WO2023000625A1 - Bobine de stimulation magnétique transcrânienne et casque pour stimulation magnétique profonde et précise - Google Patents

Bobine de stimulation magnétique transcrânienne et casque pour stimulation magnétique profonde et précise Download PDF

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Publication number
WO2023000625A1
WO2023000625A1 PCT/CN2022/071107 CN2022071107W WO2023000625A1 WO 2023000625 A1 WO2023000625 A1 WO 2023000625A1 CN 2022071107 W CN2022071107 W CN 2022071107W WO 2023000625 A1 WO2023000625 A1 WO 2023000625A1
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coil
magnetic stimulation
shaped coil
shaped
stimulation
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PCT/CN2022/071107
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English (en)
Chinese (zh)
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吴潇
张隽毅
林彦辰
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杭州米福科技有限公司
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Publication of WO2023000625A1 publication Critical patent/WO2023000625A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00Magnetotherapy
    • A61N2/004Magnetotherapy specially adapted for a specific therapy
    • A61N2/006Magnetotherapy specially adapted for a specific therapy for magnetic stimulation of nerve tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00Magnetotherapy
    • A61N2/02Magnetotherapy using magnetic fields produced by coils, including single turn loops or electromagnets

Definitions

  • the invention belongs to the field of medical equipment, and in particular relates to a transcranial magnetic stimulation coil and a helmet for deep precise magnetic stimulation.
  • Transcranial magnetic stimulation is the use of time-varying pulse electromagnetic field induced electric field to act on the central nervous system of the brain, changing the membrane potential of the cerebral cortex nerve cells, affecting the metabolism and neural electrical activity in the brain, thus causing a series of A therapeutic method in the field of brain nerves based on physiological and biochemical reactions.
  • Existing transcranial magnetic stimulation devices are mainly planar circular coils and planar 8-shaped coils.
  • the Chinese patent document with the publication number CN112582159A discloses a stimulation coil for magnetic stimulation, including a coil body, a coil hole is provided in the middle of the coil body, and the coil body includes an upper layer coil and a lower layer coil, and the upper layer Both the coil and the lower coil are tightly wound by the same wire tube, the upper coil and the lower coil are connected through a transition wire tube at the outer edge of the coil hole, and the wire tube of the outer coil of the upper coil is bent A section is folded to form a current input pipeline, and the outer coil of the lower coil is bent to extend a section to form a current output pipeline, and the bend of the current output pipeline is close to the edge of the current input pipeline. bend.
  • the Chinese patent document with the publication number CN109621211A discloses a locally enhanced figure-eight transcranial magnetic stimulation coil, by processing the equal-thickness figure-eight transcranial magnetic stimulation coil into a concave shape in the central area of the back of the coil, and keeping the coil
  • the surface of the frontal coil is on a plane, so that the equivalent electric current of the coil in the central area is closer to the stimulation area, thereby generating a magnetic field pulse stronger than that of the iso-thick structure in the central area, while affecting other areas outside the central area.
  • the influence of the regional magnetic field pulse is negligible, so that the locally enhanced figure-of-eight transcranial magnetic stimulation coil has better focus and a more concentrated stimulation range.
  • the stimulation depth of existing transcranial magnetic stimulation equipment is generally shallow. Taking the planar 8-shaped coil as an example, its focal area is small, and the stimulation depth is about 20mm below the surface of the coil, which cannot stimulate the sulcus of the cerebral cortex. It is also unable to stimulate the subcortical tissues such as the amygdala and hippocampus.
  • the invention provides a transcranial magnetic stimulation coil and a helmet for deep precise magnetic stimulation, which can safely stimulate the target area under the premise that the stimulation intensity of the non-target area is as small as possible.
  • a transcranial magnetic stimulation coil for deep precise magnetic stimulation comprising a coil fixing part and a DO double-circuit coil fixed by the coil fixing part, and the DO double-circuit coil includes an asymmetrically arranged D-shaped coil and an O-shaped coil. Coil, the two ends of the D-shaped coil and the O-shaped coil are connected to the current output device after passing through the coil fixture;
  • the D-shaped coil is arranged inside the O-shaped coil, and the D-shaped coil is close to the upper part of the O-shaped coil at the position where it intersects with the O-shaped coil, and the intersecting area constitutes the target target area;
  • the current output device outputs a reference current for the D-shaped coil to provide the reference magnetic field distribution strength and direction; the current output device provides an adjustment current for the O-shaped coil to adjust the overall magnetic field distribution strength and direction of the DO dual-circuit coil.
  • the DO double-circuit coil is provided with a target indicator for determining the stimulation point in the target area, and an observation hole is provided on the target indicator.
  • both the D-shaped coil and the O-shaped coil are formed by a plurality of wires arranged in parallel; the distance between the multiple wires of the D-shaped coil in the target area is less than 3 mm, and the distance between the non-target areas is greater than 10 mm, less than 20mm; Among them, the transition area between 3mm and 10mm is the transition area.
  • the multiple wires of the O-shaped coil are closely attached to each other, and the adjacent distance is less than 3mm.
  • the target area has an area of 10-13 square centimeters.
  • the magnetic induction intensity test of the transcranial magnetic stimulation coil needs to be carried out during the production process, so as to fine-tune the structure of the transcranial magnetic stimulation coil, including the following steps:
  • test point every 1mm on the coordinate axis of the horizontal plane projection, which is used for magnetic induction intensity test positioning and repeated testing.
  • the test points are in a state of central symmetry, and each test point can be one-to-one correspondence;
  • step (3) Simulate the treatment process so that the coil of the present invention is closely joined with the human skull model made in step (1);
  • step (4) Using the method of step (4), the three-phase Hall effect probe is successively brought close to each test point on the human skull model to obtain the magnetic induction value of each test point;
  • the thicknesses of the human skull models cut into three pieces are 2mm, 13mm and 18mm respectively.
  • the present invention also provides a magnetic stimulation helmet, which includes a helmet body and the above-mentioned transcranial magnetic stimulation coil; the transcranial magnetic stimulation coil is arranged inside the helmet body;
  • the D-shaped coil is close to the inner wall surface of the helmet body, and is used to closely fit the head during use;
  • the O-shaped coil is only close to the inner wall surface of the helmet body in the target area, and other areas They are all away from the inner wall surface of the helmet body;
  • the current output device is arranged on the helmet body and connected with the supporting host.
  • the helmet body is provided with an observation window, and the observation window is directly opposite to the observation hole of the target indicator on the target area.
  • the magnetic stimulation helmet placed on the patient's head, move the helmet, and observe through the observation window so that the observation hole of the target indicator on the coil coincides with the auxiliary mark point on the positioning cap.
  • the present invention has the following beneficial effects:
  • the transcranial magnetic stimulation coil of the present invention adopts a DO double-circuit coil, and the D-shaped coil is located on the upper layer, which mainly plays a supporting role and provides reference stimulation; the weight of the coil and the helmet can be dispersed, so that the contact part of the patient's head will not feel sick.
  • the line-to-line spacing is small, so that the magnetic field lines are focused on the target area and the impact on the non-target area is reduced; the dense wires in the target area give the target area a basic intensity and direction of the magnetic field distribution.
  • the O-shaped coil is located in the lower layer, and mainly plays the role of adjusting the magnetic induction intensity and direction. On the basis of the basic magnetic field distribution provided by the D coil, by changing the position and current intensity of the O segment coil, the magnetic field distribution intensity and direction after the DO coil is combined Adjust to match the intended design.
  • the induced magnetic field of the present invention is asymmetrically distributed, and the magnetic field at the non-target position on the coil surface is relatively small and within a safe range. Focusing at the depth target, the focusing range is wider than that of the figure-eight coil, and the induced electric field generated at a lower current output intensity can be higher than the action potential threshold of most patients' nerve cells. Under the premise that the same depth reaches a certain intensity of the induced magnetic field, the present invention requires less stimulation current than the 8-shaped coil, less stimulation to the human body contact part on the coil surface, a larger stimulation range to the target area, and stronger fault tolerance.
  • the center of gravity of the coil and the matching helmet is basically kept on the same axis as the center of gravity of the human body, which can reduce the pull of gravity on the coil and cause the shift of the focus area.
  • Fig. 1 is the structural diagram of transcranial magnetic stimulation coil in the present invention
  • Fig. 2 is a schematic diagram of another angle of the transcranial magnetic stimulation coil in the present invention.
  • Fig. 3 is the schematic diagram of magnetic stimulation helmet in the present invention.
  • Fig. 4 is the magnetic induction distribution figure of hair and scalp part during the test of the embodiment of the present invention.
  • Fig. 5 is the distribution diagram of the magnetic induction intensity of the skull and meninges during the test of the embodiment of the present invention.
  • Fig. 6 is a distribution diagram of the magnetic induction intensity of part of the cerebral cortex during the test of the embodiment of the present invention.
  • a transcranial magnetic stimulation coil for deep precise magnetic stimulation includes a coil holder 1 and a DO dual-circuit coil fixed by the coil holder, and the DO dual-circuit coil includes an asymmetric arrangement The D-shaped coil 2 and the O-shaped coil 3. The two ends of the D-shaped coil 2 and the O-shaped coil 3 respectively pass through the coil fixing part 1 and are connected to the current output device.
  • the D-shaped coil 2 is arranged inside the O-shaped coil 3, and the D-shaped coil 2 is closely attached to the upper part of the O-shaped coil 3 at the position where it intersects with the O-shaped coil 3, and the intersecting area constitutes the target area 4.
  • the current output device outputs a reference current for the D-shaped coil 2 to provide the reference magnetic field distribution strength and direction; the current output device provides an adjustment current for the O-shaped coil 3 to adjust the overall magnetic field distribution strength and direction of the DO double-circuit coil.
  • the DO double-circuit coil is provided with a target indicator 5 for determining the stimulation point in the target area 4, and an observation hole is arranged on the target indicator 5.
  • the D-shaped coil 2 is located on the upper layer and mainly plays a supporting role and provides reference stimulation.
  • the distance between the lines is relatively large and mainly plays a supporting role. It can disperse the weight of the coil and the helmet so that the patient's head contacts the part No discomfort.
  • the line-to-line spacing is small, so that the magnetic field lines are focused on the target area and the impact on the non-target area is reduced; the dense wires in the target area give the target area a basic intensity and direction of the magnetic field distribution.
  • the O-shaped coil 3 is located in the lower layer, and mainly plays the role of adjusting the magnetic induction intensity and direction. On the basis of the basic magnetic field distribution provided by the D-shaped coil 2, by changing the direction and current intensity of the O-shaped coil 3, the DO double-circuit coil can be integrated. The strength and direction of the magnetic field distribution are adjusted to meet the expected design.
  • Both the D-shaped coil 2 and the O-shaped coil 3 are formed by multiple wires arranged in parallel; the distance between the multiple wires of the D-shaped coil 2 in the target area 4 is less than 3 mm, and the distance between the wires in the non-target area is greater than 10 mm.
  • the multiple wires of the O-shaped coil 3 are closely attached to each other at various positions, and the distance between adjacent ones is less than 3mm.
  • the size of the target area 4 is approximately 3.5cm ⁇ 3.5cm, with an area of about 12.25cm2.
  • a magnetic stimulation helmet includes a helmet body 6 and a transcranial magnetic stimulation coil disposed inside the helmet body 6 .
  • the D-shaped coil 2 is close to the inner wall surface of the helmet body 6, and is used to closely fit the head during use;
  • the O-shaped coil 3 is only close to the inner wall surface of the helmet body 6 in the target area 4, and other areas are away from the inner wall surface of the helmet body 6 .
  • the helmet body 6 is provided with an observation window 7, and the observation window 7 is directly opposite to the observation hole of the target indicator 5 on the target area 4.
  • the doctor can observe the corresponding relationship between the target indicator 5 on the coil and the marking points on the supporting positioning cap of the present invention through the observation window 7, so as to intuitively consider the relative relationship between the internal stimulating coil and the patient's head during use. In order to roughly grasp the relative relationship between the stimulating magnetic field and the patient's brain target area during treatment. It can be observed whether the coil is out of the expected position and corrected during the long-term treatment process.
  • the magnetic stimulation helmet of the present invention is mainly divided into three parts, 1, the connecting part, which is mechanically connected with the host and the transcranial magnetic stimulation coil, so that it can produce the expected effective displacement in a limited extent and the helmet and the coil are relatively The location remains largely unchanged.
  • Circuit part This part connects the air duct of the cooling system and the power supply circuit that generates magnetic pulses to the helmet, and collects temperature feedback signals in real time to ensure that the coil continues to work at a suitable temperature.
  • Treatment part The function of this part is to ensure that the coil and the target area of the subject can fit as closely as possible during use and treatment. It mainly includes a shell design that is as light and fit as possible, and a transparent observation window design for the coil of the present invention at a special point.
  • auxiliary parts which are mainly auxiliary structures designed to ensure the normal use of parts 1, 2, and 3.
  • the coil of the present invention adjusts the coil direction and structure so that during the treatment process, the comprehensive center of gravity of the coil of the present invention and the matching helmet and the center of gravity of the human body are roughly kept on the same axis, so as to reduce the coil tension caused by the pulling of the coil by gravity.
  • the spatial deviation caused by the focused magnetic field and the intracranial target area of the patient improves the therapeutic effect in actual use.
  • the magnetic stimulation helmet of the present invention needs to be used with a positioning cap during the treatment process.
  • the coil matching positioning cap of the present invention adopts specific materials and designs on the premise of passing the biocompatibility test, and cooperates with the coil supporting treatment method of the present invention.
  • the target focus point of the coil of the present invention can be fitted as close as possible to the target area of the patient's head during use, thereby increasing product safety and reliability.
  • the user chooses a suitable model among the three models of large, medium and small, and assists the patient to correctly wear the supporting positioning cap of the present invention, and the requirements are as follows:
  • the brim of the front hat is flush with the brow bone of the subject and perpendicular to the bridge of the patient's nose.
  • a scale is printed on the left side of the front brim of the positioning cap, and a compass is printed on the top of the positioning cap to mark the recommended points for threshold stimulation. It must be used in conjunction with the coil and the helmet.
  • the coil magnetic induction test model adopted in the present invention includes a human skull model cut into three pieces.
  • the thickness of the three skull models is 2mm, 13mm, and 18mm, and their corresponding anatomical positions are 1, hair and scalp respectively.
  • the physiological significance of the available data of this skull model is the magnitude and distribution of the magnetic induction intensity on the scalp surface of the subject. ;2.
  • the surface of the cerebral cortex The physiological significance of the data available from this head model is the magnitude and distribution of the magnetic induction intensity received by the subject's cerebral cortex. 3.
  • the surface cortex of the skull The physiological significance of the data available from this head model is It shows the magnitude and distribution of the magnetic induction intensity that some specific tissues of the cranial cortex can receive.
  • Each layer of this model has a test point every 1mm on the coordinate axis of the horizontal plane projection, which is used for magnetic induction test positioning and repeated testing.
  • the test points are centrally symmetrical, and each layer of test points can be one-to-one correspondence, which is used to study the different effects of the magnetic induction stimulation generated by the coil on the same point in the vertical tangential direction at different depths.
  • the transcranial magnetic stimulation coil of the present invention is closely connected with the magnetic induction intensity test model of the coil of the present invention, and a semi-permanent fixation method is adopted to ensure the accuracy and repeatability of the test results.
  • the three-phase Hall effect probe needs to be close to the mark point on the model, so that the front end of the probe is tangent to the inner surface of the model. Keep it as stable as possible, and read the original magnetic induction waveform on the oscilloscope connected to the magnetic induction testing instrument after the coil outputs the pulse.
  • the magnetic field pulse of this coil is within 300 ⁇ s, it is impossible to use the software algorithm that comes with the test instrument for direct reading. It can only record the original real magnetic induction intensity waveform, and after calculation, it is obtained when the intensity is 65%.
  • the test points get the magnetic induction value. By repeating more than 500 points on the three models in this way, the magnetic induction intensity and distribution results with physiological significance can be obtained.
  • the test data are shown in Figures 4 to 6.
  • the rectangular frame abcd represents the focused area
  • the rectangular frame a'b'c'd' represents the non-focused area
  • the depth of the color corresponds to the magnitude of the magnetic induction.
  • the therapist helps the patient to correctly wear the positioning cap matched with this coil to ensure that the front brim of the cap coincides with the patient's brow bone, and the auxiliary treatment line in the middle of the positioning cap is on the same line as the bridge of the nose, so as to ensure that the treatment landmarks are worn repeatedly
  • the position relative to the patient remains basically unchanged.
  • the helmet logo is parallel to the central auxiliary treatment line of the positioning cap, fix the helmet strap with the patient's jaw, tighten the limit drawstring at the rear of the helmet, and use the medical equipment matched with this coil to output magnetic field pulses for treatment.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

L'invention concerne une bobine de stimulation magnétique transcrânienne et un casque pour une stimulation magnétique profonde et précise. La bobine de stimulation magnétique transcrânienne comprend un élément de fixation de bobine et une bobine à deux voies de type D-O qui est fixée au moyen de l'élément de fixation de bobine, la bobine à deux voies de type D-O comprend une bobine en forme de D et une bobine en forme de O qui sont disposées de manière asymétrique, et deux extrémités de la bobine en forme de D et deux extrémités de la bobine en forme de O sont reliées à un dispositif de sortie de courant après avoir traversé l'élément de fixation de bobine. La bobine en forme de D est disposée à l'intérieur de la bobine en forme de O, une position dans laquelle la bobine en forme de D et la bobine en forme de O se croisent est étroitement fixée à la partie supérieure de la bobine en forme de O, et la zone d'intersection forme une zone cible. Le dispositif de sortie de courant délivre un courant de référence pour la bobine en forme de D qui fournit une intensité et une direction de distribution de champ magnétique de référence. Le dispositif de sortie de courant fournit un courant de réglage pour la bobine en forme de O qui ajuste l'intensité et la direction de distribution de champ magnétique global de la bobine à deux voies de type D-O. La présente invention peut être utilisée pour effectuer un traitement de stimulation sur la zone cible de manière plus sûre tout en réduisant au minimum la stimulation vers des zones non cibles.
PCT/CN2022/071107 2021-07-23 2022-01-10 Bobine de stimulation magnétique transcrânienne et casque pour stimulation magnétique profonde et précise WO2023000625A1 (fr)

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CN202110835620.7A CN113559417B (zh) 2021-07-23 2021-07-23 一种用于深部精准磁刺激的经颅磁刺激线圈及头盔
CN202110835620.7 2021-07-23

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CN113559417B (zh) * 2021-07-23 2022-02-01 杭州米福科技有限公司 一种用于深部精准磁刺激的经颅磁刺激线圈及头盔
TWI821054B (zh) * 2022-11-29 2023-11-01 財團法人金屬工業研究發展中心 經顱磁刺激立體線圈裝置及設備
CN117339111A (zh) * 2023-12-05 2024-01-05 首都医科大学宣武医院 一种用于深部经颅磁刺激调控治疗装置

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