Interventional brain-computer interface stent with micro-nano shear stress transition structure

By introducing micro-nano structure arrays and pressure sensors into the brain-computer interface scaffold, the problem of platelet activation caused by electrode edge shear stress was solved, achieving long-term safe implantation of the scaffold and stable signal acquisition, and reducing the risk of thrombosis.

CN122376320APending Publication Date: 2026-07-14JIANGSU JICUI INTERVENTIONAL BRAIN COMPUTER INFORMATION TECHNOLOGY CO LTD

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
JIANGSU JICUI INTERVENTIONAL BRAIN COMPUTER INFORMATION TECHNOLOGY CO LTD
Filing Date
2026-06-08
Publication Date
2026-07-14

AI Technical Summary

Technical Problem

During long-term implantation, existing invasive brain-computer interface electrode stents can lead to increased shear stress gradients due to geometric abrupt changes at the electrode edges, resulting in platelet activation and aggregation, increasing the risk of thrombosis, and reducing signal acquisition accuracy and stent reliability.

Method used

An interventional brain-computer interface scaffold with a micro-nano shear stress transition structure is designed. By setting a micro-nano structure array in the electrode unit to buffer shear stress, and installing a pressure sensor and a fracture limiting structure on the support rod, the scaffold status can be monitored in real time, and the scaffold can be replaced or removed in a timely manner.

Benefits of technology

It effectively reduces peak shear stress, prevents platelet activation and aggregation, ensures the stability of signal acquisition and the long-term safety of the stent, reduces the risk of thrombosis, and improves the reliability of the brain-computer interface.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application relates to the technical field of brain-computer interfaces, and discloses an interventional brain-computer interface support with a micro-nano shear stress transition structure, which comprises a framework, a plurality of electrode units, a pressure sensor and a fracture limiting structure. The framework is composed of a plurality of cross-shaped supporting rods. The electrode units are arranged at the cross points of the framework, and a micro-nano structure array is formed on the surface of the transition buffer part of the electrode units. The pressure sensor is arranged on the supporting rod on the downstream side of the electrode unit. The fracture limiting structure comprises a first groove and a second groove arranged in the supporting rod. The first groove is provided with a first spring and a second spring. The second groove is filled with a soluble anchor part, and a protective film is arranged outside the second groove. The two ends of the second spring are connected with a fixing rod, and the fixing rod is inserted into the soluble anchor part for fixation. The micro-nano structure array can reduce the shear stress peak value, and the pressure sensor can monitor the corrosion degree of the micro-nano structure and the fracture state of the supporting rod, so that the long-term implant safety and signal acquisition stability are ensured.
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Description

Technical Field

[0001] This invention relates to the field of brain-computer interface technology, specifically to an interventional brain-computer interface scaffold with a micro-nano shear stress transition structure. Background Technology

[0002] Brain-computer interface (BCI) technology, by establishing a direct communication pathway between the brain and external devices, has demonstrated significant value in neurological function repair and disease diagnosis. Existing implantation methods can be divided into non-invasive and invasive types. While non-invasive BCIs are non-invasive, their signal quality is limited; invasive BCIs, although capable of acquiring high-precision neural signals, involve significant trauma from traditional craniotomy, posing risks of infection and bleeding. Interventional BCIs, as an emerging minimally invasive technique, involve implanting an electrode stent via a venous route into the inner wall of a brain blood vessel through a neurointerventional approach. This allows for the recording of cortical neural activity from within the blood vessel, eliminating the need for craniotomy and significantly reducing surgical risks.

[0003] The core of the electrode stent is a self-expanding nickel-titanium alloy framework, with platinum electrodes mounted on its surface. It can be fixed to the inner wall of the blood vessel through radial self-expansion force to prevent displacement after implantation. Specifically, the electrode stent is compressed within the delivery catheter, and upon reaching the target blood vessel, it is released and self-expands, allowing the electrodes to fit tightly against the vessel wall, thus achieving stable nerve signal acquisition.

[0004] However, during long-term implantation, the conductive area of ​​the electrode scaffold is usually a locally exposed metal structure. This conductive area protrudes relative to the surrounding insulating layer or substrate material surface, thus forming a geometrically abrupt interface at the electrode edge. When blood flows through this geometrically abrupt interface, it causes an increase in shear stress gradient, boundary layer separation, and local fluid reattachment, forming a local shear stress peak area in the abrupt region. When platelets in the circulating blood flow through this high shear stress area, they are subjected to the instantaneously increased shear force, resulting in activation and aggregation, inducing the risk of thrombosis. Thrombosis can impair the long-term stability of the electrode scaffold and the accuracy of signal acquisition, reducing the overall reliability and lifespan of brain-computer interface technology. Summary of the Invention

[0005] The purpose of this invention is to provide an interventional brain-computer interface scaffold with a micro-nano shear stress transition structure to solve the problems mentioned above.

[0006] To achieve the above objectives, the present invention provides the following technical solution: An interventional brain-computer interface scaffold with a micro / nano shear stress transition structure includes: The skeleton is composed of multiple intersecting struts, forming multiple intersection points; Multiple electrode units are disposed at the intersection of the skeleton. Each electrode unit includes a base, a central conductive part disposed in the middle of the base, a transition buffer part disposed on one side of the base and surrounding the central conductive part, and a main functional part disposed on the other side of the base. The surface of the transition buffer part forms a micro-nano structure array. Pressure sensors are mounted on multiple support rods downstream of the electrode unit; When the micro-nano structure array is eroded, its buffering capacity decreases, causing the pressure sensor's monitoring value to gradually increase. When it reaches a set threshold, a replacement reminder is given. If the support rod breaks, the pressure sensor's monitoring value drops sharply, indicating that a breakage has occurred. The fracture limiting structure includes a first groove disposed within the support rod, a second spring disposed within the first groove and two first springs connected to both ends of the second spring, the first spring being in a stretched state and the second spring being in a free state, a second groove also disposed within the first groove, the second groove being filled with a soluble anchoring part, a protective film disposed outside the second groove, and a fixing rod connected to both ends of the second spring, the fixing rod being inserted into the soluble anchoring part for fixation.

[0007] As a preferred embodiment of the interventional brain-computer interface scaffold with micro-nano shear stress transition structure described in this invention, wherein: multiple support rods equipped with the pressure sensor are connected at their two ends to form a closed mesh frame.

[0008] As a preferred embodiment of the interventional brain-computer interface scaffold with micro-nano shear stress transition structure described in this invention, wherein: the ends of the two first springs are respectively fixedly connected to two intersection points located at both ends of the support rod, and a ring is fixedly connected between the ends of the first spring and the second spring, the ring being fixedly connected to the fixing rod.

[0009] As a preferred embodiment of the interventional brain-computer interface scaffold with micro-nano shear stress transition structure described in this invention, when the support rod breaks, blood enters the second groove to dissolve the soluble anchoring part, releasing the fixation of the fixing rod. The first spring in the stretched state retracts and pulls the second spring in the natural state to extend, so that the first springs at both ends and the second spring in the middle are connected to form a tensioned state to limit the broken support rod.

[0010] As a preferred embodiment of the interventional brain-computer interface scaffold with micro-nano shear stress transition structure described in this invention, wherein: the micro-nano structure array includes multiple micropores formed on the base, the micropores are hemispherical structures, and the multiple micropores are arranged in a hexagonal close-packed array.

[0011] As a preferred embodiment of the interventional brain-computer interface scaffold with micro-nano shear stress transition structure described in this invention, the soluble anchoring part is made of soluble gelatin.

[0012] As a preferred embodiment of the interventional brain-computer interface scaffold with micro-nano shear stress transition structure described in this invention, the protective film is formed on the outer surface of the second groove by a deposition process.

[0013] As a preferred embodiment of the interventional brain-computer interface scaffold with micro-nano shear stress transition structure described in this invention, the skeleton is a continuous rhomboid cylindrical mesh structure.

[0014] As a preferred embodiment of the interventional brain-computer interface scaffold with micro-nano shear stress transition structure described in this invention, the inner side of the skeleton is provided with a wire groove for laying wires to connect to the electrode unit.

[0015] As a preferred embodiment of the interventional brain-computer interface scaffold with micro-nano shear stress transition structure described in this invention, the first spring and the second spring are made of medical elastic metal material.

[0016] Compared with the prior art, the beneficial effects of the present invention are: This invention addresses the issue of platelet activation and aggregation caused by high shear stress due to geometric abrupt changes at the electrode edge by incorporating a transition buffer section composed of a micro-nano structure array within the electrode unit of the electrode scaffold. This effectively reduces the peak shear stress generated by blood flow impact by creating a local energy dissipation zone at the interface of geometric abrupt changes at the electrode edge. Simultaneously, a pressure sensor monitors and determines the corrosion level of the micro-nano structure array and the fracture state of the support rod. Combined with a fracture limiting structure, automatic limiting is triggered when the support rod breaks. This effectively solves the problems of platelet activation and aggregation and support rod fracture caused by high shear stress due to geometric abrupt changes at the electrode edge, ensuring the safety of long-term implantation of the electrode scaffold and the stability of signal acquisition, thereby ensuring the overall reliability of brain-computer interface technology.

[0017] During blood flow, the blood first comes into contact with the micro-nano structure array of the transition buffer section. The micro-nano structures disturb the fluid and dissipate energy at the microscale, thereby reducing the peak local shear stress and effectively avoiding platelet activation and aggregation induced by instantaneous high shear stress, thus reducing the risk of thrombosis and ensuring the safety and stability of brain-computer interface signal acquisition under long-term electrode stent implantation.

[0018] By placing the pressure sensor on the support rod downstream of the electrode unit, and taking advantage of the characteristic that the buffering capacity of the micro-nano structure array gradually decreases after being eroded and corroded, the erosion force on the downstream support rod increases with the degree of corrosion of the micro-nano structure. The pressure sensor monitoring value gradually increases accordingly. When the monitoring value reaches the set threshold, it can promptly remind the user to replace the electrode. This avoids the electrode edge being directly exposed to a high shear stress environment due to the complete failure of the transition buffer structure, thereby reducing the risk of thrombosis.

[0019] After the blood flow crosses the geometrically abrupt interface, a local fluid reattachment zone is formed downstream of the electrode unit. This zone exerts a greater impact force on the stent strut, making the strut downstream of the electrode unit more prone to fatigue fracture compared to other parts. By placing a pressure sensor on the strut at this location, the system can capture the sudden drop in monitoring values ​​immediately when the strut fractures in this area, thereby enabling timely early warning and location of stent fracture and ensuring the safety of brain-computer interface stent use.

[0020] When the support rod breaks, its original structural constraints are lost, and its support force on the inner wall of the brain blood vessels changes abruptly. The pressure sensor readings then drop sharply. By recognizing this sudden drop, the brain-computer interface stent can be promptly identified as broken, allowing for timely removal of the stent. This prevents the broken stent from remaining in the blood vessels for an extended period, which could damage or obstruct blood flow, thus improving the safety of the brain-computer interface stent.

[0021] A fracture limiting structure is installed inside the stent. Under normal operating conditions, the protective membrane effectively prevents body fluid from seeping into the second groove, avoiding accidental dissolution of the soluble anchoring part due to contact with body fluid. This ensures that the fracture limiting structure is only triggered when the stent breaks. When the stent breaks, blood enters the second groove through the broken end, dissolving the soluble anchoring part, releasing the fixation of the stent. The first spring, which is in a stretched state, retracts and pulls the second spring, which is in a natural state, to extend. This connects the first springs at both ends with the second spring in the middle, creating a tensioned state. The first groove limits the stent and applies an elastic constraint force to the broken stent, effectively preventing the broken stent from swinging with the blood flow and avoiding continuous damage to the inner wall of the blood vessel after the stent breaks, thus ensuring the patient's safety before stent removal. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the three-dimensional structure of the skeleton in the form of a tubular shape according to the present invention.

[0023] Figure 2 This is a three-dimensional structural diagram of the skeleton of the present invention when unfolded.

[0024] Figure 3 for Figure 2 A magnified structural diagram at point A.

[0025] Figure 4 for Figure 2 A magnified structural diagram at point B.

[0026] Figure 5 for Figure 2 A magnified structural diagram at point C.

[0027] Figure 6 This is a schematic cross-sectional view of the base assembly structure of the present invention.

[0028] Figure 7 for Figure 6 A magnified structural diagram at point D.

[0029] Figure 8 This is a schematic diagram of the three-dimensional structure of the base assembly of the present invention.

[0030] Figure 9 This is a schematic diagram of the three-dimensional structure of the support rod assembly of the present invention.

[0031] Figure 10 This is a schematic cross-sectional view of the support rod assembly structure of the present invention.

[0032] Figure 11 for Figure 10 Enlarged structural diagram at point E.

[0033] Figure 12 This is a schematic diagram of the three-dimensional structure of the fixing rod assembly of the present invention.

[0034] In the diagram: 1. Frame; 11. Support rod; 12. Wire groove; 13. Pressure sensor; 14. First groove; 141. First spring; 142. Second spring; 15. Second groove; 16. Ring; 17. Fixing rod; 18. Protective film; 19. Soluble anchoring part; 2. Base; 21. Central conductive part; 22. Transition buffer part; 221. Micropore; 23. Main functional part. Detailed Implementation

[0035] The features and exemplary embodiments of various aspects of the present invention will now be described in detail. Numerous specific details are set forth in the following detailed description to provide a thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention may be practiced without requiring some of these specific details. The following description of embodiments is merely intended to provide a better understanding of the invention by illustrating examples of the invention. The invention is by no means limited to any specific configurations and algorithms presented below, but covers any modifications, substitutions, and improvements to elements, components, and algorithms without departing from the spirit of the invention. Well-known structures and techniques are not shown in the drawings and the following description in order to avoid unnecessarily obscuring the invention.

[0036] Example 1, referring to Figures 1-12 As a first embodiment of the present invention, an interventional brain-computer interface scaffold with a micro-nano shear stress transition structure is provided. This interventional brain-computer interface scaffold with a micro-nano shear stress transition structure includes: The frame 1 is composed of multiple intersecting support rods 11, forming multiple intersection points; Multiple electrode units are disposed at the intersection of the skeleton 1. Each electrode unit includes a base 2, a central conductive part 21 disposed in the middle of the base 2, a transition buffer part 22 disposed on one side of the base 2 and surrounding the central conductive part 21, and a main functional part 23 disposed on the other side of the base 2. A micro-nano structure array is formed on the surface of the transition buffer part 22. Pressure sensor 13 is mounted on multiple support rods 11 on the downstream side of the electrode unit; When the micro-nano structure array is eroded, its buffering capacity decreases, causing the monitoring value of pressure sensor 13 to gradually increase. When it reaches the set threshold, it prompts for replacement. If the support rod 11 breaks, the monitoring value of pressure sensor 13 drops sharply, prompting a breakage warning. The fracture limiting structure includes a first groove 14 disposed in the support rod 11, a second spring 142 disposed in the first groove 14 and two first springs 141 connected to both ends of the second spring 142. The first springs 141 are in a stretched state and the second springs 142 are in a free state. A second groove 15 is also disposed in the first groove 14. The second groove 15 is filled with a soluble anchoring part 19. A protective film 18 is disposed on the outside of the second groove 15. A fixing rod 17 is connected to both ends of the second spring 142. The fixing rod 17 is inserted into the soluble anchoring part 19 for fixation.

[0037] The skeleton 1 is made of self-expanding nickel-titanium alloy material, which can be compressed in the delivery catheter, and released and self-expanded after reaching the target blood vessel, so that the stent fits and is fixed to the inner wall of the blood vessel.

[0038] The central conductive part 21 has a diameter of 80-200 μm, a smooth surface, and is composed of a platinum metal conductive layer, used to collect brain nerve signals. The transition buffer part 22 is a ring structure with a width of 20-100 μm, and its surface forms a micro-nano structure array.

[0039] Multiple support rods 11, each equipped with a pressure sensor 13, are connected at their intersections to form a closed mesh frame. The pressure sensor 13 is a piezoresistive miniature pressure sensor with a sheet-like structure. Its working principle is based on the piezoresistive effect: when the silicon diaphragm inside the sensor is subjected to fluid pressure, it deforms, causing a change in the resistance value of the semiconductor integrated on the diaphragm. The pressure signal is converted into a voltage signal output through a Wheatstone bridge, and after amplification, it is used for monitoring by external devices.

[0040] The sensor chip size can be compressed to the micrometer level, forming a thin sheet that can be welded to the side of the support rod 11 facing the blood vessel wall without affecting the compression loading and self-expansion deployment of the stent.

[0041] The output signal of the pressure sensor 13 is led out through an insulated wire, runs along the wire groove 12 inside the skeleton 1, and is connected to the subcutaneous signal receiver to realize wireless transmission to the external monitoring device for threshold reminders and breakage warnings.

[0042] The ends of the two first springs 141 are fixedly connected to two intersection points located at both ends of the support rod 11. A ring 16 is fixedly connected between the ends of the first spring 141 and the second spring 142, and the ring 16 is fixedly connected to the fixing rod 17.

[0043] When the support rod 11 breaks, blood enters the second groove 15, dissolving the soluble anchoring part 19, releasing the fixation of the fixing rod 17, causing the first spring 141 in the stretched state to retract and pull the second spring 142 in the natural state to extend, so that the first springs 141 at both ends and the second spring 142 in the middle are connected to form a tensioned state, thereby limiting the broken support rod 11.

[0044] The micro / nano structure array includes multiple micropores 221 formed on the base 2. The micropores 221 are hemispherical structures, and the multiple micropores 221 are arranged in a hexagonal close-packed array. The micropores 221 are formed by femtosecond laser processing. The main functional part 23 is a continuous smooth surface layer with a surface roughness Ra of less than 200 nm, and a surface energy gradient difference is formed between the main functional part 23 and the transition buffer part 22.

[0045] The soluble anchoring part 19 is made of soluble gelatin. This material has good mechanical strength in the dry state, which can stably fix the fixing rod 17. When it comes into contact with blood, the gelatin gradually dissolves, usually completely dissolving within a few seconds to tens of seconds, thereby achieving reliable triggering of the fracture limiting structure.

[0046] The protective film 18 is formed on the outer surface of the second groove 15 by a deposition process. It is used to seal the soluble anchoring portion 19 within the second groove 15, preventing the soluble anchoring portion 19 from being accidentally dissolved due to the infiltration of body fluids during normal implantation. Preferably, the protective film 18 is processed by chemical vapor deposition or physical vapor deposition, with a thickness controlled between 0.1-2 μm. The protective film 18 is made of phenelzine material, which has excellent conformal coating capability, biocompatibility, and low moisture permeability.

[0047] The skeleton 1 is a continuous rhomboid cylindrical mesh structure.

[0048] The inner side of the skeleton 1 is provided with a lead groove 12 for laying lead wires to connect to the electrode unit. The lead groove 12 conceals the lead wires between the stent and the blood vessel wall, avoiding the risk of entanglement, corrosion and thrombosis caused by the lead wires being exposed to the blood flow. At the same time, it prevents the lead wires from being mechanically damaged during stent compression loading and self-expansion, ensuring the continuity of signal transmission and the stability of long-term implantation.

[0049] In addition, the output signal of the pressure sensor 13 can be led out through an insulated wire or run along the wire groove 12 inside the skeleton 1 to connect to the subcutaneous signal receiver, so as to realize wireless transmission to the external monitoring device for threshold reminders and fracture warnings.

[0050] The first spring 141 and the second spring 142 are made of medical-grade elastic metal materials (such as nickel-titanium alloy or stainless steel) to ensure the mechanical stability of long-term implantation.

[0051] During use, the brain-computer interface stent is compressed and loaded into the delivery catheter outside the body. Guided by a guidewire, it is delivered to the target blood vessel in the brain via a venous access. Once the predetermined position is reached, the outer sheath of the delivery catheter is retracted, and the electrode stent automatically unfolds due to the radial expansion force of the self-expanding nickel-titanium alloy skeleton, allowing the stent to fit tightly against the inner wall of the blood vessel. The rhomboid mesh structure of the skeleton 1 provides it with good flexibility and radial support, adapting to the physiological curvature and pulsation of the blood vessel while preventing displacement. The lead wire is led out through the lead wire groove 12 on the inner side of the skeleton 1 to the subcutaneous signal receiver, realizing the wireless transmission of nerve signals.

[0052] During long-term implantation, blood flows along the blood vessel direction through the electrode unit. The central conductive part 21 of the electrode unit protrudes relative to the surrounding insulating layer or substrate material surface, forming a geometrically abrupt interface at the electrode edge. When the blood flow reaches this geometrically abrupt interface, it first contacts the micro-nano structure array of the transition buffer part 22. The micropores 221 on it cause disturbance and energy dissipation of the fluid at the microscale, transforming the original convex boundary and smooth surface of the electrode edge into a gradual transition surface, thereby reducing the local shear stress peak. Specifically, the hexagonal close-packed micropore array can maximize the energy dissipation efficiency per unit area. The lateral size of the micropores is similar to the size of platelets, which can effectively prolong the passage time of platelets in the transition region, allowing them to gradually adapt to changes in shear stress and avoid platelet activation and aggregation induced by instantaneous high shear stress, thereby reducing the risk of thrombosis.

[0053] As the implantation time increases, the pore size of the micropores 221 gradually increases and the aspect ratio gradually decreases under the continuous erosion of blood flow. This leads to a gradual reduction in the energy dissipation capacity of the transition buffer section 22. Consequently, the blood flow impact force, which was originally buffered by the micro-nano structure, is gradually transferred to the downstream support rod 11 of the electrode unit. The erosion force borne by the downstream support rod 11 gradually increases with the degree of corrosion of the micropores 221. The pressure sensor 13 (located between the support rod 11 and the blood vessel wall, monitoring the support force) on the downstream support rod 11 monitors the value of the pressure sensor 13, which gradually increases. When the monitored value reaches a preset threshold, the external device sends a warning signal, indicating that the transition buffer section 22 is close to complete failure and needs to be replaced with the brain-computer interface stent. This active monitoring and warning mechanism avoids the electrode edge being directly exposed to a high shear stress environment due to the complete failure of the transition buffer structure, thereby reducing the risk of thrombosis.

[0054] After the blood flow crosses the geometrically abrupt interface, a local fluid reattachment zone is formed downstream of the electrode unit. Fluid dynamics studies have shown that this region exerts a greater impact force on the stent strut 11, making the strut 11 downstream of the electrode unit more prone to fatigue fracture compared to other parts. By placing the pressure sensor 13 on the strut 11 at this location and connecting the struts at intersections to form a closed mesh frame, the sensor can capture the sudden drop in monitoring value signal immediately when the strut 11 in this region fractures, thereby achieving timely early warning and location of stent fracture and ensuring the safety of brain-computer interface stent use.

[0055] When the support rod 11 breaks, the original structural constraints of the support rod are lost, and its ability to withstand the scouring force of fluid changes abruptly. The monitoring value of the pressure sensor 13 drops sharply. By identifying this sudden drop signal, the brain-computer interface stent can be promptly alerted to the breakage, so that the stent can be removed in time, avoiding the broken support rod from remaining in the blood vessel for a long time and causing damage to the inner wall of the blood vessel or obstructing blood flow under the action of blood flow.

[0056] A breakage limiting structure is provided inside the support rod 11. Under normal operating conditions, the protective film 18 is sealed to the outer surface of the second groove 15, the soluble anchoring part 19 is filled into the second groove 15, the fixing rod 17 is inserted into the soluble anchoring part 19 for fixation, the first spring 141 is in a stretched state, and the second spring 142 is in a free state. The protective film 18 can effectively prevent body fluid from penetrating into the second groove 15, avoid the soluble anchoring part 19 from being accidentally dissolved due to contact with body fluid, and ensure that the breakage limiting structure is only triggered when the support rod 11 breaks, effectively preventing accidental triggering caused by body fluid penetration.

[0057] When the support rod 11 breaks, blood enters the first groove 14 and the second groove 15 through the broken end, coming into contact with the soluble anchoring part 19 made of soluble gelatin. The soluble anchoring part 19 dissolves rapidly in the blood, releasing the fixation of the fixing rod 17. At this time, the first spring 141, which is in a stretched state, loses its restraint, retracts, and pulls the second spring 142, which is in a natural state, to extend, so that the first springs 141 at both ends and the second spring 142 in the middle are connected to form a tensioned state. Since the fixing rod 17 is fixedly connected to the connection point of the first spring 141 and the second spring 142 through the ring 16, the spring system can operate stably. The three spring segments after extension apply an elastic restraint force to the broken support rod 11 through the limiting effect of the first groove 14, automatically limiting the swing of the broken end, effectively preventing the broken support rod 11 from swinging with the blood flow, avoiding continuous damage to the inner wall of the blood vessel after the support rod 11 breaks or swinging into the blood vessel to obstruct blood flow and cause thrombosis, thereby ensuring the safety of the patient before stent removal.

[0058] In summary, through the above structural design and collaborative working mechanism, the fluid disturbance problem caused by geometrical abrupt changes at the electrode edge is effectively solved while ensuring the accuracy of brain-computer interface signal acquisition, thus achieving long-term safe implantation of the electrode scaffold. Specifically, firstly, by setting a micro-nano structure array composed of a hexagonal close-packed micropore array 221 in the transition buffer section 22 of the electrode unit, a local energy dissipation zone is formed at the interface of geometrical abrupt changes at the electrode edge, transforming the convex boundary and the smooth surface into a gradual transition surface, effectively reducing the peak value of local shear stress. At the same time, the size of the micropores 221 is similar to that of platelets, which can prolong the platelet passage time and avoid platelet activation and aggregation induced by instantaneous high shear stress, thereby reducing the risk of thrombosis from the source. Secondly, by setting a pressure sensor 13 on the downstream support rod 11 of the electrode unit, the corrosion status of the transition buffer section 22 and the structural integrity of the support rod 11 are monitored in real time. When the micropores 221 are eroded and corroded, resulting in a decrease in buffering capacity, the monitoring value increases and actively reminds replacement. When the rod 11 fractures due to fatigue, the support force drops sharply, causing the monitoring value to drop sharply and providing timely early warning and location, thus providing an accurate basis for clinical intervention. Finally, through the fracture limiting structure composed of the first groove 14, the second groove 15, the first spring 141, the second spring 142, the fixing rod 17, the protective film 18, and the soluble anchoring part 19, when the rod 11 fractures, blood enters the second groove 15 through the fracture end, causing the soluble anchoring part 19 made of soluble gelatin to dissolve, releasing the fixation of the fixing rod 17. The first spring 141, which is in a stretched state, retracts and pulls the second spring 142 to extend, so that the first spring 141 and the second spring 142 are in a tensioned state. The first groove 14 limits the application of elastic constraint force to the fractured rod 11, preventing it from swinging with the blood flow and damaging the inner wall of the blood vessel or obstructing the blood flow and causing thrombosis.

[0059] The above three mechanisms support each other and progress step by step, forming a complete safety chain from prevention to monitoring to protection. This systematically solves the problems of platelet activation and aggregation and strut 11 fracture caused by high shear stress due to geometric mutations at the electrode edge, significantly improving the safety of long-term electrode stent implantation and the reliability of brain-computer interface signal acquisition, and providing reliable technical support for the clinical translation of interventional brain-computer interface technology.

[0060] Different technical features appearing in different embodiments can be combined to achieve beneficial effects. Those skilled in the art, based on a study of the drawings, specification, and claims, should be able to understand and implement other variations of the disclosed embodiments. In the claims, the term "comprising" does not exclude other means or steps; the indefinite article "a" does not exclude a plurality; the terms "first" and "second" are used to identify names rather than to indicate any particular order. No reference numerals in the claims should be construed as limiting the scope of protection. The functionality of multiple parts appearing in the claims can be implemented by a single hardware or software module. The appearance of certain technical features in different dependent claims does not mean that these technical features cannot be combined to achieve beneficial effects.

Claims

1. An interventional brain-computer interface scaffold with a micro / nano shear stress transition structure, characterized in that, include: The skeleton is composed of multiple intersecting struts, forming multiple intersection points; Multiple electrode units are disposed at the intersection of the skeleton. Each electrode unit includes a base, a central conductive part disposed in the middle of the base, a transition buffer part disposed on one side of the base and surrounding the central conductive part, and a main functional part disposed on the other side of the base. The surface of the transition buffer part forms a micro-nano structure array. Pressure sensors are mounted on multiple support rods downstream of the electrode unit; When the micro-nano structure array is eroded, its buffering capacity decreases, causing the pressure sensor's monitoring value to gradually increase. When it reaches a set threshold, a replacement reminder is given. If the support rod breaks, the pressure sensor's monitoring value drops sharply, indicating that a breakage has occurred. The fracture limiting structure includes a first groove disposed within the support rod, a second spring disposed within the first groove and two first springs connected to both ends of the second spring, the first spring being in a stretched state and the second spring being in a free state, a second groove also disposed within the first groove, the second groove being filled with a soluble anchoring part, a protective film disposed outside the second groove, and a fixing rod connected to both ends of the second spring, the fixing rod being inserted into the soluble anchoring part for fixation.

2. The interventional brain-computer interface scaffold with a micro / nano shear stress transition structure according to claim 1, characterized in that: Multiple support rods equipped with the pressure sensor are connected at their two ends to form a closed mesh frame.

3. The interventional brain-computer interface scaffold with a micro-nano shear stress transition structure according to claim 1, characterized in that: The ends of the two first springs are respectively fixedly connected to two intersection points located at both ends of the support rod, and a ring is fixedly connected between the ends of the first spring and the second spring, and the ring is fixedly connected to the fixed rod.

4. The interventional brain-computer interface scaffold with a micro-nano shear stress transition structure according to claim 1, characterized in that: When the support rod breaks, blood enters the second groove, dissolving the soluble anchoring part, releasing the fixation of the fixing rod, causing the first spring in the stretched state to retract and pull the second spring in the natural state to extend, so that the first springs at both ends and the second spring in the middle are connected to form a tensioned state to limit the broken support rod.

5. The interventional brain-computer interface scaffold with a micro-nano shear stress transition structure according to claim 1, characterized in that: The micro-nano structure array includes multiple micropores formed on the base. The micropores are hemispherical structures and are arranged in a hexagonal close-packed array.

6. The interventional brain-computer interface scaffold with a micro / nano shear stress transition structure according to claim 1, characterized in that: The soluble anchoring part is made of soluble gelatin.

7. The interventional brain-computer interface scaffold with a micro-nano shear stress transition structure according to claim 1, characterized in that: The protective film is formed on the outer surface of the second groove by a deposition process.

8. The interventional brain-computer interface scaffold with a micro-nano shear stress transition structure according to claim 1, characterized in that: The skeleton is a continuous rhomboid cylindrical mesh structure.

9. The interventional brain-computer interface scaffold with a micro / nano shear stress transition structure according to claim 1, characterized in that: The inner side of the frame is provided with a wire groove for laying wires to connect the electrode unit.

10. The interventional brain-computer interface scaffold with a micro / nano shear stress transition structure according to claim 1, characterized in that: The first spring and the second spring are made of medical-grade elastic metal material.