A pulse generator and implantable sacral nerve stimulation system

Abstract

The present invention provides a pulse generator and an implantable sacral nerve stimulation system, wherein the pulse generator comprises a top cover and a pulse generator body, wherein an internal charging coil is arranged inside the top cover made of a biocompatible polymer material, and is directly or indirectly electrically connected to a rechargeable battery arranged inside the pulse generator; the pulse generator of the present invention is creatively divided into two parts, and the internal charging coil is placed inside the top cover made of a biocompatible polymer material, which can avoid eddy current thermal effects caused by wireless charging and improve charging efficiency; there is no need to set up structures such as a shielding layer, which simplifies the internal design and has a thinner overall thickness; in addition, compared with the prior art, the thickness of the pulse generator body is thinner, so the battery can be designed to be thicker in the thickness direction, thereby increasing the battery capacity; or the thickness of the pulse generator body is slightly increased to reduce the plane occupancy, thereby reducing surgical trauma during implantation.

Description

Technical Field

[0001] The invention relates to an implantable medical device, in particular to a rechargeable implantable pulse generator and an implantable sacral nerve stimulation system. Background Art

[0002] The sacral nerve stimulator, also known as a bladder pacemaker, can be used to treat symptoms of non-obstructive urinary retention and overactive bladder that are ineffective or intolerant of conservative treatment. It is an implantable, programmable device that generally includes an implantable device in the body and an external control device that exchange information through two-way wireless communication.

[0003] In the prior art, implantable medical devices are generally powered by batteries, emitting stimulation pulses of a specific frequency to perform long-term stimulation on specific targets, thereby improving the patient's symptoms. The price of implantable medical devices is generally high, but the lifespan is mostly short, and the main factor limiting the lifespan of implantable medical devices is the battery capacity. In order to extend the service life, some implantable medical devices are powered by high-energy-density lithium primary batteries, such as lithium-sulfite chloride batteries and lithium-polyfluorinated carbon batteries. However, once the battery is exhausted, the patient has to undergo surgery again to replace the implantable medical device, which not only causes physical trauma to the patient, but the expensive price also brings huge economic pressure to the patient.

[0004] In order to extend the service life of implantable medical devices, people have developed in vitro rechargeable implantable medical devices. Such in vitro rechargeable implantable medical devices usually include a metal titanium shell and a rechargeable battery encapsulated by the titanium shell. During the in vitro wireless charging process, eddy currents will be generated on the shell and the rechargeable battery encapsulated by the titanium shell, which will generate heat to increase the temperature of the battery and even the implanted parts of the entire implantable medical device. Excessive heating of the implanted parts will have adverse effects on the human body, and the increase in battery temperature will also affect the life of the battery itself.

[0005] Chinese patent document CN105268103A discloses an in vitro rechargeable implantable medical instrument. In order to reduce excessive heating of the battery of the implanted component, a heat shielding layer is added between the in vivo charging energy receiving circle and the rechargeable battery inside the instrument. However, the heat shielding layer must achieve electromagnetic shielding, conduct electricity and heat, and has high requirements for the installation position, which leads to high production costs, high precision requirements, and high production difficulty.

[0006] Chinese patent document CN106237516B discloses a rechargeable implantable medical device. In order to reduce the problem of excessive heat generation of the battery of the implanted component, a heat sink is added to the titanium shell on the outward side of the implanted device, and a shielding layer is also added between the charging coil and the rechargeable battery inside the implanted device. The shielding layer is required to achieve both electromagnetic shielding and heat conduction, and has high requirements for the installation position and high production difficulty.

[0007] In order to prevent the battery of the implanted component from generating excessive heat, a shielding layer is usually used in the prior art. The shielding layer is disposed between the charging coil and the rechargeable battery inside the implanted device. However, there are problems in that many functional requirements are placed on the shielding layer, and high precision is required for the installation position. Once the position deviates, the shielding and thermal or electrical conductivity effects will be affected. In addition, the addition of the shielding layer increases the thickness of the implanted device, resulting in greater trauma during implantation. Summary of the invention

[0008] Therefore, the technical problem to be solved by the present invention is to overcome the technical defects of the prior art rechargeable implantable medical devices that add components such as shielding layers to solve the problem of heat generation during charging, resulting in a complex internal structure, large thickness and large implantation trauma of the device, thereby providing a pulse generator with a simple internal structure, thin thickness and small implantation trauma.

[0009] The present invention also provides an implantable sacral nerve stimulation system having the pulse generator.

[0010] To this end, the present invention provides a pulse generator, comprising:

[0011] A top cover, made of biocompatible polymer material;

[0012] A pulse generator body connected to the top cover plane;

[0013] An internal charging coil, disposed inside the top cover;

[0014] A rechargeable battery is arranged inside the pulse generator body and is directly or indirectly electrically connected to the internal charging coil.

[0015] As a preferred solution, the biocompatible polymer material is one or more of TPU, PEEK, and nylon.

[0016] As a preferred solution, it further includes a circuit board, which is arranged inside the pulse generator body; the internal charging coil is electrically connected to the circuit board, and the circuit board is electrically connected to the rechargeable battery.

[0017] As a preferred solution, the top cover is connected to the pulse generator body in a plane through a connecting structure, and the connecting structure includes: a fixing claw and a fixing pin, the fixing claw is arranged on the pulse generator body, and the fixing pin passes through the fixing claw and the fixing pin hole on the top cover to realize the planar connection between the top cover and the pulse generator body.

[0018] As a preferred solution, the inner charging coil is arranged close to the inner wall of the top cover.

[0019] As a preferred solution, it also includes an antenna, which is arranged inside the top cover and electrically connected to the circuit board.

[0020] As a preferred solution, it also includes an electrode connector, which is arranged inside the top cover and is used to connect to the stimulation electrode or an extension line connected to the stimulation electrode.

[0021] As a preferred solution, it also includes a microprocessor module, which is arranged inside the pulse generator body and is electrically connected to the electrode connector through the circuit board to generate an electrical stimulation pulse signal.

[0022] As a preferred solution, a receiving groove for accommodating the internal charging coil, or the antenna, or the electrode connector is provided inside the top cover and is fixed by bonding with liquid silicone rubber.

[0023] As a preferred solution, a fixing screw is threadedly provided on the electrode connector, one end of the fixing screw extends into the inner cavity of the electrode connector for inserting the stimulation electrode or an extension wire connected to the stimulation electrode, and the other end is located outside the electrode connector;

[0024] A sealing plug hole is provided on the top cover opposite to the fixing screw, a screw seal is installed in the sealing plug hole, and the screw seal is provided with a normally closed elastic operating hole for an operating tool to extend into to drive the fixing screw to rotate so as to screw in or out of the inner cavity.

[0025] As a preferred solution, it also includes an end sealing ring installed on the top cover, one end of which is located inside the top cover and the other end is located outside the top cover, and one end of the end sealing ring located inside the top cover is connected to the electrode connector.

[0026] The present invention also provides an implantable sacral nerve stimulation system, comprising:

[0027] Pulse generator;

[0028] A stimulation electrode, one end of which is connected to the pulse generator and the other end of which is suitable for contacting the nerve;

[0029] An adjustable fixing anchor, used to connect the other end of the stimulation electrode to the corresponding nerve;

[0030] an external control device capable of wirelessly communicating with the pulse generator, capable of reading device information of the pulse generator and adjusting stimulation parameters, and having an external charging coil;

[0031] The pulse generator is any one of the pulse generators described above, and the external charging coil can perform electromagnetic induction charging on the internal charging coil from outside the body.

[0032] The technical solution provided by the present invention has the following advantages:

[0033] 1. The pulse generator of the present invention comprises a top cover and a pulse generator body, and the two are connected in a plane. The so-called plane connection means that when the pulse generator is implanted inside the human body, the orthographic projections of the top cover and the pulse generator body on the human skin do not overlap, and the top cover and the pulse generator body are both implanted in the human body in a close fit and are not superimposed. In the pulse generator of the present invention, the internal charging coil is arranged inside the top cover and is electrically connected to the rechargeable battery arranged inside the pulse generator body. Since the top cover is made of a biocompatible polymer material, when a charging device located outside the body charges the internal charging coil arranged inside the top cover, the top cover does not generate eddy currents, so that the outer shell of the top cover does not self-heat, thereby reducing heat generation, and further reducing the risk caused by charging heat. Compared with the prior art, the pulse generator of the present invention is creatively divided into two parts, and the internal charging coil is placed inside the top cover made of biocompatible polymer material, so as to avoid the eddy current thermal effect generated by wireless charging and improve the charging efficiency. There is no need to set up structures such as a shielding layer, which simplifies the internal design and makes the overall thickness thinner. In addition, compared with the prior art, the thickness of the pulse generator body is thinner, so the battery can be designed to be thicker in the thickness direction, thereby increasing the battery capacity; or the thickness of the pulse generator body can be slightly increased to reduce the plane occupancy, thereby reducing the surgical trauma during implantation.

[0034] 2. In the pulse generator of the present invention, the biocompatible polymer material can be one or more of TPU, PEEK, and nylon. The above materials can not only meet the requirements of biocompatibility, but also do not produce eddy current effect during charging, thereby improving the charging efficiency and avoiding the problem of over-temperature.

[0035] 3. The pulse generator of the present invention also includes a circuit board, which is arranged inside the pulse generator body, the internal charging coil is electrically connected to the circuit board, and the circuit board is electrically connected to the rechargeable battery; the circuit board is arranged inside the pulse generator body, separately from the internal charging coil, which can prevent electromagnetic influence on the circuit board during charging.

[0036] 4. In the pulse generator of the present invention, the top cover is connected to the pulse generator in a plane through a connecting structure. The connecting structure includes a fixing claw and a fixing pin. The fixing claw is connected to the pulse generator body. The fixing pin passes through the fixing claw and the fixing pin hole on the top cover to achieve a planar connection between the top cover and the pulse generator body, thereby ensuring a reasonable layout between the top cover and the pulse generator body, so that the internal charging coil placed inside the top cover is not affected by the material of the pulse generator body during charging.

[0037] 5. In the pulse generator of the present invention, the inner charging coil is arranged close to the inner wall of the top cover. When implanted in the human body, the side wall faces the skin side of the human body. During charging, the outer charging coil of the external control device is charged opposite to the inner charging coil, the interval distance is small, and the charging efficiency is high.

[0038] 6. The pulse generator of the present invention also includes an antenna, which is arranged inside the top cover and electrically connected to the circuit board; the antenna is arranged inside the biocompatible polymer top cover, the signal will not be affected by the titanium shell, and the signal strength is higher.

[0039] 7. The pulse generator of the present invention also includes an electrode connector, which is arranged inside the top cover and is used to connect to the stimulation electrode or an extension line connected to the stimulation electrode; the electrode connector is arranged inside the top cover with fewer parts, the space occupancy is more reasonable, the free space inside the pulse generator body is small, the space utilization rate is high, and the compactness is good.

[0040] 8. The pulse generator of the present invention has a fixing screw on the electrode connector, and a screw seal is installed at the sealing plug hole position of the top cover. The screw seal is opposite to the fixing screw threaded on the electrode connector. An operating tool (such as a screwdriver, etc.) can be used to tighten or loosen the fixing screw through the screw seal, thereby fixing or loosening the stimulation electrode inserted into the electrode connector or the extension wire connected to the stimulation electrode. The above arrangement can ensure both the firm fixation of the stimulation electrode and the sealing, thereby ensuring safety.

[0041] 9. The pulse generator of the present invention also includes an end sealing ring installed on the top cover, with one end located inside the top cover and the other end located outside the top cover. One end of the end sealing ring located inside the top cover is connected to the electrode connector, and a through hole is provided on the end sealing ring for the stimulation electrode to be inserted and connected to the electrode connector.

[0042] 10. The present invention also provides an implantable sacral nerve stimulation system, comprising a pulse generator, a stimulation electrode, an adjustable fixation anchor and an external control device, wherein the pulse generator is the pulse generator described above and has all the advantages of the above pulse generator. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] In order to more clearly illustrate the technical solutions in the prior art or the specific implementation manner of the present invention, the drawings used in the description of the prior art or the specific implementation manner are briefly introduced below.

[0044] Figure 1 It is a schematic diagram of the overall structure after the pulse generator of the present invention is connected to the stimulation electrode.

[0045] Figure 2 yes Figure 1 Rear view of the pulse generator.

[0046] Figure 3 yes Figure 1 Schematic diagram of the structure after the middle top cover is separated from the pulse generator body.

[0047] Figure 4 is the front view of the top cover.

[0048] Figure 5 It is the rear view of the top cover.

[0049] Figure 6 It is a schematic diagram of the structural explosion of the top cover.

[0050] Figure 7 It is a schematic diagram of the structure of the inner coil.

[0051] Figure 8 It is a schematic diagram of the structure of another inner coil.

[0052] Fig. 9 It is a schematic diagram of the application scenario of the implantable sacral nerve stimulation system of the present invention.

[0053] Figure markings: 1. top cover; 1-2a~1-2c, fixing pin hole; 2. pulse generator body; 2-1a~2-1c, fixing pin; 2-2a~2-2c, fixing claw; 3. internal charging coil; 31. first lead end of internal charging coil; 32. second lead end of internal charging coil; 4. antenna; 5. electrode connector; 51. fixing screw; 52. screw seal; 521. normally closed elastic operating hole; 53. end sealing ring; 6. stimulation electrode; 7. adjustable fixing anchor; 8. in vitro control device; 81. external charging coil; 10. pulse generator; 11. sealing plug hole. DETAILED DESCRIPTION

[0054] The technical solution of the present invention is described in detail below in conjunction with the accompanying drawings.

[0055] Example 1

[0056] This embodiment provides a sacral nerve pulse generator, such as Figure 1-6 As shown, it includes: a top cover 1, which is transparent and made of biocompatible polymer material; a pulse generator body 2, which is planarly connected to the top cover 1; an internal charging coil 3, which is arranged inside the top cover 1; and a rechargeable battery, which is arranged inside the pulse generator body 2 and is directly or indirectly electrically connected to the internal charging coil 3.

[0057] The so-called planar connection means that when the pulse generator of this embodiment is implanted in the human body, the orthographic projections of the top cover 1 and the pulse generator body 2 on the human skin do not overlap, and the top cover 1 and the pulse generator body 2 are both implanted in the human body in a close fit without being superimposed. In the pulse generator of this embodiment, the internal charging coil 3 is arranged inside the top cover 1 and is electrically connected to the rechargeable battery arranged inside the pulse generator body 2; because the top cover 1 is made of biocompatible polymer material, when the charging device located outside the body is charging the internal charging coil 3 arranged inside the top cover 1, the top cover 1 does not generate eddy currents, so the outer shell of the top cover 1 will not self-heat, thereby reducing heat generation, and further reducing the risk caused by charging heat. The pulse generator of this embodiment is creatively divided into two parts, and the internal charging coil 3 is placed inside the top cover 1 made of biocompatible polymer material to avoid the eddy current thermal effect of wireless charging and improve the charging efficiency. There is no need to set up structures such as a shielding layer, which simplifies the internal design and makes the overall thickness thinner. In addition, the thickness of the pulse generator body 2 is relatively thin, so the battery can be designed to be thicker in the thickness direction, thereby increasing the battery capacity; or the thickness of the pulse generator body 2 can be slightly increased to reduce the plane occupancy, thereby reducing the surgical trauma during implantation.

[0058] Specifically in the present embodiment, the top cover 1 and the pulse generator body 2 are both rectangular parallelepiped structures with rounded sides. According to actual needs, the top cover 1 and the pulse generator body 2 can also be set to other adaptive structures.

[0059] The top cover 1 in this embodiment is made of TPU material, and the pulse generator body 2 is a titanium shell. The material of the top cover 1 can also be PEEK or nylon. The above materials can not only meet the requirements of biocompatibility, but also do not produce eddy current effect during charging, improve the charging efficiency, and avoid the problem of overheating; traditionally, the internal charging coil 3 is placed inside the titanium shell, and the charging efficiency is low.

[0060] The device further comprises a circuit board, which is arranged inside the pulse generator body 2; the internal charging coil 3 is electrically connected to the circuit board, and the circuit board is electrically connected to the rechargeable battery. The circuit board is arranged inside the pulse generator body 2 and is separated from the internal charging coil 3, so as to prevent electromagnetic influence on the circuit board during charging.

[0061] like Figure 7-8 As shown, the structure of the internal charging coil 3 is not limited and can be round, square or other shapes as long as it can be used for charging. Figure 5 As shown, the internal charging coil 3 enters into the pulse generator body 2 through the internal charging coil first lead terminal 31 and the internal charging coil second lead terminal 32, and is electrically connected to the rechargeable battery through the circuit board.

[0062] The top cover 1 is connected to the pulse generator body 2 in a plane through a connection structure, and the connection structure includes: fixing claws 2-2a, 2-2b, 2-2c and fixing pins 2-1a, 2-1b, 2-1c, the fixing claws 2-2a, 2-2b, 2-2c are arranged on the pulse generator body 2, and the fixing pins 2-1a, 2-1b, 2-1c pass through the fixing claws 2-2a, 2-2b, 2-2c and the fixing pin holes 1-2a, 1-2b, 1-2c on the top cover 1, so as to realize the plane connection between the top cover 1 and the pulse generator body 2. The above connection structure ensures the reasonable layout between the top cover 1 and the pulse generator body 2, so that the internal charging coil 3 placed inside the top cover 1 is not affected by the material of the pulse generator body 2 during charging.

[0063] The internal charging coil 3 is a close-wound coil, which is arranged close to the inner wall of the top cover 1. When implanted in the human body, the side wall faces the skin side of the human body. During charging, the external charging coil 81 of the external control device 8 is charged directly against the internal charging coil 3, with a small interval and high charging efficiency.

[0064] It also includes an antenna 4, which is arranged inside the top cover 1 and is electrically connected to the circuit board. The antenna 4 is arranged inside the biocompatible polymer top cover 1, and the signal will not be affected by the titanium shell, and the signal strength is higher. In this embodiment, the antenna 4 is a Bluetooth antenna.

[0065] It also includes an electrode connector 5, which is arranged inside the top cover 1 and is used to connect with the stimulation electrode 6 or an extension line connected to the stimulation electrode 6. The electrode connector 5 is arranged inside the top cover 1 with fewer parts.

[0066] It also includes a microprocessor module, which is arranged inside the pulse generator body 2 and is electrically connected to the electrode connector 5 through the circuit board to generate an electrical stimulation pulse signal.

[0067] The top cover 1 is provided with a receiving groove for accommodating the internal charging coil 3, or the antenna 4, or the electrode connector 5, which is fixed by snaps or liquid silicone rubber.

[0068] The electrode connector 5 is provided with a fixing screw 51, and a screw seal 52 is installed at the sealing plug hole 11 of the top cover 1. The screw seal 52 is opposite to the fixing screw 51 screwed on the electrode connector 5. An operating tool (such as a screwdriver, etc.) can be used to pass through the screw seal 52 to tighten or loosen the fixing screw 51, so as to fix or loosen the stimulation electrode 6 inserted into the electrode connector 5 or the extension wire connected to the stimulation electrode 6; the above arrangement can ensure the firm fixation of the stimulation electrode 6 and ensure sealing, thereby ensuring safety.

[0069] It also includes an end sealing ring 53, which is installed on the top cover 1, with one end located inside the top cover 1 and the other end located outside the top cover 1. One end of the end sealing ring 53 located inside the top cover 1 is connected to the electrode connector 5; a through hole is provided on the end sealing ring 53 for the stimulation electrode 6 to be inserted and connected to the electrode connector 5.

[0070] Example 2

[0071] This embodiment provides an implantable sacral nerve stimulation system. Fig. 9 As shown, it includes: a pulse generator 10; a stimulation electrode 6, one end of which is connected to the pulse generator 10, and the other end is suitable for contacting the nerve; an adjustable fixing anchor 7, used to connect the other end of the stimulation electrode 6 with the corresponding nerve; an external control device 8, which can communicate wirelessly with the pulse generator 10, can read the device information of the pulse generator 10 and adjust the stimulation parameters, and has an external charging coil 81; the pulse generator 10 is the pulse generator described in Example 1, and the external charging coil 81 can perform electromagnetic induction charging on the internal charging coil 3 from outside the body.

[0072] The implantable sacral nerve stimulation system provided in this embodiment, since it adopts the pulse generator in Example 1, naturally has all the advantages of the above-mentioned pulse generator.

[0073] 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 pulse generator, characterized in that: include: A top cover (1) made of a biocompatible polymer material; A pulse generator body (2) is planarly connected to the top cover (1); An internal charging coil (3) arranged inside the top cover (1); An antenna (4) is arranged inside the top cover (1); An electrode connector (5) is arranged inside the top cover (1) and is used to be connected to the stimulation electrode (6) or an extension line connected to the stimulation electrode (6); A rechargeable battery, arranged inside the pulse generator body (2) and directly or indirectly electrically connected to the internal charging coil (3); The inner charging coil (3) is arranged close to the inner side wall of the top cover (1); when implanted in a human body, the side wall faces the skin side of the human body; The antenna (4) is arranged on the end side of the top cover (1) away from the pulse generator body (2); It also includes a circuit board, which is arranged inside the pulse generator body (2); the internal charging coil (3) is electrically connected to the circuit board, and the circuit board is electrically connected to the rechargeable battery; the antenna (4) is electrically connected to the circuit board; It also includes a microprocessor module, which is arranged inside the pulse generator body (2) and is electrically connected to the electrode connector (5) via the circuit board, and is used to generate an electrical stimulation pulse signal; The top cover (1) is provided with a receiving groove for accommodating the internal charging coil (3), the antenna (4), and the electrode connector (5), the opening direction of the receiving groove for accommodating the electrode connector (5) faces the first side of the pulse generator body (2), and the opening direction of the receiving groove for accommodating the internal charging coil (3) faces the second side of the pulse generator body (2), and the first side and the second side are oriented in opposite directions; A plurality of wires extend from a recessed position provided on a first side of the pulse generator body (2), are inserted upward into the interior of the top cover (1), and are connected to a position of the electrode connector (5) facing the first side; An inner charging coil first lead end (31) and an inner charging coil second lead end (32) of the inner charging coil extend from the second side to the first side and are connected to the wire.

2. The pulse generator according to claim 1, characterized in that: The biocompatible polymer material is one or more of TPU, PEEK and nylon.

3. The pulse generator according to claim 1, characterized in that: The top cover (1) is planarly connected to the pulse generator body (2) via a connecting structure, wherein the connecting structure comprises: fixing claws (2-2a, 2-2b, 2-2c) and fixing pins (2-1a, 2-1b, 2-1c), wherein the fixing claws (2-2a, 2-2b, 2-2c) are arranged on the pulse generator body (2), and the fixing pins (2-1a, 2-1b, 2-1c) pass through the fixing claws (2-2a, 2-2b, 2-2c) and the fixing pin holes (1-2a, 1-2b, 1-2c) on the top cover (1), thereby realizing planar connection between the top cover (1) and the pulse generator body (2).

4. The pulse generator according to claim 1, characterized in that: The top cover (1) is provided with a receiving groove inside for accommodating the internal charging coil (3), the antenna (4) and the electrode connector (5), which are fixed by bonding using liquid silicone rubber.

5. The pulse generator according to claim 4, characterized in that: The electrode connector (5) is threadedly provided with a fixing screw (51), one end of the fixing screw (51) extends into an inner cavity of the electrode connector (5) for inserting the stimulation electrode (6) or an extension wire connected to the stimulation electrode (6), and the other end is located outside the electrode connector (5); A sealing plug hole (11) is provided on the top cover (1) opposite to the fixing screw (51), a screw seal (52) is installed in the sealing plug hole (11), and a normally closed elastic operating hole (521) is provided on the screw seal (52) for an operating tool to extend into to drive the fixing screw (51) to rotate so as to screw into or out of the inner cavity.

6. The pulse generator according to claim 5, characterized in that: It also includes an end sealing ring (53) mounted on the top cover (1), one end of which is located inside the top cover (1) and the other end of which is located outside the top cover (1), and one end of the end sealing ring (53) located inside the top cover (1) is connected to the electrode connector (5).

7. An implantable sacral nerve stimulation system comprising: Pulse generator (10); a stimulation electrode (6), one end of which is connected to the pulse generator (10) and the other end of which is suitable for contacting a nerve; An adjustable fixing anchor (7) for connecting the other end of the stimulation electrode (6) to a corresponding nerve; an external control device (8), capable of wirelessly communicating with the pulse generator (10), capable of reading device information of the pulse generator (10) and adjusting stimulation parameters, and having an external charging coil (81); The feature is that the pulse generator (10) is the pulse generator according to any one of claims 1 to 6, and the external charging coil (81) is capable of performing electromagnetic induction charging on the internal charging coil (3) from outside the body.

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