CN102068760B - Implanted bioelectrode and preparation method thereof - Google Patents
Implanted bioelectrode and preparation method thereof Download PDFInfo
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- CN102068760B CN102068760B CN201110030598.5A CN201110030598A CN102068760B CN 102068760 B CN102068760 B CN 102068760B CN 201110030598 A CN201110030598 A CN 201110030598A CN 102068760 B CN102068760 B CN 102068760B
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- Prior art keywords
- stimulation contact
- sleeve pipe
- wire
- connecting terminal
- electrode
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- 238000002360 preparation method Methods 0.000 title abstract description 3
- 230000000638 stimulation Effects 0.000 claims description 48
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical group [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims description 22
- 229910052751 metal Inorganic materials 0.000 claims description 14
- 239000002184 metal Substances 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 14
- 229910052697 platinum Inorganic materials 0.000 claims description 11
- 230000004936 stimulating effect Effects 0.000 claims description 11
- 229910052741 iridium Inorganic materials 0.000 claims description 10
- GKOZUEZYRPOHIO-UHFFFAOYSA-N iridium atom Chemical compound [Ir] GKOZUEZYRPOHIO-UHFFFAOYSA-N 0.000 claims description 10
- 239000000956 alloy Substances 0.000 claims description 8
- 229910045601 alloy Inorganic materials 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 7
- 229910000831 Steel Inorganic materials 0.000 claims description 5
- 238000009413 insulation Methods 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 5
- 239000011368 organic material Substances 0.000 claims description 5
- 239000004814 polyurethane Substances 0.000 claims description 5
- 229920002379 silicone rubber Polymers 0.000 claims description 5
- 239000004945 silicone rubber Substances 0.000 claims description 5
- 239000010959 steel Substances 0.000 claims description 5
- 239000011230 binding agent Substances 0.000 claims description 4
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- 239000007769 metal material Substances 0.000 claims description 4
- 229920002635 polyurethane Polymers 0.000 claims description 4
- 230000004888 barrier function Effects 0.000 claims description 3
- 238000007493 shaping process Methods 0.000 claims description 3
- 238000004891 communication Methods 0.000 abstract description 2
- 230000037361 pathway Effects 0.000 abstract description 2
- 239000004020 conductor Substances 0.000 description 6
- 238000010586 diagram Methods 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 210000005036 nerve Anatomy 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 239000004809 Teflon Substances 0.000 description 2
- 229920006362 Teflon® Polymers 0.000 description 2
- 230000005611 electricity Effects 0.000 description 2
- 230000007794 irritation Effects 0.000 description 2
- 238000003754 machining Methods 0.000 description 2
- 229920000052 poly(p-xylylene) Polymers 0.000 description 2
- 210000000278 spinal cord Anatomy 0.000 description 2
- 208000018737 Parkinson disease Diseases 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 206010015037 epilepsy Diseases 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 229920003225 polyurethane elastomer Polymers 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 208000020016 psychiatric disease Diseases 0.000 description 1
- 239000011257 shell material Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
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- Electrotherapy Devices (AREA)
Abstract
The invention discloses a kind of Implanted bioelectrode and preparation method thereof, improving the reliability of electrode by increasing backup seal wire, reducing the conducting resistance of electrode.Wherein each electric pathway of electrode adds at least one backup path, the electrical communication of path still can be kept at the situation underpass of a channel failure, improve the reliability of Electrode connection, and two or more passage forms parallel relationship, can reduce electrode resistance.
Description
Technical field
The present invention relates to a kind of implantable medical devices, particularly a kind of Design and manufacture of Implanted bioelectrode.
Background technology
The application of nerve electric stimulation technology is more and more extensive, can be treated the multiple Nervous and mental diseases such as parkinson disease, myodystonia, depression, epilepsy by electricity irritation cerebral tissue, spinal cord or peripheral nervous, and the disease such as pain.Usually be implanted in patient body by surgeon by bioelectrode, electrode contacts ad-hoc location in vivo, is then transmitted in body by electrode by specific electric current by pulse generator, reaches the effect for the treatment of.
Nerve electric stimulation electrode in current clinical practice has structure as shown in Figure 1a usually, main body is an elongated pipe, external diameter is about 1.3mm, internal diameter is about 0.9mm, normally the material such as polyurethane or silicone rubber is made, outside one end of pipe, cover has the stimulation contact of one or more certain length, stimulates contact to connect with the wire being through tube interior, and wire is connected with the outer corresponding connecting terminal of pipe more respectively at the other end of pipe.Stimulate contact directly with tissue contact, usually made by the metal that the biocompatibility such as platinum, platinoiridita and gold are good, connecting terminal is made by the rustless steel etc. that rigidity is good usually, and is finally connected with pulse generator by specific mode.Connect wire and there is many seal wires helical spring form usually, have the coating of the materials such as Teflon, Parylene or ETFT to do between seal wire and seal wire and insulate.One of per share seal wire connection electrode one end stimulates contact and the corresponding connecting terminal of the other end.
The structural limitations of existing electrode is that it is to connecting the mechanical property of wire and requiring higher with the bonding strength of stimulation contact and connecting terminal, unfailing performance is low, once wire or junction point go wrong, this path just cannot work on, change electrode and mean that client need undergos surgery again, if electrode has implanted the long period face very large risk by making patient.Once there is the case because lead rupture causes electrical stimulating therapy to lose efficacy clinically.Therefore highly reliable electrode is very necessary.
Summary of the invention
Because the above-mentioned defect of prior art, the embodiment of the present invention provides a kind of electrode with backup architecture, improving the reliability of electrode, reducing the conducting resistance of electrode by increasing backup seal wire.
Technical scheme of the present invention is achieved in that
A kind of Implanted bioelectrode, comprises
Main body, described main body is elongated flexible insulating sleeve;
The stimulation contact of at least 1 ring-type, is enclosed within the outside of one end of described sleeve pipe;
Multiply metal spiral wire, being placed in described sleeve pipe and passing from described stimulation contact, wherein each stimulation contact place has at least two strands of wires to form traversing through end respectively simultaneously, and described traversing through end is connected with corresponding stimulation contact.
Electrode according to above technical scheme, wherein said sleeve pipe is made up of biocompatible high-molecular organic material.
Electrode according to above technical scheme, wherein said high-molecular organic material is silicone rubber and/or polyurethane material.
Electrode according to above technical scheme, the outer wall of one end of wherein said sleeve pipe is provided with the annular groove for accepting described stimulation contact, the length of described groove is identical with wall thickness with the length of stimulation contact with the degree of depth, described stimulation contact moving and making described stimulation contact outer surface equal with the outer surface of described sleeve pipe on described sleeve pipe can be limited, reduce the mechanical damage that may cause nervous tissue in clinical practice.
Electrode according to above technical scheme, the metal of wherein said stimulation contact is platinum, iridium or its alloy, the edge of described stimulation contact is provided with the slit of the described traversing through end for accepting the described wire passed from described sleeve pipe, its number is identical with the number of the traversing through end stimulating the described wire at contact place described in this, the length of described slit is 2-6 times of the naked filament diameter of described wire, and width is 1-3 times of the naked filament diameter of described wire.
Electrode according to above technical scheme, wherein said wire has helical spring type structure, and its metal material is selected from platinum, one of iridium or its alloy, and its naked filament diameter is about 0.1mm, and described wire outer setting has the coating of electric insulation.
Electrode according to above technical scheme, outside the other end of wherein said sleeve pipe, cover has the connecting terminal of ring-type, the metal material of described connecting terminal is selected from one of platinum, iridium, platinumiridio, rustless steel, the number of described connecting terminal is with stimulating contact identical, and described stimulation contact is connected with corresponding connecting terminal by described two strands or stranded conductor.
Electrode according to above technical scheme, wherein flexible insulating sleeve has end socket in one end of stimulation contact.
The manufacture method of bioelectrode of the present invention is:
Comprise following step
There is provided the metal spiral wire of multiply tape insulation layer, passed by 2 strands of wires respectively in same cross-section to relative direction, wire is uniformly distributed in cross-sectional circumferential more than then making it pass position when 2 bursts, removes the insulating barrier of the wire passed to form traversing through end;
There is provided processing reeded flexible insulating sleeve, be enclosed within described wire outside, subsequently the traversing through end of described wire chosen in described sleeve pipe;
The stimulation contact being processed with slit is provided, is enclosed within described jacket exterior, respectively the traversing through end of 2 strands or stranded conductor is stuck in described slit subsequently, and described traversing through end is welded on the outer wall of corresponding stimulation contact;
Adopt similar method processing connecting terminal end;
Closed by the stimulation tip side end socket of described flexible insulating sleeve, described end socket adopts thermo shaping method or uses binding agent to make.
Compared with prior art, the advantage of this structure of the present invention is that each electric pathway adds at least one backup path, the electrical communication of path still can be kept at the situation underpass of a channel failure, improve the reliability of Electrode connection, and two or more passage forms parallel relationship, can reduce electrode resistance.
Accompanying drawing explanation
Fig. 1 a is 4 helix structure schematic diagrams of the prior art, and Fig. 1 b is according to 8 bifilar helix electrode structure schematic diagrams of the present invention;
Fig. 2 is the ledge structure schematic diagram of flexible insulating sleeve;
Fig. 3 stimulates contact junction composition;
Fig. 4 is the cross-sectional view after the assembling of electrode stimulating end;
Fig. 5 is the schematic appearance after the assembling of electrode stimulating end.
Detailed description of the invention
Fig. 1 b, Fig. 2, Fig. 3, Fig. 4, Fig. 5 show a kind of embodiment of the present invention, and its moderate stimulation contact 3 is 4, and plain conductor is 8 spiral conducting lines, and sleeve pipe is fluted, has end socket electrode.
As shown in Figure 1 b, the main body of electrode adopts elongated flexible insulated sleeve, to at least 1 metal ring in sleeve pipe one end as stimulation contact, there is multiply metal spiral wire in sleeve pipe and pass from stimulation contact, having two strands of plain conductors be connected with same stimulation contact and be connected with same junction point at the other end of sleeve pipe.
The flexible insulating sleeve of electrode body selects biocompatible high-molecular organic material, as silicone rubber, polyurethane material etc.One end outer wall of flexible insulating sleeve has annular groove to stimulate contact for accepting, and groove can adopt the method such as machining or heat ductile forming to make.
The metal of the stimulation contact of electrode can select platinum, iridium and alloy thereof etc., and the number stimulating contact can be one or more, stimulates the edge of contact to have slit for accepting the plain conductor passed from flexible insulating sleeve.
The metal spiral wire of electrode has helical spring type structure, and wherein metal selects platinum, iridium and alloy thereof etc., and coating wire being also provided with the bio-safeties such as Teflon, Parylene, ETFT makes electric insulation between each silk.
Electrode overlaps outside the other end of flexible insulating sleeve has becket as junction point, be called connecting terminal, connecting terminal metal selects platinum, iridium and alloy or rustless steel etc., and number is with stimulating contact identical, and stimulation contact is connected with corresponding connecting terminal by plain conductor.
Flexible insulating sleeve has end socket in one end of stimulation contact, and end socket can adopt thermo shaping method or use binding agent to make.
The manufacture method of bioelectrode of the present invention comprises following step.
First 8 spiral conducting lines are untwisted, make the form shown in Fig. 1 b, two lead-in wires of same position are on same cross section, and stretch out from relative direction respectively, the insulating barrier of removing wire ends, by support bar 5 through in spiral conducting line, in order to keep the hollow structure of spiral conducting line in the course of processing.
Processing flexibility insulated sleeve, shell material is biocompatible silicone rubber or polyurethane etc., the groove shown in two ends manuscript 2 by heat ductile forming or the method such as machining or Laser Processing, the groove length at sleeve pipe two ends is respectively with stimulating contact identical with the becket length of connecting terminal, depth of groove is identical with becket wall thickness, for accepting the contact stimulating contact and link, spacing matches with the spacing between spiral conducting line solution supination lead-in wire.
Insulated sleeve is enclosed within spiral conducting line, the mutual alignment of both adjustment, leftmost lead-in wire 1 shown in Fig. 4 is made to be positioned at recess edge, as shown in Figure 3 have the stimulation contact metal ring set of slit on insulated sleeve, 2 lead-in wires solution be screwed on same cross section pass from relative direction respectively, and being stuck in 2 slits of same stimulation contact, stimulation slider material is platinum, iridium and alloy thereof etc.Repeat said process successively all the other 3 contacts to be enclosed within insulated sleeve.Lead-in wire laser weld or resistance spot welding method are welded on the outer wall at contact slot edge.
Adopt identical method that connecting terminal is enclosed within the sleeve pipe other end, and be welded on contact by the lead-in wire of spiral conducting line, connecting terminal material is rustless steel etc.
Adopt thermoplastic method or close stimulating the insulated sleeve of tip side with binding agent, form hemispherical head, this completes the manufacture of electrode, profile as shown in Figure 5.
Above embodiment is described for nerve electric stimulation, simply changed by the size to component each in above embodiment, number, electrode of the present invention can also be used for the electricity irritation of endocardial, muscle electric stimulation, spinal cord stimulation trial, and in other similar application.
The foregoing is only several specific embodiment of the present invention, above embodiment is only for explaining and unrestricted right of the present invention to technical scheme of the present invention and inventive concept.All technical staff in the art in conjunction with prior art, by the available other technologies scheme of logical analysis, reasoning or limited experimentation, also should be considered to drop within claims of the present invention on the inventive concept basis of this patent.
Claims (10)
1. an Implanted bioelectrode, is characterized in that, comprises
Main body, described main body is elongated flexible insulating sleeve (2);
The stimulation contact (3) of at least 1 ring-type, is enclosed within the outside of one end of described sleeve pipe;
There is the multiply metal spiral wire (1) of hollow structure, to be placed in described sleeve pipe and to pass from described stimulation contact, wherein each stimulation contact place has at least two strands of wires to form traversing through end respectively simultaneously, and described traversing through end is connected with corresponding stimulation contact;
Outside the other end of described sleeve pipe, cover has the connecting terminal of ring-type, and described at least two strands of wires are connected with same stimulation contact and are connected with same connecting terminal at the other end of described sleeve pipe; The number of described stimulation contact is identical with the number of described connecting terminal.
2. electrode according to claim 1, is characterized in that, described sleeve pipe is made up of biocompatible high-molecular organic material.
3. electrode according to claim 2, is characterized in that, described high-molecular organic material is silicone rubber and/or polyurethane material.
4. electrode according to claim 1, is characterized in that, the outer wall of one end of described sleeve pipe is provided with the annular groove for accepting described stimulation contact.
5. electrode according to claim 1, is characterized in that, the metal of described stimulation contact is platinum, iridium or its alloy, and the edge of described stimulation contact is provided with the slit of the described traversing through end for accepting the described wire passed from described sleeve pipe.
6. electrode according to claim 1, is characterized in that, described wire has helical spring type structure, and its metal material is selected from platinum, one of iridium or its alloy, and described wire outer setting has the coating of electric insulation.
7. electrode according to claim 1, it is characterized in that, the metal material of described connecting terminal is selected from one of platinum, iridium, platinumiridio, rustless steel, and the number of described connecting terminal is with stimulating contact identical, and described stimulation contact is connected with corresponding connecting terminal by described at least two strands of wires.
8. electrode according to claim 1, is characterized in that, flexible insulating sleeve has end socket (4) in one end of stimulation contact.
9. an implantable medical device, is characterized in that, comprises according to the electrode one of claim 1-8 Suo Shu.
10., according to the manufacture method of the electrode one of claim 1-8 Suo Shu, comprise
There is provided the metal spiral wire of multiply tape insulation layer, passed by 2 strands of wires respectively in same cross-section to relative direction, wire is evenly arranged in cross-sectional circumferential more than then making to pass position when 2 bursts, removes the insulating barrier of the wire passed to form traversing through end; By support bar through in spiral conducting line, in order to keep the hollow structure of spiral conducting line in the course of processing;
There is provided processing reeded flexible insulating sleeve, be enclosed within described wire outside, subsequently the traversing through end of described wire chosen in described sleeve pipe;
The stimulation contact being processed with slit is provided, is enclosed within the outside of one end of described sleeve pipe, subsequently respectively by 2 strands or be stuck in described slit more than the traversing through end of 2 strands of wires, and described traversing through end is welded on the outer wall of corresponding stimulation contact;
Adopt identical method processing connecting terminal end; Described 2 strands or to be connected with same stimulation contact more than 2 strands of wires and to be connected with same connecting terminal at the other end of described sleeve pipe; The number of described stimulation contact is identical with the number of described connecting terminal;
Closed by the stimulation tip side end socket of described flexible insulating sleeve, described end socket adopts thermo shaping method or uses binding agent to make.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110030598.5A CN102068760B (en) | 2011-01-28 | 2011-01-28 | Implanted bioelectrode and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110030598.5A CN102068760B (en) | 2011-01-28 | 2011-01-28 | Implanted bioelectrode and preparation method thereof |
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| Publication Number | Publication Date |
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| CN102068760A CN102068760A (en) | 2011-05-25 |
| CN102068760B true CN102068760B (en) | 2015-08-05 |
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Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102327668B (en) * | 2011-08-12 | 2014-01-22 | 清华大学 | Implanted bioelectrode and medical assembly comprising same |
| CN102824689B (en) | 2012-09-07 | 2014-12-24 | 清华大学 | Implanted electrode and preparation method thereof and medical assembly comprising implanted electrode |
| CN103446665B (en) * | 2013-08-29 | 2016-03-30 | 河南理工大学 | Implanted flexible biological electrode and manufacture method thereof |
| KR102318302B1 (en) * | 2014-09-12 | 2021-10-29 | 뉴로스 메디컬 인코포레이티드 | Nerve cuff electrode for neuromodulation in large human nerve trunks |
| CN104274902B (en) * | 2014-10-10 | 2017-09-22 | 清华大学 | The implanted electrode and its manufacture method of a kind of MRI compatible |
| CN105641805B (en) * | 2014-10-28 | 2017-11-28 | 常州瑞神安医疗器械有限公司 | Embedded nerve stimulator electrode contacts structure |
| CN108939287B (en) * | 2018-06-04 | 2020-09-04 | 清华大学 | Method for manufacturing flexible spiral electrode and nerve bundle detection and treatment device |
| CN110180071B (en) * | 2018-06-25 | 2021-05-04 | 谢怡飞 | Medical composite catheter metal wire layer anti-untwisting method |
| CN112245802B (en) * | 2020-10-16 | 2023-01-24 | 北京品驰医疗设备有限公司 | Guide wire handle and implantable medical system |
| CN113856048A (en) * | 2021-10-09 | 2021-12-31 | 上海神奕医疗科技有限公司 | Electrical lead, processing method, extension cord, electrode and electrical stimulation system |
| CN116099125B (en) * | 2023-02-15 | 2024-08-16 | 微智医疗器械有限公司 | Electrode structure of electric stimulator and electric stimulator |
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| US6477427B1 (en) * | 2000-03-31 | 2002-11-05 | Medtronic Inc. | Implantable stimulation lead and method of manufacture |
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| CN101829401A (en) * | 2010-05-21 | 2010-09-15 | 西安交通大学 | Implanted bioelectrode based on photoetching and other micro-nano manufacturing technologies and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN86210007U (en) * | 1986-11-20 | 1987-10-31 | 陈明发 | Filament replaceable durable bulb |
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| US6477427B1 (en) * | 2000-03-31 | 2002-11-05 | Medtronic Inc. | Implantable stimulation lead and method of manufacture |
| CN2671282Y (en) * | 2003-12-29 | 2005-01-12 | 于栋林 | Non-radiation flexible electrothermal wire |
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| CN102068760A (en) | 2011-05-25 |
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Address after: 102200 5th floor, building 1, No.1, Xingchang Road, Nanshao Town, Changping District, Beijing Patentee after: Beijing Pinchi Medical Equipment Co.,Ltd. Country or region after: China Patentee after: TSINGHUA University Address before: 102200 5th floor, building 1, No.1, Xingchang Road, Nanshao Town, Changping District, Beijing Patentee before: BEIJING PINS MEDICAL Co.,Ltd. Country or region before: China Patentee before: TSINGHUA University |