Flexible neural electrode assembly

Abstract

The invention provides a flexible neural electrode assembly which comprises a flexible neural electrode and an outer tube, and a lead connecting part of the flexible neural electrode is accommodated in a cavity of the outer tube in a buckling state; the near end of the outer tube is fixedly connected with the near side of the flexible neural electrode, the outer tube comprises an outer tube anchoring part capable of fixing the far end of the outer tube in a target area, and the far side of the outer tube is not bound with the far side of the flexible neural electrode; a space capable of relatively moving is reserved between the inner wall of the cavity of the outer tube for accommodating the lead connecting part and the lead connecting part; the outer tube has elasticity in the axial direction and is shorter than the lead connecting part; and the buckling degree of the lead connecting part in the stressed state of the outer pipe is smaller than that of the lead connecting part in the unstressed state of the outer pipe. Through the synergistic effect of the outer tube and the electrode, the overall stability of the assembly in a dynamic environment is improved, and a brand new solution is provided for long-acting and safe use of the implantable neural electrode.

Description

Technical Field

[0001] The present application belongs to the technical field of neural regulation and implantable medical devices, and in particular, relates to a flexible neural electrode assembly. Background Art

[0002] In the fields of neural stimulation, neural signal acquisition, and related chronic disease treatment and neurorehabilitation, the key technical problems that have not yet been well solved are electrode displacement and electrode material fatigue damage that may occur due to the dynamic activity of the implanted tissue during the long-term use of implantable neural electrode assemblies after implantation.

[0003] In some prior art studies, attempts have been made to improve biocompatibility and mechanical protection through the flexibility or structural design of electrode materials, but the problem of displacement of flexible electrode assemblies caused by dynamic tissue activity has not been solved. In other prior art, anchors are further provided for the flexible electrodes themselves to increase the mechanical adhesion between the electrodes and the tissues, but the deformation adaptability of the electrodes in dynamic environments is ignored, so that the electrode materials are directly exposed to stress concentration positions and cannot cope with the stress accumulation caused by the dynamic tissue environment. The resulting electrode fatigue damage problem has not been solved. In addition, in some studies, although the neural electrodes have deformable sleeves, there is a lack of global optimization of the mechanical response during long-term implantation, and the matching of the electrodes and sleeves in dynamic environments has not been studied in depth, so it is impossible to effectively avoid mechanical damage to the electrodes and material fatigue damage in long-term implantation environments with frequent tissue activity.

[0004] It can be seen that currently no technical solution has been found that can enable flexible electrodes to overcome the adverse effects of electrode displacement, fatigue damage and other adverse factors caused by tissue activity and be used more effectively and safely during long-term implantation. Summary of the invention

[0005] The present application is proposed to solve the above-mentioned problems existing in the prior art.

[0006] The purpose of the present application is to provide a flexible neural electrode assembly, which, through the coordinated design of the flexible neural electrode and the outer tube, can enable the flexible electrode to overcome the influence of adverse factors such as electrode displacement, fatigue damage and even failure caused by tissue activity, and possible mechanical damage between the flexible neural electrode and the outer tube, thereby enabling the flexible neural electrode assembly to work longer and safer during long-term implantation.

[0007] According to the first scheme of the present application, a flexible neural electrode assembly is provided, comprising 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 a flexed state in the cavity of the outer tube; 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 comprises an outer tube anchor for fixing the distal end of the outer tube in a 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 portion, and a relatively movable space is left between the inner wall of the cavity and the lead connection portion; the axial direction of the outer tube is elastic; the length of the outer tube is shorter than the length of the lead connection portion; the degree of flexion of the lead connection portion when the outer tube is under stress is less than the degree of flexion when the outer tube is not under stress.

[0008] According to the flexible neural electrode assembly of each embodiment of the present application, through the coordinated design of the flexible neural electrode and the outer tube, in particular, the lead connecting part of the flexible neural electrode is accommodated in the cavity of the elastic outer tube in a bent state. When the outer tube is deformed by force, the lead connecting part can release its reserved deformation by changing the degree of bending to avoid displacement of the flexible neural electrode or stress accumulation. As a result, 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 flexible neural electrode assembly during long-term implantation in tissues 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 parts in different views. The same reference numerals with letter suffixes or different letter suffixes may represent different instances of similar parts. The accompanying drawings generally illustrate various embodiments by way of example and not limitation, and together with the specification and claims, are used to illustrate the disclosed embodiments. When 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 present apparatus or method.

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

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

[0012] FIG3( a ) is a schematic diagram showing a preparation for implanting a proximal end of a flexible neural electrode into a target site using an implantation traction member according to an embodiment of the present application.

[0013] FIG3( b ) is a schematic diagram showing that the proximal end of the flexible neural electrode has been implanted into the target site according to an embodiment of the present application.

[0014] FIG3( c ) is a schematic diagram showing that the proximal end of the flexible nerve electrode is implanted together with the stimulator into the target site and the implanted traction member is withdrawn from the target site according to an embodiment of the present application.

[0015] Figure 4 A schematic diagram showing the connection between a stimulator and a proximal contact portion of a flexible nerve electrode according to an embodiment of the present application.

[0016] Figure 5 A schematic diagram of a processing method for a flexible neural electrode assembly according to an embodiment of the present application is shown.

[0017] Figure 6 A schematic diagram of an implantation method of a flexible neural electrode assembly according to an embodiment of the present application is shown.

[0018] 1. Flexible neural electrode assembly; 11. Flexible neural electrode; 111. Proximal contact portion; 112. Lead connection portion; 113. Distal electrode site portion; 114. Distal auxiliary implant 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. Outer tube proximal clamping groove; 13. Implant traction member; 131. Distal traction portion ; 132. Auxiliary implant needle tube; 133. Auxiliary implant needle core; 14. Auxiliary fixing piece; 15. Auxiliary limiting sheath; 16. Auxiliary puncture sheath; 17. Stimulator; 171. Feedthrough; 18. In vitro 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 DESCRIPTION

[0019] In order to enable those skilled in the art to better understand the technical solution of the present disclosure, the present disclosure is described in detail below in conjunction with the drawings and specific implementation methods. The embodiments of the present disclosure are further described in detail below in conjunction with the drawings and specific implementation methods, but are not intended to limit the present disclosure.

[0020] The words "first", "second" and similar terms used in this application do not indicate any order, quantity or importance, but are only used to distinguish different parts. The expressions "first" and "second" are only used to distinguish by numbering for the convenience of expression, and are not intended 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, and are not limited here, as long as the "first component" and the "second component" are discrete components. Furthermore, if the context provides sufficient explanation, the "first component" and the "second component" may not even be discrete components, but may be integrated into the same component, or may be interchangeable with each other.

[0021] In the present application, when a specific device is described as being 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 a specific device is described as being connected to other devices, the specific device may be directly connected to the other device without an intermediate device, or may not be directly connected to the other device but have an intermediate device.

[0022] "Include" or "comprising" and other similar words mean that the elements before the word include the elements listed after the word, and do not exclude the possibility of including other elements. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the object being described changes, the relative positional relationship may also change accordingly.

[0023] In this application, the terms "proximal" and "proximal" are intended to refer to the side close to the operator (e.g., a doctor) who performs the implantation operation, while the terms "distal" and "distal" are intended to refer to the side close to the target location where the flexible neural electrode is to be implanted.

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

[0025] like Figure 1 As shown, the flexible nerve electrode assembly 1 comprises at least a flexible nerve electrode 11 and an outer tube 12, wherein the flexible nerve electrode 11 is provided with a proximal contact portion 111, a lead connection portion 112, a distal electrode site portion 113 and a distal auxiliary implant portion 114 in sequence from proximal to distal. The lead connection portion 112 is accommodated in a cavity 121 of the outer tube 12 in a flexed state, and the proximal contact portion 111 and the distal electrode site portion 113 are electrically connected via the lead connection portion 112.

[0026] like 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 portion 111 passes through the proximal end of the outer tube 12. The outer tube 12 also includes an outer tube anchor 122, which is used to fix the distal end of the outer tube 12 to the target area, wherein the outer tube anchor 122 can be a thorn-like structure and / or a hollow structure, or other structures that are convenient for fixing the outer tube 12 to the target tissue, and 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 hard tube portion or the outside of the elastic hose portion, or it can exist simultaneously on the outside of the hard tube portion and the outside of the elastic hose portion. The thorn-like structure of the outer tube anchor 122 is used to penetrate the surface or inside of the target tissue to provide additional mechanical grip, and the hollow structure further improves the fixing performance of the outer tube 12 by interlacing with the target tissue. As an example only, the thorn-like structure may be conical or needle-shaped, and the hollow structure may be designed to be polygonal, curved or grid-shaped, etc. The combination of the thorn-like and hollow structure design can provide more flexible adaptability and reliable fixation performance in different tissue environments.

[0027] In addition, the distal end of the outer tube 12 is not bound to the distal end of the flexible neural electrode 11. The outer tube 12 has a cavity 121 for accommodating the lead connection part, and a relatively movable space is left between the inner wall of the cavity 121 and the lead connection part 112, that is, the outer tube 12 is not tightly wrapped around the outer layer of the lead connection part 112 so that the two cannot move relatively freely relative to each other, or generate greater mechanical friction during relative movement. In addition, the outer tube 12 is elastic in the axial direction, so it can be stretched axially and lengthened under stress, and the length of the outer tube 12 is shorter than the length of the lead connection part 112 regardless of whether it is under stress or not, thereby ensuring that in both states, the distal electrode site part 113 can always pass through 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 flexed state in the cavity 121. It is understandable that the outer tube 12 will become longer when it is stressed, so the bending degree of the lead connection portion 112 when the outer tube 12 is stressed will be smaller than the bending degree when the outer tube 12 is not stressed.

[0028] According to the flexible neural electrode assembly 1 of the embodiment of the present application, when tissue activity causes stress to be concentrated on the outer tube 12 and the lead connection part 112, on the one hand, the outer tube 12 can absorb the accumulated stress through elastic deformation, and on the other hand, when the outer tube 12 is stretched and deformed by force, the lead connection part 112 in the cavity 121 can release its stored deformation, and the degree of buckling will be reduced, but it will not be straightened to cause itself to be stressed, thereby 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 of the embodiment of the present application ensures that the stress generated by tissue activity will not have a significant impact on the lead connection part 112 or the distal electrode site part 113, which can significantly reduce the risk of displacement, fatigue damage and even failure of the flexible neural electrode 11, and improve the stability and reliability of the long-term implantation of the flexible neural electrode assembly 1 in the tissue. In addition, since the distal end of the outer tube 12 is not bound to the distal end of the flexible neural electrode 11 and can move relative to each other, the flexible neural electrode 11 can maintain high flexibility in a dynamic tissue environment and reduce stress concentration problems caused by external forces. In some embodiments, the distal movable range of the flexible neural electrode 11 is not less than 5 mm to ensure that during the deformation process of the outer tube 12 being stretched and compressed, the flexible neural electrode 11 can fully release the reserved deformation through changes in the degree of buckling, further reducing the risk of electrode fatigue damage that may be caused by stress concentration.

[0029] In some embodiments, the outer tube 12 may be a composite structure, which is assembled from an elastic hose portion near the proximal end and a hard hose portion near the distal end. The hard hose portion can provide additional mechanical support and facilitate the outer tube anchor 122 to be set on the hard hose portion to prevent the distal end of the outer tube 12 from accidentally shifting in the tissue; the elastic hose portion is elastic in the axial direction, so that the outer tube 12 is axially stretched and elastically deformed when subjected to force from the target tissue. Since the outer tube anchor 122 fixes the distal end of the outer tube 12 in the target target area, whether the hard tube portion or the elastic hose portion of the outer tube 12 is subjected to external force applied by the tissue, it can be converted into elastic deformation of the elastic hose portion. In this case, the lead connection portion 112 will be driven to slide freely in the cavity 121. The degree of buckling may change during the sliding process, but the buckling state is always maintained.

[0030] In some embodiments, the overall maximum stretch 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 in the flexible neural electrode assembly 1. For example, in the case of implantation in the sacral nerve, the maximum stretch rate can be set to be no less than 10%. Taking the flexible neural electrode assembly 1 to be used for sacral nerve stimulation electrodes as an example, its typical implantation location includes skin, muscles, and ligaments, etc. These tissues will produce large dynamic deformations due to patient activities (such as walking or sitting). Therefore, in this case, the maximum stretch rate of the outer tube 12 in the axial direction is required to be no less than 10% to adapt to the movement amplitude of these tissues and avoid excessive stress on various parts of the electrode assembly. When the flexible neural electrode assembly 1 is used for spinal cord stimulation electrodes, the maximum stretch rate of the outer tube 12 can be appropriately reduced due to the small activity of the tissue around the spinal cord, which is not listed here. When the length of the outer tube 12 is basically determined (usually limited to the specific implantation site), its overall stretch rate will be related to the proportion of the elastic hose portion and the stretch rate of the elastic hose portion material itself. When the above two parameters are collaboratively designed, factors to be considered include the flexibility and strength of the outer tube 12. Specifically, the higher the proportion of the elastic hose portion, the better the flexibility, the stronger the stretching ability, and the better the ability to adapt to the deformation of dynamic tissues. However, on the other hand, the outer tube 12 may be more likely to slide or shift in the tissue due to insufficient stability and insufficient anchoring effect. On the contrary, a higher proportion of the hard tube portion can enhance the anchoring force of the outer tube 12, but the overall stretching ability of the outer tube 12 will be reduced accordingly, making it more difficult to adapt to the dynamic changes of the target tissue. Therefore, it is necessary to properly set the ratio of the elastic hose portion to the hard tube portion, and to set the required maximum stretching rate of the elastic hose portion in association, so that the outer tube 12 has both overall stability and the required overall maximum stretching rate, such as 10%. In other embodiments, for example, in the connection area of ​​muscles and ligaments, when the movement amplitude of the tissue is large, the proportion of the elastic hose portion can be appropriately reduced and the proportion of the hard tube portion can be increased, thereby improving the anchoring force of the outer tube 12 and reducing the fatigue risk caused by relative movement between tissues. In the less active fat tissue or muscle area, the proportion of the elastic hose portion can be appropriately increased to enhance 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. As an example only, under normal circumstances, the length ratio of the elastic hose portion and the hard tube portion can be set to between 1:1 and 100:1 as required, and combined with the total length of the outer tube 12, the elastic hose is cooperatively set to have a maximum stretching rate in the axial direction that is not less than the first ratio, so that the maximum stretching rate of the outer tube 12 in the axial direction is not less than the overall maximum stretching rate such as 10%, wherein the specific value of the first ratio can be determined by calculation, simulation, and experiment, etc., and the present application does not limit this.

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

[0032] In some embodiments, Figure 2 As shown, the implanted traction member 13 can be located inside the cavity 121 of the outer tube 12 during the implantation process. In this case, the implanted traction member 13 passes through the cavity 121 until the distal end of the implanted traction member 13 extends from the distal end of the outer tube 12, guiding the distal end of the flexible neural electrode 11 to reach the target area.

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

[0034] In other embodiments, the flexible neural electrode assembly 1 further includes an auxiliary fixing member 14, which fixes the implant traction member 13 and the outer tube 12 in a detachable manner. In particular, when the implant traction member 13 is located outside the outer tube 12 during the implantation process, temporary fixation of the flexible neural electrode assembly 11 is achieved through mechanical connection, and after the distal end of the flexible neural electrode 11 reaches the target area, the fixed connection between the implant traction member 13 and the outer tube 12 is removed.

[0035] Furthermore, the flexible neural electrode assembly 1 may also include an auxiliary limiting sheath 15 detachably connected to the outer tube 12 and / or the implanted traction member 13, the auxiliary limiting sheath 15 is used to limit and accurately control the depth of the flexible neural electrode assembly 11 in the target tissue, and the auxiliary limiting sheath 15 cooperates with the structure of the outer tube 12 and the flexible neural electrode 11, can provide the required positioning function in the target tissue, and after the distal end of the flexible neural electrode 11 reaches the target target area, it is removed from the outer tube 12 and / or the implanted traction member 13 and withdraws from the target tissue. Optionally, the auxiliary fixing member 14 and the auxiliary limiting sheath 15 form an integrated structure, thereby simplifying the operation process of the implantation process and improving the overall stability of the flexible neural electrode assembly 1.

[0036] Normally, 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 is much smaller than the maximum stretching range of the outer tube 12, while the buckling shape of the lead connection portion 112 provides sufficient deformation margin, which can effectively absorb the stress caused by the drift, thereby 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 cases where tissue dynamics are strong, an electrode anchor 115 may be included between the lead connection portion 112 and the distal electrode site portion 113. As an example only, it may have a thorn-like structure and / or a hollow structure so as to fix the distal end of the flexible neural electrode 11 to the target area and reduce the risk of drift. The thorn-like structure can penetrate into the target tissue to enhance the anchoring force, while the hollow structure further increases the anchoring stability through close contact with the target tissue. Figure 1 and Figure 2 As 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 can effectively avoid electrode material fatigue and reduce the risk of displacement caused by tissue activity.

[0037] like Figure 2 As shown, a proximal retaining member 116 is also provided between the proximal contact portion 111 of the flexible nerve electrode 11 and the lead connection portion 112, and the proximal retaining 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 nerve electrode 11 and the proximal end of the outer tube 12. Preferably, the proximal retaining member 116 and the flexible nerve electrode 11 form an integral structure. As an example only, the proximal retaining member 116 can be set as an elastic member, so that after the outer tube 12 is stretched, the proximal retaining member 116 is deformed by 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 retaining member 116 is used to ensure the fixed connection between the proximal side of the flexible nerve electrode 11 and the proximal end of the outer tube 12. The above design not only enhances the overall stability of the flexible nerve electrode 11 and the outer tube 12, but also can provide precise positioning support during the implantation operation, reducing implantation deviations caused by sliding or detachment.

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

[0039] In other embodiments, the proximal end of the outer tube 12 is further provided with an outer tube proximal end slot 123, which is used to match and accommodate the proximal end retaining piece 116 of the flexible neural electrode 11 and increase the stability of the fixed connection between the proximal side of the flexible neural electrode 11 and the proximal end of the outer tube 12. More specifically, the specific form of the proximal retaining piece 116 may include, for example, an elastic ring, a slot structure or other design forms suitable for being fixed to the proximal end slot 123 of the outer tube. The shape and size of the proximal end slot 123 of the outer tube are closely matched with the structure of the proximal end retaining piece 116. By increasing the embedding depth and mechanical contact area, after the distal end of the flexible neural electrode 11 is implanted, the proximal end retaining piece 116 is embedded and locked with the proximal end slot 123 of the outer tube, thereby achieving a stable connection between the proximal side of the flexible neural electrode 11 and the proximal end of the outer tube 12, and can also significantly reduce the risk of sliding or loosening of the proximal end of the flexible neural electrode 11 at the proximal end of the outer tube 12. Through the above design, the proximal connection of the flexible neural electrode assembly 1 can not only provide high-strength mechanical fixation, but also adapt to the stress caused 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 complex biological environments.

[0040] like Figure 2 As shown, in some embodiments, the distal auxiliary implantation portion 114 of the flexible neural 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 structural design ensures a balance between connection strength and ease of disassembly. 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 larger than the length of the auxiliary implantation needle tube 132, so that it can expose enough protrusions during operation, so as to facilitate rapid disassembly by applying external force.

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

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

[0043] In other embodiments, the distal auxiliary implantation portion 114 of the flexible neural electrode 11 is implemented as a distal auxiliary implantation groove, which is used to provide a connection site during the implantation process, and the distal traction portion 131 is further configured with a distal clamp (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 clamp of the distal traction portion 131 and the distal auxiliary implantation groove form a snap-on connection structure, thereby achieving a detachable connection between the distal traction portion 131 and the distal end of the flexible neural electrode 11. The above connection method can ensure the convenience, operation accuracy and stability during the implantation operation, and facilitates rapid disassembly and removal after the implantation is completed.

[0044] The diameter range of the implant traction member 13 is set to 0.001 mm to 3 mm, and the maximum diameter of the distal auxiliary implant hole or the distal auxiliary implant groove is 0.002 mm to 2 mm, ensuring that the smoothness of the implantation process is not affected while providing sufficient connection strength. The implant traction member 13 can be removed from the flexible neural electrode assembly 1 after implantation, and will not affect the stability of the flexible neural electrode 11 and the outer tube 12 in the target tissue.

[0045] In some embodiments, after the distal end of the flexible nerve electrode 11 and the distal end of the outer tube 12 are implanted into, for example, target tissue target a and target tissue target b respectively using the implanted traction member 13, the proximal end of the flexible nerve electrode 11 needs to be implanted into the target site. FIG3 (a) shows a schematic diagram of preparing to implant the proximal end of the flexible nerve electrode into the target site using the implanted traction member according to an embodiment of the present application. FIG3 (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. FIG3 (c) shows a schematic diagram of implanting the proximal end of the flexible nerve electrode into the target site together with the stimulator according to an embodiment of the present application and withdrawing the implanted traction member from the target site.

[0046] As shown in Fig. 3 (a), Fig. 3 (b) and Fig. 3 (c), in other embodiments, the proximal end of the flexible nerve electrode 11 may also be provided with a proximal auxiliary fixing portion 117, and the proximal auxiliary fixing portion 117 is detachably fixed to the proximal end of the implanted traction member 13 to further optimize the convenience of operation and the stability of the overall assembly during the implantation process. As an example only, in the case where the proximal auxiliary fixing portion 117 is implemented as a proximal auxiliary fixing hole, the proximal end of the implanted traction member 13 is detachably connected to the proximal auxiliary fixing portion 117 of the flexible nerve electrode 11 in the following manner: the auxiliary implant needle core 133 passes through the proximal end of the auxiliary implant needle tube 132 and is inserted into the proximal auxiliary fixing hole of the flexible nerve electrode 11, so as to realize the detachable connection between the proximal end of the implanted traction member 13 and the proximal end of the flexible nerve electrode 11.

[0047] In other embodiments, the proximal end of the implanted traction member 13 and the proximal auxiliary fixing portion 117 can also be detachably connected in the following manner: as shown in FIG3 (a) and FIG3 (b), the proximal end of the auxiliary implant needle tube 132 is provided with a side opening, and the auxiliary implant needle core 133 passes through the side opening of the proximal end of the auxiliary implant needle tube 132 and the proximal auxiliary fixing hole of the flexible nerve electrode 11, thereby realizing the detachable connection between the proximal end of the implanted 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 that while providing sufficient connection strength, it does not significantly affect the overall flexibility and size of the flexible nerve electrode 11.

[0048] In other embodiments, the proximal auxiliary fixing portion 117 of the flexible neural electrode 11 can also be implemented as a proximal auxiliary fixing groove, and the proximal end of the implanted traction member 13 is constructed with a proximal clamp (not shown). In this case, the proximal end of the implanted traction member 13 is detachably connected to the proximal auxiliary fixing portion 117 of the flexible neural electrode 11 in the following manner: the proximal clamp of the implanted traction member 13 and the proximal auxiliary fixing portion 117 (proximal auxiliary fixing groove) form a snap-on connection structure, thereby achieving a detachable connection between the proximal end of the implanted traction member 13 and the proximal end of the flexible neural electrode 11. The above design can not only ensure the physical connection stability of the proximal end of the flexible neural electrode 11, but also allow greater operational freedom during the implantation process, facilitate rapid disassembly after implantation, and reduce the manufacturing complexity of the flexible neural electrode assembly 1.

[0049] According to the interaction mode between the implanted traction member 13 and the flexible neural electrode 11 of the embodiment of the present application, the precise guidance and positioning of the flexible neural electrode 11 during the implantation process is achieved through the precise design of the distal and proximal ends of the two. The auxiliary implantation hole or auxiliary implantation groove at the distal end provides a stable connection point, and the auxiliary fixing portion 117 at the proximal end ensures the smoothness of the implantation operation and the connection strength. After the implantation is completed, the implanted traction member 13 can be easily separated from the flexible neural electrode 11, so as not to affect the long-term stability of the flexible neural 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, which is provided with a cavity for accommodating the flexible nerve electrode 11, the outer tube 12 and the implantation traction member 13, and is used to form a channel in the target tissue to guide the implantation of the flexible nerve electrode 11 and the outer tube 12.

[0051] Figure 4 A schematic diagram showing the connection between the stimulator and the proximal contact portion of the flexible nerve electrode according to an embodiment of the present application. Figure 4 As shown, the flexible neural electrode assembly 1 may also include a stimulator 17, so as to complete 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, and the stimulator 17 is used to send stimulation pulse signals to the stimulating electrode sites of the flexible neural electrode 11 and / or collect potential signals of the target tissue through the recording electrode sites of the flexible neural electrode 11. Among them, the stimulator 17 includes a packaging shell (not shown), a stimulation circuit and / or a collection circuit (not shown), and a feedthrough 171, and the stimulation circuit and / or the collection circuit are located inside the packaging shell; the feedthrough 171 is located in the packaging shell, and is electrically connected to the stimulation circuit and / or the collection circuit, and is electrically connected to the distal electrode site through the proximal contact portion 111 of the flexible neural electrode 11, thereby realizing the signal input and output between the stimulation / collection circuit of the stimulator 17 and the distal electrode site of the flexible neural electrode 11. On this basis, as shown in FIG. 3 (c), the stimulator 17 can be implanted into the target site c using the implanted traction member 13 to realize a complete neural signal transmission circuit.

[0052] Furthermore, the stimulator 17 also includes a switching module (not shown), 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 11, 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 11.

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

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

[0055] In other embodiments, Figure 4 As shown, the flexible neural electrode assembly 1 may further include an in vitro programmer 18 , which may include a wireless communication module 181 , for example. The in vitro programmer 18 is wirelessly connected to the radio frequency communication module of the stimulator 17 via the wireless communication module 181 .

[0056] Furthermore, the extracorporeal programmer 18 may also include a wireless charging module 182, which is used to charge the power module of the stimulator 17 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, etc., which are not listed here one by one.

[0057] The target site c shown in FIG3 (c) can be located in a superficial or deep tissue region, and its specific location is adjusted according to clinical needs and the transmission path of the neural signal. By forming a stable connection between the stimulator 17 and the proximal end of the flexible neural electrode 11, the signal transmission stability and energy support after implantation are ensured.

[0058] According to the embodiment of the present application, the width of each part such as the proximal contact part 111, the lead connection part 112, the distal electrode site part 113 and the distal auxiliary implant part 114 is designed to be 100 microns to 10 mm, and the thickness is controlled below 0.2 mm, and the width of the flexible neural electrode 11 can be different at different positions. For example, the width of the distal electrode site part 113 can be relatively wide to enhance its anchoring effect in the target area, while the width of the lead connection part 112 can be narrower to reduce tissue damage during implantation, and so on. They are not listed here one by one, 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 is combined with Figure 5 , illustrating the high-precision micro-nano processing method of the flexible neural electrode assembly 1.

[0059] like Figure 5As shown, the flexible neural electrode 11 is constructed as a stacked structure along 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 .

[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 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. The flexibility of this design allows adjustment according to different usage scenarios. For example, when a wider range of stimulation is required, the flexible insulating layers on both sides of the metal conductive layer can be removed, or when it is necessary to record potential signals in different directions, the flexible insulating layers on both sides can also be removed. The distal auxiliary implant 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 implantation. 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, suitable for a variety of neural stimulation scenarios, and the number 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 neural signals, and the number 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. 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 reliability for 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 fixation performance of the distal end of the flexible neural electrode 11 in the target tissue target area.

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

[0063] In other embodiments, the flexible neural electrode 11 is constructed as a stacked structure along the thickness direction, and includes 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, and also includes a second metal conductive layer 404 and a third flexible insulating layer 405 along the thickness direction, 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 a multi-layer conductive structure can realize a more complex signal conduction path or layered function, and can support the independent conduction of multi-channel signals to meet more complex neural signal regulation requirements, enhance the overall functional diversity and signal processing capabilities of the flexible neural electrode 11, and further improve the functionality of the flexible neural electrode 11. The stimulation electrode site and the recording electrode site of the flexible neural electrode 11 are set in the first metal conductive layer 402 or the second metal conductive layer 404. In the stimulation electrode site and the recording electrode site area, the covering first flexible insulating layer 401, the second flexible insulating layer 403 and / or the third flexible insulating layer 405 are removed by photolithography and etching technology to expose the first metal conductive layer 402 or the second metal conductive layer 404, so as to ensure direct electrical signal transmission between the electrode site and the target tissue. The stimulation electrode site for sending the stimulation pulse signal and the stimulation electrode site for collecting the neural signal 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 site, which will not be repeated here.

[0064] In an embodiment 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 of SU-8 photoresist, polyparaxylene, fluorinated polymers or polyimide, or a combination of at least two of them. 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 fatigue damage problems 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, so as to better adapt to the connecting structure such as the proximal clamping member of the implanted traction member 13.

[0066] The inner diameter of both the elastic hose portion and the hard tube portion of the outer tube 12 is in the range of 0.002 mm to 5 mm, and the outer diameter is in the range of 0.003 mm to 10 mm.

[0067] In addition, the elastic hose portion and the hard tube portion of the outer tube 12 can be connected in a variety of ways, including sleeve connection, bonding or threaded connection. In a specific design, the relative position and structural form of the elastic hose and the hard tube can be adjusted according to application requirements. For example, when the outer diameter of the hard tube is large, it can be used as an outer layer to provide additional mechanical protection, while the elastic hose can be used as an inner layer to provide elastic adaptability. In addition, the hard tube portion can also be wrapped on the outside of the elastic hose portion to improve the overall tensile strength of the outer tube 12.

[0068] In some embodiments, a method for preparing the flexible neural electrode 11 as described above comprises the following steps: Step 1: Obtain a sacrificial layer on the carrier by photolithography and coating; Step 2: The first flexible insulating layer 401 is spin-coated and baked on one side of the carrier of the sacrificial layer formed in step 1, so that the thickness of the first flexible insulating layer 401 is precisely controlled to ensure the overall mechanical strength and flexibility of the flexible neural electrode 11; Step 3: On one side of the first flexible insulating layer 401 formed in step 2, a pattern of the distal electrode site portion 113 and / or the proximal contact portion 111 is defined on the first flexible insulating layer 401 by using a photolithography technique, and then the first flexible insulating layer 401 in the corresponding area is removed by an etching process 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 neural electrode 11 and the target tissue; Step 4: obtaining a first metal conductive layer 402 on one side of the first flexible insulating layer 401 formed in step 3 by photolithography, coating and electroplating; Step 5: obtaining a second flexible insulating layer 404 on the first metal conductive layer 402 formed in step 4 by spin coating and baking; Step 6: On one side of the second flexible insulating layer 404 formed in step 5, a pattern of the distal electrode site portion 113 and / or the proximal contact portion 111 is defined on the second flexible insulating layer 404 by photolithography, and then the second flexible insulating layer 403 in the corresponding area is removed by etching 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 neural electrode 11 and the target tissue; Step 7: On one side of the second flexible insulating layer 403 formed in step 6, the contour of the flexible neural electrode 11 and / or the pattern of the electrode anchor 115 and / or the proximal retaining member 116 and / or the distal auxiliary implant 114 are defined on the second flexible insulating layer 403 by photolithography, and then the first flexible insulating layer 401 and the second flexible insulating layer 403 in the corresponding area are removed by etching to obtain the contour of the flexible neural electrode 11 and / or the electrode anchor 115 and / or the proximal retaining member 116 and / or the distal auxiliary implant 114; Step 8: Remove the sacrificial layer by wet etching to release the flexible neural electrode 11.

[0069] In some embodiments, the above steps 6 and 7 can be combined into one step to improve production efficiency and reduce manufacturing complexity.

[0070] Another method for preparing the flexible neural electrode 11 includes the following steps: Step 1: Obtain a sacrificial layer on the carrier by photolithography and coating; Step 2: Spin coating and baking the first flexible insulating layer 401 on the carrier side of the sacrificial layer formed in step 1; Step 3: On one side of the first flexible insulating layer 401 formed in step 2, a pattern of the distal electrode site portion 113 and / or the proximal contact portion 111 is defined on the first flexible insulating layer 401 by using a photolithography technique, and then the first flexible insulating layer 401 in the corresponding area is removed by an etching process 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 neural electrode 11 and the target tissue; Step 4: obtaining a first metal conductive layer 402 on one side of the first flexible insulating layer 401 formed in step 3 by photolithography, coating and electroplating; Step 5: obtaining a second flexible insulating layer 403 on the first metal conductive layer 402 formed in step 4 by spin coating and baking; Step 6: On one side of the second flexible insulating layer 403 formed in step 5, define the pattern of the distal electrode site portion 113 and / or the proximal contact portion 111 on the second flexible insulating layer 403 by using photolithography and hard mask coating, and then use an etching process to remove the second flexible insulating layer 403 in the corresponding area 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 neural electrode 11 and the target tissue.

[0071] Step 7: On one side of the second flexible insulating layer 403 formed in step 6, define the contour of the flexible neural electrode 11 and / or the pattern of the electrode anchor 115 and / or the proximal retaining member 116 and / or the distal auxiliary implant part 114 on the second flexible insulating layer 403 by photolithography and hard mask coating, and then use an etching process to remove the first flexible insulating layer 401 and the second flexible insulating layer 403 in the corresponding area to obtain a complete contour of the flexible neural electrode 11 and / or the electrode anchor 115 and / or the proximal retaining member 116 and / or the distal auxiliary implant part 114 and related functional components.

[0072] Step 8: Remove the sacrificial layer by wet etching to release the flexible neural electrode 11.

[0073] The above steps not only achieve high-precision manufacturing, but also reduce production costs through optimization steps and significantly improve the reliability and adaptability of electrodes in complex biological environments.

[0074] In the above steps, the application of hard mask coating is an optional process, which can further improve the pattern accuracy, especially in the production process of key components such as the electrode site, electrode anchor 115, proximal retaining member 116 and distal auxiliary implant part 114 of the flexible neural electrode 11, which can ensure that the edges of the components are clear and the shapes are precise. It is particularly suitable for electrode components that require complex structures (such as thorn-like structures or hollow structures) to ensure the high precision and reliability of each functional component, but it may not be used in some embodiments.

[0075] In some embodiments, the above steps 6 and 7 can be combined into one step to improve production efficiency and reduce manufacturing complexity.

[0076] In the embodiment 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 properties and biocompatibility.

[0077] The flexible neural electrode assembly 1 according to the embodiment of the present application is capable of adapting to different implantation depths, tissue environments and target tissue target requirements. The following embodiment is used to illustrate an exemplary implantation scheme of the flexible neural electrode assembly 1 according to the embodiment of the present application with high precision and high stability. In this embodiment, the flexible neural electrode 11, the outer tube 12 and the implant traction member 13 are implanted as a whole into the target of the target tissue. Therefore, the flexible neural electrode 11, the outer tube 12 and the implant traction member 13 must first 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 implant traction member 13 through the distal auxiliary implant portion 114, so that the implant traction member 13 can provide the necessary guidance and operational 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 implanted traction member 13 are implanted into the target tissue target a, and 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 located in the same implantation direction, and the target tissue target b is shallower than the target tissue target a. Next, the implanted traction member 13 is separated from the flexible neural electrode 11 and the outer tube 12. Finally, the implanted traction member 13 is removed, and the distal electrode site portion 113 of the flexible neural electrode 11 and the distal end of the outer tube 12 are left at 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.

[0078] According to another implantation method of the flexible neural electrode assembly 1 of the embodiment of the present application, the following steps are performed in sequence: first, the flexible neural electrode 11 and the implanted traction member 13 can be assembled; using the guiding effect of the implanted traction member 13, the distal electrode site portion 113 of the flexible neural electrode 11 and the implanted traction member 13 are implanted into the target tissue target a; then the outer tube 12 is inserted from the implanted traction member 13 and the proximal end of the flexible neural electrode 11; next, the distal end of the outer tube 12 is implanted into the target tissue target b; then the implanted traction member 13 and the flexible neural electrode 11 and the outer tube 12 are separated; finally, the implanted traction member 13 is removed, and the distal electrode site portion 113 of the flexible neural electrode 11 and the distal end of the outer tube 12 are left at the target tissue target a and the target tissue target b respectively. 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 nerve electrode 11 and the outer tube 12 is ensured, the relative position of the flexible nerve electrode 11 and the outer tube 12 can be better controlled, and the mutual interference during the implantation process is reduced. The two 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 coordination and design optimization, and is particularly suitable for deep target areas that require precise positioning. The implanted traction member 13 provides the necessary mechanical support and guidance functions in this process to ensure that the flexible nerve electrode 11 and the outer tube 12 can accurately reach their respective target positions. After the implantation is completed, the implanted traction member 13 is unlocked from the flexible nerve electrode 11 and the outer tube 12 through a separation operation and withdraws from the target tissue. This step-by-step fixation method can improve the stability of the electrode and the outer tube, while reducing the disturbance to the surrounding tissue during the implantation process. It is particularly suitable for complex tissue environments that require more precise positioning, and can achieve efficient implantation through precise guidance and simplified operation.

[0079] In the case where the flexible neural electrode assembly 1 includes a flexible neural electrode 11, an outer tube 12, an implanted traction piece 13 and an auxiliary puncture sheath 16, another method for implanting the flexible neural electrode assembly can be adopted, the steps of which include in sequence: pre-assembling the flexible neural electrode 11, the outer tube 12 and the implanted traction piece 13; next, passing the distal electrode site portion 113 of the flexible neural electrode 11, the outer tube 12 and the implanted traction piece 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 implanted traction piece 13 into the target tissue target point a, and at the same time implanting the distal end of the outer tube 12 into the target tissue target point b; then, removing the auxiliary puncture sheath 16; separating the implanted traction piece 13 from the flexible neural electrode 11 and the outer tube 12, and removing the implanted traction piece 13, 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 point a and the target tissue target point b, respectively.

[0080] Figure 6 The present invention shows another method for implanting a flexible neural electrode assembly that can be used when the flexible neural electrode assembly 1 includes a flexible neural electrode 11, an outer tube 12, an implanted traction member 13, and an auxiliary puncture sheath 16, and the flexible neural electrode 11 includes a proximal retaining member 116 and the outer tube 12 includes an outer tube proximal retaining groove 123. The steps include: assembling the flexible neural electrode 11 and the implanted traction member 13 in advance; 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 neural electrode 11 and the implanted traction member 13 through the cavity of the auxiliary puncture sheath 17 into the target tissue target point a; in step (3), the outer tube 12 includes a proximal retaining member 116 and an outer tube proximal retaining groove 123. 12 is inserted from the proximal end of the implanted traction member 13 and the flexible nerve electrode 11, and the outer tube 12 (for example, the outer tube anchor 122) is implanted into the target tissue target b; in step (4), the auxiliary puncture sheath 16 is removed; in step (5), the implanted traction member 13 and the flexible nerve electrode 11 and the outer tube 12 are separated, and the implanted traction member 13 is removed, and the distal electrode site portion 113 of the flexible nerve electrode 11 and the distal end of the outer tube 12 are left at the target tissue target a and the target tissue target b respectively; in step (6), the proximal locking member 116 of the flexible nerve electrode 11 is embedded and locked through the proximal locking groove 123 of the outer tube, and the flexible nerve electrode 11 is kept in a flexed state in the cavity 121 of the outer tube 12.

[0081] The auxiliary fixing member 14, the auxiliary limiting sheath 15 or the auxiliary puncture sheath 16 have an inner diameter ranging from 0.005 mm to 10 mm and an outer diameter ranging from 0.007 mm to 15 mm, which can effectively adapt to the external 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 component 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 guide channel.

[0082] 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 a and the target b, while reducing the disturbance to the surrounding tissue. The auxiliary puncture sheath 16 is removed after the implantation is completed, thereby optimizing the operation process and implantation accuracy.

[0083] When the flexible neural electrode assembly 1 includes a flexible neural electrode 11, an outer tube 12, an implanted traction member 13 and a stimulator 17, and the stimulator 17 includes a feedthrough 171, and the electrode site of the distal electrode site portion 113 includes a stimulating electrode site, the following implantation steps can be adopted: first, the flexible neural electrode 11, the outer tube 12 and the implanted traction member 13 still need to be assembled; the distal electrode site portion 113 and the implanted traction member 13 are implanted into the target tissue target point a, and the distal end of the outer tube 12 is implanted into the target tissue target point b; the implanted traction member 13 and the flexible neural electrode 11 and the outer tube 12 are separated; the implanted traction member 13 is removed, and the distal end of the distal electrode site portion 113 and the distal end of the outer tube 12 are left at the target tissue target point a and the target tissue target point b respectively; the proximal contact portion 111 of the flexible neural electrode 11 is electrically connected with the feedthrough 171 of the stimulator 17; finally, the stimulator 17 is implanted into the target site c.

[0084] In the case where the flexible neural electrode assembly 1 includes a flexible neural electrode 11, an outer tube 12, an implanted traction member 13 and a stimulator 17, and the stimulator 17 includes a feedthrough 171, and the electrode site of the distal electrode site portion 113 includes a stimulating electrode site, the following implantation steps can also be used: first, assemble the flexible neural electrode 11 and the implanted traction member 13; assemble the distal electrode site portion 113 and the implanted traction member 13 and implant them into the target tissue target point a; insert the outer tube 12 from the proximal end of the implanted traction member 13 and the flexible neural electrode 11; implant the distal end of the outer tube 12 into the target tissue target point b; separate the implanted traction member 13 from the flexible neural electrode 11 and the outer tube 12; remove the implanted traction member 13, and leave the distal electrode site portion 113 and the outer tube 12 at the target tissue target point a and the target tissue target point b respectively; form an electrical connection between the proximal contact portion 111 and the feedthrough 171 of the stimulator 17; and implant the stimulator 17 into the target site c.

[0085] According to the flexible neural electrode assembly of the embodiment of the present application, the adaptability of the flexible neural electrode to the dynamic biological environment and the stability of long-term implantation are enhanced through the careful design of various structural and functional modules and implantation methods. Especially when implanted in areas with frequent tissue activities, the mutual stress between the flexible neural electrode and the tissue can be significantly reduced, thereby extending the service life of the flexible neural electrode.

[0086] 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.

[0087] 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, and the outer tube includes an outer tube anchor, which is used to fix 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; the outer tube has a cavity for accommodating the lead connecting part, and a relatively movable space is left between the inner wall of the cavity and the lead connecting 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: An electrode anchor is also included between the flexible neural electrode lead connection portion and the distal electrode site portion. 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 in 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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