Extended lead and implantable bioelectrical stimulation system

Abstract

The present application relates to a kind of extension wire and implantable bioelectricity stimulation system, wherein the extension wire is compatible with multiple fixing methods, which facilitates different doctors to select corresponding methods to fix the extension wire according to operation habits, makes the operation simpler and more convenient, and also makes the extension wire fixed more firmly, and makes the extension wire not easy to be damaged when fixed, ensures the service life of the extension wire, and reduces the use cost.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an extension lead and an implantable bioelectric stimulation system. BACKGROUND

[0002] Parkinson's disease is a common neurodegenerative disease, which is more common in the elderly, with an average age of onset of about 60 years old. The most important pathological change of Parkinson's disease is the degeneration and death of dopaminergic neurons in the substantia nigra of the midbrain, which causes a significant decrease in the content of DA in the striatum and leads to the disease. Parkinson's disease mainly manifests as static tremor, bradykinesia, postural gait disorder, etc., which can greatly affect the life of patients.

[0003] With the development of modern medical technology, stimulating the thalamic nucleus or the medial globus pallidus with electrodes can effectively improve the symptoms of Parkinson's disease. The deep brain stimulation electrode (DBS) system used includes a pulse generator (usually abbreviated as IPG) 1, an extension lead 2 and an electrode 3, as shown in Figure 1 When a patient has symptoms such as static tremor, postural gait disorder, etc. on one side of the body (only the left or right side of the body), one pulse generator 1, one extension lead 2 and one electrode 3 are usually implanted. If the patient's symptoms are bilateral, one pulse generator 1, two extension leads 2 and two electrodes 3 are usually implanted, as shown in Figure 1 The electrode 3 is generally implanted in the brain about 10 cm, the rest is buried in the subcutaneous tissue of the head, and the other end is placed in the position behind the ear and connected with the subcutaneous extension lead 2, and the extension lead 2 is connected with the pulse generator 1. The pulse generator 1 generates an electrical signal, which is transmitted to the electrode 3 through the subcutaneous extension lead 2, and then reaches the target area of the brain.

[0004] As shown in Figure 2 The extension lead 2 is composed of three parts: a lead proximal end 23, a lead intermediate segment 22 and a lead distal end 21; the lead proximal end 23 is connected with the pulse generator 1, and the lead distal end 21 is connected with the electrode 3. Since the extension lead 2 and the electrode 3 are implanted in the subcutaneous tissue of the human body, the activity of the human body may exert a certain tension on them, which may cause the displacement of the electrode. Therefore, after the extension lead 2 and the electrode 3 are connected, they need to be firmly fixed on the head. At present, during the operation, the doctor will fix the connection between the electrode 3 and the extension lead 2 in the subcutaneous tissue, and the main fixing methods are as follows: method one is to open a skull groove on the skull, place the lead distal end 21 in the skull groove, press a fixing plate on the surface of the lead distal end 21, and then use two self-tapping screws to lock the lead distal end 21 on the skull to play a fixing role; method two is to put a suture sleeve on the extension lead 2, first tighten the suture sleeve with the extension lead 2, and then suture the suture sleeve on the subcutaneous fascia to play a fixing role.

[0005] It can be seen that the conventional surgical operation needs to make a suitable slot on the skull or additionally increase the suture sleeve to achieve, which will produce the following adverse factors:

[0006] I. The depth and width of the slot on the skull are difficult to guarantee. If the slot is too deep, the distal end of the extension wire cannot be fixed by the fixing plate to achieve compression and locking. If the slot is too shallow, the locking force of the fixing plate may be too large to cause damage to the distal end of the extension wire. Therefore, the skull slot needs to be constantly corrected during the operation, which undoubtedly prolongs the operation time. Moreover, the fixing plate is a relatively hard and sharp metal material. In order to lock the extension wire, a certain locking force needs to be applied to ensure that the distal end of the extension wire has a certain elasticity. The fixing plate will leave a pressure mark on the extension wire, which may cause damage to the distal end of the extension wire under long-term static stress.

[0007] II. The suture sleeve is used to fix the distal end of the extension wire, which needs to be tightly tied on the extension wire. However, the tie itself may be too loose or too tight. If the tie is too loose, the suture sleeve and the extension wire will move relatively, which is difficult to fix. If the tie is too tight, it may also cause damage to the extension wire during the operation.

[0008] Therefore, the extension wire needs to be firmly fixed on the head, and the operation process needs to be simple and convenient, and cannot cause damage to the electrode or the extension wire. SUMMARY

[0009] The purpose of the present application is to provide an extension wire and an implantable bioelectric stimulation system, wherein the extension wire can be fixed by its own structure, and is firmly fixed without causing damage to the extension wire. In particular, it is compatible with multiple fixing methods, and the operation is more simple and convenient, and the operation time is shorter.

[0010] According to one aspect of the present application, an extension wire is provided, comprising a distal end of the wire, the distal end of the wire comprising a body and a fixing structure connected to the body, the fixing structure being used to fix the distal end of the wire on a predetermined object; the fixing structure comprises at least two fixing wings, at least two fixing wings are arranged on the body and located on opposite sides of the body, and each fixing wing has at least one fixing hole.

[0011] Optionally, the body comprises at least one arc segment, the arc segment has an outward convex arc surface, and the arc surface is used to contact with an external fixing plate.

[0012] Optionally, the arc segment is rotationally symmetrical about the axis of the body.

[0013] Optionally, the body comprises a plurality of the arc-shaped segments, and the plurality of the arc-shaped segments are arranged axially spaced apart along the body.

[0014] Optionally, the body further comprises an axial limiting structure for limiting the axial movement of the fixing plate along the body.

[0015] Optionally, the axial limiting structure comprises a protrusion, and one annular protrusion is arranged at each of the two ends of the arc-shaped segment in the axial direction, and the maximum outer diameter of the arc-shaped segment is less than or equal to the outer diameter of the protrusion.

[0016] Optionally, the maximum outer diameter of the arc-shaped segment is 4.5-5.0 mm, and the outer diameter of the protrusion is 4.8-5.2 mm.

[0017] Optionally, the protrusion and the corresponding arc-shaped segment are connected by a circular arc surface.

[0018] Optionally, the protrusion is a closed annular shape, and the annular circumference is continuous or discontinuous; or the protrusion is a non-closed annular shape, and the circumferential position of the protrusion corresponds to the circumferential position of the arc-shaped segment.

[0019] Optionally, each of the fixing holes is configured to be selectively fixed to the predetermined object by one of a screw and a surgical thread; and the axis of each of the fixing holes is arranged out of plane with the axis of the body.

[0020] Optionally, each of the fixing wings extends outward from the outer wall of the body, and the extension direction of each of the fixing wings is perpendicular to the axial direction of the body; and each of the fixing wings is in the shape of a circular arch.

[0021] Optionally, the number of the fixing wings is two, and the two fixing wings are arranged staggered in the axial direction of the body.

[0022] Optionally, the fixing structure is integrally formed with the body.

[0023] According to another aspect of the present application, there is provided an implantable bioelectric stimulation system, comprising a pulse generator, an electrode, and the extension lead as claimed in any one of the preceding claims, the extension lead comprising a lead proximal end, a lead intermediate segment, and the lead distal end connected in sequence; the lead proximal end being connected to the pulse generator, and the lead distal end being connected to the electrode.

[0024] In the extension lead and the implantable bioelectric stimulation system provided by the present application, the extension lead is provided with a fixing structure at the lead distal end, and the lead distal end can be directly fixed to the human body through the fixing structure. In this way, the extension lead can be fixed more firmly, and the extension lead is less likely to be damaged during the fixing process, thereby ensuring the service life of the extension lead and reducing the use cost.

[0025] In the extension lead and the implantable bioelectricity stimulation system provided by the application, the fixing structure comprises at least two fixing wings, the at least two fixing wings are arranged on the body of the lead distal end and located on opposite sides of the body, and each fixing wing has at least one fixing hole. The at least two fixing wings have the following effects: on the one hand, the self-tapping screw can pass through the fixing hole and be locked with the bone on the human body; on the other hand, the surgical thread can pass through the fixing hole and be tied and fixed with the subcutaneous fascia on the human body; and on the other hand, the traditional fixing plate can be used to realize the fixation, that is, the fixing plate is pressed against the lead distal end, and the extension lead is locked on the human body by using the fixing hole on the fixing plate. Therefore, the extension lead of the application is compatible with multiple fixing modes, so as to meet the operation habits of different doctors and make the operation more convenient. Meanwhile, the suture sleeve is not needed to be sleeved and tied, and the fixing hole can be directly used for tying, so that the operation is simple and the use cost is reduced.

[0026] In the extension lead and the implantable bioelectricity stimulation system provided by the application, when the fixing plate is pressed against the extension lead, the fixing wings can provide sufficient support force for the extension lead and limit the rotation of the lead, so that the fixation is more reliable.

[0027] In the extension lead and the implantable bioelectricity stimulation system provided by the application, the surface of the lead distal end used for contacting the fixing plate is designed as a convex arc surface. In this way, after the fixing plate is pressed against the arc surface, the stress is diffused to the surrounding, and the stress concentration problem does not occur, so that the damage to the lead distal end is avoided. Furthermore, in order to prevent the axial movement of the fixing plate, the axial limiting structure is arranged on the lead distal end, so that the reliability of the fixation of the fixing plate to the extension lead is higher. BRIEF DESCRIPTION OF DRAWINGS

[0028] Those skilled in the art will understand that the provided drawings are used to better understand the application, and do not constitute any limitation on the scope of the application. In the drawings:

[0029] Figure 1 is a schematic diagram of the structure of the DBS system implanted on the top of the skull when the patient's symptoms are bilateral in the prior art;

[0030] Figure 2 is a schematic diagram of the structure of the prior extension lead;

[0031] Figure 3 is a schematic diagram of the structure of the lead distal end of the extension lead in the preferred embodiment of the application;

[0032] Figure 4 is a schematic diagram of the structure of the lead distal end fixed by two fixing wings in the preferred embodiment of the application;

[0033] Figure 5 is a schematic diagram of the structure of fixing the distal end of the lead by two fixing wings in the preferred embodiment of the present application.

[0034] Figure 6 is a schematic diagram of the structure of fixing the distal end of the lead by screwing the fixing plate in the preferred embodiment of the present application.

[0035] Figure 7a is a schematic diagram of the fixing plate pressing against the cylindrical surface of the extension lead in the prior art, in which the surface of the extension lead is easy to form indentation;

[0036] Figure 7b is a schematic diagram of the fixing plate pressing against the arc surface of the extension lead in the preferred embodiment of the present application, in which the surface of the extension lead is not easy to form indentation.

[0037] The reference signs are explained as follows:

[0038] Pulse generator 1; extension lead 2; distal end 21, 20 of the lead; middle section 22 of the lead; proximal end 23 of the lead; electrode 3;

[0039] Mounting groove 4; self-tapping screw 5; surgical thread 6; fixing plate 7; cylindrical surface 201; indentation 202; protruding part 211, 214, 213; arc section 212; fixing wing 215; fixing hole 216; stress release area 217; electrode connecting part 218.

[0040] The same or similar reference signs in the drawings represent the same or similar components. DETAILED DESCRIPTION

[0041] The embodiments of the present application will be described in detail with specific reference felt to the drawings. The skilled in the art can easily understand other advantages and effects of the present application from the content disclosed in the specification. The present application can also be implemented or applied by other different embodiments, and each detail in the specification can be modified or changed based on different views and applications without departing from the spirit of the present application. It should be noted that the drawings provided in the embodiments only schematically illustrate the basic concept of the present application, and the drawings only show the components related to the present application rather than the number, shape and size of the components when actually implemented. The type, number and ratio of the components when actually implemented can be randomly changed, and the layout type of the components can be more complicated.

[0042] Furthermore, while each embodiment described below possesses one or more technical features, this does not imply that users of the present invention must simultaneously implement all technical features in any embodiment, or can only separately implement some or all technical features in different embodiments. In other words, provided it is feasible, those skilled in the art can, based on the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, thereby increasing the flexibility in implementing the present invention.

[0043] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the present invention. As used in this specification, the singular forms "a," "an," and "the" include plural objects unless otherwise expressly indicated. As used in this specification, "a plurality of" generally means two or more unless otherwise expressly indicated. As used in this specification, the term "or" generally includes the meaning of "and / or" unless otherwise expressly indicated. The term "axial" generally refers to the direction parallel to the axis of the extending conductor, and "circumferential" generally refers to the direction around the axis of the extending conductor.

[0044] Furthermore, in the following description, for ease of description, the terms "far end" and "proximal end" are used; "proximal end" is the end closer to the pulse generator; and "far end" is the end farther from the pulse generator. Additionally, numerous specific details are set forth in the following description to provide a more thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be practiced without one or more of these details. In other instances, certain technical features well-known in the art have not been described to avoid confusion with the invention.

[0045] The core idea of ​​this invention lies in providing an extension lead. Compared with traditional extension leads, this invention features a fixing structure at the distal end of the lead, allowing the distal end to be directly fixed to the human body. This design ensures a more secure fixation of the extension lead and reduces the risk of damage during fixation, thus extending its lifespan and reducing operating costs. It should be understood that the extension lead of this invention includes, but is not limited to, DBS implantable extension leads, and can also be other similar implantable extension leads, such as those for spinal nerve stimulation or vagus nerve stimulation.

[0046] To secure the extension guide via a fixing structure, the fixing structure includes at least two fixing wings. These wings are positioned on opposite sides of the body at the distal end of the extension guide, and each wing has at least one fixing hole. The purpose of these at least two fixing wings is twofold: firstly, to facilitate the attachment of self-tapping screws to bone through the fixing holes; secondly, to facilitate the passage of surgical sutures through the fixing holes for binding and fixation to the subcutaneous fascia; and thirdly, to allow for fixation using a traditional fixing plate—simply press the fixing plate against the distal end of the extension guide and secure it to the body using the holes on the fixing plate. Specifically, when the fixing plate presses against the extension guide, the two fixing wings provide sufficient support and prevent rotation, making the fixation method more secure and reducing the likelihood of loosening. Therefore, the extension guide of this invention is compatible with multiple fixation methods, better meeting the surgical habits of different doctors and making surgical procedures more convenient. Furthermore, there is no need to use a suture cannula to tighten it; the fixation hole can be used directly for tightening, which simplifies the suturing and tying process, improves surgical efficiency, and also reduces the cost of use.

[0047] It should be understood that the aforementioned surgical suture ligation and self-tapping screw fixation are usually not used simultaneously, but rather one method can be used selectively. It should also be understood that the advantage of the above fixation method is that it ensures a more secure fixation of the extension suture, preventing loosening due to issues such as the fixation plate not pressing the extension suture tightly enough or the suture tube being too loosely tied to the extension suture. Therefore, the fixation effect is good. The advantage of the above fixation method also lies in avoiding damage to the extension suture caused by excessive pressure from the fixation plate or excessively tight suture tube binding when using a fixation plate.

[0048] Further research by the inventors revealed that the surface of the extension wire pressed by the fixing plate is prone to indentation over time, which can easily damage the extension wire. The inventors further discovered that the root cause of the indentation on the wire surface is that the surface of the extension wire in contact with the fixing plate is similar to a plane, making it prone to stress concentration and thus causing indentation. To address this, the inventors designed the surface of the distal end of the wire that contacts the fixing plate as a convex arc. This allows the stress to diffuse outwards after the fixing plate applies pressure, preventing stress concentration and avoiding damage to the distal end of the extension wire when the fixing plate presses against it. Furthermore, to prevent axial movement of the fixing plate, an axial limiting structure is added to the distal end of the wire, further improving the reliability of the fixing plate in securing the extension wire.

[0049] Furthermore, the core idea of ​​this invention lies in providing an implantable bioelectric stimulation system, which includes a pulse generator, electrodes, and extension leads. The extension leads include a proximal end, a middle section, and a distal end connected sequentially. The proximal end of the lead is used to connect to the pulse generator, and the distal end is used to connect to the electrodes. Thus, the pulse generator generates an electrical signal, which is transmitted to the electrodes via the subcutaneous extension leads, and then reaches the target area to provide electrical stimulation, achieving a therapeutic purpose. The target area includes, but is not limited to, the brain, and can also be a spinal nerve or other treatment sites.

[0050] The following description, in conjunction with the accompanying drawings and preferred embodiments, further illustrates the extension lead and implantable bioelectric stimulation system proposed in this invention. In the following description, it is assumed that the extension lead is a DBS implantable extension lead, in order to illustrate the purpose, advantages and features achieved by the extension lead, but it should not be construed as limiting the invention.

[0051] This invention relates to an extension wire, which includes a distal end 20 for connection to an electrode. Figure 3 This is a schematic diagram of the structure of the distal end 20 of the conductor provided in a preferred embodiment of the present invention. Figure 3 As shown, the distal end 20 of the conductor specifically includes a body and a fixing structure connected to the body. The fixing structure includes at least two fixing wings 215, which are disposed on the body and located on opposite sides of the body, and each fixing wing 215 has at least one fixing hole 216. In this embodiment, the fixing structure includes two fixing wings 215, each with one fixing hole 216. In this case, the fixing structure is simple, the fixing operation is more convenient, and it can basically achieve the purpose of effectively fixing the conductor. At the same time, the size of the distal end of the conductor is small, which facilitates the installation and use of the conductor. Typically, the number of fixing wings 215 is set according to actual needs, including but not limited to two, and more than two, such as three or four, can also be set.

[0052] Furthermore, the number of fixing holes 216 on each fixing wing 215 is not limited to one; it can be two or more. In this embodiment, when only one fixing hole 216 is provided on each fixing wing 215, one fixing hole 216 can accommodate multiple fixing methods: one is to insert a self-tapping screw to lock the distal end 20 of the wire to the skull, and the other is to pass a surgical suture to tie the distal end 20 of the wire to the subcutaneous fascia of the head. Therefore, relatively simply, two fixing methods can be achieved through only one fixing hole 216, resulting in a simple structure and more convenient surgical operation. Further, in an alternative embodiment, different fixing holes can also be provided on the fixing wing 215 to pass surgical sutures and insert self-tapping screws respectively; that is, the holes for screw fastening and the holes for surgical suture tying can be separate.

[0053] Then combine Figure 4 to Figure 6 The preferred fixing method of the extension wire in this embodiment will be further explained.

[0054] First refer to Figure 4 This is a schematic diagram illustrating how the distal end 20 of the conductor is fixed by two fixing wings 215 screws in a preferred embodiment of the present invention. Figure 4 As shown, in procedures such as deep brain stimulation (DBS) implantation surgery, a mounting groove 4 is first created in the skull. The size of the mounting groove 4 is determined based on the size of the distal end 20 of the lead wire. The distal end 20 is then placed within the mounting groove 4. During this process, two fixing wings 215 conform to the skull, supporting the distal end 20. After adjustment, the distal end 20 is secured to the skull using two self-tapping screws 5. With this fixation method, even if the groove is too deep, the two fixing wings 215 can still effectively conform to and lock with the skull, ensuring a secure lock on the distal end 20. If the groove is too shallow, the locking force provided by the two fixing wings 215 will not be excessive, preventing damage to the distal end of the lead wire, as the distal end itself has some elasticity and the material is relatively soft. Therefore, this fixation method offers high reliability.

[0055] See next Figure 5 This is a schematic diagram of the distal end 20 of the conductor being fixed by two fixing wings 215 in a preferred embodiment of the present invention. Figure 5 As shown, in procedures such as deep brain stimulation (DBS) implantation surgery, surgical sutures 6 can be directly inserted into the fixation holes 216 of the two fixation wings 215, thereby securing the distal end 20 of the lead wire to the subcutaneous fascia of the head via the surgical sutures 6. Compared to suture cannulas, this fixation method avoids damage to the distal end of the lead wire due to overly tight sutures, and also avoids suture movement due to overly loose sutures, resulting in better fixation. Furthermore, it eliminates the need for additional suture cannulas, simplifying the surgical procedure and reducing surgical costs.

[0056] See also Figure 6 This is a schematic diagram of the distal end 20 of the conductor being fixed by screws on a fixing plate in a preferred embodiment of the present invention. Figure 6As shown, in procedures such as deep brain stimulation (DBS) implantation surgery, the existing fixation plate 7 can be used to fix the distal end 20 of the lead wire. Specifically, the fixation plate 7 is pressed against the distal end 20 of the lead wire, and two self-tapping screws 5 are used to fix the fixation plate 7, thereby locking the distal end 20 of the lead wire to the skull. In this fixation method, the two fixation wings 215 also fit against the skull, providing support for the distal end 20 of the lead wire to prevent deformation or damage due to excessive force, and also preventing rotation of the distal end of the lead wire. Therefore, compared with existing technologies, this fixation method provides better fixation of the distal end of the lead wire and is less likely to cause damage to the distal end of the lead wire.

[0057] Considering that the surface of the distal end 20 of the conductor is easily indented by the fixing plate 7, specifically as follows: Figure 7a As shown, if the fixing plate 7 is pressed onto the cylindrical surface 201 of the distal end 20 of the conductor, it is equivalent to pressing against a flat surface. In this case, a relatively serious stress concentration will occur, making it easy for indentations 202 to form on the pressed surface of the distal end 20 of the conductor over a long period of time, causing damage to the distal end 20 of the conductor. To solve this technical problem, such as Figure 3 As shown, at least one arc-shaped segment 212 is provided on the body of the distal end 20 of the conductor. The arc-shaped segment 212 has an outwardly convex arc surface, mainly a circular arc surface, so that the fixing plate 7 presses against the arc surface. Here, "outwardly convex" means that the outer surface of the body protrudes in a direction away from the axis of the body, and the shape of the convexity in the axial cross section is arc-shaped. The effect of doing so is as follows: Figure 7b As shown, since the convex arc surface is equivalent to a sphere, when the fixing plate 7 presses against the arc segment 212 of the far end 20 of the conductor, the stress will diffuse to the periphery, making it less likely to form an indentation on the surface of the conductor, thereby avoiding damage to the far end of the conductor.

[0058] Furthermore, the arc-shaped segment 212 can be partially arranged along the circumference of the body, that is, a portion of the outer surface of the body convexes outward to form an arc surface. Further, multiple arc-shaped segments 212 can be spaced apart along the circumference of the body, preferably arranged symmetrically. Even further, the arc-shaped segments 212 are rotationally symmetrical about the axis of the body, so that the entire circumference of the body is a convex arc surface. In this case, it is more convenient for the doctor to operate when using the fixation plate 7, and the operation time is shorter. Furthermore, to facilitate the doctor in selecting a suitable fixation position according to the situation, it is preferable that the body includes multiple arc-shaped segments 212 spaced apart along the axial direction of the body, more preferably two arc-shaped segments 212 spaced apart along the axial direction of the body, which basically meets the actual usage requirements.

[0059] Continue reading Figure 3 and combined Figure 6The distal end 20 of the guide wire also includes an axial limiting structure for restricting the movement of the fixation plate 7 along the axial direction of the body. Preferably, the axial limiting structure includes a protrusion, and one protrusion is provided at each end of each arc segment 212 along the axial direction, so as to restrict the movement of the fixation plate 7 along the axial direction by means of the protrusions at both ends, ensuring the reliability of the fixation, facilitating the positioning of the fixation plate, making the surgical operation more convenient and precise, and also simplifying the structure. Specifically, when there are two arc segments 212, an annular protrusion 214 is provided between the two arc segments 212, and an annular protrusion 211 and a protrusion 213 are also provided at the other ends of the two arc segments 212, respectively. The outer diameter of each protrusion is preferably greater than or equal to the maximum outer diameter of the arc segment 212. In this embodiment, the protrusion 214 is a circumferentially continuous closed ring. More specifically, the body of the distal end 20 of the conductor also includes a cylindrical segment (not labeled, the cylindrical segment includes the protrusion), and an arcuate segment 212 is formed between two cylindrical segments. Each arcuate segment 212 has a step between it and its adjacent cylindrical segment. Preferably, the ends of the steps are rounded to form a rounded surface. Furthermore, the maximum outer diameter of each arcuate segment 212 is preferably less than or equal to the outer diameter of the cylindrical segment to avoid increasing the size of the distal end of the conductor. For example, the maximum outer diameter of the arcuate segment 212 can be selected as 4.5 mm to 5.0 mm, and the outer diameter of the cylindrical segment can be selected as 4.8 mm to 5.2 mm. The height of each protrusion can be selected as 0.8 mm to 1.2 mm, wherein the axial width of the protrusion 214 located between two arcuate segments 212 can be 1.0 mm to 1.5 mm. In another embodiment, the protrusion is a circumferentially discontinuous closed ring, that is, multiple protrusion structures spaced circumferentially together form a protrusion. In another embodiment, the arc-shaped segment 212 is partially disposed along the circumference of the body, and the protrusion extends along the circumference of the body in a non-closed ring shape, such as a semi-ring, a 1 / 3 ring, or a 1 / 4 ring. The circumferential position of the protrusion corresponds to the circumferential position of the arc-shaped segment 212, that is, the protrusion and the arc-shaped segment 212 are on the same axis.

[0060] This invention does not limit the connection method between the fixing wing 215 and the body. Preferably, the fixing wing 215 and the body are integrally formed, for example, by injection molding, which is convenient to manufacture and low in cost. Moreover, the material of the distal end 20 of the wire can be a relatively soft material with a certain strength, such as polyurethane or silicone. In this embodiment, each fixing wing 215 extends outward from the outer wall of the body, and the extension direction of each fixing wing 215 is preferably perpendicular to the axis of the body, thereby optimizing the size of the distal end of the wire, making the size of the distal end of the wire as small as possible, and reducing surgical trauma. Furthermore, when the fixing hole 216 is used to cooperate with the self-tapping screw, the axis of the fixing hole 216 is usually set opposite to the axis of the body, and the axis of the fixing hole can be perpendicular to the axis of the body after translation. This setting makes it convenient for the doctor to directly insert the screw in a direction perpendicular to the skull, which is labor-saving and convenient. This structure also makes it convenient for the doctor to operate the surgical suture 6 for ligation. In other cases, such as when the fixing hole 216 is used to pass through the surgical suture 6, the positional relationship between the axis of the fixing hole 216 and the axis of the body is not particularly limited.

[0061] Furthermore, it is preferable to offset the two fixed wings 215 along the axial direction of the body, i.e., as follows: Figure 3As shown in the positional relationship, the distal end of the lead wire is more securely fixed, resulting in a better fixation effect. In other embodiments, the two fixing wings 215 can also be arranged axially side by side, i.e., their axial positions are the same. Furthermore, the structures of the two fixing wings 215 are preferably identical, and both fixing wings 215 are located on the same central axis plane at the distal end of the lead wire to ensure uniform force distribution at the distal end of the lead wire. In addition, the size of each fixing wing 215 should not be too large or too small. If it is too large, it will cause discomfort to the patient; if it is too small, it will be difficult to guarantee the locking effect. Therefore, the width of each fixing wing 215 along the axial direction of the body is preferably 3.5mm to 4.0mm, and more preferably, the thickness of each fixing wing 215 is 1.5mm to 2.0mm. The present invention does not impose a particular limitation on the shape of the fixing wings 215. For example, in this embodiment, the fixing wings 215 are preferably arched. In this case, the width of the fixing wing along the axial direction and the length along the radial direction are equal, resulting in a small size, small space occupation, and convenient processing. Furthermore, each fixing hole 216 is preferably a circular hole for easy processing. The diameter of the circular hole is not particularly limited, for example, it can be selected from 1.6mm to 2.0mm. In other embodiments of the present invention, the number of fixing wings 215 may also be three or four. When the number of fixing wings 215 is three, the three fixing wings 215 are preferably respectively arranged on opposite sides of the body and staggered in the axial direction of the body. When the number of fixing wings 215 is four, it is preferable to arrange two fixing wings 215 on each opposite side of the body. The two fixing wings 215 on the same side are spaced apart in the axial direction of the body, and two fixing wings 215 can be arranged opposite each other at the same axial position, that is, two pairs of fixing wings 215 are spaced apart along the axial direction.

[0062] Furthermore, the distal end 20 of the conductor also includes an electrode connection portion 218 disposed at the distal end for connection with an electrode. The distal end 20 of the conductor also includes a stress relief area 217 disposed at the proximal end. Preferably, one fixed wing 215 located at the proximal end is away from (maintains a certain distance from) the stress relief area 217, while the other fixed wing 215 located at the distal end is away from (maintains a certain distance from) the electrode connection portion 218. Furthermore, the axial distance between the two fixed wings 215 can be selected as 16mm to 18mm.

[0063] This invention also relates to an implantable bioelectric stimulation system, comprising a pulse generator, electrodes, and extension leads. The extension leads include a proximal end, a middle section, and a distal end 20 connected sequentially. The proximal end is connected to the pulse generator, and the distal end 20 is connected to the electrodes. The pulse generator generates an electrical signal, which is transmitted to the electrodes via the subcutaneous extension leads and reaches the target area in the brain. The implantable bioelectric stimulation system may include one or two electrodes; correspondingly, one electrode corresponds to one extension lead, and two electrodes correspond to two extension leads. The implantable bioelectric stimulation system can be used for spinal nerve stimulation, vagus nerve stimulation, or deep brain nerve stimulation, etc.

[0064] It should be understood that this invention mainly relates to improvements on the distal end 20 of the extension conductor, while the proximal end and the middle section of the extension conductor can adopt existing structures, which will not be described in detail here. It should also be understood that the material of the distal end of the conductor can be any existing extension conductor material, including but not limited to silicone and polyurethane.

[0065] Therefore, according to the technical solution provided by the embodiments of the present invention, by setting a fixing structure at the distal end of the lead wire, it is convenient to directly fix the distal end of the lead wire to the human body. This design allows the extension lead wire to be fixed more firmly and is less prone to damage during the fixing process. Furthermore, the extension lead wire of the present invention is compatible with multiple fixing methods to meet the surgical operating habits of different doctors, making the surgical procedure more convenient. At the same time, there is no need to use a suture cannula for tightening; it can be directly tightened using the fixing holes, simplifying the operation and reducing surgical costs.

[0066] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. An extension lead for an implantable bioelectric stimulation system, comprising a distal end of the lead, characterized in that, The distal end of the wire is used to be placed in the mounting groove of the skull. The distal end of the wire includes a body and a fixing structure integrally formed and connected to the body. The fixing structure is used to fix the distal end of the wire to a predetermined object. The fixing structure includes at least two fixing wings, which are disposed on the body and located on opposite sides of the body. Each fixing wing has at least one fixing hole. The at least two fixing wings are used to fit against the skull. When not using a fixation plate, at least two of the fixation wings are used for securing self-tapping screws through the fixation holes to the skull, or for securing surgical sutures through the fixation holes to the subcutaneous fascia. When using the fixing plate, at least two of the fixing wings are used to support the distal end of the conductor while preventing the distal end of the conductor from rotating. The body includes an axial limiting structure and an arc segment. The arc segment has an outwardly convex arc surface, and the surface on the distal end of the conductor for contacting the fixing plate is also an outwardly convex arc surface. The axial limiting structure is used to restrict the movement of the fixing plate along the axial direction of the body.

2. The extension conductor according to claim 1, characterized in that, The arc-shaped segment is rotationally symmetrical about the axis of the body.

3. The extension conductor according to claim 2, characterized in that, The body includes a plurality of arc-shaped segments, which are spaced apart along the axial direction of the body.

4. The extension wire according to claim 1, characterized in that, The axial limiting structure includes a protrusion, and an annular protrusion is provided at both ends of the arc segment along the axial direction. The maximum outer diameter of the arc segment is less than or equal to the outer diameter of the protrusion.

5. The extension wire according to claim 4, characterized in that, The maximum outer diameter of the arc-shaped segment is 4.5 mm to 5.0 mm, and the outer diameter of the protrusion is 4.8 mm to 5.2 mm.

6. The extension wire according to claim 4, characterized in that, The protrusion and the corresponding arc segment are transitioned by a circular arc surface.

7. The extension conductor according to claim 4, characterized in that, The protrusion is a closed ring, and the ring may be continuous or discontinuous in the circumferential direction; or, the protrusion is a non-closed ring, and the circumferential position of the protrusion corresponds to the circumferential position of the arc segment.

8. The extension conductor according to any one of claims 1-7, characterized in that, The axis of each of the fixing holes is arranged on the opposite plane to the axis of the body.

9. The extension conductor according to any one of claims 1-7, characterized in that, Each of the fixed wings extends outward from the outer wall of the body, and the extension direction of each fixed wing is perpendicular to the axial direction of the body; each fixed wing is in the shape of an arch.

10. The extension conductor according to any one of claims 1-7, characterized in that, The number of fixed wings is two, and the two fixed wings are staggered in the axial direction of the main body.

11. An implantable bioelectric stimulation system, characterized in that, The device includes a pulse generator, electrodes, and an extension wire according to any one of claims 1 to 10, the extension wire comprising a proximal end, a middle section, and a distal end of the wire connected in sequence; the proximal end of the wire is connected to the pulse generator, and the distal end of the wire is connected to the electrodes.

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