Pulse generator and implanted sacral nerve stimulation system
Technical Field
The invention relates to an implantable medical device, in particular to a chargeable implantable pulse generator and an implantable sacral nerve stimulation system.
Background
The sacral nerve stimulator is also called a bladder pacemaker, can be used for treating symptoms of non-obstructive urinary retention and overactive bladder which are not effective or intolerant to conservative treatment, is an implantable programmable device, and generally comprises an internal implantation instrument and an external control device, and the internal implantation instrument and the external control device exchange information through two-way wireless communication.
In the prior art, the implantable medical device is generally powered by a battery, emits stimulation pulses with specific frequency, and stimulates specific targets for a long time, so that symptoms of patients are improved. The price of implantable medical devices is generally high, but the lifetime is mostly short, and the main factor limiting the lifetime of implantable medical devices is the battery capacity. In order to extend the useful life, some implantable medical devices are powered by high energy density lithium primary batteries, such as lithium-chlorosulfite batteries and lithium-polyfluorocarbon batteries. However, once the battery is exhausted, the patient has to undergo the operation again to replace the implantable medical device, which not only causes physical trauma to the patient, but also brings great economic pressure to the patient at an expensive price.
In order to extend the life of implantable medical devices, externally charged implantable medical devices have been developed. The external charging type implanted medical device generally comprises a metal titanium shell and a rechargeable battery encapsulated by the titanium shell, wherein in the external wireless charging process, vortex flow is generated on the shell and the rechargeable battery encapsulated by the titanium shell, and heat is further generated to raise the temperature of the battery and the implanted part of the whole implanted medical device. Excessive heating of the implanted components can have adverse effects on the human body, and the rise in battery temperature can also affect the life of the battery itself.
Chinese patent document CN105268103a discloses an external charging type implanted medical instrument, which adds a heat shielding layer between an internal charging energy receiving ring and a rechargeable battery in the instrument in order to reduce excessive heat generation of an implanted component battery, however, the heat shielding layer needs to realize electromagnetic shielding, and also needs to be capable of conducting electricity and heat, and has high requirements on an installation position, thereby resulting in high production cost, high precision requirement and high production difficulty.
Chinese patent document CN106237516B discloses a rechargeable implant medical device, which, in order to reduce the problem of excessive heat productivity of the battery of the implant component, adds a heat sink on the titanium shell on the outward side of the implant device, and also adds a shielding layer between the charging coil and the rechargeable battery inside the implant device, where the shielding layer is required to realize both electromagnetic shielding and heat conduction, and has high requirement on the installation position and high production difficulty.
In the prior art, in order to avoid overlarge heating value of a battery of an implantation component, a shielding layer is generally adopted and is arranged between a charging coil and a rechargeable battery in an implantation device, and the problems are that the shielding layer has more functional requirements, the mounting position accuracy is high, the shielding and heat conduction or electric conduction effects are affected once the position is deviated, and in addition, the thickness of the implantation device is increased after the shielding layer is additionally arranged, so that the wound is larger during implantation.
Disclosure of Invention
Therefore, the technical problem to be solved by the invention is to overcome the technical defects of complex internal structure, large thickness and large implantation wound of the rechargeable implantation medical instrument in the prior art caused by adding a shielding layer and other parts for solving the problems of charging and heating, thereby providing the pulse generator with simple internal structure, thin thickness and small implantation wound.
The invention also provides an implantable sacral nerve stimulation system with the pulse generator.
To this end, the invention provides a pulse generator comprising:
the top cover is made of biocompatible high polymer materials;
The pulse generator main body is connected with the top cover plane;
An internal charging coil arranged inside the top cover;
And the rechargeable battery is arranged inside the pulse generator main body and is directly or indirectly electrically connected with the internal charging coil.
As a preferable scheme, the biocompatible polymer material is one or more of TPU, PEEK and nylon.
The internal charging coil is electrically connected with the circuit board, and the circuit board is electrically connected with the rechargeable battery.
As a preferable scheme, the top cover is connected with the pulse generator main body through a connecting structure plane, the connecting structure comprises a fixed claw and a fixed pin, the fixed claw is arranged on the pulse generator main body, and the fixed pin penetrates through the fixed claw and a fixed pin hole on the top cover to realize plane connection of the top cover and the pulse generator main body.
As a preferred aspect, the inner charging coil is disposed proximate to an inner sidewall of the top cover.
As a preferred scheme, the device further comprises an antenna which is arranged inside the top cover and is electrically connected with the circuit board.
As a preferred solution, the device further comprises an electrode connector, which is arranged inside the top cover and is used for being connected with the stimulating electrode or an extension line connected with the stimulating electrode.
As a preferred scheme, the device also comprises a microprocessor module which is arranged inside the pulse generator main body and is electrically connected with the electrode connector through the circuit board for generating an electric stimulation pulse signal.
As a preferable mode, the top cover is internally provided with a containing groove for containing the internal charging coil, the antenna or the electrode connector, and the internal charging coil, the antenna or the electrode connector is fixed by liquid silicone rubber adhesion.
As a preferable scheme, a fixing screw is screwed on the electrode connector, one end of the fixing screw extends into an inner cavity of the electrode connector for inserting the stimulating electrode or an extension line for connecting the stimulating electrode, and the other end of the fixing screw is positioned outside the electrode connector;
the top cover opposite to the fixing screw is provided with a sealing plug hole, a screw sealing piece is arranged in the sealing plug hole, and the screw sealing piece is provided with a normally closed elastic operation hole for an operation tool to extend in to drive the fixing screw to rotate so as to screw in or screw out of the inner cavity.
As a preferred scheme, the electrode connector further comprises an end sealing ring which is arranged on the top cover, one end of the end sealing ring is positioned inside the top cover, the other end of the end sealing ring is positioned outside the top cover, and one end of the end sealing ring positioned inside the top cover is connected with the electrode connector.
The present invention also provides an implantable sacral nerve stimulation system comprising:
A pulse generator;
a stimulation electrode, one end of which is connected with the pulse generator, and the other end of which is suitable for being contacted with the nerve;
An adjustable anchor for connecting the other end of the stimulating electrode with a corresponding nerve;
The external control device can be in wireless communication with the pulse generator, can read the device information of the pulse generator and adjust the stimulation parameters, and is provided with an external charging coil;
the pulse generator is any one of the above, and the external charging coil is capable of electromagnetic induction charging the internal charging coil from outside the body.
The technical scheme provided by the invention has the following advantages:
1. The pulse generator comprises a top cover and a pulse generator main body, wherein the top cover and the pulse generator main body are in plane connection, the plane connection means that when the pulse generator is implanted into a human body, orthographic projections of the top cover and the pulse generator main body on the skin of the human body are not overlapped, the top cover and the pulse generator main body are respectively implanted into the human body in a fitting way and are not overlapped. Compared with the prior art, the pulse generator is creatively divided into two parts, the internal charging coil is arranged in the top cover made of the biocompatible polymer material, so that the eddy current heat effect generated by wireless charging is avoided, the charging efficiency is improved, the structure such as a shielding layer is not needed, the internal design is simplified, the whole thickness is thinner, in addition, compared with the prior art, the thickness of the pulse generator main body is thinner, the battery can be designed to be thicker in the thickness direction, the battery capacity is increased, or the thickness of the pulse generator main body is slightly increased, the plane occupation is reduced, and the operation wound during implantation is reduced.
2. The pulse generator provided by the invention has the advantages that the biocompatible high polymer material can be one or more of TPU, PEEK and nylon, the requirement of biocompatibility can be met, the vortex effect is not generated during charging, the charging efficiency is improved, and the problem of overhigh temperature can be avoided.
3. The pulse generator further comprises a circuit board, wherein the circuit board is arranged in the pulse generator main body, the internal charging coil is electrically connected with the circuit board, the circuit board is electrically connected with the rechargeable battery, and the circuit board is arranged in the pulse generator main body and is separated from the internal charging coil, so that electromagnetic influence on the circuit board during charging can be prevented.
4. According to the pulse generator, the top cover is connected with the pulse generator through the connecting structure in a plane, the connecting structure comprises the fixed claw and the fixed pin, the fixed claw is connected with the pulse generator main body, the fixed pin penetrates through the fixed claw and the fixed pin hole on the top cover, the plane connection of the top cover and the pulse generator main body is realized, the reasonable layout between the top cover and the pulse generator main body is ensured, and the inner charging coil placed in the top cover is prevented from being influenced by the material of the pulse generator main body during charging.
5. The pulse generator provided by the invention has the advantages that the inner charging coil is arranged close to the inner side wall of the top cover, when the pulse generator is implanted into a human body, the side wall faces the skin side of the human body, and when the pulse generator is charged, the outer charging coil and the inner charging coil of the external control device are opposite to each other for charging, so that the interval distance is small, and the charging efficiency is high.
6. The pulse generator also comprises an antenna which is arranged in the top cover and is electrically connected with the circuit board, wherein the antenna is arranged in the biocompatible polymer top cover, signals cannot be influenced by the titanium shell, and the signal strength is higher.
7. The pulse generator also comprises an electrode connector which is arranged in the top cover and is used for being connected with the stimulating electrode or an extension line for connecting the stimulating electrode, wherein the electrode connector is arranged in the top cover with fewer parts, the space occupation is more reasonable, the empty space in the pulse generator main body is small, the space utilization rate is high, and the compactness is good.
8. The pulse generator is characterized in that a fixing screw is arranged on an electrode connector, a screw sealing piece is arranged at a sealing plug hole position of a top cover, the screw sealing piece is opposite to the fixing screw position screwed on the electrode connector, an operation tool (such as a screwdriver) can screw or unscrew the fixing screw through the screw sealing piece, and the fixing or loosening of a stimulation electrode penetrating into the electrode connector or an extension line connected with the stimulation electrode is realized.
9. The pulse generator also comprises an end sealing ring which is arranged on the top cover, one end of the end sealing ring is positioned in the top cover, the other end of the end sealing ring is positioned outside the top cover, one end of the end sealing ring positioned in the top cover is connected with the electrode connector, and the end sealing ring is provided with a through hole for inserting the stimulating electrode to be connected with the electrode connector.
10. The invention also provides an implantable sacral nerve stimulation system comprising a pulse generator, a stimulation electrode, an adjustable anchor and an extracorporeal control device, wherein the pulse generator is the pulse generator, and has all the advantages of the pulse generator.
Drawings
In order to more clearly illustrate the technical solutions in the prior art or in the embodiments of the present invention, the following brief description is given of the drawings used in the description of the prior art or the embodiments.
Fig. 1 is a schematic diagram of the overall structure of the pulse generator of the present invention after connection to a stimulating electrode.
Fig. 2 is a rear view of the pulse generator of fig. 1.
Fig. 3 is a schematic view of the structure of fig. 1 with the cap separated from the pulser body.
Fig. 4 is a front view of the top cover.
Fig. 5 is a rear view of the top cover.
Fig. 6 is a schematic exploded view of the structure of the top cover.
Fig. 7 is a schematic structural view of the inner coil.
Fig. 8 is a schematic view of another inner coil structure.
Fig. 9 is a schematic diagram of an application scenario of the implantable sacral nerve stimulation system of the present invention.
The pulse generator comprises the following components of 1, a top cover, 1-2 a-1-2 c, a fixing pin hole, 2, a pulse generator main body, 2-1 a-2 c, a fixing pin, 2-2 a-2 c, a fixing claw, 3, an inner charging coil, 31, an inner charging coil first lead terminal, 32, an inner charging coil second lead terminal, 4, an antenna, 5, an electrode connector, 51, a fixing screw, 52, a screw sealing piece, 521, a normally closed elastic operation hole, 53, an end sealing ring, 6, a stimulating electrode, 7, an adjustable fixing anchor, 8, an external control device, 81, an outer charging coil, 10, a pulse generator, 11 and a sealing plug hole.
Detailed Description
The technical scheme of the invention is described in detail below with reference to the accompanying drawings.
Example 1
The sacral nerve pulse generator comprises a top cover 1, a pulse generator main body 2, an internal charging coil 3 and a rechargeable battery, wherein the top cover 1 is transparent and made of biocompatible high polymer materials, the pulse generator main body 2 is connected with the plane of the top cover 1, the internal charging coil 3 is arranged inside the top cover 1, and the rechargeable battery is arranged inside the pulse generator main body 2 and is directly or indirectly electrically connected with the internal charging coil 3.
The plane connection means that when the pulse generator of the present embodiment is implanted in the human body, the front projections of the top cover 1 and the pulse generator body 2 on the skin of the human body do not overlap, and the top cover 1 and the pulse generator body 2 are both implanted in the human body in a fitting manner and are not overlapped. The pulse generator of the embodiment has the advantages that the internal charging coil 3 is arranged inside the top cover 1 and is electrically connected with the rechargeable battery arranged inside the pulse generator main body 2, and because the top cover 1 is made of biocompatible high polymer materials, when the charging device positioned outside the body is just charging the internal charging coil 3 arranged inside the top cover 1, the top cover 1 does not generate vortex, so that the shell of the top cover 1 does not generate self-heat, thereby reducing heat generation and further reducing the risk caused by charging and heating. The pulse generator of the embodiment is creatively divided into two parts, an internal charging coil 3 is arranged in a top cover 1 made of biocompatible high polymer material, so that the eddy current thermal effect of wireless charging is avoided, the charging efficiency is improved, a shielding layer and other structures are not needed, the internal design is simplified, the whole thickness is thinner, in addition, the thickness of a pulse generator main body 2 is thinner, the battery design can be thicker in the thickness direction, the battery capacity is increased, or the thickness of the pulse generator main body 2 is slightly increased, the plane occupation is reduced, and the operation wound during implantation is reduced.
In this embodiment, the top cover 1 and the pulse generator main body 2 are both in cuboid structures with round peripheries, and the top cover 1 and the pulse generator main body 2 can be also set to be in other adaptive structures according to actual needs.
The top cover 1 in this embodiment is made of TPU, and the pulse generator main body 2 is a titanium shell. The material of the top cover 1 can also be PEEK or nylon. The material can meet the requirement of biocompatibility, does not generate eddy effect during charging, improves the charging efficiency, can avoid the problem of overhigh temperature, and has lower charging efficiency by arranging the inner charging coil 3 inside the titanium shell conventionally.
The internal charging coil 3 is electrically connected with the circuit board, and the circuit board is electrically connected with the rechargeable battery. The circuit board is provided inside the pulser main body 2, and is provided separately from the internal charging coil 3, so that electromagnetic influence on the circuit board during charging can be prevented.
As shown in fig. 7 to 8, the structure of the inner charging coil 3 is not limited, and may be circular, square or other shape as long as it can be used for charging. As shown in fig. 5, the internal charging coil 3 enters the inside of the pulser main 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.
The top cover 1 is connected with the pulse generator main body 2 through a connecting structure plane, the connecting structure comprises fixing claws 2-2a, 2-2b and 2-2c and fixing pins 2-1a, 2-1b and 2-1c, the fixing claws 2-2a, 2-2b and 2-2c are arranged on the pulse generator main body 2, and the fixing pins 2-1a, 2-1b and 2-1c penetrate through the fixing claws 2-2a, 2-2b and 2-2c and the fixing pin holes 1-2a, 1-2b and 1-2c on the top cover 1 to realize plane connection of the top cover 1 and the pulse generator main body 2. The above-mentioned connection structure has guaranteed the reasonable layout between top cap 1 and the pulse generator main part 2, makes the interior charging coil 3 of placing in top cap 1 inside avoid the influence of pulse generator main part 2 material when charging.
The inner charging coil 3 is dense Rao Xianjuan, is close to the inside wall setting of top cap 1, and when implanting the human back, this lateral wall is towards the skin side of human, and when charging, the outer charging coil 81 of external control device 8 just charges with the inner charging coil 3, and the interval distance is little, and charging efficiency is high.
The antenna 4 is arranged inside the top cover 1 and is electrically connected with the circuit board. The antenna 4 is arranged inside the biocompatible polymer top cover 1, signals cannot be influenced by the titanium shell, and the signal intensity is higher. In this embodiment, the antenna 4 is a bluetooth antenna.
The electrode connector 5 is arranged inside the top cover 1 and is used for being connected with the stimulation electrode 6 or an extension line connected with the stimulation electrode 6. The electrode connector 5 is provided inside the top cover 1 with fewer parts.
The device also comprises a microprocessor module which is arranged inside the pulse generator main body 2 and is electrically connected with the electrode connector 5 through the circuit board for generating an electric stimulation pulse signal.
The top cover 1 is internally provided with a containing groove for containing the internal charging coil 3, the antenna 4 or the electrode connector 5, and is fixed by using a buckle or liquid silicone rubber for bonding.
The electrode connector 5 is provided with a fixing screw 51, the sealing plug hole 11 of the top cover 1 is provided with a screw sealing piece 52, the screw sealing piece 52 is opposite to the fixing screw 51 screwed on the electrode connector 5, an operating tool (such as a screwdriver) can screw or unscrew the fixing screw 51 through the screw sealing piece 52, and the fixing or loosening of the stimulating electrode 6 penetrating into the electrode connector 5 or an extension line connected with the stimulating electrode 6 is realized.
The electrode connector is characterized by further comprising an end sealing ring 53, wherein the end sealing ring 53 is arranged on the top cover 1, one end of the end sealing ring 53 is positioned in the top cover 1, the other end of the end sealing ring is positioned outside the top cover 1, one end of the end sealing ring 53 positioned in the top cover 1 is connected with the electrode connector 5, and a through hole is formed in the end sealing ring 53 and used for inserting a stimulation electrode 6 to be connected with the electrode connector 5.
Example 2
This embodiment provides an implantable sacral nerve stimulation system, as shown in fig. 9, comprising a pulse generator 10, a stimulation electrode 6, an adjustable anchor 7, an external control device 8, an external charging coil 81, and an external charging coil 81, wherein one end of the stimulation electrode 6 is connected with the pulse generator 10, the other end of the stimulation electrode is suitable for being in contact with a nerve, the adjustable anchor 7 is used for connecting the other end of the stimulation electrode 6 with the corresponding nerve, the external control device 8 can be in wireless communication with the pulse generator 10 and can read device information of the pulse generator 10 and adjust stimulation parameters, and 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.
The implantable sacral nerve stimulation system provided in this embodiment naturally has all the advantages of the pulse generator described above, since the pulse generator in embodiment 1 is employed.
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.