An in vitro protection device assembly for a flexible neural electrode

Abstract

The present application provides an in vitro protection device assembly for a flexible nerve electrode. It includes a lead connection part of the flexible nerve electrode located outside the body and a protective sheath. The protective sheath can extend axially and accommodates the lead connection part in a buckled state within a tubular cavity. The protective sheath successively includes a first tube section and a second tube section from proximal to distal. The first tube section has stronger axial extensibility, and the second tube section has stronger mechanical strength. The proximal end of the first tube section forms a proximal fixing part of the protective sheath to fix the proximal end of the protective sheath to the proximal side of the lead connection part. The distal end of the second tube section forms a distal fixing part of the protective sheath to fix the distal end of the protective sheath to the distal side of the lead connection part and enables the lead connection part to extend from the target tissue to outside the body. The present application provides targeted protection for the in vitro part of the flexible nerve electrode, making it not easily aged and mechanically damaged due to external force pulling, thereby improving the performance stability of the electrode and extending its service life.

Description

Technical Field

[0001] This application belongs to the technical field of implantable medical devices, and particularly relates to an in vitro protection device assembly for a flexible nerve electrode. Background Art

[0002] As a key implantable medical device, flexible nerve electrodes are widely used in the fields of nerve signal acquisition and electrostimulation therapy, and are applicable to various clinical scenarios such as chronic disease treatment, nerve rehabilitation, and neuroscience research. The remarkable feature of flexible nerve electrodes lies in their excellent flexibility and biocompatibility, which can effectively adapt to the complex in-vivo tissue environment and significantly reduce damage to surrounding tissues. However, in practical applications, for example, in stereo-electroencephalography (SEEG) and electrocorticography (ECoG), the lead part of the flexible nerve electrode needs to extend outside the body to connect to external devices. This part of the flexible nerve electrode exposed outside the body is prone to mechanical damage or external force pulling during operation and use, affecting the performance stability and service life of the flexible nerve electrode.

[0003] Most current research on the protection methods of flexible nerve electrodes mainly focuses on the in-vivo part. For example, by optimizing the deformation performance of flexible nerve electrodes to enable them to better adapt to the dynamic environment of in-vivo tissues, but these existing technologies do not pay special attention to the special environmental requirements of the external part of the flexible nerve electrode.

[0004] Due to the fact that the external environment is more susceptible to multiple factors such as external mechanical forces, humidity, and pollution, the external part of the flexible nerve electrode is directly exposed to such an environment, facing problems such as a relatively high risk of mechanical damage, poor connection stability, and easy slippage or displacement under external forces. These problems may not only lead to a decline in the performance of the flexible nerve electrode but also affect the safety and reliability of long-term use. Existing technologies have not been able to provide a special protection design for the external part. Therefore, in practical use scenarios, the mechanical protection and connection stability of the external part of the flexible nerve electrode have not been fully solved. Summary of the Invention

[0005] In view of the above problems, this application is proposed to solve the above problems existing in the prior art.

[0006] The purpose of this application is to provide an in vitro protection device assembly for a flexible nerve electrode, which can provide protection such as environmental shielding, mechanical support, and external force dispersion for the lead connection part of the flexible nerve electrode located outside the body, making it not easily aged and mechanically damaged due to external force pulling that may occur in the external environment, thereby improving the stability of the overall performance of the flexible nerve electrode and extending its service life.

[0007] According to a first aspect of the present application, there is provided an in vitro protection device assembly for a flexible neural electrode, including a lead connection portion of the flexible neural electrode and a protective sheath. The protective sheath houses the lead connection portion in a flexed state within its tubular cavity. The protective sheath is axially extensible, and the lead connection portion and the protective sheath are located outside the body. Moreover, the protective sheath sequentially includes a first tube segment and a second tube segment from proximal to distal. The first tube segment has stronger axial extensibility relative to the second tube segment, and the second tube segment has stronger mechanical strength relative to the first tube segment. And, a proximal fixing portion of the protective sheath is formed at the proximal end of the first tube segment, and the proximal fixing portion is used to fix the proximal end of the protective sheath to the proximal side of the lead connection portion. A distal fixing portion of the protective sheath is formed at the distal end of the second tube segment, and the distal fixing portion is used to fix the distal end of the protective sheath to the distal side of the lead connection portion and enable the lead connection portion to extend from the target tissue to outside the body, where the target tissue includes at least the brain tissue.

[0008] For the in vitro protection device assembly for a flexible neural electrode according to various embodiments of the present application, an elastic protective sheath and a supporting fixing mechanism are used to isolate and fix the lead connection portion of the flexible neural electrode located outside the body. And through the segmented design of the protective sheath, the second tube segment at the distal end has higher mechanical strength, so as to better provide mechanical support and protection for the lead connection portion to extend from the target tissue to outside the body. At the same time, the first tube segment at the proximal end has better extensibility, so as to disperse the relatively large mechanical stress that may be generated by the external environment, avoid adverse effects such as aging and mechanical damage that may be brought to the flexible neural electrode, especially its lead connection portion, and can ensure that the external part will not have longitudinal displacement or loosening when subjected to external force, which can improve the operation convenience and performance stability of the flexible neural electrode, extend its overall service life, and make it have significant advantages in long-term use. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0010] Figure 1 FIG. shows a schematic structural view of an in vitro protection device assembly for a flexible neural electrode and its peripheral components according to an embodiment of the present application.

[0011] Figure 2Schematic diagram showing the socket connection method of the first pipe section and the second pipe section according to an embodiment of the present application.

[0012] Figure 3 Schematic diagram showing the assembly method of the in vitro protection device assembly for a flexible nerve electrode according to an embodiment of the present application.

[0013] Figure 4 Schematic diagram showing the installation method of the in vitro protection device assembly according to an embodiment of the present application.

[0014] 1. In vitro protection device assembly (assembly) for flexible nerve electrode; 11. Lead connection part (lead connection part) of flexible nerve electrode; 12. Protection sheath; 121. Tubular cavity; 122. First pipe section; 123. Second pipe section; 124. Proximal fixing part; 125. Distal fixing part; 13. Proximal snap part; 14. Distal snap part; 15. Contact connector; 16. Distal auxiliary fixing device; 161. Tubular channel; 2. Distal electrode site part; 3. Proximal contact part; 4. Target tissue appendage. Detailed implementation manners

[0015] To enable those skilled in the art to better understand the technical solutions of the present disclosure, the present disclosure will be described in detail below in conjunction with the accompanying drawings and specific implementation manners. The embodiments of the present disclosure will be further described in detail below in conjunction with the accompanying drawings and specific embodiments, but it is not a limitation to the present disclosure.

[0016] The "first", "second" and similar terms used in the present application do not indicate any order, quantity or importance, but are only used to distinguish different parts. The expressions "first" and "second" are only numbered for convenience of expression, and 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, which are not limited here, as long as the "first component" and the "second component" are discrete components. Further, when sufficient explanation is given in the context, the "first component" and the "second component" may not even be discrete components, may be integrated into the same component, or may be replaceable with each other.

[0017] In the present application, when it is described that a specific device is located between a first device and a second device, there may or may not be an intermediate device between the specific device and the first device or the second device. When it is described that a specific device is connected to other devices, the specific device may be directly connected to the other devices without an intermediate device, or may not be directly connected to the other devices but have an intermediate device.

[0018] Words such as "comprising" or "including" mean that the elements before this word cover the elements listed after this word, and do not exclude the possibility of also covering other elements. Words such as "upper", "lower", "left", "right", etc. are only used to represent relative positional relationships. When the absolute position of the object being described changes, the relative positional relationship may also change accordingly.

[0019] In this application, the terms "proximal" and "proximal side" are intended to represent the side close to the operator (such as a doctor) performing the flexible nerve electrode implantation operation, while the terms "distal" and "distal side" are intended to represent the side close to the target object and target tissue to which the flexible nerve electrode is to be implanted.

[0020] According to an embodiment of the present application, there is provided an in vitro protection device assembly for a flexible nerve electrode. Figure 1 The structural schematic diagram of an in vitro protection device assembly (hereinafter simply referred to as the assembly) for a flexible nerve electrode according to an embodiment of the present application and its peripheral components is shown.

[0021] As Figure 1 shown, the assembly 1 includes a lead connection part 11 of the flexible nerve electrode and a protection sheath 12, and both the lead connection part 11 and the protection sheath 12 are located outside the body. Taking the target tissue to which the flexible nerve electrode is to be implanted as the brain tissue, the whole assembly 1 is located outside the skull.

[0022] As Figure 1 shown, the protection sheath 12 accommodates the lead connection part 11 in its tubular cavity 121 in a flexed state, and the protection sheath 12 can extend axially. Protecting the lead connection part 11 inside the protection sheath 12 can effectively prevent contaminants such as moisture and dust from eroding the lead connection part 11 through the sealing design of the protection sheath 12, thereby greatly improving the reliability and stability of the flexible nerve electrode during long-term use.

[0023] More specifically, the protection sheath 12 sequentially includes a first pipe section 122 and a second pipe section 123 from proximal to distal. The first pipe section 122 has stronger axial extensibility relative to the second pipe section 123, and the second pipe section 123 has stronger mechanical strength relative to the first pipe section 122. It should be noted that although the second pipe section 123 is harder than the first pipe section 122, it should still maintain a certain degree of flexibility to avoid causing hard damage to the distal part of the lead connection part under natural or stressed states.

[0024] As Figure 1As shown, a proximal fixing portion 124 of the protective sheath 12 is formed at the proximal end of the first pipe section 122. The proximal fixing portion 124 is used to fix the proximal end of the protective sheath 12 to the proximal side of the lead connection portion 11. In addition, a distal fixing portion 125 of the protective sheath 12 is formed at the distal end of the second pipe section 123. The distal fixing portion 125 is used to fix the distal end of the protective sheath 12 to the distal side of the lead connection portion 11 and enable the lead connection portion 11 to extend from the target tissue to the outside of the body. The target tissue includes at least the brain tissue and may also be other tissues such as the spinal cord, peripheral nerves, sympathetic ganglia or vagus nerves. The present application does not make any limitation in this regard.

[0025] The in-vitro protection device assembly for a flexible nerve electrode according to an embodiment of the present application is particularly applicable to the scenario where a flexible nerve electrode is implanted into tissues such as the brain tissue and its lead connection portion needs to be led out of the body for connection to other testing devices. The in-vitro protection device assembly of the embodiment of the present application uses an elastic protective sheath and a supporting fixing mechanism to isolate and fix the lead connection portion of the flexible nerve electrode located outside the body. Through the segmented design of the protective sheath, the mechanical strength of the second pipe section at the distal end is higher, so as to better provide mechanical support and protection for the lead connection portion to extend from the target tissue to the outside of the body. At the same time, the first pipe section at the proximal end has better extensibility, so as to disperse the relatively large mechanical stress that may be generated by the in-vitro environment, avoid adverse effects such as aging and mechanical damage that may be brought to the flexible nerve electrode, especially its lead connection portion, and ensure that the in-vitro part will not have longitudinal displacement or loosening when subjected to external force, which can improve the operation convenience and performance stability of the flexible nerve electrode, extend its overall service life, and make it have significant advantages in long-term use.

[0026] In some embodiments, the first pipe section and the second pipe section may be made of the same material. Among them, the wall thickness of the second pipe section is greater than that of the first pipe section. Generally, the thicker the wall, the stronger the mechanical strength. Only as an example, the second pipe section may be made of thermoplastic polyurethane or silica gel with higher hardness, and the wall thickness ranges from 0.1 mm to 5 mm to ensure sufficient support and durability while meeting the use requirements of the long-term in-vitro environment.

[0027] In other embodiments, the first pipe section and the second pipe section may also be made of different materials, and the material hardness of the second pipe section is higher than that of the first pipe section. The specific materials are not specifically limited in the present application.

[0028] By way of example only, the first pipe segment can be made of a material with high flexibility and low coefficient of friction, such as silicone, rubber or polyurethane. The diameter range can be designed to be from 0.5 mm to 50 mm, and the wall thickness range is from 0.1 mm to 5 mm to accommodate flexible nerve electrodes of different specifications. The second pipe segment can use the same material as the first pipe segment and be strengthened by increasing the wall thickness, or can use different materials, such as thermoplastic polyurethane or polyethylene with higher hardness, and the wall thickness is equivalent to or greater than that of the first pipe segment, so as to provide additional support in terms of mechanical strength.

[0029] Through the testing, recording and statistical analysis of the typical application scenarios of the flexible nerve electrode in this application, the maximum extension ratio of the protective sheath in the axial direction should be not less than 10%. In this way, the demand for stress dispersion caused by external force pulling in most cases in the in vitro environment can be met.

[0030] In some embodiments, there may be no additional joint between the first pipe segment and the second pipe segment, and it is achieved in an integrally formed manner. In addition, in the case of integral forming of the pipe segments, the second pipe segment may have a certain gradual transition in the proximal part, for example, by gradually adjusting the wall thickness or gradually adjusting the material hardness to achieve a gradual change in axial extensibility and mechanical strength, and at the same time, it can also reduce the influence of the hard boundary on the lead connection part in the tubular cavity of the protective sheath. In other embodiments, the first pipe segment and the second pipe segment can also be connected by bonding, such as using medical-grade epoxy resin, UV-curing glue or silicone glue as the adhesive to achieve a high-strength and high-reliability connection.

[0031] Figure 2 The figure shows a schematic diagram of the socket connection mode of the first pipe segment and the second pipe segment according to the embodiment of the present application. In some embodiments, the first pipe segment and the second pipe segment can also be connected by socketing. When using the socket connection mode, the second pipe segment is socketed outside the distal end of the first pipe segment, or conversely, the first pipe segment is socketed outside the distal end of the second pipe segment. Both methods are acceptable, and the proximal end of the second pipe segment and the distal end of the first pipe segment can be fixed to each other or not fixed to each other. Figure 2 The figure shows the case where the second pipe segment 123 is socketed outside the distal end of the first pipe segment 122, and the proximal end of the second pipe segment and the distal end of the first pipe segment are not fixed to each other, and, from Figure 2As can be seen, the distal end of the first pipe section 122 is fixedly connected to the distal end fixing part 125 of the protection sheath 12. In this way, although there is no direct fixing structure between the first pipe section 122 and the second pipe section 123, they are actually indirectly fixed through the distal end fixing part 125. In this design, the distal end fixing part 125 serves as a common fixing point, providing support for the distal ends of the first pipe section 122 and the second pipe section 123 respectively. Compared with directly fixing the two pipe sections, a key function of this design is that even when the second pipe section 123 is relatively long, the overall tensile performance of the protection sheath 12 will not be affected, and it can still ensure that the protection sheath 12 as a whole has good axial extension performance. Therefore, by adopting the indirect fixing method of the two pipe sections as shown in Figure 3, the first pipe section 122 can be ensured not to be affected by the length and hardness of the second pipe section during stretching, so as to meet the index requirements of the maximum extension ratio of the protection sheath 12 in the axial direction.

[0032] Back to Figure 1 , it can be seen that when the proximal end of the protection sheath 12 is fixedly connected to the proximal side of the lead connection part 11 via the proximal end fixing part 124, and the distal end of the protection sheath 12 is fixedly connected to the distal side of the lead connection part 11 via the distal end fixing part 125, the lead connection part 11 is completely accommodated inside the tubular cavity 121, and even when the protection sheath 12 undergoes maximum stretching, the lead connection part 11 can still maintain a buckled state. During the deformation process of the protection sheath 12, the lead connection part 11 can freely slide inside the tubular cavity 121. This buckled state allows the lead connection part 11 to retain a certain amount of deformation inside the protection sheath, so as to disperse stress through sliding when external mechanical stress acts, and even when the protection sheath 12 has reached the tensile limit under external force, it can still avoid directly applying force to the flexible nerve electrode body. This design ensures the long-term stability of the flexible nerve electrode after implantation and provides an effective protection effect.

[0033] In some embodiments, a biocompatible coating (not shown) may be provided on the inner surface of the tubular cavity 121 to reduce the friction between the lead connection part 11 and the inner surface of the tubular cavity 121 during free sliding inside the tubular cavity 121, slow down the aging of the lead connection part 11 during use, and thus further extend the service life of the component 1.

[0034] Figure 3 The schematic diagram shows the assembly method of the in vitro protection device assembly for the flexible nerve electrode according to the embodiment of the present application. As Figure 3 shown, in some embodiments, the component 1 may further include a proximal snap part 13. The proximal snap part 13 is fixedly connected to the proximal side of the lead connection part 11, and the proximal snap part 13 is engaged with the proximal end fixing part 124 of the protection sheath 12 to fixedly connect the proximal end of the protection sheath 12 to the proximal side of the lead connection part 11.

[0035] In some embodiments, before the distal electrode site portion 2 of the flexible nerve electrode is implanted into the target tissue, the proximal snap portion 13 and the proximal fixing portion 124 are pre-fixed and connected. This pre-preliminary fixing method enables the protective sheath 12 to provide basic structural stability throughout the implantation process through the cooperation between the proximal snap portion 13 and the proximal fixing portion 124. The advantage of this method is that it can make the implantation operation simpler and more precise, reducing the risk of improper cooperation that may occur during the implantation process.

[0036] In some other embodiments, the proximal snap portion 13 and the proximal fixing portion 124 can also be fixedly connected after the distal electrode site portion 2 of the flexible nerve electrode is implanted into the target tissue.

[0037] As Figure 3 shown, the component 1 can further include a distal snap portion 14. The distal snap portion 14 is fixedly connected to the distal end of the lead connection portion 11, and the distal snap portion 14 can be engaged with the distal fixing portion 125 to fix the distal end of the protective sheath 12 to the distal end of the lead connection portion 11.

[0038] On this basis, the distal snap portion 14 can further be provided with a seal (not shown) so that after the distal fixing portion 125 and the distal snap portion 14 are fixed, the distal snap portion 14 can be sealed with the lead connection portion 11. In addition, the distal snap portion 14 can move axially along the lead connection portion 11. Specifically, in implementation, for example, the distal snap portion 14 can be connected to the lead connection portion 11 through an adjustable axial device (not shown), thereby enabling the operator to move the distal snap portion 14 manually or mechanically to slide it axially along the lead connection portion 11. Through this design, the operator can adjust the implantation depth according to the implantation path before and during the implantation of the flexible nerve electrode, so as to precisely control the fixing position of the distal snap portion 14, and further control the precise position of the flexible nerve electrode in the target tissue. Specifically, the position of the distal snap portion 14 can be adjusted before the flexible nerve electrode is implanted so that an appropriate distance is maintained between the distal snap portion 14 and the surface of the target tissue, avoiding the flexible nerve electrode from penetrating too deeply or deviating from the target area. And once the distal electrode site portion 2 of the flexible nerve electrode is successfully implanted into the target tissue, the distal snap portion 14 will provide stable mechanical anchoring for the component 1.

[0039] The above-mentioned seal can be arranged, for example, inside and at the outer edge of the distal snap part 14, and its material can be selected from silicone, thermoplastic polyurethane or other biocompatible materials with elasticity and resilience. The structure of the seal is designed to be annular, gasket-shaped or conical, and can form a tight fit through radial or axial compression when the distal fixing part 125 of the protection sheath 12 is sleeved and fixed to the distal snap part 14. This seal can effectively isolate external moisture, dust and other pollutants from entering the inside of the protection sheath and prevent body fluids such as cerebrospinal fluid from flowing out. At the same time, the design of this seal further ensures that the distal snap part 14 and the distal fixing part 125 of the protection sheath 12 can be firmly connected, thereby enhancing the stability and service life of the device. This sealed and elastic structure exhibits excellent protective performance for flexible nerve electrodes in a dynamic external force environment. Even when subjected to tensile or bending stress, the sealing performance of the protection sheath will not be damaged, further ensuring the safety of the lead connection part.

[0040] In some embodiments, for example, before implanting the distal electrode site part 2 of the flexible nerve electrode into the target tissue, the distal snap part 14 and the distal fixing part 125 can be fixedly connected in advance. In other embodiments, the distal snap part 14 and the distal fixing part 125 can also be constructed as an integral structure. Through this integrated design, the connection interface between the distal snap part 14 and the distal fixing part 125 is eliminated, the overall structure of the component 1 is simplified, the assembly steps are reduced, the complexity during implanting into the target tissue is lowered, and at the same time, the connection stability and sealing performance of the device are further improved.

[0041] In other embodiments, it can also be as Figure 3 shown. First, implant the distal electrode site part 2 into the target tissue, and then, fixedly connect the distal snap part 14 and the distal fixing part 125 (as shown in step S1 in Figure 3 ). When the distal electrode site part 2 is implanted into the target tissue and the distal snap part 14 and the distal fixing part 125 are fixedly connected, the proximal end of the protection sheath 12 can be further stretched, and the proximal fixing part 124 of the protection sheath 12 can be fixed to the proximal snap part 13 (as shown in step S2 in Figure 3 ). After that, release the protection sheath 12 (as shown in step S3 in Figure 3 ), and it can be seen that the protection sheath 12 will automatically shrink to the natural state without being under tension (as shown in step S4 in Figure 3 ), thereby completing the installation of the component 1. It can be seen from Figure 3 that in the state where the component 1 is installed and not under external tensile force, the lead connection part 11 is accommodated inside the tubular cavity 121 of the protection sheath 12 in a buckled state.

[0042] During the use of Component 1 according to the embodiments of the present application, the assembly and fixation of the protection sheath 12 with other components are key steps to achieve mechanical protection and signal stability. Before implantation, the distal fixation portion 125 and the distal snap portion 14 of the protection sheath 12 are in a separated state, and the proximal fixation portion 124 and the proximal snap portion 13 are also not fixed. At this time, each component of Component 1 is in an independent state, providing sufficient flexibility for subsequent implantation operations. The operator can select the specific sequence of assembly and fixation according to the specific implantation site, operating habits, etc., and the present application does not limit this.

[0043] As Figure 3 shown, in some embodiments, Component 1 may further include a contact connector 15, and the contact connector 15 forms an electrical connection with the proximal contact portion 3 of the flexible nerve electrode. The contact connector 15 is designed as an independent electrical connection component and can be connected to an external device by plugging or clamping, ensuring that electrical signals can be transmitted from the recording or stimulating electrode site portion of the flexible nerve electrode to the external device. As described above, when Component 1 includes a proximal snap portion 13, the proximal snap portion 13 is fixedly connected to the proximal side of the lead connection portion 11, and the proximal snap portion 12 is engaged with the proximal fixation portion 124 of the protection sheath 12 to fix the proximal side of the protection sheath 12 to the proximal side of the lead connection portion 11, the contact connector 15 and the proximal snap portion 13 are integrated into one structure. In this way, not only the component structure is simplified, but also the tight fit between the proximal snap portion 13 and the proximal fixation portion 124 is enhanced, protecting the contacts of the flexible nerve electrode from the external environment, ensuring the stability of the connection and the anti-external force ability, and further improving the stability of the connection.

[0044] Figure 4 Shows a schematic diagram of the installation method of the in vitro protection device component according to the embodiments of the present application.

[0045] In some embodiments, Component 1 (partially shown) may further include a distal auxiliary fixation device 16, and the distal auxiliary fixation device 16 is fixedly connected to the target tissue appendage 4 by means such as screw anchoring, adhesion fixation, etc. For example, when the target tissue is the brain tissue, the target tissue appendage 4 may be the skull, for example. When the target tissue is other parts, the corresponding target tissue appendage 4 may also be other parts or structures, and the present application does not limit this. The distal auxiliary fixation device 16 provides an additional anchor point to ensure that the flexible nerve electrode can be accurately controlled during implantation, while further enhancing the stability of the distal snap portion 14, preventing any displacement or loosening after implantation, and also ensuring the best fit of the protection sheath 12 and the flexible nerve electrode after implantation. In addition, the above design can enable the flexible nerve electrode to flexibly adapt to different implantation paths and target tissue types, ensure that the flexible nerve electrode is always in the correct position, and provide reliable guarantee for subsequent signal acquisition or electrical stimulation.

[0046] As shown Figure 4 in FIG. Figure 4 , the distal auxiliary fixation device 16 has a tubular channel 161 that penetrates from outside the body to inside the body at a preset angle, so as to provide an implantation path for the flexible nerve electrode and guide the distal electrode site portion 2 to accurately pass through the tubular channel and then implant into the target tissue. The tubular channel 161 longitudinally penetrates the entire device, extending from outside the body to the entrance position of the target tissue, so that the flexible nerve electrode can maintain a stable guiding state during the implantation process, reducing the possibility of lateral deviation or bending.

[0047] In some embodiments, the tubular channel 161 serves as the guiding structure of the distal auxiliary fixation device 16, so that the lead connection portion 11 penetrates out of the body at its preset angle after implantation and extends in a manner that leaves the target tissue appendage 4. The above preset angle can be, for example, approximately 90 degrees, that is, the tubular channel 161 is nearly perpendicular to the target tissue appendage 4 on which it is installed. In other embodiments, the specific angle when the tubular channel 161 penetrates can also be determined in association with the specific position of the target tissue to be implanted by the component 1, the tissue anatomical requirements, and the shape of the target tissue appendage 4, etc., so as to facilitate the operation and application of the component 1. The present application does not make specific limitations on this.

[0048] In some embodiments, the distal auxiliary fixation device 16 can be first fixed to the target tissue appendage 4, and then other components in the component 1 are connected to it. That is to say, the distal auxiliary fixation device 16 enhances the connection stability between the flexible nerve electrode and the target tissue appendage 4 by providing an additional fixed fulcrum for the flexible nerve electrode, especially the component 1, and can ensure that the flexible nerve electrode will not be displaced or damaged due to external forces or other factors during long-term use after implantation, achieving a more stable positioning and protection effect of the flexible nerve electrode. In addition, the distal auxiliary fixation device 16 is also used to precisely control the implantation position, direction, and depth of the flexible nerve electrode before implantation and ensure that the distal buckle portion 14 always remains outside the target tissue.

[0049] Taking the target tissue appendage 4 as the skull as an example, the outer side of the distal auxiliary fixation device 16 can, for example, have threads for screwing into the surface layer of the skull without entering the brain tissue, ensuring the stable fixation of the flexible nerve electrode during the implantation operation and providing an accurate implantation channel. To ensure a good guiding effect, the longitudinal length of the tubular channel 161 should not be too short. For example, it can be set to not less than 20 mm, so as to effectively constrain the implantation trajectory of the electrode during the implantation of the flexible electrode and provide sufficient support and guiding effect for it.

[0050] In some embodiments, after the target tissue is implanted at the distal electrode site portion 2, the distal fixing portion 125 can be fixedly connected to the distal auxiliary fixing device 16. Further, the distal fixing portion 125 is also provided with a seal (not shown) for enabling overall sealing between the protection sheath 12, the distal auxiliary fixing device 16, and the lead connection portion 11 after the distal fixing portion 125 is fixedly connected to the distal auxiliary fixing device 16, and for sealing and covering the lead connection portion 11 inside the protection sheath 12. By forming a closed space in the structure, it is possible to prevent external contaminants from entering the target tissue along the tubular channel 161 of the distal auxiliary fixing device 16, and at the same time, it is also possible to prevent body fluid leakage, meeting the use requirements in complex environments.

[0051] As Figure 4 shown, when the assembly 1 includes a distal snap portion 14, the distal snap portion 14 is fixedly connected to the distal side of the lead connection portion 11 and engages with the distal fixing portion 125, thereby fixing the distal end of the protection sheath 12 to the distal side of the lead connection portion 11, and the assembly 1 further includes a distal auxiliary fixing device 16 and is fixedly connected to a target tissue accessory 4 such as the skull, etc., after the distal electrode site portion 2 of the flexible nerve electrode is implanted into the target tissue, the distal fixing portion 125 can be fixedly connected to both the distal snap portion 14 and the distal auxiliary fixing device 16. That is to say, on the distal side, the following steps can be performed: Step SS1: Fix the distal auxiliary fixing device 16 to the target tissue accessory 4; Step SS2: Implant the distal electrode site portion 2 of the flexible nerve electrode into the target tissue; Step SS3: Fix the distal snap portion 14 to the distal auxiliary fixing device 16; Step SS4: Fix the distal fixing portion 125 to both the distal snap portion 14 and the distal auxiliary fixing device 16. Among them, Step SS3 and Step SS4 can be combined into one step, that is, fixedly connect the distal fixing portion 125 of the protection sheath 12 to the distal snap portion 14 and the distal auxiliary fixing device 16 at one time. The operation on the proximal side is similar to the description in combination with Figure 3 and mainly includes stretching the proximal end of the protection sheath 12, fixing the proximal fixing portion 124 of the protection sheath 12 to the proximal snap portion 13, and then releasing the protection sheath 12 so that the lead connection portion 11 of the flexible nerve electrode is accommodated inside the tubular cavity 121 of the protection sheath 12 in a flexed state.

[0052] In some other embodiments, the protective sheath 12 proximal to the component 1 can be first assembled and fixed to each of the other components, and finally the components distal to the component 1 are assembled. Finally, the complete sealed installation of the component 1 is completed. The specific steps include: Step 1: Fix the proximal fixing portion 124 of the protective sheath 12 to the proximal snap portion 13; Step 2: Fix the distal auxiliary fixing device 16 to the target tissue appendage 4; Step 3: Implant the distal electrode site portion 2 of the flexible nerve electrode into the target tissue; Step 4: Stretch the distal end of the protective sheath 12, and fix the distal fixing portion 125 of the protective sheath 12 to the distal snap portion 14 and the distal auxiliary fixing device 16; Step 5: Release the protective sheath 12 so that the lead connection portion 11 of the flexible nerve electrode is accommodated in the tubular cavity 121 of the protective sheath 12 in a flexed state.

[0053] In addition, the distal snap portion 14 may further be provided with a seal (not shown) so that after the distal fixing portion 125 is fixedly connected to the distal snap portion 14 and the distal auxiliary fixing device 16, the lead connection portion 11 can be hermetically wrapped inside the protective sheath 12.

[0054] By stretching the protective sheath 12, the operator can fix the proximal fixing portion 124 of the protective sheath 12 to the proximal snap portion 13 and fix the distal fixing portion 125 of the protective sheath 12 to the distal snap portion 14. These processes ensure the reliable connection between the protective sheath 12 and the flexible nerve electrode, and the stretched protective sheath 12 can completely cover the lead connection portion 11.

[0055] According to the in vitro protection device assembly of the embodiments of the present application, through the special design of the protective sheath and the cooperation with the components of the flexible nerve electrode, as well as the optimized design and precise cooperation of the connection method and the fixing process between the protective sheath and the flexible nerve electrode, not only the operation steps are simplified, but also the comprehensive protection effect on the in vitro part after the implantation of the flexible nerve electrode is greatly improved. At the same time, the stability and safety of the electrode operation and use are enhanced, providing a reliable guarantee for its long-term use in complex environments.

[0056] The width of each part of the flexible nerve electrode according to the embodiments of the present application is designed to be 100 μm to 10 mm, and the thickness is controlled below 0.2 mm. To meet different functional requirements, the width of the flexible nerve electrode can vary at different positions. For example, the lead connection portion is narrower to reduce the occupied space, while the distal electrode site portion is wider to enhance the anchoring effect in the body. The specific dimensions of each part are not limited in the present application.

[0057] In some embodiments, the distal electrode site portion of the flexible neural electrode may, for example, include at least one stimulation electrode site and / or one recording electrode site. The maximum diameter of the stimulation electrode site is not less than 100 μm to ensure sufficient electrical stimulation coverage. The number of stimulating flexible neural electrodes can be set to 1 to 100 according to actual needs. At the same time, the stimulation electrode site also has the function of recording local field points. The maximum diameter of the recording electrode site is not more than 100 μm, which is suitable for high-precision neural signal recording. The number of recording flexible neural electrodes is 1 to 1000, and the recording electrode site is mainly involved in recording single-cell action potential signals. These flexible neural electrode sites are electrically connected to the proximal contact portion through a lead connection portion. The metal conductive layer of the lead connection portion is made of metals with excellent biocompatibility such as gold, platinum or iridium to ensure efficient conduction performance.

[0058] The flexible neural electrode according to the embodiment of the present application is constructed as a stacked structure along the thickness direction, for example, it may include a first insulating layer, a second insulating layer, and a metal conductive layer located between the first insulating layer and the second insulating layer. In addition, the first insulating layer and / or the second insulating layer are not provided at the electrode site of the distal electrode site portion of the flexible neural electrode in the embodiment of the present application.

[0059] Furthermore, according to the embodiment of the present application, the flexible neural electrode adopts a multi-layer structure design, and the metal conductive layer between the first insulating layer and the second insulating layer includes a first metal conductive layer arranged in contact with the first insulating layer and a second metal conductive layer arranged in contact with the second insulating layer. In order to ensure the electrical isolation between the conductive layers and the flexible stability of the overall structure, a third insulating layer can also be arranged between the first metal conductive layer and the second metal conductive layer in the thickness direction of the lead connection part, which can also increase the mechanical flexibility of the flexible neural electrode and ensure that the flexible neural electrode does not cause additional mechanical stress to the neural tissue during implantation.

[0060] In addition, the design can be further optimized so that both the first metal conductive layer and the second metal conductive layer can be set as multiple parallel conductive paths. These conductive paths are isolated by a fourth flexible insulating layer to ensure the electrical independence and stability of each conductive path. Among them, multiple first metal conductive layers are arranged in parallel, and a fourth flexible insulating layer is arranged between adjacent first metal conductive layers; similarly, multiple second metal conductive layers are arranged in parallel, and the fourth flexible insulating layer is also arranged between adjacent second metal conductive layers. This design enables the flexible neural electrode to support multi-channel signal transmission at the same time, improving its adaptability in complex neural signal stimulation and recording applications.

[0061] In some embodiments, each insulating layer can be made of, for example, one or a combination of SU-8 photoresist, parylene, poly-p-xylene, fluorinated polymer, or polyimide, so as to balance excellent mechanical properties and biocompatibility. Specifically, as a commonly used lithography material, SU-8 photoresist has high mechanical strength and good biocompatibility, and is suitable for manufacturing flexible neural electrodes in the microelectronics field; poly-p-xylene and polyimide, as thermoplastic materials, have good chemical stability, heat resistance, and mechanical properties; fluorinated polymer materials have stronger corrosion resistance and electrical insulation properties, and are suitable for long-term use in complex biological environments. These flexible insulating layers can not only effectively isolate the metal conductive layer of the flexible neural electrode, but also enable the flexible neural electrode to make good contact with nerve tissue after implantation, avoiding tissue damage and displacement of the flexible neural electrode caused by excessive rigidity of the flexible neural electrode. At the same time, the biocompatibility of these materials ensures that the flexible neural electrode can be stably used in the body for a long time without having a negative impact on the surrounding tissues.

[0062] At the distal end of the flexible neural electrode in the embodiments of the present application, the stimulating electrode site and / or the recording electrode site can selectively not be provided with the first flexible insulating layer and / or the second flexible insulating layer, so as to directly expose the metal conductive layer.

[0063] In some embodiments, the metal conductive layer of the flexible neural electrode can use highly conductive materials, such as metal materials like gold, platinum, iridium, etc., to ensure that the flexible neural electrode has excellent conductivity and biocompatibility when performing electrical stimulation and signal recording. These materials have good stability after long-term in-vivo implantation, are not likely to cause biocompatibility problems, and can effectively avoid the decline in electrical performance between the flexible neural electrode and the surrounding tissues.

[0064] In addition, although exemplary embodiments have been described herein, the scope includes any and all embodiments based on the present disclosure having equivalent elements, modifications, omissions, combinations (e.g., schemes that cross various embodiments), adaptations, or alterations. The elements in the claims will be broadly interpreted based on the language employed in the claims and are not limited to the examples described in this specification or during the implementation of the present application, and the examples will be interpreted as non-exclusive. Therefore, this specification and the examples are intended to be considered only as examples, and the true scope and spirit are indicated by the claims and the full scope of their equivalents.

[0065] The foregoing description is intended to be illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. For instance, other embodiments may be utilized by those of ordinary skill in the art upon reading the above description. Additionally, in the above detailed description, various features may be grouped together to simplify the disclosure. This should not be construed as an intention that any non-claimed disclosed feature is necessary for any claim. On the contrary, the subject matter of the present invention may be less than all of the features of a particular disclosed embodiment. Thus, the claims are hereby incorporated into the detailed description by way of example or embodiment, where each claim stands on its own as a separate embodiment, and it is contemplated that these embodiments may be combined with each other in various combinations or permutations. The scope of the present invention should be determined with reference to the claims and the full scope of equivalents to which such claims are entitled.

Claims

1. An in vitro protection device assembly for a flexible neural electrode, characterized in that, Comprising a lead connection part and a protective sheath of a flexible nerve electrode, the protective sheath accommodating the lead connection part in a buckled state in its tubular cavity, the protective sheath being axially extensible, and the lead connection part and the protective sheath being located outside the body; and, The protective sheath sequentially includes a first tube section and a second tube section from proximal to distal, the first tube section having stronger axial extensibility relative to the second tube section, and the second tube section having stronger mechanical strength relative to the first tube section; and, A proximal fixing part of the protective sheath is formed at the proximal end of the first tube section, and the proximal fixing part is used to fix the proximal end of the protective sheath to the proximal side of the lead connection part; a distal fixing part of the protective sheath is formed at the distal end of the second tube section, and the distal fixing part is used to fix the distal end of the protective sheath to the distal side of the lead connection part and enable the lead connection part to extend outside the body for connecting an external device; The extracorporeal protection device assembly further includes a distal auxiliary fixing device, the distal auxiliary fixing device being fixedly connected to a target tissue accessory mechanism, the target tissue including at least the brain tissue, and the target tissue accessory mechanism including at least the skull.

2. The in vitro protection device assembly according to claim 1, wherein The first tube section and the second tube section are made of the same material, wherein the wall thickness of the second tube section is greater than that of the first tube section; or, the first tube section and the second tube section are made of different materials, and the material hardness of the second tube section is higher than that of the first tube section.

3. The in vitro protection device assembly according to claim 1 or 2, characterized in that The first tube section and the second tube section are integrally formed, or are connected by an adhesive method, or are connected by a sleeving method.

4. The in vitro protection device assembly according to claim 3, characterized in that, In the case where the first tube section and the second tube section are connected by a sleeving method, the second tube section is sleeved outside the distal end of the first tube section, or the first tube section is sleeved outside the distal end of the second tube section; and, The proximal end of the second tube section and the distal end of the first tube section are fixed to each other or not fixed to each other.

5. The in vitro protection device assembly according to claim 4, wherein The distal end of the first tube section is fixedly connected to the distal fixing part of the protective sheath.

6. The in vitro protection device assembly according to claim 1 or 2, characterized in that In the case where the proximal end of the protective sheath is fixed to the proximal side of the lead connection part via the proximal fixing part, and the distal end of the protective sheath is fixed to the distal side of the lead connection part via the distal fixing part, the lead connection part is completely accommodated inside the tubular cavity and is in a buckled state, and can freely slide inside the tubular cavity during the deformation process of the protective sheath.

7. The in vitro protection device assembly according to claim 6, wherein A biocompatible coating is provided on the inner surface of the tubular cavity to reduce the friction between the lead connection part and the inner surface of the tubular cavity when the lead connection part freely slides inside the tubular cavity.

8. The in vitro protection device assembly according to claim 1 or 2, characterized in that, The maximum extension ratio of the protective sheath in the axial direction is not less than 10%.

9. The in vitro protection device assembly according to claim 1 or 2, characterized in that, The extracorporeal protection device assembly further includes a proximal snap part, the proximal snap part being fixed to the proximal side of the lead connection part, and the proximal snap part being engaged with the proximal fixing part of the protective sheath to fix the proximal end of the protective sheath to the proximal side of the lead connection part.

10. The in vitro protection device assembly according to claim 9, wherein, Before the distal electrode site part of the flexible nerve electrode is implanted into the target tissue, the proximal snap part and the proximal fixing part are pre-fixed and connected.

11. The in vitro protection device assembly according to claim 9, characterized in that, After the distal electrode site part of the flexible nerve electrode is implanted into the target tissue, the proximal snap part and the proximal fixing part are fixedly connected again.

12. The in vitro protection device assembly according to claim 1, wherein, The extracorporeal protection device assembly further includes a distal snap portion, the distal snap portion is fixedly connected to the distal side of the lead connection portion, and the distal snap portion can be engaged with the distal fixing portion to fix the distal end of the protection sheath to the distal side of the lead connection portion.

13. The in vitro protection device assembly according to claim 12, characterized in that, The distal snap portion is provided with a seal so that after the distal fixing portion is fixed to the distal snap portion, the distal snap portion and the lead connection portion are sealed.

14. The in vitro protection device assembly according to claim 12 or 13, characterized in that, The distal snap portion can move axially along the lead connection portion.

15. The in vitro protection device assembly according to claim 12 or 13, characterized in that, Before the distal electrode site portion of the flexible nerve electrode is implanted into the target tissue, the distal snap portion and the distal fixing portion are pre-fixed and connected.

16. The in vitro protection device assembly according to claim 15, wherein The distal snap portion and the distal fixing portion are constructed as an integral structure.

17. The in vitro protection device assembly according to claim 12 or 13, characterized in that, After the distal electrode site portion of the flexible nerve electrode is implanted into the target tissue, the distal snap portion and the distal fixing portion are fixedly connected again.

18. The in vitro protection device assembly according to claim 1, characterized in that, The distal auxiliary fixing device has a tubular channel that penetrates from outside the body to inside the body at a preset angle, so as to guide the distal electrode site portion of the flexible nerve electrode to pass through the tubular channel and then be implanted into the target tissue.

19. The in vitro protection device assembly according to claim 1 or 18, characterized in that, After the distal electrode site portion is implanted into the target tissue, the distal fixing portion is fixedly connected to the distal auxiliary fixing device.

20. The in vitro protection device assembly according to claim 19, wherein, The distal fixing portion is provided with a seal so that after the distal fixing portion is fixedly connected to the distal auxiliary fixing device, the lead connection portion is hermetically wrapped inside the protection sheath.

21. The in vitro protection device assembly according to claim 1 or 2, characterized in that, The extracorporeal protection device assembly further includes a distal snap portion, the distal snap portion is fixedly connected to the distal side of the lead connection portion, and the distal snap portion can be engaged with the distal fixing portion to fix the distal end of the protection sheath to the distal side of the lead connection portion; The extracorporeal protection device assembly further includes a distal auxiliary fixing device, the distal auxiliary fixing device is fixedly connected to the target tissue accessory mechanism, and the target tissue accessory mechanism at least includes the skull; After the distal electrode site portion is implanted into the target tissue, the distal fixing portion is fixedly connected to both the distal snap portion and the distal auxiliary fixing device.

22. The in vitro protection device assembly according to claim 21, wherein, The distal snap portion is provided with a seal so that after the distal fixing portion is fixedly connected to both the distal snap portion and the distal auxiliary fixing device, the lead connection portion is hermetically wrapped inside the protection sheath.

23. The in vitro protection device assembly according to claim 1 or 2, characterized in that, The extracorporeal protection device assembly further includes a contact connector, and the contact connector forms an electrical connection with the proximal contact portion of the flexible nerve electrode.

24. The in vitro protection device assembly according to claim 23, wherein, The extracorporeal protection device assembly further includes a proximal snap portion, the proximal snap portion is fixedly connected to the proximal side of the lead connection portion, and the proximal snap portion is engaged with the proximal fixing portion of the protection sheath to fix the proximal end of the protection sheath to the proximal side of the lead connection portion; The proximal snap portion and the contact connector are an integral structure.

25. The in vitro protection device assembly according to claim 1 or 2, characterized in that, The flexible nerve electrode is constructed as a laminated structure in the thickness direction, including a first insulating layer, a second insulating layer, and a metal conductive layer located between the first insulating layer and the second insulating layer.

26. The in vitro protection device assembly according to claim 25, wherein At the electrode site of the distal electrode site portion of the flexible nerve electrode, the first insulating layer and / or the second insulating layer are not provided.

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