Systems and methods for facilitating delivery of transcranial magnetic stimulation

Abstract

Systems and methods for facilitating delivery of transcranial magnetic stimulation are disclosed. The apparatus and methods for facilitating delivery of transcranial magnetic stimulation are achieved by receiving anatomical data of a person (170), the anatomical data defining a shape of at least the person's skull and an outer surface of the skin surrounding the skull; receiving information from a tracking system (130) about a real-time position and orientation of the person's (170) head; and controlling a multi-axis robotic arm (120) to hold a TMS stimulation device (110) in an optimal position and orientation relative to the head for targeting a predetermined location within the skull with the TMS stimulation device (110) based on the anatomical data and the information about the real-time position and orientation of the head; wherein the optimal position and orientation are such that a surface of the TMS stimulation device (110) is at a predetermined distance from the outer surface of the skin.

Description

Technical Field

[0001] This invention relates to transcranial magnetic stimulation (TMS) and TMS performed via a robotic arm. Background Technology

[0002] Accurate and repeatable positioning of the TMS stimulation device (e.g., coil) is crucial during TMS delivery. While numerous solutions exist for holding and positioning the TMS stimulation device, these solutions rely on firmly pressing the device against the head to attempt to maximize stimulation delivery and minimize head movement. However, pressing the TMS stimulation device against the head can cause discomfort and even lead to abandonment of the device due to this discomfort. In many cases, even when possible, such abandonment makes TMS delivery difficult.

[0003] While some TMS applications have adopted robotic solutions, these solutions simply move the coil to a fixed position. The coil remains in this fixed position during TMS delivery and moves between TMS applications. Such solutions rely on keeping the head stationary or maintaining pressure on the head, as described above. Summary of the Invention

[0004] By employing a robotic arm and tracking system, the TMS solution according to the present invention allows for the delivery of transcranial magnetic stimulation without pressing the TMS stimulation device against the head. Such non-contact delivery is particularly beneficial in certain clinical situations (e.g., depression or chronic pain) where individuals may feel discomfort or aversion to devices that touch their heads.

[0005] Furthermore, the TMS solution according to embodiments of the present invention avoids the problems associated with systems that require pressure to be applied to the head to function. In systems that require pressure to the head, it is certain, due to error or other reasons, that the TMS stimulation device should be pressed against the head with much greater force. This can result in the device being pressed quite forcefully against the subject's head, causing the patient to flinch. Such flinching causes TMS to stop and requires repositioning the TMS stimulation device until contact can be re-established, which may only cause the patient to flinch again due to the uncomfortable and embarrassing position.

[0006] Conversely, embodiments of the invention provide a system in which the TMS stimulation device is suspended substantially above the head in a fixed position relative to the head. The head is tracked, and this tracking is used to maintain the fixed suspension position relative to the head. This suspension provides less discomfort and disturbance to the patient during TMS. For example, embodiments of the invention provide significantly reduced sound, vibration, and heat transfer because it is essentially not in contact with the head.

[0007] This invention is defined by the features of the independent claims. Certain specific embodiments are defined in the dependent claims.

[0008] According to a first aspect of the invention, an apparatus for facilitating the delivery of transcranial magnetic stimulation (TMS) is provided, comprising: a controller configured to be functionally connected to a tracking system and a multi-axis robotic arm having a TMS stimulation device fixed thereon; the controller being configured to:

[0009] - Receive human anatomical data, which defines at least the shape of the human skull and the outer surface of the skin surrounding the skull;

[0010] - Receive information about the real-time position and orientation of a person's head from the tracking system; and

[0011] - Control the multi-axis robotic arm based on anatomical data and information about the real-time position and orientation of the head to keep the TMS stimulation device in the optimal position and orientation relative to the head so as to aim the TMS stimulation device at a predetermined location within the skull.

[0012] The optimal position and orientation are such that the surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin.

[0013] According to a second aspect of the invention, a method is provided for facilitating the delivery of transcranial magnetic stimulation (TMS) via a device comprising a controller, a tracking system, and a multi-axis robotic arm having a fixed TMS stimulation device, the method comprising the following steps:

[0014] - Receive human anatomical data, which defines at least the shape of the human skull and the outer surface of the skin surrounding the skull;

[0015] - Receive information about the real-time position and orientation of a person's head from the tracking system; and

[0016] - Send control signals to control the multi-axis robotic arm based on anatomical data and information about the real-time position and orientation of the head, so as to keep the TMS stimulation device in the optimal position and orientation relative to the head, so as to aim the TMS stimulation device at a predetermined location within the skull.

[0017] The optimal position and orientation are such that the surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin.

[0018] According to a third aspect of the invention, a non-transitory computer-readable medium is provided, having stored thereon a computer-readable instruction set that, when executed by at least one processor, causes a device configured to be functionally connected to a tracking system and a multi-axis robotic arm having a fixed transcranial magnetic stimulation (TMS) device to at least:

[0019] - Receive human anatomical data, which defines at least the shape of the human skull and the outer surface of the skin surrounding the skull;

[0020] - Receive information about the real-time position and orientation of a person's head from the tracking system; and

[0021] - Send control signals to control the multi-axis robotic arm based on anatomical data and information about the real-time position and orientation of the head, so as to keep the TMS stimulation device in the optimal position and orientation relative to the head, so as to aim the TMS stimulation device at a predetermined location within the skull.

[0022] The optimal position and orientation are such that the surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin.

[0023] According to a fourth aspect of the invention, an apparatus for facilitating the delivery of transcranial magnetic stimulation (TMS) is provided, comprising: means for receiving anatomical data of a person, the anatomical data defining at least the shape of the skull and the outer surface of the skin surrounding the skull; means for receiving information about the real-time position and orientation of the person's head; and means for controlling a multi-axis robotic arm having a fixed TMS stimulation device based on the anatomical data and the information about the real-time position and orientation of the head to maintain the TMS stimulation device in an optimal position and orientation relative to the head so as to aim the TMS stimulation device at a predetermined location within the skull; wherein the optimal position and orientation such that the surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin. Attached Figure Description

[0024] Figure 1 Example devices capable of supporting at least some embodiments of the present invention are shown;

[0025] Figure 2A-2C An embodiment of the present invention is shown, which details the position of the TMS stimulation device relative to the head;

[0026] Figure 3 These are example devices capable of supporting at least some embodiments of the present invention;

[0027] Figure 4 This is a flowchart of a method according to at least some embodiments of the present invention. Detailed Implementation

[0028] definition

[0029] Throughout this application, reference may be made to the patient. It should be understood that this terminology is used for convenience and refers to the transcranial magnetic stimulation target achieved by embodiments of the present invention.

[0030] In this context, TMS stimulation devices include, but are not limited to, coils or electromagnetic coils. TMS stimulation devices may include a housing, coils, other electronic components, and a handle.

[0031] The outer surface of the skin can refer to, for example, the outer layer of the epidermis or its outer surface. In some embodiments, the outer surface of the skin may also be assumed to be the epidermal layer for ease of modeling. Such edges may be derived from medical imaging.

[0032] As discussed in this article, location can be, for example, a place, a position, a point, and a point in space. Similarly, orientation can be, for example, alignment or direction.

[0033] Embodiments of the present invention provide a system that facilitates consistent and more comfortable delivery of TMS. By tracking the head and taking into account not only the skull but also the surrounding anatomy, the robotic arm can maintain the position and orientation of the TMS stimulation device, allowing it to hover at a predetermined distance away from said anatomy. This hovering reduces patient discomfort and even allows the head to move during a round of stimulation between TMS pulse deliveries, another factor increasing patient comfort during TMS delivery.

[0034] Figure 1 An apparatus 100 for facilitating the delivery of transcranial magnetic stimulation (TMS) according to at least some embodiments of the invention is shown. As shown, the apparatus includes: a controller 150 configured to be functionally connected to a tracking system 130 and a multi-axis robotic arm 120 having a TMS stimulation device 110 fixed thereon. The controller 150 is configured to receive anatomical data of a person 170, the anatomical data defining at least the shape of the skull and the outer surface of the skin surrounding the skull. The controller is also configured to receive information from the tracking system 130 regarding the real-time position and orientation of the head of the person 170; and to control the multi-axis robotic arm 120 based on the anatomical data and the information regarding the real-time position and orientation of the head to maintain the TMS stimulation device 110 in an optimal position and orientation relative to the head, so as to aim the TMS stimulation device 110 at a predetermined location within the skull. Figure 1 As shown, the optimal position and orientation make the surface of the TMS stimulation device 110 a predetermined distance 160 from the outer surface of the skin.

[0035] In at least some embodiments of the invention, anatomical data is derived from medical imaging, including but not limited to at least one of the following: magnetic resonance imaging (MRI), computed tomography (CT), X-ray, and ultrasound. Medical images may contain information that can be directly interpreted as representing the skull and skin of an individual. In some cases, anatomical data is derived by interpreting or adapting medical imaging data. For example, imaging data may have a clear indication of the skull, but the skin may not be clearly shown; in such cases, assumptions can be made about the skin to provide anatomical data about the skin surrounding the skull. For example, the outer surface of the skin may be assumed to be at a fixed distance from the skull. In some embodiments, anatomical data defining at least the shape of a person's skull may be, for example, the shape of the brain or the shape of the cranium.

[0036] Various tracking systems can be used in conjunction with embodiments of the present invention. For example, tracking systems according to certain embodiments of the present invention are configured to track markers applied to an individual's head. Such markers can be applied to consistent locations based on anatomical landmarks to provide a consistent mapping of anatomical data to the real-time location of the head.

[0037] Several methods and apparatuses for determining the position of the TMS stimulation device 110 are known, and several such methods and apparatuses are described in more detail, at least by reference to US 2008 / 0058582 (i.e., "Transcranial magnetic stimulation induction coil device with attachment portion for receiving tracking device"), which is incorporated herein by reference. At least some of these methods include tracking markers on or attached to the stimulation device 110. However, in at least some embodiments, tracking of the stimulation device is not necessary because the geometry and position of the robotic arm with the stimulation device can provide the current position and orientation of the stimulation device. Furthermore, markers may be attached to one or more locations on the subject's head. For example, a controller according to at least some embodiments of the invention may derive or calculate the current position and orientation of the stimulation device based on the known geometry and position of the robotic arm. Such calculations may be performed using, for example, forward or inverse kinematics.

[0038] At least some embodiments of the present invention employ image recognition to track at least one of the subject's head and the TMS stimulation device. For example, a camera may be used to capture images of the TMS stimulation device and / or the subject's head, and image recognition technology can then determine the specific location and orientation of the TMS stimulation device and / or the subject's head. Some embodiments employ artificial intelligence (AI) or machine learning techniques to better track the object through image recognition. Some embodiments may even use image recognition to co-register real-time information about the position and orientation of the patient's head with anatomical data.

[0039] Anatomical data can be adjusted according to certain embodiments of the invention. Such adjustments can be made before or after the controller receives the data. For example, according to some embodiments, the controller is configured to adjust at least one of the following based on the current position of the surface of the TMS stimulation device: anatomical data of the defined outer surface of the skin of person 170, and a predetermined distance from the outer surface of the skin. For example, the anatomical data can be updated or adjusted such that, based on information about the position of the TMS stimulation device relative to the individual's head, the outer surface of the skin is now considered to be located at a point on the surface of the TMS stimulation device.

[0040] In some embodiments of the invention, anatomical data is adjusted based on the receipt of an updated signal. For example, such a signal may originate from a manual switch, a software switch, a sensor mounted on the face or surface of the TMS stimulation device, or such as... Figure 1 The foot pedal 155 is shown. In embodiments where sensors (e.g., touch sensors) are used on the face or surface of the TMS stimulation device, a calibration mode can be employed. In such a calibration mode, the robotic arm can enter a “training mode” in which movement is guided by control signals or by manual manipulation of the robotic arm or TMS stimulation device. In such a training mode, the face or surface of the TMS stimulation device contacts the patient’s head at least once, but possibly multiple times. At each contact, a new data point is derived to update the anatomical data. A preferred approach would be to have the TMS stimulation device contact the patient’s head at multiple different locations to update the anatomical data. Such a training mode can also be used to coordinate anatomical data with real-world tracking of the patient’s head, for example, taking into account errors in the tracking or registration of anatomical data with real-world data. The use of the training mode can also provide boundary conditions and increase the safety and accuracy of the apparatus and methods described herein.

[0041] In some embodiments, the system or anatomical data is calibrated or adjusted by bringing the TMS stimulation device into contact with the patient's head at least once (e.g., at least three times). In some embodiments, the TMS stimulation device is brought into contact with the patient's head at least 26 times. Such calibration or adjustment methods improve registration accuracy.

[0042] In some embodiments, the controller 150 is further configured to perform at least one calibration step, including sending a control signal configured to move the TMS stimulation device 110 toward the head until mechanical pressure or contact with the TMS stimulation device 110 is detected, for example, by at least one of the following: sensors attached to the TMS stimulation device and sensors of the robotic arm (one or more).

[0043] Figure 2A A TMS stimulation device 210 is shown in contact with a human head, which may occur during calibration or anatomical data adjustment, as discussed herein. The surface 212 of the TMS stimulation device contacts the outer surface of the skin 274 surrounding the skull 272. As discussed, the surface 212 may include sensors for detecting this contact. In some embodiments, the sensor may be such that it provides information about a specific location on the surface 212 that is in contact with the outer surface of the skin 274.

[0044] Similarly, Figure 2A As shown, the TMS stimulation device 210 is held by an adapter 225, which allows the TMS stimulation device 210 to be connected to the robotic arm 220. Such an adapter 225 can be configured to engage with the end effector of the robotic arm 220. In some embodiments, the end effector of the robotic arm 220 can act as the adapter 225. This arrangement allows the TMS stimulation device 210 to be positioned and oriented in one location to target a location within the skull 272, such as within the brain 276, for example, the cortex.

[0045] In addition to or as an alternative to touch sensors fixed to the TMS stimulation device, sensors on the robotic arm itself are used in some embodiments. For example, the robotic arm's sensors and / or motors can determine when there is excessive resistance to the movement of the robotic arm, for instance, by monitoring one or more of the following: voltage, current, acceleration, angular velocity, and angular acceleration of the motors and / or sensors. Such data obtained from the robotic arm can be used to trigger data updates or provide other inputs. In some embodiments of the invention employing touch sensors, due to the hovering method implemented by these embodiments, the touch sensors do not need to provide constant pressure sensing during TMS stimulation delivery. At least some embodiments employing touch sensors will selectively disable the touch sensors during stimulation to avoid damage to the sensors themselves or the circuitry connected to them.

[0046] In some embodiments, the user can manually bring the TMS stimulation device to the point of contact with the patient's head, for example as described above. At this time, the user or even the patient can provide a signal via a switch, for example... Figure 1The foot pedal 155. The user can feel the contact, ask the patient to indicate the contact, or use one of the above switches or inputs to determine contact with the patient's head.

[0047] Adjustments to the anatomical data described herein can be used to account for errors in imaging or imaging conversion. These adjustments can also provide adaptations for the patient's hair. For example, the system may indicate that a certain hovering distance is impossible based on sensor inputs suggesting that the TMS stimulation device is in and / or will be in contact with something (e.g., the patient or other entities near the patient). Alternatively, the user may notice that a certain hovering distance or a predetermined distance from the skin's outer surface indicated by the anatomical data is impossible. Based on such indications or determinations, the user can adjust the anatomical data independently or as prompted by the system, for example, as outlined in the adjustment and calibration techniques mentioned herein.

[0048] In some embodiments, the controller 150 is configured to perform a specific type of automatic calibration. In such an embodiment, the controller is configured to send a control signal to move the TMS stimulation device 110 to a first position further away from the head than the optimal position and orientation, for example, approximately 10 cm from the head. Thereafter, the controller moves the TMS stimulation device 110 from the first position toward the head until pressure on the TMS stimulation device 110 is detected. In some embodiments, the controller is configured to cause the first movement to occur at a first speed and the second movement to occur at a second speed slower than the first speed.

[0049] In at least some embodiments, anatomical data defining the outer surface of the skin surrounding the skull is derived through a calibration process. For example, in cases where the anatomical data is based on medical imaging, the skin layer at certain locations may not be well defined, or even defined at all. As another example, even if the TMS stimulation device is configured to hover above the outer surface of the skin, hair can cause the outer surface of the skin to become an irrationally targeted object when it is thick enough to exert pressure on the patient.

[0050] In some embodiments, the anatomical data defining the outer surface of the skin surrounding the skull may initially be blank when received by the controller. For example, there may be no explicit data defining the outer surface of the skin. In such cases, the controller may be configured to derive and / or update the data using the data adjustment methods described herein.

[0051] Figure 2B and 2C This illustrates both the expected hovering and the scenario where data adjustments may be necessary. The figure depicts the skull 272 and the skin 274 surrounding the skull and brain 276. Figure 2BIn this configuration, the TMS stimulation device 210 is held at a predetermined distance of 1 mm from the outer surface of the skin 274 by a robotic arm 220 via an adapter 225. The robotic arm maintains this position relative to the head throughout the entire TMS delivery session. However, as... Figure 2C As shown, sometimes it is necessary to adjust the anatomical data.

[0052] exist Figure 2C Within the controller, the target position 278 has been received and is therefore the optimal position and orientation for actual contact with the head, or even possibly within the skull 274. Even for a predetermined distance offset of 1 mm, resistance will be encountered and detected due to contact with the head when attempting to position the TMS stimulation device 210 at the target position 278. In some embodiments, such contact with the head may trigger a warning, stop the movement of the robotic arm, and / or initiate calibration or adjustment steps as discussed herein.

[0053] At least some embodiments of the invention employ a calibration step that uses anatomical data about the shape of the skull as an initial constraint to define anatomical data for the outer surface of the skin surrounding the skull. For example, using the calibration steps described herein, a TMS stimulation device can begin at a predetermined distance from the skull and approach it until pressure or contact is detected, thereby defining the outer surface of the skin at that location. Some embodiments may approach an initial optimal TMS delivery location and orientation until contact is detected, and then withdraw a predetermined distance to reach the optimal location and orientation. Other embodiments attempt to bring the coil to a reference location that will provide the strongest dose per delivered energy, and then withdraw a predetermined distance once pressure is detected. The reference location may be, for example, a location directly on the skull or on the skin surrounding the skull. Such calibration steps are used to eliminate errors in imaging and tracking.

[0054] In some embodiments of the invention, anatomical data defining the shape of the skull are based on anatomical data defining the outer surface of the skin surrounding the skull. In other embodiments, anatomical data defining the outer surface of the skin surrounding the skull are based on anatomical data defining the shape of the skull.

[0055] According to some embodiments of the invention, the controller 150 is further configured to: receive a predetermined position within the skull; and calculate, based on the received predetermined position within the skull, an optimal position and orientation for the surface of the TMS stimulation device 110 at a predetermined distance from the outer surface of the skin. In some embodiments, the predetermined distance from the outer surface of the skin is 0.5 mm to 5 mm, preferably not exceeding 2 mm, and most preferably not exceeding 1 mm.

[0056] At least some controllers according to embodiments of the invention are configured to receive a desired dose of TMS to be delivered at a location within the skull, and to calculate the necessary energy to be delivered to the TMS stimulation device, such that the dose is delivered at a predetermined distance from the outer surface of the skin. Some embodiments are configured such that the controller sends a signal configured to energize the TMS stimulation device and thus deliver TMS.

[0057] In addition to the benefits provided by the ability to hover during TMS, certain embodiments of the invention also provide automated movement of the TMS stimulation device from one location to another via a robotic arm, for example, from a location for first stimulation dose delivery to a location for second stimulation dose delivery. In such embodiments, a controller 150 is configured to calculate at least one path for the multi-axis robotic arm 120 to move the TMS stimulation device 110 to an optimal position and orientation, wherein the calculated path ensures that neither the multi-axis robotic arm 120 nor the TMS stimulation device 110 contacts the patient's head or other body parts. The controller 150 then sends a control signal configured to move the multi-axis robotic arm 120 along at least one path. Such automated movement may also be employed in some embodiments that perform calibration or anatomical data adjustments.

[0058] Some embodiments of the invention employ a camera (e.g., a 2 / 3D camera or other sensor) mounted on a robotic arm or TMS stimulation device, which provides collision detection and avoidance. Such a camera or sensor can detect or avoid collisions with the patient or other objects in the environment, such as the chair the patient is sitting in. This detection and avoidance can also be incorporated into the calculation of the path of movement of the robotic arm.

[0059] Some embodiments of the invention provide a controller 150 configured to define boundary conditions surrounding at least one of the head and the TMS stimulation device 110; and to prevent activation or energization of the TMS stimulation device 110 if the boundary conditions are violated. These boundary conditions prevent situations where, due to lack of calibration or other errors, the system causes the TMS stimulation device 110 to repeatedly press against the patient, leading them to abandon the device simply because the system repeatedly contacts the patient. Boundary conditions also provide increased safety, as the system can be configured to stop operation, for example, if the patient suddenly decides to leave. As an example, boundary conditions can take the form of an imaginary box or other defined volume, perhaps the size of a matchbox drawn in space. Under initial conditions, these volumes or boxes surround a fixed point on the head or the TMS stimulation device. If the fixed point leaves the box, the controller is configured to take further action. For example, the controller can be configured to retract the robotic arm from the patient to prevent accidental collisions if the boundary conditions have been violated. The controller can also be configured to send a warning signal to the operator that the boundary conditions have been violated, optionally signaling to stop further operations.

[0060] Figure 3 Example devices capable of supporting at least some embodiments of the present invention are shown. The illustrated device is 300, which may include, for example, a computer device, such as... Figure 1 The controller 150. Included in the device 300 is a processor 310, which may include, for example, a single-core or multi-core processor, wherein a single-core processor includes one processing core, and a multi-core processor includes more than one processing core. For example, processor 310 may include a Qualcomm Snapdragon 800 processor. Processor 310 may include more than one processor. Processing cores may include, for example, a Cortex-A8 processing core manufactured by Intel Corporation or a Brisbane processing core manufactured by Advanced Micro Devices Corporation. Processor 310 may include at least one application-specific integrated circuit (ASIC). Processor 310 may include at least one field-programmable gate array (FPGA). The foregoing processor types are non-limiting examples, and an Intel i7 processor or other suitable type of processor may be used.

[0061] Device 300 may include memory 320. Memory 320 may include random access memory and / or permanent memory. Memory 320 may include at least one RAM chip. Memory 320 may include magnetic, optical, and / or holographic memory. Memory 320 may be at least partially accessible by processor 310. Memory 320 may be a means for storing information. Memory 320 may include computer instructions configured to run by processor 310. When computer instructions configured to cause processor 310 to perform certain actions are stored in memory 320, and device 300 as a whole is configured to run under the guidance of processor 310 using computer instructions from memory 320, processor 310 and / or at least one of its processing cores may be considered configured to perform said certain actions.

[0062] Device 300 may include a transmitter 330. Device 300 may include a receiver 340. The transmitter 330 and receiver 340 may be configured to send and receive information respectively according to the system; for example, the transmitter 330 may send information to a monitor for display to the user, and / or the receiver 340 may receive input information about the location and / or orientation of another device.

[0063] Device 300 may include a near field communication (NFC) transceiver 350. The NFC transceiver 350 may support at least one NFC technology, such as NFC, Bluetooth, Wibree, or similar technologies.

[0064] Device 300 may include a user interface (UI) 360. UI 360 may include at least one of a display, a keyboard, and a touchscreen. A user can operate device 300 through UI 360, for example, to start or terminate the operation of a program.

[0065] Processor 310 may be equipped with a transmitter arranged to output information from processor 310 to other devices included in device 300 via electrical wires within device 300. Such a transmitter may include a serial bus transmitter arranged to output information to memory 320 for storage, for example, via at least one electrical wire. Alternatively, the transmitter may include a parallel bus transmitter. Similarly, processor 310 may include a receiver arranged to receive information from other devices included in device 300 via electrical wires within device 300. Such a receiver may include a serial bus receiver arranged to receive information from receiver 340, for example, via at least one electrical wire, for processing within processor 310. Alternatively, the receiver may include a parallel bus receiver.

[0066] Device 300 may include Figure 3 Other devices not shown. For example, if device 300 includes a computer device, it may include at least one clock or auxiliary power unit (APU) to provide battery power in the event of a main power failure.

[0067] Processor 310, memory 320, transmitter 330, receiver 340, NFC transceiver 350, and / or UI 360 can be interconnected in various ways via electrical wires within device 300. For example, each of the above-described devices can be individually connected to a main bus within device 300 to allow the devices to exchange information. However, as those skilled in the art will understand, this is merely an example, and various ways of interconnecting at least two of the above-described devices can be selected according to embodiments without departing from the scope of the invention.

[0068] Figure 4 A flowchart illustrating a method for facilitating the delivery of transcranial magnetic stimulation (TMS) via a device 100 comprising a controller 150, a tracking system 130, and a multi-axis robotic arm 120 having a fixed TMS stimulation device 110, according to at least some embodiments of the present invention, is shown. Reference Figure 1 The method has been described, but it should be understood that it can be executed on another suitable device. Figure 4 As shown, the method includes at least steps 410, 420, and 430. Step 410 involves receiving anatomical data of a person 170, which defines at least the shape of the skull and the outer surface of the skin surrounding the skull. Step 420 involves receiving information from a tracking system 130 regarding the real-time position and orientation of the head of the person 170. Step 430 involves sending control signals to control a multi-axis robotic arm 120 based on the anatomical data and the information regarding the real-time position and orientation of the head, to maintain a TMS stimulation device 110 in an optimal position and orientation relative to the head, so as to aim the TMS stimulation device 110 at a predetermined location within the skull; wherein the optimal position and orientation such that the surface of the TMS stimulation device (110) is at a predetermined distance from the outer surface of the skin.

[0069] At least some methods according to the invention also involve receiving a predetermined location within the skull; and calculating, based on the received predetermined location within the skull, the optimal position and orientation of the surface of the TMS stimulation device (110) at a predetermined distance from the outer surface of the skin.

[0070] Some methods according to embodiments of the invention involve adjusting at least one of the following based on the current position of the surface of the TMS stimulation device: anatomical data of a person (170) defining the outer surface of the skin, and a predetermined distance from the outer surface of the skin. In some of these embodiments, the adjustment is performed based on receiving an update signal, such as a signal from a switch 155 or a pressure sensor fixed to the surface of the TMS stimulation device 110.

[0071] Some methods according to the invention further include performing at least one calibration step, which includes sending a control signal configured to move the TMS stimulation device 110 toward the head until mechanical pressure or contact with the TMS stimulation device 110 is detected. Some methods also include the steps of: receiving a desired dose of TMS at a location to be delivered intracranial; and calculating the necessary energy to be delivered to the TMS stimulation device 110 such that the dose is delivered at a predetermined distance from the outer surface of the skin.

[0072] Some embodiments of the present invention include a non-transitory computer-readable medium having stored thereon a computer-readable instruction set that, when executed by at least one processor, causes a device configured to be functionally connected to a tracking system and a multi-axis robotic arm having a fixed TMS stimulation device to at least: receive anatomical data of a person, the anatomical data defining at least the shape of the person's skull and the outer surface of the skin surrounding the skull; receive information from the tracking system regarding the real-time position and orientation of the person's head; and send control signals to control the multi-axis robotic arm based on the anatomical data and the information regarding the real-time position and orientation of the head, to maintain the TMS stimulation device in an optimal position and orientation relative to the head, so as to aim the TMS stimulation device at a predetermined location within the skull; wherein the optimal position and orientation such that the surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin.

[0073] At least some embodiments of the present invention include a computer program configured to facilitate the methods described herein.

[0074] In some embodiments of the invention, a stimulation device is considered suitable for use as long as the curvature of the surface facing the head during stimulation is not greater than the assumed or average curvature of the head. In other words, the curvature of the stimulation device should not be greater than the head of the individual to be stimulated to avoid the problem of maintaining distance from the individual's skull.

[0075] Embodiments of the present invention can be used with a variety of TMS stimulation devices employing multiple coil designs. For example, butterfly coils, curved wing coils, and figure-eight coils are particularly well-suited for use.

[0076] In at least some embodiments of the invention, the controller includes data regarding the dimensions of the TMS stimulation device and the robotic arm. The controller may also include data regarding the position and orientation of the TMS stimulation device relative to the robotic arm.

[0077] In at least some embodiments of the invention, the target or target location is the location of the maximum e-field (electric field) to be delivered by the TMS stimulation device when activated or energized. For example, the target may be intracortical. In at least some embodiments, the TMS stimulation device is positioned and oriented to target a predetermined location such that the maximum electric field of the predetermined stimulation will appear at that location. In some embodiments, a dose is calculated such that a selected V / m dose is delivered to the target location, such as the stimulation line of sight on the cortex. Some embodiments employ the dose initially intended for delivery while the TMS stimulation device is in contact with the patient's head, compensating for the TMS stimulation device maintaining a predetermined distance away from the head. Some embodiments achieve the predetermined distance by taking into account the expected dose and target location and determining the position and orientation relative to the patient's head from which the dose will be delivered.

[0078] At least some embodiments of the present invention provide a system in which a desired dose is provided and calculations are performed to determine the location of contact with the patient's head where the desired dose will be delivered. An optimal location and orientation are then determined such that the contact point is at a predetermined distance from the head. For example, 0.5-2 mm from the head.

[0079] At least some embodiments of the present invention provide a device for facilitating the delivery of transcranial magnetic stimulation (TMS), comprising:

[0080] - Multi-axis robotic arm;

[0081] - A TMS stimulation device fixed to a multi-axis robotic arm;

[0082] - A tracking system configured to track at least the head of an individual; and

[0083] - A controller that is functionally connected to the multi-axis robotic arm and tracking system;

[0084] The controller is configured as follows:

[0085] - Receive human anatomical data, which defines at least the shape of the human skull and the outer surface of the skin surrounding the skull;

[0086] - Receive information about the real-time position and orientation of a person's head from the tracking system; and

[0087] - Control the multi-axis robotic arm based on anatomical data and information about the real-time position and orientation of the head to keep the TMS stimulation device in the optimal position and orientation relative to the head so as to aim the TMS stimulation device at a predetermined location within the skull.

[0088] The optimal position and orientation are such that the surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin.

[0089] Some embodiments of the present invention provide a device for facilitating the delivery of transcranial magnetic stimulation (TMS), the device being configured to be functionally connected to a tracking system and a multi-axis robotic arm having a fixed TMS stimulation device, the device including at least one processing core and at least one memory including computer program code, said at least one memory and computer program code being configured to utilize said at least one processing core such that the device at least:

[0090] - Receive human anatomical data, which defines at least the shape of the human skull and the outer surface of the skin surrounding the skull;

[0091] - Receive information about the real-time position and orientation of a person's head from the tracking system; and

[0092] - Control the multi-axis robotic arm based on anatomical data and information about the real-time position and orientation of the head to keep the TMS stimulation device in the optimal position and orientation relative to the head so as to aim the TMS stimulation device at a predetermined location within the skull.

[0093] The optimal position and orientation are such that the surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin.

[0094] Suitable robotic devices used in embodiments of the invention include at least one motor, such as a servo motor, stepper motor, hydraulic motor, or pneumatic motor, linked to at least one joint, such as a rotary joint or linear joint. In a preferred embodiment, the robotic device is a robotic arm comprising at least five motors and at least five rotary joints connected by links arranged one after another. Individual or integrated controllers controlling the aforementioned motors are used to control the robot's movement. For example, the Universal Robots UR5 robot is suitable for use with the present invention. Other types of robot manipulators may also be used with the present invention.

[0095] As discussed in this article, human anatomical data can be human anatomical data or anatomical data derived from or through humans.

[0096] It should be understood that the embodiments of the invention disclosed herein are not limited to the specific structures, processes, or materials disclosed herein, but extend to equivalents that will be recognized by those skilled in the art. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not restrictive.

[0097] Throughout this specification, references to "one embodiment" or "embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment of the invention. Therefore, the phrases "in one embodiment" or "in an embodiment" appearing in various places throughout the specification do not necessarily refer to the same embodiment.

[0098] As used herein, for convenience, multiple entries, structural elements, constituent elements, and / or materials may be presented in a common list. However, these lists should be interpreted as if each member of the list were individually identified as a separate and unique member. Therefore, without the indication to the contrary, no single member in such a list should be construed as being factually equivalent to any other member in the same list solely based on its presentation in a common group. Furthermore, various embodiments and examples of the invention, along with alternatives to its various components, are mentioned herein. It should be understood that these embodiments, examples, and alternatives should not be construed as factual equivalents of each other, but should be regarded as separate and autonomous representations of the invention.

[0099] Furthermore, the described features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. Numerous specific details, such as examples of length, width, shape, etc., are provided in the following description to provide a thorough understanding of embodiments of the invention. However, those skilled in the art will recognize that the invention can be practiced without one or more specific details, or using other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the invention.

[0100] While the foregoing examples illustrate the principles of the invention in one or more specific applications, it will be apparent to those skilled in the art that many modifications can be made to the form, use, and details of the implementation without departing from the principles and concepts of the invention, without requiring inventiveness. Therefore, the invention is not intended to be limited except as defined by the following claims.

[0101] The verbs “comprising” and “including” are used in this document as open-ended restrictions, neither excluding nor requiring the presence of features not yet listed. Unless otherwise expressly stated, the features recited in the dependent claims may be freely combined with each other. Furthermore, it should be understood that the use of “a” or “an” (i.e., the singular form) in this document does not exclude a plurality.

[0102] List of abbreviations

[0103] TMS transcranial magnetic stimulation

[0104] Reference tag list

[0105] 100 devices

[0106] 110 TMS stimulation device

[0107] 120 robotic arm

[0108] 130 Tracking System

[0109] 150 controller

[0110] 155 Foot pedal / switch

[0111] 160 Pre-determined distance

[0112] 170 people

[0113] 210 TMS Stimulation Device

[0114] Surface of 212 TMS stimulation device

[0115] 220 robotic arms

[0116] 225 Adapter

[0117] 272 Skull

[0118] 274. The outer surface of the skin

[0119] 276 Brain

[0120] 278 Target Location

[0121] 300 device

[0122] 310 processor

[0123] 320 memory

[0124] 330 transmitter

[0125] 340 receiver

[0126] 350 transceiver

[0127] 360 UI

Claims

1. A device (100) for facilitating the delivery of transcranial magnetic stimulation (TMS), comprising: - A controller (150) is configured to be functionally connected to a tracking system (130) and a multi-axis robotic arm (120) having a TMS stimulation device (110) fixed to the multi-axis robotic arm (120). The controller (150) is configured to: - Anatomical data of a receiving person (170), the anatomical data defining at least the shape of the skull of the person and the outer surface of the skin surrounding the skull; - Receive information about the real-time position and orientation of the person's (170) head from the tracking system (130); as well as - The multi-axis robotic arm (120) is controlled based on the anatomical data and information about the real-time position and orientation of the head to maintain the TMS stimulation device (110) in an optimal position and orientation relative to the head during TMS stimulation so as to aim the TMS stimulation device (110) at a predetermined location within the skull. The optimal position and orientation are such that the surface of the TMS stimulation device (110) is at a predetermined non-zero distance from the outer surface of the skin, and the anatomical data is derived from medical imaging, and the controller is configured to send a warning signal to the operator or stop the multi-axis robotic arm (120) in response to determining that the multi-axis robotic arm (120) has contacted the head.

2. The device according to claim 1, wherein, The controller (150) is also configured to: - Receive a predetermined location within the skull; and - Calculate the optimal position and orientation of the surface of the TMS stimulation device (110) at the predetermined distance from the outer surface of the skin based on the received predetermined position within the skull.

3. The device according to claim 1 or 2, wherein, The predetermined distance from the outer surface of the skin is 0.5 mm to 5 mm.

4. The device according to claim 3, wherein, The predetermined distance from the outer surface of the skin does not exceed 2 mm.

5. The device according to claim 3, wherein, The predetermined distance from the outer surface of the skin does not exceed 1 mm.

6. The device according to claim 1 or 2, wherein, The controller (150) is also configured to adjust at least one of the following based on the current position of the surface of the TMS stimulation device (110): - Anatomical data of the person (170) defining the outer surface of the skin, and - The predetermined distance from the outer surface of the skin.

7. The device according to claim 6, wherein, The controller (150) is also configured to perform the adjustment based on receiving an update signal, such as a signal from a switch (155) or a pressure sensor fixed to the surface of the TMS stimulation device (110).

8. The device according to claim 1 or 2, wherein, The controller (150) is also configured to perform at least one calibration step, the calibration step including sending a control signal configured to move the TMS stimulation device (110) toward the head until mechanical pressure or contact with the TMS stimulation device (110) is detected.

9. The device according to claim 1 or 2, wherein, The controller (150) is also configured to: - Receive a predetermined dose of TMS to be delivered at the location within the skull; - Calculate the necessary energy to be delivered to the TMS stimulation device (110) so that the dose is delivered at a predetermined distance from the outer surface of the skin.

10. The device according to claim 1 or 2, wherein, The controller (150) is also configured to: - Calculate at least one path that causes the multi-axis robotic arm (120) to move the TMS stimulation device (110) to the optimal position and orientation, wherein the path is calculated such that neither the multi-axis robotic arm (120) nor the TMS stimulation device (110) contacts the head; and - Send control signals configured to move the multi-axis robotic arm (120) along at least one path.

11. The device according to claim 1 or 2, wherein, The anatomical data are derived from medical imaging based on at least one of the following: magnetic resonance imaging (MRI), computed tomography (CT), X-ray, and ultrasound.

12. The device according to claim 1 or 2, wherein, The controller (150) is also configured to: -Boundary conditions defining at least one of the head and the TMS stimulation device (110); and - If the boundary condition is violated, activation of the TMS stimulation device (110) is prevented.

13. A method for facilitating the delivery of transcranial magnetic stimulation (TMS) via a device (100), said device (100) comprising a controller (150), a tracking system (130), and a multi-axis robotic arm (120) having a fixed TMS stimulation device (110), said method comprising the steps of: - Anatomical data of a receiving person (170), the anatomical data defining at least the shape of the skull of the person and the outer surface of the skin surrounding the skull; - Receive information about the real-time position and orientation of the person's (170) head from the tracking system (130); as well as - Send control signals to control the multi-axis robotic arm (120) based on the anatomical data and information about the real-time position and orientation of the head, so as to keep the TMS stimulation device (110) in an optimal position and orientation relative to the head during TMS stimulation, so as to aim the TMS stimulation device (110) at a predetermined location within the skull; The features are that the optimal position and orientation are such that the surface of the TMS stimulation device (110) is at a predetermined non-zero distance from the outer surface of the skin, and the anatomical data is derived from medical imaging, and the method is: in response to determining that the multi-axis robotic arm (120) has contacted the head, sending a warning signal to the operator or stopping the multi-axis robotic arm (120).

14. The method of claim 13, further comprising the step of: - Receive a predetermined location within the skull; and - Calculate the optimal position and orientation of the surface of the TMS stimulation device (110) at the predetermined distance from the outer surface of the skin based on the received predetermined position within the skull.

15. The method of claim 13 or 14, further comprising adjusting at least one of the following based on the current position of the surface of the TMS stimulation device: - Anatomical data of the person (170) defining the outer surface of the skin, and - The predetermined distance from the outer surface of the skin.

16. The method according to claim 15, wherein, The adjustment is performed based on the receipt of an update signal, such as a signal from a switch (155) or a pressure sensor fixed to the surface of the TMS stimulation device (110).

17. The method of claim 13 or 14, further comprising performing at least one calibration step, the calibration step comprising sending a control signal configured to move the TMS stimulation device (110) toward the head until mechanical pressure or contact with the TMS stimulation device (110) is detected.

18. The method according to claim 13 or 14, further comprising the step of: - Receive a predetermined dose of TMS to be delivered at the location within the skull; - Calculate the necessary energy to be delivered to the TMS stimulation device (110) so that the dose is delivered at a predetermined distance from the outer surface of the skin.

19. A non-transitory computer-readable medium storing a set of computer-readable instructions that, when executed by at least one processor, cause a device configured to be functionally connected to a tracking system and a multi-axis robotic arm having a fixed transcranial magnetic stimulation (TMS) device to at least: - Receive anatomical data of a person, the anatomical data defining at least the shape of the skull of the person and the outer surface of the skin surrounding the skull; - Receive information about the real-time position and orientation of the person's head from the tracking system; as well as - Send control signals to control the multi-axis robotic arm based on the anatomical data and information about the real-time position and orientation of the head, so as to keep the TMS stimulation device in an optimal position and orientation relative to the head during TMS stimulation, so as to aim the TMS stimulation device at a predetermined location within the skull. The device is characterized in that the optimal position and orientation cause the surface of the TMS stimulation device to be at a predetermined non-zero distance from the outer surface of the skin, and the anatomical data is derived from medical imaging, and when the computer-readable instruction set is executed, the device further causes the device to: send a warning signal to the operator or stop the multi-axis robotic arm (120) in response to determining that the multi-axis robotic arm (120) has contacted the head.

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