In-vitro protection device assembly for flexible neural electrode

Abstract

The application provides an in vitro protection device assembly for a flexible neural electrode. Comprising a lead connecting part of a flexible neural electrode located in vitro and a protective sheath, the protective sheath can extend axially, and the lead connecting part is contained in the tubular cavity in a buckling state; the protective sheath sequentially comprises a first pipe section and a second pipe section from near to far, the first pipe section has higher axial extensibility, and the second pipe section has higher mechanical strength; a near-end fixing part of the protective sheath is formed at the near end of the first tube section, and the near end of the protective sheath is fixed with the near side of the lead connecting part; a far-end fixing part of the protective sheath is formed at the far end of the second tube section, the far end of the protective sheath is fixed with the far side of the lead connecting part, and the lead connecting part extends out of the body from the target tissue. Targeted protection is provided for the in-vitro part of the flexible neural electrode, so that the flexible neural electrode is not prone to aging and mechanical damage caused by external force traction, the performance stability of the electrode is improved, and the service life of the electrode is prolonged.

Description

Technical Field

[0001] The present application belongs to the technical field of implantable medical devices, and in particular, relates to an in vitro protective device assembly for flexible neural electrodes. Background Art

[0002] As a key implantable medical device, flexible neural electrodes are widely used in the field of neural signal acquisition and electrical stimulation therapy, and are suitable for a variety of clinical scenarios such as chronic disease treatment, neurorehabilitation and neuroscience research. The notable features of flexible neural electrodes are their excellent flexibility and biocompatibility, which can effectively adapt to the complex tissue environment in the body and significantly reduce damage to surrounding tissues. However, in practical applications, such as stereo-electroencephalography (SEEG) and electrocorticography (ECoG), the lead part of the flexible neural electrode needs to be extended outside the body to connect to external devices. This part of the flexible neural electrode exposed to the outside of the body is susceptible to mechanical damage or external force pulling during operation and use, affecting the performance stability and service life of the flexible neural electrode.

[0003] Most of the current research on the protection methods of flexible neural electrodes focuses on the in vivo part, such as optimizing the deformation properties of flexible neural electrodes to enable them to better adapt to the dynamic environment of in vivo tissues. However, these existing technologies do not pay special attention to the special environmental requirements of the in vitro part of the neural electrodes.

[0004] Since the in vitro environment is more susceptible to external mechanical forces, humidity, pollution and other factors, the external part of the flexible neural electrode is directly exposed to such an environment, facing high risk of mechanical damage, poor connection stability, easy slippage or displacement under external force and other problems. These problems may not only lead to performance degradation of the flexible neural electrode, but also affect the safety and reliability of long-term use. The existing technology has not yet provided a special protection design for the external part. Therefore, in actual usage scenarios, the mechanical protection and connection stability of the external part of the flexible neural electrode have not been fully solved. Summary of the invention

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

[0006] The purpose of the present application is to provide an in vitro protective device assembly for a flexible neural electrode, which can provide environmental shielding, mechanical support, external force dispersion and other protective functions for the lead connection part of the flexible neural electrode located outside the body, so that it is not easily aged and mechanically damaged by external force pulling that may be generated in the in vitro environment, thereby improving the stability of the overall performance of the flexible neural electrode and extending its service life.

[0007] According to the first scheme of the present application, an in vitro protection device assembly for a flexible neural electrode is provided, comprising a lead connection part and a protective sheath of the flexible neural electrode, wherein the protective sheath accommodates the lead connection part in a tubular cavity thereof in a bent state, the protective sheath can extend axially, and the lead connection part and the protective sheath are located outside the body; and the protective sheath comprises a first tube segment and a second tube segment in sequence from near to far, the first tube segment has a stronger axial extensibility than the second tube segment, and the second tube segment has a stronger mechanical strength than the first tube segment; and a proximal fixing part of the protective sheath is formed at the proximal end of the first tube segment, 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; and a distal fixing part of the protective sheath is formed at the distal end of the second tube segment, 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 allows the lead connection part to extend from a target tissue to outside the body, and the target tissue at least includes brain tissue.

[0008] According to the in vitro protection device assembly for flexible neural electrodes of various embodiments of the present application, an elastic protective sheath and a matching fixing mechanism are used to isolate and fix the lead connection part of the flexible neural electrode located outside the body of the body, and the segmented design of the protective sheath makes the second tube segment at the distal end have higher mechanical strength, thereby better providing mechanical support and protection for the lead connection part extending from the target tissue to outside the body, and at the same time makes the first tube segment at the proximal end have better extensibility, thereby dispersing the large mechanical stress that may be generated by the in vitro environment, avoiding adverse effects such as aging and mechanical damage to the flexible neural electrode, especially its lead connection part, and ensuring that the in vitro part will not be longitudinally displaced or loosened when subjected to external force, thereby improving the operational convenience and performance stability of the flexible neural electrode, extending its overall service life, and giving it 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 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 structural diagram of an in vitro protection device assembly for a flexible neural electrode and its peripheral components according to an embodiment of the present application is shown.

[0011] Figure 2A schematic diagram of a sleeve connection method of a first pipe segment and a second pipe segment according to an embodiment of the present application is shown.

[0012] Figure 3 A schematic diagram showing an assembly method of an in vitro protection device assembly for a flexible neural electrode according to an embodiment of the present application is shown.

[0013] Figure 4 A schematic diagram of an installation method of an extracorporeal protection device assembly according to an embodiment of the present application is shown.

[0014] 1. An in vitro protective device assembly (assembly) for a flexible neural electrode; 11. A lead connection portion (lead connection portion) of a flexible neural electrode; 12. A protective sheath; 121. A tubular cavity; 122. A first tube segment; 123. A second tube segment; 124. A proximal fixing portion; 125. A distal fixing portion; 13. A proximal snap portion; 14. A distal snap portion; 15. A contact connector; 16. A distal auxiliary fixing device; 161. A tubular channel; 2. A distal electrode site portion; 3. A proximal contact portion; 4. Target tissue attachments. DETAILED DESCRIPTION

[0015] 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.

[0016] 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.

[0017] 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.

[0018] "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.

[0019] In this application, the terms "near" and "proximal" are intended to refer to the side close to the operator (e.g., a doctor) who performs the flexible neural electrode implantation operation, while the terms "distal" and "distal" are intended to refer to the side close to the target object and target tissue into which the flexible neural electrode is to be implanted.

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

[0021] like Figure 1 As shown, component 1 includes a lead connection part 11 and a protective sheath 12 of a flexible neural electrode, and both the lead connection part 11 and the protective sheath 12 are located outside the body. Taking the brain tissue as an example, the target tissue to be implanted with the flexible neural electrode, the component 1 as a whole is located outside the skull.

[0022] like Figure 1 As shown, the protective sheath 12 accommodates the lead connection part 11 in a bent state in its tubular cavity 121, and the protective sheath 12 can extend axially. The lead connection part 11 is protected inside the protective sheath 12, and the sealing design of the protective sheath 12 can effectively prevent moisture, dust and other pollutants from corroding the lead connection part 11, thereby greatly improving the reliability and stability of the flexible neural electrode in long-term use.

[0023] More specifically, the protective sheath 12 includes a first tube segment 122 and a second tube segment 123 from proximal to distal, the first tube segment 122 has a stronger axial extensibility than the second tube segment 123, and the second tube segment 123 has a stronger mechanical strength than the first tube segment 122. It is worth noting that although the second tube segment 123 is harder than the first tube segment 122, it should still maintain a certain degree of flexibility to avoid hard damage to the distal part of the lead connection portion in a natural or stressed state.

[0024] like Figure 1As shown, the proximal end of the first tube segment 122 is formed with a proximal fixing portion 124 of the protective sheath 12, and the proximal fixing portion 124 is used to fix the proximal end of the protective sheath 12 to the proximal side of the lead connecting portion 11. In addition, the distal end of the second tube segment 123 is formed with a distal fixing portion 125 of the protective sheath 12, and the distal fixing portion 125 is used to fix the distal end of the protective sheath 12 to the distal side of the lead connecting portion 11, and to extend the lead connecting portion 11 from the target tissue to the outside of the body, wherein the target tissue includes at least brain tissue, and may also be other tissues such as spinal cord, peripheral nerves, sympathetic ganglia or vagus nerves, which is not limited in this application.

[0025] According to the in vitro protection device assembly for flexible neural electrodes according to the embodiment of the present application, it is particularly suitable for the scene where the flexible neural electrode is implanted in tissues such as brain tissues and its lead connection part needs to be led out of the body to connect other test equipment. The in vitro protection device assembly of the embodiment of the present application utilizes an elastic protective sheath and a matching fixing mechanism to isolate and fix the lead connection part of the flexible neural electrode located outside the body from the environment, and through the segmented design of the protective sheath, the second tube segment at the distal end has a higher mechanical strength, thereby better providing mechanical support and protection for the lead connection part extending from the target tissue to the outside of the body, and at the same time, the first tube segment at the proximal end has better extensibility, thereby dispersing the larger mechanical stress that may be generated by the in vitro environment, avoiding the adverse effects such as aging and mechanical damage that may be caused to the flexible neural electrode, especially its lead connection part, and ensuring that the in vitro part will not be longitudinally displaced or loosened when subjected to external force, which can improve the convenience of operation and performance stability of the flexible neural electrode, extend its overall service life, and make it have significant advantages in long-term use.

[0026] In some embodiments, the first tube segment and the second tube segment can be made of the same material, wherein the wall thickness of the second tube segment is greater than the wall thickness of the first tube segment, and generally, a thicker wall has a stronger mechanical strength. As an example only, the second tube segment can be made of thermoplastic polyurethane or silicone with a higher hardness, and the wall thickness ranges from 0.1 mm to 5 mm to ensure sufficient support and durability, while adapting to the use requirements of a long-term in vitro environment.

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

[0028] As an example only, the first tube segment can be made of a material with high flexibility and low friction coefficient, such as silicone, rubber or polyurethane, and the diameter range can be designed to be 0.5mm to 50mm, and the wall thickness range is 0.1mm to 5mm to accommodate flexible neural electrodes of different specifications. The second tube segment can be made of the same material as the first tube segment, and the wall thickness can be increased to achieve reinforcement, or a different material can be used, such as thermoplastic polyurethane or polyethylene with higher hardness, and the wall thickness is equivalent to or greater than that of the first tube segment, so as to provide additional support in terms of mechanical strength.

[0029] Through testing, recording and statistical analysis of typical application scenarios of the flexible neural electrodes in this application, the maximum extension ratio of the protective sheath in the axial direction should be no less than 10%. In this way, it can meet the requirements of stress dispersion caused by external force pulling in most cases in the in vitro environment.

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

[0031] Figure 2 A schematic diagram of the sleeve connection of the first pipe segment and the second pipe segment according to an embodiment of the present application is shown. In some embodiments, the first pipe segment and the second pipe segment can also be connected by a sleeve connection. When the sleeve connection is adopted, the second pipe segment is sleeved on the outer distal end of the first pipe segment, or vice versa, the first pipe segment is sleeved on the outer 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 they can be not fixed to each other. Figure 2 The second pipe section 123 is shown to be sleeved on the outer portion of the distal end of the first pipe section 122, and the proximal end of the second pipe section and the distal end of the first pipe section are not fixed to each other, and Figure 2It can be seen that the distal end of the first tube segment 122 is fixedly connected to the distal fixing portion 125 of the protective sheath 12. In this way, although there is no direct fixing structure between the first tube segment 122 and the second tube segment 123, they are actually indirectly fixed through the distal fixing portion 125. In this design, the distal fixing portion 125 serves as a common fixing point to provide support for the distal ends of the first tube segment 122 and the second tube segment 123 respectively. Compared with the direct fixing of the two tube segments, a key function of this design is that even if the second tube segment 123 is longer, the overall tensile performance of the protective sheath 12 will not be affected, and the protective sheath 12 can still be ensured to have good axial extension performance as a whole. Therefore, the indirect fixing method of the two tube segments as shown in 3 can make the first tube segment 122 not be affected by the length and hardness of the second tube segment when stretched, thereby ensuring that the index requirements of the maximum extension ratio of the protective sheath 12 in the axial direction are met.

[0032] Back to Figure 1 It can be seen that when the proximal end of the protective sheath 12 is fixed to the proximal side of the lead connection part 11 via the proximal fixing part 124, and the distal end of the protective sheath 12 is fixed to the distal side of the lead connection part 11 via the distal fixing part 125, the lead connection part 11 is completely contained in the tubular cavity 121, and even if the protective sheath 12 is stretched to the maximum extent, the lead connection part 11 can still maintain a flexed state. During the deformation of the protective sheath 12, the lead connection part 11 can slide freely in the tubular cavity 121. This flexed state allows the lead connection part 11 to retain a certain amount of deformation inside the protective sheath, thereby dispersing the stress by sliding when external mechanical stress acts. Even if the protective sheath 12 has reached the limit of stretching under the action of external force, it can still avoid applying force directly to the flexible neural electrode body. This design ensures the long-term stability of the flexible neural electrode after implantation and provides effective protection.

[0033] In some embodiments, the inner surface of the tubular cavity 121 may be provided with a biocompatible coating (not shown) to reduce the friction between the lead connection portion 11 and the inner surface of the tubular cavity 121 when the lead connection portion 11 slides freely in the tubular cavity 121, thereby slowing down the aging of the lead connection portion 11 during use, thereby further extending the service life of the component 1.

[0034] Figure 3 A schematic diagram of an assembly method of an in vitro protective device assembly for a flexible neural electrode according to an embodiment of the present application is shown. Figure 3 As shown, in some embodiments, the component 1 may further include a proximal snap portion 13, which is fixed to the proximal side of the lead connecting portion 11, and the proximal snap portion 13 is engaged with the proximal fixing portion 124 of the protective sheath 12 to fix the proximal end of the protective sheath 12 to the proximal side of the lead connecting portion 11.

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

[0036] In other embodiments, after the distal electrode site portion 2 of the flexible neural electrode is implanted into the target tissue, the proximal buckle portion 13 and the proximal fixing portion 124 may be fixedly connected.

[0037] like Figure 3 As shown, the component 1 may further include a distal snap-on portion 14 , which is fixed to the distal side of the lead connecting portion 11 , and the distal snap-on portion 14 can be engaged with the distal fixing portion 125 to fix the distal end of the protective sheath 12 to the distal side of the lead connecting portion 11 .

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

[0039] The above-mentioned seal can be arranged on the inside and the outer edge of the distal buckle part 14, for example, 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 protective sheath 12 is sleeved and fixed to the distal buckle part 14. The seal can effectively isolate external moisture, dust and other pollutants from entering the interior of the protective sheath and prevent body fluids such as cerebrospinal fluid from flowing out. At the same time, the design of the seal further ensures that the distal buckle part 14 and the distal fixing part 125 of the protective sheath 12 can be firmly connected, thereby enhancing the stability and service life of the device. This sealed and elastic structure shows excellent protection performance for flexible neural electrodes under dynamic external force environments. Even if it is subjected to tensile or bending stress, the sealing of the protective sheath will not be damaged, further ensuring the safety of the lead connection part.

[0040] In some embodiments, for example, the distal buckle portion 14 and the distal fixing portion 125 can be pre-fixed and connected before the distal electrode site portion 2 of the flexible neural electrode is implanted into the target tissue. In other embodiments, the distal buckle portion 14 and the distal fixing portion 125 can also be constructed as an integrated structure. Through this integrated design, the connection interface between the distal buckle portion 14 and the distal fixing portion 125 is eliminated, the overall structure of the component 1 is simplified, the assembly steps are reduced, the complexity of implantation into the target tissue is reduced, and the connection stability and sealing performance of the device are further improved. In other embodiments, Figure 3 As shown, the distal electrode site portion 2 is first implanted into the target tissue, and then the distal buckle portion 14 is fixedly connected to the distal fixing portion 125 (as shown in FIG. Figure 3 When the distal electrode site portion 2 is implanted in the target tissue and the distal buckle portion 14 is fixedly connected to the distal fixing portion 125, the proximal end of the protective sheath 12 can be further stretched and the proximal fixing portion 124 of the protective sheath 12 can be fixed to the proximal buckle portion 13 (as shown in step S1 in FIG. 1 ). Figure 3 As shown in step S2 in FIG. 1 ), thereafter, the protective sheath 12 is released (as shown in FIG. 1 ). Figure 3 As shown in step S3 in FIG. 1 , it can be seen that the protective sheath 12 will automatically shrink to a natural state without tension (such as Figure 3 As shown in step S4 in FIG. 1 ), the installation of component 1 is completed. Figure 3 It can be seen that when the assembly 1 is installed and not subjected to external tension, the lead connection portion 11 is accommodated in the tubular cavity 121 of the protective sheath 12 in a bent state.

[0041] During use of the component 1 according to the embodiment of the present application, the assembly and fixation of the protective sheath 12 with other components is a key link in achieving mechanical protection and signal stability. Before implantation, the distal fixing portion 125 and the distal snap portion 14 of the protective sheath 12 are in a separated state, and the proximal fixing portion 124 and the proximal snap portion 13 are also not fixed. At this time, the various components of the component 1 are in an independent state, providing sufficient flexibility for subsequent implantation operations. The operator can select the specific order of assembly and fixation as needed according to the specific implantation site, operating habits, etc., and the present application does not limit this.

[0042] like Figure 3 As shown, in some embodiments, the component 1 may further include a contact connector 15, which forms an electrical connection with the proximal contact portion 3 of the flexible neural electrode. The contact connector 15 is designed as an independent electrical connection component, which can be connected to an external device by plugging or clamping to ensure that the electrical signal can be transmitted from the recording or stimulation electrode site of the flexible neural electrode to the external device. As mentioned above, when the component 1 includes a proximal buckle portion 13, the proximal buckle portion 13 is fixed to the proximal side of the lead connection portion 11, and the proximal buckle portion 12 is engaged with the proximal fixing portion 124 of the protective sheath 12 so as to fix the proximal end of the protective sheath 12 to the proximal side of the lead connection portion 11, the contact connector 15 and the proximal buckle portion 13 are realized as an integrated structure, so that not only the component structure is simplified, but also the close fit between the proximal buckle portion 13 and the proximal fixing portion 124 is enhanced, the contacts of the flexible neural electrode are protected from the external environment, the stability of the connection and the ability to resist external forces are ensured, and the stability of the connection is further improved.

[0043] Figure 4 A schematic diagram of an installation method of an extracorporeal protection device assembly according to an embodiment of the present application is shown.

[0044] In some embodiments, the component 1 (partially shown) also includes a distal auxiliary fixing device 16, which is fixedly connected to the target tissue attachment 4 by means such as threaded anchoring, adhesive fixation, etc. For example, when the target tissue is brain tissue, the target tissue attachment 4 can be, for example, a skull. When the target tissue is other parts, the corresponding target tissue attachment 4 can also be other parts or structures, and the present application does not limit this. The distal auxiliary fixing device 16 provides an additional anchor point to ensure that the flexible neural electrode can be accurately controlled during the implantation process, while further enhancing the stability of the distal buckle portion 14 to prevent any displacement or loosening after implantation, and also ensures the optimal adaptability of the protective sheath 12 and the flexible neural electrode after implantation. In addition, the above design scheme enables the flexible neural electrode to flexibly adapt to different implantation paths and target tissue types, ensures that the flexible neural electrode is always in the correct position, and provides reliable protection for subsequent signal acquisition or electrical stimulation.

[0045] like Figure 4 As shown, the distal auxiliary fixation device 16 has a tubular channel 161 that penetrates from the outside of the body to the inside of 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 be implanted into the target tissue. The tubular channel 161 runs through the entire device longitudinally, extending from the outside of 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.

[0046] In some embodiments, the tubular channel 161 serves as a guide structure of the distal auxiliary fixation device 16, so that after implantation, the lead connection portion 11 passes out of the body at a preset angle and extends away from the target tissue attachment 4. The preset angle may be, for example, about 90 degrees, that is, the tubular channel 161 is nearly perpendicular to the target tissue attachment 4 where it is installed. In other embodiments, the specific angle of the tubular channel 161 when it passes through may also be determined in association with the specific position of the target tissue to be implanted with the component 1, the tissue anatomical requirements, and the shape of the target tissue attachment 4, so as to facilitate the operation and application of the component 1, and the present application does not make specific limitations on this.

[0047] In some embodiments, the distal auxiliary fixing device 16 can be first fixed to the target tissue attachment 4, and then other components in the component 1 are connected thereto. That is, the distal auxiliary fixing device 16 enhances the connection stability between the flexible neural electrode and the target tissue attachment 4 by providing an additional fixing fulcrum for the flexible neural electrode, especially the component 1, and can ensure that the flexible neural electrode will not be displaced or damaged due to external forces or other factors during long-term use after implantation, thereby achieving a more stable positioning and protection effect for the flexible neural electrode. In addition, the distal auxiliary fixing device 16 is also used to accurately control the implantation position, direction, and depth of the flexible neural electrode before implantation, and to ensure that the distal buckle portion 14 always remains outside the target tissue.

[0048] Taking the target tissue attachment 4 as the skull as an example, the outer side of the distal auxiliary fixing device 16 may have a thread for screwing into the skull surface, but will not enter the brain tissue, to ensure that the flexible neural electrode is firmly fixed during the implantation operation and provide a precise implantation channel. In order 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 20mm, so as to ensure that the implantation trajectory of the electrode is effectively constrained during the implantation of the flexible electrode, and provide sufficient support and guidance for it.

[0049] In some embodiments, after the distal electrode site portion 2 is implanted in the target tissue, the distal fixing portion 125 can be fixedly connected to the distal auxiliary fixing device 16. Furthermore, the distal fixing portion 125 is also provided with a sealing member (not shown), which is used to achieve an overall seal between the protective sheath 12, the distal auxiliary fixing device 16 and the lead connecting portion 11 after the distal fixing portion 125 is fixedly connected to the distal auxiliary fixing device 16, and to seal the lead connecting portion 11 inside the protective sheath 12. By forming a closed space in the structure, external contaminants can be prevented from entering the target tissue along the tubular channel 161 of the distal auxiliary fixing device 16, and body fluid leakage can also be prevented, meeting the use requirements in complex environments.

[0050] like Figure 4 As shown, when the component 1 includes a distal buckle portion 14, the distal buckle portion 14 is fixed to the distal side of the lead connection portion 11 and is engaged with the distal fixing portion 125, so as to fix the distal end of the protective sheath 12 to the distal side of the lead connection portion 11, and the component 1 also includes a distal auxiliary fixing device 16 and is fixedly connected to a target tissue attachment 4 such as a skull, the distal fixing portion 125 can be fixedly connected to both the distal buckle portion 14 and the distal auxiliary fixing device 16 after the distal electrode site portion 2 is implanted into the target tissue. That is, at the distal side, the following steps can be performed: Step SS1: fix the distal auxiliary fixing device 16 to the target tissue attachment 4; Step SS2: implant the distal electrode site portion 2 of the flexible neural electrode into the target tissue; Step SS3: fix the distal buckle portion 14 to the distal auxiliary fixing device 16; Step SS4: fix the distal fixing portion 125 to both the distal buckle portion 14 and the distal auxiliary fixing device 16. Among them, step SS3 and step SS4 can be combined into one step, that is, the distal fixing portion 125 of the protective sheath 12 is fixed to the distal buckle portion 14 and the distal auxiliary fixing device 16 at one time. Figure 3 The description is similar to that of , mainly including stretching the proximal end of the protective sheath 12, fixing the proximal fixing portion 124 of the protective sheath 12 with the proximal buckle portion 13, and then releasing the protective sheath 12, so that the lead connecting portion 11 of the flexible nerve electrode is accommodated in the tubular cavity 121 of the protective sheath 12 in a bent state.

[0051] In other embodiments, the protective sheath 12 on the proximal side of the component 1 may be first assembled and fixed with other components, and then the distal components of the component 1 may be assembled to finally complete the complete sealing installation of the component 1. The specific steps include: step 1: fixing the proximal fixing portion 124 of the protective sheath 12 with the proximal buckle portion 13; step 2: fixing the distal auxiliary fixing device 16 to the target tissue attachment 4; step 3: implanting the distal electrode site portion 2 of the flexible neural electrode into the target tissue; step 4: stretching the distal end of the protective sheath 12, and fixing the distal fixing portion 125 of the protective sheath 12 with the distal buckle portion 14 and the distal auxiliary fixing device 16; step 5: releasing the protective sheath 12, so that the lead connection portion 11 of the flexible neural electrode is accommodated in the tubular cavity 121 of the protective sheath 12 in a flexed state.

[0052] In addition, the distal buckle portion 14 may also be provided with a seal (not shown) so that after the distal fixing portion 125 and the distal buckle portion 14 and the distal auxiliary fixing device 16 are fixedly connected, the lead connection portion 11 can be sealed and wrapped inside the protective sheath 12 .

[0053] By stretching the protective sheath 12, the operator can fix the proximal fixing portion 124 of the protective sheath 12 with the proximal buckle portion 13, and fix the distal fixing portion 125 of the protective sheath 12 with the distal buckle portion 14. These processes ensure a 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.

[0054] According to the in vitro protection device assembly of the embodiment of the present application, through the special design of the protective sheath and the coordination with the various components of the flexible neural electrode, as well as the optimized design and precise coordination of the connection method and fixation process between the protective sheath and the flexible neural electrode, not only the operation steps are simplified, but also the comprehensive protection effect of the in vitro part of the flexible neural electrode after implantation is greatly improved, while also enhancing the stability and safety of the electrode operation and use, providing reliable guarantee for its long-term use in complex environments.

[0055] According to the embodiment of the present application, the width of each part of the flexible neural electrode is designed to be 100 μm to 10 mm, and the thickness is controlled to be less than 0.2 mm. In order to meet different functional requirements, the width of the flexible neural electrode can vary at different positions. For example, the lead connection part is narrower to reduce the occupied space, while the distal electrode site part is wider to enhance the anchoring effect in the body. The specific size of each part is not limited in this application.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] In some embodiments, each insulating layer can be made of one or more combinations of SU-8 photoresist, parylene, polyparaxylene, fluorinated polymers or polyimides, for example, to take into account excellent mechanical properties and biocompatibility. Specifically, SU-8 photoresist, as a commonly used photolithography material, has high mechanical strength and good biocompatibility, and is suitable for the manufacture of flexible neural electrodes in the field of microelectronics; polyparaxylene 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 be in good contact with the neural 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 used stably and for a long time in the body without negatively affecting the surrounding tissues.

[0061] At the distal end of the flexible neural electrode of the embodiment of the present application, the stimulation electrode site and / or the recording electrode site may selectively not be provided with the first flexible insulating layer and / or the second flexible insulating layer, thereby directly exposing the metal conductive layer.

[0062] In some embodiments, the metal conductive layer of the flexible neural electrode can use highly conductive materials, such as gold, platinum, iridium and other metal materials, to ensure that the flexible neural electrode has excellent electrical conductivity and biocompatibility during electrical stimulation and signal recording. These materials have good stability after long-term implantation in the body, are not prone to biocompatibility issues, and can effectively avoid electrical performance degradation between the flexible neural electrode and surrounding tissues.

[0063] 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.

[0064] 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. An in vitro protective device assembly for a flexible neural electrode, characterized in that: A lead wire connection part and a protective sheath of a flexible nerve electrode are included, wherein the protective sheath accommodates the lead wire connection part in a bent state in a tubular cavity thereof, the protective sheath is axially extendable, and the lead wire connection part and the protective sheath are located outside the body; and The protective sheath includes a first tube segment and a second tube segment in order from proximal to distal, the first tube segment has a stronger axial extensibility than the second tube segment, and the second tube segment has a stronger mechanical strength than the first tube segment; and A proximal fixing portion of a 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 connecting portion; a distal fixing portion of a 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 connecting portion, and to allow the lead connecting portion to extend from the target tissue to outside the body, and the target tissue at least includes brain tissue.

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

3. The in vitro protection device assembly according to claim 1 or 2, characterized in that: The first pipe section and the second pipe section are integrally formed, or connected by bonding, or connected by sleeve connection.

4. The in vitro protection device assembly according to claim 3, characterized in that: When the first pipe segment and the second pipe segment are connected by sleeve connection, the second pipe segment is sleeved on the outer distal end of the first pipe segment, or the first pipe segment is sleeved on the outer distal end of the second pipe segment; 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, characterized in that: The distal end of the first tube segment is fixedly connected to the distal end fixing portion of the protective sheath.

6. The in vitro protection device assembly according to claim 1 or 2, characterized in that: When 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 bent state, and can slide freely in the tubular cavity during the deformation of the protective sheath.

7. The in vitro protection device assembly according to claim 6, characterized in that: The inner surface of the tubular cavity is provided with a biocompatible coating to reduce the friction between the lead connection part and the inner surface of the tubular cavity when the lead connection part slides freely in 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 in vitro protection device assembly also includes a proximal snap portion, which is fixed to the proximal side of the lead connection portion and engages with the proximal fixing portion of the protective sheath to fix the proximal end of the protective sheath to the proximal side of the lead connection portion.

10. The in vitro protection device assembly according to claim 9, characterized in that: Before the distal electrode site portion of the flexible neural electrode is implanted into the target tissue, the proximal buckle portion is pre-fixedly connected with the proximal fixing portion.

11. The in vitro protection device assembly according to claim 9, characterized in that: After the distal electrode site portion of the flexible neural electrode is implanted into the target tissue, the proximal buckle portion is fixedly connected to the proximal fixing portion.

12. The in vitro protection device assembly according to claim 1, characterized in that: The in vitro protection device assembly also includes a distal buckle portion, which is fixed to the distal side of the lead connection portion and can be engaged with the distal fixing portion to fix the distal end of the protective 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 buckle portion is provided with a sealing member, so that after the distal fixing portion is fixed to the distal buckle portion, the distal buckle portion and the lead connecting portion are sealed.

14. The in vitro protection device assembly according to claim 12 or 13, characterized in that: The distal buckle portion is movable axially along the lead connecting 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 neural electrode is implanted into the target tissue, the distal buckle portion is pre-fixedly connected with the distal fixing portion.

16. The in vitro protection device assembly according to claim 15, characterized in that: The distal buckle 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 neural electrode is implanted into the target tissue, the distal buckle portion is fixedly connected to the distal fixing portion.

18. The in vitro protection device assembly according to claim 1, characterized in that: The in vitro protection device assembly further comprises a distal auxiliary fixation device, wherein the distal auxiliary fixation device is fixedly connected to a target tissue attachment mechanism, and the target tissue attachment mechanism at least comprises a skull.

19. The in vitro protection device assembly according to claim 18, characterized in that: The distal auxiliary fixation 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 through the tubular channel and then be implanted into the target tissue.

20. The in vitro protection device assembly according to claim 18 or 19, 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.

21. The in vitro protection device assembly according to claim 20, characterized in that: The distal fixing portion is provided with a sealing member, so that after the distal fixing portion is fixedly connected to the distal auxiliary fixing device, the lead wire connecting portion is sealed and covered inside the protective sheath.

22. The in vitro protection device assembly according to claim 1 or 2, characterized in that: The in-vitro protection device assembly further comprises a distal buckle portion, which is fixed to the distal side of the lead wire connection portion, and the distal buckle portion can be engaged with the distal end fixing portion to fix the distal end of the protection sheath to the distal side of the lead wire connection portion; The in-vitro protection device assembly further comprises a distal auxiliary fixation device, wherein the distal auxiliary fixation device is fixedly connected to a target tissue attachment mechanism, and the target tissue attachment mechanism at least comprises a skull; After the distal electrode site portion is implanted into the target tissue, the distal fixing portion is fixedly connected to the distal buckle portion and the distal auxiliary fixing device.

23. The in vitro protection device assembly according to claim 22, characterized in that: The distal buckle portion is provided with a sealing member, so that after the distal fixing portion is fixedly connected with the distal buckle portion and the distal auxiliary fixing device, the lead wire connecting portion is sealed and covered inside the protective sheath.

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

25. The in vitro protection device assembly according to claim 24, characterized in that: The in-vitro protection device assembly further comprises a proximal buckle portion, which is fixed to the proximal side of the lead wire connection portion, and the proximal buckle portion is engaged with the proximal end fixing portion of the protection sheath to fix the proximal end of the protection sheath to the proximal side of the lead wire connection portion; The proximal buckle portion and the contact connector are an integral structure.

26. The in vitro protection device assembly according to claim 1 or 2, characterized in that: The flexible neural electrode is constructed as a stacked structure along 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.

27. The in vitro protection device assembly according to claim 26, characterized in that: The first insulating layer and / or the second insulating layer is not provided at the electrode site of the distal electrode site portion of the flexible neural electrode.

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