on anatomical landmarks that provide reliable access to nerve conduction pathways. The standardized positioning approach enabled reproducible measurements that support comparative analysis between different stimulation modalities.

[0072] As shown in Fig. 6B, the configuration of stimulating electrodes used for nerve detection and baseline measurements during the experimental validation process is shown. The stimulating electrode arrangement provided reference measurements for comparison with magnetic coil 1stimulation results, establishing baseline nerve conduction characteristics for each test subject. In some cases, the electrical stimulation parameters were optimized to achieve consistent nerve activation while maintaining subject comfort and safety. The electrode positioning was guided by nerve conduction study protocols that ensure reliable stimulus delivery to target nerve structures. The stimulating electrode configuration served as a control condition for evaluating the relative effectiveness of magnetic stimulation approaches. The experimental design incorporated multiple electrode positions to map nerve conduction pathways and identify optimal stimulation sites for subsequent magnetic coil testing.

[0073] Referring to Fig. 6C, the placement of the microcoil and recording electrodes in the experimental configuration is shown. The microcoil positioning was precisely controlled to ensure consistent magnetic field delivery to the target nerve structure while maintaining appropriate distance relationships with the recording electrodes. In some cases, the microcoil placement may be guided by anatomical measurements that account for tissue depth and nerve pathway orientation. The recording electrode positions may be maintained consistently with the electrical stimulation configuration to enable direct comparison of response characteristics. Fig. 6D shows the relative positioning between the wrist and microcoil during stimulation procedures, demonstrating the spatial relationships that influence magnetic field penetration and nerve activation.

[0074] The graphs in Figs. 6E and 6F provide the recorded responses that provided comparative analysis between electric stimulation and microcoil stimulation techniques, with traces from both the SNUFF region shown 600 and thumb recordings shown 602. The recorded waveforms may demonstrate the characteristic response patterns generated by each stimulation modality, enabling quantitative comparison of response amplitude, timing, and morphology.

[0075] In some cases, the electric stimulation responses show early onset times of 1.20 ms and 1.55 ms compared to microcoil stimulation onset times of 1.95 ms and 2.30 ms, indicating differences in activation mechanisms between the two approaches. The time differential measurements may reveal that both techniques produce consistent conduction velocity calculations of 114 m / s despite the different onset characteristics. The response amplitude characteristics may vary between stimulation modalities while maintaining consistent conduction properties, suggesting that magnetic stimulation may activate nerve structures through different biophysical mechanisms compared to direct electrical stimulation.

[0076] Fig. 6G presents multiple recordings from the SNUFF region of the same subject using microcoil stimulation, demonstrating the reproducibility and consistency of magnetic stimulation responses across repeated trials. The waveform consistency indicates stable magnetic field generation and reliable nerve activation characteristics during multiple stimulation sessions. Fig. 6H shows further SNUFF recordings from different subjects during microcoil stimulation, illustrating the variability in response characteristics across different individuals while maintaining consistent activation patterns. The inter-subject variability may reflect individual differences in nerve anatomy, tissue properties, and magnetic field sensitivity while demonstrating the general effectiveness of magnetic stimulation across diverse subject populations.

[0077] The experimental validation results demonstrate that magnetic stimulation approaches can generate measurable neural responses comparable to conventional electrical stimulation techniques while offering distinct advantages in terms of non-invasive delivery and spatial selectivity. The recorded responses show clear compound action potentials generated through magnetic field activation of peripheral nerve structures, confirming the effectiveness of magnetic stimulation in producing therapeutic neural activation. In some cases, the magnetic stimulation responses exhibit different temporal characteristics compared to electrical stimulation while maintaining equivalent conduction velocities and physiological response patterns. The validation studies may support the feasibility of magnetic stimulation as an alternative to invasive electrical stimulation approaches for therapeutic neural modulation applications.

[0078] The comparative analysis between stimulation techniques may reveal that magnetic coil stimulation produces consistent neural activation with response characteristics that demonstrate equivalent conduction properties to electrical stimulation methods. The experimental data show that magnetic stimulation can achieve therapeutic neural activation through non-invasive field application while maintaining response reliability and reproducibility across multiple testing sessions. In some cases, the magnetic stimulation approach may offer advantages in terms of patient comfort and treatment accessibility compared to electrode-based electrical stimulation techniques. The validation results support the use of the magnetic stimulation systems and methods described herein for clinical applications where non-invasive neural modulation approaches provide therapeutic benefits. The experimental methodologies may establish standardized protocols for evaluating magnetic stimulation effectiveness in peripheral nerveapplications, providing a foundation for extending these techniques to spinal cord and central nervous system targets.

[0079] Manufacturing specifications for the multimodal stimulation system may incorporate precision fabrication techniques that ensure consistent performance characteristics across multiple device units. The following are non-limiting examples. Many other options and configurations are within the scope of the present disclosure.

[0080] The copper strip materials used in coil construction may be sourced with specific conductivity requirements of 99.9% pure copper with thickness tolerances maintained within ±5 micrometers. Flex circuit fabrication may utilize photolithographic processes with line width accuracy of ±2 micrometers to achieve precise conductor geometry throughout the eight-layer construction. The polyimide substrate material may be selected for thermal stability up to 200°C and dielectric strength exceeding 7 kV / mm to ensure reliable operation during high-voltage pulse generation. Quality control procedures may include electrical testing of each coil layer to verify resistance values within 10.21±0.26 mQ and inductance measurements of 4.43±0.13 pH before final assembly. 3D-printed mold components may be fabricated using high-temperature resistant materials with dimensional accuracy of ±0.1mm to ensure proper coil positioning and mechanical stability during operation.

[0081] Epoxy encapsulation procedures may follow standardized protocols that ensure complete electrical isolation while maintaining thermal conductivity characteristics for heat dissipation. The epoxy material selection may prioritize dielectric strength exceeding 15 kV / mm and thermal conductivity of at least 0.8 W / mK to balance electrical isolation with thermal management requirements. Curing processes may be conducted at controlled temperatures of 80°C for 4 hours followed by post-cure conditioning at 150°C for 2 hours to achieve optimal mechanical and electrical properties. The ceramic A12O3 core components may be precision machined to dimensional tolerances of ±0.05mm and surface finish specifications of 0.4 micrometers Ra to ensure consistent magnetic coupling characteristics. Assembly procedures may incorporate torque specifications for mechanical fasteners and standardized positioning fixtures to maintain consistent coil geometry across production units. Final inspection protocols may include high-voltage testing at 2.5 times operating voltage and thermal cycling tests from -20°C to +85°C to verify long-term reliability under clinical operating conditions.

[0082] Safety testing procedures may encompass comprehensive evaluation protocols that address both electromagnetic compatibility and biocompatibility requirements for medical device applications. Electromagnetic interference testing may be conducted according to IEC 60601-1-2 standards with measurements performed in both conducted and radiated emission categories across frequency ranges from 150 kHz to 6 GHz. The testing protocols may include evaluation of immunity to electrostatic discharge, radiofrequency electromagnetic fields, electrical fast transients, and surge voltages to ensure reliable operation in clinical environments. Acoustic emission measurements may be performed using calibrated sound level meters with frequency response extending to 40 kHz to characterize ultrasonic output levels and ensure compliance with hearing safety guidelines. Temperature rise testing may utilize thermal imaging cameras and embedded thermocouples to map surface temperatures during maximum power operation, with acceptance criteria limiting temperature increases to below 20°C above ambient conditions. Biocompatibility evaluation may follow ISO 10993 testing protocols including cytotoxicity, sensitization, and irritation studies using materials that contact patient skin during treatment procedures.

[0083] Configurations such as described above were tested. Dosing studies conducted in rodent models were used to demonstrate the relationship between stimulation parameters and therapeutic outcomes through systematic evaluation of pulse amplitude, frequency, and duration variables. Common peroneal nerve injury models were established in male Wistar rats weighing 250-350g with baseline mechanical threshold measurements performed using von Frey filaments before surgical intervention. Post-surgical allodynia development was confirmed through daily behavioral testing showing threshold reductions from baseline values of 26.61±2.09g to postinjury levels of 1 ,76±0.30g within 7 days of nerve injury procedures. Stimulation treatments were applied at varying power levels from 10% to 100% of maximum system output with treatment durations ranging from 30 seconds to 5 minutes to establish dose-response relationships. Temperature monitoring during treatments utilized fiber-optic temperature sensors positioned at the coil surface with continuous recording throughout stimulation sessions to ensure thermal safety limits are maintained. Behavioral outcome measurements were performed at 24-hour intervals following treatment with mechanical threshold testing using automated von Frey testing apparatus to quantify anti-allodynic effects.

[0084] Experimental results from rodent studies revealed dose-dependent therapeutic responses with optimal outcomes achieved at specific combinations of magnetic field strength and ultrasonic pressure levels. Low-power stimulation at 10-40% of maximum output may produce minimal behavioral changes with mechanical thresholds remaining near post-injury baseline levels throughout the observation period. Intermediate power levels at 50% maximum output generated detectable improvements in mechanical thresholds in approximately 30% of treated animals with response durations of 24-48 hours. Maximum power stimulation at 100%> output produced compound action potentials with amplitudes of l.l±0.5mV and durations of 262.0±19.9ms in peripheral nerve recordings, indicating successful neural activation through the combined stimulation approach. Complete reversal of allodynic mechanical thresholds were achieved within 24 hours of treatment with threshold values returning to pre-injury levels of 27.30±1.44g in responsive animals. The therapeutic effects persisted for 4-5 days following single treatment sessions with gradual return to post-injury baseline levels. Thus, treatment protocols can be used to maintain long-term therapeutic benefits.

[0085] Histological analysis of treated neural tissue showed preservation of normal cellular architecture without evidence of thermal damage or inflammatory responses following optimized stimulation protocols. Hematoxylin and eosin staining of dorsal root ganglion sections revealed normal neuronal morphology with intact cell bodies and satellite cell organization in animals receiving therapeutic stimulation treatments. Active caspase-3 immunostaining performed at 6 hours post-treatment showed minimal apoptotic activity comparable to sham-treated control animals, indicating absence of acute cellular damage from the stimulation procedures. Activating transcription factor 3 expression levels remained within normal ranges, suggesting that the stimulation parameters do not induce cellular stress responses associated with tissue injury. Fluoro-jade staining performed at 1 week post-treatment showed absence of degenerating neurons in stimulated tissue regions, confirming the safety of the therapeutic stimulation protocols. Temperature measurements during histological studies confirmed that tissue temperatures remain below 43 °C throughout treatment sessions, staying within established safety guidelines for therapeutic heating applications.

[0086] Large animal validation studies conducted in farm pig models provided further translational data supporting the clinical feasibility of the multimodal stimulation approach for treating neuropathic pain conditions. Female Yorkshire pigs weighing 40-60 kg underwentcommon peroneal nerve injury procedures followed by randomized assignment to treatment or sham control groups with behavioral assessments performed by blinded observers. Mechanical sensitivity testing utilized electronic von Frey devices with force measurements recorded at multiple anatomical locations to map the spatial distribution of allodynic responses. Social behavior assessments included evaluation of feeding patterns, locomotor activity, and interaction with environmental enrichment objects to provide comprehensive measures of pain-related behavioral changes. Treatment protocols involved daily stimulation sessions for 3 consecutive days with follow-up behavioral assessments performed weekly for 4 weeks to evaluate treatment durability. Dosing optimization was performed through iterative adjustment of stimulation parameters based on behavioral response magnitude and duration, with final protocols selected to achieve maximum therapeutic benefit while maintaining safety margins.

[0087] Dosing optimization studies in clinical populations can establish therapeutic windows that balance treatment efficacy with patient comfort and safety considerations. Initial dose escalation protocols may begin at 20% of maximum system output with incremental increases of 10% per treatment session until therapeutic responses are achieved or tolerance limits are reached. Patient- reported comfort scores may be recorded during each stimulation session using numerical rating scales from 0-10 to monitor treatment tolerability and identify optimal stimulation intensities for individual patients. Skin temperature measurements may be performed using infrared thermometry before, during, and after each treatment session to ensure surface heating remains within acceptable limits below, for example, 42°C. Treatment duration optimization may involve systematic evaluation of session lengths from 15 minutes to 60 minutes to determine minimum effective treatment times while maximizing patient compliance and clinical workflow efficiency. Frequency optimization studies may compare daily treatment schedules with alternate-day protocols to identify optimal treatment intervals that maintain therapeutic benefits while minimizing treatment burden on patients and clinical resources.

[0088] As described above, the present disclosure provides systems and methods that can be implemented using computer systems. Referring to Fig. 7, one non-limiting example of a system 700 in accordance with the present disclosure is provided. The system 700 may include a computing system 710, which can take any of a variety of forms, including a computer, including a laptop, or may be a phone, tablet, watch, or other device, including a wearable. The computing system 710 can include a processor or controller 712, a display 714, one or more inputs 716, oneor more communication systems 718, and / or memory 720. In some configurations, the controller 712 can be any suitable hardware processor or combination of processors, such as a central processing unit (“CPU”), a graphics processing unit (“GPU”), and so on. In some configurations, the display 714 can include any suitable display devices, such as a liquid crystal display (“LCD”) screen, a light-emitting diode (“LED”) display, an organic LED (“OLED”) display, an electrophoretic display (e.g., an “e-ink” display), a computer monitor, a touchscreen, a television, a screen of a mobile device, such as a phone or tablet, and so on. In some configurations, the inputs 716 can include any suitable input devices and / or sensors that can be used to receive user input, such as a keyboard, a mouse, a touchscreen, a microphone, and so on.

[0089] In some configurations, the communications systems 718 can include any suitable hardware, firmware, and / or software for communicating information. The computing system 710 can communicate over a communication network 722 and / or any other suitable communication networks. For example, the communications systems 718 can include one or more transceivers, one or more communication chips and / or chip sets, and so on. In a more particular example, the communications systems 718 can include hardware, firmware, and / or software that can be used to establish a Wi-Fi connection, a Bluetooth connection, a cellular connection, an Ethernet connection, and so on.

[0090] In some configurations, the memory 720 can include any suitable storage device or devices that can be used to store instructions, values, data, or the like, that can be used, for example, by the controller 712 to present content using the display 714, to communicate with a server 724 via the communications systems 718, and so on. The memory 720 can include any suitable volatile memory, non-volatile memory, storage, or any suitable combination thereof. For example, the memory 720 can include random-access memory (“RAM”), read-only memory (“ROM”), electrically programmable ROM (“EPROM”), electrically erasable ROM (“EEPROM”), other forms of volatile memory, other forms of non-volatile memory, one or more forms of semi -volatile memory, one or more flash drives, one or more hard disks, one or more solid state drives, one or more optical drives, and so on. In some configurations, the memory 720 can have encoded thereon, or otherwise stored therein, a computer program for controlling operation of computing device 710. In such configurations, the processor / controller 712 can execute at least a portion of the computer program. In doing so, information can be presented (e.g., images, user interfaces,graphics, tables), content can be received from the server 724, and so on. For example, the controller 712 and the memory 720, and / or local processors.

[0091] The server 724 can include a communications system 726 for communicating, for example, via the communication network 722. The server 724 can also include a processor / controller 728, a display 730, one or more inputs 732, and / or memory 734. As described with respect to the computing system, the controller 728 can be any suitable hardware processor or combination of processors, such as a CPU, a GPU, and so on. The display 730 can include any suitable display devices, such as an LCD screen, LED display, OLED display, electrophoretic display, a computer monitor, a touchscreen, a television, and so on. The input 732 can include any suitable input devices and / or sensors that can be used to receive user input, such as a keyboard, a mouse, a touchscreen, a microphone, and so on. The communications systems 726 can include hardware, firmware, and / or software that can be used to establish a Wi-Fi connection, a Bluetooth connection, a cellular connection, an Ethernet connection, and so on. Finally, the memory 834 can include any suitable volatile memory, non-volatile memory, storage, or any suitable combination thereof.

[0092] Thus, the systems and methods provided herein provide a miniaturized and multilayer transdermal / cranial stimulation (TMS) system to realize a low-intensity-focused ultrasound and / or trans-spinal magnetic stimulation. The systems and methods provided herein translate one of the main weaknesses of TMS, namely the loud and undesired click sound output, to an advantage to generate ultrasound waves that are used therapeutically. The systems and methods provided herein can provide non-invasive multimodal dorsal root ganglia stimulation to treat sciatica, as well as other conditions.

[0093] The systems and methods provided herein demonstrate that a single three-minute LIFU modulatory treatment of the dorsal root ganglion (DRG) limits anti -nociceptive responses in small and large animal models for days to weeks. While promising, other spinal cord regions typically used for pain treatment (i.e., dorsal columns in spinal cord stimulation) remain difficult to target due to the proximity of bone and neural structures in the spine. Trans-spinal magnetic stimulation (TSMS) has been introduced and may penetrate tissue deeply. However, however, historically, it is lacking in spatial resolution. The LIFU / TSMS systems and methods provided herein are effective for the treatment of neural structures to treat neuropathic back and leg pain, and other locations. The addition of a non-invasive, non-pharmacological treatment for chronic neuropathic pain is highly significant for all patients and especially children with this disorder.

[0094] It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The present disclosure is readily extended to other aspects and implementations and may be practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings.

[0095] As used herein in the context of computer implementation, unless otherwise specified or limited, the terms “component,” “system,” “module,” “controller,” “framework,” and the like are intended to encompass part or all of computer-related systems that include hardware, software, a combination of hardware and software, or software in execution. For example, a component may be, but is not limited to being, a processor device, a process being executed (or executable) by a processor device, an object, an executable, a thread of execution, a computer program, or a computer. By way of illustration, both an application running on a computer and the computer can be a component. One or more components (or system, module, and so on) may reside within a process or thread of execution, may be localized on one computer, may be distributed between two or more computers or other processor devices, or may be included within another component (or system, module, and so on).

[0096] In the methods described herein, the steps can be carried out in any order without departing from the principles of the disclosure, except when a temporal or operational sequence is explicitly recited. Recitation in a claim to the effect that first a step is performed, and then several other steps are subsequently performed, shall be taken to mean that the first step is performed before any of the other steps, but the other steps can be performed in any suitable sequence, unless a sequence is further recited within the other steps. For example, claim elements that recite “Step A, Step B, Step C, Step D, and Step E” shall be construed to mean step A is carried out first, step E is carried out last, and steps B, C, and D can be carried out in any sequence between steps A and E, and thatthe sequence still falls within the literal scope of the claimed process. A given step or sub-set of steps can also be repeated.

[0097] Furthermore, specified steps can be carried out concurrently unless explicit claim language recites that they be carried out separately. For example, a claimed step of doing X and a claimed step of doing Y can be conducted simultaneously within a single operation, and the resulting process will fall within the literal scope of the claimed process.

[0098] The term “substantially” or “about” as used herein refers to a majority of, or mostly, as in at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.5%, at least about 99.9%, at least about 99.99%, or at least about 99.999% or more.

[0099] As used in the claims, the phrase “at least one of A, B, and C” means at least one of A, at least one of B, and / or at least one of C, or any one of A, B, or C or combination of A, B, or C. A, B, and C are elements of a list, and A, B, and C may be anything contained in the Specification.

[0100] The following discussion is presented to enable a person skilled in the art to make and use aspects of the disclosure. Various modifications to the illustrated configurations or processes will be readily apparent to those skilled in the art, and the generic principles herein can be applied to other aspects and applications within the scope of the present disclosure and the understanding of one of skill based thereon. Thus, the present disclosure is not intended to be limited to particular embodiments or aspects shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein. The following detailed description is to be read with reference to the figures, in which like components or elements in different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected aspects and configurations or processes and are not intended to limit the scope of the disclosure. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of the disclosure. 1

Claims

CLAIMS1. A stimulation system for providing therapeutic treatment to a patient, comprising: a treatment device having at least one coil configured to generate both a magnetic field and ultrasound pulses; a power source configured to deliver power to the treatment device to energize the at least one coil; and a processor configured to coordinate timing and delivery of magnetic stimulation and ultrasonic stimulation by the at least one coil to treat a patient using the treatment device.

2. The stimulation system of claim 1, wherein the processor system is configured to execute control algorithms that account for different propagation speeds of ultrasonic waves at approximately 1,500 m / s versus near-instantaneous propagation of electromagnetic fields.

3. The stimulation system of claim 1, wherein the at least one coil comprises a first coil and a second coil configured in a figure-8 arrangement.

4. The stimulation system of claim 1, wherein the at least one coil comprises a first coil and a second coil comprising circular ribbons with a diameter of 25mm each, connected in series so that current flowing through the coils sums constructively.

5. The stimulation system of claim 4, wherein the circular ribbons are formed from copper strips wrapped to create a ribbon structure providing lower resistance characteristics compared to conventional wire windings.

6. The stimulation system of claim 1, wherein the at least one coil includes a multilayered construction with copper parallel lines bonded to a polyimide substrate.

7. The stimulation system of claim 1, wherein the at least one coil includes multiple parallel current paths to control overall coil resistance.

8. The stimulation system of claim 1, further comprising a ceramic A12O3 core positioned within the at least one coil to achieve a desired stimulation strength and cooling performance.

9. The stimulation system of claim 1, further comprising temperature sensors positioned to monitor thermal conditions and provide real-time temperature feedback to the processor system for thermal protection control.

10. The stimulation system of claim 9, further comprising a cooling unit connected to the treatment device through a cooling connection to maintain optimal operating temperatures during high-current pulse generation.

11. An apparatus comprising: a memory having instructions for controlling a treatment device to treat pain of a patient by coordinating timing and delivery of magnetic stimulation and ultrasonic stimulation from the treatment device to the patient; and a processor configured to access the memory and control operation of the treatment device.

12. The apparatus of claim 11, wherein the processor is further configured to coordinate magnetic field generation with ultrasound pulse production through at least one coil of the treatment device to achieve therapeutic effects through multimodal neuromodulation.

13. The apparatus of claim 11, wherein the processor is configured to calculate timing delays based on approximately 1,500 m / s propagation speed of ultrasonic pulses compared to near-instantaneous propagation of electromagnetic fields to coordinate timing and delivery of magnetic stimulation and ultrasonic stimulation from the treatment device to the patient.

14. The apparatus of claim 11, further comprising a pulse generator configured to produce voltage signals with specific timing characteristics designed to optimize both magnetic and ultrasonic stimulation effects.

15. The apparatus of claim 14, further comprising an amplifier array coupled to the pulse generator and configured to amplify the voltage signals to generate magnetic fields and corresponding ultrasound pulses using a coil of the therapeutic device.

16. The apparatus of claim 11, further comprising a display configured to receive stimulation parameters and monitor system status during therapeutic treatment of the patient.

17. The apparatus of claim 16, wherein the display is configured to present information about both magnetic field strength and ultrasonic stimulation and provide visual feedback regarding coordination between the magnetic stimulation and ultrasonic stimulation.

18. A method of controlling a system to configure treatment, comprising: activating a processor to coordinate operation of at least one coil configured to generate both magnetic fields and ultrasound pulses; generating pulse commands that define timing, amplitude, and sequence of stimulation pulses for both magnetic fields and ultrasound pulses from the at least one coil; and synchronizing magnetic field generation with ultrasound pulse production through the at least one coil to perform multimodal therapeutic stimulation.

19. The method of claim 18, further comprising monitoring temperature conditions during stimulation pulse generation and implementing thermal protection algorithms that limit pulse parameters to maintain the temperature conditions below a threshold.

20. The method of claim 18, further comprising generating square-wave voltage pulses that are applied directly to the at least one coil to create rounded sawtooth current pulses shaped by L / R time constant characteristics of coil inductance and resistance.

21. The method of claim 18, wherein the ultrasound pulses are one of focused ultrasound (FUS) pulses or low intensity focused ultrasound (LIFUS) pulses.

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