A flexible neural electrode assembly

Abstract

The present application provides a flexible neural electrode assembly, including a flexible neural electrode and an outer tube. The lead connection portion of the flexible neural electrode is accommodated in the cavity of the outer tube in a buckled state. The proximal end of the outer tube is fixedly connected to the proximal side of the flexible neural electrode. The outer tube includes an outer tube anchor capable of fixing the distal end of the outer tube to the target area, and the distal side of the outer tube is not bound to the distal side of the flexible neural electrode. There is a relatively movable space between the inner wall of the cavity of the outer tube accommodating the lead connection portion and the lead connection portion. The outer tube is axially elastic and its length is shorter than the length of the lead connection portion. The degree of buckling of the lead connection portion under the stressed state of the outer tube is less than that under the unstressed state of the outer tube. Through the synergistic effect of the outer tube and the electrode, the present application improves the overall stability of the assembly in a dynamic environment, providing a new solution for the long-term and safe use of implantable neural electrodes.

Description

Technical Field

[0001] This application belongs to the technical field of neuromodulation and implantable medical devices, and particularly relates to a flexible nerve electrode assembly. Background Art

[0002] In the fields of nerve stimulation, nerve signal acquisition, and the treatment of related chronic diseases and nerve rehabilitation, during the long-term use of implantable nerve electrode assemblies after implantation, key technical problems that have not been well solved include electrode displacement and fatigue damage of electrode materials caused by the dynamic activities of the implanted tissues.

[0003] In some prior art studies, attempts have been made to improve biocompatibility and mechanical protection through the flexibility of electrode materials or structural design, but the problem of electrode displacement caused by tissue dynamic activities has not been solved. In some other prior arts, anchoring members for fixation are further provided for the flexible electrode itself, increasing the mechanical adhesion between the electrode and the tissue, but the deformation adaptability of the electrode in a dynamic environment is ignored, resulting in the direct exposure of the electrode material to stress concentration positions and the inability to cope with the stress accumulation problem caused by the dynamic tissue environment. The resulting electrode fatigue damage problem has not been solved. Additionally, in some studies, although the nerve electrode has a deformable sleeve, there is a lack of global optimization of the mechanical response during long-term implantation, and the matching between the electrode and the sleeve in a dynamic environment has not been deeply studied. Therefore, it is impossible to effectively avoid mechanical damage and material fatigue damage of the electrode in a long-term implantation environment with frequent tissue activities.

[0004] It can be seen that currently, no technical solution has been found that can enable the flexible electrode to overcome the adverse factors such as electrode displacement and fatigue damage caused by tissue activities, and can work more effectively and safely during long-term implantation. Summary of the Invention

[0005] This application is proposed to solve the above problems existing in the prior art.

[0006] The purpose of this application is to provide a flexible nerve electrode assembly, which through the collaborative design of the flexible nerve electrode and the outer tube, can enable the flexible electrode to overcome electrode displacement, fatigue damage and even failure caused by tissue activities, as well as the adverse factors such as possible mechanical damage between the flexible nerve electrode and the outer tube, so that the flexible nerve electrode assembly can work more effectively and safely during long-term implantation.

[0007] According to a first aspect of the present application, there is provided a flexible neural electrode assembly, including a flexible neural electrode and an outer tube. Wherein, the flexible neural electrode is successively provided with a proximal contact part, a lead connection part, a distal electrode site part, and a distal auxiliary implantation part from near to far; the lead connection part is accommodated in the cavity of the outer tube in a buckled state; the proximal contact part and the distal electrode site part are electrically connected via the lead connection part; the proximal end of the outer tube is fixedly connected to the proximal side of the flexible neural electrode, and the outer tube includes an outer tube anchor for fixing the distal end of the outer tube in the target area, and the distal side of the outer tube is not bound to the distal side of the flexible neural electrode; the outer tube has a cavity for accommodating the lead connection part, and there is a relatively movable space between the inner wall of the cavity and the lead connection part; the outer tube has elasticity in the axial direction; the length of the outer tube is shorter than the length of the lead connection part; the degree of buckling of the lead connection part under the force of the outer tube is less than its degree of buckling in the state where the outer tube is not stressed.

[0008] For the flexible neural electrode assembly according to various embodiments of the present application, through the collaborative design of the flexible neural electrode and the outer tube, especially by accommodating the lead connection part of the flexible neural electrode in the cavity of the elastic outer tube in a buckled state, when the outer tube is deformed by force, the lead connection part can release its reserved deformation amount by changing the degree of buckling to avoid the displacement of the flexible neural electrode or the accumulation of stress. Thus, the risk of displacement, fatigue damage and even failure of the flexible neural electrode can be significantly reduced, and the stability and reliability of the long-term implantation of the flexible neural electrode assembly in the tissue can be improved. Brief Description of the Drawings

[0009] In the drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar components in different views. The same reference numerals with alphabetical suffixes or different alphabetical suffixes may represent different instances of similar components. The drawings generally illustrate various embodiments by way of example and not limitation, and are used together with the description and the claims to explain the disclosed embodiments. Where appropriate, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the device or method.

[0010] Figure 1 The schematic diagram of the partial composition structure of the flexible neural electrode assembly according to the embodiment of the present application is shown.

[0011] Figure 2 The schematic diagram of another composition structure of the flexible neural electrode assembly according to the embodiment of the present application is shown.

[0012] Figure 3(a) shows the schematic diagram of preparing to implant the proximal end of the flexible neural electrode into the target site by using the implant traction piece according to the embodiment of the present application.

[0013] FIG. 3(b) shows a schematic diagram of the proximal end of a flexible nerve electrode implanted into a target site according to an embodiment of the present application.

[0014] FIG. 3(c) shows a schematic diagram of implanting the proximal end of a flexible nerve electrode together with a stimulator into a target site and the implanting traction member being withdrawn from the target site according to an embodiment of the present application.

[0015] Figure 4 Shows a schematic diagram of a stimulator connected to the proximal contact portion of a flexible nerve electrode according to an embodiment of the present application.

[0016] Figure 5 Shows a schematic diagram of a processing method of a flexible nerve electrode assembly according to an embodiment of the present application.

[0017] Figure 6 Shows a schematic diagram of an implantation method of a flexible nerve electrode assembly according to an embodiment of the present application.

[0018] 1. Flexible nerve electrode assembly; 11. Flexible nerve electrode; 111. Proximal contact portion; 112. Lead connection portion; 113. Distal electrode site portion; 114. Distal auxiliary implantation portion; 115. Electrode anchor; 116. Proximal clamping member; 117. Proximal auxiliary fixing portion; 12. Outer tube; 121. Cavity of outer tube 12; 122. Outer tube anchor; 123. Proximal card slot of outer tube; 13. Implanting traction member; 131. Distal traction portion; 132. Auxiliary implantation needle tube; 133. Auxiliary implantation needle core; 14. Auxiliary fixing member; 15. Auxiliary limiting sheath; 16. Auxiliary puncture sheath; 17. Stimulator; 171. Feedthrough; 18. External programmer; 181. Wireless communication module; 182. Wireless charging module; 401. First flexible insulating layer; 402. First metal conductive layer; 403. Second flexible insulating layer; 404. Second metal conductive layer; 405. Third flexible insulating layer. Detailed Embodiments

[0019] To enable those skilled in the art to better understand the technical solutions of the present disclosure, the present disclosure will be described in detail below with reference to the accompanying drawings and specific embodiments. The embodiments of the present disclosure will be further described in detail below with reference to the accompanying drawings and specific examples, but shall not be construed as a limitation to the present disclosure.

[0020] In this application, the terms "first", "second" and similar terms do not denote any order, quantity or importance, but are only used to distinguish different parts. The expressions "first" and "second" are only numbered for convenience of expression, and do not aim to imply that the "first component" and the "second component" must have different physical properties. In fact, the "first component" and the "second component" may have the same or different structures, which are not limited herein, as long as the "first component" and the "second component" are discrete components. Further, when sufficient explanation is given in the context, the "first component" and the "second component" may not even be discrete components, may be integrated into the same component, or may be replaceable with each other.

[0021] In this application, when it is described that a specific device is located between a first device and a second device, there may or may not be an intermediate device between the specific device and the first device or the second device. When it is described that a specific device is connected to other devices, the specific device may be directly connected to the other devices without an intermediate device, or may not be directly connected to the other devices and have an intermediate device.

[0022] Words such as "comprising" or "including" mean that the elements before this word are covered by the elements listed after this word, and do not exclude the possibility of also covering other elements. "Up", "down", "left", "right", etc. are only used to represent relative position relationships. When the absolute position of the object being described changes, the relative position relationship may also change accordingly.

[0023] In this application, the terms "proximal" and "proximal side" are intended to represent the side close to the operator (such as a doctor) performing the implantation operation, while the terms "distal" and "distal side" are intended to represent the side close to the target position of the flexible nerve electrode to be implanted.

[0024] According to an embodiment of the present application, a flexible nerve electrode assembly is provided. Figure 1 A partial component structure diagram of a flexible nerve electrode assembly according to an embodiment of the present application is shown.

[0025] As Figure 1 shown, the flexible nerve electrode assembly 1 at least includes a flexible nerve electrode 11 and an outer tube 12. Among them, the flexible nerve electrode 11 is sequentially provided with a proximal contact part 111, a lead connection part 112, a distal electrode site part 113 and a distal auxiliary implantation part 114 from proximal to distal. The lead connection part 112 is accommodated in the cavity 121 of the outer tube 12 in a bent state, and the proximal contact part 111 and the distal electrode site part 113 are electrically connected via the lead connection part 112.

[0026] As Figure 1As shown, the proximal end of the outer tube 12 is fixedly connected to the proximal side of the flexible nerve electrode 11, and the proximal contact part 111 penetrates out of the proximal end of the outer tube 12. The outer tube 12 further includes an outer tube anchor 122 for fixing the distal end of the outer tube 12 to the target area. Wherein, the outer tube anchor 122 can be a spiky structure and / or a hollow structure, or other structures that facilitate the fixation of the outer tube 12 to the target tissue. The present application does not limit this. The maximum diameter range of the outer tube anchor 122 can be set between 0.1 mm and 10 mm, and the number can be 1 to 100. The outer tube anchor 122 can exist alone on the outside of the rigid tube part or the outside of the flexible hose part, or can exist simultaneously on the outside of the rigid tube part and the outside of the flexible hose part. The spiky structure of the outer tube anchor 122 is used to penetrate into the surface or inside of the target tissue to provide additional mechanical grasping force, and the hollow structure further improves the fixation performance of the outer tube 12 through the interlaced engagement with the target tissue. Only as an example, the spiky structure can be conical or needle-shaped, and the hollow structure can be designed as polygonal, curved or grid-shaped, etc. The combined design of the spiky and hollow structures can provide more flexible adaptability and reliable fixation performance in different tissue environments.

[0027] In addition, the distal ends of the outer tube 12 and the flexible nerve electrode 11 are not bound to each other. The outer tube 12 has a cavity 121 for accommodating the lead connection part, and there is a relatively movable space between the inner wall of the cavity 121 and the lead connection part 112. That is to say, the outer tube 12 does not tightly wrap around the outer layer of the lead connection part 112 so that the two cannot move relatively freely, or generate a large mechanical friction when moving relatively. In addition, the axial direction of the outer tube 12 has elasticity, so it can be axially stretched and elongated under the force state. And, whether in the force state or in the non-force state, the length of the outer tube 12 is shorter than the length of the lead connection part 112. Thus, it can be ensured that in both states, the distal electrode site part 113 can always penetrate out of the distal end of the outer tube 12 and be exposed to the target area, and the lead connection part 112 can always maintain a buckled state in the cavity 121. It can be understood that the outer tube 12 will become longer under the force state. Therefore, the degree of buckling of the lead connection part 112 under the force state of the outer tube 12 will be less than its degree of buckling under the non-force state of the outer tube 12.

[0028] According to the flexible neural electrode assembly 1 of the embodiments of the present application, when tissue activity causes stress to concentrate at the outer tube 12 and the lead connection part 112, on the one hand, the outer tube 12 can absorb the concentrated stress through elastic deformation. On the other hand, when the outer tube 12 is stressed and expands, contracts or deforms, the lead connection part 112 in the cavity 121 can release the deformation amount it has stored. The buckling degree will be reduced, but it will not be straightened to cause stress on itself, thus avoiding electrode damage and functional failure caused by excessive stretching, and will not transfer stress to the distal electrode site part 113, showing good adaptability and durability in a dynamic tissue environment. The coordinated setting of the outer tube 12 and the flexible neural electrode 11 in the embodiments of the present application enables the stress generated by tissue activity not to have an obvious impact on the lead connection part 112 or the distal electrode site part 113, and can significantly reduce the risk of displacement, fatigue damage and even failure of the flexible neural electrode 11, improving the stability and reliability of the long-term implantation of the flexible neural electrode assembly 1 in tissue. In addition, since the distal side of the outer tube 12 is not bound to the distal side of the flexible neural electrode 11 and they can move relative to each other, the flexible neural electrode 11 can maintain a high degree of flexibility in a dynamic tissue environment, reducing the problem of stress concentration caused by external forces. In some embodiments, the distal movable range of the flexible neural electrode 11 is not less than 5 millimeters to ensure that during the deformation process of the outer tube 12 under tension and compression, the flexible neural electrode 11 can fully release the stored deformation amount through the change of the buckling degree, further reducing the risk of electrode fatigue damage that may be caused by stress concentration.

[0029] In some embodiments, the outer tube 12 can be a composite structure, assembled from an elastic hose part near the proximal end and a rigid tube part near the distal end. The rigid tube part can provide additional mechanical support and facilitate the setting of the outer tube anchor 122 on the rigid tube part to prevent accidental displacement of the distal end of the outer tube 12 in the tissue; the elastic hose part has elasticity in the axial direction so that the outer tube 12 can be axially stretched and elastically deformed when subjected to a force from the target tissue. Since the outer tube anchor 122 fixes the distal end of the outer tube 12 to the target area, therefore, whether the rigid tube part or the elastic hose part of the outer tube 12 is subjected to an external force exerted by the tissue, it can be converted into the elastic deformation of the elastic hose part. In this case, it will drive the lead connection part 112 to freely slide in the cavity 121. During the sliding process, the buckling degree may change, but it always remains in a buckled state.

[0030] In some embodiments, the overall maximum tensile rate of the outer tube 12 in the axial direction can be set in combination with the activity level of the tissue to be implanted with the flexible nerve electrode assembly 1. For example, in the case of implanting the sacral nerve, the maximum tensile rate can be set to not less than 10%. Taking the flexible nerve electrode assembly 1 to be used as a sacral nerve stimulation electrode as an example only, its typical implantation positions include skin, muscle, and ligament, etc. These tissues will generate large dynamic deformations due to patient activities (such as walking or sitting). Therefore, in this case, the maximum tensile rate of the outer tube 12 in the axial direction needs to be not less than 10% in order to adapt to the movement amplitude of these tissues and avoid excessive stress on each part of the electrode assembly. When the flexible nerve electrode assembly 1 is used as a spinal cord stimulation electrode, since the activities of the tissues around the spinal cord are small, the maximum tensile rate of the outer tube 12 can be appropriately reduced, which will not be listed one by one here. When the length of the outer tube 12 is basically determined (usually limited by the specific implantation site), its overall tensile rate is related to the proportion of the elastic hose part and the tensile rate of the elastic hose part material itself. When co-designing the above two parameters, the factors to be considered include the flexibility and strength of the outer tube 12. Specifically, the higher the proportion of the elastic hose part, the better the flexibility, the stronger the tensile ability, and it can better adapt to the deformation of dynamic tissues. However, on the other hand, it may be more likely to cause the outer tube 12 to slide or shift in the tissue due to insufficient stability and anchoring effect. On the contrary, a higher proportion of the rigid tube part can enhance the anchoring force of the outer tube 12, but the overall tensile ability of the outer tube 12 will be correspondingly reduced, and it is more difficult to adapt to the dynamic changes of the target tissue. Therefore, it is necessary to appropriately set the proportion of the elastic hose part and the rigid tube part, and correspondingly set the maximum tensile rate of the required elastic hose part, so that the outer tube 12 has overall stability and also ensures the overall maximum tensile rate such as 10%. In some other embodiments, for example, in the connection area of muscle and ligament, when the movement amplitude of the tissue is large, the proportion of the elastic hose part can be appropriately reduced and the proportion of the rigid tube part can be increased, so as to improve the anchoring force of the outer tube 12 and reduce the fatigue risk caused by relative movement between tissues. In adipose tissue or muscle parts with small activities, the proportion of the elastic hose part can be appropriately increased to enhance the elastic adaptability and reduce the risk of stress concentration at the implantation site. The above design can maximize the stability and durability of the outer tube in different tissue environments. Only as an example, usually, the length ratio of the elastic hose part and the rigid tube part can be set between 1:1 and 100:1 as needed, and in combination with the total length of the outer tube 12, the elastic hose is synergistically set to have a maximum tensile rate not less than the first ratio in the axial direction, so that the maximum tensile rate of the outer tube 12 in the axial direction is not less than the overall maximum tensile rate such as 10%. The specific value of the first ratio can be determined by means such as calculation, simulation, and experiment, and this application does not limit this.

[0031] In some embodiments, in order to implant the flexible nerve electrode assembly 1 into a target tissue, such as Figure 2 shown, the flexible nerve electrode assembly 1 may further include an implantation traction member 13. The distal end of the implantation traction member 13 is configured with a distal traction portion 131, and the distal traction portion 131 is detachably connected to the distal auxiliary implantation portion 114 of the flexible nerve electrode 11 and is used to guide the distal end of the flexible nerve electrode 11 to the target area.

[0032] In some embodiments, such as Figure 2 shown, the implantation traction member 13 may be located inside the cavity 121 of the outer tube 12 during the implantation process. In this case, the implantation traction member 13 passes through the inside of the cavity 121 until the distal end of the implantation traction member 13 extends out from the distal end of the outer tube 12 to guide the distal end of the flexible nerve electrode 11 to the target area.

[0033] In other embodiments, the implantation traction member 13 may also assist in completing the implantation process of the flexible nerve electrode 11 from the outside of the cavity 121 (not shown). This method can simplify the structure inside the flexible nerve electrode assembly 1 and reduce potential interference.

[0034] In other embodiments, the flexible nerve electrode assembly 1 further includes an auxiliary fixing member 14. The auxiliary fixing member 14 is fixedly connected to the implantation traction member 13 and the outer tube 12 in a detachable manner. Especially when the implantation traction member 13 is located outside the outer tube 12 during the implantation process, the flexible nerve electrode assembly 11 is temporarily fixed by a mechanical connection method, and after the distal end of the flexible nerve electrode 11 reaches the target area, the fixed connection between the implantation traction member 13 and the outer tube 12 is removed.

[0035] Furthermore, the flexible nerve electrode assembly 1 may further include an auxiliary limiting sheath 15 detachably connected to the outer tube 12 and / or the implantation traction member 13. The auxiliary limiting sheath 15 is used to limit and precisely control the depth of the flexible nerve electrode assembly 11 in the target tissue, and the auxiliary limiting sheath 15 is matched with the structures of the outer tube 12 and the flexible nerve electrode 11, and can provide the required positioning function in the target tissue and be removed from the outer tube 12 and / or the implantation traction member 13 and withdrawn from the target tissue after the distal end of the flexible nerve electrode 11 reaches the target area. Optionally, the auxiliary fixing member 14 and the auxiliary limiting sheath 15 form an integral structure, thereby simplifying the operation process of the implantation process and improving the overall stability of the flexible nerve electrode assembly 1.

[0036] Under normal circumstances, the drift of the distal electrode site portion 113 is physically limited by the range of tissue activity. Experimental results show that the actual drift amount is much smaller than the maximum stretching range of the outer tube 12, and the buckling form of the lead connection portion 112 provides sufficient deformation margin to effectively absorb the stress caused by the drift, thus ensuring the integrity and functionality of the lead connection portion 112, as well as the risk of failure of the flexible neural electrode assembly 1 due to stress concentration in a dynamic environment. However, in some specific implantation environments, such as when the tissue dynamics is relatively strong, an electrode anchor 115 may also be included between the lead connection portion 112 and the distal electrode site portion 113. By way of example only, it may have a spiky structure and / or a hollow structure to fix the distal end of the flexible neural electrode 11 to the target area and reduce the drift risk. The spiky structure can penetrate into the target tissue to enhance the anchoring force, and the hollow structure further increases the anchoring stability by closely contacting the target tissue. As Figure 1 and Figure 2 shown, the electrode anchor 115 extends from the distal end of the outer tube 12 and forms an integral structure with the distal end of the flexible neural electrode 11. The electrode anchor 115 can maintain the stability of the flexible neural electrode assembly 1 after implantation. The outer tube anchor 122 of the outer tube 12 and the electrode anchor 115 of the flexible neural electrode 11 form a double-anchoring structure, which can effectively improve the stability of the flexible neural electrode assembly 1 in a dynamic biological environment, and at the same time can effectively avoid electrode material fatigue and reduce the displacement risk caused by tissue activity.

[0037] As Figure 2 shown, a proximal clamping member 116 is also provided between the proximal contact portion 111 and the lead connection portion 112 of the flexible neural electrode 11. The proximal clamping member 116 is tightly fitted into the proximal end of the outer tube 12 to achieve a fixed connection between the proximal side of the flexible neural electrode 11 and the proximal end of the outer tube 12. Preferably, the proximal clamping member 116 and the flexible neural electrode 11 form an integral structure. By way of example only, the proximal clamping member 116 can be set as an elastic member. After the outer tube 12 is stretched, the proximal clamping member 116 is deformed by the force and tightly fitted into the proximal end of the cavity 121 of the outer tube 12, and the elastic restoring force of the proximal clamping member 116 is used to ensure the fixed connection between the proximal side of the flexible neural electrode 11 and the proximal end of the outer tube 12. The above design not only enhances the overall stability of the flexible neural electrode 11 and the outer tube 12, but also provides precise positioning support during the implantation operation, reducing the implantation deviation caused by sliding or detachment.

[0038] More specifically, the operation of stretching the outer tube 12 not only facilitates the insertion of the proximal clamping member 116, but also effectively reduces the force required for the proximal clamping member 116 to deform, thus optimizing the convenience of the implantation operation.

[0039] In some other embodiments, a proximal slot 123 is further provided at the proximal end of the outer tube 12 for matingly receiving the proximal engaging member 116 of the flexible nerve electrode 11 and increasing the stability of the fixed connection between the proximal side of the flexible nerve electrode 11 and the proximal end of the outer tube 12. More specifically, the specific form of the proximal engaging member 116 may include, for example, an elastic ring, a slot structure, or other design forms suitable for being fixedly engaged with the proximal slot 123 of the outer tube. The shape and size of the proximal slot 123 of the outer tube are closely matched with the structure of the proximal engaging member 116. After the distal end of the flexible nerve electrode 11 is implanted, the proximal engaging member 116 and the proximal slot 123 of the outer tube are inserted and locked, thereby realizing a stable connection between the proximal side of the flexible nerve electrode 11 and the proximal end of the outer tube 12, and significantly reducing the risk of sliding or loosening of the proximal end of the flexible nerve electrode 11 at the proximal position of the outer tube 12. Through the above design, while providing high-strength mechanical fixation, the proximal connection of the flexible nerve electrode assembly 1 can also adapt to the stress generated by the dynamic deformation of the outer tube 12 on the connection part, thereby further improving the adaptability and reliability of the overall assembly in a complex biological environment.

[0040] As Figure 2 shown, in some embodiments, the distal auxiliary implantation portion 114 of the flexible nerve electrode 11 can be implemented as a distal auxiliary implantation hole, and the implantation traction member 13 includes an auxiliary implantation needle tube 132 and an auxiliary implantation needle core 133. A cavity is provided in the auxiliary implantation needle tube 132 to accommodate the auxiliary implantation needle core 133, and the balance between connection strength and disassembly convenience is ensured through structural design. More specifically, the connection and disassembly of the auxiliary implantation needle tube 132 and the auxiliary implantation needle core 133 can be achieved through precisely matched structural dimensions. For example, the inner diameter of the auxiliary implantation needle tube 132 is designed to be slightly larger than the cross-sectional diameter of the auxiliary implantation needle core 133, so as to ensure that the auxiliary implantation needle core 133 can slide smoothly while maintaining the same angle as the auxiliary implantation needle tube 132; the length of the auxiliary implantation needle core 133 can be designed to be slightly longer than the length of the auxiliary implantation needle tube 132, so that it can expose enough protruding part during operation to facilitate quick disassembly by applying an external force.

[0041] In some embodiments, the distal traction portion 131 and the distal auxiliary implantation portion 114 of the flexible nerve electrode 11 are detachably connected in the following manner: the auxiliary implantation needle core 133 passes through the distal end of the auxiliary implantation needle tube 132 and is inserted into the distal auxiliary implantation hole of the flexible nerve electrode 11, thereby realizing the detachable connection between the distal traction portion 131 and the distal end of the flexible nerve electrode 11. This connection method, through the rigidity of the auxiliary implantation needle core 133 and the precise dimensional fit of the distal auxiliary implantation hole, enables the distal end of the flexible nerve electrode 11 to accurately reach the target area under the guidance of the implantation traction member 13.

[0042] In some other embodiments, the distal traction portion 131 and the distal auxiliary implantation portion 114 of the flexible nerve electrode 11 are detachably connected in the following manner: the distal end of the auxiliary implantation needle tube 132 is provided with a side opening, and the auxiliary implantation needle core 133 passes through the side opening at the distal end of the auxiliary implantation needle tube 132 and through the distal auxiliary implantation hole of the flexible nerve electrode 11, realizing the detachable connection between the distal traction portion 131 and the distal end of the flexible nerve electrode 11, and at the same time providing a more flexible connection method.

[0043] In some other embodiments, the distal auxiliary implantation portion 114 of the flexible nerve electrode 11 is implemented as a distal auxiliary implantation groove for providing a connection site during the implantation process, and the distal traction portion 131 is further configured with a distal clamping member (not shown). In this case, the distal traction portion 131 and the distal auxiliary implantation portion 114 are detachably connected in the following manner: the distal clamping member of the distal traction portion 131 and the distal auxiliary implantation groove form a snap connection structure, thereby realizing the detachable connection between the distal traction portion 131 and the distal end of the flexible nerve electrode 11. The above connection method can ensure the convenience, operation accuracy and stability during the implantation operation, and is also convenient for quick disassembly and removal after the implantation is completed.

[0044] The diameter range of the implantation traction member 13 is set to 0.001 mm to 3 mm, and the maximum diameter of the distal auxiliary implantation hole or the distal auxiliary implantation groove is 0.002 mm to 2 mm, ensuring sufficient connection strength without affecting the smoothness of the implantation process. The implantation traction member 13 can be removed from the flexible nerve electrode assembly 1 after the implantation is completed, without affecting the stability of the flexible nerve electrode 11 and the outer tube 12 in the target tissue.

[0045] In some embodiments, after the distal ends of the flexible nerve electrode 11 and the outer tube 12 are respectively implanted into, for example, the target tissue target point a and the target tissue target point b by using the implantation traction member 13, it is also necessary to implant the proximal end of the flexible nerve electrode 11 into the target site. Fig. 3(a) shows a schematic diagram of preparing to implant the proximal end of the flexible nerve electrode into the target site according to an embodiment of the present application. Fig. 3(b) shows a schematic diagram of the proximal end of the flexible nerve electrode having been implanted into the target site according to an embodiment of the present application. Fig. 3(c) shows a schematic diagram of implanting the proximal end of the flexible nerve electrode together with the stimulator into the target site and the implantation traction member withdrawing from the target site according to an embodiment of the present application.

[0046] As shown in FIGS. 3(a), 3(b) and 3(c), in some other embodiments, a proximal auxiliary fixing portion 117 may also be provided at the proximal end of the flexible nerve electrode 11. The proximal auxiliary fixing portion 117 is detachably fixed to the proximal end of the implantation traction member 13 to further optimize the operation convenience during the implantation process and the stability of the overall assembly. Only as an example, when the proximal auxiliary fixing portion 117 is implemented as a proximal auxiliary fixing hole, the proximal end of the implantation traction member 13 and the proximal auxiliary fixing portion 117 of the flexible nerve electrode 11 are detachably connected in the following manner: The auxiliary implantation needle core 133 passes out from the proximal end of the auxiliary implantation needle tube 132 and is inserted into the proximal auxiliary fixing hole of the flexible nerve electrode 11, realizing the detachable connection between the proximal end of the implantation traction member 13 and the proximal end of the flexible nerve electrode 11.

[0047] In some other embodiments, the proximal end of the implantation traction member 13 and the proximal auxiliary fixing portion 117 may also be detachably connected in the following manner: As shown in FIGS. 3(a) and 3(b), the proximal end of the auxiliary implantation needle tube 132 is provided with a side opening. The auxiliary implantation needle core 133 passes through the side opening at the proximal end of the auxiliary implantation needle tube 132 and passes through the proximal auxiliary fixing hole of the flexible nerve electrode 11, thereby realizing the detachable connection between the proximal end of the implantation traction member 13 and the proximal end of the flexible nerve electrode 11. The proximal auxiliary fixing portion 117 is in the form of an auxiliary fixing hole or an auxiliary fixing groove, which can ensure sufficient connection strength while not significantly affecting the overall flexibility and size of the flexible nerve electrode 11.

[0048] In some other embodiments, the proximal auxiliary fixing portion 117 of the flexible nerve electrode 11 may also be implemented as a proximal auxiliary fixing groove, and a proximal clamping member (not shown) is constructed at the proximal end of the implantation traction member 13. In this case, the proximal end of the implantation traction member 13 and the proximal auxiliary fixing portion 117 of the flexible nerve electrode 11 are detachably connected in the following manner: The proximal clamping member of the implantation traction member 13 and the proximal auxiliary fixing portion 117 (proximal auxiliary fixing groove) form a snap connection structure, thereby realizing the detachable connection between the proximal end of the implantation traction member 13 and the proximal end of the flexible nerve electrode 11. The above design can not only ensure the physical connection stability of the proximal end of the flexible nerve electrode 11, but also allow a greater degree of freedom in operation during the implantation process, facilitate quick disassembly after implantation, and reduce the manufacturing complexity of the flexible nerve electrode assembly 1.

[0049] According to the interaction mode between the implant traction member 13 and the flexible nerve electrode 11 in the embodiments of the present application, through the precise design of their distal and proximal ends, precise guidance and positioning of the flexible nerve electrode 11 during the implantation process are achieved. The auxiliary implantation holes or auxiliary implantation grooves at the distal end provide stable connection points, and the auxiliary fixing portion 117 at the proximal end ensures the smoothness and connection strength of the implantation operation. After the implantation is completed, the implant traction member 13 can be easily separated from the flexible nerve electrode 11, so as not to affect the long-term stability of the flexible nerve electrode 11 and the outer tube 12 in the target area.

[0050] In some embodiments, the flexible nerve electrode assembly 1 may further include an auxiliary puncture sheath 16. The auxiliary puncture sheath 16 is provided with a cavity for accommodating the flexible nerve electrode 11, the outer tube 12, and the implant traction member 13, and is used to form a channel for guiding the implantation of the flexible nerve electrode 11 and the outer tube 12 in the target tissue.

[0051] Figure 4 A schematic diagram showing the connection between the stimulator and the proximal contact portion of the flexible nerve electrode according to the embodiments of the present application. As Figure 4 shown, the flexible nerve electrode assembly 1 may further include a stimulator 17, so as to complete a functional implantation in combination with the stimulator 17. The electrode sites of the distal electrode site portion 113 include recording electrode sites and stimulating electrode sites. The stimulator 17 is used to send stimulating pulse signals to the stimulating electrode sites of the flexible nerve electrode 11 and / or collect potential signals of the target tissue through the recording electrode sites of the flexible nerve electrode 11. Among them, the stimulator 17 includes a packaging housing (not shown), a stimulating circuit and / or a collecting circuit (not shown), and a feedthrough 171. The stimulating circuit and / or the collecting circuit are located inside the packaging housing; the feedthrough 171 is located in the packaging housing, forms an electrical connection with the stimulating circuit and / or the collecting circuit, and forms an electrical connection with the distal electrode site through the proximal contact portion 111 of the flexible nerve electrode 11, so as to realize the signal input and output between the stimulating / collecting circuit of the stimulator 17 and the distal electrode site of the flexible nerve electrode 11. On this basis, as shown in FIG. 3(c), the stimulator 17 can be implanted into the target site c by using the implant traction member 13 to realize a complete nerve signal transmission loop.

[0052] Furthermore, the stimulator 17 further includes a switching module (not shown). The switching module is electrically connected to the stimulating circuit and is used to control the stimulating circuit to switch between a first working state and a second working state; wherein, the stimulating circuit in the first working state is used to send stimulating pulse signals to the stimulating electrode sites of the flexible nerve electrode 11, and the stimulating circuit in the second working state is used to collect potential signals of the target tissue through the recording electrode sites of the flexible nerve electrode 11.

[0053] Further, the stimulator 17 further includes a radio frequency communication module (not shown) for wireless communication connection with an external device, so as to receive instructions such as loading a stimulation signal from the external device or transmit the collected potential signals, etc. to the external device, etc., which is not specifically limited in this application.

[0054] In addition, the stimulator 17 may further include a power supply module (not shown) and a rechargeable battery module (not shown), wherein the power supply module is electrically connected to the rechargeable battery module, and the rechargeable battery module is used to supply power to the power supply module.

[0055] In some other embodiments, as Figure 4 shown, the flexible nerve electrode assembly 1 may further include an external programmer 18. The external programmer 18 includes, for example, a wireless communication module 181, and the external programmer 18 is wirelessly connected to the radio frequency communication module of the stimulator 17 through the wireless communication module 181.

[0056] Further, the external programmer 18 may further include a wireless charging module 182. The wireless charging module 182 is used to charge the power supply module of the stimulator 17 and perform at least one or more of the following operations on the power supply module: charging monitoring operation, charging control operation, overvoltage protection operation, overcurrent protection operation, etc., which are not listed one by one here.

[0057] The target site c shown in FIG. 3(c) may be located in a superficial or deep tissue area, and its specific position is adjusted according to clinical needs and the transmission path of nerve signals. By firmly connecting the stimulator 17 to the proximal end of the flexible nerve electrode 11, the signal transmission stability and energy support after implantation are ensured.

[0058] According to the embodiments of the present application, the widths of the proximal contact part 111, the lead connection part 112, the distal electrode site part 113, the distal auxiliary implantation part 114, etc. are designed to be 100 microns to 10 millimeters, and the thickness is controlled below 0.2 millimeters. Moreover, the width of the flexible nerve electrode 11 may be different at different positions. For example, the width of the distal electrode site part 113 may be relatively wide to enhance its anchoring effect in the target area, while the width of the lead connection part 112 may be narrower to reduce tissue damage during the implantation process, and, etc., which are not listed one by one here. As long as the structural design can effectively improve the flexibility of the implantation operation and enhance the stability of the electrode after implantation. The following combines Figure 5 , to illustrate the high-precision micro-nano processing method of the flexible nerve electrode assembly 1.

[0059] As Figure 5As shown, the flexible neural electrode 11 is constructed as a laminated structure in the thickness direction, including at least a first flexible insulating layer 401, a second flexible insulating layer 403, and a first metal conductive layer 402 located between the first flexible insulating layer 401 and the second flexible insulating layer 403.

[0060] In some embodiments, the first flexible insulating layer 401 and / or the second flexible insulating layer 403 are not provided at the distal electrode site portion 113, such as at the stimulation electrode site and / or the recording electrode site. The metal conductive layer of the distal electrode site portion 113 can be "exposed" on one side (lacking one of the first flexible insulating layer 401 or the second flexible insulating layer 403) or "exposed" on both sides (lacking both the first flexible insulating layer 401 and the second flexible insulating layer 403) according to specific application requirements. This design flexibility allows adjustment according to different usage scenarios. For example, when a larger range of stimulation is required, the flexible insulating layers on both sides of the metal conductive layer can be removed, or when more accurate recording of potential signals in different directions is needed, the flexible insulating layers on both sides can also be removed. The distal auxiliary implantation portion 114 is formed on the first flexible insulating layer 401 and / or the second flexible insulating layer 403, thereby enhancing the operability and positioning accuracy of the flexible neural electrode 11 during the implantation process. The diameter of the stimulation electrode site on the distal electrode site portion 113 is not less than 50 microns to ensure sufficient electrical stimulation coverage and is suitable for various nerve stimulation scenarios, and the number thereof can range from 1 to 200. The diameter of the recording electrode site is not greater than 200 microns to be suitable for recording accurate nerve signals, and the number thereof can range from 1 to 2000. These electrode sites are connected to the proximal contact portion 111 through a metal conductive layer such as the first metal conductive layer 402, and each metal conductive layer can be made of a metal material with high conductivity and good biocompatibility such as gold, platinum, or iridium, so as to ensure the reliability of long-term use.

[0061] When an electrode anchor 115 is further included between the lead connection portion 112 and the distal electrode site portion 113, the electrode anchor 115 is formed on the first flexible insulating layer 401 and / or the second flexible insulating layer 403, thereby enhancing the fixing performance of the distal end of the flexible neural electrode 11 in the target tissue target area.

[0062] When a proximal clamping member 116 is further provided between the proximal contact portion 111 and the lead connection portion 112 of the flexible neural electrode 11, the proximal clamping member 116 is formed on the first flexible insulating layer 401 and / or the second flexible insulating layer 403.

[0063] In some other embodiments, the flexible neural electrode 11 is constructed as a laminated structure in the thickness direction and at least includes a first flexible insulating layer 401, a second flexible insulating layer 403, and a first metal conductive layer 402 located between the first flexible insulating layer 401 and the second flexible insulating layer 403. In the thickness direction, it further includes a second metal conductive layer 404 and a third flexible insulating layer 405, and the second metal conductive layer 404 is located between the second flexible insulating layer 403 and the third flexible insulating layer 405. The introduction of the multi-layer conductive structure can achieve more complex signal conduction paths or hierarchical functions, support the independent conduction of multi-channel signals, adapt to more complex neural signal regulation requirements, enhance the overall functional diversity and signal processing ability of the flexible neural electrode 11, and further improve the functionality of the flexible neural electrode 11. The stimulation electrode sites and recording electrode sites of the flexible neural electrode 11 are arranged on the first metal conductive layer 402 or the second metal conductive layer 404. In the areas of the stimulation electrode sites and recording electrode sites, the covered first flexible insulating layer 401, second flexible insulating layer 403, and / or third flexible insulating layer 405 are removed through photolithography and etching techniques to expose the first metal conductive layer 402 or the second metal conductive layer 404, ensuring direct electrical signal transmission between the electrode sites and the target tissue. The stimulation electrode sites for sending stimulation pulse signals and the stimulation electrode sites for collecting neural signals can share the same metal conductive layer to further simplify the structural design of the flexible neural electrode 11. The specific etching area depends on the design requirements of the electrode sites and will not be elaborated here.

[0064] In the embodiments of the present application, the materials of the first flexible insulating layer 401, the second flexible insulating layer 403, and the third flexible insulating layer 405 can be, for example, any one or at least two combinations of SU-8 photoresist, parylene, fluoropolymer, or polyimide. This material selection can not only improve the insulation performance but also enhance the overall mechanical strength of the flexible neural electrode 11, further avoiding the problem of fatigue damage that may occur after long-term implantation.

[0065] In addition, the maximum diameter of the proximal auxiliary fixing portion 117 can be set, for example, between 0.003 mm and 12 mm to better adapt to connection structures such as the proximal clamping member of the implant traction member 13.

[0066] The inner diameter ranges of both the elastic hose portion and the hard tube portion of the outer tube 12 are between 0.002 mm and 5 mm, and the outer diameter ranges are between 0.003 mm and 10 mm.

[0067] In addition, the flexible hose portion and the rigid tube portion of the outer tube 12 can be connected in various ways, including processes such as sleeving, bonding, or threaded connection. In a specific design, the flexible hose and the rigid tube can adjust their relative positions and structural forms according to application requirements. For example, when the outer diameter of the rigid tube is relatively large, it can be used as the outer layer to provide additional mechanical protection, while the flexible hose serves as the inner layer to provide elastic adaptability. In addition, the rigid tube portion can also be coated on the outside of the flexible hose portion to improve the overall tensile performance of the outer tube 12.

[0068] In some embodiments, a preparation method of the flexible nerve electrode 11 as described above includes the following steps:

[0069] Step 1: Obtain a sacrificial layer on a carrier through photolithography and coating.

[0070] Step 2: Spin-coat and bake a first flexible insulating layer 401 on the side of the carrier of the sacrificial layer formed in Step 1. In this way, the thickness of the first flexible insulating layer 401 is precisely controlled, which can ensure the overall mechanical strength and flexibility of the flexible nerve electrode 11.

[0071] Step 3: On one side of the first flexible insulating layer 401 formed in Step 2, use photolithography technology to define the patterns of the distal electrode site portion 113 and / or the proximal contact portion 111 on the first flexible insulating layer 401, and then use an etching process to remove the corresponding areas of the first flexible insulating layer 401 to obtain the distal electrode site portion 113 and / or the proximal contact portion 111 facing the first flexible insulating layer 401, so as to achieve direct electrical signal transmission between the flexible nerve electrode 11 and the target tissue.

[0072] Step 4: Obtain a first metal conductive layer 402 through photolithography, coating, and electroplating on one side of the first flexible insulating layer 401 formed in Step 3.

[0073] Step 5: Spin-coat and bake a second flexible insulating layer 404 on the first metal conductive layer 402 formed in Step 4.

[0074] Step 6: On one side of the second flexible insulating layer 404 formed in Step 5, use photolithography to define the patterns of the distal electrode site portion 113 and / or the proximal contact portion 111 on the second flexible insulating layer 404, and then use an etching process to remove the corresponding areas of the second flexible insulating layer 403 to obtain the distal electrode site portion 113 and / or the proximal contact portion 111 facing the second flexible insulating layer 403, so as to achieve direct electrical signal transmission between the flexible nerve electrode 11 and the target tissue.

[0075] Step 7: On one side of the second flexible insulating layer 403 formed in Step 6, use photolithography to define the pattern of the flexible nerve electrode 11 profile and / or the electrode anchor 115 and / or the proximal clamping part 116 and / or the distal auxiliary implantation part 114 on the second flexible insulating layer 403, and then use an etching process to remove the first flexible insulating layer 401 and the second flexible insulating layer 403 in the corresponding areas to obtain the flexible nerve electrode 11 profile and / or the electrode anchor 115 and / or the proximal clamping part 116 and / or the distal auxiliary implantation part 114;

[0076] Step 8: Remove the sacrificial layer by wet etching to release the flexible nerve electrode 11.

[0077] In some embodiments, the above Step 6 and Step 7 can be combined into the same step to improve production efficiency and reduce manufacturing complexity.

[0078] Another preparation method of the flexible nerve electrode 11 includes the following steps:

[0079] Step 1: Obtain a sacrificial layer on the carrier through photolithography and coating;

[0080] Step 2: Spin-coat and bake the first flexible insulating layer 401 on the carrier side of the sacrificial layer formed in Step 1;

[0081] Step 3: On one side of the first flexible insulating layer 401 formed in Step 2, use photolithography technology to define the pattern of the distal electrode site part 113 and / or the proximal contact part 111 on the first flexible insulating layer 401, and then use an etching process to remove the first flexible insulating layer 401 in the corresponding areas to obtain the distal electrode site part 113 and / or the proximal contact part 111 facing the first flexible insulating layer 401, so as to realize the direct electrical signal transmission between the flexible nerve electrode 11 and the target tissue;

[0082] Step 4: Obtain the first metal conductive layer 402 on one side of the first flexible insulating layer 401 formed in Step 3 through photolithography, coating and electroplating;

[0083] Step 5: Spin-coat and bake to obtain the second flexible insulating layer 403 on the first metal conductive layer 402 formed in Step 4;

[0084] Step 6: On one side of the second flexible insulating layer 403 formed in Step 5, use photolithography and hard mask coating to define the pattern of the distal electrode site part 113 and / or the proximal contact part 111 on the second flexible insulating layer 403, and then use an etching process to remove the second flexible insulating layer 403 in the corresponding areas to obtain the distal electrode site part 113 and / or the proximal contact part 111 facing the second flexible insulating layer 403, so as to realize the direct electrical signal transmission between the flexible nerve electrode 11 and the target tissue.

[0085] Step 7: On one side of the second flexible insulating layer 403 formed in Step 6, use photolithography and hard mask coating to define the pattern of the flexible neural electrode 11 profile and / or the electrode anchor 115 and / or the proximal clamping part 116 and / or the distal auxiliary implantation part 114 on the second flexible insulating layer 403. Then, use an etching process to remove the first flexible insulating layer 401 and the second flexible insulating layer 403 in the corresponding areas to obtain the complete flexible neural electrode 11 profile and / or the electrode anchor 115 and / or the proximal clamping part 116 and / or the distal auxiliary implantation part 114 and related functional components.

[0086] Step 8: Remove the sacrificial layer by wet etching to release the flexible neural electrode 11.

[0087] The above steps not only achieve high-precision manufacturing, but also reduce production costs by optimizing the steps, and significantly improve the reliability and adaptability of the electrode in a complex biological environment.

[0088] In the above steps, the application of the hard mask coating is an optional process, which can further improve the pattern accuracy. Especially in the manufacturing process of key components such as the electrode sites of the flexible neural electrode 11, the electrode anchor 115, the proximal clamping part 116, and the distal auxiliary implantation part 114, it can ensure that the edges of the components are clear and the shapes are precise, and is particularly suitable for electrode components that require complex structures (such as spiky structures or hollow structures) to ensure the high precision and reliability of each functional component. However, it may not be used in some embodiments.

[0089] In some embodiments, the above Step 6 and Step 7 can be combined into the same step to improve production efficiency and reduce manufacturing complexity.

[0090] In the embodiments of the present application, the materials of the first metal conductive layer 402 and the second metal conductive layer 404 are selected from highly conductive and corrosion-resistant metals such as gold, platinum, or iridium to ensure good electrical performance and biocompatibility.

[0091] According to an embodiment of the present application, the flexible neural electrode assembly 1 can adapt to different implantation depths, tissue environments, and target tissue target requirements. The following embodiments will illustrate an exemplary implantation scheme with high precision and high stability of the flexible neural electrode assembly 1 according to an embodiment of the present application. In this embodiment, the flexible neural electrode 11, the outer tube 12, and the implantation traction member 13 are implanted into the target of the target tissue as a whole. Therefore, first, the flexible neural electrode 11, the outer tube 12, and the implantation traction member 13 need to be assembled together. Specifically, the distal electrode site portion 113 of the flexible neural electrode 11 is connected to the distal traction portion 131 of the implantation traction member 13 through the distal auxiliary implantation portion 114, so that the implantation traction member 13 can provide necessary guidance and operation support for the flexible neural electrode 11. The distal end of the outer tube 12 is in the initial position to be implanted after assembly; then, through surgical operation, the distal electrode site portion 113 of the flexible neural electrode 11 and the implantation traction member 13 are implanted into the target tissue target a, and at the same time, the distal end of the outer tube 12 is implanted into the final implantation position target tissue target b. The target tissue target a and the target tissue target b are in the same implantation direction, and the target tissue target b is shallower than the target tissue target a; next, the implantation traction member 13 is separated from the flexible neural electrode 11 and the outer tube 12; finally, the implantation traction member 13 is taken out, and the distal electrode site portion 113 of the flexible neural electrode 11 and the distal end of the outer tube 12 are left in the target tissue target a and the target tissue target b respectively. This overall implantation method not only ensures the implantation success rate and accuracy but also has the advantages of simple operation steps and reduced implantation time.

[0092] Another implantation method of the flexible neural electrode assembly 1 according to an embodiment of the present application includes sequentially performing the following steps: First, the flexible neural electrode 11 and the implantation traction member 13 can be assembled; by using the guiding effect of the implantation traction member 13, the distal electrode site portion 113 of the flexible neural electrode 11 and the implantation traction member 13 are implanted into the target tissue target a; then, the outer tube 12 is sleeved from the proximal ends of the implantation traction member 13 and the flexible neural electrode 11; next, the distal end of the outer tube 12 is implanted into the target tissue target b; then, the implantation traction member 13 is separated from the flexible neural electrode 11 and the outer tube 12; finally, the implantation traction member 13 is taken out, and the distal electrode site portion 113 of the flexible neural electrode 11 and the distal end of the outer tube 12 are respectively left at the target tissue target a and the target tissue target b. The target tissue target a and the target tissue target b are located in the same implantation direction, and the target tissue target b is shallower than the target tissue target a. Through step-by-step operation, the relative independence of the flexible neural electrode 11 and the outer tube 12 is ensured, the relative positions of the flexible neural electrode 11 and the outer tube 12 can be better controlled, the mutual interference during the implantation process is reduced, and both form long-term mechanical stability at their respective target points. This separation and fixation process significantly improves the stability, success rate, and accuracy of the implantation operation through mechanical cooperation and design optimization, and is particularly suitable for deep target areas that require precise positioning. The implantation traction member 13 provides the necessary mechanical support and guiding function during this process, ensuring that the flexible neural electrode 11 and the outer tube 12 can accurately reach their respective target positions. After the implantation is completed, the implantation traction member 13 is unlocked and withdrawn from the target tissue through a separation operation. This step-by-step fixation method can improve the stability of the electrode and the outer tube, while reducing the disturbance to the surrounding tissues during the implantation process, and is particularly suitable for complex tissue environments that require more precise positioning, and can achieve efficient implantation through precise guidance and simplified operation.

[0093] In the case where the flexible neural electrode assembly 1 includes a flexible neural electrode 11, an outer tube 12, an implantation traction member 13, and an auxiliary puncture sheath 16, another implantation method of the flexible neural electrode assembly can be adopted. The steps sequentially include: pre-assembling the flexible neural electrode 11, the outer tube 12, and the implantation traction member 13; next, passing the distal electrode site portion 113 of the flexible neural electrode 11, the outer tube 12, and the implantation traction member 13 through the cavity of the auxiliary puncture sheath 16; further implanting the distal electrode site portion 113 of the flexible neural electrode 11 and the implantation traction member 13 into the target tissue target a, and at the same time implanting the distal end of the outer tube 12 into the target tissue target b; then, taking out the auxiliary puncture sheath 16; separating the implantation traction member 13 from the flexible neural electrode 11 and the outer tube 12, and taking out the implantation traction member 13, and leaving the distal electrode site portion 113 of the flexible neural electrode 11 and the distal end of the outer tube 12 at the target tissue target a and the target tissue target b respectively.

[0094] Figure 6 Another implantation method of the flexible nerve electrode assembly that can be adopted is shown in the case where the flexible nerve electrode assembly 1 includes a flexible nerve electrode 11, an outer tube 12, an implantation traction member 13, and an auxiliary puncture sheath 16, and the flexible nerve electrode 11 includes a proximal clamping member 116, and the outer tube 12 includes a proximal card slot 123 of the outer tube. The steps sequentially include: pre-assembling the flexible nerve electrode 11 and the implantation traction member 13; then, in step (1), implanting the auxiliary puncture sheath 16 into the target tissue; in step (2), implanting the distal electrode site portion 113 of the flexible nerve electrode 11 and the implantation traction member 13 through the cavity of the auxiliary puncture sheath 17 into the target tissue target point a; in step (3), sleeving the outer tube 12 from the proximal ends of the implantation traction member 13 and the flexible nerve electrode 11, and implanting the outer tube 12 (such as the outer tube anchoring member 122) into the target tissue target point b; in step (4), removing the auxiliary puncture sheath 16; in step (5), separating the implantation traction member 13, the flexible nerve electrode 11, and the outer tube 12, and removing the implantation traction member 13, leaving the distal electrode site portion 113 of the flexible nerve electrode 11 and the distal end of the outer tube 12 at the target tissue target point a and the target tissue target point b respectively; in step (6), embedding and locking the proximal clamping member 116 of the flexible nerve electrode 11 through the proximal card slot 123 of the outer tube, and keeping the flexible nerve electrode 11 in a flexed state within the cavity 121 of the outer tube 12.

[0095] For the above-mentioned auxiliary fixing member 14, auxiliary limiting sheath 15 or auxiliary puncture sheath 16, the inner diameter range of these components is 0.005 mm to 10 mm, and the outer diameter range is 0.007 mm to 15 mm, which can effectively adapt to the outer shape dimensions of the flexible nerve electrode 11 and the outer tube 12. The auxiliary fixing member 14 can effectively increase the overall stability of the assembly during implantation, the auxiliary limiting sheath 15 can accurately control the implantation depth, and the auxiliary puncture sheath 16 can simplify the implantation operation by forming a guiding channel.

[0096] With the cooperation of the auxiliary puncture sheath 16, the distal electrode site portion 113 of the flexible nerve electrode 11 and the distal end of the outer tube 12 can be accurately implanted into the target points a and b, while reducing the disturbance to the surrounding tissues. The auxiliary puncture sheath 16 is removed after the implantation is completed, thus optimizing the operation process and implantation accuracy.

[0097] When the flexible nerve electrode assembly 1 includes a flexible nerve electrode 11, an outer tube 12, an implantation traction member 13 and a stimulator 17, and the stimulator 17 includes a feedthrough 171, and the electrode sites of the distal electrode site portion 113 include stimulation electrode sites, the following implantation steps can be adopted: First, it is still necessary to assemble the flexible nerve electrode 11, the outer tube 12 and the implantation traction member 13; implant the distal electrode site portion 113 and the implantation traction member 13 into the target tissue target a, and at the same time implant the distal end of the outer tube 12 into the target tissue target b; separate the implantation traction member 13 from the flexible nerve electrode 11 and the outer tube 12; take out the implantation traction member 13, and leave the distal electrode site portion 113 and the distal end of the outer tube 12 at the target tissue target a and the target tissue target b respectively; form an electrical connection between the proximal contact portion 111 of the flexible nerve electrode 11 and the feedthrough 171 of the stimulator 17; finally, implant the stimulator 17 into the target site c.

[0098] When the flexible nerve electrode assembly 1 includes a flexible nerve electrode 11, an outer tube 12, an implantation traction member 13 and a stimulator 17, and the stimulator 17 includes a feedthrough 171, and the electrode sites of the distal electrode site portion 113 include stimulation electrode sites, the following implantation steps can also be adopted: First, assemble the flexible nerve electrode 11 and the implantation traction member 13; assemble and implant the distal electrode site portion 113 and the implantation traction member 13 into the target tissue target a; put the outer tube 12 on the proximal ends of the implantation traction member 13 and the flexible nerve electrode 11; implant the distal end of the outer tube 12 into the target tissue target b; separate the implantation traction member 13 from the flexible nerve electrode 11 and the outer tube 12; take out the implantation traction member 13, and leave the distal electrode site portion 113 and the outer tube 12 at the target tissue target a and the target tissue target b respectively; form an electrical connection between the proximal contact portion 111 and the feedthrough 171 of the stimulator 17; implant the stimulator 17 into the target site c.

[0099] According to the flexible nerve electrode assembly of the embodiment of the present application, through the careful design of each structural and functional module and the implantation method, the adaptability of the flexible nerve electrode to the dynamic biological environment and the stability of long-term implantation are enhanced. Especially when implanted in areas with frequent tissue activities, the mutual stress between the flexible nerve electrode and the tissue can be significantly reduced, and the service life of the flexible nerve electrode can be extended.

[0100] In addition, although exemplary embodiments have been described herein, the scope includes any and all embodiments based on the present disclosure with equivalent elements, modifications, omissions, combinations (e.g., various embodiments intersecting schemes), adaptations or changes. The elements in the claims are to be interpreted broadly based on the language adopted in the claims, and are not limited to the examples described in this specification or during the enforcement of this application, which examples are to be interpreted as non-exclusive. Therefore, this specification and examples are intended to be considered as examples only, and the true scope and spirit are indicated by the claims and the full scope of their equivalents.

[0101] The above description is intended to be illustrative rather than restrictive. For example, the above examples (or one or more schemes thereof) may be used in combination with each other. For example, a person of ordinary skill in the art may use other embodiments when reading the above description. In addition, in the above-mentioned specific embodiments, various features may be grouped together to simplify the present disclosure. This should not be interpreted as an intention that a disclosed feature that is not claimed for protection is necessary for any claim. On the contrary, the subject matter of the present invention may be less than all the features of a particular disclosed embodiment. Thus, the claims are incorporated herein into the specific embodiments as examples or embodiments, wherein each claim is independently a separate embodiment, and it is considered that these embodiments may be combined with each other in various combinations or arrangements. The scope of the present invention should be determined with reference to the claims and the full scope of equivalent forms granted by these claims.

Claims

1. A flexible neural electrode assembly, characterized in that: It includes a flexible neural electrode and an outer tube, wherein: The flexible neural electrode is provided with a proximal contact portion, a lead connection portion, a distal electrode site portion and a distal auxiliary implant portion in sequence from proximal to distal; the lead connection portion is accommodated in the cavity of the outer tube in a bent state; the proximal contact portion and the distal electrode site portion are electrically connected via the lead connection portion; The proximal end of the outer tube is fixedly connected to the proximal side of the flexible neural electrode, the outer tube includes an outer tube anchor, which is used to fix the distal end of the outer tube to the target area, the flexible neural electrode lead connection part and the distal electrode site part include an electrode anchor, which is used to fix the distal end of the flexible neural electrode to the target area, and the distal side of the outer tube is not bound to the distal side of the flexible neural electrode; the outer tube has a cavity for accommodating the lead connection part, and a relatively movable space is left between the inner wall of the cavity and the lead connection part; the axial direction of the outer tube is elastic; The length of the outer tube is shorter than the length of the lead wire connection part; the buckling degree of the lead wire connection part when the outer tube is under stress is smaller than the buckling degree of the lead wire connection part when the outer tube is not under stress.

2. The flexible neural electrode assembly according to claim 1, characterized in that: The flexible neural electrode assembly also includes an implant traction member, the distal end of which is configured with a distal traction portion, which is detachably connected to the distal auxiliary implant portion of the flexible neural electrode and is used to guide the distal end of the flexible neural electrode to reach the target area.

3. The flexible neural electrode assembly according to claim 1, characterized in that: The outer tube is a composite structure, which is assembled from an elastic hose portion near the proximal end and a hard tube portion near the distal end; The outer tube anchor is arranged on the hard tube portion; The elastic hose portion has elasticity in the axial direction, so that the outer tube is axially stretched and elastically deformed when subjected to a force from the target tissue; When the outer tube is subjected to force and elastically deformed, the lead wire connecting portion slides in the cavity and changes its bending degree.

4. The flexible neural electrode assembly according to claim 3, characterized in that: The elastic hose has a maximum elongation rate in the axial direction that is not less than a first ratio, so that the outer tube has a maximum elongation rate in the axial direction that is not less than 10%.

5. The flexible neural electrode assembly according to claim 1, characterized in that: The outer tube anchor has a thorn-like structure and / or a hollow structure.

6. The flexible neural electrode assembly according to claim 2, characterized in that: The implantation traction member is located inside the cavity of the outer tube or outside the cavity of the outer tube.

7. The flexible neural electrode assembly according to claim 2, characterized in that: The flexible neural electrode assembly also includes an auxiliary fixing member, which fixes the implanted traction member and the outer tube in a detachable manner, and removes the fixed connection between the implanted traction member and the outer tube after the distal end of the flexible neural electrode reaches the target area.

8. The flexible neural electrode assembly according to claim 7, characterized in that: The flexible neural electrode assembly also includes an auxiliary limiting sheath detachably connected to the outer tube and / or the implanted traction member, wherein the auxiliary limiting sheath is used to limit the depth of the flexible neural electrode assembly in the target tissue, and is removed from the outer tube and / or the implanted traction member and exits the target tissue after the distal end of the flexible neural electrode reaches the target area.

9. The flexible neural electrode assembly according to claim 8, characterized in that: The auxiliary fixing member and the auxiliary limiting sheath form an integral structure.

10. The flexible neural electrode assembly according to claim 1, characterized in that: The electrode anchor has a thorn-like structure and / or a hollow structure so as to fix the distal end of the flexible neural electrode at the target area.

11. The flexible neural electrode assembly according to claim 10, characterized in that: The electrode anchor forms an integral structure with the distal end of the flexible neural electrode.

12. The flexible neural electrode assembly according to claim 1, characterized in that: A proximal retaining piece is also provided between the proximal contact portion of the flexible nerve electrode and the lead connecting portion, and the proximal retaining piece is tightly fitted into the proximal end of the outer tube to achieve a fixed connection between the proximal side of the flexible nerve electrode and the proximal end of the outer tube.

13. The flexible neural electrode assembly according to claim 12, characterized in that: The proximal clamping piece of the flexible nerve electrode forms an integral structure with the flexible nerve electrode.

14. The flexible neural electrode assembly according to claim 12, characterized in that: The proximal retaining member of the flexible nerve electrode is an elastic member. After the outer tube is stretched, the proximal retaining member is deformed by force and tightly fits into the proximal end of the outer tube cavity, and the elastic restoring force of the proximal retaining member maintains a fixed connection between the proximal side of the flexible nerve electrode and the proximal end of the outer tube.

15. The flexible neural electrode assembly according to claim 12, characterized in that: The proximal end of the outer tube is also provided with an outer tube proximal end slot for matchingly accommodating the proximal end retaining member of the flexible nerve electrode and increasing the stability of the fixed connection between the proximal side of the flexible nerve electrode and the proximal end of the outer tube.

16. The flexible neural electrode assembly according to claim 2, characterized in that: The distal auxiliary implantation portion of the flexible neural electrode is a distal auxiliary implantation hole, and the implantation traction member comprises an auxiliary implantation needle tube and an auxiliary implantation needle core. A cavity is provided in the auxiliary implantation needle tube to accommodate the auxiliary implantation needle core.

17. The flexible neural electrode assembly according to claim 16, characterized in that: The distal traction part and the distal auxiliary implant part of the flexible nerve electrode are detachably connected in the following manner: the auxiliary implant needle core passes through the distal end of the auxiliary implant needle tube and is inserted into the distal auxiliary implant hole of the flexible nerve electrode, thereby realizing the detachable connection between the distal traction part and the distal end of the flexible nerve electrode.

18. The flexible neural electrode assembly according to claim 16, characterized in that: The distal traction part and the distal auxiliary implant part of the flexible nerve electrode are detachably connected in the following manner: a side opening is provided at the distal end of the auxiliary implant needle tube, and the auxiliary implant needle core passes through the side opening at the distal end of the auxiliary implant needle tube and the distal auxiliary implant hole of the flexible nerve electrode, thereby realizing the detachable connection between the distal traction part and the distal end of the flexible nerve electrode.

19. The flexible neural electrode assembly according to claim 2, characterized in that: The distal auxiliary implantation portion of the flexible nerve electrode is a distal auxiliary implantation groove, and the distal traction portion of the implantation traction member is configured with a distal clamping member.

20. The flexible neural electrode assembly according to claim 19, characterized in that: The distal traction part of the implanted traction member and the distal auxiliary implant part of the flexible nerve electrode are detachably connected in the following manner: the distal clamping part of the distal traction part of the implanted traction member and the distal auxiliary implant groove form a snap-on connection structure to achieve detachable connection between the distal traction part and the distal end of the flexible nerve electrode.

21. The flexible neural electrode assembly according to claim 2, characterized in that: The proximal end of the flexible nerve electrode is provided with a proximal auxiliary fixing portion, and the proximal auxiliary fixing portion is fixed to the proximal end of the implanted traction member in a detachable manner.

22. The flexible neural electrode assembly according to claim 21, characterized in that: The proximal auxiliary fixing portion of the flexible nerve electrode is a proximal auxiliary fixing hole, and the implant traction member comprises an auxiliary implant needle tube and an auxiliary implant needle core. A cavity is provided in the auxiliary implant needle tube to accommodate the auxiliary implant needle core.

23. The flexible neural electrode assembly according to claim 22, characterized in that: The proximal end of the implanted traction member and the proximal auxiliary fixing portion of the flexible nerve electrode are detachably connected in the following manner: the auxiliary implant needle core passes through the proximal end of the auxiliary implant needle tube and is inserted into the proximal auxiliary fixing hole of the flexible nerve electrode, thereby realizing the detachable connection between the proximal end of the implanted traction member and the proximal end of the flexible nerve electrode.

24. The flexible neural electrode assembly according to claim 22, characterized in that: The proximal end of the implant traction member and the proximal auxiliary fixing part of the flexible nerve electrode are detachably connected in the following manner: a side opening is provided at the proximal end of the auxiliary implant needle tube, and the auxiliary implant needle core passes through the side opening at the proximal end of the auxiliary implant needle tube and the proximal auxiliary fixing hole of the flexible nerve electrode, thereby realizing the detachable connection between the proximal end of the implant traction member and the proximal end of the flexible nerve electrode.

25. The flexible neural electrode assembly according to claim 2, characterized in that: The proximal auxiliary fixing portion of the flexible nerve electrode is a proximal auxiliary fixing groove, and the proximal end of the implanted traction member is structured with a proximal clamping member.

26. The flexible neural electrode assembly according to claim 25, characterized in that: The proximal end of the implanted traction member and the proximal auxiliary fixing part of the flexible nerve electrode are detachably connected in the following manner: the proximal clamping member of the implanted traction member and the groove of the proximal auxiliary fixing part of the flexible nerve electrode form a snap-on connection structure, thereby realizing the detachable connection between the proximal end of the implanted traction member and the proximal end of the flexible nerve electrode.

27. The flexible neural electrode assembly according to claim 2, characterized in that: The flexible nerve electrode assembly also includes an auxiliary puncture sheath, which is provided with a cavity for accommodating the flexible nerve electrode, the outer tube and the implantation traction member, and is used to form a channel in the target tissue for guiding the implantation of the flexible nerve electrode and the outer tube.

28. The flexible neural electrode assembly according to claim 1, characterized in that: The electrode sites of the distal electrode site portion include recording electrode sites and stimulation electrode sites, and the flexible neural electrode assembly also includes a stimulator for sending stimulation pulse signals to the stimulation electrode sites of the flexible neural electrode and / or collecting potential signals of the target tissue through the recording electrode sites of the flexible neural electrode.

29. The flexible neural electrode assembly according to claim 28, characterized in that: The stimulator comprises a packaging shell, a stimulation circuit and / or a collection circuit, and a feedthrough; The stimulation circuit and / or acquisition circuit are located inside the packaging shell; The feedthrough is located in the packaging shell and is electrically connected to the stimulation circuit and / or the collection circuit.

30. The flexible neural electrode assembly according to claim 29, characterized in that: The stimulator also includes a switching module, which is electrically connected to the stimulation circuit and is used to control the stimulation circuit to switch between a first working state and a second working state; wherein the stimulation circuit in the first working state is used to send a stimulation pulse signal to the stimulation electrode site of the flexible neural electrode, and the stimulation circuit in the second working state is used to collect the potential signal of the target tissue through the recording electrode site of the flexible neural electrode.

31. The flexible neural electrode assembly according to claim 29, characterized in that: The stimulator also includes a radio frequency communication module for wirelessly communicating with external equipment.

32. The flexible neural electrode assembly according to claim 29, characterized in that: The stimulator also includes a power module and a rechargeable battery module. The power module is electrically connected to the rechargeable battery module, and the rechargeable battery module is used to provide power to the power module.

33. The flexible neural electrode assembly according to claim 31, characterized in that: The flexible neural electrode assembly also includes an in vitro programmer, which includes a wireless communication module. The in vitro programmer is wirelessly connected to the radio frequency communication module of the stimulator via the wireless communication module.

34. The flexible neural electrode assembly according to claim 33, characterized in that: The in vitro programmer also includes a wireless charging module, which is used to charge the power module of the stimulator and perform at least one or more of the following operations on the power module: charging monitoring operation, charging control operation, overvoltage protection operation and overcurrent protection operation.

35. The flexible neural electrode assembly according to any one of claims 1 to 34, characterized in that: The flexible neural electrode is constructed as a stacked structure along the thickness direction, and at least includes a first flexible insulating layer, a second flexible insulating layer, and a first metal conductive layer located between the first flexible insulating layer and the second flexible insulating layer.

36. The flexible neural electrode assembly according to claim 35, characterized in that: The first flexible insulating layer and / or the second flexible insulating layer are not provided at the electrode site of the distal electrode site portion.

37. The flexible neural electrode assembly according to claim 35, characterized in that: The distal auxiliary implant portion is formed on the first flexible insulating layer and / or the second flexible insulating layer.

38. The flexible neural electrode assembly according to claim 35, characterized in that: In the case where an electrode anchor is further included between the flexible neural electrode lead connection portion and the distal electrode site portion, the electrode anchor is formed on the first flexible insulating layer and / or the second flexible insulating layer.

39. The flexible neural electrode assembly according to claim 35, characterized in that: In the case where a proximal retaining member is further provided between the proximal contact portion and the lead connecting portion of the flexible nerve electrode, the proximal retaining member is formed on the first flexible insulating layer and / or the second flexible insulating layer.

40. The flexible neural electrode assembly according to any one of claims 1 to 34, characterized in that: The flexible neural electrode is constructed as a stacked structure along the thickness direction, and at least includes a first flexible insulating layer, a second flexible insulating layer, and a first metal conductive layer located between the first flexible insulating layer and the second flexible insulating layer; The flexible neural electrode further includes a second metal conductive layer and a third flexible insulating layer along the thickness direction, and the second metal conductive layer is located between the second flexible insulating layer and the third flexible insulating layer.

41. The flexible neural electrode assembly according to claim 35, characterized in that: The method for preparing the flexible neural electrode comprises the following steps: Step 1: Obtain a sacrificial layer on the carrier by photolithography and coating; Step 2: Spin coating and baking a first flexible insulating layer on one side of the carrier of the sacrificial layer formed in step 1; Step 3: On one side of the first flexible insulating layer formed in step 2, a pattern of a distal electrode site portion and / or a proximal contact portion is defined on the first flexible insulating layer by using a photolithography technique, and then the first flexible insulating layer in a corresponding area is removed by using an etching process to obtain a distal electrode site portion and / or a proximal contact portion facing the first flexible insulating layer; Step 4: obtaining a first metal conductive layer on one side of the first flexible insulating layer formed in step 3 by photolithography, coating and electroplating; Step 5: obtaining a second flexible insulating layer on the first metal conductive layer formed in step 4 by spin coating and baking; Step 6: On one side of the second flexible insulating layer formed in step 5, a pattern of a distal electrode site portion and / or a proximal contact portion is defined on the second flexible insulating layer by photolithography, and then the second flexible insulating layer in a corresponding area is removed by an etching process to obtain a distal electrode site portion and / or a proximal contact portion facing the second flexible insulating layer; Step 7: On one side of the second flexible insulating layer formed in step 6, a pattern of a flexible neural electrode contour and / or an electrode anchor and / or a proximal retaining member and / or a distal auxiliary implant portion is defined on the second flexible insulating layer by photolithography, and then the first flexible insulating layer and the second flexible insulating layer in the corresponding area are removed by etching to obtain the flexible neural electrode contour and / or the electrode anchor and / or the proximal retaining member and / or the distal auxiliary implant portion; Step 8: Remove the sacrificial layer by wet etching to release the flexible neural electrode.

42. The flexible neural electrode assembly according to claim 35, characterized in that: The method for preparing the flexible neural electrode comprises the following steps: Step 1: Obtain a sacrificial layer on the carrier by photolithography and coating; Step 2: Spin coating and baking a first flexible insulating layer on one side of the carrier of the sacrificial layer formed in step 1; Step 3: On one side of the first flexible insulating layer formed in step 2, a pattern of a distal electrode site portion and / or a proximal contact portion is defined on the first flexible insulating layer by using a photolithography technique, and then the first flexible insulating layer in a corresponding area is removed by using an etching process to obtain a distal electrode site portion and / or a proximal contact portion facing the first flexible insulating layer; Step 4: obtaining a first metal conductive layer on one side of the first flexible insulating layer formed in step 3 by photolithography, coating and electroplating; Step 5: obtaining a second flexible insulating layer on the first metal conductive layer formed in step 4 by spin coating and baking; Step 6: On one side of the second flexible insulating layer formed in step 5, a pattern of a distal electrode site portion and / or a proximal contact portion is defined on the second flexible insulating layer by using photolithography and hard mask plating, and then the second flexible insulating layer in a corresponding area is removed by using an etching process to obtain a distal electrode site portion and / or a proximal contact portion facing the second flexible insulating layer; Step 7: On one side of the second flexible insulating layer formed in step 6, a pattern of a flexible neural electrode contour and / or an electrode anchor and / or a proximal retaining member and / or a distal auxiliary implant portion is defined on the second flexible insulating layer by photolithography and hard mask coating, and then the first flexible insulating layer and the second flexible insulating layer in the corresponding area are removed by etching to obtain the flexible neural electrode contour and / or the electrode anchor and / or the proximal retaining member and / or the distal auxiliary implant portion; Step 8: Remove the sacrificial layer by wet etching to release the flexible neural electrode.

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