Flexible electrode connection assembly and flexible electrode system

Abstract

The application discloses a flexible electrode connecting assembly and a flexible electrode system, and the flexible electrode connecting assembly comprises a connecting wire, a flexible electrode and an adapter. In the assembly process of the flexible electrode assembly, the first contact part and the interface contact part are inserted into the cavity through the opening along the axial direction of the adapter, and each conductive elastic bridge is in contact with the electrode contact and the first wire contact at the corresponding position, so that the electrode contact and the corresponding first wire contact are electrically connected through the conductive elastic bridge. According to the flexible electrode connecting assembly, the conductive core wire, the first contact and the positioning part are directly arranged on the connecting wire, the structure is relatively simple, and the modular extrusion cooperation of the connecting wire and the adapter can be realized, so that the quick and stable cross-electrode electrical conduction and sealing fixation between the connecting wire and the flexible electrode are realized. The connecting wire and the flexible electrode are inserted into the cavity of the adapter through the opening of the adapter, so that the electrode contact of the flexible electrode and the first wire contact of the connecting wire are stably connected.

Description

Technical Field

[0001] This invention relates to the field of flexible electrode technology, and in particular to a flexible electrode connection assembly and a flexible electrode system. Background Technology

[0002] In bioelectrical signal acquisition and tissue electrical stimulation scenarios, flexible electrodes, with their excellent flexibility and deformation capabilities, can conform to soft tissue surfaces. Compared to rigid electrodes, they reduce mechanical stimulation to body tissues and are widely used in related medical devices. Flexible electrodes are generally positioned at the distal end to contact the target tissue. The electrical signal from the electrode site needs to be transmitted to an external circuit via an output circuit, or the electrical stimulation signal needs to be transmitted to the electrode site via a stimulation circuit to achieve signal recording or electrical stimulation output.

[0003] In related technologies, the circuit lead-out structure of flexible electrodes is relatively complex, the process requirements for the transition position are high, and it is difficult to achieve pluggable and sealed assembly. Therefore, there is an urgent need for a flexible electrode assembly with reasonable structure, convenient assembly and positioning, stable conductive connection and good sealing performance. Summary of the Invention

[0004] The present invention aims to at least solve one of the technical problems existing in the prior art. To this end, one object of the present invention is to provide a flexible electrode connection assembly with a relatively simple structure, which facilitates quick and stable cross-electrode electrical conduction and sealing fixation between the connecting wire and the flexible electrode.

[0005] According to a first aspect of the present invention, a flexible electrode connection assembly includes: a connecting wire, the connecting wire including a support sleeve, the support sleeve having a first contact portion, the first contact portion including at least one first wire contact, the support sleeve having at least one conductive core wire, one end of the conductive core wire being electrically connected to the first wire contact, and the support sleeve having a positioning portion at the end near the first contact portion; a flexible electrode, the flexible electrode having an interface contact portion, the interface contact portion including at least one electrode contact, and the flexible electrode having an auxiliary assembly hole at the end near the interface contact portion, the auxiliary assembly hole cooperating with the positioning portion to achieve pre-assembly of the connecting wire and the flexible electrode; when the connecting wire and the flexible electrode are in a pre-assembled state, the interface contact portion is located at the first contact. The outer peripheral surface of the first contact portion has the electrode contacts facing away from the outer peripheral surface of the first contact portion. The electrode contacts are arranged one-to-one with the first wire contacts, and the first wire contacts are at least partially exposed and not covered by the electrode contacts. A connector has a cavity, and an opening is formed at one axial end of the connector. The cavity communicates with the outside through the opening. At least one conductive elastic bridge is provided on the inner wall of the cavity of the connector. During the assembly of the flexible electrode connection assembly, along the axial direction of the connector, the first contact portion and the interface contact portion are inserted into the cavity through the opening. Each conductive elastic bridge simultaneously abuts against the corresponding electrode contact and the first wire contact, so that the electrode contact and the corresponding first wire contact form an electrical connection through the conductive elastic bridge.

[0006] According to an embodiment of the present invention, the flexible electrode connection assembly has a conductive core wire, a first contact, and a positioning part directly disposed on the connecting wire. This results in a relatively simple structure and facilitates quick and stable cross-electrode electrical conduction and sealing fixation between the connecting wire and the flexible electrode through modular compression fitting of the connecting wire and the adapter. The connecting wire and the flexible electrode are inserted together into the cavity of the adapter through the opening of the adapter, enabling a stable electrical connection between the electrode contact of the flexible electrode and the first wire contact of the connecting wire.

[0007] According to some embodiments of the present invention, the first wire contact is an annular structure, the electrode contact is disposed on the outer periphery of the first wire contact, and the conductive elastic bridging member abuts against and electrically connects the electrode contact and the first wire contact respectively.

[0008] According to some embodiments of the present invention, the conductive elastic bridging element is an annular conductive spring, and an annular groove is formed on the inner wall of the cavity, and the annular conductive spring is embedded in the annular groove; or the conductive elastic bridging element is a conductive spring sheet, and the conductive spring sheet is disposed on the inner wall of the cavity.

[0009] According to some embodiments of the present invention, the flexible electrode connection assembly further includes: a sealing element, the sealing element abutting against the outer peripheral surface of the support sleeve and the inner wall of the cavity respectively.

[0010] According to some embodiments of the present invention, the positioning part is coaxially disposed at the end of the support sleeve, and the cross-sectional area of ​​the positioning part is smaller than the cross-sectional area of ​​the end of the support sleeve.

[0011] According to some embodiments of the present invention, the interface contact portion of the first contact portion and / or the flexible electrode is provided with positioning marks.

[0012] According to some embodiments of the present invention, a locking component is provided at the opening of the adapter, the locking component being used to lock the adapter and the support sleeve.

[0013] According to some embodiments of the present invention, the connecting wire further includes a second contact portion, the second contact portion including at least one second wire contact, the second wire contact and the first wire contact being electrically connected through the conductive core wire.

[0014] According to some embodiments of the present invention, the flexible electrode further includes a connecting lead portion and a distal site portion. The connecting lead portion is provided with at least one connecting lead, and the distal site portion is provided with at least one electrode site. The electrode site is used to perform electrical stimulation and / or signal recording on the target tissue. The plurality of electrode sites are electrically connected to the plurality of electrode contacts in a one-to-one correspondence through the corresponding connecting lead.

[0015] According to some embodiments of the present invention, the flexible electrode has a layered structure, the flexible electrode includes a first insulating layer, a conductive layer and a second insulating layer arranged along its thickness direction; the electrode sites, the electrode contacts and the connecting leads are all disposed in the conductive layer; and / or the electrode sites and the electrode contacts are exposed through windows penetrating the first insulating layer and / or the second insulating layer; and / or the auxiliary assembly holes penetrate the first insulating layer and the second insulating layer.

[0016] According to some embodiments of the present invention, the first insulating layer and / or the second insulating layer comprises at least one of polyimide, parylene, polyurethane and silicone; and / or, the conductive layer comprises at least one of gold, platinum and iridium.

[0017] According to some embodiments of the present invention, the sealing element is a sealing ring, which is disposed on the inner wall of the cavity of the adapter, and the sealing ring forms a seal with the connecting wire and the flexible electrode.

[0018] According to some embodiments of the present invention, the sealing ring is disposed at least at the end near the opening of the adapter.

[0019] According to some embodiments of the present invention, the other end of the cavity of the adapter away from the opening is a sealed interface.

[0020] According to a second aspect of the present invention, a flexible electrode system includes: a flexible electrode connection assembly, wherein the flexible electrode connection assembly is the same as the flexible electrode connection assembly described in the first aspect of the present invention; and an implantable stimulator, wherein the implantable stimulator has a stimulation circuit and / or a signal acquisition and recording circuit internally; wherein a second contact portion of the connecting wire of the flexible electrode connection assembly is electrically connected to the implantable stimulator to transmit stimulation signals and / or physiological signals between the implantable stimulator and the flexible electrode.

[0021] According to some embodiments of the present invention, the implantable stimulator includes a sealed housing, a feedthrough, and a connector, wherein the second wire contact of the connecting wire is electrically connected to the feedthrough through the connector.

[0022] According to a third aspect of the present invention, a flexible electrode system includes: a flexible electrode connection assembly, wherein the flexible electrode connection assembly is the same as the flexible electrode connection assembly described in the first aspect of the present invention; an external stimulator, wherein the external stimulator is internally provided with a stimulation circuit and / or a signal acquisition and recording circuit; wherein the second contact portion of the connecting wire is electrically connected to the external stimulator to transmit stimulation signals and / or physiological signals between the external stimulator and the flexible electrode.

[0023] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0024] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which: Figure 1 This is a schematic diagram of a flexible electrode connection assembly according to an embodiment of the present invention; Figure 2 This is a cross-sectional view of a flexible electrode connection assembly according to an embodiment of the present invention; Figure 3 yes Figure 2 Enlarged view of part A shown in the center circle; Figure 4 This is a schematic diagram of the connection wires and flexible electrodes of the flexible electrode connection assembly according to an embodiment of the present invention; Figure 5 This is a schematic diagram of the connection wire and flexible electrode of the flexible electrode connection assembly according to an embodiment of the present invention, wherein the auxiliary assembly hole and the positioning part are not matched; Figure 6 This is a schematic diagram of the connecting wires of a flexible electrode connection assembly according to an embodiment of the present invention; Figure 7 This is a schematic diagram of a flexible electrode system according to an embodiment of the present invention.

[0025] Figure label: 100. Flexible electrode connection assembly; 1. Connecting wire; 10. Support sleeve; 11. First contact part; 111. First wire contact; 14. Positioning part; 15. Second contact part; 151. Second wire contact; 2. Flexible electrode; 21. Interface contact portion; 211. Electrode contact; 23. Auxiliary assembly hole; 24. Distal end point portion; 3. Adapter; 31. Cavity; 32. Opening; 33. Elastic element; 34. Conductive elastic bridging element; 35. Anti-rotation part; 4. Sealing components; 5. Locking assembly; 200. Flexible electrode system; 201. Implantable stimulator (external stimulator). Detailed Implementation

[0026] The following is for reference. Figures 1-7 A flexible electrode connection assembly 100 according to an embodiment of the first aspect of the present invention is described.

[0027] like Figures 1-7 As shown, the flexible electrode connection assembly 100 according to a first aspect embodiment of the present invention includes a connecting wire 1, a flexible electrode 2, and an adapter 3.

[0028] Specifically, the connecting wire 1 includes a support sleeve 10, on which a first contact portion 11 is provided. The first contact portion 11 includes at least one first wire contact 111. At least one conductive core wire is provided inside the support sleeve 10, with one end of the conductive core wire electrically connected to the first wire contact 111. A positioning portion 14 is provided at the end of the support sleeve 10 near the first contact portion 11. The flexible electrode 2 is provided with an interface contact portion 21, which includes at least one electrode contact 221. An auxiliary assembly hole 23 is provided at the end of the flexible electrode 2 near the interface contact portion 21. The auxiliary assembly hole 23 cooperates with the positioning portion 14 to achieve pre-assembly of the connecting wire 1 and the flexible electrode 2.

[0029] When the connecting wire 1 and the flexible electrode 2 are in a pre-assembled state, the interface contact part 21 is located on the outer peripheral surface of the first contact part 11, the electrode contact 221 faces away from the outer peripheral surface of the first contact part 11, the electrode contact 221 is arranged in a one-to-one correspondence with the first wire contact 111, and the first wire contact 111 is at least partially exposed and not covered by the electrode contact 221.

[0030] The adapter 3 has a cavity 31, and an opening 32 is formed at one axial end of the adapter 3. The cavity 31 communicates with the outside through the opening 32. At least one conductive elastic bridging member 34 is provided on the inner wall of the cavity 31 of the adapter 3.

[0031] The interface contact portion 21 of the flexible electrode 2 is located on the outer peripheral surface of the first contact portion 11 of the connecting wire 1, and the electrode contact 221 on the flexible electrode 2 faces away from the outer peripheral surface of the connecting wire 1.

[0032] During the assembly of the flexible electrode connection assembly 100, along the axial direction of the adapter 3, the first contact part 11 and the interface contact part 21 are inserted into the cavity 31 through the opening 32. Each conductive elastic bridge 34 simultaneously abuts against the corresponding electrode contact 221 and the first wire contact 111, so that the electrode contact 221 and the corresponding first wire contact 111 are electrically connected through the conductive elastic bridge 34.

[0033] For example, in Figure 1 and Figure 2 In the example, the electrode contact 221 on the flexible electrode 2 faces away from the outer peripheral surface of the connecting wire 1, and the first wire contact 111 is at least partially exposed and not covered by the electrode contact 221. This facilitates the exposure of the electrode contact 221 towards the conductive elastic bridge 34, reducing the distance between the conductive elastic bridge 34 and the electrode contact 221, thereby ensuring a stable electrical connection between the conductive elastic bridge 34 and the electrode contact 221. The support sleeve 10 is a hollow part with an axially extending receiving cavity inside, which can accommodate the insertion of at least one conductive core wire. The connecting wire 1 of this application has a built-in conductive core wire, providing a receiving space for the conductive core wire and making full use of the space of the support sleeve 10. The first contact portion 11 on the support sleeve 10 can be located at one end of the support sleeve 10, and at least one first wire contact 111 transmits electrical signals through the conductive core wire. The positioning part 14 at one end of the support sleeve 10 near the first contact part 11 is adapted to cooperate with the auxiliary assembly hole 23 of the flexible electrode 2, thereby completing the positioning of the flexible electrode 2 outside the support sleeve 10, so that when the connecting wire 1 is fed toward the cavity 31 of the adapter 3, one end of the interface contact part 21 of the connecting wire 1 and the flexible electrode 2 can enter the cavity 31 at the same time, realizing the synchronous delivery and assembly of the connecting wire 1 and the flexible electrode 2.

[0034] During the assembly of the flexible electrode connection assembly 100, the interface contact portion 21 on the flexible electrode 2 can be attached to the first contact portion 11 on the support sleeve 10, and form a positioning fit with the positioning portion 14 through the auxiliary assembly hole 23. The two are inserted into the cavity 31 of the adapter 3 together, so that the electrode contact 221 and the first wire contact 111 respectively abut against the inner wall of the adapter 3 and form an electrical connection.

[0035] Therefore, no additional independent pushing mechanism is needed, which simplifies the structure of the flexible electrode connection assembly 100. The flexible electrode 2 can be assembled with the adapter 3 along with the connecting wire 1. The assembly path is controllable, which helps to improve the assembly efficiency of the flexible electrode connection assembly 100. Specifically, through the modular extrusion fit between the connecting wire 1 and the adapter 3, quick and stable cross-electrode electrical conduction and sealing fixation between the connecting wire 1 and the flexible electrode 2 are achieved. The connecting wire 1 and the flexible electrode 2 are inserted together into the cavity 31 of the adapter 3 through the opening 32, so that the electrode contact 221 of the flexible electrode 2 and the first wire contact 111 of the connecting wire 1 can achieve a stable electrical connection.

[0036] For example, the other end of the conductive core wire can be electrically connected to the implanted stimulator 201 or the external stimulator 201.

[0037] Reference Figure 2 and Figure 3 The conductive elastic bridging element 34 electrically connects the electrode contact 221 on the flexible electrode 2 and the first wire contact 111 of the connecting wire 1. Thus, on the one hand, during axial feeding, the conductive elastic bridging element 34 can press the flexible electrode 2 against the outer surface of the connecting wire 1, thereby ensuring the flatness of the flexible electrode 2; on the other hand, the conductive elastic bridging element 34 facilitates the electrical connection between the electrode contact 221 of the flexible electrode 2 and the first wire contact 111 of the connecting wire 1, thereby achieving stable transmission of stimulation signals and / or physiological signals between the flexible electrode 2 and the connecting wire 1.

[0038] Optionally, refer to Figure 2 and Figure 3 Along the circumference of the support sleeve 10, the interface contact portion 21 of the flexible electrode 2 and the first contact portion 11 of the connecting wire 1 are spaced apart on the outer circumferential surface of the support sleeve 10. The conductive elastic bridging member 34 connects the interface contact portion 21 and the first contact portion 11 simultaneously. This helps to avoid mutual squeezing and interference between the interface contact portion 21 of the flexible electrode 2 and the first contact portion 11 of the connecting wire 1, and prevents scraping, stacking, and mutual squeezing deformation during the assembly and insertion into the cavity 31 of the adapter 3, thus protecting the structural integrity of the flexible electrode. At the same time, the spaced arrangement facilitates heat dissipation and reduces heat accumulation between the flexible electrode and the connecting wire 1.

[0039] When the flexible electrode connection assembly 100 is assembled, the interface contact portion 21 on the flexible electrode 2 can be attached to the first contact portion 11 on the support sleeve 10, and form a positioning fit with the positioning portion 14 through the auxiliary assembly hole 23. The two are inserted into the cavity 31 of the adapter 3 together. The electrode contact 221 of the flexible electrode 2 and the first wire contact 111 of the connecting wire 1 elastically abut against the corresponding conductive elastic bridge 34, so that the electrode contact 221 and the first wire contact 111 form an electrical connection.

[0040] According to an embodiment of the present invention, the flexible electrode connection assembly 100 has a conductive core wire, a first contact portion 11, and a positioning portion 14 directly disposed on the connecting wire 1. This structure is relatively simple and facilitates quick and stable cross-electrode electrical conduction and sealing fixation between the connecting wire 1 and the adapter 3 through modular compression fitting. The connecting wire 1 and the flexible electrode 2 are inserted together into the cavity 31 of the adapter 3 through the opening 32, enabling a stable electrical connection between the electrode contact 221 of the flexible electrode 2 and the first wire contact 111 of the connecting wire 1.

[0041] According to some embodiments of the present invention, with reference to Figure 2 and Figure 3 At least one elastic element 33 is provided on the inner wall of the cavity 31 of the adapter 3. The elastic element 33 can abut against the surface of the flexible electrode 2 away from the connecting wire 1. Thus, the deformation of the elastic element 33 can compensate for the assembly gap between the support sleeve 10 and the inner wall of the cavity 31 of the adapter 3, and can eliminate dimensional tolerances caused by part machining. The elastic element 33 can provide radial preload, increase the frictional resistance between the two, suppress axial movement and radial wobble between the flexible electrode 2 and the connecting wire 1, improve the coaxiality of the insertion fit, and at the same time buffer the displacement caused by vibration and impact, reducing the risk of loosening.

[0042] Furthermore, multiple elastic elements 33 can be arranged axially at intervals on the inner wall of the adapter 3. After the support sleeve 10, carrying the connecting wire 1 and the flexible electrode 2, is inserted, it simultaneously abuts against multiple elastic elements 33, forming multiple support and limiting segments along the axial direction. In the description of this invention, "multiple" means two or more. Thus, on the one hand, the machining tolerance between the support sleeve 10 and the adapter 3 can be compensated in segments, improving the coaxiality of the support sleeve 10 after insertion, effectively suppressing the radial swing and skew of the support sleeve 10; on the other hand, multiple positions jointly provide radial preload, increasing frictional resistance, further suppressing the axial movement between the flexible electrode 2 and the connecting wire 1, and enhancing the resistance to vibration and impact.

[0043] According to other embodiments of the present invention, refer to Figure 2 and Figure 3The first wire contact 111 has a ring-shaped structure, and the electrode contact 221 is disposed on the outer periphery of the first wire contact 111. The conductive elastic bridging member 34 abuts against and electrically connects the electrode contact 221 and the first wire contact 111 respectively. The ring-shaped first wire contact 111 facilitates the increase of electrical connection points, thereby reducing the assembly accuracy of the flexible electrode 2 in the circumferential direction of the support sleeve 10 and helping to improve the assembly efficiency of the flexible electrode connection assembly 100. When the flexible electrode 2 is fitted on the outer peripheral surface of the support sleeve 10, and the electrode contact 221 and the first wire contact 111 correspond, the conductive elastic bridging member 34, through its abutment against the electrode contact 221 and the first wire contact 111, helps to ensure the reliability and stability of the electrical connection between the electrode contact 221 and the first wire contact 111.

[0044] According to further embodiments of the present invention, with reference to Figure 2 and Figure 3 The conductive elastic bridging component 34 is a ring-shaped conductive spring. An annular groove is formed on the inner wall of the cavity 31, and the ring-shaped conductive spring is embedded in the annular groove. The annular groove positions the ring-shaped conductive spring to prevent it from shifting along the axial direction of the adapter 3 during the assembly of the support sleeve 10 into the adapter 3. This allows the ring-shaped conductive spring to wrap around and elastically cover or simultaneously connect the flexible electrode 2 and the connecting wire 1 after the support sleeve 10, flexible electrode 2, and connecting wire 1 are inserted into the adapter 3. This facilitates a stable electrical connection between the first interface contact 21 of the flexible electrode 2 and the second interface contact 21 of the connecting wire 1.

[0045] Furthermore, the annular conductive spring is an annular inclined coil spring.

[0046] According to some specific embodiments of the present invention, the conductive elastic bridging member 34 is a conductive spring sheet, which is disposed on the inner wall of the cavity 31. Each conductive spring sheet can independently correspond to and abut against the corresponding electrode contact 211 and the first wire contact 111, ensuring that each electrode contact 211 and the first wire contact 111 obtain sufficient clamping force and achieve a stable electrical connection.

[0047] The conductive spring can be arranged in a ring shape, enabling synchronous contact at multiple points around the circumference. This effectively increases the conductive contact area, forms multiple parallel conductive paths, reduces contact resistance, facilitates stable transmission of current or electrical signals, and reduces heat generation at the contact points. After the support sleeve 10, flexible electrode 2, and connecting wire 1 are inserted into the adapter 3, the ring-shaped conductive spring can wrap around and elastically cover or simultaneously connect the flexible electrode 2 and the connecting wire 1 from the circumference, facilitating the electrical connection between the electrode contact 221 and the first wire contact 111 via the conductive spring.

[0048] In addition, both the ring-shaped conductive spring and the conductive sheet have elastic compensation capabilities, which can compensate for the gap changes caused by component assembly tolerances and thermal expansion and contraction; under vibration conditions, they can maintain stable contact pressure and are not prone to contact loosening, signal jumps, or circuit failure.

[0049] According to some embodiments of the present invention, with reference to Figures 1-3 The flexible electrode connection assembly 100 further includes a sealing element 4. The sealing element 4 abuts against the outer peripheral surface of the support sleeve 10 and the inner wall of the cavity 31, respectively. The sealing element 4 can be sleeved on the outer periphery of the support sleeve 10 or disposed on the inner wall of the cavity 31. No specific limitation is made here. By tightly fitting against the outer peripheral surface of the support sleeve 10 and the inner wall of the cavity 31, the sealing element 4 achieves the sealing of the insertion gap. The sealing element 4, relying on its own elasticity to adapt to the insertion and assembly of the support sleeve 10, can compensate for the dimensional tolerances of the parts, while not affecting the normal insertion and removal of the support sleeve 10.

[0050] For example, the sealing element 4 can be a sealing ring sleeved on the support sleeve 10; or a sealing ring installed on the inner wall of the cavity 31; or the sealing element 4 can be an interference fit surface on the inner wall of the cavity 31. No specific limitation is made here.

[0051] According to some embodiments of the present invention, with reference to Figure 2 , Figure 3 , Figure 4 and Figure 6 The positioning part 14 is coaxially disposed at the end of the support sleeve 10, and the cross-sectional area of ​​the positioning part 14 is smaller than the cross-sectional area of ​​the end of the support sleeve 10. The positioning part 14 and the support sleeve 10 body are coaxially disposed, which can ensure the coaxiality of the positioning fit, avoid eccentricity and misalignment during assembly, and further improve the positioning accuracy and assembly stability.

[0052] For example, the positioning part 14 is a positioning protrusion that protrudes axially from the far end face of the support sleeve 10. The outer diameter of the positioning protrusion is in clearance fit with the diameter of the auxiliary assembly hole 23, which is conducive to realizing the radial positioning of the support sleeve 10 during the pre-assembly stage.

[0053] According to some embodiments of the present invention, the interface contact portion 21 of the first contact portion 11 and / or the flexible electrode 2 is provided with positioning marks (not shown in the figure). The support sleeve 10, the flexible electrode 2 and the connecting wire 1 extend axially into the cavity 31 of the adapter 3 for insertion assembly. The positioning marks can be used to determine whether the support sleeve 10, the flexible electrode 2 and the connecting wire 1 are properly inserted relative to the cavity 31 of the adapter 3, thereby realizing the identification and verification of the assembly position. This avoids assembly deviations such as the support sleeve 10, the flexible electrode 2 and the connecting wire 1 being inserted too deeply or not properly inserted, reduces the difficulty of judgment in manual assembly, improves assembly consistency, and reduces assembly failure problems caused by abnormal insertion positions.

[0054] According to some specific embodiments of the present invention, refer to Figure 2 and Figure 3 A locking component 5 is provided at the opening 32 of the adapter 3. The locking component 5 is used to lock the adapter 3 and the support sleeve 10. After the support sleeve 10, the flexible electrode 2 and the connecting wire 1 are inserted into the adapter 3, the locking component 5 is used to lock the adapter 3 and the support sleeve 10. This can limit the axial movement between the flexible electrode 2, the connecting wire 1 and the adapter 3, and prevent loosening or displacement due to vibration or external pulling force, which helps to improve the structural stability of the flexible electrode connection component 100.

[0055] For example, the locking component 5 can be constructed as a threaded locking structure, with an internal thread provided at the end of the adapter 3 away from the opening 32. The locking component 5 is screwed into the adapter 3 through threaded engagement. During the tightening process, the end of the locking component 5 can abut against the end face of the support sleeve 10 to achieve axial locking and fixation; or the locking component 5 can also be constructed as a radial clamping locking structure, which is fixed by clamping the outer periphery of the support sleeve 10. The specific structure can be adjusted according to the actual assembly requirements, and is not limited here.

[0056] In addition, it can be used in conjunction with the positioning mark to determine the position of the assembly before locking, ensuring that the assembly position is accurate before locking and improving the overall assembly accuracy and connection reliability.

[0057] According to some embodiments of the present invention, with reference to Figure 6 The connecting wire 1 also includes a second contact portion 15, which includes at least one second wire contact 151. The second wire contact 151 and the first wire contact 111 are electrically connected through a conductive core wire. The first wire contact 111 is disposed on one side of the flexible electrode 2 and is used to receive the electrical signal transmitted from the electrode site of the electrode 2. The conductive core wire establishes a conductive path between the first wire contact 111 and the second wire contact 151, enabling the electrical signal of the flexible electrode 2 to be led outward. Using a conductive core wire for conduction provides a certain deformation margin compared to direct hard contact, which can buffer the positional displacement caused by assembly errors and vibrations, and reduce the risk of contact failure. At the same time, the conductive core wire can realize long-distance signal transmission. The second wire contact 151 can be arranged in a position on the connecting wire 1 that is convenient for external connection, facilitating subsequent connection with external circuits and plug-in components to realize the output of electrical stimulation signals or the acquisition and transmission of physiological signals.

[0058] According to some embodiments of the present invention, with reference to Figure 3 and Figure 5The cavity 31 of the adapter 3 may be provided with an anti-rotation part 35 at its proximal end, and the positioning part 14 of the connecting wire 1 may engage with the anti-rotation part 35 after being inserted into the position. Optionally, the cross-sections of both the anti-rotation part 35 and the positioning part 14 of the connecting wire 1 may be non-circular, and the positioning part 14 of the support sleeve 10 may engage with the anti-rotation part 35 after being inserted into the position, so that the circumferential relative rotation between the support sleeve 10 and the adapter 3 after the insertion is completed.

[0059] Furthermore, the flexible electrode 2 has a layered structure, comprising a first insulating layer, a conductive layer, and a second insulating layer arranged along its thickness direction. This layered structure enhances the flexibility of the flexible electrode 2, helps reduce mechanical damage to human tissue, minimizes biological rejection, and ensures stable signal transmission. The conductive layer is sandwiched between the first and second insulating layers, protected on both sides. This prevents accidental leakage or short circuits on either side of the conductive layer and isolates it from external moisture and impurities. Furthermore, the layered structure provides excellent overall flexibility; when the electrode bends and deforms, the two insulating layers share the deformation stress, reducing the risk of breakage due to tension and improving the overall structural stability and lifespan of the flexible electrode 2.

[0060] The electrode sites, electrode contacts 221, and connecting leads are all located on the conductive layer. The electrode sites, electrode contacts 221, and connecting leads are integrated on the conductive layer, and the electrode sites and electrode contacts 221 are electrically connected through the connecting leads.

[0061] The electrode sites and the first electrode contact 221 are exposed through windows penetrating the first insulating layer and / or the second insulating layer. Only a portion of the conductive layer is exposed to form the electrode contact area (i.e., the electrode sites and the first electrode contact 221) for electrical signal interaction; the remaining portion of the conductive layer is completely covered and isolated by the first and second insulating layers. This ensures that the electrode contact area can normally complete signal acquisition or electrical stimulation output, while also providing insulation protection for non-working areas of the conductive layer, preventing leakage and short circuits at non-target locations. Simultaneously, it prevents moisture and corrosive media from intruding into the conductive layer, reducing oxidation and corrosion failure, and improving the safety and long-term stability of the flexible electrode 2.

[0062] The auxiliary assembly hole 23 penetrates the first insulating layer and the second insulating layer. During the assembly process of the flexible electrode 2, the auxiliary assembly hole 23 can cooperate with the positioning part 14 to achieve rapid alignment of the flexible electrode 2, which can limit the translation and rotational displacement of the flexible electrode 2 and improve the assembly position accuracy.

[0063] Optionally, the auxiliary assembly hole 23 may penetrate only the first and second insulating layers without passing through the conductive layer. This ensures the conductive layer remains intact, preventing damage to the internal conductive layer and avoiding open circuits and impedance abnormalities caused by holes in the conductive layer. Simultaneously, it helps ensure the insulation of the position that mates with the positioning part 14, preventing signal acquisition deviations.

[0064] Optionally, the auxiliary assembly hole 23 penetrates both the first and second insulating layers as well as the conductive layer. This provides positioning for the first, conductive, and second insulating layers, effectively suppressing interlayer slippage and misalignment, preventing relative displacement between the insulating and conductive layers, and ensuring the assembly position accuracy of the electrode contact area. Although the conductive layer is removed at the opening, the auxiliary assembly hole 23 is a non-conductive working area and will not disrupt the conductive path between the electrode sites and the electrode contacts 221 and the connecting leads. This allows for precise assembly positioning while avoiding signal anomalies caused by interlayer misalignment, improving the overall structural consistency of the assembled flexible electrode 2.

[0065] According to some embodiments of the present invention, the first insulating layer and / or the second insulating layer comprises at least one of polyimide, parylene, polyurethane, and silicone. Polyimide possesses excellent electrical insulation properties, thermal stability, and mechanical strength. The film can be processed to ultra-thin thickness, is resistant to repeated bending, has strong chemical corrosion resistance, can stably isolate the conductive lines of the flexible electrode 2, and its insulation performance is not easily degraded under high-temperature conditions. It can effectively prevent leakage and short circuits, improve the overall structural reliability of the electrode, and is suitable for the precision processing technology of the flexible electrode 2. Parylene can form a uniform and dense conformal insulating film through vapor deposition. The film layer is free of pinholes, has an outstanding water vapor barrier effect, high chemical inertness, and good insulation ability. It can comprehensively cover the electrode lines, inhibit the intrusion of water vapor and corrosive media into the electrode interior, reduce the risk of insulation failure, and has good bending performance, making it suitable for the insulating encapsulation of miniaturized flexible electrodes 2. Polyurethane elastomers combine flexibility with a certain degree of tensile strength, exhibiting good deformation adaptability. They are not prone to brittle fracture and detachment when bending or slightly stretched along with the electrode, demonstrating excellent adhesion to the electrode substrate. They also provide good insulation and barrier properties, resist flexural fatigue, buffer deformation stress, prevent delamination between the insulation and conductive layers, and improve the stability of the flexible electrode 2 under repeated deformation. Silicone, on the other hand, is soft, has a low modulus, and excellent deformation flexibility, allowing it to withstand large-angle bending deformations. It offers stable insulation performance, resistance to aging and damp heat, and good biocompatibility. It can protect the conductive areas of the electrode, reducing the risk of insulation layer cracking caused by external bending forces, making it suitable for insulation protection of the flexible electrode 2 in wearable and soft tissue contact scenarios.

[0066] Therefore, the above materials all possess excellent flexibility and bending resistance, and are not prone to cracking or falling off when repeatedly bent with the flexible electrode 2, thus maintaining the structural integrity of the first and second insulating layers; at the same time, they have good electrical insulation properties, avoiding leakage and short circuit problems; the materials have good chemical stability, are resistant to damp heat and environmental corrosion, which can reduce the risk of moisture and impurities entering the electrode, protect the conductive circuit, and improve the overall reliability and service life of the flexible electrode 2.

[0067] The conductive layer includes at least one of gold, platinum, and iridium. Gold exhibits excellent chemical stability, is resistant to oxidation and corrosion, possesses strong electrochemical inertness, excellent conductivity, and good ductility. During repeated bending and deformation of the flexible electrode 2, the conductive layer is less prone to breakage, resulting in stable contact impedance. It is also less prone to electrochemical side reactions, ensuring the stability of signal acquisition or electrical stimulation output, making it suitable for use as the conductive layer in precision flexible electrodes 2. Platinum possesses excellent conductivity and electrochemical stability, strong corrosion resistance, and is not easily corroded in complex environments such as humidity and bodily fluids. It has a wide electrochemical window, low polarization, and can reduce impedance drift between electrode interfaces, resulting in low signal distortion. It can maintain the performance of the conductive layer for a long time, improving the long-term reliability of the flexible electrode 2. Iridium has outstanding resistance to electrochemical corrosion, excellent oxidation resistance, moderate hardness, and good resistance to electrochemical ablation. Under cyclic electrical stimulation conditions, the conductive layer experiences minimal loss. It can form an iridium oxide active layer, effectively enhancing charge injection capability, reducing interfacial impedance, facilitating electrical signal output and acquisition, and extending the service life of the flexible electrode 2. Alloys formed from any one of gold, platinum, and iridium can combine the advantages of conductivity and corrosion resistance of single metals, while adjusting the mechanical properties of the material, improving film adhesion, and alleviating the problem of easy cracking when pure metal films are bent; they can also optimize electrochemical properties, inhibit metal layer migration and peeling, and balance conductivity, electrochemical stability and bending fatigue resistance, making them suitable for the long-term deformation use requirements of flexible electrodes 2.

[0068] Therefore, the aforementioned precious metals and their alloys exhibit excellent electrical conductivity, high electrochemical and chemical stability, and resistance to environmental corrosion. They can maintain the integrity of the conductive path and the stability of the interface impedance under bending deformation conditions, thereby reducing signal drift and material loss and ensuring the reliability of electrical signal acquisition or electrical stimulation output of the flexible electrode 2.

[0069] According to some embodiments of the present invention, the sealing element 4 is a sealing ring, which is disposed on the inner wall of the cavity 31 of the adapter 3, and the sealing ring forms a seal with the connecting wire 1 and the flexible electrode 2. The inner side of the sealing ring forms an interference fit with the outer periphery of the connecting wire 1 and the outer periphery of the flexible electrode 2, respectively, which can radially seal the insertion gap between the support sleeve 10 and the inner wall of the cavity 31 of the adapter 3, preventing external body fluids and impurities from seeping into the cavity 31 of the adapter 3, thereby avoiding water vapor and corrosive media from eroding the electrical connection parts in the cavity 31, reducing the risk of insulation failure and contact corrosion, and improving the long-term stability of the internal electrical connection structure.

[0070] Furthermore, the sealing ring is positioned at least at the end near the opening 32 of the adapter 3. Placing the sealing ring near the opening 32 allows for direct sealing at the opening of the support sleeve 10, minimizing the path for external impurities to penetrate and blocking the intrusion channel at the source. This further enhances the effectiveness of the sealing protection, preventing infiltrators from spreading along the insertion gap into the electrical connection area deep within the cavity 31. It is also more suitable for the complex fluid environment in implant-related scenarios, thus improving the reliability of the flexible electrode connection assembly 100.

[0071] According to other embodiments of the present invention, the end of the cavity 31 of the adapter 3 away from the opening 32 is a sealed interface. Thus, the sealed interface isolates the cavity 31 of the adapter 3 from the external environment, preventing direct contact between the electrical connection parts within the cavity 31 and the external environment, further enhancing the protective effect of the electrical connection structure. The sealed interface can be integrally formed with the body of the adapter 3, reducing the sealing risks associated with splicing and assembly, improving the overall integrity of the flexible electrode connection assembly 100, and simplifying the assembly process while achieving airtight protection.

[0072] According to a second aspect embodiment of the flexible electrode system 200, referring to Figure 7 The device includes: a flexible electrode connection assembly 100, which is the flexible electrode connection assembly 100 of the first aspect embodiment of the present invention described above; an implantable stimulator 201, which is provided with a stimulation circuit and / or a signal acquisition and recording circuit; wherein, the second contact portion 15 of the connecting wire 1 of the flexible electrode connection assembly 100 is electrically connected to the implantable stimulator 201 to transmit stimulation signals and / or physiological signals between the implantable stimulator 201 and the flexible electrode 2.

[0073] According to an embodiment of the present invention, the flexible electrode system 200 has a simple structure, reducing the number of complex multi-layered transition structures and welding points, thus lowering the manufacturing difficulty of the flexible electrode system 200 and the alignment difficulty during assembly. Simultaneously, a reliable and stable electrical connection between the flexible electrode connection component 100 and the implantable stimulator 201 ensures continuous signal conduction between the electrode site and the implantable stimulator 201, effectively suppressing problems such as contact impedance drift and open circuits. Whether for tissue electrical stimulation output or physiological electrical signal acquisition, the continuity and consistency of signal transmission are guaranteed. Therefore, the overall system component composition is simplified, reducing sources of failure, and ensuring stable performance of the flexible electrode system 200 even under bending, vibration, and body fluid immersion environments, thereby improving the overall reliability and service life of the flexible electrode system 200.

[0074] According to some embodiments of the present invention, the implantable stimulator 201 includes a sealed shell, a feedthrough, and a connector. The second contact portion 15 of the connecting wire 1 is electrically connected to the feedthrough through the connector. The second contact portion 15 serves as an intermediate transition point, achieving a transition connection between the conductive core wire and the feedthrough through the connector. This reduces the assembly stress caused by direct connection between the feedthrough and the flexible electrode 2, minimizes the risk of disconnection under vibration and deformation conditions, and ensures the stability of the electrical stimulation output and physiological signal acquisition pathway of the entire flexible electrode system 200.

[0075] Reference Figure 7 According to a third aspect of the present invention, a flexible electrode system 200 includes: a flexible electrode connection assembly 100, which is the same as the flexible electrode connection assembly 100 described in the first aspect of the present invention; an external stimulator 201, which has a stimulation circuit and / or a signal acquisition and recording circuit inside; wherein, the second contact portion 15 of the connecting wire 1 is electrically connected to the external stimulator 201 to transmit stimulation signals and / or physiological signals between the external stimulator 201 and the flexible electrode 2.

[0076] According to an embodiment of the flexible electrode system 200 of the present invention, the flexible electrode 2 is electrically connected to the external stimulator 201 via a connecting wire 1. For example, the electrical stimulation signal output by the external stimulator 201 can be transmitted to the flexible electrode 2 via the connecting wire 1, and the electrode site of the flexible electrode 2 acts on the target tissue to achieve electrical stimulation therapy; or, the tissue physiological electrical signal collected by the flexible electrode 2 can also be transmitted back to the external stimulator 201 via the connecting wire 1 to complete signal recording and analysis. The flexible electrode system 200 places the external stimulator 201 outside the body, eliminating the need for implanting a large circuit unit, simplifying the structure of the flexible electrode connection assembly 100, reducing the implantation volume and surgical difficulty, facilitating debugging, parameter adjustment and equipment maintenance, and improving the safety and practicality of the flexible electrode system 200.

[0077] Other configurations and operations of the flexible electrode connection assembly 100 and the flexible electrode system 200 according to embodiments of the present invention are known to those skilled in the art and will not be described in detail here.

[0078] In the description of this invention, it should be understood that the terms "center", "thickness", "upper", "lower", "front", "rear", "inner", "outer", "axial", "radial", "circumferential", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0079] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0080] In the description of this specification, references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example.

[0081] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A flexible electrode connection assembly (100), characterized in that, include: A connecting wire (1) is provided, the connecting wire (1) includes a support sleeve (10), the support sleeve (10) is provided with a first contact part (11), the first contact part (11) includes at least one first wire contact (111), the support sleeve (10) is provided with at least one conductive core wire, one end of the conductive core wire is electrically connected to the first wire contact (111), and the end of the support sleeve (10) near the first contact part (11) is provided with a positioning part (14). A flexible electrode (2) is provided with an interface contact portion (21), the interface contact portion (21) includes at least one electrode contact (211), and the flexible electrode (2) is provided with an auxiliary assembly hole (23) at the end near the interface contact portion (21). The auxiliary assembly hole (23) cooperates with the positioning portion (14) to realize the pre-assembly of the connecting wire (1) and the flexible electrode (2). When the connecting wire (1) and the flexible electrode (2) are in a pre-assembled state, the interface contact part (21) is provided on the outer peripheral surface of the first contact part (11), the electrode contact (211) faces away from the outer peripheral surface of the first contact part (11), the electrode contact (211) is provided in a one-to-one correspondence with the first wire contact (111), and the first wire contact (111) is at least partially exposed and not covered by the electrode contact (211); The adapter (3) has a cavity (31) and an opening (32) is formed at one axial end of the adapter (3). The cavity (31) communicates with the outside through the opening (32). At least one conductive elastic bridge (34) is provided on the inner wall of the cavity (31) of the adapter (3). During the assembly of the flexible electrode connection assembly (100), along the axial direction of the adapter (3), the first contact part (11) and the interface contact part (21) are inserted into the cavity (31) through the opening (32), and each of the conductive elastic bridges (34) simultaneously abuts against the corresponding electrode contact (211) and the first wire contact (111), so that the electrode contact (211) and the corresponding first wire contact (111) are electrically connected through the conductive elastic bridge (34).

2. The flexible electrode connection assembly (100) according to claim 1, characterized in that, The first wire contact (111) has a ring structure, and the electrode contact (211) is disposed on the outer periphery of the first wire contact (111). The conductive elastic bridge (34) abuts against and electrically connects the electrode contact (211) and the first wire contact (111).

3. The flexible electrode connection assembly (100) according to claim 1, characterized in that, The conductive elastic bridging element (34) is a ring-shaped conductive spring, and the inner wall of the cavity (31) is formed with a ring groove, in which the ring-shaped conductive spring is embedded; or, The conductive elastic bridging element (34) is a conductive spring sheet, which is disposed on the inner wall of the cavity (31).

4. The flexible electrode connection assembly (100) according to claim 1, characterized in that, Also includes: The sealing element (4) abuts against the outer peripheral surface of the support sleeve (10) and the inner wall of the cavity (31).

5. The flexible electrode connection assembly (100) according to claim 1, characterized in that, The positioning part (14) is coaxially disposed at the end of the support sleeve (10), and the cross-sectional area of ​​the positioning part (14) is smaller than the cross-sectional area of ​​the end of the support sleeve (10).

6. The flexible electrode connection assembly (100) according to claim 1, characterized in that, The interface contact portion (21) of the first contact portion (11) and / or the flexible electrode (2) is provided with positioning marks.

7. The flexible electrode connection assembly (100) according to claim 1, characterized in that, The adapter (3) has a locking component (5) at the opening (32) for locking the adapter (3) and the support sleeve (10).

8. The flexible electrode connection assembly (100) according to any one of claims 1-7, characterized in that, The connecting wire (1) further includes a second contact portion (15), the second contact portion (15) includes at least one second wire contact (151), and the second wire contact (151) and the first wire contact (111) are electrically connected through the conductive core wire.

9. The flexible electrode connection assembly (100) according to claim 1, characterized in that, The flexible electrode (2) further includes a connecting lead portion and a distal site portion (24). The connecting lead portion is provided with at least one connecting lead, and the distal site portion (24) is provided with at least one electrode site. The electrode site is used to perform electrical stimulation and / or signal recording on the target tissue. Multiple electrode sites are electrically connected to multiple electrode contacts (211) in a one-to-one correspondence through the corresponding connecting lead.

10. The flexible electrode connection assembly (100) according to claim 9, characterized in that, The flexible electrode (2) has a layered structure, and the flexible electrode (2) includes a first insulating layer, a conductive layer and a second insulating layer arranged along its thickness direction; The electrode sites, the electrode contacts (211), and the connecting leads are all located in the conductive layer; And / or, The electrode sites and the electrode contacts (211) are exposed through windows penetrating the first insulating layer and / or the second insulating layer; and / or, The auxiliary assembly hole (23) penetrates the first insulating layer and the second insulating layer.

11. The flexible electrode connection assembly (100) according to claim 10, characterized in that, The first insulating layer and / or the second insulating layer comprises at least one of polyimide, parylene, polyurethane, and silicone; and / or, The conductive layer includes at least one of gold, platinum, and iridium.

12. The flexible electrode connection assembly (100) according to claim 4, characterized in that, The sealing element (4) is a sealing ring, which is disposed on the inner wall of the cavity (31) of the adapter (3), and the sealing ring forms a seal with the connecting wire (1) and the flexible electrode (2).

13. The flexible electrode connection assembly (100) according to claim 12, characterized in that, The sealing ring is provided at least at the end near the opening (32) of the adapter (3).

14. The flexible electrode connection assembly (100) according to claim 1, characterized in that, The cavity (31) of the adapter (3) is a sealed interface at the other end away from the opening (32).

15. A flexible electrode system (200), characterized in that, include: Flexible electrode connection assembly (100), wherein the flexible electrode connection assembly (100) is any one of claims 1-14. An implantable stimulator (201) is provided with a stimulation circuit and / or a signal acquisition and recording circuit inside; wherein, the second contact portion (15) of the connecting wire (1) of the flexible electrode connection assembly (100) is electrically connected to the implantable stimulator (201) to transmit stimulation signals and / or physiological signals between the implantable stimulator (201) and the flexible electrode (2).

16. The flexible electrode system (200) according to claim 15, characterized in that, The implantable stimulator (201) includes a sealed housing, a feeder, and a connector, wherein the second contact portion (15) of the connecting wire (1) is electrically connected to the feeder through the connector.

17. A flexible electrode system (200), characterized in that, include: Flexible electrode connection assembly (100), wherein the flexible electrode connection assembly (100) is any one of claims 1-14. An external stimulator (201) is provided with a stimulation circuit and / or a signal acquisition and recording circuit inside; wherein, the second contact part (15) of the connecting wire (1) is electrically connected to the external stimulator (201) to transmit stimulation signals and / or physiological signals between the external stimulator (201) and the flexible electrode (2).

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