Auxiliary implantation device and auxiliary implantation system of flexible neural electrode

Abstract

The present invention provides an auxiliary implantation device and an auxiliary implantation system for a flexible neural electrode. The auxiliary implantation device for a flexible neural electrode comprises: at least one traction member, comprising a head end and a tail end opposite to each other along its longitudinal direction, the head end being attached to the flexible neural electrode; a receiving assembly, comprising at least one receiving component, the receiving component comprising a receiving shell and a receiving channel penetrating the receiving shell, the receiving channel being configured to accommodate the at least one traction member; wherein at least part of the receiving channel has a rough surface, the rough surface being configured such that when the traction member moves in the receiving channel, the rough surface generates a friction force that hinders the relative movement of the traction member and the receiving channel.

Description

Technical Field

[0001] The present invention relates to the field of brain-computer interface, and in particular to an auxiliary implantation device and an auxiliary implantation system for flexible neural electrodes. Background Art

[0002] The implantation technology of neural electrodes is an advanced medical method in the field of neuroscience and neuromedicine. By implanting tiny electrodes in the brain or nervous system, neural signals can be accurately monitored and adjusted to achieve the purpose of treating diseases related to the nervous system. In addition, neural electrodes also have the function of recording neural signals in specific brain areas, and these recorded signals can be transmitted to computers for analysis.

[0003] The implant device of neural electrode is the key equipment to realize the neural electrode implant technology. With the continuous advancement of science and technology, the implant device of neural electrode is also constantly developing and improving. Summary of the invention

[0004] According to an embodiment of the present invention, a flexible neural electrode auxiliary implantation device and an auxiliary implantation system thereof are provided.

[0005] According to a first aspect of the present invention, there is provided an auxiliary implantation device for a flexible neural electrode, comprising:

[0006] at least one traction member, comprising a head end and a tail end opposite to each other along a longitudinal direction thereof, wherein the head end is attached to the flexible neural electrode;

[0007] A receiving assembly, comprising at least one receiving component, wherein the receiving component comprises a receiving shell and a receiving channel passing through the receiving shell, wherein the receiving channel is configured to accommodate the at least one traction member;

[0008] At least part of the receiving channel has a rough surface, and the rough surface is configured such that when the traction member moves in the receiving channel, the rough surface generates a friction force that hinders the relative movement between the traction member and the receiving channel.

[0009] In at least some embodiments, the receiving channel includes at least one protrusion disposed on a wall thereof, the protrusion protruding in a direction pointing from the wall toward a channel center of the receiving channel to form the rough surface.

[0010] In at least some embodiments, the receiving channel extends along a first direction, and the wall includes a first wall and a second wall opposite to each other in a second direction, the second direction intersects with the first direction and is located in the same plane; the at least one protrusion includes a first protrusion arranged on the first wall and a second protrusion arranged on the second wall, and the protrusion directions of the first protrusion and the second protrusion are opposite.

[0011] In at least some embodiments, there are a plurality of first protrusions, and a plurality of second protrusions, and the plurality of first protrusions and the plurality of second protrusions are alternately arranged along the first direction.

[0012] In at least some embodiments, the protrusion is elastic and is configured such that when the traction member is located in the receiving channel, the protrusion forms an elastic contact with the traction member.

[0013] In at least some embodiments, the protrusion is configured to be at least one of a sawtooth shape, a corrugated shape, and a boss shape.

[0014] In at least some embodiments, the receiving channel is constructed as an open groove that passes through the receiving shell, the open groove extends along a first direction and includes a first slot, a second slot that are opposite to each other in the first direction, and an open channel connected between the first slot and the second slot, and at least a portion of the open channel has the rough surface.

[0015] In at least some embodiments, the receiving channel is configured as an internal channel penetrating the receiving shell, the internal channel extends along a first direction and is surrounded by the receiving shell, and a portion of the internal channel has the rough surface.

[0016] In at least some embodiments, the internal channel includes a first portion, a second portion, and a third portion located between the first portion and the second portion, the third portion having the rough surface.

[0017] In at least some embodiments, at least one of the first portion and the second portion is configured to cooperate with a shape of the traction member to retain the traction member in the internal passage.

[0018] In at least some embodiments, the receiving channel extends along a first direction, and the receiving assembly includes at least one row of receiving components arranged along a third direction perpendicular to the first direction, and the at least one row of receiving components includes one or more of the receiving components.

[0019] In at least some embodiments, the at least one row of receiving components includes a plurality of the receiving components, and two adjacent receiving components among the plurality of the receiving components are slidably connected to each other in the first direction.

[0020] In at least some embodiments, the auxiliary implantation device further comprises:

[0021] The guide assembly is arranged between the two adjacent receiving components, and the guide assembly includes a guide rail and a guide bar extending along a first direction. The guide rail and the guide bar are mutually embedded in a shape-matched manner, so that the two adjacent receiving components are slidably connected to each other.

[0022] In at least some embodiments, the receiving assembly includes a plurality of rows of receiving components, and the plurality of rows of receiving components are arranged in intervals in the third direction and do not contact each other.

[0023] In at least some embodiments, the receiving channel extends along a first direction, the receiving assembly includes at least two receiving units arranged in a matrix manner in a plane perpendicular to the first direction, and the receiving unit includes a plurality of receiving components; one of the at least two receiving units moves in the first direction relative to the other receiving unit, so that all the receiving components in the one receiving unit move in the first direction relative to all the receiving components in the other receiving unit.

[0024] In at least some embodiments, the at least two receiving units are adjacent to each other in the second direction, and the auxiliary implantation device further comprises:

[0025] The guide assembly is arranged between the at least two receiving units, and the guide assembly includes a guide rail and a guide bar extending along a first direction, and the guide rail and the guide bar are mutually engaged in a shape-matching manner, so as to connect the at least two receiving units slidably to each other.

[0026] In at least some embodiments, the auxiliary implantation device further includes a main clamping component, which includes two clamping plates, and the two clamping plates are opposite to each other in the second direction and clamp the receiving component from opposite sides of the receiving component respectively.

[0027] In at least some embodiments, the main clamping assembly further includes a connecting assembly disposed between the clamping sheet and the receiving assembly, wherein the connecting assembly is configured to allow the receiving assembly to be detachably connected to the clamping sheet.

[0028] In at least some embodiments, the connection assembly includes at least one of a plug-in connection, a snap-on connection, and a magnetic connection.

[0029] In at least some embodiments, the auxiliary implant device also includes an auxiliary clamping assembly, which includes a clamping member that at least partially surrounds the main clamping assembly and the receiving assembly to clamp the main clamping assembly and the receiving assembly clamped by the main clamping assembly.

[0030] In at least some embodiments, the friction force generated by the rough surface is defined as a friction force threshold, and the traction member is configured to move in the receiving channel along an extension direction of the receiving channel under the action of an external force greater than the friction force threshold.

[0031] In at least some embodiments, the auxiliary implant device further includes a positioning portion, and the positioning portion is configured to be displayed under medical imaging to guide the auxiliary implant device to reach a target position.

[0032] In at least some embodiments, the positioning portion is disposed on at least one of the traction member, the receiving component, and the flexible neural electrode.

[0033] In at least some embodiments, the positioning portion is disposed on a distal end of the flexible neural electrode.

[0034] In at least some embodiments, the locating portion includes a metal marking.

[0035] In at least some embodiments, the positioning portion includes a plurality of adjacently arranged metal marks.

[0036] According to a second aspect of the present invention, there is also provided an auxiliary implantation system of a flexible neural electrode, comprising:

[0037] at least one flexible neural electrode comprising a proximal end, a distal end, and an electrical connection extending between the proximal end and the distal end; and

[0038] The auxiliary implantation device as described in any of the preceding embodiments,

[0039] Wherein, the head end of the traction member is attached to the distal end of the flexible nerve electrode.

[0040] In at least some embodiments, the auxiliary implant system includes at least two flexible neural electrodes, and the proximal ends of the at least two flexible neural electrodes are integrally constructed.

[0041] In at least some embodiments, the distal end of the flexible neural electrode includes at least one neural electrode site and an auxiliary implantation hole; the head end of the traction member passes through the auxiliary implantation hole, and the diameter of the auxiliary implantation hole is smaller than the diameter of the main body of the traction member, so that the flexible neural electrode rests on the head end of the traction member.

[0042] In at least some embodiments, the auxiliary implantation system further includes an auxiliary fixing portion, and the auxiliary fixing portion is configured to further fix the distal end of the flexible nerve electrode to the head end of the traction member.

[0043] In at least some embodiments, the auxiliary fixing portion is configured as an adhesive disposed between the auxiliary implantation hole of the flexible nerve electrode and the head end of the traction member.

[0044] In at least some embodiments, the adhesive includes a dissolvable material.

[0045] In at least some embodiments, the electrical connection portion includes at least one metal wire and an insulating layer surrounding the metal wire, and the insulating layer electrically insulates and encapsulates the at least one metal wire, thereby achieving electrical insulation between the metal wires.

[0046] In at least some embodiments, the flexible neural electrode is configured in a linear or non-linear manner in a relaxed state.

[0047] In at least some embodiments, the flexible neural electrode is spiral-shaped in a relaxed state.

[0048] In at least some embodiments, the auxiliary implantation system further includes a guiding mechanism, which is connected to the main clamping assembly and guides the main clamping assembly to move along different spatial directions.

[0049] In at least some embodiments, the guiding mechanism includes a guiding rod, and the main clamping assembly is mounted on the guiding rod and is movable along an extending direction of the guiding rod.

[0050] In at least some embodiments, the guide rod extends along the second direction, and the movement range of the main clamping assembly is less than or equal to a distance threshold, and the distance threshold is set to the farthest distance from the target area in the second direction.

[0051] In at least some embodiments, the guiding mechanism further includes a support seat and a sliding assembly slidably connected to the support seat, wherein the sliding assembly is connected to the guide rod and is configured to move in at least one of a first direction, a second direction, and a third direction so as to move the guide rod in the at least one direction. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings of the embodiments will be briefly introduced below. Obviously, the drawings in the following description only relate to some embodiments of the present invention, but are not intended to limit the present invention.

[0053] Figure 1 A partial stereoscopic view of an auxiliary implantation device according to an embodiment of the present invention;

[0054] Figure 2 A three-dimensional diagram of a flexible neural electrode to be implanted according to an embodiment of the present invention;

[0055] Figure 3 A three-dimensional diagram of a traction member of an auxiliary implantation device according to an embodiment of the present invention;

[0056] Figure 4 A three-dimensional diagram of a receiving device of an auxiliary implantation device according to an embodiment of the present invention;

[0057] Figure 5 for Figure 1 A partial view of the auxiliary implant device, wherein the traction member fixed in the receiving device is fixed to the flexible neural electrode;

[0058] Figure 6 A three-dimensional diagram of a receiving device of an auxiliary implantation device according to another embodiment of the present invention;

[0059] Figure 7 A three-dimensional diagram of an auxiliary implant device and a flexible neural electrode fixed thereto according to another embodiment of the present invention;

[0060] Figure 8 is another stereoscopic view of the auxiliary implantation system according to an embodiment of the present invention, wherein the flexible neural electrode has been implanted into the target position with the aid of the auxiliary implantation system;

[0061] Fig. 9 for Figure 8 A partial stereoscopic view of the auxiliary implant system shown;

[0062] Fig.10 Another perspective view of the auxiliary implantation system according to an embodiment of the present invention, wherein the guide mechanism is shown;

[0063] Fig.11 A partial stereoscopic diagram showing an auxiliary implantation system according to an embodiment of the present invention, which is suitable for implantation of multiple flexible nerve electrodes;

[0064] Fig.12 Another perspective view showing an auxiliary implantation system according to another embodiment of the present invention, which is suitable for implantation of multiple flexible neural electrodes and includes an auxiliary clamping assembly;

[0065] Fig.13 Show Fig.11 Another perspective view of the auxiliary implant system shown, wherein a plurality of flexible neural electrodes are fixed by a receiving assembly;

[0066] Fig.14 Another stereoscopic view showing an auxiliary implant device according to another embodiment of the present invention, wherein a plurality of flexible neural electrodes integrated at the proximal end are fixed by a receiving assembly;

[0067] Fig.15 A partial stereoscopic view of an auxiliary implantation system according to an embodiment of the present invention, showing a guide assembly and a connection assembly;

[0068] Fig.16 is a three-dimensional diagram of an auxiliary implantation system according to an embodiment of the present invention, wherein the receiving assembly includes a plurality of receiving units that are movable relative to each other;

[0069] Fig.17 It is a schematic diagram of the operation of the auxiliary implantation system according to an embodiment of the present invention, wherein a single flexible neural electrode is implanted with the aid of the auxiliary implantation system;

[0070] Fig.18 This is another schematic diagram of the operation of the auxiliary implant system according to another embodiment of the present invention, wherein a plurality of flexible neural electrodes are implanted with the aid of the auxiliary implant system. DETAILED DESCRIPTION

[0071] In order to make the purpose, technical solution and advantages of the embodiment of the present invention clearer, the technical solution of the embodiment of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the embodiment of the present invention. Obviously, the described embodiment is a part of the embodiment of the present invention, not all of the embodiments. Based on the described embodiment of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0072] Unless otherwise defined, the technical terms or scientific terms used herein shall have the usual meanings understood by persons of ordinary skill in the field to which the present invention belongs. The words "first", "second" and similar terms used in the present invention do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "include" or "comprise" mean that the elements or objects appearing before the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects. "Inside", "outside", "upper", "lower" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0073] In the field of modern neuroscience and neuromedicine, the precise implantation of flexible neural electrodes plays a key role in the treatment of neurological diseases and the development of brain-computer interfaces. At present, the assembly of flexible neural electrodes and auxiliary traction parts usually needs to be done manually during surgery, which is not only time-consuming but also highly dependent on the operator's experience and skills. Since the height of the electrode or the relative position between the electrodes may be adjusted during surgery, this further brings about operational difficulty and complexity, and also increases the requirements for accuracy and safety during implantation.

[0074] In addition, existing implant assistance tools are often unable to take into account the implantation requirements of both single electrodes and multi-electrode arrays at the same time, and are unable to provide the flexible control and real-time adjustment capabilities required during the implantation process. These limitations directly affect the functional performance of implanted electrodes, including the ability to record and regulate neural signals, thereby limiting the application effect and scope of application of related technologies such as neural electrode technology and brain-computer interfaces. The above problems are particularly prominent in the implantation process of multiple electrodes. How to quickly and accurately assemble each electrode with the auxiliary traction device and implant it to the target position has become a key bottleneck restricting the development of brain-computer interface technology for accurate, high-throughput neural signal recording and regulation.

[0075] An embodiment of the present invention provides an auxiliary implantation device for a flexible neural electrode, comprising at least one traction member and a receiving assembly; the at least one traction member comprises a head end and a tail end opposite to each other along its longitudinal direction, and the head end is attached to the flexible neural electrode; the receiving assembly comprises at least one receiving component, the receiving component comprises a receiving shell and a receiving channel passing through the receiving shell, and the receiving channel is configured to accommodate the at least one traction member; wherein at least a portion of the receiving channel has a rough surface, and the rough surface is configured such that when the traction member moves in the receiving channel, the rough surface generates a friction force that hinders the relative movement of the traction member and the receiving channel.

[0076] In the field of neuroscience and neuromedicine, precise implantation of neural electrodes is crucial for the treatment of neurological diseases and the development of brain-computer interfaces. Modern flexible neural electrodes are well compatible with neural tissue, but they are easily bent and deformed during implantation and rely on hard traction needles. Therefore, existing implant devices are insufficient in terms of operational accuracy and convenience, which affects the development of brain-computer interface technology.

[0077] In the auxiliary implantation device provided in the above-mentioned embodiment, by providing a receiving channel for accommodating the traction member and making at least a part of the receiving channel have a rough surface, not only the friction between the traction member and the receiving structure is enhanced, thereby maintaining the stable position of the traction member, but also the traction member is allowed to move when appropriate external force is applied, thereby ensuring the accuracy and safety of the implantation process.

[0078] The embodiment of the present invention also provides an auxiliary implantation system of a flexible neural electrode, including the auxiliary implantation device. In the auxiliary implantation system, through the unique combination of a traction member and a receiving component and the design of multiple receiving units, the flexible implantation of a single or multiple electrodes can be realized, the difficulty of operation can be reduced, and the safety and flexibility can be increased, which has a profound impact on neuroscience research and clinical practice.

[0079] The present invention is described below by specific embodiments. In order to keep the following description of the embodiments of the present invention clear and concise, the detailed description of known functions and known components may be omitted. When any component of the embodiments of the present invention appears in more than one accompanying drawings, the component may be represented by the same reference numeral in each of the accompanying drawings.

[0080] Figure 1 , Figures 3 to 5 The auxiliary implantation device according to one embodiment of the present invention is schematically shown. Figure 6 , Figure 7 The auxiliary implantation device according to another embodiment of the present invention is schematically shown, which is used to implant Figure 2 The flexible neural electrode 5 shown is implanted at the target position of the surgical subject.

[0081] For example, Figure 2The flexible neural electrode 5 shown includes a proximal end 51, a distal end 52, and an electrical connection 53 extending between the proximal end and the distal end.

[0082] For example, the width of the flexible neural electrode 5 can range from 0.001 to 10 mm, and the thickness can range from 0.0001 to 1 mm. This width and thickness range enables the flexible neural electrode 5 to be suitable for different neural tissues and implantation depths. The longitudinal length range of the flexible neural electrode 5 in the relaxed state is set between 0.1 and 50 cm. The selection of this length range is intended to ensure that the electrode can flexibly adapt to implantation areas of different sizes while maintaining sufficient operating space and adjustability. The specific structure of the flexible neural electrode 5 will be further described below.

[0083] The implant assisting device comprises at least one Figure 2 The traction member 1 shown and Figure 4 or Figure 6 The receiving assembly 2A shown. The traction member 1 includes a head end 13 and a tail end 12 that are opposite to each other along its longitudinal direction, and the head end 13 is attached to the flexible nerve electrode 5; the receiving assembly 2A includes at least one receiving component 2, and the receiving component 2 includes a receiving shell 21 and a receiving channel 22 that passes through the receiving shell, and the receiving channel 22 is configured to accommodate the at least one traction member 1. At least part of the receiving channel 22 has a rough surface, and the rough surface is configured such that when the traction member 1 moves in the receiving channel 22, the rough surface generates a friction force that hinders the relative movement of the traction member 1 and the receiving channel 22.

[0084] For example, the traction member 1 is as follows Figure 3As shown, the traction member 1 is constructed in a longitudinal manner and can be made of tungsten wire, medical stainless steel, titanium alloy or other materials with good biocompatibility and appropriate strength. The length of the traction member 1 can range from 0.1 to 50 cm. This length range allows the system to adapt to implantation requirements at different depths, and can meet the precise implantation requirements from shallow neural networks to deep brain structures. The cross-sectional diameter of the traction member 1 can be between 0.01 and 3 mm. This diameter range ensures that the traction member 1 has sufficient rigidity to avoid bending or breaking during implantation, while being small enough to reduce tissue damage. The head end 13 of the traction member 1 can be designed as a sharp tip (such as a traction needle), which is crucial to ensure that it penetrates the tissue smoothly to the target area. The length of the head end 13 can be between 0.01 and 50 mm. This length range ensures that the traction member 1 maintains sufficient penetration when penetrating the tissue without causing excessive tissue damage. The head end 13 can be processed with precision machining technology, usually high-precision mechanical cutting and grinding processes. This process can be completed by computer numerical control machining equipment to ensure that the shape, sharpness and dimensional accuracy of the head end 13 meet specific requirements. In addition to traditional mechanical processing methods, the tip 13 can also be manufactured using an electrochemical etching method. The advantage of this manufacturing method is that it can form an extremely sharp and precise shape of the tip 13 without generating significant mechanical stress. In addition to the sharp tip design, the tip 13 of the traction member can also be designed to be blunt. This design is intended to reduce damage to blood vessels during implantation, allowing blood vessels to "slide" through the puncture path and reduce the possibility of puncturing blood vessels during implantation. The blunt tip design helps reduce the risk of bleeding during implantation, while also helping to reduce tissue damage and irritation. In some cases, the blunt tip design can also reduce pain during implantation and improve patient comfort. In addition, the blunt tip design of the traction member 1 also takes into account the psychological factors of patients and doctors.

[0085] The receiving component 2A is designed to provide stable support and precise guidance for the traction member 1. The size and structural design of the receiving component 2A can be adjusted accordingly according to the diversification of surgical requirements, thereby ensuring high efficiency and safety during the implantation of the flexible nerve electrode 5. The receiving component 2A includes at least one receiving part 2, the size of which is designed to be in the range of 0.1 to 50 cm in length, width and height. The selection of this size range is intended to enable the receiving part 2 to adapt to surgical areas of different sizes while ensuring its stability and convenience of carrying during operation. The material selection of the receiving part 2 is based on the mechanical strength, biocompatibility and light weight characteristics it needs to have. Commonly used materials include but are not limited to polycarbonate, polyimide, polymethyl methacrylate and other high-performance medical plastics. These materials not only have good biocompatibility, but also provide sufficient structural strength and appropriate elasticity to ensure reliability during surgery. The receiving part 2 is usually manufactured by precision injection molding or CNC machine tool processing to meet complex or customized designs and achieve higher dimensional accuracy and surface finish. Furthermore, the receiving part 2 can also be mass-produced by means of injection molding, thereby ensuring high precision and consistency of complex shapes.

[0086] For example, at least part of the receiving channel 22 has a rough surface, that is, the receiving channel 22 of the receiving component 2 has a rough surface at least partially, thereby increasing the friction coefficient of the contact interface between the receiving channel 22 and the traction member 1, thereby increasing the friction between the receiving component 2 and the traction member 1. The friction force is defined as a friction threshold, and only when the traction member 1 overcomes the friction threshold under the action of an external force can the relative movement between the traction member 1 and the receiving component 2 be allowed to move in the receiving channel 22. This helps to fix the traction member 1 more effectively and reliably, but at the same time can release the traction member 1 when needed, thereby achieving more precise control of the traction member 1. In the embodiment of the present invention, the "friction threshold" is obtained by carefully calculating and adjusting the interface design and material selection between the receiving structure and the traction member. The determination of this threshold takes into account a variety of factors, including but not limited to the material properties of the traction member and the receiving structure, the roughness of the contact surface, the dry and wet state of the contact surface, and the weight and size of the traction member. The main purpose of setting this threshold is to balance the stability and mobility of the traction member during the surgical operation, ensuring that the traction member will not move unexpectedly when not subjected to a predetermined external force, and that the traction member can move longitudinally along the receiving structure when the applied external force exceeds the threshold. This design enables the traction member to maintain appropriate stability and flexibility during different stages of the surgical operation, thereby improving the accuracy and safety of the implantation operation.

[0087] For example, Figure 4 and Figure 6As shown, the receiving channel 22 includes at least one protrusion 23 arranged on its wall, and the protrusion 23 protrudes in a direction from the wall to the channel center of the receiving channel 22, thereby forming a rough surface. Here, this surface roughening can be as follows Figure 4 As shown, it is arranged in the entire receiving channel 22, and can also be arranged as shown in FIG. Figure 6 As shown, it is arranged only partially in the receiving channel 22 .

[0088] In the case where the cross-sectional size of the receiving channel 22 is larger than the diameter of the traction member 13, a protrusion 23 can be provided on the wall of the receiving channel 22 so that the outer surface of the traction member 13 contacts or abuts against the protrusion 23 to generate friction, thereby increasing the friction between the receiving structure 2 and the traction member 1. In addition, it can be ensured that the friction between the receiving structure and the traction member is sufficient to prevent the traction member from moving unnecessarily due to gravity or slight operating errors, while ensuring that the traction member can move smoothly along the predetermined path when an appropriate external force is applied.

[0089] For example, Figure 4 As shown, the receiving channel 22 includes two lateral walls facing each other, namely, a first wall 221 and a second wall 222. Figure 4 In the embodiment shown, the direction of the longitudinal extension of the receiving channel 22 is defined as the first direction y, and the direction intersecting (e.g., orthogonal) the first direction y and perpendicular to the two walls 221, 222 is defined as the second direction x, that is, the first direction y and the second direction x intersect each other and are located in the same plane (e.g., the xy plane). This direction is also applicable to the description of other embodiments of the present invention. The first direction y is provided with a surface roughening on the entire receiving channel 22. To this end, the first wall 221 and the second wall 222 are opposite to each other in the first direction x, and a plurality of first protrusions 231 are provided on the first wall 221, and a plurality of second protrusions 232 are provided on the second wall 222, and the first protrusions 231 and the second protrusions 232 are respectively protruded in opposite directions and are alternately arranged along the first direction y. In the embodiment of the present invention, by staggering the first protrusions 231 and the second protrusions 232 along the first direction y, the overall force of the traction member can be made more uniform under the premise of increasing the friction between the receiving component 2 and the traction member 1, and the stability of the traction member is further enhanced.

[0090] Further, for example, the first protrusion 231 and the second protrusion 232 may be arranged alternately and staggered. The orthographic projection of the first protrusion 231 on the second wall 222 does not overlap with the second protrusion 232, or the orthographic projection of the second protrusion 232 on the first wall 221 does not overlap with the first protrusion 231. Through the above arrangement, the number of protrusions can be reduced while enhancing the stability of the traction member, thereby reducing the difficulty of manufacturing the receiving channel.

[0091] For example, Figure 4 As shown, the receiving channel 22 is configured as an open slot 22' that penetrates the receiving housing 21, and the open slot 22' includes a first slot, a second slot, and an open channel connected between the first slot and the second slot. Further, for example, the open slot 22' is connected to the top surface of the receiving housing 21 with its first slot, and is connected to the bottom surface of the receiving housing 21 with its second slot, wherein the open slot 22' is open on the end surface of the receiving housing 21 parallel to the xy plane.

[0092] Figure 4 In the embodiment of the present invention, the first protrusion 231 and the second protrusion 232 are respectively arranged on two opposite walls (the first wall 221 and the second wall 222) of the receiving channel 22. It is understood that in other embodiments of the present invention, the protrusion may be arranged on the third wall between the first wall 221 and the second wall 222. The embodiment of the present invention does not limit the position of the protrusion in the receiving channel. However, when setting the position of the protrusion, it is necessary to consider the forces on the traction member in different directions to ensure that the traction member can be firmly fixed at any operating angle.

[0093] In such Figure 6 In the embodiment shown, the receiving channel 22 is configured as an internal channel 22" that runs through the interior of the receiving housing 21. The internal channel 22" extends along the first direction y and is surrounded by the receiving channel 22, for example, in the circumferential direction. Surface roughening is provided only on part of the receiving channel 22 along the first direction y. To this end, the internal channel 22" can be divided into a plurality of partial sections along the first direction y, for example, Figure 6 As shown in the figure, the receiving channel 22 is divided into a first part 22a close to the top surface of the receiving housing 21, a second part 22b close to the bottom surface of the receiving housing 21, and a third part 22c located therebetween. The first part 22a and / or the second part 22b can hold the traction member 1 in a form-fitting manner, and the third part 22c has a rough surface. To this end, protrusions 23 that protrude in opposite directions and are alternately arranged in the first direction y are respectively provided on two lateral walls of the third part 22c that are opposite to each other in the second direction x, so that the receiving channel 22 only partially forms a rough surface. Figure 6 The raised portion 23 in the embodiment also includes a first raised portion 231 and a second raised portion 232. The distribution and advantages of the first raised portion 231 and the second raised portion 232 can be referred to in the previous Figure 4 The description is not repeated here.

[0094] Figure 4 By setting multiple protrusions, the "friction threshold" can be increased. When the weight of the traction part is relatively large, or it is more likely to be accidentally moved by external forces during operation, it is more suitable to use Figure 4 structure. Figure 6The inner channel is designed to be used when the diameter of the traction member itself is too small to arrange additional protrusions in the inner channel. The receiving channel 22 provided with multiple protrusions 23 can be adjusted in its inner shape as needed, for example, a toothed structure, a concave-convex structure, a curved surface structure or other friction enhancing structures can be formed.

[0095] In the embodiment of the present invention, the transverse cross-sectional dimension of the open groove 22' or the internal channel 22" is designed to be between 0.03 and 15 mm or can be adjusted as needed to accommodate traction members of different sizes and diameters passing through the inside of the open groove 22' or the internal channel 22", ensuring that the traction member is implanted into the target area along a predetermined longitudinal path during various implantation operations. The height of the protruding portion 23 relative to the lateral wall toward the receiving channel 22 is less than the transverse cross-sectional dimension of the open groove 22' or the internal channel 22", for example, the height can be between 0.1 and 10 mm, to ensure that the traction member can pass smoothly without being interfered by the protruding portion.

[0096] For example, the protrusion 23 is elastic so that when the traction member 1 is located in the receiving channel 22, the protrusion 23 forms an elastic contact with the traction member 1. To this end, the protrusion 23 can be made of an elastic material. As a result, a deformable contact interface is formed between the traction member 1 and the receiving channel 22 to increase the friction. During the assembly process of the traction member 1 and the receiving part 2, these protrusions can cause a slight deformation of the traction member 1 while elastically deforming themselves, thereby increasing the friction between the receiving part 2 and the traction member 1. At the same time, this deformation is carefully controlled to ensure that it does not affect the predetermined implantation angle of the traction member 1. In addition, as mentioned above, the protrusion 23 also produces elastic deformation itself during the assembly process of the receiving part 2 and the traction member 1, so that the protrusion 23 can tightly surround the traction member 1 when the traction member 1 is implanted, thereby increasing the friction between the traction member 1 and the traction member 1, and ensuring the stability of the traction member 1 during operation.

[0097] For example, Figure 1 , Figure 5 , Figures 7 to 10 The flexible neural electrode 5 is shown being held by an auxiliary implantation device. Figure 1 , Figure 5 , Figures 7 to 10 In the illustrated embodiment, the receiving assembly 2A of the auxiliary implantation device includes only one receiving part 2. The traction member 1 is inserted into the receiving channel 22 of the receiving part 2, wherein the head end 13 of the traction member 1 is attached to the flexible neural electrode 5.

[0098] For example, the receiving component 2A may also include a plurality of receiving parts 2. The direction perpendicular to both the first direction y and the second direction x is defined as a third direction z. The receiving component 2A includes at least one row of receiving parts 2 arranged along the third direction z, and each row of receiving parts includes at least one receiving part 2. In the case where the receiving component 2A includes a plurality of receiving parts 2, the receiving component 2A can be used to receive a plurality of traction members 1 to achieve batch implantation of a plurality of flexible neural electrodes. Furthermore, since each receiving part 2 is provided with a receiving channel for accommodating the traction member and at least part of the receiving channel has a rough surface, it can improve the accuracy of assembling each electrode with the auxiliary traction member and implanting it into the target position during the implantation of multiple electrodes, thereby ensuring the accuracy and safety of the high-throughput implantation process.

[0099] For example Figures 11 to 16 As shown, the receiving assembly 2A includes two rows of receiving components arranged along the third direction z, each row of receiving components includes four receiving components 2, that is, it includes receiving components 2 arranged in a 4×2 matrix. The two rows of receiving components 2 are spaced apart from each other in the third direction z to maintain a spacing, and do not contact each other, so as not to interfere with each other.

[0100] Fig.11 , Fig.12 The flexible neural electrode 5 inserted into one of the receiving parts 2 is shown by way of example. Figures 13 to 16 The illustrated embodiment shows receiving components 2 arranged in a 4×2 matrix and a flexible neural electrode 5 arranged in each of the receiving components 2 .

[0101] For example, four receiving parts 2 in each row are connected to each other slidably in the first direction y. Fig.15 The guide assembly 24 shown in FIG. The guide assembly 24 includes, for example, a guide rail 241 and a guide bar 242 extending along the first direction y and having a matching shape. Fig.15As shown, for two receiving components 2 arranged adjacent to each other in the same row, a guide rail 241 is provided on the outer side wall of the receiving shell 21 of one of the receiving components 2, and a guide bar 242 is provided on the opposite outer side wall of the receiving shell 21 of the other receiving component 2 adjacent to it. Through the shape-matching engagement between the guide bar 241 and the guide rail 242, the two receiving components 2 can be connected to each other by sliding along the first direction y. Thus, the receiving assembly 2A including a plurality of receiving components 2 can be divided into a plurality of receiving units 2B as required, each receiving unit 2B including a plurality of receiving components 2, and adjacent receiving units 2B can move relatively along the first direction y, so that all the receiving components 2 in the one receiving unit 2B move relative to all the receiving components 2 in the other receiving unit 2B in the first direction y. By providing a guide assembly, it is advantageous to realize the separate and independent control of a plurality of receiving units 2B, for example, all the neural electrodes of the same receiving unit are first implanted into the first target position at the same time, and then all the neural electrodes in the other receiving unit are implanted into the second target position together.

[0102] For example, the auxiliary implant device further includes a main clamping component 3, which includes two clamping pieces 31 that are opposite to each other in the second direction x and clamp the receiving component 2 from opposite sides of the receiving component 2A. The main clamping component 3 also includes a connecting component 32 arranged between the clamping piece 31 and the receiving component 2A, and the connecting component 32 is configured to make the receiving component 2A detachably connected to the clamping piece 31. Thus, the receiving component 2A can also be detachably and reliably fixed on one of the clamping pieces 31 without the two clamping pieces 31 applying pressure to the receiving component 2A from both sides.

[0103] like Fig.15 As shown in the example, a part of the connection component 32 constructed as a magnet is arranged on the inner side of the clamping sheet 31, and the receiving shell 21 of the outermost receiving part 2 in the receiving component 2A is arranged with its outer side surface opposite to the inner side of the clamping sheet 31, and another magnet corresponding to the magnet on the clamping sheet 31 is arranged on the outer side surface as another part of the connection component 32. Through the magnetic attraction of the magnets arranged on the clamping sheet 31 and the receiving shell 21, on the one hand, the receiving component 2A can be firmly and reliably fixed on the inner side of one of the clamping sheets 31, and on the other hand, it is convenient for the receiving component 2A to slide relative to the clamping sheet 31. In addition to the magnet, the connection component 32 may also include one or more of plug-in and snap-on connections.

[0104] For example, the implant assisting device also includes Fig.12 The auxiliary clamping assembly 4 shown. The auxiliary clamping assembly 4 includes, for example, Fig.12The two clamps shown have substantially the same structure and have a substantially U-shaped cross section. The clamp located at the top clamps the receiving assembly 2A from both sides of the receiving assembly 2A with its U-shaped arms, and the connecting section connecting the two U-shaped arms at least partially covers and is close to the receiving assembly 2A from the front of the receiving assembly 2A, thereby clamping the receiving assembly 2A as a whole. The clamp located at the bottom clamps the receiving assembly 2A together with the main clamping assembly 3 that clamps the receiving assembly 2A with its U-shaped arms. This auxiliary clamping assembly 4 is particularly suitable for a receiving part 2 having a receiving channel 22 configured as an open groove 22', which can reliably prevent the traction member 1 from accidentally coming out of the open groove 22'. At the same time, when the traction member 1 needs to be adjusted or repositioned, the operator can easily loosen the auxiliary clamping assembly 4, make necessary adjustments to the traction member 1, and then use the auxiliary clamping assembly 4 to fix it again, which provides a safe and flexible operating method. In other embodiments, the auxiliary clamping assembly 4 can also include only one clamp.

[0105] For example, Figure 8 and Fig. 9 As shown, the auxiliary implant device further includes a positioning portion 8. The positioning portion 8 is configured to be displayed under medical imaging to guide the auxiliary implant device to the target position. To this end, the positioning portion 8 includes, for example, a metal marker, so that an image that is clearly distinguishable from the surrounding physiological tissue can be generated under medical imaging. The positioning portion 8 can be optionally arranged on at least one of the traction member 1, the receiving member 2, and the flexible neural electrode 5. Figure 8 and Fig. 9 As shown, the positioning portion 8 is arranged on the distal end 52 of the flexible nerve electrode 5. The positioning portion 8 includes three adjacently arranged metal markers. This special layout enables it to be clearly displayed under medical imaging to avoid misreading.

[0106] Fig.10 The auxiliary implantation system according to an embodiment of the present invention is exemplarily shown, which comprises at least one flexible neural electrode 5 , an auxiliary implantation device and a guiding mechanism 6 .

[0107] For example, the flexible neural electrode 5 can be divided into multiple types such as linear type, non-linear type and mixed type in terms of its electrode shape. Fig.10A linear flexible neural electrode 5 is schematically shown. The linear flexible neural electrode 5 is longitudinally straight in a relaxed state. The non-linear flexible neural electrode is more flexible and can be spiral or other non-linear in shape, so that it can produce different degrees of deformation when subjected to longitudinal tension. This design enables the non-linear electrode to withstand deformation greater than its longitudinal length in a relaxed state without causing mechanical damage to the electrode, thereby enhancing the applicability and safety of the electrode. The hybrid electrode is designed as a hybrid structure including a linear portion and a non-linear portion. In addition, a traction array can include flexible neural electrodes of various forms, including a combination of linear and non-linear flexible neural electrodes. This design diversity allows the most suitable type of flexible neural electrode to be selected based on specific implantation requirements and the geometric characteristics of the target area. In actual operation, this increases the flexibility of the implantation surgery and helps to achieve more precise and personalized treatment.

[0108] For example, the electrical connection part 53 is designed to ensure effective signal transmission of the flexible neural electrode. As a core component of the flexible neural electrode 5, the electrical connection part 53 is composed of two or more flexible insulating layers, in which at least one metal connection wire layer is embedded.

[0109] For example, the flexible insulating layer is made of a flexible insulating material, which includes but is not limited to polyimide, parylene, silicone, etc. These materials are good at their excellent biocompatibility and electrical insulation properties, and can effectively protect the metal connecting wire layer to prevent electrical signal interference and tissue damage when the flexible neural electrode 5 is implanted in the body. At the same time, these flexible insulating materials have good flexibility, which helps the flexible neural electrode 5 to adapt to deformation during implantation. The material of the metal connecting wire layer should have good electrical conductivity and mechanical strength. For example, the selected metal materials include gold, platinum, iridium or their alloys, which can provide the necessary mechanical strength and flexibility while maintaining high conductivity. The arrangement and thickness design of the metal connecting wire layer ensure the efficiency and stability of signal transmission while avoiding affecting the mechanical properties of the flexible neural electrode itself. This multi-layer structure of the flexible neural electrode, combined with the design of its width, length and shape, ensures the efficiency, stability and safety of the electrode during implantation and use. These metal connecting wire layers are arranged between the flexible insulating layers to transmit electrical signals. Each metal connection wire layer contains multiple metal connection wires, which are wrapped by a flexible insulating layer to ensure complete insulation between each other. This design allows the electrode to maintain stable electrical performance in the body while reducing any possible short circuit risk.

[0110] For example, the distal end 52 of the flexible neural electrode 5 includes at least one neural electrode site 521 and an auxiliary implantation hole 522 .

[0111] For example, the neural electrode sites 521 are designed to record or stimulate specific areas in the brain. Each neural electrode site 521 is connected to the proximal 51 recording or stimulation circuit via an electrical connection 53 to achieve electrical interconnection. This design enables each neural electrode site 521 to independently receive or send signals, thereby providing accurate neural activity monitoring or targeted stimulation.

[0112] For example, the head end 13 of the traction member 1 passes through the auxiliary implantation hole 522, wherein the diameter of the auxiliary implantation hole 522 is smaller than the diameter of the main body 11 of the traction member 1, so that the distal end 52 of the flexible neural electrode 5 abuts against the head end 13 of the traction member 1. Figure 4 As shown, as a structure for cooperating with the traction member 1, the auxiliary implantation hole 522 should be precisely designed in size, so as to achieve stable control and precise implantation of the flexible neural electrode 5 on the one hand, and to be able to detach from the traction member 1 after reaching a predetermined implantation depth, so as to avoid additional damage to the implanted object. The diameter design range of the auxiliary implantation hole 522 can be 0.009 to 2.9 mm, and this range is selected to ensure that the auxiliary implantation hole 522 can be adapted to traction members of different sizes, and at the same time ensure that the head end 13 of the traction member can smoothly pass through the auxiliary implantation hole 522, while not allowing the main body 11 of the traction member 1 to pass through the auxiliary implantation hole 22.

[0113] For example, in order to further ensure the reliable connection between the head end 13 of the traction member 1 and the auxiliary implantation hole 22, an auxiliary fixing part 7 is also provided. The auxiliary fixing part 7 is constructed as an adhesive provided between the auxiliary implantation hole 522 of the flexible nerve electrode 5 and the head end 13 of the traction member 1. In order to meet the safety and biocompatibility requirements of clinical operation, the adhesive is selected from soluble materials, such as polyethylene glycol or other medical biocompatible materials. These materials have good biodegradability and biocompatibility in the body, and can gradually dissolve after implantation, thereby reducing the potential impact or stimulation on surrounding tissues. In addition, the use of such soluble materials also facilitates the removal of the traction member 1 after the implantation process is completed. In specific operations, after the traction member 1 penetrates the auxiliary implantation hole 522 of the flexible nerve electrode 5 with its head end 13, the auxiliary fixing part 7 is laid on the connection part to enhance the stability of the connection. After the implantation operation is completed, due to the soluble characteristics of the material of the auxiliary fixing part 7, it will gradually dissolve and release the traction member 1, thereby allowing the traction member 1 to be removed separately.

[0114] For example, in the case of using multiple flexible neural electrodes 5, the proximal ends 51 of the flexible neural electrodes 5 can be independently constructed, such as Fig.10 As shown, the proximal end 51 of each flexible neural electrode 5 can also be constructed in an integrated manner, such as Fig.14 As shown. Fig.14In the embodiment shown, the plurality of flexible nerve electrodes 5 are connected to the head end 13 of the traction member 1 at their respective distal ends 52, while their proximal ends 51 have an integrated structure. This structure is provided with a plurality of electrical connections, each of which independently provides a separate circuit connection for a corresponding flexible nerve electrode. The flexible insulating layer material used is selected taking into account its biocompatibility and flexibility to adapt to the environment and dynamic changes of the nerve electrode in the body.

[0115] For example, the flexible nerve electrode 5 can be fixed to the traction member 1 either before or after the auxiliary implant device is assembled. That is, the distal end 52 of the flexible nerve electrode 5 can be connected to the head end 13 of the traction member 1 first, and then the traction member 1 can be implanted in the receiving part 2; or the traction member 1 can be implanted in the receiving part 2 first, and then the distal end 52 of the flexible nerve electrode 5 can be connected to the head end 13 of the traction member 1. This flexible connection method provides additional convenience and safety, especially in complex or long-term implantation operations. For example, usually, the connection between the traction member 1 and the flexible nerve electrode 5 is performed before the traction member 1 is fixed to ensure the overall stability and precise alignment of the traction member 1 and the electrode during the implantation process. However, in some cases, such as when the operator finds that the traction member 1 that has been fixed needs to be fine-tuned or replaced, this design allows the traction member 1 to remain fixed while allowing the operator to easily reconnect the electrode to the head end 13 of the traction member 1. This not only improves the flexibility of the implantation process, but also greatly reduces the repeated operations and potential risks caused by the detachment of the traction member 1 from the flexible nerve electrode 5. In addition, if a flexible nerve electrode 5 accidentally falls off from the traction member 1 during the implantation process, this design also allows for quick and convenient reconnection. The operator can simply put the detached flexible nerve electrode back on the head end 13 of the traction member 1 and make necessary adjustments without completely removing or repositioning the already fixed traction member 1. Such a design not only ensures the continuity and efficiency of the implantation operation, but also significantly reduces additional intervention and potential risks to the patient.

[0116] For example, the implant-assisted system also includes Fig.10 The guiding mechanism 6 shown in the figure comprises a guide rod 61 connected to the main clamping assembly 3, a support seat 62 fixed on the workbench, and a sliding assembly 63 slidably connected to the support seat 62.

[0117] For example, the guide rod 61 extends along the second direction x, and allows the clamping piece 31 of the main clamping assembly 3 connected thereto to move in the second direction x along the extension direction of the guide rod 61. The upper limit of the moving range of the main clamping assembly 31 is defined as a distance threshold. The flexible neural electrode 5 itself has a certain elasticity and has tolerance for pulling within a suitable range, but excessive pulling will cause mechanical damage to the flexible neural electrode 5 itself, and may also pull it out of the implant, thereby destroying its integrity and functionality. In the case where multiple flexible neural electrodes 5 need to be implanted in one implantation operation with the help of the same auxiliary implantation system, the moving range of the receiving component 2 is strictly controlled. Therefore, the farthest distance of the main clamping assembly 3 relative to the target area in the second direction x should not exceed the distance threshold to prevent the receiving component 2 from causing any form of mechanical damage to the implanted flexible neural electrode 5 or accidentally pulling out the implanted flexible neural electrode 5 during the movement, ensuring that it remains firmly in the target position.

[0118] For example, the sliding assembly 62 includes a vertical connecting rod 63a extending along the first direction y, a transverse connecting rod 63b extending along the second direction x, and a bottom connecting rod 63c extending along the third direction z. One end of the transverse connecting rod 63b is coupled to the guide rod 61, and the other end is movably connected to the vertical connecting rod 63a, so that the guide rod 61 and the auxiliary implant device can be driven to move in the first direction y. The vertical connecting rod 63a is also slidably supported in the support seat 62 along the third direction z, so that the guide rod 61 and the auxiliary implant device can be driven to move in the third direction z.

[0119] Obviously, the sliding assembly 62 may also have other structures as long as it can realize the movement of the guide rod 61 in at least one of the spatial directions, that is, the first direction y, the second direction x and the third direction z.

[0120] With the aid of the auxiliary implantation system of the present invention, the flexible neural electrode 5 can be implanted in different working modes. The working modes include, for example, a single electrode implantation mode, a full array implantation mode, and a partial implantation mode. The single electrode implantation mode is suitable for implanting a single flexible neural electrode 5 with the aid of the auxiliary implantation system. The full array implantation mode and the partial implantation mode are suitable for implanting multiple flexible electrodes 5 with the aid of the auxiliary implantation system.

[0121] By way of example Fig.17 Introducing the single-electrode implantation mode of the assisted implantation system.

[0122] like Fig.17As shown, the auxiliary implantation system includes an auxiliary implantation device, a flexible neural electrode 5 and a guiding mechanism 6. In the single electrode implantation mode, the receiving component 2A of the auxiliary implantation device includes only one receiving part 2, and the clamping piece 31 of the main clamping component 3 clamps the receiving component 2A, that is, the only receiving part 2, from both sides. Fig.17 Only the guide rod 61 of the guide mechanism 6 is shown, and the clamping piece 31 clamps the receiving part 2 from both sides with one end thereof and is slidably connected to the guide rod 61 with the other end thereof.

[0123] The traction member 1 is fixed in the receiving channel 22 of the receiving component 2 under the action of friction, wherein the traction member 1 penetrates the auxiliary implantation hole provided on the distal end 52 of the flexible nerve electrode 5 with its head end 13, thereby fixing the flexible nerve electrode 5 to the traction member 1.

[0124] By means of the movement of the guide mechanism 6, the assembled auxiliary implant device together with the single flexible nerve electrode 5 held by it is moved to above the target position Z along the second direction x, and then, the auxiliary implant device is lowered along the first direction y to a predetermined depth by means of the guide mechanism 6, so that the distal end 52 of the flexible nerve electrode 5 is buried in the predetermined target position Z. Subsequently, the auxiliary implant device is raised along the first direction y again by means of the guide mechanism 6, so that the head end 13 of the traction member 1 of the auxiliary implant device is disengaged from the auxiliary implant hole 522 of the flexible nerve electrode 5, so as to separate the auxiliary implant device from the flexible nerve electrode 5. Thus, the implantation of the single flexible nerve electrode 5 in the single electrode implantation mode is completed.

[0125] The full array implantation mode and the partial implantation mode are suitable for the implantation of multiple flexible nerve electrodes 5 .

[0126] Fig.13 and Fig.14 The auxiliary implant device applicable to the full array implant mode is shown as an example. In the full array implant mode, the receiving component 2A of the auxiliary implant device includes a plurality of receiving components 2, which are arranged in a 4×2 array, for example. Fig.13 As shown, each receiving component 2 is fixed with an independently constructed flexible neural electrode 5 in the receiving channel 22. Fig.14 In the embodiment shown, the receiving component 2A is fixed with a plurality of flexible nerve electrodes 5A of proximal integrated structure, wherein the distal ends 52 of the flexible nerve electrodes 5A are respectively fixed to the head end 13 of the traction member 1, and the proximal ends 51 thereof are integrated to form a whole. The clamping pieces 31 of the main clamping component 3 clamp the receiving component 2A from both sides.

[0127] For example, by utilizing the movement of the guide mechanism 6, the assembled auxiliary implant device together with the multiple flexible nerve electrodes 5 held by it is moved to above the target position along the second direction x. Then, the auxiliary implant device is lowered to a predetermined depth along the first direction y by means of the guide mechanism 6, so that the distal end 52 of the flexible nerve electrode 5 is simultaneously buried in the predetermined target position. Subsequently, the auxiliary implant device is again raised along the first direction y by means of the guide mechanism 6, so that the head end 13 of each traction member 1 of the auxiliary implant device is disengaged from the auxiliary implant hole 522 of each flexible nerve electrode 5, so as to achieve the synchronous separation of the auxiliary implant device and the flexible nerve electrode 5. Thus, the implantation of multiple flexible nerve electrodes 5 in the full array implantation mode is completed.

[0128] Combination Fig.18 The partial implantation mode of the auxiliary implantation system is introduced. In the partial implantation mode, multiple flexible nerve electrodes 5 can be implanted into multiple target positions (such as the first target position Z1 and the second target position Z2) that are far apart.

[0129] like Fig.13 and Fig.14 The auxiliary implant device shown can also be applied to the partial implant mode of the auxiliary implant system. In the partial implant mode, the receiving component 2A of the auxiliary implant device also includes a plurality of receiving components 2, which are arranged in a 4×2 array, for example. Fig.13 As shown, each receiving component 2 is fixed with an independently constructed flexible neural electrode 5 in the receiving channel 22. Fig.14 In the embodiment shown, the receiving component 2A is fixed with a plurality of flexible nerve electrodes 5A of proximal integrated structure, wherein the distal ends 52 of the flexible nerve electrodes 5A are respectively fixed to the head end 13 of the traction member 1, and the proximal ends 51 thereof are integrated to form a whole. The clamping pieces 31 of the main clamping component 3 clamp the receiving component 2A from both sides.

[0130] By utilizing the movement of the guiding mechanism 6, the assembled auxiliary implant device together with the multiple flexible nerve electrodes 5 held by it is moved along the second direction x to above the first target position Z1. The receiving component 2A is divided into two left and right receiving units 2B along the second direction x, wherein each receiving unit 2B includes 2×2 receiving parts 2. At this time, the receiving unit 2B on the left side is lowered to a predetermined depth along the first direction y relative to the main clamping component 3 by means of the guiding mechanism 6, so that the distal end 52 of the flexible nerve electrode 5 fixed by the receiving unit 2B on the left side is buried in the predetermined first target position Z1; while the receiving unit 2B on the right side maintains its initial height unchanged. As a result, relative movement occurs between the two receiving units 2B. As mentioned above, the relative movement can be achieved by means of the guiding component 24 including the guide rail 241 and the guide bar 242. When the left and right receiving units 2B move relative to each other in the first direction y, the clamping piece 31 temporarily releases the clamping of the entire receiving assembly 2A, and at this time, the receiving component 2 in each receiving unit 2B directly adjacent to the inner side surface of each clamping piece 31 is connected to the clamping piece 31, thereby preventing the receiving component 2 from falling uncontrollably. For example, the receiving component 2 and the clamping piece 31 are connected to each other through a connecting component 32 configured as a magnet.

[0131] Subsequently, the implanted flexible neural electrode 5 on the left side is separated from the receiving unit 2B on the left side that was originally fixed to it. To this end, the receiving unit 2B on the left side can be moved upward along the first direction y as a whole together with the traction member 1 retained in its receiving channel 22, thereby driving the head end 13 of the traction member 1 to escape from the auxiliary implantation hole 522 of the flexible neural electrode 5. The receiving unit 2B on the left side can also be kept at its current height, while only an upward force along the first direction y is applied to the traction member 1. When the force exceeds the friction force threshold, the traction member 1 overcomes the friction force between it and the receiving channel 22 and moves upward, so that the head end 13 escapes from the auxiliary implantation hole 522 of the flexible neural electrode 5. In this way, the separation of the auxiliary implant device and the flexible neural electrode 5 is achieved.

[0132] Subsequently, the receiving component 2A is further moved by sliding the main clamping component 3 on the guiding mechanism 6, so that the receiving unit 2B on the right side is located above the second target position Z2. During this process, the moving range of the main clamping component 3 should not exceed the distance threshold to prevent interference with the already implanted flexible neural electrode 5. Especially in the case of a flexible neural electrode with a proximal integrated structure, the moving range of the main clamping component 3 is kept within the distance threshold, thereby preventing the implanted flexible neural electrode 5 from being pulled out. Then, the receiving unit 2B on the right side is lowered relative to the main clamping component 3 along the first direction y to a predetermined depth, thereby burying the distal end 52 of the flexible neural electrode 5 fixed by the receiving unit 2B on the right side into the predetermined second target position Z2.

[0133] Subsequently, the implanted right flexible nerve electrode 5 is separated from the right receiving unit 2B previously fixed thereto.

[0134] Thereby, the implantation of multiple flexible nerve electrodes 5 in the partial implantation mode is completed.

[0135] The partial implantation mode is certainly not limited to implantation at two target locations, but can also be applicable to implantation of flexible neural electrodes at three, four or even more target locations.

[0136] The implantation process of the flexible neural electrode can be monitored by means of medical imaging. To this end, a positioning portion 8 configured as a metal marker is arranged on at least one of the traction member 1, the receiving member 2 and the flexible neural electrode 5, so that the relative position between the flexible neural electrode and the target position is clearly displayed under medical imaging, thereby more accurately controlling the implantation process.

[0137] The auxiliary implantation device and auxiliary implantation system provided by the embodiment of the present invention can improve the flexibility and accuracy of the flexible neural electrode surgical implantation process. Utilizing the auxiliary implantation system of the embodiment of the present invention, electrodes can be implanted as a whole or selectively in steps, allowing precise positioning of full array electrodes, single electrodes, and partial electrodes. In the full array implantation mode, the control mechanism can lower the traction array as a whole to achieve overall implantation of the target area; in the single or partial implantation mode, only one or more selected traction components can be lowered to achieve precise step-by-step implantation. By providing a receiving channel with a rough surface, the traction member can be fixed or released. These features together provide a more flexible and adaptable flexible neural electrode implantation solution than traditional methods, significantly improving surgical safety and efficiency.

[0138] In this article, there are a few points to note:

[0139] (1) The drawings of the embodiments of the present invention only involve structures related to the embodiments of the present invention. Other structures may refer to conventional designs.

[0140] (2) In the absence of conflict, the embodiments of the present invention and the features therein may be combined with each other to obtain new embodiments.

[0141] (3) The above description is merely an exemplary embodiment of the present invention and is not intended to limit the scope of protection of the present invention. The scope of protection of the present invention is determined by the appended claims.

Claims

1. A flexible neural electrode auxiliary implantation device, characterized in that: The auxiliary implantation device comprises: at least one traction member, comprising a head end and a tail end opposite to each other along a longitudinal direction thereof, wherein the head end is attached to the flexible neural electrode; A receiving assembly, comprising at least one receiving component, wherein the receiving component comprises a receiving shell and a receiving channel passing through the receiving shell, wherein the receiving channel is configured to accommodate the at least one traction member; Wherein, at least part of the receiving channel has a rough surface, and the rough surface is configured such that when the traction member moves in the receiving channel, the rough surface generates a friction force that hinders the relative movement between the traction member and the receiving channel, The receiving channel includes at least one protrusion arranged on its wall, and the protrusion protrudes in a direction from the wall to the channel center of the receiving channel to form the rough surface, so that the outer surface of the traction member contacts or abuts against the protrusion to generate friction. Wherein, the receiving channel extends along a first direction, the wall includes a first wall and a second wall opposite to each other in a second direction, the second direction intersects with the first direction and is located in the same plane; the at least one protrusion includes a first protrusion arranged on the first wall and a second protrusion arranged on the second wall, the protrusion directions of the first protrusion and the second protrusion are opposite, and the first protrusion and the second protrusion are alternately arranged, the orthographic projection of the first protrusion on the second wall does not overlap with the second protrusion, and the orthographic projection of the second protrusion on the first wall does not overlap with the first protrusion, The receiving channel extends along a first direction, the receiving assembly includes at least one row of receiving components arranged along a third direction perpendicular to the first direction, the at least one row of receiving components includes a plurality of receiving components, and two adjacent receiving components among the plurality of receiving components are slidably connected to each other in the first direction. Among them, the auxiliary implantation device also includes: a guide component, which is arranged between the two adjacent receiving parts, and the guide component includes a guide rail and a guide bar extending along a first direction, and the guide rail and the guide bar are fit together in shape, so that the two adjacent receiving parts can be slidably connected to each other.

2. The auxiliary implantation device according to claim 1, characterized in that: There are a plurality of the first protrusions and a plurality of the second protrusions, and the plurality of the first protrusions and the plurality of the second protrusions are alternately arranged along the first direction.

3. The auxiliary implantation device according to claim 1, characterized in that: The protrusion has elasticity and is configured such that when the traction member is located in the receiving channel, the protrusion forms elastic contact with the traction member.

4. The auxiliary implantation device according to claim 1, characterized in that: The protrusion is configured in at least one of a sawtooth shape, a corrugated shape, and a boss shape.

5. The auxiliary implantation device according to claim 1, characterized in that: The receiving channel is configured as an open groove penetrating the receiving shell, the open groove extending along a first direction and including a first notch, a second notch and an open channel connected between the first notch and the second notch opposite to each other in the first direction, at least a portion of the open channel having the rough surface.

6. The auxiliary implantation device according to claim 1, characterized in that: The receiving channel is configured as an internal channel penetrating the receiving housing, the internal channel extending along a first direction and surrounded by the receiving housing, and a portion of the internal channel has the rough surface.

7. The auxiliary implantation device according to claim 6, characterized in that: The inner channel includes a first portion, a second portion, and a third portion located between the first portion and the second portion, the third portion having the rough surface.

8. The auxiliary implantation device according to claim 7, characterized in that: At least one of the first portion and the second portion is configured to cooperate with a shape of the traction member to retain the traction member in the internal passage.

9. The auxiliary implantation device according to claim 1, characterized in that: The receiving assembly includes a plurality of rows of receiving components, and the plurality of rows of receiving components are arranged at intervals in the third direction and do not contact each other.

10. The auxiliary implantation device according to claim 1, characterized in that: The receiving channel extends along a first direction, the receiving assembly comprises at least two receiving units arranged in a matrix manner in a plane perpendicular to the first direction, and the receiving unit comprises a plurality of the receiving components; One of the at least two receiving units moves in the first direction relative to the other receiving unit, so that all receiving components in the one receiving unit move in the first direction relative to all receiving components in the other receiving unit.

11. The auxiliary implantation device according to claim 10, characterized in that: The at least two receiving units are adjacent to each other in the second direction, and the auxiliary implantation device further comprises: The guide assembly is arranged between the at least two receiving units, and the guide assembly includes a guide rail and a guide bar extending along a first direction, and the guide rail and the guide bar are mutually engaged in a shape-matching manner, so as to connect the at least two receiving units slidably to each other.

12. The auxiliary implantation device according to claim 1, characterized in that: The auxiliary implantation device also includes: The main clamping component comprises two clamping plates, which are opposite to each other in the second direction and clamp the receiving component from opposite sides of the receiving component respectively.

13. The auxiliary implantation device according to claim 12, characterized in that: The main clamping assembly also includes: A connecting component is arranged between the clamping piece and the receiving component, and the connecting component is configured to enable the receiving component to be detachably connected to the clamping piece.

14. The auxiliary implantation device according to claim 13, characterized in that: The connection assembly includes at least one of plug-in connection, snap-on connection, and magnetic connection.

15. The auxiliary implantation device according to claim 12, characterized in that: The auxiliary implantation device also includes: The auxiliary clamping assembly comprises a clamping member, wherein the clamping member at least surrounds a portion of the main clamping assembly and the receiving assembly to clamp the main clamping assembly and the receiving assembly clamped by the main clamping assembly.

16. The auxiliary implantation device according to claim 1, characterized in that: The friction force generated by the rough surface is defined as a friction force threshold, and the traction member is configured to move in the receiving channel along an extension direction of the receiving channel under the action of an external force greater than the friction force threshold.

17. The auxiliary implantation device according to claim 1, characterized in that: The auxiliary implantation device further includes a positioning portion, and the positioning portion is configured to be displayed under medical imaging to guide the auxiliary implantation device to reach a target position.

18. The auxiliary implantation device according to claim 17, characterized in that: The positioning portion is arranged on at least one of the pulling member, the receiving component and the flexible nerve electrode.

19. The auxiliary implantation device according to claim 18, characterized in that: The positioning portion is arranged on the distal end of the flexible nerve electrode.

20. The auxiliary implantation device according to claim 17, characterized in that: The positioning portion includes a metal mark.

21. The auxiliary implantation device according to claim 20, characterized in that: The positioning portion includes a plurality of adjacently arranged metal marks.

22. A flexible neural electrode auxiliary implantation system, characterized in that: The auxiliary implantation system comprises: at least one flexible neural electrode comprising a proximal end, a distal end, and an electrical connection extending between the proximal end and the distal end; and The auxiliary implantation device according to any one of claims 1 to 21, Wherein, the head end of the traction member is attached to the distal end of the flexible nerve electrode.

23. The assisted implantation system according to claim 22, characterized in that: The auxiliary implant system includes at least two flexible neural electrodes, and the proximal ends of the at least two flexible neural electrodes are integrally constructed.

24. The assisted implantation system according to claim 23, characterized in that: The distal end of the flexible neural electrode includes at least one neural electrode site and an auxiliary implantation hole; The head end of the traction member passes through the auxiliary implantation hole, and the diameter of the auxiliary implantation hole is smaller than the diameter of the main body of the traction member, so that the flexible nerve electrode abuts against the head end of the traction member.

25. The auxiliary implantation system according to claim 24, characterized in that: The auxiliary implantation system further includes an auxiliary fixing portion, which is configured to further fix the distal end of the flexible nerve electrode to the head end of the traction member.

26. The auxiliary implantation system according to claim 25, characterized in that: The auxiliary fixing portion is configured as an adhesive disposed between the auxiliary implantation hole of the flexible nerve electrode and the head end of the traction member.

27. The auxiliary implantation system according to claim 26, characterized in that: The adhesive includes a dissolvable material.

28. The assisted implantation system according to claim 22, characterized in that: The electrical connection portion includes at least one metal wire and an insulating layer surrounding the metal wire, wherein the insulating layer respectively encapsulates the at least one metal wire in an electrically insulating manner, thereby achieving electrical insulation between the metal wires.

29. The assisted implantation system according to claim 22, characterized in that: The flexible neural electrode is designed to be linear or non-linear in a relaxed state.

30. The auxiliary implantation system according to claim 29, characterized in that: The flexible neural electrode is in a spiral shape in a relaxed state.

31. The auxiliary implantation system according to claim 22, characterized in that: The auxiliary implantation system also includes a guiding mechanism, which is connected to the main clamping component and guides the main clamping component to move along different spatial directions.

32. The auxiliary implantation system according to claim 31, characterized in that: The guiding mechanism comprises a guiding rod, and the main clamping assembly is mounted on the guiding rod and is movable along an extending direction of the guiding rod.

33. The auxiliary implantation system according to claim 32, characterized in that: The guide rod extends along the second direction, and the moving range of the main clamping assembly is less than or equal to a distance threshold, and the distance threshold is set to the farthest distance from the target area in the second direction.

34. The auxiliary implantation system according to claim 32, characterized in that: The guiding mechanism also includes a supporting seat and a sliding assembly slidably connected to the supporting seat, wherein the sliding assembly is connected to the guide rod and is configured to move in at least one of a first direction, a second direction and a third direction so as to move the guide rod in the at least one direction.

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