WO2024046346A1 - 脉冲发生器及其组装方法和刺激系统 - Google Patents

脉冲发生器及其组装方法和刺激系统 Download PDF

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Publication number
WO2024046346A1
WO2024046346A1 PCT/CN2023/115708 CN2023115708W WO2024046346A1 WO 2024046346 A1 WO2024046346 A1 WO 2024046346A1 CN 2023115708 W CN2023115708 W CN 2023115708W WO 2024046346 A1 WO2024046346 A1 WO 2024046346A1
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WIPO (PCT)
Prior art keywords
module
pulse generator
channel
cover
battery
Prior art date
Application number
PCT/CN2023/115708
Other languages
English (en)
French (fr)
Inventor
徐周东
吴国良
朱为然
章海涛
李正
刘彬
夏宁
袁枝平
Original Assignee
景昱医疗科技（苏州）股份有限公司
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Publication date
Application filed by 景昱医疗科技（苏州）股份有限公司 filed Critical 景昱医疗科技（苏州）股份有限公司
Publication of WO2024046346A1 publication Critical patent/WO2024046346A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation

Definitions

  • the present application relates to the technical field of implantable medical devices, for example, to a pulse generator and its assembly method and stimulation system.
  • Nerve electrical stimulation is a commonly used method for the treatment of neurological disorders and rehabilitation of nerve injuries.
  • the nerve electrical stimulation system applies electrical stimulation to relevant parts through pulse generators and electrodes implanted in the body.
  • the assembly process of implantable pulse generators is relatively complex. Multiple components of the pulse generator are connected using a stacking scheme. During assembly, the previous step must be completed before the next step can be carried out. Multiple different processes cannot be carried out at the same time, resulting in product degradation. The assembly cycle is longer. Before the product is assembled and shipped from the factory, when a product failure occurs, the product cannot be used and needs to be completely disassembled and reassembled before it can be used, which will cause a large consumption of raw materials and labor costs and is not conducive to cost control.
  • This application provides a pulse generator, assembly method and stimulation system to solve the above problems.
  • This application provides a pulse generator, including: a connection module, a generator module and a battery module.
  • the connection module includes a top cover and a channel assembly, at least a portion of the channel assembly being disposed within the top cover and configured for insertion of an insert.
  • the generator module includes a first housing, a circuit board and a battery connection assembly.
  • the connection module is installed on the generator module.
  • the circuit board is disposed in the first housing and electrically connected to the channel assembly.
  • the battery module includes a second housing and a battery located in the second housing.
  • the battery module is installed on the generator module and located outside the generator module. The battery is electrically connected to the battery through a battery connection assembly. circuit board.
  • the top cover is an insulating member.
  • the top cover includes a front cover and a back cover.
  • the front cover and the back cover form a receiving cavity after being joined.
  • the back cover is provided with at least 10 holes facing the inside of the front cover. A first channel slot.
  • the channel assembly includes a channel cover and a plurality of connectors.
  • a second channel groove corresponding to the first channel groove is provided on the side of the channel cover facing the rear cover. After the channel cover and the rear cover are joined, the third channel groove A channel groove and a second channel groove form an axial channel for inserting the insert, and a plurality of spaced-apart channels are distributed on the axial channel.
  • Radial grooves, each radial groove is provided with a connector configured as an electrical connection insert, and the plurality of connectors are all electrically connected to the circuit board.
  • each 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 The second metal layer is electrically connected to the first metal layer in the radial groove corresponding to the through hole through a through hole, and the plurality of connectors are electrically connected to the circuit board through the first metal layer and the second metal layer.
  • the generator module further includes a feedthrough, which is an insulating member.
  • a plurality of third metal layers are provided on the feedthrough, and each third metal layer is electrically connected to the a second metal layer and circuit board.
  • connection module further includes a charging coil and an antenna
  • the charging coil is embedded in the front cover or the back cover
  • the antenna is disposed on a side of the channel cover facing away from the radial groove.
  • the feedthrough 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, and the two fifth metal layers are electrically connected to the charging coil respectively. and a circuit board, the fourth metal layer and the two fifth metal layers are respectively close to opposite ends of the feedthrough.
  • the first housing is provided with a first catch portion facing the top cover
  • the front cover or the back cover is provided with a second catch portion
  • the connection module is installed on the generator module. When it is on, the first locking part and the second locking part are locked together.
  • the first latching part is provided with a latching slot
  • the second latching part is a beveled protrusion provided on the inner surface of the back cover
  • the connection module is installed on the generator When the first clamping part is on the device module, the first clamping part is clamped on the second clamping part under the guidance of the inclined surface of the second clamping part.
  • the front cover is provided with an opening that communicates the inside and outside of the accommodation cavity, and the opening of the front cover is a notch located on the edge of the front cover or an opening that does not extend to the edge of the front cover;
  • the back cover is provided with a first auxiliary positioning portion toward the edge of the first housing, the first housing is provided with a second auxiliary positioning portion engaged with the back cover, and the connection module is installed on the When the generator module is mounted on the generator module, the first auxiliary positioning part and the second auxiliary positioning part are engaged.
  • the first housing is provided with a tongue plate that penetrates into the accommodation cavity
  • the accommodation cavity is provided with insulating packaging material configured to fill the gap
  • the insulating packaging material seals the front Cover the opening
  • the insulating packaging material wraps the tongue plate.
  • the channel assembly further includes a waterproof member and a positioning member.
  • the waterproof member and the positioning member are arranged at the opening of the axial channel from the outside to the inside.
  • the waterproof member and the positioning member are provided with There is a hole configured for an insert member to pass through and enter the axial channel, the positioning member is configured to fix the insert member, and the plurality of connectors are coil springs.
  • connection module further includes an identification piece, and the identification piece is arranged on the top of the Inside the cover, the identification piece is a metal piece and has a hollow structure, and the hollow structure of the identification piece forms the logo of the identification piece.
  • the top cover is provided with suture holes.
  • the battery connection assembly includes a positive connector and a negative connector
  • the battery module further includes a positive terminal and a negative terminal respectively connected to the battery, and the positive terminal is electrically connected to the positive connector, The negative terminal is electrically connected to the negative connector.
  • the generator module further includes a thermometer, the thermometer is electrically connected to the circuit board, and the thermometer is configured to measure the temperature of the battery.
  • the first shell and the second shell are titanium shells and are welded together to form a sealed accommodation space, and the second shell is reused as the shell of the battery itself.
  • This application also provides an assembly method of a pulse generator.
  • the pulse generator is the pulse generator described in any one of the above.
  • the assembly method includes:
  • connection module Assemble the connection module, generator module and battery module independently;
  • connection module on the generator module.
  • the assembly method further includes:
  • Insulating packaging material is injected into the top cover to connect the top cover and the first housing together.
  • the insulating encapsulating material is epoxy resin.
  • the present application also provides a stimulation system, including: stimulation electrodes, the pulse generator described in any one of the above and a conductor.
  • An inserter is provided on the conductor, and the inserter is inserted into the channel assembly.
  • the pulse generator The generator is electrically connected to the stimulation electrode through the wire.
  • the stimulation system further includes a converter, the number of stimulation electrodes is multiple, the converter is electrically connected to the pulse generator and is configured to divide the stimulation pulse signal of the pulse generator into multiple Each stimulation pulse signal is released through a stimulation electrode.
  • the lead includes an extension lead and a plurality of electrode leads
  • the converter is electrically connected to the pulse generator through an extension lead
  • each stimulation electrode is electrically connected to the converter through an insert on an electrode lead. device.
  • Figure 1 is a schematic structural diagram of a pulse generator according to an embodiment of the present application.
  • FIG. 2 is a schematic structural diagram of the pulse generator according to the embodiment of the present application, with the front cover removed;
  • FIG. 3 is a schematic structural diagram of the pulse generator according to the embodiment of the present application, with the front cover and first housing removed;
  • Figure 4 is an exploded schematic diagram of the pulse generator according to the embodiment of the present application.
  • Figure 5 is a schematic structural diagram of a connection module according to an embodiment of the present application.
  • Figure 6 is a cross-sectional view of the connection module according to the embodiment of the present application.
  • FIG. 7 is an exploded schematic diagram of the generator module according to the embodiment of the present application.
  • Figure 8 is an exploded schematic diagram of the connection module according to the embodiment of the present application.
  • Figure 9 is a schematic structural diagram of a pulse generator according to an embodiment of the present application.
  • FIG. 10 is a schematic structural diagram of the stimulation system according to the embodiment of the present application.
  • Figure 11 is a schematic flowchart of an assembly method according to an embodiment of the present application.
  • Connection module 11. Top cover; 111. Front cover; 112. Back cover; 1121. First auxiliary positioning part; 113. First channel slot; 114. Channel cover; 115. Second channel slot; 116. Axial channel; 117. Radial groove; 118. First metal layer; 119. Second metal layer; 120. Through hole; 12. Channel component; 121. Waterproof part; 122. Positioning part; 13. Charging Coil; 131, charging terminal; 14, antenna; 15, second clamping part; 16, opening; 17, connector; 18, identification piece; 19, suture hole; 2, generator module; 21, feedthrough piece ; 221. Fourth metal layer; 222. Fifth metal layer; 22. Third metal layer; 23. Circuit board; 24. Thermometer; 25. First shell; 251.
  • First clamping portion 252. Tongue Board; 253. Second auxiliary positioning part; 3.
  • Battery module 31. Positive connector; 32. Negative connector; 33. Second housing; 34. Battery; 41. Extension wire; 42. Electrode wire; 43. Stimulating electrode; 44. Pulse generator; 45. Converter; 46. Insert.
  • this application provides a pulse generator, including: a connection module 1, a generator module 2 and a battery module 3.
  • 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 is configured for insertion of an insert, such as an extension wire 41. end.
  • the generator module 2 includes a first housing 25, a circuit board 23 and a battery connection assembly.
  • the connection module 1 is installed on the generator module 2.
  • the circuit board 23 is arranged on the first housing 25. and electrically connected to the channel component 12 .
  • the battery module 3 includes a second housing 33 and a battery 34 located in the second housing 33. The second housing 33 is reused as the housing of the battery 34 itself. In other words, the second housing 33 is the battery 34.
  • the battery module 3 is installed on the generator module 2 and located outside the generator module 2.
  • the battery 34 is electrically connected to the circuit board 23 through a battery connection assembly.
  • the pulse generator as independent connection module 1, generator module 2 and battery module 3, the three independent modules can be assembled separately and multi-threaded in their respective assembly processes, shortening the pulse generator The overall assembly cycle is short, and when the assembled pulse generator is damaged, the damaged module can be replaced without scrapping the entire pulse generator, reducing the company's production costs.
  • the assembly of the connection module 1, the generator module 2 and the battery module 3 includes two steps.
  • the first step is the assembly of each module itself. Take the generator module 2 as an example. When the generator module 2 is assembled by itself, first The circuit board 23 and the battery connection component are sequentially installed in the second housing 33 and fixed to complete the preliminary assembly.
  • the second step is to butt and assemble the generator module 2 and the assembled connection module 1.
  • the bottom and the assembled battery module 3 Assembly to complete the assembly of the pulse generator. After the assembly is completed, when any assembly module fails or is damaged during inspection, the damaged module can be removed and replaced with a module of the same type and reassembled, which can save costs.
  • connection module 1, generator module 2 and battery module 3 can each be designed into different models. Different models of modules adopt standard or unified interfaces.
  • the battery module 3 can be made into modules with different power levels. , which can match a variety of power needs, and can be configured with small-capacity batteries or large-capacity batteries, or round batteries or square batteries, etc.
  • the top cover 11 is an insulating member, which may be made of plastic material.
  • the top cover 11 includes a front cover 111 and a back cover 112.
  • the front cover 111 and the back cover 112 may be two insulating shells with matching shapes.
  • the front cover 111 and the rear cover 112 are joined to form a receiving cavity.
  • the rear cover 112 is provided with at least one first channel groove 113 toward the inner side of the front cover 111 .
  • the channel assembly 12 includes a channel cover 114 and a plurality of connectors 17.
  • the channel cover 114 is provided with a second channel groove 115 corresponding to the first channel groove 113 on one side facing the rear cover 112.
  • the first channel groove 113 and the second channel groove 115 can be 1 of the axial channel 116 respectively.
  • a plurality of radial grooves 117 are spaced on the axial channel 116, and each radial groove 117 is divided into A connecting piece 17 configured as an electrically connecting insert is provided.
  • the radial groove 117 is internally connected to the axial channel 116 .
  • the connecting piece 17 is, for example, a coil spring and an electrical wire.
  • the connecting piece 17 is electrically connected to the circuit board 23 .
  • a first channel groove 113 is formed on the back cover 112, and a second channel groove 115 is formed on the channel cover 114. When connected, the first channel groove 113 and the second channel groove 115 are buckled by the channel cover 114 and the back cover 112.
  • An axial channel 116 is formed, and a connecting piece 17 is connected in the axial channel 116 .
  • a first channel slot 113 is opened on the back cover 112 As a part of the axial channel 116, the first channel groove 113 cooperates with the second channel groove 115 to form the axial channel 116.
  • This method is more integrated and fully utilizes the structure of the back cover 112 to reduce the thickness. Prefabricating the assembly structure on the top cover 11 can greatly reduce the dimensional fit tolerance when assembling multiple components on the top cover 11, thereby reducing the overall volume of the pulse generator and making it more portable.
  • the bottom of the back cover 112 may also have a strip-shaped protrusion, which is used to match the groove corresponding to the bottom of the back cover 112 on the generator module 2 and play a fixing role by filling with sealant during assembly.
  • the inner wall of the radial groove 117 is provided with a first metal layer 118 and a through hole 120 connecting the inside and outside of the channel cover 114, and 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 radial groove 117 corresponding to the through hole 120 through a through hole 120.
  • the connector 17 passes through the first metal layer 118 and the second metal layer 119.
  • Layer 119 is electrically connected to circuit board 23 .
  • the first metal layer 118 and the second metal layer 119 may be formed on the channel cover 114 through processes such as electroplating, which are not listed here. When working, the generator module 2 generates a stimulation signal.
  • the stimulation signal is transmitted through the second metal layer 119 and through the through hole 120, and then transmitted to the connector 17 through the first metal layer 118. Finally, the connector 17 transmits the stimulation signal. After feeding the insert, it is transported to other parts to complete the signal transmission.
  • the first metal layer 118 and the second metal layer 119 are both conductive metal materials with uniform thickness. They are adhered to or formed on the inside of the channel, the through hole 120 and the outside respectively, and have good electrical connection stability. At the same time, the first metal layer 118 The contact area when connecting to the second metal layer 119 is larger. Compared with the connection between points and points and between points, the surface-to-surface metal layer connection in this embodiment has stronger stability.
  • the first metal layer 118 and the second metal layer 119 are not easy to fall off or move and cause a short circuit. When the pulse generator is subjected to vibration or impact, the first metal layer 118 and the second metal layer 119 can still maintain good electrical connection.
  • the generator module 2 further includes a feedthrough 21.
  • the feedthrough 21 is an insulating member.
  • a plurality of third metal layers 22 are provided on the feedthrough 21.
  • Each third metal layer 22 is disposed on the feedthrough 21.
  • the metal layer 22 is electrically connected to the second metal layer 119 and the circuit board 23 respectively.
  • the plurality of third metal layers 22 and the plurality of second metal layers 119 are connected in a one-to-one correspondence.
  • the stimulation signal generated by the generator module 2 is electrically connected and transmitted through the plurality of third metal layers 22 and the second metal layer 119 To the connection module 1, the stimulation signal is transmitted to the outside through the plug-in plug in the connection module 1, and finally the stimulation signal is applied to the point to be stimulated through the stimulation electrode.
  • the battery connection assembly includes a positive connector 31 and a negative connector 32.
  • the battery module 3 also includes a positive terminal and a negative terminal (not shown) respectively connected to the battery 34.
  • the positive terminal is electrically connected to the positive connector 31
  • the negative terminal is electrically connected to the negative connector 32 .
  • the generator module 2 further includes a thermometer 24 , the thermometer 24 is electrically connected to the circuit board 23 , and the thermometer 24 is configured to measure the temperature of the battery 34 .
  • the thermometer 24 can extend into the battery module 3, or the battery module 3 is provided with a recess, and the temperature measuring end of the thermometer 24 contacts the recess on the battery module 3.
  • the thermometer 24 is, for example, a contact type temperature sensor. The sensor measures the temperature of the battery 34 through heat transfer during operation.
  • the thermometer 24 can also be a non-contact infrared thermometer, and measures the temperature of the battery 34 through the infrared thermometer. Temperature information can be stored in the memory or transmitted to external devices for medical staff to understand the internal conditions of the pulse generator in a timely manner.
  • connection module 1 also includes a charging coil 13 and an antenna 14.
  • the charging coil 13 is embedded in the front cover 111 or the back cover 112.
  • the external wireless charger and the charging coil 13 sense , thereby generating an induced current, which will eventually store the generated power 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.
  • the induced current generated by the charging coil 13 is transmitted through the connection between the coil and the circuit board 23.
  • the current is transmitted through the lines on the circuit board 23, and enters the battery through the positive connector 31 and the negative connector 32 to store electricity.
  • the above wireless charging method can maintain the service life of the pulse generator for a long time.
  • the charging coil 13 is buried in the front cover 111 or the back cover 112.
  • the front cover 111 or the back cover 112 is generally made of inorganic insulating materials. Made of, for example, polymer materials, it can reduce or avoid the eddy current thermal effect, and the charging efficiency is high.
  • the charging coil 13 after the charging coil 13 is embedded, it can avoid the charging coil 13 from occupying space, which is beneficial to reducing the size of the product.
  • the antenna 14 is disposed on a side of the channel cover 114 facing away from the radial groove 117 , and a fourth metal layer 221 and two fifth metal layers 222 are disposed on the feedthrough 21 .
  • the metal layer 221 is electrically connected to the antenna 14 and the circuit board 23 respectively, and 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 layer 222 are respectively close to each other. Opposite ends of the feedthrough 21 .
  • the user can communicate with the pulse generator and an external receiving device through the antenna 14, so that the internal information of the pulse generator is fed back to the external receiving device in real time, so that the external receiving device can understand the working parameters of the pulse generator, such as the working parameters of the pulse generator.
  • the battery temperature, battery power, or temperature information inside the generator module 2 helps external medical staff to judge the performance stability of the pulse generator, and can also control the pulse generator through the antenna 14 .
  • the fifth metal layer 222 and the charging coil 13 are electrically connected to the charging terminals 131 led to the outside of the front cover 111 or the back cover 112 respectively, so that the current of the charging coil 13 passes through the circuit board 23 and finally charges the battery module 3 .
  • the fourth metal layer 221 and the fifth metal layer 222 are respectively close to the opposite ends of the feedthrough 21 , that is, the fourth metal layer 221
  • the fifth metal layer 222 is close to one end of the feed-through member 21 and close to the opposite end of the feed-through member 21 . Therefore, the signal caused by the fifth metal layer 222 to the fourth metal layer 221 used for communication can be reduced. interference, the signal transmission reliability is higher.
  • the first housing 25 is provided with a first clamping portion 251 facing the top cover 11
  • the front cover 111 or the back cover 112 is provided with a second clamping portion 15
  • the connection module 1 is installed on
  • the first clamping part 251 is, for example, a clamping plug with a bevel
  • the second clamping part 15 is, for example, a clamping ring with a clamping groove.
  • the plug is clamped in the slot of the clamping ring to form a clamping connection.
  • the front cover 111 and the rear cover 111 are connected with each other.
  • the cover 112 is clamped together through the first clamping part 251 and the second clamping part 15.
  • the assembly method is relatively simple and does not require complicated processes to complete the assembly, which reduces the assembly steps and shortens the assembly cycle of the pulse generator.
  • the first card portion 251 is provided with a card slot
  • the second card portion 15 is a beveled protrusion provided on the inner surface of the back cover 112
  • the connection module 1 is installed on the back cover 112.
  • the first clamping part 251 is clamped on the second clamping part 15 under the guidance of the inclined surface of the second clamping part 15 .
  • the protrusion with the inclined surface will first contact the first clamping part 251, and the first clamping part 251 acts on the inclined surface.
  • the bottom is pushed to deflect at a certain angle until the protrusion of the second clamping part 15 moves into the groove of the first clamping part 251.
  • the first clamping part 251 returns to the vertical angle and clamps and fixes the second clamping part 15. During assembly, it facilitates assembly personnel to assemble quickly and accurately, shortening the overall assembly cycle of the pulse generator.
  • the first clamping part 251 and the second clamping part 15 also serve as auxiliary positioning to prevent the connection module 1 and the generator module 2 from deviating from the preset position when they are assembled.
  • the front cover 111 is provided with an opening 16 that communicates with the inside and outside of the accommodation cavity.
  • the opening 16 may be a strip-shaped opening.
  • the opening 16 of the front cover 111 may be located on the front cover 111
  • the edge gap can also 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 to connect the connection module 1 and the generator module 2 during assembly. Personnel can directly connect the above-mentioned second metal layer 119 and the third metal layer 22 through the strip-shaped opening 16 through the welding wire, the fourth metal layer 221 and the antenna 14 through the welding wire, and the fifth metal layer 222 and the charging terminal.
  • the second function is that after the second metal layer 119 and the third metal layer 22 are welded together, and after passing the test, glue for curing can be injected into the interior of the pulse generator through the opening 16 here, thereby connecting the module. 1 and the generator module 2 are connected together and effectively encapsulate multiple internal components to ensure waterproofing.
  • the back cover 112 is provided with a first auxiliary positioning portion 1121 toward the edge of the first housing 25 .
  • the first auxiliary positioning portion 1121 may be a protrusion on the edge of the first housing 25 .
  • the second auxiliary positioning part 253 may be the first shell.
  • the first auxiliary positioning part 1121 is a groove
  • the second auxiliary positioning part 253 is a protrusion on the first housing 25, when the connection module 1 is installed on the generator module 2 , the first auxiliary positioning part 1121 and the second auxiliary positioning part 253 are engaged, 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, Therefore, when the connection module 1 is installed on the generator module 2, the first auxiliary positioning part 1121 and the second auxiliary positioning part 253 play an auxiliary positioning role, and at the same time, the edge of the back cover 112 will not warp, improving Flatness of the entire pulse generator.
  • the first housing 25 is provided with a tongue plate 252 that goes deep into the accommodation cavity, and the accommodation cavity is provided with an insulating encapsulating material configured to fill the gap.
  • the insulating encapsulating material is, for example, epoxy resin.
  • the insulating packaging material blocks the opening 16 on the front cover 111
  • the insulating packaging material wraps the tongue plate 252 .
  • the tongue plate 252 will be inserted into the preset position inside the accommodation cavity at the same time to guide and assist in positioning the connection between the first clamping part 251 and the second clamping part 15. Function, it simplifies the position calibration steps of the first clamping part 251 and the second clamping part 15 during assembly, and facilitates assembly.
  • the insulating packaging material wraps the tongue plate 252, which can effectively improve the connection module 1 and The connection strength of the generator module 2 is improved, and multiple internal components are effectively encapsulated to ensure waterproofing.
  • the channel assembly 12 further includes a waterproof member 121 and a positioning member 122.
  • the waterproof member 121 and the positioning member 122 are sequentially arranged at the opening of the axial channel 116 from outside to inside.
  • the member 121 and the positioning member 122 are provided with holes configured for the insert member to pass through and enter the axial channel 116.
  • the positioning member 122 is configured to fix the insert member, and the connecting member 17 is a coil spring.
  • the waterproof member 121 is made of rubber, silicone or other materials by injection molding, for example.
  • the insert is inserted through the axial opening and inserted straight along the axial channel 116 until the connection positions on the insert are in one-to-one correspondence with all the coil springs, and then the inserted insert is fastened with fasteners.
  • One end is clamped and fixed in the connection module 1.
  • the fasteners may be bolts threaded on the back cover 112. During assembly, the operator screws the bolts so that the nuts press the axial surface of the insert to complete the fix
  • connection module 1 further includes an identification piece 18.
  • the identification piece 18 is provided in the top cover 11.
  • the identification piece 18 is a metal piece and has a hollow structure.
  • the identification piece 18 has a hollow structure.
  • the hollow structure forms the logo of the identification piece 18.
  • the metal piece can use the hollow part as a mark to record the models of the pulse generator's connection module 1, generator module 2, battery module 3 and other modules.
  • medical staff By scanning the user's body with an X-ray machine, information about multiple modules of the pulse generator can be learned through the identification piece 18, which facilitates medical staff to learn more information about the pulse generator.
  • the top cover 11 is provided with suture holes 19 .
  • the medical staff can pass the suture thread through the opening 16 and sew the pulse generator into the user's body to prevent the user's activities in daily life from causing the position of the pulse generator to shift in the body, thereby reducing the pulse. Generator failure rate.
  • the first housing 25 and the second housing 33 are titanium shells and are welded together to form a sealed accommodation space.
  • the step of assembling the battery module 3 at the bottom of the generator module 2 can be completed before the generator module 2 and the connection module 1 are assembled, and is not limited here.
  • the titanium shell is a biocompatible material and will not cause rejection after being implanted in the patient's body.
  • the formed airtight accommodation space can play a waterproof role.
  • This application also provides an assembly method of a pulse generator.
  • the pulse generator is the pulse generator described in any of the above embodiments. As shown in Figure 11, the assembly method includes: Step S1 to Step S3 .
  • Step S1 Assemble the connection module 1, the generator module 2 and the battery module 3 independently.
  • the above three modules are made and assembled through multiple processes that can be carried out simultaneously. Different modules can be completed independently through different production lines and processes during assembly, and can pass their respective inspection processes after completion of assembly. Product quality testing and multi-thread processing and assembly have better assembly efficiency than the one-stop assembly method, shortening the overall assembly time of the pulse generator. At the same time, the three independent modules can easily replace the damaged module after damage, and Assemble this module of the same model with two other modules again to form a new pulse generator.
  • Step S2 Assemble and connect the first housing 25 and the second housing 33 so that the battery module 3 is installed on the generator module 2 .
  • the first housing 25 and the second housing 33 are docked, so that the positive connector 31 and the negative connector 32 protruding from the battery module 3 are docked at the bottom of the generator module 2.
  • the battery module 3 can provide power for the operation of the generator module 2. Power support.
  • step S2 includes step S21: connecting the first housing 25 and the second housing through welding assembly. After the first housing 25 and the second housing 33 are connected, the first housing 25 and the second housing 33 are sealed and connected through a welding process.
  • Step S3 Install the connection module 1 on the generator module 2.
  • the generator module 2 and the connection module 1 can be buckled together, and the conductive layers of the connection module 1 and the generator module 2 can be electrically connected. , and then the initially assembled pulse generator can be functionally tested through the testing process.
  • step S3 includes step S31: injecting insulating packaging material into the top cover 11 to connect the top cover 11 and the first housing 25 together.
  • the pulse generator that has passed the functional test will finally be filled with insulating packaging material through the opening on the top cover 11. After curing, the pulse generator will form a sealed state as a whole and can be waterproof when implanted in the patient's body.
  • the insulating encapsulating material may be epoxy resin.
  • This application also provides a stimulation system, including: stimulation electrode 43, any one of the above embodiments
  • the pulse generator 44 and the wire are provided with an insert 46 on the wire.
  • the insert 46 is inserted into the channel assembly 12.
  • the pulse generator 44 is electrically connected to the stimulation electrode 43 through the wire.
  • the connection point of the insert 46 corresponds to the position of the coil spring on the channel component 12.
  • the stimulation system further includes a converter 45 and a plurality of stimulation electrodes 43.
  • the converter 45 is electrically connected to the pulse generator 44 and configured to divide the stimulation pulse signal of the pulse generator 44. It is a multi-channel stimulation pulse signal, and each stimulation pulse signal is released through a stimulation electrode 43 respectively.
  • the pulse generator 44 is usually provided with two channel components 12, and is connected to two stimulation electrodes 43 through the two channel components 12, thereby realizing the release of two pulse stimulations. Currently, the two pulse stimulations cannot meet the treatment needs, and stimulation electrodes 43 need to be added.
  • multiple channel modules can be provided on the converter 45, and the channel modules can be inserted into the inserter 46.
  • one channel of multi-contact stimulation pulses can be separated into multiple channels of multi-contact stimulation pulses.
  • Each stimulation pulse signal of the contact point is released through a stimulation electrode 43, thereby achieving the requirement of applying electrical stimulation by more than two stimulation electrodes 43 and meeting the clinical demand for stimulation with more electrodes.
  • the wires include an extension wire 41 and a plurality of electrode wires 42
  • the converter 45 is electrically connected to the pulse generator 44 through the extension wire 41
  • each stimulation electrode 43 passes through an electrode wire 42 .
  • the insert 46 is electrically connected to the converter 45 and facilitates the electrical connection between the pulse generator 44 and the plurality of stimulation electrodes 43 by providing extension wires 41 and a plurality of electrode wires 42 .
  • the converter 45 can also be directly connected to the pulse generator 44 .

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Abstract

一种脉冲发生器及其组装方法和刺激系统，脉冲发生器包括：连接模块（1）、发生器模块（2）和电池模块（3），连接模块（1）包括顶盖（11）和通道组件（12），通道组件（12）的至少一部分设置在顶盖（11）内并设置为供插入件插入。发生器模块（2）包括第一壳体（25）、电路板（23）和电池连接组件，连接模块（1）安装在发生器模块（2）上，电路板（23）设置在第一壳体（25）内并电连接通道组件（12）。电池模块（3）包括第二壳体（33）和位于第二壳体（33）内的电池（34），电池模块（3）安装在发生器模块（2）上并位于发生器模块（2）外，电池（34）通过电池连接组件电连接电路板（23）。

Description

脉冲发生器及其组装方法和刺激系统
本申请要求在2022年09月01日提交中国专利局、申请号为202211065837.5的中国专利申请的优先权，该申请的全部内容通过引用结合在本申请中。
技术领域
本申请涉及植入式医疗设备技术领域，例如涉及一种脉冲发生器及其组装方法和刺激系统。
背景技术
神经电刺激是一种常用的治疗神经功能失调和神经损伤康复的手段，神经电刺激系统通过植入体内的脉冲发生器和电极向相关部位施加电刺激。可植入脉冲发生器的组装工艺较为复杂，脉冲发生器的多个部件采用堆叠方案连接，组装时必须完成前一个步骤之后，才能开展下一步，多个不同工序无法同时进行，从而导致产品的组装周期较长。在产品组装出厂前，当出现产品故障时，产品无法使用，需要全部拆卸并再次组装才能使用，会造成原材料和人工成本的大量消耗，不利于成本控制。
发明内容
本申请提供一种脉冲发生器及组装方法和刺激系统，用于解决上述问题。
本申请提供了一种脉冲发生器，包括：连接模块、发生器模块和电池模块。
所述连接模块包括顶盖和通道组件，所述通道组件的至少一部分设置在顶盖内并设置为供插入件插入。所述发生器模块包括第一壳体、电路板和电池连接组件，所述连接模块安装在所述发生器模块上，所述电路板设置在所述第一壳体内并电连接所述通道组件。所述电池模块包括第二壳体和位于第二壳体内的电池，所述电池模块安装在所述发生器模块上并位于所述发生器模块外，所述电池通过电池连接组件电连接所述电路板。
在一个实施例中，所述顶盖为绝缘件，所述顶盖包括前盖和后盖，所述前盖和后盖接合后形成容纳腔，所述后盖朝向前盖的内侧设置有至少一个第一通道槽。
所述通道组件包括通道盖和多个连接件，所述通道盖朝向后盖的一侧设置有与第一通道槽对应的第二通道槽，所述通道盖和后盖接合后，所述第一通道槽和第二通道槽形成供插入件插入的轴向通道，所述轴向通道上间隔分布多个 径向凹槽，每个径向凹槽内设置有一个设置为电连接插入件的连接件，所述多个连接件均电连接电路板。
在一个实施例中，所述每个径向凹槽的内壁上设置有第一金属层以及连通通道盖内外的通孔，所述通道盖的外表面设置有多个第二金属层，每个第二金属层通过一个通孔与所述通孔对应的径向凹槽内的第一金属层电连接，所述多个连接件均通过第一金属层和第二金属层电连接电路板。
在一个实施例中，所述发生器模块还包括馈通件，所述馈通件为绝缘件，所述馈通件上设置有多个第三金属层，每个第三金属层电连接所述一个第二金属层和电路板。
在一个实施例中，所述连接模块还包括充电线圈和天线，所述充电线圈埋设在所述前盖或后盖内，所述天线设置在所述通道盖的背向径向凹槽的一侧，所述馈通件上设置有第四金属层和两个第五金属层，所述第四金属层电连接所述天线和电路板，两个第五金属层分别电连接所述充电线圈和电路板，所述第四金属层和两个第五金属层分别靠近所述馈通件相对的两端。
在一个实施例中，所述第一壳体上设置有朝向顶盖的第一卡部，所述前盖或后盖上设置有第二卡部，所述连接模块安装在所述发生器模块上时，所述第一卡部和第二卡部相卡接。
在一个实施例中，所述第一卡部上设置有卡槽，所述第二卡部为设置在所述后盖内表面上的带斜面的凸起，所述连接模块安装在所述发生器模块上时，所述第一卡部在所述第二卡部的斜面的导向作用下卡接在所述第二卡部上。
在一个实施例中，所述前盖上设置有连通容纳腔内外的开孔，所述前盖的开孔是位于所述前盖边缘的缺口或非延伸至所述前盖边缘的开孔；
所述后盖朝向所述第一壳体的边缘设置有第一辅助定位部，所述第一壳体上设置有与后盖相接合的第二辅助定位部，所述连接模块安装在所述发生器模块上时，所述第一辅助定位部和第二辅助定位部相接合。
在一个实施例中，所述第一壳体上设置有深入所述容纳腔内的舌板，所述容纳腔设置有设置为填充缝隙的绝缘封装料，所述绝缘封装料封堵所述前盖上的开孔，所述绝缘封装料包裹所述舌板。
在一个实施例中，所述通道组件还包括防水件和定位件，所述防水件和定位件从外到内依次设置在所述轴向通道的开口处，所述防水件和定位件上设置有设置为供插入件穿过并进入所述轴向通道的孔，所述定位件设置为固定所述插入件，所述多个连接件为圈簧。
在一个实施例中，所述连接模块还包括标识件，所述标识件设置在所述顶 盖内，所述标识件为金属件并为镂空结构，所述标识件的镂空结构形成所述标识件的标识。
在一个实施例中，所述顶盖上设置有缝线孔。
在一个实施例中，所述电池连接组件包括正极连接器和负极连接器，所述电池模块还包括分别连接所述电池的正极端子和负极端子，所述正极端子电连接所述正极连接器，所述负极端子电连接所述负极连接器。
所述发生器模块还包括测温器，所述测温器电连接所述电路板，所述测温器设置为测量所述电池的温度。
在一个实施例中，所述第一壳体和第二壳体均为钛壳并焊接在一起以形成密闭容纳空间，所述第二壳体复用为所述电池本身的壳体。
本申请还提供了一种脉冲发生器的组装方法，所述脉冲发生器为上述任意一项所述的脉冲发生器，所述组装方法包括：
分别独立地组装连接模块、发生器模块和电池模块；
组装连接第一壳体和第二壳体，以使所述电池模块安装在发生器模块上；
将所述连接模块安装在所述发生器模块上。
在一个实施例中，组装方法还包括：
通过焊接组装连接第一壳体和第二壳体；
向所述顶盖内注入绝缘封装料以使顶盖和第一壳体连接在一起。
在一个实施例中，所述绝缘封装料为环氧树脂。
本申请还提供了一种刺激系统，包括：刺激电极、上述任意一项所述的脉冲发生器和导线，所述导线上设置有插入件，所述插入件插入所述通道组件，所述脉冲发生器通过所述导线电连接所述刺激电极。
在一个实施例中，所述刺激系统还包括转换器，刺激电极的数量为多个，所述转换器电连接所述脉冲发生器并设置为将所述脉冲发生器的刺激脉冲信号分为多路刺激脉冲信号，每一路刺激脉冲信号通过一个刺激电极进行释放。
在一个实施例中，所述导线包括延伸导线和多个电极导线，所述转换器通过延伸导线电连接所述脉冲发生器，每个刺激电极通过一个电极导线上的插入件电连接所述转换器。
附图说明
图1是本申请实施例的脉冲发生器的结构示意图；
图2是本申请实施例的脉冲发生器除去前盖的结构示意图；
图3是本申请实施例的脉冲发生器除去前盖和第一壳体的结构示意图；
图4是本申请实施例的脉冲发生器的爆炸示意图；
图5是本申请实施例的连接模块的结构示意图；
图6是本申请实施例的连接模块的剖视图；
图7是本申请实施例的发生器模块的爆炸示意图；
图8是本申请实施例的连接模块的爆炸示意图；
图9是本申请实施例的脉冲发生器的结构示意图；
图10是本申请实施例的刺激系统的结构示意图；
图11是本申请实施例的组装方法的流程示意图。
图中：1、连接模块；11、顶盖；111、前盖；112、后盖；1121、第一辅助定位部；113、第一通道槽；114、通道盖；115、第二通道槽；116、轴向通道；117、径向凹槽；118、第一金属层；119、第二金属层；120、通孔；12、通道组件；121、防水件；122、定位件；13、充电线圈；131、充电端子；14、天线；15、第二卡部；16、开孔；17、连接件；18、标识件；19、缝线孔；2、发生器模块；21、馈通件；221、第四金属层；222、第五金属层；22、第三金属层；23、电路板；24、测温器；25、第一壳体；251、第一卡部；252、舌板；253、第二辅助定位部；3、电池模块；31、正极连接器；32、负极连接器；33、第二壳体；34、电池；41、延伸导线；42、电极导线；43、刺激电极；44、脉冲发生器；45、转换器；46、插入件。
具体实施方式
现在将参考附图描述示例实施方式。然而，示例实施方式能够以多种形式实施，且不应被理解为限于在此阐述的实施方式；相反，提供这些实施方式使得本申请更全面，并将示例实施方式的构思传达给本领域的技术人员。在图中相同的附图标记表示相同或类似的结构，因而将省略对它们的重复描述。
本申请中所描述的表达位置与方向的词，均是以附图为例进行的说明，但根据需要也可以做出改变，所做改变均包含在本申请保护范围内。
参照图1至8，本申请提供了一种脉冲发生器，包括：连接模块1、发生器模块2和电池模块3。
所述连接模块1包括顶盖11和通道组件12，所述通道组件12的至少一部分设置在顶盖11内并设置为供插入件插入，插入件例如是延伸导线41的插入 端。所述发生器模块2包括第一壳体25、电路板23和电池连接组件，所述连接模块1安装在所述发生器模块2上，所述电路板23设置在所述第一壳体25内并电连接所述通道组件12。所述电池模块3包括第二壳体33和位于第二壳体33内的电池34，第二壳体33复用为所述电池34本身的壳体，换言之，第二壳体33就是电池34本身的壳体，由此，无需在电池34的壳体外再设置一个壳体，从而简化产品结构，节约成本。所述电池模块3安装在所述发生器模块2上并位于所述发生器模块2外，所述电池34通过电池连接组件电连接所述电路板23。
通过将脉冲发生器设计为分别独立的连接模块1、发生器模块2和电池模块3，三个相互独立的模块在各自的组装工序时，可以分别单独进行，多线程进行组装，缩短脉冲发生器的整体组装周期，并且组装后的脉冲发生器出现损坏时，可以更换损坏的该模块，无需将整个脉冲发生器报废处理，降低企业的生产成本。
连接模块1、发生器模块2和电池模块3在组装时包括两个步骤，第一个步骤是每个模块自身的组装，以发生器模块2为例，发生器模块2在自身组装时，首先将电路板23、电池连接组件依次安装在第二壳体33内固定后完成初步组装，第二个步骤是将发生器模块2和组装后的连接模块1对接组装，底部和组装后的电池模块3组装，从而完成脉冲发生器的组装。完成组装后，在检测时，当任意的组装模块出现故障或损坏时，可以将损坏的该模块取下，并更换同类型的模块再次组装，能够节约成本。并且相对独立的多个模块在组装时，可以分别在多个工位上互不影响的同时独立的进行组装，能够保证较高的工作效率，缩短每个脉冲发生器的生产工期。此外，采用模块化设计的连接模块1、发生器模块2和电池模块3可以分别各自设计成不同的型号，不同型号的模块采用标准或统一接口，例如，电池模块3可以做成电量不同的模块，从而可以匹配多种电量需求，可以配置小容量电池或大容量电池，或者，圆形电池或方形电池等。
在一个实施例中，所述顶盖11为绝缘件，可以为塑胶材质，所述顶盖11包括前盖111和后盖112，前盖111和后盖112可以是形状匹配的两个绝缘壳体，所述前盖111和后盖112接合后形成容纳腔，所述后盖112朝向前盖111的内侧设置有至少一个第一通道槽113。
所述通道组件12包括通道盖114和多个连接件17，所述通道盖114朝向后盖112的一侧设置有与第一通道槽113对应的第二通道槽115，所述通道盖114和后盖112接合后，所述第一通道槽113和第二通道槽115形成供插入件插入的轴向通道116，第一通道槽113和第二通道槽115可以分别是轴向通道116的1/2部分，所述轴向通道116上间隔分布多个径向凹槽117，每个径向凹槽117内分 别设置有一个设置为电连接插入件的连接件17，径向凹槽117和轴向通道116内部连通，连接件17例如是圈簧和电导丝，所述连接件17电连接电路板23。后盖112上形成第一通道槽113，通道盖114上形成有第二通道槽115，在连接时，第一通道槽113和第二通道槽115经过通道盖114和后盖112的扣合下形成一个轴向通道116，轴向通道116内连接有连接件17。相较于在后盖112和前盖111之间单独设置两个通道盖114，两个通道盖114接合形成轴向通道116的组装方式，本实施例在后盖112上开设第一通道槽113，第一通道槽113作为轴向通道116的一部分与第二通道槽115配合共同形成轴向通道116，该方式集成化更高，充分利用后盖112的结构，减小厚度，在后盖112上预先制作装配结构，能够很大程度上减少顶盖11上的多个部件组装时的尺寸配合公差，进而从整体上减小脉冲发生器的体积，更加轻便。
其中，后盖112的底部还可以具有一段条形凸起，用来和发生器模块2上对应后盖112的底部的凹槽配合，在组合时通过填充密封胶等起到固定作用。
示例性的，所述径向凹槽117的内壁上设置有第一金属层118以及连通通道盖114内外的通孔120，所述通道盖114的外表面设置有多个第二金属层119，每个第二金属层119分别通过一个通孔120与该通孔120对应的径向凹槽117内的第一金属层118电连接，所述连接件17通过第一金属层118和第二金属层119电连接电路板23。第一金属层118和第二金属层119可以是通过电镀等工艺形成在通道盖114上，在此不一一列举。在工作时，发生器模块2产生刺激信号，刺激信号通过第二金属层119传递并穿过通孔120后，通过第一金属层118传递到连接件17上，最终连接件17将刺激信号传递给插入件后输送至其他部位，完成信号传递。第一金属层118和第二金属层119均为厚度均匀的导电金属材料，分别贴合或形成在通道的内侧、通孔120及外侧，具有良好的电连接稳定性，同时第一金属层118和第二金属层119连接时的接触面积较大，相较于点与点、以及点与面之间的连接，本实施例的面与面的金属层连接，具有更强的稳定性，同时第一金属层118和第二金属层119不易脱落和不易移动并导致短路，当脉冲发生器受到振动或碰撞时，第一金属层118和第二金属层119仍然能保持良好的电连接作用。
在一个实施例中，所述发生器模块2还包括馈通件21，所述馈通件21为绝缘件，所述馈通件21上设置有多个第三金属层22，每个第三金属层22分别电连接所述一个第二金属层119和电路板23。多个第三金属层22和多个第二金属层119一一对应连接，在工作时，发生器模块2产生的刺激信号通过多个第三金属层22和第二金属层119电连接并传递到连接模块1，刺激信号通过连接模块1内插接的插入件传递到外部，最终通过刺激电极将刺激信号作用在待刺激点。
在一个实施例中，所述电池连接组件包括正极连接器31和负极连接器32，所述电池模块3还包括分别连接所述电池34的正极端子和负极端子(未示出)，所述正极端子电连接所述正极连接器31，所述负极端子电连接所述负极连接器32。在电池模块3和发生器模块2连接后，电池模块3通过正极连接器31和负极连接器32分别对应连接在发生器模块2的底部接口，为发生器模块2供电。
示例性的，所述发生器模块2还包括测温器24，所述测温器24电连接所述电路板23，所述测温器24设置为测量所述电池34的温度。测温器24可以延伸至所述电池模块3内，或者，电池模块3上设置有凹部，测温器24的测温端接触电池模块3上的凹部，测温器24例如是接触式的温度传感器，在工作时通过热传递的方式测出电池34的温度，测温器24也可以是非接触式的红外测温仪，通过红外测温仪测出电池34的温度。温度信息可以储存在储存器内，也可以传递给外部设备，供医护人员及时了解脉冲发生器的内部情况。
示例性的，所述连接模块1还包括充电线圈13和天线14，所述充电线圈13埋设在所述前盖111或后盖112内，在充电时，外部的无线充电器和充电线圈13感应，从而产生感应电流，感应电流最终通过电池模块3将产生的电量储存，用户无需通过物理方式更换脉冲发生器的电池，来维持脉冲发生器持续工作。充电线圈13产生的感应电流通过线圈和电路板23的连接处传递，电流经过电路板23上的线路传递，并通过正极连接器31和负极连接器32进入到电池内蓄电。采用上述无线充电方式能够长久维持脉冲发生器的使用寿命，此外，将充电线圈13埋设在所述前盖111或后盖112内，一方面，由于前盖111或后盖112一般为无机绝缘材料制成，例如由高分子材料制成，能够减小或避免产生涡流热效应，充电效率高，另一方面，充电线圈13埋入后，能够避免充电线圈13占用空间，有利于减小产品尺寸。
所述天线14设置在所述通道盖114的背向径向凹槽117的一侧，所述馈通件21上设置有第四金属层221和两个第五金属层222，所述第四金属层221分别电连接所述天线14和电路板23，两个第五金属层222分别电连接所述充电线圈13和电路板23，所述第四金属层221和第五金属层222分别靠近所述馈通件21相对的两端。用户可以通过天线14使脉冲发生器与外部接收装置进行通信，从而使脉冲发生器的内部信息实时反馈给外部接收装置，从而外部的接收装置可以了解到脉冲发生器的工作参数，例如工作时的电池温度、电池电量，或者发生器模块2内部的温度信息，帮助外部的医护人员对脉冲发生器的性能稳定性做出判断，还可以通过天线14对脉冲发生器进行控制。第五金属层222和充电线圈13分别与引出到前盖111或后盖112外部的充电端子131电性连接，从而使充电线圈13的电流经过电路板23最终为电池模块3进行充电。第四金属层221和第五金属层222分别靠近所述馈通件21相对的两端，即第四金属层221 靠近所述馈通件21的一端，第五金属层222靠近所述馈通件21相对的另一端，由此，能够减少第五金属层222对用于通信的第四金属层221的信号造成干扰，信号传输可靠性更高。
示例性的，所述第一壳体25上设置有朝向顶盖11的第一卡部251，所述前盖111或后盖112上设置有第二卡部15，所述连接模块1安装在所述发生器模块2上时，所述第一卡部251和第二卡部15相卡接。其中，第一卡部251例如是带有斜面的卡接插头，第二卡部15例如是带有卡槽的卡环，插头卡接在卡环的槽内形成卡接，前盖111和后盖112通过第一卡部251和第二卡部15卡接在一起，组装方式较为简便，不需要复杂的工序完成组装，减少了组装步骤，缩短了脉冲发生器的组装周期。
示例性的，所述第一卡部251上设置有卡槽，所述第二卡部15为设置在所述后盖112内表面上的带斜面的凸起，所述连接模块1安装在所述发生器模块2上时，所述第一卡部251在所述第二卡部15的斜面的导向作用下卡接在所述第二卡部15上。在连接时，将连接模块1的连接端和发生器模块2的连接端竖直对接，带有斜面的凸起，会最先抵接第一卡部251，第一卡部251在斜面的作用下被推动偏移一定角度，直至第二卡部15的凸起移动到第一卡部251的槽内，第一卡部251恢复竖直的角度，将第二卡部15卡紧固定，在组装时，方便组装人员快速准确的组装，缩短脉冲发生器的整体组装周期。第一卡部251和第二卡部15还具有辅助定位的作用，防止连接模块1和发生器模块2组装时偏离预设位置。
在一个实施例中，所述前盖111上设置有连通容纳腔内外的开孔16，开孔16可以是条形状开孔，所述前盖111的开孔16可以是位于所述前盖111边缘的缺口，也可以是非延伸至所述前盖111边缘的开孔，开孔16具有两个作用，第一个作用是，在组装时，将连接模块1和发生器模块2连接后，组装人员可以通过条形状开孔16，直接将上述的第二金属层119和第三金属层22通过焊线连接、第四金属层221和天线14通过焊线连接、第五金属层222和充电端子131通过焊线连接，无需组装人员将连接模块1和发生器模块2的全部电路板23露出操作，简化组装步骤，降低产品的报废率。第二作用是，第二金属层119和第三金属层22焊线结束，并经过测试合格后可以通过此处的开孔16向脉冲发生器的内部注入用来固化的胶，从而将连接模块1和发生器模块2连接在一起，并有效封装内部的多个元件，起到防水作用。
后盖112朝向所述第一壳体25的边缘设置有第一辅助定位部1121，第一辅助定位部1121可以是第一壳体25的边缘的凸起，所述第一壳体25上设置有与后盖112相接合的第二辅助定位部253，第二辅助定位部253可以是第一壳体 25上的凹槽，或者，第一辅助定位部1121是凹槽，第二辅助定位部253是第一壳体25上的凸起，所述连接模块1安装在所述发生器模块2上时，所述第一辅助定位部1121和第二辅助定位部253相接合，例如第一辅助定位部1121插入第二辅助定位部253，或者，第二辅助定位部253插入第一辅助定位部1121，由此，在连接模块1安装在所述发生器模块2上时，第一辅助定位部1121和第二辅助定位部253起到辅助定位作用，同时，后盖112的边缘不会翘起，提高整个脉冲发生器的平整度。
在一个实施例中，所述第一壳体25上设置有深入所述容纳腔内的舌板252，所述容纳腔设置有设置为填充缝隙的绝缘封装料，绝缘封装料例如是环氧树脂，所述绝缘封装料封堵所述前盖111上的开孔16，所述绝缘封装料包裹所述舌板252。在连接模块1和发生器模块2对接时，舌板252会同时插入在容纳腔的内部预设的位置处，为上述第一卡部251和第二卡部15的连接起到导向和辅助定位作用，简化了第一卡部251和第二卡部15在组装时位置校准步骤，方便组装，绝缘封装料注入并固化后，绝缘封装料包裹所述舌板252，能够有效提高连接模块1和发生器模块2的连接强度，并有效封装内部的多个元件，起到防水作用。
在一个实施例中，所述通道组件12还包括防水件121和定位件122，所述防水件121和定位件122从外到内依次设置在所述轴向通道116的开口处，所述防水件121和定位件122上设置有设置为供插入件穿过并进入所述轴向通道116的孔，所述定位件122设置为固定所述插入件，所述连接件17为圈簧。其中，防水件121例如通过橡胶或硅胶等材料通过注塑而成。在组装时，插入件通过轴向开口插入，并沿着轴向通道116径直插入，直至插入件上的连接位置和所有的圈簧保持一一对应，然后通过紧固件将插入的插入件的一端夹紧固定在连接模块1内。其中紧固件可以是螺纹连接在后盖112上的螺栓，在组装时，操作人员旋拧螺栓，使螺帽压紧插入件的轴面，完成固定。
在一个实施例中，所述连接模块1还包括标识件18，所述标识件18设置在所述顶盖11内，所述标识件18为金属件并为镂空结构，所述标识件18的镂空结构形成所述标识件18的标识，金属件可以通过镂空部分作为标记，来记录该脉冲发生器的连接模块1、发生器模块2和电池模块3等模块的型号，在使用时，医护人员用X光机扫描用户的身体，可以通过标识件18了解到脉冲发生器的多个模块的信息，方便医护人员了解到更多关于脉冲发生器的信息。
在一个实施例中，所述顶盖11上设置有缝线孔19。在使用时，医护人员可以通过缝合线穿过开孔16，将脉冲发生器缝合在用户的体内，防止用户在日常生活的活动，导致脉冲发生器在体内的位置发生偏移，从而减小脉冲发生器的故障率。
示例性的，所述第一壳体25和第二壳体33均为钛壳并焊接在一起以形成密闭容纳空间。在组装时，电池模块3组装在发生器模块2的底部的这一步骤可以放在发生器模块2和连接模块1组装前完成，在此不做限定。钛壳为生物相容性材料，植入在患者体内后，不会出现排斥反应。形成的密闭容纳空间能够起到防水作用。
本申请还提供了一种脉冲发生器的组装方法，所述脉冲发生器为上述任意一项实施例所述的脉冲发生器，如图11所示，所述组装方法包括：步骤S1至步骤S3。
步骤S1：分别独立地组装连接模块1、发生器模块2和电池模块3。
通过多道、可同时进行的工序分别将以上三个模块做出并组装完毕，不同的模块在组装时可以通过不同的产线和工序独立完成，并且在完成组装后可以通过各自的检测工序，检测产品质量，多线程加工组装，相较于一条龙组装方式具有更优的组装效率，缩短了脉冲发生器的整体组装时间，同时相互独立的三个模块在损坏后方便替换损坏的模块，并将同型号的该模块再次和另外两个模块组装，形成新的脉冲发生器。
步骤S2：组装连接第一壳体25和第二壳体33，以使所述电池模块3安装在发生器模块2上。第一壳体25和第二壳体33对接，使电池模块3伸出的正极连接器31和负极连接器32对接在发生器模块2的底部，电池模块3可以为发生器模块2的工作提供电力支持。
在一实施方式中，步骤S2包括步骤S21：通过焊接组装连接第一壳体25和第二壳体。第一壳体25和第二壳体33在连接后，通过焊接工序将第一壳体25和第二壳体33密封连接。
步骤S3：将所述连接模块1安装在所述发生器模块2上。
可以在将电池模块3和发生器模块2连接后，再将发生器模块2和连接模块1通过卡扣的形式扣合在一起，并继续将连接模块1和发生器模块2的导电层电连接，随后可以通过测试工序，将初步组装成型的脉冲发生器进行功能测试。
在一实施方式中，步骤S3包括步骤S31：向所述顶盖11内注入绝缘封装料以使顶盖11和第一壳体25连接在一起。功能测试合格的脉冲发生器将会最终通过顶盖11上的开口，向内部灌装绝缘封装料，固化后脉冲发生器整体形成密封的状态，在植入患者的体内使用时，可以实现防水。其中绝缘封装料可以是环氧树脂。
本申请还提供了一种刺激系统，包括：刺激电极43、上述任意一个实施例 所述的脉冲发生器44和导线，所述导线上设置有插入件46，所述插入件46插入所述通道组件12，所述脉冲发生器44通过所述导线电连接所述刺激电极43。插入件46的连接位点和通道组件12上的圈簧的位置一一对应，在工作时，脉冲发生器44产生的电刺激信号，通过通道模组12和连接在通道组件12内的插入件46传递，然后通过导线传递到刺激电极43，并通过刺激电极43将刺激信号释放在患者的待刺激点，辅助患者刺激治疗，帮助患者恢复神经功能。
在一实施方式中，所述刺激系统还包括转换器45和多个刺激电极43，所述转换器45电连接所述脉冲发生器44并设置为将所述脉冲发生器44的刺激脉冲信号分为多路刺激脉冲信号，每一路刺激脉冲信号分别通过一个刺激电极43进行释放。脉冲发生器44通常设置两个通道组件12，并通过两个通道组件12连接两个刺激电极43，进而实现释放两路脉冲刺激，目前两路脉冲刺激已经无法满足治疗需求，需要增加刺激电极43的数量，本实施方式中，转换器45上可以设置多个通道模组，通道模组可以供插入件46插入，通过设置转换器45，能够将一路多触点的刺激脉冲分离为多路多触点的刺激脉冲，每一路刺激脉冲信号再通过一个刺激电极43进行释放，由此可以实现超过两个刺激电极43施加电刺激的要求，满足临床更多根电极刺激的需求。
在一实施方式中，所述导线包括延伸导线41和多个电极导线42，所述转换器45通过延伸导线41电连接所述脉冲发生器44，每个刺激电极43通过一个电极导线42上的插入件46电连接所述转换器45，通过设置延伸导线41和多个电极导线42，便于脉冲发生器44和多个刺激电极43之间的电连接。转换器45也可以直接连接脉冲发生器44。
尽管上面已经示出和描述了本申请的实施例，上述实施例是示例性的，不能理解为对本申请的限制，在不脱离本申请的原理和宗旨的情况下，在申请的范围内可以对上述实施例进行变化、修改、替换和变型，所有的这些改变都应该属于本申请权利要求的保护范围之内。

Claims (20)

  1. 一种脉冲发生器，包括：
    连接模块，所述连接模块包括顶盖和通道组件，所述通道组件的至少一部分设置在所述顶盖内并设置为供插入件插入；
    发生器模块，所述发生器模块包括第一壳体、电路板和电池连接组件，所述连接模块安装在所述发生器模块上，所述电路板设置在所述第一壳体内并电连接所述通道组件；
    电池模块，所述电池模块包括第二壳体和位于所述第二壳体内的电池，所述电池模块安装在所述发生器模块上并位于所述发生器模块外，所述电池通过所述电池连接组件电连接所述电路板。
  2. 根据权利要求1所述的脉冲发生器，其中，所述顶盖为绝缘件，所述顶盖包括前盖和后盖，所述前盖和所述后盖接合后形成容纳腔，所述后盖朝向所述前盖的内侧设置有至少一个第一通道槽；
    所述通道组件包括通道盖和多个连接件，所述通道盖朝向所述后盖的一侧设置有与所述第一通道槽对应的第二通道槽，所述通道盖和所述后盖接合后，所述第一通道槽和所述第二通道槽形成供所述插入件插入的轴向通道，所述轴向通道上间隔分布多个径向凹槽，每个径向凹槽内设置有一个设置为电连接所述插入件的连接件，所述多个连接件均电连接所述电路板。
  3. 根据权利要求2所述的脉冲发生器，其中，所述每个径向凹槽的内壁上设置有第一金属层以及连通所述通道盖内外的通孔，所述通道盖的外表面设置有多个第二金属层，每个第二金属层通过一个通孔与所述通孔对应的径向凹槽内的第一金属层电连接，所述多个连接件均通过所述第一金属层和所述第二金属层电连接所述电路板。
  4. 根据权利要求3所述的脉冲发生器，其中，所述发生器模块还包括馈通件，所述馈通件为绝缘件，所述馈通件上设置有多个第三金属层，每个第三金属层电连接所述一个第二金属层和所述电路板。
  5. 根据权利要求4所述的脉冲发生器，其中，所述连接模块还包括充电线圈和天线，所述充电线圈埋设在所述前盖或所述后盖内，所述天线设置在所述通道盖的背向所述多个径向凹槽的一侧，所述馈通件上设置有第四金属层和两个第五金属层，所述第四金属层电连接所述天线和所述电路板，所述两个第五金属层分别电连接所述充电线圈和所述电路板，所述第四金属层和所述两个第五金属层分别靠近所述馈通件相对的两端。
  6. 根据权利要求2所述的脉冲发生器，其中，所述第一壳体上设置有朝向所述顶盖的第一卡部，所述前盖或所述后盖上设置有第二卡部，在所述连接模 块安装在所述发生器模块上的情况下，所述第一卡部和所述第二卡部相卡接。
  7. 根据权利要求6所述的脉冲发生器，其中，所述第一卡部上设置有卡槽，所述第二卡部为设置在所述后盖内表面上的带斜面的凸起，在所述连接模块安装在所述发生器模块上的情况下，所述第一卡部在所述第二卡部的斜面的导向作用下卡接在所述第二卡部上。
  8. 根据权利要求2所述的脉冲发生器，其中，所述前盖上设置有连通所述容纳腔内外的开孔，所述前盖的开孔是位于所述前盖边缘的缺口或非延伸至所述前盖边缘的开孔；
    所述后盖朝向所述第一壳体的边缘设置有第一辅助定位部，所述第一壳体上设置有与所述后盖相接合的第二辅助定位部，在所述连接模块安装在所述发生器模块上的情况下，所述第一辅助定位部和所述第二辅助定位部相接合。
  9. 根据权利要求8所述的脉冲发生器，其中，所述第一壳体上设置有深入所述容纳腔内的舌板，所述容纳腔设置有设置为填充缝隙的绝缘封装料，所述绝缘封装料封堵所述前盖上的开孔，所述绝缘封装料包裹所述舌板。
  10. 根据权利要求2所述的脉冲发生器，其中，所述通道组件还包括防水件和定位件，所述防水件和所述定位件从外到内依次设置在所述轴向通道的开口处，所述防水件和所述定位件上设置有设置为供所述插入件穿过并进入所述轴向通道的孔，所述定位件设置为固定所述插入件，所述多个连接件为圈簧。
  11. 根据权利要求1所述的脉冲发生器，其中，所述连接模块还包括标识件，所述标识件设置在所述顶盖内，所述标识件为金属件并为镂空结构，所述标识件的镂空结构形成所述标识件的标识。
  12. 根据权利要求1所述的脉冲发生器，其中，所述顶盖上设置有缝线孔。
  13. 根据权利要求1所述的脉冲发生器，其中，所述电池连接组件包括正极连接器和负极连接器，所述电池模块还包括分别连接所述电池的正极端子和负极端子，所述正极端子电连接所述正极连接器，所述负极端子电连接所述负极连接器；
    所述发生器模块还包括测温器，所述测温器电连接所述电路板，所述测温器设置为测量所述电池的温度。
  14. 根据权利要求1所述的脉冲发生器，其中，所述第一壳体和所述第二壳体均为钛壳并焊接在一起以形成密闭容纳空间，所述第二壳体复用为所述电池本身的壳体。
  15. 一种脉冲发生器的组装方法，其中，所述脉冲发生器为权利要求1至 14中任意一项所述的脉冲发生器，所述组装方法包括：
    分别独立地组装连接模块、发生器模块和电池模块；
    组装连接第一壳体和第二壳体，以使所述电池模块安装在所述发生器模块上；
    将所述连接模块安装在所述发生器模块上。
  16. 根据权利要求15所述的组装方法，还包括：
    通过焊接组装连接所述第一壳体和所述第二壳体；
    向顶盖内注入绝缘封装料以使所述顶盖和所述第一壳体连接在一起。
  17. 根据权利要求16所述的组装方法，其中，所述绝缘封装料为环氧树脂。
  18. 一种刺激系统，包括：
    刺激电极；
    权利要求1至14中任意一项所述的脉冲发生器；
    导线，所述导线上设置有插入件，所述插入件设置为插入通道组件，所述脉冲发生器通过所述导线电连接所述刺激电极。
  19. 根据权利要求18所述的刺激系统，其中，所述刺激系统还包括转换器，所述刺激电极的数量为多个，所述转换器电连接所述脉冲发生器并设置为将所述脉冲发生器的刺激脉冲信号分为多路刺激脉冲信号，每一路刺激脉冲信号通过一个刺激电极进行释放。
  20. 根据权利要求19所述的刺激系统，其中，所述导线包括延伸导线和多个电极导线，所述转换器通过所述延伸导线电连接所述脉冲发生器，每个刺激电极通过一个电极导线上的插入件电连接所述转换器。
PCT/CN2023/115708 2022-09-01 2023-08-30 脉冲发生器及其组装方法和刺激系统 WO2024046346A1 (zh)

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