CN110721402A - Implanted nerve electrode system - Google Patents

Implanted nerve electrode system Download PDF

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Publication number
CN110721402A
CN110721402A CN201810778309.1A CN201810778309A CN110721402A CN 110721402 A CN110721402 A CN 110721402A CN 201810778309 A CN201810778309 A CN 201810778309A CN 110721402 A CN110721402 A CN 110721402A
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implantable neural
neural electrode
electrode system
subcutaneous
lead
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CN201810778309.1A
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CN110721402B (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 implanted nerve electrode system, which comprises an implanted nerve electrode, a subcutaneous lead and a percutaneous interface, wherein the implanted nerve electrode is connected with the subcutaneous lead through the 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 implanted nerve electrode is electrically connected with the connector through a subcutaneous lead which passes through the lumen of the percutaneous tube.

Description

Implanted nerve electrode system
Technical Field
The invention relates to the field of medical instruments, in particular to a carbon nano-pipeline-based neural electrode system.
Background
Aiming at intractable neurodegenerative diseases or nerve function injuries, traditional medicines or operations are difficult to cure, and the medical field has increasingly turned attention to a nerve function repair mode based on artificial electronic equipment. For example, Parkinson's disease, epilepsy, and depression can be treated by deep brain electrical stimulation. As a physical channel between artificial electronic equipment and a biological nervous system, the implanted nerve electrode can record nerve electrical 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 electrical signal acquisition and nerve electrical stimulation, when an implanted electrode system is designed, biocompatibility, stability, signal-to-noise ratio and the like of the electrode material are mainly considered; the transmission interaction capacity, the mechanical performance and the like of the bioelectricity signals are mainly considered in the aspect of the matched elements.
The traditional nerve electrode mostly adopts materials such as silicon, polyimide, platinum iridium alloy wire and the like to record and stimulate in vivo nerve electrical signals, but the unification of high biocompatibility, flexibility (low mechanical damage), high signal-to-noise ratio and high charge injection capability is difficult to achieve. Chinese patent CN106963358A discloses an implantable neural electrode based on carbon nanotube wire. The carbon nano pipeline has unusual tensile strength, can be processed to a very thin diameter level and is not torn by the internal force of organism tissues; in addition, the simple substance carbon has excellent biocompatibility, extremely small impedance per unit area and high charge injection capability, and the durability and the effectiveness of effective electric stimulation under the extremely small diameter are ensured. The carbon nano pipeline has very low bending modulus, is far higher than metals such as platinum, iridium and the like in flexibility under the condition of extremely small diameter, is well attached to nerve fibers, and causes little mechanical damage to tissues. Therefore, carbon nanotube wire is an ideal electrode material for long-term implantation. However, carbon nanotube wire, as a very thin electrode material, cannot be routed directly out of the epidermis through subcutaneous routing. In addition, the diameter of the carbon nanotube wire is in the micron order, so that the carbon nanotube wire is large in mechanical adaptation with a thick electrode lead, and the problems of falling, high noise and the like are easily caused.
Disclosure of Invention
In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is how to lead the subcutaneous lead of the implantable neural electrode out of the epidermis, and how to ensure the mechanical adaptation of the carbon nanotube wire electrode and the subcutaneous lead.
In view of the above-mentioned deficiencies of the prior art, the present invention provides an implantable neural electrode system including 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 implanted nerve electrode is electrically connected with the connector through a subcutaneous lead which passes through the lumen of the percutaneous tube.
Further, the implantable neural electrode is made of carbon nanotube wire. Optionally, the implantable neural electrode is made of platinum iridium alloy wire.
Further, the subcutaneous fixation portion is a flange disc integrally formed with the percutaneous tube.
Further, the subcutaneous fixing part and the percutaneous tube are made of medical silica gel.
Further, the connector is a pin header or a female header, and the inside of the tube cavity is filled with an insulating material. The insulating material is preferably epoxy AB glue or silicone glue.
Preferably, the diameter of the lumen of the percutaneous tube is 3mm to 10 mm.
Further, the middle lead is arranged between the implanted nerve electrode and the subcutaneous lead, and the diameter of the middle lead is larger than that of the carbon nano-pipeline and smaller than that of the subcutaneous lead.
Preferably, the intermediate wire is made of platinum-iridium alloy or stainless steel.
Preferably, the diameter of the implanted neural electrode made of carbon nanotube wire is 10nm to 100 μm.
Preferably, the subcutaneous leads have a diameter of 50 μm to 1 mm.
Further, the implanted nerve electrode comprises an electrode exposed part and an electrode insulating part, the middle lead comprises a first non-insulating part and an insulating part, and the electrode exposed part is arranged to be wound on the first non-insulating part and is sequentially coated with a first conductive material and a first insulating material.
Preferably, the first conductive material is conductive silver adhesive, and the first insulating material is epoxy resin AB adhesive or medical silica gel.
Further, the intermediate conductor further comprises a second uninsulated section configured to wrap around the subcutaneous lead and further coated with a second conductive material and a second insulating material in sequence.
Preferably, the second conductive material is conductive silver adhesive, and the second insulating material is epoxy resin AB adhesive or medical silica gel.
Compared with the prior art, the invention has the following specific beneficial effects:
1. the carbon nanotube wire material has excellent flexibility and tensile strength, and compared with traditional electrode materials such as platinum-iridium alloy wires and the like, the carbon nanotube wire material is not easy to cause mechanical damage to tissues after long-term implantation in vivo and is not easy to break by internal force of the tissues.
2. The carbon nano pipeline neural electrode is connected with a percutaneous interface by introducing a middle lead and a subcutaneous lead, and protective measures are set for the first-level and second-level connecting positions, so that the possibility of falling, breaking and the like caused by overlarge diameter difference between the neural electrode and the subcutaneous wiring is effectively reduced.
3. By adopting the thinner subcutaneous lead, the damage to the organism is reduced, and the possibility of the lead falling caused by the movement of the organism is reduced.
4. The percutaneous interface adopts a 3D printing technology, is integrally designed, has small size and high biocompatibility, is suitable for long-term implantation, and improves the signal-to-noise ratio of the neural signal record.
5. The subcutaneous wiring is connected with the pin header base and the pin header through a percutaneous interface tube cavity in a welding mode; gaps among the pin header, the subcutaneous routing and the inner wall of the percutaneous interface tube cavity are filled with medical epoxy resin; the lower end of the pin header is connected with the subcutaneous wiring, and the upper end can be additionally led out to external processing/signal input equipment.
The conception, the specific structure and the technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, the features and the effects of the present invention.
Drawings
FIG. 1 is a schematic view of an implantable electrode, a middle lead and a subcutaneous lead in accordance with one embodiment of the present invention;
FIG. 2 is a schematic view of an implantable electrode, a medial lead, a subcutaneous lead, and a percutaneous interface in accordance with an embodiment of the present invention;
FIG. 3 is a schematic representation of a preferred embodiment of the present invention used in the cortical and deep brain areas;
wherein, 200: neural electrodes (carbon nanotube wire electrodes); 300: a middle lead; 400: subcutaneous lead wire
1. Exposed part of electrode
2. Electrode insulation part
3. Exposed part of intermediate conductor
4. Intermediate conductor insulation part
5. Subcutaneous lead wire
6. Insulating layer at joint of nerve electrode and middle lead
7. Insulating layer at joint of middle lead and subcutaneous lead
8. Outer wall of percutaneous lumen
9. Inner wall of percutaneous lumen
10. Subcutaneous fixation part
11. Percutaneous tube
12. Pin header
13. Pin header
14. Implanted electrode and middle 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, a medial lead 300, a subcutaneous lead 400, and a percutaneous interface 100.
The implanted nerve electrode is made of carbon nanotube wires in the embodiment shown in the drawings, and the diameter of the carbon nanotube wires is 10 μm. 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 to 10 nm. The implantable neural 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 electrical signals or for stimulating nerves. The electrode length of the carbon nanotube wire of the exposed portion ranges 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 of the insulating portion has a thickness of 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 a middle lead 300. The implanted nerve electrode comprises an electrode exposure part 1 and an electrode insulation part 2; the intermediate wire 300 includes an uninsulated section 3 and an insulated section 4, and the electrode exposed section 1 is configured to be wound on the uninsulated section 3 and further coated with a conductive material and an insulating material 6 in this order. In this embodiment, the conductive material is conductive silver paste, and the insulating material is epoxy AB paste or medical silica gel. At the other end, the medial lead 300 is connected to a subcutaneous lead 400. The uninsulated section 3 of the intermediate conductor 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 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 nanotube wire and smaller than the subcutaneous lead. The intermediate wire preferably has a diameter of 10 μm to 200 μm. Whereas the diameter of the subcutaneous leads is preferably 50 μm to 1 mm. Referring to fig. 2, a subcutaneous lead 400 is connected 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 anchoring portion 10, which in the embodiment shown is a flanged disc integrated with the percutaneous tube 3D printing, but in other embodiments other structures for anchoring purposes are possible. In this embodiment, the subcutaneous fixation portion and the percutaneous tube are made of medical grade silicone.
At the second end of the transcutaneous tube 11 there is provided a connector 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 female header or other connector configuration is also possible. The subcutaneous lead 5 is electrically connected with the pin header through the lumen of the percutaneous tube. The inside packing of lumen has insulating material, and insulating material is epoxy AB glue or silica gel. The diameter of the lumen of the percutaneous tube is preferably 3mm to 10 mm.
Fig. 3 shows a specific embodiment applied to a laboratory mouse, in which a carbon nanotube wire electrode is implanted into a peripheral nerve bundle for recording the electrical signal distribution of peripheral nerve fibers and the local electrical stimulation of the nerve fibers in a motion state. Two or more channels of carbon nanotube line electrodes can be implanted in a single nerve bundle, the carbon nanotube line electrodes and a subcutaneous lead are connected by adopting electrode interconnection wires, the subcutaneous lead is directly connected to a percutaneous interface, and finally, the subcutaneous lead is interacted with external equipment through a pin header. In the figure, 15, 16 and 17 are the peripheral nerve fascicles, the peripheral nerve adventitia and the peripheral nerve trunk of the experimental mouse, respectively. The nerve electrodes 14 are implanted in the peripheral nerve bundle 16 and connected to the subcutaneous leads 5 via an intermediate lead, which is connected to the pin header via a percutaneous interface 18.
The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.

Claims (17)

1. 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 implanted nerve electrode is electrically connected with the connector through the subcutaneous lead, and the subcutaneous lead passes through the lumen of the percutaneous tube.
2. The implantable neural electrode system of claim 1, wherein the implantable neural electrode is made of carbon nano-tubing.
3. The implantable neural electrode system of claim 1, wherein the implantable neural electrode is made of platinum iridium alloy wire.
4. The implantable neural electrode system of claim 1, wherein the subcutaneous fixation is a flanged disc integrally formed with the percutaneous tube.
5. The implantable neural electrode system of claim 4, wherein the subcutaneous fixation portion and the percutaneous tube are made of medical grade silicone.
6. The implantable neural electrode system of claim 1, wherein the connector is a pin header or a box header, and the lumen interior is filled with an insulating material.
7. The implantable neural electrode system of claim 6, wherein the insulating material is epoxy AB glue or silicone.
8. The implantable neural electrode system of claim 1, wherein the lumen diameter of the percutaneous tube is 3mm to 10 mm.
9. The implantable neural electrode system of claim 2, further comprising an intermediate wire, the intermediate wire being positioned between the implantable neural electrode and the subcutaneous lead, the intermediate wire having a diameter larger than the carbon nanotube wire and smaller than the subcutaneous lead.
10. The implantable neural electrode system of claim 9, wherein the intermediate lead is made of platinum iridium alloy or stainless steel.
11. The implantable neural electrode system of claim 9, wherein the implantable neural electrode made of the carbon nanotube wire has a diameter of 10nm to 100 μ ι η.
12. The implantable neural electrode system of claim 11, wherein the intermediate lead is 10 μ ι η to 200 μ ι η in diameter.
13. The implantable neural electrode system of claim 12, wherein the subcutaneous lead is 50 μ ι η to 1mm in diameter.
14. The implantable neural electrode system of claim 9, wherein 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 around the first non-insulated portion, and further coated with a first conductive material and a first insulating material.
15. The implantable neural electrode system of claim 14, wherein the first conductive material is conductive silver paste and the first insulating material is epoxy AB paste or medical silica gel.
16. The implantable neural electrode system of claim 14, wherein the intermediate lead further comprises a second uninsulated section configured to wrap around the subcutaneous lead and further coated with a second conductive material and a second insulating material in sequence thereon.
17. The implantable neural electrode system of claim 16, wherein the second conductive material is conductive silver paste and the second insulating material is epoxy AB paste or medical silica gel.
CN201810778309.1A 2018-07-16 2018-07-16 Implantable neural electrode system Active CN110721402B (en)

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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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