Neuronavigation transcranial brain energy delivery and detection system and method

Abstract

A neuronavigation transcranial brain stimulation system comprising: i) a treatment device including an energy supply and / or detection instrument configured to be placed over a target brain region of an individual's head for treatment; ii) a generator for powering the energy supply and / or detection instrument; and iii) one or more imaging devices incorporated into the energy supply and / or detection instrument and configured to enable direct visualization of the position of the energy supply and / or detection instrument on the individual's head over the target brain region.

Description

[Technical Field]

[0001] The present disclosure relates to neuronavigation transcranial brain energy delivery and / or detection systems and methods. The present disclosure is particularly useful for transcranial magnetic stimulation (TMS), i.e., methods and devices for properly positioning a transcranial magnetic stimulation device on a patient's head and delivering magnetic stimulation to specific brain regions. The present disclosure can also be advantageously used to provide neuronavigation for devices that stimulate, emit, or sense energy emissions from the brain, such as focused ultrasound (FUS), transcranial electrical stimulation (TES), electroencephalography (EEG), magnetoencephalography (MEG), near-infrared spectroscopy (NIRS), and gamma knife radiation, each of which has a relatively small effective area of ​​stimulation, emission, or sensation. As such, each requires a system, i.e., device and process, to assist in accurate neuronavigation. [Background technology]

[0002] Neuronavigation transcranial systems and methods are known in the art for applying stimulation to target brain regions in patients with disorders such as depression, obsessive-compulsive disorder (OCD), depression with anxiety, nicotine addiction, as well as neurological diseases including major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder (PTSD), eating disorders, personality disorders, alcohol, drug and other substance use disorders, gambling, smoking cessation, as well as neurological diseases including Alzheimer's disease, mild cognitive impairment and other dementias, migraine, movement disorders such as Parkinson's disease, Asperger's syndrome, multiple sclerosis (MS), ALS, Tourette's syndrome, blepharospasm, stroke, autism, tinnitus, chronic pain, ADHD, epilepsy, poor memory function, and poor sleep patterns. Similarly, neuronavigation transcranial systems and methods are known in the art for applying radiation to targeted brain regions of an individual to alter the permeability of the blood-brain barrier for drug delivery, or for treating brain tumors (including meningiomas, acoustic neuromas, pituitary tumors, gliomas, and metastatic brain tumors), arteriovenous malformations, trigeminal neuralgia, epilepsy, Parkinson's disease, essential tremor, pain syndromes, and cavernous malformations. Finally, neuronavigation transcranial systems and methods are known in the art for detecting cerebral energy emissions from targeted brain regions of an individual for functional localization of brain function before tumor or epilepsy surgery, diagnosing epilepsy and identifying seizure types, identifying brain regions involved in specific cognitive functions, assessing cerebral hemodynamics in conditions such as stroke or traumatic brain injury, monitoring cerebral hemodynamic responses during therapeutic interventions in stroke rehabilitation, aiding in the diagnosis of sleep disorders, and preventing brain damage by monitoring cerebral oxygen saturation in premature infants.

[0003] In each of these disorders and diseases, a specific set of brain regions is known to be functionally or anatomically abnormal, and successful treatment or diagnosis requires identifying and precisely targeting one or more of these regions during stimulation, radiation, or sensing. To reliably stimulate the desired brain region, the energy delivery and / or sensing device must be consistently and precisely positioned at the target scalp site overlying that brain region and maintained in place throughout the entire energy delivery and / or sensing procedure. Stimulation of non-targeted brain regions can reduce or eliminate therapeutic efficacy and, in extreme cases, can result in severe adverse events such as worsening of symptoms, excessive pain during treatment, or, in rare cases, seizures. Radiation to non-targeted brain regions can cause neurological deficits, cerebral edema, radiation necrosis, secondary tumors, cognitive decline, endocrine dysfunction, and vascular damage. Furthermore, incorrect placement of brain energy emission detection devices (e.g., EEG, MEG) can lead to missed diagnoses, delayed treatment, inaccurate location of tumors to be surgically treated, or reduced signal quality.

[0004] The process of positioning brain energy delivery and / or detection devices on the head and maintaining them in that position during treatment is known as "neuronavigation." In current clinical practice, the most common technique for neuronavigation involves placing a cloth cap on the patient's head, taking head and scalp measurements, and using those measurements to define a coordinate system (e.g., the "10-20 International Electroencephalogram System") and providing markers on the patient's head. The device operator uses these markers to identify target sites on the cap, place the brain energy delivery and / or detection device at the marked target site, and then draw a (partial) outline of the device on the cap to maintain a consistent device orientation during and between treatment sessions. However, this method can be inaccurate and does not provide direct visual confirmation that the center of the device is (1) directly over the target location or (2) actually in physical contact (i.e., touching) the patient's head.

[0005] To noninvasively and precisely stimulate, sense, or radiate the brain, neurotechnology must be in the correct location on the head. With some technologies, such as transcranial electrical stimulation (TES) and electroencephalography (EEG), the signals detected by brain stimulation or sensing are fairly uniform across the scalp, even within millimeters or centimeters. In this case, positioning does not need to be as precise, but accurate placement still improves signal quality. However, many technologies exist, such as transcranial magnetic stimulation (TMS), magnetoencephalography (MEG), or gamma knife radiation, each of which has a relatively small effective area of ​​stimulation, sensing, or radiation. Therefore, they each require technology to assist with their placement. Unfortunately, this type of neuronavigation technology, such as frameless stereotaxy using infrared or electromagnetic fields, is complex, bulky, and expensive. We have instead developed a unique system that enables comparable neuronavigation accuracy by utilizing direct visualization with an imaging device placed directly over the focal point of stimulation, sensing, or radiation.

[0006] Additionally, the patient may move during treatment and / or the navigation aid may shift from the desired position. In such cases, the technician operating the device must pause the treatment, reposition the device, and then resume the procedure. In the worst case scenario, the patient may move their head in a way that causes the brain energy delivery and / or detection device to move but not noticeably shift from the target, resulting in a continued session with the potential adverse effects noted above. Current methods lack direct visual or other documentation to confirm: (1) that the brain energy delivery and / or detection device is optimally positioned over the desired target region; (2) that the brain energy delivery and / or detection device remains over the desired target region throughout the stimulation session; and (3) that the brain energy delivery and / or detection device maintains physical contact with the patient's head surface throughout the session.

[0007] A more complex and less commonly used neuronavigation technique (Fig. 1) involves a computerized frameless stereotaxic positioning system consisting of (1) a set of optical position markers, such as small reflective beads 70, attached in a specific 3D arrangement to the TMS coil and a tracker on the patient's head, (2) a stereo camera 71 that visualizes and localizes these markers in 3D space, and (3) computer software 72 that uses the 3D marker position information from the camera to estimate the relative position and orientation of the patient's head and the coil, and then visualizes these positions on a screen viewed by the operator as a neuronavigation guide before and during treatment. Such systems typically, but not always, also include (4) an MRI or other 3D image of the patient's head and brain, which the software aligns with the estimated 3D head position, allowing the operator to visualize the brain region at the coil's focus in real time during coil positioning and treatment.

[0008] For example, Patent Documents 1 and 2 disclose a neuronavigation technique for a TMS coil that utilizes an optical tracking system using an infrared reflector, as described above. This technique is commercially available and is also used in clinical settings, such as neurosurgery, that requires neuronavigation.

[0009]

[0003] Patent Literature 3 discloses another device for positioning a TMS coil on a patient's head using a multi-joint robot. This approach also has several major drawbacks, including the need for an MRI scan for each patient, the excessive additional cost and complexity of the device itself, and the need for several weeks of additional training for the operator to become proficient in using the system correctly. Furthermore, this system can fail if (1) the specified target is incorrect, (2) the coil marker is inaccurately calibrated, (3) the marker on the patient's head shifts out of position during a session after calibration, (4) the operator's skills are insufficient, or (5) the coil does not make full contact with the scalp, even if contact appears to be made on the neuronavigation system.

[0010] The complexity of this external tracking approach with MRI guidance also significantly limits the variety and number of locations where patients can receive treatment or diagnosis with brain energy delivery and / or detection systems. This system is typically limited to hospital settings due to the need for high-field MRI, extensive computational resources, specialized analysts to process the images, and technicians well-trained to operate the cumbersome neuronavigation equipment. As a result, this approach is rarely utilized in the most accessible medical settings, such as primary care clinics, mental health centers, nursing homes, outpatient specialty clinics, or workplace health centers. Instead, patients seeking MRI-guided neuronavigation treatment or diagnosis typically must make repeated visits to academic or tertiary care centers, which creates additional cost and convenience barriers and limits accessibility to those in need of TMS treatment.

[0011] The above discussion of the prior art stems in part from U.S. Patent No. 4,915,415 (the "'915 patent"), which describes a TMS system that includes a TMS alignment system that includes a magnetic field generating means having a coil for generating a variable magnetic field to be applied to a specific portion of a patient's head and a holder for holding the coil, and a camera means for recognizing a predetermined reference mark on a specific portion of the patient's ear (e.g., the tragus), the magnetic field generating means and the recognition means being designed so that the recognition means aligns with the mark to set the coil in a proper orientation relative to the specific portion of the patient's head.

[0012] According to the '915 patent, the above-described configuration allows the magnetic field generating means to be positioned relative to reference marks on specific portions of the patient's ear, thereby enabling the user of the TMS system to position the magnetic field generating means without the skill required by conventional systems.

[0013] The recognition means of the '915 patent includes at least one imaging device, i.e., a camera carried on an external arm extending from the device. Alignment involves aligning the optical axis of the imaging device with the markings, thereby allowing the coil to be positioned in the proper orientation relative to the particular area on the patient.

[0014] Preferably, the TMS system of the '915 patent further includes an optical device capable of emitting a directional beam, the optical device being disposed adjacent to the imaging device, and in this case, alignment includes aligning an intersection of the optical axes of the optical device with the mark, thereby allowing the TMS coil to be positioned in an appropriate location relative to a particular area on the patient.

[0015] In another embodiment of the '915 patent, the TMS system further includes a movement mechanism for moving the coil holder along the surface of the patient's head, and control means for controlling the movement mechanism according to output from the recognition means to automatically position the holder relative to the mark.

[0016] As previously mentioned, problems with the TMS alignment system proposed in the '915 patent are that it requires direct marking on the patient, making the system bulky, and the arms required to hold the camera and imaging device are also bulky and prone to bending and / or misalignment. The patient alignment marks can also be obscured by the patient's hair. The added components, as previously mentioned, also carry the risk of inaccurately estimating the coil's actual position. Finally, these additional components reduce the overall accessibility of TMS treatment by requiring extensive additional training for technicians to properly operate the neuronavigation device and by limiting treatment locations to locations that happen to have fixed, multi-ton MRI scanners. [Prior art documents] [Patent documents]

[0017] [Patent Document 1] Japanese Patent Application Laid-Open No. 2003-180649 [Patent Document 2] Japanese Patent Application Laid-Open No. 2004-000636 [Patent Document 3] Japanese Patent Application Laid-Open No. 2006-320425 [Patent Document 4] U.S. Patent No. 10,004,915 Summary of the Invention [Problem to be solved by the invention]

[0018] This disclosure is based on the premise that a major source of potential treatment error and uncertainty can be removed from the process of neuronavigating a brain energy delivery and / or detection device if (1) the target region on the head can be accurately visualized at all times, and (2) contact sensors can directly indicate whether the center of the brain energy delivery and / or detection device is in contact with the scalp throughout the procedure. In this disclosure, an optical scalp landmarking technique is provided that can significantly improve consistency in positioning the brain energy delivery and / or detection device at a predetermined site on the scalp between stimulation sessions and provide a direct visual record (rather than an estimated calculation) of whether the device is properly positioned and maintained in consistent contact with the scalp in that location throughout each stimulation session. In other words, rather than inferring the location of the TMS coil from an external perspective using sensors or markers placed externally on the head (as in Figure 1), the disclosed technique uses sensors placed on the device itself to essentially provide a perspective of the brain energy delivery and / or detection device. Furthermore, the novel approach disclosed herein allows technicians and supervising physicians to directly visualize the target site as they place the device, significantly reducing the time required for new technicians to become proficient. Furthermore, a verifiable record of placement accuracy can be generated during each treatment session. Finally, the disclosed approach does not require the use of expensive and cumbersome additional components, such as stereo cameras, MRI machines, and sophisticated processing software, or reflector markers that require calibration before treatment. This reduction in cost and complexity, along with a significantly accelerated operator learning curve, facilitates broader access to neuronavigation therapy and diagnosis in a wider range of settings, beyond the more limited number of specialized centers with large, expensive equipment requiring a large number of personnel. [Means for solving the problem]

[0019] Generally, according to aspect A of the present disclosure, there is provided a neuronavigation transcranial brain energy supply and / or detection system including: i) a brain energy supply device including an energy supply instrument configured to be placed on a target brain region of an individual's head for energy supply; and ii) a power generation unit for providing power to the energy supply instrument, if the brain energy supply device requires power; and / or iii) a brain energy detection device including an energy detection instrument configured to be placed on a target brain region of an individual's head for energy detection; iv) a receiving unit for receiving signals from the energy detection instrument, if the brain energy detection device requires a receiver; and v) one or more imaging devices integrated into the energy supply and / or detection instrument, configured to enable direct visualization of the position of the energy supply and / or detection instrument on the individual's head over the target brain region.

[0020] According to one embodiment of aspect A, the imaging device includes one or more cameras, preferably one or more visible light imaging cameras, one or more ultraviolet imaging cameras, or one or more infrared imaging cameras.

[0021] According to another embodiment of aspect A, the imaging device includes a single camera centrally located relative to the energy-delivery and / or detection instrument, and optionally two or more cameras located to the sides of the energy-delivery and / or detection instrument or two or more cameras located off-center but within the housing of the energy-delivery and / or detection instrument.

[0022] In further embodiments of the aspect, the brain energy supply and / or detection system further includes one or more accelerometers configured to sense orientation and / or changes in orientation of the placement of the energy supply and / or detection instrument, and / or one or more contact sensors configured to detect contact and force between the energy supply and / or detection instrument and the individual's head, the contact sensors preferably including one or more force sensitive resistors, one or more capacitive touch sensors, or one or more ultrasonic position / touch sensors, and optionally the neuronavigation brain energy supply and detection system is configured to optionally adjust energy supply to the brain if the one or more imaging devices or detection instruments and / or the plurality of sensors detect movement away from the target brain region by the neuronavigation transcranial brain energy supply and detection system.

[0023] In a further embodiment of aspect A, the neuronavigation transcranial brain energy delivery and / or detection system further includes one or more imaging devices external to the energy delivery and / or detection instrument and configured to enable simultaneous visualization of the individual's head and the energy delivery and / or detection instrument, the imaging devices preferably including one or more cameras, one or more LIDAR detectors, or one or more ultrasound detectors.

[0024] In yet a further embodiment of aspect A, the neuronavigation transcranial brain energy delivery and / or detection system further includes a storage device configured to create a record of the imaging device, contact sensor, accelerometer, or other sensor of the energy delivery and / or detection instrument before, during, and / or after use, which record may be used to infer the position of the instrument relative to the individual's head.

[0025] In yet another embodiment of aspect A, the imaging device is optionally configured to transmit an image of the individual's scalp vasculature, the individual's skin pattern, the individual's skull structure, or the individual's brain tissue, as the case may be.

[0026] In another embodiment of aspect A, the brain energy supply and / or detection system comprises: i) Transcranial photobiomodulation using infrared or coherent light; ii) transcranial focused ultrasound; iii) transcranial magnetic stimulation; iv) brain stimulation systems, including transcranial electrical stimulation; or v) particle beams containing gamma particles or electrons, or vi) Brain irradiation systems, including photons from the electromagnetic spectrum, including radio waves, x-rays, ultraviolet rays, and gamma rays; or vii) an optical imaging system selected from near-infrared spectroscopy (NIRS), diffuse optical tomography (DOT) or optical coherence tomography (OCT), laser speckle imaging (LSI), photoacoustic imaging (PAI), and laser Doppler imaging (LDI); viii) transcranial focused ultrasound (FUS), or ix) brain activity detection systems, including magnetoencephalography (MEG); or x) particle detectors containing gamma particles or electrons, or xi) brain radiation detection systems, including photons from the electromagnetic spectrum, including radio waves, x-rays, ultraviolet rays, and gamma rays.

[0027] In yet another embodiment of aspect A, the neuronavigation transcranial brain energy delivery and / or detection system further includes a support arm configured to support an energy delivery and / or detection instrument, the support arm including one or more elongated rods having one or more sections at least partially filled with an electrorheological fluid configured to reversibly change viscosity in response to an applied electromagnetic field.

[0028] According to aspect B, the present disclosure also provides a neuronavigation transcranial kit including a neuronavigation transcranial brain energy supply and / or detection system as described above with respect to aspect A, and a head cap having indicia including target marks, text, visual textures, images, mosaics, grids, symbols, visual codes, and / or color marks configured to cover anatomical regions of an individual's head.

[0029] In one embodiment of aspect B, the transcranial magnetic stimulation kit includes a cap-shaped feature configured to cover a target region of an individual's head and / or including indicia configured to allow continuous measurement of the relative position and orientation of the cap and the individual's head before, during, and after use.

[0030] In another embodiment of aspect B, the neuronavigation energy supply and / or detection kit further includes a power / receiver cable detachable from the energy supply and / or detection instrument and configured to pass between the generator and the brain energy supply and / or brain energy detection device.

[0031] According to aspect C of the present disclosure, there is provided a method for supplying and / or detecting energy from a target brain region of an individual by directing energy to or receiving energy from the target brain region, the method comprising: i) providing a neuronavigation transcranial brain energy supply and / or detection system including an energy supply and / or detection instrument and one or more imaging devices as described above with respect to aspect A; ii) positioning the energy supply and / or detection instrument over the target region using the imaging device to visualize the placement of the energy supply and / or detection instrument relative to the target region in three translational or rotational dimensions, wherein precise positioning of the energy supply and / or detection instrument is optionally facilitated by visual, auditory, and / or tactile feedback; and iii) starting and stopping the one or more energy supply and / or detection instruments according to a usage protocol.

[0032] In one embodiment, aspect C includes providing the individual with a head cap having indicia including target marks, text, visual textures, images, mosaics, grids, symbols, visual codes, and / or color marks configured to cover anatomical regions of the individual's head, and positioning the energy delivery and / or detection instruments over the target areas using an imaging device to visualize placement of the energy delivery and / or detection instruments relative to the indicia.

[0033] In another embodiment of aspect C, precise positioning of the energy delivery and / or detection instrument is facilitated by visual, auditory and / or tactile feedback.

[0034] In yet another embodiment of aspect C, the treatment is performed using a brain stimulation system including i) transcranial photobiomodulation using infrared or coherent light, ii) transcranial focused ultrasound, iii) transcranial magnetic stimulation, iv) transcranial electrical stimulation, or v) particle beams including gamma particles and electrons, or vi) brain irradiation systems including photons from the electromagnetic spectrum including radio waves, x-rays, ultraviolet rays, and gamma rays, or vii) near-infrared spectroscopy (NIRS), diffuse optical tomography (DOT), or optical coherence tomography (OCT). The treatment may include a treatment selected from the group consisting of: an optical imaging system selected from optical coherence tomography (OCT), laser speckle imaging (LSI), photoacoustic imaging (PAI), and laser Doppler imaging (LDI); viii) a brain activity detection system including transcranial focused ultrasound (FUS); or ix) a brain activity detection system including magnetoencephalography (MEG); or x) a particle detector including gamma particles and electrons; or xi) a brain radiation detection system including photons from the electromagnetic spectrum including radio waves, x-rays, ultraviolet rays, and gamma rays.

[0035] According to aspect D of the present disclosure, there is provided a transcranial magnetic stimulation (TMS) coil head configured to be placed over a target brain region for treatment, the TMS coil head including: a housing containing one or more coil windings therein; and a phase change material (PCM) in contact with the one or more windings within the housing, optionally with a discontinuous winding path to maximize the contact area of ​​the PCM with the windings; or the TMS coil head includes a conductive cooling unit in physical contact with the TMS coil head, preferably a patient-facing surface, to dissipate heat, either acting as a passive heat sink or actively cooling using conduction, convection, or electrical cooling, preferably as a Peltier thermocouple.

[0036] According to aspect E of the disclosure, there is provided a brain energy supply or brain energy detection instrument including one or more imaging devices incorporated into the energy supply and / or detection instrument and configured to enable direct visualization of the position of the energy supply and / or detection instrument, and a permanent or detachable mounting joint on top of the energy supply and / or detection instrument, the mounting joint being centered laterally relative to a central vertical axis passing through the energy supply and / or detection instrument, the energy supply and / or detection instrument optionally including an auxiliary component configured to connect to the mounting joint via a single-action connection / disconnection mechanism.

[0037] According to aspect F of the disclosure, there is provided a method for stimulating a target brain region by transcranial magnetic stimulation, the method including: i) providing a neuronavigation transcranial magnetic stimulation system including a TMS coil according to aspect A above and one or more imaging devices; ii) positioning the TMS coil over the target region using the imaging devices to visualize the placement of the TMS coil; and iii) starting and / or stopping one or more magnetic induction coils according to a treatment protocol.

[0038] According to one embodiment of aspect F, the method includes providing the patient with a head cap having landmark markings in the form of a grid, text, and / or color markings configured to cover anatomical regions of the patient's head, and positioning the TMS coil over the target area using an imaging device to visualize placement of the TMS coil relative to the landmarks, where accurate positioning of the TMS coil is optionally facilitated by visual, auditory, and / or tactile feedback.

[0039] More particularly, according to a preferred embodiment of the present disclosure, there is provided a neuronavigation transcranial brain energy supply and / or detection system comprising: i) a brain energy supply device including an energy supply instrument configured to be placed on a target brain region of an individual's head for energy supply; and ii) a power generation unit for supplying power to the energy supply instrument, if the brain energy supply device requires power; and / or iii) a brain energy detection device including an energy detection instrument configured to be placed on a target brain region of an individual's head for energy detection; and iv) a receiving unit for receiving signals from the energy detection instrument, if the brain energy detection device requires a receiver; and v) one or more imaging devices integrated with the energy supply and / or detection instrument and configured to enable direct visualization of the position of the energy supply and / or detection instrument on the individual's head over the target brain region.

[0040] In one embodiment of the neuronavigation transcranial brain energy delivery and / or detection system, the imaging device includes one or more cameras, preferably one or more visible light imaging cameras, one or more ultraviolet imaging cameras, or one or more infrared imaging cameras.

[0041] In one embodiment, the imaging device preferably includes a single camera centrally located relative to the brain energy supply and / or detection instrument, and optionally two or more cameras located to the sides of the instrument, or two or more cameras located off-center but within the housing of the instrument.

[0042] In another embodiment, the neuronavigation transcranial brain energy supply and / or detection system further includes one or more accelerometers configured to sense the placement orientation and / or changes in orientation of the instrument, and / or one or more contact sensors configured to detect contact and force between the instrument and the patient's head, the contact sensors preferably including one or more force sensitive resistors, one or more capacitive touch sensors, or one or more ultrasonic position / touch sensors, and optionally the neuronavigation brain energy supply and detection system is configured to adjust energy supply and / or detection in any of the three translational or rotational dimensions based on the position, velocity, or acceleration of the instrument relative to the target brain region as estimated by measurements from an implanted imaging device or sensor.

[0043] In another embodiment, the neuronavigation transcranial brain energy delivery and / or detection system further includes one or more imaging devices external to the instrument and configured to enable simultaneous visualization of the patient's head and the instrument, the imaging devices preferably including one or more cameras, one or more LIDAR detectors, or one or more ultrasound detectors.

[0044] In yet another embodiment, the neuronavigation transcranial brain energy delivery and / or detection system further includes a memory device configured to create a record of the position of the instrument before, during, and / or after surgery.

[0045] In further embodiments of the neuronavigation transcranial brain energy delivery and / or detection system, the imaging device is configured to transmit images of the patient's scalp vasculature, the patient's skin pattern, the patient's skull structure, or the patient's brain tissue, as the case may be.

[0046] In yet another embodiment of the neuronavigation transcranial brain energy delivery and / or detection system, the system comprises: i. Transcranial photobiomodulation using infrared or coherent light; ii. Transcranial focused ultrasound, iii. Transcranial magnetic stimulation; iv. Neurostimulation systems, including transcranial electrical stimulation; or v. an optical imaging system selected from near-infrared spectroscopy (NIRS), diffuse optical tomography (DOT) or optical coherence tomography (OCT), laser speckle imaging (LSI), photoacoustic imaging (PAI), and laser Doppler imaging (LDI); vi. Transcranial focused ultrasound (FUS), or vii. Neuronavigation neuroimaging systems, including magnetoencephalography (MEG); or viii. Particle beams containing gamma particles or electrons, or ix. Neuronavigation neuroradiation systems, including photons from the electromagnetic spectrum, including radio waves, x-rays, ultraviolet rays, and gamma rays.

[0047] In a further embodiment, the neuronavigation transcranial brain energy supply and / or detection system further includes a support arm configured to support the therapeutic instrument, the support arm including one or more elongated rods having one or more sections of differing stiffness, and optionally including an electrorheological, magnetorheological, pneumatic, or hydraulic material configured to reversibly change stiffness, at least in part, in response to an electromagnetic field or by adjusting the amount of material within the rod.

[0048] The present disclosure also provides a neuronavigation transcranial treatment kit including the above-described neuronavigation transcranial brain energy supply and / or detection system and a head cap having indicia, including target marks, text, visual textures, images, mosaics, grids, symbols, visual codes, and / or color marks, configured to cover anatomical regions of an individual's head, and optionally, the geometric features and / or specific indicia of the head cap are configured to align with or highlight distinct anatomical features of the individual's head to enable continuous measurement of the position and orientation of the cap relative to the individual's head before, during, and after use. The neuronavigation energy supply and / or detection kit further includes a power / receiver cable detachable from the energy supply and / or detection instrument and configured to pass between the generator or signal receiver and the brain energy supply and / or brain energy detection device.

[0049] In one embodiment of the transcranial magnetic stimulation kit, markers configured to cover a target area of ​​a patient's head and / or to allow continuous measurement of the relative position and orientation of the cap and the patient's head before, during, and after treatment are included.

[0050] The present disclosure also provides a method for treating a target brain region by directing energy to or receiving energy from a target brain region of a patient in need of treatment, the method comprising: i) providing a neuronavigation transcranial brain energy delivery and / or detection system including an energy delivery and / or detection instrument and one or more imaging devices as described above; ii) positioning the energy delivery and / or detection instrument over the target region using the imaging device to visualize the placement of the energy delivery and / or detection instrument relative to the target region in three translational or rotational dimensions, wherein precise positioning of the energy delivery and / or detection instrument is optionally facilitated by visual, auditory, and / or tactile feedback; and iii) starting and stopping the one or more energy delivery and / or detection instruments according to a treatment protocol.

[0051] In one embodiment, the method includes providing a patient with a head cap having indicia including target marks, text, visual textures, images, mosaics, grids, symbols, visual codes, and / or color marks configured to cover anatomical regions of the individual's head, and positioning an energy delivery and / or detection instrument over the target area using an imaging device to visualize placement of the energy delivery and / or detection instrument relative to the indicia.

[0052] In yet another embodiment of the method, the treatment comprises: i. Transcranial photobiomodulation using infrared or coherent light; ii. Transcranial focused ultrasound, iii. Transcranial magnetic stimulation; iv. Neurostimulation systems, including transcranial electrical stimulation; or v. an optical imaging system selected from near-infrared spectroscopy (NIRS), diffuse optical tomography (DOT) or optical coherence tomography (OCT), laser speckle imaging (LSI), photoacoustic imaging (PAI), and laser Doppler imaging (LDI); vi. Transcranial focused ultrasound (FUS), or vii. Neuronavigation neuroimaging systems, including magnetoencephalography (MEG); or viii. Particle beams containing gamma particles or electrons, or ix. A therapy selected from the group consisting of: neuronavigation neuroradiation systems, including photons from the electromagnetic spectrum, including radio waves, x-rays, ultraviolet rays, and gamma rays.

[0053] The present disclosure provides a transcranial magnetic stimulation (TMS) system configured to be placed over a target brain region for treatment, the TMS coil head including a housing containing one or more coil windings therein, and a phase change material (PCM) in contact with the one or more windings within the housing, optionally with a discontinuous winding path to maximize the contact area of ​​the PCM with the windings; or the TMS coil head including a conductive cooling unit in physical contact with the TMS coil head, preferably a patient-facing surface, to dissipate heat, either acting as a passive heat sink or actively cooling using conduction, convection, or electrical cooling, preferably as a Peltier thermocouple.

[0054] The present disclosure also provides a brain energy delivery or brain energy detection instrument including one or more imaging devices incorporated into the energy delivery and / or detection instrument and configured to enable direct visualization of the position of the energy delivery and / or detection instrument, and a permanent or detachable mounting fitting centered on a top of the energy delivery and / or detection instrument transversely to a central vertical axis passing through the energy delivery and / or detection instrument, the energy delivery and / or detection instrument optionally including an auxiliary component configured to connect to the mounting fitting via a single-action release mechanism.

[0055] The present disclosure also provides a method of stimulating a target brain region by transcranial magnetic stimulation, the method comprising: i) providing a neuronavigation transcranial magnetic stimulation system including a TMS coil and one or more imaging devices as described above; ii) positioning the TMS coil over the target area using an imaging device to visualize the placement of the TMS coil; and iii) starting and / or stopping the one or more magnetic induction coils according to a treatment protocol; Optionally, providing the patient with a head cap having indicia, including target marks, text, visual textures, images, mosaics, grids, symbols, visual codes, and / or color marks, configured to cover anatomical regions of the patient's head, and positioning the TMS coil over the target area using an imaging device to visualize placement of the TMS coil relative to the indicia, wherein accurate positioning of the TMS coil is optionally facilitated by visual, auditory, and / or tactile feedback.

[0056] More particularly, when applied to a TMS treatment system, one or more imaging devices are incorporated into the TMS coil to allow direct visualization of the placement of the center of the TMS coil on the head. In one embodiment, a single camera is incorporated directly into the center of the TMS coil to allow direct visualization of the area under the TMS coil. In another embodiment of the present disclosure, two or more cameras are incorporated outside and / or to the sides of the center of the TMS coil. The cameras may have visible light imaging capabilities, ultraviolet imaging capabilities, or infrared imaging capabilities.

[0057] In another embodiment, the TMS coil also incorporates one or more contact sensors to detect whether the patient's head is in contact with the coil before, during, and throughout a treatment session. The contact sensors may include force-sensitive resistors, capacitive touch sensors, ultrasonic position / touch sensors, and / or thermal / infrared sensors.

[0058] In another embodiment, one or more imaging devices configured to allow simultaneous visualization of the patient's head (and any associated markings) and the coil are also incorporated external to the TMS coil as an independent measure of their relative positions. These additional external coil cameras may include one or more cameras, LIDAR detectors, and / or ultrasound detectors.

[0059] In one embodiment, a specialized treatment cap is provided having indicia with various marks, including grid marks, text and / or color marks, that correspond to specific anatomical locations on the patient's head.

[0060] In another embodiment, the TMS system is configured to record and optionally transmit in real time video of the placement of the TMS coil during treatment. In yet another embodiment, the TMS coil includes one or more accelerometers to provide a secondary record of the orientation of the TMS coil during treatment, allowing the healthcare provider to detect subtle drifts or deviations in the coil during treatment and adjust the orientation of the TMS coil accordingly.

[0061] More specifically, in one embodiment, a transcranial magnetic stimulation system is provided, the TMS system including a TMS pulse generator and an induction coil configured to generate a magnetic field to be applied to a brain region of a patient, and one or more imaging devices integrated into the coil and configured to allow direct visualization of the TMS coil on the patient's head. The imaging devices may include one or more cameras, preferably one or more visible light imaging cameras, one or more ultraviolet imaging cameras, or one or more infrared imaging cameras.

[0062] The transcranial magnetic stimulation system may further include one or more accelerometers configured to sense orientation and / or changes in orientation of the placement of the TMS coil.

[0063] The transcranial magnetic stimulation system may further include a storage device configured to create a video record of the placement of the TMS coil during treatment.

[0064] Additionally, a transcranial magnetic stimulation neuronavigation kit is provided that includes the transcranial magnetic stimulation system described above and a patient head cap having grid marks, text, and / or color marks configured to cover anatomical regions of a patient's head. The patient head cap may include marks configured to cover target regions of the patient's head and / or marks configured to enable continuous measurement of the position and orientation of the cap relative to the patient's head before, during, and after treatment.

[0065] In yet another embodiment, a specialized treatment cap is provided having indicia with various marks, including grid marks, text and / or color marks, that correspond to specific anatomical locations on the patient's head.

[0066] In yet another embodiment, rather than adopting the current standard of care of placing a treatment cap a few centimeters above the eyebrow, measuring the distance from the nasion to the edge of the cap, and then attempting to precisely reposition the cap at each subsequent session, re-measuring each time, a cap shape is provided in which the edge reaches a tip at the midline. This tip allows for immediate visual confirmation of correct placement without the need for a tape measure. Additionally, the cap is provided with a marker indicating where the cap should be relative to the tragus (the skin fold at the tip of the ear) as an additional marker to ensure a stable fit of the cap on the head.

[0067] With both a tip marker and bilateral tragus markers, these three markers can not only be used for basic visual confirmation, but by using the smartphone camera, an AI algorithm can be employed to ensure proper cap positioning, and the smartphone camera can be slowly moved from the patient's left side to the front and then to the right side to ensure the cap is properly positioned.

[0068] In another embodiment, the TMS system is configured to record and optionally transmit in real time video of the placement of the TMS coil during treatment. In yet another embodiment, the TMS coil includes one or more accelerometers configured to provide a secondary record of the orientation of the TMS coil during treatment, allowing the healthcare provider to detect subtle drifts or deviations in the coil during treatment and adjust the orientation of the TMS coil accordingly.

[0069] In another embodiment, a transcranial magnetic stimulation system is provided, including a TMS system configured to generate a magnetic field for application to a brain region of a patient, the TMS system including a TMS pulse generator and an induction coil, and one or more imaging devices integrated into the coil and configured to allow direct visualization of the TMS coil on the patient's head. The imaging devices may include one or more cameras, preferably one or more visible light imaging cameras, one or more ultraviolet imaging cameras, or one or more infrared imaging cameras.

[0070] The transcranial magnetic stimulation system may further include one or more accelerometers configured to sense orientation and / or changes in orientation of the placement of the TMS coil.

[0071] The transcranial magnetic stimulation system may further include a storage device configured to create a video record of the placement of the TMS coil during treatment.

[0072] Additionally, a transcranial magnetic stimulation neuronavigation kit is provided that includes the transcranial magnetic stimulation system described above and a patient head cap having grid marks, text, and / or color marks configured to cover anatomical regions of a patient's head. The patient head cap may include marks configured to cover target regions of the patient's head and / or marks configured to enable continuous measurement of the position and orientation of the cap relative to the patient's head before, during, and after treatment.

[0073] A feature and advantage of the transcranial magnetic stimulation system of the present disclosure is that the placement of an imager or camera in the center of the TMS coil head structure allows for direct visualization of the TMS coil on the patient's head. The conventional, so-called "doughnut-shaped" coil TMS coil heads 102A, 102B employed in prior art TMS coil heads illustrated in Figures 10 and 11 are geometrically unsuitable for incorporating an imager or camera centrally located between the coils.

[0074] In accordance with the present disclosure, a TMS coil structure is provided that allows for the positioning of one or more imaging devices, i.e., one or more cameras, including a single camera, centered within the center of the TMS coil head. However, to facilitate the positioning of the camera within the center of the TMS coil head, the coil cannot simply be wrapped or tied, as is the case with conventional "doughnut-shaped" coils 102A, 102B of the prior art (FIG. 10), which use string 104 or tape 106 to bind the coil wires. Therefore, in accordance with the present disclosure, a number of spacers or pegs are provided inside the bottom and / or top of the coil head holder to hold the wires in place.

[0075] Conventional prior art transcranial magnetic stimulation systems also rely on circulating a coolant within the TMS coil head to dissipate excess heat and maintain the TMS coil head at a temperature appropriate and comfortable for the patient. However, providing a novel wire coil geometry that allows for central positioning of an imaging device, including a camera, within the center of the TMS coil head prevents the cooling of the TMS coil head by continuously circulating a coolant within the coil. Therefore, according to the present disclosure, a phase change material (PCM) is employed that is permanently packed around the wire within the TMS coil head. The PCM has sufficient thermal energy absorption capacity to cool the coil during treatment. Therefore, according to a further aspect of the present disclosure, the TMS coil head is configured to be easily replaced between treatment sessions. To facilitate this replacement, the present disclosure provides a detachable cable configured to be detachably secured to the TMS coil head or TMS pulse generator. Conventional TMS coils can be used nonstop by circulating a coolant through the cooler. According to the present disclosure, each TMS system includes multiple TMS coils, allowing healthcare providers to easily swap coil heads between patients. Thus, unlike conventional prior art TMS coil heads that require circulating coolant through the TMS coil head and energizing the coil, the TMS coil head of the present disclosure is much simpler in construction and does not require circulating coolant. Additionally, the PCM-cooled coil head of the present disclosure requires only a single cable junction, i.e., connection to the TMS pulse generator.

[0076] In another aspect, the PCM-cooled coil head of the present disclosure provides a detachable power cable configured to deliver power from the pulse generator to the TMS coil head, which can also be removed from the TMS coil head, another advantage over conventional TMS coil heads that require fixed and expensive wiring for both circulating the coolant and delivering the electrical pulses.

[0077] The use of a PCM sealed within the TMS coil head as a coolant has additional advantages. For one, the density of the PCM is much lighter than conventional coolants such as Galden® HT135. As a result, the TMS coil head of the present disclosure is lightweight and does not require a heavy, bulky, and difficult-to-use TMS coil holder arm (see FIG. 11 ). Therefore, the lightweight nature of the TMS coil head of the present disclosure allows for the use of a lightweight, compact, ergonomic handle on top of the TMS coil head, as opposed to the conventional TMS coil head shown in FIG. 11 , which has a “paddle-shaped” handle 110 extending out from the side of the coil head 112, which forces the operator to wield the coil head like a sword, resulting in operator fatigue.

[0078] In another embodiment, the PCM further enhances heat dissipation by including thermally conductive materials such as metal particulates (eg, copper, tin, or aluminum), carbon allotropes (such as graphite or graphene), or thermal paste.

[0079] The TMS coil head configuration of the present disclosure, with its compact, ergonomic handle on top of the coil head, also allows for the power cable to be attached through the top of the coil head, which provides an additional advantage over traditional paddle-style coil heads where the power hose is connected through the handle.

[0080] In one embodiment, the TMS coil head further includes a permanent or removable mounting fitting at the top of the coil head, vertically centered on the central vertical axis of the coil windings.

[0081] In another aspect, the auxiliary fixture to which the mounting joint is connected has a single-action detachment mechanism.

[0082] More particularly, one aspect of the present disclosure provides a TMS coil head configured to be placed over a target brain region for treatment, the TMS coil head including a housing containing one or more coil windings therein and a PCM in contact with the one or more windings within the housing.

[0083] In one embodiment, the TMS coil head includes one or more imaging devices, including an imaging device centrally positioned in the center of the TMS housing and configured to enable direct imaging of the center of the TMS coil housing on the patient's head.

[0084] In one embodiment, the coil windings are positioned on either side of the center of the TMS coil head.

[0085] In one embodiment, the TMS coils on either side of the center of the TMS coil head are mirror images of each other.

[0086] In another embodiment, the housing includes a bottom and a top, and the TMS coil is secured in place around a spacer or peg extending from the bottom or top.

[0087] In another embodiment, the TMS coil is secured in place around spacers or pegs extending from the bottom and held down by pegs extending from the top, or vice versa.

[0088] In a further embodiment, the coil is secured in place with adhesive at the bottom or top.

[0089] In another embodiment, the TMS coil head further comprises an ergonomically shaped handle attached to the top of the TMS coil head.

[0090] In a further embodiment, the TMS coil head further comprises a heat sink element in contact with the PCM.

[0091] The present disclosure also provides a TMS system including: (1) a pulse generator; and (2) a TMS coil head including a PCM as described above.

[0092] In one embodiment, the TMS system further includes one or more imaging devices, including a single imaging device centrally positioned in the center of the TMS coil head and configured to enable direct imaging of the center of the TMS coil head on the patient's head.

[0093] In a further embodiment, the TMS system includes one or more imaging devices, including one or more cameras, including a single camera centrally located in the center of the TMS coil head.

[0094] In another embodiment, the TMS system includes one or more imaging devices, including one or more visible light imaging cameras, one or more ultraviolet imaging cameras, or one or more infrared imaging cameras.

[0095] In another embodiment, the TMS system includes one or more imaging devices including two or more cameras positioned on either side of the TMS coil head.

[0096] In a further embodiment, the TMS system includes one or more imaging devices including two or more cameras located off-center but within the housing of the TMS coil head.

[0097] In yet another embodiment, the TMS system further includes one or more accelerometers configured to sense the orientation or change in orientation of the placement of the TMS coil head.

[0098] In a further embodiment, the TMS system further comprises one or more contact sensors configured to detect contact and force between the TMS coil head and the patient's head.

[0099] In further embodiments, the TMS system includes one or more contact sensors including one or more force sensitive resistors, one or more capacitive touch sensors, or one or more ultrasonic position / touch sensors.

[0100] In a further embodiment, the TMS system further includes one or more imaging devices external to the TMS coil head and configured to allow simultaneous visualization of the patient's head and the TMS coil head.

[0101] In still further embodiments, the TMS system includes one or more imaging devices including one or more cameras, one or more LIDAR detectors, or one or more ultrasound detectors external to the one or more TMS coil heads.

[0102] In a further embodiment, the TMS system further comprises a memory device configured to create a record of the position of the TMS coil head before and during treatment.

[0103] In another embodiment, the TMS system optionally includes one or more imaging devices configured to transmit images of the patient's scalp vasculature, the patient's skin pattern, the patient's skull structure, or the patient's brain tissue.

[0104] The present disclosure also provides a treatment cap configured to provide visual guidance in a medical procedure, including a skull cap having a central edge at its tip configured to align with the patient's nasion point, and / or landmark marks on either side of the cap configured to align with the patient's ear tragus.

[0105] The present disclosure also includes a TMS kit including a TMS system including: i) a pulse generator; ii) a TMS coil head including a PCM as described above and configured to be placed over a target brain region for treatment; and iii) a patient treatment instrument cap having a pointed edge on a center line and a landmark marking configured to cover a target location on a patient's head.

[0106] In one embodiment, the TMS kit includes a treatment cap having landmark marks including a central edge of the tip configured to align with the patient's nasion point and / or a tragus mark on each side of the cap configured to align with the tragus of the patient's ear or the tip that bisects the line connecting the patient's pupils.

[0107] In one embodiment, the TMS kit further comprises a smartphone camera configured to image the position of the head cap.

[0108] In a further embodiment, the neuronavigation TMS kit further includes one or more imaging devices, including a single imaging device centered in the center of the TMS coil head and configured to allow direct visualization of the center of the TMS coil head.

[0109] In further embodiments, the neuronavigation TMS kit further comprises one or more imaging devices, including one or more visible light imaging cameras, one or more ultraviolet imaging cameras, or one or more infrared imaging cameras.

[0110] In another embodiment, the neuronavigation TMS kit further comprises one or more contact sensors configured to detect contact and force between the TMS coil head and the patient's head.

[0111] In a further embodiment, the neuronavigation TMS kit further includes one or more imaging devices, including two or more cameras positioned on the sides of the TMS coil head.

[0112] In a further embodiment, the neuronavigation TMS kit further includes one or more imaging devices, including two or more cameras located off-center but within the housing of the TMS coil head.

[0113] In another embodiment, the neuronavigation TMS kit further comprises one or more accelerometers configured to sense the orientation or change in orientation of the placement of the TMS coil head.

[0114] In another embodiment, the neuronavigation TMS kit further comprises one or more contact sensors including one or more force sensitive resistors, one or more capacitive touch sensors, or one or more ultrasound position / touch sensors.

[0115] In a further embodiment, the neuronavigation TMS kit further comprises one or more imaging devices external to the TMS coil head and configured to allow simultaneous visualization of the patient's head and the TMS coil.

[0116] In another embodiment, the neuronavigation TMS kit further includes one or more imaging devices including one or more cameras, one or more LIDAR detectors, or one or more ultrasound detectors.

[0117] In a further embodiment, the TMS kit further comprises a memory device configured to create a record of the position of the TMS coil head before and during treatment.

[0118] In another embodiment, the neuronavigation TMS kit optionally further comprises one or more imaging devices configured to transmit images of the patient's scalp vasculature, the patient's skin pattern, the patient's skull structure, or the patient's brain tissue.

[0119] The present disclosure also provides a method of stimulating a target brain region with TMS, the method including the steps of: i) providing a neuronavigation TMS system including a TMS coil head including a PCM; ii) positioning the TMS coil head over the target region using a single imaging device centered in the center of the TMS coil head and configured to enable direct visualization and placement of the TMS coil head over the target brain region; iii) starting and stopping the TMS coil head according to a treatment protocol; and iv) passively cooling the TMS coil head by contact with the encapsulated PCM.

[0120] In one aspect, the method includes providing a patient with a treatment instrument cap having landmark marks in the form of at least one of a grid, text, and color marks configured to cover anatomical regions of the patient's head, and positioning the TMS coil head over a target brain region using one or more imaging devices to visualize placement of the TMS coil head relative to the landmarks. In certain embodiments, the treatment cap has a central edge of its tip configured to align with the patient's nasion and / or landmark marks on both sides of the cap configured to align with the patient's tragus.

[0121] In another embodiment, accurate positioning of the TMS coil head is facilitated by at least visual, auditory, and tactile feedback.

[0122] TMS pulses are more comfortable for patients at certain rotation angles. For example, a TMS coil rotated 90 degrees may be more comfortable than a 0-degree rotation. However, one problem with delivering stimulation with a conventional paddle-type coil head at certain rotation angles is that the power cable and cooling hoses coming from the paddle handle of the TMS coil head may hang down onto the patient's face, which can be uncomfortable for patients. Therefore, rather than placing the coil in an uncomfortable position, the present system allows the coil to be rotated 180 degrees relative to the uncomfortable position and then the electrical polarity is reversed, generating the same electric field. In essence, a normal waveform in one direction is equivalent to a reversed waveform with the coil upside down.

[0123] This rotation-induced polarity reversal is uniquely possible in this system because 1) it is the only system that combines a camera and cap with markers that allow for coil head rotation by detecting coil rotation, and 2) the power electronics can easily reverse the waveform, and it can also be applied in cases where an operator uses the device only manually and makes the decision to manually reverse the waveform polarity.

[0124] In yet another embodiment of the present disclosure, there is provided a TMS coil head configured to be placed over a target brain region for treatment, the TMS coil head including: a housing containing one or more coil windings therein, the one or more coil windings configured to generate a maximum magnetic field at a common focal point; and one or more imaging devices including a single camera configured to cover the common focal point to allow direct visualization of the position of the TMS coil head relative to a target location on a patient's head.

[0125] In one embodiment, the TMS coil head includes two coil windings located on either side of the center of the TMS coil head, in such an embodiment, the two coil windings are preferably mirror images of each other.

[0126] In another embodiment, the one or more imaging devices include one or more cameras, including a single camera covering a common focal point of one or more coil windings. In such an embodiment, the one or more imaging devices preferably include one or more visible light imaging cameras, one or more ultraviolet imaging cameras, or one or more infrared imaging cameras, and / or the one or more imaging devices also include two or more cameras located on the sides of the TMS coil head. Alternatively, the one or more imaging devices may also include two or more cameras located off-center but within the housing of the TMS coil head.

[0127] In another embodiment, the TMS coil head includes one or more accelerometers configured to sense the orientation or change in orientation of the placement of the TMS coil head.

[0128] In yet another embodiment, the TMS coil head includes one or more contact sensors configured to detect contact and force between the TMS coil head and the patient's head. In such an embodiment, the contact sensors preferably include one or more force-sensitive resistors, one or more capacitive touch sensors, or one or more ultrasound position / touch sensors.

[0129] In yet another embodiment, the TMS coil head further includes one or more imaging devices configured to enable simultaneous visualization of the patient's head and the TMS coil head, in such an embodiment, the one or more imaging devices preferably include one or more cameras, one or more LIDAR detectors, or one or more ultrasound detectors.

[0130] In another embodiment, the TMS coil head further includes a memory device configured to create a record of the position of the TMS coil head before and during treatment.

[0131] In a preferred embodiment, a contact sensor configured to determine whether the TMS coil remains in contact with the scalp in the same location throughout the entire TMS stimulation session is also provided. In one embodiment, an optical scalp landmarking technique is provided, which can significantly improve consistency in positioning the TMS coil at a predetermined site on the scalp between sessions and provide a direct visual record (rather than an estimated calculation) of whether the coil is properly positioned and maintains consistent contact with the scalp in that location throughout each stimulation session. In other words, rather than estimating coil position from an external perspective using sensors or markers placed externally on the head (as in Figure 1 ), the disclosed technique uses sensors placed on the coil itself, essentially providing a point of view of the coil. Furthermore, the disclosed novel technique allows technicians and supervising physicians to directly visualize the target site as they place the coil, significantly reducing the time required for new technicians to become proficient without extending it. Furthermore, a verifiable record of placement accuracy can be generated during each treatment session. Finally, the disclosed techniques do not require the prior art's use of expensive and cumbersome additional components, such as stereo cameras, MRI machines, and sophisticated processing software, or reflector markers that require calibration before treatment. This reduction in cost and complexity, along with a significantly accelerated operator learning curve, facilitates broader access to neuronavigational TMS treatment in a wider range of settings beyond the more limited number of specialized centers with large, expensive equipment requiring significant personnel.

[0132] In another embodiment of the present disclosure, in addition to providing an imaging device configured to provide direct visualization of the coil for positioning the coil's focal point at a target region of the patient's brain, two or more cameras located outside the center and / or to the sides of the TMS coil are also incorporated, and the cameras may have visible light imaging capabilities, ultraviolet imaging capabilities, or infrared imaging capabilities.

[0133] According to another embodiment of the present disclosure, the TMS coil also incorporates one or more contact sensors configured to detect whether the coil is in contact with the patient's head before, during, and until the end of a treatment session, which may include force-sensitive resistors, capacitive touch sensors, ultrasonic position / touch sensors, and / or thermal / infrared sensors.

[0134] In another embodiment of the present disclosure, one or more imaging devices configured to enable simultaneous visualization of the patient's head (and any associated markings) and the coil are also incorporated external to the coil as an independent measure of their relative positions. These additional external coil cameras may include one or more cameras, LIDAR detectors, and / or ultrasound detectors.

[0135] In yet another embodiment of the present disclosure, a specialized treatment cap is provided having indicia with various marks, including grid marks, text and / or color marks, that correspond to specific anatomical locations on the patient's head.

[0136] In yet another embodiment of the present disclosure, a therapeutic cap shape is provided in which the edge of the cap reaches a tip on the midline. This tip allows for immediate visual confirmation of correct placement without the need for a tape measure. Additionally, the cap is provided with a marking indicating the position of the cap relative to the tragus (the skin fold at the tip of the ear) as an additional marker to ensure a stable fit of the cap on the head.

[0137] With both the tip position marker and the bilateral tragus markers, these three markers can not only be used for basic visual confirmation, but by using the smartphone camera, an AI algorithm can be employed to ensure proper cap positioning, and the smartphone camera can be slowly moved from the patient's left side to the front and then to the right side to ensure the cap is properly positioned.

[0138] In yet another embodiment of the present disclosure, the TMS system is configured to record and optionally transmit in real time video of the placement of the TMS coil during treatment. In yet another embodiment, the TMS coil includes one or more accelerometers configured to provide a secondary record of the orientation of the TMS coil during treatment, allowing the healthcare provider to detect subtle drifts or deviations in the coil during treatment and adjust the orientation of the TMS coil accordingly.

[0139] In another embodiment of the present disclosure, a transcranial magnetic stimulation system is provided, including a TMS system configured to generate a magnetic field to be applied to a brain region of a patient, the TMS system including a TMS pulse generator and an induction coil, and an imaging device integrated into the coil and configured to allow direct visualization of the TMS coil and position the coil on the patient's head so that the coil is focused on a target region of the patient's brain. The imaging device may include a camera, preferably a visible light imaging camera, an ultraviolet imaging camera, or an infrared imaging camera.

[0140] In another embodiment of the present disclosure, the TMS system may further include one or more accelerometers configured to sense the orientation and / or change in orientation of the placement of the TMS coil.

[0141] In a further embodiment of the present disclosure, the TMS system may further include a storage device configured to create a video record of the placement of the TMS coil during treatment.

[0142] Also provided is a transcranial magnetic stimulation neuronavigation kit that includes the TMS system described above and a patient head cap having grid marks, text, and / or color marks configured to cover anatomical regions of a patient's head. The patient head cap may include marks configured to cover target regions of the patient's head and / or marks configured to enable continuous measurement of the position and orientation of the cap relative to the patient's head before, during, and after treatment.

[0143] Further features of the present disclosure will become apparent from the following detailed description taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0144] [Figure 1] FIG. 1 is a schematic diagram of a conventional frameless stereotactic MRI-guided neuronavigation system according to the prior art. [Figure 2] FIG. 1 is a schematic diagram of a TMS system according to an embodiment of the present disclosure. [Figure 3] FIG. 1 is a schematic diagram of a TMS coil according to an embodiment of the present disclosure. [Figure 4] FIG. 1B is a bottom view of a TMS coil element of the present disclosure. [Figure 5] FIG. 2 is a block diagram of a power control circuit according to the present disclosure. [Figure 6A] FIG. 2 is a perspective view of a cap element of the present disclosure. [Figure 6B] FIG. 2 is a perspective view of a cap element of the present disclosure. [Figure 7A] FIG. 10 is a perspective view of an alternative cap element of the present disclosure. [Figure 7B] FIG. 10 is a perspective view of an alternative cap element of the present disclosure. [Figure 7C] FIG. 10 is a perspective view of an alternative cap element of the present disclosure. [Figure 7D] FIG. 10 is a perspective view of an alternative cap element of the present disclosure. [Figure 7E] FIG. 10 is a perspective view of an alternative cap element of the present disclosure. [Figure 7F] FIG. 10 is a perspective view of an alternative cap element of the present disclosure. [Figure 8A] 1 is a diagram of the skin, vasculature, bone and cortical elements of a patient's head. [Figure 8C] 1 is a diagram of the skin, vasculature, bone and cortical elements of a patient's head. [Figure 9] 1 is a flow diagram of one embodiment of a method of the present disclosure. [Figure 10] FIG. 1 is a top view showing the coil windings of a conventional prior art TMS coil head. [Figure 11] FIG. 1 is a perspective view of a conventional prior art TMS system with a conventional prior art TMS coil head. [Figure 12] FIG. 1 is a plan view of a partially exploded TMS coil head according to one embodiment of the present disclosure. [Figure 12A] FIG. 1 is an enlarged plan view of a partially exploded TMS coil head according to one embodiment of the present disclosure. [Figure 13] FIG. 1 is a cross-sectional view of a TMS coil head according to an embodiment of the present disclosure. [Figure 14] FIG. 1 is a perspective view of a TMS coil head according to an embodiment of the present disclosure. [Figure 14A] FIG. 1 is a close-up view of a TMS coil head according to an embodiment of the present disclosure. [Figure 14B1] FIG. 1 is a cross-sectional side view of a TMS coil head according to an embodiment of the present disclosure. [Figure 14B2] FIG. 1 is a cross-sectional side view of a TMS coil head according to an embodiment of the present disclosure. [Figure 14C] FIG. 1 is a perspective view of a coil retention arm according to one embodiment of the present disclosure. [Figure 14D] FIG. 14D is a cross-sectional view of a portion of the coil holding arm of FIG. 14C. [Figure 14E] FIG. 14D is a cross-sectional view of a portion of the coil holding arm of FIG. 14C. [Figure 15] FIG. 1 is a cross-sectional view of a detachable power cable according to one embodiment of the present disclosure. [Figure 16] FIG. 1 is a schematic diagram of a mapping technique according to the present disclosure. [Figure 17] 1A-1D are perspective views of various TMS coils according to the present disclosure. [Figure 18] 1A-1D are perspective views of various TMS coils according to the present disclosure. [Figure 19] 1A-1D are perspective views of various TMS coils according to the present disclosure. [Figure 20] 1A-1D are perspective views of various TMS coils according to the present disclosure. [Figure 21] 1A-1D are perspective views of various TMS coils according to the present disclosure. [Figure 22]1A-1D are perspective views of various TMS coils according to the present disclosure. [Figure 23] 1A-1D are perspective views of various TMS coils according to the present disclosure. [Figure 24] 1A-1D are perspective views of various TMS coils according to the present disclosure. [Figure 25] 1A-1D are perspective views of various TMS coils according to the present disclosure. [Figure 26] FIG. 1 is a plan view of an optical imaging device according to the present disclosure. [Figure 27] 1 is a cross-sectional view of an optical imaging device according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0145] As used herein, the term "transcranial magnetic stimulation (TMS) coil" is intended to mean the magnetic induction coils themselves and their housings.

[0146] 2-5, in one embodiment, a neuronavigation transcranial magnetic stimulation system 10 includes one or more TMS coils, which themselves consist of magnetic induction windings 12 within a housing 14 with conductors within a cable 24. Alternatively, the housing 14 may be connected to a non-biological support mechanism. The housing 14 includes a handle 16 sized to fit comfortably in a human hand. The housing 14 includes a top surface 18 and a bottom surface 20, which may be arched to facilitate a tight fit with the patient's head.

[0147] The neuronavigational transcranial magnetic stimulation system 10 also includes a pulse generator 61 with an internal control unit and associated power supply. The pulse generator transmits power to the windings 12 via a cable 24. The pulse generator 61 is configured to communicate with a smartphone, tablet, or PC 62, which contains programming for the device to send parameters to the pulse generator 61 and for the device to receive data from the pulse generator. The neuronavigational transcranial magnetic stimulation system 10 is intended to treat and / or alleviate specific symptoms by applying magnetic stimulation of a specific intensity and frequency through the patient's skull 28 to a target brain region 26 within the patient's skull. The coil 21 may be held in place by an operator 63, a coil holder 64, or both.

[0148] With particular reference to FIG. 4 , housing 14 includes imaging device 30 configured to face downward from bottom surface 20, i.e., toward the patient's head during use, to enable direct visualization of the patient's head. In one embodiment, imaging device 30 is centered relative to the magnetic induction coil. Imaging device 30 is preferably a camera and may be a visible light imaging camera, an ultraviolet imaging camera, or an infrared imaging camera. With particular reference to FIG. 5 , in one embodiment, imaging device 30 is connected via cable 36 to display and storage device 38, which may be a smartphone, tablet, or PC. In another embodiment, imaging device 30 is connected via cable 32 to pulse generator 61. Cable 32 may run within cable 24. Optionally, pulse generator 61 can transmit imaging information to device 38, which may be a smartphone, tablet, or PC. This connection 65 may be wired or wireless, such as Bluetooth, Wi-Fi, or NFC.

[0149] Alternatively, the imaging device may include a spaced apart imaging device located off-center to the side of the magnetic induction coil windings 12, as shown by dashed line 40. Alternatively, two or more imaging devices, as shown by dashed line 40A, may be mounted facing downward away from the center of the housing, but spaced apart from each other a fixed distance from the center of the windings 12 within the housing, or mounted adjacent the edges of the windings 12.

[0150] Optionally, one or more contact sensors 41 configured to detect force between the coil and the patient's head may also be provided and mounted on the underside of the housing 14. The contact sensors 41 may include one or more force-sensitive sensors, one or more capacitance sensors, or one or more infrared sensors.

[0151] 6A and 6B, a preferred embodiment of the present disclosure provides a treatment cap 50 sized and shaped to fit snugly against a patient's head. The cap is constructed of a material intentionally designed to stretch, allowing it to accommodate a range of head sizes slightly larger than its unstretched size. Preferably, the cap 50 is provided in a kit with multiple different sizes to accommodate patients of different sizes. Generally, five sizes are sufficient to fit most adult heads, with a sixth size for adolescents and a seventh size for children and infants. The cap 50 includes indicia 52 in the form of a specific grid of anatomical markers printed on the cap. The indicia or markers may include text, colors, and / or symbols to identify specific target locations on the wearer's head and / or shapes and patterns to orient the TMS winding 12 and facilitate magnetic guidance in the correct location and direction. These indicia may consist of symbols, QR codes, a color spectrum, or any combination thereof. The indicia may be common to multiple caps manufactured. Alternatively, cap 50 may instead have unique indicia 57 at one or more locations to uniquely distinguish the cap or any location thereon (FIG. 7A). Alternatively, cap 50 may have a printed pattern or color gradient to guide placement (FIG. 7B). The cap may also include indicia to customize the cap for an individual patient.

[0152] 7C and 7D, in another embodiment, the present disclosure uses a unique cap 50A shape in which, rather than using a cap with a flat lip 300, the lip 300 meets at the midline at a tip 302 that allows for immediate visual confirmation of correct placement without the need for a tape measure.

[0153] As mentioned above, many neurostimulation and neuroradiation technologies require precise placement of their hardware. Navigation caps with hand-drawn or pre-printed markers on them are frequently used. Proper placement of the hardware is then guided by these markers, either visually or with the aid of one or more imaging devices. Unfortunately, traditional sewing techniques are highly imprecise, with seam alignment tolerances on the order of a few percent of an inch. As a result, head caps, which are typically made from three or more pieces of fabric sewn together, exhibit significant variations from cap to cap. This is inadequate when millimeter-level precision is required.

[0154] To improve the accuracy of the cap's shape and the precision of the pre-printed landmarks, we developed a unique system to cut the neuronavigation head cap from a single 2D pattern and sew it together with multiple seams on both sides to create a 3D cap that conforms to the head, significantly reducing fabric misalignment on the sides and top of the head.

[0155] 7E and 7F, the cap 50A is preferably cut from a single piece of fabric 60 to form a center portion 62 and side portions 64A, 64B that are joined to the center portion 62. The center portion 62 and side portions 64A, 64B are to be sewn together with a continuous seam 66.

[0156] Additionally, the cap may have a mark 304 positioned to indicate where the cap should be relative to the tragus 306 (the fold of skin at the tip of the ear) as an additional marker to ensure a stable fit of the cap on the head.

[0157] With both the tip edge 300 and the bilateral tragus markers 306, these three markers can not only be used for basic visual confirmation, but by using the camera of the smartphone 310, an AI algorithm can be employed to ensure proper cap positioning, slowly moving the smartphone camera from the patient's left side to the front and then to the right side to ensure the cap is properly positioned.

[0158] Yet another feature and advantage of the present disclosure, by providing a central camera in the center of the TMS coil and a cap with the above-mentioned markings, is that it can detect rotation of the coil and, if necessary, change or reverse the polarity of the power electronics, thereby inverting or reversing the polarity of the waveform, thereby improving patient comfort.

[0159] The magnetic field of a magnetic induction coil has a specific orientation (it is directional, not symmetrical), and the angle at which the magnetic induction coil is placed in a given position can make a big difference in how the patient experiences the treatment. Specifically, even if the exact same central location is used, placing the coil at different angles can activate different central and peripheral nerves. In the latter case, this can cause discomfort at some angles but not others. For example, at some angles, a patient's jaw may wiggle during TMS, but at others it may not. Therefore, the shape and pattern of the landmarks uniquely identify each angle at which the magnetic induction coil is placed, allowing the observer, in conjunction with the camera, to verify that they are properly and consistently aligned. Notably, because the landmarks are neither radially nor bilaterally symmetrical, a 180-degree rotation of the magnetic induction coil will result in different perspectives of any marker, again making it uniquely identified. Similarly, the text and color combination of the anatomical markings uniquely identify each location. Areas commonly used as stimulation targets and reference locations in the field of therapeutic TMS are further differentiated using color to enable quick and accurate setup. This allows the healthcare provider to verify that the magnetic induction winding 12 is properly positioned on the wearer's head and is not distorted or tilted. The image size also allows for an estimate of the coil's distance from the wearer's head to ensure full coil contact when viewed by the imaging device.

[0160] In another embodiment, no special treatment cap is used. Instead, patient-specific anatomical features are utilized to position and maintain the coil in place. Referring to Figures 8A-8C, these features may include the pattern of the epidermis 80, dermis 81, and subcutaneous tissue 82, scalp vascularity 83, bone density 84, and neural tissue configuration 85, as acquired using optical or infrared cameras and / or functional near-infrared spectroscopy.

[0161] This allows for the creation of a multimodal "fingerprint" of the exact location of the stimulation target and the positioning of the magnetic induction coil accordingly, based on the unique anatomical features of each patient's scalp itself, rather than on a pre-marked cap. The image pattern may be recorded and saved for future treatment.

[0162] Features and advantages of the present disclosure arise from the use of one or more imaging devices internal or external to the brain energy delivery and / or detection instrument, which not only ensures proper placement of the transcranial magnetic stimulation system but also allows for continuous monitoring of placement, including the ability to record and / or transmit placement data in real time throughout the procedure. Additionally, the inclusion of target markers 54 (FIG. 6B) on the cap allows the healthcare provider to precisely position the instrument relative to the target region of the brain. Alignment can be facilitated by visual, auditory, and / or tactile feedback.

[0163] 9, another feature and advantage of the present disclosure through the use of an integrated imaging device is that it can provide a warning signal to a healthcare provider if the brain energy delivery and / or detection device becomes dislodged or displaced (e.g., due to patient movement). Furthermore, to protect the patient from potential harm, the brain energy delivery and / or detection system can be programmed to not initiate until properly positioned, and to stop or pause delivery of stimulation pulses if the device becomes displaced beyond a certain tolerance, prompting the operator to correct the position before proceeding.

[0164] A feature and advantage of the transcranial magnetic stimulation system of the present disclosure is that the placement of an imager or camera in the center of the TMS coil head structure allows for direct visualization of the TMS coil on the patient's head. The conventional, so-called "doughnut-shaped" coil TMS coil heads 102A, 102B employed in prior art TMS coil heads illustrated in Figures 10 and 11 are geometrically unsuitable for incorporating an imager or camera centrally located between the coils.

[0165] In accordance with the present disclosure, a TMS coil configuration is provided that allows for the positioning of one or more imaging devices, i.e., one or more cameras, including a single camera, centered within the center of the TMS coil head. However, to facilitate centering of the camera within the center of the TMS coil head, the coil cannot simply be wrapped or tied, as is the case with conventional "doughnut-shaped" coils 102A, 102B of the prior art (FIG. 10), which use string 104 or tape 106 to bind the coil wires. Therefore, in accordance with a preferred embodiment of the present disclosure, a number of spacers or pegs are provided inside the bottom and / or top of the coil head holder to hold the wires in place.

[0166] Conventional prior art transcranial magnetic stimulation systems also rely on circulating a coolant within the TMS coil head to dissipate excess heat and maintain the TMS coil head at a temperature appropriate and comfortable for the patient. However, providing a novel wire coil geometry that allows for central positioning of an imaging device, including a camera, within the center of the TMS coil head prevents the cooling fluid from continuously circulating within the coil. Therefore, according to the present disclosure, a PCM is permanently packed around the wire within the TMS coil head. The PCM has sufficient thermal energy absorption capacity to cool the coil during treatment. Therefore, according to a further aspect of the present disclosure, the TMS coil head is configured to be easily replaced between treatment sessions. To facilitate this replacement, the present disclosure provides a detachable cable configured to be detachably secured to the TMS coil head or TMS pulse generator. Conventional TMS coils can be used nonstop by circulating a coolant through the cooler. According to the present disclosure, each TMS system includes multiple TMS coils, allowing healthcare providers to easily replace coil heads between patients. Thus, unlike conventional prior art TMS coil heads that are configured to circulate coolant through the TMS coil head and then energize the coil, the TMS coil head of the present disclosure is much simpler in construction and does not require any configuration to circulate coolant. Additionally, the PCM-cooled coil head of the present disclosure requires only a single cable junction, namely, to the TMS pulse generator.

[0167] In another aspect, the PCM-cooled coil head of the present disclosure provides a detachable power cable configured to deliver power from the pulse generator to the TMS coil head, which can also be removed from the TMS coil head, another advantage over conventional TMS coil heads that require fixed and expensive wiring for both circulating the coolant and delivering the electrical pulses.

[0168] The use of a PCM sealed within the TMS coil head as a coolant has additional advantages. For one, the density of the PCM is much lighter than conventional coolants such as Galden® HT135. As a result, the TMS coil head of the present disclosure is lightweight and does not require a heavy, bulky, and difficult-to-use TMS coil holder arm (see FIG. 11 ). Therefore, the lightweight nature of the TMS coil head of the present disclosure allows for the use of a lightweight, compact, ergonomic handle on top of the TMS coil head, as opposed to the conventional TMS coil head shown in FIG. 11 , which has a “paddle-shaped” handle 110 extending out from the side of the coil head 112, which forces the operator to wield the coil head like a sword, resulting in operator fatigue.

[0169] 12, 12A, 13, and 14, a TMS coil head 200 according to another embodiment of the present disclosure includes a liquid-tight housing 202 having a bottom portion 204 and a top portion 206. The housing 202 has a slight concave shape to conform to the patient's head. The bottom portion 204 includes a plurality of recessed winding paths 207 and spacers or pegs 208 to guide the placement of the wire within the housing. The wire constitutes a therapeutic coil for providing TMS magnetic stimulation to the patient's brain. The wire includes a wire structure consisting of a continuous wire 209 wound into a series of continuous wire loops 210 and 212. The wire loops 210 and 212 are approximate mirror images of each other. The wire 209 includes a conductive coil and a dielectric coating.

[0170] The wire loops 210, 212 are typically glued in place with adhesive applied within the channels 207 and / or between the pegs 208 before the wire loops 210, 212 are placed in place on the bottom portion 204. Additional downward-extending pegs located on the top portion 206 may be provided to hold down the wire loops 210, 212. Alternatively, channels or pegs may be formed in / on the inside of the top portion 206, and the wire loops placed in place within the top portion 206. The pegs also ensure that the wire loops are spaced apart from one another, allowing the phase change material to flow between the loops and contact the wires, improving thermal contact with the wires. The wire loops 210, 212 may be placed in place manually or robotically. The free end of the wire 209 is threaded through a hole or connector (not shown) in the top portion 206 and then connected to a power cable, which may be connected to, for example, a power generator of a neuronavigation transcranial magnetic stimulation system, as previously described. However, the conventional circulation type coil head cooling system is unnecessary as will be described later and may be omitted.

[0171] A PCM 276, such as PulselCE Organic A36, which is typically in a solid state at ambient temperature, is heated until melted. The molten PCM is then poured into the bottom or top of the housing, as the case may be, to cover and seal the wire loops 210 and 212. The PCM is then cooled and solidified. PCMs have the advantage of absorbing significantly more thermal energy during the melting process than static fluids. For example, Galden® HT 135, a traditionally used circulating heat transfer agent in conventional TMS coil heads, absorbs 0.23 J / gK of heat, while PulselCE Organic A36 PCM absorbs approximately 250 J / g of heat simply by melting. However, unlike static heat transfer agents such as Galden® HT 135, PCMs have a low ability to conduct heat over distance. Therefore, PCMs only function when they are in close proximity to the heat source. Therefore, in accordance with the present disclosure, heat transfer from the wire coil to the PCM is maximized by placing the wire coil with spacing between loops and solidifying the liquid PCM in place to contact the wire coil.

[0172] As mentioned above, the preferred PCM material is PulselCE Organic A36. However, other materials, such as metal particulates (e.g., copper, tin, or aluminum), carbon allotropes (e.g., graphite or graphene), or thermal pastes, can be mixed with the PCM to improve its thermal conductivity. Additionally, a solid heat sink with poor electrical conductivity (e.g., aluminum oxide) can be attached to the wire coil.

[0173] Once the PCM has solidified, the coil head is assembled, the bottom 204 and top 206 are sealed, the power cable 220 is attached, and the coil head 200 is ready for use. The PCM within the coil head has sufficient cooling capacity to last a typical treatment time (i.e., 0.5-10 minutes). Once treatment is complete, the coil head is cooled, solidifying the PCM and making it reusable. Referring to FIG. 13, to accelerate cooling between uses, the coil head 200 may include a solid heat sink element 222 extending from the coil to the surface of the coil head 200. The coil head 200 can then be placed on a cooling device 224. In one embodiment, the cooling device 224 is passive, utilizing ambient air to cool the heat sink element, which then transfers the cooling to the PCM within the coil head 200. In another embodiment, an active cooling device, such as a Peltier thermocouple, can enhance the cooling rate.

[0174] Additionally, rather than forming the TMS pulse generator or TMS coil head enclosure out of heavy metals, the TMS pulse generator or TMS coil head enclosure 258 can be formed out of a lightweight polymeric material and the interior and / or exterior surfaces 260, 262 of the enclosure 258 can be coated with a conductive material, such as silver, graphene, copper, carbon nanotubes, and mixtures thereof, to reduce or eliminate unwanted electromagnetic interference emissions from the TMS pulse generator or TMS coil head.

[0175] 14 and 14A, because the density of the PCM used is much lighter than that of conventional coolants, such as Galden® HT 135, the coil head 200 is relatively lightweight and can be easily moved by hand. To facilitate holding and moving the coil head 200, the coil head 200 is provided with a handle 250 having an overhang 252 that is ergonomically sized and shaped to fit a human hand. The handle also allows the operator to operate the coil head 200 "freehand," facilitating movement of the coil head 200 over the patient's head. In addition to being gentle on the operator's hands, the handle is positioned sufficiently far away from the wires within the coil head 200 to prevent TMS pulses from shocking the operator's hand. It should be noted that various modifications may be made to the above disclosure.

[0176] Many neurostimulation, neuroimaging, and neuroradiation technologies require precise placement of therapeutic instruments. Some systems use large, miniature crane-like devices to precisely hold such devices on the subject's head. These devices are expensive and bulky. Other systems instead use articulating arms made of two or more rigid components. While these devices can hold the hardware in place with a smaller footprint, they often require simultaneous manipulation and fixation of multiple joints on the patient's head, posing a risk of dropping the hardware onto the patient's head. Unfortunately, training operators to use them often takes weeks. Other attempts have also attempted to suspend such hardware using flexible, bendable arms. However, flexible or bendable arms strong enough to hold the weight of the therapeutic instruments at a fixed distance are undesirable because they are so rigid that it becomes extremely difficult to adjust the position of the suspended therapeutic instruments to the millimeter. This is because the force required to bend or flex the arm can cause it to either overshoot the intended target, or, once over the intended target, the very stiff arm can recoil and fall short of the target, causing it to undershoot.

[0177] The present disclosure provides a therapeutic instrument support system by providing a support arm that includes sections of selectively varying stiffness, with a distal portion of the support arm including the least stiff section.

[0178] Referring to FIG. 14B1, the coil head 200 may also be connected to a support arm 270 (see FIG. 14C) via a ball 260 and swivel connector 266. The connector 266 preferably includes a clamping and release lever 268 configured to allow for quick, tool-less replacement or adjustment of the coil head 200. The ball 260 preferably lies on a vertical axis 262 of the coil head 200.

[0179] 14B2, in yet another embodiment, the coil head 200 may be cooled before or between uses by placing it in a cooling unit or cooling tray 275. The cooling tray 275 may include a heat sink that passively cools the coil head 200, or the cooling tray 275 itself may be actively cooled by circulating air and / or fluid through the cooling tray 275.

[0180] 14C-E, in accordance with another embodiment, a support arm 270 is provided that includes an elongate member having one or more sections with varying stiffness. This is achieved by forming the support arm 270 with one or more hollow, flexible sections 272, 274 and filling at least a portion of these sections with an electrorheological fluid configured to reversibly change viscosity in response to an applied electromagnetic field. The electrorheological fluid comprises non-conductive but electrically active microparticles 277 (typically up to about 50 microns in diameter) suspended in an electrically insulating fluid 279 (see FIGS. 14D and 14E). The apparent viscosity of these fluids can be reversibly changed in response to an electric field. Changing the viscosity of the fluid also changes the effective stiffness of the flexible sections 272, 274 of the support arm 270, i.e., the sections containing the electrorheological fluid. As a result, support arms 270 with varying stiffness can be provided by selectively passing an electric current through each section of the support arm 270. This allows a technician or healthcare provider to easily position the coil head 200 in place and then simply activate an electrical switch to essentially lock the coil head in place.

[0181] Referring to FIG. 15, the power cable 24, which may be detachable from the TMS head and / or pulse generator, includes multiple conductors 80. + ,80 - where half of the conductors, i.e., conductors marked with a plus "+" sign, indicate current flowing into the TMS coil and conductors marked with a "-" sign, indicate current flowing out of the TMS coil head.

[0182] In yet another embodiment of the present disclosure shown in FIG. 16 , optimal positions of the landmarks on the head cap for patient treatment are selected as follows: First, the patient undergoes MRI or fMRI to determine the exact coordinates of the brain region to be treated, either anatomically or functionally. However, because TMS is non-invasive, it is not possible to actually set a target location inside the patient's head. Therefore, these coordinates (3D coordinates within the head or 2D coordinates on the scalp) are acquired, and the positions are projected or mapped onto the landmarks on the cap, and a specific rotation angle is optionally set. For example, this treatment cap can also be effectively used for radiation delivery for radiation oncology treatment of the brain.

[0183] The foregoing disclosure illustrates the advantages of employing a single imager between two similar coils in a two-coil TMS head system, and for the same reasons, locating an imager, i.e., camera, directly above the focal point of the TMS coil head as described above can be advantageously employed in other coil head designs. For example, as shown in FIG. 17, a TMS coil head according to the teachings of U.S. Patent Application Publication No. 2016 / 0206896 includes three coils 70, 72, and 74, with an imager camera 76 positioned directly above the focal points of the three coils.

[0184] Referring to FIG. 18, in another embodiment, the TMS coil head may include four coils 82, 84, 86, 88 with a camera 90 directly above the focal points of the four coils.

[0185] 19-25 show yet other, more complex coil head geometries taken from U.S. Patent Application Publication No. 2016 / 0206895 (FIGS. 7 and 8), U.S. Patent Application Publication No. 2016 / 0206896 (FIGS. 11 and 13B), U.S. Patent Application Publication No. 2014 / 0235926 (FIGS. 7 and 8), and U.S. Patent Application Publication No. 2014 / 0235927 (FIG. 8), respectively, the contents of which are incorporated herein by reference, that can benefit from having a single camera directly over the focal point of the coil in accordance with the present disclosure.

[0186] While the foregoing disclosure has primarily focused on the use of a camera placed directly above a focal point to deliver transcranial magnetic stimulation (TMS) to a patient, the techniques of the present disclosure may be advantageously applied to any neuronavigation-enabled device configured to perform neurostimulation, neuroimaging, or neuroradiation. These devices may target landmarks on a cap, determine their location without a cap by skin texture or head markings, or use IR (infrared) detection to detect vascular structures, cranial inhomogeneities, or brain anatomy, but the scope of application is not limited to the following: (1) Neurostimulation: A neuronavigation neurostimulation system including one or more imaging devices integrated directly above the stimulation focus and configured to enable direct visualization of one or more locations on the patient's head, a worn head cap (with or without pre-printed landmarks), or tissues beneath the skin (comprising vasculature, skull, or brain tissue), wherein the neurostimulation technology includes one or more of the following: i. Transcranial photobiomodulation using infrared or coherent light; ii. Transcranial focused ultrasound, iii. Transcranial magnetic stimulation, and iv. Transcranial electrical stimulation configured to induce changes in neuronal firing patterns. (2) Neuroimaging: A neuronavigation neuroimaging system configured to provide one or more of the following: a. Optical Imaging: including but not limited to: i. Near-infrared spectroscopy (NIRS), diffuse optical tomography (DOT) or optical coherence tomography (OCT), laser speckle imaging (LSI), photoacoustic imaging (PAI), and laser Doppler imaging (LDI), b. Transcranial focused ultrasound (FUS), and c. Magnetoencephalography (MEG). (3) Neuroradiation: A neuronavigation neuroradiation system configured to provide one or more of the following: i. Particle beams (including gamma particles and electrons); ii. Photons from the electromagnetic spectrum, including radio waves, X-rays, ultraviolet rays, and gamma rays. b. and is configured to cause biochemical effects, including, but not limited to, chemical reactions, alterations in cellular processes, alterations in tissue or cell membrane integrity, or alterations in electrical or chemical communication between cells (including neurons, glia, blood vessels, and abnormal tissues (e.g., tumors)).

[0187] For example, Figure 26 shows a near-infrared spectroscopy device 1300 having an optical imaging device 1302 surrounded by six equally spaced near-infrared emitters or detectors 1304. Also, Figure 27 shows an ultrasound device 1310 having an optical imaging device 1312 on the focal axis 1314 of the ultrasound device.

[0188] Various modifications can be made to the foregoing disclosure, and further modifications can be made without departing from the spirit and scope of the disclosure.

Claims

1. 1. A neuronavigation transcranial brain energy delivery and / or detection system, comprising: i) a brain energy delivery device including an energy delivery instrument configured to be placed on an individual's head over a target brain region for energy delivery; and ii) a power generation unit for supplying power to the energy supply device if the brain energy supply device requires power; and / or iii) a brain energy detection device including an energy detection instrument configured to be placed on a target brain region of an individual's head for energy detection; iv) a receiving unit for receiving signals from the energy detection instrument if the brain energy detection device requires a receiver; and v) including one or more imaging devices integrated into the energy delivery and / or detection instrument and configured to allow direct visualization of the position of the energy delivery and / or detection instrument on the individual's head over the target brain region; Neuronavigation transcranial brain energy delivery and / or detection system.

2. 2. The neuronavigation transcranial brain energy supply and / or detection system of claim 1, wherein the imaging device includes one or more cameras, preferably one or more visible light imaging cameras, one or more ultraviolet imaging cameras, or one or more infrared imaging cameras, and the imaging device preferably includes a single camera located centrally with respect to the energy supplying and / or detection instrument, and optionally two or more cameras located to the sides of the energy supplying and / or detection instrument, or two or more cameras located off-center but within the housing of the energy supplying and / or detection instrument.

3. 3. The neuronavigation transcranial brain energy supply and / or detection system of claim 1 or claim 2, further comprising one or more accelerometers configured to sense orientation and / or changes in orientation of the placement of the energy supply and / or detection instrument, and / or one or more contact sensors configured to detect contact and force between the energy supply and / or detection instrument and the individual's head, preferably comprising one or more force sensitive resistors, one or more capacitive touch sensors, or one or more ultrasonic position / touch sensors, and optionally configured to adjust energy supply and / or detection in any of three translational or rotational dimensions based on the position, velocity, or acceleration of the instrument relative to the target brain region as estimated by measurements from an implanted imaging device or sensor.

4. 4. The neuronavigation transcranial brain energy supply and / or detection system of claim 1, further comprising: (i) one or more imaging devices external to the energy supply and / or detection instrument and configured to enable simultaneous visualization of the individual's head and the energy supply and / or detection instrument, preferably comprising one or more cameras, one or more LIDAR detectors, or one or more ultrasound detectors; and / or (ii) a storage device configured to create records of the imaging devices, contact sensors, accelerometers, or other sensors of the energy supply and / or detection instrument before, during, and / or after use, which records are used to infer the position of the instrument relative to the individual's head.

5. 5. The neuronavigation transcranial brain energy supply and / or detection system of claim 1, wherein the imaging device is configured to transmit images of an individual's scalp vasculature, an individual's skin pattern, an individual's skull structure, or an individual's brain tissue, as the case may be.

6. The brain energy supply and / or detection system comprises: i. Transcranial photobiomodulation using infrared or coherent light; ii. Transcranial focused ultrasound, iii. Transcranial magnetic stimulation; iv. Brain stimulation systems, including transcranial electrical stimulation; or v. Particle beams containing gamma particles or electrons, or vi. Brain irradiation systems involving photons from the electromagnetic spectrum, including radio waves, x-rays, ultraviolet rays, and gamma rays; or vii. an optical imaging system selected from near-infrared spectroscopy (NIRS), diffuse optical tomography (DOT) or optical coherence tomography (OCT), laser speckle imaging (LSI), photoacoustic imaging (PAI), and laser Doppler imaging (LDI); viii. Transcranial focused ultrasound (FUS), or ix. Brain activity detection systems, including magnetoencephalography (MEG); or x. Particle detectors containing gamma particles or electrons, or xi. The neuronavigation transcranial brain energy delivery and / or detection system of any one of claims 1 to 5, selected from the group consisting of brain radiation detection systems comprising photons from the electromagnetic spectrum, including radio waves, x-rays, ultraviolet rays, and gamma rays.

7. 7. The neuronavigation transcranial brain energy supply and / or detection system of claim 1, further comprising a support arm configured to support the energy supply and / or detection instrument, the support arm comprising one or more elongated rods having one or more sections of differing stiffness, optionally comprising an electrorheological, magnetorheological, pneumatic, or hydraulic material configured to reversibly change stiffness, at least in part, in response to an electromagnetic field or by adjusting the amount of material within the rod.

8. 8. A neuronavigation transcranial kit comprising the neuronavigation transcranial brain energy supply and / or detection system of any one of claims 1 to 7 and a head cap having indicia including target marks, text, visual textures, images, mosaics, grids, symbols, visual codes, and / or color marks configured to cover anatomical sites or target areas of an individual's head, and optionally the geometric features and / or specific indicia of the cap are configured to align with or highlight distinct anatomical features of the individual's head to enable continuous measurement of the relative position and orientation of the cap with respect to the individual's head before, during, and after use, and / or the indicia are configured to enable continuous measurement of the relative position and orientation of the cap with respect to the patient's head before, during, and / or after treatment.

9. The neuronavigation energy supply and / or detection kit of claim 8, further comprising a power / receiver cable detachable from the energy supply and / or detection instrument and configured to pass between a generator or signal receiver and the brain energy supply and / or brain energy detection device.

10. 1. A method of delivering and / or detecting energy from a target brain region of an individual by directing energy to or receiving energy from said target brain region, comprising: i) providing a neuronavigation transcranial brain energy delivery and / or detection system comprising an energy delivery and / or detection instrument according to any one of claims 1 to 7 and one or more imaging devices; ii) positioning the energy delivery and / or detection instrument over the target area using the imaging device to visualize placement of the energy delivery and / or detection instrument relative to the target area in three translational or rotational dimensions, where accurate positioning of the energy delivery and / or detection instrument is optionally facilitated by visual, auditory and / or tactile feedback; and iii) starting and stopping said one or more energy supply and / or detection instruments according to a usage protocol.

11. 11. The method of claim 10, comprising providing an individual with a head cap having indicia including target marks, text, visual textures, images, mosaics, grids, symbols, visual codes, and / or color marks configured to cover anatomical regions of the individual's head, and positioning the energy delivery and / or detection instruments over the target areas using the imaging device to visualize placement of the energy delivery and / or detection instruments relative to the indicia.

12. Treatment is i. Transcranial photobiomodulation using infrared or coherent light; ii. Transcranial focused ultrasound, iii. Transcranial magnetic stimulation; iv. Brain stimulation systems, including transcranial electrical stimulation; or v. Particle beams containing gamma particles or electrons, or vi. Brain irradiation systems involving photons from the electromagnetic spectrum, including radio waves, x-rays, ultraviolet rays, and gamma rays; or vii. an optical imaging system selected from near-infrared spectroscopy (NIRS), diffuse optical tomography (DOT) or optical coherence tomography (OCT), laser speckle imaging (LSI), photoacoustic imaging (PAI), and laser Doppler imaging (LDI); viii. Transcranial focused ultrasound (FUS), or ix. Brain activity detection systems, including magnetoencephalography (MEG); or x. Particle detectors containing gamma particles or electrons, or xi. The method of claim 10 or claim 11, comprising treatment selected from the group consisting of brain radiation detection systems, including photons from the electromagnetic spectrum, including radio waves, x-rays, ultraviolet rays, and gamma rays.

13. 1. A transcranial magnetic stimulation (TMS) system configured for placement over a target brain region for treatment, the TMS coil head including a housing containing one or more coil windings therein, and a phase change material (PCM) in contact with the one or more windings within the housing, the PCM optionally comprising a discontinuous winding path to maximize the contact area of ​​the PCM with the windings; or the TMS coil head including a conductive cooling unit in physical contact with a surface of the TMS coil head, preferably a patient-facing surface, to dissipate heat, either acting as a passive heat sink or actively cooling using conduction, convection, or electrical cooling, preferably as a Peltier thermocouple.

14. 1. A brain energy supply or brain energy detection device comprising: one or more imaging devices integrated into said energy supply and / or detection device and configured to enable direct visualization of the position of said energy supply and / or detection device; and a permanent or detachable mounting joint on a top of said energy supply and / or detection device, centered transversely relative to a central vertical axis passing through said energy supply and / or detection device, and optionally including an auxiliary component configured to connect to said mounting joint via a single-action detachment mechanism.

15. 1. A method of stimulating a target brain region by transcranial magnetic stimulation, comprising: i) providing a neuronavigation transcranial magnetic stimulation system including a TMS coil and one or more imaging devices according to claim 1; ii) positioning the TMS coil over the target area using the imaging device to visualize the placement of the TMS coil; and iii) activating and / or deactivating one or more magnetic induction coils according to a treatment protocol; Optionally, providing the patient with a head cap having indicia, including target marks, text, visual textures, images, mosaics, grids, symbols, visual codes, and / or color marks, configured to cover anatomical regions of the patient's head; and positioning the TMS coil over the target area using the imaging device to visualize placement of the TMS coil relative to the landmark; The method, comprising the step of optionally facilitating accurate positioning of the TMS coil with visual, auditory and / or tactile feedback.

Images