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WO2025111963A1 - Électrode en fibre d'implant minimalement invasive de structure gaine-noyau et son procédé de préparation - Google Patents

Électrode en fibre d'implant minimalement invasive de structure gaine-noyau et son procédé de préparation Download PDF

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Publication number
WO2025111963A1
WO2025111963A1 PCT/CN2023/135596 CN2023135596W WO2025111963A1 WO 2025111963 A1 WO2025111963 A1 WO 2025111963A1 CN 2023135596 W CN2023135596 W CN 2023135596W WO 2025111963 A1 WO2025111963 A1 WO 2025111963A1
Authority
WO
WIPO (PCT)
Prior art keywords
printing
electrode
preparation
conductive
paste
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/CN2023/135596
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English (en)
Chinese (zh)
Inventor
林瑾
李青松
刘志远
李光林
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shenzhen Institute of Advanced Technology of CAS
Original Assignee
Shenzhen Institute of Advanced Technology of CAS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shenzhen Institute of Advanced Technology of CAS filed Critical Shenzhen Institute of Advanced Technology of CAS
Priority to PCT/CN2023/135596 priority Critical patent/WO2025111963A1/fr
Publication of WO2025111963A1 publication Critical patent/WO2025111963A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/263—Bioelectric electrodes therefor characterised by the electrode materials

Definitions

  • the invention belongs to the technical field of electrophysiological detection and monitoring, and in particular relates to a skin-core structure fiber electrode for minimally invasive implantation and a preparation method thereof.
  • implantable electrodes have the advantage of being non-invasive, implantable electrodes can obtain bioelectric signals with higher accuracy, which is crucial for a deep understanding of physiological mechanisms and disease changes.
  • implantable electrodes can achieve long-term detection, which is of great significance for long-term tracking of diseases and evaluation of treatment effects. Therefore, implantable electrodes show irreplaceable advantages in the field of neuroelectrophysiological signal detection and have broad application prospects.
  • An injectable electrode reported in the prior art literature (Advanced healthcare materials, 2019, 8(23): 1900892).
  • the electrode is made of prepolymer and silver microparticle materials. After being injected into the target position by syringe, the material solidifies to form an electrode.
  • This method can reduce surgical trauma and infection risks, but this solution cannot form a fibrous structure, and it is difficult to effectively encapsulate and protect the conductor in one step, and it is difficult to truly achieve on-demand preparation and stable use in specific parts.
  • the silver filler used in this paper is potentially toxic and easily oxidized, which will affect the functional stability, safety and long-term reliability of the electrode. Therefore, the development of new implantable electrodes using safe materials and less trauma is the current technical demand and development direction.
  • the solution uses carbon fiber as the skeleton material, and selects conductive polymers with good biocompatibility as the active layer, and silicone that is non-toxic to organisms as the coating substrate to ensure that the electrode has good biological stability.
  • the components are fully mixed to obtain a flowable prepolymer suitable for injection.
  • the prepolymers are then placed in different syringe needles, and the different components are kept separate through coaxial flexible connection pipes, and are formed and cured in situ at the ends to form a skin-core structure.
  • the front needle of the injection printing device directly penetrates into a specific tissue site, and then continuously prints fiber electrodes at the target monitoring position, and the skin-core structure electrode is obtained after the polymer is naturally cured.
  • the present invention provides a new method for manufacturing coaxial fiber electrodes that are minimally invasively implanted and in situ formed.
  • the present invention uses materials with good biocompatibility to make printing slurry and adopts a minimally invasive implantation preparation method, which significantly reduces the manufacturing complexity and cost, greatly reduces surgical trauma, and improves the biocompatibility and long-term stability of the electrode.
  • the present invention adopts materials with good biocompatibility to prepare slurry with rheological properties suitable for printing, and uses a syringe to minimally invasively implant the slurry into the biological tissue of the target part through a coaxial channel and quickly solidify it, and prints the coaxial electrode in situ. Thanks to the characteristics of rapid in situ solidification, the electrode can be closely combined with the biological tissue, and can be quickly prepared at a fixed point in the body. At the same time, there is no need for large-area incision and exposure, and it has the advantages of small incisions for minimally invasive implantation, and realizes the in situ printing and minimally invasive implantation of fiber electrodes.
  • In situ solidification can accurately position the electrode at a specific monitoring point according to the anatomical structure and needs of the organism. This precise positioning helps to obtain more accurate and individualized monitoring results.
  • the fiber electrode skin-core structure has the characteristics of self-encapsulation, which can effectively protect the electrode material from the influence of the external environment, help to extend the service life of the electrode, and avoid the instability of the electrode performance during use.
  • the present invention provides a new strategy for minimally invasive implantation and in situ preparation of electrophysiological monitoring electrodes.
  • the present invention provides a method for preparing a skin-core structure fiber electrode for minimally invasive implantation, comprising the following steps:
  • the conductive paste comprises the following components in percentage by mass: 0-85% conductive filler, 15-90% polymer matrix material, and 0-10% additive;
  • the encapsulation slurry comprises a polymer capable of rapid prototyping and nano silicon dioxide with a mass concentration of 0-20%;
  • adding PEG to the conductive paste helps to improve its dispersibility, allowing CNF to be evenly dispersed in the conductive polymer, thereby improving the rheological properties of the paste.
  • silica gel can be combined with CNF, conductive polymer and PEG to give the conductive paste semi-cured properties and formability.
  • the encapsulation paste is usually composed of non-toxic materials such as silica gel to protect the electrode and provide biocompatibility.
  • the main function of the encapsulation paste is to cover the conductive paste to form a protective film for the electrode. Protective layer, thereby improving the stability and biocompatibility of the electrode.
  • the electrode slurry adopts an injectable rheological precursor, which remains in a plastic flow state when injected into the body. It can autonomously conform to the surface morphology of the target tissue and "lock" the optimal highly fitting interface after subsequent in situ curing, thereby ensuring the accurate conformity of the electrode to the biological tissue and improving the stability after implantation.
  • Step (2) Loading slurry: The conductive slurry and encapsulation slurry prepared in step (1) are loaded into two syringes respectively and connected to the inner tube and outer tube of the coaxial needle respectively; in this way, the different components can be kept separated so as to be combined at the end to form a coaxial fiber, forming a skin-core structure.
  • the conductive layer slurry of the inner channel is first printed with a length of 0.01-20 mm to form an exposure monitoring point, and then the inner layer and the outer layer are printed synchronously to form a coaxial fiber electrode;
  • Minimally invasive implantation using a medical syringe can directly inject and solidify the electrode conductive slurry into the target biological body to construct an implantable electrode, avoiding the traditional hard electrode implantation method that requires large-area open surgical exposure and can significantly reduce surgical trauma.
  • One-step forming of skin-core structure implantable electrode Using coaxial needle, the one-piece forming of skin-core structure implantable electrode is realized. In this process, the encapsulation layer slurry is injected into the outer channel, and the conductive layer slurry is injected into the inner channel. After the conductive layer slurry is extruded for a section as a signal detection point, the encapsulation layer slurry and the conductive layer slurry are extruded synchronously, so that the encapsulation layer and the conductive layer are formed in one piece at the same time, simplifying the preparation process of the electrode.
  • the conductive filler in step (1) is selected from a mixture of one or more of carbon materials, conductive polymers, and metal conductive materials;
  • the polymer matrix material is platinum two-component silica gel
  • the additive is selected from a mixture of one or more of polyethylene glycol (PEG) and glycerol.
  • the carbon material is selected from a mixture of one or more of carbon nanofibers (CNF), carbon nanotubes, graphene, and carbon black.
  • CNF carbon nanofibers
  • carbon nanotubes carbon nanotubes
  • graphene graphene
  • carbon black carbon black
  • the conductive polymer is selected from a mixture of one or more of poly(3,4-ethylenedioxythiophene)-poly(styrene sulfonic acid) (PEDOT:PSS), polypyrrole, and polyaniline.
  • the metal conductive material is selected from gold nanowires/sheets/particles, silver nanowires/sheets/particles, copper nanowires/sheets/particles, A mixture of one or more of threads/sheets/particles.
  • the encapsulation slurry in step (1) is silica gel.
  • the particle size of the nano silicon dioxide in step (1) is 1-100 nm.
  • the conductive paste and the encapsulation paste are both injectable rheological bodies.
  • the curing time in step (4) is 5-30 minutes.
  • the present invention provides a skin-core structure fiber electrode for minimally invasive implantation, which is prepared by any of the preparation methods described above.
  • Minimally invasive implantation technology Compared with traditional hard implant electrodes that require highly invasive open surgery, the present invention adopts a minimally invasive injection implantation method, which can significantly reduce the surgical wound surface, reduce the risk of trauma caused by anesthesia and incision, and make the electrode implantation process safer and more reliable.
  • the present invention adopts an injectable flowable polymer, which avoids the tedious steps of designing electrodes according to application requirements before surgery. Different amounts of electrode slurry can be prepared according to specific application requirements, and the length of the fiber electrode can be adjusted, thereby realizing flexible and convenient electrode preparation without complicated prefabricated mold design.
  • the present invention uses carbon fiber as the skeleton material, conductive polymers with good biocompatibility as the active layer, and non-toxic silica gel as the coating substrate. These materials have good biostability and compatibility, making the electrode more stable and reliable in the body.
  • the present invention adopts coaxial needle high-precision printing technology.
  • the inner core is a conductive functional layer and the outer shell is a packaging layer. This enables the electrode to have long-term and stable self-packaging performance after implantation. Direct contact between the functional layer and the tissue and effective isolation from the outside can be achieved without additional operation.
  • the slurry of the present invention is still in a plastic flow state, and can conform to the tissue surface morphology autonomously, and lock the best highly fitting interface in the subsequent in-situ curing process, thereby ensuring the accurate conformal coordination between the electrode and the biological tissue and improving the implantation stability.
  • the present invention adopts safe materials and injection in-situ curing preparation method, which makes the electrode preparation process simpler and faster, reduces the production complexity and cost, and provides a better solution for the preparation of implantable neuroelectrophysiological signal monitoring electrodes.
  • FIG1 is a schematic diagram of minimally invasive implantation of a coaxial fiber electrode according to the present invention, wherein: 1 encapsulation layer slurry; 2 conductive layer slurry; 3 coaxial structure; 4 exposure monitoring point: conductive layer;
  • FIG2 is a top view of a coaxial fiber electrode
  • FIG3 is a cross-sectional view of a coaxial fiber electrode.
  • Embodiment 1 is a diagrammatic representation of Embodiment 1:
  • carbon nanofibers, PEDOT:PSS, PEG and silica gel were weighed in a mass ratio of 10%, 25%, 5% and 60% respectively, and placed in a deaerator for stirring for 2 minutes to ensure that the conductive layer slurry is fully uniform. Then, the encapsulation layer slurry was prepared by mixing the platinum and two-component silica gel in proportion, and then adding 5% nano-silica and placing in a deaerator for stirring for 2 minutes to eliminate bubbles and ensure uniform mixing.
  • the machine running program and the appropriate air pressure (2.5kg/cm 3 for the conductive layer and 3.5kg/cm 3 for the encapsulation layer), inject the prepared conductive layer slurry and encapsulation layer slurry into two syringes respectively, and place the pistons into the syringes respectively.
  • the two syringes are connected to the two ends of the coaxial needle respectively, where the conductive layer slurry is connected to the inner channel and the encapsulation layer slurry is connected to the outer channel (as shown in Figure 1), and then connect the syringe-air pump connector and start printing to prepare the electrode.
  • the conductive layer slurry of the inner channel is first printed with a length of 2mm to form an exposure monitoring point, and then the inner and outer layers are printed synchronously to form a coaxial fiber electrode.
  • Embodiment 2 is a diagrammatic representation of Embodiment 1:
  • carbon nanofibers, PEDOT:PSS, PEG and silica gel were weighed in a mass ratio of 10%, 25%, 7.5% and 57.5%, respectively, and placed in a deaerator for stirring for 2 minutes to ensure that the conductive layer slurry is fully uniform. Then, the encapsulation layer slurry was prepared by mixing the platinum and two-component silica gel in proportion, and then adding 10% of nano-silica and placing in a deaerator for stirring for 2 minutes to eliminate bubbles and ensure uniform mixing.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente divulgation concerne le domaine de la technologie de détection et de surveillance électrophysiologiques, et en particulier, une électrode en fibre d'implant minimalement invasive d'une structure gaine-noyau et son procédé de préparation. Le procédé comprend : 1, la préparation de pâtes d'impression : la préparation séparée d'une pâte conductrice et d'une pâte d'encapsulation ; 2, le chargement de pâtes : le chargement de la pâte conductrice préparée dans un canal interne, et le chargement de la pâte d'encapsulation dans un canal externe ; 3, la détermination de la piste d'impression et de l'impression d'implant : la détermination d'une piste d'impression à l'aide d'une image par résonance magnétique, le forage à l'aide d'un instrument chirurgical ou l'insertion directe d'une aiguille d'injection coaxiale à une position cible, et l'impression de l'électrode ; et 4, la conception d'interface : l'insertion, après la fin de l'impression, d'un fil conducteur dans une extrémité de l'électrode en fibre coaxiale non durcie, et le durcissement de la pâte conductrice et de la pâte d'encapsulation dans un état naturel. La présente divulgation réduit significativement la complexité et le coût de fabrication, réduit considérablement les traumatismes chirurgicaux, et améliore la biocompatibilité et la stabilité à long terme de l'électrode.
PCT/CN2023/135596 2023-11-30 2023-11-30 Électrode en fibre d'implant minimalement invasive de structure gaine-noyau et son procédé de préparation Pending WO2025111963A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2023/135596 WO2025111963A1 (fr) 2023-11-30 2023-11-30 Électrode en fibre d'implant minimalement invasive de structure gaine-noyau et son procédé de préparation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2023/135596 WO2025111963A1 (fr) 2023-11-30 2023-11-30 Électrode en fibre d'implant minimalement invasive de structure gaine-noyau et son procédé de préparation

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108215165A (zh) * 2018-01-25 2018-06-29 清华大学 一种皮芯结构纤维智能图案及其打印方法和应用
CN110320254A (zh) * 2019-06-24 2019-10-11 复旦大学 可注射的多级螺旋纤维状传感器及其制备方法和使用方法
US20190357847A1 (en) * 2016-12-12 2019-11-28 Neuronoff, Inc. Electrode curable and moldable to contours of a target in bodily tissue and methods of manufacturing and placement and dispensers therefor
US20200188660A1 (en) * 2017-06-08 2020-06-18 Neuronoff, Inc. Electrode cured and manufactured in the body, and related methods and devices
CN113100773A (zh) * 2021-04-12 2021-07-13 中国科学院深圳先进技术研究院 一种直接在皮肤上纺丝制备纤维膜干电极的方法
CN116602684A (zh) * 2023-04-20 2023-08-18 厦门大学 一种微创植入式的复合纤维传感器的制备及其应用

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190357847A1 (en) * 2016-12-12 2019-11-28 Neuronoff, Inc. Electrode curable and moldable to contours of a target in bodily tissue and methods of manufacturing and placement and dispensers therefor
US20200188660A1 (en) * 2017-06-08 2020-06-18 Neuronoff, Inc. Electrode cured and manufactured in the body, and related methods and devices
CN108215165A (zh) * 2018-01-25 2018-06-29 清华大学 一种皮芯结构纤维智能图案及其打印方法和应用
CN110320254A (zh) * 2019-06-24 2019-10-11 复旦大学 可注射的多级螺旋纤维状传感器及其制备方法和使用方法
CN113100773A (zh) * 2021-04-12 2021-07-13 中国科学院深圳先进技术研究院 一种直接在皮肤上纺丝制备纤维膜干电极的方法
CN116602684A (zh) * 2023-04-20 2023-08-18 厦门大学 一种微创植入式的复合纤维传感器的制备及其应用

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