CN111643815A - A pulse generator and implantable sacral nerve stimulation system - Google Patents

Abstract

The invention provides a pulse generator and an implanted sacral nerve stimulation system, wherein the pulse generator comprises a top cover and a pulse generator main body, wherein an internal charging coil is arranged inside the top cover made of a biocompatible high polymer material and is directly or indirectly electrically connected with a rechargeable battery arranged inside the pulse generator; the pulse generator is creatively divided into two parts, and the internal charging coil is arranged inside the top cover made of a biocompatible high polymer material, so that the eddy heat effect caused by wireless charging can be avoided, and the charging efficiency is improved; the structure such as a shielding layer is not needed, the internal design is simplified, and the overall thickness is thinner; in addition, compared with the prior art, the thickness of the pulse generator main body is thinner, so that the battery can be designed to be thicker in the thickness direction, and the battery capacity is increased; or the thickness of the pulse generator body is slightly increased, so that the plane occupation is reduced, thereby reducing the surgical trauma during the implantation.

Description

A pulse generator and implantable sacral nerve stimulation system

technical field

The invention relates to implantable medical instruments, in particular to a rechargeable implantable pulse generator and an implantable sacral nerve stimulation system.

Background technique

Sacral nerve stimulator, also known as bladder pacemaker, can be used to treat the symptoms of non-obstructive urinary retention and overactive bladder that are ineffective or intolerable to conservative treatment. Into the instrument and the external control device, the two exchange information through two-way wireless communication.

In the prior art, implantable medical devices are generally powered by batteries and emit stimulation pulses of a specific frequency to perform long-term stimulation on specific targets, thereby improving the symptoms of patients. The price of implantable medical devices is generally higher, but the lifespan is mostly short, and the main factor limiting the lifespan of implantable medical devices is battery capacity. In order to prolong the service life, some implantable medical devices are powered by lithium primary batteries with high energy density, such as lithium-chlorine sulfite batteries and lithium-polyfluorocarbon batteries. However, once the battery is exhausted, the patient has to undergo surgery again and replace the implanted medical device, which not only causes physical trauma to the patient, but also brings huge economic pressure to the patient due to the high price.

In order to prolong the service life of implantable medical devices, external rechargeable implantable medical devices have been developed. The external rechargeable implantable medical device usually includes a metal titanium shell and a rechargeable battery encapsulated by the titanium shell. During the process of external wireless charging, eddy currents will be generated on the shell and the rechargeable battery encapsulated by the titanium shell, thereby generating heat. 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 battery temperature will increase, which will also affect the life of the battery itself.

Chinese patent document CN105268103A discloses an external rechargeable implantable medical instrument. In order to reduce the excessive heat generation of the battery of the implanted part, a thermal shielding layer is added between the in vivo charging energy receiving ring and the rechargeable battery inside the instrument. However, the thermal shielding layer It is not only necessary to achieve electromagnetic shielding, but also to be able to conduct electricity and conduct heat, and the requirements for the installation position are also high, which leads to high production costs, high precision requirements, and high production difficulties.

Chinese patent document CN106237516B discloses a rechargeable implantable medical device. In order to reduce the problem of excessive heat generation in the battery of the implanted part, a heat sink is added to the titanium shell on the outward side of the implanted device, and also a heat sink is added on the outer side of the implanted device. A shielding layer is added between the charging coil inside the implanted device and the rechargeable battery. The shielding layer is required to achieve both electromagnetic shielding and heat conduction, and has high requirements on the installation location and is difficult to produce.

In the prior art, in order to avoid excessive heat generation of the battery of the implanted part, a shielding layer is usually used, which is arranged between the charging coil and the rechargeable battery inside the implanted device. , and the accuracy of the installation position is high, once the position is deviated, it will affect the shielding and thermal or electrical conductivity; in addition, after the shielding layer is added, the thickness of the implanted device increases, resulting in greater trauma during implantation.

SUMMARY OF THE INVENTION

Therefore, the technical problem to be solved by the present invention is to overcome the technical defects of the rechargeable implantable medical device in the prior art, in order to solve the problem of charging and heating, the shielding layer and other components are added, which leads to the technical defects of complex internal structure, large thickness and large implantation trauma. , thereby providing a pulse generator with simple internal structure, thin thickness and less implantation trauma.

The present invention also provides an implantable sacral nerve stimulation system with the above pulse generator.

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

The top cover is made of biocompatible polymer material;

The main body of the pulse generator is connected with the top cover plane;

an inner charging coil, arranged inside the top cover;

A rechargeable battery is arranged inside the main body of the pulse generator, and is directly or indirectly electrically connected to the inner charging coil.

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

As a preferred solution, it also includes a circuit board, which is arranged inside the main body of the pulse generator; the inner charging coil is electrically connected to the circuit board, and the circuit board is electrically connected to the rechargeable battery.

As a preferred solution, the top cover and the main body of the pulse generator are connected in a plane through a connection structure, and the connection structure includes: a fixing claw and a fixing pin, and the fixing claw is arranged on the main body of the pulse generator, so that the The fixing pin passes through the fixing claw and the fixing pin hole on the top cover to realize the plane connection between the top cover and the main body of the pulse generator.

As a preferred solution, the inner charging coil is disposed close to the inner side wall of the top cover.

As a preferred solution, an antenna is also included, which is arranged inside the top cover and is electrically connected to the circuit board.

As a preferred solution, an electrode connector is also included, which is arranged inside the top cover and is used to connect with the stimulation electrode or the extension wire connected to the stimulation electrode.

As a preferred solution, it also includes a microprocessor module, which is arranged inside the main body of the pulse generator, and is electrically connected to the electrode connector through the circuit board, so as to generate electrical stimulation pulse signals.

As a preferred solution, an accommodating groove for placing the inner charging coil, the antenna, or the electrode connector is provided inside the top cover, and is fixed by bonding with liquid silicone rubber.

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

The top cover opposite to the fixing screw is provided with a sealing plug hole, a screw sealing member is installed in the sealing plug hole, and the screw sealing member is provided with an operating tool to extend into to drive the fixing screw to rotate The normally closed elastic manipulation hole is screwed in or out of the inner cavity.

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

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

pulse generator;

a stimulating electrode, one end is connected to the pulse generator, and the other end is adapted to be in contact with the nerve;

An adjustable anchor for connecting the other end of the stimulating electrode with the corresponding nerve;

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;

The pulse generator is the pulse generator described in any one of the above, and the outer charging coil can perform electromagnetic induction charging on the inner charging coil from outside the body.

The technical scheme provided by the present invention has the following advantages:

1. The pulse generator of the present invention includes a top cover and a main body of the pulse generator, 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 top cover and the main body of the pulse generator are on the skin of the human body. The orthographic projections on it do not overlap, and the top cover and the main body of the pulse generator are fitted and implanted inside the human body without overlapping; in the pulse generator of the present invention, the inner charging coil is arranged inside the top cover, and is arranged with the pulse generator. The rechargeable battery inside the main body is electrically connected; since the top cover is made of biocompatible polymer material, when the charging device located outside the body is charging the inner charging coil set inside the top cover, the top cover does not generate eddy current, Therefore, the top cover shell does not generate heat by itself, thereby reducing heat generation, thereby reducing the risk of heat generation during charging. Compared with the prior art, the pulse generator of the present invention is creatively divided into two parts, and the inner 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 charging. In addition, compared with the prior art, the thickness of the main body of the pulse generator is thinner, so the battery can be designed to be thicker in the thickness direction. , thereby increasing the battery capacity; or slightly increasing the thickness of the pulse generator body to reduce the plane occupancy, thereby reducing the surgical trauma during implantation.

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-mentioned materials can not only meet the requirements of biocompatibility, but also do not generate electricity during charging. The eddy current effect improves the charging efficiency and avoids the problem of excessive temperature.

3. The pulse generator of the present invention further comprises a circuit board, the circuit board is arranged inside the main body of the pulse generator, the inner charging coil is electrically connected with the circuit board, and the circuit board is electrically connected with the rechargeable battery; the circuit board is arranged in the main body of the pulse generator; Internally, it is separated from the inner charging coil, which can prevent the electromagnetic influence on the circuit board during charging.

4. In the pulse generator of the present invention, the top cover and the pulse generator are connected by a connecting structure plane, and the connecting structure includes a fixed claw and a fixed pin, the fixed claw is connected with the main body of the pulse generator, and the fixed pin passes through the fixed claw and the top cover. The fixed pin hole realizes the plane connection between the top cover and the main body of the pulse generator, which ensures a reasonable layout between the top cover and the main body of the pulse generator, so that the inner charging coil placed inside the top cover is protected from the main body of the pulse generator during charging. Material influence.

5. In the pulse generator of the present invention, the inner charging coil is arranged close to the inner side wall of the top cover. When implanted into the human body, the side wall faces the skin side of the human body. When charging, the outer charging coil of the external control device is connected to the inner charging coil. For charging, the interval distance is small, and the charging efficiency is high.

6. The pulse generator of the present invention also includes an antenna, which is arranged inside the top cover and is 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 .

7. The pulse generator of the present invention also comprises an electrode connector, which is arranged inside the top cover and is used to connect with the stimulating electrode or the extension line connecting the stimulating electrode; the electrode connector is arranged inside the top cover with fewer parts, The space occupation is more reasonable, the free space inside the main body of the pulse generator is small, the space utilization rate is high, and the compactness is good.

8. In the pulse generator of the present invention, the electrode connector is provided with a fixing screw, the sealing plug hole of the top cover is provided with a screw seal, and the screw seal is opposite to the fixing screw screwed on the electrode connector, and an operating tool is used. (such as a screwdriver, etc.) can be passed through the screw seal to tighten or loosen the fixing screw to realize the fixing or loosening of the stimulation electrode penetrated into the electrode connector or the extension wire connected to the stimulation electrode; the above setting can not only To ensure the firm fixation of the stimulating electrode, and to ensure the sealing, so as to ensure safety.

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

10. The present invention also provides an implantable sacral nerve stimulation system, comprising a pulse generator, a stimulating electrode, an adjustable anchor and an external control device, wherein the pulse generator is the above-mentioned pulse generator, and has the above-mentioned pulse generator. all the advantages.

Description of drawings

In order to more clearly illustrate the technical solutions in the prior art or the specific embodiments of the present invention, the accompanying drawings used in the description of the prior art or the specific embodiments are briefly introduced below.

FIG. 1 is a schematic diagram of the overall structure of the present invention after the pulse generator is connected to the stimulation electrode.

FIG. 2 is a rear view of the pulse generator of FIG. 1 .

FIG. 3 is a schematic structural diagram of the top cover in FIG. 1 after being separated from the main body of the pulse generator.

Figure 4 is a front view of the top cover.

Figure 5 is a rear view of the top cover.

Figure 6 is a schematic exploded view of the structure of the top cover.

FIG. 7 is a schematic diagram of the structure of the inner coil.

FIG. 8 is a schematic structural diagram of another inner coil.

FIG. 9 is a schematic diagram of an application scenario of the implantable sacral nerve stimulation system of the present invention.

Reference signs: 1. Top cover; 1-2a～1-2c, fixing pin hole; 2. Main body of pulse generator; 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. Often 53. End sealing ring; 6. Stimulating electrode; 7. Adjustable anchor; 8. External control device; 81. External charging coil; 10. Pulse generator; 11. Sealing plug hole.

Detailed ways

The technical solutions of the present invention will be described in detail below with reference to the accompanying drawings.

Example 1

This embodiment provides a sacral nerve pulse generator, as shown in FIGS. 1-6 , including: a top cover 1, which is transparent and made of a biocompatible polymer material; a pulse generator main body 2, which is connected with the top cover 1 plane connection; inner charging coil 3, arranged inside the top cover 1; rechargeable battery, arranged inside the pulse generator main body 2, and electrically connected to the inner charging coil 3 directly or indirectly.

The so-called plane connection means that when the pulse generator of this embodiment is implanted into the human body, the orthographic projections of the top cover 1 and the pulse generator main body 2 on the human skin do not overlap, and the top cover 1 and the pulse generator main body 2 are both. The fit is implanted inside the human body and is not superimposed. In the pulse generator of this embodiment, the inner charging coil 3 is arranged inside the top cover 1 and is electrically connected to the rechargeable battery arranged inside the pulse generator main body 2; since the top cover 1 is made of biocompatible polymer material , when the charging device located outside the body is charging the inner charging coil 3 disposed inside the top cover 1, the top cover 1 does not generate eddy current, so the outer shell of the top cover 1 will not self-heat, thereby reducing the heat generation, thereby reducing the charging Risk of fever. The pulse generator of this embodiment is creatively divided into two parts, and the inner charging coil 3 is placed inside the top cover 1 made of biocompatible polymer material, so as to avoid the eddy current thermal effect of wireless charging and improve the charging efficiency, and no setting is required. The structure of the shielding layer simplifies the internal design, and the overall thickness is relatively thin; in addition, the thickness of the pulse generator body 2 is relatively thin, so the battery can be designed thicker in the thickness direction, thereby increasing the battery capacity; or make the pulse generator The thickness of the main body 2 is slightly increased, resulting in a lower plane occupancy, thereby reducing surgical trauma upon implantation.

Specifically, in this embodiment, the top cover 1 and the pulse generator main body 2 are both rounded cuboid structures. According to actual needs, the top cover 1 and the pulse generator main body 2 can also be set to other adaptive structures.

In this embodiment, the top cover 1 is made of TPU material, and the main body 2 of the pulse generator 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 excessive temperature; traditionally, the inner charging coil 3 is placed inside the titanium shell, charging less efficient.

It also includes a circuit board, which is arranged inside the pulse generator main body 2; the inner 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 main body 2, and is arranged separately from the inner charging coil 3, which can prevent the electromagnetic influence on the circuit board during charging.

As shown in Figs. 7-8, the structure of the inner charging coil 3 is not limited, and may be circular, square or other shapes, as long as it can be used for charging. As shown in FIG. 5 , the inner charging coil 3 enters the pulse generator body 2 through the first lead end 31 of the inner charging coil and the second lead end 32 of the inner charging coil, and is electrically connected to the rechargeable battery through the circuit board.

The top cover 1 and the main body 2 of the pulse generator are connected 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 main 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, realize the plane connection between the top cover 1 and the main body 2 of the pulse generator. The above connection structure ensures a reasonable layout between the top cover 1 and the pulse generator main body 2, so that the inner charging coil 3 placed inside the top cover 1 is not affected by the material of the pulse generator main body 2 during charging.

The inner charging coil 3 is a dense coil, which is arranged close to the inner side wall of the top cover 1. When implanted into the human body, the side wall faces the skin side of the human body. During charging, the outer charging coil 81 of the external control device 8 is connected to The inner charging coil 3 is facing for charging, the distance is small, and the charging efficiency is high.

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, 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.

An electrode connector 5 is also included, which is arranged inside the top cover 1 and is used for connecting with the stimulation electrode 6 or the extension line connecting the stimulation electrode 6 . The electrode connector 5 is arranged inside the top cover 1 with fewer parts.

It also includes a microprocessor module, which is arranged inside the pulse generator main body 2 and is electrically connected to the electrode connector 5 through the circuit board for generating electrical stimulation pulse signals.

The top cover 1 is provided with an accommodating groove for placing the inner charging coil 3 , the antenna 4 , or the electrode connector 5 , which is fixed by means of a buckle or liquid silicone rubber.

The electrode connector 5 is provided with a fixing screw 51, and a screw seal 52 is installed at the position of 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. A tool (such as a screwdriver, etc.) can pass through the screw seal 52 to tighten or loosen the fixing screw 51 to realize the fixing or loosening of the stimulation electrode 6 penetrated into the electrode connector 5 or the extension wire connected to the stimulation electrode 6 ; The above setting can not only ensure the firm fixation of the stimulating electrode 6, but also ensure the sealing, thereby ensuring safety.

It also includes an end sealing ring 53, which is installed on the top cover 1, one end is located inside the top cover 1, the other end is located outside the top cover 1, and the end sealing ring is located inside the top cover 1 One end of 53 is connected with the electrode connector 5 ; the end sealing ring 53 is provided with a through hole for inserting the stimulating electrode 6 and connecting with the electrode connector 5 .

Example 2

This embodiment provides an implantable sacral nerve stimulation system, as shown in FIG. 9 , including: a pulse generator 10; a stimulation electrode 6, one end is connected to the pulse generator 10, and the other end is suitable for contacting the nerve; An adjustment anchor 7 is used to connect the other end of the stimulation electrode 6 with the corresponding nerve; an external control device 8 can communicate wirelessly with the pulse generator 10 and can read and adjust the device information of the pulse generator 10 Stimulation parameters, and has an external charging coil 81; the pulse generator 10 is the pulse generator described in Embodiment 1, and the external charging coil 81 can perform electromagnetic induction charging on the internal charging coil 3 from outside the body.

Since the implantable sacral nerve stimulation system provided in this embodiment adopts the pulse generator in Embodiment 1, it naturally has all the advantages of the above-mentioned pulse generator.

Obviously, the above-mentioned embodiments are only examples for clear description, and are not intended to limit the implementation manner. For those of ordinary skill in the art, changes or modifications in other different forms can also be made on the basis of the above description. There is no need and cannot be exhaustive of all implementations here. And the obvious changes or changes derived from this are still within the protection scope of the present invention.

Claims (10)

1. a pulse generator, is characterized in that: comprise: a top cover (1), made of biocompatible polymer material; The pulse generator main body (2) is connected to the top cover (1) plane; an inner charging coil (3), arranged inside the top cover (1); an antenna (4), arranged inside the top cover (1); an electrode connector (5), arranged inside the top cover (1), for connecting with the stimulation electrode (6) or an extension line connected to the stimulation electrode (6); A rechargeable battery is arranged inside the pulse generator main body (2), and is directly or indirectly electrically connected to the inner charging coil (3). 2 . The pulse generator according to claim 1 , wherein the biocompatible polymer material is one or more of TPU, PEEK, and nylon. 3 . 3. The pulse generator according to claim 1, characterized in that: it further comprises a circuit board, which is arranged inside the pulse generator main body (2); the inner charging coil (3) is electrically connected to the circuit board , the circuit board is electrically connected with the rechargeable battery; the antenna (4) is electrically connected with the circuit board. 4. The pulse generator according to claim 1, characterized in that: the top cover (1) and the pulse generator main body (2) are connected in a plane through a connection structure, and the connection structure comprises: a fixing claw (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 in the pulse On the generator main body (2), the fixing pins (2-1a, 2-1b, 2-1c) pass through the fixing claws (2-2a, 2-2b, 2-2c) and the top cover ( The fixing pin holes (1-2a, 1-2b, 1-2c) on 1) realize the plane connection between the top cover (1) and the pulse generator main body (2). 5 . The pulse generator according to claim 1 , wherein the inner charging coil ( 3 ) is arranged close to the inner side wall of the top cover ( 1 ). 6 . 6 . The pulse generator according to claim 1 , wherein: the top cover ( 1 ) is provided with the inner charging coil ( 3 ), the antenna ( 4 ), or the electrode for placing the inner charging coil ( 3 ). 7 . The accommodating groove of the connector (5) is bonded and fixed with liquid silicone rubber. 7. The pulse generator according to claim 3, characterized in that: further comprising a microprocessor module, arranged inside the pulse generator main body (2), and connected to the electrode connector (5) through the circuit board ) is electrically connected for generating electrical stimulation pulse signals. 8. The pulse generator according to claim 6 or 7, characterized in that: A fixing screw (51) is screwed on the electrode connector (5), and one end of the fixing screw (51) extends into the electrode connector (5) for supplying the stimulating electrode (6) or the lumen into which the extension wire of the stimulation electrode (6) is inserted, 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 sealing member (52) is installed in the sealing plug hole (11), and the screw sealing member (52) is provided with a normally closed elastic operating hole (521) through which an operating tool is inserted to drive the fixing screw (51) to rotate to screw in or out of the inner cavity. 9. The pulse generator according to claim 8, characterized in that it further comprises an end sealing ring (53), which is mounted on the top cover (1), one end is located inside the top cover (1), and the other is inside the top cover (1). One end 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). 10. An implantable sacral nerve stimulation system comprising: pulse generator (10); a stimulation electrode (6), one end is connected to the pulse generator (10), and the other end is adapted to be in contact with the nerve; An adjustable fixation anchor (7) for connecting the other end of the stimulating electrode (6) with the 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); It is characterized in that: the pulse generator (10) is the pulse generator according to any one of claims 1-11, and the outer charging coil (81) can perform external charging on the inner charging coil (3) from outside the body. Electromagnetic induction charging.

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