CN102068760A - Implantable biological electrode and manufacturing method thereof - Google Patents
Implantable biological electrode and manufacturing method thereof Download PDFInfo
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- CN102068760A CN102068760A CN2011100305985A CN201110030598A CN102068760A CN 102068760 A CN102068760 A CN 102068760A CN 2011100305985 A CN2011100305985 A CN 2011100305985A CN 201110030598 A CN201110030598 A CN 201110030598A CN 102068760 A CN102068760 A CN 102068760A
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Abstract
The invention discloses an implantable biological electrode and a manufacturing method thereof. By arranging a backup conducting wire, the reliability of an electrode is improved and the conducting resistance of the electrode is reduced. Each electric path of the electrode is provided with at least one backup channel to ensure that the electrical communication of the path still can be maintained under the condition of the failure of one channel, so that the reliability of the connection of the electrode is improved; moreover, the parallel connection relationship is formed by two or more channels, so that the resistance of the electrode can be reduced.
Description
Technical field
The present invention relates to a kind of implantable medical devices, particularly a kind of design of implantating biological electrode and manufacturing.
Background technology
The nerve electric stimulation technology is used more and more widely, can treat the spiritual class diseases of multiple nerve such as parkinson disease, myodystonia, depression, epilepsy by electricity irritation cerebral tissue, spinal cord or peripheral nervous, and disease such as pain.Usually by surgeon bioelectrode is implanted in the patient body, electrode contacts ad-hoc location in vivo is transmitted to particular current in the body by electrode by pulse generator then, reaches the effect of treatment.
Nerve electric stimulation electrode in the clinical practice at present has structure as shown in Figure 1a usually, main body is an elongated pipe, the about 1.3mm of external diameter, the about 0.9mm of internal diameter, normally material such as polyurethane or silicone rubber is made, be with the stimulation contact of one or more certain-lengths in an end of the pipe outside, stimulate the contact to connect with the lead that is through tube interior, lead the other end of pipe more respectively with pipe outer corresponding connecting terminal continuous.Stimulate the contact directly with the tissue contact, made by biocompatibility good metal such as platinum, platinoiridita and gold usually, connecting terminal is made by the good rustless steel of rigidity etc. usually, and finally continuous with pulse generator by specific mode.Connect lead and have the helical spring form of many seal wires usually, have the coating of materials such as Teflon, Parylene or ETFT to do insulation between seal wire and the seal wire.One of per share seal wire connection electrode one end stimulates contact and the corresponding connecting terminal of the other end.
The structure limitation of existing electrode is that it has relatively high expectations to the mechanical property that connects lead and with the bonding strength that stimulates contact and connecting terminal, unfailing performance is low, in case lead or junction point go wrong, this path just can't work on, change electrode and mean that patient need undergo surgery once more, will make patient face very big risk if electrode has been implanted the long period.Once occurred clinically because the case that lead rupture causes electrical stimulating therapy to lose efficacy.Therefore highly reliable electrode is very necessary.
Summary of the invention
Because the above-mentioned defective of prior art, the embodiment of the invention provides a kind of electrode that has backup architecture, by increasing the reliability that the backup seal wire improves electrode, reduces the conducting resistance of electrode.
Technical scheme of the present invention is achieved in that
A kind of implantating biological electrode comprises
Main body, described main body are elongated flexible insulation sleeve pipe;
At least 1 cyclic stimulation contact is enclosed within the outside of a described telescopic end;
Multiply metal spiral lead places in the described sleeve pipe and from described stimulation contact to pass, and wherein each stimulates the place, contact to have at least two strands of leads to form traversing through end respectively simultaneously, and described traversing through end is connected with the corresponding contact that stimulates.
According to the described electrode of above technical scheme, wherein said sleeve pipe is made by biocompatible high-molecular organic material.
According to the described electrode of above technical scheme, wherein said high-molecular organic material is silicone rubber and/or polyurethane material.
According to the described electrode of above technical scheme, the outer wall of a wherein said telescopic end is provided with the annular groove that is used to accept described stimulation contact, the length of described groove is identical with wall thickness with the length that stimulates the contact with the degree of depth, can limit described stimulation contact moving and make described stimulation contact outer surface equal on described sleeve pipe, reduce in the clinical practice mechanical damage that may cause nervous tissue with described telescopic outer surface.
According to the described electrode of 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 that is used for accepting the described lead that passes from described sleeve pipe, its number is identical with the number of the traversing through end of the described lead at this place, described stimulation contact, the length of described slit is 2-6 times of the naked filament diameter of described lead, and width is 1-3 a times of the naked filament diameter of described lead.
According to the described electrode of above technical scheme, wherein said lead has the helical spring type structure, and its metal material is selected from one of platinum, iridium or its alloy, and its naked filament diameter is about 0.1mm, and described lead outer setting has the coating of electric insulation.
According to the described electrode of above technical scheme, the wherein said telescopic other end outside is with cyclic connecting terminal, 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 the contact identical, described two strands or stranded conductor with described stimulation contact and accordingly connecting terminal link to each other.
According to the described electrode of above technical scheme, wherein the flexible insulation sleeve pipe has end socket at an end that stimulates the contact.
The manufacture method of bioelectrode of the present invention is:
Comprise following step
The metal spiral lead of multiply tape insulation layer is provided, in same cross-section 2 strands of leads is passed to relative direction respectively, lead then makes it pass the position at the cross-sectional circumferential uniform distribution during more than 2 bursts, and the insulating barrier that removes the lead that passes is to form traversing through end;
Provide processing reeded flexible insulation sleeve pipe, it is enclosed within described lead outside, subsequently the traversing through end of described lead is chosen in described sleeve pipe;
The stimulation that is processed with slit contact is provided, it is enclosed within described jacket exterior, respectively the traversing through end of 2 strands or stranded conductor is stuck in the 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;
The telescopic stimulation tip side of described flexible insulation is sealed with end socket, and 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 has increased at least one backup path, the electrical communication that still can keep path at the situation underpass of a channel failure, improved the reliability that electrode connects, and two or more passages form relation in parallel, can reduce electrode resistance.
Description of drawings
Fig. 1 a is 4 helix structure sketch maps of the prior art, and Fig. 1 b is according to 8 bifilar helix electrode structure sketch maps of the present invention;
Fig. 2 is the telescopic ledge structure sketch map of flexible insulation;
Fig. 3 stimulates the 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.
The specific embodiment
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, and the end socket electrode is arranged.
Shown in Fig. 1 b, the main body of electrode adopts the elongated flexible insulated sleeve, at least 1 becket is enclosed within sleeve pipe one end as stimulating the contact, multiply metal spiral lead is arranged and from stimulating the contact to pass in the sleeve pipe, have two money paid for shares to belong to lead and be connected with same stimulation contact and link to each other with same junction point at the telescopic other end.
The flexible insulation sleeve pipe of electrode body is selected biocompatible high-molecular organic material for use, as silicone rubber, polyurethane material etc.The telescopic end outer wall of flexible insulation has annular groove to be used for accepting to stimulate the contact, and groove can adopt methods such as machining or heat ductile forming to make.
The metal of the stimulation contact of electrode can be selected platinum, iridium and alloy thereof etc. for use, and stimulating the number of contact can be one or more, stimulates the edge of contact to have slit to be used for accepting the plain conductor that passes from the flexible insulation sleeve pipe.
The metal spiral lead of electrode has the helical spring type structure, and wherein metal is selected platinum, iridium and alloy thereof etc. for use, and the coating that also is provided with bio-safeties such as Teflon, Parylene, ETFT on the lead makes electric insulation between each.
Electrode is with becket as junction point in the telescopic other end of the flexible insulation outside, be called connecting terminal, the connecting terminal metal is selected platinum, iridium and alloy or rustless steel etc. for use, and number is with stimulating the contact identical, and plain conductor will stimulate the contact to link to each other with corresponding connecting terminal.
The flexible insulation sleeve pipe has end socket at an end that stimulates the 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.
At 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, remove the insulating barrier of lead-in wire end, with support bar 5 through in the spiral conducting line, in order in the course of processing, to keep the hollow structure of spiral conducting line.
The processing flexibility insulated sleeve, shell material is biocompatible silicone rubber or polyurethane etc., process groove shown in Figure 2 at two ends by methods such as heat ductile forming or machining or Laser Processings, the groove length at sleeve pipe two ends is identical with the becket length that stimulates contact and connecting terminal respectively, depth of groove is identical with the becket wall thickness, be used to accept to stimulate the contact of contact and link, the spacing that spacing is separated between the supination lead-in wire with spiral conducting line is complementary.
Insulated sleeve is enclosed within on the spiral conducting line, adjust both mutual alignments, make leftmost lead-in wire 1 shown in Figure 4 be positioned at recess edge, as shown in Figure 3 the stimulation contact metal ring set that slit is arranged on insulated sleeve, pass from relative direction respectively separating 2 lead-in wires that are screwed on the same cross section, and be stuck in 2 slits of same stimulation contact, the stimulation slider material is platinum, iridium and alloy thereof etc.Repeating said process is enclosed within all the other 3 contacts on the insulated sleeve successively.Lead-in wire is welded on the outer wall at contact slot edge with laser weld or resistance spot welding method.
Adopt identical method that connecting terminal is enclosed within the sleeve pipe other end, and with the wire bonds of spiral conducting line on the contact, the connecting terminal material is a rustless steel etc.
Adopt the thermoplastic method or will stimulate the insulated sleeve of tip side to seal with binding agent, form hemispherical head, so just finished the manufacturing of electrode, profile as shown in Figure 5.
Above embodiment is that example describes with the nerve electric stimulation, simply change by size, number each member in the above embodiment, electrode of the present invention can also be used for electricity irritation, muscle electric stimulation, the spinal cord stimulation trial of heart inside, and in other similar application.
The above only is several specific embodiment of the present invention, and above embodiment only is used for technical scheme of the present invention and inventive concept are explained and unrestricted claim scope of the present invention.All technical staff in the art in conjunction with prior art, by the available other technologies scheme of logical analysis, reasoning or limited experiment, also should be considered to drop within the claim protection domain of the present invention on the inventive concept basis of this patent.
Claims (10)
1. an implantating biological electrode is characterized in that, comprises
Main body, described main body are elongated flexible insulation sleeve pipe (2);
At least 1 cyclic stimulation contact (3) is enclosed within the outside of a described telescopic end;
Multiply metal spiral lead (1) places in the described sleeve pipe and from described stimulation contact to pass, and wherein each stimulates the place, contact to have at least two strands of leads to form traversing through end respectively simultaneously, and described traversing through end is connected with the corresponding contact that stimulates.
2. electrode according to claim 1 is characterized in that described sleeve pipe is made by 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 a described telescopic end is provided with the annular groove that is used to accept 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 that is used for accepting the described lead that passes from described sleeve pipe.
6. electrode according to claim 1 is characterized in that described lead has the helical spring type structure, and its metal material is selected from one of platinum, iridium or its alloy, and described lead outer setting has the coating of electric insulation.
7. electrode according to claim 1, it is characterized in that, the described telescopic other end outside is with cyclic connecting terminal, 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 the contact identical, and described at least two strands of leads link to each other described stimulation contact with corresponding connecting terminal.
8. electrode according to claim 1 is characterized in that, the flexible insulation sleeve pipe has end socket (4) at an end that stimulates the contact.
9. an implantable medical device is characterized in that, comprises the described electrode according to one of claim 1-8.
10. according to the manufacture method of one of claim 1-8 described electrode, comprise
The metal spiral lead of multiply tape insulation layer is provided, in same cross-section 2 strands of leads is passed to relative direction respectively, lead then makes during more than 2 bursts and passes the position and arrange evenly that on cross-sectional circumferential the insulating barrier that removes the lead that passes is to form traversing through end;
Provide processing reeded flexible insulation sleeve pipe, it is enclosed within described lead outside, subsequently the traversing through end of described lead is chosen in described sleeve pipe;
The stimulation that is processed with slit contact is provided, it is enclosed within described jacket exterior, respectively the traversing through end of 2 strands or stranded conductor is stuck in the 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;
The telescopic stimulation tip side of described flexible insulation is sealed with end socket, and described end socket adopts thermo shaping method or uses binding agent to make.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201110030598.5A CN102068760B (en) | 2011-01-28 | 2011-01-28 | Implanted bioelectrode and preparation method thereof |
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| CN201110030598.5A CN102068760B (en) | 2011-01-28 | 2011-01-28 | Implanted bioelectrode and preparation method thereof |
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| CN102068760A true CN102068760A (en) | 2011-05-25 |
| CN102068760B CN102068760B (en) | 2015-08-05 |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013023404A1 (en) * | 2011-08-12 | 2013-02-21 | 清华大学 | Implanted biological electrode and medical assembly including same |
| CN103446665A (en) * | 2013-08-29 | 2013-12-18 | 河南理工大学 | Implanted flexible biological electrode and manufacturing method thereof |
| CN104274902A (en) * | 2014-10-10 | 2015-01-14 | 清华大学 | Implanted electrode compatible with MRI and manufacturing method thereof |
| CN107073263A (en) * | 2014-09-12 | 2017-08-18 | 纽若斯医疗公司 | Nerve cuff electrode for the neuromodulation in large-scale human neural stem |
| 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 |
| CN108939287A (en) * | 2018-06-04 | 2018-12-07 | 清华大学 | The manufacturing method and nerve tract of flexible screw electrode detect therapeutic device |
| US10155106B2 (en) | 2012-09-07 | 2018-12-18 | Tsinghua University | Method for making implantable lead |
| CN110180071A (en) * | 2018-06-25 | 2019-08-30 | 谢怡飞 | A kind of anti-method of untwisting of medical treatment composite conduit tinsel layer |
| CN112245802A (en) * | 2020-10-16 | 2021-01-22 | 北京品驰医疗设备有限公司 | Guide wire handle and implantable medical system |
| WO2023056762A1 (en) * | 2021-10-09 | 2023-04-13 | 上海神奕医疗科技有限公司 | Electrical lead, processing method, extension line, electrode and electrical stimulation system |
| CN116099125A (en) * | 2023-02-15 | 2023-05-12 | 微智医疗器械有限公司 | Electrode structure of electric stimulator and electric stimulator |
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Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US10080890B2 (en) | 2011-08-12 | 2018-09-25 | Tsinghua University | Implantable biological electrode and medical assembly including the same |
| WO2013023404A1 (en) * | 2011-08-12 | 2013-02-21 | 清华大学 | Implanted biological electrode and medical assembly including same |
| US10155106B2 (en) | 2012-09-07 | 2018-12-18 | Tsinghua University | Method for making implantable lead |
| CN103446665A (en) * | 2013-08-29 | 2013-12-18 | 河南理工大学 | Implanted flexible biological electrode and manufacturing method thereof |
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| CN107073263B (en) * | 2014-09-12 | 2021-07-23 | 纽若斯医疗公司 | Nerve cuff electrode for neuromodulation in large human nerve trunks |
| CN107073263A (en) * | 2014-09-12 | 2017-08-18 | 纽若斯医疗公司 | Nerve cuff electrode for the neuromodulation in large-scale human neural stem |
| CN104274902A (en) * | 2014-10-10 | 2015-01-14 | 清华大学 | Implanted electrode compatible with MRI and manufacturing method thereof |
| 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 |
| CN108939287A (en) * | 2018-06-04 | 2018-12-07 | 清华大学 | The manufacturing method and nerve tract of flexible screw electrode detect therapeutic device |
| 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 |
| CN110180071A (en) * | 2018-06-25 | 2019-08-30 | 谢怡飞 | A kind of anti-method of untwisting of medical treatment composite conduit tinsel layer |
| CN112245802A (en) * | 2020-10-16 | 2021-01-22 | 北京品驰医疗设备有限公司 | Guide wire handle and implantable medical system |
| WO2023056762A1 (en) * | 2021-10-09 | 2023-04-13 | 上海神奕医疗科技有限公司 | Electrical lead, processing method, extension line, electrode and electrical stimulation system |
| CN116099125A (en) * | 2023-02-15 | 2023-05-12 | 微智医疗器械有限公司 | Electrode structure of electric stimulator and electric stimulator |
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| CN102068760B (en) | 2015-08-05 |
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