Stimulation electrode intermediates, stimulation electrode manufacturing method and stimulation electrode

Abstract

This application relates to an intermediate material for a stimulation electrode, a method for manufacturing a stimulation electrode, and a stimulation electrode. The intermediate material includes: a carrier tube with multiple wire-feeding channels, each wire-feeding channel completely penetrating the carrier tube along its axial direction; multiple guide wires, each corresponding to a wire-feeding channel; and multiple sheet-like contacts, any two sheet-like contacts spaced apart. Each sheet-like contact is constrained on the carrier tube and fixedly connected to a different guide wire. Using this intermediate material to manufacture a stimulation electrode reduces the complexity and difficulty of the manufacturing process, thereby improving production efficiency.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a stimulation electrode intermediate, a stimulation electrode manufacturing method and a stimulation electrode. BACKGROUND

[0002] Electrical stimulation therapy is a mature therapy for treating diseases by implanting a stimulation electrode to apply an electrical pulse to a specific target nerve, which is widely used in diseases such as Parkinson's disease, essential tremor, dystonia, epilepsy, refractory obsessive-compulsive disorder and refractory depression. Specifically, the stimulation electrode includes a carrier tube and a contact, the stimulation electrode applies an electrical pulse to the target nerve through the contact, and the carrier tube serves to carry the contact. The traditional contact is annular, which is sleeved on the carrier tube. When the contact applies an electrical pulse, the stimulation current spreads uniformly in all directions in a spherical shape, which will cause the nerves near the target nerve to be affected by the stimulation current, resulting in side effects such as speech disorders and muscle cramps, forcing the doctor to reduce the stimulation intensity, affecting the efficacy.

[0003] In a new generation of stimulation electrodes, the contact is designed in a sheet shape, and multiple contacts are distributed around the circumference of the carrier tube. Due to the blocking of the carrier tube, the stimulation current generated by the contact can only spread in a local area. In other words, the stimulation current generated by the contact in the new generation of stimulation electrodes spreads only in a specific area, which is beneficial to realize directional focusing of the stimulation current on the target nerve and prevent the nerves near the target nerve from being affected by the stimulation current to produce side effects.

[0004] In order to realize independent control of each contact, each contact is fixedly connected with a guide wire, and the guide wire is used to conduct current to the contact.

[0005] At present, the method for manufacturing a stimulation electrode with a sheet-shaped contact is as follows: first, a plurality of sheet-shaped contacts are processed and manufactured, then the sheet-shaped contacts are respectively welded to different wires, and then the sheet-shaped contacts are fixed at different positions of a mold to form the stimulation electrode by a pouring process. This manufacturing method needs to temporarily fix each sheet-shaped contact one by one when welding the guide wire, and after welding the guide wire, it is also necessary to fix each sheet-shaped contact one by one in the mold, so the manufacturing process is complicated, the manufacturing difficulty is large, and the production efficiency is low. SUMMARY

[0006] Therefore, it is necessary to provide a stimulation electrode intermediate, a stimulation electrode manufacturing method and a stimulation electrode in view of the above problems.

[0007] In order to solve the above problems, the technical scheme of the present application is as follows:

[0008] A stimulation electrode intermediate, the stimulation electrode intermediate comprising:

[0009] A carrier tube is provided with a plurality of wire passing channels, each of which extends through the carrier tube along its axial direction;

[0010] A plurality of guide wires are provided, each of which is arranged in one of the wire passing channels and extends through the corresponding wire passing channel;

[0011] A plurality of sheet contacts are arranged in pairs of two, each of which is fixed to one of the guide wires and is limited to the carrier tube.

[0012] The stimulation electrode intermediate body has at least the following advantages:

[0013] In the process of manufacturing the stimulation electrode intermediate body, each of the guide wires is arranged in one of the wire passing channels and each of the sheet contacts is limited to the carrier tube. Then, each of the guide wires is pulled out of the corresponding wire passing channel and is fixed to the corresponding sheet contact.

[0014] On the basis of the stimulation electrode intermediate body, the stimulation electrode intermediate body can be placed in a mold and be filled with a material to form a stimulation electrode.

[0015] In summary, in the process of manufacturing the stimulation electrode using the stimulation electrode intermediate body, the stimulation electrode intermediate body is fixed to the mold, and each of the sheet contacts does not need to be fixed to the mold. Therefore, the stimulation electrode manufactured using the stimulation electrode intermediate body can reduce the complexity and difficulty of the manufacturing process and can improve the production efficiency.

[0016] In one embodiment, the carrier tube comprises a small-diameter portion and a large-diameter portion, the wire passing channels in the large-diameter portion are circumferentially closed wire holes, the wire passing channels in the small-diameter portion are wire grooves that extend through the outer circumference of the small-diameter portion, each of the guide wires is configured to extend out of the wire groove along the radial direction of the small-diameter portion, and each of the sheet contacts is limited to the small-diameter portion.

[0017] In this way, the guide wire is conveniently pulled out of the wire slot and fixed to the corresponding sheet-shaped contact. It is worth mentioning that the wire slot is a circumferentially closed space, and the wire slot is a relatively open space. The guide wire is relatively easy to pass through the wire slot, and it is relatively difficult to pass through the wire slot. Therefore, compared with the technical solution in which the wire channel is entirely composed of circumferentially closed wire slots, the technical solution provided by the present application, in which the wire channel is partially composed of wire slots, can shorten the wire slot, thereby facilitating the guide wire to pass through the wire channel. Moreover, each guide wire is inserted into the corresponding wire channel one by one. In the embodiment in which the carrier tube is an elastic member, after each guide wire is inserted, the carrier tube may be deformed slightly. When a large number of guide wires are inserted into some wire channels, the deformation of the carrier tube has accumulated to a large extent, causing the wire slots that are not inserted with guide wires to be squeezed. The squeezing of the wire slots increases the difficulty of the guide wire passing through the wire slots. The technical solution provided by the present application, in which the wire channel is partially composed of wire slots, can shorten the wire slot, and the distance of the guide wire in the wire slot is shortened, which is conducive to reducing the difficulty of the guide wire passing through the wire slot.

[0018] In one embodiment, the stimulation electrode intermediate body further comprises a plurality of connecting bridges, and the plurality of connecting bridges and the plurality of sheet-shaped contacts are integrally formed to form a sheet-shaped contact intermediate body; the sheet-shaped contact intermediate body is tightly sleeved on the small-diameter portion; in the same sheet-shaped contact intermediate body, any two adjacent sheet-shaped contacts are arranged at intervals in the circumferential direction of the small-diameter portion and are fixedly connected by the connecting bridges.

[0019] In this way, during the manufacturing process of the stimulation electrode intermediate body, only the sheet-shaped contact intermediate body needs to be integrally manufactured, and each sheet-shaped contact does not need to be positioned one by one. Then, the sheet-shaped contact intermediate body is sleeved on the small-diameter portion, and the sheet-shaped contact intermediate body is rotated to position each sheet-shaped contact at a suitable position, without the need to position each sheet-shaped contact at a suitable position one by one.

[0020] On the basis of the stimulation electrode intermediate body with the sheet-shaped contact intermediate body, the stimulation electrode can be manufactured by first performing a first pouring on the stimulation electrode intermediate body, filling the gap between any two adjacent sheet-shaped contacts with the insulating pouring material, and demolding after the pouring material solidifies. At this time, any two adjacent sheet-shaped contacts are also fixed together through the pouring material solidified therebetween, and after the pouring material in each wire slot and the gap between any two adjacent sheet-shaped contacts solidifies, each sheet-shaped contact is reliably fixed on the small-diameter portion. Then, at least a part of each connecting bridge is removed to electrically isolate any two sheet-shaped contacts from each other, to obtain a stimulation electrode semi-finished product. In this process, because at least a part of the connecting bridge is removed, a gap without being filled appears between the two adjacent sheet-shaped contacts. Then, a second pouring is performed on the stimulation electrode semi-finished product, filling the gap between any two adjacent sheet-shaped contacts with the insulating pouring material, and demolding after the pouring material solidifies to obtain a stimulation electrode finished product. In the stimulation electrode finished product, the gap between any two adjacent sheet-shaped contacts is filled with the insulating pouring material, and the electrically conductive substance such as the tissue fluid of the human body cannot enter between the two adjacent sheet-shaped contacts, and each sheet-shaped contact is independently controllable.

[0021] In the process of manufacturing the stimulation electrode by using the stimulation electrode intermediate body, only the stimulation electrode intermediate body needs to be fixed into the mold, and each sheet-shaped contact does not need to be fixed into the mold one by one.

[0022] In summary, the stimulation electrode manufactured by using the stimulation electrode intermediate body does not need to manufacture each sheet-shaped contact one by one, and does not need to fix each sheet-shaped contact into the mold one by one, but only needs to perform an operation on the sheet-shaped contact intermediate body after the sheet-shaped contact intermediate body is manufactured. Therefore, the stimulation electrode manufactured by using the stimulation electrode intermediate body can reduce the complexity and manufacturing difficulty of the stimulation electrode manufacturing process, and can improve the production efficiency.

[0023] Moreover, in the prior art, because each sheet-shaped contact is fixed into the mold one by one, the integrity of the whole composed of all the sheet-shaped contacts can be poor. In the embodiment shown in the figure, the plurality of sheet-shaped contacts are integrally manufactured into a sheet-shaped contact intermediate body, and in the process of manufacturing the stimulation electrode by using the above manufacturing method, the relative positions between the sheet-shaped contacts do not change, and therefore the integrity of the whole composed of all the sheet-shaped contacts in the same sheet-shaped contact intermediate body is good. In the case of containing a plurality of sheet-shaped contact intermediate bodies, because the sheet-shaped contact intermediate bodies are tightly sleeved on the carrier tube, the integrity of the whole composed of all the sheet-shaped contacts is still good.

[0024] In one of the embodiments, each of the sheet-shaped contacts is provided with a connecting channel, which penetrates the sheet-shaped contact completely along the radial direction of the small-diameter portion; the connecting channel on each of the sheet-shaped contacts is aligned with a different wire slot, and each of the wire is arranged in a different connecting channel and fixedly connected to the sheet-shaped contact.

[0025] In this way, on the one hand, when assembling the stimulation electrode intermediate body, the connecting channel and the wire slot play a positioning role, and the sheet-shaped contact intermediate body is rotated to the appropriate position when each connecting channel is aligned with the corresponding wire slot. On the other hand, the wire is also convenient to be fixedly connected with the sheet-shaped contact in the state of being arranged in the connecting channel.

[0026] In one of the embodiments, the connecting channel penetrates one end of the sheet-shaped contact along the axial direction of the small-diameter portion to form an opening, and the opening on each of the sheet-shaped contacts is aligned with a different wire slot.

[0027] In this way, the wire can enter the connecting channel through the opening, which is convenient for the wire to enter the connecting channel and be fixedly connected with the sheet-shaped contact.

[0028] In one of the embodiments, the stimulation electrode intermediate body further comprises a spacer made of elastic polymer material, which is sleeved on adjacent sheet-shaped contact intermediate bodies, and the spacer completely covers the side of each connecting bridge on the adjacent sheet-shaped contact intermediate bodies, which faces away from the small-diameter portion.

[0029] In this way, because the side of the connecting bridge, which faces away from the small-diameter portion, is completely covered by the spacer, the side of each connecting bridge, which faces away from the small-diameter portion, will not stick to the pouring material during the first pouring process, which avoids increasing the difficulty of the operation of removing at least a part of each connecting bridge. The spacer is made of elastic polymer material and is relatively easy to remove, for example, the spacer can be cut and then torn off. After the first demolding, the spacer is removed first, so that the side of the connecting bridge, which faces away from the small-diameter portion, is exposed, and then at least a part of the connecting bridge is removed.

[0030] In one of the embodiments, the spacer comprises an outer ring body and an inner ring body, the inner ring body extends from the inner wall of the outer ring body along the radial direction of the outer ring body; the inner wall of the inner ring body completely covers the outer periphery of the small-diameter portion, and the end face of the inner ring body completely covers each connecting bridge on adjacent sheet-shaped contact intermediate bodies, which is close to the end of the inner ring body; the outer ring body is sleeved on adjacent sheet-shaped contact intermediate bodies, and completely covers the side of each connecting bridge on adjacent sheet-shaped contact intermediate bodies, which faces away from the small-diameter portion.

[0031] In this way, the side of each connecting bridge opposite the small-diameter portion and the end of each connecting bridge close to the inner ring body are completely covered by the isolation piece. In the first pouring process, the side of each connecting bridge opposite the small-diameter portion and the end of each connecting bridge close to the inner ring body will not be adhered to the pouring material, facilitating the subsequent operation of "removing at least a portion of each connecting bridge". Moreover, after the isolation piece is removed, the tool (for example, a sharp blade or a grinding wheel) used for the operation of "removing at least a portion of each connecting bridge" can be inserted into the space originally occupied by the isolation piece, so that the operation of "removing at least a portion of each connecting bridge" can be performed at the best angle, which is conducive to quickly and efficiently completing the operation of "removing at least a portion of each connecting bridge".

[0032] In one of the embodiments, each of the sheet-shaped contacts includes an exposed portion and a buried portion; along the radial direction of the small-diameter portion, the exposed portion protrudes from the buried portion; along the axial direction of the small-diameter portion, the buried portion protrudes from the exposed portion; the two ends of each of the connecting bridges are fixed to the buried portions of two of the sheet-shaped contacts, respectively; and the isolation piece is sleeved on the buried portions, and the exposed portions are all located outside the isolation piece.

[0033] In this way, the exposed portions will not be damaged in the processes of removing the isolation piece and removing at least a portion of each connecting bridge.

[0034] In one of the embodiments, a plurality of sheet-shaped contact intermediates are provided, one isolation piece is arranged between any two adjacent sheet-shaped contact intermediates, and the two ends of any one of the isolation pieces between two adjacent sheet-shaped contact intermediates are in contact with the end faces of the exposed portions on the adjacent two sheet-shaped contact intermediates, respectively.

[0035] In this way, the isolation piece also plays a positioning role, which can ensure that the distance between the two adjacent sheet-shaped contact intermediates remains unchanged. This makes it unnecessary for the stimulation electrode intermediate to provide an additional structure for ensuring that the distance between the two adjacent sheet-shaped contact intermediates remains unchanged, which is conducive to simplifying the structure of the stimulation electrode intermediate, reducing the assembly steps of the stimulation electrode intermediate, and further improving the production efficiency of the stimulation electrode.

[0036] The present application also provides a first stimulation electrode manufacturing method based on the stimulation electrode intermediate described above, which contains sheet-shaped contact intermediates but does not contain isolation pieces. The first stimulation electrode manufacturing method includes the following steps:

[0037] The stimulation electrode intermediate is subjected to a first pouring process, so that the insulating pouring material fills the wire grooves and the gaps between any two adjacent sheet-shaped contacts. After the pouring material is solidified, the stimulation electrode intermediate is demolded.

[0038] remove at least a part of each connecting bridge to electrically isolate any two sheet contacts from each other, to obtain a stimulation electrode semi-finished product;

[0039] perform a second infusion on the stimulation electrode semi-finished product to fill the gap between any two adjacent sheet contacts with the insulating infusion material, and demold after the infusion material solidifies.

[0040] The first stimulation electrode manufacturing method has at least the following beneficial effects:

[0041] In the first stimulation electrode manufacturing method, it is not necessary to manufacture each sheet contact one by one, nor is it necessary to fix each sheet contact one by one into the mold, but only to fix the stimulation electrode intermediate into the mold. Therefore, the first stimulation electrode manufacturing method can reduce the complexity and difficulty of the manufacturing process, and can improve the production efficiency.

[0042] Moreover, in the prior art, because each sheet contact is fixed into the mold one by one, the integrity of the whole formed by all the sheet contacts can be poor. In the stimulation electrode intermediate relied on by the first stimulation electrode manufacturing method, the plurality of sheet contacts are integrally manufactured into a sheet contact intermediate, and the relative positions between the sheet contacts do not change during the process of manufacturing the stimulation electrode by using the first stimulation electrode manufacturing method. Therefore, the integrity of the whole formed by all the sheet contacts in the same sheet contact intermediate is good. In the case of containing a plurality of sheet contact intermediates, because the sheet contact intermediates are tightly sleeved on the carrier tube, the integrity of the whole formed by all the sheet contacts is still good.

[0043] The present application also provides a second stimulation electrode manufacturing method, which is based on the above-mentioned stimulation electrode intermediate containing sheet contact intermediates and isolation pieces, and includes the following steps:

[0044] perform a first infusion on the stimulation electrode intermediate to fill each of the wire grooves and the gap between any two adjacent sheet contacts with the insulating infusion material, and demold after the infusion material solidifies;

[0045] remove all of the isolation pieces;

[0046] remove at least a part of each connecting bridge to electrically isolate any two sheet contacts from each other, to obtain a stimulation electrode semi-finished product;

[0047] perform a second infusion on the stimulation electrode semi-finished product to fill the gap between any two adjacent sheet contacts with the insulating infusion material, and demold after the infusion material solidifies.

[0048] The second stimulation electrode manufacturing method has at least the following beneficial effects:

[0049] In the second stimulation electrode manufacturing method, it is not necessary to manufacture each sheet-shaped contact one by one, nor to fix each sheet-shaped contact to the mold one by one, but only to fix the stimulation electrode intermediate to the mold. Therefore, the second stimulation electrode manufacturing method can reduce the complexity and difficulty of the manufacturing process, and can improve the production efficiency. Moreover, in the second stimulation electrode manufacturing method, because the spacer completely covers the side of each connecting bridge on the adjacent sheet-shaped contact intermediate opposite to the carrier tube, in the first perfusion process of the stimulation electrode intermediate, the side of each connecting bridge opposite to the carrier tube will not stick to the perfusion material, which facilitates the subsequent removal of at least part of the connecting bridge.

[0050] Moreover, in the prior art, because each sheet-shaped contact is fixed to the mold one by one, the integrity of the whole composed of all the sheet-shaped contacts may be poor. In the present application, a plurality of sheet-shaped contacts are integrally manufactured into a sheet-shaped contact intermediate, and the relative positions between the sheet-shaped contacts will not change during the manufacturing of the stimulation electrode by the second stimulation electrode manufacturing method. Therefore, the integrity of the whole composed of all the sheet-shaped contacts in the same sheet-shaped contact intermediate is good. In the case of containing a plurality of sheet-shaped contact intermediates, because the sheet-shaped contact intermediates are closely sleeved on the carrier tube, the integrity of the whole composed of all the sheet-shaped contacts is still good.

[0051] The present application also provides a stimulation electrode manufactured by the above-mentioned first stimulation electrode manufacturing method or the second stimulation electrode manufacturing method.

[0052] The stimulation electrode has at least the following beneficial effects:

[0053] Because the stimulation electrode is manufactured by the above-mentioned stimulation electrode manufacturing method, it is not necessary to manufacture each sheet-shaped contact one by one, nor to fix each sheet-shaped contact to the mold one by one, which reduces the complexity and difficulty of the manufacturing process, and makes the production efficiency of the stimulation electrode higher. Moreover, a plurality of sheet-shaped contacts are integrally manufactured into a sheet-shaped contact intermediate, and the relative positions between the sheet-shaped contacts will not change during the manufacturing of the stimulation electrode by the above-mentioned stimulation electrode manufacturing method. Therefore, the integrity of the whole composed of all the sheet-shaped contacts in the same sheet-shaped contact intermediate is good. In the case of containing a plurality of sheet-shaped contact intermediates, because the sheet-shaped contact intermediates are closely sleeved on the carrier tube, the integrity of the whole composed of all the sheet-shaped contacts is still good. BRIEF DESCRIPTION OF DRAWINGS

[0054] Figure 1 A perspective view of a stimulation electrode intermediate according to an embodiment of the present application;

[0055] Figure 2 for Figure 1 Enlarged view of point A in the middle;

[0056] Figure 3 for Figure 1 A three-dimensional schematic diagram of the stimulation electrode intermediate body after the isolation component is hidden.

[0057] Figure 4 for Figure 3 Enlarged view of point B in the middle;

[0058] Figure 5 for Figure 1 A three-dimensional schematic diagram of the load-bearing pipe;

[0059] Figure 6 for Figure 5 Enlarged view of point C in the middle;

[0060] Figure 7 For axial observation along the small diameter section Figure 6 The view obtained from the carrier tube shown;

[0061] Figure 8 for Figure 1 A schematic diagram of the intermediate of the stimulation electrode shown.

[0062] Figure 9 for Figure 8 Enlarged view of point D in the middle;

[0063] Figure 10 for Figure 9 Enlarged view of point E in the middle;

[0064] Figure 11 for Figure 9 A three-dimensional schematic diagram of the intermediate body of the plate-shaped contact;

[0065] Figure 12 This is a perspective view of a sheet-like contact intermediate according to another embodiment of this application;

[0066] Figure 13 This is a schematic diagram showing the connection relationship between the sheet-like contact intermediate and the developing element in another embodiment of this application;

[0067] Figure 14 This is a perspective view of the isolation member according to another embodiment of this application;

[0068] Figure 15 for Figure 14 The longitudinal section view of the isolation component shown;

[0069] Figure 16 For based on Figure 1 An exploded view of the stimulation electrode made from the stimulation electrode intermediate shown.

[0070] Figure 17 for Figure 16 an enlarged view of F in FIG. 1;

[0071] Figure 18 for Figure 17 an enlarged view of G in FIG. 1.

[0072] Reference Signs:

[0073] 1, carrier tube; 11, small-diameter portion; 12, large-diameter portion; 13, wire running passage; 131, wire running hole; 132, wire running groove; 2, wire guide; 3, sheet-shaped contact intermediate body; 31, sheet-shaped contact; 311, exposed portion; 312, embedded portion; 313, connection passage; 3131, opening; 32, connection bridge; 4, spacer; 41, outer ring body; 42, inner ring body; 5, ring-shaped contact; 6, end body; 7, developing member. DETAILED DESCRIPTION

[0074] In order to make the above objectives, features and advantages of the present application more apparent, specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. It will be apparent, however, to one skilled in the art that the present application can be practiced in a variety of ways beyond the specific embodiments described herein without departing from the spirit of the present application, and that the present application is not limited to the specific embodiments disclosed below.

[0075] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are merely for the purpose of facilitating the description of the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0076] In addition, the terms "first", "second", etc. are used only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second", etc. can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically limited.

[0077] In the present application, unless specifically defined otherwise and limited, the terms "mount", "connect", "connection", "fixed", and the like should be understood broadly, for example, can be fixed connection, can also be detachable connection, or integrated; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be the internal communication of two elements or the interaction relationship of two elements, unless otherwise specifically limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0078] In the present application, unless specifically defined otherwise and limited, the first feature is "on" or "under" the second feature. The first and second features can be in direct contact, or the first and second features can be indirectly contacted through an intermediate medium. Moreover, the first feature "above", "above" and "above" the second feature can be the first feature directly above or obliquely above the second feature, or only indicates that the first feature is higher than the second feature in horizontal height. The first feature "below", "below" and "below" the second feature can be the first feature directly below or obliquely below the second feature, or only indicates that the first feature is lower than the second feature in horizontal height.

[0079] It should be noted that when an element is referred to as "fixed to" or "provided on" another element, it can be directly on another element or there can be a middle element. When an element is considered to be "connected" to another element, it can be directly connected to another element or a middle element can exist at the same time. The terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used herein are for illustrative purposes only and are not the only embodiment.

[0080] Referring to Figures 1 to 11 , the present application first provides a stimulating electrode intermediate body, which comprises a carrier tube 1, a guide wire 2 and a plurality of sheet contacts 31.

[0081] Referring to Figure 6 , the carrier tube 1 is provided with a plurality of wire passing channels 13, each wire passing channel 13 completely penetrates the carrier tube 1 along the axial direction of the carrier tube 1. Referring to Figure 10 , the guide wire 2 is provided with a plurality of guide wires 2, and the guide wire 2 is provided one by one with the wire passing channel 13, and each guide wire 2 is provided in the corresponding wire passing channel 13. Referring to Figure 4 and Figure 11 , any two sheet contacts 31 are spaced apart, and each sheet contact 31 is limited on the carrier tube 1 and is fixedly connected to different guide wires 2.

[0082] In the process of manufacturing the stimulating electrode intermediate, each wire 2 is threaded into the corresponding wire channel 13 one by one, and each sheet contact 31 is limited on the carrier tube 1. Then the wire 2 is pulled out of the wire channel 13 and fixed to the corresponding sheet contact 31.

[0083] On the basis of the stimulating electrode intermediate, the stimulating electrode intermediate can be put into a mold, and the stimulating electrode intermediate is perfused to form a stimulating electrode.

[0084] In summary, in the process of manufacturing the stimulating electrode by using the stimulating electrode intermediate, only the stimulating electrode intermediate needs to be fixed in the mold, and each sheet contact 31 does not need to be fixed in the mold. Therefore, the stimulating electrode manufactured by using the stimulating electrode intermediate can reduce the complexity and difficulty of the manufacturing process, and can improve the production efficiency.

[0085] In some embodiments, the wire 2 is welded to the contact.

[0086] In other embodiments, the wire 2 is bonded to the contact. For example, the wire 2 and the contact are bonded by a light-cured adhesive, and after UV curing, the wire 2 and the contact are fixed together.

[0087] Preferably, the carrier tube 1 is an elastic member. For example, the carrier tube 1 is made of polyurethane or silicone.

[0088] In some embodiments, the carrier tube 1 can also be a rigid member.

[0089] Referring to Figure 6 and Figure 9 , the carrier tube 1 includes a small-diameter portion 11 and a large-diameter portion 12. The small-diameter portion 11 is a section of the carrier tube 1 with a smaller diameter, and the large-diameter portion 12 is a section of the carrier tube 1 with a larger diameter. The part of the wire channel 13 located in the large-diameter portion 12 is a circumferentially closed wire hole 131, and the part of the wire channel 13 located in the small-diameter portion 11 is a wire groove 132, which penetrates the outer circumference of the small-diameter portion 11. Each wire 2 is configured to extend radially out of the wire groove 132 along the small-diameter portion 11. Referring to Figure 4 and Figure 11, each sheet-shaped contact 31 is limited on the small-diameter part 11. In this way, the guide wire 2 is conveniently pulled out from the wire slot 132 and fixed on the corresponding sheet-shaped contact 31. It is worth mentioning that the wire hole 131 is a circumferentially closed space, and the wire slot 132 is a relatively open space. The guide wire 2 is relatively easy to pass through the wire hole 131, but relatively difficult to pass through the wire slot 132. Therefore, compared with the technical solution in which the wire passage 13 is entirely composed of circumferentially closed wire holes 131, the technical solution provided by the present application in which the wire passage 13 is partially composed of wire slots 132 can shorten the wire hole 131, thereby facilitating the guide wire 2 to pass through the wire passage 13. Moreover, each guide wire 2 is sequentially passed through the corresponding wire passage 13, and in the embodiment in which the carrier tube 1 is an elastic member, after each guide wire 2 is passed through, the carrier tube 1 may be deformed slightly. When a large number of guide wires 2 are passed through some wire passages 13, the deformation of the carrier tube 1 has accumulated to a large extent, causing the wire hole 131 that is not passed through by the guide wire 2 to be squeezed. The squeezing of the wire hole 131 increases the difficulty of the guide wire 2 passing through the wire hole 131. The technical solution provided by the present application in which the wire passage 13 is partially composed of wire slots 132 can shorten the wire hole 131, and the distance of the guide wire 2 in the wire hole 131 is shortened, which is conducive to reducing the difficulty of the guide wire 2 passing through the wire hole 131.

[0090] In some embodiments, the sheet-shaped contact 31 can be partially embedded in the small-diameter part 11 to limit the sheet-shaped contact 31 on the small-diameter part 11.

[0091] Referring to Figure 4 , Figure 9 and Figure 11 , the stimulation electrode intermediate body further comprises a plurality of connecting bridges 32, and the plurality of connecting bridges 32 and the plurality of sheet-shaped contacts 31 are integrally formed to constitute a sheet-shaped contact intermediate body 3. The sheet-shaped contact intermediate body 3 is tightly sleeved on the small-diameter part 11. In the same sheet-shaped contact intermediate body 3, any two adjacent sheet-shaped contacts 31 are arranged at intervals in the circumferential direction of the small-diameter part 11 and are fixedly connected by the connecting bridge 32. In this way, during the manufacturing of the stimulation electrode intermediate body, only the sheet-shaped contact intermediate body 3 needs to be integrally manufactured, and each sheet-shaped contact 31 does not need to be positioned at a suitable position one by one. After the sheet-shaped contact intermediate body 3 is sleeved on the small-diameter part 11 and the sheet-shaped contact intermediate body 3 is rotated, each sheet-shaped contact 31 can be positioned at a suitable position, and each sheet-shaped contact 31 does not need to be positioned at a suitable position one by one.

[0092] On the basis of the stimulating electrode intermediate body with the sheet-shaped contact intermediate body 3, the stimulating electrode can be manufactured by first performing a first infusion on the stimulating electrode intermediate body, so that the insulating infusion material fills up the gap between each wire slot 132 and any two adjacent sheet-shaped contacts 31, and after the infusion material is solidified, the stimulating electrode intermediate body is demolded. At this time, any two adjacent sheet-shaped contacts 31 are also fixed together through the infusion material solidified between the two, and after the infusion material in each wire slot 132 and the infusion material in the gap between any two adjacent sheet-shaped contacts 31 are solidified, each sheet-shaped contact 31 is reliably fixed on the small-diameter portion 11. Then, at least a part of each connecting bridge 32 is removed to electrically isolate any two sheet-shaped contacts 31 from each other, so that a stimulating electrode semi-finished product is obtained. In this process, because at least a part of the connecting bridge 32 is removed, a gap without being filled appears between the two adjacent sheet-shaped contacts 31. Then, a second infusion is performed on the stimulating electrode semi-finished product, so that the insulating infusion material fills up the gap between any two adjacent sheet-shaped contacts 31, and after the infusion material is solidified, the stimulating electrode semi-finished product is demolded to obtain a stimulating electrode finished product. In the stimulating electrode finished product, the gap between any two adjacent sheet-shaped contacts 31 is filled up with the insulating infusion material, and the electrically conductive substance (such as the tissue fluid of the human body) cannot enter between the two adjacent sheet-shaped contacts 31, and each sheet-shaped contact 31 is independently controllable.

[0093] It can be understood that, in the process of manufacturing the stimulating electrode by using the stimulating electrode intermediate body shown in Figure 9 , only the stimulating electrode intermediate body needs to be fixed into the mold, and each sheet-shaped contact 31 does not need to be fixed into the mold one by one.

[0094] In summary, in the process of manufacturing the stimulating electrode by using the stimulating electrode intermediate body shown in Figure 9 , each sheet-shaped contact 31 does not need to be manufactured one by one, and each sheet-shaped contact 31 does not need to be fixed into the mold one by one, and only the operation on the sheet-shaped contact intermediate body 3 needs to be performed after the sheet-shaped contact intermediate body 3 is manufactured. Therefore, in the process of manufacturing the stimulating electrode by using the stimulating electrode intermediate body shown in Figure 9 , the complexity and difficulty of the process of manufacturing the stimulating electrode can be reduced, and the production efficiency can be improved.

[0095] It is worth mentioning that, in the prior art, because each sheet-shaped contact 31 is fixed into the mold one by one, the integrity of the whole formed by all the sheet-shaped contacts 31 can be poor. However, in the process of manufacturing the stimulating electrode by using the stimulating electrode intermediate body shown in Figure 9In the shown embodiment, the plurality of sheet contacts 31 are integrally manufactured as one sheet contact intermediate body 3, and during the manufacturing of the stimulation electrode by using the above-mentioned manufacturing method, the relative positions between the sheet contacts 31 do not change, and thus the integrity of the whole of the sheet contacts 31 in the same sheet contact intermediate body 3 is good. In the case of containing a plurality of sheet contact intermediate bodies 3, because the sheet contact intermediate bodies 3 are closely sleeved on the carrier tube 1, the integrity of the whole of the sheet contacts 31 is still good.

[0096] For example, in the design of the stimulation electrode, the sheet contacts 31 are usually designed to be located on the same cylindrical surface. The prior art of fixing the sheet contacts 31 to the mold one by one is difficult to ensure that the sheet contacts 31 are located on the same cylindrical surface, and thus the integrity of the whole of the sheet contacts 31 is poor. In the shown embodiment, the sheet contact intermediate body 3 with the sheet contacts 31 located on the same cylindrical surface is easy to manufacture, and during the manufacturing of the stimulation electrode by using the above-mentioned manufacturing method, the relative positions between the sheet contacts 31 do not change, and thus the sheet contacts 31 in the same sheet contact intermediate body 3 are still located on the same cylindrical surface, and the integrity of the whole of the sheet contacts 31 in the same sheet contact intermediate body 3 is good. In the case of containing a plurality of sheet contact intermediate bodies 3, because the sheet contact intermediate bodies 3 are closely sleeved on the carrier tube 1, the sheet contacts 31 are still located on the same cylindrical surface, and the integrity of the whole of the sheet contacts 31 is still good. Figure 9

[0097] Exemplarily, the operation of “removing at least a part of each connecting bridge 32” can be completed by one or a combination of more of mechanical cutting, laser cutting and grinding processes.

[0098] Preferably, the sheet contact intermediate body 3 is made of platinum-iridium alloy, which is conducive to the smooth completion of the operation of “removing at least a part of each connecting bridge 32”.

[0099] Optionally, the sheet contact intermediate body 3 is made of gold, copper alloy or stainless steel.

[0100] Exemplarily, the sheet contact intermediate body 3 is provided with 2, 3, 4, 5, 6, 7, 8, 9 or 10 sheet contacts 31.

[0101] Referring to Figure 4 and Figure 11 ​Each of the sheet contacts 31 is provided with a connecting channel 313 which penetrates the sheet contact 31 completely along the radial direction of the small-diameter portion 11. The connecting channel 313 on each of the sheet contacts 31 is aligned with a different wire slot 132 respectively, and each of the wire 2 is arranged in a different connecting channel 313 and fixedly connected to the sheet contact 31. On one hand, when assembling the stimulating electrode intermediate, the connecting channel 313 and the wire slot 132 play a positioning role, and the sheet contact intermediate 3 is rotated to the appropriate position when each connecting channel 313 is aligned with the corresponding wire slot 132. On the other hand, the wire 2 is also convenient to be fixedly connected to the sheet contact 31 in the state of being arranged in the connecting channel 313.

[0102] Referring to Figure 4 and Figure 11 , the connecting channel 313 penetrates one end of the sheet contact along the axial direction of the small-diameter portion 11 to form an opening 3131, and the opening 3131 on each of the sheet contacts 31 is aligned with a different wire slot 132 respectively. In this way, the wire 2 can enter the connecting channel 313 through the opening 3131, which is convenient for the wire 2 to enter the connecting channel 313 and be fixedly connected to the sheet contact 31.

[0103] The operation of "removing at least a part of each connecting bridge 32" can cause burrs at the position of the connecting bridge 32. Referring to Figure 4 and Figure 11 , each sheet contact 31 has an exposed part 311, and the sheet contact 31 applies electrical stimulation through the exposed part 311. Along the radial direction of the small-diameter portion 11, the side of the exposed part 311 opposite to the small-diameter portion 11 is relatively far away from the small-diameter portion 11, and the side of the connecting bridge 32 opposite to the small-diameter portion 11 is relatively close to the small-diameter portion 11. In this way, during the above-mentioned second pouring process, it is only necessary to ensure that the pouring material is flush with the side of the exposed part 311 opposite to the small-diameter portion 11, and the position of the connecting bridge 32 is buried in the pouring material, even if the operation of "removing at least a part of each connecting bridge 32" causes burrs at the position of the connecting bridge 32, the burrs are located in the solidified pouring material and will not be exposed, so that the burrs can be prevented from damaging human tissues.

[0104] In some embodiments, the distance between any two adjacent sheet contacts 31 is between 0.08mm and 0.15mm, in other words, the distance between any two adjacent sheet contacts 31 is very small.

[0105] Referring to Figure 4 and Figure 11Each of the sheet-like contacts 31 has an exposed portion 311, and the sheet-like contacts 31 apply the electrical stimulation through the exposed portions 311. The size of the connecting bridges 32 is greater than the distance between any two adjacent exposed portions 311 along the circumferential direction of the small-diameter portion 11. In this way, the size of the connecting bridges 32 in the circumferential direction of the small-diameter portion 11 is relatively large, facilitating the operation of "removing at least a portion of each of the connecting bridges 32".

[0106] Referring to Figure 4 and Figure 11 Each of the sheet-like contacts 31 also includes a buried portion 312, which is arranged at one end of the exposed portion 311 in the axial direction of the small-diameter portion 11. In any two adjacent sheet-like contacts 31, the distance between the two adjacent buried portions 312 along the circumferential direction of the small-diameter portion 11 is greater than the distance between the two adjacent exposed portions 311. The two ends of each of the connecting bridges 32 are fixed to the two adjacent buried portions 312, respectively, and each of the connecting bridges 32 is arranged apart from the exposed portions 311. On the one hand, this makes the size of the connecting bridges 32 in the circumferential direction of the small-diameter portion 11 relatively large. On the other hand, this can prevent the exposed portions 311 from being damaged when at least a portion of each of the connecting bridges 32 is removed.

[0107] Preferably, the connecting channels 313 are arranged in the buried portions 312. The guide wire 2 can be fixedly connected to the walls of the connecting channels 313 or to the side of the buried portions 312 that faces away from the small-diameter portion 11.

[0108] Referring to Figure 4 and Figure 11 Each of the sheet-like contacts 31 has an exposed portion 311, and the sheet-like contacts 31 apply the electrical stimulation through the exposed portions 311. The thickness of each of the connecting bridges 32 is less than the thickness of the exposed portions 311. In this way, the connecting bridges 32 are relatively thin, facilitating the operation of "removing at least a portion of each of the connecting bridges 32".

[0109] It should be noted that the perfusion material is very hard after solidification, and if the side of the connecting bridges 32 that faces away from the small-diameter portion 11 is covered with the perfusion material, the operation of "removing at least a portion of each of the connecting bridges 32" will be much more difficult.

[0110] Referring to Figure 2 , Figure 9 , Figure 14 and Figure 15The stimulation electrode intermediate also includes a spacer 4 made of an elastic polymer material. The spacer 4 is fitted onto adjacent sheet-like contact intermediates 3, completely covering the side of each connecting bridge 32 on the adjacent sheet-like contact intermediates 3 that faces away from the small diameter portion 11. Because the side of the connecting bridge 32 facing away from the small diameter portion 11 is completely covered by the spacer 4, the side of each connecting bridge 32 facing away from the small diameter portion 11 will not stick to the injection material during the first injection process. This avoids increasing the difficulty of the operation of "removing at least a portion of each connecting bridge 32". The spacer 4 is made of an elastic polymer material and is relatively easy to remove; for example, the spacer 4 can be cut open and torn off. After the first demolding, the spacer 4 is removed first, thereby exposing the side of the connecting bridge 32 facing away from the small diameter portion 11, and then at least a portion of the connecting bridge 32 is removed.

[0111] For example, the spacer 4 is made of polyurethane, silicone, polyether block amide, or polyimide.

[0112] exist Figure 14 and Figure 15 In the illustrated embodiment, the isolator 4 includes an outer ring 41 and an inner ring 42, with the inner ring 42 extending radially from the inner wall of the outer ring 41. The inner wall of the inner ring 42 is completely fitted to the outer periphery of the small-diameter portion 11, and the end face of the inner ring 42 completely covers the end of each connecting bridge 32 on the adjacent sheet-like contact intermediate body 3 that is close to the inner ring 42. The outer ring 41 is fitted onto the adjacent sheet-like contact intermediate body 3 and completely covers the side of each connecting bridge 32 on the adjacent sheet-like contact intermediate body 3 that is away from the small-diameter portion 11. In this way, the side of the connecting bridge 32 away from the small-diameter portion 11 and the end close to the inner ring 42 are completely covered by the isolator 4. During the first filling process, the side of each connecting bridge 32 away from the small-diameter portion 11 and the end close to the inner ring 42 will not be covered by filling material, which facilitates the subsequent operation of "removing at least a portion of each connecting bridge 32". Moreover, after removing the spacer 4, the tools (e.g., sharp blades or grinding wheels) required for the operation of "removing at least a portion of each connecting bridge 32" can be inserted into the space originally occupied by the spacer 4, thereby performing the operation of "removing at least a portion of each connecting bridge 32" at the optimal angle, which is conducive to completing the operation of "removing at least a portion of each connecting bridge 32" quickly and efficiently.

[0113] Preferably, the inner ring 42 is interference-fitted onto the small diameter portion 11, and the outer ring 41 is interference-fitted onto the adjacent sheet-like contact intermediate body 3. In this way, the sheet-like contact intermediate body 3 is fixed to the small diameter portion 11 by the spacer 4.

[0114] In some embodiments, the inner ring body 42 is tightly sleeved on the small-diameter portion 11, and the two ends of the outer ring body 41 are tightly sleeved on the two sheet-shaped contact intermediates 3 respectively. In this way, the two sheet-shaped contact intermediates 3 are fixed on the small-diameter portion 11 by the isolation member 4, and the relative positions of the two sheet-shaped contact intermediates 3 remain unchanged. In other words, the isolation member 4 plays a fixing role.

[0115] Preferably, the outer ring body 41 and the inner ring body 42 are integrally formed.

[0116] Optionally, the outer ring body 41 is bonded to the inner ring body 42.

[0117] In the embodiment shown in Figure 9 In the embodiment shown in Figure 9 Preferably, in the embodiment shown in

[0118] Referring to Figure 4 , Figures 11 to 13 Each sheet-shaped contact 31 includes an exposed portion 311 and a buried portion 312. The exposed portion 311 protrudes from the buried portion 312 along the radial direction of the small-diameter portion 11. The buried portion 312 protrudes from the exposed portion 311 along the axial direction of the small-diameter portion 11. The two ends of each connecting bridge 32 are fixed to the buried portions 312 of the two sheet-shaped contacts 31 respectively. The isolation member 4 is sleeved on the buried portions 312, and the exposed portions 311 are all located outside the isolation member 4. In this way, the exposed portions 311 will not be damaged in the processes of removing the isolation member 4 and removing at least a part of each connecting bridge 32.

[0119] In the process of completing the two injections, the buried portions 312 can be completely covered by the injected material, so that in the finished stimulating electrode, only the exposed portions 311 of the sheet-shaped contacts 31 are exposed, and the current on the sheet-shaped contacts 31 is transmitted to the target nerve only through the exposed portions 311, that is, only the exposed portions 311 of the sheet-shaped contacts 31 are in contact with the human tissue. In the process of manufacturing the stimulating electrode, the exposed portions 311 will not be damaged, which can prevent the exposed portions 311 from scratching the human tissue.

[0120] Preferably, referring to Figure 11 , the connecting channel 313 is arranged on the buried portion 312.

[0121] Referring to Figures 11 to 13The side of the embedding portion 312 opposite to the small-diameter portion 11 is located on the same cylindrical surface as the side of the connecting bridge 32 opposite to the small-diameter portion 11. In this way, the inner wall of the outer ring body 41 can simultaneously fit the side of the embedding portion 312 opposite to the small-diameter portion 11 and the side of the connecting bridge 32 opposite to the small-diameter portion 11, which is conducive to achieving that the outer ring body 41 completely fits and covers the side of the connecting bridge 32 opposite to the small-diameter portion 11.

[0122] Referring to Figure 2 and Figure 9 The sheet-shaped contact intermediate bodies 3 are provided in plurality, and one spacer 4 is arranged between any two adjacent sheet-shaped contact intermediate bodies 3, and the two ends of any one spacer 4 located between two adjacent sheet-shaped contact intermediate bodies 3 respectively fit the end faces of the exposed portions 311 on the two adjacent sheet-shaped contact intermediate bodies 3. In this way, the spacer 4 also plays a positioning role, and can ensure that the spacing between the two adjacent sheet-shaped contact intermediate bodies 3 remains unchanged. This makes it unnecessary for the stimulating electrode intermediate body to be provided with an additional structure for ensuring that the spacing between the two adjacent sheet-shaped contact intermediate bodies 3 remains unchanged, which is conducive to simplifying the structure of the stimulating electrode intermediate body, reducing the assembly steps of the stimulating electrode intermediate body, and further conducive to improving the production efficiency of the stimulating electrode.

[0123] Exemplarily, the stimulating electrode intermediate body includes 2, 3, 4, 5, 6, 7, 8, 9, or 10 sheet-shaped contact intermediate bodies 3.

[0124] Preferably, in the embodiments shown in Figure 14 and Figure 15 The two ends of the inner ring body 42 of any one spacer 4 located between two adjacent sheet-shaped contact intermediate bodies 3 respectively fit the end faces of the respective connecting bridges 32 on the two adjacent sheet-shaped contact intermediate bodies 3. The two ends of the outer ring body 41 of any one spacer 4 located between two adjacent sheet-shaped contact intermediate bodies 3 respectively fit the end faces of the exposed portions 311 on the two adjacent sheet-shaped contact intermediate bodies 3.

[0125] Preferably, in the embodiments shown in Figure 14 and Figure 15 The inner ring body 42 of any one spacer 4 located between two adjacent sheet-shaped contact intermediate bodies 3 is interference-fitted on the small-diameter portion 11, and the two ends of the outer ring body 41 of any one spacer 4 located between two adjacent sheet-shaped contact intermediate bodies 3 are respectively interference-fitted on the embedding portions 312 on the two adjacent sheet-shaped contact intermediate bodies 3.

[0126] Referring to Figure 11 and Figure 12Each sheet contact 31 comprises two embedded portions 312, and the two embedded portions 312 of each sheet contact 31 are respectively arranged at two ends of the exposed portion 311 in the axial direction of the carrier tube 1, and any one is located between the two adjacent sheet contact intermediates 3. The spacer 4 is respectively sleeved on the two adjacent embedded portions 312.

[0127] In Figure 11 and Figure 12 , any two adjacent sheet contacts 31 are fixedly connected by two connecting bridges 32, one of which is fixedly arranged between the two embedded portions 312 of the two adjacent sheet contacts 31 close to the large diameter portion 12, and the other is fixedly arranged between the two embedded portions 312 of the two adjacent sheet contacts 31 away from the large diameter portion 12.

[0128] In other embodiments, any two adjacent sheet contacts 31 can also be fixedly connected by only one connecting bridge 32.

[0129] Referring to Figure 2 and Figure 9 , the stimulating electrode intermediate body further comprises a ring contact 5, and the ring contact 5 is tightly sleeved on the small diameter portion 11. In this way, the stimulating electrode made of the stimulating electrode intermediate body contains both sheet contacts 31 and ring contacts 5, which makes the stimulating electrode not only provide omnidirectional stimulation, but also provide directional stimulation.

[0130] In some embodiments, the stimulating electrode intermediate body only comprises one kind of contact, which is the sheet contact 31, and all the sheet contacts 31 belong to the same sheet contact intermediate body 3. In these embodiments, one end of the sheet contact intermediate body 3 is arranged in abutment with the end face of the large diameter portion 12.

[0131] In some embodiments, the stimulating electrode intermediate body only comprises one kind of contact, which is the sheet contact 31, and all the sheet contacts 31 belong to the same sheet contact intermediate body 3. In these embodiments, one end of the sheet contact intermediate body 3 is arranged in abutment with the end face of the large diameter portion 12.

[0132] In Figure 2 and Figure 9In the illustrated embodiment, the stimulation electrode intermediate includes two annular contacts 5 and multiple sheet-like contact intermediates 3. All sheet-like contact intermediates 3 are located between the two annular contacts 5. Any sheet-like contact intermediate 3 is separated from an adjacent annular contact 5 or sheet-like contact intermediate 3 by a spacer 4. Both ends of each spacer 4 are respectively attached to an adjacent sheet-like contact intermediate 3 or annular contact 5. One end of one of the annular contacts 5 is attached to the end face of the large-diameter portion 12. During the first infusion process, a portion of the infusion material can flow to the annular contacts 5 away from the large-diameter portion 12. This portion of the infusion material bonds the annular contacts 5 away from the large-diameter portion 12 to the small-diameter portion 11. After this portion of the infusion material cures (this portion of the infusion material, after curing, forms...), the remaining material is used to further solidify the annular contacts 5. Figure 9 After the end body 6 shown, the annular contact 5, which is away from the large diameter portion 12, is fixed together with the small diameter portion 11.

[0133] Preferably, the annular contact 5 and end body 6, which are away from the large diameter portion 12, completely seal the end of the small diameter portion 11 away from the large diameter portion 12.

[0134] It can be manufactured in the following ways Figure 2 The stimulation electrode intermediate shown: First, the carrier tube 1, the annular contact 5, the sheet contact intermediate 3, and the separator 4 are manufactured one by one. Then, according to... Figure 2 In the order shown, each annular contact 5, each isolator 4, and each sheet contact intermediate 3 are sequentially fitted onto the small diameter portion 11, and they are moved toward the large diameter portion 12 along the axial direction of the small diameter portion 11 until they can no longer move toward the large diameter portion 12 along the axial direction of the small diameter portion 11.

[0135] In other embodiments, the annular contact 5 may be provided as one or as three or more. In these embodiments, the positional and connection relationships between the annular contact 5, the sheet contact intermediate 3, and the spacer 4 are as follows: Figure 2 The embodiments shown are the same.

[0136] Preferred options, please refer to Figure 2 Each sheet-like contact 31, on the side away from the small diameter portion 11, the outer periphery of each annular contact 5, and the outer periphery of each isolator 4 are all located on the same cylindrical surface as the outer periphery of the large diameter portion 12. During the two infusion processes, the inner wall of the mold is ensured to conform to the outer periphery of the intermediate body of the stimulation electrode, and the outer periphery of each sheet-like contact 31, on the side away from the small diameter portion 11, the outer periphery of each annular contact 5, the outer periphery of each isolator 4, and the outer periphery of the large diameter portion 12 are all in contact with the inner wall of the mold. Thus, the outer periphery of the finished stimulation electrode obtained after two infusions is a cylindrical surface, which facilitates the implantation of the stimulation electrode into the patient's body.

[0137] See Figure 13In some embodiments, a plurality of imaging members 7 are arranged on the stimulating electrode intermediate body, and the imaging members 7 are made of imaging material. One imaging member 7 is arranged on each sheet contact 31, and the imaging members 7 arranged on any two sheet contacts 31 in the same sheet contact intermediate body 3 are different in shape. These imaging members 7 can be displayed by using common imaging techniques such as MRI, CT, X-ray, fluorescence imaging, stereoscopic imaging, etc., so as to distinguish the positions and orientations of the sheet contacts 31.

[0138] Exemplarily, the imaging members 7 can be geometric figures, Arabic numerals or letters.

[0139] Preferably, the imaging members 7 are arranged on the embedding part 312.

[0140] The present application also provides a first stimulating electrode manufacturing method based on the stimulating electrode intermediate body containing the sheet contact intermediate body 3 but not containing the isolation member 4, and the stimulating electrode manufacturing method comprises the following steps:

[0141] S11. First pouring is performed on the stimulating electrode intermediate body, so that the insulating pouring material fills the wire slot 132 and the gap between any two adjacent sheet contacts 31, and the pouring material is demolded after being solidified.

[0142] S12. At least a part of each connecting bridge 32 is removed, so that any two sheet contacts 31 are electrically isolated from each other, and a stimulating electrode semi-finished product is obtained.

[0143] S13. Second pouring is performed on the stimulating electrode semi-finished product, so that the insulating pouring material fills the gap between any two adjacent sheet contacts 31, and the pouring material is demolded after being solidified.

[0144] In the first stimulating electrode manufacturing method, each sheet contact 31 does not need to be manufactured one by one, and each sheet contact 31 does not need to be fixed in the mold one by one, but only the stimulating electrode intermediate body needs to be fixed in the mold. Therefore, the first stimulating electrode manufacturing method can reduce the complexity and difficulty of the manufacturing process, and can improve the production efficiency.

[0145] It is worth mentioning that in the prior art, because each sheet contact 31 is fixed to the mold one by one, the integrity of the whole formed by all the sheet contacts 31 can be poor. In the stimulation electrode intermediate relied on by the first stimulation electrode manufacturing method, the plurality of sheet contacts 31 are integrally manufactured into a sheet contact intermediate 3, and during the manufacturing of the stimulation electrode by using the first stimulation electrode manufacturing method, the relative positions between the sheet contacts 31 will not change, and therefore the integrity of the whole formed by all the sheet contacts 31 in the same sheet contact intermediate 3 is good. In the case of containing a plurality of sheet contact intermediates 3, because the sheet contact intermediates 3 are closely sleeved on the carrier tube 1, the integrity of the whole formed by all the sheet contacts 31 is still good.

[0146] For example, in the design of the stimulation electrode, each sheet contact 31 is usually designed to be located on the same cylindrical surface. The prior art of fixing each sheet contact 31 to the mold one by one can hardly ensure that each sheet contact 31 is located on the same cylindrical surface, and therefore the integrity of the whole formed by all the sheet contacts 31 is poor. In the stimulation electrode intermediate relied on by the first stimulation electrode manufacturing method, the sheet contact intermediate 3 with each sheet contact 31 located on the same cylindrical surface is easy to manufacture, and during the manufacturing of the stimulation electrode by using the first stimulation electrode manufacturing method, the relative positions between the sheet contacts 31 will not change, and therefore all the sheet contacts 31 in the same sheet contact intermediate 3 are still located on the same cylindrical surface, and the integrity of the whole formed by all the sheet contacts 31 in the same sheet contact intermediate 3 is good. In the case of containing a plurality of sheet contact intermediates 3, because the sheet contact intermediates 3 are closely sleeved on the carrier tube 1, all the sheet contacts 31 are still located on the same cylindrical surface, and the integrity of the whole formed by all the sheet contacts 31 is still good.

[0147] Preferably, the step S11 comprises the following step: S111, during the first pouring of the stimulation electrode intermediate, ensuring that the side of each connecting bridge 32 facing away from the small-diameter portion 11 is completely attached to the inner wall of the mold. In this way, the side of the connecting bridge 32 facing away from the small-diameter portion 11 will not stick to the pouring material, and it is convenient to remove at least part of the connecting bridge 32 subsequently.

[0148] The present application also provides a second stimulation electrode manufacturing method, which is based on a stimulation electrode intermediate containing a sheet contact intermediate 3 and a spacer 4, and the stimulation electrode manufacturing method comprises the following steps:

[0149] S21, the stimulation electrode intermediate is subjected to first pouring, so that the insulating pouring material fills each wire slot 132 and the gap between any two adjacent sheet contacts 31, and after the pouring material is solidified, the mold is removed.

[0150] S22, remove all the separators 4.

[0151] S23, remove at least a part of each connecting bridge 32 to electrically isolate any two sheet contacts 31 from each other, and obtain a stimulation electrode semi-finished product.

[0152] S24, perform a second infusion on the stimulation electrode semi-finished product, so that the insulating infusion material fills the gap between any two adjacent sheet contacts 31, and then demold after the infusion material is solidified.

[0153] In the second stimulation electrode manufacturing method, it is not necessary to manufacture each sheet contact 31 one by one, nor to fix each sheet contact 31 one by one into the mold, but only to fix the stimulation electrode intermediate into the mold. Therefore, the second stimulation electrode manufacturing method can reduce the complexity and difficulty of the manufacturing process, and can improve the production efficiency. Moreover, in the second stimulation electrode manufacturing method, because the separator 4 completely covers the side of each connecting bridge 32 on the sheet contact intermediate 3 that faces away from the carrier tube 1, the side of each connecting bridge 32 that faces away from the carrier tube 1 will not stick to the infusion material during the first infusion of the stimulation electrode intermediate, making it easier to remove at least a part of the connecting bridge 32 later.

[0154] It is worth noting that in the prior art, because each sheet contact 31 is fixed into the mold one by one, the integrity of the whole formed by all the sheet contacts 31 may be poor. In the present application, a plurality of sheet contacts 31 are integrally manufactured into a sheet contact intermediate 3, and the relative positions between the sheet contacts 31 will not change during the manufacturing of the stimulation electrode using the second stimulation electrode manufacturing method. Therefore, the integrity of the whole formed by all the sheet contacts 31 in the same sheet contact intermediate 3 is good. In the case of containing a plurality of sheet contact intermediates 3, because the sheet contact intermediates 3 are tightly sleeved on the carrier tube 1, the integrity of the whole formed by all the sheet contacts 31 is still good.

[0155] In the case of the stimulation electrode intermediate shown in FIG. 1B, one specific step of the second stimulation electrode manufacturing method is as follows: Figure 2

[0156] S31, manufacture a mold, the inner wall of which is shaped and fitted to the outer periphery of the stimulation electrode intermediate shown in FIG. 1B; and Figure 2 S32, fix the stimulation electrode intermediate shown in FIG. 1B into the mold manufactured in S31. Figure 2 ​The intermediate stimulation electrode shown is placed into the mold, ensuring that the side of each sheet contact 31 facing away from the small diameter portion 11, the outer periphery of each annular contact 5, the outer periphery of each isolator 4, and the outer periphery of the large diameter portion 12 are completely in contact with the inner wall of the mold; an insulating potting material is injected into the mold, so that the insulating potting material fills the gap between each wire groove 132 and any two adjacent sheet contacts 31, and the mold is demolded after the potting material has solidified.

[0157] S32, Remove all isolation components 4.

[0158] S33. Remove at least a portion of each connecting bridge 32 to electrically isolate any two sheet contacts 31 from each other, thereby obtaining a semi-finished stimulation electrode.

[0159] S34. Manufacture a mold, the inner wall of which is consistent with... Figure 2 The outer periphery of the stimulation electrode intermediate shown is conformally adapted; the stimulation electrode semi-finished product is placed into the mold, ensuring that the side of each sheet contact 31 facing away from the small diameter portion 11, the outer periphery of each annular contact 5, the outer periphery of each separator 4, and the outer periphery of the large diameter portion 12 are completely in contact with the inner wall of the mold; insulating potting material is injected into the mold, so that the insulating potting material fills the gap between any two adjacent sheet contacts 31, the gap between any two sheet contact intermediates 3, and the gap between any group of adjacent sheet contact intermediates 3 and annular contacts 5; after the potting material has solidified, the mold is removed.

[0160] Preferably, the above-mentioned injection material is epoxy resin adhesive.

[0161] Alternatively, the above-mentioned injection material can also be silicone or polyurethane.

[0162] In the various stimulation electrode manufacturing methods described above, the operation of "removing at least a portion of each connecting bridge 32" can be accomplished by one or a combination of mechanical cutting, laser cutting, and grinding processes. The operation of "removing at least a portion of each connecting bridge 32" can be to remove only a portion of each connecting bridge 32, or to remove all of each connecting bridge 32.

[0163] In some embodiments, a cut can be made in the connecting bridge 32 along the axial direction of the small diameter portion 11 with a sharp blade, thereby forming a slit on the connecting bridge 32, which electrically isolates the two sheet-like contacts 31 at both ends of the connecting bridge 32 from each other.

[0164] In some embodiments, the connecting bridge 32 can be cut twice at different locations along the axial direction of the small diameter portion 11 with a sharp blade, and the portion of the connecting bridge 32 located between the two cuts is removed, thereby forming a larger gap on the connecting bridge 32, which allows the two sheet-like contacts 31 at both ends of the connecting bridge 32 to be electrically isolated from each other.

[0165] In some embodiments, the connection bridge 32 can be cut in two along the axial direction of the small-diameter portion 11 at two connection locations of the connection bridge 32 and the two sheet-shaped contacts 31 by separate blades, so as to completely cut off the connection bridge 32, and thus a large gap is formed between the two sheet-shaped contacts 31, which electrically isolates the two sheet-shaped contacts 31 from each other.

[0166] The sharp blade can be a graver.

[0167] With reference to Figures 16 to 18 The application also provides a stimulation electrode manufactured by the stimulation electrode manufacturing method. Since the stimulation electrode is manufactured by the stimulation electrode manufacturing method, each sheet-shaped contact 31 does not need to be manufactured and fixed into the mold one by one, and the complexity and difficulty of the manufacturing process are reduced, which makes the production efficiency of the stimulation electrode higher. Moreover, the plurality of sheet-shaped contacts 31 are integrally manufactured into one sheet-shaped contact intermediate body 3, and the relative positions between the sheet-shaped contacts 31 do not change during the manufacturing of the stimulation electrode by the stimulation electrode manufacturing method, so the integrity of the whole formed by all the sheet-shaped contacts 31 in the same sheet-shaped contact intermediate body 3 is better. In the case of containing a plurality of sheet-shaped contact intermediate bodies 3, the integrity of the whole formed by all the sheet-shaped contacts 31 is still better because the sheet-shaped contact intermediate bodies 3 are tightly sleeved on the carrier tube 1.

[0168] The technical features of the above-described embodiments can be combined in any manner. For the sake of brevity, not all possible combinations of the technical features in the above-described embodiments are described, but it should be understood that any combination of the technical features is within the scope of the present application as long as the combination does not result in contradictions.

[0169] The above-described embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it should not be understood as a limitation on the protection scope of the present application. It should be noted that, for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present application, and these are within the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the appended claims.

Claims

1. A stimulating electrode intermediate, characterized in that, The utility model relates to a kind of stimulation electrode intermediate body, including: Carrying pipe (1), it is equipped with multiple wire passing channels (13) on the carrying pipe (1), each wire passing channel (13) is along the axial direction of the carrying pipe (1) and completely penetrates the carrying pipe (1); Wire guide (2) is equipped with multiple wire guides;The wire guide (2) is set up one by one with the wire passing channel (13), and each wire guide (2) is set in the corresponding wire passing channel (13); Multiple sheet contacts (31), any two sheet contacts (31) are spaced apart;Each sheet contact (31) is limited on the carrying pipe (1) and is respectively fixedly connected with different wire guides (2); The carrying pipe (1) includes small-diameter part (11) and large-diameter part (12);The wire passing channel (13) is located in the part of the large-diameter part (12) as the wire passing hole (131) of circumferential closure, the wire passing channel (13) is located in the part of the small-diameter part (11) as wire groove (132), and the wire groove (132) penetrates the outer circle of the small-diameter part (11);Each wire guide (2) is configured to be able to extend the wire groove (132) along the radial direction of the small-diameter part (11), and each sheet contact (31) is limited in the small-diameter part (11); The stimulation electrode intermediate body further includes multiple connecting bridges (32), and the multiple connecting bridges (32) and the multiple sheet contacts (31) are integrally formed into a sheet contact intermediate body (3);The sheet contact intermediate body (3) is closely sleeved on the small-diameter part (11);In the same sheet contact intermediate body (3), any two adjacent sheet contacts (31) are spaced apart in the circumferential direction of the small-diameter part (11) and are fixedly connected by the connecting bridge (32); The stimulation electrode intermediate body further includes a spacer (4) made of an elastic polymer material, the spacer (4) is sleeved on adjacent sheet contact intermediate bodies (3), and each connecting bridge (32) on the adjacent sheet contact intermediate bodies (3) is completely attached and covered on the side away from the small-diameter part (11).

2. The stimulating electrode intermediate of claim 1, wherein, Each sheet contact (31) is provided with a connecting channel (313), and the connecting channel (313) completely penetrates the sheet contact (31) along the radial direction of the small-diameter part (11);The connecting channel (313) on each sheet contact (31) is respectively aligned with different wire grooves (132), and each wire guide (2) is set in different connecting channels (313) and fixedly connected to the sheet contact (31).

3. The stimulating electrode intermediate of claim 2, wherein, The connecting channel (313) penetrates one end of the sheet contact along the axial direction of the small-diameter part (11) to form an opening (3131), and the opening (3131) on each sheet contact (31) is respectively aligned with different wire grooves (132).

4. The stimulating electrode intermediate of claim 1, wherein, The spacer (4) comprises an outer ring body (41) and an inner ring body (42), the inner ring body (42) extends from the inner wall of the outer ring body (41) along the radial direction of the outer ring body (41); the inner wall of the inner ring body (42) is completely fitted with the outer periphery of the small-diameter part (11), and the end face of the inner ring body (42) completely covers each connecting bridge (32) on the adjacent sheet-shaped contact intermediate body (3) close to one end of the inner ring body (42); the outer ring body (41) is sleeved on the adjacent sheet-shaped contact intermediate body (3), and completely covers each connecting bridge (32) on the adjacent sheet-shaped contact intermediate body (3) away from the small-diameter part (11).

5. The stimulating electrode intermediate of claim 1 or claim 4, wherein, Each sheet-shaped contact (31) comprises an exposed part (311) and a buried part (312); along the radial direction of the small-diameter part (11), the exposed part (311) protrudes from the buried part (312); along the axial direction of the small-diameter part (11), the buried part (312) protrudes from the exposed part (311); both ends of each connecting bridge (32) are fixed to the buried parts (312) of two sheet-shaped contacts (31) respectively; the spacer (4) is sleeved on the buried part (312), and the exposed part (311) is located outside the spacer (4).

6. The stimulating electrode intermediate of claim 5, wherein, A plurality of sheet-shaped contact intermediate bodies (3) are provided, one spacer (4) is arranged between any two adjacent sheet-shaped contact intermediate bodies (3), and both ends of any spacer (4) located between two adjacent sheet-shaped contact intermediate bodies (3) are fitted with the end faces of the exposed parts (311) on the adjacent two sheet-shaped contact intermediate bodies (3).

7. A method of manufacturing a stimulating electrode based on the stimulating electrode intermediate according to any one of claims 1 to 6, characterized in that The method comprises the following steps: Firstly, the stimulation electrode intermediate body is poured to fill each wire slot (132) and the gap between any two adjacent sheet-shaped contacts (31) with insulating pouring material, and then the pouring material is demolded after solidification; All the spacers (4) are removed; At least a part of each connecting bridge (32) is removed to electrically isolate any two sheet-shaped contacts (31) from each other, thereby obtaining a stimulation electrode semi-finished product; Secondly, the stimulation electrode semi-finished product is poured to fill the gap between any two adjacent sheet-shaped contacts (31) with insulating pouring material, and then the pouring material is demolded after solidification.

8. A stimulating electrode, characterized by The stimulation electrode is manufactured by the method of claim 7. The stimulation electrode is manufactured by the method of claim 7.

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