WO2023056762A1

WO2023056762A1 - Electrical lead, processing method, extension line, electrode and electrical stimulation system

Info

Publication number: WO2023056762A1
Application number: PCT/CN2022/101564
Authority: WO
Inventors: 吕依蔓; 唐龙军; 徐永强; 王晓凯
Original assignee: 上海神奕医疗科技有限公司
Priority date: 2021-10-09
Filing date: 2022-06-27
Publication date: 2023-04-13
Also published as: CN113856048A

Abstract

Provided in the present invention are an electrical lead, a processing method, an electrode extension line, an implantable bioelectrode and an implantable electrical stimulation system. The electrical lead comprises a conductive body, which is arranged in a spiral manner, wherein the conductive body comprises an outer cover, and a plurality of conductive structures, which are insulated from each other; the outer cover wraps the plurality of conductive structures, which are insulated from each other; each conductive structure comprises a plurality of conductive wires; all the conductive structures are arranged side by side; and a cross section of the conductive body is flat. The processing method comprises: processing a plurality of conductive wires into a conductive structure; and processing a plurality of conductive structures, which are insulated from each other, into a conductive body, which is arranged in a spiral manner and has a flat cross section. By means of the present invention, the situation of a whole conductive path being disconnected due to the breakage of a certain conductive wire in a conductive structure during a use process can be prevented; moreover, the risk of a whole product failing due to the breakage of a certain conductive wire in the conductive structure caused by an inevitable damage during a production process can also be reduced.

Description

Electrical leads, processing methods, extension cords, electrodes and electrical stimulation systems

technical field

The invention relates to the technical field of medical devices, in particular to an electric lead, a processing method, an electrode extension line, an implanted biological electrode and an implanted electrical stimulation system.

Background technique

Implantable active medical devices are now widely used in the treatment of various diseases, especially in the treatment of physical and psychological diseases. Compared with many traditional treatment methods, this treatment method has better and direct curative effects. One of the implantable active devices is a nerve electrical stimulator, which transmits pulse signals to nerve tissue through electrodes to improve the normal skills of the human body, such as: implantable deep brain stimulation (Deep Brain Stimulation, DBS) can Effectively improve the limb control and coordination of Parkinson's patients.

Parkinson's Disease (PD) is a common neurodegenerative disease, and drug therapy is the main treatment in its early and middle stages. With the gradual increase in the dosage of intervention drugs and the development of the disease, the risk of side effects of drugs, the psychological burden of patients and the resistance of patients to drugs also increase. In the middle and advanced stages of Parkinson's disease, surgical treatment is an effective supplement to drug treatment. There are two main types of surgical treatment, nerve nucleus lesion and deep brain nerve stimulation. Among them, deep brain electrical stimulation is the first choice for surgical treatment because of its small trauma, safety and effectiveness. Patients who have undergone deep brain stimulation surgery can significantly improve their limb control and coordination, and take fewer doses of drugs.

The deep brain stimulation system is divided into the implanted part inside the body and the programmed part outside the body. The implanted part in the body, as shown in FIG. 1 , consists of three parts: a pulse generator 10 (hereinafter referred to as IPG), an electrode extension line 20 and an implanted bio-electrode 30 . The IPG 10 is used to provide electrical stimulation pulse signals to the electrodes; the electrode extension line 20 is used to connect the implantable bioelectrode 30 and the IPG 10; the implantable bioelectrode 30 is used to implant the human brain tissue to stimulate predetermined therapeutic targets in the brain tissue point area.

After being implanted into the human body, the distal end of the implanted bioelectrode 30 is placed in the patient's predetermined treatment target area; the implanted bioelectrode 30 is fixed on the surface of the skull through the skull fixation device 40; the proximal end of the implanted bioelectrode 30 The distal end of the electrode extension line 20 is connected; the electrode extension line 20 extends to the vicinity of the clavicle through a subcutaneous tunnel; the proximal end of the electrode extension line 20 is connected to the IPG 10.

Since the implantable bio-electrode 30 and the electrode extension wire 20 are implanted into the human body for a long time, each material thereof must be a biosafety material. Since the implantable bioelectrode 30 and the electrode extension wire 20, especially the electrode extension wire pass through the neck, shoulder and chest of the human body, the patient's daily activities will exert a certain external force on it for a long time and cyclically, so it needs to have a high fatigue resistance Performance; it also needs to have good elasticity to reduce the discomfort caused by pulling during daily activities of the patient, and to avoid excessive stress on various fixing points, such as the proximal end of the electrode extension line.

The electric wires in the prior art are generally monofilament spiral type. Although the monofilament spiral electric wire can meet the requirements of fatigue resistance and elasticity, considering the raw materials and production may cause certain damage to the guide wire and the damage is difficult to detect and remedy. As a result, the probability that multiple channels of the monofilament helical electrical conductor, for example, 8 channels are turned on at the same time is very low, which greatly increases the post-production cost.

It should be noted that the information disclosed in the background technology section of the invention is only intended to deepen the understanding of the general background technology of the invention, and should not be regarded as an acknowledgment or in any form to imply that the information constitutes information already known to those skilled in the art. current technology.

Contents of the invention

The object of the present invention is to provide an electric wire, a processing method, an electrode extension wire, an implanted bio-electrode and an electric stimulation system, which can not only improve the fatigue resistance and elasticity of the electric wire, but also improve the damage resistance of the electric wire, Reduces the risk of failure due to disconnection of any one conductive path.

In order to achieve the above object, the present invention provides an electric wire, which includes a conductive body arranged in a spiral shape. The conductive body includes a sheath and a plurality of conductive structures insulated from each other. The sheath wraps a plurality of conductive structures insulated from each other. The conductive structure includes multiple conductive wires, the multiple conductive structures are arranged side by side, and the cross section of the conductive body is flat.

Optionally, the conductive structure is a twisted wire structure, and a plurality of conductive wires are twisted to form a conductive structure.

Optionally, the conductive structure further includes an insulating layer, and the insulating layer wraps a plurality of conductive wires.

Optionally, the outer skin is made of thermoplastic material, and the thickness of the outer skin is 0.05-0.15 mm.

Optionally, the softening deformation temperature of the thermoplastic material is lower than 150°C.

Optionally, the conductive body further includes a shielding layer, and the shielding layer is disposed on the inner surface of the outer skin.

Optionally, the conductance wire is a platinum-iridium material or a composite material containing silver.

In order to achieve the above object, the present invention also provides a processing method of an electric wire, comprising: prefabricating a conductive structure, the conductive structure includes a plurality of conductive wires; processing the multiple conductive structures insulated from each other to be arranged in a spiral shape and have a flat cross section The conductive body comprises a skin and a plurality of conductive structures insulated from each other, and the skin wraps the multiple conductive structures insulated from each other.

Optionally, the prefabricated conductive structure includes: twisting a plurality of conductive wires to form a twisted wire; and plating an insulating layer on the outside of the twisted wire to form a conductive structure.

Optionally, processing the multiple conductive structures that are insulated from each other into a conductive body that is arranged in a spiral shape and has a flat cross section includes: arranging and processing the multiple conductive structures that are insulated from each other neatly, so that all A skin is provided on the outside of the conductive structure to form a linear primary product with a flat cross section; the linear primary product with a flat cross section is spirally wound into a spiral conductive body.

Optionally, processing the multiple conductive structures that are insulated from each other into a conductive body that is arranged in a spiral shape and has a flat cross section includes: aligning the multiple conductive structures that are insulated from each other in a row and performing co-extrusion molding, so that A conductive body that is arranged in a spiral shape and has a flat cross section is formed.

In order to achieve the above purpose, the present invention also provides an implantable bioelectrode, including the above electric lead.

In order to achieve the above object, the present invention also provides an electrode extension wire, including the above-mentioned electric wire.

To achieve the above object, the present invention also provides an implantable electrical stimulation system, comprising the above implantable bioelectrode and/or the above electrode extension wire.

Compared with the prior art, the electric wire provided by the invention, the processing method, the electrode extension wire, the implanted bio-electrode and the electric stimulation system have the following advantages: (1) due to the conduction in the conductive body of the electric wire provided by the invention The structure includes a plurality of conductive wires. Therefore, the conduction of any one or several conductive wires in the conductive structure can make the conductive path where the electric wire is located. Compared with the traditional single-filament spiral wire structure design, it can effectively avoid In the process of use, due to the breakage of a certain conductive wire in the conductive structure, the entire conductive path where the conductive structure is located is disconnected. The electric guide wire breaks, and then causes the risk of failure of the whole product, thereby improving the yield rate of the electric wire or the product using the electric wire provided by the invention. In addition, the electric wire provided by the invention not only has high fatigue resistance and elasticity, but also improves its long-term resistance to external force.

(2) Since the conductive structure in the present invention is a twisted wire structure, not only the fatigue resistance and damage resistance of the conductive structure provided by the present invention can be effectively improved, but also it can be more convenient to pass multiple conductive wires reasonably Arrangement is performed to reduce the size of the conductive structure, so that the appearance of the conductive structure is more rounded, and it is more convenient to form a conductive body arranged in a spiral shape.

(3) Since the conductive structure in the present invention also includes an insulating layer, the insulating layer can not only avoid the conduction between each conductive structure and cause a short circuit, but also can wrap all the conductive wires that constitute the conductive structure to prevent Scattered filaments occur during processing of conductive bodies.

(4) Since the conductive body in the present invention also includes an outer skin, thus, all the conductive structures constituting the conductive body can be wrapped up by the outer skin, which is more convenient to process a plurality of conductive structures insulated from each other into a spiral shape, so as to improve the performance. The invention provides the elasticity of the electrical conductor.

(5) Since the cross-section of the conductive body in the present invention is flat, not only can effectively reduce the outer diameter size of the electric wire provided by the present invention, but also can make each conductive structure as far as possible when deformed under force. Stress and deformation are uniform, preventing breakage due to excessive stress on a single conductive structure.

Description of drawings

Fig. 1 is a schematic diagram of an implantable brain neurostimulation system (DBS) implanted in a body.

FIG. 2 is a partial structure and a partially enlarged schematic diagram of an electric wire in an embodiment of the present invention.

FIG. 3 is a schematic flow chart of a method for processing an electrical lead in an embodiment of the present invention.

FIG. 4 is a schematic diagram of the overall structure and partial enlargement of the implantable bioelectrode in an embodiment of the present invention.

FIG. 5 is a schematic diagram of the overall structure of an electrode extension line in an embodiment of the present invention.

FIG. 6 is a partial cross-sectional view of the electrode extension line shown in FIG. 5 .

Fig. 7 is a schematic diagram of an implantable electrical stimulation system in an embodiment of the present invention.

Wherein, the reference signs are as follows: pulse generator-10; electrode extension line-20; extension tube-21; sleeve tube-22; plug-23; implantable bioelectrode-30; electrode tube-31; electrode assembly-32 ; first electrode-321; connector-33; second electrode-331; developing ring-34; guide wire-35; fixing device-40; conductive body-50; conductive structure-51; -512; skin -52.

Detailed ways

The electrical leads, processing methods, electrode extension wires, implantable bio-electrodes and electrical stimulation systems proposed by the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer from the following description. It should be noted that the drawings are in a very simplified form and all use imprecise scales, which are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present invention. In order to make the objects, features and advantages of the present invention more comprehensible, please refer to the accompanying drawings. It should be noted that the structures, proportions, sizes, etc. shown in the drawings attached to this specification are only used to match the content disclosed in the specification, for those who are familiar with this technology to understand and read, and are not used to limit the implementation of the present invention. Conditions, any modification of structure, change of proportional relationship or adjustment of size, under the same or similar situation as the effect and purpose of the present invention, should still fall within the technical content disclosed in the present invention within the range that can be covered. The specific design features of the invention disclosed herein, including, for example, specific dimensions, orientations, locations and shapes will be determined in part by the particular intended application and use environment. Also, in the embodiments described below, the same reference numerals may be used in common between different drawings to denote the same parts or parts having the same functions, and repeated descriptions thereof will be omitted. In this specification, similar reference numerals and letters are used to refer to similar items, therefore, once an item is defined in one figure, it does not require further discussion in subsequent figures. Additionally, if the methods herein include a series of steps, the order in which the steps are presented is not necessarily the only order in which the steps can be performed, and some steps may be omitted and/or some other steps not described herein may be replaced by added to the method.

It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply that there is a relationship between these entities or operations. There is no such actual relationship or order between them. Furthermore, the term "comprises", "comprises" or any other variation thereof is intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus comprising a set of elements includes not only those elements, but also includes elements not expressly listed. other elements of or also include elements inherent in such a process, method, article, or device. Without further limitations, an element defined by the phrase "comprising a ..." does not preclude the presence of additional identical elements in the process, method, article, or device that includes the element. The singular forms "a", "an" and "the" include plural objects, the term "or" is usually used in the meaning including "and/or", and the term "several" is usually used in the meaning including "at least one". The term "at least two" is usually used with the meaning of "two or more", and the terms "first", "second" and "third" are used only For descriptive purposes, and should not be understood as indicating or implying relative importance or implying the number of technical features indicated.

In describing the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " Rear", "Left", "Right", "Vertical", "Horizontal", "Top", "Bottom", "Inner", "Outer", "Axial", "Radial", "Circumferential" The orientation or positional relationship indicated by etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, use a specific Azimuth configuration and operation, therefore, should not be construed as limiting the invention.

In the description of the present invention, unless otherwise clearly specified and limited, the terms "installation", "connection", "connection" and "fixation" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection , or integrated; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components or the interaction relationship between two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention in specific situations.

In the present invention, unless otherwise clearly specified and limited, a first feature being "on" or "under" a second feature may include direct contact between the first and second features, and may also include the first and second features Not in direct contact but through another characteristic contact between them. Moreover, "above", "above" and "above" the first feature on the second feature include that the first feature is directly above and obliquely above the second feature, or simply means that the first feature is horizontally higher than the second feature. "Below", "beneath" and "under" the first feature to the second feature include that the first feature is directly below and obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.

The main purpose of the present invention is to provide an electric wire, a processing method, an electrode extension wire, an implanted bio-electrode and an implanted electric stimulation system, which can not only improve the fatigue resistance and elasticity of the electric wire, but also improve the Damage resistance, reducing the risk of failure caused by the disconnection of any one conductive path. It should be noted that the proximal end in the present invention refers to the end close to the operator, and the distal end refers to the end far away from the operator, that is, the end close to the lesion of the patient.

To achieve the above object, the present invention provides an electric lead, please refer to FIG. 2 , which schematically shows a partial structure and a partially enlarged schematic view of the electric lead provided by an embodiment of the present invention. As shown in FIG. 2 , the electric wire provided by the present invention includes a conductive body 50 arranged in a spiral shape. The conductive body 50 includes a plurality of conductive structures 51 insulated from each other, and the conductive structure 51 includes a plurality of conductive wires 511 . Since the conductive structure 51 in the conductive body 50 of the electric lead provided by the present invention includes a plurality of electric guide wires 511, any one or several electric guide wires 511 in the conductive structure 51 can be conducted so that the conduction where the electric lead is located Compared with the structural design of the traditional monofilament helical wire, the present invention can effectively avoid the disconnection of the entire conductive path where the conductive structure 51 is located due to the breakage of a certain conductive wire 511 in the conductive structure 51 during use. situation arises, it can also effectively reduce the risk of breaking one of the conductive wires 511 in the conductive structure 51 due to unavoidable damage in the production process, thereby causing the failure of the entire product, thereby improving the efficiency of the electric wire or the use of the electric wire provided by the present invention. Lead product yield. In addition, the electric wire provided by the invention not only has high fatigue resistance and elasticity, but also improves its long-term resistance to external force.

It should be noted that, as those skilled in the art can understand, mutual insulation referred to in the present invention means that any two conductive structures 51 are not electrically connected. In addition, it should be noted that, as those skilled in the art can understand, the number of conductive structures 51 in the conductive body 50 corresponds to the number of conductive paths, and the specific number can be set according to actual needs. Currently, conductive structures 51 commonly used in nerve stimulation If the number of channels is 4, 8, 16, 32, then the number of conductive structures 51 is set to 4, 8, 16, 32 correspondingly. In addition, it should be noted that, as those skilled in the art can understand, the more the number of conductive wires 511 in the conductive structure 51, the softer the conductive structure 51, the stronger the damage resistance, and the better the probability of passing, but It is also more difficult to shape. Therefore, it is necessary to comprehensively consider all aspects to select a suitable number of conductive wires 511 to form the conductive structure 51 in the present invention.

In an exemplary embodiment, the conductive structure 51 is a twisted wire structure, and a plurality of conductive wires 511 are twisted to form the conductive structure 51 . Thus, by twisting a plurality of conductive wires 511 to form the conductive structure 51, not only the fatigue resistance and damage resistance of the conductive structure 51 provided by the present invention can be effectively improved, but also it is more convenient to form a conductive structure 51 reasonably. All the conductive wires 511 of the structure 51 are arranged so as to reduce the size of the conductive structure 51 , make the appearance of the conductive structure 51 more rounded, and facilitate the formation of the conductive body 50 arranged in a spiral shape. It should be noted that, in other embodiments, the conductive structure 51 may also be a linear structure, that is, a plurality of conductive wires 511 are arranged in parallel to form a bundle-shaped conductive structure 51 .

Specifically, when the conductive structure 51 is a twisted wire structure, the conductive structure 51 may include 3, 7 or 19 conductive wires 511 . As shown in FIG. 2 , when the conductive structure 51 includes 19 conductive wires 511 , the center of the conductive structure 51 includes 1 conductive wire 511 , the inner layer includes 6 conductive wires 511 , and the outer layer includes 12 conductive wires 511 . As those skilled in the art can understand, when the conductive structure 51 includes 7 conductive wires 511, the center of the conductive structure 51 includes 1 conductive wire 511, and the outer layer includes 6 conductive wires 511; when the conductive structure 51 includes 3 When there are three conductive wires 511 , the three conductive wires 511 are tangent to each other and twisted to form the conductive structure 51 .

Further, the conductive structure 51 further includes an insulating layer 512, and the insulating layer 512 wraps all the conductive wires 511 in the conductive structure. Thus, by arranging the insulating layer 512 on the outside of all the conductive wires 511 that constitute the conductive structure 51 to form the conductive structure 51, not only can the conduction between the various conductive structures 51 be avoided and cause a short circuit, but also all the conductive structures 51 can be formed. The conductive wire 511 is wrapped to prevent loose wires from appearing during the processing of the conductive body 50 . Specifically, the material of the insulating layer 512 can be selected but not limited to ETFE (ethylene-tetrafluoroethylene copolymer) or PTFE (polytetrafluoroethylene). Because ETFE and PTFE not only have better insulation and biocompatibility, but also can maintain better strength under a thinner thickness, thus, by using ETFE or PTFE as the material of the insulating layer 512, it can make When the insulating layer 512 meets the thinner thickness requirement, it can still tightly wrap all the electrical wires 511 .

As shown in FIG. 2 , in an exemplary embodiment, the conductive body 50 further includes a skin 52 , and the skin 52 wraps all the conductive structures 51 . Since the conductive structure 51 includes a plurality of conductive wires 511, although the conductive structure 51 is flexible, it is difficult to shape it into a spiral shape. The present invention wraps all the conductive structures 51 by setting the sheath 52, which can be more convenient for multiple insulated wires. The conductive structure 51 is processed into a spiral shape, so as to improve the elasticity of the electrical lead provided by the present invention.

The material of the sheath 52 is preferably a thermoplastic material. By adopting a thermoplastic material as the material of the sheath 52 , it is easier to process a plurality of electrically insulated conductive structures 51 into a spiral shape. In addition, in order to facilitate processing and molding, the softening deformation temperature of the thermoplastic material used to manufacture the outer skin 52 is lower than 150°C, preferably, lower than 100°C. Considering various factors, PU (polyurethane) can be used, preferably, TPU (plastic polyurethane elastomer rubber) is adopted as the material of the outer skin 52 in the present invention, thus, by adopting TPU as the material of the outer skin 52, the outer skin can be made 52 has a certain strength and thermoplasticity.

Further, in order to reduce the influence of the sheath 52 on the overall outer diameter of the electric lead, the thickness of the sheath 52 in the present invention is 0.05-0.15 mm. Therefore, by setting the thickness of the outer skin 52 to 0.05-0.15mm, not only can firmly wrap all the conductive structures 51 constituting the conductive body, so as to facilitate the processing of multiple conductive structures 51 that are insulated from each other into a spiral shape, At the same time, the sheath 52 with this thickness will not cause a substantial increase in the overall outer diameter of the electric wire.

In order to further improve the use effect of the electric lead provided by the present invention, the conductive body 50 further includes a shielding layer (not shown in the figure), and the shielding layer is arranged between the outer skin 52 and the conductive structure 51 . Thus, by providing a shielding layer between the outer skin 52 and the conductive structure 51, a certain electromagnetic shielding effect can be played by the shielding layer, so that the equipment using the electric lead provided by the present invention can be subjected to an externally applied electromagnetic field. , still works fine. In addition, the setting of the shielding layer can also play a role in strengthening the mechanical properties, further improving the fatigue resistance of the electric wire provided by the present invention. Specifically, the shielding layer can be a metal mesh. Of course, as those skilled in the art can understand, the shielding layer can also be a structure other than the metal mesh, such as a metal coating, or a coating of other materials with electromagnetic shielding functions. wait.

As shown in FIG. 2 , in an exemplary embodiment, all the conductive structures 51 constituting the conductive body are arranged side by side, and the cross section of the conductive body 50 is flat. Therefore, by arranging all the conductive structures 51 that constitute the conductive body side by side to form a flat spiral conductive body 50, not only can effectively reduce the outer diameter of the electrical wire provided by the present invention, but also make each conductive structure 51 Stress and deformation should be as uniform as possible during force deformation, so as to prevent the single conductive structure 51 from being easily broken due to excessive force.

It should be noted that, as those skilled in the art can understand, when the electric lead provided by the present invention is used on an implantable active device, since it needs to be implanted in the human body for a long time, it is used to make the electric lead provided by the present invention All materials must have a certain degree of biological safety. Since the conductive structure 51 in the present invention is the basic structure of an electric wire, it needs to have good electrical conductivity and strength, so the conductive wire 511 used to form the conductive structure 51 is preferably a platinum-iridium material or a composite material containing silver.

Based on the same inventive concept, the present invention also provides a method for processing an electric wire. Please refer to FIG. 3 , which schematically shows a flow chart of the method for processing an electric wire provided by an embodiment of the present invention. As shown in Figure 3, the processing method of the electric wire provided by the present invention includes the following steps: Step S100, prefabricate the conductive structure, the conductive structure includes a plurality of conductive wires; step S200, process the multiple conductive structures insulated from each other into a spiral shape A conductive body with a flat cross section is provided. The conductive body includes a skin and a plurality of mutually insulated conductive structures, and the skin wraps the multiple mutually insulated conductive structures.

Specifically, when prefabricating the conductive structure, an insulating layer can be provided on the outside of the conductive structure, so that the various conductive structures constituting the conductive body are insulated from each other, or when a plurality of conductive structures are processed into a spirally arranged conductive body, During the process, each conductive structure is insulated from each other by means of an existing process. It should be noted that, as those skilled in the art can understand, the number of conductive wires constituting the conductive structure and the number of conductive structures constituting the conductive body can be set according to actual needs.

Further, the prefabricated conductive structure includes: twisting a plurality of conductive wires to form a twisted wire; plating the outside of the twisted wire with an insulating layer to form a conductive structure.

Therefore, by twisting a plurality of conductive wires to form a conductive structure, not only the fatigue resistance and damage resistance of the conductive structure provided by the present invention can be effectively improved, but also more conveniently The conductive wires are arranged to reduce the size of the conductive structure, so that the appearance of the conductive structure is more rounded, and it is more convenient to form a conductive body arranged in a spiral shape. By coating the outside of the stranded wire with an insulating layer, it can not only effectively avoid the short circuit caused by the conduction between the various conductive structures, but also wrap all the conductive wires that make up the stranded wire to prevent loose wires from appearing during the processing of the conductive body. .

Further, in some embodiments, processing the plurality of conductive structures insulated from each other into a conductive body arranged in a spiral shape and having a flat cross section includes: aligning the plurality of conductive structures insulated from each other in a row and processing , to arrange outer skins on the outside of all conductive structures to form a linearly arranged preliminary product with a flat cross section; spirally wind the linearly arranged preliminary product with a flat cross section into a spirally arranged conductive ontology.

Specifically, a plurality of conductive structures that are insulated from each other can be arranged neatly and fixed in a row as required, and then processed by extrusion or plating to make the outer skin wrap all the conductive structures to form a preliminary product, and then according to According to actual needs, according to the preset winding ratio, the primary product with the outer skin is wound into a spiral structure, and finally the whole is shaped into a spiral structure by thermoplastic molding such as baking to form a spiral setting with a flat cross section conductive body. Therefore, by arranging all the conductive structures constituting the conductive body side by side to form a flat spiral conductive body, not only can the outer diameter of the electric wire provided by the present invention be effectively reduced, but also each conductive structure can be deformed under force. The force and deformation should be as uniform as possible, so as to prevent the single conductive structure from being easily broken due to excessive force.

In some other embodiments, processing a plurality of conductive structures insulated from each other into a conductive body arranged in a spiral shape and having a flat cross section includes: aligning the plurality of conductive structures insulated from each other in a row and performing co-extrusion molding to form a conductive body arranged in a spiral shape and having a flat cross section.

Specifically, a plurality of electrically insulated conductive structures can be arranged neatly and fixed in a row as required, and then shaped into a helical structure by co-extrusion molding to form a helical structure with a flat cross section. conductive body.

To sum up, the processing method of the electric wire provided by the present invention has high flexibility from the manufacture of the conductive structure to the processing of the spirally arranged conductive body, and the specific processing technology can be adjusted according to actual needs, so that it can be applied to the electrode , Electrode extension wires and other products.

Based on the same inventive concept, the present invention also provides an implantable bioelectrode, which includes the above-mentioned electrical lead. Please refer to FIG. 4 , which schematically shows the overall structure and partial enlarged schematic diagram of the implantable bioelectrode provided by an embodiment of the present invention. As shown in Figure 4, the implantable bioelectrode provided by the present invention also includes an electrode tube 31, the above-mentioned electric wire is pierced in the electrode tube 31, and the distal end of the electrode tube 31 is provided with an electrode assembly 32, and the electrode assembly 32 It includes a plurality of first electrodes 321 arranged at intervals and insulated from each other. The proximal end of the electrode tube 31 is provided with a connector 33. The connector 33 includes a plurality of second electrodes 331 arranged at intervals and insulated from each other. The electrode assembly 32 and the connector 33 The first electrode 321 corresponds to the second electrode 331 one-to-one, and the two are connected through the conductive structure in the electric wire, that is, the number of the conductive structure in the electric wire is the same as the number of the first electrode 321. The number and the number of the second electrodes 331 are the same. Since the implantable bioelectrode provided by the present invention includes the above electric wires, the implantable bioelectrode provided by the present invention not only has good fatigue resistance and elasticity, but also can effectively reduce discomfort such as being pulled by the patient during daily activities. At the same time, it also has a good ability to resist unavoidable damage, which reduces the risk of monofilament breakage caused by unavoidable damage during the production process, which in turn leads to the failure of the entire implantable bioelectrode, and improves the implantable bioelectrode. Yield in the production process.

As shown in FIG. 4 , a developing ring 34 is also provided at the distal end of the electrode tube 31 . Therefore, by setting the developing ring 34 , it is convenient to determine the circumferential position of the first electrode 321 during the operation, and it is convenient for the doctor to confirm the direction corresponding to the first electrode 321 used and to perform precise electrical stimulation therapy on the patient.

As shown in FIG. 4 , a guide wire 35 is also pierced inside the electrode tube 31 . Therefore, by passing the guide wire 35 in the electrode tube 31 , the delivery performance of the implantable bio-electrode can be improved, and it is more convenient to implant the implantable bio-electrode into the body of the patient.

It should be noted that, as those skilled in the art can understand, the implantable bioelectrodes provided by the present invention are not limited to be used in DBS (brain nerve stimulation) systems, and can also be used in other implantable electrical stimulation systems, For example, it is used in nerve stimulation systems such as VNS (vagus nerve stimulation) and SCS (spinal nerve stimulation), as well as products such as cardiac pacemakers and heart rate regulators.

Based on the same inventive concept, the present invention also provides an electrode extension wire, which includes the above-mentioned electric wire. Please refer to Figure 5 and Figure 6, wherein Figure 5 schematically shows the overall structure of the electrode extension line provided by an embodiment of the present invention, and Figure 6 schematically shows a partial view of the electrode extension line shown in Figure 5 cutaway view. As shown in Figures 5 and 6, the electrode extension wire also includes an extension tube 21, the extension tube 21 is pierced with the above-mentioned electric wire, and the distal end of the extension tube 21 is provided with a sleeve 22 for being sleeved in the implanted On the proximal connector of the type bioelectrode, the proximal end of the extension tube 21 is provided with a plug 23, and the plug 23 is used to connect with a stimulator, such as a pulse generator. Since the electrode extension wire provided by the present invention includes the above-mentioned electrical leads, the electrode extension wire provided by the present invention not only has good fatigue resistance and elasticity, but can effectively reduce the discomfort of patients being pulled during daily activities, and at the same time It also has a good ability to resist unavoidable damage, which reduces the risk of single-filament breakage due to unavoidable damage during the production process, thereby causing the failure of the entire electrode extension line, and improves the yield in the production process of the electrode extension line.

It should be noted that, as those skilled in the art can understand, the electrode extension wire provided by the present invention is not limited to be used on the DBS (brain nerve stimulation) system, and can also be used for other implantable electrical stimulation systems, such as using On VNS (vagus nerve stimulation), SCS (spinal nerve stimulation) and other nerve stimulation systems.

Based on the same inventive concept, the present invention also provides an implantable electrical stimulation system, which includes the above-mentioned implantable bioelectrode and/or electrode extension wire. Please refer to FIG. 7 , which schematically shows a schematic diagram of an implantable electrical stimulation system provided by an embodiment of the present invention. As shown in FIG. 7 , the implantable electrical stimulation system provided by the present invention includes an implantable bioelectrode 30 , an electrode extension wire 20 and a pulse generator 10 , wherein the distal end of the electrode extension wire 20 is connected to the implantable bioelectrode 30 The proximal end of the electrode extension line 20 is connected to the pulse generator 10 . Since the implantable neurostimulation system provided by the present invention includes the above-mentioned implanted bioelectrodes 30 and/or electrode extension wires 20, the electrodes and/or extension wires of the implantable electrical stimulation system provided by the present invention not only It has good fatigue resistance and elasticity, which can effectively reduce the discomfort of patients being pulled during daily activities, and also has good resistance to inevitable damage, which reduces the breakage of monofilaments caused by inevitable damage during the production process , thereby causing the risk of failure of the entire implantable electrical stimulation system, and improving the yield rate in the production process of the implantable electrical stimulation system.

It should be noted that, as those skilled in the art can understand, the implantable electrical stimulation system provided by the present invention is not limited to the DBS (brain nerve stimulation) system, and can also be other implantable electrical stimulation systems, such as VNS ( Vagus nerve stimulation), SCS (spinal nerve stimulation) and other nerve stimulation systems, as well as electrical stimulation systems such as cardiac pacemakers and heart rate regulation.

In summary, compared with the prior art, the electric wire provided by the invention, the processing method, the electrode extension wire, the implanted bioelectrode and the electric stimulation system have the following advantages: (1) due to the conductive body of the electric wire provided by the invention The conductive structure includes multiple conductive wires. Therefore, the conduction of any one or several conductive wires in the conductive structure can make the conductive path where the electric wire is located. Compared with the structural design of the traditional single-filament helical wire , which can effectively avoid the breakage of the entire conductive path where the conductive structure is located due to the breakage of a certain conductive wire in the conductive structure during use, and can also effectively reduce the damage in the conductive structure caused by inevitable damage during the production process. The risk that a certain electric wire breaks, thereby causing the failure of the whole product, thus improves the yield rate of the electric wire or the product using the electric wire provided by the present invention. In addition, compared with the structural design of the traditional monofilament helical wire, the electrical wire provided by the invention not only has higher fatigue resistance and elasticity, but also improves its long-term resistance to external force.

In addition, in the description of this specification, descriptions with reference to the terms "one embodiment", "some embodiments", "example", "specific examples", or "some examples" mean that the descriptions described in conjunction with the embodiments or examples A particular feature, structure, material, or characteristic is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the above terms are not necessarily directed to the same embodiment or example. Furthermore, the described specific features, structures, materials or characteristics may be combined in any suitable manner in any one or more embodiments or examples. In addition, those skilled in the art can combine and combine different embodiments or examples and features of different embodiments or examples described in this specification without conflicting with each other.

The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by those of ordinary skill in the field of the present invention based on the above disclosures shall fall within the protection scope of the present invention. Obviously, those skilled in the art can make various changes and modifications to the invention without departing from the spirit and scope of the invention. Thus, the present invention is also intended to include these modifications and variations, provided they fall within the scope of the present invention and its equivalent technologies.

Claims

An electric wire is characterized in that it includes a conductive body arranged in a spiral shape, the conductive body includes a sheath and a plurality of conductive structures insulated from each other, the sheath wraps the plurality of conductive structures insulated from each other, each The conductive structure includes a plurality of conductive wires, the plurality of conductive structures are arranged side by side, and the cross section of the conductive body is flat.
The electric wire according to claim 1, wherein the conductive structure is a twisted wire structure, and the plurality of conductive wires are twisted to form the conductive structure.
The electrical wire according to claim 1, wherein the conductive structure further comprises an insulating layer, and the insulating layer wraps the plurality of electrical wires.
The electric wire according to claim 1, characterized in that, the material of the sheath is thermoplastic material.
4. The electrical lead according to claim 4, wherein the thermoplastic material has a softening deformation temperature of less than 150°C.
The electrical lead according to claim 1, characterized in that the thickness of the sheath is 0.05-0.15mm.
The electrical lead according to claim 1, wherein the conductive body further comprises a shielding layer, and the shielding layer is disposed on the inner surface of the outer skin.
The electric wire according to claim 1, characterized in that, the electric wire is made of platinum-iridium material or a composite material containing silver.
A method for processing an electric wire, characterized in that it comprises:

a prefabricated conductive structure comprising a plurality of conductive wires;

Processing a plurality of conductive structures insulated from each other into a conductive body arranged in a spiral shape and having a flat cross section, the conductive body includes an outer skin and the plurality of conductive structures insulated from each other, and the outer skin wraps the conductive structures insulated from each other A plurality of conductive structures are described.
The method for processing an electric wire according to claim 9, wherein the prefabricated conductive structure comprises:

twisting a plurality of conducting wires to form a strand;

The exterior of the strands is plated with an insulating layer to form a conductive structure.
The method for processing an electric wire according to claim 9, wherein the plurality of conductive structures that are insulated from each other are processed into a conductive body that is arranged in a spiral shape and has a flat cross section, including:

arranging the plurality of conductive structures insulated from each other in a row and processing, so as to provide a skin on the outside of the plurality of conductive structures to form a linear arrangement and a flat cross-section of the preliminary product;

The preliminary product that is arranged in a straight line and has a flat cross section is spirally wound into a conductive body that is arranged in a spiral shape and has a flat cross section.
The method for processing an electric wire according to claim 9, wherein the plurality of conductive structures that are insulated from each other are processed into a conductive body that is arranged in a spiral shape and has a flat cross section, including:

The plurality of conductive structures insulated from each other are neatly arranged in a row and co-extruded to form a conductive body arranged in a spiral shape and having a flat cross section.
An implantable bioelectrode, characterized in that it comprises the electrical lead according to any one of claims 1-8.
An electrode extension wire, characterized in that it comprises the electric wire according to any one of claims 1-8.
An implantable electrical stimulation system, characterized by comprising the implantable bio-electrode according to claim 13 and/or the electrode extension wire according to claim 14.