A pulse generator, method of assembly and stimulation system

Abstract

The application discloses a pulse generator, an assembling method thereof and a stimulation system, the pulse generator comprising a connecting module, a generator module and a battery module, the connecting module comprising a top cover and a channel assembly, at least a part of the channel assembly being arranged in the top cover and being used for inserting an insert. The generator module comprises a first shell, a circuit board and a battery connecting assembly, the connecting module is mounted on the generator module, the circuit board is arranged in the first shell and is electrically connected with the channel assembly. The battery module comprises a second shell and a battery arranged in the second shell, the battery module is mounted on the generator module and is located outside the generator module, and the battery is electrically connected with the circuit board through the battery connecting assembly. The independent modules can be respectively and independently assembled in the respective assembling procedures, the assembling is performed in multiple threads, the overall assembling period of the pulse generator is shortened, and when the assembled pulse generator is damaged, the damaged module can be replaced, so that the production cost of the enterprise is reduced.

Description

Technical Field

[0001] This invention relates to the field of implantable medical device technology, and more particularly to a pulse generator, its assembly method, and stimulation system. Background Technology

[0002] Neuro-electrical stimulation (NES) is a commonly used method for treating neurological dysfunctions and rehabilitating nerve injuries. NES systems apply electrical stimulation to relevant areas via implanted pulse generators and electrodes. Current assembly processes for implantable pulse generators are quite complex. The components of the pulse generator are connected using a stacking method, requiring each step to be completed before proceeding to the next, making it impossible to perform multiple different processes simultaneously, resulting in a long assembly cycle. Before the product leaves the factory, if a malfunction occurs, the product becomes unusable and requires complete disassembly and reassembly, leading to significant consumption of raw materials and labor costs, which is detrimental to cost control. Summary of the Invention

[0003] The purpose of this invention is to provide a pulse generator, assembly method, and stimulation system to solve the above-mentioned problems.

[0004] The objective of this invention is achieved through the following technical solution:

[0005] A pulse generator includes: a connection module, a generator module, and a battery module.

[0006] The connection module includes a top cover and a channel assembly, at least a portion of which is disposed within the top cover and used for insertion of an insert. The generator module includes a first housing, a circuit board, and a battery connection assembly. The connection module is mounted on the generator module, and the circuit board is disposed within the first housing and electrically connected to the channel assembly. The battery module includes a second housing and a battery located within the second housing. The battery module is mounted on the generator module and located outside the generator module. The battery is electrically connected to the circuit board via the battery connection assembly.

[0007] In one embodiment, the top cover is an insulating element, the top cover includes a front cover and a rear cover, the front cover and the rear cover are joined to form a receiving cavity, and the rear cover is provided with at least one first channel groove on the inner side facing the front cover.

[0008] The channel assembly includes a channel cover and multiple connectors. The channel cover has a second channel groove corresponding to the first channel groove on the side facing the rear cover. After the channel cover and the rear cover are joined, the first channel groove and the second channel groove form an axial channel for inserting the insert. Multiple radial grooves are distributed at intervals on the axial channel. Each radial groove is provided with a connector for electrically connecting the insert. The connector is electrically connected to a circuit board.

[0009] In one embodiment, the inner wall of the radial groove is provided with a first metal layer and a through hole connecting the inside and outside of the channel cover. The outer surface of the channel cover is provided with a plurality of second metal layers. Each second metal layer is electrically connected to the first metal layer in the corresponding radial groove through a through hole. The connector is electrically connected to the circuit board through the first metal layer and the second metal layer.

[0010] In one embodiment, the generator module further includes a feedthrough, which is an insulating component. The feedthrough has multiple third metal layers, and each third metal layer is electrically connected to a second metal layer and a circuit board.

[0011] In one embodiment, the connection module further includes a charging coil and an antenna. The charging coil is embedded in the front cover or the rear cover. The antenna is disposed on one side of the radial groove of the channel cover. The feedthrough component is provided with a fourth metal layer and two fifth metal layers. The fourth metal layer is electrically connected to the antenna and the circuit board, respectively. The two fifth metal layers are electrically connected to the charging coil and the circuit board, respectively. The fourth metal layer and the fifth metal layer are respectively close to opposite ends of the feedthrough component.

[0012] In one embodiment, the first housing is provided with a first locking portion facing the top cover, and the front cover or the rear cover is provided with a second locking portion. When the connecting module is installed on the generator module, the first locking portion and the second locking portion are engaged.

[0013] In one embodiment, the first card part is provided with a card slot, and the second card part is a protrusion with a bevel on the inner surface of the rear cover. When the connecting module is installed on the generator module, the first card part is engaged with the second card part under the guiding action of the bevel of the second card part.

[0014] In one embodiment, the front cover is provided with an opening that communicates with the inside and outside of the receiving cavity. The opening of the front cover is a notch located at the edge of the front cover or an opening that does not extend to the edge of the front cover.

[0015] The rear cover has a first auxiliary positioning part on the edge facing the first housing, and the first housing has a second auxiliary positioning part. When the connecting module is installed on the generator module, the first auxiliary positioning part and the second auxiliary positioning part are engaged.

[0016] In one embodiment, the first housing is provided with a tongue plate extending into the receiving cavity, the receiving cavity is provided with an insulating encapsulating material for filling gaps, the insulating encapsulating material seals the opening on the front cover, and the insulating encapsulating material wraps the tongue plate.

[0017] In one embodiment, the channel assembly further includes a waterproof component and a positioning component, which are arranged sequentially from the outside to the inside at the opening of the axial channel. The waterproof component and the positioning component are provided with holes for the insert to pass through and enter the axial channel. The positioning component is used to fix the insert. The connecting component is a coil spring.

[0018] In one embodiment, the connection module further includes an identification element disposed inside the top cover. The identification element is a metal part with a hollow structure, and the hollow structure of the identification element forms the identification of the identification element.

[0019] In one embodiment, the top cover is provided with stitching holes.

[0020] In one embodiment, the battery connection assembly includes a positive connector and a negative connector, and the battery module further includes a positive terminal and a negative terminal respectively connected to the battery, wherein the positive terminal is electrically connected to the positive connector and the negative terminal is electrically connected to the negative connector.

[0021] The generator module also includes a temperature sensor electrically connected to the circuit board, which is used to measure the temperature of the battery.

[0022] In one embodiment, both the first and second housings are titanium shells and welded together to form a sealed containment space, and the second housing is reused as the housing of the battery itself.

[0023] A method for assembling a pulse generator, wherein the pulse generator is any one of the pulse generators described above, the assembly method comprising:

[0024] S1: Assemble the connection module, generator module, and battery module independently;

[0025] S2: Assemble and connect the first housing and the second housing so that the battery module is mounted on the generator module;

[0026] S3: Install the connection module onto the generator module.

[0027] In one embodiment, the assembly method further includes:

[0028] The first and second housings are connected by welding assembly;

[0029] Insulating encapsulant is injected into the top cover to connect the top cover and the first housing together.

[0030] In one embodiment, the insulating encapsulant is epoxy resin.

[0031] A stimulation system includes: a stimulation electrode, a pulse generator as described in any one of the above, and a wire, wherein an insert is disposed on the wire, the insert is inserted into the channel assembly, and the pulse generator is electrically connected to the stimulation electrode through the wire.

[0032] In one embodiment, the stimulation system further includes a converter and a plurality of stimulation electrodes. The converter is electrically connected to the pulse generator and is used to divide the stimulation pulse signal of the pulse generator into multiple stimulation pulse signals, each of which is released through a stimulation electrode.

[0033] In one embodiment, the lead wire includes an extension lead wire and a plurality of electrode leads, the converter is electrically connected to the pulse generator via the extension lead wire, and each of the stimulation electrodes is electrically connected to the converter via an insert on an electrode lead wire.

[0034] Compared with the prior art, the beneficial effects of the present invention include at least the following:

[0035] By designing the pulse generator into separate connection modules, generator modules, and battery modules, the three independent modules can be assembled independently in their respective assembly processes, allowing for multi-threaded assembly. This shortens the overall assembly cycle of the pulse generator. Furthermore, if the assembled pulse generator is damaged, the damaged module can be replaced instead of scrapping the entire pulse generator, thus reducing the company's production costs. Attached Figure Description

[0036] Figure 1 This is a schematic diagram of the pulse generator according to an embodiment of the present invention;

[0037] Figure 2 This is a schematic diagram of the pulse generator structure with the front cover removed according to an embodiment of the present invention;

[0038] Figure 3 This is a schematic diagram of the pulse generator of this invention with the front cover and the first housing removed;

[0039] Figure 4 This is an exploded schematic diagram of the pulse generator according to an embodiment of the present invention;

[0040] Figure 5 This is a schematic diagram of the connection module according to an embodiment of the present invention;

[0041] Figure 6 This is a cross-sectional view of the connection module according to an embodiment of the present invention;

[0042] Figure 7 This is an exploded view of the generator module according to an embodiment of the present invention;

[0043] Figure 8This is an exploded view of the connection module according to an embodiment of the present invention;

[0044] Figure 9 This is a schematic diagram of the stimulation system according to an embodiment of the present invention.

[0045] In the diagram: 1. Connecting module; 11. Top cover; 111. Front cover; 112. Rear cover; 1121. First auxiliary positioning part; 113. First channel groove; 114. Channel cover; 115. Second channel groove; 116. Axial channel; 117. Radial groove; 118. First metal layer; 119. Second metal layer; 12. Channel assembly; 121. Waterproof component; 122. Positioning component; 13. Charging coil; 131. Charging terminal; 15. Second card 16. Opening; 17. Connector; 18. Identifier; 19. Seam hole; 2. Generator module; 21. Feedthrough; 221. Fourth metal layer; 222. Fifth metal layer; 22. Third metal layer; 23. Circuit board; 25. First housing; 251. First card part; 252. Tongue plate; 253. Second auxiliary positioning part; 3. Battery module; 31. Positive connector; 32. Negative connector; 41. Extension wire; 42. Electrode wire. Detailed Implementation

[0046] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, they are provided to make the invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted.

[0047] The terms used to express position and direction in this invention are illustrated with reference to the accompanying drawings, but changes can be made as needed, and all such changes are included within the scope of protection of this invention.

[0048] Reference Figure 1-8 The present invention provides a pulse generator, comprising: a connection module 1, a generator module 2, and a battery module 3.

[0049] The connection module 1 includes a top cover 11 and a channel assembly 12. At least a portion of the channel assembly 12 is disposed within the top cover 11 and used for inserting an insert, such as the insertion end of an extension wire 41. The generator module 2 includes a first housing 25, a circuit board 23, and a battery connection assembly. The connection module 1 is mounted on the generator module 2. The circuit board 23 is disposed within the first housing 25 and electrically connected to the channel assembly 12. The battery module 3 includes a second housing and a battery located within the second housing. The second housing is reused as the housing of the battery itself; in other words, the second housing is the housing of the battery itself. Therefore, there is no need to set up a housing outside the battery housing, thereby simplifying the product structure and saving costs. The battery module 3 is mounted on the generator module 2 and located outside the generator module 2. The battery is electrically connected to the circuit board 23 through the battery connection assembly.

[0050] The assembly of connection module 1, generator module 2, and battery module 3 involves two steps. The first step is the assembly of each module itself. Taking generator module 2 as an example, during its assembly, the circuit board 23 and battery connection assembly are sequentially installed and fixed inside the second housing to complete the initial assembly. The second step is to assemble generator module 2 with the assembled connection module 1, and then assemble the bottom with the assembled battery module 3, thus completing the pulse generator assembly. After assembly, during testing, if any assembled module malfunctions or is damaged, the damaged module can be removed and replaced with a module of the same type for reassembly, saving costs. Furthermore, the relatively independent modules can be assembled independently at multiple workstations without interfering with each other, ensuring high work efficiency and shortening the production cycle of each pulse generator. Furthermore, the modular design of the connection module 1, generator module 2, and battery module 3 can be designed into different models. Different models of modules use standard or unified interfaces. For example, the battery module 3 can be made into modules with different capacities, so as to match various power requirements. It can be configured with small-capacity batteries or large-capacity batteries, or round batteries, square batteries, etc.

[0051] In one embodiment, the top cover 11 is an insulating component and may be made of plastic. The top cover 11 includes a front cover 111 and a rear cover 112. The front cover 111 and the rear cover 112 are preferably two insulating shells with matching shapes. The front cover 111 and the rear cover 112 form a receiving cavity after being joined together. The rear cover 112 is provided with at least one first channel groove 113 on the inner side facing the front cover 111.

[0052] The channel assembly 12 includes a channel cover 114 and a plurality of connectors 17. The channel cover 114 has a second channel groove 115 corresponding to the first channel groove 113 on the side facing the rear cover 112. After the channel cover 114 and the rear cover 112 are engaged, the first channel groove 113 and the second channel groove 115 form an axial channel 116 for inserting the insert. The first channel groove 113 and the second channel groove 115 are preferably 1 / 2 portions of the axial channel 116, respectively. A plurality of radial grooves 117 are distributed at intervals on the axial channel 116. Each radial groove 117 is provided with a connector 17 for electrically connecting the insert. The radial grooves 117 and the axial channel 116 are internally connected. The connector 17 is, for example, a coil spring and an electrical conductor wire. The connector 17 is electrically connected to a circuit board 23. A first channel groove 113 is formed on the rear cover 112, and a second channel groove 115 is formed on the channel cover 114. During connection, the first channel groove 113 and the second channel groove 115 form an axial channel 116 through the engagement of the channel cover 114 and the rear cover 112. A connector 17 (not shown in the figure) is connected inside the axial channel 116. Compared with the traditional assembly method of separately setting two channel covers 114 between the rear cover 112 and the front cover 111, and the two channel covers 114 are joined to form the axial channel 116, this embodiment opens the first channel groove 113 on the rear cover 112. The first channel groove 113, as part of the axial channel 116, cooperates with the second channel groove 115 to form the axial channel 116. This method has higher integration, makes full use of the structure of the rear cover 112, reduces the thickness, and prefabricates the assembly structure on the rear cover 112, which can greatly reduce the dimensional tolerances when assembling the various components on the top cover 11, thereby reducing the overall volume of the pulse generator and making it lighter.

[0053] The bottom of the back cover 112 may also have a strip-shaped protrusion, which is used to cooperate with the groove on the generator module 2 corresponding to the bottom of the back cover 112. During assembly, it can be fixed by filling with sealant.

[0054] Preferably, the inner wall of the radial groove 117 is provided with a first metal layer 118 and a through hole connecting the inside and outside of the channel cover 114. The outer surface of the channel cover 114 is provided with a plurality of second metal layers 119. Each second metal layer 119 is electrically connected to the first metal layer 118 in the corresponding radial groove 117 through a through hole. The connector 17 is electrically connected to the circuit board 23 through the first metal layer 118 and the second metal layer 119. The first metal layer 118 and the second metal layer 119 can be formed on the channel cover 114 by processes such as electroplating, which will not be listed here. During operation, the generator module 2 generates a stimulation signal. The stimulation signal is transmitted through the second metal layer 119 and through the through hole, then through the first metal layer 118 and to the connector 17. Finally, the connector 17 transmits the stimulation signal to the insert and then to other parts, completing the signal transmission. The first metal layer 118 and the second metal layer 119 are both conductive metal materials with uniform thickness. They are respectively attached to or formed on the inner side, through hole and outer side of the channel, and have good electrical connection stability. At the same time, the contact area when the first metal layer 118 and the second metal layer 119 are connected is large. Compared with the traditional point-to-point and point-to-surface connections, the surface-to-surface metal layer connection of this embodiment has stronger stability. In addition, the first metal layer 118 and the second metal layer 119 are not easy to fall off or move and cause short circuits. When the pulse generator is subjected to vibration or collision, the first metal layer 118 and the second metal layer 119 can still maintain good electrical connection.

[0055] In one embodiment, the generator module 2 further includes a feedthrough 21, which is an insulating component. The feedthrough 21 has multiple third metal layers 22, each of which is electrically connected to a second metal layer 119 and a circuit board 23. The multiple third metal layers 22 and the multiple second metal layers 119 are connected in a one-to-one correspondence. During operation, the stimulation signal generated by the generator module 2 is transmitted to the connection module 1 through the multiple third metal layers 22 and the second metal layers 119 via electrical connections. The stimulation signal is then transmitted to the outside through an insert within the connection module 1, and finally applied to the stimulation point via a stimulation electrode.

[0056] In one embodiment, the battery connection assembly includes a positive connector 31 and a negative connector 32. The battery module 3 further includes a positive terminal and a negative terminal (not shown) respectively connected to the battery. The positive terminal is electrically connected to the positive connector 31, and the negative terminal is electrically connected to the negative connector 32. After the battery module 3 and the generator module 2 are connected, the positive connector 31 and the negative connector 32 of the battery module 3 are respectively connected to the bottom interface of the generator module 2 to supply power to the generator module 2.

[0057] Preferably, the generator module 2 further includes a thermometer (not shown in the figure), which is electrically connected to the circuit board 23 and is used to measure the temperature of the battery. The thermometer may extend into the battery module 3, or the battery module 3 may have a recess on it, with the measuring end of the thermometer contacting the recess. The thermometer can be, for example, a contact temperature sensor that measures the battery temperature through heat transfer during operation, or it can be a non-contact infrared thermometer that measures the battery temperature. The temperature information can be stored in a memory or transmitted to external devices, allowing medical personnel to monitor the internal condition of the pulse generator.

[0058] Preferably, the connection module 1 further includes a charging coil 13 and an antenna (not shown in the figure). The charging coil 13 is embedded in the front cover 111 or the rear cover 112. During charging, the external wireless charger and the charging coil 13 sense each other, thereby generating an induced current. The induced current ultimately stores the generated electricity through the battery module 3. The user does not need to physically replace the battery of the pulse generator to maintain the continuous operation of the pulse generator. Specifically, the induced current generated by the charging coil 13 is transmitted through the connection between the coil and the circuit board 23, and then the current is transmitted through the lines on the circuit board 23, and enters the battery for storage through the positive connector 31 and the negative connector 32. The above-mentioned wireless charging method can maintain the service life of the pulse generator for a long time. In addition, embedding the charging coil 13 in the front cover 111 or the rear cover 112 has two advantages. First, since the front cover 111 or the rear cover 112 is generally made of inorganic insulating material, such as polymer material, it can reduce or avoid the eddy current heating effect and achieve high charging efficiency. Second, after the charging coil 13 is embedded, it can avoid occupying space, which is beneficial to reducing the product size.

[0059] The antenna is disposed on one side of the radially recessed groove 117 of the channel cover 114. The feedthrough 21 has a fourth metal layer 221 and two fifth metal layers 222. The fourth metal layer 221 is electrically connected to the antenna and the circuit board 23, respectively. The two fifth metal layers 222 are electrically connected to the charging coil 13 and the circuit board 23, respectively. The fourth metal layer 221 and the fifth metal layers 222 are located near opposite ends of the feedthrough 21. Users can use the antenna to communicate between the pulse generator and an external receiving device, allowing the pulse generator's internal information to be fed back to the external receiving device in real time. This enables the external receiving device to understand the pulse generator's operating parameters, such as battery temperature, battery level, or internal temperature information of the generating module, helping external medical personnel assess the pulse generator's performance and stability. The user can also control the pulse generator via the antenna. The fifth metal layer 222 and the charging coil 13 are electrically connected to the charging terminal 131, which is led out to the outside of the front cover 111 or the rear cover 112, respectively, so that the current of the charging coil 13 is ultimately used to charge the battery module 3 through the circuit board 23. The fourth metal layer 221 and the fifth metal layer 222 are respectively close to the opposite ends of the feedthrough member 21, that is, the fourth metal layer 221 is close to one end of the feedthrough member 21, and the fifth metal layer 222 is close to the opposite end of the feedthrough member 21. This reduces the interference of the fifth metal layer 222 on the signal of the fourth metal layer 221 used for communication, and improves the reliability of signal transmission.

[0060] Preferably, the first housing 25 is provided with a first locking portion 251 facing the top cover 11, and the front cover 111 or the rear cover 112 is provided with a second locking portion 15. When the connecting module 1 is installed on the generator module 2, the first locking portion 251 and the second locking portion 15 are engaged. The first locking portion 251 is, for example, a locking plug with a bevel, and the second locking portion 15 is, for example, a retaining ring with a retaining groove. The plug is engaged in the groove of the retaining ring to form a locking connection. The front cover 111 and the rear cover 112 are engaged together by the first locking portion 251 and the second locking portion 15. The assembly method is relatively simple, does not require complex processes to complete the assembly, reduces assembly steps, and shortens the assembly cycle of the pulse generator.

[0061] Preferably, the first locking part 251 is provided with a locking groove, and the second locking part 15 is a beveled protrusion on the inner surface of the rear cover 112. When the connecting module 1 is installed on the generator module 2, the first locking part 251 is locked onto the second locking part 15 under the guidance of the beveled surface. During connection, the connecting end of the connecting module 1 and the connecting end of the generator module 2 are vertically aligned. The beveled protrusion will first abut against the first locking part 251. The first locking part 251 is pushed and offset by a certain angle under the action of the bevel until the protrusion of the second locking part 15 moves into the groove of the first locking part 251. The first locking part 251 returns to the vertical angle, locking the second locking part 15 tightly. During assembly, this facilitates quick and accurate assembly by the assembly personnel, shortening the overall assembly cycle of the pulse generator. The first locking part 251 and the second locking part 15 also have an auxiliary positioning function to prevent the connecting module 1 and the generator module 2 from deviating from the preset position during assembly.

[0062] Furthermore, the front cover 111 is provided with an opening 16 that connects the inside and outside of the receiving cavity. The opening 16 can be a strip-shaped opening. The opening 16 of the front cover 111 can be a notch located at the edge of the front cover 111, or it can be an opening that does not extend to the edge of the front cover 111. The opening 16 has two functions. The first function is that, during assembly, after the connection module 1 and the generator module 2 are connected, the assembly personnel can directly connect the second metal layer 119 and the third metal layer 22, the fourth metal layer 221 and the antenna, and the fifth metal layer 222 and the charging terminal 131 through the strip-shaped opening 16 by wire bonding. This eliminates the need for the assembly personnel to expose all the circuit boards 23 of the connection module 1 and the generator module 2, simplifying the assembly steps and reducing the scrap rate of the product. The second function is that after the second metal layer 119 and the third metal layer 22 are welded together and pass the test, adhesive for curing can be injected into the pulse generator through the opening 16 here, thereby connecting the connection module 1 and the generator module 2 together and effectively encapsulating the internal components, thus playing a waterproof role.

[0063] The rear cover 112 has a first auxiliary positioning part 1121 facing the edge of the first housing 25. The first auxiliary positioning part 1121 can be a protrusion. The first housing 25 has a second auxiliary positioning part 253. The second auxiliary positioning part 253 can be a groove, or the first auxiliary positioning part 1121 can be a groove and the second auxiliary positioning part 253 can be a protrusion. When the connecting module is installed on the generator module, the first auxiliary positioning part 1121 and the second auxiliary positioning part 253 engage. For example, the first auxiliary positioning part 1121 is inserted into the second auxiliary positioning part 253, or the second auxiliary positioning part 253 is inserted into the first auxiliary positioning part 1121. Thus, when the connecting module is installed on the generator module, the first auxiliary positioning part 1121 and the second auxiliary positioning part 253 play an auxiliary positioning role. At the same time, the edge of the rear cover 112 will not lift up, improving the flatness of the entire pulse generator.

[0064] Furthermore, the first housing 25 is provided with a tongue plate 252 extending into the receiving cavity. The receiving cavity is provided with an insulating encapsulating material for filling gaps. The insulating encapsulating material is, for example, epoxy resin. The insulating encapsulating material seals the opening 16 on the front cover 111 and wraps the tongue plate 252. When the connecting module 1 and the generator module 2 are docked, the tongue plate 252 is simultaneously inserted into a preset position inside the receiving cavity, which guides and assists in positioning the connection of the first locking part 251 and the second locking part 15. This simplifies the position calibration steps of the first locking part 251 and the second locking part 15 during assembly, making assembly easier. After the insulating encapsulating material is injected and cured, it wraps the tongue plate 252, which can effectively improve the connection strength between the connecting module 1 and the generator module 2 and effectively encapsulate the internal components, providing a waterproof function.

[0065] In one embodiment, the channel assembly 12 further includes a waterproof component 121 and a positioning component 122, which are sequentially arranged from the outside to the inside at the opening of the axial channel 116. The waterproof component 121 and the positioning component 122 are provided with holes for the insert to pass through and enter the axial channel 116. The positioning component 122 is used to fix the insert, and the connecting component 17 is a coil spring. The waterproof component 121 is, for example, made of rubber or silicone through injection molding. During assembly, the insert is inserted through the axial opening and straight along the axial channel 116 until the connection position on the insert corresponds one-to-one with all the coil springs. Then, one end of the inserted insert is clamped and fixed in the connecting module 1 using fasteners. The fasteners can be bolts threaded onto the back cover 112. During assembly, the operator tightens the bolts to press the nut against the axial surface of the insert, completing the fixation.

[0066] Further preferably, the connection module 1 also includes an identification element 18, which is disposed inside the top cover 11. The identification element 18 is a metal part with a hollow structure, and the hollow structure of the identification element 18 forms the identification of the identification element 18. The metal part can use the hollow part as a mark to record the model of the connection module 1, generator module 2 and power module of the pulse generator. When in use, medical staff can learn about the information of each module of the pulse generator through the identification element 18 when scanning the user's body with an X-ray machine, which makes it convenient for medical staff to learn more about the pulse generator.

[0067] In one embodiment, the top cover 11 is provided with a suture hole 19. During use, medical personnel can suture the pulse generator into the user's body by passing a suture through the opening 19, preventing the pulse generator from shifting in position during the user's daily activities, thereby reducing the failure rate of the pulse generator.

[0068] Preferably, both the first housing 25 and the second housing are titanium shells and welded together to form a sealed containment space. During assembly, the step of assembling the battery module 3 at the bottom of the generator module 2 is preferably completed before the assembly of the generator module 2 and the connecting module 1, but this is not limited to this step. The titanium shell is a biocompatible material and will not cause rejection after implantation in the patient. The formed sealed containment space provides waterproofing.

[0069] The present invention also provides a method for assembling a pulse generator, wherein the pulse generator is the pulse generator described in any of the above embodiments, and the assembly method includes steps S1 to S3.

[0070] Step S1: Assemble the connection module 1, generator module 2 and battery module 3 independently.

[0071] First, the three modules are manufactured and assembled through multiple simultaneous processes. Different modules can be assembled independently through different production lines and processes. After assembly, each module can be inspected for product quality through its own testing process. This multi-threaded processing and assembly method has better assembly efficiency than the traditional one-stop assembly method, shortening the overall assembly time of the pulse generator. At the same time, if the three independent modules are damaged, the damaged module can be easily replaced by another module of the same model and assembled with the other two modules to form a new pulse generator.

[0072] Step S2: Assemble and connect the first housing 25 and the second housing so that the battery module 3 is mounted on the generator module 2. The first housing 25 and the second housing are mated so that the protruding positive connector 31 and negative connector 32 of the battery module 3 are mated at the bottom of the generator module 2, so that the battery module 3 can provide power support for the operation of the generator module 2.

[0073] In one specific embodiment, step S2 includes step S21: assembling and connecting the first housing 25 and the second housing by welding. After the first housing 25 and the second housing are connected, they are sealed together by a welding process.

[0074] Step S3: Install the connection module 1 onto the generator module 2.

[0075] After connecting the battery module 3 and the generator module 2, the generator module 2 and the connection module 1 can be fastened together by a snap-fit ​​mechanism. The conductive layers of the connection module 1 and the generator module 2 can then be electrically connected. Subsequently, the pulse generator that has been initially assembled can be functionally tested through a testing process.

[0076] In one specific embodiment, step S3 includes step S31: injecting insulating encapsulant into the top cover 11 to connect the top cover 11 and the first housing 25 together. The pulse generator that passes the functional test will ultimately have the insulating encapsulant filled into it through the opening on the top cover 11. After curing, the pulse generator will form a sealed state, achieving waterproofing when implanted in the patient's body. The insulating encapsulant is preferably epoxy resin.

[0077] The present invention also provides a stimulation system, comprising: a stimulation electrode, a pulse generator as described in any of the above embodiments, and a wire. An insert is disposed on the wire, the insert being inserted into the channel assembly 12. The pulse generator is electrically connected to the stimulation electrode via the wire. The connection points of the insert correspond one-to-one with the positions of the coiled springs on the channel assembly 12. During operation, the electrical stimulation signal generated by the pulse generator is transmitted through the channel module and the insert connected within the channel assembly 12, then transmitted to the stimulation electrode via the wire, and released at the patient's stimulation point through the stimulation electrode, assisting the patient in stimulation therapy and helping the patient recover nerve function.

[0078] In one specific embodiment, the stimulation system further includes a converter and multiple stimulation electrodes. The converter is electrically connected to the pulse generator and is used to divide the stimulation pulse signal from the pulse generator into multiple stimulation pulse signals, each of which is released through a stimulation electrode. Existing pulse generators typically have two channel components 12, which are connected to two stimulation electrodes to release two pulse stimulation signals. Currently, two pulse stimulation signals are insufficient to meet treatment needs, requiring an increase in the number of stimulation electrodes. In this embodiment, the converter can be equipped with multiple channel modules, which can be used for inserts. By using the converter, a single multi-contact stimulation pulse can be separated into multiple multi-contact stimulation pulses, each of which is then released through a stimulation electrode. This allows for the application of electrical stimulation through more than two stimulation electrodes, meeting the clinical need for more electrode stimulation.

[0079] In one specific embodiment, the wires include an extension wire 41 and a plurality of electrode wires 42. The converter is electrically connected to the pulse generator via the extension wire 41, and each of the stimulation electrodes is electrically connected to the converter via an insert on an electrode wire 42. By providing the extension wire 41 and the plurality of electrode wires 42, the electrical connection between the pulse generator and the plurality of stimulation electrodes is facilitated.

[0080] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the invention without departing from the principles and spirit of the invention, and all such changes should fall within the protection scope of the claims of the present invention.

Claims

1. A pulse generator, characterized in that, include: A connection module, the connection module including a top cover and a channel assembly, at least a portion of the channel assembly being disposed within the top cover and used for inserting an insert; A generator module, comprising a first housing, a circuit board, and a battery connection assembly, wherein the connection module is mounted on the generator module, and the circuit board is disposed within the first housing and electrically connected to the channel assembly; A battery module, comprising a second housing and a battery located within the second housing, the battery module being mounted on and located outside the generator module, the battery being electrically connected to the circuit board via a battery connection assembly.

2. The pulse generator according to claim 1, characterized in that, The top cover is an insulating component. The top cover includes a front cover and a rear cover. The front cover and the rear cover are joined to form a receiving cavity. The rear cover has at least one first channel groove on its inner side facing the front cover. The channel assembly includes a channel cover and multiple connectors. The channel cover has a second channel groove corresponding to the first channel groove on the side facing the rear cover. After the channel cover and the rear cover are joined, the first channel groove and the second channel groove form an axial channel for inserting the insert. Multiple radial grooves are distributed at intervals on the axial channel. Each radial groove is provided with a connector for electrically connecting the insert. The connector is electrically connected to a circuit board.

3. The pulse generator according to claim 2, characterized in that, The inner wall of the radial groove is provided with a first metal layer and a through hole connecting the inside and outside of the channel cover. The outer surface of the channel cover is provided with a plurality of second metal layers. Each second metal layer is electrically connected to the first metal layer in the corresponding radial groove through a through hole. The connector is electrically connected to the circuit board through the first metal layer and the second metal layer.

4. The pulse generator according to claim 3, characterized in that, The generator module also includes a feedthrough component, which is an insulating component. The feedthrough component has multiple third metal layers, and each of the third metal layers is electrically connected to a second metal layer and a circuit board.

5. The pulse generator according to claim 4, characterized in that, The connection module also includes a charging coil and an antenna. The charging coil is embedded in the front cover or the rear cover. The antenna is located on one side of the radial groove of the channel cover. The feedthrough component is provided with a fourth metal layer and two fifth metal layers. The fourth metal layer is electrically connected to the antenna and the circuit board, respectively. The two fifth metal layers are electrically connected to the charging coil and the circuit board, respectively. The fourth metal layer and the fifth metal layer are located near the opposite ends of the feedthrough component.

6. The pulse generator according to claim 2, characterized in that, The first housing is provided with a first locking part facing the top cover, and the front cover or the rear cover is provided with a second locking part. When the connecting module is installed on the generator module, the first locking part and the second locking part are engaged.

7. The pulse generator according to claim 6, characterized in that, The first card part is provided with a card slot, and the second card part is a protrusion with a bevel on the inner surface of the rear cover. When the connecting module is installed on the generator module, the first card part is engaged with the second card part under the guidance of the bevel of the second card part.

8. The pulse generator according to claim 2, characterized in that, The front cover is provided with an opening that connects the inside and outside of the receiving cavity. The opening of the front cover is a notch located at the edge of the front cover or an opening that does not extend to the edge of the front cover. The rear cover has a first auxiliary positioning part on the edge facing the first housing, and the first housing has a second auxiliary positioning part. When the connecting module is installed on the generator module, the first auxiliary positioning part and the second auxiliary positioning part are engaged.

9. The pulse generator according to claim 8, characterized in that, The first housing is provided with a tongue plate that extends into the receiving cavity. The receiving cavity is provided with an insulating encapsulating material for filling gaps. The insulating encapsulating material seals the opening on the front cover and wraps the tongue plate.

10. The pulse generator according to claim 2, characterized in that, The channel assembly also includes a waterproof component and a positioning component, which are arranged sequentially from the outside to the inside at the opening of the axial channel. The waterproof component and the positioning component are provided with holes for the insert to pass through and enter the axial channel. The positioning component is used to fix the insert. The connecting component is a coil spring.

11. The pulse generator according to claim 1, characterized in that, The connection module also includes an identification element, which is disposed inside the top cover. The identification element is a metal part with a hollow structure, and the hollow structure of the identification element forms the identification of the identification element.

12. The pulse generator according to claim 1, characterized in that, The top cover is provided with stitching holes.

13. The pulse generator according to claim 1, characterized in that, The battery connection assembly includes a positive connector and a negative connector. The battery module also includes a positive terminal and a negative terminal that are respectively connected to the battery. The positive terminal is electrically connected to the positive connector, and the negative terminal is electrically connected to the negative connector. The generator module also includes a temperature sensor electrically connected to the circuit board, which is used to measure the temperature of the battery.

14. The pulse generator according to claim 1, characterized in that, Both the first and second housings are titanium shells and are welded together to form a sealed containment space. The second housing is reused as the housing of the battery itself.

15. A method for assembling a pulse generator, characterized in that, The pulse generator is the pulse generator according to any one of claims 1-14, and the assembly method includes: The connection module, generator module, and battery module are assembled independently. Assemble and connect the first housing and the second housing so that the battery module is mounted on the generator module; The connection module is installed on the generator module.

16. The assembly method according to claim 15, characterized in that, Also includes: The first and second housings are connected by welding assembly; Insulating encapsulant is injected into the top cover to connect the top cover and the first housing together.

17. The assembly method according to claim 16, characterized in that, The insulating encapsulant is epoxy resin.

18. A stimulation system, characterized in that, include: Stimulating electrodes; The pulse generator according to any one of claims 1-14; A wire with an insert inserted into the channel assembly, and a pulse generator electrically connected to the stimulation electrode via the wire.

19. The stimulation system according to claim 18, characterized in that, The stimulation system also includes a converter and multiple stimulation electrodes. The converter is electrically connected to the pulse generator and is used to divide the stimulation pulse signal of the pulse generator into multiple stimulation pulse signals, each of which is released through a stimulation electrode.

20. The stimulation system according to claim 19, characterized in that, The lead includes an extension lead and multiple electrode leads. The converter is electrically connected to the pulse generator via the extension lead, and each of the stimulation electrodes is electrically connected to the converter via an insert on an electrode lead.

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