CN105056397B - Implantable neural electrical stimulation electrode assemblie and its application process - Google Patents

Implantable neural electrical stimulation electrode assemblie and its application process Download PDF

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Publication number
CN105056397B
CN105056397B CN201510596458.2A CN201510596458A CN105056397B CN 105056397 B CN105056397 B CN 105056397B CN 201510596458 A CN201510596458 A CN 201510596458A CN 105056397 B CN105056397 B CN 105056397B
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sleeve pipe
fixture
protection sleeve
electrical stimulation
implantable neural
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CN105056397A (en
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许扶
吴峰
文雄伟
郝红伟
李路明
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Beijing Pins Medical Co Ltd
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Beijing Pins Medical Co Ltd
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Abstract

The present invention relates to a kind of implantable neural electrical stimulation electrode assemblie and its application process, the implantable neural electrical stimulation electrode assemblie, which includes an electrode catheter, the puncture needle and one for finding target spot, is used for the puncture tube for aiding in the electrode catheter to be put into target spot;The electrode catheter includes wire, protection sleeve pipe and fixture; the wire is located at the protection sleeve pipe and through the whole protection sleeve pipe; the fixture is sheathed on the predetermined position of the protection sleeve pipe; the protection sleeve pipe is one end open one end is closed, interior empty sleeve structure body; the open end of the protection sleeve pipe is provided with the connection end including multiple connecting terminals; closed end, which is provided with, includes the stimulation end of multiple stimulation contacts, and the middle part of the protection sleeve pipe is provided with fixture and visual label.

Description

Implantable neural electrical stimulation electrode assemblie and its application process
Technical field
The invention belongs to implantation medical equipment manufacturing technology field, and in particular to a kind of implantable neural electrical stimulation electrode Component and its application process.
Background technology
Implantable neural electrical stimulator is a kind of active implantable medical devices.Implantable neural electrical stimulator passes through The mode of electro photoluminescence come it is excited, suppress or regulation nervous system conduction, recover or improve controlling for function of human body running so as to reach Therapeutic effect.Implantable neural electrical stimulation therapy to more than 20 kind maladjusted nervous system diseases it is verified that have definite treatment Effect.Compared with traditional pharmaceutical methods and surgical operation damage method, implantable nerve irritation therapy is reversible safely, in clinic On just used more and more.Implantable neural electrical stimulator can be subdivided into implanted brain according to the difference of stimulation location Deep brain stimulation system, implanted cortex stimulating system, implanted spinal cord stimulation trial system, implanted Sacral nerve electrical stimulation system System, implanted vagus nerve electric stimulation etc., or be brain depth stimulator, vagus nerve stimulator, spinal stimulator, sacrum Nerve stimulator, peripheral nerve stimulation device etc..
Similar with widely used cardiac pacemaker system, implantable neural electrical stimulator is also by generation stimulus signal The electrode catheter composition of impulse generator and transmission stimulus signal.The signal that impulse generator is produced is delivered to by electrode catheter Stimulation location(Target spot)Produce therapeutic effect.To obtain therapeutic effect steady in a long-term, it is necessary to which holding electrode is supravasal Stimulate contact and target position constant.Therefore, when electrode catheter is implanted into, it should adopt an effective measure electrode catheter and tissue It is fixed.
The class being widely used at present is by independent geometrical clamp(Or fixed sleeving, fixed anchor)Realized Deng device, The relevant apparatus for example in U.S. Patent application US20090030492A1, US005484445A mentioned.
The electrode assemblie of this kind of implantable neural electrical stimulator is respectively fixed geometrical clamp and tissue, admittedly when being implanted into Clamp is mutually fixed with electrode catheter, so that the fixation between electrode catheter and tissue is realized, this implantable neural electrical stimulation Electrode assemblie usually requires larger operative incision, larger to damage to patient.
The content of the invention
In view of this, it is necessory to provide, a kind of simple in construction, doctor is easily operated, patient trauma is small, lower-cost Implantable neural electrical stimulation electrode assemblie and its application process.
A kind of implantable neural electrical stimulation electrode assemblie includes setting on a puncture needle for being used to find target spot, the puncture needle It is equipped with mark groove;One electrode catheter, it includes wire, protection sleeve pipe and fixture, and the wire is located at the protection sleeve pipe And through the whole protection sleeve pipe, the fixture is sheathed on the predetermined position of the protection sleeve pipe, the protection sleeve pipe is One end open one end closure, interior empty sleeve structure body, the protection sleeve pipe, adjacent with opening end are provided with Connection end including multiple connecting terminals, the end adjacent with the closed end, which is provided with, includes the stimulation of multiple stimulation contacts End, the middle part of the protection sleeve pipe, close to the stimulation end is provided with fixture, the connection end with it is described solid Determine to be provided between part the first visual label of the monitoring to paracentesis depth when being implanted into for electrode catheter, the fixture is used Fixed in the position after electrode catheter implantation;And, a puncture tube, for aiding in the electrode catheter to be put into target spot, institute Puncture tube is stated for tubular body structure, the internal diameter of the puncture tube is more than the external diameter of the electrode catheter and the puncture needle, described Puncture tube can be sheathed on the electrode catheter and the puncture needle, the puncture tube and be provided with mark groove.
The fixture includes multiple fixed-wings and a fixed part, and the multiple fixed-wing and a fixed part are structure as a whole Body, the fixture is sheathed on the protection sleeve pipe by the fixed part, and each fixed-wing is connected with the fixed part, each Direction of the free end away from the fixed part tilts extension to fixed-wing in a free state, collapsible by external force, releases external force bullet Property affranchises state.
The material of the fixture is polyurethane, silicon rubber or polyurethane-silastic copolymer.
It is described to protect the middle part of sleeve pipe, be further provided with one second visual label, the second visual label position Between first visual label and the connection end.
It is described to protect the middle part of sleeve pipe, two X-ray developing marks be further provided with, in the starting of the fixture Position and terminated site respectively set one.
The wire is the stainless steel wire with insulating barrier, vitallium line, Nitinol line, platinumiridio line, tungsten Alloy wire or carbon nano tube line.
The surface of the wire is further provided with improving the parylene coating or fluoroplastics of lubricity or biocompatibility Coating.
The stimulation contact be platinum or platinumiridio, or surface covering platinum or platinumiridio coating loop configuration Body.
A kind of application method of implantable neural electrical stimulation electrode assemblie, comprises the following steps:First, puncture needle is put into Target spot is found in destination organization, and the puncture needle mark groove made exposes to destination organization;When the probe of puncture needle is found To after target spot, puncture tube is placed in destination organization along the puncture needle so that mark groove on the puncture tube with Mark groove alignment on the puncture needle, and the puncture needle is extracted;Afterwards, electrode catheter is passed through into the puncture tube Hollow space is implanted into destination organization, treats that the visual label on electrode catheter aligns with the mark groove on puncture tube;Then from mesh The fixed-wing for marking the fixture on the tissue extraction puncture tube, the electrode catheter opens, is embedded into destination organization, realizes and plants Enter the fixation of the electrode catheter of formula nerve electric stimulation electrode assemblie.
Relative to prior art, the implantable neural electrical stimulation electrode assemblie that the present invention is provided has the advantages that: The implant surgery of electrode becomes simple puncturing operation, also, puncture needle, puncture tube and electrode by traditional surgical operation Conduit has corresponding visual label, and operation technique is simpler for doctor, the used time of performing the operation is reduced;For patient Speech, can replace general anesthesia, anesthetic risks are greatly reduced with local anaesthesia, while puncturing operation wound is small, wound healing is fast, So that patient is more comfortable.Therefore, the implantable neural electrical stimulation electrode assemblie of the invention provided is simple in construction, doctor is easy to behaviour Make, patient trauma is small, cost is relatively low.
Brief description of the drawings
Fig. 1 is the schematic diagram for the implantable neural electrical stimulation electrode assemblie electrode catheter that first embodiment of the invention is provided.
Fig. 2 is the application decomposition schematic diagram for the implantable neural electrical stimulation electrode assemblie that first embodiment of the invention is provided.
Fig. 3 is the schematic diagram for the implantable neural electrical stimulation electrode assemblie electrode catheter that second embodiment of the invention is provided.
Fig. 4 is the schematic diagram for the implantable neural electrical stimulation electrode assemblie that second embodiment of the invention is provided.
Fig. 5 is the schematic diagram for the implantable neural electrical stimulation electrode assemblie electrode catheter that third embodiment of the invention is provided.
Fig. 6 is the schematic diagram for the implantable neural electrical stimulation electrode assemblie electrode catheter that fourth embodiment of the invention is provided.
Main element symbol description
Electrode catheter 100
Handhold element 101
Connect end 110
Connecting terminal 111
Protect sleeve pipe 120
Opening 121
Closed end 122
Stimulate end 140
Stimulate contact 141
First visual label 150
Second visual label 155
Fixture 160
Fixed-wing 161
Fixed part 162
X-ray developing mark thing 170
Puncture needle 300
Puncture needle marks band 310
Puncture tube 400
Tissue 180
Target spot 185
Following embodiment will further illustrate the present invention with reference to above-mentioned accompanying drawing.
Embodiment
Below with reference to accompanying drawing describe in detail implantable neural electrical stimulation electrode assemblie provided in an embodiment of the present invention and its Application process.The example of the embodiment is shown in the drawings, wherein identical label represents identical components or with identical or class Like the component of function.The embodiments described below with reference to the accompanying drawings are exemplary, it is intended to for explaining the present invention, and can not It is interpreted as limitation of the present invention.
In the description of the invention, it is to be understood that term " longitudinal direction ", " transverse direction ", " on ", " under ", "front", "rear", The orientation or position relationship of the instruction such as "left", "right", " vertical ", " level ", " top ", " bottom " " interior ", " outer " is based on accompanying drawing institutes The orientation or position relationship shown, is for only for ease of the description present invention and simplifies description, rather than indicate or imply signified dress Put or element there must be specific orientation, with specific azimuth configuration and operation, therefore it is not intended that to the limit of the present invention System.
In the description of the invention, it is necessary to illustrate, unless otherwise clearly defined and limited, term " installation ", " phase Even ", " connection ", " fixation " should be interpreted broadly, for example, it may be fixedly connected or be detachably connected, or integration Connection;Can be mechanical connection or electromagnetic force connection;Can be joined directly together, can also be indirect by intermediary It is connected, can is the connection of two element internals.For the ordinary skill in the art, on being understood with concrete condition State the concrete meaning of term in the present invention.
Fig. 1 and Fig. 2 is referred to, first embodiment of the invention provides implantable neural electrical stimulation electrode assemblie.It is described to plant Entering formula nerve electric stimulation electrode assemblie includes electrode catheter 100, puncture needle 300 and puncture tube 400.The puncture needle 300 is used for Target stimulation sites are found, target stimulation sites are medically also referred to as target spot 185.The puncture tube 400 is led for auxiliary electrode Pipe 100 is put into target spot.The implantable neural electrical stimulation electrode assemblie of the present invention is sold as overall, and implantation to nerve is used as The element of electro photoluminescence is the electrode catheter 100.
The electrode catheter 100 includes handhold element 101, wire (figure is not indicated), protection sleeve pipe 120 and fixture 160. In the insertion of the handhold element 101 protection sleeve pipe 120, the rigidity for strengthening electrode facilitates operation technique.The wire is located at The protection sleeve pipe 120 simultaneously protects sleeve pipe 120 through entirely described.The fixture 160 is sheathed on the protection sleeve pipe 120 Predetermined position.Handhold element 101 departs from electrode catheter, taken out after electrode catheter implantation.
The material of the wire can be the stainless steel wire of tape insulation layer, vitallium line, Nitinol line, platinumiridio Line, tungsten alloy wire or carbon nano tube line etc., can be present for the form of twisted wire or helix, to improve overall anti-fatigue performance. Further, it can make coating material to improve lubricity or biocompatibility on the surface of the wire, such as it is heavy on surface Product parylene coating or plastic coating of fluoride etc..
The protection sleeve pipe 120 is that relative two ends are opening 121 and closed end 122, interior empty sleeve structure body, institute The head for stating closed end 122 is smooth curved surface, such as hemispherical.It is the protection sleeve pipe 120, adjacent with the opening 121 End be provided with connection end 110, the end adjacent with the closed end 122 be provided with stimulation end 140.The protective case The middle part of pipe 120, the close stimulation end 140 are provided with fixture 160, the connection end 110 and the fixture 160 Between be provided with visual label 150.The material of the protection sleeve pipe 120 can be common for polyurethane, silicon rubber or polyurethane-silicon rubber Polymers etc..
The connection end 110 is provided with multiple connecting terminals 111, and the connecting terminal 111 can be loop configuration body, by The conductive composition of the material with biocompatibility, such as MP35N or stainless steel.
The stimulation end 140 is provided with multiple stimulation contacts 141, and the stimulation contact 141 can be loop configuration body, by The conductive composition of the material with biocompatibility, such as platinum or platinumiridio, or surface covering platinum or platinumiridio are applied The material of layer, is electrically connected by way of resistance spot welding or laser spot welding with the wire.Contact is stimulated described in the present embodiment 141 be platinumiridio ring.
The pulse signal of the multiple connecting terminal 111 pulse signal different for receiving or different time sections, it is described The pulse signal that multiple connecting terminals 111 are received is sent to different stimulation contacts 141 by different wires, multiple to realize Contact 141 is stimulated to convey different pulse signal or the pulse signal of different time sections etc. to target spot 185.Corresponding connecting terminal Connected between 111 and stimulation contact 141 by corresponding wire, adjacent the multiple connecting terminal 111 or the multiple thorn Split between sharp contact 141 by insulator, to keep electrical isolation.
The visual label 150 is used for the monitoring to paracentesis depth when electrode catheter is implanted into, and can be in the protective case Etched on pipe 120, brush, paste color or structure with obvious distinction, for example, brushed on the protection sleeve pipe 120 white Vitta line, or paste white ribbon etc. on the protection sleeve pipe 120.In the present embodiment, the visual label 150 is with white Silicon rubber thin band is pasted onto the mark band on the protection sleeve pipe 120.
In the present embodiment, the number of the fixture 160 is four, and each fixture 160 includes four Hes of fixed-wing 161 One fixed part 162, the fixture 160 is sheathed on the protection sleeve pipe 120, each fixed-wing by fixed part its described 162 161 are connected with the fixed part 162, each fixed-wing 161 direction of the free end away from the fixed part 162 in a free state Tilt extension.The fixture 160, which is used for the position after the electrode catheter 100 is implanted into, to be fixed.The fixture 160 has single Direction shrinkage, when the electrode catheter 100 is implanted into by the puncture tube 400, the fixed-wing 161 shrinks, convenient to puncture Implantation, and the fixed-wing 161 is opened, is embedded into tissue automatically after the implantation, and fixation is produced to electrode catheter. The material of the fixture 160 is polyurethane, silicon rubber or polyurethane-silastic copolymer.In the present embodiment, the fixture 160 are made by hardness for 80A silastic material, and the fixed part 162 of the fixture 160 is bonded in the guarantor by binder On protecting pipe 120.
The puncture needle 300, which is used to find, be provided with target spot 185, the puncture needle 300 mark groove 310, described to wear Thorn pipe 400 is used to aid in the stimulation contact 141 of the electrode catheter 100 to be put into the position of target spot 185.The puncture tube 400 it is interior Caliber is more than the external diameter of the puncture needle 300 and electrode catheter 100, so that so that the puncture tube 400 is smoothly arranged In the puncture needle 300 or electrode catheter 100.The puncture tube 400 is provided with mark groove (not indicating).Here by figure 2 further illustrate the application method for the implantable neural electrical stimulation electrode assemblie that the present embodiment is provided.Using the present invention's The puncture needle 300 is first put into tissue 180 and searches out target spot 185 by implantable neural electrical stimulation electrode assemblie Shi doctor Position, now the mark groove 310 of the puncture needle 300 expose to tissue 180, then along the puncture needle 300 place the puncture tube 400 in tissue 180 so that mark groove and the puncture needle on the puncture tube 400 Mark groove 310 on 300 aligns, and then extracts the puncture needle 300 from tissue 180, electrode catheter 100 is passed through into institute The hollow space implantation tissue 180 of puncture tube 400 is stated, the visual label 150 and puncture tube 400 on electrode catheter 100 is treated On mark groove alignment, that is, have shown electrode catheter reach precalculated position.Then the puncture tube is extracted from tissue 180 400, the fixed-wing 161 of the fixture 160 on the electrode catheter 100 opens, is embedded into tissue 180, realizes institute State the fixation of electrode catheter 100.
Fig. 3 and Fig. 4 is referred to, the implantable neural electrical stimulation electrode assemblie and electrode that second embodiment of the invention is provided are led Pipe 100.The implantable neural electrical stimulation electrode assemblie and electrode catheter 100 of the present embodiment and the implanted of above-mentioned first embodiment Nerve electric stimulation electrode assemblie and electrode catheter 100 are essentially identical, and difference is that the electrode catheter 100 is further wrapped One second visual label 155 is included, second visual label 155 and first visual label 150 are spaced apart, relative to First visual label 150 is set close to the connection end 110, therefore, second visual label 155 is located at described first Between visual label 150 and the connection end 110.
Using the implantable neural electrical stimulation electrode assemblie Shi doctor of the present embodiment by electrode catheter 100 along puncture tube 400 Insert human body, when the first visual label 150 of electrode catheter 100 aligns with the top surface of puncture tube 400, electrode catheter 100 Stimulate end 140 to reach precalculated position, now stop the insert action of electrode catheter 100;Then holding electrode conduit 100 is not It is dynamic, puncture tube 400 is outwards pulled out, when the top surface of puncture tube 400 aligns with the second visual label 155 of electrode catheter 100, electricity The fixture 160 of pole conduit 100 fully extended puncture tube 400.When the fixture 160 of electrode catheter 100 is in puncture tube 400 Its fixed-wing 161 is in compressive state, now has larger frictional force between electrode catheter 100 and puncture tube 400, in this phase Between, doctor should carefully be operated, it is to avoid electrode catheter 100 or puncture tube 400 are moved with other side.
Referring to Fig. 5, the electrode catheter for the implantable neural electrical stimulation electrode assemblie that third embodiment of the invention is provided 100.The electrode catheter 100 of the implantable neural electrical stimulation electrode assemblie of the present embodiment and the implanted god of above-mentioned first embodiment Electrode catheter 100 through electric stimulation electrode component is essentially identical, and difference is that the electrode catheter 100 further comprises Two X-ray developing marks 170, are arranged at starting position and each one of the terminated site of the fixture 160.The X-ray development Mark 170 is used for after electrode catheter 100 is implanted into the position that fixture 160 is determined under X-ray.The X-ray developing mark 170 by Larger material of decaying to X-ray absorption makes, such as the polymer of tantalum, platinum, platinumiridio, platinum-tungsten alloys or baric.This In embodiment, X-ray developing mark 170 is made by platinumiridio.
Referring to Fig. 6, the electrode catheter for the implantable neural electrical stimulation electrode assemblie that fourth embodiment of the invention is provided 100.The electrode catheter 100 of the implantable neural electrical stimulation electrode assemblie of the present embodiment and the implanted god of above-mentioned second embodiment The essentially identical difference of electrode catheter 100 through electric stimulation electrode component is that the electrode catheter 100 further comprises two Individual X-ray developing mark 170, is arranged at starting position and each one of the terminated site of the fixture 160.The X-ray development mark Note 170 is used for after electrode catheter 100 is implanted into the position that fixture 160 is determined under X-ray.The X-ray developing mark 170 is by right The material making that X-ray absorption is decayed larger, such as the polymer of tantalum, platinum, platinumiridio, platinum-tungsten alloys or baric.This reality Apply in example, X-ray developing mark 170 is made by platinumiridio.
Relative to prior art, the implantable neural electrical stimulation electrode assemblie that the present invention is provided has the advantages that: The implant surgery of electrode becomes simple puncturing operation, also, puncture needle, puncture tube and electrode by traditional surgical operation Conduit has corresponding visual label, and operation technique is simpler for doctor, the used time of performing the operation is reduced;For patient Speech, can replace general anesthesia, anesthetic risks are greatly reduced with local anaesthesia, while puncturing operation wound is small, wound healing is fast, So that patient is more comfortable.Therefore, the implantable neural electrical stimulation electrode assemblie of the invention provided is simple in construction, doctor is easy to behaviour Make, patient trauma is small, cost is relatively low.
In addition, those skilled in the art can also do other changes in spirit of the invention, certainly, these are according to present invention essence The change that god is done, should all be included within scope of the present invention.

Claims (8)

1. a kind of implantable neural electrical stimulation electrode assemblie, it is characterised in that including:
Mark groove is provided with one puncture needle for finding target spot, the puncture needle;
One electrode catheter, it includes wire, protection sleeve pipe and fixture, and the wire is located at the protection sleeve pipe and through whole The protection sleeve pipe, the fixture is sheathed on the predetermined position of the protection sleeve pipe, and the protection sleeve pipe is one end open one End closure, interior empty sleeve structure body, the protection sleeve pipe, adjacent with opening end are provided with including multiple companies The connection end of contact point, the end adjacent with the closed end, which is provided with, includes the stimulation end of multiple stimulation contacts, described Protect the middle part of sleeve pipe, the stimulation end be provided with fixture, between the connection end and the fixture First visual label of the monitoring to paracentesis depth being provided with when being implanted into for electrode catheter, the fixture is used for the electricity Position after the implantation of pole conduit is fixed, and the fixture includes multiple fixed-wings and a fixed part, each fixed-wing with it is described solid Determine portion to be connected, each fixed-wing tilts extension in direction of the free end away from the fixed part in a free state, can be received by external force Contracting, releases external force elasticity and affranchises state, and,
One puncture tube, for aiding in the electrode catheter to be put into target spot, the puncture tube is tubular body structure, the puncture tube Internal diameter is more than the external diameter of the electrode catheter and the puncture needle, and the puncture tube can be sheathed on the electrode catheter and described Mark groove is provided with puncture needle, the puncture tube.
2. implantable neural electrical stimulation electrode assemblie as claimed in claim 1, it is characterised in that the multiple fixed-wing and one Fixed part is structure as a whole body, and the fixture is sheathed on the protection sleeve pipe by the fixed part.
3. implantable neural electrical stimulation electrode assemblie as claimed in claim 2, it is characterised in that the material of the fixture is Polyurethane, silicon rubber or polyurethane-silastic copolymer.
4. implantable neural electrical stimulation electrode assemblie as claimed in claim 1, it is characterised in that the centre of the protection sleeve pipe Position, it is further provided with one second visual label, second visual label is located at first visual label and the company Connect between end.
5. the implantable neural electrical stimulation electrode assemblie as described in claim 1 or 4, it is characterised in that the protection sleeve pipe Middle part, two X-ray developing marks are further provided with, one is respectively set in the starting position of the fixture and terminated site It is individual.
6. implantable neural electrical stimulation electrode assemblie as claimed in claim 1, it is characterised in that the wire is tape insulation layer Stainless steel wire, vitallium line, Nitinol line, platinumiridio line, tungsten alloy wire or carbon nano tube line.
7. implantable neural electrical stimulation electrode assemblie as claimed in claim 6, it is characterised in that the surface of the wire enters one Step, which is provided with, improves the parylene coating or plastic coating of fluoride of lubricity or biocompatibility.
8. implantable neural electrical stimulation electrode assemblie as claimed in claim 1, it is characterised in that the stimulation contact be platinum or Platinumiridio, or surface cover the loop configuration body of platinum or platinumiridio coating.
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CN107812312A (en) * 2017-10-13 2018-03-20 北京品驰医疗设备有限公司 A kind of expanding pilot device
CN107982632A (en) * 2017-10-13 2018-05-04 复旦大学附属眼耳鼻喉科医院 Animal artificial cochlea electrode implant and application thereof
CN109011136A (en) * 2018-09-05 2018-12-18 中国人民解放军陆军总医院 Deep brain stimulation electrode component, lesions located in deep brain device and its application method
CN109908467B (en) * 2019-04-25 2024-04-30 北京品驰医疗设备有限公司 Nerve electric stimulation electrode assembly and preparation method thereof
CN111686369B (en) * 2020-06-22 2024-02-27 山东大学齐鲁医院 Barb device and system for preventing sacral nerve stimulating electrode from inward displacement
CN111729193B (en) * 2020-06-24 2023-05-30 北京品驰医疗设备有限公司 Isolation ring, composite contact, electrode and manufacturing method of electrode
CN112604155B (en) * 2020-12-31 2024-05-28 北京品驰医疗设备有限公司 Method for manufacturing direction electrode developing mark and direction electrode developing mark
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