Stimulating electrodes and methods of making the same

Abstract

The embodiment of the present application discloses a stimulating electrode and a manufacturing method thereof. The stimulating electrode comprises a stimulating part, an extension part and a plurality of connecting parts connected in sequence. A plurality of stimulating contacts are arranged on the stimulating part, and a plurality of connecting contacts are arranged on each of the plurality of connecting parts. The extension part comprises a main stem, a plurality of branches and a plurality of wires. One end of the main stem is connected with the stimulating part, and the other end is connected with the plurality of branches. The plurality of branches are connected with the plurality of connecting parts one by one. The plurality of wires are arranged in the main stem and the plurality of branches, and the stimulating contacts and the connecting contacts are electrically connected one by one. The plurality of connecting contacts are arranged on the plurality of connecting parts respectively, so that the length of the connecting part is controlled.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a stimulation electrode and its manufacturing method. Background Technology

[0002] Spinal nerve stimulation (SCS) is a neuromodulation technique that uses implanted electrodes to deliver electrical pulses, selectively activating the dorsal column nerve fibers of the spinal cord, thereby "gate-controlling" the transmission of pain signals to the brain. This therapy is primarily suitable for chronic pain that is difficult to control with traditional medications or surgery, such as postoperative back pain syndrome, complex regional pain syndrome, and intractable neuralgia. SCS not only significantly relieves pain and improves limb function but also reduces opioid dependence and improves patients' long-term quality of life, making it an important pillar of interventional pain management.

[0003] As clinical demands for stimulation precision continue to increase, the number of stimulation contacts on the stimulation section and the number of wires in the extension section are constantly increasing, leading to an increase in the number of connection contacts in the connection section. However, the length of the connection section is limited by the structure of the pulse generator's insertion cavity. If the number of connection contacts is too large, resulting in an excessively long connection section, it will not only affect the insertion stability between the connection section and the pulse generator. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a stimulation electrode and a method for manufacturing the same, wherein the stimulation electrode controls the length of the connection portion by grouping multiple contact points, thereby ensuring insertion stability and control accuracy.

[0005] In a first aspect, embodiments of the present invention provide a stimulation electrode, the stimulation electrode comprising: The stimulation section is equipped with multiple stimulation contacts; Multiple connecting parts are provided for connecting to the pulse generator, and multiple connection contact points are provided; The extension section includes a main trunk, multiple branches, multiple wires, and connecting components. The main trunk is connected to the stimulation section, the multiple branches are connected to the multiple connecting sections one by one, and the multiple wires are arranged inside the main trunk and branches to connect the multiple stimulation contacts one by one with the multiple connecting contacts. The connection between the trunk and the branches is sealed and enclosed within the connecting assembly, and at least a portion of the trunk and / or branches is a composite structure with a braided layer.

[0006] Furthermore, the connection component includes: A sleeve, one end of which is fitted onto the end of the main trunk near the branch, and the other end extending to the end of each branch near the main trunk, wrapping and securing the ends of all branches; and Filler adhesive, filled into the sleeve, is used to seal and fix the main trunk and branches.

[0007] Furthermore, multiple branches are arranged side by side within the casing; The cross-sectional area of ​​the sleeve gradually decreases from the middle towards the end where the main trunk is located.

[0008] Furthermore, the stimulation part also includes a first substrate, with multiple stimulation contacts disposed on the first substrate, the diameter of the first substrate being 0.3 mm to 2 mm.

[0009] Furthermore, the stimulation contacts are annular contacts, with multiple stimulation contacts arranged along the length of the first substrate, and the distance between two adjacent stimulation contacts is 0.5 mm to 8 mm.

[0010] Furthermore, the stimulation part is equipped with no fewer than 8 stimulation contacts.

[0011] Furthermore, the stimulation electrode includes multiple distinguishing marks, which are disposed on branches or connections, and the distinguishing marks include one or more of color marks, number marks, or raised dot marks.

[0012] Furthermore, both the trunk and branches include exposed segments and enclosed segments wrapped by connected components; The woven layer is at least partially disposed in the wrapping section, or the woven layer extends from one end of the exposed section near the wrapping section to the other end; The braided layer includes non-metallic braided layers and / or metallic braided layers.

[0013] Secondly, embodiments of the present invention also provide a method for fabricating a stimulation electrode as described in the first aspect, comprising: Thread multiple wires through the main trunk, and thread the first end of each wire through the corresponding branch; Electrically connect the first end of each conductor group to the corresponding multiple contact points on the connecting part; Connect the second end of each wire to the corresponding stimulation contact on the stimulation part; The end of the main trunk near the branch and the end of each branch near the main trunk are sealed and secured using connecting components.

[0014] Furthermore, the end of the main trunk near the branch and the end of each branch near the main trunk are sealed and secured using a connecting assembly, including: The sheath is inserted into the stimulation section or connecting section and placed on the main trunk and branches, with the branches arranged side by side inside the sheath. Inject filler into the sleeve to seal and fix the main trunk and branches inside the sleeve.

[0015] This invention provides a stimulation electrode and its manufacturing method. The stimulation electrode includes a stimulation part, an extension part, and multiple connecting parts connected in sequence. The stimulation part has multiple stimulation contacts, and each of the multiple connecting parts has multiple connection contacts. The extension part includes a main stem, multiple branches, and multiple wires. One end of the main stem is connected to the stimulation part, and the other end is connected to the multiple branches. Each branch is connected to one of the multiple connecting parts. The multiple wires are disposed within the main stem and the multiple branches, electrically connecting the stimulation contacts to the connection contacts one-to-one. This invention controls the length of the connecting parts by distributing multiple connection contacts on multiple connecting parts. The connection between the main body and each branch is sealed within a connecting assembly, and at least a portion of the main stem and / or branches is provided with a braided layer to improve the structural reliability and sealing of the extension part at the bifurcation points, reducing the risk of wire breakage and short circuits. Attached Figure Description

[0016] The above and other objects, features and advantages of the present invention will become clearer from the following description of embodiments of the invention with reference to the accompanying drawings, in which: Figure 1 This is a schematic diagram of the overall structure of a stimulation electrode according to the present invention; Figure 2 This is a schematic diagram of the internal structure of a connection component according to the present invention; Figure 3 This is a schematic diagram of the overall structure of another stimulation electrode of the present invention; Figure 4 This is a schematic diagram of the internal structure of another connecting component of the present invention; Figure 5 This is a schematic diagram of the overall structure of another stimulation electrode of the present invention; Figure 6 This is a flowchart illustrating the method for fabricating the stimulation electrode of the present invention. Figure 1 ; Figure 7 This is a flowchart illustrating the method for fabricating the stimulation electrode of the present invention. Figure 2 .

[0017] Figure label: 10-Stimulation section; 11-Stimulation contact; 12-First substrate; Q, Q'-Contact unit; 20, 20' - Connecting part; 21, 21' - Connecting contact point; 22 - Distinguishing mark; 23, 23' - Second base; 24 - Connecting ring; 30, 30' - Extension section; 31, 31' - Main trunk; 32, 32' - Branch; 33 - Conductor; 34, 34' - Connecting assembly; 341, 341' - Sleeve; X - Length direction; A, A' - Exposed segment; B, B' - Wrapped segment. Detailed Implementation

[0018] The present invention is described below based on embodiments, but the invention is not limited to these embodiments. In the detailed description of the invention below, certain specific details are described in detail. Those skilled in the art will fully understand the invention even without these details. To avoid obscuring the essence of the invention, well-known methods, processes, flows, elements, and circuits are not described in detail.

[0019] Furthermore, those skilled in the art should understand that the accompanying drawings provided herein are for illustrative purposes only and are not necessarily drawn to scale.

[0020] Unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," 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 invention according to the specific circumstances.

[0021] Unless the context explicitly requires it, words such as "including" or "comprising" throughout the invention document should be interpreted as including rather than exclusive or exhaustive; that is, meaning "including but not limited to".

[0022] In the description of this invention, it should be understood that the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Furthermore, in the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0023] Reference Figure 1-4 The present invention provides a stimulation electrode, which includes a stimulation part 10, a plurality of connecting parts 20, 20', and extension parts 30, 30'. The stimulation part 10 is used for implantation in the epidural space of the spinal cord, the connecting parts 20, 20' are used for electrical connection to a pulse generator, and the extension parts 30, 30' are connected between the stimulation part 10 and the connecting parts 20, 20' to form a stimulation signal transmission path.

[0024] The stimulation electrode is equipped with multiple stimulation contacts 11 and multiple connecting contacts 21, 21'. The multiple stimulation contacts 11 can meet the multi-contact requirements of clinical applications. The multiple connecting contacts 21, 21' are divided into multiple groups, with each group of connecting contacts 21, 21' located on multiple connecting portions 20, 20', thus relatively reducing the number of connecting contacts 21, 21' on a single connecting portion 20, 20'. This design not only avoids unstable insertion and poor contact caused by excessively long connecting portions 20, 20', but also keeps the spacing between adjacent connecting contacts 21, 21' within a reasonable range, thereby effectively avoiding signal crosstalk and improving the independent control accuracy of each stimulation contact 11. Correspondingly, the extensions 30 and 30' include multiple branches 32 and 32' to connect to each of the connecting parts 20 and 20' respectively, so that the multiple wires 33 inside the stimulation electrode can be connected from the stimulation part 10 to the connecting parts 20 and 20' in an orderly manner, thus completing the corresponding electrical connection between the stimulation contact 11 and the connecting contact 21 and 21'.

[0025] Optionally, the multiple stimulation contacts 11 are divided into multiple contact units Q and Q' according to their function or location, and each connecting part 20 and 20' is correspondingly provided with one contact unit Q and Q'. Each connecting part 20 and 20' is provided with multiple connecting contacts 21 and 21', which are connected one-to-one with the multiple stimulation contacts 11 in the corresponding contact unit Q and Q' through the wires 33 in the extension parts 30 and 30', thereby facilitating the establishment of an independent signal transmission circuit for each connecting contact 21 and 21' and realizing precise control of the target nerve region. Optionally, a contact unit Q and Q' may contain multiple adjacent stimulation contacts 11 or multiple non-adjacent stimulation contacts 11.

[0026] In this invention, the extensions 30 and 30' include main trunks 31 and 31', multiple branches 32 and 32', multiple conductors 33, and connecting components 34 and 34'. The main trunks 31 and 31' and the branches 32 and 32' are hollow tubular structures, with internal cavities extending axially and having a circular or elliptical cross-sectional shape. The inner diameter of the main trunks 31 and 31' matches the overall outer diameter of the multiple conductors 33, while the inner diameter of the branches 32 and 32' is adapted to the outer diameter of the corresponding conductor groups passing through them.

[0027] Multiple wires 33 are concentrated within the lumens of the main tubes 31 and 31'. The first ends of the multiple wires 33 are divided into multiple groups, and each group extends through corresponding branches 32 and 32' to the connecting parts 20 and 20', achieving electrical connection with multiple contact points 21 and 21' on each connecting part 20 and 20'. The second ends of the multiple wires 33 all extend to the stimulation part 10 and are electrically connected to each stimulation contact 11 in the corresponding contact units Q and Q'. This grouping wiring method makes the wiring paths of the multiple wires 33 clear and orderly, facilitating the corresponding connection of the contact points 21 and 21' with the stimulation contacts 11.

[0028] Optionally, the multiple wires 33 are divided into multiple wire groups according to the number of branches 32, 32', with each wire group corresponding to one branch 32, 32'. The first end of each wire group extends through the corresponding branch 32, 32' to the connecting portion 20, 20', and is electrically connected to each connecting contact point 21, 21' on the corresponding connecting portion 20, 20'. The second end of each wire group extends through the main branch 31, 31' to the stimulation portion 10, and is electrically connected to each stimulation contact point 11 in the corresponding contact unit Q, Q'. By grouping the multiple wires 33 and distributing them within multiple branches 32, 32', it helps to achieve an orderly arrangement of the wires 33, avoiding entanglement and compression of the multiple wires 33 inside the extension portion 30, 30', thereby reducing the risk of short circuits or open circuits between the wires 33, and significantly improving the electrical reliability and service life of the stimulation electrode.

[0029] Optionally, when multiple conductors 33 are grouped, each conductor group can be arranged by limiting the position of each conductor group through a positioning clamp with a wire groove, or it can be spirally wound into a group, or each conductor group can be wrapped and shaped by a covering layer, and then the pre-fixed conductor groups are inserted into the main trunks 31, 31'.

[0030] In this invention, the extension 30 further includes a connecting component 34, which is disposed at the bifurcation point between the main trunk 31 and the branch 32. The main trunks 31 and 31' and each branch 32 and 32' are connected by the connecting components 34 and 34' to strengthen and fix the overall structure. The ends of the main trunks 31 and 31' near the branches 32 and 32' and the ends of each branch 32 and 32' near the main trunk 31 and 31' are all enclosed within the connecting components 34 and 34' to limit the relative displacement and torsion between the main trunk 31 and each branch 32, thereby improving the stability of the connection and the reliability of the structure.

[0031] Specifically, the connecting components 34 and 34' include sleeves 341 and 341' and filler adhesive (not shown in the figure). Sleeves 341 and 341' are hollow tubular structures open at both ends, with an axially continuous cavity inside. The thickness of sleeves 341 and 341' is between 0.7mm and 2mm. One end of sleeves 341 and 341' used for connection with the main shafts 31 and 31' is the first end, and the other end is the second end. The length direction of sleeves 341 and 341' is defined from the first end to the second end. Multiple blocking portions (not shown) are spaced apart along the length direction on the inner wall of sleeves 341 and 341' near the first end. These blocking portions are annular protrusions or other shaped protrusions. From the second end to the first end of sleeves 341 and 341', the volume of the multiple blocking portions increases, meaning the space blocked by the multiple blocking portions increases, and the space of the cavity at the multiple blocking portions decreases. During the injection of filler adhesive, the resistance to overflow of filler adhesive from the first end of sleeve 341, 341' is increased, the uniformity of filler adhesive in sleeve 341, 341' is improved, and the sealing performance of the connection between sleeve 341, 341' and main body 31, 31' is improved.

[0032] The sheaths 341 and 341' are made of silicone rubber, offering good stability and suitability for long-term implantation. In some embodiments of this invention, the sheaths 341 and 341' have a double-layer structure. The inner layer is made of polyurethane, which facilitates bonding with filler adhesives (such as medical-grade UV-cured adhesives, silicone adhesives, or epoxy resins), resulting in better connection stability. The outer layer of the sheaths 341 and 341' is made of silicone rubber, possessing high strength and wear resistance, suitable for long-term implantation and contact with human tissue, thus improving the stability of the electrode leads after implantation.

[0033] The first end of the sleeves 341 and 341' has the same shape and size as the main trunks 31 and 31', and is fitted onto the outer side of the main trunks 31 and 31' near the branches 32 and 32'. The second end of the inner wall of the sleeves 341 and 341' extends to the end of each branch 32 and 32' near the main trunk 31 and 31', and wraps and fixes the ends of all branches 32 and 32'. The ends of multiple branches 32 and 32' are arranged side by side in the cavity of the sleeves 341 and 341'; or, the ends of multiple branches 32 and 32' are evenly distributed circumferentially, with gaps between the branches 32 and 32' and without mutual compression.

[0034] Furthermore, the outer surfaces and both ends of the sheaths 341 and 341' are smoothed. Specifically, the outer surfaces of the sheaths 341 and 341' are deburred and sharpened through grinding or polishing processes to form a continuous, smooth outer wall surface. Both the first and second end ports of the sheaths 341 and 341' are provided with chamfered or rounded corner structures to eliminate sharp edges at the ports. This smoothing treatment effectively reduces wear between the sheaths 341 and 341' and surrounding tissues after implantation, lowering the risk of tissue inflammation. Optionally, the sheaths 341 and 341' can be made of a flexible polymer material.

[0035] A filler adhesive is applied to the sleeve body to seal and fix the main trunks 31, 31' and each branch 32, 32'. Specifically, the filler adhesive fills the gaps between the sleeves 341, 341' and the wires 33, the gaps between the sleeves 341, 341' and the main trunks 31, 31', and the gaps between the sleeves 341, 341' and the branches 32, 32'. The filler adhesive can fix the relative position of each wire 33, preventing relative movement and wear during use. Furthermore, the filler adhesive is also used to seal the ports of the main trunks 31, 31' and the ports of the branches 32, 32', preventing bodily fluids from seeping into the extensions 30, 30' along the gaps between the wires 33 and the main trunks 31, 31' and the branches 32, 32'.

[0036] It should be noted that the filler adhesive refers to materials such as medical-grade light-curing adhesive, silicone adhesive or epoxy resin, which are filled into the cavities of sleeves 341 and 341' and cured to seal and encapsulate the main trunks 31 and 31' and branches 32 and 32'.

[0037] In other embodiments of the invention, reference is made to... Figure 5 The main trunk 31 and branch 32 are tubular structures, and at least a portion of the main trunk 31 and / or branch 32 is a composite structure with a braided layer. The braided layer 35 is disposed on the inner or outer side of the tube wall of the main trunk 31 and / or branch 32, or embedded in the middle layer of the tube wall in the form of a sandwich layer, so that at least a portion of the main trunk 31 and / or branch 32 forms a composite tube. The braided layer 35 can significantly improve the tensile strength on both sides of the connecting component 34, while maintaining good flexibility, thereby protecting the internal wires 33 from damage during long-term use.

[0038] Reference Figure 2 and Figure 4 The main trunks 31 and 31' and branches 32 and 32' each include exposed segments A and A' and wrapped segments B and B' that are enclosed by the connected components 34.

[0039] The braided layer 35 is at least partially disposed in the wrapping sections B and B'. Specifically, one end of the braided layer 35 is disposed in the wrapping sections B and B' of the main trunks 31 and 31', and the other end extends into the exposed sections A and A' of the main trunks 31 and 31'; and / or, one end of the braided layer 35 is disposed in the wrapping sections B and B' of the branches 32 and 32', and the other end extends into the exposed sections A and A' of the branches 32 and 32'.

[0040] Optionally, the braided layer 35 extends from one end of the exposed sections A and A' near the wrapping sections B and B' to the other end. Specifically, the braided layer 35 extends from one end of the exposed sections A and A' near the main trunk 31 and 31' wrapping sections B and B' to the other end; and / or, the braided layer 35 extends from one end of the exposed sections A and A' near the branch 32 and 32' wrapping sections B and B' to the other end.

[0041] Optionally, the woven layer 35 includes a non-metallic woven layer. This non-metallic woven layer is formed by weaving a woven mesh or reinforcing membrane material.

[0042] Optionally, the braided layer 35 includes a metal braided layer. This metal braided layer is made of a specific metal (such as stainless steel or nickel-titanium alloy) and woven into a specific structure (such as a monofilament braided mesh or a parallel-filament braided mesh), which improves the structural strength of the extension 30 while forming an electromagnetic shielding layer, thereby enhancing the magnetic resonance compatibility of the stimulation electrode.

[0043] Optionally, the braided layer 35 is a multi-layer structure design, using a composite structure of non-metallic braided layer and metallic braided layer, which can improve the strength of the electrode structure and also have magnetic resonance compatibility.

[0044] Optionally, the main trunks 31 and 31' are provided with a metal braided layer, one end of which is located in the wrapping section B and B' of the main trunks 31 and 31', and the other end extends into the exposed section A and A' of the main trunks 31 and 31'. The branches 32 and 32' are provided with a non-metallic braided layer of woven mesh or reinforcing membrane material. One end of this non-metallic braided layer is located in the wrapping section B and B' of the branches 32 and 32', and the other end extends into the exposed section A and A' of the branches 32 and 32'. The length of the metal braided layer on the main trunks 31 and 31' is not less than half the total length of the extensions 30 and 30' to ensure magnetic resonance compatibility.

[0045] In this invention, the stimulation part 10 is further provided with a first base 12, and a plurality of stimulation contacts 11 are disposed on the first base 12. The diameter of the first base 12 ranges from 0.3 mm to 2 mm to accommodate the limited space of the epidural space of the spinal cord. The first base 12 is made of medical-grade polymer material (such as polyurethane, silicone rubber or other polymer materials) and has good biocompatibility. The stimulation contacts 11 are annular contacts, arranged circumferentially around the first base 12, and are made of conductive metal (such as platinum-iridium alloy or cobalt alloy), which has excellent conductivity, corrosion resistance and biocompatibility. The plurality of stimulation contacts 11 are arranged along the length direction X of the first base 12, and the spacing between two adjacent stimulation contacts 11 can be set to different values ​​between 0.5 mm and 8 mm according to the nerve distribution density of different segments of the spinal cord to achieve precise stimulation.

[0046] Each connecting portion 20, 20' also includes a second substrate 23, 23'. The second substrate 23, 23' is a tubular structure with a chamfered end away from the stimulation portion 10 to form a smooth transition. This chamfered structure guides the connection between the stimulation electrode and the pulse generator, facilitating the smooth insertion of the second substrate 23, 23' into the top cover of the pulse generator. Connecting contact points 21, 21' are located on the second substrate 23, 23', and the connecting contact points 21, 21' on each connecting portion 20, 20' are mutually insulated. Multiple connecting contact points 21, 21' are arranged at intervals along the length X of the second substrate 23, 23' to prevent short circuits between adjacent connecting contact points 21, 21'. The second substrate 23, 23' can be made of medical-grade polyurethane or silicone rubber.

[0047] In this invention, the number of stimulation contacts 11 provided on the stimulation part 10 can be determined according to clinical needs to cover a sufficiently large nerve area and provide a rich combination of stimulation.

[0048] Optionally, the number of stimulation contacts 11 can be set to 16 or 32, etc., to provide more precise stimulation control and more combinations of stimulation modes. Correspondingly, the number of connecting contacts 21 and 21' on each connecting part 20, 20' is specifically set according to the number of stimulation contacts 11, including but not limited to: 16 stimulation contacts 11 can be set to two groups of 8 connecting contacts 21 or four groups of 4 connecting contacts 21'; 32 stimulation contacts 11 can be set to four groups of 8 connecting contacts, or two groups of 16 connecting contacts, or a combination of one group of 16 connecting contacts and two groups of 8 connecting contacts.

[0049] Reference Figure 5 The stimulation electrode also includes multiple distinguishing markers 22 to facilitate the identification of different branches 32, 32' or connecting parts 20, 20' during surgery, and to accurately connect each connecting part 20, 20' to the corresponding channel on the pulse generator.

[0050] Optionally, the distinguishing mark 22 can be provided on the outer surface of the branches 32, 32' or the outer surface of the connecting parts 20, 20'. Furthermore, the distinguishing mark 22 can be one or more of the following: color markings (such as color rings of different colors), numerical markings (such as molded numbers 1, 2, 3), and raised dot markings (such as different numbers of raised dots). The distinguishing mark 22 helps the surgeon quickly and accurately match each connecting part 20, 20' with the corresponding pulse generator connection channel during the implantation procedure.

[0051] In this invention, each connecting part 20, 20' is provided with a connecting ring 24 on the side near the extension part 30, 30', for engaging and locking with the insertion cavity of the pulse generator, thereby achieving auxiliary locking between the connecting parts 20, 20' and the pulse generator. When locking, the connecting ring 24 can distribute the compressive force to the housing of the connecting parts 20, 20', preventing the locking force from concentrating on the wire welding points inside the connecting parts 20, 20' or the connection points between the wire 33 and the connecting contact points 21, 21'. This effectively reduces the risk of the internal wire 33 breaking due to compression, the welding points cracking due to stress, or the second substrate 23, 23' being damaged due to localized pressure, significantly improving the structural durability and signal transmission stability of the stimulation electrode during repeated insertion and removal.

[0052] The following example illustrates the concept of 16 stimulation contacts: Reference Figure 1 and Figure 2 In one embodiment of the present invention, the stimulation electrode includes a stimulation portion 10, two connecting portions 20, and an extension portion 30. Sixteen stimulation contacts 11 are arranged sequentially along the length direction X of the stimulation portion 10 and are evenly divided into two contact units Q. Each connecting portion 20 is provided with eight connecting contacts 21 corresponding to one contact unit Q. The extension portion 30 includes a main trunk 31, two branches 32, and 16 wires 33. The 16 wires 33 are divided into two wire groups and passed through the main trunk 31 in the manner described above, and are correspondingly connected to each stimulation contact 11 and each connecting contact 21.

[0053] In this design, the first end port of the sleeve 341, used for connection to the main trunk 31, is smaller than the second end port used for connection to the branch 32. The cross-sectional area of ​​the sleeve 341 gradually decreases from the middle towards the end containing the main trunk, i.e., towards the first port. Two branches 32 are arranged side-by-side within the sleeve 341, with one branch 32 aligned with the main trunk 31 and the other branch 32 offset from the main trunk 31. Figure 2 The section from the middle of the sheath 341 to the first port has a cross-sectional shape that is approximately a right trapezoid along the length of the sheath 341, with the inclined side facing the main stem 31 serving as the inclined waist. During surgical implantation, the end of the "inclined waist" of the sheath 341 facing the implantation direction is closer to the center, and the end size becomes smaller, resulting in less resistance and greater stability during wire implantation.

[0054] Reference Figure 3 and Figure 4 In another embodiment of the present invention, the stimulation electrode includes a stimulation portion 10, four connecting portions 20', and an extension portion 30'. Sixteen stimulation contacts 11 are arranged sequentially along the length direction X of the stimulation portion 10 and are evenly divided into four contact units Q'. Each connecting portion 20' corresponds to one contact unit Q', and each connecting portion 20' is provided with four connecting contacts 21'. The extension portion 30' includes a main trunk 31', four branches 32', and sixteen wires 33. The sixteen wires 33 are divided into four wire groups in the manner described above and correspondingly connect each stimulation contact 11 and each connecting contact 21'.

[0055] Reference Figure 4 The ends of the four branches 32' are arranged in a row within the cavity of the sleeve 341'. Each branch 32' remains separate and does not contact the others within the cavity of the sleeve 341', and its relative position is maintained by filler adhesive. The main trunk 31' corresponds to the middle of the four branches 32', that is, the main trunk 31' is located on the centerline of the width direction of the sleeve 341', and the four branches 32' are symmetrically distributed on both sides of this centerline. Figure 4 As shown, the first end port of the sleeve 341' used to connect with the main trunk 31' is smaller than the second port used to connect with the branch 32'. The cross-sectional shape of the section from the middle of the sleeve 341' to the first port is approximately an isosceles trapezoid, and the two "waist sides" are inclined towards the first port and closer to the main trunk 31', so that the resistance is smaller and more stable during the implantation of the stimulation electrode.

[0056] The stimulation electrode of this invention effectively solves the problem of excessively long connection parts, affecting insertion stability and control accuracy, caused by an increase in stimulation contacts, by setting multiple connection parts. The main trunk and / or branches are set as a composite structure near the tube wall of the sleeve. The braided layer significantly improves the tensile strength of the main trunk and branches at both ends of the sleeve while maintaining good flexibility. The braided layer with a specific metal structure can also improve the magnetic resonance compatibility of the electrode.

[0057] The present invention also provides a method for fabricating the stimulation electrode of any of the above embodiments. (Refer to...) Figure 6 The manufacturing method includes the following steps: Step S1: Thread multiple wires into the main trunk and thread the first end of each wire group into the corresponding branch.

[0058] Specifically, the main trunk and branches are hollow tubular structures with axially continuous cavities and circular or elliptical cross-sectional shapes. The inner diameter of the main trunk matches the overall outer diameter of the conductors, while the inner diameter of the branches matches the outer diameter of the corresponding conductor groups inserted within them, accommodating multiple conductors and providing passageways. During wiring, the main trunk and all branches are first placed in predetermined positions. Then, the first ends of the pre-grouped conductors are guided into their respective branches and exit from the other end of the branches. Additionally, the second ends of all conductors are inserted into the main trunk near the connection point and exit from the other end of the main trunk.

[0059] Understandably, it is also possible to insert all the wires from the end of the main trunk closest to the stimulation point, and then guide the grouped multiple wires into the corresponding branches, or other sequences, as long as the wires are threaded.

[0060] Step S2: Connect the first end of each conductor group to the corresponding multiple contact points on the connecting part.

[0061] In this step, the ends of each conductor group are first connected and fixed to the respective contact points to achieve electrical connection. Then, each contact point is fitted onto the second substrate, arranging them sequentially along the length of the connection while maintaining a predetermined spacing. After the contact points are arranged, they are positioned and fixed in their predetermined positions on the second substrate using methods such as heat fusion or bonding. This step also includes injecting filler adhesive into a portion of the cavity of the second substrate, which, after curing, acts as a rigid filler to improve the bending resistance of the connection and facilitate insertion into the top cover of the pulse generator. A chamfer is provided at the end of the second substrate away from the extension to form a smooth transition end. Optionally, in this step, the end of each conductor is connected and fixed to the contact points using processes such as welding or crimping to achieve electrical connection.

[0062] Step S3: Connect the second end of each wire to the corresponding stimulation contact on the stimulation part.

[0063] In this step, the ends of the multiple stimulation contacts and the extension wires are first connected and fixed to achieve electrical connection. Then, the wires are placed in a mold according to predetermined positions, and molten polymer material (such as polyurethane or silicone rubber) is injected. After the material solidifies, it forms a first substrate that fixes the stimulation contacts and encapsulates the wires. Optionally, in this step, the ends of each wire are connected and fixed to the stimulation contacts through processes such as welding or crimping to achieve electrical connection. This step can be performed on a dedicated fixture to maintain precise spacing between the stimulation contacts.

[0064] Step S4: Secure the end of the main trunk near the branch and the end of each branch near the main trunk by wrapping them together with the connecting components.

[0065] Reference Figure 7 Specifically, this step includes: Step S41: Insert the sheath from the direction of the stimulation part or the connecting part, and place the sheath on the main trunk and each branch.

[0066] Optionally, in this step, the sleeve can be made of materials such as polyolefin or polytetrafluoroethylene.

[0067] Step S42: Inject the filling material into the sleeve, and seal and fix the main trunk and branches inside the sleeve.

[0068] In this step, liquid filler adhesive (such as medical-grade light-curing adhesive, silicone adhesive, or epoxy resin) is injected into the gap between the sleeve and the extension part through a glue injection needle. Then, the filler adhesive is cured by light or heat to form the filling part.

[0069] The manufacturing method of this embodiment has clear steps, is easy to operate, has good repeatability and process stability, and can efficiently and reliably manufacture stimulation electrodes with multiple connections and multiple branches.

[0070] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. For those skilled in the art, the present invention can be modified and varied in various ways. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principle of the present invention should be included within the scope of protection of the present invention.

Claims

1. A stimulation electrode, characterized in that, The stimulation electrode includes: The stimulation section is equipped with multiple stimulation contacts; Multiple connecting parts are provided for connecting to the pulse generator, and multiple connection contact points are provided; The extension includes a main trunk, multiple branches, multiple wires, and a connecting assembly. The main trunk is connected to the stimulation part, the multiple branches are connected to the multiple connecting parts in a one-to-one correspondence, and the multiple wires are disposed inside the main trunk and branches to connect the multiple stimulation contacts to the multiple connecting contacts in a one-to-one correspondence. The connection between the main trunk and the branch is sealed within the connecting assembly, and at least a portion of the main trunk and / or the branch is a composite structure with a braided layer.

2. The stimulation electrode according to claim 1, characterized in that, The connection component includes: A sleeve, a hollow structure with openings at both ends, one end of which is fitted onto the end of the main trunk near the branch, and the other end extends to the end of each branch near the main trunk, wrapping and securing the end of the branch; and Filler adhesive is used to fill the sleeve body to seal and fix the main trunk and the branches.

3. The stimulation electrode according to claim 2, characterized in that, Multiple branches are arranged side by side within the sleeve, and the cross-sectional area of ​​the sleeve gradually decreases from the middle towards the end where the main stem is located.

4. The stimulation electrode according to claim 1, characterized in that, The stimulation part further includes a first substrate, and a plurality of stimulation contacts are disposed on the first substrate, the diameter of the first substrate being 0.3 mm to 2 mm.

5. The stimulation electrode according to claim 4, characterized in that, The stimulation contact is a ring-shaped contact, and multiple stimulation contacts are arranged along the length direction of the first substrate, with the distance between two adjacent stimulation contacts being 0.5 mm to 8 mm.

6. The stimulation electrode according to claim 1, characterized in that, The stimulation part is provided with no less than 8 stimulation contacts.

7. The stimulation electrode according to claim 1, characterized in that, The stimulation electrode includes multiple distinguishing marks, which are disposed on the branch or the connecting portion. The distinguishing marks include one or more of color marks, number marks, or raised dot marks.

8. The stimulation electrode according to claim 1, characterized in that, Both the trunk and the branches include exposed sections and enclosed sections wrapped by the connecting components; The woven layer is at least partially disposed in the wrapping section, or the woven layer extends from one end of the exposed section near the wrapping section to the other end; The braided layer includes a non-metallic braided layer and / or a metallic braided layer.

9. A method for manufacturing a stimulation electrode as described in any one of claims 1-8, characterized in that, The manufacturing method includes: The multiple wires are threaded into the main trunk, and the first end of each wire is threaded into the corresponding branch; The first end of each of the wires is electrically connected to the corresponding contact points on the connecting part. The second end of each of the wires is electrically connected to the corresponding stimulation contact on the stimulation part; The end of the main trunk near the branch and the end of each branch near the main trunk are sealed and secured by the connecting assembly.

10. The manufacturing method according to claim 9, characterized in that, The main trunk near the branch and the branches near the main trunk are sealed and secured by the connecting assembly, including: The sleeve is inserted into the stimulation part or the connecting part and is fitted onto the main trunk and each of the branches, with each of the branches arranged side by side inside the sleeve; Filler adhesive is injected into the sleeve to seal and fix the main trunk and branches within the sleeve.

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