Coil holding unit and transcranial magnetic stimulation device

Abstract

In order to provide a therapeutic coil unit capable of correctly and reliably attaching an rTMS therapeutic coil to a treatment site, and a transcranial magnetic stimulation device provided with the therapeutic coil unit, a coil holding unit (20) is provided with: a frame member on which a transcranial magnetic stimulation coil device is attached, the frame member being provided with a window section (14) through which a magnetically stimulated site can be observed; the coil device is provided with a display (6) that shows the center position of the magnetic field when the coil device is mounted.

Description

Technical Field

[0001] This invention relates to magnetic stimulation, and to a magnetic stimulation device coil holding unit that allows the therapist to easily align and fix the therapeutic coil used in the magnetic stimulation therapy device with the treatment area on the head. Background Technology

[0002] In recent years, transcranial magnetic stimulation (rTMS) has garnered increasing attention as a treatment for neuropathic diseases such as refractory neuropathic pain, Parkinson's disease, Parkinson's syndrome, depression, PTSD, and post-stroke rehabilitation, for which drug therapy may not be effective. For patients unresponsive to various antidepressants such as tricyclic antidepressants, MAOIs, and SARIs, rTMS has shown efficacy and was even included in Japanese insurance in 2019, raising hopes for its potential as a new treatment option.

[0003] rTMS is a treatment method that uses pulsed magnetic fields to induce eddy currents that stimulate cortical neurons, thereby non-invasively altering the activity of the cortex and subcortex. The eddy currents generated within the cortex stimulate neurons to release neurotransmitters, and repeated, regular stimulation can improve depressive symptoms.

[0004] In the treatment of depression, high-frequency rTMS is performed on the left dorsolateral prefrontal cortex of the brain. While serious side effects such as seizures are infrequent with rTMS, side effects such as scalp pain, headache, and discomfort are identifiable. The presence and proper placement of the coil in the correct position on the patient's head significantly influence the occurrence of discomfort. During rTMS treatment, the physician and / or technician determine the required magnetic intensity and the precise placement of the stimulation coil on the patient's head. In subsequent treatments, the coil must be correctly positioned in the determined location.

[0005] Prior art literature Patent documents Patent Document 1: WO2004 / 080526 (Japanese Patent Publication No. 2006-520671); Patent Document 2: WO2007 / 123147. Summary of the Invention

[0006] The problem that the invention aims to solve Transcranial magnetic stimulation (TMS) is used for non-invasive treatment of mental and neurological disorders. During treatment, aligning the center of the coil (the center generating the magnetic field) with the treatment site is effective in minimizing the impact on non-treatment areas. Furthermore, to maximize the therapeutic effect of magnetic stimulation, the treatment coil should be kept as close to the treatment site as possible. This is because the electric field weakens as the coil moves away from the treatment site.

[0007] Patent Document 1 discloses a device for positioning a treatment coil in a predetermined position, which includes a wearable frame component having a window for mounting the coil and an adjustment structure for positioning the coil in an ideal position for each patient.

[0008] The device in question uses a resin fixation device shaped to fit the patient's head for positioning. However, the frame needs to be adjusted and constructed for each patient, which takes time before treatment begins. Furthermore, using the bridge of the nose as the starting point for positioning can easily lead to errors relative to the treatment position.

[0009] Patent document 2 discloses a head fixation device for transcranial magnetic stimulation therapy, which includes a resin shell molded to conform to the shape of the subject's head. In this fixation device, the shell needs to be custom-molded to fit the shape of the subject's nasal root and ears, requiring time before treatment begins. Furthermore, the fixation device employs a relative positioning method, for example, using the bridge of the nose as a starting point, which tends to introduce errors relative to the treatment position.

[0010] In transcranial magnetic stimulation (TMS) using conventional treatment coils and coil holders, the holders are designed to adapt the coil placement to the subject's head shape, making it easy for the subject to align the treatment position with the coil center. However, because the treatment position is inferred from an indirect positional relationship based on the subject's head shape, it is difficult to ensure the correct position relative to the treatment point based on each patient's head shape and size, and it is difficult to minimize the offset between the treatment position and the treatment coil position. Furthermore, while providing dedicated holders for each patient solves the above problems, the increased cost due to the need for customized holders for a large number of patients becomes a concern.

[0011] Furthermore, while accurate positioning can be ensured by using cameras or 3D positioning systems, which are known technologies, the high cost of the necessary devices / systems for positioning becomes an obstacle to equipment adoption.

[0012] Solution for solving the problem The present invention provides a therapeutic coil unit as shown below and a transcranial magnetic stimulation device having the same as thereon as a device capable of correctly and reliably wearing the therapeutic coil of rTMS at the treatment site.

[0013] 1) A coil holding unit that holds a coil device that generates a magnetic field in a predetermined position, wherein the magnetic field is used to perform magnetic stimulation on a user, the coil holding unit being characterized by having a frame member having a coil mounting part for mounting and fixing the coil device and a window for observing the magnetic stimulation site, and having a display showing the center position of the magnetic field when the coil device is mounted in the window of the frame member, wherein magnetic stimulation is performed on the predetermined position by aligning the display with the position marked on the user's skin for treatment.

[0014] 2) The coil holding unit described in 1) above is characterized in that the aforementioned display member is a fibrous or strip-shaped member mounted between the frame members constituting the window portion, and when the coil device is installed in the coil holding unit, it is in contact with at least the treatment area of ​​the head.

[0015] 3) The coil holding unit described in 1) above is characterized in that the aforementioned frame component and display component are non-magnetic components.

[0016] 4) The coil holding unit described in 1) above is characterized in that the aforementioned frame member covers the user's head and has a window portion capable of identifying at least the area including the dorsolateral prefrontal cortex of the user's head.

[0017] 5) The coil holding unit described in 1) above is characterized in that it has a fixing device that fixes the coil holding unit to the user's jaw and back of the head when the display and the treatment site are aligned in a predetermined position.

[0018] 6) The coil holding unit described in 1) above is characterized in that the coil holding unit has at least two protrusions for mounting the coil device in a predetermined position.

[0019] 7) The coil holding unit described in 1) above is characterized in that the aforementioned frame component covers the user's head, and a guide rod is provided on the user's front side of the aforementioned frame component, the guide rod being installed along the user's midline and defining the position of the frame component and the tip of the patient's nose.

[0020] 8) The coil holding unit described in 7) above is characterized in that it has an indicator at the end of the aforementioned guide rod that indicates the position of the user's nose tip.

[0021] 9) A transcranial magnetic stimulation device comprising a coil device that generates a magnetic field to magnetically stimulate a user’s head, and a coil holding unit that holds the coil device in a predetermined position on the head, the coil holding unit comprising a frame member having a coil mounting portion for mounting the coil device on the head, a window portion for observing the magnetic stimulation portion, a display showing the center position of the magnetic field when the coil device is mounted on the window portion, and a fixing member for fixing the coil holding unit by aligning the display with the position of a marked treatment site.

[0022] 10) The transcranial magnetic stimulation device described in 9) above is characterized in that the aforementioned frame component covers the user's head, and a guide rod is provided on the user's front side of the aforementioned frame component, the guide rod being installed along the user's midline and defining the position of the frame component and the tip of the patient's nose.

[0023] The effects of the invention When the treatment coil of a transcranial magnetic stimulation (TMS) device is placed against the treatment site of a patient, it is difficult to confirm whether the center of the magnetic field of the treatment coil is correctly aligned with the treatment site. The TMS device of the present invention includes a treatment coil holding unit that fixes the treatment coil in a manner that aligns the treatment position of the patient's head with the center of the magnetic field of the treatment coil. By visually aligning the display of the treatment coil holding unit with the treatment site of the patient's head, the center of the magnetic field of the treatment coil can be correctly located at the treatment site. Furthermore, the treatment coil can be easily aligned and fixed for different treatment sites corresponding to various diseases, preventing magnetic stimulation of the wrong site during treatment.

[0024] Furthermore, by having a guide rod on the front side of the frame component of the coil holding unit that runs along the patient's midline and positions the tip of the patient's nose, the patient can align the coil holding unit, which has been aligned in a medical institution, while looking in a mirror, thus paving the way for home treatment of transcranial magnetic stimulation. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of a previous transcranial magnetic stimulation device.

[0026] Figure 2 This is an external view of an example of a first embodiment of the coil holding unit of the present invention.

[0027] Figure 3 This is an external view of the coil assembly.

[0028] Figure 4 This is a schematic diagram illustrating a method of wearing a transcranial magnetic stimulation device incorporating the coil holding unit and coil device of the present invention.

[0029] Figure 5 This is an external view of an example of a second embodiment of the coil holding unit of the present invention.

[0030] Figure 6 This is an external view of an example of a third embodiment of the coil holding unit of the present invention.

[0031] Figure 7 This is an external view showing an example of the third embodiment of the coil holding unit of the present invention in a wearing state.

[0032] Figure 8 This is an external view showing an example of the incorrectly worn state of the coil holding unit of the present invention in a third embodiment. Detailed Implementation

[0033] The transcranial magnetic stimulation device and treatment coil holding unit of the present invention are described as an example of a treatment device for a patient presenting with depressive symptoms.

[0034] like Figure 1 As shown, the transcranial magnetic stimulation (TMS) device generates a pulsed magnetic field in the coil device 2 by supplying a pulsed current from the coil drive power supply 1 via the cable 3. By varying this magnetic field, weak eddy currents are locally induced according to Faraday's law, thereby stimulating neurons in the brain. The stimulation site on the head needs to be correctly determined. The coil device 2 is fixed to the treatment coil fixation table 10 in a manner that prevents positional shift during treatment, and the magnetic therapy continues while the patient is seated in a chair.

[0035] Various parts of the brain control emotions such as joy, anger, sorrow, and happiness, as well as sleep and appetite. In patients presenting with depressive symptoms, activity in the left dorsolateral prefrontal cortex (DLPFC) decreases, while the amygdala exhibits an overactive response. rTMS activates the DLPFC through magnetic stimulation, allowing motivation and thinking abilities to function normally, and subsequently inhibits the overactive response of the amygdala.

[0036] To perform rTMS therapy, it is necessary to find the appropriate stimulation site and intensity. The location of the DLPFC is the F3 point measured by EEG, and the stimulation site and appropriate stimulation intensity are determined based on the BeamF3 method. The BeamF3 method specifically determines the F3 location based on a predetermined algorithm by measuring three head values. By specifically determining and marking the F3 point at the beginning of treatment, subsequent treatments do not require prior localization; the marked location is then irradiated with magnetic energy.

[0037] The marking is preferably done directly on the head using an oil-based marker or ink, or other non-fading paint. However, when marking directly on the head, there is a disadvantage: the marking is difficult to see due to hair, and it gradually fades when the scalp is washed, such as in a shower.

[0038] Therefore, during treatment, a head-fitting cap, such as a swimming cap, can be worn and marked. If the cap is made of a mesh or stretchy material like a swimming cap, there is a possibility that the marking position may shift each time the cap is worn, so it is preferable to use a non-stretchable material such as cotton.

[0039] The cap is worn during treatment and removed after treatment, so patients need to wear it in the same way each time. The cap worn during rTMS treatment has a line in the center corresponding to the midline. It can be worn in the same position each time by aligning the line with the nose line of the face corresponding to the user's midline, and making the line under the cap horizontal with the user's eyebrow line, etc.

[0040] [Coil Holding Unit] exist Figure 2 The diagram shows an external view of an example of a first embodiment of the coil holding unit of the present invention.

[0041] The coil holding unit 20 holds the coil device, which generates a magnetic field to stimulate the patient's head, in a predetermined position on the head. The coil device is installed, and magnetic stimulation is applied directly to the head. The coil fixing cap 4 is worn on the head and secured to it by a fastening strap 5. The coil fixing cap 4 has a frame component with a window 14 that serves as an opening for observing the magnetic stimulation site. The fastening strap 5, such as a dial-type ratchet strap 11, allows for size changes and adjustment of the coil holding unit to suit the user's head size. To reduce coil misalignment during treatment, a chin strap or other fixation device can also be included to secure the coil to the patient's jaw as needed.

[0042] The window portion 14 includes a treatment position display 6, which serves as a display for the center position of the magnetic field when the coil device is installed. By visually aligning the treatment position display 6 with the marked treatment area, magnetic stimulation can be applied to the designated location. The treatment position display 6 is a fibrous or strip-like component mounted between the frame members constituting the window portion 14, and has a central ring for indicating the center position of the coil. However, if the center position of the coil can be indicated by changes in shape or color other than the ring, the treatment position display 6 does not need to have a specific shape. To prevent attenuation of the magnetic field or displacement of the magnetic field center position due to the space between the coil device and the head when wearing the coil device, it is preferable to use a material such as elastic rubber so that the surface of the coil device and the treatment position display 6 are pressed together against the head for contact.

[0043] exist Figure 5 In the second embodiment of the treatment position display, a coil holding unit is shown in which two strip-shaped members 6' are arranged in a cross configuration. The intersection of the two strips can be positioned at the center of the coil for alignment with the treatment position.

[0044] The coil holding unit generates a magnetic field to perform treatment by mounting a coil device. Therefore, components such as the frame and treatment position display are made of non-magnetic materials such as resin and fiber to avoid affecting the magnetic field. Preferably, the materials used are those that maintain the strength of the coil device and are biocompatible due to contact with the body; resin components such as polylactic acid, polypropylene, or polyacetal can be used. Where metal parts are required, such as at joints, titanium is preferred.

[0045] exist Figure 3 The diagram shows the external appearance of coil device 2. It is a view taken from the scalp contact side, showing the excitation coil housed within the frame. Depending on the application, the excitation coil may be a typical circular coil, a figure-eight coil, or a butterfly coil with a modified coil angle, etc. Figure 3 It has a built-in figure-eight coil, and the center 7 of the coil indicates the center position of the magnetic field generated by the excitation coil of the coil device 2. When assembled into the coil holding unit, the position of the center 7 of the coil is consistent with the position of the ring of the treatment position display 6.

[0046] When the coil device 2 is installed on the coil holding unit, the treatment position display 6 is pressed by the coil device 2 and comes into contact with the treatment area on the head. Within the area where the coil device 2 is installed, the treatment coil holding unit has a structure that does not interfere with the magnetic field, and the coil device preferably has a structure that can be formed in a way that allows it to be close to the treatment area.

[0047] The coil holding unit has at least two protrusions 9 for mounting the coil device in a predetermined position. These protrusions 9 engage with the recesses 12 and 13 of the coil device to fix and hold both in the predetermined position. In the proposed embodiment, the coil holding unit side has protrusions, and the coil device side has engagement portions with recesses; however, the combination of protrusions and recesses, and the shape of the engagement portions, can be appropriately selected.

[0048] exist Figure 4 The diagram illustrates a method for wearing a transcranial magnetic stimulation device incorporating the coil holding unit and coil assembly of the present invention.

[0049] When performing magnetotherapy as shown in (4a), the physician specifically determines the magnetotherapy location during the initial consultation, marking the treatment area on the patient's head. In cases of depression treatment, the DLPFC is irradiated at the F3 point of brainwave measurement, with the stimulation site determined based on the BeamF3 method. The patient wears a small, elastic cotton cap, on which the markings are made.

[0050] Next, as shown in (4b), the coil holding unit of the present invention is worn, and as shown in (4c), the position of the treatment position display 6 is aligned with the marked position, and the coil holding unit is fixed to the head. Thereon, as shown in (4d), the coil device is assembled onto the coil holding unit, and treatment begins.

[0051] As a device for treating depression, the window of the coil holding unit needs to be able to identify the area including the patient's dorsolateral prefrontal cortex.

[0052] exist Figure 6 The diagram shows an external view of an example of a third embodiment of the coil holding unit of the present invention. The embodiments involved are described in... Figure 2 The coil holding unit 20 of the first embodiment shown in the diagram has a guide rod 21 on the user-facing side of the frame portion 4' covering the outer periphery of the head in the coil fixing cap 4. The end of the guide rod 21 is the tip of the nose, and the guide rod 21 is installed along the midline of the patient. In medical institutions, after the position of the coil holding unit 20 is adapted to align the positions of the treatment position 8 and the treatment position display 6, the guide rod 21 is fixed to the frame portion 4'. In addition to completely fixing the frame portion 4' and the guide rod 21 by means of adhesives or welding, a method showing the fixing position can also be used.

[0053] At the end of the guide rod 21 is a ring-shaped indicator 22 that indicates the tip of the user's nose. The shape of the indicator 22 is not particularly limited, as long as it serves as a mark of the position of the tip of the nose.

[0054] like Figure 7As shown, the user puts on the coil holding unit while looking in a mirror, so that the guide rod 21 becomes straight along its own midline and the indicator part 22 at the end of the guide rod is positioned at the tip of the nose. This allows the user to maintain a state in which the position of the treatment position display 6 of the coil holding unit is consistent with the position of the marked treatment site. By fixing the state in question, the user can assemble the coil of the transcranial magnetic stimulation device into the correct position by itself.

[0055] The user checks himself in the mirror to confirm if... Figure 8 The coil holding unit is shown with vertical offset (8a, 8b), horizontal offset (8c, 8d), and horizontal diagonal offset (8e, 8f), as shown. Figure 7 As shown, it can be adjusted to the correct wearing position, and can be used for home treatment in addition to treatment in medical institutions.

[0056] In the device in question, there is no need to confirm the treatment position. In addition to the method of assembling the coil of the transcranial magnetic stimulation device after wearing the coil holding unit, the transcranial magnetic stimulation device can also be aligned with the coil pre-assembled in the coil holding unit.

[0057] Industrial availability The present invention is a coil holding unit that holds the coil device used in transcranial magnetic stimulation therapy in a predetermined position, and can be used as a transcranial magnetic stimulation device.

[0058] Explanation of reference numerals in the attached figures 1. Coil drive power supply 2. Coil assembly 3 Cables 4. 4' Coil Fixing Cap 5 Fastening straps 6' Treatment position display 7. Coil center 8 Treatment Location 9. Protrusion 10. Treatment coil fixation table 11. Dial-type ratchet belt 12 recess 13 recess 14. Window section 20 Coil Holding Unit 21 guide rods 22. Instruction section.

Claims

1. A coil holding unit for holding a coil device that generates a magnetic field in a predetermined position, wherein the magnetic field is used to provide magnetic stimulation to a user, the coil holding unit being characterized by having a frame member having a coil mounting portion for mounting and fixing the coil device and a window portion for observing the magnetic stimulation site, and having a display showing the center position of the magnetic field when the coil device is mounted in the window portion of the frame member, wherein magnetic stimulation is provided at the predetermined position by aligning the display with the position of a marked treatment site.

2. The coil holding unit according to claim 1, characterized in that, The display element is a fibrous or strip-shaped component mounted between the frame components constituting the window, and is in contact with the treatment site at least when the coil device is installed in the coil holding unit.

3. The coil holding unit according to claim 1, characterized in that, The frame component and the display component are non-magnetic components.

4. The coil holding unit according to claim 1, characterized in that, The frame component covers the user's head and has a window that allows identification of at least the dorsolateral prefrontal cortex of the user's head.

5. The coil holding unit according to claim 1, characterized in that, Equipped with a fixation device, the fixation device secures the coil holding unit to the user's jaw and back of the head while aligning the display and the treatment site in a predetermined position.

6. The coil holding unit according to claim 1, characterized in that, The coil mounting portion has at least two fitting portions for mounting and fixing the coil device to the coil holding unit.

7. The coil holding unit according to claim 1, characterized in that, The frame component covers the user's head, and a guide rod is provided on the user's front side of the frame component. The guide rod is installed along the user's midline and defines the position of the frame component and the tip of the user's nose.

8. The coil holding unit according to claim 7, characterized in that, The end of the guide rod has an indicator showing the position of the user's nose tip.

9. A transcranial magnetic stimulation device comprising a coil device that generates a magnetic field to magnetically stimulate a user's head, and a coil holding unit that holds the coil device in a predetermined position on the head, the coil holding unit comprising a frame member having a coil mounting portion for mounting the coil device on the head and a window portion for observing the magnetic stimulation portion, a display showing the center position of the magnetic field when the coil device is mounted on the window portion, and a fixing member for aligning the display with the position of a marked treatment site to fix the coil holding unit.

10. The transcranial magnetic stimulation device according to claim 9, characterized in that, The frame component covers the user's head, and a guide rod is provided on the user's front side of the frame component. The guide rod is installed along the user's midline and defines the position of the frame component and the tip of the user's nose.

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