Trans-pelvic sacral nerve magnetic stimulation device

Abstract

The invention relates to the technical field of medical instruments, in particular to a pelvic sacral nerve magnetic stimulation device which comprises a magnetic stimulation coil assembly suitable for generating a stimulation magnetic field after being electrified, and the magnetic stimulation coil assembly is electrically connected with a host; and the body surface electric signal receiving piece is electrically connected with the host and is suitable for being positioned on the perianal skin to receive the skin electromyographic signals. When the transpelvic sacral nerve magnetic stimulation equipment is used, the body surface electric signal receiving sheet is pasted on the perianal skin to receive the skin electromyographic signals. The stimulation position of the magnetic stimulation coil assembly is adjusted according to the skin electromyographic signals. When the sacral nerve magnetic stimulation device is used, the device does not need to be implanted, the application difficulty and the use risk of the sacral nerve magnetic stimulation device are greatly reduced, and a user can carry out sacral nerve magnetic stimulation by using the pelvic sacral nerve magnetic stimulation device at home by himself / herself.

Description

Technical Field

[0001] The invention relates to the technical field of medical instruments, and in particular to a transpelvic sacral nerve magnetic stimulation device. Background Art

[0002] Transcranial magnetic stimulation is a non-invasive neuromodulation therapy that does not go through the whole body blood circulation. It achieves the effect of treating diseases by focusing magnetic pulses with the intensity equivalent to nuclear magnetic resonance on the relevant parts of the brain to stimulate nerve cells. Repetitive transcranial magnetic stimulation technology is a new medical technology developed on the basis of bioelectromagnetic theory. It is based on the Faraday electromagnetic induction principle. A strong current is used to generate a magnetic field on the coil. The magnetic field then penetrates the skull into the cerebral cortex non-invasively and causes a local micro-induced current in the corresponding cortex, changing the membrane potential of the cerebral cortex to cause the cerebral cortex to produce relevant physiological effects, such as stimulating the release of neurotransmitters such as pentanoic acid, norepinephrine, and dopamine, normalizing the function of neurotransmitters, and thus playing a therapeutic role. In practical applications, it is not limited to the stimulation of the brain, and peripheral nerves and muscles can also be stimulated.

[0003] High-frequency, high-intensity repetitive transcranial magnetic stimulation can produce a sum of excitatory postsynaptic potentials, leading to abnormal excitation of the nerves at the stimulation site. Low-frequency stimulation has the opposite effect, treating diseases by bidirectionally adjusting the balance between the excitation and inhibition functions of the brain. The local nerves of repetitive transcranial magnetic stimulation affect the functions of multiple parts through the connection and interaction between neural networks; different intensities, frequencies, stimulation sites, and coil directions are required to achieve good therapeutic effects for different patients' brain function conditions.

[0004] The sacral nerve stimulation in the prior art is divided into two steps. The first step is percutaneous nerve assessment. When the symptom relief reaches more than 50% during the test phase, the second step of permanent implantation is considered. The sacral nerve stimulator is generally inserted from the posterior foramen of S2 to S4, and punctured through the upper edge of the sacral foramen to the anterior edge of the sacral foramen. The nerve stimulation in the second step is the main mechanism of its effectiveness, which makes the sacral nerve stimulation surgery invasive and expensive. A small number of patients experience pain and infection at the implantation site, which requires device removal and antibiotic treatment. Summary of the invention

[0005] Therefore, the technical problem to be solved by the present invention is to overcome the defects of the prior art sacral nerve stimulation surgery that is expensive and may cause infection at the implantation site, thereby providing a transpelvic sacral nerve magnetic stimulation device.

[0006] In order to solve the above technical problems, the present invention provides a transpelvic sacral nerve magnetic stimulation device, comprising:

[0007] A magnetic stimulation coil assembly, which is suitable for generating a stimulation magnetic field after being powered on, and the magnetic stimulation coil assembly is electrically connected to the host;

[0008] The body surface electrical signal receiving piece is electrically connected to the host and is suitable for being positioned on the perianal skin to receive skin surface electromyographic signals.

[0009] Optionally, the magnetic stimulation coil assembly includes a pair of stimulation coils, and both stimulation coils are figure-8 coils.

[0010] Optionally, it also includes a pair of fixed disks, which are arranged in parallel, a pair of mounting shafts are connected between the pair of fixed disks, the stimulation coil is rotatably mounted on the mounting shafts, and the stimulation coil and the mounting shafts are arranged in a one-to-one correspondence.

[0011] Optionally, a driving member is installed in the installation shaft, and the stimulation coil is cooperatively connected with the driving end of the driving member.

[0012] Optionally, the driving member is conductively connected to the host.

[0013] Optionally, a connecting wire is connected between the body surface electrical signal receiving sheet and the host, and the connecting wire is plugged into and matched with the host.

[0014] Optionally, an operating shaft is connected between the pair of fixed disks, and an operating handle is installed on the operating shaft.

[0015] Optionally, a fixing strap is connected to the fixing plate.

[0016] Optionally, an inductive sensor is provided in the body surface electrical signal receiving sheet, and the inductive sensor is used to receive electromyographic signals on the skin surface.

[0017] Optionally, a processor is built into the host, and when the input signal of the body surface electrical signal receiving sheet presents a predetermined waveform, the processor outputs an electrical signal to the magnetic stimulation coil assembly.

[0018] The technical solution of the present invention has the following advantages:

[0019] 1. The transpelvic sacral nerve magnetic stimulation device provided by the present invention includes: a magnetic stimulation coil assembly, which is suitable for generating a stimulating magnetic field after being energized, and the magnetic stimulation coil assembly is electrically connected to the host; a body surface electrical signal receiving sheet, which is electrically connected to the host, and the body surface electrical signal receiving sheet is suitable for being positioned on the perianal skin to receive skin surface electromyographic signals. When the transpelvic sacral nerve magnetic stimulation device is in use, the body surface electrical signal receiving sheet is pasted on the perianal skin to receive skin surface electromyographic signals. The stimulation position of the magnetic stimulation coil assembly is adjusted according to the skin electromyographic signals. When in use, there is no need to implant the device, which greatly reduces the application difficulty and use risk of the sacral nerve magnetic stimulation device, allowing users to use the transpelvic sacral nerve magnetic stimulation device to perform sacral nerve magnetic stimulation at home.

[0020] 2. The transpelvic sacral nerve magnetic stimulation device provided by the present invention comprises a pair of stimulation coils, both of which are 8-shaped coils. The pair of stimulation coils cooperate with each other to stimulate the bilateral sacral nerves simultaneously, and are adjusted according to individual differences.

[0021] 3. The transpelvic sacral nerve magnetic stimulation device provided by the present invention also includes a pair of fixing plates, the pair of fixing plates are arranged in parallel, a pair of mounting shafts are connected between the pair of fixing plates, the stimulation coils are rotatably mounted on the mounting shafts, and the stimulation coils are arranged in a one-to-one correspondence with the mounting shafts. By rotating the angle of the magnetic stimulation coils, the device can form magnetic fields of different directions and different strengths.

[0022] 4. The transpelvic sacral nerve magnetic stimulation device provided by the present invention has a processor built into the host. When the input signal of the body surface electrical signal receiving sheet presents a predetermined waveform, the processor outputs an electrical signal to the magnetic stimulation coil assembly. The host includes a pulse current generating circuit of a multi-channel coil array, which is used to generate a pulse current with a very high amplitude. The pulse current generating circuit is conductively connected to the magnetic stimulation coil assembly to transmit the pulse current to the magnetic stimulation coil assembly to generate a magnetic field. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0024] Figure 1 It is a schematic diagram of the structure of a transpelvic sacral nerve magnetic stimulation device provided in an embodiment of the present invention.

[0025] Figure 2 This is a schematic structural diagram from another angle of the transpelvic sacral nerve magnetic stimulation device provided in an embodiment of the present invention.

[0026] Figure 3 It is a schematic structural diagram of a magnetic stimulation coil assembly provided in an embodiment of the present invention.

[0027] Explanation of the accompanying reference numerals: 1. Body surface electrical signal receiving plate; 2. Stimulation coil; 3. Fixed disk; 4. Connecting wire; 5. Installation axis; 6. Fixing strap; 7. Operating handle; 8. Main unit; 9. Operating axis. DETAILED DESCRIPTION

[0028] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0029] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0030] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0031] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0032] Figures 1 to 3 The figure shows a transpelvic sacral nerve magnetic stimulation device provided in this example, which includes a magnetic stimulation coil assembly, a body surface electrical signal receiving sheet 1 and a fixing plate 3 for mounting the magnetic stimulation coil assembly.

[0033] The magnetic stimulation coil assembly generates a stimulating magnetic field after being energized. The magnetic stimulation coil assembly in this embodiment includes a pair of stimulation coils 2, and the stimulation coils 2 are all 8-shaped coils. The bilateral sacral nerves are stimulated simultaneously by a pair of stimulation coils cooperating with each other, and are adjusted according to individual differences. A pair of fixed disks 3 are provided, and a pair of fixed disks 3 are arranged in parallel. A pair of mounting shafts 5 are connected between the pair of fixed disks 3. The stimulation coil 2 is rotatably mounted on the mounting shafts 5, and the stimulation coil 2 and the mounting shafts 5 are arranged one by one. A driving motor as a driving member is installed on the mounting shafts 5 between the fixed disks 3, and the stimulation coil 2 is cooperatively connected with the driving end of the driving member.

[0034] In this embodiment, a host 8 for controlling the magnetic stimulation coil assembly is also included. The host 8 is conductively connected to the magnetic stimulation coil assembly, the body surface electrical signal receiving sheet 1 is connected to the host 8, and the driving member is electrically connected to the host 8. A processor is built into the host 8. When the input signal of the body surface electrical signal receiving sheet presents a predetermined waveform, the processor outputs an electrical signal to the magnetic stimulation coil assembly. A connecting line 4 is connected between the body surface electrical signal receiving sheet 1 and the host 8, and the connecting line 4 is plugged into the host 8. One or more body surface electrical signal receiving sheets 1 can be provided, and the specific number of body surface electrical signal receiving sheets 1 can be adjusted according to actual conditions. In this embodiment, two body surface electrical signal receiving sheets 1 are provided, and an inductive sensor is provided in the body surface electrical signal receiving sheet 1. The inductive sensor is used to receive skin surface electromyographic signals.

[0035] In order to facilitate the replacement of the body surface electrical signal receiving sheet 1, the body surface electrical signal receiving sheet 1 is electrically connected to the magnetic stimulation coil assembly of the host 8 through a connecting wire 4, and the connecting wire 4 is plugged into the host 8. In some other embodiments, the body surface electrical signal receiving sheet 1 can also be electrically connected to the stimulation coil 2 through a conductive connection with the driving member. When in use, the body surface electrical signal receiving sheet 1 is positioned on the perianal skin to receive skin and muscle electromyographic signals. The body surface electrical signal receiving sheet 1 is electrically connected to the driving member, and the driving member is used to receive the surface electrical signals collected by the body surface electrical signal receiving sheet 1, and automatically adjust the corresponding angle of the stimulation coil 2 according to the body surface electrical signals.

[0036] For ease of use, an operating shaft 9 is connected between a pair of fixed disks 3, and an operating handle 7 is installed on the operating shaft 9. The wire on the host 8 is connected to the fixed disk 3 through the operating handle 7, and is finally conductively connected to the drive member on the fixed disk 3 and the stimulation coil 2. A fixing strap 6 is connected to the fixed disk 3, and the fixing strap 6 is used to cooperate with the waist of the human body, so that the magnetic stimulation coil assembly can be placed in the third sacral vertebra (S3) and the fourth sacral vertebra (S4) area of ​​the posterior sacral foramen of the sacrum behind the buttocks of the human body under the support of the fixed disk 3. In order to facilitate manual adjustment, an operating handle 7 is installed on the installation shaft. The control line passes through the inside of the operating handle 7, one end of the control line is connected to the host 8, and the other end is electrically connected to the magnetic stimulation coil assembly. The rotation angle of the stimulation coil 2 and the intensity of the emitted magnetic field are controlled by the host 8.

[0037] The principle and usage of the transpelvic sacral nerve magnetic stimulation device provided in this embodiment are similar to those of a transcranial magnetic stimulator, but according to the expansion of application scenarios, its application in the direction of sacral nerve stimulation is structurally designed. A stimulation feedback module is also added to remind the user to adjust the stimulation site. The two magnetic stimulation coils 2 are respectively rotatably mounted on the two mounting shafts 5 of the fixed disk 3. The coil position is automatically or manually rotated and adjusted according to the perianal feedback signal received by the patient. The device can be fixed to the human body by an adjustable elastic fixing strap 6. The surface electrical signal receiving sheet 1 is connected to the host 8 by a plug, which is convenient for the replaceable conductive sheet, and the patient positions it by himself and sticks it to the perianal skin to receive skin and muscle electromyographic signals.

[0038] The patient's motor stimulation threshold is based on the motor cortex hand area as a reference, and two surface electrical signal receiving sheets 1 are used as recording electrodes and reference electrodes respectively, wherein the surface electrical signal receiving sheet used as the recording electrode is attached to the belly of the first dorsal interosseous muscle of the hand on the opposite side of the cerebral hemisphere to be stimulated remotely, and the surface electrical signal receiving sheet used as the reference electrode is attached to the ciliary muscle of the first dorsal interosseous muscle of the hand on the opposite side of the cerebral hemisphere to be stimulated remotely, and the ground line is connected, and the subject's first motor area (M1 area), that is, the fourth and sixth areas of the precentral gyrus and the anterior part of the paracentral lobule are located, and the magnetic stimulation coil assembly is moved near the area, and the stimulation is triggered at the same time, and the contraction of the subject's hand muscles can be observed, and the site mark that can stably elicit the maximum motor evoked potential (MEP) is found, which is the representative area of ​​the first dorsal interosseous muscle of the hand on the corresponding side of the subject, and the subject's motor threshold, central motor conduction time, MEP quiescent period and other physiological parameters are measured at the marked site. The minimum stimulation intensity at which the amplitude of more than 3 out of 5 MEPs stably induced in the subject's relaxed state exceeds 50 μV is taken as the resting motor threshold. The sacral nerve stimulation intensity is 50%-80% of the resting motor threshold, depending mainly on the patient's tolerance.

[0039] The treatment stimulation sites are the second sacral vertebra (S2), the third sacral vertebra (S3), and the fourth sacral vertebra (S4) nerve roots. The midpoint of the line connecting the coccyx and the upper edge of the bone is taken, and then one horizontal finger is left and right as S3. Before stimulation, the surface electrical signal receiving sheet 1 is attached to the skin near the anus to receive the stimulation signal. If the local muscle electrical signal related to magnetic stimulation is not generated, the coil rotation angle is automatically adjusted, and it rotates downward 10° from the initial position each time, or the coil position is manually rotated, the height of the fixing belt is adjusted, etc., until the signal is felt. The stimulation frequency, intensity, and time can be adjusted manually, or the system settings can be used: there are several settings, high frequency is 15Hz for excitement, low frequency 0.5HZ for inhibition, stimulation time is 10s, interval is 30s, each treatment is 30 minutes, 1-2 times a day.

[0040] The home transpelvic sacral nerve magnetic stimulator device provided in this embodiment has a specific frequency setting, a sacral nerve magnetic stimulation fixing belt, and a stimulation position feedback adjustment device. It can be used as a substitute for the sacral nerve stimulator, facilitating home physical therapy for patients with various pelvic floor diseases, and can be operated by the patient himself without invasive implantation.

[0041] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A transpelvic sacral nerve magnetic stimulation device, characterized in that: include: a magnetic stimulation coil assembly, which is suitable for generating a stimulation magnetic field after being energized, and the magnetic stimulation coil assembly is electrically connected to a host (8); A body surface electrical signal receiving sheet (1) is electrically connected to the host (8), and the body surface electrical signal receiving sheet (1) is suitable for being positioned on the perianal skin to receive skin surface electromyographic signals.

2. The transpelvic sacral nerve magnetic stimulation device according to claim 1, characterized in that: The magnetic stimulation coil assembly comprises a pair of stimulation coils (2), and the stimulation coils (2) are both 8-shaped coils.

3. The transpelvic sacral nerve magnetic stimulation device according to claim 2, characterized in that: It also comprises a pair of fixed disks (3), the pair of fixed disks (3) are arranged in parallel, a pair of mounting shafts (5) are connected between the pair of fixed disks (3), the stimulation coil (2) is rotatably mounted on the mounting shafts (5), and the stimulation coil (2) and the mounting shafts (5) are arranged in a one-to-one correspondence.

4. The transpelvic sacral nerve magnetic stimulation device according to claim 3, characterized in that: A driving member is installed inside the installation shaft (5), and the stimulation coil (2) is cooperatively connected with the driving end of the driving member.

5. The transpelvic sacral nerve magnetic stimulation device according to claim 4, characterized in that: The driving component is electrically connected to the host.

6. The transpelvic sacral nerve magnetic stimulation device according to any one of claims 1 to 4, characterized in that: A connecting line (4) is connected between the body surface electrical signal receiving sheet (1) and the host (8), and the connecting line (4) is plugged into and matched with the host (8).

7. The transpelvic sacral nerve magnetic stimulation device according to claim 3 or 4, characterized in that: An operating shaft (9) is connected between the pair of fixed plates (3), and an operating handle (7) is mounted on the operating shaft (9).

8. The transpelvic sacral nerve magnetic stimulation device according to claim 7, characterized in that: A fixing strap (6) is connected to the fixing plate (3).

9. The transpelvic sacral nerve magnetic stimulation device according to any one of claims 1 to 4, characterized in that: The body surface electrical signal receiving sheet (1) is provided with an inductive sensor, and the inductive sensor is used to receive skin surface electromyographic signals.

10. The transpelvic sacral nerve magnetic stimulation device according to any one of claims 1 to 4, characterized in that: The host (8) has a built-in processor, and when the input signal of the body surface electrical signal receiving sheet (1) presents a predetermined waveform, the processor outputs an electrical signal to the magnetic stimulation coil assembly.

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