WO2022210333A1 - 星状神経節磁気刺激装置並びにその装着方法及び使用方法 - Google Patents

星状神経節磁気刺激装置並びにその装着方法及び使用方法 Download PDF

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Publication number
WO2022210333A1
WO2022210333A1 PCT/JP2022/014295 JP2022014295W WO2022210333A1 WO 2022210333 A1 WO2022210333 A1 WO 2022210333A1 JP 2022014295 W JP2022014295 W JP 2022014295W WO 2022210333 A1 WO2022210333 A1 WO 2022210333A1
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Prior art keywords
stellate ganglion
magnet
neck
magnetic
ganglion
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Ceased
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PCT/JP2022/014295
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English (en)
French (fr)
Japanese (ja)
Inventor
雅和 八木
芳樹 澤
浩禎 桝田
幸太郎 吉田
史統 水上
恵理 金田
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University of Osaka NUC
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Osaka University NUC
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Priority to EP22780547.0A priority Critical patent/EP4316575A4/en
Priority to JP2023511163A priority patent/JPWO2022210333A1/ja
Priority to US18/284,467 priority patent/US20240157164A1/en
Publication of WO2022210333A1 publication Critical patent/WO2022210333A1/ja
Anticipated expiration legal-status Critical
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/06—Magnetotherapy using magnetic fields produced by permanent magnets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/004—Magnetotherapy specially adapted for a specific therapy
    • A61N2/006—Magnetotherapy specially adapted for a specific therapy for magnetic stimulation of nerve tissue

Definitions

  • the present invention relates to a stellate ganglion magnetic stimulator that magnetically stimulates the stellate ganglion, and a method of wearing and using the same.
  • a ganglion is a collection of nerve cell bodies in the peripheral nervous system, and sympathetic nerves that control the blood circulation of the upper body are concentrated in the stellate ganglion (see Figure 1). Sympathetic overexcitation is known to cause various symptoms such as hot flashes and chronic pain.
  • Patent Document 1 describes that stellate ganglion block injection relieves chronic pain and the like.
  • Non-Patent Document 1 proposes a technique for reducing hot flashes by wearing a headgear-type device including anodes and cathodes on the head and applying transcranial electrical stimulation.
  • Patent Document 1 the stellate ganglion block injection proposed in Patent Document 1 above cannot be used casually outside of medical institutions, and there is a risk of side effects and infection due to direct insertion of the needle into the body.
  • the anode and cathode must be placed in the motor cortex region and the supraorbital region of the cerebral hemisphere, respectively, and the feeling of use is poor, and the effect is not necessarily sufficient. That's not what it means.
  • the object of the present invention is to provide a technical means excellent in convenience, usability, and safety for stellate ganglion block that can effectively suppress sympathetic overexcitation.
  • the present invention a head portion having a magnet that generates magnetism;
  • a neck portion that is detachably mounted around the wearer's neck, ear, or head and presses the head portion against the epidermis corresponding to the stellate ganglion in order to apply the magnetic stimulation to the stellate ganglion.
  • the magnet comprises at least two magnet pieces, It is preferable that the at least two magnet pieces are arranged so as to satisfy 30° ⁇ 180°, where ⁇ is the angle between the axes of the at least two magnet pieces.
  • the magnet comprises at least three magnet pieces, The at least three magnet pieces are arranged so that 30° ⁇ ⁇ ⁇ 180° and 30° ⁇ ⁇ ⁇ 180° are satisfied, where ⁇ and ⁇ are angles between axes of adjacent magnet pieces. preferable.
  • the magnet In the stellate ganglion magnetic stimulation device of the present invention, it is preferable that the magnet generates a magnetic field such that a magnetic flux density of 20 mT or more reaches the corresponding stellate ganglion.
  • the neck includes an expansion and contraction mechanism for expanding and contracting the neck along the circumference of the neck, is preferred.
  • the present invention determining the location of the stellate ganglion based on the location of at least one of the wearer's seventh cervical and first thoracic vertebrae; marking the epidermis corresponding to the determined location of the stellate ganglion; attaching the neck portion around the neck;
  • a method of wearing or using a stellate ganglion magnetic stimulator, comprising the step of arranging the head according to the mark; also provide
  • FIG. 2 is an explanatory diagram of a stellate ganglion G; 1 is a schematic diagram showing the location of the stellate ganglion G; FIG. 1 is a schematic diagram of a stellate ganglion magnetic stimulator 1.
  • FIG. 3 is a diagram showing a specific configuration example of a magnet 3;
  • FIG. 3 is a diagram showing a specific configuration example of the head unit 2;
  • FIG. 4 is a diagram showing another specific configuration example of the magnet 3.
  • FIG. 4A and 4B are diagrams showing a specific configuration example of the neck portion 4;
  • FIG. It is a measurement result (graph) showing the activity of the sympathetic nerve and the parasympathetic nerve when a magnet is attached to the left neck and when the magnet is not attached. It is a figure explaining order arrangement
  • FIG. FIG. 10 is a diagram illustrating the positional relationship between magnets M1 and M2 in Animal Experiment Example 2;
  • the stellate ganglion G is located approximately at the level of the seventh cervical vertebrae (C7) to the second thoracic vertebrae (Th2) and is thinly attached to the bone.
  • C7 cervical vertebrae
  • Th2 second thoracic vertebrae
  • the approximate location of the stellate ganglion G can be determined as follows (see FIG. 2).
  • the patient who is the wearer of the stellate ganglion magnetic stimulator according to the present invention, looks down and checks the seventh cervical vertebra (C7) that protrudes behind the neck.
  • the patient touches the sternocleidomastoid muscle 92 (the muscle that originates at the sternum and clavicle and terminates at the mastoid process of the temporal bone and the occipital bone).
  • the stellate ganglion G is located generally anteriorly or posteriorly to the sternocleidomastoid muscle 92 at the intersection (closest) between the sternocleidomastoid muscle 92 and the seventh cervical vertebra (C7).
  • this is an empirical method of stellate ganglion identification and does not imply anatomical accuracy.
  • the stellate ganglion magnetic stimulation device 1 (hereinafter referred to as the device 1) according to the present embodiment includes a head unit 2 and a neck portion 4. Each component will be described in detail below.
  • the head part 2 has a magnet 3 that generates magnetism.
  • the magnet 3 may be a permanent magnet that forms a static magnetic field or an electromagnet that forms a dynamic magnetic field, but the permanent magnet will be explained here.
  • At least one head portion 2 is sufficient, but in this embodiment, two head portions 2 are assumed to correspond to two stellate ganglia G. FIG.
  • each head section 2 preferably includes at least two magnet pieces 31 and 32 as the magnet 3 (see FIG. 4).
  • the magnet pieces 31 and 32 are preferably arranged so that 30° ⁇ 180° is satisfied, where ⁇ is the angle formed by their axes (that is, lines indicating the direction in which the magnetic poles of the magnet pieces 31 and 32 are aligned) L1 and L2. It is preferable that they are arranged so as to satisfy 60° ⁇ 180°. Also, the upper limit of ⁇ may be 120°.
  • the magnet pieces 31 and 32 may have a columnar shape, or may have a cylindrical shape from the viewpoint of weight reduction.
  • the magnet segments 31 and 32 may have substantially the same surface magnetic flux density, or one magnet segment (eg, magnet segment 31) may have a higher surface magnetic flux density than the other magnet segment (eg, magnet segment 32).
  • the magnetic pole arrangement of the magnet pieces 31 and 32 may be arranged in order or may be arranged in reverse.
  • the north pole of the magnet piece 31 and the south pole of the magnet piece 32 face the target (ie, the stellate ganglion G of the wearer 9), and the south pole of the magnet piece 31 and the south pole of the magnet piece 32
  • the N pole facing the target side is called forward arrangement (see FIG. 9(A)).
  • a reverse arrangement see FIG. 9B.
  • the magnet pieces 31 and 32 are housed in the housing portions 21 and 22 of the head portion 2, respectively.
  • the storage portions 21 and 22 also serve to prevent accidents caused by the magnet pieces strongly attracting each other.
  • the storage sections 21 and 22 are connected to each other via a connecting section 23.
  • the connecting portion 23 is made of, for example, a flexible resin material, and can change the irradiation direction of the magnetic force by the magnet pieces 31 and 32 (that is, the directions of the axes L1 and L2) by deforming (see FIG. 5B). . Therefore, it is possible to efficiently irradiate the magnetic force of the magnet pieces 31 and 32 toward the stellate ganglion G as a target.
  • the head portion 2 when the housing portions 21 and 22 of the head portion 2 are composed of a housing space (not shown) for the magnet pieces 31 and 32 and a lid (not shown) for closing the housing space, the head portion 2 is: It may have at least one pair of claws 24 .
  • the claws 24 are provided, for example, on the opposite surfaces (for example, the upper surface and the lower surface) of the connecting portion 23.
  • the lid By fitting the upper and lower claws 24, the lid is fixed, and the magnet pieces 31 and 32 are securely attached to the storage portions 21 and 22. can be stored inside.
  • rails or a slide mechanism may be provided on the connecting portion 23 or the like so that the storage portions 21 and 22 can move relative to each other.
  • each head portion 2 may include at least three magnet pieces 33 to 35 as the magnet 3 from the viewpoint of stimulating the stellate ganglion G more strongly or more efficiently (see FIG. 6).
  • the magnet pieces 33 to 35 are preferably arranged so as to satisfy 30° ⁇ ⁇ ⁇ 180° and 30° ⁇ ⁇ ⁇ 180°, where ⁇ and ⁇ are the angles formed by the adjacent axes L3 to L5. Above all, it is preferable that they are arranged so as to satisfy 60° ⁇ 120° and 60° ⁇ 120°.
  • the upper limits of ⁇ and ⁇ may each be 120°. In this case, the number of storage units included in the head unit 2 is at least three (not shown).
  • each head section 2 may include one magnet piece as the magnet 3 (see FIG. 3).
  • a switch mechanism for controlling the magnetic force of the magnet 3 may be provided.
  • Such a switch mechanism is a switch or circuit which controls the current through the coil when the magnet 3 is an electromagnet.
  • the magnetic force of the magnet 3 is controlled by inserting, for example, a sheet for controlling the magnetic field into the device holding the magnet 3 or the storage units 21 and 22 .
  • the magnets 3 are appropriately adjusted so that a predetermined magnetic flux density reaches the target stellate ganglion G within the range in which the effects of the present invention can be obtained.
  • the lower limit of the magnetic flux density to be reached may be 20 mT, preferably 40 mT.
  • the upper limit of the magnetic flux density to be reached may be 150 mT, preferably 60 mT.
  • the magnet 3 for example, a neodymium magnet, a samarium magnet, or a ferrite magnet can be preferably used.
  • a soft magnetic material such as permalloy may be used together with the magnet.
  • the neck portion 4 is a ring-shaped member detachably mounted around the neck 91 of the wearer 9 to hold the device 1 at a desired position on the neck 91.
  • the neck portion 4 presses the head portion 2 against the epidermis corresponding to the stellate ganglion G so that the magnetic field generated by the magnet 3 acts on the stellate ganglion G.
  • the head portion 2 is arranged at both ends of the neck portion 4 . Additional head portions 2 may be provided at other portions of the neck portion 4 .
  • the neck portion 4 may be worn around the wearer's 9 ears or head.
  • the neck portion 4 preferably has an elastic mechanism 41 that expands and contracts the neck portion 4 along the circumference of the neck portion 91 .
  • an elastic mechanism 41 that expands and contracts the neck portion 4 along the circumference of the neck portion 91 .
  • expansion mechanism 41 for example, a rod-shaped or plate-shaped member that is stored in the neck portion 4 or pulled out from the neck portion 4 by sliding can be suitably used, but it is not limited to this.
  • the neck portion 4 may have a cushion 42 on the surface facing the neck 91 of the wearer 9 . Due to the cushioning action of the cushion, the burden on the neck 91 of the wearer 9 can be reduced.
  • the neck portion 4 may be configured by connecting a plurality of rod-shaped or arm-shaped members 4A and 4B, for example, and in that case, for example, they may be connected by a hinge 4C so as to be foldable.
  • the location of the stellate ganglion G is determined (or guessed) as accurately as possible.
  • the position of the stellate ganglion G can be determined from the position information of the 6th and 7th cervical vertebrae (C6, C7) obtained by neck echo.
  • C6 C7 6th and 7th cervical vertebrae
  • the position of the sternocleidomastoid muscle 92 and the anterior or posterior position of the sternocleidomastoid muscle 92 at the intersection of the sternocleidomastoid muscle 92 and the seventh cervical vertebra (C7) can be determined as the position of the stellate ganglion G. can.
  • a physiological index that reflects the state of the sympathetic nerves can be used.
  • a system that senses the above physiological index in a relatively short period of time and displays the sensed physiological index.
  • the system may automatically start sensing the above-described physiological index, and determine whether the attachment position of the magnet 3 is appropriate based on the change in the obtained physiological index over time.
  • a specific example is an earphone-type device that can measure peripheral blood flow.
  • a blood flow meter can be utilized.
  • an ultrasonic blood flow meter for example, HUNTLEIGH ultrasonic blood flow meter Dopplex DMX manufactured by Muranaka Medical Instruments Co., Ltd.
  • an ultrasonic blood flow meter can be preferably used.
  • a mark M is made on the epidermis of the neck 91 corresponding to the estimated position of the stellate ganglion G.
  • the epidermis of the neck 91 which is the shortest distance from the estimated position of the stellate ganglion G, is marked M with a vegetable dye or the like. Two or more marks M may be used.
  • the neck portion 4 of the device 1 is temporarily attached to the neck portion 91 of the wearer 9 .
  • the attachment site for example, a protruding bone behind the neck 91 of the wearer 9 is suitable.
  • Adjust the expansion and contraction mechanism of the neck portion 4 to fit the neck portion 4 to the circumference of the neck portion 91 .
  • the head part 2 is aligned with the mark M and arranged.
  • the neck portion 4 preferably presses the head portion 2 against the neck portion 91 of the wearer 9 .
  • the head part 2 will be fixed so as not to deviate from the stellate ganglion G, and that the magnetic field generated by the magnet 3 will sufficiently act on the stellate ganglion G.
  • the magnetic stimulation from the neck part 4 acts on the stellate ganglion G, suppresses the overexcitation of the sympathetic nerves, and is expected to eliminate or reduce various symptoms.
  • Presumed symptoms include symptoms of hot flashes and sweating (hot flashes) occurring during menopause.
  • the device 1 is compact, unobtrusive, and non-invasive, so it can be worn for a long time and can be worn when going out. Also, the device 1 is easy to use and safe. Furthermore, since the device 1 is easily portable, use of the device 1 can be started as soon as symptoms appear. Thus, the convenience of the device 1 is high.
  • heart rate variability analysis we evaluated how the autonomic nerves work when a magnet is applied to the left neck of a person and when it is not applied.
  • the heart rate variability analysis system used here is analysis software called Reflex Meijin (trademark) of Crosswell Co., Ltd.
  • the permanent magnet used here is the following neodymium magnet (N40) manufactured by Neomag Co., Ltd. Shape: Cylindrical Dimensions: Diameter 25mm x Height 15mm Surface magnetic flux density: 476mT Magnetization Direction: Height Direction The permanent magnets used were two neodymium magnets arranged in series. The time for applying the permanent magnet is 20 minutes.
  • Fig. 8 shows the analysis results.
  • HF is the high frequency component power of the measured waveform and LF is the low frequency component power of the waveform.
  • CCV(HF) is a high-frequency component of the fluctuation of the waveform and serves as a parasympathetic index.
  • LF/HF is a balance index between sympathetic nerves and parasympathetic nerves, and when the value is high, it is an index of sympathetic nerves.
  • the permanent magnets used in this experiment are two neodymium magnets (N40) manufactured by Neomag Co., Ltd. arranged in series. Each neodymium magnet is ring-shaped, with an outer diameter of 43.9 mm, an inner diameter of 33.1 mm, and a height of 22 (mm).
  • the weight of the rat used was 220 g, and the distance from the surface of the neck to the stellate ganglion was estimated from "Atlas of Cross-Sectional Anatomy of Rat" published by Adthree Co., Ltd., which was 10 mm.
  • the magnetic field gradient of the present magnet estimated from numerical analysis by the applicant is 7 mT/mm-9 mT/mm.
  • aluminum bronze (C6191B) was used as the sham magnet.
  • This metal is a copper alloy with additions of iron, manganese, nickel, etc. to an alloy based on copper and aluminum.
  • two cylindrical copper alloys having a diameter of 40 mm and a length of 19 mm were arranged in series. The copper alloy is set approximately equal in weight to the neodymium magnet described above.
  • the permanent magnets (hereinafter referred to as "the magnets") used in this experiment were three neodymium magnets (N40) manufactured by Neomag Co., Ltd. arranged in series. Each neodymium magnet is cylindrical, with an outer diameter of 40 mm and a height of 20 mm.
  • a pair of subject magnets M1, M2 were placed on the neck of a pig P such that their axes intersect at approximately 90 degrees (see FIG. 10).
  • the pig P used is a microminipig with a body weight of 10-14 kg, and the distance to the surface stellate ganglion PG of the neck is 30-50 mm, as estimated from the dissection and CT images. Also, the magnetic field gradient of the present magnet estimated from numerical analysis by the applicant is 1.5 mT/mm-2.5 mT/mm.
  • the magnetic field gradient range in which the stellate ganglion magnetic stimulation device and method disclosed in this embodiment provide a safe effect in the stellate ganglion is approximately 1.5 mT / mm or more and less than 7 mT / mm (20 mT for magnetic flux density ⁇ 150 mT).
  • an electromagnet as the magnet 3 (that is, to form a dynamic magnetic field).
  • current is generated in the body non-invasively to stimulate nerves.
  • This may also include mechanisms aimed at magnetic amplification. That is, low-frequency magnetic stimulation to the stellate ganglion G can suppress nerve activity.
  • embedded type magnets are also possible.
  • the position of the stellate ganglion G may be determined from the position of the 1st thoracic vertebra instead of or in addition to the 7th cervical vertebra.
  • the stellate ganglion magnetic stimulator according to the present invention is suitably used, for example, for suppressing or alleviating hot flash symptoms seen in menopausal women, but it can be applied to symptoms other than hot flashes. Not even.
  • the main cause of hot flash symptoms is abnormal excitation of the sympathetic nerves caused by abnormalities in the body temperature center associated with the decline of female hormones. It is.
  • existing treatments include hormone replacement therapy, SSRIs, Chinese herbal medicines, and equol, but none of them satisfy both high efficacy and safety.
  • the stellate ganglion magnetic stimulator according to the present invention is applied to symptoms other than hot flashes, for example, in addition to the stellate ganglion, the maxillary ganglion located between C2 and C3, and Stimulation targets the middle cervical ganglion located at C6 in FIG. 1, the vertebral artery ganglion located between the middle cervical ganglion and the stellate ganglion, and other systemic nervous systems. It is also possible.

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  • 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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PCT/JP2022/014295 2021-03-30 2022-03-25 星状神経節磁気刺激装置並びにその装着方法及び使用方法 Ceased WO2022210333A1 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP22780547.0A EP4316575A4 (en) 2021-03-30 2022-03-25 MAGNETIC STIMULATION DEVICE FOR THE STELLAR GANGLION, AND METHODS OF WEARING AND USING THE SAME
JP2023511163A JPWO2022210333A1 (https=) 2021-03-30 2022-03-25
US18/284,467 US20240157164A1 (en) 2021-03-30 2022-03-25 Stellate ganglion magnetic stimulation device, and methods for wearing and using same

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JP2021-057239 2021-03-30
JP2021057239 2021-03-30

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See also references of EP4316575A4

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EP4316575A1 (en) 2024-02-07

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