Stimulating electrode intermediate, stimulating electrode manufacturing method, and stimulating electrode

Abstract

The invention relates to a stimulating electrode intermediate, a stimulating electrode manufacturing method and a stimulating electrode. The stimulating electrode intermediate comprises a bearing tube; the plurality of guide wires are arranged, and each guide wire is arranged in the bearing tube in a penetrating manner; the sheet-shaped contact intermediate body is tightly sleeved on the bearing tube; the sheet-shaped contact intermediate body is integrally formed by a plurality of sheet-shaped contacts and a plurality of connecting bridges, the sheet-shaped contacts are fixedly connected with different guide wires respectively, and any two adjacent sheet-shaped contacts are arranged in the circumferential direction of the bearing pipe at intervals and are fixedly connected through the connecting bridges. When the stimulating electrode intermediate is used for manufacturing a stimulating electrode, the complexity degree and the manufacturing difficulty of the stimulating electrode manufacturing process can be reduced, the production efficiency can be improved, and the integrity of a whole formed by all the sheet-shaped contacts can be ensured to be good.

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 circumferentially around 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] Currently, the method for manufacturing a stimulation electrode with a sheet-shaped contact is to first process and manufacture a plurality of sheet-shaped contacts, then weld the sheet-shaped contacts to different wires respectively, and then fix the sheet-shaped contacts at different positions of a mold to form the stimulation electrode through a pouring process. This manufacturing method needs to fix each sheet-shaped contact in the mold one by one, the manufacturing process is complicated, the manufacturing difficulty is large, and the production efficiency is low. SUMMARY

[0005] 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.

[0006] In order to solve the above problems, the technical solutions of the present application are as follows:

[0007] A stimulation electrode intermediate, the stimulation electrode intermediate comprising:

[0008] a carrier tube;

[0009] a plurality of guide wires, each of the guide wires being arranged in the carrier tube;

[0010] The sheet-shaped contact intermediate body is tightly sleeved on the carrier tube; the sheet-shaped contact intermediate body is integrally formed by a plurality of sheet-shaped contacts and a plurality of connecting bridges, each sheet-shaped contact is fixedly connected with a different guide wire, and any two adjacent sheet-shaped contacts are spaced apart in the circumferential direction of the carrier tube and are fixedly connected by the connecting bridges.

[0011] The stimulation electrode intermediate body has at least the following beneficial effects:

[0012] In the process of manufacturing 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 manufactured one by one. Then, the sheet-shaped contact intermediate body is sleeved on the carrier tube, and the sheet-shaped contact intermediate body is rotated to position each sheet-shaped contact to the appropriate position, without the need to position each sheet-shaped contact to the appropriate position one by one.

[0013] Based on the stimulation electrode intermediate body, the stimulation electrode can be manufactured by the following method: first, the stimulation electrode intermediate body is subjected to a first infusion, so that the insulating infusion material fills the gap between any two adjacent sheet-shaped contacts, and after the infusion material is solidified, the mold is removed. At this time, any two adjacent sheet-shaped contacts are also fixed together by the solidified infusion material. 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, the stimulation electrode semi-finished product is subjected to a second infusion, so that the insulating infusion material fills the gap between any two adjacent sheet-shaped contacts, and after the infusion material is solidified, the mold is removed 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 infusion material, and conductive substances such as human tissue fluid cannot enter between the two adjacent sheet-shaped contacts, and each sheet-shaped contact is independently controllable.

[0014] In the process of manufacturing the stimulation electrode using the stimulation electrode intermediate body, only the stimulation electrode intermediate body needs to be fixed in the mold, and each sheet-shaped contact does not need to be fixed in the mold one by one.

[0015] In summary, the stimulation electrode manufactured 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 in 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 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.

[0016] Moreover, in the prior art, because each tab contact is fixed into the mold one by one, the integrity of the whole formed by all the tab contacts can be poor. In the present application, the plurality of tab contacts are integrally manufactured into a tab contact intermediate body, and during the manufacturing of the stimulation electrode by using the above manufacturing method, the relative positions between the tab contacts do not change, and therefore the integrity of the whole formed by all the tab contacts in the same tab contact intermediate body is good. In the case of containing a plurality of tab contact intermediate bodies, because the tab contact intermediate bodies are tightly sleeved on the carrier tube, the integrity of the whole formed by all the tab contacts is still good.

[0017] For example, in the design of the stimulation electrode, each tab contact is usually designed to be located on the same cylindrical surface. The prior art of fixing each tab contact into the mold one by one can hardly ensure that each tab contact is located on the same cylindrical surface, and therefore the integrity of the whole formed by all the tab contacts is poor. In the present application, the tab contact intermediate body in which each tab contact is located on the same cylindrical surface is easy to manufacture, and during the manufacturing of the stimulation electrode by using the above manufacturing method, the relative positions between the tab contacts do not change, and therefore all the tab contacts in the same tab contact intermediate body are still located on the same cylindrical surface, and the integrity of the whole formed by all the tab contacts in the same tab contact intermediate body is good. In the case of containing a plurality of tab contact intermediate bodies, because the tab contact intermediate bodies are tightly sleeved on the carrier tube, all the tab contacts are still located on the same cylindrical surface, and the integrity of the whole formed by all the tab contacts is still good.

[0018] In one embodiment, each of the tab contacts has an exposed part through which the tab contact applies electrical stimulation, and along the radial direction of the carrier tube, the side of the exposed part opposite to the carrier tube is relatively far away from the carrier tube, and the side of the bridge opposite to the carrier tube is relatively close to the carrier tube.

[0019] In this way, during the above second pouring process, it is only necessary to ensure that the pouring material is flush with the side of the exposed part opposite to the carrier tube, and the place where the bridge is located is buried in the pouring material, and even if the operation of "removing at least a part of each bridge" causes burrs at the place where the bridge is located, 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.

[0020] In one embodiment, each of the tab contacts has an exposed part through which the tab contact applies electrical stimulation, and along the circumferential direction of the carrier tube, the size of the bridge is greater than the distance between any two adjacent exposed parts.

[0021] In this way, the size of the connecting bridge in the circumferential direction of the carrier tube is relatively large, facilitating the operation of removing at least a part of each connecting bridge.

[0022] In one of the embodiments, each of the sheet-shaped contacts further comprises a buried portion arranged at one end of the exposed portion in the axial direction of the carrier tube; in any two adjacent sheet-shaped contacts, the distance between the two adjacent buried portions is greater than the distance between the two adjacent exposed portions in the circumferential direction of the carrier tube; and each of the connecting bridges is fixed at two ends to the two adjacent buried portions, and is arranged apart from the exposed portion.

[0023] In this way, on the one hand, the size of the connecting bridge in the circumferential direction of the carrier tube is relatively large. On the other hand, this can prevent the exposed portion from being damaged when at least a part of each connecting bridge is removed.

[0024] In one of the embodiments, each of the sheet-shaped contacts has an exposed portion through which the sheet-shaped contact applies the electrical stimulation; and the thickness of each of the connecting bridges is less than the thickness of the exposed portion.

[0025] In this way, the connecting bridge is relatively thin, facilitating the operation of removing at least a part of each connecting bridge.

[0026] In one of the embodiments, the stimulation electrode intermediate body further comprises a spacer made of elastic polymer material, the spacer being sleeved on the intermediate bodies of the adjacent sheet-shaped contacts, and the spacer completely covers the side of each of the connecting bridges on the intermediate bodies of the adjacent sheet-shaped contacts, which faces away from the carrier tube.

[0027] In this way, because the side of the connecting bridge, which faces away from the carrier tube, is completely covered by the spacer, the side of each connecting bridge, which faces away from the carrier tube, 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 carrier tube, is exposed, and then at least a part of the connecting bridge is removed.

[0028] In one embodiment, the isolating member includes 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 is completely fitted with the outer circumference of the supporting tube, and the end face of the inner ring body completely fits and covers each of the connecting bridges on the adjacent sheet-like contact intermediate body close to the end of the inner ring body; the outer ring body is sleeved on the adjacent sheet-like contact intermediate body, and completely fits and covers each of the connecting bridges on the adjacent sheet-like contact intermediate body on the side facing away from the supporting tube.

[0029] With this arrangement, the side of the connecting bridge facing away from the support tube and the end closest to the inner ring are completely covered by the spacer. During the initial pouring process, the side of each connecting bridge facing away from the support tube and the end closest to the inner ring are protected from the pouring material, facilitating the subsequent removal of at least a portion of each connecting bridge. Furthermore, after removing the spacer, the tool required for this removal (e.g., a sharp blade or grinding wheel) can be inserted into the space previously occupied by the spacer, allowing the removal of at least a portion of each connecting bridge to be performed at an optimal angle, facilitating a quick and efficient removal of at least a portion of each connecting bridge.

[0030] In one embodiment, each of the sheet-like contacts includes an exposed portion and an embedded portion; along the radial direction of the supporting tube, the exposed portion protrudes from the embedded portion; along the axial direction of the supporting tube, the embedded portion protrudes from the exposed portion; the two ends of each of the connecting bridges are respectively fixed to the embedded portions of the two sheet-like contacts; the isolating piece is sleeved on the embedded portion, and the exposed portion is entirely located outside the isolating piece.

[0031] With this arrangement, the exposed portion will not be damaged during the two processes of removing the spacer and removing at least a portion of each connecting bridge.

[0032] In one embodiment, there are multiple sheet-like contact intermediates, and one isolating member is provided between any two adjacent sheet-like contact intermediates. The two ends of any isolating member located between two adjacent sheet-like contact intermediates are respectively fitted with the end faces of the exposed portions on the two adjacent sheet-like contact intermediates.

[0033] With this arrangement, the spacer also serves as a positioning element, ensuring that the spacing between two adjacent sheet-shaped contact intermediates remains constant. This eliminates the need for additional structure in the stimulation electrode intermediate to ensure a constant spacing between two adjacent sheet-shaped contact intermediates, facilitating a streamlined structure and reducing the number of assembly steps for the stimulation electrode intermediate, thereby improving the production efficiency of the stimulation electrode.

[0034] The application also provides a first stimulating electrode manufacturing method based on the stimulating electrode intermediate body, and the first stimulating electrode manufacturing method comprises the following steps:

[0035] The stimulating electrode intermediate body is subjected to a first infusion, so that the insulating infusion material fills the gap between any two adjacent sheet-shaped contacts, and the infusion material is demolded after solidification;

[0036] At least a part of each connecting bridge is removed, so that any two sheet-shaped contacts are electrically isolated from each other, and a stimulating electrode semi-finished product is obtained;

[0037] The stimulating electrode semi-finished product is subjected to a second infusion, so that the insulating infusion material fills the gap between any two adjacent sheet-shaped contacts, and the infusion material is demolded after solidification.

[0038] The first stimulating electrode manufacturing method at least has the following beneficial effects:

[0039] In the first stimulating electrode manufacturing method, each sheet-shaped contact does not need to be manufactured and fixed into the mold one by one, but only the stimulating electrode intermediate body needs to be fixed into 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.

[0040] Moreover, in the prior art, because each sheet-shaped contact is fixed into the mold one by one, the integrity of the whole formed by 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 body, and the relative positions between the sheet-shaped contacts do not change in the process of manufacturing the stimulating electrode by using the first stimulating electrode manufacturing method. Therefore, the integrity of the whole formed by 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 formed by all the sheet-shaped contacts is still good.

[0041] The application also provides a second stimulating electrode manufacturing method based on the stimulating electrode intermediate body, and the second stimulating electrode manufacturing method comprises the following steps:

[0042] The stimulating electrode intermediate body is subjected to a first infusion, so that the insulating infusion material fills the gap between any two adjacent sheet-shaped contacts, and the infusion material is demolded after solidification;

[0043] All the isolation members are removed;

[0044] At least a part of each connecting bridge is removed, so that any two sheet-shaped contacts are electrically isolated from each other, and a stimulating electrode semi-finished product is obtained;

[0045] The second time, the insulating infusion material fills the gap between any two adjacent sheet contacts, and the infusion material is demolded after solidification.

[0046] The second stimulation electrode manufacturing method has at least the following beneficial effects:

[0047] In the second stimulation electrode manufacturing method, each sheet contact does not need to be manufactured and fixed into the mold one by one, but only the stimulation electrode intermediate needs to be fixed 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 isolation piece completely covers the side of each connecting bridge on the adjacent sheet contact intermediate that faces away from the carrier tube, the side of each connecting bridge that faces away from the carrier tube will not stick to the infusion material during the first infusion of the stimulation electrode intermediate, making it easier to remove at least part of the connecting bridge later.

[0048] In addition, 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 may be poor. In the present application, a 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 manufacturing of the stimulation electrode using the second 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.

[0049] 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.

[0050] The stimulation electrode has at least the following beneficial effects:

[0051] Because the stimulation electrode is manufactured using the above-mentioned stimulation electrode manufacturing method, it is not necessary to manufacture each sheet contact one by one during the manufacturing process, nor is it necessary to fix each sheet contact one by one into a mold. This reduces the complexity and difficulty of the manufacturing process, which makes the production efficiency of the stimulation electrode higher. Moreover, the multiple sheet contacts are integrally formed into a sheet contact intermediate. During the manufacturing process of the stimulation electrode using the above-mentioned stimulation electrode manufacturing method, the relative positions of the individual sheet contacts will not change. Therefore, the integrity of the whole composed of all the sheet contacts in the same sheet contact intermediate is better. In the case of containing multiple sheet contact intermediates, because the sheet contact intermediates are tightly sleeved on the carrier tube, the integrity of the whole composed of all the sheet contacts is still better. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Figure 1 This is a three-dimensional schematic diagram of a stimulation electrode intermediate body according to one embodiment of the present application;

[0053] Figure 2 for Figure 1 A magnified schematic diagram of point A in the middle;

[0054] Figure 3 for Figure 1 An exploded schematic diagram of the stimulating electrode midbody is shown;

[0055] Figure 4 for Figure 3 A magnified schematic diagram of point B in the middle;

[0056] Figure 5 for Figure 4 Enlarged schematic diagram of point C in the middle;

[0057] Figure 6 for Figure 4 A three-dimensional schematic diagram of the intermediate body of the middle sheet contact;

[0058] Figure 7 This is a three-dimensional schematic diagram of a sheet contact intermediate body according to another embodiment of the present application;

[0059] Figure 8 This is a schematic diagram of the connection relationship between the sheet-shaped contact intermediate and the developing element in another embodiment of the present application;

[0060] Figure 9 This is a schematic three-dimensional diagram of an isolation element according to another embodiment of the present application;

[0061] Figure 10 for Figure 9 a longitudinal cross-sectional view of the separator shown;

[0062] Figure 11 Based on Figure 1An exploded view of a stimulating electrode made from the stimulating electrode intermediate shown;

[0063] Figure 12 To Figure 11 An enlarged view of the area D;

[0064] Figure 13 To Figure 12 An enlarged view of the area E.

[0065] Reference Signs:

[0066] 1. carrier tube; 11. small diameter portion; 12. large diameter portion; 2. guide wire; 3. sheet contact intermediate; 31. sheet contact; 311. exposed portion; 312. embedded portion; 32. connecting bridge; 4. spacer; 41. outer ring body; 42. inner ring body; 5. ring contact; 6. end body; 7. developing member. DETAILED DESCRIPTION

[0067] In order to make the above objectives, features and advantages of the present application more clear and comprehensible, the specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, a lot of specific details are set forth in order to fully understand the present application. However, the present application can be implemented in many different ways from those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present application, and therefore the present application is not limited to the specific embodiments disclosed below.

[0068] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "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 only 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.

[0069] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined with "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "a plurality of" is at least two, for example, two, three, etc., unless otherwise explicitly specified.

[0070] In the present application, unless specifically defined otherwise, the terms "mount", "connected", "connecting", "fixed", and the like, should be construed broadly and can be either fixed connections or detachable connections, or integral; can be mechanical connections, or electrical connections; can be direct connections, or indirect connections through intermediaries; can be internal communication between two elements, or interaction between two elements, unless specifically defined otherwise. The specific meanings of the above terms in the present application can be understood by those skilled in the art according to the specific circumstances.

[0071] In the present application, unless specifically defined otherwise, the first feature is "on" or "under" the second feature can be that the first and second features are in direct contact, or the first and second features are in indirect contact through intermediaries. Moreover, the first feature "above", "over" and "on" the second feature can be that the first feature is directly above or obliquely above the second feature, or simply indicates that the first feature is higher in horizontal height than the second feature. The first feature "below", "under" and "under" the second feature can be that the first feature is directly below or obliquely below the second feature, or simply indicates that the first feature is lower in horizontal height than the second feature.

[0072] It should be noted that when an element is referred to as "fixed to" or "provided on" another element, it can be directly on the other element or there can be a mediating element. When an element is referred to as "connected to" another element, it can be directly connected to the other element or there can be a mediating element. The terms "vertical", "horizontal", "up", "down", "left", "right", and similar expressions used herein are for illustrative purposes only and do not represent the only implementation.

[0073] Referring to Figures 1 to 6 , the present application first provides a stimulating electrode intermediate body, which comprises a carrier tube 1, a guide wire 2 and a sheet contact intermediate body 3.

[0074] Referring to Figure 5 , the guide wire 2 is provided with a plurality of guide wires 2, each guide wire 2 is provided in the carrier tube 1. Referring to Figure 2 , the sheet contact intermediate body 3 is tightly sleeved on the carrier tube 1. Referring to Figures 6 to 8 , the sheet contact intermediate body 3 is integrally formed by a plurality of sheet contacts 31 and a plurality of connecting bridges 32, each sheet contact 31 is fixedly connected to a different guide wire 2, and any two adjacent sheet contacts 31 are spaced apart in the circumferential direction of the carrier tube 1 and fixedly connected by the connecting bridge 32.

[0075] In the process of manufacturing the stimulation electrode intermediate, only the sheet-shaped contact intermediate 3 needs to be manufactured integrally, and each sheet-shaped contact 31 does not need to be manufactured individually. After the sheet-shaped contact intermediate 3 is sleeved on the carrier tube 1, and the sheet-shaped contact intermediate 3 is rotated, each sheet-shaped contact 31 can be positioned at a proper position, and each sheet-shaped contact 31 does not need to be positioned at a proper position.

[0076] On the basis of the stimulation electrode intermediate, the stimulation electrode can be manufactured by the following method: first, the stimulation electrode intermediate is subjected to a first pouring, so that the insulating pouring material fills the gap between any two adjacent sheet-shaped contacts 31, and after the pouring material is solidified, the stimulation electrode intermediate is demolded. At this time, any two adjacent sheet-shaped contacts 31 are also fixed together by the solidified pouring material. Then, at least a part of each connecting bridge 32 is removed, so that any two sheet-shaped contacts 31 are electrically isolated from each other, and a stimulation 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, the stimulation electrode semi-finished product is subjected to a second pouring, so that the insulating pouring material fills the gap between any two adjacent sheet-shaped contacts 31, and after the pouring material is solidified, the stimulation electrode semi-finished product is demolded, and a stimulation electrode finished product is obtained. In the stimulation electrode finished product, the gap between any two adjacent sheet-shaped contacts 31 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 31, and each sheet-shaped contact 31 is independently controllable.

[0077] It can be understood that, in the process of manufacturing the stimulation electrode by using the stimulation electrode intermediate, only the stimulation electrode intermediate needs to be fixed in the mold, and each sheet-shaped contact 31 does not need to be fixed in the mold.

[0078] In summary, in the process of manufacturing the stimulation electrode by using the stimulation electrode intermediate, each sheet-shaped contact 31 does not need to be manufactured individually, and each sheet-shaped contact 31 does not need to be fixed in the mold. Only after the sheet-shaped contact intermediate 3 is manufactured, the sheet-shaped contact intermediate 3 is operated. Therefore, the stimulation electrode manufactured by using the stimulation electrode intermediate can reduce the complexity and manufacturing difficulty of the stimulation electrode manufacturing process, and can improve the production efficiency.

[0079] It is worth mentioning that in the prior art, because each tab contact 31 is fixed to the mold one by one, the integrity of the whole formed by all the tab contacts 31 can be poor. In the present application, the plurality of tab contacts 31 are integrally manufactured into a tab contact intermediate body 3, and during the manufacturing of the stimulation electrode by using the above manufacturing method, the relative positions between the tab contacts 31 will not change, thus the integrity of the whole formed by all the tab contacts 31 in the same tab contact intermediate body 3 is good. In the case of containing a plurality of tab contact intermediate bodies 3, because the tab contact intermediate bodies 3 are tightly sleeved on the carrier tube 1, the integrity of the whole formed by all the tab contacts 31 is still good.

[0080] For example, in the design of the stimulation electrode, each tab contact 31 is usually designed to be located on the same cylindrical surface. The prior art of fixing each tab contact 31 to the mold one by one can hardly ensure that each tab contact 31 is located on the same cylindrical surface, thus the integrity of the whole formed by all the tab contacts 31 is poor. In the present application, the tab contact intermediate body 3 in which each tab contact 31 is located on the same cylindrical surface is easy to manufacture, and during the manufacturing of the stimulation electrode by using the above manufacturing method, the relative positions between the tab contacts 31 will not change, thus all the tab contacts 31 in the same tab contact intermediate body 3 are still located on the same cylindrical surface, and the integrity of the whole formed by all the tab contacts 31 in the same tab contact intermediate body 3 is good. In the case of containing a plurality of tab contact intermediate bodies 3, because the tab contact intermediate bodies 3 are tightly sleeved on the carrier tube 1, all the tab contacts 31 are still located on the same cylindrical surface, and the integrity of the whole formed by all the tab contacts 31 is still good.

[0081] 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.

[0082] Preferably, the tab 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”.

[0083] Optionally, the tab contact intermediate body 3 is made of gold, copper alloy or stainless steel.

[0084] Exemplarily, the tab contact intermediate body 3 is provided with 2, 3, 4, 5, 6, 7, 8, 9 or 10 tab contacts 31.

[0085] Preferably, the carrier tube 1 is a flexible member. Exemplarily, the carrier tube 1 is made of polyurethane or silicone.

[0086] In some embodiments, the carrier tube 1 can also be a rigid member.

[0087] In some embodiments, the guide wire 2 is welded to the contact.

[0088] In other embodiments, the guide wire 2 is adhered to the contact. Illustratively, the guide wire 2 and the contact are adhered by a light-cured adhesive, and after UV curing, the guide wire 2 and the contact are fixed together.

[0089] The operation of removing at least a portion of each connecting bridge 32 can result in burrs at the locations of the connecting bridges 32. Referring to Figure 4 and Figure 6 Each sheet-shaped contact 31 has an exposed portion 311, through which the sheet-shaped contact 31 applies the electrical stimulation. Along the radial direction of the carrier tube 1, the side of the exposed portion 311 facing away from the carrier tube 1 is relatively far away from the carrier tube 1, and the side of the connecting bridge 32 facing away from the carrier tube 1 is relatively close to the carrier tube 1. Thus, during the second pouring process described above, as long as the pouring material is ensured to be flush with the side of the exposed portion 311 facing away from the carrier tube 1, the locations of the connecting bridges 32 are buried in the pouring material, even if the operation of removing at least a portion of each connecting bridge 32 results in burrs at the locations of the connecting bridges 32, the burrs are located in the solidified pouring material and are not exposed, thus preventing the burrs from injuring human tissues.

[0090] In some embodiments, the distance between any two adjacent sheet-shaped contacts 31 is between 0.08 mm and 0.15 mm, in other words, the distance between any two adjacent sheet-shaped contacts 31 is small.

[0091] Referring to Figure 4 and Figure 6 Each sheet-shaped contact 31 has an exposed portion 311, through which the sheet-shaped contact 31 applies the electrical stimulation. Along the circumferential direction of the carrier tube 1, the size of the connecting bridge 32 is greater than the distance between any two adjacent exposed portions 311. Thus, the size of the connecting bridge 32 in the circumferential direction of the carrier tube 1 is relatively large, facilitating the operation of removing at least a portion of each connecting bridge 32.

[0092] Referring to Figure 4 and Figure 6 Each sheet-shaped contact 31 further includes a buried portion 312, which is located at one end of the exposed portion 311 in the axial direction of the carrier tube 1. In any two adjacent sheet-shaped contacts 31, along the circumferential direction of the carrier tube 1, the distance between the two adjacent buried portions 312 is greater than the distance between the two adjacent exposed portions 311. The two ends of each connecting bridge 32 are fixed to the two adjacent buried portions 312, respectively, and each connecting bridge 32 is spaced apart from the exposed portion 311. On the one hand, this makes the size of the connecting bridge 32 in the circumferential direction of the carrier tube 1 relatively large. On the other hand, this can prevent the exposed portion 311 from being accidentally injured when each connecting bridge 32 is removed at least partially.

[0093] Referring to Figure 4 and Figure 6 Each sheet contact 31 has an exposed portion 311 through which the sheet contact 31 applies the electrical stimulation. The thickness of each connecting bridge 32 is less than the thickness of the exposed portion 311. In this way, the connecting bridges 32 are relatively thin, facilitating the removal of at least a portion of each connecting bridge 32.

[0094] It should be noted that the potting material is hard after curing, and if the side of the connecting bridges 32 facing away from the carrier tube 1 is covered with the potting material, the removal of at least a portion of each connecting bridge 32 is more difficult.

[0095] Referring to Figure 2 , Figure 4 , Figure 9 and Figure 10 The stimulation electrode intermediate further comprises a spacer 4 made of an elastic polymer material, the spacer 4 being arranged around the adjacent sheet contact intermediates 3, the spacer 4 completely covering the side of each connecting bridge 32 of the adjacent sheet contact intermediates 3 facing away from the carrier tube 1. Since the side of each connecting bridge 32 facing away from the carrier tube 1 is completely covered by the spacer 4, the side of each connecting bridge 32 facing away from the carrier tube 1 is not covered with the potting material during the first potting process, which avoids increasing the difficulty of the removal of 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, by cutting the spacer 4 and then tearing it off. After the first demolding, the spacer 4 is removed first, so that the side of the connecting bridges 32 facing away from the carrier tube 1 is exposed, and then at least a portion of the connecting bridges 32 is removed.

[0096] Exemplarily, the spacer 4 is made of polyurethane, silicone, polyether block amide or polyimide.

[0097] In Figure 9 and Figure 10In the shown embodiment, the spacer 4 comprises an outer ring body 41 and an inner ring body 42, the inner ring body 42 extending radially from the inner wall of the outer ring body 41 along the outer ring body 41. The inner wall of the inner ring body 42 completely fits the outer periphery of the carrier tube 1, and the end face of the inner ring body 42 completely fits and 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 fits and covers each connecting bridge 32 on the adjacent sheet-shaped contact intermediate body 3 away from the carrier tube 1. In this way, the side of each connecting bridge 32 away from the carrier tube 1 and the end close to the inner ring body 42 are completely covered by the spacer 4, and the side of each connecting bridge 32 away from the carrier tube 1 and the end close to the inner ring body 42 will not be adhered with the pouring material during the first pouring process, facilitating the subsequent operation of "removing at least part of each connecting bridge 32". Moreover, after the spacer 4 is removed, the tool (for example, a sharp blade or a grinding wheel) used for the operation of "removing at least part of each connecting bridge 32" can be inserted into the space originally occupied by the spacer 4, so that the operation of "removing at least part of each connecting bridge 32" can be performed at the best angle, which is beneficial to quickly and efficiently complete the operation of "removing at least part of each connecting bridge 32".

[0098] Preferably, the inner ring body 42 is sleeved on the carrier tube 1 with an interference fit, and the outer ring body 41 is sleeved on the adjacent sheet-shaped contact intermediate body 3 with an interference fit. In this way, the sheet-shaped contact intermediate body 3 is fixed to the carrier tube 1 by the spacer 4.

[0099] In some embodiments, the inner ring body 42 is sleeved on the carrier tube 1 with an interference fit, and the outer ring body 41 is sleeved on the two sheet-shaped contact intermediate bodies 3 with an interference fit at both ends. In this way, the two sheet-shaped contact intermediate bodies 3 are fixed to the carrier tube 1 by the spacer 4, and the relative pose between the two sheet-shaped contact intermediate bodies 3 is kept unchanged. In other words, the spacer 4 plays a fixing role.

[0100] Preferably, the outer ring body 41 and the inner ring body 42 are integrally formed.

[0101] Optionally, the outer ring body 41 is bonded to the inner ring body 42.

[0102] In some embodiments, the spacer 4 comprises an outer ring body 41, and does not comprise an inner ring body 42. Figure 4 In the shown embodiment, the spacer 4 only has the outer ring body 41, and does not have the inner ring body 42. Preferably, the outer ring body 41 is sleeved on the two sheet-shaped contact intermediate bodies 3 with an interference fit at both ends. Figure 4 In the shown embodiment, the two sheet-shaped contact intermediate bodies 3 are fixed together by the spacer 4, and the relative pose between the two sheet-shaped contact intermediate bodies 3 is kept unchanged. In other words, the spacer 4 plays a fixing role.

[0103] Referring to Figures 6 to 8Each of the sheet-shaped contact 31 comprises an exposed part 311 and a buried part 312. The exposed part 311 protrudes from the buried part 312 along the radial direction of the carrier tube 1. The buried part 312 protrudes from the exposed part 311 along the axial direction of the carrier tube 1. The two ends of each of the connecting bridges 32 are fixed to the buried parts 312 of the two sheet-shaped contacts 31 respectively. The insulating member 4 is sleeved on the buried parts 312, and the exposed parts 311 are all located outside the insulating member 4. In this way, the exposed parts 311 will not be damaged in the process of removing the insulating member 4 and removing at least part of each of the connecting bridges 32.

[0104] In the process of completing the two injections, the buried parts 312 can be completely covered by the injection material, so that in the finished stimulation electrode, only the exposed parts 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 parts 311, that is, only the exposed parts 311 of the sheet-shaped contacts 31 are in contact with the human tissue. In the process of manufacturing the stimulation electrode, the exposed parts 311 will not be damaged, which can prevent the exposed parts 311 from scratching the human tissue.

[0105] Referring to Figures 6 to 8 , the side of the buried part 312 opposite to the carrier tube 1 is located on the same cylindrical surface as the side of the connecting bridge 32 opposite to the carrier tube 1. In this way, the inner wall of the outer ring body 41 can simultaneously fit the side of the buried part 312 opposite to the carrier tube 1 and the side of the connecting bridge 32 opposite to the carrier tube 1, 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 carrier tube 1.

[0106] Referring to Figure 2 , a plurality of sheet-shaped contact intermediates 3 are provided, one insulating member 4 is arranged between any two adjacent sheet-shaped contact intermediates 3, and the two ends of any one of the insulating members 4 located between the two adjacent sheet-shaped contact intermediates 3 are respectively fitted with the end faces of the exposed parts 311 on the two adjacent sheet-shaped contact intermediates 3. In this way, the insulating member 4 also plays a positioning role, which can ensure that the distance between the two adjacent sheet-shaped contact intermediates 3 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 3 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.

[0107] Illustratively, the stimulation electrode intermediate comprises 2, 3, 4, 5, 6, 7, 8, 9 or 10 sheet-shaped contact intermediates 3.

[0108] Preferably, in Figure 9 and Figure 10In the shown embodiment, the two ends of the inner ring body 42 of any one of the isolation members 4 located between two adjacent sheet-shaped contact intermediates 3 respectively abut the end faces of the respective connecting bridges 32 on the adjacent two sheet-shaped contact intermediates 3. The two ends of the outer ring body 41 of any one of the isolation members 4 located between two adjacent sheet-shaped contact intermediates 3 respectively abut the end faces of the exposed portions 311 on the adjacent two sheet-shaped contact intermediates 3.

[0109] Preferably, in Figure 9 and Figure 10 the shown embodiment, the inner ring body 42 of any one of the isolation members 4 located between two adjacent sheet-shaped contact intermediates 3 is interference-fitted on the carrier tube 1, and the two ends of the outer ring body 41 of any one of the isolation members 4 located between two adjacent sheet-shaped contact intermediates 3 are respectively interference-fitted on the buried portions 312 on the adjacent two sheet-shaped contact intermediates 3.

[0110] Referring to Figure 6 and Figure 7 , each sheet-shaped contact 31 includes two buried portions 312, and the two buried portions 312 of each sheet-shaped contact 31 are respectively located at the two ends of the exposed portion 311 in the axial direction of the carrier tube 1, and any one of the isolation members 4 located between two adjacent sheet-shaped contact intermediates 3 is respectively fitted on the adjacent two buried portions 312.

[0111] In Figure 6 and Figure 7 the shown embodiment, any two adjacent sheet-shaped contacts 31 are fixedly connected by two connecting bridges 32, one of which is fixedly arranged between the two buried portions 312 at one end of the two adjacent sheet-shaped contacts 31, and the other of which is fixedly arranged between the two buried portions 312 at the other end of the two adjacent sheet-shaped contacts 31.

[0112] In other embodiments, any two adjacent sheet-shaped contacts 31 can also be fixedly connected by only one connecting bridge 32.

[0113] Referring to Figure 2 and Figure 4 , the stimulating electrode intermediate further includes a ring-shaped contact 5, which is tightly fitted on the carrier tube 1. In this way, the stimulating electrode made of the stimulating electrode intermediate contains both sheet-shaped contacts 31 and ring-shaped contacts 5, which enables the stimulating electrode to provide both omnidirectional stimulation and directional stimulation.

[0114] Referring to Figure 4 , the carrier tube 1 includes a small-diameter portion 11 and a large-diameter portion 12, the small-diameter portion 11 being a section of the carrier tube 1 with a smaller diameter, and the large-diameter portion 12 being a section of the carrier tube 1 with a larger diameter. The sheet-shaped contact intermediate 3 is tightly fitted on the small-diameter portion 11.

[0115] In some embodiments, the stimulation electrode intermediate body includes only one kind of the sheet-like contact 31, and all the sheet-like contacts 31 belong to one sheet-like contact intermediate body 3. In these embodiments, one end of the sheet-like contact intermediate body 3 is arranged in abutment with the end face of the large-diameter portion 12.

[0116] In some embodiments, the stimulation electrode intermediate body includes only one kind of the sheet-like contact 31, and all the sheet-like contacts 31 belong to one sheet-like contact intermediate body 3. In these embodiments, one end of the sheet-like contact intermediate body 3 is arranged in abutment with the end face of the large-diameter portion 12.

[0117] In Figure 2 and Figure 4 In the embodiments shown in FIG. 6, the stimulation electrode intermediate body includes two ring-like contacts 5 and a plurality of sheet-like contact intermediate bodies 3, all the sheet-like contact intermediate bodies 3 are located between the two ring-like contacts 5, and any one sheet-like contact intermediate body 3 is separated from the adjacent ring-like contact 5 or sheet-like contact intermediate body 3 by a spacer 4, both ends of each spacer 4 are in abutment with the adjacent sheet-like contact intermediate body 3 or ring-like contact 5. One end of one of the ring-like contacts 5 is in abutment with the end face of the large-diameter portion 12. In the first pouring process, a portion of the pouring material can flow to the ring-like contact 5 away from the large-diameter portion 12, and this portion of the pouring material will bond the ring-like contact 5 away from the large-diameter portion 12 and the carrier tube 1 together, and after the portion of the pouring material solidifies (the portion of the pouring material solidifies to form the end body 6 shown in FIG. 7), the ring-like contact 5 away from the large-diameter portion 12 is fixed to the carrier tube 1. Figure 4

[0118] The stimulation electrode intermediate body shown in FIG. 8 can be manufactured in the following manner: first, the carrier tube 1, the ring-like contact 5, the sheet-like contact intermediate body 3, and the spacer 4 are manufactured one by one, and then, in the order shown in FIG. 9, each ring-like contact 5, each spacer 4, and each sheet-like contact intermediate body 3 are sequentially sleeved onto the carrier tube 1 and moved along the axial direction of the carrier tube 1 towards the large-diameter portion 12 until they cannot be moved along the axial direction of the carrier tube 1 towards the large-diameter portion 12. Figure 2 Figure 2

[0119] In some embodiments, the ring-like contact 5 can also be provided with only one or three or more, and in these embodiments, the positional relationship and connection relationship between the ring-like contact 5, the sheet-like contact intermediate body 3, and the spacer 4 are the same as those in the embodiments shown in FIG. 8. Figure 2

[0120] Preferably, refer to Figure 2 ​​​​The side of each sheet contact 31 opposite to the carrier tube 1, the outer periphery of each ring contact 5, and the outer periphery of each isolation piece 4 are located on the same cylindrical surface as the outer periphery of the large-diameter portion 12. During the two pouring processes, the inner wall of the mold is ensured to be in conformal fit with the outer periphery of the stimulation electrode intermediate body, and the side of each sheet contact 31 opposite to the carrier tube 1, the outer periphery of each ring contact 5, the outer periphery of each isolation piece 4, and the outer periphery of the large-diameter portion 12 are ensured to be in abutment with the inner wall of the mold. Thus, the outer periphery of the stimulation electrode product obtained after the two pouring processes is a cylindrical surface, which facilitates the implantation of the stimulation electrode into the patient's body.

[0121] Referring to Figure 8 In some embodiments, a plurality of developing pieces 7 are arranged on the stimulation electrode intermediate body, and the developing pieces 7 are made of a developing material. One developing piece 7 is arranged on each sheet contact 31, and the developing pieces 7 on any two sheet contacts 31 in the same sheet contact intermediate body 3 are different in shape. The developing pieces 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.

[0122] Exemplarily, the developing pieces 7 can be geometric figures, Arabic numerals, or letters.

[0123] Preferably, the developing pieces 7 are arranged on the embedding portion 312.

[0124] The present application also provides a first stimulation electrode manufacturing method based on a stimulation electrode intermediate body without isolation pieces 4, which comprises the following steps:

[0125] S11. The stimulation electrode intermediate body is subjected to a first pouring process, so that the insulating pouring material fills the gap between any two adjacent sheet contacts 31, and the pouring material is demolded after solidification.

[0126] 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 stimulation electrode semi-finished product is obtained.

[0127] S13. The stimulation electrode semi-finished product is subjected to a second pouring process, so that the insulating pouring material fills the gap between any two adjacent sheet contacts 31, and the pouring material is demolded after solidification.

[0128] In the first stimulation electrode manufacturing method, each sheet contact 31 does not need to be manufactured and fixed to the mold one by one, but only the stimulation electrode intermediate body needs to be fixed to 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.

[0129] It is worth mentioning that in the prior art, because each tab contact 31 is fixed to the mold one by one, the integrity of the whole formed by all the tab contacts 31 can be poor. In the present application, the plurality of tab contacts 31 are integrally manufactured into a tab contact intermediate body 3, and the relative positions between the tab contacts 31 do not change during the manufacturing of the stimulation electrode by using the first stimulation electrode manufacturing method. Therefore, the integrity of the whole formed by all the tab contacts 31 in the same tab contact intermediate body 3 is good. In the case of containing a plurality of tab contact intermediate bodies 3, because the tab contact intermediate bodies 3 are tightly sleeved on the carrier tube 1, the integrity of the whole formed by all the tab contacts 31 is still good.

[0130] For example, in the design of the stimulation electrode, each tab contact 31 is usually designed to be located on the same cylindrical surface. The prior art of fixing each tab contact 31 to the mold one by one can hardly ensure that each tab contact 31 is located on the same cylindrical surface, and thus the integrity of the whole formed by all the tab contacts 31 can be poor. In the present application, the tab contact intermediate body 3 in which each tab contact 31 is located on the same cylindrical surface is easy to manufacture, and the relative positions between the tab contacts 31 do not change during the manufacturing of the stimulation electrode by using the first stimulation electrode manufacturing method. Therefore, all the tab contacts 31 in the same tab contact intermediate body 3 are still located on the same cylindrical surface, and the integrity of the whole formed by all the tab contacts 31 in the same tab contact intermediate body 3 is good. In the case of containing a plurality of tab contact intermediate bodies 3, because the tab contact intermediate bodies 3 are tightly sleeved on the carrier tube 1, all the tab contacts 31 are still located on the same cylindrical surface, and the integrity of the whole formed by all the tab contacts 31 is still good.

[0131] Preferably, the step S11 comprises the following step: S111, during the first pouring of the stimulation electrode intermediate body, ensuring that the side of each connecting bridge 32 facing away from the carrier tube 1 is completely attached to the inner wall of the mold. In this way, the side of the connecting bridge 32 facing away from the carrier tube 1 will not stick to the pouring material, and it is convenient to remove at least part of the connecting bridge 32 later.

[0132] The present application also provides a second stimulation electrode manufacturing method based on a stimulation electrode intermediate body containing a separation piece 4, which comprises the following steps:

[0133] S21, the stimulation electrode intermediate body is subjected to a first pouring, so that the insulating pouring material fills the gap between any two adjacent tab contacts 31, and the pouring material is demolded after solidification.

[0134] S22, all the separation pieces 4 are removed.

[0135] S23 , removing at least a portion of each connecting bridge 32 to electrically isolate any two sheet-shaped contacts 31 from each other, thereby obtaining a semi-finished stimulation electrode.

[0136] S24 , performing a second potting on the semi-finished stimulation electrode so that the insulating potting material fills the gap between any two adjacent sheet contacts 31 , and demoulding after the potting material is solidified.

[0137] In the second stimulation electrode manufacturing method, it is not necessary to manufacture each sheet contact 31 one by one, nor is it necessary to fix each sheet contact 31 into a mold one by one. It is only necessary to fix the stimulation electrode intermediate into the mold. Therefore, the second stimulation electrode manufacturing method can reduce the complexity and manufacturing difficulty of the manufacturing process, and can improve production efficiency. Moreover, in the second stimulation electrode manufacturing method, because the isolation member 4 completely fits and covers the side of each connecting bridge 32 on the adjacent sheet contact intermediate 3 facing away from the supporting tube 1, during the first perfusion process of the stimulation electrode intermediate, the side of each connecting bridge 32 facing away from the supporting tube 1 will not be stuck with the perfusion material, which facilitates the subsequent removal of at least a portion of the connecting bridge 32.

[0138] 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 may be poor. In the present application, however, multiple sheet contacts 31 are integrally formed into a sheet contact intermediate 3. During the process of manufacturing the stimulation electrode using the second stimulation electrode manufacturing method, the relative positions of the individual sheet contacts 31 will not change. Therefore, the integrity of the whole formed by all the sheet contacts 31 in the same sheet contact intermediate 3 is better. In the case of containing multiple sheet contact intermediates 3, because the sheet contact intermediates 3 are tightly mounted on the supporting tube 1, the integrity of the whole formed by all the sheet contacts 31 is still good.

[0139] Based on Figure 2 In the case of the stimulation electrode intermediate shown, the specific steps of the second stimulation electrode manufacturing method are as follows:

[0140] S31, make a mould, the inner wall of the mould and Figure 2 The peripheral contouring of the stimulating electrode midbody is shown. Figure 2 The stimulation electrode intermediate body is placed into the mold, ensuring that the side of each sheet contact 31 facing away from the carrier tube 1, the periphery of each annular contact 5, the periphery of each spacer 4, and the 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 until it completely fills the gap between any two adjacent sheet contacts 31. After the potting material solidifies, the mold is removed.

[0141] S32. Remove all the spacers 4.

[0142] S33 , removing at least a portion of each connecting bridge 32 to electrically isolate any two sheet-shaped contacts 31 from each other, thereby obtaining a semi-finished stimulation electrode.

[0143] S34, make a mould, the inner wall of the mould and Figure 2 The periphery of the stimulation electrode intermediate body is contoured and adapted. The semi-finished stimulation electrode is placed into the mold, ensuring that the side of each sheet contact 31 facing away from the support tube 1, the periphery of each annular contact 5, the periphery of each spacer 4, and the periphery of the large-diameter portion 12 are completely aligned with the inner wall of the mold. Insulating potting material is injected into the mold, filling the gap between any two adjacent sheet contacts 31, the gap between any two sheet contact intermediate bodies 3, and the gap between any group of adjacent sheet contact intermediate bodies 3 and annular contacts 5. The mold is then removed after the potting material solidifies.

[0144] Preferably, the above-mentioned potting material is epoxy resin glue.

[0145] Optionally, the above-mentioned potting material may also be silicone or polyurethane.

[0146] In each of the above-mentioned stimulation electrode manufacturing methods, 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.

[0147] In some embodiments, a sharp blade can be used to cut the connecting bridge 32 along the axial direction of the supporting tube 1 to form a slit on the connecting bridge 32. This slit electrically isolates the two sheet contacts 31 at both ends of the connecting bridge 32 from each other.

[0148] In some embodiments, the connecting bridge 32 can be cut twice along the axial direction of the supporting tube 1 at different positions using 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. This gap electrically isolates the two sheet contacts 31 at both ends of the connecting bridge 32 from each other.

[0149] In some embodiments, a separate blade can be used to cut the connecting bridge 32 twice along the axial direction of the supporting tube 1 at the two connections between the connecting bridge 32 and the two sheet contacts 31, thereby completely removing the connecting bridge 32, thereby leaving a large gap between the two sheet contacts 31. This gap electrically isolates the two sheet contacts 31 from each other.

[0150] The sharp blade may be a carving knife.

[0151] Referring to Figures 11 to 13 The present application also provides a stimulating electrode manufactured by the stimulating electrode manufacturing method. Since the stimulating electrode is manufactured by the stimulating electrode manufacturing method, the stimulating electrode manufacturing method does not need to manufacture each of the sheet-shaped contacts 31 one by one, and does not need to fix each of the sheet-shaped contacts 31 into the mold one by one, so that the complexity and difficulty of the manufacturing process are reduced, and the production efficiency of the stimulating electrode is high. 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 will not change during the manufacturing of the stimulating electrode by the stimulating electrode manufacturing method, so that the integrity of the whole formed by all the sheet-shaped contacts 31 in the same sheet-shaped contact intermediate body 3 is good. In the case of containing a plurality of sheet-shaped contact intermediate bodies 3, since the sheet-shaped contact intermediate bodies 3 are closely sleeved on the carrier tube 1, the integrity of the whole formed by all the sheet-shaped contacts 31 is still good.

[0152] 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 disclosure as long as there is no contradiction.

[0153] The above-described embodiments only express several implementation manners of the present application, and the description is specific and detailed, but it should not be understood as a limitation on the protection scope of the present application. It should be pointed out that, for those skilled in the art, some modifications and improvements can be made without departing from the concept of the present application, and these are all 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 stimulation electrode intermediate, characterized in that: include: a carrier tube (1); A plurality of guide wires (2) are provided, and each guide wire (2) is passed through the supporting tube (1); The sheet-like contact intermediate body (3) is tightly sleeved on the supporting tube (1); the sheet-like contact intermediate body (3) is formed by integrally forming a plurality of sheet-like contacts (31) and a plurality of connecting bridges (32); each sheet-like contact (31) is fixedly connected to a different guide wire (2), and any two adjacent sheet-like contacts (31) are spaced apart in the circumferential direction of the supporting tube (1) and fixedly connected via the connecting bridge (32).

2. The stimulation electrode intermediate according to claim 1, characterized in that Each of the sheet-like contacts (31) has an exposed portion (311), and the sheet-like contact (31) applies electrical stimulation through the exposed portion (311); along the radial direction of the support tube (1), the side of the exposed portion (311) facing away from the support tube (1) is relatively far away from the support tube (1), and the side of the connecting bridge (32) facing away from the support tube (1) is relatively close to the support tube (1).

3. The stimulation electrode intermediate according to claim 1, characterized in that: Each of the sheet-like contacts (31) has an exposed portion (311), and the sheet-like contact (31) applies electrical stimulation through the exposed portion (311); along the circumferential direction of the supporting tube (1), the size of the connecting bridge (32) is greater than the distance between any two adjacent exposed portions (311).

4. The stimulation electrode intermediate according to claim 3, characterized in that: Each of the sheet-like contacts (31) further includes an embedded portion (312), and the embedded portion (312) is arranged at one end of the exposed portion (311) in the axial direction of the supporting tube (1); in any two adjacent sheet-like contacts (31), along the circumferential direction of the supporting tube (1), the spacing between the two adjacent embedded portions (312) is greater than the spacing between the two adjacent exposed portions (311); the two ends of each connecting bridge (32) are respectively fixed to the two adjacent embedded portions (312), and each connecting bridge (32) is spaced apart from the exposed portion (311).

5. The stimulation electrode intermediate according to claim 1, characterized in that: Each of the sheet-like contacts (31) has an exposed portion (311), and the sheet-like contact (31) applies electrical stimulation through the exposed portion (311); and the thickness of each of the connecting bridges (32) is smaller than the thickness of the exposed portion (311).

6. The stimulation electrode intermediate according to claim 1, characterized in that: The stimulation electrode intermediate body further comprises an isolating member (4) made of an elastic polymer material, wherein the isolating member (4) is sleeved on the adjacent sheet-like contact intermediate body (3), and the isolating member (4) completely fits and covers the side of each connecting bridge (32) on the adjacent sheet-like contact intermediate body (3) facing away from the supporting tube (1).

7. The stimulation electrode intermediate according to claim 6, characterized in that: The isolating member (4) comprises an outer ring body (41) and an inner ring body (42), wherein 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 in contact with the outer periphery of the supporting tube (1), and the end face of the inner ring body (42) completely covers the end of each connecting bridge (32) on the adjacent sheet-like contact intermediate body (3) close to the inner ring body (42); the outer ring body (41) is sleeved on 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) facing away from the supporting tube (1).

8. The stimulation electrode intermediate according to claim 6 or claim 7, characterized in that: Each of the sheet-like contacts (31) includes an exposed portion (311) and an embedded portion (312); along the radial direction of the supporting tube (1), the exposed portion (311) protrudes from the embedded portion (312); along the axial direction of the supporting tube (1), the embedded portion (312) protrudes from the exposed portion (311); both ends of each of the connecting bridges (32) are respectively fixed to the embedded portions (312) of the two sheet-like contacts (31); the isolating member (4) is sleeved on the embedded portion (312), and the exposed portion (311) is entirely located outside the isolating member (4).

9. The stimulation electrode intermediate according to claim 8, characterized in that: There are a plurality of the sheet-like contact intermediate bodies (3), and one isolating member (4) is provided between any two adjacent sheet-like contact intermediate bodies (3). Both ends of any isolating member (4) located between two adjacent sheet-like contact intermediate bodies (3) are respectively fitted with the end faces of the exposed portions (311) on the two adjacent sheet-like contact intermediate bodies (3).

10. A method for manufacturing a stimulation electrode, based on the stimulation electrode intermediate according to any one of claims 1 to 5, characterized in that: Including steps: Performing a first perfusion on the stimulating electrode intermediate body so that the insulating perfusion material fills the gap between any two adjacent sheet contacts (31), and demoulding after the perfusion material solidifies; Removing at least a portion of each connecting bridge (32) to electrically isolate any two sheet-shaped contacts (31) from each other, thereby obtaining a semi-finished stimulation electrode; The stimulation electrode semi-finished product is perfused for the second time so that the insulating perfusion material fills the gap between any two adjacent sheet contacts (31), and the mold is removed after the perfusion material is solidified.

11. A method for manufacturing a stimulation electrode, based on the stimulation electrode intermediate according to any one of claims 6 to 9, characterized in that: Including steps: Performing a first perfusion on the stimulating electrode intermediate body so that the insulating perfusion material fills the gap between any two adjacent sheet contacts (31), and demoulding after the perfusion material solidifies; Remove all of the isolation members (4); Removing at least a portion of each connecting bridge (32) to electrically isolate any two sheet-shaped contacts (31) from each other, thereby obtaining a semi-finished stimulation electrode; The stimulation electrode semi-finished product is perfused for the second time so that the insulating perfusion material fills the gap between any two adjacent sheet contacts (31), and the mold is removed after the perfusion material is solidified.

12. A stimulation electrode, characterized in that: Made by the stimulation electrode manufacturing method according to claim 10 or claim 11.

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