Multi-conducting flexible implantable electrode and method of making same

Abstract

The application provides a multi-conducting elastic implant electrode and a preparation method thereof. The multi-conducting elastic implant electrode comprises an electrode body, the electrode body comprises a plurality of electrode segments, each electrode segment comprises an electrode ring, a clamping column and a connecting column, the electrode ring is sleeved outside the connecting column, the plurality of electrode segments are arranged, the clamping column and the connecting column are sequentially and alternately arranged and fixedly connected, two adjacent clamping columns clamp the electrode ring, and the electrode ring and the clamping column are in sealed arrangement; the clamping column is provided with a through hole penetrating through two end surfaces; each electrode ring is electrically connected with a wire, free ends of the wires pass through the through hole and are located on the same side of the electrode body. The application can improve the flexibility of the implant electrode as a whole and can effectively improve the adaptability of the product implanted in the body.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of nerve stimulation, in particular to a multi-conduction flexible implant electrode and a preparation method thereof. BACKGROUND

[0002] The preparation method of the implant electrode existing on the market at present is mainly perfusion method, first using a physical method to weld the lead wire and the electrode ring, then perfusing glue into the electrode ring, repeating this step to make the front part of a stimulation electrode. This method is more complicated and the flexibility of the product produced is not enough. For implanted products, the adaptability to the human body is poor. SUMMARY

[0003] In order to improve the flexibility of the implant electrode, the present application provides a multi-conduction flexible implant electrode and a preparation method thereof.

[0004] The multi-conduction flexible implant electrode and the preparation method thereof provided by the present application adopt the following technical scheme:

[0005] In a first aspect, a multi-conduction flexible implant electrode comprises:

[0006] An electrode body, the electrode body comprising a plurality of electrode segments, each electrode segment comprising an electrode ring, a clamping column and a connecting column, both of which are flexible materials, and the electrode ring being sleeved outside the connecting column;

[0007] The plurality of electrode segments are arranged such that the clamping columns and the connecting columns are sequentially and alternately arranged and fixedly connected, the adjacent two clamping columns clamping the electrode ring, and the electrode ring and the clamping column being in sealed arrangement; the clamping column is provided with a through hole penetrating through both end faces; each electrode ring is electrically connected with a lead wire, and the free end of each lead wire passes out of the through hole and is located on the same side of the electrode body.

[0008] By adopting the above technical scheme, the lead wires connected with each electrode ring pass out of the same side of the electrode segment and are connected with an external power supply, so that each electrode ring emits a stimulation signal; the clamping columns and the connecting columns are sequentially and alternately arranged, and the clamping column and the adjacent connecting column are fixedly connected, so as to increase the strength of the whole implant electrode; both the clamping column and the connecting column are flexible, which can improve the flexibility of the whole implant electrode compared with perfusing glue into the electrode ring, and can effectively improve the adaptability of the product implanted in the body. The electrode ring is sleeved on the connecting column, the connecting column and the two clamping columns adjacent to itself are fixedly connected, the two clamping columns adjacent to the connecting column can clamp and position the electrode ring, so that the electrode ring will not rotate, the glue perfusion method is eliminated, and the production method of the implant electrode is more simple and convenient.

[0009] Optionally, the electrode body end is provided with a blocking section, the end of the connecting column is an implantation end, the blocking section is fixedly connected with the implantation end, and the implantation end is blocked.

[0010] By adopting the above technical scheme, the blocking section is connected with the connecting column, which on the one hand cooperates with the clamping column to fix the electrode ring, and on the other hand blocks the connecting column of the end, thereby blocking the implantation end. After the implantation end is placed in the body, the body material can be prevented from entering the implanted electrode.

[0011] Optionally, the plurality of through holes are distributed at intervals in the circumferential direction of the connecting column, and the plurality of through holes correspond one-to-one to the wires.

[0012] By adopting the above technical scheme, by rotating the electrode ring, each wire can be kept straight and pass out of the implanted electrode from the same side. Different wires pass through different through holes, so that the phenomenon of entanglement between different wires can be avoided, the probability of damage to the implanted electrode is reduced, and the service life of the implanted electrode is improved.

[0013] Optionally, the clamping column and the connecting column are made of thermoplastic material.

[0014] By adopting the above technical scheme, the thermoplastic material has plasticity at a certain temperature and can be solidified after cooling. After the plurality of electrode sections are arranged in sequence, the contact surfaces of the clamping columns and the adjacent connecting columns are heated, so that the end surfaces of the clamping columns and the connecting columns are melted. After cooling, the clamping columns and the adjacent connecting columns can be fixedly connected, and the preparation method of the implanted electrode can be simplified.

[0015] Optionally, the clamping column is provided with a first insertion hole penetrating through both end surfaces, the connecting column is provided with a second insertion hole penetrating through both end surfaces and opposite to the first insertion hole, and the first insertion hole and the second insertion hole are both for inserting a mandrel.

[0016] By adopting the above technical scheme, on the one hand, the mandrel is inserted into the first insertion hole and the second insertion hole, so that the clamping columns and the connecting columns are arranged alternately. When the plurality of electrode sections are arranged, the clamping columns and the connecting columns can always be coaxial and will not be dislocated. On the other hand, by inserting the mandrel, the plurality of electrode sections can be pressed towards each other, so that the electrode ring is clamped by the two adjacent clamping columns, and the connecting column and the clamping column are tightly attached, thereby ensuring the connection strength between the connecting column and the clamping column and the strength of the electrode ring clamped by the two adjacent clamping columns. In addition to being inserted by the mandrel, the first insertion hole and the second insertion hole are also inserted by the implantation wire, so as to implant the implanted electrode into the body by using the implantation wire.

[0017] Optionally, the first insertion hole is located at the center of the clamping column.

[0018] By adopting the above technical scheme, the mandrel is inserted into the clamping column, the clamping column is uniformly distributed at the periphery of the mandrel, the stability of the clamping column inserted on the mandrel can be improved, and the stability of the implanted electrode inserted on the implanted wire can be improved, so that the possibility of relative rotation between the implanted electrode and the implanted wire during implantation of the implanted electrode into the body is reduced.

[0019] Optionally, each first insertion hole and each second insertion hole are coaxially arranged and have the same size.

[0020] By adopting the above technical scheme, the sizes of the first insertion hole and the second insertion hole are adapted to the uniform mandrel or implanted wire, the clamping column and the connecting column are inserted on the mandrel or implanted wire, the stability of the clamping column and the connecting column can be ensured, and the mandrel or implanted wire can be pulled out of the first insertion hole and the second insertion hole after the clamping column and the connecting column are fixedly connected.

[0021] Optionally, the wire is connected with a terminal at one end, the terminal is adapted to the inner side of the electrode ring and is electrically connected with the electrode ring.

[0022] By adopting the above technical scheme, the terminal is adapted to the inner side of the electrode ring, the contact area of the terminal and the electrode ring can be increased, and the firmness of the electrical connection between the wire and the electrode ring can be improved.

[0023] In a second aspect, a preparation method of a multi-conducting elastic implanted electrode includes the following steps:

[0024] providing a plurality of electrode segments, each of the electrode segments including an electrode ring, a clamping column and a connecting column made of flexible material, and electrically connecting each of the electrode rings with a wire, and drilling a through hole penetrating through two end faces on the clamping column;

[0025] sequentially arranging the plurality of electrode segments, so that the clamping columns and the connecting columns are sequentially and alternately arranged, the free ends of the wires are pulled out from the through holes, each of the electrode rings is sleeved on the corresponding connecting column, the clamping column and the adjacent connecting column and the electrode ring are attached to each other, and the free ends of the wires are located on the same side of the plurality of electrode segments; and

[0026] fixedly connecting each of the clamping columns and the adjacent connecting columns.

[0027] By adopting the technical scheme, the clamping columns and the connecting columns are flexible, and compared with filling glue into the electrode ring, the flexibility of the implanted electrode as a whole can be improved, and the adaptability of the product implanted in the body can be effectively improved. The clamping columns and the connecting columns are fixedly connected, so that the implanted electrode forms a whole, the strength of the implanted electrode as a whole is improved, and the filling glue mode is avoided, so that the manufacturing method of the implanted electrode is more simple.

[0028] Optionally, the step of sequentially arranging the plurality of electrode segments comprises the following steps:

[0029] Holes are formed in the clamping columns and the connecting columns;

[0030] A mandrel is provided, and the mandrel is sequentially inserted into the holes of the clamping columns and the connecting columns, so that the plurality of electrode segments are sequentially arranged.

[0031] By adopting the technical scheme, the mandrel is inserted into the holes of the clamping columns and the connecting columns, the clamping columns and the connecting columns are alternately arranged, and when the plurality of electrode segments are arranged, the clamping columns and the connecting columns can always be coaxial and will not be dislocated. On the other hand, by inserting the mandrel, the plurality of electrode segments can be pressed towards each other, so that the electrode ring is clamped by the two adjacent clamping columns, and the connecting columns and the clamping columns are closely attached to each other, so as to ensure the connecting strength between the connecting columns and the clamping columns and the strength of the electrode ring clamped by the two adjacent clamping columns. After the clamping columns and the connecting columns are fixedly connected, the mandrel can be pulled out of the holes of the clamping columns and the connecting columns.

[0032] Optionally, the method further comprises the following steps of providing a blocking segment, arranging the blocking segment on one side of the end of the plurality of electrode segments which is provided with the connecting column, and

[0033] The blocking segment is fixedly connected with the adjacent connecting column.

[0034] By adopting the technical scheme, the blocking segment is connected with the connecting column, which cooperates with the clamping column to fix the electrode ring, and the connecting column at the end of the blocking segment blocks the implanted end, so that after the implanted end is put into the body, the material in the body can be prevented from entering the implanted electrode.

[0035] Optionally, the steps of fixedly connecting the blocking segment with the adjacent connecting column and fixedly connecting each clamping column with the adjacent connecting column comprise the following steps:

[0036] A heat shrink tube is provided, and the heat shrink tube is sleeved on the plurality of electrode segments and the blocking segment, and the material of the blocking segment, the clamping column and the connecting column is a thermoplastic material.

[0037] The heat shrink tubing, the contact surfaces of the sealing section and adjacent connecting posts, and the contact surfaces of each clamping post and adjacent connecting posts are heated to fix the sealing section to the adjacent connecting posts and each connecting post to the adjacent clamping post; and,

[0038] Remove the heat shrink tubing after it has cooled down.

[0039] By adopting the above technical solution, after arranging the sealing segment and multiple electrode segments in sequence, heating the contact surfaces of the sealing segment and adjacent connecting posts, as well as the contact surfaces of each clamping post and adjacent connecting posts, can melt the end faces of the sealing segment, clamping posts, and connecting posts. After cooling, a fixed connection can be achieved between the sealing segment and adjacent connecting posts, and between each clamping post and adjacent connecting posts, which simplifies the preparation method of implanted electrodes.

[0040] In summary, this application includes at least one of the following beneficial technical effects:

[0041] 1. Flexible clamping posts and flexible connecting posts are fixedly connected to form an integral implantable electrode, which can increase the overall strength of the implantable electrode and improve its flexibility, effectively improving the adaptability of the product to the body.

[0042] 2. The clamping post and connecting post are made of thermoplastic material. By heating the contact surfaces of the clamping post and connecting post, the clamping post and connecting post can be fixedly connected, which simplifies the preparation method of implanted electrode.

[0043] 3. Both the clamping post and the connecting post are equipped with insertion holes for inserting the mandrel, which facilitates the arrangement of multiple electrode segments and makes it easy to squeeze multiple electrode segments towards each other, so that the electrode ring is clamped by two adjacent clamping posts, and the connecting post and the clamping post are tightly attached to each other, thereby ensuring the connection strength between the connecting post and the clamping post, and ensuring the strength of the clamping of the electrode ring by two adjacent clamping posts.

[0044] 4. Slide the heat shrink tubing over multiple electrode segments and heat the heat shrink tubing. This will allow the multiple electrode segments to fit together tightly and simultaneously achieve a fixed connection between the clamping post and the connecting post. Attached Figure Description

[0045] Figure 1 This is a schematic diagram of the structure of the multi-conductivity elastic implanted electrode in the embodiments of this application;

[0046] Figure 2 yes Figure 1 Schematic diagram of the structure of the middle electrode body;

[0047] Figure 3 yes Figure 2 A schematic diagram of the structure of the middle electrode body (with the electrode ring hidden);

[0048] Figure 4 is Figure 1 Structure diagram of the connection between the electrode ring and the lead wire;

[0049] Figure 5 is Figure 1 Structure diagram of the electrode segment and the mandrel from the first perspective;

[0050] Figure 6 is Figure 1 Structure diagram of the electrode segment and the mandrel from the second perspective;

[0051] Figure 7 is Figure 1 Structure diagram of the occlusion segment.

[0052] Mark explanation: 100, electrode body; 101, electrode segment; 102, implant end; 103, connection end; 200, occlusion segment; 300, mandrel; 1, electrode ring; 11, mounting surface; 12, identification surface; 2, clamping column; 21, through hole; 22, first insertion hole; 3, connection column; 31, second insertion hole; 4, lead wire; 5, terminal. DETAILED DESCRIPTION

[0053] The following will be combined with the Figures 1-7 Further detailed description of the present application.

[0054] Example 1

[0055] Example 1 of the present application discloses a multi-conducting flexible implant electrode. Referring to Figure 1 , the multi-conducting flexible implant electrode comprises an electrode body 100 and an occlusion segment 200, the electrode body 100 comprises a plurality of electrode segments 101, each electrode segment 101 comprises an electrode ring 1, a clamping column 2 and a connection column 3 which are all flexible materials (since the connection column 3 is located in the electrode ring 1, Figure 1 The connection column 3 is not shown in the figure).

[0056] Combined with Figure 2 and Figure 3 In each electrode segment 101, the connection column 3 is located on the same side of the clamping column 2, the electrode ring 1 is sleeved outside the connection column 3, and the two end surfaces of the electrode ring 1 are flush with the two end surfaces of the connection column 3, that is, the height of the electrode ring 1 is the same as the height of the connection column 3. The material of the electrode ring 1 is a medical and nuclear magnetic compatible metal material, such as platinum-iridium alloy, titanium alloy, etc.

[0057] The electrode ring 1 and the clamping column 2 are in sealed arrangement, in this embodiment, the end surface of the clamping column 2 in contact with the electrode ring 1 covers the end surface of the electrode ring 1 in contact with the clamping column 2, and the two clamping columns 2 clamp the electrode ring 1 at the same time, which can seal the two sides of the electrode ring 1. In other embodiments, a medical-grade sealing material can also be used to seal between the electrode ring 1 and the clamping column 2.

[0058] Further, in the embodiment, the clamping column 2 is in a cylindrical shape, reducing the discomfort caused to the body when implanted in the body, and the connecting column 3 is in a cylindrical shape, facilitating the fitting inside the electrode ring 1. In other embodiments, the clamping column 2 and the connecting column 3 can also be in other columnar shapes.

[0059] The plurality of electrode segments 101 are arranged such that the clamping columns 2 and the connecting columns 3 are arranged alternately in sequence, and the clamping column 2 is fixedly connected with the adjacent connecting column 3. Since the two end faces of the electrode ring 1 are flush with the two end faces of the connecting column 3, the adjacent two clamping columns 2 clamp the electrode ring 1, the electrode ring 1 does not rotate, and the relative position of the electrode ring 1 and the connecting column 3 remains unchanged.

[0060] Referring to Figure 4 Each electrode ring 1 is electrically connected with a wire 4, the wire 4 is located inside the electrode ring 1, that is, between the electrode ring 1 and the connecting column 3, and the wire 4 is connected with the inner side face of the electrode ring 1, which can protect the wire 4. The material of the wire 4 is a medical metal material that can pass through nuclear magnetic resonance and has small resistance, such as platinum-iridium alloy, MP35, silver alloy, etc.

[0061] Referring to Figure 5 and Figure 6 The clamping column 2 is provided with a through hole 21 penetrating through the two end faces, and the through hole 21 is located between the connecting column 3 and the electrode ring 1. In the embodiment, the extension direction of the through hole 21 is the same as the extension direction of the clamping column 2, and the free ends of the wires 4 are all located on the same side of the plurality of electrode segments 101 and pass through the through hole 21. Since the electrode ring 1 is clamped by the adjacent two clamping columns 2, the electrode ring 1 does not rotate relative to the clamping column 2, so the end portion of the wire 4 fixed to the electrode ring 1 also does not rotate.

[0062] The clamping column 2 and the adjacent connecting column 3 can be fixedly connected by bonding or other methods. In the embodiment, the materials of the clamping column 2 and the connecting column 3 are thermoplastic materials, especially medical-grade thermoplastic materials, which can be selected as the main materials, such as TPU and TPE. The thermoplastic material has plasticity at a certain temperature and can be solidified after cooling. After the plurality of electrode segments 101 are arranged in sequence, the contact surfaces of the clamping column 2 and the connecting column 3 are heated, so that the end faces of the clamping column 2 and the connecting column 3 are melted, and after cooling, the clamping column 2 and the connecting column 3 are fixedly connected, which can simplify the preparation method of the implanted electrode.

[0063] In combination with Figure 1 and Figure 3 The end portion of the electrode body 100 is the connecting column 3, one end of which is the implanted end 102, and the end portion of the clamping column 2 is the connecting end 103. The blocking segment 200 is fixedly connected with the implanted end 102, blocks the implanted end 102, and cooperates with the clamping column 2 at the most end portion of the implanted end 102 to clamp the electrode ring 1 at the most end portion of the implanted end 102.

[0064] The blocking section 200 is connected with the connecting column 3, which cooperates with the clamping column 2 to fix the electrode ring 1, and blocks the connecting column 3 at the end to block the implanting end 102 of the implanted electrode.

[0065] In order to facilitate the connection between the blocking section 200 and the connecting column 3, the material of the blocking section 200 is a thermoplastic material, especially a medical-grade thermoplastic material, which can be selected as the main material, such as TPU and TPE. The contact surface of the blocking section 200 and the connecting column 3 is heated, so that the end surface of the blocking section 200 and the connecting column 3 is melted, and after cooling, the blocking section 200 and the connecting column 3 are fixedly connected.

[0066] In this embodiment, referring to Figure 7 , the blocking section 200 can have the same structure as the clamping column 2. The end of the blocking section 200 away from the connecting column 3 is heated to melt it, and the perforations 21 and the first insertion hole 22 on the blocking section 200 are blocked to achieve blocking. The blocking section 200 is produced at the same time as the clamping column 2, without the need for additional new processes to prepare the blocking section 200 with a different structure from the clamping column 2. In other embodiments, the blocking section 200 can also be in other shapes such as blocks and strips, as long as it can clamp the electrode ring 1 and block the connecting column 3.

[0067] It can be understood that the implanting end 102 of the implanted electrode is the front end, and the end of the implanted electrode through which the lead wire 4 passes out is the rear end. The lead wire 4 connected to the electrode ring 1 needs to pass out of the perforations 21 of all the clamping columns 2 from the rear. The perforations 21 on the clamping column 2 can be one or more, and the lead wire 4 is provided with an insulating skin layer, and multiple lead wires 4 can pass through the same perforation 21.

[0068] In this embodiment, the perforations 21 are provided in multiple numbers, and the multiple perforations 21 are distributed at intervals in the circumferential direction of the clamping column 2, and the multiple perforations 21 correspond to the lead wires 4 one by one. Rotating the electrode ring 1 can make the lead wires 4 on each electrode ring 1 located on different sides of the corresponding connecting column 3, so that each lead wire 4 can remain straight and pass out of the connecting end 103 of the implanted electrode. Different lead wires 4 pass through different perforations 21, which can avoid the phenomenon of entanglement between different lead wires 4, reduce the probability of damage to the implanted electrode, and improve the service life of the implanted electrode.

[0069] Referring to Figure 4 , in order to facilitate the connection between the electrode ring 1 and the lead wire 4, one end of the lead wire 4 is connected with a terminal 5, the terminal 5 is matched with the inner side surface of the electrode ring 1, and is electrically connected with the electrode ring 1, which can increase the contact area of the terminal 5 and the electrode ring 1, and improve the firmness of the electrical connection between the lead wire 4 and the electrode ring 1. The material of the terminal 5 is a medical and nuclear magnetic resonance material, such as platinum-iridium alloy and titanium alloy.

[0070] In an optional embodiment, the inner side of the electrode ring 1 is arc-shaped, and the surface of the terminal 5 connected to the inner side of the electrode ring 1 is arc-shaped. In this embodiment, the inner side of the electrode ring 1 has a mounting surface 11 arranged in a plane, and the side of the terminal 5 facing the electrode ring 1 is a plane. The terminal 5 is adapted to the mounting surface 11. Compared with the terminal 5 having an arc surface, the terminal 5 having a plane is easier to produce, so that the terminal 5 is more adapted to the electrode ring 1.

[0071] In order to ensure that the wires 4 on each electrode ring 1 are located on different sides of the corresponding connecting column 3, the outer side of the electrode ring 1 has an identification surface 12 opposite to the terminal 5. The identification surface 12 is provided with an identification part. By providing the identification part, the position of the identification part can be identified, and each electrode ring 1 can be rotated so that the identification part on each electrode ring 1 faces different directions, so that the terminals 5 on each electrode ring 1 can be arranged in the circumferential direction of the connecting column 3, so that the wires 4 connected to each electrode ring 1 can not interfere with each other.

[0072] In this embodiment, the identification surface 12 is arranged in a plane, and the part of the outer side of the electrode ring 1 except the identification surface 12 is a circular arc surface. The identification part is formed on the identification surface 12 which is a plane. The position of the wire 4 can be directly determined by the plane of the identification surface 12, which eliminates the need for marking on the identification surface 12 by pasting labels or the like, and eliminates the risk that the pasted pictures may fall off. In other embodiments, the identification part is a label. The label can be formed by pasting or carving, which is convenient for the preparation of the electrode ring 1.

[0073] The electrode ring 1 and the terminal 5 are electrically connected by soldering, resistance welding or laser welding, so as to ensure the stability of the electrical connection between the electrode ring 1 and the terminal 5.

[0074] In order to facilitate the arrangement of the plurality of electrode segments 101, with reference to Figure 5 , the clamping column 2 is provided with a first insertion hole 22 penetrating through the two end surfaces, with reference to Figure 6 , the connecting column 3 is provided with a second insertion hole 31 penetrating through the two end surfaces and opposite to the first insertion hole 22. The first insertion hole 22 and the second insertion hole 31 are both for inserting the mandrel 300.

[0075] In one aspect, the mandrel 300 is inserted into the first insertion hole 22 and the second insertion hole 31, so that the clamping columns 2 and the connecting columns 3 are arranged alternately, and the plurality of electrode segments 101 can be arranged to ensure that the clamping columns 2 and the connecting columns 3 are always coaxial and cannot be dislocated. In another aspect, by inserting the mandrel 300, the plurality of electrode segments 101 can be pressed towards each other, so that the electrode ring 1 is clamped by the two adjacent clamping columns 2, and the connecting column 3 and the clamping column 2 are closely attached to each other, thereby ensuring the connecting strength between the connecting column 3 and the clamping column 2 and the clamping strength of the two adjacent clamping columns 2 on the electrode ring 1. The first insertion hole 22 and the second insertion hole 31 are provided for inserting the mandrel 300 and the implantation wire, so that the implantation wire can be used to implant the implantable electrode into the body.

[0076] In the embodiment, the first insertion hole 22 is located at the center of the clamping column 2, and the plurality of through holes 21 are uniformly arranged around the second insertion hole 31. The mandrel 300 is inserted into the clamping column 2, and the clamping columns 2 located around the mandrel 300 are uniformly distributed, which can improve the stability of the clamping column 2 inserted on the mandrel 300 and the stability of the implantable electrode inserted on the implantation wire, and reduce the possibility of relative rotation between the implantable electrode and the implantation wire during implantation of the implantable electrode into the body.

[0077] The first insertion hole 22 and the second insertion hole 31 are coaxially arranged and have the same size, and the size of the first insertion hole 22 and the second insertion hole 31 is suitable for the uniform mandrel 300 or the implantation wire. The clamping column 2 and the connecting column 3 are inserted into the mandrel 300 or the implantation wire, which can ensure the stability of the clamping column 2 and the connecting column 3, and facilitate the pulling out of the mandrel 300 or the implantation wire from the first insertion hole 22 and the second insertion hole 31 after the clamping column 2 and the connecting column 3 are fixedly connected.

[0078] In other embodiments, the first insertion hole 22 and the second insertion hole 31 can also have different sizes. Since the connecting column 3 and the clamping column 2 are both elastic, the mandrel 300 / implantation wire can be in interference fit with the first insertion hole 22 and the second insertion hole 31.

[0079] The implementation principle of the multi-conducting elastic implantable electrode in Embodiment 1 is as follows:

[0080] The implantation wire is inserted into the first insertion hole 22 and the second insertion hole 31, and the implantation wire can be used to implant the implantation end 102 of the implantable electrode into the body. After being implanted into the body, the implantation wire can be taken out. The lead 4 connected to each electrode ring 1 passes through the through hole 21 of the clamping column 2 and is connected to the outside power supply through the connecting end 103 of the electrode body 100, so that each electrode ring 1 emits a stimulation signal. The clamping column 2 and the connecting column 3 are arranged alternately, and the clamping column 2 and the adjacent connecting column 3 are fixedly connected, which can increase the strength of the whole implantable electrode. The clamping column 2 and the connecting column 3 are both flexible, which can improve the flexibility of the whole implantable electrode compared with filling glue into the electrode ring 1, and can effectively improve the adaptability of the product implanted into the body.

[0081] The electrode ring 1 is sleeved on the connecting column 3, the connecting column 3 and two clamping columns 2 adjacent to the connecting column 3 are fixedly connected, the two clamping columns 2 adjacent to the connecting column 3 can clamp and position the electrode ring 1, the electrode ring 1 cannot rotate, the glue pouring mode is avoided, and the manufacturing method of the implanted electrode is more convenient.

[0082] Embodiment 2

[0083] The embodiment 2 of the present application discloses a manufacturing method of a multi-conduction elastic implanted electrode, comprising the following steps:

[0084] A plurality of electrode segments 101 are provided, each of which comprises an electrode ring 1, a clamping column 2 and a connecting column 3 which are all flexible materials. Specifically, a first type of column is prepared, the first type of column is the same in shape as the clamping column 2, and a plurality of clamping columns 2 are formed by cutting the first type of column by using a cutting tool; a second type of column is prepared, the second type of column is the same in shape as the connecting column 3, and a plurality of connecting columns 3 are formed by cutting the second type of column by using a cutting tool.

[0085] Each of the electrode rings 1 is electrically connected with a wire 4. In the embodiment, the wire 4 is connected with the inner side of the electrode ring 1, a through hole 21 is formed in the clamping column 2 and penetrates two end faces, so that one end of the wire 4 is connected with the electrode ring 1, and the other end can be taken out from the through hole 21.

[0086] The plurality of electrode segments 101 are sequentially arranged, and the free ends of the wires 4 are taken out from the through holes 21, so that the clamping columns 2 and the connecting columns 3 are alternately arranged, the electrode rings 1 are sleeved on the corresponding connecting columns 3, the end faces of the electrode rings 1 are flush with the end faces of the connecting columns 3, the clamping columns 2 and the adjacent connecting columns 3 and the electrode rings 1 are closely attached to each other, and the free ends of the wires 4 are located on the same side of the plurality of electrode segments 101.

[0087] A blocking segment 200 is provided, and the blocking segment 200 is arranged on the side of the electrode body 100 where the connecting column 3 is located. The blocking segment 200 is fixedly connected with the adjacent connecting column 3, and each clamping column 2 is fixedly connected with the adjacent connecting column 3.

[0088] In the embodiment, the blocking segment 200 and the plurality of electrode segments 101 are arranged first, and then the blocking segment 200 and the plurality of electrode segments 101 are fixedly connected. Specifically, the step of sequentially arranging the plurality of electrode segments 101 comprises the following steps:

[0089] Insertion holes (i.e., first insertion holes 22 and second insertion holes 31) are formed in the clamping columns 2 and the connecting columns 3;

[0090] A mandrel 300 is provided, and the mandrel 300 is sequentially inserted into the insertion holes of the clamping columns 2 and the connecting columns 3, so that the plurality of electrode segments 101 are sequentially arranged.

[0091] In an alternative embodiment, when arranging the plurality of electrode segments 101, the clamping columns 2 and the connecting columns 3 are arranged alternately, and the adjacent clamping columns 2 and the connecting columns 3 are bonded, so that the fixing connection between the plurality of electrode segments 101 is realized during the arrangement. By using the mandrel 300, the coaxial connection of the clamping columns 2 and the connecting columns 3 can be ensured.

[0092] In the embodiment, the first insertion hole 22 is located at the center of the connecting column 3, and the second insertion hole 31 is located at the center of the clamping column 2, so that the clamping column 2 and the connecting column 3 cannot rotate when being inserted on the mandrel 300.

[0093] Further, the fixing connection of the blocking segment 200 and the adjacent connecting column 3 and the fixing connection of each clamping column 2 and the adjacent connecting column 3 specifically include the following steps:

[0094] A heat shrink tube is provided, the material of the heat shrink tube is FEP material, the heat shrink tube is sleeved on the plurality of electrode segments 101 and the blocking segment 200, the material of the clamping column 2 and the connecting column 3 is thermoplastic material, in particular, medical-grade thermoplastic material. The contact surface of the heat shrink tube, the blocking segment 200 and the adjacent connecting column 3 is heated, so that the blocking segment 200 and the adjacent connecting column 3 are fixedly connected, and each connecting column 3 and the adjacent clamping column 2 are fixedly connected. After cooling, the heat shrink tube is removed.

[0095] The heat shrink tube is sleeved on the electrode segment 101 and the blocking segment 200, and during the heat shrink process of the heat shrink tube, the clamping column 2 and the adjacent connecting column 3 and the blocking segment 200 and the adjacent connecting column 3 can be closely attached, so that the connection strength of the entire implanted electrode can be ensured after heating and cooling.

[0096] The material of the heat shrink tube, the clamping column 2 and the connecting column 3 is thermoplastic material, after the heat shrink tube, the clamping column 2 and the connecting column 3 are arranged, the contact surface of the heat shrink tube, the blocking segment 200 and the adjacent connecting column 3 is heated, so that the fixing connection of the clamping column 2 and the connecting column 3 is realized, and the operation is convenient.

[0097] In the embodiment, the shape of the blocking segment 200 is the same as that of the clamping column 2, so that the blocking segment 200 and the clamping column 2 can be produced at the same time, and the production process is simplified. The end of the blocking segment 200 away from the electrode segment 101 is heated, so that the perforation 21 and the first insertion hole 22 on the end of the blocking segment 200 away from the electrode segment 101 are blocked, so that the blocking of the implanted end 102 of the implanted electrode is realized.

[0098] In other embodiments, the blocking segment 200 can be a block or other shapes, and is made of thermoplastic material, in particular, medical-grade thermoplastic material. The blocking segment 200 is inserted into the end of the mandrel 300 through the insertion slot with the slot opening towards the electrode segment 101, so that the blocking segment 200 abuts against the adjacent connecting column 3.

[0099] The implementation principle of the preparation method of the multi-conducting elastic implant electrode in embodiment 2 is as follows:

[0100] The blocking section 200 and the plurality of electrode sections 101 are sequentially sleeved on the mandrel 300. Specifically, when the electrode section 101 is installed, the mandrel 300 is inserted into the first insertion hole 22 of the connecting column 3, the electrode ring 1 is sleeved on the connecting column 3, the mandrel 300 is inserted into the second insertion hole 31 of the clamping column 2, the wire 4 connected with the electrode ring 1 is led out from the perforation 21 of the clamping column 2, and each electrode section 101 is sequentially installed. The wire 4 connected with each electrode ring 1 is sequentially led out from the perforation 21 of each clamping column 2. The heat shrink tube is sleeved on the blocking section 200 and the plurality of electrode sections 101, the heat shrink tube is heated, the heat shrink tube is shrunk to extrude the plurality of electrode sections 101, the connecting column 3 and the adjacent clamping column 2 / blocking section 200 are tightly attached, and the connecting column 3 and the clamping column 2 / blocking section 200 are hot-melt connected, so as to ensure the connecting strength between the connecting column 3 and the clamping column 2 / blocking section 200 and the clamping strength of the electrode ring 1. After cooling and fixing, the mandrel 300 is taken out, and the heat shrink tube is peeled off. The end of the blocking section 200 away from the electrode section 101 is heated to be hot-melt sealed, and the implant section of the implant electrode is obtained. The clamping column 2 and the connecting column 3 are flexible, and relative to the glue filling into the electrode ring 1, the flexibility of the implant electrode as a whole can be improved, and the adaptability of the product implanted in the body can be effectively improved.

[0101] The above are preferred embodiments of the present application, and do not limit the protection scope of the present application. Therefore, equivalent changes made on the basis of the structure, shape, and principle of the present application should be covered within the protection scope of the present application.

Claims

1. A multi-conductivity elastic implantable electrode, characterized in that, The electrode body (100) includes multiple electrode segments (101), each of which includes an electrode ring (1), a clamping post (2) made of flexible material, and a connecting post (3). The electrode ring (1) is sleeved on the connecting post (3). The multiple electrode segments (101) are arranged such that the clamping post (2) and the connecting post (3) are arranged alternately and fixedly connected. Two adjacent clamping posts (2) clamp the electrode ring (1), and the electrode ring (1) and the clamping post (2) are sealed together. The clamping post (2) has a through hole (21) that passes through both ends. Each electrode ring (1) is electrically connected to a wire (4), and the free end of each wire (4) passes through the through hole (21) and is located on the same side of the electrode body (100). The clamping post (2) is provided with a first insertion hole (22) that penetrates both ends, and the connecting post (3) is provided with a second insertion hole (31) that penetrates both ends and is opposite to the first insertion hole (22). Both the first insertion hole (22) and the second insertion hole (31) are for inserting the mandrel (300).

2. The multi-conductivity elastic implantable electrode according to claim 1, characterized in that, It also includes a blocking section (200), one end of the electrode body (100) is an implantation end (102), the blocking section (200) is fixedly connected to the implantation end (102) to block the implantation end (102), and cooperates with the clamping post (2) at the far end of the implantation end (102) to clamp the electrode ring (1) at the far end of the implantation end (102).

3. The multi-conductivity elastic implantable electrode according to claim 1, characterized in that, The perforation (21) is provided in multiple ways, and the multiple perforations (21) are distributed at intervals around the connecting post (3). The multiple perforations (21) correspond one-to-one with the wire (4); and / or, the clamping post (2) and the connecting post (3) are both made of thermoplastic material.

4. The multi-conductivity elastic implantable electrode according to claim 1, characterized in that, The first insertion hole (22) is located at the center of the clamping post (2); and / or, each of the first insertion holes (22) and each of the second insertion holes (31) are the same size and are coaxially arranged.

5. The multi-conductivity elastic implantable electrode according to claim 1, characterized in that, One end of the wire (4) is connected to a terminal (5), which is adapted to the inner side of the electrode ring (1) and is electrically connected to the electrode ring (1).

6. A method for preparing a multi-conductivity elastic implantable electrode as described in any one of claims 1 to 5, characterized in that, Includes the following steps: Multiple electrode segments (101) are provided, each of which includes an electrode ring (1), a clamping post (2) made of flexible material, and a connecting post (3); each electrode ring (1) is electrically connected to a wire (4), and a through hole (21) is opened on the clamping post (2) to penetrate both ends. Insertion holes are made on both the clamping post (2) and the connecting post (3); each electrode ring (1) is sleeved on the corresponding connecting post (3), and multiple electrode segments (101) are arranged in sequence, so that multiple clamping posts (2) and multiple connecting posts (3) are arranged alternately, and the free ends of each wire (4) are passed out from the through hole (21); a mandrel (300) is provided, and the mandrel (300) is inserted into the insertion holes of the clamping post (2) and the connecting post (3) in sequence; The clamping post (2) and the adjacent connecting post (3) and the electrode ring (1) are in contact; the free ends of each of the wires (4) are located on the same side of the plurality of electrode segments (101); and each of the clamping posts (2) and the adjacent connecting post (3) are fixedly connected.

7. The method for preparing a multi-conductivity elastic implantable electrode according to claim 6, characterized in that, It also includes providing a sealing segment (200) arranged on one side of the plurality of electrode segments (101) with the end of the connecting post (3); and fixing the sealing segment (200) to the adjacent connecting post (3).

8. The method for preparing a multi-conductivity elastic implanted electrode according to claim 7, characterized in that, The process of fixing the sealing segment (200) to the adjacent connecting post (3) and fixing each clamping post (2) to the adjacent connecting post (3) includes the following steps: providing heat shrink tubing and sleeved the heat shrink tubing on the plurality of electrode segments (101) and the sealing segment (200), wherein the sealing segment (200), clamping post (2) and connecting post (3) are all made of thermoplastic material; heating the contact surfaces of the heat shrink tubing, the sealing segment (200) and the adjacent connecting post (3), and the contact surfaces of each clamping post (2) and the adjacent connecting post (3) to fix the sealing segment (200) to the adjacent connecting post (3) and fix each connecting post (3) to the adjacent clamping post (2); and removing the heat shrink tubing after cooling.

Images