Stimulating electrode, stimulating assembly and method of manufacturing a stimulating electrode

Abstract

This application relates to a stimulation electrode, a stimulation component, and a method for manufacturing the stimulation electrode. The stimulation electrode includes: a tube body that is elastic and hollow inside; a stimulation contact that is annular or C-shaped in projection on at least one plane parallel to the cross-section of the tube body and is sleeved within the tube body; a guide wire for electrically connecting a pulse generator and the stimulation contact; a portion of the guide wire is housed within the tube body, and another portion of the guide wire extends out of the tube body to form a clamped section; when the tube body is not subjected to external force, the clamped section is elastically abutted against the inner wall of the stimulation contact in the radial direction of the outer peripheral wall of the tube body, thereby electrically connecting with the stimulation contact through elastic abutment. This application fundamentally solves the problem that the guide wire and stimulation contact are prone to breakage at the solder joint in the trend of miniaturization of stimulation electrodes.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to stimulating electrodes, stimulating components, and methods for manufacturing stimulating electrodes. Background Technology

[0002] The stimulation assembly includes a stimulation electrode and a pulse generator. One end of the stimulation electrode has a connecting contact point, which is electrically connected to the pulse generator; the other end of the stimulation electrode has a stimulation contact point, which applies electrical stimulation to the relevant nerve or muscle tissue to exert a therapeutic effect; the connecting contact point and the stimulation contact point are usually electrically connected by a guide wire, with the two ends of the guide wire welded to the connecting contact point and the stimulation contact point respectively.

[0003] The patient's daily activities (such as heartbeat, breathing, limb movement, muscle contraction, etc.) cause the implanted stimulation electrode to undergo continuous displacement and deformation along with the surrounding tissue, thus subjecting the slender guidewire to repeated bending, twisting, and stretching. During this process, minute cyclic stresses are continuously generated at the solder joints between the guidewire and the stimulation contact.

[0004] The smaller the size of the stimulation electrode, the more precisely it can achieve targeted stimulation in confined anatomical spaces, while simultaneously reducing tissue damage and chronic inflammation. Therefore, stimulation electrodes are becoming increasingly miniaturized.

[0005] However, the junction between the guidewire and the solder joint is relatively weak. As the stimulating electrodes become increasingly miniaturized, the size of the guidewire and stimulating contacts continues to decrease, making the junction between the guidewire and the solder joint even weaker and less resistant to fatigue. Under the long-term effects of the aforementioned cyclic stress, the junction between the guidewire and the solder joint is more prone to the initiation and gradual propagation of microcracks until complete fracture. In short, with the miniaturization of stimulating electrodes, the guidewire and stimulating contacts are increasingly prone to breakage at the solder joint. Once the guidewire and stimulating contacts break, the stimulating electrode can no longer apply electrical stimulation and loses its therapeutic function. Summary of the Invention

[0006] Therefore, it is necessary to provide a stimulation electrode, a stimulation component, and a method for manufacturing the stimulation electrode to address the above-mentioned problems.

[0007] To address the above problems, this application provides the following technical solution: A stimulation electrode comprising: The tube body is elastic and hollow inside; The stimulation contact has a projection in the shape of a ring or C on at least one plane parallel to the cross-section of the tube body, and is fitted onto the tube body; A guidewire is used to electrically connect the pulse generator and the stimulation contact; part of the guidewire is housed in the tube, and another part of the guidewire extends out of the tube to become a clamped section; when the tube is not subjected to external force, the clamped section is elastically abutted against the inner wall of the stimulation contact in the radial direction of the outer peripheral wall of the tube, so as to be electrically connected to the stimulation contact by elastic abutment.

[0008] This stimulating electrode has at least the following beneficial effects: Compared to traditional welding methods, this stimulation electrode achieves electrical connection between the guidewire and the stimulation contact through a reliable elastic abutment structure, eliminating the reliance on welding connections between the guidewire and stimulation contact. Specifically, radially on the outer peripheral wall of the tube, the tube elastically abuts the clamped section of the guidewire against the inner wall of the stimulation contact, thereby clamping the clamped section together with the stimulation contact and confining it to the inner wall of the stimulation contact, achieving a direct electrical connection between the guidewire and the stimulation contact without welding points. This application fundamentally solves the problem of guidewire and stimulation contact easily breaking at welding points in the trend of miniaturization of stimulation electrodes. Therefore, it significantly improves the reliability and fatigue life of the electrical connection between the guidewire and the stimulation contact, ensuring that the stimulation electrode can work stably and continuously in vivo, reducing the risk of treatment interruption due to stimulation electrode failure.

[0009] Moreover, by using a flexible tube to abut the guidewire to the stimulation contact point, no additional fixing components are required, which helps to reduce the overall size of the stimulation electrode and meet the miniaturization design requirements of the stimulation electrode.

[0010] Furthermore, traditional welding connections are point contacts, while the stimulation electrode in this application achieves line-to-surface contact through the aforementioned elastic abutment, increasing the conductivity points between the guide wire and the stimulation contact, resulting in better conductivity.

[0011] Furthermore, the miniature stimulating electrodes are very small, and in these electrodes, the solder joints can only be located outside the stimulating contact, easily protruding from the contact and prone to forming burrs that can scratch human tissue. In the stimulating electrode provided in this application, the clamping segment is located inside the stimulating contact and is not exposed. The outside of the stimulating contact is free of burrs or other protrusions, which helps protect human tissue.

[0012] Finally, in existing technologies, the stimulation contact and the tube body are not fixedly connected, and their relative rotation is not restricted. In existing stimulation electrodes that use welding to achieve electrical connection, the stimulation contact and the tube body may rotate relative to each other during human activity. Since the weld point position is fixed, either the guide wire follows the weld point position, resulting in a longer guide wire protruding from the tube body, and the change in the position of the guide wire inside the tube may lead to unstable connection of the guide wire. When the stimulation contact rotates back, the guide wire protruding from the tube body cannot be retracted, forming a redundant length. This redundant length of guide wire may cut human tissue and is also prone to breakage; or the guide wire does not follow the weld point position. When the guide wire and weld point rotate with the stimulation contact, the guide wire is directly pulled off, or the weld point position is damaged. In summary, existing welding methods result in a shorter service life of the guide wire, and prolonged use may also cause hidden harm, such as cutting human tissue. In the stimulation electrode provided in this application, even if the stimulation contact rotates relative to the tube body, it does not affect the line-to-surface contact between the two. Even if the stimulation contact rotates back and forth relative to the tube body, it is difficult to form redundant length because there is an elastic abutment between the stimulation contact and the tube body and the guide wire is relatively movable. Even if redundant length is formed, it will be limited between the stimulation contact and the tube body and will not expose the cutting of human tissue, thereby avoiding hidden damage during long-term use.

[0013] In one embodiment, the tube is elastic and can be axially stretched by an external force to reduce its outer diameter to form a stretched state, and after the external force is removed, the outer diameter is restored to form a normal state. In the stretched state, the sum of the outer circumference diameter of the tube and the diameter of the clamped section is less than or equal to the inner diameter of the stimulation contact, while in the normal state, the sum of the outer circumference diameter of the tube and the diameter of the clamped section is greater than the inner diameter of the stimulation contact.

[0014] This configuration allows for the application of an axial external force to the tube, narrowing it. With the clamped section conforming to the tube in a straight line or corrugated shape (such as an M-shape, W-shape, or similar) parallel to the tube, the stimulation contact can be easily fitted onto the clamped section. After the external force is removed, the tube returns to its normal state, allowing the clamped section to elastically abut against the inner wall of the stimulation contact in the radial direction of the tube's outer periphery, achieving a non-destructive and convenient synchronous mechanical and electrical connection.

[0015] In one embodiment, the tube is elastic and can be axially stretched by an external force to reduce its outer diameter to form a stretched state, and after the external force is removed, the outer diameter is restored to form a normal state. In the stretched state, the sum of the outer circumference diameter of the tube and at least twice the diameter of the clamped segment is less than or equal to the inner diameter of the stimulation contact, and in the normal state, the sum of the outer circumference diameter of the tube and at least twice the diameter of the clamped segment is greater than the inner diameter of the stimulation contact.

[0016] This configuration allows the clamped segment to be spirally wound around the tube body or distributed in a wavy, bent pattern along the entire outer circumference of the tube body. Specifically, the clamped segment can be spirally wound around the outer circumferential wall of the tube body, and then an axial force is applied to the tube body to make it thinner (or an axial force can be applied before winding to make the tube body thinner). At this point, the stimulation contact can be easily fitted onto the clamped segment. After the external force is removed, the tube body returns to its normal state, thereby elastically abutting the clamped segment against the inner wall of the stimulation contact in the radial direction of the outer circumferential wall of the tube body, achieving a non-destructive and convenient synchronous mechanical and electrical connection.

[0017] In one embodiment, the clamped section is bent and disposed on the outer peripheral wall of the tube body.

[0018] This design, with the clamped segment contacting the stimulation contact via a bending structure, increases the contact length between the clamped segment and the stimulation contact, thereby increasing the number of conductive sites between the guidewire and the stimulation contact, resulting in better conductivity. Furthermore, while increasing the number of conductive sites between the guidewire and the stimulation contact, it avoids increasing the overall radial dimension of the stimulation electrode, which is beneficial for miniaturization and micro-sizing of the stimulation electrode. Additionally, this increases the contact length and friction between the clamped segment and the stimulation contact and the tube body, preventing axial movement of the guidewire within the tube body and enhancing the long-term stability of the electrical connection. Simultaneously, the bending structure provides a buffering effect, better dispersing and absorbing external stress, further improving the guidewire's resistance to bending and tension, which helps ensure a reliable electrical connection between the guidewire and the stimulation contact.

[0019] In one embodiment, the clamped segment is spirally wound around the outer peripheral wall of the tube body.

[0020] This design, with the clamped section contacting the stimulation contact via a helical structure, increases the contact length between the clamped section and the stimulation contact, thereby increasing the number of conductive points between the guidewire and the stimulation contact and resulting in good conductivity. Furthermore, the manufacturing process is simple, avoiding shape changes caused by the melting of the stimulation contact during welding. In addition, the increased contact length and friction between the clamped section, the stimulation contact, and the tube body prevent axial movement of the guidewire within the tube body, enhancing the long-term stability of the electrical connection. Simultaneously, the helical structure provides a certain degree of elastic buffering, better dispersing and absorbing external stress, further improving the guidewire's resistance to bending and tension, which is beneficial for ensuring a reliable electrical connection between the guidewire and the stimulation contact.

[0021] In one embodiment, the tube body includes interconnected support sections and non-support sections, the outer circumferential diameter of the support sections is smaller than the outer circumferential diameter of the non-support sections, and there is a step between the support sections and the non-support sections; The clamped section of the guidewire is disposed on the outer peripheral wall of the support section, and the step can prevent the clamped section from moving from the support section to the non-support section; The stimulation contact is sleeved on the support section; when the tube body is not subjected to external force, the clamping section is abutted against the inner wall of the stimulation contact in the radial direction of the outer peripheral wall of the support section, so as to be electrically connected to the stimulation contact by elastic contact.

[0022] This design uses two steps to hold the two ends of the stimulation contact in place, clamping the clamped section in the middle. Even if the shape of the clamped section (such as the pitch or wavy shape) changes, it still remains in contact with the inner wall of the stimulation contact, resulting in good conductivity. Furthermore, the steps confine the clamped section to the support section, preventing it from slipping to the non-support section during assembly and ensuring that the clamped section is always in the correct position to mate with the stimulation contact.

[0023] In one embodiment, the outer peripheral surface of the stimulation contact is flush with the outer peripheral surface of the non-support segment.

[0024] This design ensures that the outer surface of the stimulation electrode is smooth and uniform, which facilitates the smooth passage of the stimulation electrode through the catheter or tissue during implantation or use, reduces friction and damage to surrounding tissues, and improves biocompatibility and ease of operation.

[0025] In one embodiment, the tube body has a through hole located in the support section, and the through hole is used for the guide wire to extend out of the tube body; when the tube body is not subjected to external force, the stimulation contact can cover the through hole.

[0026] With this configuration, a portion of the guidewire can pass through the through hole to become the clamping section, which is convenient for the clamping section to be placed on the outer peripheral wall of the support section. The stimulation contact covering the through hole can prevent the guidewire from being exposed.

[0027] In one embodiment, when the tube body is not subjected to external force, the two ends of the stimulation contact point respectively abut against the step.

[0028] With this setup, the two ends of the stimulation contact are held in place by the steps, ensuring that the guide wire is clamped between the support section and the stimulation contact. Even if the shape of the guide wire (such as the pitch or the wavy shape) changes, it will still be in contact with the inner wall of the stimulation contact, thus maintaining good conductivity.

[0029] In one embodiment, the tube body has a through hole located in the support section, and the through hole is used for the guide wire to extend out of the tube body; when the tube body is not subjected to external force, the stimulation contact can cover the through hole, and the stimulation contact and the tube body are in elastic contact, so that the stimulation contact can seal the through hole.

[0030] This design prevents bodily fluids from flowing into the tube through the opening, which could affect the lifespan of the stimulation electrode or cause stimulation failure.

[0031] In one embodiment, the guidewire further includes a welding segment welded to the stimulation contact, and the clamped segment is further distal to the guidewire than the welding segment.

[0032] This configuration provides dual electrical connection protection. In addition to the clamping section's contact, a welding section is added as an auxiliary electrical connection. By placing the clamping section further away from the guide wire's distal end, the welding section is separated from the other slender parts of the guide wire. The bending, torsion, and tension repeatedly experienced by the other slender parts of the guide wire are almost entirely exerted on the clamping section, not the welding section. The welding section is in a relatively low-stress position, effectively protecting the fragile weld joint.

[0033] In one embodiment, the guidewire further includes a welding section welded to the stimulation contact, the stimulation contact having a groove at one end near the welding section, the welding section being located within the groove.

[0034] This design, by creating a groove at one end of the stimulation contact to accommodate the welding segment, prevents the welding segment from protruding from the electrode surface. This protects the welding point from external physical impacts while maintaining the smoothness of the outer surface of the stimulation electrode, facilitating implantation and reducing tissue irritation.

[0035] This application also provides a stimulation component, which includes a pulse generator and the above-described stimulation electrodes, wherein the guide wire is electrically connected to the pulse generator.

[0036] This application also provides a method for manufacturing a stimulation electrode, which is used to manufacture the above-mentioned stimulation electrode. The method includes the following steps: A portion of the guidewire is passed through the wall of the tube body so that a portion of the guidewire is located outside the tube body; An external force is applied to elongate the tube, thereby making the tube thinner; With the tube body narrowed, the stimulation contact is placed on the portion of the guidewire outside the tube body; When the external force is released, the tube body recovers, so that during the process of recovering the outer circumferential diameter, the guide wire is elastically abutted against the inner wall of the stimulation contact in the radial direction of the outer circumferential wall of the tube body.

[0037] This method for manufacturing stimulation electrodes has at least the following beneficial effects: This method for manufacturing stimulation electrodes utilizes the elasticity of the tube. After thinning the tube, the stimulation contact can be smoothly fitted onto the tube and guidewire, avoiding damage to the guidewire. Furthermore, the tube's resilience allows the guidewire to elastically abut against the inner wall of the stimulation contact, thus clamping the guidewire together with the stimulation contact. This achieves a direct, solderless electrical connection between the guidewire and the stimulation contact, fundamentally solving the problem of guidewire and stimulation contact easily breaking at solder joints in the trend of miniaturization of stimulation electrodes. Moreover, this method for manufacturing stimulation electrodes is simple to manufacture and has high conductivity reliability. Attached Figure Description

[0038] Figure 1 This is a schematic diagram of the structure of a stimulation electrode according to an embodiment of this application; Figure 2 for Figure 1 An exploded view of the structure shown; Figure 3 for Figure 2 An exploded view of the structure shown; Figure 4 for Figure 1 The diagram shows a three-dimensional representation of the remaining portion of the stimulation electrode after all stimulation contacts have been removed, with the tube body in a transparent state. Figure 5 This is a perspective view of a tube body according to an embodiment of this application; Figure 6 for Figure 5 Enlarged view of point A in the middle; Figure 7 for Figure 1 A three-dimensional schematic diagram of the stimulation contact point; Figure 8 This is a schematic diagram of the structure of the stimulation electrode according to another embodiment of this application.

[0039] Figure label: 1. Tube body; 11. Support section; 12. Non-support section; 13. Step; 14. Through hole; 2. Stimulation contact; 21. Groove; 3. Guide wire; 31. Clamped section; 32. Welded section; 4. Support component. Detailed Implementation

[0040] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0041] In the description of this 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", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0042] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0043] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0044] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0045] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0046] In the stimulation electrode of this application, "proximal" and "distal" are both referenced to the pulse generator, with the end closer to the pulse generator being the proximal end and the end farther from the pulse generator being the distal end.

[0047] See Figures 1 to 8 This application first provides a stimulation electrode.

[0048] In one embodiment, the stimulation electrode includes a tube 1, which is elastic and hollow inside.

[0049] In one embodiment, the stimulation electrode further includes a stimulation contact 2, the projection of which on at least one plane parallel to the cross-section of the tube body 1 is annular or C-shaped and is sleeved on the tube body 1.

[0050] In one embodiment, the stimulation electrode further includes a guide wire 3 for electrically connecting the pulse generator and the stimulation contact 2. A portion of the guide wire 3 is housed within the tube body 1, and another portion of the guide wire 3 extends out of the tube body 1 to form a clamped section 31. When the tube body 1 is not subjected to external force, the clamped section 31 is elastically abutted against the inner wall of the stimulation contact 2 radially from the outer peripheral wall of the tube body 1, thereby electrically connecting with the stimulation contact 2 through elastic abutment.

[0051] It is understandable that the stimulation contact 2 can be a ring-shaped, C-shaped or a combination of both, as long as it can be fitted onto the tube 1 and form an elastic contact with the tube 1.

[0052] Compared to traditional welding methods, this stimulation electrode achieves electrical connection between the guidewire 3 and the stimulation contact 2 through a reliable elastic abutment structure, eliminating the reliance on welding connections between the guidewire 3 and the stimulation contact 2. Specifically, radially on the outer peripheral wall of the tube body 1, the tube body 1 elastically abuts the clamped section 31 of the guidewire 3 against the inner wall of the stimulation contact 2, thereby clamping the clamped section 31 together with the stimulation contact 2, confining the clamped section 31 to the inner wall of the stimulation contact 2, achieving a direct electrical connection between the guidewire 3 and the stimulation contact 2 without welding points. This application fundamentally solves the problem of easy disconnection at the welding point between the guidewire 3 and the stimulation contact 2 under the trend of miniaturization of stimulation electrodes. Therefore, it significantly improves the reliability and fatigue life of the electrical connection between the guidewire 3 and the stimulation contact 2, ensuring that the stimulation electrode can work stably and continuously in vivo, reducing the risk of treatment interruption due to stimulation electrode failure.

[0053] Moreover, by using the flexible tube 1 to abut the guide wire 3 against the stimulation contact 2, no additional fixing parts are needed, which helps to reduce the overall size of the stimulation electrode and meet the miniaturization design requirements of the stimulation electrode.

[0054] Furthermore, traditional welding connections are point contacts, while the stimulation electrode in this application achieves line-to-surface contact through the aforementioned elastic abutment, increasing the conductive sites between the guide wire 3 and the stimulation contact 2, resulting in better conductivity.

[0055] Furthermore, the miniature stimulation electrode is very small in size. In a miniature stimulation electrode, the solder joint can only be located outside the stimulation contact 2, which can easily protrude from the stimulation contact 2 and form burrs that can scratch human tissue. In the stimulation electrode provided in this application, the clamping section 31 is located inside the stimulation contact 2 and is not exposed on the outside. There are no burrs or other protrusions on the outside of the stimulation contact 2, which helps to protect human tissue.

[0056] Finally, in the existing technology, the stimulation contact 2 and the tube body 1 are not fixedly connected, and their relative rotation is not restricted. In existing stimulation electrodes that use welding to achieve electrical connection, the stimulation contact 2 and the tube body 1 may rotate relative to each other during human activity. Since the welding point position is fixed, either the guide wire 3 follows the welding point position, and the length of the guide wire 3 protruding outside the tube body 1 increases, and the change in the position of the guide wire 3 inside the tube body 1 may cause instability in the connection of the guide wire 3. When the stimulation contact 2 rotates back, the guide wire 3 protruding outside the tube body 1 cannot be retracted, forming a redundant length. This redundant length of guide wire 3 may cut human tissue and is also prone to breakage; or the guide wire 3 does not follow the welding point position. When the guide wire 3 welding point rotates with the stimulation contact 2, it may directly break the guide wire 3 or damage the welding point position. In summary, the existing welding method leads to a shorter service life of the guide wire 3, and long-term use may also cause hidden damage, such as cutting human tissue. In the stimulation electrode provided in this application, even if the stimulation contact 2 rotates relative to the tube body 1, it does not affect the line-to-surface contact between the two. The stimulation contact 2 rotates back and forth relative to the tube body 1. Since there is an elastic abutment between the stimulation contact 2 and the tube body 1 and the guide wire 3 is relatively movable, it is difficult to form redundant length. Even if redundant length is formed, it will be limited between the stimulation contact 2 and the tube body 1 and will not expose the cutting of human tissue, thereby avoiding hidden damage during long-term use.

[0057] It is understandable that, since the tube body 1 is elastic, when the stimulation contact 2 is overfitted onto the outside of the tube body 1, the guide wire 3 between them will be embedded inside the tube body 1, thereby forming a conformal groove on the tube body 1. This conformal groove can further prevent the guide wire 3 from shifting, thus ensuring the reliability of the electrical connection between the guide wire 3 and the stimulation contact 2.

[0058] In some embodiments, the tube 1 is elastic and can be axially stretched by an external force to reduce its outer diameter, forming a stretched state, and returns to its normal state after the external force is removed. In the stretched state, the sum of the outer diameter of the tube 1 and the diameter of the clamped section 31 is less than or equal to the inner diameter of the stimulation contact 2, while in the normal state, the sum of the outer diameter of the tube 1 and the diameter of the clamped section 31 is greater than the inner diameter of the stimulation contact 2. Thus, an axial external force can be applied to the tube 1 to thin it, and the stimulation contact 2 can be easily fitted onto the clamped section 31 when the clamped section 31 is in a straight line or corrugated shape (such as an M-shape, W-shape, or similar shape) parallel to the tube 1. After the external force is removed, the tube 1 returns to its normal state, thereby elastically abutting the clamped section 31 against the inner wall of the stimulation contact 2 radially on the outer peripheral wall of the tube 1, achieving a non-destructive and convenient mechanical and electrical synchronous connection.

[0059] In some embodiments, the tube 1 is elastic and can be axially stretched by an external force to reduce its outer diameter, forming a stretched state, and recovers its outer diameter after the external force is removed, forming a normal state. In the stretched state, the sum of the outer diameter of the tube 1 and at least twice the diameter of the clamped segment 31 is less than or equal to the inner diameter of the stimulation contact 2, and in the normal state, the sum of the outer diameter of the tube 1 and at least twice the diameter of the clamped segment 31 is greater than the inner diameter of the stimulation contact 2. This allows the clamped segment 31 to be spirally wound around the tube 1 or distributed in a wavy pattern along the entire outer circumference of the tube 1. Specifically, the clamped segment 31 can be spirally wound around the tube 1 against its outer wall, and then an axial external force is applied to the tube 1 to thin it (or an axial external force is applied before winding to thin the tube 1), at which point the stimulation contact 2 can be easily fitted onto the clamped segment 31. After the external force is removed, the tube 1 returns to its normal state, thereby elastically abutting the clamped section 31 against the inner wall of the stimulation contact 2 in the radial direction of the outer peripheral wall of the tube 1, achieving a non-destructive and convenient mechanical and electrical synchronous connection.

[0060] In some embodiments, the clamped section 31 is disposed on the outer peripheral wall of the tube body 1 in a straight or slightly curved form.

[0061] In some embodiments, the clamping segment 31 is bent and disposed on the outer peripheral wall of the tube body 1. This bending structure allows the clamping segment 31 to contact the stimulation contact 2, increasing the contact length between the clamping segment 31 and the stimulation contact 2, thus increasing the conductive points between the guidewire 3 and the stimulation contact 2. This enables line contact or even surface contact between the stimulation contact 2 and the guidewire 3, resulting in good conductivity. Furthermore, by increasing the conductive points between the guidewire 3 and the stimulation contact 2, the overall radial dimension of the stimulation electrode is prevented from increasing, which is beneficial for miniaturization and micro-miniaturization of the stimulation electrode. Additionally, this increases the contact length and friction between the clamping segment 31 and the stimulation contact 2 and the tube body 1, preventing the guidewire 3 from shifting axially in the tube body 1 and enhancing the long-term stability of the electrical connection. Simultaneously, the bending structure provides a buffering effect, better dispersing and absorbing external stress, further improving the bending and tensile strength of the guidewire 3, which helps ensure a reliable electrical connection between the guidewire 3 and the stimulation contact 2. Exemplarily, the clamping segment 31 is wavy or serrated.

[0062] See Figure 3 and Figure 4In some embodiments, the clamped section 31 is spirally wound around the outer peripheral wall of the tube body 1. This spiral structure allows the clamped section 31 to contact the stimulation contact 2, increasing the contact length between the clamped section 31 and the stimulation contact 2, thus increasing the conductive points between the guide wire 3 and the stimulation contact 2, resulting in good electrical conductivity. Furthermore, the manufacturing process is simple, avoiding shape changes caused by the melting of the stimulation contact 2 during welding. In addition, the increased contact length and friction between the clamped section 31 and the stimulation contact 2 and the tube body 1 prevent the guide wire 3 from shifting axially in the tube body 1, enhancing the long-term stability of the electrical connection. Simultaneously, the spiral structure provides a certain degree of elastic buffering, better dispersing and absorbing external stress, further improving the bending and tensile strength of the guide wire 3, which is beneficial for ensuring a reliable electrical connection between the guide wire 3 and the stimulation contact 2.

[0063] The shape and structure of the clamped section 31 are not limited to those listed above. Any suitable shape and structure shall be considered to fall within the protection scope of this application, as long as the clamped section 31 can be clamped together by the tube body 1 and the stimulation contact 2 in the radial direction of the tube body 1.

[0064] Preferably, the stimulation contact 2 is interference-fitted onto the tube body 1. This ensures that the stimulation contact 2 is reliably fixed to the tube body 1, and the continuous radial compressive force generated by the interference fit allows the clamped section 31 to fit tightly against the stimulation contact 2.

[0065] See Figures 2 to 5 The tube body 1 includes an interconnected support section 11 and a non-support section 12. The outer diameter of the support section 11 is smaller than that of the non-support section 12, and a step 13 exists between the support section 11 and the non-support section 12. The clamping section 31 of the guidewire 3 is disposed on the outer peripheral wall of the support section 11, and the step 13 prevents the clamping section 31 from moving from the support section 11 to the non-support section 12. The stimulation contact 2 is sleeved on the support section 11. When the tube body 1 is not subjected to external force, the clamping section 31 is abutted against the inner wall of the stimulation contact 2 radially by the support section 11, so as to electrically connect with the stimulation contact 2 by elastic contact. In this way, the two ends of the stimulation contact 2 can be held abutted by the two steps 13, and the clamping section 31 is clamped in the middle. Even if the shape of the clamping section 31 (such as the pitch or wavy shape) changes, it still contacts the inner wall of the stimulation contact 2, resulting in good conductivity. Furthermore, the step 13 confines the clamped section 31 to the support section 11, preventing the clamped section 31 from sliding to the non-support section 12 during assembly, and ensuring that the clamped section 31 is always in the correct position to engage with the stimulation contact 2.

[0066] Preferably, the stimulation contact 2 is interference-fitted onto the support section 11. This ensures that the stimulation contact 2 is reliably fixed to the support section 11, and the continuous radial compressive force generated by the interference fit allows the clamped section 31 to fit tightly against the stimulation contact 2.

[0067] In some embodiments, a tube of equal diameter is selected as the tube body 1 during the manufacturing of the stimulation electrode, and the outer diameter of the tube is larger than the inner diameter of the stimulation contact 2. After the stimulation contact 2 is interference-fitted onto the tube body 1, the portion of the tube body 1 covered by the stimulation contact 2 forms a support section 11, and the portion of the tube body 1 outside the stimulation contact 2 forms a non-support section 12. A step 13 is formed between the support section 11 and the non-support section 12 due to their flexible material and interference fit. That is, the outer diameter of the support section 11 of the tube body 1 is compressed under the clamping force of the stimulation contact 2, thereby forming a step 13 between the support section 11 and the non-support section 12.

[0068] In some embodiments, during the manufacturing of the stimulation electrode, an annular groove is formed on the outer peripheral wall of the equal-diameter tube, the axis of the annular groove being coincident with or parallel to the axis of the equal-diameter tube. Then, the equal-diameter tube with the annular groove is selected as the tube body 1, wherein the portion of the tube body 1 with the annular groove forms a support section 11, the portion of the outer peripheral wall of the tube body 1 that remains unchanged (i.e., the portion without the annular groove) forms a non-support section 12, and the end face of the annular groove forms a step 13.

[0069] See Figure 1 In some embodiments, the outer peripheral surface of the stimulation contact 2 is flush with the outer peripheral surface of the non-supported segment 12. This ensures a smooth and uniform outer surface of the stimulation electrode, facilitating its smooth passage through catheters or tissues during implantation or use, reducing friction and damage to surrounding tissues, and improving biocompatibility and ease of operation.

[0070] In other embodiments, the outer peripheral surface of the stimulation contact 2 may also protrude radially from the outer peripheral surface of the non-support section 12. In these embodiments, the outer peripheral surfaces of the stimulation electrodes are staggered, and after implantation into the body, the muscle tissue eventually grows into a shape that fits the outer peripheral surface of the stimulation electrodes, which is beneficial for fixing the stimulation electrodes.

[0071] See Figure 5 and Figure 6 In some embodiments, a through hole 14 is provided on the tube body 1, located in the support section 11, for the guide wire 3 to extend out of the tube body 1. When the tube body 1 is not subjected to external force, the stimulation contact 2 can cover the through hole 14. In this way, a portion of the guide wire 3 can pass through the through hole 14 to become the clamping section 31, which is convenient for the clamping section 31 to be placed on the outer peripheral wall of the support section 11. The stimulation contact 2 covering the through hole 14 can prevent the guide wire 3 from being exposed.

[0072] Preferably, the stimulation contact 2 and the tube body 1 are in elastic contact so that the stimulation contact 2 can seal the through hole 14. This prevents bodily fluids from flowing into the tube body 1 through the through hole 14, which could affect the service life of the stimulation electrode or cause stimulation failure.

[0073] In some embodiments, the through hole 14 can be a circular hole, a square hole, or a cut without material reduction, as long as it allows the guide wire 3 to extend out of the tube body 1.

[0074] In other embodiments, the tube body 1 does not have a dedicated through hole 14. When assembling the stimulation electrode, the tube body 1 is punctured with a tool and a portion of the guide wire 3 is hooked out.

[0075] contrast Figure 1 , Figure 3 and Figure 6 When the tube body 1 is not subjected to external force, the two ends of the stimulation contact 2 are respectively abutted against the step 13. In this way, the two ends of the stimulation contact 2 are abutted by the step 13, which can ensure that the guide wire 3 is clamped between the support section 11 and the stimulation contact 2. Even if the shape of the guide wire 3 (such as the pitch or the wavy shape) changes, it will still be in contact with the inner wall of the stimulation contact 2, thus maintaining good conductivity.

[0076] See Figure 2 In some embodiments, the guidewire 3 further includes a welding section 32, which is welded to the stimulation contact 2. The clamping section 31 is further away from the distal end of the guidewire 3 than the welding section 32. This provides dual electrical connection protection. In addition to the contact of the clamping section 31, the welding section 32 is added as an auxiliary electrical connection method. By positioning the clamping section 31 further away from the distal end of the guidewire 3, the welding section 32 is separated from the other elongated parts of the guidewire 3. The bending, torsion, and tension repeatedly experienced by the other elongated parts of the guidewire 3 are almost entirely exerted on the clamping section 31 and cannot affect the welding section 32. The welding section 32 is in a position with relatively low stress, effectively protecting the fragile weld point.

[0077] See Figure 3 , Figure 5 and Figure 6 In some embodiments, the through-hole 14 is located on the side closer to the proximal end of the support section 11, and the welding section 32 is located on the side closer to the distal end. In this way, the clamping section 31 of the guide wire 3 is longer, and the connection is more stable.

[0078] In other embodiments, the through-hole 14 is located on the side closer to the distal end of the support section 11, and the welding section 32 is located on the side closer to the proximal end. This also makes the clamping section 31 of the guide wire 3 longer and the connection more stable.

[0079] In one embodiment, the clamped section 31 of the guidewire 3 has a tightly wound structure to achieve surface contact with the inner peripheral wall of the stimulation contact 2.

[0080] See Figure 2 and Figure 7In some embodiments, the guidewire 3 further includes a welding section 32, which is welded to the stimulation contact 2. The stimulation contact 2 has a groove 21 near the welding section 32, and the welding section 32 is located within the groove 21. By providing a groove 21 at one end of the stimulation contact 2 to accommodate the welding section 32, the welding section 32 is prevented from protruding from the electrode surface. This protects the welding point from external physical impact and maintains the smoothness of the outer surface of the stimulation electrode, facilitating implantation and reducing tissue irritation.

[0081] The gap between any two of the stimulation contact 2, tube body 1, and welded section 32 can be sealed by injection to prevent tissue fluid or body fluid from seeping into the stimulation electrode. Existing technologies can be used for injection sealing, which will not be elaborated upon in this application.

[0082] It should be noted that the welding section 32 is provided as a redundant electrical connection structure. Specifically, the main electrical connection path between the guidewire 3 and the stimulation contact 2 is the abutting contact between the clamping section 31 and the inner wall of the stimulation contact 2; the welding section 32 is not a necessary structure for achieving the electrical connection, but rather serves as an additional guarantee outside the main electrical connection path. When the welding of the welding section 32 fails, the guidewire 3 and the stimulation contact 2 can still achieve a reliable electrical connection due to the abutting contact between the clamping section 31 and the inner wall of the stimulation contact 2.

[0083] In some embodiments, the distal end of the guidewire 3 is configured as part of the welding segment 32, i.e., the welding segment 32 extends to the distal end of the guidewire 3. In other embodiments, the welding segment 32 maintains a predetermined distance from the distal end of the guidewire 3, i.e., the welding segment 32 does not extend to the distal end of the guidewire 3, and the distal end of the guidewire 3 is inserted into the space between the tube body 1 and the stimulation contact 2 after the guidewire 3 is folded back.

[0084] In some embodiments, only one stimulation contact 2 and one guide wire 3 are provided. The portion of the guide wire 3 housed in the tube body 1 can be electrically insulated by wrapping an insulating layer around the guide wire 3, or the electrical isolation between the guide wires 3 can be achieved through the structure inside the tube body 1.

[0085] In one embodiment, the tube body 1 has multiple through cavities axially arranged inside, and one or more guide wires 3 are arranged in each through cavity. The guide wires 3 in different through cavities can be electrically isolated from each other through the through cavities.

[0086] In some embodiments, both the stimulation contact 2 and the guide wire 3 are provided in multiples. In order to prevent accidental contact and conduction between the guide wires 3, the portion of each guide wire 3 housed in the tube body 1 is wrapped with an insulating layer.

[0087] In some embodiments, both stimulation contacts 2 and guide wires 3 are provided in multiple ways. The tube body 1 is a multi-lumen tube with multiple independent cavities. Each independent cavity is used to accommodate one guide wire 3. Since each cavity is an independent cavity that is separated from each other, this has prevented accidental contact and conduction between guide wires 3. Therefore, the part of each guide wire 3 that is accommodated in the tube body 1 may not be wrapped with an insulating layer.

[0088] See Figure 3 In some embodiments, multiple stimulation contacts 2 and guide wires 3 are provided in a one-to-one correspondence, with any two adjacent stimulation contacts 2 spaced apart. This allows the stimulation electrodes to achieve multi-channel stimulation. By setting multiple mutually spaced stimulation contacts 2 and their corresponding guide wires 3, multi-point, independent, and precise electrical stimulation can be achieved. The spacing effectively prevents signal crosstalk between different channels, expanding the stimulation area while ensuring the independence of each stimulation contact 2 and the precision of the stimulation.

[0089] For example, the stimulation contact 2 and the guide wire 3 are provided with 2, 3, 4 or 5, and other numbers can be set as needed. This embodiment does not impose specific limitations.

[0090] In some embodiments, only one stimulation contact 2 and one guide wire 3 may be provided.

[0091] See Figures 2 to 5 Multiple support segments 11 and non-support segments 12 are provided, and the support segments 11 and non-support segments 12 are arranged alternately. The support segments 11 are arranged one-to-one with the stimulation contacts 2. By overfitting each stimulation contact 2 with its corresponding support segment 11, the spacing between any two adjacent stimulation contacts 2 is achieved.

[0092] In some embodiments, an annular structure can be fitted onto the non-supporting segment 12, which further ensures that any two adjacent stimulation contacts 2 are separated. In these embodiments, to ensure a smooth and uniform outer surface of the stimulation electrode, the annular structure is coaxially arranged with the supporting segment 11. Axially, the annular structure has the same dimensions as the non-supporting segment 12 on which it is located. Furthermore, the outer peripheral surface of the annular structure is flush with the outer peripheral surface of the stimulation electrode.

[0093] In some embodiments, the tube body 1 is made of elastic TPU (thermoplastic polyurethane elastomer), elastic PEBAX (polyether block amide), or silicone.

[0094] See Figure 8In some embodiments, to adapt to the needs of different surgeries, the stimulation electrode also includes a support 4, which is a hollow tubular structure, with the tube body 1 fitted onto the support 4. During implantation, the doctor inserts a guide wire with a certain rigidity into the support 4, using the guide wire to guide the stimulation electrode deeper into the human tissue and adjust the position of the stimulation electrode. For example, the support 4 is made of a relatively hard TPU or a relatively hard PEBAX. The material of the tube body 1 is not limited to those listed above; it is acceptable as long as it has appropriate elasticity, biocompatibility, and sufficient fatigue strength, and can provide stable radial pressure (i.e., elastic resistance) to the clamped segment 31 while withstanding the complex physiological environment within the body for a long period of time.

[0095] The material of the support 4 is not limited to those listed above, as long as it can provide reliable axial and radial support for the tube 1 and the overall structure, while meeting the requirements of the implant for corrosion resistance and biosafety.

[0096] The support can be a hollow tubular structure or a solid columnar structure.

[0097] The present application further provides a stimulation component, which includes a pulse generator and the above-mentioned stimulation electrode, with the guide wire 3 electrically connected to the pulse generator.

[0098] In this stimulation assembly, the stimulation electrode achieves electrical connection between the guidewire 3 and the stimulation contact 2 through a reliable elastic abutment structure, eliminating the reliance on welding connections between the guidewire 3 and the stimulation contact 2. Specifically, radially on the outer peripheral wall of the tube body 1, the tube body 1 elastically abuts the clamped section 31 of the guidewire 3 against the inner wall of the stimulation contact 2, thereby clamping the clamped section 31 together with the stimulation contact 2, confining the clamped section 31 to the inner wall of the stimulation contact 2, and achieving a direct electrical connection between the guidewire 3 and the stimulation contact 2 without welding points. This application fundamentally solves the problem that the guidewire 3 and the stimulation contact 2 are prone to disconnection at the welding points under the trend of miniaturization of stimulation electrodes. As a result, the reliability and fatigue life of the electrical connection between the guidewire 3 and the stimulation contact 2 are significantly improved, ensuring that the stimulation electrode can work stably and for a long time in vivo, reducing the risk of treatment interruption due to stimulation electrode failure.

[0099] Moreover, by using the flexible tube 1 to abut the guide wire 3 against the stimulation contact 2, no additional fixing parts are needed, which helps to reduce the overall size of the stimulation electrode and meet the miniaturization design requirements of the stimulation electrode.

[0100] Furthermore, traditional welding connections are point contacts, while the stimulation electrode in this application achieves line-to-surface contact through the aforementioned elastic abutment, increasing the conductive sites between the guide wire 3 and the stimulation contact 2, resulting in better conductivity.

[0101] Furthermore, the miniature stimulation electrode is very small in size. In a miniature stimulation electrode, the solder joint can only be located outside the stimulation contact 2, which can easily protrude from the stimulation contact 2 and form burrs that can scratch human tissue. In the stimulation electrode provided in this application, the clamping section 31 is located inside the stimulation contact 2 and is not exposed on the outside. There are no burrs or other protrusions on the outside of the stimulation contact 2, which helps to protect human tissue.

[0102] Finally, in the existing technology, the stimulation contact 2 and the tube body 1 are not fixedly connected, and their relative rotation is not restricted. In existing stimulation electrodes that use welding to achieve electrical connection, the stimulation contact 2 and the tube body 1 may rotate relative to each other during human activity. Since the welding point position is fixed, either the guide wire 3 follows the welding point position, and the length of the guide wire 3 protruding outside the tube body 1 increases, and the change in the position of the guide wire 3 inside the tube body 1 may cause instability in the connection of the guide wire 3. When the stimulation contact 2 rotates back, the guide wire 3 protruding outside the tube body 1 cannot be retracted, forming a redundant length. This redundant length of guide wire 3 may cut human tissue and is also prone to breakage; or the guide wire 3 does not follow the welding point position. When the guide wire 3 welding point rotates with the stimulation contact 2, it may directly break the guide wire 3 or damage the welding point position. In summary, the existing welding method leads to a shorter service life of the guide wire 3, and long-term use may also cause hidden damage, such as cutting human tissue. In the stimulation electrode provided in this application, even if the stimulation contact 2 rotates relative to the tube body 1, it does not affect the line-to-surface contact between the two. The stimulation contact 2 rotates back and forth relative to the tube body 1. Since there is an elastic abutment between the stimulation contact 2 and the tube body 1 and the guide wire 3 is relatively movable, it is difficult to form redundant length. Even if redundant length is formed, it will be limited between the stimulation contact 2 and the tube body 1 and will not expose the cutting of human tissue, thereby avoiding hidden damage during long-term use.

[0103] In some embodiments, the stimulation electrode further includes a connecting contact point (not shown in the figure), which is fixed to the tube body 1. One end of the guidewire 3 away from the stimulation contact point 2 is electrically connected to the connecting contact point. The connecting contact point is pluggable and detachable to the pulse generator to realize the electrical connection between the guidewire 3 and the pulse generator.

[0104] In some embodiments, the guide wire 3 is electrically connected to the pulse generator by means of welding, threaded connection or other connection methods.

[0105] This application also provides a method for manufacturing a stimulation electrode, which is used to manufacture the above-mentioned stimulation electrode. The method for manufacturing the stimulation electrode includes the following steps: S100. Pass part of the guide wire 3 through the wall of the tube body 1 so that part of the guide wire 3 is outside the tube body 1; S200. Apply external force to elongate tube 1, so that tube 1 becomes thinner; S300. With the tube body 1 becoming thinner, the stimulation contact 2 is placed on the part of the guide wire 3 outside the tube body 1. S400, release the external force, the tube 1 recovers, so that in the process of recovering the outer diameter of the tube 1, the guide wire 3 is elastically abutted against the inner wall of the stimulation contact 2 in the radial direction of the outer peripheral wall of the tube 1.

[0106] In step S400, the portion of the tube body 1 located outside the stimulation contact 2 can fully recover its outer diameter because it is not constrained by the stimulation contact 2, and this portion forms the non-supported section 12; the portion of the tube body 1 covered by the stimulation contact 2 cannot fully recover its outer diameter because it is constrained by the stimulation contact 2, and this portion forms the support section 11. The support section 11 elastically abuts the guide wire 3 against the inner wall of the stimulation contact 2 in the radial direction of the outer peripheral wall of the tube body 1, and the portion of the guide wire 3 that is elastically abutted against the inner wall of the stimulation contact 2 by the support section 11 forms the clamped section 31.

[0107] This method for manufacturing a stimulation electrode utilizes the elasticity of the tube 1. After thinning the tube 1, the stimulation contact 2 is smoothly fitted onto the tube 1 and the guide wire 3, avoiding damage to the guide wire 3. Furthermore, the rebound property of the tube 1 allows the guide wire 3 to elastically abut against the inner wall of the stimulation contact 2, thus clamping the guide wire 3 together with the stimulation contact 2. This achieves a direct electrical connection between the guide wire 3 and the stimulation contact 2 without solder joints, fundamentally solving the problem of easy breakage at solder joints between the guide wire 3 and the stimulation contact 2 in the trend of miniaturization of stimulation electrodes. Moreover, this method for manufacturing stimulation electrodes is simple to manufacture and has high conductivity reliability.

[0108] Preferably, in step S100, a tube with elasticity that can be axially stretched by an external force to reduce its outer diameter is selected as the tube body 1; in step S200, the tube body 1 is lengthened to make the tube body 1 thinner.

[0109] In some embodiments, the following step is included before step S300: S500, with the tube body 1 thinned, a portion of the guide wire 3 is spirally wound around the outer peripheral wall of the tube body 1 to form a spiral structure. In step S300, with the tube body 1 thinned, the stimulation contact 2 is fitted onto the spiral structure. Thus, in the final stimulation electrode, the guide wire 3 contacts the stimulation contact 2 through the spiral structure, which increases the contact length between the guide wire 3 and the stimulation contact 2, increasing the number of conductive sites and improving conductivity. Furthermore, the increased contact length and friction between the guide wire 3, the stimulation contact 2, and the tube body 1 prevents the guide wire 3 from shifting axially in the tube body 1, enhancing the long-term stability of the electrical connection. Simultaneously, the spiral structure provides a certain elastic buffering effect, better dispersing and absorbing external stress, further improving the bending and tensile strength of the guide wire 3, which is beneficial for ensuring a reliable electrical connection between the guide wire 3 and the stimulation contact 2.

[0110] In some embodiments, the following steps are included before step S500: S600, the stimulation contact 2 is fitted onto the tube body 1, and the stimulation contact 2 is positioned closer to the proximal end of the tube body 1 than the position where the guide wire 3 exits the tube body 1. In step S500, starting from the position where the guide wire 3 exits the tube body 1, the guide wire 3 is spirally wound towards the distal end of the tube body 1 to form a spiral structure. In step S300, the stimulation contact 2 is moved toward the spiral structure and fitted onto the spiral structure. Thus, in step S300, it is easy to fit the stimulation contact 2 onto the spiral structure formed by the guide wire 3 by moving it.

[0111] In some embodiments, the following step is included before step S500: S600, the stimulation contact 2 is fitted onto the tube body 1, and the stimulation contact 2 is closer to the distal end of the tube body 1 than the position where the guide wire 3 exits the tube body 1. In step S500, starting from the position where the guide wire 3 exits the tube body 1, the guide wire 3 is spirally wound towards the proximal end of the tube body 1 to form a spiral structure. In step S300, the stimulation contact 2 is moved toward the spiral structure and fitted onto the spiral structure. Thus, in step S300, it is easy to fit the stimulation contact 2 onto the spiral structure formed by the guide wire 3 by moving it.

[0112] In some embodiments, the inner diameter of the stimulation contact 2 is D0, the diameter of the guidewire 3 is d0, and the real-time outer diameter of the tube body 1 is defined as D. In some embodiments, in step S200, the tube body 1 is lengthened to make it thinner to ≤D0-2d0. In step S500, with D≤D0-2d0, a portion of the guidewire 3 is spirally wound around the outer peripheral wall of the tube body 1.

[0113] Preferably, in some embodiments, the inner diameter of the stimulation contact 2 is D0, the diameter of the guidewire 3 is d0, and the real-time outer diameter of the tube body 1 is defined as D. In some embodiments, in step S200, the tube body 1 is lengthened to make it thinner to = D0 - 2d0. In step S500, with D = D0 - 2d0, a portion of the guidewire 3 is spirally wound around the tube body 1 along its outer peripheral wall. This ensures that the radial gap between the outer peripheral wall of the tube body 1 and the inner wall of the stimulation contact 2 matches the size of one turn of the guidewire 3, preventing the tube body 1 from applying excessive radial outward force to the spiral structure formed by the guidewire 3 in step S500. This helps reduce mechanical stress damage to the guidewire 3 during clamping, protects the structural integrity of the guidewire 3, and thus improves the electrical connection reliability and long-term service life of the stimulation electrode. It also helps maintain the spiral structure shape of the guidewire 3, preventing the spiral structure from being excessively stretched during the process of the tube body 1 restoring its outer peripheral diameter.

[0114] In step S100, a tube of equal diameter is selected as the tube body 1. In step S300, an annular stimulation contact 2 is selected, and the outer diameter of the stimulation contact 2 is equal to the outer diameter of the tube of equal diameter. Thus, after manufacturing, the outer peripheral surface of the non-support section 12 is flush with the outer peripheral surface of the stimulation contact 2. This ensures that the overall outer diameter of the stimulation electrode is consistent and the surface is smooth, which is not only aesthetically pleasing but, more importantly, facilitates implantation and reduces friction and damage to tissues.

[0115] Those skilled in the art will understand that the structure and method applied to the stimulation contact 2 in this application can be equivalently applied to the connection contact, which is used to connect to the pulse generator.

[0116] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0117] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of protection of this application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the appended claims.

Claims

1. A stimulation electrode, characterized in that, include: The tube (1) is elastic and hollow inside; The stimulation contact (2) is projected in a ring or C shape on at least one plane parallel to the cross-section of the tube (1) and is sleeved on the tube (1). A guide wire (3) is used to electrically connect the pulse generator and the stimulation contact (2); part of the guide wire (3) is housed in the tube (1), and another part of the guide wire (3) extends out of the tube (1) to become a clamped section (31); when the tube (1) is not subjected to external force, the clamped section (31) is elastically abutted against the inner wall of the stimulation contact (2) by the tube (1) in the radial direction of the outer peripheral wall of the tube (1) so as to be electrically connected to the stimulation contact (2) by elastic abutment.

2. The stimulation electrode according to claim 1, characterized in that, The tube (1) is elastic and can be stretched axially by an external force to reduce its outer diameter to form a stretched state, and after the external force is removed, the outer diameter is restored to form a normal state. In the stretched state, the sum of the outer diameter of the tube (1) and the diameter of the clamped section (31) is less than or equal to the inner diameter of the stimulation contact (2), and in the normal state, the sum of the outer diameter of the tube (1) and the diameter of the clamped section (31) is greater than the inner diameter of the stimulation contact (2).

3. The stimulation electrode according to claim 1, characterized in that, The tube (1) is elastic and can be stretched axially by an external force to reduce its outer diameter to form a stretched state, and after the external force is removed, the outer diameter is restored to form a normal state. In the stretched state, the sum of the outer circumferential diameter of the tube body (1) and at least twice the diameter of the clamped section (31) is less than or equal to the inner diameter of the stimulation contact (2), and in the normal state, the sum of the outer circumferential diameter of the tube body (1) and at least twice the diameter of the clamped section (31) is greater than the inner diameter of the stimulation contact (2).

4. The stimulation electrode according to claim 1, characterized in that, The clamped section (31) is bent and disposed on the outer peripheral wall of the tube body (1); or, The clamped section (31) is spirally wound around the outer peripheral wall of the tube body (1).

5. The stimulation electrode according to claim 1, characterized in that, The tube body (1) includes a support section (11) and a non-support section (12) connected to each other. The outer diameter of the support section (11) is smaller than the outer diameter of the non-support section (12), and there is a step (13) between the support section (11) and the non-support section (12). The clamped section (31) of the guide wire (3) is disposed on the outer peripheral wall of the support section (11), and the step (13) can prevent the clamped section (31) from moving from the support section (11) to the non-support section (12). The stimulation contact (2) is sleeved on the support section (11); when the tube body (1) is not subjected to external force, the clamping section (31) is abutted against the inner wall of the stimulation contact (2) by the support section (11) on the radial side of the outer peripheral wall of the support section (11) so as to be electrically connected to the stimulation contact (2) by elastic contact.

6. The stimulation electrode according to claim 5, characterized in that, The outer peripheral surface of the stimulation contact (2) is flush with the outer peripheral surface of the non-support segment (12); and / or, The tube body (1) has a through hole (14) located in the support section (11). The through hole (14) is used to allow the guide wire (3) to extend out of the tube body (1). When the tube body (1) is not subjected to external force, the stimulation contact (2) can cover the through hole (14).

7. The stimulation electrode according to claim 5, characterized in that, When the tube (1) is not subjected to external force, the two ends of the stimulation contact (2) respectively abut against the step (13); and / or, The tube body (1) has a through hole (14) located in the support section (11). The through hole (14) is used to allow the guide wire (3) to extend out of the tube body (1). When the tube body (1) is not subjected to external force, the stimulation contact (2) can cover the through hole (14) and the stimulation contact (2) and the tube body (1) are in elastic contact so that the stimulation contact (2) can seal the through hole (14).

8. The stimulation electrode according to claim 1, characterized in that, The guidewire (3) further includes a welding section (32) welded to the stimulation contact (2), the clamped section (31) being further distal to the guidewire (3) than the welding section (32); and / or, The guide wire (3) also includes a welding section (32), which is welded to the stimulation contact (2). The stimulation contact (2) has a groove (21) at one end near the welding section (32), and the welding section (32) is located in the groove (21).

9. A stimulation component, characterized in that, It includes a pulse generator and a stimulation electrode according to any one of claims 1 to 8, wherein the guide wire (3) is electrically connected to the pulse generator.

10. A method for manufacturing a stimulating electrode, used to manufacture the stimulating electrode according to any one of claims 1 to 8, characterized in that, Including the following steps: Pass a portion of the guide wire (3) through the wall of the tube body (1) so that a portion of the guide wire (3) is located outside the tube body (1); An external force is applied to elongate the tube (1) to make the tube (1) thinner; With the tube (1) tapering, the stimulation contact (2) is placed on the portion of the guide wire (3) outside the tube (1); When the external force is released, the tube (1) recovers, so that in the process of recovering the outer diameter of the tube (1), the guide wire (3) is elastically abutted against the inner wall of the stimulation contact (2) in the radial direction of the outer peripheral wall of the tube (1).

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