Nerve stimulator

Abstract

The utility model discloses a nerve stimulator. The nerve stimulator comprises a middle shell; the stimulation acquisition module is mounted in the middle shell; the feed-through assembly is located on the end face of the middle shell and electrically connected with the stimulation acquisition module; the mounting cover is mounted on the end surface of the middle shell and covers the feed-through assembly; the flexible electrode comprises a first extension section and a second extension section, the first extension section and the second extension section are bent mutually, and the first extension section is of a sheet-shaped structure and is provided with a near-end contact part suitable for being electrically connected with the feed-through assembly; the second extension section is provided with a far-end electrode site part for applying electrical stimulation to a target tissue and / or recording a target tissue signal, the first extension section is arranged between the mounting cover and the end face of the middle shell, and the first extension section is connected to the side, facing the mounting cover, of the feed-through assembly and extends along the end face of the middle shell; and the second extension section penetrates out of a gap between the mounting cover and the middle shell. The sealing performance of the whole structure is improved by forming multi-layer sealing.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a nerve stimulator. Background Art

[0002] With the continuous advancement of medical technology, the use of implantable electrical stimulation to treat pain symptoms has become increasingly common. Implantable neurostimulation systems usually include flexible electrodes and multiple components. After the neurostimulator is implanted in the body, it will be surrounded by body fluids. In order to ensure the normal operation of the implanted nervous system in the body, it is necessary to ensure that the feedthrough components, connector units and other components in the neurostimulator have good sealing properties. However, the sealing between the feedthrough component and the mounting cover of the neurostimulator in the related art is poor, and it is difficult for the neurostimulator to achieve the expected effect during the implantation process. In actual use, a small amount of body fluid will still enter the housing through the electrode seal. The body fluid will spread along the electrode to all the conductive rings and cause the circuit of the entire conductive component to be paralyzed. The reliability is not high. In addition, the sealing structure of the existing technology is complex and difficult to assemble. Utility Model Content

[0003] The present invention aims to solve at least one of the technical problems in the prior art. To this end, one object of the present invention is to provide a neurostimulator that improves the sealing performance of the overall structure by forming a multi-layer seal.

[0004] To achieve the above-mentioned purpose, according to an embodiment of the present utility model, a neurostimulator is proposed, comprising: a middle shell; a stimulation acquisition module, the stimulation acquisition module comprising a stimulation and / or acquisition circuit and being installed in the middle shell; a feedthrough assembly, the feedthrough assembly being located at the end face of the middle shell and being electrically connected to the stimulation acquisition module; a mounting cover, the mounting cover being mounted on the end face of the middle shell and covering the feedthrough assembly; a flexible electrode, the flexible electrode comprising a first extension section and a second extension section, the first extension section and the second extension section being bent towards each other, the first extension section being a sheet-like structure and being provided with a proximal contact portion suitable for being electrically connected to the feedthrough assembly, the The second extension section is provided with a lead portion and a distal electrode site portion for applying electrical stimulation to the target tissue and / or recording the target tissue signal, the proximal contact portion and the distal electrode site portion are electrically connected through the lead portion, the first extension section is arranged between the mounting cover and the end face of the middle shell, the first extension section is connected to the side of the feedthrough assembly facing the mounting cover and extends along the end face of the middle shell, and the second extension section passes through the gap between the mounting cover and the middle shell; the mounting cover applies pressure to the flexible electrode toward the feedthrough assembly so that the proximal contact portion of the flexible electrode is electrically connected to the stimulation acquisition module through the feedthrough assembly.

[0005] According to the neurostimulator of the embodiment of the present invention, the flexible electrode extends from the end face of the middle shell to the side to form a side seal. At the same time, the flexible electrode is clamped by the pressure connector and the feed-through assembly in the thickness direction to form a seal, thereby increasing the sealing performance of the overall structure.

[0006] According to some specific embodiments of the present utility model, the feedthrough assembly includes: a feedthrough end cover, which is installed on the end surface of the middle shell; a feedthrough body, which is installed on the feedthrough end cover, and the feedthrough body is constructed with a plurality of conductive contacts arranged in an array, and the plurality of conductive contacts are isolated by insulating material, one side of the conductive contact of the feedthrough body is electrically connected to the stimulation acquisition module, and the other side of the conductive contact of the feedthrough body is electrically connected to the proximal electrode contact portion of the flexible electrode.

[0007] Furthermore, the mounting cover is constructed with a side edge extending toward the side of the middle shell, the side edge and the side of the middle shell form a channel for accommodating the flexible electrode, and the second extension section of the flexible electrode extends along the channel and passes through.

[0008] According to some specific embodiments of the present invention, the feedthrough end cover is constructed with a first positioning column extending in the direction of the mounting cover, and the flexible electrode and the mounting cover are constructed with a first positioning hole corresponding to the position of the first positioning column. The flexible electrode passes through the first positioning column and is installed with the feedthrough end cover, and the mounting cover passes through the first positioning column and is installed with the feedthrough end cover.

[0009] According to some specific embodiments of the present invention, the end cover of the middle shell is constructed with a second positioning column extending in the direction of the mounting cover, and the flexible electrode and the mounting cover are constructed with a second positioning hole corresponding to the position of the second positioning column. The flexible electrode passes through the second positioning column and is installed with the end cover of the middle shell, and the mounting cover passes through the second positioning column and is installed with the end cover of the middle shell.

[0010] According to some specific embodiments of the present invention, the neurostimulator further includes: a pressure connector, which is installed on the side of the mounting cover facing the middle shell, and the pressure connector is provided with a plurality of elastic structures, which generate compression deformation during the installation process of the mounting cover and the middle shell and form pressure on the proximal contact portion of the flexible electrode, so that the proximal contact portion of the flexible electrode forms an electrical connection with the feedthrough body.

[0011] Furthermore, the elastic structure of the pressure connector is a metal reed or a metal probe.

[0012] Furthermore, the elastic structure of the pressure connector is an elastic polymer bump.

[0013] According to some specific embodiments of the present invention, the neurostimulator further includes: a first sealing gasket, which is arranged between the mounting cover and the feedthrough end cover and is sealed around the feedthrough body, and the proximal contact portion of the flexible electrode is sealed between the pressure connector and the sealing gasket.

[0014] According to some specific embodiments of the present invention, the neurostimulator further includes: a second sealing gasket, which is arranged between the mounting cover and the end cover of the middle shell and is used to seal the proximal contact portion of the flexible electrode and the feedthrough body.

[0015] According to some specific embodiments of the embodiments of the present utility model, the feedthrough assembly further includes: a feedthrough adapter, which is installed on the side of the feedthrough end cover facing the stimulation acquisition module, and the feedthrough adapter is electrically connected to the feedthrough body; wherein the stimulation acquisition module is constructed with a first pin, and the first pin is electrically connected to the feedthrough body; and / or the stimulation acquisition module is constructed with a second pin, and the second pin is electrically connected to the feedthrough adapter.

[0016] Furthermore, a first mounting groove is constructed on the side of the feedthrough end cover facing the stimulation acquisition module, and the feedthrough adapter is installed in the first mounting groove; a second mounting groove is constructed on the side of the feedthrough end cover facing the mounting cover, and the feedthrough body is installed in the second mounting groove, and the feedthrough body and the feedthrough adapter are electrically connected at the center of the first mounting groove and the second mounting groove.

[0017] According to some specific embodiments of the present invention, the feedthrough end cover is constructed with a threaded structure, the mounting cover is constructed with a countersunk hole corresponding to the position of the threaded structure, and the mounting cover and the feedthrough end cover are screwed together and installed by fasteners passing through the countersunk hole and the threaded structure.

[0018] Furthermore, a sealing ring is provided in the countersunk hole of the mounting cover, and the sealing ring surrounds the fastener.

[0019] According to some specific embodiments of the present invention, the middle shell end cover is constructed with a threaded structure, the mounting cover is constructed with a countersunk hole corresponding to the position of the threaded structure, and the mounting cover and the middle shell end cover are screwed together and installed by fasteners passing through the countersunk hole and the threaded structure.

[0020] Furthermore, a sealing ring is provided in the countersunk hole of the mounting cover, and the sealing ring surrounds the fastener.

[0021] According to some specific embodiments of the present invention, the neurostimulator further includes: a coil module and an antenna module, the coil module and the antenna module are installed on a side of the middle shell away from the feedthrough assembly, the antenna module is used to interact with the stimulation acquisition module data, and the coil module is used to charge the battery of the stimulation acquisition module.

[0022] Furthermore, the neurostimulator includes an end shell, the end shell is installed at one end of the middle shell, and the coil module and the antenna module are installed in the end shell.

[0023] Furthermore, the end shell is an epoxy resin part or a silicone part.

[0024] Furthermore, the middle shell is made of titanium alloy.

[0025] According to some specific embodiments of the present invention, in the neurostimulator, the flexible electrode is a layered structure, including: a first insulating layer; a second insulating layer; a first conductive layer, wherein the first conductive layer is arranged between the first insulating layer and the second insulating layer; the proximal contact portion of the flexible electrode is exposed from the first insulating layer and / or the second insulating layer; and the distal electrode site portion of the flexible electrode is exposed from the first insulating layer and / or the second insulating layer.

[0026] According to some specific embodiments of the present invention, the first insulating layer is polyimide or parylene.

[0027] According to some specific embodiments of the present invention, the second insulating layer is polyimide or parylene.

[0028] According to some specific embodiments of the present invention, the first conductive layer is gold or platinum.

[0029] According to some specific embodiments of the present invention, the flexible electrode further includes: a third insulating layer,

[0030] The second conductive layer is disposed between the second insulating layer and the third insulating layer.

[0031] The proximal contact portion of the flexible electrode is exposed from the first insulating layer and / or the third insulating layer; the distal electrode site portion of the flexible electrode is exposed from the first insulating layer and / or the third insulating layer.

[0032] Additional aspects and advantages of the present invention will be given in part in the following description and will become apparent from the following description or learned through practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments in conjunction with the following drawings, in which:

[0034] Figure 1 is a structural schematic diagram of a neurostimulator according to an embodiment of the present utility model;

[0035] Figure 2 is a cross-sectional view of a neurostimulator according to an embodiment of the present invention;

[0036] Figure 3 is a cross-sectional view of a feedthrough assembly of a neurostimulator according to an embodiment of the present invention;

[0037] Figure 4 is a cross-sectional view of the neurostimulator according to an embodiment of the present invention from another angle;

[0038] Figure 5 is a knot of a mounting cover of a neurostimulator according to an embodiment of the present invention;

[0039] Figure 6 is a schematic structural diagram of a flexible electrode of a neurostimulator according to an embodiment of the present utility model;

[0040] Figure 7 is a cross-sectional view of a flexible electrode of a neurostimulator according to an embodiment of the present utility model;

[0041] Figure 8 It is a cross-sectional view of a flexible electrode of a neurostimulator according to another embodiment of the present invention.

[0042] Reference numerals:

[0043] Neurostimulator 1, middle housing 100, stimulation acquisition module 200, feedthrough assembly 300, mounting cover 400,

[0044] Flexible electrode 500, coil module 600, antenna module 700, conductive contact 301,

[0045] Feedthrough end cap 310, feedthrough body 320, first sealing gasket 330, feedthrough adapter 340, first positioning column 311,

[0046] First mounting groove 312, second mounting groove 313, electrode mounting groove 331, side edge 401,

[0047] First positioning hole 402, counterbore 403, sealing ring 404, pressure connector 410, electrode protection tube 501,

[0048] The first extension section 510, the second extension section 520, the end housing 601, the first pin 31, the second pin 32,

[0049] A first insulating layer 11 , a first conductive layer 12 , a second insulating layer 13 , a second conductive layer 14 , and a third insulating layer 15 . DETAILED DESCRIPTION

[0050] The following describes embodiments of the present invention in detail. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended only to explain the present invention and are not to be construed as limiting the present invention.

[0051] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like to indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0052] In the description of the present invention, "first feature" and "second feature" may include one or more such features.

[0053] In the description of the present invention, “multiple” means two or more, and “several” means one or more.

[0054] The following describes a neurostimulator 1 according to an embodiment of the present invention with reference to the accompanying drawings.

[0055] Such as 1- Figure 8 As shown, the neurostimulator 1 according to an embodiment of the present invention includes a middle housing 100 , a stimulation acquisition module 200 , a feedthrough assembly 300 , a mounting cover 400 , a flexible electrode 500 and a pressure connector 410 .

[0056] The stimulation acquisition module 200 includes stimulation and / or acquisition circuitry and is mounted within the middle housing 100. The feedthrough assembly 300 is located on an end surface of the middle housing 100 and is electrically connected to the stimulation acquisition module 200. The mounting cover 400 is mounted on an end surface of the middle housing 100 and covers the feedthrough assembly 300. The flexible electrode 500 includes a first extension section 510 and a second extension section 520. The first extension section 510 is a sheet-like structure and has a proximal contact portion suitable for electrically connecting to the feedthrough assembly 300. The second extension section 520 has a lead portion and a distal electrode site portion for applying electrical stimulation to the target tissue and / or recording signals from the target tissue. The proximal contact portion and the distal electrode site portion are electrically connected via the lead portion. The first extension section 510 is disposed between the mounting cover 400 and the end surface of the middle housing 100. The first extension section 510 is connected to the side of the feedthrough assembly 300 facing the mounting cover 400 and extends along the end surface of the middle housing 100. The second extension section 520 extends through the gap between the mounting cover 400 and the middle housing 100. A pressure connector 410 is mounted on the mounting cover 400. The pressure connector 410 applies pressure to the flexible electrode 500 toward the feedthrough assembly 300 to electrically connect the proximal contact portion of the flexible electrode 500 to the stimulation acquisition module 200 through the feedthrough assembly 300.

[0057] For example, during the operation, the implantation position of the flexible electrode 500 is confirmed after the patient's skin is cut. When the distal electrode site of the flexible electrode 500 is implanted at the designated position, the position of the neurostimulator 1 is confirmed, and the end of the flexible electrode 500 is moved from subcutaneously to the position where the neurostimulator 1 is fixed. At this time, the proximal contact part of the flexible electrode 500 is fixedly connected to the neurostimulator 1, thereby implanting the neurostimulator 1 with the flexible electrode 500 into the human body, and the wound is sutured to complete the operation.

[0058] According to the neurostimulator 1 of the embodiment of the present invention, a first extension section 510 and a second extension section 520 are formed by the flexible electrode 500. The first extension section 510 is arranged between the end face of the mounting cover 400 and the middle shell 100, and the second extension section 520 passes through the gap between the mounting cover 400 and the middle shell 100, that is, the flexible electrode 500 extends from the end face of the middle shell 100 to the side, so that the pressure connector 410 can apply pressure to the flexible electrode 500 uniformly while sealing the flexible electrode 500 between the mounting cover 400 and the middle shell 100, and between the mounting cover 400 and the feedthrough assembly 300, thereby increasing the sealing performance of the overall structure.

[0059] Furthermore, if Figure 2 and Figure 3As shown, the feedthrough assembly 300 includes a feedthrough end cap 310 and a feedthrough body 320. The feedthrough end cap 310 is mounted on the end surface of the middle housing 100. The feedthrough body 320 is mounted on the feedthrough end cap 310. The feedthrough body 320 is constructed with a plurality of conductive contacts 301 arranged in an array, and the plurality of conductive contacts 301 are separated by insulating material. One side of the conductive contacts 301 of the feedthrough body 320 is electrically connected to the stimulation acquisition module, and the other side of the conductive contacts 301 of the feedthrough body 320 is electrically connected to the proximal electrode contact portion of the flexible electrode 500. In this way, the acquisition stimulation module 200 is connected to the proximal contact portion of the flexible electrode 500 through the feedthrough body 320.

[0060] The flexible electrode 500 is in the form of a sheet, with multiple conductive contacts 301 separated by insulating material. The flexible electrode 500 is connected to the multiple conductive contacts 301. The array of multiple conductive contacts 301 can provide multiple stimulation points, which means that the nerves can be stimulated more precisely and the precision of the stimulation can be improved. Through the multiple conductive contacts 301, stimulation can be performed over a larger area, expanding the effective range of stimulation. The structure of the sheet-shaped flexible electrode 500 allows it to fit closely to the tissue surrounding the nerves, ensuring more accurate and uniform contact between the multiple stimulation points and the nerves.

[0061] In addition, the feedthrough end cover 310 is installed on one side of the middle shell 100 for fixing the feedthrough body 320. The feedthrough body 320 is installed at the center of the feedthrough end cover 310, with one side electrically connected to the stimulation acquisition module 200 and the other side connected to the flexible electrode 500. A sealing structure is formed between the feedthrough end cover 310 and the feedthrough body 320, which improves the sealing performance of the overall structure. It can effectively prevent foreign substances such as moisture and dust from entering the interior of the neurostimulator 1, ensuring the normal operation of the internal circuits and components. At the same time, the multi-layer sealing structure can also effectively protect sensitive components such as the internal stimulation acquisition module 200 and the feedthrough component 300, ensuring that they are not affected by the external environment, thereby improving the safety and reliability of the neurostimulator 1.

[0062] Furthermore, if Figure 1 As shown, the mounting cover 400 is configured with a side edge extending toward the side of the middle housing 100 , and the side edge and the side of the middle housing 100 form a channel for accommodating the flexible electrode 500 , and the second extension section 520 of the flexible electrode 500 extends along the channel and passes through.

[0063] The flexible electrode 500 is fitted with an electrode protective tube 501. The flexible electrode 500 includes a first extension section 510 and a second extension section 520. The first extension section 510 extends along the end surface of the middle housing 100, while the second extension section 520 extends along the outer side of the middle housing 100. The electrode protective tube 501 is configured as a sheet-like structure, extending the flexible electrode 500, and is positioned on one side of the first extension section 510. The end of the second extension section 520 adjacent to the first extension section 510 is also a sheet-like structure, while the end distal to the first extension section 510 is a tubular structure. By positioning the electrode protective tube 501 around the flexible electrode 500, it protects the flexible electrode 500 from environmental influences, such as wear and scratches, extending its service life. Furthermore, the presence of the electrode protective tube 501 reduces direct contact between the flexible electrode 500 and surrounding tissue, further reducing the risk of tissue damage.

[0064] In some specific embodiments of the present invention, Figure 4 As shown, the feedthrough end cover 310 is constructed with a first positioning column 311 extending in the direction of the mounting cover 400, and the flexible electrode 500 and the mounting cover 400 are constructed with a first positioning hole corresponding to the position of the first positioning column 311. The flexible electrode 500 passes through the first positioning column 311 and is installed with the feedthrough end cover 310, and the mounting cover 400 passes through the first positioning column 311 and is installed with the feedthrough end cover 310.

[0065] The cooperation between the first positioning post 311 and the first positioning hole 402 can ensure accurate docking between the feedthrough end cap 310 and the mounting cover 400. This precise docking helps to ensure the correct position of internal components such as the feedthrough body 320 and the flexible electrode 500, reducing assembly errors. At the same time, the first positioning post 311 can also provide additional mechanical support, enhancing the overall stability of the feedthrough end cap 310 and the mounting cover 400. This support can prevent structural displacement due to external impact or vibration, ensuring the reliability of the neurostimulator 1 during use.

[0066] The use of first positioning posts 311 and corresponding first positioning holes 402 simplifies the assembly process. Installers can easily align the feedthrough end cap 310 with the mounting cover 400, improving assembly efficiency and reducing assembly time. Furthermore, the first positioning posts 311 pass through the flexible electrode 500 and the mounting cover 400 for installation, enhancing sealing performance. Tightening the first positioning posts 311 ensures that the feedthrough assembly 300 maintains a tight seal at the joint, thereby achieving a good seal.

[0067] In other specific embodiments of the present invention, the end cover of the middle shell 100 is constructed with a second positioning column (not shown in the figure) extending in the direction of the mounting cover 400, and the flexible electrode 500 and the mounting cover 400 are constructed with a second positioning hole (not shown in the figure) corresponding to the position of the second positioning column. The flexible electrode 500 passes through the second positioning column and is installed with the end cover of the middle shell 100, and the mounting cover 400 passes through the second positioning column and is installed with the end cover of the middle shell 100.

[0068] Thus, the middle shell 100 and the mounting cover 400 are penetrated by the second positioning column and the second positioning hole, and the feedthrough assembly 300 is clamped and sealed between the mounting cover 400 and the middle shell 100, which can ensure that the feedthrough assembly 300 maintains a good compression state at the joint, thereby achieving good sealing performance.

[0069] In some specific embodiments of the present invention, the pressure connector 410 is provided with a plurality of elastic structures (not shown in the figure), which generate compression deformation during the installation process of the mounting cover 400 and the middle shell 100 and form pressure on the proximal contact portion of the flexible electrode 500, so that the proximal contact portion of the flexible electrode 500 forms an electrical connection with the feedthrough body 320.

[0070] Furthermore, the elastic structure of the pressure connector 410 is a metal reed or a metal probe.

[0071] Furthermore, the elastic structure of the pressure connector 410 is an elastic polymer bump.

[0072] The pressure connector 410 applies pressure uniformly, increasing the contact area and pressure between the pressure connector 410 and the feedthrough body 320 , so that the proximal contact portion of the flexible electrode 500 is stably electrically connected to the feedthrough body 320 .

[0073] In some specific embodiments of the present invention, the neurostimulator 1 further includes a first sealing gasket 330. The first sealing gasket 330 is disposed between the mounting cover 400 and the feedthrough end cover 310 and is sealed around the feedthrough body 320. The proximal contact portion of the flexible electrode 500 is sealed between the pressure connector 410 and the sealing gasket.

[0074] The first sealing gasket 330 is sealed around the outer peripheral side of the feedthrough body 320 to ensure the seal between the feedthrough body 320 and the support end cover 310, forming a first layer of seal. At the same time, the seal between the feedthrough body 320 and the first sealing gasket 330 can also be increased to form a second layer of seal. The mounting cover 400 is mounted on the end face of the middle shell 100 and covers the outside of the feedthrough assembly 300, and is used to close the feedthrough assembly 300. The first sealing gasket 330 is not only sealed around the outer peripheral side of the feedthrough body 320, but is also sealed in the thickness direction by the support end cover 310 and the mounting cover 400, forming a third layer of seal. A multiple sealing structure is formed between the support end cover 310, the feedthrough body 320, and the first sealing gasket 330, thereby improving the sealing performance of the overall structure. The multi-layer sealing structure can effectively prevent foreign substances such as moisture and dust from entering the interior of the neurostimulator 1, ensuring the normal operation of the internal circuits and components. At the same time, the multi-layer sealing structure can also effectively protect the internal collection stimulation module 200, feedthrough component 300 and other sensitive components, ensuring that they are not affected by the external environment, thereby improving the safety and reliability of the neurostimulator 1.

[0075] Furthermore, if Figure 4 As shown, the first sealing gasket 330 is configured with an electrode mounting groove 331, which extends to the edge of the first sealing gasket 330 facing the side edge 401. The electrode protective tube 501 is disposed within the electrode mounting groove 331 and extends into the electrode channel. The first sealing gasket 330 can be made of a flexible material, and its thickness changes with applied force. The electrode mounting groove 331 accommodates the motor protective tube 501, allowing it to form a close contact with the first sealing gasket 330, thereby improving the sealing performance of the overall structure of the neurostimulator 1. Furthermore, the electrode mounting groove 331 provides a stable mounting position for the electrode protective tube 501, helping to maintain its stability and fixation. By placing the electrode protective tube 501 within the electrode mounting groove 331, damage caused by movement or vibration can be effectively reduced. Furthermore, by placing the electrode protective tube 501 within the electrode mounting groove 331, the installation process is simplified and more efficient. This structure facilitates accurate positioning of the electrode protective tube 501 during assembly, reducing assembly time and complexity. Furthermore, the structure of the electrode mounting groove 331 can help evenly distribute the pressure on the first sealing gasket 330 , thereby improving the sealing effect and reducing local stress concentration, thereby preventing the first sealing gasket 330 from being damaged or aged.

[0076] In other embodiments, the neurostimulator 1 further includes a second sealing gasket (not shown), which is disposed between the mounting cover 400 and the end cap of the middle housing 100 and is used to seal the proximal contact portion of the flexible electrode 500 and the feedthrough body 320. For example, the second sealing member can be sealed around the outer periphery of the feedthrough assembly 300, forming a fully enclosed structure of the feedthrough body 320 to ensure good sealing.

[0077] In some specific embodiments of the present invention, Figure 2 As shown, the feedthrough assembly 300 also includes a feedthrough adapter 340. The feedthrough adapter 340 is mounted on the side of the feedthrough end cap 310 facing the stimulus collection module 200 and is electrically connected to the feedthrough body 320. The stimulus collection module 200 is configured with a first pin 31, which is electrically connected to the feedthrough body 320. Furthermore, the stimulus collection module 200 is configured with a second pin 32, which is electrically connected to the feedthrough adapter 340.

[0078] That is, both the first pin 31 and the second pin 32 of the stimulation acquisition module 200 can be connected to the feedthrough body 320 . When one of them is connected to the feedthrough body 320 , the other is connected to the feedthrough adapter 340 .

[0079] By providing the first pin 31 and the second pin 32, different devices can be flexibly connected and switched according to different needs and application scenarios, thereby improving the compatibility and applicability of the neurostimulator 1. This structure makes circuit design more flexible, allowing the optimal electrical connection method to be selected as needed, thereby optimizing circuit performance.

[0080] In some specific embodiments of the present invention, Figure 3 As shown, a first mounting slot 312 is configured on the side of the feedthrough end cap 310 facing the stimulation acquisition module, and the feedthrough adapter 340 is installed in the first mounting slot 312. A second mounting slot 313 is configured on the side of the feedthrough end cap 310 facing the mounting cover 400, and the feedthrough body 320 is installed in the second mounting slot 321. The feedthrough body 320 and the feedthrough adapter 340 are electrically connected at the center of the first mounting slot 312 and the second mounting slot 313.

[0081] The first mounting slot 312 is used to mount the feedthrough adapter 340, ensuring electrical connection between the feedthrough adapter 340 and the stimulation acquisition module 200. The second mounting slot 313 is used to mount the feedthrough body 320, ensuring electrical connection between the feedthrough body 320 and the flexible electrode 500. The feedthrough body 320 and the feedthrough adapter 340 are electrically connected at the center of the first mounting slot 312 and the second mounting slot 313, ensuring a reliable electrical connection between the two and enabling signal and energy transmission.

[0082] When the mounting cover 400 is installed with the middle shell 100, the pressure connector 410 will apply pressure to the flexible electrode 500. The presence of the pressure connector 410 can effectively press the flexible electrode 500 onto the feedthrough body 320. This physical compression ensures close contact between the flexible electrode 500 and the feedthrough body 320, thereby achieving a reliable electrical connection and reducing the risk of poor contact. In addition, the pressure applied by the pressure connector 410 can compensate for minor unevenness between the flexible electrode 500 and the feedthrough body 320 to a certain extent, improve the stability of the connection, ensure that the current can pass smoothly during use, and avoid disconnection due to vibration or movement. At the same time, the pressure connector 410 can effectively reduce contact resistance, making the transmission of electrical signals smoother, thereby improving the overall performance of the neurostimulator 1 and ensuring the treatment effect.

[0083] In some embodiments of the present invention, pressure connector 410 is made of a flexible material, and its thickness changes with applied force. Because pressure connector 410 is flexible, it elastically deforms in response to applied pressure. This ensures that appropriate pressure is applied between mounting cap 400 and feedthrough assembly 300, firmly maintaining the electrical connection between flexible electrode 500 and feedthrough body 320 and improving the quality of the electrical connection.

[0084] In some specific embodiments of the present invention, Figure 5 As shown, the feedthrough end cap 310 is constructed with a threaded structure, and the mounting cover 400 is constructed with a countersunk hole 403. The feedthrough end cap 310 is screwed and installed by fasteners penetrating the countersunk hole 403. The threaded structure is symmetrically arranged on both sides of the first positioning column 311, and the positions of the threaded structure and the countersunk hole 403 also correspond. The countersunk hole 403 structure can provide better positioning for the fastener, preventing the fastener from deviating from the center during installation, making the docking of the mounting cover 400 and the feedthrough end cap 310 more precise, ensuring the correct position of the internal components. In addition, as Figure 7 and Figure 8 As shown, the first positioning post 311 may also be disposed around the feed-through body 320 .

[0085] Furthermore, a sealing ring 404 is provided in the counterbore 403 of the mounting cover 400 , and the sealing ring surrounds the fastener.

[0086] Sealing ring 404 surrounds the fastener, forming a strong seal with mounting cover 400 and feedthrough end cap 310, effectively protecting the internal electronic components from moisture and contamination, and improving the durability of the device. Furthermore, this threaded connection makes installation and removal simple and convenient. Users only need to tighten or loosen the fasteners with the appropriate tools to perform assembly or maintenance, thus improving the user experience.

[0087] In other embodiments, the end cap of the middle housing 100 is configured with a threaded structure, and the mounting cover 400 is configured with a countersunk hole corresponding to the position of the threaded structure. The mounting cover 400 and the end cap of the middle housing 100 are screwed together by fasteners passing through the countersunk hole and the threaded structure. By aligning the threaded structure with the countersunk hole, the fasteners can be used to mount the middle housing 100 and the mounting cover 400, thereby also achieving the purpose of mounting the mounting cover 400 and the middle housing 100.

[0088] Furthermore, a sealing ring 404 is provided in the counterbore of the mounting cover 400 and surrounds the fastener, thereby forming a good seal between the mounting cover 400 and the feedthrough end cap 310, effectively protecting the internal electronic components from moisture and contamination, and improving the durability of the device.

[0089] In some specific embodiments of the present invention, Figure 4 As shown, the neurostimulator 1 also includes a coil module 600 and an antenna module 700. The coil module 600 and the antenna module 700 are installed on the side of the middle shell 100 away from the feedthrough assembly 300. The antenna module 700 is used to interact with the stimulation acquisition module 200 for data, and the coil module 600 is used to charge the battery of the stimulation acquisition module 200. The coil module 600 and the antenna module 700 are installed together in the coil base after being electrically connected, and are fixed together inside the middle shell 100 by fasteners. As an energy receiving end, the coil module 600 can ensure that the neurostimulator 1 can obtain energy in a non-contact manner after being implanted in the human body. The antenna module 700 is used for wireless data interaction with the stimulation acquisition module 200.

[0090] Antenna module 700 can receive and transmit data, ensuring real-time communication between various components of the device, allowing the neurostimulator 1 to adjust output stimulation parameters as needed. Using wireless signals, antenna module 700 allows external devices (such as smartphones or computers) to remotely monitor and control the neurostimulator 1. This provides users with more flexible and convenient management options. Furthermore, antenna module 700 can transmit device operating status and health data, enabling doctors or users to obtain relevant information in real time, allowing them to adjust usage strategies or perform maintenance.

[0091] In some specific embodiments of the present invention, Figure 4 As shown, the neurostimulator 1 further includes an end housing 601, which is mounted on one end of the middle housing 100. The coil module 600 and the antenna module 700 are mounted on the end housing 601. Furthermore, the end housing 601 is made of epoxy resin or silicone, which does not affect signal transmission, improves compatibility, and reduces interference with the stimulation acquisition module.

[0092] Furthermore, the end shell 601 is an epoxy resin part or a silicone part, and the middle shell 100 is a titanium alloy part.

[0093] By constructing the middle housing 100 from a titanium alloy and the end housing 601 from epoxy resin or silicone, the components within the middle housing 100 and the second housing 400 are effectively magnetically compatible, preventing electromagnetic interference. Heat generated within the first and second housings 100 and 400 is not conducted to each other, and heat generated by the charging coil 510 is quickly dissipated, improving heat dissipation efficiency and preventing interference with the operation of the collection and stimulation module 200 within the first housing 100.

[0094] In some specific embodiments of the present invention, Figure 7 As shown, the flexible electrode 500 is a layered structure, including: a first insulating layer 11 , a second insulating layer 13 and a first conductive layer 12 .

[0095] The first conductive layer 12 is disposed between the first insulating layer 11 and the second insulating layer 13. The proximal contact portion of the flexible electrode 500 is exposed from the first insulating layer 11 and / or the second insulating layer 13. The distal electrode site portion of the flexible electrode 500 is exposed from the first insulating layer 11 and / or the second insulating layer 13.

[0096] The proximal contact portion is exposed from the first and second insulating layers 11, 13, and electrically connected to the feedthrough assembly 300, thereby further connecting to the stimulation acquisition module. The distal electrode site portion is exposed from the first and second insulating layers 11, 13, and electrically connected to the target tissue. This creates electrical conduction between the proximal and distal contact portions of the flexible electrode 500, enabling the stimulation acquisition module to collect and stimulate the target tissue.

[0097] In some embodiments, the first insulating layer 11 is made of polyimide or parylene. Further, the second insulating layer 13 is made of polyimide or parylene. The first conductive layer 12 is made of gold or platinum.

[0098] In some specific embodiments of the present invention, Figure 8 As shown, the flexible electrode 500 is a layered structure, and further includes: a third insulating layer 15 and a second conductive layer 14 , wherein the second conductive layer 14 is disposed between the second insulating layer 13 and the third insulating layer 15 .

[0099] The proximal contact portion of the flexible electrode 500 is exposed from the first insulating layer 11 and the third insulating layer 15. The distal electrode site portion of the flexible electrode 500 is exposed from the first insulating layer 11 and / or the third insulating layer 15. The first conductive layer 12 and the second conductive layer 14 are exposed to conduct electricity.

[0100] In some specific embodiments of the present invention, the middle shell 100 is made of titanium alloy and has high biocompatibility with the target tissue to be implanted.

[0101] Other structures and operations according to the embodiments of the present invention are known to those skilled in the art and will not be described in detail here.

[0102] Throughout this specification, reference to terms such as "one embodiment," "some embodiments," "illustrative embodiments," "example," "specific example," or "some examples" means that a specific feature, structure, material, or characteristic described in conjunction with the embodiment or example is included in at least one embodiment or example of the present invention. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment or example.

[0103] Although the embodiments of the present invention have been shown and described, those skilled in the art will appreciate that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and purpose of the present invention, and that the scope of the present invention is defined by the claims and their equivalents.

Claims

1. A neurostimulator, characterized in that: include: Middle shell; a stimulation acquisition module, comprising stimulation and / or acquisition circuits and mounted in the middle housing; a feedthrough assembly, the feedthrough assembly being located on an end surface of the middle housing and being electrically connected to the stimulation acquisition module; a mounting cover, the mounting cover being mounted on an end surface of the middle housing and covering the feedthrough assembly; A flexible electrode, the flexible electrode comprising a first extension segment and a second extension segment, the first extension segment and the second extension segment being bent toward each other, the first extension segment being a sheet-like structure and provided with a proximal contact portion adapted to be electrically connected to the feedthrough assembly, the second extension segment being provided with a lead portion and a distal electrode site portion for applying electrical stimulation to a target tissue and / or recording signals from the target tissue, the proximal contact portion and the distal electrode site portion being electrically connected via the lead portion, the first extension segment being disposed between the mounting cover and an end face of the middle shell, the first extension segment being connected to a side of the feedthrough assembly facing the mounting cover and extending along the end face of the middle shell, and the second extension segment passing through a gap between the mounting cover and the middle shell; The mounting cover applies pressure to the flexible electrode in the direction of the feedthrough assembly, so that the proximal contact portion of the flexible electrode forms an electrical connection with the stimulation acquisition module through the feedthrough assembly.

2. The neurostimulator according to claim 1, wherein The feedthrough assembly comprises: A feedthrough end cover, the feedthrough end cover being mounted on an end surface of the middle shell; A feedthrough body is mounted on the feedthrough end cap, the feedthrough body being constructed with a plurality of conductive contacts arranged in an array, the plurality of conductive contacts being isolated by insulating material, one side of the conductive contact of the feedthrough body being electrically connected to the stimulation acquisition module, and the other side of the conductive contact of the feedthrough body being electrically connected to the proximal electrode contact portion of the flexible electrode.

3. The neurostimulator according to claim 2, wherein The mounting cover is configured with a side edge extending toward the side of the middle shell. The side edge and the side of the middle shell form a channel for accommodating the flexible electrode. The second extension section of the flexible electrode extends along the channel and passes through.

4. The neurostimulator according to claim 2, wherein The feedthrough end cover is constructed with a first positioning column extending in the direction of the mounting cover, and the flexible electrode and the mounting cover are constructed with a first positioning hole corresponding to the position of the first positioning column. The flexible electrode passes through the first positioning column and is installed with the feedthrough end cover, and the mounting cover passes through the first positioning column and is installed with the feedthrough end cover.

5. The neurostimulator according to claim 2, wherein The end cover of the middle shell is constructed with a second positioning column extending in the direction of the mounting cover, and the flexible electrode and the mounting cover are constructed with a second positioning hole corresponding to the position of the second positioning column. The flexible electrode passes through the second positioning column and is installed on the end cover of the middle shell, and the mounting cover passes through the second positioning column and is installed on the end cover of the middle shell.

6. The neurostimulator according to claim 2, characterized in that Also includes: A pressure connector is installed on the side of the mounting cover facing the middle shell, and the pressure connector is provided with multiple elastic structures. The elastic structures generate compression deformation during the installation process of the mounting cover and the middle shell and form pressure on the proximal contact portion of the flexible electrode, so that the proximal contact portion of the flexible electrode forms an electrical connection with the feedthrough body.

7. The neurostimulator according to claim 6, characterized in that The elastic structure of the pressure connector is a metal reed or a metal probe.

8. The neurostimulator according to claim 7, characterized in that The elastic structure of the pressure connector is an elastic polymer bump.

9. The neurostimulator according to claim 2, wherein Also includes: A first sealing gasket is provided between the mounting cover and the feedthrough end cover and is sealed around the feedthrough body, and the proximal contact portion of the flexible electrode is sealed between the pressure connector and the sealing gasket.

10. The neurostimulator according to claim 2, wherein Also includes: A second sealing gasket is provided between the mounting cover and the end cover of the middle shell, and is used for sealing the proximal contact portion of the flexible electrode and the feed-through body.

11. The neurostimulator according to claim 2, wherein The feedthrough assembly further comprises: a feedthrough adapter, the feedthrough adapter being mounted on a side of the feedthrough end cap facing the stimulation acquisition module, the feedthrough adapter being electrically connected to the feedthrough body; Wherein, the stimulation acquisition module is configured with a first pin, and the first pin is electrically connected to the feedthrough body; And / or, the stimulation acquisition module is configured with a second pin, and the second pin is electrically connected to the feed-through adapter.

12. The neurostimulator according to claim 11, wherein A first mounting groove is configured on one side of the feedthrough end cap facing the stimulation acquisition module, and the feedthrough adapter is mounted in the first mounting groove; A second mounting groove is configured on one side of the feedthrough end cover facing the mounting cover, the feedthrough body is mounted in the second mounting groove, and the feedthrough body and the feedthrough adapter are electrically connected at the center of the first mounting groove and the second mounting groove.

13. The neurostimulator according to claim 2, wherein The feedthrough end cover is constructed with a threaded structure, the mounting cover is constructed with a countersunk hole corresponding to the position of the threaded structure, and the mounting cover and the feedthrough end cover are screwed and installed by fasteners passing through the countersunk hole and the threaded structure.

14. The neurostimulator according to claim 13, wherein A sealing ring is provided in the countersunk hole of the mounting cover, and the sealing ring surrounds the fastener.

15. The neurostimulator according to claim 13, wherein The middle shell end cover is constructed with a threaded structure, and the mounting cover is constructed with a countersunk hole corresponding to the position of the threaded structure. The mounting cover and the middle shell end cover are screwed and installed by fasteners passing through the countersunk hole and the threaded structure.

16. The neurostimulator according to claim 15, characterized in that A sealing ring is provided in the countersunk hole of the mounting cover, and the sealing ring surrounds the fastener.

17. The neurostimulator according to claim 1, wherein Also includes: A coil module and an antenna module are installed on a side of the middle shell away from the feedthrough assembly. The antenna module is used to interact with the stimulation acquisition module for data, and the coil module is used to charge the battery of the stimulation acquisition module.

18. The neurostimulator according to claim 17, wherein Also includes: The end shell is installed at one end of the middle shell, and the coil module and the antenna module are installed in the end shell.

19. The neurostimulator according to claim 18, wherein The end shell is an epoxy resin part or a silicone part.

20. The neurostimulator according to claim 1, wherein The middle shell is made of titanium alloy.

21. The neurostimulator according to claim 1, wherein the flexible electrode is a layered structure comprising: a first insulating layer; a second insulating layer; a first conductive layer, the first conductive layer being disposed between the first insulating layer and the second insulating layer; The proximal contact portion of the flexible electrode is exposed from the first insulating layer and / or the second insulating layer; The distal electrode site portion of the flexible electrode is exposed from the first insulating layer and / or the second insulating layer.

22. The flexible electrode according to claim 21, characterized in that The first insulating layer is polyimide or parylene.

23. The neurostimulator according to claim 21, wherein The second insulating layer is made of polyimide or parylene.

24. The neurostimulator according to claim 21, wherein The first conductive layer is gold or platinum.

25. The neurostimulator according to claim 21, wherein Also includes: a third insulating layer; a second conductive layer, the second conductive layer being disposed between the second insulating layer and the third insulating layer; The proximal contact portion of the flexible electrode is exposed from the first insulating layer and / or the third insulating layer; The distal electrode site portion of the flexible electrode is exposed from the first insulating layer and / or the third insulating layer.

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