CN100469402C - Implant type electronic acupuncture and moxibustion therapeutic device - Google Patents

Implant type electronic acupuncture and moxibustion therapeutic device Download PDF

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CN100469402C
CN100469402C CNB200610089626XA CN200610089626A CN100469402C CN 100469402 C CN100469402 C CN 100469402C CN B200610089626X A CNB200610089626X A CN B200610089626XA CN 200610089626 A CN200610089626 A CN 200610089626A CN 100469402 C CN100469402 C CN 100469402C
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pulse generator
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pulse
electrode
coil
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CN1876200A (en
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李路明
郝红伟
马伯志
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Tsinghua University
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Tsinghua University
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Abstract

The related implantation-type electric acupuncture therapy unit comprises some electrodes implanted on in-vivo point and a pulse generator, wherein it includes auto mode and magnetic-control mode fit to stimulate with single or dual electrodes, uses percutaneous wireless communication to control parameter, has well precision and long lifetime, and convenient to long-period treatment.

Description

Implant type electronic acupuncture and moxibustion therapeutic device
Technical field
The present invention relates to a kind of implant type electronic acupuncture and moxibustion therapeutic device, belong to the implantation medical equipment technical field.
Background technology
Acupuncture is the means of the distinctive treatment disease of a kind of China, and its be a kind of Therapeutic Method of " in external treatment " by the effect of meridians, acupuncture points on the human body, and is used certain maneuver, treats general disease.At present, acupuncture has obtained almost global approval, it is reported, effectively sick kind of acupuncture and moxibustion therapy reaches more than 300 kinds, and wherein obvious results just has kind more than 100.In the practical application of acupuncture, twirling or rotating of the acupuncture needle and develop into acusector from hands, after promptly sticking a needle into acupuncture points on the human body and bringing about the desired sensation, on needle set, pass to current impulse, utilize pin and two kinds of stimulations of electricity to combine with disease preventing and treating, its advantage be can replace the people do the long period continue handle the needle, save manpower, and can control quantity of stimulus more objectively.
When using acusector moxibustion method treatment disease, the disease that has only needs for several times that treatment gets final product, but the chronic disease that has chronic neurological disorders especially needs long-term treatment, as pain, parkinson disease, senile dementia, depression, drug dependence etc.Existing electronic acupuncture and moxibustion therapeutic device, major part is the instrument of external application, at first will find the position, acupuncture point accurately during use, then electrode is thrust or sticks on the acupuncture point, energising stimulates again.External acupuncture point electro-acupuncture treatment no doubt has simple, the economic advantage of device, but in the therapy of this transcutaneous electrostimulation, the location at acupuncture point, the stickup of electrode etc. all operation place one's entire reliance upon manually, and the reliability of treatment, concordance and quantitative property are still not ideal enough; In addition, most patient can not be in hospital or out-patient treatment in hospital for a long time, yet can't guarantee promptness and accuracy especially by the treatment of patient or its family members operation.In this case, the electronic acupuncture and moxibustion therapeutic device of research implanted, implant pulse generator and electrode subcutaneous simultaneously, the self-timing of realizing therapy equipment starts, the perhaps mode of patient's start-up by hand electricity irritation, the stability and the reliability of electronic acupuncture and moxibustion therapeutic can be provided greatly, have important medical meaning and application prospect.
The at present domestic research report that does not also have implant type electronic acupuncture and moxibustion therapeutic device, in prior art, United States Patent (USP) 5,094,242 and 5,211,175 disclose a kind of method and device of implanting acusector, this electric needle therapeutic instrument belongs to half implanting device in essence, and promptly pulse generator is external, and the place, acupuncture point implants receiving circuit and needle electrode in the body; In use, external pulse generator is launched electromagnetic pulse by antenna, and intravital receiving circuit is given electrode with the coil-induced pulse electromagnetic energy delivery that arrives, and stimulates corresponding acupoints, and the bottom of receiving circuit package casing is as positive pole, and needle electrode is as negative pole.United States Patent (USP) 6; 377; 853 overall plan is identical with above-mentioned patent; but improve in the part; comprise use stranded wire as the lead of needle electrode to improve soft degree; increase protector at the interface position of needle electrode and receiving circuit package casing and break, and near electrode contacts, increase fixation to prevent dislocation of electrode to prevent that interface is impaired.
The therapeutic process of existing semi-implantation type electronic acupuncture and moxibustion therapeutic device is exactly the process that device receives electromagnetic energy in external pulse generator emission, the body, there are many defectives in this scheme in application, for example therapeutic process can not break away from device outside, must the manually-operated device outside treat, thus the patient especially the gerontal patient use inconvenience; The stimulating current parameter not only depends on the external pulse generator parameter, the also coupling state of the inside and outside coil of receptor influence, have only the external pulse generator of maintenance could not keep stimulus parameter stable in the shift position in the therapeutic process, thereby can not be free movable during patient treatment, and the homogeneous treatment can't not guarantee the parameter unanimity substantially.
Summary of the invention
At the deficiencies in the prior art, the purpose of this invention is to provide a kind of implant type electronic acupuncture and moxibustion therapeutic device, realize easy to use and reliable, the accurate implantation type electric stimulation treatment of parameter stability to human acupoint.
The invention is characterized in, this device comprises pulse generator and electrode, described pulse generator and electrode are made the integral type cylindrical structural, wherein, pulse generator is packaged into cylindrical, and the shell encapsulating material uses the biocompatible materials that comprises polyurethane or silicone rubber or pottery or metal material; Electrode contacts sticks on two ends or intermediary any position of described pulse generator, and links to each other with the output control circuit outfan of this pulse generator inside.When described pulse generator encapsulates with metal material, the shell electric insulation of each electrode contacts and this pulse generator.
Feature of the present invention is that also optional two electrode contacts constitute the bipolar stimulation pattern as both positive and negative polarity.
Feature of the present invention is that also described pulse generator comprises:
Live part, be connected in series successively by coil, charge management circuit, battery and constitute, coil receives external charger electromagnetic energy emitted by the electromagnetic coupled mode, frequency in tens KHz between the hundreds of KHz, and the coil of Implantable Pulse Generator and the transmitting coil of external charger are the placement that is coupled of parallel axes mode, the former is cylindric, in cylinder shape magnetic core is arranged, the latter is a flat, in flat square or circular magnetic core is arranged, wherein the material of magnetic core is ferrite, amorphous, crystallite, ultracrystallite or permalloy;
The pulse generation part, input links to each other with the outfan of battery in the live part, and pulse frequency is between 1-250Hz, but both constant frequency pulse output, but also the different frequency pulse is alternately exported, and both can export continuously, also can intermittently export;
The outfan of coil and battery links to each other in the communications portion, input and described live part;
Microprocessor, input links to each other with the outfan of battery in the described live part, and microprocessor control signal output links to each other with the respective input of communications portion with described pulse generation part respectively;
Output control part, it is a multi-channel gating switch, the control signal input links to each other with described microprocessor corresponding output end, the pulse signal input terminal of this output control part links to each other with described pulse generation part corresponding output end, and each the road output of this output control part links to each other with the corresponding electrode contact;
Reed switch, control signal output ends links to each other with described microprocessor respective input.
Compared with prior art, the present invention has following beneficial effect: (1) implant type electronic acupuncture and moxibustion therapeutic device of the present invention, and rational in infrastructure reliable, be fit to long-term the implantation and use; (2) can program control set stimulus parameter after independent, long-play, not only therapeutic process controlled fully, can repeat, uncertainty when having avoided prior art to treat, and therapeutic process need not medical personnel or family members assist, and has saved the human resources greatly; (3) use internal cell as power supply, the parameters such as amplitude, cycle, pulsewidth, sequential that impose on the electric stimulation pulse at acupuncture point can accurately be controlled; (4) use percutaneous wireless charging technology, can prolong the service life of implant type electronic acupuncture and moxibustion therapeutic device greatly, not only help more effectively treating disease, and can reduce patient's financial burden.
Description of drawings
Fig. 1 is a circuit theory sketch map of the present invention;
Fig. 2 is the body interior loop of wireless percutaneous charging of the present invention and the coupling sketch map of external coil;
Fig. 3 is the sketch map of one of embodiment of the invention;
Fig. 4 is two a sketch map of the embodiment of the invention;
Fig. 5 is three a sketch map of the embodiment of the invention.
The specific embodiment
For achieving the above object, implant type electronic acupuncture and moxibustion therapeutic device is made of the electrode and the pulse generator at corresponding acupuncture point in the implant into body.Electrode contains plural stimulation contact, and in the unipolar stimulation pattern, the pulse generator shell is as positive pole, and an electrode contacts is as negative pole; In the bipolar stimulation pattern, select two electrode contacts respectively as both positive and negative polarity.Pulse generator contains coil, charge management circuit, battery, microprocessor, pulse generating circuit, output control circuit, telecommunication circuit and reed switch, wherein:
Coil, charge management circuit links to each other successively with battery, constitute the power supply of pulse generator, coil receives external charger electromagnetic energy emitted by the electromagnetic coupled mode, frequency in tens KHz between the hundreds of KHz, be controlled to be battery charge by charge management circuit, be microcontroller then, pulse generating circuit and telecommunication circuit power supply, and the coil of Implantable Pulse Generator and the transmitting coil of external charger are the placement that is coupled of parallel axes mode, the former is cylindric, in cylinder shape magnetic core is arranged, the latter is a flat, in flat square or circular magnetic core is arranged, wherein the material of magnetic core is a ferrite, amorphous, crystallite, ultracrystallite or permalloy;
Microprocessor internal is integrated DA transducer, intervalometer, FLASH memorizer, RAM memorizer and communication port, its outfan links to each other with the input of pulse generating circuit, telecommunication circuit and output control circuit;
Microprocessor control DA transducer output control pulse, behind pulse generating circuit, obtain parameters such as amplitude, pulsewidth, cycle accurately, adjustable flexibly, and the boost pulse of automatic charge balance, output control circuit is under the control of microcontroller, the different contacts of gate pulse ganerator shell or electrode are as both positive and negative polarity, boost pulse is delivered to corresponding stimulation target spot, pulse frequency is between 1-250Hz, but both constant frequency pulse output, but also alternately output of different frequency pulse, both can export continuously, also can intermittently export;
Coil and telecommunication circuit constitute the communication function module of Implantable Pulse Generator jointly, under the serial ports control of microcontroller, with 2ASK modulation system and external program control device transmission binary data information;
When external use Magnet applies externally-applied magnetic field, the reed switch adhesive, microprocessor detects the adhesive action of reed switch, and the duty of clamp-pulse generator is switched.
Further, Implantable Pulse Generator has automatic mode and two kinds of duties of magnetic control pattern, and running parameter separately can be by vitro program controlled device setting, and the pulse generator acquiescence is operated in automatic mode, the Magnet pattern is started by the external controlling magnet of brushing, and realizes instant electronic stimulation.
Further, electrode and pulse generator can be split-type structural: the lead outer surface of electrode applies insulant and cover penetrates in the insulation tube, and electrode contacts is circular, is sleeved on the insulation tube outer surface with a determining deviation, and with wire bonds together; Perhaps, the multiple conducting wires outer surface apply insulant or respectively cover penetrate insulation tube, parallel then or strand together, the tip of lead is exposed, as stimulating the contact.Wherein, lead can be spiral type.
Further, pulse generator and electrode can be the cylindrical structural of integral type, and pulse generator is packaged into cylindrical, and electrode contacts sticks on the two ends of cylindrical pulse generator, and intermediary any position, and link to each other with circuit in the pulse generator.
Pulse generator is controlled by microprocessor, has two kinds of duties of automatic mode and magnetic control pattern, and running parameter separately can be provided with by vitro program controlled device.Pulse generator is operated under the automatic mode at ordinary times, can send a series of trains of pulse at regular intervals according to doctor's setting and carry out stimulation therapy, if the boost pulse amplitude of automatic mode is made as zero, does not then stimulate at ordinary times.Brush out-of-dately above Implantable Pulse Generator when Magnet, pulse generator enters the magnetic control mode of operation, sends the boost pulse of setup parameter.The magnetic control mode of operation has been taken into account therapeutic modality commonly used at present, promptly carries out the several times treatment every day, for example stimulates every day 4 times, each 30 minutes, stimulates 30 seconds in and for example per 5 minutes.Pulse generator as power supply, uses the external charger based on the electromagnetic coupled principle to carry out the percutaneous wireless charging by chargeable lithium cell.
Electrode requires good biocompatibility, stability height, and have the power supply of a plurality of electrode contacts and stimulate and select for use, thereby the selection of electricity irritation target spot is more flexible, even certain displacement takes place in electrode, change also able to programme activates the contact of using and realizes trying one's best effective electricity irritation, can not cause thrashing.
Above-mentioned characteristic, guaranteed that implant type electronic acupuncture and moxibustion therapeutic device has the advantage of (can stimulate automatically or Magnet startup stimulation) easy to use, stimulus parameter stable accurately (battery powered, microprocessor control), long service life (but wireless charging), the compatibility good (multi-electrode contact combination), compared with prior art to have obvious improvement.
As shown in Figure 1, Implantable Pulse Generator of the present invention is made of coil 11, charge management circuit 12, battery 13, microprocessor 14, pulse generating circuit 15, output control circuit 16, telecommunication circuit 17 and reed switch 18.
Coil 11, charge management circuit 12 and battery 13 have constituted the power supply of Implantable Pulse Generator.Battery is a lithium ion battery, and present implantable lithium ion battery makes rapid progress, and the charge and discharge cycles of existing commercial product can reach more than 1000 times, has the weight that is low to moderate 0.2 gram, satisfies the demand of miniature implant type electronic acupuncture and moxibustion therapeutic device.Coil receives external charger electromagnetic energy emitted, is controlled to be lithium cell charging by charge management circuit, management charging progress, control charging current and battery temperature.Charge management circuit can be selected existing IC chip for use, as the BQ24200 of TI company.
Microprocessor 14 is selected the high integration low-power scm for use, has multiple energy-saving mode, integrated FLASH, RAM, intervalometer, COM port, DA transducer etc.One or more DA transducer output control pulses of microprocessor 14 control, behind pulse generating circuit 15, obtain parameters such as amplitude, pulsewidth, cycle accurately, adjustable flexibly, and the boost pulse of charge balance automatically.A plurality of contacts of the shell of pulse generator and electrode are all able to programme as stimulating the contact to use, the core of output control circuit 16 is multi-channel gating switch, under the control of microcontroller 14, the different stimulation contact of gating is delivered to corresponding stimulation target spot with boost pulse and realizes electronic stimulation as both positive and negative polarity as required.
Coil 11 and the telecommunication circuit 17 common communication function modules that constitute Implantable Pulse Generator are under the serial ports control of microcontroller 14, with 2ASK modulation system and external program control device transmission binary data information.
Reed switch 18 is a magnetic-sensitive elements, can select open type for use, when applying externally-applied magnetic field with Magnet, reed switch 18 adhesives, microprocessor 14 detects the adhesive action of reed switch 18, and under programme-control, pulse generator will switch to the magnetic control stimulus modelity after Magnet is removed.
As shown in Figure 2, the coil 11 of Implantable Pulse Generator adopts the parallel axes mode to place with the transmitting coil of external charger 33, intermediate phase is every the shell 34 of Implantable Pulse Generator and the skin histology 35 of human body, and two coil inside all comprise magnetic core, to improve electromagnetic coupled efficient.The shape of described transmitting coil 33 and receiving coil 11, size, magnetic core and inequality: the receiving coil 11 that implants requires to reduce as far as possible volume and weight, and therefore inside is the less cylindric magnetic core 31 of volume; External transmitting coil 33 is a flat, and its area is much larger than receiving coil 11, inside be 1 or polylith flat circle or square core 32.Shaped design is that the transmitting coil of flat can produce the magnetic field 36 that is evenly distributed in big plane.Because the size of Implantable Pulse Generator and weight limits strictness, especially required thickness is thin, even reach 5mm with interior degree, so coil 11 can be weldingly fixed on the circuit board, coil is all parallel with shell 34 with circuit board, not only can strengthen the tolerance performance of transmitting coil and receiving coil position, charging process is simple, stable, and helps the installation and the assembling of coil and circuit board.
Below for embodiment, the structure of implant type electronic acupuncture and moxibustion therapeutic device is described further.
Embodiment 1:
As shown in Figure 3, the pulse generator of implant type electronic acupuncture and moxibustion therapeutic device and electrode are split-type structural.Pulse generator 20 is therefrom drawn multiple conducting wires 22 by the sealing of biocompatible materials such as polyurethane, silicone rubber, pottery or metal, links to each other with electrode contacts 21, realizes the electrical connection from the pulse generating circuit to the electrode contacts.Electrode contacts 21 is platinum or platinumiridio material, is processed into circular; Lead 22 is made for rustless steel, platinum, platinumiridio or Co-base alloy material, and outer surface applies insulant and cover is through in the insulation tube 23.Lead 22 can be spiral type, thereby has better pliability; Insulation tube 23 is made for biocompatible material, can select polyurethane or silicone rubber.Electrode contacts 21 is sleeved on insulation tube 23 outer surfaces with a determining deviation, and welds together with lead 22.Thereby, multiple conducting wires mutually insulated, and realized insulation by insulation tube 23 with tissue, and stimulate electric pulse to realize stimulation therapy to meridian point by electrode contacts.Electrode contacts 21 can have a plurality of, only draws 2 among the figure as signal.
Embodiment 2:
As shown in Figure 4, the pulse generator of implant type electronic acupuncture and moxibustion therapeutic device and electrode are split-type structural.Pulse generator 20 is therefrom drawn multiple conducting wires 24 by the sealing of biocompatible materials such as polyurethane, silicone rubber, pottery or metal.Lead 24 is made for platinum or platinumiridio material, and outer surface applies insulant or cover is through formation insulating barrier 25 in the insulation tube.Insulating barrier 25 is made for biocompatible material, can select polyurethane or silicone rubber.Many eradication edge leads walk abreast or twist together as electrode, and the tip of lead 24 is exposed, as stimulating the contact.Lead can be spiral type, not only has better pliability, and after spiral electrode contacts implant into body tissue and the healing, is difficult for getting loose, and helps the fixed-site of electrode contacts.The electrode that lead 24, insulating barrier 25 constitute can have many, only draws 2 among the figure as signal.
In embodiment 1 and embodiment 2, implant type electronic acupuncture and moxibustion therapeutic device has unipolar stimulation and two kinds of patterns of bipolar stimulation, and a plurality of contacts of the shell of pulse generator 20 and electrode are all able to programme as stimulating the contact to use.If pulse generator 20 is by Metal Packaging, then its shell can directly stimulate the contact to use as one, constitutes the unipolar stimulation pattern, and promptly the pulse generator shell is anodal, and a contact selecting electrode is as negative pole; If pulse generator 20 by non-conducting materials such as polyurethane, silicone rubber or pottery encapsulation, can be pasted tinsel 20 ' at its inner surface near lead, and be connected, can be used as the positive pole of unipolar stimulation pattern equally with circuit in the pulse generator 20.In the bipolar stimulation pattern, two electrode contacts selecting electrode are respectively as both positive and negative polarity.
Embodiment 3:
As shown in Figure 5, the pulse generator of implant type electronic acupuncture and moxibustion therapeutic device and electrode are the cylindrical structural of integral type.Implantable Pulse Generator 26 is packaged into cylindrical, the shell encapsulating material is biocompatible materials such as polyurethane, silicone rubber, pottery or metal, electrode contacts 27 Pastings are at the two ends of cylindrical pulse generator 26, and intermediary any position, and link to each other with circuit in the pulse generator 26.If the sheathing material of pulse generator 26 is a metal, then electrode contacts 27 needs and casing insulation.The electrode contacts 27 that is positioned at pulse generator 26 shell middle parts can have a plurality of, only draws 1 among the figure as signal.
Because the development of miniature implanted battery, microelectric technique and MEMS technology, the implant type electronic acupuncture and moxibustion therapeutic device that the present invention proposes can be realized abundant electricity irritation function with very little size and weight.Especially columniform miniature implant type electronic acupuncture and moxibustion therapeutic device because of having columniform profile and very little size, might be implanted meridians or position, acupuncture point easily by the mode of similar injection, realizes satisfactory therapeutic effects.
Aforesaid way is the preferred embodiment of the present invention, for those skilled in the art, on the electric needle therapeutic instrument basis that the invention discloses implanted, chargeable, multi-electrode contact, be easy to expect being applied to various implanted functional electric stimulation systems, and be not limited only to the described system structure of the specific embodiment of the invention, therefore previously described mode is just preferred, and does not have restrictive meaning.

Claims (4)

1. implant type electronic acupuncture and moxibustion therapeutic device, it is characterized in that: this device comprises pulse generator and electrode, described pulse generator and electrode are made the integral type cylindrical structural, wherein, pulse generator is packaged into cylindrical, and the shell encapsulating material uses the biocompatible materials that comprises polyurethane or silicone rubber or pottery or metal material; Electrode contacts sticks on two ends or intermediary any position of described pulse generator, and links to each other with the output control circuit outfan of this pulse generator inside.
2. implant type electronic acupuncture and moxibustion therapeutic device according to claim 1 is characterized in that: when described pulse generator encapsulates with metal material, and the shell electric insulation of each electrode contacts and this pulse generator.
3. implant type electronic acupuncture and moxibustion therapeutic device according to claim 1 is characterized in that: optional two electrode contacts constitute the bipolar stimulation pattern as both positive and negative polarity.
4. implant type electronic acupuncture and moxibustion therapeutic device according to claim 1 is characterized in that: described pulse generator comprises:
Live part, be connected in series successively by coil, charge management circuit, battery and constitute, coil receives external charger electromagnetic energy emitted by the electromagnetic coupled mode, frequency in tens KHz between the hundreds of KHz, and the coil of Implantable Pulse Generator and the transmitting coil of external charger are the placement that is coupled of parallel axes mode, the former is cylindric, in cylinder shape magnetic core is arranged, the latter is a flat, in flat square or circular magnetic core is arranged, wherein the material of magnetic core is ferrite, amorphous, crystallite, ultracrystallite or permalloy;
The pulse generation part, input links to each other with the outfan of battery in the live part, and pulse frequency is between 1-250Hz, but both constant frequency pulse output, but also the different frequency pulse is alternately exported, and both can export continuously, also can intermittently export;
The outfan of coil and battery links to each other in the communications portion, input and described live part;
Microprocessor, input links to each other with the outfan of battery in the described live part, and microprocessor control signal output links to each other with the respective input of communications portion with described pulse generation part respectively;
Output control part, it is a multi-channel gating switch, the control signal input links to each other with described microprocessor corresponding output end, the pulse signal input terminal of this output control part links to each other with described pulse generation part corresponding output end, and each the road output of this output control part links to each other with the corresponding electrode contact;
Reed switch, control signal output ends links to each other with described microprocessor respective input.
CNB200610089626XA 2006-07-07 2006-07-07 Implant type electronic acupuncture and moxibustion therapeutic device Active CN100469402C (en)

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Publication number Priority date Publication date Assignee Title
CN1994491B (en) * 2006-12-28 2010-04-21 黄晓卿 Implantable remotely-controlled electric acupuncture device
CN101244314B (en) * 2007-02-16 2013-02-27 上海塔瑞莎健康科技有限公司 Electrostimulation platform system, method for setting therapy mode and storage medium
US9399143B2 (en) * 2008-10-31 2016-07-26 Medtronic, Inc. Antenna for implantable medical devices formed on extension of RF circuit substrate and method for forming the same
CN102284135A (en) * 2011-06-30 2011-12-21 杭州电子科技大学 High-voltage pulse electric field therapy apparatus based on single needle-shaped electrodes
CN105435366A (en) * 2015-12-21 2016-03-30 宁波贝思转化医学研究中心有限公司 Implanted neural adjustment and control system
CN105787264A (en) * 2016-02-23 2016-07-20 北京佳时正通科技有限责任公司 Method for processing medical information
CN112473009B (en) * 2020-11-25 2023-12-12 浙江大学 Tumor therapeutic equipment
CN113057640A (en) * 2021-03-15 2021-07-02 四川省人民医院 Implanted microneedle electrode, preparation method and functional instrument chip system
CN117414527B (en) * 2023-11-21 2024-03-29 浙江迈达佩思医疗科技有限公司 Implantable electrode device for percutaneous acupoint stimulation and implantation method thereof

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