Flexible electrode for implantable neural signal device, implantable neural signal device and preparation method of flexible electrode

Abstract

The present application provides a flexible electrode for an implantable neural signal device, an implantable neural signal device, and a method for preparing the flexible electrode. The implantable neural signal device includes a feedthrough, and the flexible electrode is electrically connected to the feedthrough. The flexible electrode includes a distal electrode portion, a proximal electrode portion, and a lead connection portion. The proximal electrode portion includes an electrode body and a conductive contact, and the conductive contact is formed with a hollow structure. The hollow structure is configured to deform when the conductive contact is stressed, so that the conductive contact abuts against the feedthrough to form an electrical connection. The hollow structure of the flexible electrode can cause the conductive contact to deform after being stressed, enhancing the deformation ability at the electrode connection, enabling the deformed conductive contact to make closer contact with the feedthrough, and being beneficial to improving the electrical connection reliability between the conductive contact and the feedthrough.

Description

Technical Field

[0001] The present application relates to the technical field of flexible electrodes, and particularly to a flexible electrode for an implantable neural signal device, an implantable neural signal device, and a method for preparing the flexible electrode. Background Art

[0002] Currently, neural signal systems incorporating implantable neural signalers have been widely used in the medical field. In such systems, the implantable neural signaler is implanted into a patient's body to achieve treatment of the diseased site and collection of related signals from the diseased site. For example, a nerve stimulator sends electrical stimulation pulses to parts such as the brain or spinal cord to regulate nerve activity, thereby treating neurological diseases such as Parkinson's disease, epilepsy, depression, and pain. To achieve dynamic regulation of nerve activity, the nerve stimulator can also record signals from parts such as the brain and automatically adjust the stimulation parameters according to the relevant signals.

[0003] However, the traditional implantable electrode is constructed as a rigid tubular structure and forms an electrical connection with the stimulator body through a helical coil spring. However, the implantable electrode and the helical coil spring assembly are relatively large in volume, and the flexibility of the electrode is insufficient, unable to meet the flexibility requirements of the implantable electrode. If a flexible electrode is used to overcome the flexibility problem, the contact surface between the flexible electrode and the feedthrough is a plane, and there is a certain gap between the two, which easily leads to the problem of low electrical connection reliability, that is, the flexible electrode is prone to sliding with the feedthrough, resulting in misalignment of the conductive contacts and affecting the stability of the electrical connection. Summary of the Invention

[0004] Aiming at the above technical problems existing in the prior art, the present application provides a flexible electrode for an implantable neural signal device, an implantable neural signal device, and a method for preparing the flexible electrode. The hollow structure of the flexible electrode enables the conductive contact to deform under force, enhancing the deformation ability at the electrode connection, so that the deformed conductive contact can make closer contact with the feedthrough, which is beneficial to improving the electrical connection reliability between the conductive contact and the feedthrough.

[0005] An embodiment of the present application provides a flexible electrode for an implantable neural signal device. The implantable neural signal device includes a feedthrough, and the flexible electrode is electrically connected to the feedthrough. The flexible electrode includes a distal electrode portion, a proximal electrode portion, and a lead connection portion. The distal electrode portion includes at least one electrode site for applying electrical stimulation to and / or collecting potential signals from a target tissue. The proximal electrode portion includes an electrode body and at least one conductive contact provided on the electrode body. The conductive contact has a hollow structure configured to cause the conductive contact to deform when the conductive contact is stressed, so that the deformed conductive contact abuts against the feedthrough to form an electrical connection. The lead connection portion includes a lead, and two ends of the lead are respectively electrically connected to the conductive contact of the proximal electrode portion and the electrode site of the distal electrode portion. The distal electrode portion, the proximal electrode portion, and the lead connection portion are sequentially arranged along the length direction of the flexible electrode.

[0006] In some embodiments, the conductive contact has a contact middle portion and a contact deformation portion that are electrically connected, and the contact deformation portion is disposed around the outer periphery of the contact middle portion.

[0007] In some embodiments, the hollow structure is formed on the contact deformation portion, and / or the hollow structure is formed between the contact deformation portion and the electrode body.

[0008] In some embodiments, there are a plurality of the hollow structures, and the plurality of hollow structures are spaced apart around the contact middle portion.

[0009] In some embodiments, there are a plurality of the contact deformation portions, and the plurality of contact deformation portions are respectively electrically connected to the contact middle portion and the lead connection portion.

[0010] In some embodiments, the plurality of contact deformation portions are evenly arranged around the outer periphery of the contact middle portion.

[0011] In some embodiments, the contact deformation portion includes a plurality of sequentially connected bending structures, and the hollow structure is formed between the plurality of bending structures and the electrode body, and the plurality of bending structures are configured to be stretched and deformed along the stress direction when stressed.

[0012] In some embodiments, the bending directions of adjacent bending structures are opposite to each other.

[0013] In some embodiments, the contact deformation portion includes a spiral structure connected to the contact middle portion, and the spiral structure spirals outward around the contact middle portion in sequence and is electrically connected to the lead connection portion.

[0014] In some embodiments, the hollow structure is formed on the contact deformation part, and the hollow structure has a plurality of broken line parts forming a closed cavity, and the plurality of broken line parts are arranged around the middle part of the contact.

[0015] In some embodiments, a plurality of through holes are formed in the middle part of the contact, and the plurality of through holes are used to provide a deformation space for the middle part of the contact.

[0016] In some embodiments, the deformation range of the conductive contact in the thickness direction of the proximal electrode part is not less than 10 microns.

[0017] In some embodiments, there are a plurality of conductive contacts, and the plurality of conductive contacts are linearly arranged or arranged in an array along the length direction of the proximal electrode part.

[0018] In some embodiments, the thickness of the flexible electrode is not greater than 200 microns.

[0019] In some embodiments, the flexible electrode includes a first insulating layer, a first conductive layer, and a second insulating layer stacked along the thickness direction. The conductive contact, the electrode site, and the lead are all arranged on the first conductive layer, and the conductive contact and the electrode site are exposed to the first insulating layer and / or the second insulating layer.

[0020] In some embodiments, the flexible electrode further includes a second conductive layer and a third insulating layer. The second conductive layer is arranged on the side of the second insulating layer facing away from the first conductive layer, and the third insulating layer is arranged on the side of the second conductive layer facing away from the second insulating layer.

[0021] The embodiment of the present application also provides an implantable nerve signal device, including the flexible electrode for the implantable nerve signal device described above, and further including an acting component. The acting component includes a first housing, an acting module, and a feedthrough. The acting module is arranged in the first housing, the feedthrough is arranged on the first housing, and the flexible electrode is electrically connected to the acting module through the feedthrough; wherein, the acting module includes a stimulation module and / or a collection module.

[0022] In some embodiments, the acting component further includes an electrode cover. The electrode cover covers the proximal electrode part of the flexible electrode, and a pressure connecting piece is arranged on the side surface of the electrode cover facing the flexible electrode. The pressure connecting piece is used to apply a force to the conductive contact of the proximal electrode part to make it abut against the feedthrough.

[0023] In some embodiments, the feedthrough includes an insulating carrier and a feedthrough conductor. The insulating carrier is rotatably arranged on one side of the first housing, the feedthrough conductor penetrates through the insulating carrier, and both ends of the feedthrough conductor are electrically connected to the conductive contact and the acting module respectively.

[0024] In some embodiments, there are a plurality of feed-through conductors, and the plurality of feed-through conductors are arranged in an array on the insulating carrier.

[0025] In some embodiments, the pressure connection member includes at least one elastic member, the elastic members are arranged in one-to-one correspondence with the conductive contacts, and the elastic members are used to apply a force to the conductive contacts of the flexible electrode so that the conductive contacts are in contact with the feed-through members to form an electrical connection.

[0026] In some embodiments, the outer edge of the electrode cover and the outer edge of the first housing are mounted to each other, and a first sealing gasket is provided between the outer edge of the electrode cover and the outer edge of the first housing.

[0027] In some embodiments, the pressure connection member further includes a seat body and a second sealing gasket member. The seat body is connected to the distal side of the electrode cover, and the seat body is provided with a mounting hole. The elastic member is arranged in the mounting hole. The second sealing gasket is arranged on the seat body and surrounds the outer peripheral side of the elastic member, and the second sealing gasket is located on the inner peripheral side of the first sealing gasket.

[0028] The embodiment of the present application further provides a method for manufacturing a flexible electrode, which is used to manufacture the flexible electrode for the implantable neural signal device described above. The flexible electrode includes a first insulating layer, a first conductive layer, and a second insulating layer stacked along the thickness direction. The conductive contacts, electrode sites, and leads are all arranged on the first conductive layer, and the conductive contacts and electrode sites are exposed from the first insulating layer and / or the second insulating layer. The method for manufacturing the flexible electrode includes:

[0029] Spin-coating and baking an insulating paste to form a first insulating layer;

[0030] Removing a part of the first insulating layer corresponding to the electrode site to expose the electrode site through the first insulating layer;

[0031] Forming a first conductive layer above the first insulating layer by photolithography and coating;

[0032] Spin-coating and baking an insulating paste on the side of the first conductive layer facing away from the first insulating layer to form a second insulating layer;

[0033] Removing a part of the second insulating layer corresponding to the electrode site and the conductive contact to expose the electrode site and the conductive contact through the second insulating layer;

[0034] Removing a part of the first insulating layer and the second insulating layer corresponding to the hollow structure.

[0035] Compared with the prior art, the beneficial effects of the embodiments of the present application are: the present application can better adapt to the shape and movement of the neural tissue by using a flexible electrode, thereby reducing the mechanical pressure and damage to the surrounding tissue, and a hollow structure is formed on the conductive contact of the proximal electrode portion of the flexible electrode, which can cause the conductive contact to deform after being subjected to force, thereby enhancing the deformation ability of the electrode connection, so that the deformed conductive contact can be in closer contact with the feedthrough, which is beneficial to improving the reliability of the electrical connection between the conductive contact and the feedthrough, and ensuring the conduction effect at the contact point, and the conductive contact after being subjected to pressure is no longer in the same plane with the rest of the flexible electrode due to deformation, which enables the conductive contact to be stably limited to the position in contact with the feedthrough, which can ensure that the conductive contact is difficult to displace, and further improves the reliability of the electrical connection. In addition, after the deformed conductive contact is in closer contact with the feedthrough, the contact gap between the conductive contact and the feedthrough can be reduced as much as possible, thereby facilitating the improvement of the sealing between the conductive contact and the feedthrough, and ensuring that the implantable neural signal device can be implanted stably for a long time. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] 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.

[0037] Figure 1 It is a cross-sectional view of an implantable neural signal device using the flexible electrode of an embodiment of the present application.

[0038] Figure 2 It is a schematic diagram of the three-dimensional structure of an implantable neural signal device using the flexible electrode of an embodiment of the present application.

[0039] Figure 3 This is a planar structural diagram of the flexible electrode according to an embodiment of the present application, and the contact deformation portion shown in the diagram includes a bending structure.

[0040] Figure 4 This is a schematic diagram of the three-dimensional structure of the flexible electrode according to an embodiment of the present application.

[0041] Figure 5 This is a planar structural diagram of the flexible electrode according to an embodiment of the present application, and the contact deformation portion shown in the diagram includes a spiral structure.

[0042] Figure 6 This is a planar structural diagram of the flexible electrode according to an embodiment of the present application. The hollow structure shown in the figure has multiple fold line portions.

[0043] Figure 7 This is a partial structural diagram of the flexible electrode according to an embodiment of the present application. A through hole is formed in the middle of the contact shown in the figure.

[0044] Figure 8 This is a schematic three-dimensional structure diagram of an electrode cover and a pressure connector of an implantable neural signal device using the flexible electrode according to an embodiment of the present application.

[0045] Figure 9 This is a flowchart of a method for manufacturing a flexible electrode according to an embodiment of the present application.

[0046] Components denoted by reference numerals in the figure:

[0047] 1. Feedthrough; 11. Insulating carrier; 12. Feedthrough conductor; 2. Flexible electrode; 3. Distal electrode portion; 31. Electrode site; 4. Proximal electrode portion; 41. Electrode body; 42. Conductive contact; 43. Hollow structure; 44. Middle of the contact; 45. Deformed portion of the contact; 46. Through hole; 5. Lead connection portion; 6. Function component; 61. First housing; 62. Circuit board; 7. Electrode cover; 8. Pressure connector; 81. Elastic member; 82. Seat body; 83. Second gasket; 9. First gasket. Detailed implementation manners

[0048] To enable those skilled in the art to better understand the technical solutions of the present application, the present application will be described in detail below with reference to the accompanying drawings and specific implementation manners. The embodiments of the present application will be further described in detail below with reference to the accompanying drawings and specific embodiments, but this is not a limitation to the present application.

[0049] The "first", "second" and similar terms used in the present application do not denote any order, quantity or importance, but are only used to distinguish different parts. Terms such as "including" or "comprising" mean that the elements before this term cover the elements listed after this term, and do not exclude the possibility of also covering other elements. Terms such as "upper", "lower", "left", "right" are only used to represent relative positional relationships, and when the absolute position of the object being described changes, the relative positional relationship may also change accordingly.

[0050] In the present application, when it is described that a specific device is located between a first device and a second device, there may or may not be an intermediate device between the specific device and the first device or the second device. When it is described that a specific device is connected to other devices, the specific device may be directly connected to the other devices without an intermediate device, or may not be directly connected to the other devices and have an intermediate device.

[0051] All terms used in this application (including technical or scientific terms) have the same meaning as understood by those of ordinary skill in the art to which this application pertains, unless otherwise specifically defined. It should also be understood that terms defined in a general dictionary, such as those, should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense, unless specifically defined as such here.

[0052] Techniques, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be regarded as part of the specification.

[0053] In this application, the term "proximal" is intended to mean the side closer to the operator (such as a doctor) performing the implantation operation, while the term "distal" is intended to mean the side closer to the target area of the implantable neural signal device to be implanted. Similarly, the term "proximal end" is intended to mean the end closer to the operator (such as a doctor) performing the implantation operation, while the term "distal end" is intended to mean the side closer to the target area of the implantable neural signal device to be implanted.

[0054] All terms used in this application (including technical or scientific terms) have the same meaning as understood by those of ordinary skill in the art to which this application pertains, unless otherwise specifically defined. It should also be understood that terms defined in a general dictionary, such as those, should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense, unless specifically defined as such here. Techniques, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be regarded as part of the specification.

[0055] An embodiment of this application provides a flexible electrode for an implantable neural signal device. As Figures 1 to 4 shown, the implantable neural signal device includes a feedthrough 1, the flexible electrode 2 is electrically connected to the feedthrough 1, and the flexible electrode 2 includes a distal electrode portion 3, a proximal electrode portion 4, and a lead connection portion 5. The distal electrode portion 3 includes at least one electrode site 31, and the electrode site 31 is used to apply electrical stimulation to the target tissue and / or collect the potential signal of the target tissue. The proximal electrode portion 4 includes an electrode body 41 and at least one conductive contact 42 provided on the electrode body 41. The conductive contact 42 is formed with a hollow structure 43, and the hollow structure 43 is configured to cause the conductive contact 42 to deform when the conductive contact 42 is stressed, so that the deformed conductive contact 42 abuts against the feedthrough 1 to form an electrical connection. The lead connection portion 5 includes a lead, and both ends of the lead are electrically connected to the conductive contact 42 of the proximal electrode portion 4 and the electrode site 31 of the distal electrode portion 3 respectively. The distal electrode portion 3, the proximal electrode portion 4, and the lead connection portion 5 are arranged in sequence along the length direction of the flexible electrode 2.

[0056] In the case where the above-mentioned implantable neural signal device includes a stimulator, the stimulator can be electrically connected to the electrode site 31 of the distal electrode portion 3 to apply electrical stimulation to the target tissue through the electrode site 31.

[0057] In the case where the above-mentioned implantable neural signal device includes a collector, the collector can be electrically connected to the electrode site 31 of the distal electrode portion 3 to collect the potential signal of the target tissue through the electrode site 31.

[0058] The above-mentioned flexible electrode 2 can be made of a flexible material, and the flexible material used can endow the flexible electrode 2 with good flexibility and biocompatibility to better adapt to the shape and movement of neural tissue, thereby reducing the mechanical pressure and damage to surrounding tissues.

[0059] The above-mentioned flexible electrode 2 can be configured as a sheet structure.

[0060] When the above-mentioned flexible electrode 2 is in a static state, that is, in a state without external force, the conductive contact 42 can be understood as being undeformed or freely deformable.

[0061] The force applied to the above-mentioned conductive contact 42 can come from the pressure connection member 8 of the implantable neural signal device (the specific structure of the pressure connection member 8 is described below and will not be elaborated here), or can also come from other components of the implantable neural signal device, as long as it can achieve stable contact with the conductive contact 42, and the present application does not make specific limitations in this regard.

[0062] The above-mentioned hollow structure 43 can enable the conductive contact 42 to have sufficient deformation space in the thickness direction of the flexible electrode 2 after the conductive contact 42 is stressed, so that the conductive contact 42 can stably abut against the feedthrough member 1 to form an electrical connection.

[0063] The above-mentioned conductive contact 42 can be partially or entirely made of an elastic material to further increase the deformable space of the conductive contact 42, so that the conductive contact 42 can abut against the feedthrough member 1 through deformation.

[0064] The above-mentioned hollow structures 43 can be multiple, and the multiple hollow structures 43 can be arranged at intervals from each other to facilitate the conductive contact 42 to deform more uniformly after being stressed.

[0065] The deformation of the above-mentioned conductive contact 42 can be understood as the deformation that the conductive contact 42 arches away from the plane where the electrode body 41 is located. Specifically, the shape of the conductive contact 42 before deformation can be planar, and at this time it can be in the same plane as the electrode body 41, and the shape of the conductive contact 42 after deformation can be arched, and at this time the conductive contact 42 and the electrode body 41 are in different planes. Exemplarily, such as Figure 3 and Figure 4As shown Figure 3 The conductive contact 42 shown in Figure 3 is in the state before deformation. Figure 4 The conductive contact 42 shown in Figure 4 is in the state after deformation.

[0066] The cross-sectional area of the above-mentioned hollow structure 43 is less than or equal to 90% of the cross-sectional area of the conductive contact 42 where the hollow structure 43 is located. In this way, a larger current passing area can be formed on the conductive contact 42 to meet the effective electrical connection area between the conductive contact 42 and the feedthrough 1.

[0067] The above-mentioned hollow structure 43 can be arranged in an axisymmetric or centrosymmetric manner, or can be arranged in an array. The present application does not specifically limit the arrangement manner of the hollow structure 43, as long as the deformed conductive contact 42 can stably abut against the feedthrough 1.

[0068] The shape of the above-mentioned hollow structure 43 can be one or more of the following: circular, elliptical, arc-shaped, and polygonal, or can also be a combination of one or more shapes of irregular polygons. The shape of the hollow structure 43 can be specifically designed according to the required deformation range of the conductive contact 42.

[0069] By adopting the flexible electrode 2 in the present application, it can better adapt to the shape and movement of nerve tissues, thereby reducing the mechanical pressure and damage to surrounding tissues. Moreover, a hollow structure 43 is formed on the conductive contact 42 of the proximal electrode portion 4 of the flexible electrode 2. The hollow structure 43 can enable the conductive contact 42 to deform after being stressed, enhancing the deformation ability at the electrode connection. This enables the deformed conductive contact 42 to be in closer contact with the feedthrough 1, which is beneficial to improving the electrical connection reliability between the conductive contact 42 and the feedthrough 1, ensuring the conduction effect at the contact. And due to the deformation, the conductive contact 42 after being pressed is no longer in the same plane as the rest of the flexible electrode 2, which enables the conductive contact 42 to be stably limited at the position in contact with the feedthrough 1, and can ensure that the conductive contact 42 is difficult to displace, further improving the electrical connection reliability. In addition, after the deformed conductive contact 42 is in closer contact with the feedthrough 1, the contact gap between the conductive contact 42 and the feedthrough 1 can be minimized as much as possible, which is beneficial to improving the sealing performance between the conductive contact 42 and the feedthrough 1, ensuring that the implantable nerve signal device can be implanted stably for a long time.

[0070] In some embodiments, as Figures 3 to 7 shown, the conductive contact 42 has a contact middle part 44 and a contact deformation part 45 that are electrically connected, and the contact deformation part 45 is arranged around the outer periphery of the contact middle part 44.

[0071] In this way, the middle part 44 of the contact can be deformed and displaced under force through the contact deformation part 45 provided outside the middle part 44 of the contact, so as to realize the stable contact between the middle part 44 of the contact and the feedthrough part 1, thereby improving the reliability of electrical connection.

[0072] The above-mentioned middle part 44 of the contact can be located at the center of the conductive contact 42. There can be multiple contact deformation parts 45, and the multiple contact deformation parts 45 are respectively electrically connected to the middle part 44 of the contact and the lead wire.

[0073] The above-mentioned contact deformation parts 45 can be arranged in a centrosymmetric manner relative to the middle part 44 of the contact.

[0074] The above-mentioned middle part 44 of the contact can have a conductive layer and an insulating layer arranged in a stacked manner. The conductive layer of the middle part 44 of the contact is attached to the feedthrough part 1, and the insulating layer of the middle part 44 of the contact is arranged away from the feedthrough part 1 relative to the conductive layer. This insulating layer can be understood as a layer structure that bears force. The external force acts on the insulating layer of the middle part 44 of the contact, and then acts on the conductive layer of the middle part 44 of the contact through the insulating layer of the middle part 44 of the contact, so that the conductive layer can be deformed and abutted against the feedthrough part 1. Among them, the external force applied to the insulating layer of the middle part 44 of the contact can be realized by the pressure connecting part 8 of the implantable neural signal device.

[0075] The above-mentioned contact deformation part 45 and the electrode body 41 can also have a conductive layer and an insulating layer arranged in a stacked manner. The arrangements of the conductive layers and insulating layers of the contact deformation part 45, the middle part 44 of the contact, and the electrode body 41 can be the same or different, and the present application does not make specific limitations on this.

[0076] The shape of the middle part 44 of the contact after being deformed under force can be spherical arc-shaped. Specifically, it can be combined with Figure 4 , Figure 4 shows the state of the middle part 44 of the contact after being deformed under force. The convex surface of the spherical arc-shaped middle part 44 of the contact can be understood as the side surface in contact with the feedthrough part 1, and the concave surface of the spherical arc-shaped middle part 44 of the contact can be understood as the force-bearing surface of the middle part 44 of the contact. When the concave surface is stressed, the middle part 44 of the contact deforms. Specifically, the concave surface is the side surface in contact with the pressure connecting part 8.

[0077] The shape of the above-mentioned middle part 44 of the contact can be one of the following: circular, elliptical, and polygonal. Specifically, the shape of the middle part 44 of the contact can be adapted to the shape of the feedthrough part 1, so that the fitting performance is better when the middle part 44 of the contact is electrically connected to the feedthrough part 1, and the electrical connection is more stable.

[0078] In some embodiments, a hollow structure 43 is formed on the contact deformation part 45; and / or, a hollow structure 43 is formed between the contact deformation part 45 and the electrode body 41. In this way, through the combination with the contact deformation part 45, the above-mentioned hollow structure 43 can make the structural design of the conductive contact 42 more compact and reasonable.

[0079] Exemplarily, as Figure 3 and Figure 5 shown, Figure 3 and Figure 5 the hollow structure 43 shown in is formed between the contact deformation part 45 and the electrode body 41; as Figure 6 shown, Figure 6 the hollow structure 43 shown in can be understood as being formed on the contact deformation part 45.

[0080] In some embodiments, there are multiple hollow structures 43, and the multiple hollow structures 43 are arranged at intervals around the middle part 44 of the contact. In this way, through the multiple hollow structures 43, the conductive contact 42 can be deformed more uniformly after being stressed.

[0081] Specifically, in combination with Figure 6 , Figure 6 there are three hollow structures 43 shown in, and the three hollow structures 43 are arranged at intervals and evenly around the middle part 44 of the contact.

[0082] In some embodiments, as Figures 3 to 7 shown, there are multiple contact deformation parts 45, and the multiple contact deformation parts 45 are respectively electrically connected to the middle part 44 of the contact and the lead connection part 5. In this way, the stable deformation of the middle part 44 of the contact can be realized through the contact deformation part 45, and the middle part 44 of the contact and the lead connection part 5 can be stably electrically connected through the contact deformation part 45.

[0083] The above-mentioned multiple contact deformation parts 45 can be distributed on both sides of the middle part 44 of the contact in an axisymmetric manner, or can be distributed on the periphery of the middle part 44 of the contact in a centrosymmetric manner. The present application does not make specific limitations on the distribution manner of the contact deformation part 45.

[0084] In some embodiments, the multiple contact deformation parts 45 are evenly arranged around the outer periphery of the middle part 44 of the contact. In this way, the middle part 44 of the contact can be deformed more uniformly after being stressed, and the problem of deflection of the middle part 44 of the contact caused by unbalanced stress after being stressed can be prevented.

[0085] In some embodiments, as Figure 3 and Figure 7 shown, the contact deformation part 45 includes a plurality of sequentially connected bending structures, a hollow structure 43 is formed between the plurality of bending structures and the electrode body 41, and the plurality of bending structures are configured to be stretched and deformed along the stress direction after being stressed.

[0086] The shape of the above-mentioned bending structure can be one of the following: S-shaped and M-shaped. Of course, the above-mentioned bending structure can also be an irregular bending shape, as long as the bending structure can realize electrical connection with the middle part 44 of the contact and the lead connection part 5 respectively.

[0087] As Figure 3As shown, the above-mentioned bending structure can be located on opposite sides of the middle part 44 of the contact, so that the middle part 44 of the contact can apply a tensile force to the bending structures on both sides after being stressed, and the deformation of the bending structures on both sides can be used to achieve uniform deformation, so as to ensure stable contact with the feedthrough 1.

[0088] The above-mentioned bending structure can perform a stretching movement after being stressed based on the design of size and shape, or can perform a stretching movement after being stressed based on the design of material. For example, the bending structure can be partially or entirely made of an elastic material.

[0089] In some embodiments, as Figure 3 and Figure 7 shown, the bending directions of adjacent bending structures are opposite to each other.

[0090] In some embodiments, as Figure 5 shown, the contact deformation part 45 includes a spiral structure connected to the middle part 44 of the contact. The spiral structure spirals outward around the middle part 44 of the contact in sequence and is electrically connected to the lead connection part 5. In this way, the middle part 44 of the contact can be stressed more evenly through the spiral structure, so as to deform stably and contact the feedthrough 1.

[0091] As Figure 5 shown, the above-mentioned spiral structure can spiral outward along the outer peripheral side of the middle part 44 of the contact until it forms an electrical connection with the lead connection part 5.

[0092] The above-mentioned spiral structure can include spiral segments connected to opposite sides of the middle part 44 of the contact to further increase the stress uniformity of the middle part 44 of the contact.

[0093] In some embodiments, as Figure 6 shown, a hollow structure 43 is formed on the contact deformation part 45, and the hollow structure 43 has a plurality of broken line parts forming a closed cavity, and the plurality of broken line parts are arranged around the middle part 44 of the contact. The design of the above-mentioned hollow structure 43 can make the middle part 44 of the contact stressed more evenly, so as to deform stably and contact the feedthrough 1.

[0094] The above-mentioned broken line parts can extend outward in a broken line shape along the outer peripheral side of the middle part 44 of the contact.

[0095] The closed cavity formed by the above-mentioned broken line parts can have a plurality of acute angle structures, such as a V-shaped acute angle structure. The shapes of the plurality of broken line parts can be the same, and the plurality of broken line parts can be evenly arranged around the middle part 44 of the contact to further increase the stress uniformity of the middle part 44 of the contact.

[0096] In some embodiments, as Figure 7 shown, a plurality of through holes 46 are formed on the middle part 44 of the contact. The plurality of through holes 46 are used to provide a deformation space for the middle part 44 of the contact, so as to facilitate the deformation of the middle part 44 of the contact after being stressed and contact the feedthrough 1.

[0097] The through holes 46 in the middle part 44 of the above-mentioned contact can be arranged in an array.

[0098] When the through holes 46 are arranged in an array, after the middle part 44 of the contact deforms, it is beneficial to the discharge of gas, so as to avoid wrinkles in the middle part 44 of the contact, and can make the conductive contact 42 fit more closely with the feedthrough 1, improving the stability of the electrical connection.

[0099] In some embodiments, the deformation range of the conductive contact 42 in the thickness direction of the proximal electrode part 4 is not less than 10 microns. The above deformation range can cause a large deformation of the conductive contact 42, which can not only make the conductive contact 42 adapt to the contact surface for electrical connection with the feedthrough 1, but also cooperate with the pressure connecting part 8 of the implantable nerve signal device, so as to play a better positioning role.

[0100] In some embodiments, as Figures 3 to 6 shown, there are multiple conductive contacts 42, and the multiple conductive contacts 42 are linearly arranged or arranged in an array along the length direction of the proximal electrode part 4.

[0101] The above arrangement of the conductive contacts 42 makes full use of the space of the proximal electrode part 4, ensures a large contact area between the conductive contacts 42 and the feedthrough 1, and thus ensures the reliability of the electrical connection.

[0102] The above conductive contact 42 can be connected to one feedthrough 1 or can be connected to multiple feedthroughs 1 in a one-to-one correspondence. The present application does not make specific limitations on this, as long as a stable electrical connection between the conductive contact 42 and the feedthrough 1 can be achieved.

[0103] In some embodiments, the thickness of the flexible electrode 2 is not greater than 200 microns. In this way, a large flexible deformation can be generated by the relatively thin flexible electrode 2 to better adapt to the shape and movement of the nerve tissue. Moreover, the relatively thin flexible electrode 2 can fit better with the feedthrough 1, thereby avoiding too large a gap and effectively ensuring the installation sealing performance of the flexible electrode 2.

[0104] In some embodiments, the flexible electrode 2 includes a first insulating layer, a first conductive layer and a second insulating layer laminated along the thickness direction. The conductive contact 42, the electrode site 31 and the lead are all arranged on the first conductive layer, and the conductive contact 42 and the electrode site 31 are exposed to the first insulating layer and / or the second insulating layer.

[0105] The above first insulating layer can be made of one or more of the following materials: polyimide, parylene and high molecular fluoride.

[0106] The above second insulating layer can be made of one or more of the following materials: polyimide, parylene, fluororesin and fluororubber.

[0107] The above-mentioned first conductive layer can be made of one or more of the following materials: gold, platinum, titanium, chromium, and iridium, which have good electrical conductivity and good corrosion resistance.

[0108] In some embodiments, the flexible electrode 2 further includes a second conductive layer and a third insulating layer. The second conductive layer is disposed on the side of the second insulating layer facing away from the first conductive layer, and the third insulating layer is disposed on the side of the second conductive layer facing away from the second insulating layer.

[0109] The above-mentioned second conductive layer can be made of one or more of the following materials: gold, platinum, titanium, chromium, and iridium, which have good electrical conductivity and good corrosion resistance. Specifically, the above-mentioned second conductive layer can be made of the same or different materials as the first conductive layer, and the present application does not make specific limitations in this regard.

[0110] The above-mentioned third insulating layer can be made of the same or different materials as the first insulating layer and / or the second insulating layer, and the present application does not make specific limitations in this regard.

[0111] The embodiments of the present application also provide an implantable neural signal device. As Figure 1 and Figure 2 shown, the implantable neural signal device includes the above-mentioned flexible electrode for the implantable neural signal device, and further includes an acting component 6. The acting component 6 includes a first housing 61, an acting module, and a feedthrough 1. The acting module is disposed in the first housing 61, the feedthrough 1 is disposed on the first housing 61, and the flexible electrode 2 is electrically connected to the acting module through the feedthrough 1; wherein, the acting module includes a stimulation module and / or a collection module. A circuit board 62 electrically connected to the stimulation module and / or the collection module may also be disposed in the above-mentioned first housing 61.

[0112] The above-mentioned first housing 61 can be made of a metal material. The metal material used for the first housing 61 can be a titanium alloy, or other metal materials such as stainless steel and aluminum alloy, which have excellent strength, stiffness, and biocompatibility. The present application does not make specific limitations on the metal material used for the first housing 61, as long as it can be implanted into a living body.

[0113] The implantable neural signal device using the above-mentioned flexible electrode 2 can better adapt to the shape and movement of neural tissue by using the flexible electrode 2, thereby reducing mechanical pressure and damage to surrounding tissues. In addition, a hollow structure 43 is formed on the conductive contact 42 of the proximal electrode portion 4 of the flexible electrode 2. The hollow structure 43 can cause the conductive contact 42 to deform after being subjected to force, thereby enhancing the deformation ability of the electrode connection, so that the deformed conductive contact 42 can be in closer contact with the feedthrough 1, which is beneficial to improving the electrical connection reliability between the conductive contact 42 and the feedthrough 1, ensuring the conduction effect at the contact point, and the conductive contact 42 after being pressed is no longer in the same plane with the rest of the flexible electrode 2 due to deformation, which enables the conductive contact 42 to be stably confined in a position in contact with the feedthrough 1, which can ensure that the conductive contact 42 is difficult to displace, further improving the electrical connection reliability. In addition, after the deformed conductive contact 42 is in closer contact with the feedthrough 1, the contact gap between the conductive contact 42 and the feedthrough 1 can be reduced as much as possible, thereby facilitating the improvement of the sealing between the conductive contact 42 and the feedthrough 1, and ensuring that the implantable neural signal device can be implanted stably for a long time.

[0114] In some embodiments, Figure 1 and Figure 8 As shown, the action component 6 also includes an electrode cover 7, which covers the proximal electrode portion 4 of the flexible electrode 2. A pressure connector 8 is provided on the side of the electrode cover 7 facing the flexible electrode 2. The pressure connector 8 is used to apply a force to the conductive contact 42 of the proximal electrode portion 4 to make it press against the feed-through 1.

[0115] In this way, a stable force can be applied to the conductive contact 42 through the above-mentioned pressure connector 8, so that the conductive contact 42 can stably abut against the feedthrough 1, effectively improving the conduction effect at the contact point between the conductive contact 42 and the feedthrough 1, thereby ensuring that the flexible electrode 2 can be stably electrically connected to the action module through the feedthrough 1.

[0116] The pressure connector 8 and the feedthrough 1 can be respectively arranged on opposite sides of the flexible electrode 2 , specifically on both sides in the thickness direction of the flexible electrode 2 , so that the conductive contacts 42 of the flexible electrode 2 can be deformed and pressed against the feedthrough 1 under the action of the pressure connector 8 .

[0117] When the functional module includes a stimulation module, since the simulator is first electrically connected to the flexible electrode 2 for simulation operations, and after the parameters are confirmed in the simulation operations, the implantable neural signal device is used for the formal implantation operation. Therefore, the installation operation of the flexible electrode 2 and the functional component 6 is performed before the formal implantation operation. By using the above-mentioned pressure connector 8, when the flexible electrode 2 is installed on the functional component 6, a force is applied to the conductive contact 42 of the flexible electrode 2 to make it abut against the feedthrough 1, so that the conductive contact 42 can be deformed by the force, thereby ensuring that the conductive contact 42 can establish a stable electrical connection relationship with the functional module through the feedthrough 1.

[0118] In some embodiments, the above-mentioned pressure connector 8 can be used to apply an elastic force to the conductive contact 42, so that the conductive contact 42 can stably abut against the feedthrough 1. In some other embodiments, the above-mentioned pressure connector 8 can move under the control of a control signal to act on the conductive contact 42 to apply a force to the conductive contact 42 to make it abut against the feedthrough 1. For example, the pressure connector 8 includes a telescopic structure, and the telescopic structure can perform a telescopic movement to act on the conductive contact 42 after receiving the control signal.

[0119] The above-mentioned electrode cover 7 can be installed on the distal surface of the first housing 61. Specifically, the electrode cover 7 can be connected to the first housing 61 in a detachable connection manner. For example, the electrode cover 7 is connected to the first housing 61 in a pivoting connection manner. Another example is that the electrode cover 7 is provided with mounting holes, and mounting screws can be installed in the mounting holes to achieve disassembly and assembly with the first housing 61. In some other embodiments, the electrode cover 7 can be connected to the first housing 61 in a sliding connection manner. The present application does not specifically limit the connection manner between the electrode cover 7 and the first housing 61.

[0120] The above-mentioned electrode cover 7 can be made of one or more of the following materials: polyether ether ketone, epoxy resin.

[0121] In some embodiments, such as Figure 1 As shown, the feedthrough 1 includes an insulating carrier 11 and a feedthrough conductor 12. The insulating carrier 11 is disposed on one side of the first housing 61, the feedthrough conductor 12 penetrates through the insulating carrier 11, and both ends of the feedthrough conductor 12 are electrically connected to the conductive contact 42 and the functional module respectively. In this way, the electrical connection between the conductive contact 42 and the functional module can be achieved through the feedthrough conductor 12.

[0122] The above-mentioned feedthrough conductor 12 can penetrate through the insulating carrier 11, and the insulating carrier 11 can be in surface-to-surface contact with the proximal electrode portion 4 of the flexible electrode 2 to provide a supporting effect on the flexible electrode 2 through the insulating carrier 11. One end or both ends of the feedthrough conductor 12 can protrude from the surface of the insulating carrier 11, which can make the feedthrough conductor 12 easier to contact the conductive contact 42 and improve the stability of the electrical connection.

[0123] The shape of the insulating carrier 11 may be adapted to the shape of the proximal electrode portion 4, so that the proximal electrode portion 4 can be better supported by the insulating carrier 11. Exemplarily, the shape of the insulating carrier 11 may be one of the following: circular, elliptical, and polygonal.

[0124] The insulating carrier 11 may be made of insulating material, such as ceramic.

[0125] The feed-through conductor 12 may be made of metal material, such as at least one of gold, platinum and iridium.

[0126] In some embodiments, Figure 1 As shown, there are a plurality of feed-through conductors 12 , and the plurality of feed-through conductors 12 are arranged in an array on the insulating carrier 11 .

[0127] There are also a plurality of the conductive contacts 42 , which are arranged one-to-one with the feed-through conductors 12 to form a larger current conduction area, thereby ensuring the reliability of the electrical connection between the feed-through 1 and the conductive contacts 42 .

[0128] In some embodiments, Figure 1 and Figure 8 As shown, the pressure connector 8 includes at least one elastic member 81, which is arranged one by one with the conductive contact 42, and the elastic member 81 is used to apply a force to the conductive contact 42 of the flexible electrode 2 so that the conductive contact 42 is pressed against the feed-through member 1 to form an electrical connection.

[0129] In this way, the elastic member 81 can apply a stable elastic force to the conductive contact 42, so that the conductive contact 42 can stably abut against the feedthrough 1, effectively improving the conduction effect at the contact point between the conductive contact 42 and the feedthrough 1. In addition, the elastic member 81 has a simple structural design, which can reduce the manufacturing cost of the implantable neural signal device while applying a stable force to the conductive contact 42.

[0130] The elastic member 81 may be deformed based on the structural design to exert a force on the conductive contact 42, such as a spring, a spring, etc. The elastic member 81 may also be deformed based on the material design to exert a force on the conductive contact 42, such as silicone, rubber, etc.

[0131] The above-mentioned elastic member 81 can be multiple, and the multiple elastic members 81 are arranged along the length direction of the flexible electrode 2 and are arranged one by one with the conductive contacts 42, so as to apply elastic force to each conductive contact 42 respectively, so that the conductive contact 42 can be deformed along the thickness direction of the flexible electrode 2, so that each conductive contact 42 can form an electrical connection with the feed-through member 1, thereby achieving a better electrical connection effect.

[0132] In some embodiments,Figure 1 As shown, the outer edge of the electrode cap 7 and the outer edge of the first housing 61 are installed with each other, and a first gasket 9 is provided between the outer edge of the electrode cap 7 and the outer edge of the first housing 61. After the implantable neural signal device is implanted into the target tissue, the first gasket 9 can prevent body fluid from flowing into the interior of the first housing 61 between the first housing 61 and the electrode cap 7, improving the sealing performance and safety of the implantable neural signal device.

[0133] In some embodiments, as Figure 1 and Figure 8 shown, the pressure connector 8 further includes a seat body 82 and a second gasket member 83. The seat body 82 is connected to the distal side of the electrode cap 7, and the seat body 82 is provided with a mounting hole. The elastic member 81 is disposed in the mounting hole. The second gasket is disposed on the seat body 82 and surrounds the outer peripheral side of the elastic member 81, and the second gasket is located on the inner peripheral side of the first gasket 9.

[0134] In this way, the installation sealing performance between the pressure connector 8, the flexible electrode 2 and the feedthrough 1 can be ensured by the second gasket.

[0135] The above-mentioned second gasket can surround the outer edge of the pressure connector 8 and is located on the outer peripheral side of the conductive contact 42, so as to play a better sealing role to further prevent body fluid from contacting the conductive contact 42 of the flexible electrode 2 after the implantable neural signal device is implanted into the target tissue.

[0136] The embodiment of the present application also provides a method for manufacturing a flexible electrode 2, which is used to manufacture the above-mentioned flexible electrode for an implantable neural signal device. The flexible electrode 2 includes a first insulating layer, a first conductive layer and a second insulating layer laminated along the thickness direction. The conductive contact 42, the electrode site 31 and the lead are all arranged on the first conductive layer, and the conductive contact 42 and the electrode site 31 are exposed to the first insulating layer and / or the second insulating layer. As Figure 9 shown, the method for manufacturing the flexible electrode 2 includes steps S101 to S106.

[0137] Step S101: Spin-coat and bake the insulating paste to form the first insulating layer.

[0138] Step S102: Remove the part corresponding to the electrode site 31 on the first insulating layer to expose the electrode site 31 through the first insulating layer.

[0139] Step S103: Form the first conductive layer above the first insulating layer by photolithography and coating.

[0140] Step S104: Spin-coat and bake the insulating paste on the side of the first conductive layer facing away from the first insulating layer to form the second insulating layer.

[0141] Step S105: Remove the portions on the second insulating layer corresponding to the electrode sites 31 and the conductive contacts 42, so as to expose the electrode sites 31 and the conductive contacts 42 through the second insulating layer.

[0142] Step S106: Remove the portions on the first insulating layer and the second insulating layer corresponding to the hollow structure 43.

[0143] The above method for manufacturing the flexible electrode 2 can manufacture a flexible electrode 2 with advantages such as being convenient for positioning, having a good sealing effect, and high electrical connection stability.

[0144] After obtaining the second insulating layer in step S104, step S105 and step S106 can be performed simultaneously, that is, the first insulating layer, the first conductive layer, and the second insulating layer are etched synchronously, so as to remove the patterns corresponding to the electrode sites 31 and the conductive contacts 42 on the second insulating layer and the hollow structure 43 on the conductive contacts 42 at the same time, so as to reduce the operation steps for manufacturing the flexible electrode 2.

[0145] The above coating can be understood as physical vapor deposition coating or electroplating, and the coating method can be specifically selected according to the materials of the first insulating layer, the first conductive layer, and the second insulating layer.

[0146] In addition, although exemplary embodiments have been described herein, the scope includes any and all embodiments based on the present application having equivalent elements, modifications, omissions, combinations (e.g., solutions that cross various embodiments), adaptations, or changes. The elements in the claims will be broadly interpreted based on the language used in the claims and are not limited to the examples described in this specification or during the implementation of the present application, and the examples will be interpreted as non-exclusive.

[0147] The above description is intended to be illustrative rather than restrictive. For example, the above examples (or one or more of them) can be used in combination with each other. For example, those of ordinary skill in the art can use other embodiments when reading the above description. Additionally, in the above specific implementation manners, various features can be grouped together to simplify the present application. This should not be construed as an intention that the disclosed features not claimed are necessary for any claim. On the contrary, the subject matter of the present application can be less than all the features of the specific disclosed embodiments. Thus, the claims are incorporated herein as examples or embodiments into the specific implementation manners, where each claim independently serves as a separate embodiment, and considering these embodiments, they can be combined with each other in various combinations or arrangements. The scope of the present application should be determined with reference to the appended claims and the full scope of the equivalent forms empowered by these claims.

[0148] The above embodiments are only exemplary embodiments of the present application and are not used to limit the present application. The protection scope of the present application is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions within the essence and protection scope of the present application, and such modifications or equivalent substitutions should also be regarded as falling within the protection scope of the present application.

Claims

1. A flexible electrode for an implantable neural signal device, characterized in that: The implantable neural signal device comprises a feedthrough, the flexible electrode is electrically connected to the feedthrough, and the flexible electrode comprises: A distal electrode portion, comprising at least one electrode site, wherein the electrode site is used to apply electrical stimulation to a target tissue and / or collect a potential signal of the target tissue; A proximal electrode portion, comprising an electrode body and at least one conductive contact disposed on the electrode body, wherein the conductive contact is formed with a hollow structure, and the hollow structure is configured to deform the conductive contact when a force is applied to the conductive contact, so that the deformed conductive contact abuts against the feed-through to form an electrical connection; A lead connection portion, comprising a lead, wherein two ends of the lead are electrically connected to the conductive contact of the proximal electrode portion and the electrode site of the distal electrode portion, respectively, and the distal electrode portion, the proximal electrode portion and the lead connection portion are sequentially arranged along the length direction of the flexible electrode; the conductive contact has an electrically connected contact middle portion and a contact deformation portion, and the contact deformation portion is arranged around the periphery of the contact middle portion; The hollow structure is formed on the contact deformation portion; and / or, The hollow structure is formed between the contact deformation portion and the electrode body.

2. The flexible electrode for an implantable neural signal device according to claim 1, characterized in that: There are multiple hollow structures, and the multiple hollow structures are arranged at intervals around the middle of the contact.

3. The flexible electrode for an implantable neural signal device according to claim 1, characterized in that: There are a plurality of contact deformation parts, and the plurality of contact deformation parts are electrically connected to the contact middle part and the lead connection part respectively.

4. The flexible electrode for an implantable neural signal device according to claim 3, characterized in that: A plurality of contact deformation portions are evenly arranged around the periphery of the middle portion of the contact.

5. The flexible electrode for an implantable neural signal device according to claim 1, characterized in that: The contact deformation portion includes a plurality of bending structures connected in sequence, the hollow structure is formed between the plurality of bending structures and the electrode body, and the plurality of bending structures are configured to be stretched and deformed along the direction of force after being subjected to force.

6. The flexible electrode for an implantable neural signal device according to claim 5, characterized in that: The bending directions of the adjacent bending structures are opposite to each other.

7. The flexible electrode for an implantable neural signal device according to claim 1, characterized in that: The contact deformation portion includes a spiral structure connected to the middle portion of the contact, the spiral structure spirals outwards around the middle portion of the contact in sequence, and is electrically connected to the lead connection portion.

8. The flexible electrode for an implantable neural signal device according to claim 1, characterized in that: The hollow structure is formed on the contact deformation portion, and the hollow structure has a plurality of fold line portions forming a closed cavity, and the plurality of fold line portions are arranged around the middle portion of the contact.

9. The flexible electrode for an implantable neural signal device according to claim 1, characterized in that: A plurality of through holes are formed on the middle portion of the contact, and the plurality of through holes are used to provide a deformation space for the middle portion of the contact.

10. The flexible electrode for an implantable neural signal device according to claim 1, characterized in that: The deformation range of the conductive contact in the thickness direction of the proximal electrode portion is not less than 10 microns.

11. The flexible electrode for an implantable neural signal device according to claim 1, characterized in that: There are multiple conductive contacts, and the multiple conductive contacts are arranged linearly or in an array along the length direction of the proximal electrode portion.

12. The flexible electrode for an implantable neural signal device according to claim 1, characterized in that: The thickness of the flexible electrode is no more than 200 microns.

13. The flexible electrode for an implantable neural signal device according to claim 1, characterized in that: The flexible electrode includes a first insulating layer, a first conductive layer, and a second insulating layer stacked in a thickness direction, the conductive contacts, electrode sites, and leads are all arranged in the first conductive layer, and the conductive contacts and electrode sites are exposed to the first insulating layer and / or the second insulating layer.

14. The flexible electrode for an implantable neural signal device according to claim 13, characterized in that: The flexible electrode further includes a second conductive layer and a third insulating layer. The second conductive layer is disposed on a side of the second insulating layer facing away from the first conductive layer. The third insulating layer is disposed on a side of the second conductive layer facing away from the second insulating layer.

15. An implantable neural signal device, characterized in that: It comprises a flexible electrode for an implantable neural signal device as described in any one of claims 1 to 14, and also comprises an action component, the action component comprises a first shell, an action module and a feed-through, the action module is arranged in the first shell, the feed-through is arranged on the first shell, and the flexible electrode is electrically connected to the action module through the feed-through; wherein the action module comprises a stimulation module and / or an acquisition module.

16. The implantable neural signal device according to claim 15, characterized in that: The action component also includes an electrode cover, which covers the proximal electrode part of the flexible electrode. A pressure connector is provided on the side of the electrode cover facing the flexible electrode, and the pressure connector is used to apply a force to the conductive contact of the proximal electrode part to make it press against the feedthrough.

17. The implantable neural signal device according to claim 15, characterized in that: The feed-through component includes an insulating carrier and a feed-through conductor. The insulating carrier is disposed on one side of the first shell. The feed-through conductor passes through the insulating carrier, and two ends of the feed-through conductor are electrically connected to the conductive contact and the action module respectively.

18. The implantable neural signal device according to claim 17, characterized in that: There are a plurality of feed-through conductors, and a plurality of the feed-through conductor arrays are arranged on the insulating carrier.

19. The implantable neural signal device according to claim 16, characterized in that: The pressure connector includes at least one elastic member, which is arranged in one-to-one correspondence with the conductive contacts, and the elastic member is used to apply a force to the conductive contacts of the flexible electrode so that the conductive contacts are pressed against the feed-through member to form an electrical connection.

20. The implantable neural signal device according to claim 19, characterized in that: The outer edge of the electrode cover and the outer edge of the first shell are mounted on each other, and a first sealing gasket is arranged between the outer edge of the electrode cover and the outer edge of the first shell.

21. The implantable neural signal device according to claim 20, characterized in that: The pressure connector also includes a seat body and a second sealing gasket. The seat body is connected to the distal side of the electrode cover, and a mounting hole is provided on the seat body. The elastic member is arranged in the mounting hole. The second sealing gasket is arranged on the seat body and surrounds the outer peripheral side of the elastic member, and the second sealing gasket is located on the inner peripheral side of the first sealing gasket.

22. A method for preparing a flexible electrode, characterized in that: A method for preparing a flexible electrode for an implantable neural signal device according to any one of claims 1 to 14, wherein the flexible electrode comprises a first insulating layer, a first conductive layer, and a second insulating layer stacked in a thickness direction, wherein the conductive contacts, electrode sites, and leads are all arranged in the first conductive layer, and the conductive contacts and electrode sites are exposed to the first insulating layer and / or the second insulating layer, and wherein the method for preparing the flexible electrode comprises: Spin coating and baking the insulating slurry to form a first insulating layer; removing a portion of the first insulating layer corresponding to the electrode site to expose the electrode site through the first insulating layer; forming a first conductive layer on the first insulating layer by photolithography and coating; Spin coating and baking an insulating paste on a side of the first conductive layer facing away from the first insulating layer to form a second insulating layer; removing portions of the second insulating layer corresponding to the electrode sites and the conductive contacts to expose the electrode sites and the conductive contacts through the second insulating layer; Portions of the first insulating layer and the second insulating layer corresponding to the hollow structure are removed.

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