CN107661571B - Flexible auditory nerve stimulating electrode array with multilayer structure - Google Patents

Flexible auditory nerve stimulating electrode array with multilayer structure Download PDF

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Publication number
CN107661571B
CN107661571B CN201710812115.4A CN201710812115A CN107661571B CN 107661571 B CN107661571 B CN 107661571B CN 201710812115 A CN201710812115 A CN 201710812115A CN 107661571 B CN107661571 B CN 107661571B
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layer
flexible
electrode
conductive metal
insulating film
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CN107661571A (en
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田岚
韩琳
吴瑞安
马发江
霍新宇
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Shandong University
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Shandong University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0541Cochlear electrodes

Abstract

The invention discloses a flexible artificial auditory nerve stimulating electrode with a multilayer structure and a manufacturing method thereof, wherein the flexible artificial cochlea electrode array component is designed and manufactured by adopting flexible insulating film materials with biocompatibility according to the space occupation distribution rule of the tail end of a cochlea auditory nerve and adopting the steps of multilayer structure, via holes, wiring, shaping and the like, and the method comprises the following specific steps: the method comprises the steps of (1) designing and manufacturing electrode points of electrode layers of through holes (2) at specific positions of flexible film materials, (3) conducting electrode layer waterproof treatment, 4 conducting electrode connection wires of lead layers, 5 conducting electrode connection wire layer waterproof treatment, and 6 conducting deformation and pouring molding to manufacture needle-shaped electrodes. The electrode design and manufacturing method has the characteristics of multilayer structure, firm electrodes, high frequency resolution of sensing electrodes, customization, fine electrode needles and the like, can meet the requirements of individualized and accurate hearing disability treatment, and can be used for docking various types of sound coding processors.

Description

Flexible auditory nerve stimulating electrode array with multilayer structure
Technical Field
The invention relates to a flexible artificial auditory nerve stimulating electrode with a multilayer structure and a manufacturing method thereof.
Background
The external sound signals can be stimulated by appropriate electric signals through sound signal acquisition, analysis and coding, the nerve terminals are butted, the auditory nerve conduction paths are activated, the malformations of certain auditory systems are treated, and the auditory perception is recovered, such as an electronic cochlea or an artificial cochlea.
The number of the current artificial cochlea electrodes is less, generally less than 30, the electrodes are butted with the tail ends of auditory nerves in the cochlea in a relatively rough mapping relation, and external stimulation signals activate the conduction of the nerve paths so as to restore the auditory perception of the human ear. Because of the characteristics of voice sound signals, the rough electrode distribution can better transmit language information, can reach voice intelligibility of more than 95%, but still has a lot of abundant sound information which is difficult to normally perceive, such as tone perception of music and Chinese, and the like, and the sound sensing effect of a cochlear implant needs to be improved. The electrode contacts are implanted as many as possible under the condition of meeting the whole caliber of an electrode array is fine, so that the electrode array is very important for accurate treatment and improvement of the sound resolving power of the artificial cochlea. On the basis, the dialect sound effect which is closer to normal hearing can be achieved by utilizing the strong self-learning and self-adapting capability of the auditory nerve and brain cognitive system.
However, the inside of the cochlea is a spirally curved structure, the cochlear canal is narrow, and the sensing electrode for acoustic nerve stimulation should have good flexibility and long-term biocompatibility. Meanwhile, the shape, the size, the auditory nerve distribution and the like of the individual cochlea of the patient possibly have a certain specificity, and the individual electrode structure is very important to be convenient for design and customization; however, the existing design and manufacture of cochlear implant electrodes have the problems that the number of electrodes is not easy to increase, sometimes the electrodes are not firm enough and are easy to fall off, the individual electrode design is not easy to realize, and the like.
Disclosure of Invention
In order to solve the technical problems in the prior art, the invention discloses a flexible auditory nerve stimulating electrode array with a multilayer structure and a manufacturing method thereof. According to the invention, flexible and biocompatible film materials are adopted according to the distribution rule of the occupation of the tail end of the auditory nerve of the cochlea, and the steps of punching, wiring, shaping and the like are adopted in a multi-layer structure, so that the flexible stimulating electrode array is designed and manufactured.
The technical scheme adopted by the invention is as follows:
the invention provides a flexible auditory nerve stimulating electrode array with a multilayer structure, which comprises a flexible insulating film material layer, wherein the upper layer of the flexible insulating film material layer is a conductive metal layer, and the lower layer of the flexible insulating film material layer is a conductive metal layer; one of the conductive metal layers is used for manufacturing an electrode layer, and the other conductive metal layer is used for manufacturing a lead layer; the electrode made of the electrode layer is communicated with the lead wire made of the lead wire layer.
Furthermore, waterproof protection layers are arranged on the surfaces of the two conductive metal layers.
Furthermore, a waterproof protective film is coated on the surfaces of the flexible insulating film material which is in contact with tissues in the electrode layer and the lead layer.
Further, a layer of adhesive material may be added between the flexible insulating film material layer and the conductive metal layer in order to improve the adhesion of the metal.
Further, in the lead layer design, a multi-layer lead layer design can be adopted as required; the multi-layer lead layer is connected with different electrodes of the electrode layer.
The invention also provides a manufacturing method (single-side processing) of the flexible auditory nerve stimulating electrode array with the multilayer structure, which comprises the following specific steps:
step 1, providing a substrate; spin-coating a first flexible insulating film material layer on the substrate, and standing until the flexible insulating film material layer is solidified;
step 2, depositing a first conductive metal layer on the surface of the first flexible insulating film material layer, and etching a metal pattern;
step 3, spin coating a second flexible insulating film material layer on the first conductive metal layer;
step 4, arranging a via hole on the component obtained in the step 3;
step 5, depositing a second conductive metal layer on the surface of the second flexible insulating film material layer, and etching a metal pattern; the through holes in the step 4 are communicated with the patterns of the first conductive metal layer and the second conductive metal layer;
step 6, stripping the component obtained in the step 5 from the hard substrate;
and 7, shaping.
Further; taking the first conductive metal layer as a lead layer, and taking the second conductive metal layer as an electrode layer; the layout of the conductive metal electrode array of the electrode layer is designed and manufactured according to a printed circuit mode; the conducting metal film wire and pin layout of the lead layer are also designed and manufactured in a printed circuit mode;
further, the shaping method in the step 7 is as follows: the flexible metal filament support is used as an axis to be curled and poured into a shape similar to a long cone with an electrode layer outside and a lead layer, wherein the flexible metal filament support is provided with an extractable filament support.
The invention also provides a manufacturing method (double-side processing) of the flexible auditory nerve stimulating electrode array with the multilayer structure, which comprises the following specific steps:
step 1, providing a substrate; spin-coating a first flexible insulating film material layer on the substrate, and standing until the flexible insulating film material layer is solidified;
step 2, arranging via holes on the first flexible insulating film material layer and making holes;
step 3, depositing a first conductive metal layer on the surface of the first flexible insulating film material layer, and etching a metal pattern; the method comprises the steps of carrying out a first treatment on the surface of the
Step 4, spin coating a layer (namely a second layer) of flexible insulating film material on the surface of the component obtained in the step 3;
step 5, stripping the prepared sample from the hard substrate, turning the sample over (namely reversing the bottom surface to the upper surface), properly protecting the bottom surface of the processed sample, and fixing the processed sample on the hard substrate;
step 5, depositing a second conductive metal layer on the upper surface of the sample, and etching a metal pattern; wherein the method comprises the steps of
The via hole of the first conductive metal layer and the second conductive metal layer.
And 6, peeling the manufactured sample from the hard substrate.
Step 7; shaping.
Further; taking the first conductive metal layer as a lead layer, and taking the second conductive metal layer as an electrode layer; the layout of the conductive metal electrode array of the electrode layer is designed and manufactured according to a printed circuit mode; the conducting metal film wire and pin layout of the lead layer are also designed and manufactured in a printed circuit mode;
further, the shaping method in the step 7 is as follows: the flexible metal filament support is used as an axis to be curled and poured into a shape similar to a long cone with an electrode layer outside and a lead layer, wherein the flexible metal filament support is provided with an extractable filament support.
The invention has the beneficial effects that:
1. the number of implantable electrodes and leads is large: the increase of the number of leads in the electrode manufacturing is critical, and the number of the manufactured electrodes can be far more than that of the existing manufacturing method of the cochlea electrode by adopting the manufacturing method. For example, when the radius of the round window is 0.5mm, the circumference of the volute bottom is about 3mm, when the lead width is 20um and the lead interval is 20um, about 70 leads can be laid out, and the number of the leads of the existing cochlear electrode is generally less than 30.
2. The electrode is firm: the electrode which is made to grow out by adopting electron beam evaporation and deposition is firmer and not easy to fall off; the existing artificial cochlea electrode mostly adopts a die to pour and fix the electrode, and the operation implantation process is easy to fall off.
3. The individuation design is more convenient: the aperture of the cochlea round window is about 0.6mm to 5mm different from person to person, and the whole diameter of the electrode is slender by adopting the design and processing method, and the position of the stimulating electrode can be customized and the thin film structure with different thickness can be selected according to the individual cochlea structure and the hearing damage condition of a patient, so that an individual and accurate electrode product is constructed.
Drawings
The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiments of the application and together with the description serve to explain the application and do not constitute an undue limitation to the application.
Fig. 1 a multilayer structure of the invention, wherein: 1-1 electrode layer, 1-2 flexible insulating film material layer, 1-3 lead layer;
fig. 2 is a chart of the curl setting process of the present invention, wherein: 2-1 is an electrode, 2-2 is a lead, and 2-3 is a via-fill metal location.
Detailed Description
It should be noted that the following detailed description is illustrative and is intended to provide further explanation of the present application. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments in accordance with the present application. As used herein, the singular is also intended to include the plural unless the context clearly indicates otherwise, and furthermore, it is to be understood that the terms "comprises" and/or "comprising" when used in this specification are taken to specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof.
As introduced by the background technology, the design and the manufacture of the cochlear implant electrode in the prior art have the problems of difficulty in increasing the number of electrodes, difficulty in falling off due to insufficient firmness sometimes, difficulty in realizing the individual electrode design and the like;
in an exemplary embodiment of the present application, as shown in fig. 1, a multi-layer structured flexible artificial auditory nerve stimulating electrode is provided; the flexible insulation film comprises a flexible insulation film material layer 1-2, wherein the upper layer of the flexible insulation film material layer 1-2 is a conductive metal layer, and the lower layer of the flexible insulation film material layer is also a conductive metal layer; one of the conductive metal layers is used for manufacturing an electrode layer 1-1, and the other conductive metal layer is used for manufacturing a lead layer 1-3; the electrode made of the electrode layer is communicated with the lead wire made of the lead wire layer; the specific communication mode is that the electrode layer 1-1 and the lead layer 1-3 are communicated by arranging a via hole.
Furthermore, waterproof protection layers are further arranged on the surfaces of the two conductive metal layers.
Furthermore, a waterproof protective film is coated on the surfaces of the flexible insulating film material which is in contact with tissues in the electrode layer and the lead layer.
Further, a layer of adhesive material may be added between the flexible insulating film material layer and the conductive metal layer in order to improve the adhesion of the metal.
Further, in the lead layer design, a multi-layer lead layer design can be adopted as required; the multi-layer lead layer is connected with different electrodes of the electrode layer.
Engraving an electrode 2-1 on the electrode layer; carving a lead 2-2 on the lead layer; the electrode 2-1 and the lead 2-2 are communicated through a via hole 2-3.
According to the invention, flexible and biocompatible film materials are adopted according to the distribution rule of the occupation of the tail end of the auditory nerve of the cochlea, and the steps of punching, wiring, shaping and the like are adopted in a multi-layer structure, so that the flexible electric stimulation electrode array is designed and manufactured. The specific manufacturing method comprises two types, wherein one type is a single-side processing method; one such method is a double-sided process, which is described in detail below,
example 1 one-sided processing method:
providing a rigid substrate (for supporting the whole device during manufacture)
Step 1: a layer of PDMS is spin coated, optionally to a thickness of, for example, 100um.
And 2, depositing a metal film with optional thickness of 75nm.
Step 3: and etching to obtain the required pattern, such as lead layer.
Step 4: and spin-coating a layer of PDMS on the surface of the structure, wherein the thickness is optional, such as 100um.
Step 5: and designing via holes on the PDMS layer in the step 4, and punching.
Step 6: a further metal film is deposited, optionally to a thickness of, for example, 75nm.
Step 7: and etching to obtain the required pattern, such as electrode layer.
Step 8: the sample was peeled from the hard substrate.
Step 9: crimping, pouring and forming by taking a flexible metal filament support as an axis to form a similar long cone shape with an electrode layer outside and a lead layer inside, wherein the filament support can be extracted; the specific method is shown in fig. 2, and the flexible conical cochlear electrode can be obtained by crimping the electrode along the arrow direction.
Example 2 double sided processing method
Providing a rigid substrate (for supporting the whole device during manufacture)
Step 1; a layer of PDMS is spin coated, and the thickness can be set, for example, to 100um.
Step 2: and designing via holes on the PDMS layer and punching.
And 3, depositing a layer of metal film on the surface, wherein the thickness is optional, such as: at 75nm
Step 4: and etching to obtain the required pattern, such as lead layer.
Step 5: a further layer of PDMS is spin coated, and the thickness can be set to be 100um.
Step 6: the prepared sample is peeled off from the hard substrate, and the other surface of the sample is turned over to properly protect the bottom surface of the processed sample, and then the processed sample is fixed on the hard substrate.
Step 7: and depositing a metal film with a thickness of 75nm on the upper surface.
Step 8: etching to obtain the required pattern, such as electrode layer.
Step 9: the sample was peeled from the hard substrate.
Step 10: the flexible metal filament support is used as an axis to be curled and poured into a shape similar to a long cone with an electrode layer outside and a lead layer, wherein the flexible metal filament support is provided with an extractable filament support.
The flexible insulating film material in the two embodiments is Polydimethylsiloxane (PDMS), although other flexible film materials with similar properties can be used; before spin coating the flexible insulating material layer, pre-coating an anti-adhesion layer on the substrate, so that the later stripping is convenient; the deposited metal film is evaporated by electron beam, and the selected metal material has the performances of good conductivity, good biological stability, softness and the like, such as gold; ultraviolet lithography is adopted in the metal etching process; the method for etching the conductive pattern comprises spin-coating photoresist, exposing, developing, depositing metal and washing off the photoresist.
The via-fill conductive metal in both embodiments may be gold.
PDMS can be used as the waterproof protective layer material.
The electrode layer may be formed by ultraviolet lithography to expose the electrode.
The shape of each electrode contact can be determined by the degree of crimping, and can be customized according to practical requirements, such as ring shape, u-shape, rectangle, etc.
According to the invention, according to the distribution rule of the occupation of the tail end of the auditory nerve of the cochlea, the flexible artificial cochlea electrode array component is designed and manufactured by adopting an insulating flexible film material with biocompatibility and adopting the steps of multilayer structure, via hole, wiring, shaping and the like.
While the foregoing description of the embodiments of the present invention has been presented in conjunction with the drawings, it should be understood that it is not intended to limit the scope of the invention, but rather, it is intended to cover all modifications or variations within the scope of the invention as defined by the claims of the present invention.

Claims (7)

1. The flexible auditory nerve stimulating electrode array with the multilayer structure is characterized by comprising a flexible insulating film material layer, wherein the upper layer of the flexible insulating film material layer is a conductive metal layer, and the lower layer of the flexible insulating film material layer is also a conductive metal layer; one of the conductive metal layers is used for manufacturing an electrode layer, and the other conductive metal layer is used for manufacturing a lead layer; the electrode made of the electrode layer is communicated with the lead wire made of the lead wire layer;
the manufacturing method of the flexible auditory nerve stimulating electrode array with the multilayer structure comprises the following specific steps:
step 1, providing a substrate; spin-coating a first flexible insulating film material layer on the substrate, and standing until the flexible insulating film material layer is solidified;
step 2, depositing a first conductive metal layer on the surface of the first flexible insulating film material layer, and etching a metal pattern;
step 3, spin coating a second flexible insulating film material layer on the first conductive metal layer;
step 4, arranging a via hole on the component obtained in the step 3;
step 5, depositing a second conductive metal layer on the surface of the second flexible insulating film material layer, and etching a metal pattern; the through holes in the step 4 are communicated with the patterns of the first conductive metal layer and the second conductive metal layer;
step 6, stripping the component obtained in the step 5 from the hard substrate;
and 7, shaping, namely: the flexible metal filament support is used as an axis to be curled and poured into a shape similar to a long cone with an electrode layer outside and a lead layer, wherein the flexible metal filament support is provided with an extractable filament support.
2. The flexible auditory nerve stimulating electrode array of claim 1, wherein a waterproof protective layer is further provided on the surface of both of said conductive metal layers.
3. The flexible auditory nerve stimulating electrode array of claim 1, wherein a waterproof protective film is applied to the surfaces of the electrode layer and the lead layer, where the flexible insulating film material is in contact with tissue.
4. The multi-layer structured flexible auditory nerve stimulating electrode array according to claim 1, wherein a layer of adhesive material is interposed between the flexible insulating film material layer and the conductive metal layer.
5. The flexible auditory nerve stimulating electrode array of claim 1, wherein in said lead layer design, a multi-layer lead layer design may be used as desired; the multi-layer lead layer is connected with different electrodes of the electrode layer.
6. The multi-layer flexible auditory nerve stimulating electrode array of claim 1, wherein a first conductive metal layer is used as a lead layer and a second conductive metal layer is used as an electrode layer; the layout of the conductive metal electrode array of the electrode layer is designed and manufactured according to a printed circuit mode; the conductive metal film connection lines and pin layout of the lead layer are also designed and manufactured in a printed circuit mode.
7. The manufacturing method of the flexible auditory nerve stimulating electrode array with the multilayer structure is characterized by comprising the following specific steps:
step 1, providing a substrate; spin-coating a first flexible insulating film material layer on the substrate, and standing until the flexible insulating film material layer is solidified;
step 2, arranging via holes on the first flexible insulating film material layer and making holes;
step 3, depositing a first metal layer on the first flexible insulating film material layer; etching a required pattern on the first metal layer;
step 4, spin-coating a flexible insulating film material layer on the surface of the component obtained in the step 3;
step 5, stripping the prepared sample from the hard substrate, turning over the other surface of the sample, properly protecting the bottom surface of the processed sample, and fixing the processed sample on the hard substrate;
step 6, depositing a second conductive metal layer on the upper surface of the sample, and etching a metal pattern;
step 7, peeling the prepared sample from the hard substrate;
step 8, shaping;
wherein, the first conductive metal layer is used as a lead layer, and the second conductive metal layer is used as an electrode layer; the layout of the conductive metal electrode array of the electrode layer is designed and manufactured according to a printed circuit mode; the conducting metal film wire and pin layout of the lead layer are also designed and manufactured in a printed circuit mode;
the shaping method in the step 7 is as follows: the flexible metal filament support is used as an axis to be curled and poured into a shape similar to a long cone with an electrode layer outside and a lead layer, wherein the flexible metal filament support is provided with an extractable filament support.
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CN108261605B (en) * 2018-02-13 2021-07-30 山东大学 Flexible single-layer conductive microstructure artificial cochlea electrode and manufacturing method thereof
US11452865B2 (en) 2019-10-10 2022-09-27 Advanced Bionics Ag Apparatus and methods for making cochlear implant electrode arrays
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