Implantation system and method for implanting flexible neural electrodes

Abstract

The present application provides an implantation system and an implantation method for implanting a flexible neural electrode. The implantation system includes a flexible neural electrode and an auxiliary implantation assembly. An auxiliary implantation portion is provided on the flexible neural electrode. The auxiliary implantation assembly includes a sleeve assembly and a guide wire, the sleeve assembly includes an inner sleeve and an outer sleeve, the guide wire has a contracted state contracted in the inner sleeve and an extended state passing through the distal end of the inner sleeve, and the extended end of the guide wire is connected to the auxiliary implantation portion; wherein, when the guide wire is in a contracted state, the flexible neural electrode is in a curled state curled between the inner sleeve and the outer sleeve; when the guide wire is in an extended state, the flexible neural electrode moves with the guide wire to the target area and unfolds to convert from a curled state to an unfolded state. The above structure can achieve the purpose of implantation through a small slit on the target object, and the auxiliary implantation assembly can ensure that the flexible neural electrode is accurately implanted and evenly attached to the implant surface.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and more specifically to an implantation system and an implantation method for implanting flexible neural electrodes. Background Art

[0002] In neuroscience research and clinical diagnosis of neurological diseases, surface array electrodes are often used to measure electrical signals on the surface of neural tissue. Intracranial cortical electrodes and spinal cord electrodes in surface array electrodes are widely used in the clinical treatment and diagnosis of neurological diseases. For example, in the diagnosis of epilepsy, intracranial neural electrodes can be attached to the surface of neural tissue to monitor EEG and identify epileptic lesions in the brain.

[0003] At present, the method used to implant surface array electrodes into the brain is to place the surface array electrodes on the patient's brain plane through craniotomy. However, as more brain surface neural signals can be monitored in recent years, the number of electrode points on the surface array electrodes has increased accordingly, and the corresponding size has increased. This type of craniotomy implantation surgical method has become more difficult to operate, and the patient's wound area is larger, which is not conducive to the patient's later recovery. Summary of the invention

[0004] In response to the above-mentioned technical problems existing in the prior art, the present application provides an implantation system and method for implanting flexible neural electrodes, which can achieve the purpose of implantation through a small slit on the target object, and through auxiliary implantation components, can ensure that the flexible neural electrodes are accurately implanted and smoothly attached to the implant surface.

[0005] In a first aspect, an embodiment of the present application provides an implantation system for implanting a flexible neural electrode, comprising:

[0006] A flexible neural electrode having an auxiliary implantation portion disposed thereon;

[0007] An auxiliary implantation component, comprising a sleeve assembly and a guide wire, wherein the sleeve assembly comprises an inner sleeve and an outer sleeve sleeved outside the inner sleeve, the guide wire has a contracted state contracted in the inner sleeve, and an extended state passing through the distal end of the inner sleeve, and the extended end of the guide wire is connected to the auxiliary implantation part; wherein,

[0008] When the guide wire is in the contracted state, the flexible nerve electrode is in a curled state curled between the inner sleeve and the outer sleeve; when the guide wire is in the extended state, the flexible nerve electrode moves with the guide wire to the target area and unfolds to convert from the curled state to the unfolded state.

[0009] In some embodiments, the auxiliary implantation portion of the flexible neural electrode is a hole or a slit.

[0010] In some embodiments, a bending portion is formed at the distal end of the guide wire, and the bending portion is passed through the auxiliary implant portion to drive the flexible neural electrode to move via the guide wire.

[0011] In some embodiments, the guide wire is made of a shape memory material.

[0012] In some embodiments, when the guide wire is in the extended state, the guide wire is configured to form a target shape that matches the outer contour of the flexible neural electrode under the influence of the environment.

[0013] In some embodiments, when the length of the portion where the distal end of the guide wire protrudes from the distal end of the inner sleeve is not greater than a first threshold, the guide wire is in the retracted state; when the length of the portion where the distal end of the guide wire protrudes from the distal end of the inner sleeve is greater than the first threshold, the guide wire changes from the retracted state to the extended state.

[0014] In some embodiments, the flexible neural electrode includes a signal transmission portion and an electrode site portion, and the electrode site portion is electrically interconnected with a recording circuit and / or a stimulation circuit through the signal transmission portion to record neural signals via the recording circuit and / or regulate neural signals via the stimulation circuit.

[0015] In some embodiments, the signal transmission part includes multiple flexible insulation layers and a metal signal wire layer disposed between adjacent flexible insulation layers, the metal signal wire layer is at least one layer, and the flexible insulation layer wraps the metal signal wire layer.

[0016] In some embodiments, the flexible insulating layer is made of a flexible polymer material, and the flexible polymer material at least includes one or more combinations of polyimide materials, polymer materials, photosensitive polymers, and fluorine-containing polymers.

[0017] In some embodiments, the auxiliary implant portion is disposed at the distal end of the flexible neural electrode; and / or,

[0018] The auxiliary implant part is arranged in the middle or near one side of the distal end of the flexible nerve electrode.

[0019] In some embodiments, the proximal end of the inner sleeve is provided with a first connection structure connected to the proximal end of the guide wire to define the relative position of the guide wire and the inner sleeve during implantation; and / or,

[0020] The proximal end of the outer sleeve is provided with a second connection structure connected to the proximal end of the inner sleeve to limit the relative positions of the outer sleeve and the inner sleeve during the implantation process.

[0021] In a second aspect, an embodiment of the present application provides an implantation method for an implantation system, which is applied to the above-mentioned implantation system for implanting a flexible neural electrode, and the implantation method includes:

[0022] guiding the flexible neural electrode to a first target area of ​​a target implant via the auxiliary implant component;

[0023] Extending the distal end of the guide wire from the distal end of the inner sleeve so that the guide wire is converted from the contracted state to the extended state;

[0024] The flexible nerve electrode is guided by the guide wire to pass through between the outer sleeve and the inner sleeve and reach a second target area, so that the flexible nerve electrode is converted from a curled state to an unfolded state; wherein the second target area is the target target area;

[0025] The inner sleeve is moved forward to the distal end of the guide wire, so that the distal end of the guide wire is separated from the auxiliary implant part, and the flexible neural electrode is left on the surface of the target implant;

[0026] The auxiliary implant component is moved away from the target implant.

[0027] In some embodiments, extending the distal end of the guide wire from the distal end of the inner cannula specifically includes:

[0028] Directly act on the guide wire to make the distal end of the guide wire extend from the distal end of the inner sleeve.

[0029] In a third aspect, an embodiment of the present application provides an implantation method for an implantation system, which is applied to the above-mentioned implantation system for implanting a flexible neural electrode, and the implantation method includes:

[0030] guiding the flexible neural electrode to a second target area of ​​the target implant via the auxiliary implant component; wherein the second target area is the target target area;

[0031] Acting on the outer sleeve to move the outer sleeve backward to a third target area of ​​the target implant;

[0032] Then, the inner sleeve is acted on to make the inner sleeve move backward to the fourth target area of ​​the target implant, and at the same time, the guide wire is released from the inner sleeve, so that the guide wire can be converted from the contracted state to the extended state;

[0033] Guiding the flexible neural electrode via the guide wire to transform from a curled state to an unfolded state;

[0034] The inner sleeve is moved forward to the distal end of the guide wire, so that the distal end of the guide wire is separated from the auxiliary implant part, and the flexible neural electrode is left on the surface of the target implant;

[0035] The auxiliary implant component is moved away from the target implant.

[0036] In some embodiments, the fourth target area is closer to the second target area than to the third target area.

[0037] Compared with the prior art, the beneficial effect of the embodiments of the present application is that: by setting a sleeve assembly and a guide wire, the present application can achieve the purpose of implanting a flexible neural electrode by opening a smaller slit on the target object. The flexible neural electrode can be accurately implanted into the target area after being converted from a curled state to an unfolded state. It can be flatly attached to the target area, reducing the impact of the auxiliary implant component on the surface of the implanted target object, and enabling the flexible neural electrode to be implanted with low damage and precision, thereby solving the problem of large damage and difficulty in flat attachment caused by the current implantation of flexible neural electrodes. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In the drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar components in different views. The drawings generally illustrate various embodiments by way of example and not limitation, and together with the description and claims, serve to illustrate the disclosed embodiments. When appropriate, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the present apparatus or method.

[0039] Figure 1 This is a schematic diagram of a flexible neural electrode structure for an implant system according to an embodiment of the present application. The flexible surface neural electrode shown in the figure is a cerebral cortex electrode.

[0040] Figure 2 This is a schematic diagram of a flexible neural electrode structure for an implant system according to an embodiment of the present application. The flexible surface neural electrode shown in the figure is an epidural spinal cord electrode.

[0041] Figure 3 This is a schematic diagram of the partial structure of an auxiliary implant assembly according to an embodiment of the present application. Part (a) of the figure shows that the guide wire is in a retracted state, and part (b) shows that the guide wire partially extends out of the sleeve assembly.

[0042] Figure 4 This is a schematic diagram of the partial structure of an auxiliary implant assembly according to an embodiment of the present application. In the figure, part (a) shows a guide wire in a retracted state, and part (b) shows a guide wire in an extended state.

[0043] Figure 5 This is a partial operation diagram of an implantation method for an implantation system according to Embodiment 1 of the present application.

[0044] Figure 6 This is another partial operation diagram of the implantation method for the implantation system according to the first embodiment of the present application.

[0045] Figure 7 It is a schematic diagram of the operation of the implantation method for the implantation system according to the second embodiment of the present application.

[0046] Figure 8 This is a first flow chart of an implantation method for an implantation system according to an embodiment of the present application.

[0047] Fig. 9 This is a second flow chart of an implantation method for an implantation system according to an embodiment of the present application.

[0048] The components indicated by the reference numerals in the figures are:

[0049] 1. Flexible neural electrode; 11. Auxiliary implantation part; 12. Infiltration hole; 13. Signal transmission part; 14. Electrode site part; 2. Auxiliary implantation component; 21. Sleeve component; 211. Inner sleeve; 212. Outer sleeve; 22. Guide wire; 221. Bending part; 3. First connection structure; 4. Second connection structure. DETAILED DESCRIPTION

[0050] In order to enable those skilled in the art to better understand the technical solution of the present application, the present application is described in detail below in conjunction with the accompanying drawings and specific implementation examples. The embodiments of the present application are further described in detail below in conjunction with the accompanying drawings and specific implementation examples, but are not intended to limit the present application.

[0051] The words "first", "second" and similar words used in this application do not indicate any order, quantity or importance, but are only used to distinguish different parts. The words "include" or "comprise" and similar words mean that the elements before the word include the elements listed after the word, and do not exclude the possibility of including other elements. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0052] In the present application, when a specific device is described as being located between a first device and a second device, there may or may not be an intermediate device between the specific device and the first device or the second device. When a specific device is described as being connected to other devices, the specific device may be directly connected to the other device without an intermediate device, or may not be directly connected to the other device but have an intermediate device.

[0053] All terms (including technical terms or scientific terms) used in this application have the same meaning as those understood by ordinary technicians in the field to which this application belongs, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and should not be interpreted in an idealized or extremely formal sense, unless explicitly defined herein.

[0054] Technologies, methods, and equipment known to ordinary technicians in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be considered as part of the specification.

[0055] In one embodiment of the present application, an implantation system for implanting flexible neural electrodes is provided. The implantation system for implanting flexible neural electrodes can be used in the medical field. When the current surface array electrodes are implanted in the brain, it is necessary to perform a craniotomy at the target position of the patient's brain, and then place the surface array electrodes to meet the requirement of smooth attachment of the surface array electrodes on the brain plane. When the surface array electrodes are implanted outside the spinal dura mater, it is necessary to place the surface array electrodes through surgical procedures such as laminectomy or laminectomy. However, these traditional surgical methods are highly traumatic and are not conducive to the patient's later recovery. In order to meet the development needs of minimally invasive surgery, the present application provides an implantation system for implanting flexible neural electrodes. The following will be combined with the accompanying drawings to introduce in detail an implantation system for implanting flexible neural electrodes according to an embodiment of the present application.

[0056] like Figures 1 to 5 As shown, the implantation system for implanting a flexible neural electrode includes a flexible neural electrode 1 and an auxiliary implantation component 2. An auxiliary implantation portion 11 is provided on the flexible neural electrode 1. The auxiliary implantation component 2 includes a sleeve component 21 and a guide wire 22, the sleeve component 21 includes an inner sleeve 211 and an outer sleeve 212 sleeved outside the inner sleeve 211, the guide wire 22 has a contracted state contracted in the inner sleeve 211, and an extended state passing through the distal end of the inner sleeve 211, and the extended end of the guide wire 22 is connected to the auxiliary implantation portion 11; wherein, when the guide wire 22 is in a contracted state, the flexible neural electrode 1 is in a curled state curled between the inner sleeve 211 and the outer sleeve 212; when the guide wire 22 is in an extended state, the flexible neural electrode 1 moves with the guide wire 22 to the target area and unfolds, so as to be converted from a curled state to an unfolded state.

[0057] Optionally, the flexible surface neural electrode may be a thin film electrode, an intracranial neural electrode and a spinal cord electrode processed by micro-nanotechnology, or an intracranial neural electrode and a spinal cord electrode used clinically. For example, the flexible surface neural electrode may be a cerebral cortex electrode, an epidural spinal cord electrode, or an electrode used in other parts, which is not specifically limited in the present application. For example, Figure 1 and Figure 2 As shown, Figure 1 The flexible surface neural electrode shown in FIG. 1 is a cerebral cortical electrode. Figure 2 The flexible surface neural electrode shown in is an epidural spinal cord electrode.

[0058] like Figure 3 and Figure 4 As shown, Figure 3 The guide wire 22 shown in part (a) is in a retracted state. Figure 3 The guide wire 22 shown in part (b) partially extends out of the sleeve assembly 21. Figure 4 The guide wire 22 shown in part (a) is in a retracted state. Figure 4 Part (b) shows the guide wire 22 in an extended state.

[0059] Optionally, the auxiliary implant part 11 can be a through hole, the number of the through holes is not less than 1, the shape of the through hole is elliptical, circular, polygonal or a combination of two thereof, and the size of the through hole ranges from 0.05 mm to 10 mm, for example, 0.05 mm, 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 10 mm, etc., preferably 0.1 mm.

[0060] Optionally, the inner sleeve 211 and the outer sleeve 212 are pipes with a hollow structure. The inner sleeve 211 and the outer sleeve 212 respectively have a distal end away from the operator and a proximal end close to the operator. The distal ends of the inner sleeve 211 and the outer sleeve 212 are open structures. The distal end opening structure design of the inner sleeve 211 can switch the guide wire 22 between the retracted state and the extended state without affecting the movement of the guide wire 22. The distal end opening structure design of the outer sleeve 212 can make the inner sleeve 211, the guide wire 22 and the flexible neural electrode 1 retract or pass through the outer sleeve 212.

[0061] Optionally, the cross-sections of the inner sleeve 211 and the outer sleeve 212 may be elliptical, circular, polygonal, or a combination thereof. The diameter of the outer sleeve 212 is greater than the diameter of the inner sleeve 211, and a gap is formed between the inner wall of the outer sleeve 212 and the inner wall of the inner sleeve 211 to accommodate the flexible neural electrode 1.

[0062] Optionally, the diameters of the inner sleeve 211 and the outer sleeve 212 range from 0.05 to 20 mm, for example, 0.05 mm, 0.5 mm, 1 mm, 5 mm, 10 mm, 20 mm, etc. The diameter of the inner sleeve 211 is preferably 1 mm, and the diameter of the outer sleeve 212 is preferably 5 mm.

[0063] Optionally, the material of the inner sleeve 211 and the outer sleeve 212 can be one or a combination of several polymer materials. For example, the polymer material can be polyimide, polyurethane or polyvinyl chloride. The sleeve assembly 21 made of polymer material can effectively reduce the damage to brain tissue during implantation and improve the safety of the implant system.

[0064] Optionally, the diameter of the guide wire 22 is 0.01 to 1 millimeter (mm), for example, 0.01 mm, 0.05 mm, 0.1 mm, 0.5 mm, 1 mm, etc., preferably 0.2 mm.

[0065] Optionally, when the above-mentioned flexible neural electrode 1 is in a curled state, it can be curled in a scroll shape between the inner sleeve 211 and the outer sleeve 212, or it can be folded and stored between the inner sleeve 211 and the outer sleeve 212. The present application does not make specific limitations on this. It is sufficient to stably accommodate the flexible neural electrode 1 without destroying the flexible neural electrode 1.

[0066] It is understandable that the target area can be the target position to which the flexible neural electrode 1 is to act, and the purpose of the implantation system is to implant the flexible neural electrode 1 into the target area so that it adheres to the surface of the corresponding tissue there.

[0067] By setting up the sleeve component 21 and the guide wire 22, the present application can achieve the purpose of implanting the flexible neural electrode 1 by opening a smaller slit on the target object. The flexible neural electrode 1 can be accurately implanted into the target area after being converted from a curled state to an unfolded state. It can be flatly attached to the target area, reducing the impact of the auxiliary implant component 2 on the surface of the implanted target object, and realizing the low-damage and accurate implantation of the flexible neural electrode 1, thereby solving the problem of large damage and difficulty in flat attachment caused by the current implantation of the flexible neural electrode 1.

[0068] In some embodiments, the auxiliary implantation portion 11 of the flexible neural electrode 1 is a hole or a slit.

[0069] In some embodiments, Figure 3 As shown, a bending portion 221 is formed at the distal end of the guide wire 22 , and the bending portion 221 is penetrated through the auxiliary implantation portion 11 to drive the flexible neural electrode 1 to move via the guide wire 22 .

[0070] Optionally, the bent portion 221 of the guide wire 22 can be anchored to the auxiliary implant portion 11, and the flexible neural electrode 1 can be driven to perform reciprocating motion by pushing and pulling the guide wire 22.

[0071] Optionally, the bend 221 formed at the distal end of the guide wire 22 can be specifically constructed in a teardrop shape, which passes through the auxiliary implant part 11, and the distal end size of the bend 221 is larger than the size of the auxiliary implant part 11, so that the bend 221 can drive the flexible neural electrode 1 through the auxiliary implant part 11.

[0072] Optionally, the guide wire 22 can be made of a flexible deformable material. The bending portion 221 can flexibly drive the flexible neural electrode 1 to move when the force acting on it is small. The bending portion 221 can also be deformed after being subjected to force to disengage from the auxiliary implant portion 11 and relieve the effect on the flexible neural electrode 1.

[0073] In the above embodiment, the movement of the flexible neural electrode 1 can be controlled more conveniently and accurately by utilizing the bending portion 221 of the guide wire 22, thereby effectively improving the accuracy and convenience of the implantation system for implanting the flexible neural electrode.

[0074] In some embodiments, the guide wire 22 is made of a morphological memory material. The guide wire 22 made of the above morphological memory material can be deformed after the surrounding environment meets the preset conditions, such as the temperature condition can meet the preset temperature, and the shape of the guide wire 22 can reach the preset shape without changing the shape at will. It can be understood that the guide wire 22 made of the morphological memory material can return to its original shape after deformation, thereby ensuring that the flexible neural electrode 1 can be smoothly unfolded under the guidance of the deformed shape of the guide wire 22.

[0075] Optionally, the shape memory material may be a shape memory polymer, a shape memory alloy, etc. For example, the shape memory alloy may be a nickel-cobalt shape memory alloy or a nickel-titanium shape memory alloy, etc.

[0076] Optionally, the surface of the guide wire 22 may be wrapped with an outer insulating layer to keep the surface of the guide wire 22 smooth and prevent the guide wire 22 from causing destructive damage to the flexible nerve electrode 1 .

[0077] In the above embodiment, the guide wire 22 made of the shape memory material can be used to conveniently and accurately control the flexible neural electrode 1 to be attached to the target area, thereby effectively ensuring the accuracy and convenience of the implantation system for implanting the flexible neural electrode.

[0078] In some embodiments, Figure 4 As shown, when the guide wire 22 is in the extended state, the guide wire 22 is configured to form a target shape adapted to the outer contour of the flexible neural electrode 1 under the influence of the environment.

[0079] When the guide wire 22 extends from the distal end of the inner sleeve 211, the shape of the guide wire 22 can be changed to a target shape that matches the outer contour of the flexible nerve electrode 1, thereby improving the stability between the guide wire 22 and the flexible nerve electrode 1, reducing the possibility of displacement or falling off between the two, and ensuring that the flexible nerve electrode 1 can be smoothly unfolded when the operator uses the implant system.

[0080] For example, Figure 4 As shown, Figure 4 The target shape of the extended guide wire 22 shown in FIG. 2 is adapted to the outer contour of the cerebral cortex electrode.

[0081] In the above embodiment, the guide wire 22 has a target shape that matches the outer contour of the flexible nerve electrode 1 when it is extended, so that the flexible nerve electrode 1 can be smoothly and smoothly unfolded under the guidance of the guide wire 22 having the target shape after extending out of the outer sleeve 212, which can effectively ensure the reliability of the implantation system for implanting the flexible nerve electrode and improve the accuracy and experience of the operator's operation. In addition, the guide wire 22 that matches the outer contour of the flexible nerve electrode 1 can make the implantation operation simpler and more accurate, effectively reduce the risk and time of the operation, and improve the success rate of the operation.

[0082] In some embodiments, Figure 4 As shown, when the length of the portion where the distal end of the guide wire 22 protrudes from the distal end of the inner sleeve 211 is not greater than a first threshold value, the guide wire 22 is in a retracted state; when the length of the portion where the distal end of the guide wire 22 protrudes from the distal end of the inner sleeve 211 is greater than the first threshold value, the guide wire 22 changes from a retracted state to an extended state.

[0083] In this way, the guide wire 22 can be changed from the contracted state to the extended state only after it is extended to a certain length, and the state will not change immediately after being extended, thereby ensuring the stability of the state change of the guide wire 22.

[0084] In the above embodiment, by controlling the length of the distal end of the guide wire 22 protruding from the distal end of the inner sleeve 211, the switching of the guide wire 22 between the contracted state and the extended state can be flexibly and accurately controlled, effectively improving the accuracy and controllability of the operation during the implantation process.

[0085] In some embodiments, Figure 1 and Figure 2 As shown, the flexible neural electrode 1 includes a signal transmission part 13 and an electrode site part 14. The electrode site part 14 is electrically interconnected with a recording circuit and / or a stimulation circuit through the signal transmission part 13 to record neural signals via the recording circuit and / or regulate neural signals via the stimulation circuit.

[0086] Optionally, the electrode site portion 14 may be one or more, and the electrode site portion 14 may transmit electrical signals with external equipment via the signal transmission portion 13 connected thereto.

[0087] Optionally, the constituent material of the electrode site portion 14 is a conductive metal or a conductive polymer. For example, it can be gold, platinum, iridium, platinum-iridium alloy, carbon composite material or PEDOT:PSS (poly (3,4-ethylenedioxythiophene) and poly (styrene sulfonic acid)) conductive polymer, etc. For the convenience of description and understanding, poly (3,4-ethylenedioxythiophene) and poly (styrene sulfonic acid)) conductive polymer is directly referred to as PEDOT:PSS conductive polymer in the following text.

[0088] Optionally, the shape of the electrode site portion 14 may be circular, square, rectangular, hexagonal or diamond-shaped, etc., preferably circular. The circular structure has the most stable diffusion pattern when measuring neural signals.

[0089] Optionally, the diameter of the electrode site portion 14 may range from 0.01 to 5 millimeters (mm), and may be 0.01 mm, 0.1 mm, 0.5 mm, 1 mm, 2 mm or 5 mm, etc.

[0090] Optionally, the electrode sites 14 may be arranged in an array or randomly arranged according to experimental requirements. The spacing between the multiple electrode sites 14 may range from 0.01 to 5 millimeters (mm), such as 0.01 mm, 0.1 mm, 0.5 mm, 1 mm, 2 mm or 5 mm.

[0091] Optionally, the plurality of electrode site portions 14 may have the same size or may have different sizes respectively.

[0092] Optionally, a permeable hole 12 may be provided around the electrode site portion 14, and the permeable hole 12 may help to assist the penetration and infiltration of the bonding liquid, thereby ensuring good adhesion between the flexible neural electrode 1 and the implanted target.

[0093] Optionally, the shape of the permeable hole 12 may be circular, oval, rectangular, square, etc. The size of the permeable hole 12 may range from 0.1 to 10 millimeters (mm), such as 0.1 mm, 0.5 mm, 1 mm, 5 mm or 10 mm.

[0094] The size of the electrode site portion 14, the site shape of the electrode site portion 14, the spacing between multiple electrode site portions 14, and the arrangement of the permeation holes 12 can be determined and arranged according to actual needs, and the embodiments disclosed in this application do not impose any limitations on this.

[0095] In the above embodiment, the electrode site portion 14 is connected to the recording circuit and the stimulation circuit through the signal transmission portion 13, and the signal output of the electrode site portion 14 can be monitored and recorded in real time. More precise control can be achieved by adjusting the stimulation signal parameters, thereby effectively ensuring the use effect of the implantation system for implanting flexible neural electrodes.

[0096] In some embodiments, the signal transmission part 13 includes multiple flexible insulation layers and a metal signal wire layer disposed between adjacent flexible insulation layers. The metal signal wire layer is at least one layer, and the flexible insulation layer wraps the metal signal wire layer.

[0097] Optionally, there may be multiple metal signal wire layers, which are stacked one on top of the other. Furthermore, a flexible insulating layer is provided between adjacent metal signal wire layers, which can reduce the size of the flexible neural electrode 1 while integrating more electrode site portions 14, and can effectively reduce interference between neural signals.

[0098] Optionally, the number of metal signal wire layers is arranged corresponding to the number of electrode site portions 14, and the plurality of electrode site portions 14 are respectively connected to the corresponding metal signal wire layers. The plurality of metal signal wire layers are insulated from each other by a flexible insulating layer.

[0099] Optionally, the metal signal conductor layer may be made of one or more conductive materials selected from the group consisting of noble metals, conductive metals, and conductive polymers. For example, the conductive material may be gold, platinum, iridium, platinum-iridium alloy, carbon composite material, or PEDOT:PSS conductive polymer.

[0100] In the above embodiment, by providing a flexible insulating layer between the metal signal conductor layers and wrapping the metal signal conductor layers with the flexible insulating layer, mutual interference between neural signals can be effectively prevented, thereby improving the anti-interference ability and accuracy of neural signal transmission.

[0101] Taking the intracranial nerve electrode and spinal cord electrode processed by micro-nano processing technology, the insulating part is polyimide, the electrode site part 14 and the metal signal conductor layer are gold as an example to illustrate the manufacturing process of the thin film electrode. The thin film electrode adopts a hard substrate, such as glass, quartz, silicon wafer, etc. as the supporting material of the thin film electrode to meet the flatness requirements of the thin film electrode. The sacrificial layer of the thin film electrode is processed on the substrate, such as adding a layer of removable material, such as an aluminum layer or a nickel layer, so that the thin film electrode can be separated from the substrate. The flexible insulating layer polyimide is processed on the substrate by a film forming process. The polyimide can be a photosensitive polyimide or a non-photosensitive polyimide. The photosensitive polyimide needs to be spin-coated and baked before photolithography patterning film formation, while the non-photosensitive polyimide needs spin-coating and baking and imidization film formation under a high-temperature vacuum environment. The metal signal conductor layer is patterned by photoresist, magnetron sputtering or evaporation of a gold layer to obtain a patterned electrode site part 14 and a metal signal conductor layer. Then, the second flexible insulating layer is processed by the same method. If multiple layers of metal signal conductor layers and flexible insulating layers are required, the above process can be repeated. Multiple layers of flexible insulating layers and metal signal conductor layers can integrate more electrode sites 14 while reducing the size of the electrode, and can achieve high-density integration of the flexible neural electrode 1. The electrode site 14 of the flexible neural electrode 1 is exposed and the overall patterning is achieved by patterning of polyimide. Photosensitive polyimide needs to be patterned by photolithography, and non-photosensitive polyimide needs to be patterned by dry or wet etching.

[0102] In some embodiments, the flexible insulating layer is made of a flexible polymer material, and the flexible polymer material includes at least one or more combinations of polyimide materials, polymer materials, photosensitive polymers, and fluorine-containing polymers. The fluorine-containing polymers may be specifically fluorine resins.

[0103] For example, the flexible polymer material may be polyimide, SU-8 (epoxy negative photoresist), polyparaxylene or silica gel.

[0104] Flexible polymer materials have good insulation properties and can effectively prevent signal interference between metal signal wires. Flexible polymer materials have good softness and flexibility, can adapt to different shapes and curved surfaces, and can make the flexible insulation layer flexibly cover the metal signal wire layer to provide effective insulation protection.

[0105] In the above embodiment, the flexible insulating layer made of flexible polymer material can effectively improve the stability and anti-interference ability of neural signal transmission, thereby improving the reliability of the implantation system for implanting flexible neural electrodes.

[0106] In some embodiments, Figure 1 and Figure 2As shown, the auxiliary implant part 11 is arranged at the distal end of the flexible neural electrode 1; and / or, the auxiliary implant part 11 is arranged at the middle or adjacent to one side of the distal end of the flexible neural electrode 1.

[0107] The structures of the target areas of different patients may be different, and individual adaptation can be performed according to the different conditions of the patients, which helps to improve the fit between the flexible neural electrode 1 and the target area, thereby reducing damage and risks during the implantation process.

[0108] In the above embodiment, the auxiliary implant part 11 can be flexibly arranged on the flexible neural electrode 1 according to different usage scenarios and requirements, which effectively improves the universality of the implant system for implanting flexible neural electrodes.

[0109] In some embodiments, the proximal end of the inner sleeve 211 is provided with a first connecting structure 3 connected to the proximal end of the guide wire 22 to limit the relative positions of the guide wire 22 and the inner sleeve 211 during the implantation process; and / or, the proximal end of the outer sleeve 212 is provided with a second connecting structure 4 connected to the proximal end of the inner sleeve 211 to limit the relative positions of the outer sleeve 212 and the inner sleeve 211 during the implantation process.

[0110] It is understandable that the guide wire 22 and the inner sleeve 211 are fixed by the first connecting structure 3 during the implantation process. The guide wire 22 can move axially along the inner sleeve 211, and can pass through and retract at the distal end of the inner catheter. The passing through is represented by the bent portion 221 of the guide wire 22 passing through the distal end of the sleeve, and the passed guide wire 22 can be mutually anchored with the flexible neural electrode 1 through the auxiliary implantation portion 11, thereby achieving the fixation of the flexible neural electrode and the auxiliary implantation component 2. The retraction is represented by the bent portion 221 of the guide wire 22 retracting into the interior of the inner sleeve 211 through the distal end, and the guide wire 22 and the auxiliary implantation portion 11 of the flexible neural electrode 1 are separated from each other.

[0111] A second connection structure 4 is provided between the proximal end of the outer sleeve 212 and the proximal end of the inner sleeve 211 , and the moving position of the inner sleeve 211 is accurately fixed by the second connection structure 4 during the implantation process.

[0112] In the above embodiment, the first connecting structure 3 and the second connecting structure 4 can limit the displacement of the guide wire 22 and the inner sleeve 211 during the implantation process, effectively improving the safety of the sleeve assembly 21, thereby further improving the reliability and safety of the implantation system for implanting flexible neural electrodes.

[0113] An embodiment of the present application also provides an implantation method for an implant system, which is applied to the above-mentioned implantation system for implanting flexible neural electrodes.

[0114] like Figure 8 As shown, the implantation method includes steps S101 to S105.

[0115] Step S101: guiding the flexible neural electrode 1 to a first target area of ​​a target implant via the auxiliary implant component 2.

[0116] Step S102: Extend the distal end of the guide wire 22 from the distal end of the inner sleeve 211 to convert the guide wire 22 from the contracted state to the extended state.

[0117] Step S103: guiding the flexible nerve electrode 1 through the guide wire 22 to pass through between the outer sleeve 212 and the inner sleeve 211 and reach the second target area, so that the flexible nerve electrode 1 is converted from a curled state to an unfolded state; wherein the second target area is the target target area.

[0118] Step S104: Move the inner sleeve 211 forward to the distal end of the guide wire 22 so that the distal end of the guide wire 22 is separated from the auxiliary implant part 11, and the flexible neural electrode 1 is left on the surface of the target implant.

[0119] Step S105: moving the auxiliary implant component 2 away from the target implant.

[0120] like Figures 5 to 7 As shown in FIG. 1 , the implantation system for implanting flexible neural electrodes is taken as an example of a flexible cortical electrode implanted on the surface of the brain. Figure 5 As shown in part (a), the inner sleeve 211 and the guide wire 22 retracted into the inner sleeve 211 are placed on the front or back of the electrode site portion 14 of the flexible neural electrode 1, and aligned with the auxiliary implantation portion 11 of the flexible neural electrode 1. After alignment, the guide wire 22 is moved axially from the proximal end of the inner sleeve 211 to the distal end of the inner sleeve 211 until the guide wire 22 at the distal end of the extended inner sleeve 211 is anchored to the auxiliary implantation portion 11 of the flexible neural electrode 1, and the proximal guide wire 22 and the proximal end of the inner catheter are fixed by the first connecting structure 3. Figure 5 As shown in part (b), the flexible nerve electrode 1 is curled around the inner sleeve 211, and the curled flexible nerve electrode 1 is spatially limited by the outer sleeve 212, and the proximal end of the outer sleeve 212 and the proximal end of the inner sleeve 211 are fixed by the second connecting structure 4, forming a composite structure of the flexible nerve electrode 1 and the auxiliary implant component 2.

[0121] like Figure 5As shown in part (c), the composite structure of the flexible neural electrode 1 and the auxiliary implant component 2 is implanted into the first target area of ​​the target implant through a skull slit or a puncture needle, the first connecting structure 3 between the proximal end of the inner sleeve 211 and the proximal end of the guide wire 22 is unlocked, the proximal end of the guide wire 22 is moved axially toward the distal end, and the distal end of the guide wire 22 is extended from the distal end of the inner sleeve 211 to guide the flexible neural electrode 1 to pass through the outer sleeve 212. After the extended portion of the guide wire 22 exceeds the first threshold, the guide wire 22 is converted from a contracted state to an extended state, thereby driving the curled flexible neural electrode 1 to reach the second target area and unfold it smoothly.

[0122] like Figure 6 As shown in part (a) of Figure 5 After the flexible neural electrode 1 shown in part (c) is fully deployed, the second connection structure 4 between the proximal end of the outer sleeve 212 and the proximal end of the inner sleeve 211 is unlocked, and the inner sleeve 211 is moved forward to reach the distal end of the guide wire 22; the distal end of the guide wire 22 is retracted into the inner sleeve 211, thereby achieving the separation of the guide wire 22 from the auxiliary implantation part 11 of the flexible neural electrode 1. Figure 6 As shown in part (b), the auxiliary implant component 2 is removed from the target implant, and the flexible neural electrode 1 is left inside the target implant. Finally, the sleeve component 21 is removed from the cranial slit to complete the implantation of the flexible neural electrode 1. This method can be implanted through a small incision on the target object, and the guide wire 22 and the sleeve component 21 are used to ensure that the electrode is flatly attached to the surface of the target implant.

[0123] Through the above-mentioned implantation method, the purpose of implanting the flexible neural electrode 1 can be achieved by opening a smaller slit on the target object. The flexible neural electrode 1 can be accurately implanted into the target area after being converted from a curled state to an unfolded state. It can be flatly attached to the target area, reducing the impact of the auxiliary implant component 2 on the surface of the implanted target object, and realizing the low-damage and accurate implantation of the flexible neural electrode 1, thereby solving the problem of large damage and difficulty in flat attachment caused by the current implantation of the flexible neural electrode 1.

[0124] In some embodiments, the step S102 of extending the distal end of the guide wire 22 from the distal end of the inner sleeve 211 specifically includes: directly acting on the guide wire 22 to make the distal end of the guide wire 22 extend from the distal end of the inner sleeve 211. Figure 5 and Figure 6 As shown, Figure 5 and Figure 6 Shown in the figure is an operational schematic diagram of the implantation method for the implantation system of Example 1, that is, an operational schematic diagram of the implantation method that directly acts on the guide wire 22 without acting on the outer sleeve 212, so as to extend the distal end of the guide wire 22 from the distal end of the inner sleeve 211, thereby implanting the flexible neural electrode 1.

[0125] The embodiment of the present application also provides another implantation method for an implant system, which is applied to the above-mentioned implantation system for implanting flexible neural electrodes.

[0126] like Fig. 9 As shown, the implantation method includes steps S201 to S206.

[0127] Step S201: guiding the flexible neural electrode 1 to reach the second target area of ​​the target implant via the auxiliary implant component 2; wherein the second target area is the target target area.

[0128] Step S202: Acting on the outer sleeve 212, moving the outer sleeve 212 backward to the third target area of ​​the target implant.

[0129] Step S203: Then act on the inner sleeve 211, so that the inner sleeve 211 moves back to the fourth target area of ​​the target implant, and at the same time the guide wire 22 escapes from the inner sleeve 211, so that the guide wire 22 can be converted from the contracted state to the extended state.

[0130] Step S204: guiding the flexible nerve electrode 1 to transform from a curled state to an unfolded state via the guide wire 22 .

[0131] Step S205: Move the inner sleeve 211 forward to the distal end of the guide wire 22 so that the distal end of the guide wire 22 is separated from the auxiliary implant part 11, and the flexible neural electrode 1 is left on the surface of the target implant.

[0132] Step S206: moving the auxiliary implant component 2 away from the target implant.

[0133] In some embodiments, the fourth target area is closer to the second target area than to the third target area.

[0134] like Figure 7 As shown, Figure 7 FIG. 2 is a schematic diagram of the operation of the implantation method for the implantation system in the second embodiment, in which the implanted flexible neural electrode 1 is taken as an example as a flexible spinal cord electrode. Figure 7As shown in part (a), the inner sleeve 211 and the guide wire 22 retracted into the inner sleeve 211 are placed on the front or back of the electrode site portion 14 of the flexible nerve electrode 1, and aligned with the auxiliary implantation portion 11 of the flexible nerve electrode 1. After alignment, the guide wire 22 is moved axially from the proximal end of the inner sleeve 211 to the distal end of the inner sleeve 211, until the guide wire 22 at the distal end of the extended inner sleeve 211 is anchored to the auxiliary implantation portion 11 of the flexible nerve electrode 1, and the proximal guide wire 22 and the proximal end of the inner catheter are fixed by the first connecting structure 3. The flexible nerve electrode 1 is curled around the inner sleeve 211, and the curled flexible nerve electrode 1 is limited by the outer sleeve 212, forming a composite structure of the flexible nerve electrode 1 and the auxiliary implantation component 2.

[0135] like Figure 7 As shown in part (b), the auxiliary implant component 2 pulls the flexible neural electrode 1 to be implanted into the second target area of ​​the target implant, and the outer sleeve 212 moves backward and retracts to the third target area of ​​the target implant.

[0136] like Figure 7 As shown in part (c), the inner sleeve 211 moves backward and retracts to the fourth target area of ​​the target implant. The guide wire 22 is transformed from a contracted state to an extended state, corresponding to the shape of the flexible neural electrode 1. At the same time, the flexible neural electrode 1 is guided to transform from a curled state to an unfolded state.

[0137] like Figure 7 As shown in part (d), after the flexible neural electrode 1 is fully extended, the inner sleeve 211 is moved forward and reaches the distal end of the guide wire 22, so that the distal end of the guide wire 22 is retracted into the inner sleeve 211, thereby achieving the separation of the guide wire 22 from the auxiliary implant part 11 of the flexible neural electrode 1.

[0138] like Figure 7 As shown in part (e), the auxiliary implant component 2 is removed from the target implant, and the flexible neural electrode 1 is left on the surface of the target implant. Finally, the auxiliary implant component 2 is removed from the cranial slit to complete the implantation of the flexible neural electrode 1. This method can be implanted through a small incision on the target object, and the guide wire 22, the inner sleeve 211 and the outer sleeve 212 support components ensure that the electrode is flatly attached to the surface of the target implant.

[0139] In addition, although exemplary embodiments have been described herein, the scope includes any and all embodiments based on the present application with equivalent elements, modifications, omissions, combinations (e.g., schemes that cross various embodiments), adaptations or changes. The elements in the claims will be interpreted broadly based on the language used in the claims, and are not limited to the examples described in this specification or during the practice of the present application, and the examples will be interpreted as non-exclusive.

[0140] The above description is intended to be illustrative rather than restrictive. For example, the above examples (or one or more schemes thereof) may be used in combination with each other. For example, a person of ordinary skill in the art may use other embodiments when reading the above description. In addition, in the above-mentioned specific embodiments, various features may be grouped together to simplify the present application. This should not be interpreted as an intention that a disclosed feature that is not required to be protected is necessary for any claim. On the contrary, the subject matter of the present application may be less than all the features of a particular disclosed embodiment. Thus, the claims are incorporated herein as examples or embodiments in the specific embodiments, wherein each claim is independently a separate embodiment, and it is considered that these embodiments may be combined with each other in various combinations or arrangements. The scope of the present application should be determined with reference to the attached claims and the full scope of equivalent forms granted by these claims.

[0141] The above embodiments are only exemplary embodiments of the present application and are not intended to limit the present application. The protection scope of the present application is defined by the claims. Those skilled in the art may make various modifications or equivalent substitutions to the present application within the essence and protection scope of the present application, and such modifications or equivalent substitutions shall also be deemed to fall within the protection scope of the present application.

Claims

1. An implantation system for implanting a flexible neural electrode, characterized in that: include: A flexible neural electrode having an auxiliary implantation portion disposed thereon; An auxiliary implant component, comprising a sleeve component and a guide wire, wherein the sleeve component comprises an inner sleeve and an outer sleeve sleeved outside the inner sleeve, the guide wire is made of a shape memory material, and the guide wire has a contracted state contracted in the inner sleeve, and an extended state passing through the distal end of the inner sleeve, and the extended end of the guide wire is connected to the auxiliary implant part; wherein, When the guide wire is in the contracted state, the flexible neural electrode is in a curled state between the inner sleeve and the outer sleeve; when the guide wire is in the extended state, the guide wire is constructed to form a target shape that matches the outer contour of the flexible neural electrode under the influence of the environment, and the flexible neural electrode moves with the guide wire to the target area and unfolds, so as to be converted from the curled state to the unfolded state, so that the flexible neural electrode is flatly attached to the target area; wherein, A bending portion is formed at the distal end of the guide wire, and the bending portion is penetrated through the auxiliary implantation portion to drive the flexible neural electrode to move via the guide wire.

2. The implantation system for implanting a flexible neural electrode according to claim 1, characterized in that: The auxiliary implantation part of the flexible neural electrode is a hole or a slit.

3. The implantation system for implanting a flexible neural electrode according to any one of claims 1 to 2, characterized in that: When the length of the portion of the distal end of the guide wire protruding from the distal end of the inner sleeve is not greater than a first threshold, the guide wire is in the contracted state; When the length of the portion of the distal end of the guide wire protruding from the distal end of the inner sleeve is greater than the first threshold, the guide wire changes from the contracted state to the extended state.

4. The implantation system for implanting a flexible neural electrode according to any one of claims 1 to 2, characterized in that: The flexible neural electrode includes a signal transmission part and an electrode site part. The electrode site part is electrically interconnected with a recording circuit and / or a stimulation circuit through the signal transmission part to record neural signals via the recording circuit and / or regulate neural signals via the stimulation circuit.

5. The implantation system for implanting a flexible neural electrode according to claim 4, characterized in that: The signal transmission part includes multiple flexible insulating layers and a metal signal wire layer arranged between adjacent flexible insulating layers. The metal signal wire layer is at least one layer, and the flexible insulating layer wraps the metal signal wire layer.

6. The implantation system for implanting a flexible neural electrode according to claim 5, characterized in that: The flexible insulating layer is made of a flexible polymer material, and the flexible polymer material at least includes one or more combinations of polyimide materials, polymer materials, photosensitive polymers, and fluorine-containing polymers.

7. The implantation system for implanting a flexible neural electrode according to any one of claims 1 to 2, characterized in that: The auxiliary implant part is arranged at the distal end of the flexible neural electrode; and / or, The auxiliary implant part is arranged in the middle or near one side of the distal end of the flexible nerve electrode.

8. The implantation system for implanting a flexible neural electrode according to any one of claims 1 to 2, characterized in that: The proximal end of the inner sleeve is provided with a first connection structure connected to the proximal end of the guide wire to limit the relative position of the guide wire and the inner sleeve during the implantation process; and / or, The proximal end of the outer sleeve is provided with a second connection structure connected to the proximal end of the inner sleeve to limit the relative positions of the outer sleeve and the inner sleeve during the implantation process.

Images