CN110721402B - Implantable neural electrode system - Google Patents

Implantable neural electrode system Download PDF

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Publication number
CN110721402B
CN110721402B CN201810778309.1A CN201810778309A CN110721402B CN 110721402 B CN110721402 B CN 110721402B CN 201810778309 A CN201810778309 A CN 201810778309A CN 110721402 B CN110721402 B CN 110721402B
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implantable neural
neural electrode
subcutaneous
electrode system
lead
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CN110721402A (en
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隋晓红
王逸林
朱璟然
朱丰源
苏江媛
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Shanghai Jiaotong University
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Shanghai Jiaotong 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
    • A61N1/0529Electrodes for brain stimulation
    • A61N1/0534Electrodes for deep brain stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02Inorganic materials
    • A61L31/024Carbon; Graphite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • A61N1/0551Spinal or peripheral nerve electrodes

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Psychology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Electrotherapy Devices (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

The invention discloses an implantable neural electrode system, which comprises an implantable neural electrode, a subcutaneous lead and a percutaneous interface; the percutaneous interface comprises a percutaneous tube, the percutaneous tube is provided with a first end and a second end, the first end is provided with a subcutaneous fixing part, and the second end is provided with a connector which can be electrically connected with the outside; the implantable neural electrode is electrically connected to the connector by a subcutaneous lead that passes through the lumen of the percutaneous tube.

Description

Implantable neural electrode system
Technical Field
The invention relates to the field of medical equipment, in particular to a nerve electrode system based on a carbon nano pipeline.
Background
Aiming at refractory neurodegenerative diseases or nerve function injury, traditional medicines or operations are difficult to cure, and the medical community has increasingly diverted the eyes to nerve function repair modes based on artificial electronic equipment. For example, diseases such as Parkinson's disease, epilepsy and depression can be treated by deep brain electrical stimulation. As the physical channel of the artificial electronic equipment and the biological nervous system, the implanted nerve electrode can record nerve electric signals or stimulate nerve tissues, and the performance of the implanted nerve electrode directly determines the effectiveness of nerve function repair.
In order to realize long-term stable in-vivo nerve electric signal acquisition and nerve electric stimulation, the biocompatibility, stability, signal-to-noise ratio and the like of an electrode material are mainly considered when an implantable electrode system is designed; the aspects of the matching element mainly consider transmission interaction capability, mechanical performance and the like of bioelectric signals.
The traditional nerve electrode is mostly made of materials such as silicon, polyimide, platinum iridium alloy wires and the like for recording and stimulating in-vivo nerve electrical signals, but the unification of high biocompatibility, flexibility (low mechanical injury), high signal-to-noise ratio and high charge injection capacity is difficult to achieve. Chinese patent No. CN106963358A discloses an implantable neural electrode based on carbon nano-tubes. The carbon nano-tube line has unusual tensile strength, can be processed to a very thin diameter level and is not broken by internal force of organism tissues; in addition, the simple substance carbon has excellent biocompatibility, the impedance of unit area is extremely small, the charge injection capability is extremely high, and the durability and the effectiveness of effective electrical stimulation under extremely small diameter are ensured. Particularly, the carbon nano-tube line has very low bending modulus, and under the extremely small diameter, the flexibility is far higher than that of metals such as platinum, iridium and the like, the carbon nano-tube line is well attached to nerve fibers, and the mechanical damage to tissues is very small. Thus, carbon nano-wires are ideal electrode materials for long-term implantation. However, carbon nanotubes as an extremely fine electrode material cannot be drawn directly out of the epidermis through subcutaneous traces. In addition, the diameter of the carbon nano-tube line is in the micron level, so that the mechanical adaptation of the carbon nano-tube line with a thicker electrode lead is larger, and the problems of falling off, high noise and the like are easily caused.
Disclosure of Invention
In view of the above-mentioned drawbacks of the prior art, the present invention aims to solve the technical problem of how to lead the subcutaneous lead of the implantable neural electrode out of the epidermis and to ensure the mechanical adaptation of the carbon nano-tube line electrode and the subcutaneous lead.
In view of the above-described deficiencies of the prior art, the present invention provides an implantable neural electrode system comprising an implantable neural electrode, a subcutaneous lead, and a percutaneous interface; the percutaneous interface comprises a percutaneous tube, the percutaneous tube is provided with a first end and a second end, the first end is provided with a subcutaneous fixing part, and the second end is provided with a connector which can be electrically connected with the outside; the implantable neural electrode is electrically connected with the connector through a subcutaneous lead, and the subcutaneous lead passes through the lumen of the percutaneous tube.
Further, the implantable neural electrode is made of carbon nano-tube lines. Alternatively, the implantable neural electrode is made of platinum iridium alloy wire.
Further, the subcutaneous fixation is a flange disc integrally formed with the percutaneous tube.
Further, the subcutaneous fixation and the percutaneous tube are made of medical silicone.
Further, the connector is a pin header or a bus bar, and the inside of the tube cavity is filled with insulating materials. The insulating material is preferably epoxy AB glue or silicone.
Preferably, the percutaneous tube has a lumen diameter of 3mm to 10mm.
Further, an intermediate lead is included, the intermediate lead being positioned between the implantable neural electrode and the subcutaneous lead, the intermediate lead having a diameter greater than the carbon nano-tube line and less than the subcutaneous lead.
Preferably, the intermediate wire is made of platinum iridium alloy or stainless steel.
Preferably, the diameter of the implantable neural electrode made of carbon nano-wires is 10nm to 100 μm.
Preferably, the diameter of the subcutaneous leads is 50 μm to 1mm.
Further, the implantable neural electrode includes an electrode-exposed portion and an electrode-insulated portion, the intermediate lead includes a first non-insulated portion and an insulated portion, the electrode-exposed portion is configured to be wound over the first non-insulated portion, and a first conductive material and a first insulating material are further coated thereon in sequence.
Preferably, the first conductive material is conductive silver colloid, and the first insulating material is epoxy resin AB colloid or medical silica gel.
Further, the intermediate wire further comprises a second non-insulated portion arranged to be wound over the subcutaneous lead and having a second conductive material and a second insulating material sequentially coated thereon.
Preferably, the second conductive material is conductive silver colloid, and the second insulating material is epoxy resin AB colloid or medical silica gel.
Compared with the prior art, the invention has the following specific beneficial effects:
1. the carbon nano-tube line material has excellent flexibility and tensile strength, and compared with the traditional electrode materials such as platinum iridium alloy wires, the carbon nano-tube line material is not easy to cause mechanical damage to tissues after being implanted for a long time, and is not easy to be torn by internal force of the tissues.
2. The carbon nano-tube line nerve electrode is connected with the percutaneous interface by introducing an intermediate lead and a subcutaneous lead, and a protection measure is arranged at the connection position of the first stage and the second stage, so that the possibility of falling off, fracture and the like caused by overlarge difference between the diameters of the nerve electrode and the subcutaneous lead is effectively reduced.
3. By using a finer subcutaneous lead, damage to the living body is reduced and the potential for wire shedding due to movement of the living body is reduced.
4. The percutaneous interface adopts a 3D printing technology to carry out integrated design, has small size and high biocompatibility, is suitable for long-term implantation, and improves the signal-to-noise ratio of nerve signal recording.
5. The subcutaneous routing is connected with the needle arrangement base through the percutaneous interface tube cavity in a welding way; gaps among the needle arranging, the subcutaneous wire and the inner wall of the percutaneous interface lumen are filled with medical epoxy resin; the lower end of the pin header is connected with the subcutaneous wiring, and the upper end of the pin header can be additionally led out to an external processing/signal input device.
The conception, specific structure, and technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, features, and effects of the present invention.
Drawings
FIG. 1 is a schematic view of an implantable electrode, intermediate lead and subcutaneous lead according to one embodiment of the present invention;
FIG. 2 is a schematic view of an implantable electrode, intermediate lead, subcutaneous lead, and percutaneous interface according to one embodiment of the invention;
FIG. 3 is a schematic illustration of a preferred embodiment of the present invention in use in the cortex and deep brain regions;
wherein 200: neural electrodes (carbon nanotube wire electrodes); 300: an intermediate wire; 400: subcutaneous lead
1. Electrode exposed portion
2. Electrode insulating portion
3. Intermediate conductor exposed portion
4. Intermediate conductor insulation
5. Subcutaneous lead
6. Insulating layer at junction of nerve electrode and intermediate lead
7. Insulating layer at junction of intermediate wire and subcutaneous lead wire
8. Percutaneous lumen outer wall
9. Percutaneous lumen inner wall
10. Subcutaneous fixation
11. Percutaneous tube
12. Needle arrangement seat
13. Pin header
14. Implantable electrode and intermediate lead thereof
15. Peripheral nerve bundle
16. Peripheral nerve adventitia
17. Peripheral nerve trunk
18. Percutaneous interface
Detailed Description
Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
One embodiment according to the present invention is shown in fig. 1-3.
As shown in fig. 1-2, the implantable electrode system includes an implantable neural electrode 200, an intermediate lead 300, a subcutaneous lead 400, and a percutaneous interface 100.
The implantable neural electrode is made of carbon nano-wires, which have a diameter of 10 μm, in the embodiment shown in the drawings. In other embodiments, the diameter of the carbon nanotube wire is preferably between 10nm and 100 μm. The carbon nano-tube line is formed by drawing a plurality of single carbon nano-tubes with the diameter of 0.1nm-10 nm. The implantable nerve electrode based on the carbon nano-tube line comprises an exposed part and an insulating part, wherein the exposed part and the insulating part are derived from the same carbon nano-tube line electrode, the carbon nano-tube line electrode of the exposed part is directly exposed, and the carbon nano-tube line electrode of the insulating part is wrapped by the insulating layer; the exposed portion is used for recording of an electrical signal or stimulating a nerve. The exposed portion of the carbon nanotube wire electrode has a length ranging from 1 μm to 500 μm. The insulating layer material of the insulating part is C-type Parylene (Parylene-C) or medical silica gel (Silicone). The insulating layer thickness of the insulating portion is 1 μm to 5 μm. In still other embodiments, the implantable neural electrode may also be made of platinum iridium alloy wire.
Referring to fig. 1, an implantable neural electrode 200 is connected to one end of an intermediate lead 300. The implantable neural electrode comprises an electrode exposure part 1 and an electrode insulation part 2; the intermediate wire 300 comprises an uninsulated section 3 and an insulated section 4, the electrode exposed section 1 being arranged to be wound over the uninsulated section 3 and having a conductive material and an insulating material 6 applied thereto in sequence. In this embodiment, the conductive material is conductive silver paste, and the insulating material is epoxy resin AB paste or medical silica gel. At the other end, intermediate lead 300 is connected to subcutaneous lead 400. The uninsulated section 3 of the intermediate wire 300 is wound around the subcutaneous lead 5 with the conductive material and the insulating material 7 thereon. In this embodiment, the conductive material is conductive silver paste, and the insulating material is epoxy resin AB paste or medical silica gel. The intermediate wire is preferably made of platinum iridium alloy or stainless steel. The diameter of the intermediate wire should be larger than the carbon nano-tube wire and smaller than the subcutaneous lead. The intermediate wire preferably has a diameter of 10 μm to 200 μm. While the diameter of the subcutaneous leads is preferably 50 μm to 1mm. Referring to fig. 2, a subcutaneous lead 400 is coupled to the percutaneous interface 100. The percutaneous interface 100 includes a percutaneous tube 11. The percutaneous tube 11 has an outer wall 8 and an inner wall 9. The percutaneous tube 11 has a first end and a second end. At the first end there is a subcutaneous fixation 10, which in the embodiment shown is a flange disc formed integrally with the percutaneous tube for 3D printing, but in other embodiments other structures for fixation are possible. In this embodiment, the subcutaneous fixation and percutaneous tube are made of medical silicone.
At the second end of the percutaneous tube 11, a connector is provided, which is electrically connectable to the outside, in this embodiment, a pin header 13 provided on a pin header 12, although in other embodiments, a pin header or other connector structure is also possible. The subcutaneous lead 5 is electrically connected to the needle bar through the lumen of the percutaneous tube. The inside of the tube cavity is filled with insulating materials, and the insulating materials are epoxy resin AB glue or silica gel. The percutaneous tube preferably has a lumen diameter of 3mm to 10mm.
Fig. 3 shows a specific embodiment applied to a laboratory mouse, in which carbon nanotube wire electrodes are implanted into peripheral nerve bundles for recording peripheral nerve fiber electrical signal emission and local electrical stimulation of nerve fibers in a motor state. Two-channel or multi-channel carbon nano tube line electrodes can be implanted in a single nerve bundle, the carbon nano tube lines are connected with subcutaneous leads through electrode interconnection wires, the subcutaneous leads are directly connected to a percutaneous interface, and finally interaction with external equipment is carried out through a needle arrangement. In the figures, 15, 16 and 17 are the peripheral nerve bundles, peripheral adventitia and peripheral nerve trunk, respectively, of the experimental mice. The nerve electrodes 14 are implanted in the peripheral nerve bundle 16 and connected to the subcutaneous leads 5 by intermediate leads, which are connected to the needle bars by percutaneous interfaces 18.
The foregoing describes in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be made in accordance with the concepts of the invention by one of ordinary skill in the art without undue burden. Therefore, all technical solutions which can be obtained by logic analysis, reasoning or limited experiments based on the prior art by the person skilled in the art according to the inventive concept shall be within the scope of protection defined by the claims.

Claims (14)

1. An implantable neural electrode system, comprising
Implantable neural electrodes, subcutaneous leads, and percutaneous interfaces;
the percutaneous interface comprises a percutaneous tube, wherein the percutaneous tube is provided with a first end and a second end, the first end is provided with a subcutaneous fixing part, and the second end is provided with a connector which can be electrically connected with the outside;
the implantable neural electrode is electrically connected with the connector through the subcutaneous lead, and the subcutaneous lead passes through the lumen of the percutaneous tube;
the implanted nerve electrode is made of a carbon nano-tube line, and the subcutaneous fixing part is a flange disc integrally formed with the percutaneous tube; the implantable neural electrode further comprises an intermediate lead, wherein the intermediate lead is positioned between the implantable neural electrode and the subcutaneous lead, and the diameter of the intermediate lead is larger than that of the carbon nano-tube line and smaller than that of the subcutaneous lead.
2. The implantable neural electrode system of claim 1, wherein the implantable neural electrode is made of platinum iridium alloy wire.
3. The implantable neural electrode system of claim 1, wherein the subcutaneous fixation and the percutaneous tube are made of medical silicone.
4. The implantable neural electrode system of claim 1, wherein the connector is a pin header or a box header, and the lumen is filled with an insulating material.
5. The implantable neural electrode system of claim 4, wherein the insulating material is epoxy AB glue or silicone.
6. The implantable neural electrode system of claim 1, wherein the lumen diameter of the percutaneous tube is 3mm to 10mm.
7. The implantable neural electrode system of claim 1, wherein the intermediate lead is made of platinum iridium alloy or stainless steel.
8. The implantable neural electrode system of claim 1, wherein the diameter of the implantable neural electrode made of the carbon nano-tube line is 10nm to 100 μm.
9. The implantable neural electrode system of claim 8, wherein the intermediate lead is 10 μιη to 200 μιη in diameter.
10. The implantable neural electrode system of claim 9, wherein the subcutaneous lead has a diameter of 50 μιη to 1mm.
11. The implantable neural electrode system of claim 1, wherein the implantable neural electrode includes an electrode-exposed portion and an electrode-insulated portion, the intermediate lead including a first uninsulated portion and an insulated portion, the electrode-exposed portion being configured to wrap over the first uninsulated portion and further having a first conductive material and a first insulating material applied thereto in sequence.
12. The implantable neural electrode system of claim 11, wherein the first conductive material is conductive silver paste and the first insulating material is epoxy AB paste or medical silicone.
13. The implantable neural electrode system of claim 11, wherein the intermediate lead further comprises a second non-insulated portion configured to wrap over the subcutaneous lead and further coated with a second conductive material and a second insulating material in sequence thereon.
14. The implantable neural electrode system of claim 13, wherein the second conductive material is conductive silver paste and the second insulating material is epoxy AB paste or medical silicone.
CN201810778309.1A 2018-07-16 2018-07-16 Implantable neural electrode system Active CN110721402B (en)

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CN110721402B true CN110721402B (en) 2023-11-21

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Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5997524A (en) * 1997-07-18 1999-12-07 Vasca, Inc. Catheter assembly for percutaneous access to subcutaneous port
CN101198372A (en) * 2004-05-04 2008-06-11 罗切斯特大学 Leadless implantable intravascular electrophysiologic device for neurologic/cardiovascular sensing and stimulation
CN101234226A (en) * 2008-01-22 2008-08-06 上海市手外科研究所 Easy-to-take-out peripheral nerve semi-implantation type electric stimulation electrode and method
CN101342405A (en) * 2008-08-22 2009-01-14 西安交通大学 Implanted bioelectrode
CN101502699A (en) * 2009-03-09 2009-08-12 西安交通大学 Implantation type bioelectrode and method for producing the same
CN201643410U (en) * 2010-04-02 2010-11-24 苏州鼎迈医疗科技有限公司 Extension lead protective sleeve of implanted nerve electrical stimulation system
CN201643422U (en) * 2010-04-02 2010-11-24 苏州鼎迈医疗科技有限公司 Implanted neural electrical stimulation system with drug releasing device
CN102210901A (en) * 2010-04-02 2011-10-12 鼎迈医疗科技(苏州)有限公司 Extension lead for implantable neuroelectric stimulation system
CN203677734U (en) * 2014-01-06 2014-07-02 刘荣东 Magnetic guiding device of percutaneous lead
CN104941065A (en) * 2015-06-30 2015-09-30 北京品驰医疗设备有限公司 Implanted type electrical nerve stimulation system and protection sleeve applied to same
CN106963358A (en) * 2017-04-14 2017-07-21 上海交通大学 A kind of embedded nerve electrode based on carbon nano tube line

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5997524A (en) * 1997-07-18 1999-12-07 Vasca, Inc. Catheter assembly for percutaneous access to subcutaneous port
CN101198372A (en) * 2004-05-04 2008-06-11 罗切斯特大学 Leadless implantable intravascular electrophysiologic device for neurologic/cardiovascular sensing and stimulation
CN101234226A (en) * 2008-01-22 2008-08-06 上海市手外科研究所 Easy-to-take-out peripheral nerve semi-implantation type electric stimulation electrode and method
CN101342405A (en) * 2008-08-22 2009-01-14 西安交通大学 Implanted bioelectrode
CN101502699A (en) * 2009-03-09 2009-08-12 西安交通大学 Implantation type bioelectrode and method for producing the same
CN201643410U (en) * 2010-04-02 2010-11-24 苏州鼎迈医疗科技有限公司 Extension lead protective sleeve of implanted nerve electrical stimulation system
CN201643422U (en) * 2010-04-02 2010-11-24 苏州鼎迈医疗科技有限公司 Implanted neural electrical stimulation system with drug releasing device
CN102210901A (en) * 2010-04-02 2011-10-12 鼎迈医疗科技(苏州)有限公司 Extension lead for implantable neuroelectric stimulation system
CN203677734U (en) * 2014-01-06 2014-07-02 刘荣东 Magnetic guiding device of percutaneous lead
CN104941065A (en) * 2015-06-30 2015-09-30 北京品驰医疗设备有限公司 Implanted type electrical nerve stimulation system and protection sleeve applied to same
CN106963358A (en) * 2017-04-14 2017-07-21 上海交通大学 A kind of embedded nerve electrode based on carbon nano tube line

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