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.
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.