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CN114613531A - Lead for implantable electrical stimulation device, manufacturing method thereof and lead assembly - Google Patents

Lead for implantable electrical stimulation device, manufacturing method thereof and lead assembly Download PDF

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Publication number
CN114613531A
CN114613531A CN202210351502.3A CN202210351502A CN114613531A CN 114613531 A CN114613531 A CN 114613531A CN 202210351502 A CN202210351502 A CN 202210351502A CN 114613531 A CN114613531 A CN 114613531A
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CN
China
Prior art keywords
insulating
linear conductor
layer
electrical stimulation
insulating layer
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CN202210351502.3A
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Chinese (zh)
Inventor
韩大计
许扶
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Beijing Pins Medical Co Ltd
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Beijing Pins Medical Co Ltd
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Priority to CN202210351502.3A priority Critical patent/CN114613531A/en
Publication of CN114613531A publication Critical patent/CN114613531A/en
Pending legal-status Critical Current

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    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01BCABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B7/00Insulated conductors or cables characterised by their form
    • H01B7/04Flexible cables, conductors, or cords, e.g. trailing cables
    • H01B7/048Flexible cables, conductors, or cords, e.g. trailing cables for implantation into a human or animal body, e.g. pacemaker leads
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01BCABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B13/00Apparatus or processes specially adapted for manufacturing conductors or cables
    • H01B13/008Apparatus or processes specially adapted for manufacturing conductors or cables for manufacturing extensible conductors or cables
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01BCABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B13/00Apparatus or processes specially adapted for manufacturing conductors or cables
    • H01B13/06Insulating conductors or cables
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01BCABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B13/00Apparatus or processes specially adapted for manufacturing conductors or cables
    • H01B13/06Insulating conductors or cables
    • H01B13/14Insulating conductors or cables by extrusion
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01BCABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B7/00Insulated conductors or cables characterised by their form
    • H01B7/02Disposition of insulation
    • H01B7/0208Cables with several layers of insulating material
    • H01B7/0225Three or more layers
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01BCABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B7/00Insulated conductors or cables characterised by their form
    • H01B7/02Disposition of insulation
    • H01B7/0275Disposition of insulation comprising one or more extruded layers of insulation
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01BCABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B7/00Insulated conductors or cables characterised by their form
    • H01B7/04Flexible cables, conductors, or cords, e.g. trailing cables
    • H01B7/045Flexible cables, conductors, or cords, e.g. trailing cables attached to marine objects, e.g. buoys, diving equipment, aquatic probes, marine towline
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01BCABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B7/00Insulated conductors or cables characterised by their form
    • H01B7/06Extensible conductors or cables, e.g. self-coiling cords
    • H01B7/065Extensible conductors or cables, e.g. self-coiling cords having the shape of an helix
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01RELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
    • H01R31/00Coupling parts supported only by co-operation with counterpart
    • H01R31/06Intermediate parts for linking two coupling parts, e.g. adapter

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  • Engineering & Computer Science (AREA)
  • Manufacturing & Machinery (AREA)
  • Ocean & Marine Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Electrotherapy Devices (AREA)

Abstract

The application provides a lead for an implantable electrical stimulation device, a manufacturing method thereof and a lead assembly. The present application relates to an implantable electrical stimulation device, and more particularly, to a lead wire for an implantable electrical stimulation device, in which a helically wound linear conductor portion is embedded in an insulating portion, and the linear conductor portion and the insulating portion are molded together. Thus, the space occupied by the entire lead can be reduced, and particularly, the outer diameter can be made small, while the performance such as the insulation performance of the lead is substantially unchanged. Moreover, the elongation performance of the wire is better. The manufacturing method of the application is beneficial to large-scale production.

Description

Lead for implantable electrical stimulation device, manufacturing method thereof and lead assembly
Technical Field
The application relates to a lead structure of an implanted electrical stimulation device, in particular to a lead for the implanted electrical stimulation device, a manufacturing method thereof and a lead assembly.
Background
Currently, with the development of neurostimulation technology, more and more symptoms have proven to be effective by electrical stimulation of nerves or specific areas, such as deep brain electrical stimulation for parkinson's disease, essential tremor, etc., deep resolved vagal electrical stimulation for epilepsy, urinary related sacral electrical stimulation, and spinal cord electrical stimulation for pain relief.
In implantable electrical stimulation devices used to implement the above-described electrostimulation, a lead assembly including a lead is an important component of the implantable electrical stimulation device, which functions to couple the electrodes to a pulse generator for delivering the stimulation signal. The lead assembly is connected with the contacts at the two ends of the lead assembly through the leads in the lead assembly. However, in the conventional lead assembly for an implantable electrical stimulation apparatus, as shown in fig. 3, the lead comprises a conductor 10, an inner insulating tube 20 and an outer insulating tube 30, wherein the conductor 10 generally linearly extends into the clamping cavities of the inner insulating tube 20 and the outer insulating tube 30. In the lead wire having such a structure, the space between the inner insulating tube 20 and the outer insulating tube 30 is large, so that the space occupied by the entire lead wire is large, and the lead wire is highly likely to be inserted into a living body such as a human body. In addition, the conductor 10 extending linearly has a poor expansion and contraction ability, easily causes a pulling feeling to a user and the conductor 10 is easily broken, and the lead wire needs to be assembled layer by layer, and the assembling operation of the inner insulating tube 20/the outer insulating tube 30 is difficult, so that it is inconvenient for mass production.
Disclosure of Invention
The present application has been made in view of the drawbacks of the above-mentioned techniques. An object of the present application is to provide a novel lead for an implantable electrical stimulation device and a manufacturing method thereof, which has a smaller overall occupied space and better extensibility than the existing lead under the condition of ensuring the performance of the lead to be basically unchanged. Furthermore, the application also provides a lead assembly for the implantable electrical stimulation device, which comprises the lead.
In order to achieve the above object, the present application adopts the following technical solutions.
The present application provides a wire for an implantable electrical stimulation apparatus, the wire including an insulating portion and a linear conductor portion formed as one body, the linear conductor portion being embedded in the insulating portion in a spirally wound manner, both end portions of the linear conductor portion respectively protruding from the insulating portion in an axial direction of the wire.
In an alternative, the wire is integrally formed in a circular tube shape, and a through hole penetrating along the axial direction is formed inside the wire.
In another alternative, the insulating portion includes a first insulating layer located radially inward of the conductor layer constituted by the linear conductor portions and having a first radial thickness, and a second insulating layer located radially outward of the conductor layer and having a second radial thickness.
In another optional scheme, the lead further comprises a metal shielding layer integrally molded with the insulating part, the metal shielding layer is embedded in the insulating part and is spaced apart from the conductor layer, and the metal shielding layer is located on the radial outer side of the conductor layer.
In another alternative, the metallic shield layer extends over the entire circumference of the conductor in the circumferential direction.
In another optional scheme, the insulating part further comprises a third insulating layer, the metal shielding layer is located on the radial outer side of the second insulating layer, and the third insulating layer is located on the radial outer side of the metal shielding layer and has a third radial thickness.
In another alternative, the insulating part is made of a medical polymer material.
In another alternative, the insulating portion is formed integrally with the linear conductor portion by deposition molding of a gaseous material, solvent evaporation molding after application of a solution, extrusion thermoforming by putting into a tool, or extrusion molding.
The present application further provides a method for manufacturing a lead for an implantable electrical stimulation device according to any one of the above technical solutions, where the method for manufacturing the lead includes:
a first assembling step in which the linear conductor portion is spirally wound on the insulating tube,
a first molding step of molding a second insulating layer radially outside the linear conductor portion to integrally mold the insulating tube, the second insulating layer, and the linear conductor portion.
In an alternative, in the case where the wire includes a metal shield layer, the manufacturing method further includes:
a second assembling step in which a metal mesh is fitted over a radially outer side of the second insulating layer;
and a second molding step of molding a third insulating layer on a radially outer side of the metal mesh so that the insulating tube, the second insulating layer, the third insulating layer, the linear conductor portion, and the metal mesh are molded as one body.
In another alternative, in the first assembling step, a core rod is inserted into the inside of the insulating tube or a material is filled in the inside of the insulating tube to support the insulating tube,
removing the core pin or removing the internal filling material after the first molding step.
In another alternative, in the first assembling step, a core rod is inserted into the inside of the insulating tube or a material is filled in the inside of the insulating tube to support the insulating tube,
after the second molding step, the core rod is removed or the internal filling material is removed.
The present application further provides a method for manufacturing a lead for an implantable electrical stimulation device according to any one of the above technical solutions, where the method includes:
a first step of spirally winding a linear conductor portion;
and secondly, wrapping the linear conductor part, the insulating part and the linear conductor part by using a high polymer material and simultaneously extruding and molding.
The present application further provides a wire assembly comprising:
the lead for the implantable electrical stimulation device according to any one of the above technical solutions;
a plug section formed with a plurality of first contacts; and
a receptacle section formed with a plurality of second contacts,
the lead is located between and connected to the plug section and the socket section, and the two end portions of the linear conductor portion of the lead respectively extend into the plug section and the socket section, so that the first contact and the second contact are electrically connected through the linear conductor portion.
By adopting the technical scheme, the application provides a novel wire for an implanted electrical stimulation device and a manufacturing method thereof. Thus, the space occupied by the whole lead can be reduced, particularly the outer diameter is small, while the performance such as insulation of the manufactured lead is basically unchanged. Moreover, the elongation performance of the wire is better. The application also provides a manufacturing method which is beneficial to mass production of the lead and a lead assembly for the implanted electrical stimulation device comprising the lead.
Drawings
Fig. 1A is a schematic diagram illustrating an overall structure of a lead assembly for an implantable electrical stimulation device according to a first embodiment of the present application.
Fig. 1B is a perspective schematic view illustrating a structure of a lead of the lead assembly for an implantable electrical stimulation device of fig. 1A.
Fig. 1C is a cross-sectional schematic view illustrating the structure of a lead of the lead assembly for an implantable electrical stimulation device of fig. 1A.
Fig. 1D is a schematic view for explaining a method of manufacturing the conductive line in fig. 1B.
Fig. 1E is a perspective schematic view showing a structure of a modification of the wire assembly in fig. 1A.
Fig. 1F is a cross-sectional view schematically showing the structure of a modification in fig. 1E.
Fig. 2A is a schematic cross-sectional view showing the structure of a lead assembly for an implantable electrical stimulation apparatus according to a second embodiment of the present application.
Fig. 2B is a schematic view for explaining a method of manufacturing the conductive line in fig. 2A.
Fig. 2C is a cross-sectional view schematically showing the structure of a modified example of the wire assembly in fig. 2A.
Fig. 3 is a schematic cross-sectional view of a conventional lead for an implantable electrical stimulation device.
Description of the reference numerals
10 conductor 20 inner insulating tube 30 outer insulating tube
1 plug segment 11 first contact
2 socket section 21 second contact
3-conductor 31 first insulating layer 32 second insulating layer 33 conductor layer 34 metallic shield layer 35 third insulating layer
The T insulating tube C is provided with a linear conductor part M, a metal mesh A and a radial direction R.
Detailed Description
Exemplary embodiments of the present application are described below with reference to the accompanying drawings. It should be understood that the detailed description is only intended to teach one skilled in the art how to practice the present application, and is not intended to be exhaustive or to limit the scope of the application.
In the present application, "axial", "radial" and "circumferential" refer to the axial, radial and circumferential directions of the wire, respectively, unless otherwise specified.
The following description is made in conjunction with the accompanying drawings for an implantable electrical stimulation apparatus according to a first embodiment of the present application.
(lead assembly for implantable electrical stimulation device according to the first embodiment of the present application)
As shown in fig. 1A, the lead assembly for an implantable electrical stimulation apparatus according to the first embodiment of the present application includes a plug section 1, a socket section 2 and a lead 3 assembled together, and the lead 3 is located between the plug section 1 and the socket section 2 and connected with the plug section 1 and the socket section 2.
In the present embodiment, as shown in fig. 1A, the plug section 1 is formed with a plurality of first contacts 11 arranged at intervals in the axial direction a, the receptacle section 2 is formed with a plurality of second contacts 21 arranged at intervals in the axial direction a, and the first contacts 11 and the second contacts 21 are electrically conducted via the wires 3. In this way, an excitation current for electrical stimulation can be conducted between the first contact 11 and the second contact 21 via the conductor 3.
In the present embodiment, as shown in fig. 1A to 1C, the wire 3 is formed in a circular tube shape as a whole, and a through hole penetrating along the axial direction a is formed inside the wire 3. Specifically, the lead 3 includes an insulating portion made of a medical polymer material (e.g., silicone rubber, polyurethane, etc.) and a linear conductor portion C made of a conductive metal, which are molded as one body. The insulating portion includes a first insulating layer 31 and a second insulating layer 32, and the linear conductor portion C is spirally wound to constitute a conductor layer 33. The first insulation layer 31 is located radially inward of the conductor layer 33 in the radial direction R and has a first radial thickness, and the second insulation layer 32 is located radially outward of the conductor layer 33 in the radial direction R and has a second radial thickness. In this way, both the inner and outer circumferential surfaces of the wire 3 are formed of the insulating portion, thereby providing necessary insulating performance. Further, a portion of the linear conductor portion C located between both axial end portions is buried in the insulating portion, and both axial end portions of the linear conductor portion C protrude from the insulating portion and respectively protrude into the plug section 1 and the socket section 2, so that the first contact 11 and the second contact 21 are electrically conducted via the linear conductor portion C.
By adopting the above configuration, the helically wound linear conductor portion C is embedded in the insulating portion, and the linear conductor portion C and the insulating portion are molded together, whereby the space occupied by the entire lead wire, particularly the outer diameter, can be reduced while the performance such as the insulation property of the lead wire 3 to be manufactured is substantially unchanged. Further, since the linear conductor portion C is spirally wound, it has a certain expansion and contraction capability, and the pulling feeling of the wire to the user can be reduced.
As shown in fig. 1B and 1C, in the implementation of the wire 3 of the wire assembly according to the first embodiment of the present application, the lengths of both the first insulating layer 31 and the second insulating layer 32 are equal in the axial direction a, so that it is possible to provide necessary insulating and supporting effects.
In addition, as shown in fig. 1E and 1F, in the modification of the wire 3 of the wire assembly according to the first embodiment of the present application, the length of the first insulating layer 31 is greater than the length of the second insulating layer 32 in the axial direction a, so that it is possible to provide better insulating and supporting effects.
A method of manufacturing the lead 3 of the lead assembly for an implantable electrical stimulation apparatus according to the first embodiment of the present application is explained below.
As shown in fig. 1D, the manufacturing method of the lead 3 of the lead assembly for implantable electrical stimulation apparatus according to the first embodiment of the present application comprises the following steps:
first, the linear conductor portion C is spirally wound on an insulating tube T for forming the first insulating layer 31. In this step, the linear conductor part C may be spirally wound first and then fitted to the insulating tube T, or the linear conductor part C may be directly spirally wound around the insulating tube T. In consideration of the need to reinforce the support of the insulating tube T when the linear conductor portion C is attached to the insulating tube T, a core rod or an internal filler (e.g., silicone rubber) may be inserted into the insulating tube T in advance.
Next, the second insulating layer 32 is formed on the radial outer side of the linear conductor portion C, and the forming method may be any one of deposition forming of a gaseous material (for example, by parylene deposition), solvent evaporation forming after coating a solution (for example, a polymer material solution), and extrusion thermoforming through a tooling die.
In the above process, with the configuration of the lead wire 3 of the lead wire assembly of the first embodiment, both axial end portions of the linear conductor portion C may be exposed for a certain length from the insulating tube T and the second insulating layer 32; with the configuration of the modification of the lead wire assembly of the first embodiment, the length of the insulating tube T may be made larger than the length of the second insulating layer 32 and both axial end portions of the linear conductor portion C may be exposed from the second insulating layer 32 by a certain length. After molding, the insulating tube T, the second insulating layer 32, and the linear conductor portion C are integrated.
Finally, the core rod can be removed from the insulating tube T or the internal filling material can be removed.
In addition, the lead 3 of the lead assembly for the implantable electrical stimulation device according to the first embodiment of the present application has another manufacturing method, which includes the following steps:
first, the linear conductor portion C is spirally wound;
next, the linear conductor portion C is wrapped with a polymer material, and the first insulating layer 31, the second insulating layer 32, and the linear conductor portion C are simultaneously extrusion-molded, wherein the polymer material forms the first insulating layer 31 and the second insulating layer 32.
In the case of manufacturing the lead wire assembly using the lead wire 3, both axial end portions of the linear conductor portion C can be connected to the first contact 11 of the plug section 1 and the second contact 21 of the socket section 2, respectively, to achieve electrical conduction. Specifically, one end of the linear conductor portion C may be formed with the first contact 11 of the plug section 1 by heat fusion, injection molding, or the like, and the other end of the linear conductor portion C may be formed with the second contact 21 of the socket section 2 by molding, injection molding, or the like.
By adopting the manufacturing method, the lead 3 of the lead assembly for the implantable electrical stimulation device according to the first embodiment of the application can be manufactured in a manner favorable for large-scale industrial production, and the manufacturing method has high efficiency and the manufactured lead has stable and firm structure.
The following description is made in conjunction with the accompanying drawings for an implantable electrical stimulation apparatus according to a second embodiment of the present application.
(lead assembly for implantable electrical stimulation device according to the second embodiment of the present application)
The technical concept of the lead assembly for an implantable electrical stimulation device according to the second embodiment of the present application is substantially the same as that of the lead assembly for an implantable electrical stimulation device according to the first embodiment of the present application, and the following description is mainly made of the difference in structure between the two.
As shown in fig. 2A, in the present embodiment, the lead 3 of the lead assembly for an implantable electrical stimulation device further includes a metal shielding layer 34 integrally molded with the insulating portion. The metal shield layer 34 has a mesh structure, the metal shield layer 34 is buried in the insulating portion and spaced apart from the conductor layer 33, and the metal shield layer 34 is located radially outside the conductor layer 33. In the axial direction a, the axial length of the metallic shield layer 34 can be controlled in a flexible manner. The metallic shield layer 34 extends over the entire circumference in the circumferential direction of the conductor.
Further, the metal shielding layer 34 is located radially outside the second insulating layer 32, and the insulating portion further includes a third insulating layer 35, where the third insulating layer 35 is located radially outside the metal shielding layer 34 and has a third radial thickness. Thus, the insulating section can still exhibit the required insulating performance.
By adopting the above technical solution, the lead assembly for an implantable electrical stimulation apparatus according to the second embodiment of the present application can not only exhibit the same function as that of the first embodiment, but also shield heat generation of the linear conductor part C during the nuclear magnetic resonance detection process by the metal shield layer 34.
As shown in fig. 2A, in the implementation of the wire 3 of the wire assembly according to the second embodiment of the present application, the metallic shield layer 34 is equal in length to the insulating portion in the axial direction a, so that the necessary insulating and supporting effects can be provided.
In addition, as shown in fig. 2C, in the modification of the wire 3 of the wire assembly according to the second embodiment of the present application, the length of the first insulating layer 31 is greater than the length of any one of the second insulating layer 32, the metal shield layer 34, and the third insulating layer 35 in the axial direction a, so that it is possible to provide better insulating and supporting effects. The length of the metal shielding layer 34 is equal to the length of the second and third insulating layers 32, 35, so that the necessary shielding effect can be provided.
A method of manufacturing the lead 3 of the lead assembly for an implantable electrical stimulation apparatus according to the second embodiment of the present application is described below.
As shown in fig. 2B, the method for manufacturing the lead 3 of the lead assembly for an implantable electrical stimulation apparatus according to the second embodiment of the present application comprises the following steps:
first, the linear conductor portion C is spirally wound on an insulating tube T for forming the first insulating layer 31. In this step, the linear conductor part C may be spirally wound first and then fitted to the insulating tube T, or the linear conductor part C may be directly spirally wound around the insulating tube T. In consideration of the need to reinforce the support of the insulating tube T when the linear conductor portion C is attached to the insulating tube T, a core rod or an internal filler (e.g., silicone rubber) may be inserted into the insulating tube T in advance.
Next, the second insulating layer 32 is formed on the radial outer side of the linear conductor portion C, and the forming method may be any one of deposition forming of a gaseous material (for example, by parylene deposition), solvent evaporation forming after coating a solution (for example, a polymer material solution), and extrusion thermoforming through a tooling die.
Further, the metal mesh M may be wrapped around the radially outer side of the second insulating layer 32, or the metal mesh M may be woven on the second insulating layer 32.
Then, the third insulating layer 35 is formed on the radial outer side of the metal mesh M by any one of deposition forming of a gaseous material (for example, by parylene deposition), solvent evaporation forming after coating a solution (for example, a polymer solution), and extrusion thermoforming through a tooling die.
In the above process, with the configuration of the lead wire 3 of the lead wire assembly of the second embodiment, both axial end portions of the linear conductor portion C may be exposed for a certain length from the insulating tube T and the second insulating layer 32; in the configuration of the modified example of the lead wire assembly according to the second embodiment, the length of the insulating tube T may be made longer than any one of the second insulating layer 32, the metal mesh M, and the third insulating layer 35, and both end portions of the linear conductor portion C may be exposed from the second insulating layer 32, the metal mesh M, and the third insulating layer 35 by a certain length. The insulating tube T, the second insulating layer 32, the third insulating layer 35, the metal mesh M, and the linear conductor portion C are integrated after molding.
Finally, the core rod can be removed from the insulating tube T or the internal filling material can be removed.
In addition, the lead 3 of the lead assembly for the implantable electrical stimulation device according to the second embodiment of the present application has another manufacturing method, which includes the following steps:
first, the linear conductor portion C is spirally wound;
next, the linear conductor portion C is wrapped with a polymer material, and the first insulating layer 31, the second insulating layer 32, and the linear conductor portion C are simultaneously extrusion-molded, wherein the polymer material forms the first insulating layer 31 and the second insulating layer 32.
Further, the metal mesh M may be wrapped around the radially outer side of the second insulating layer 32, or the metal mesh M may be woven on the second insulating layer 32. In consideration of the need to reinforce the support of the insulating layer when the metal mesh M is sleeved/woven outside the second insulating layer 32, a core bar or an internal filling material (e.g., silicone rubber) may be inserted inside the first insulating layer 31 before the metal mesh M is sleeved/woven.
Then, the third insulating layer 35 is formed on the radial outer side of the metal mesh M by any one of deposition forming of a gaseous material (for example, by parylene deposition), solvent evaporation forming after coating a solution (for example, a polymer solution), and extrusion thermoforming through a tooling die.
Finally, the core rod can be removed or the internal filling material can be removed from the inside of the first insulating layer 31.
In the case of manufacturing the lead wire assembly using the lead wire 3, both axial end portions of the linear conductor portion C can be connected to the first contact 11 of the plug section 1 and the second contact 21 of the socket section 2, respectively, to achieve electrical conduction. Specifically, one end of the linear conductor portion C may be formed with the first contact 11 of the plug section 1 by heat fusion, injection molding, or the like, and the other end of the linear conductor portion C may be formed with the second contact 21 of the socket section 2 by molding, injection molding, or the like.
The technical solution of the present application is explained in detail in the above specific examples, and supplementary description is provided below.
i. It is understood that the linear conductor portion C may be a conductive metal having a coating layer. After the linear conductor portion C is spirally wound, adjacent turns may have a certain interval therebetween.
The axial length of the metallic shield layer 34 may be adjusted as desired, and may not necessarily coincide with the axial length of the insulation.
The lumen of the lead may be used for insertion therethrough of a support structure supporting the plug segment 1.
in an alternative, the thickness of the second insulating layer 32 may be reduced appropriately, even omitting the second insulating layer 32, on the premise that the linear conductor portion C itself has been insulation-wrapped.
v. in the case of manufacturing the wire 3 of the present application by the above-described manufacturing method, insertion of a core rod or a filler material into the insulating tube T is optional. That is, the core rod and the filler material may not be used in the case where the insulating tube T does not need to be supported in the manufacturing method.

Claims (10)

1.一种植入式电刺激设备用导线,其特征在于,所述导线(3)包括成型为一体的绝缘部和线状导体部(C),所述线状导体部(C)以螺旋状卷绕的方式埋入所述绝缘部,在所述导线(3)的轴向(A)上所述线状导体部(C)的两端部分别从所述绝缘部伸出。1. A lead wire for an implantable electrical stimulation device, characterized in that the lead wire (3) comprises an integrally formed insulating portion and a linear conductor portion (C), wherein the linear conductor portion (C) is formed in a spiral shape. The insulating portion is embedded in a winding manner, and both ends of the linear conductor portion (C) protrude from the insulating portion in the axial direction (A) of the wire (3). 2.根据权利要求1所述的植入式电刺激设备用导线,其特征在于,所述导线(3)整体形成为圆管形状,所述导线(3)的内部形成有沿着所述轴向(A)贯通的通孔。2 . The lead wire for implantable electrical stimulation equipment according to claim 1 , wherein the lead wire ( 3 ) is formed in the shape of a round tube as a whole, and the inside of the lead wire ( 3 ) is formed along the shaft. 3 . A through hole penetrating to (A). 3.根据权利要求1或2所述的植入式电刺激设备用导线,其特征在于,所述绝缘部包括第一绝缘层(31)和第二绝缘层(32),所述第一绝缘层(31)位于由所述线状导体部(C)构成的导体层(33)的径向内侧且具有第一径向厚度,所述第二绝缘层(32)位于所述导体层(33)的径向外侧且具有第二径向厚度。3. The lead wire for an implantable electrical stimulation device according to claim 1 or 2, wherein the insulating portion comprises a first insulating layer (31) and a second insulating layer (32), the first insulating layer The layer (31) is located radially inward of the conductor layer (33) composed of the linear conductor portion (C) and has a first radial thickness, and the second insulating layer (32) is located in the conductor layer (33) ) radially outside and has a second radial thickness. 4.根据权利要求3所述的植入式电刺激设备用导线,其特征在于,所述导线还包括与所述绝缘部成型为一体的金属屏蔽层(34),所述金属屏蔽层(34)埋入所述绝缘部中且与所述导体层(33)间隔开,所述金属屏蔽层(34)位于所述导体层(33)的径向外侧。4. The lead wire for implantable electrical stimulation equipment according to claim 3, characterized in that, the lead wire further comprises a metal shielding layer (34) formed integrally with the insulating portion, and the metal shielding layer (34) ) is embedded in the insulating portion and spaced apart from the conductor layer (33), and the metal shield layer (34) is located radially outside the conductor layer (33). 5.根据权利要求4所述的植入式电刺激设备用导线,其特征在于,所述绝缘部还包括第三绝缘层(35),所述金属屏蔽层(34)位于所述第二绝缘层(32)的径向外侧,所述第三绝缘层(35)位于所述金属屏蔽层(34)的径向外侧且具有第三径向厚度。5. The lead wire for implantable electrical stimulation equipment according to claim 4, wherein the insulating portion further comprises a third insulating layer (35), and the metal shielding layer (34) is located on the second insulating layer On the radially outer side of the layer (32), the third insulating layer (35) is located on the radially outer side of the metal shielding layer (34) and has a third radial thickness. 6.根据权利要求1或2所述的植入式电刺激设备用导线,其特征在于,所述绝缘部通过气态材料沉积成型、涂覆溶液后溶剂挥发成型、放入工具内挤压热成型或挤出成型而与所述线状导体部(C)成型为一体。6. The lead wire for implantable electrical stimulation equipment according to claim 1 or 2, wherein the insulating part is formed by deposition of a gaseous material, volatilization of a solvent after coating a solution, and extrusion and thermoforming in a tool. Or extrusion-molded and integrally molded with the linear conductor portion (C). 7.一种权利要求1至6中任一项所述的植入式电刺激设备用导线的制造方法,其特征在于,所述制造方法包括:7. A method for manufacturing a lead wire for an implantable electrical stimulation device according to any one of claims 1 to 6, wherein the method for manufacturing comprises: 第一组装步骤,其中将线状导体部(C)螺旋状卷绕到绝缘管(T)上,A first assembling step in which the linear conductor portion (C) is helically wound onto the insulating tube (T), 第一成型步骤,其中在所述线状导体部(C)的径向外侧成型第二绝缘层(32),使所述绝缘管(T)、所述第二绝缘层(32)和所述线状导体部(C)成型为一体。A first molding step in which a second insulating layer (32) is molded on the radially outer side of the linear conductor portion (C) so that the insulating tube (T), the second insulating layer (32) and the The linear conductor portion (C) is integrally formed. 8.根据权利要求7所述的制造方法,其特征在于,在所述导线(3)包括金属屏蔽层(34)的情况下,所述制造方法还包括:8. The manufacturing method according to claim 7, characterized in that, when the wire (3) comprises a metal shielding layer (34), the manufacturing method further comprises: 第二组装步骤,其中在所述第二绝缘层(32)的径向外侧套装金属网(M);A second assembling step, wherein a metal mesh (M) is sheathed on the radial outer side of the second insulating layer (32); 第二成型步骤,其中在金属网(M)的径向外侧成型第三绝缘层(35),使所述绝缘管(T)、所述第二绝缘层(32)、所述第三绝缘层(35)、所述线状导体部(C)和所述金属网(M)成型为一体。The second forming step, wherein a third insulating layer (35) is formed on the radially outer side of the metal mesh (M), so that the insulating tube (T), the second insulating layer (32), and the third insulating layer are formed. (35) The linear conductor portion (C) and the metal mesh (M) are integrally formed. 9.一种权利要求1至6中任一项所述的植入式电刺激设备用导线的制造方法,其特征在于,所述制造方法包括:9. The method for manufacturing a lead wire for an implantable electrical stimulation device according to any one of claims 1 to 6, wherein the method for manufacturing comprises: 第一步,将线状导体部(C)螺旋状卷绕;In the first step, the linear conductor part (C) is spirally wound; 第二步,利用高分子材料包裹线状导体部(C),绝缘部和线状导体部(C)同时挤出成型。In the second step, the linear conductor part (C) is wrapped with a polymer material, and the insulating part and the linear conductor part (C) are extruded simultaneously. 10.一种导线组件,其特征在于,所述导线组件包括:10. A wire assembly, characterized in that the wire assembly comprises: 权利要求1至6中任一项所述的植入式电刺激设备用导线;The lead wire for an implantable electrical stimulation device according to any one of claims 1 to 6; 插头段(1),其形成有多个第一触点(11);以及a plug segment (1) formed with a plurality of first contacts (11); and 插座段(2),其形成有多个第二触点(21),a socket segment (2) formed with a plurality of second contacts (21), 其中,所述导线(3)位于所述插头段(1)和所述插座段(2)之间且与所述插头段(1)和所述插座段(2)相连,所述导线(3)的线状导体部(C)的所述两端部分别伸入所述插头段(1)和所述插座段(2),使得所述第一触点(11)和所述第二触点(21)经由所述线状导体部(C)电性导通。Wherein, the wire (3) is located between the plug segment (1) and the socket segment (2) and is connected with the plug segment (1) and the socket segment (2), the wire (3) The two ends of the linear conductor portion (C) of ) respectively protrude into the plug segment (1) and the socket segment (2), so that the first contact (11) and the second contact The point (21) is electrically connected via the linear conductor portion (C).
CN202210351502.3A 2022-04-02 2022-04-02 Lead for implantable electrical stimulation device, manufacturing method thereof and lead assembly Pending CN114613531A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040055776A1 (en) * 2000-06-27 2004-03-25 Zoran Milijasevic Stretchable conducting lead
CN102458563A (en) * 2009-04-30 2012-05-16 麦德托尼克公司 Termination of a shield within an implantable medical lead
CN104274902A (en) * 2014-10-10 2015-01-14 清华大学 Implanted electrode compatible with MRI and manufacturing method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040055776A1 (en) * 2000-06-27 2004-03-25 Zoran Milijasevic Stretchable conducting lead
CN102458563A (en) * 2009-04-30 2012-05-16 麦德托尼克公司 Termination of a shield within an implantable medical lead
CN104274902A (en) * 2014-10-10 2015-01-14 清华大学 Implanted electrode compatible with MRI and manufacturing method thereof

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