CN113577536B - Implantable lead electrode, preparation method and sacral nerve stimulator - Google Patents
Implantable lead electrode, preparation method and sacral nerve stimulator Download PDFInfo
- Publication number
- CN113577536B CN113577536B CN202010365555.1A CN202010365555A CN113577536B CN 113577536 B CN113577536 B CN 113577536B CN 202010365555 A CN202010365555 A CN 202010365555A CN 113577536 B CN113577536 B CN 113577536B
- Authority
- CN
- China
- Prior art keywords
- electrode
- coating layer
- lead electrode
- implantable lead
- electrolyte solution
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 210000005036 nerve Anatomy 0.000 title abstract description 34
- 238000002360 preparation method Methods 0.000 title abstract description 8
- 239000011247 coating layer Substances 0.000 claims abstract description 87
- 239000010410 layer Substances 0.000 claims abstract description 69
- 238000003487 electrochemical reaction Methods 0.000 claims abstract description 33
- 239000000463 material Substances 0.000 claims abstract description 28
- 230000002441 reversible effect Effects 0.000 claims abstract description 26
- 229910052751 metal Inorganic materials 0.000 claims abstract description 25
- 239000002184 metal Substances 0.000 claims abstract description 25
- 239000008151 electrolyte solution Substances 0.000 claims description 29
- 238000004070 electrodeposition Methods 0.000 claims description 27
- 238000000034 method Methods 0.000 claims description 24
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims description 24
- 229910052697 platinum Inorganic materials 0.000 claims description 12
- 230000008569 process Effects 0.000 claims description 11
- HTXDPTMKBJXEOW-UHFFFAOYSA-N dioxoiridium Chemical group O=[Ir]=O HTXDPTMKBJXEOW-UHFFFAOYSA-N 0.000 claims description 9
- 229910000457 iridium oxide Inorganic materials 0.000 claims description 9
- 238000006243 chemical reaction Methods 0.000 claims description 8
- 238000005240 physical vapour deposition Methods 0.000 claims description 7
- 238000000151 deposition Methods 0.000 claims description 6
- 238000001704 evaporation Methods 0.000 claims description 6
- 230000008020 evaporation Effects 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 5
- 239000011261 inert gas Substances 0.000 claims description 4
- 238000010992 reflux Methods 0.000 claims description 4
- QGZKDVFQNNGYKY-UHFFFAOYSA-O Ammonium Chemical compound [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 claims description 3
- YYPRCEMOTKNKRB-UHFFFAOYSA-H [Na].Cl[Ir](Cl)(Cl)(Cl)(Cl)Cl Chemical compound [Na].Cl[Ir](Cl)(Cl)(Cl)(Cl)Cl YYPRCEMOTKNKRB-UHFFFAOYSA-H 0.000 claims description 3
- 238000000231 atomic layer deposition Methods 0.000 claims description 3
- 238000005229 chemical vapour deposition Methods 0.000 claims description 3
- XTEGARKTQYYJKE-UHFFFAOYSA-N chloric acid Chemical compound OCl(=O)=O XTEGARKTQYYJKE-UHFFFAOYSA-N 0.000 claims description 3
- 229940005991 chloric acid Drugs 0.000 claims description 3
- 239000003792 electrolyte Substances 0.000 claims description 3
- 239000002001 electrolyte material Substances 0.000 claims description 3
- 238000000623 plasma-assisted chemical vapour deposition Methods 0.000 claims description 3
- 238000007747 plating Methods 0.000 claims description 3
- 239000000243 solution Substances 0.000 claims description 3
- 238000003756 stirring Methods 0.000 claims description 3
- 238000001771 vacuum deposition Methods 0.000 claims description 3
- 238000007738 vacuum evaporation Methods 0.000 claims description 3
- 239000007864 aqueous solution Substances 0.000 claims description 2
- 230000008021 deposition Effects 0.000 claims description 2
- 239000006185 dispersion Substances 0.000 claims description 2
- 238000001755 magnetron sputter deposition Methods 0.000 claims description 2
- 239000013077 target material Substances 0.000 claims description 2
- 229910052774 Proactinium Inorganic materials 0.000 claims 1
- 230000000451 tissue damage Effects 0.000 abstract description 10
- 231100000827 tissue damage Toxicity 0.000 abstract description 10
- 239000002800 charge carrier Substances 0.000 abstract description 8
- 230000003628 erosive effect Effects 0.000 abstract description 7
- 230000007383 nerve stimulation Effects 0.000 description 24
- 239000011248 coating agent Substances 0.000 description 18
- 238000000576 coating method Methods 0.000 description 18
- 238000001994 activation Methods 0.000 description 14
- 230000000638 stimulation Effects 0.000 description 13
- 230000004913 activation Effects 0.000 description 11
- 238000002347 injection Methods 0.000 description 9
- 239000007924 injection Substances 0.000 description 9
- 229920001940 conductive polymer Polymers 0.000 description 8
- 239000012530 fluid Substances 0.000 description 8
- 238000012360 testing method Methods 0.000 description 8
- 210000004027 cell Anatomy 0.000 description 7
- 230000008859 change Effects 0.000 description 7
- 230000002427 irreversible effect Effects 0.000 description 7
- 230000002757 inflammatory effect Effects 0.000 description 5
- 239000002861 polymer material Substances 0.000 description 5
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 4
- YKPUWZUDDOIDPM-SOFGYWHQSA-N capsaicin Chemical compound COC1=CC(CNC(=O)CCCC\C=C\C(C)C)=CC=C1O YKPUWZUDDOIDPM-SOFGYWHQSA-N 0.000 description 4
- 239000013078 crystal Substances 0.000 description 4
- 238000010586 diagram Methods 0.000 description 4
- 229910003460 diamond Inorganic materials 0.000 description 4
- 239000010432 diamond Substances 0.000 description 4
- 229910001092 metal group alloy Inorganic materials 0.000 description 4
- 230000001537 neural effect Effects 0.000 description 4
- 229920000642 polymer Polymers 0.000 description 4
- 229920001296 polysiloxane Polymers 0.000 description 4
- 229920002635 polyurethane Polymers 0.000 description 4
- 239000004814 polyurethane Substances 0.000 description 4
- 230000002829 reductive effect Effects 0.000 description 4
- NRTOMJZYCJJWKI-UHFFFAOYSA-N Titanium nitride Chemical compound [Ti]#N NRTOMJZYCJJWKI-UHFFFAOYSA-N 0.000 description 3
- 239000008363 phosphate buffer Substances 0.000 description 3
- 229920000052 poly(p-xylylene) Polymers 0.000 description 3
- -1 polytetrafluoroethylene Polymers 0.000 description 3
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 description 3
- 230000004936 stimulating effect Effects 0.000 description 3
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 description 2
- HBBGRARXTFLTSG-UHFFFAOYSA-N Lithium ion Chemical compound [Li+] HBBGRARXTFLTSG-UHFFFAOYSA-N 0.000 description 2
- PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 2
- 239000004642 Polyimide Substances 0.000 description 2
- 229960002504 capsaicin Drugs 0.000 description 2
- 235000017663 capsaicin Nutrition 0.000 description 2
- 239000002041 carbon nanotube Substances 0.000 description 2
- 229910021393 carbon nanotube Inorganic materials 0.000 description 2
- 239000004020 conductor Substances 0.000 description 2
- 238000007796 conventional method Methods 0.000 description 2
- 238000002484 cyclic voltammetry Methods 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 229910052731 fluorine Inorganic materials 0.000 description 2
- 239000011737 fluorine Substances 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 229910021389 graphene Inorganic materials 0.000 description 2
- 239000000017 hydrogel Substances 0.000 description 2
- 239000012212 insulator Substances 0.000 description 2
- 229910052741 iridium Inorganic materials 0.000 description 2
- GKOZUEZYRPOHIO-UHFFFAOYSA-N iridium atom Chemical compound [Ir] GKOZUEZYRPOHIO-UHFFFAOYSA-N 0.000 description 2
- 230000000670 limiting effect Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 229910001416 lithium ion Inorganic materials 0.000 description 2
- BPUBBGLMJRNUCC-UHFFFAOYSA-N oxygen(2-);tantalum(5+) Chemical compound [O-2].[O-2].[O-2].[O-2].[O-2].[Ta+5].[Ta+5] BPUBBGLMJRNUCC-UHFFFAOYSA-N 0.000 description 2
- 230000035790 physiological processes and functions Effects 0.000 description 2
- 229920001721 polyimide Polymers 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 229910001925 ruthenium oxide Inorganic materials 0.000 description 2
- WOCIAKWEIIZHES-UHFFFAOYSA-N ruthenium(iv) oxide Chemical compound O=[Ru]=O WOCIAKWEIIZHES-UHFFFAOYSA-N 0.000 description 2
- 229910052709 silver Inorganic materials 0.000 description 2
- 239000004332 silver Substances 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 229910001936 tantalum oxide Inorganic materials 0.000 description 2
- MTPVUVINMAGMJL-UHFFFAOYSA-N trimethyl(1,1,2,2,2-pentafluoroethyl)silane Chemical compound C[Si](C)(C)C(F)(F)C(F)(F)F MTPVUVINMAGMJL-UHFFFAOYSA-N 0.000 description 2
- 229910001369 Brass Inorganic materials 0.000 description 1
- 229910000906 Bronze Inorganic materials 0.000 description 1
- 229910000570 Cupronickel Inorganic materials 0.000 description 1
- 229910000737 Duralumin Inorganic materials 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 229910000617 Mangalloy Inorganic materials 0.000 description 1
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 1
- 229910021607 Silver chloride Inorganic materials 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 229910052786 argon Inorganic materials 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 230000003925 brain function Effects 0.000 description 1
- 239000010951 brass Substances 0.000 description 1
- 239000010974 bronze Substances 0.000 description 1
- 229910017052 cobalt Inorganic materials 0.000 description 1
- 239000010941 cobalt Substances 0.000 description 1
- GUTLYIVDDKVIGB-UHFFFAOYSA-N cobalt atom Chemical compound [Co] GUTLYIVDDKVIGB-UHFFFAOYSA-N 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- KUNSUQLRTQLHQQ-UHFFFAOYSA-N copper tin Chemical compound [Cu].[Sn] KUNSUQLRTQLHQQ-UHFFFAOYSA-N 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 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
- 229920001971 elastomer Polymers 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 238000001566 impedance spectroscopy Methods 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 238000007733 ion plating Methods 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000001451 molecular beam epitaxy Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000008035 nerve activity Effects 0.000 description 1
- 210000002569 neuron Anatomy 0.000 description 1
- 229910052759 nickel Inorganic materials 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 229910052755 nonmetal Inorganic materials 0.000 description 1
- 150000002843 nonmetals Chemical class 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 230000004792 oxidative damage Effects 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 239000002953 phosphate buffered saline Substances 0.000 description 1
- 238000000053 physical method Methods 0.000 description 1
- OTYBMLCTZGSZBG-UHFFFAOYSA-L potassium sulfate Chemical compound [K+].[K+].[O-]S([O-])(=O)=O OTYBMLCTZGSZBG-UHFFFAOYSA-L 0.000 description 1
- 229910052939 potassium sulfate Inorganic materials 0.000 description 1
- 235000011151 potassium sulphates Nutrition 0.000 description 1
- 238000011946 reduction process Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- HKZLPVFGJNLROG-UHFFFAOYSA-M silver monochloride Chemical compound [Cl-].[Ag+] HKZLPVFGJNLROG-UHFFFAOYSA-M 0.000 description 1
- 229910000679 solder Inorganic materials 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000012265 solid product Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 238000004544 sputter deposition Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 239000010409 thin film Substances 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 238000006276 transfer reaction Methods 0.000 description 1
- 230000001960 triggered effect Effects 0.000 description 1
- 238000007740 vapor deposition Methods 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
-
- C—CHEMISTRY; METALLURGY
- C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
- C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
- C25D5/00—Electroplating characterised by the process; Pretreatment or after-treatment of workpieces
- C25D5/02—Electroplating of selected surface areas
-
- C—CHEMISTRY; METALLURGY
- C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
- C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
- C25D7/00—Electroplating characterised by the article coated
-
- C—CHEMISTRY; METALLURGY
- C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
- C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
- C25D9/00—Electrolytic coating other than with metals
- C25D9/04—Electrolytic coating other than with metals with inorganic materials
- C25D9/08—Electrolytic coating other than with metals with inorganic materials by cathodic processes
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Metallurgy (AREA)
- Materials Engineering (AREA)
- Electrochemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Radiology & Medical Imaging (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Inorganic Chemistry (AREA)
- Electrotherapy Devices (AREA)
Abstract
The application relates to an implantable lead electrode, a preparation method and a sacral nerve stimulator. The implantable lead electrode includes a first electrode lead and one or more electrode contacts. The electrode includes a first conductive layer and a coating layer. And a coating layer is arranged on the outer side wall of the electrode, and the material of the coating layer is a reversible electrochemical reaction material. When the electrode is in contact with the tissue interface, the coating layer is in direct contact with the tissue interface, and only reversible electrochemical reaction exists between the electrode and the tissue. When the current from the pulse generator increases, only a reversible electrochemical reaction occurs. In the event of a reversible electrochemical reaction, the charge carriers do not permanently leave the metal surface, and therefore the balance of charge in the metal and the tissue can be maintained. In this embodiment, no significant tissue damage and/or electrode erosion at the electrode-tissue interface is caused when the electrical pulse stimulus is applied by the pulse generator.
Description
Technical Field
The application relates to the technical field of medical equipment, in particular to an implantable lead electrode, a preparation method and a sacral nerve stimulator.
Background
Implantable lead electrodes are an important tool for neuroscience. Implantable lead electrodes are capable of monitoring a specific set of neurons with high accuracy over a long period of time. Currently in scientific research, implantable lead electrodes are used to strongly relate low-level neuronal circuits to high-level brain function. In addition, implantable lead electrodes may also be used to regulate the activity of internal organs of the human body (e.g., the intestines, bladder, heart). Clinically, implantable lead electrodes also enable the development of closed-loop neural stimulation and neural prosthesis systems using fine neurophysiologic feedback signals. For example, implantable lead electrodes are included in implantable sacral nerve impulse systems.
For lead electrodes for implantable sacral nerve stimulation or other implantable lead electrodes, two types of electrochemical reactions typically occur at the electrode-tissue interface: irreversible electrochemical reactions and reversible electrochemical reactions. In a reversible electrochemical reaction, the charge carriers do not permanently leave the metal surface, and therefore the balance of charges in the metal and tissue can be maintained. In irreversible electrochemical reactions, the oxidation and reduction processes produce charge carriers that permanently leave the metal surface, and thus the charge carriers on the electrode become depleted and eroded. Charge carriers that permanently transfer from the metal to the tissue can also cause oxidative damage to the tissue.
There are both reversible and irreversible electrochemical reactions in conventional implantable lead electrodes, and as the stimulation current from the pulse generator increases, more irreversible electrochemical reactions occur. The current reaches a maximum magnitude when the rate of the irreversible electrochemical reaction reaches a safety limit. Beyond this safety limit, irreversible electrochemical reactions at the electrode-tissue interface can cause significant tissue damage and/or electrode erosion.
Disclosure of Invention
Based on this, it is desirable to provide an implantable lead electrode, method of manufacture, and sacral nerve stimulator that address the problem of conventional implantable lead electrodes that can easily cause significant tissue damage and/or electrode erosion at the electrode-tissue interface.
An implantable lead electrode, comprising:
a first electrode lead including a first portion; the first portion is a portion that first enters when a living body is implanted along the implanted lead electrode;
the electrode contacts comprise a first conductive layer and a coating layer, the first conductive layer is coated on the outer side wall of the first conductive layer, and the coating layer is made of reversible electrochemical reaction materials.
In one embodiment, the coating layer comprises at least one of platinum, iridium oxide, titanium nitride, titanium carbide, ruthenium oxide, tantalum oxide, carbon nanotubes, nanocrystalline diamond, graphene, a conductive polymer, or a conductive hydrogel.
In one embodiment, the coating layer is a smooth conductive coating or a roughened conductive coating.
In one embodiment, the thickness of the coating layer in the direction of coating the first conductive layer is 10nm to 1000nm.
In one embodiment, the first electrode lead includes a second portion and a third portion, the second portion being contiguous with the third portion, the third portion being the last portion to enter when implanted in a living being along the implantable lead electrode;
the implantable lead electrode further includes:
a second conductive layer coated on the outer side walls of the second part and the third part of the first electrode lead; and
and the first insulating layer is coated on the outer side wall of the second conductive layer.
In one embodiment, the material of the first insulating layer is at least one of polyurethane, silicone, polytetrafluoroethylene, fluorine-containing polymer, parylene or polyimide.
In one embodiment, the first electrode lead further comprises a third portion, the third portion being contiguous with the second portion, the third portion being the last portion to enter when implanted into a living being along the implantable lead electrode;
the implantable lead electrode further includes:
and the fixing element is coated on the first insulating layer and is arranged at the third part of the first electrode wire at intervals.
A method of making an implantable lead electrode comprising:
providing a first electrode lead comprising a first portion; the first portion is a portion that first enters when a living body is implanted along the implanted lead electrode;
one or more electrode contacts are arranged on the outer side wall of the first part at intervals; the electrode contact comprises a first conductive layer and a coating layer, wherein the first conductive layer is coated on the outer side wall of the first electrode wire, and the coating layer is coated on the outer side wall of the first conductive layer; the material of the coating layer is a reversible electrochemical reaction material; the coating layer is prepared by any one of electrodeposition, chemical vapor deposition, plasma enhanced chemical vapor deposition, physical vapor deposition or atomic layer deposition.
In one embodiment, the step of preparing the coating layer by an electrodeposition method includes:
providing an electrodeposition cell and introducing an electrolyte solution into the electrodeposition cell;
providing a pre-fabricated implantable lead electrode and a return electrode, respectively placing the pre-fabricated implantable lead electrode and the return electrode in the electrolyte solution;
and electrifying the prefabricated implanted lead electrode and the reflux electrode by taking the prefabricated implanted lead electrode as a cathode and taking the reflux electrode as an anode, and continuously stirring the electrolyte solution so that the electrolyte material in the electrolyte solution forms the coating layer on the outer side wall of the first conductive layer.
In one embodiment, the coating layer is an iridium oxide layer;
the electrolyte solution is formed by adding ammonium hexachloroplatinate and sodium hexachloroiridium into an aqueous solution or a chloric acid solution.
A sacral nerve stimulator, comprising:
a pulse stimulation generator for generating stimulation pulses;
the sacral nerve stimulating electrode is electrically connected with the pulse stimulating generator, and the sacral nerve stimulating electrode is the implanted lead electrode.
The application relates to an implantable lead electrode, a preparation method and a sacral nerve stimulator. The implantable lead electrode includes a first electrode lead and one or more electrode contacts. The first electrode lead includes a first portion; the first portion is the portion that first enters when the living body is implanted along the implanted lead electrode. One or more electrode contacts, which cover the first electrode wire, are arranged on the outer side wall of the first part. The electrode contact includes a first conductive layer and a coating layer. And a coating layer is arranged on the outer side wall of the electrode contact, and the material of the coating layer is reversible electrochemical reaction material. When the electrode contact is in contact with the tissue interface, the coating layer is in direct contact with the tissue interface, and only reversible electrochemical reaction exists between the electrode contact and the tissue. When the current from the pulse generator increases, only a reversible electrochemical reaction occurs. In the event of a reversible electrochemical reaction, the charge carriers do not permanently leave the metal surface, and therefore the balance of charge in the metal and the tissue can be maintained. In this embodiment, no significant tissue damage and/or electrode erosion at the electrode-tissue interface is caused when the electrical pulse stimulus is applied by the pulse generator.
Drawings
In order to more clearly illustrate the technical solutions of embodiments or conventional techniques of the present application, the drawings required for the descriptions of the embodiments or conventional techniques will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person of ordinary skill in the art.
FIG. 1 is a schematic diagram of an implantable lead electrode according to one embodiment of the present application;
FIG. 2 is a schematic diagram of a specific electrode structure portion of an implantable lead electrode provided in one embodiment of the present application;
FIG. 3 is a schematic diagram of a specific electrode structure portion of an implantable lead electrode provided in one embodiment of the present application;
FIG. 4 is a schematic flow chart of a method for preparing an implantable lead electrode according to one embodiment of the present disclosure;
FIG. 5 is a schematic flow chart of a method for preparing an implantable lead electrode according to one embodiment of the present disclosure;
FIG. 6 is a schematic illustration of a process for preparing an implantable lead electrode according to one embodiment of the present application;
FIG. 7 is a schematic representation of electrographic results from the sacral nerve before and after injection of a fluid in a test mouse, as provided in one embodiment of the present application;
fig. 8 is a schematic representation of electrographic results from the sacral nerve before and after injection of another fluid in a test mouse, as provided in one embodiment of the present application;
FIG. 9 is a graph of experimental recordings of the process of small nerve activation using electrodes with surfaces not coated with the coating provided in one embodiment of the present application;
FIG. 10 is a graph of experimental recordings of the large nerve activation process provided in one embodiment of the present application using electrodes with surfaces that are not coated with the coating layer;
fig. 11 is a graph of experimental recordings of a process of large nerve activation using electrodes surface coated with iridium oxide coating provided in one embodiment of the present application.
Reference numerals illustrate:
implantable lead electrode 100
First electrode lead 10 first portion 11 second portion 12 third portion 13
Electrode contact 20 first conductive layer 21 coating layer 22
The second conductive layer 121 and the first insulating layer 122 fix the element 131
Electrolyte solution 101 return electrode 106 reference electrode 107 lead 108 piston 109
Magnetic stirrer 110 prefabricated implantable lead electrode 200
Detailed Description
In order to facilitate an understanding of the present application, a more complete description of the present application will now be provided with reference to the relevant figures. Preferred embodiments of the present application are shown in the accompanying drawings. This application may, however, be embodied in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
It will be understood that when an element is referred to as being "fixed to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.
The sacral nerve stimulation (Sacral Nerve Stimulation, acronym SNS) device includes an implantable pulse generator (Implantable pulse generator, acronym IPG) and an implantable sacral nerve stimulated lead electrode. The implanted sacral nerve stimulation lead electrode comprises a sacral nerve stimulation lead body and one or more sacral nerve stimulation electrodes arranged on the sacral nerve stimulation lead body. Hereinafter the sacral nerve stimulation lead body may be referred to simply as SNS lead body. The implantable pulse generator is configured to generate a pulsed stimulation current. The lead electrodes of the implantable sacral nerve stimulation are configured to deliver a pulsed stimulation current to tissue surrounding the one or more sacral nerve stimulation electrodes.
The physiological state information detected by the conventional implantable lead electrode is noisy, and cannot help a physician to determine an accurate treatment scheme according to the physiological state information detected by the conventional implantable lead electrode.
Referring to fig. 1, the present application provides an implantable lead electrode 100, comprising: a first electrode lead 10 and an electrode contact 20 provided to the first electrode lead 10. The first electrode lead 10 comprises a first portion 11. The first portion 11 is the portion that is first to be accessed when a living body is implanted along the implantable lead electrode 100. One of the electrode contacts 20 may be included in the implantable lead electrode 100 according to actual needs, or the implantable lead electrode 100 may include a plurality of the electrode contacts 20 disposed at intervals.
Specifically, the material of the first electrode lead 10 may be at least one of a metal, a metal alloy, or a conductive polymer. For example, the metal may be platinum, silver, iridium, nickel or cobalt. The metal alloy can be a solid product with metal property obtained by mixing and melting one metal and another metal or a plurality of non-metals and cooling and solidifying. For example, the metal alloy may be manganese steel, stainless steel, brass, bronze, white copper, solder, or duralumin. The conductive polymer can be conductive polymer material, and the polymer with conjugated pi-bond is chemically or electrochemically doped to be converted into a conductor from an insulator. The length and thickness of the first electrode wire 10 are not particularly limited, and may be arbitrarily adjusted according to the design requirements of the implantable lead electrode 100.
The electrode contact 20 is arranged to wrap around the first electrode lead 10. And the electrode contact 20 is provided at an outer sidewall of the first portion 11. A plurality of electrode contacts 20 are arranged at intervals. The electrode contact 20 includes a first conductive layer 21 and a coating layer 22. The first conductive layer 21 is coated on the outer side wall of the first electrode wire 10. The first conductive layer 21 may be a metal, for example: any of platinum, stainless steel, or iridium. The coating layer 22 is coated on the outer side wall of the first conductive layer 21. The material of the coating layer 22 is a reversible electrochemical reaction material.
In this embodiment, the coating layer 22 is disposed on the outer side wall of the electrode contact 20, and the material of the coating layer 22 is a reversible electrochemical reaction material. The implantable lead electrode 100 provided in this embodiment has the coating layer 22 in direct contact with the tissue interface when the electrode contact 20 is in contact with the tissue interface, and only reversible electrochemical reactions exist between the electrode contact 20 and the tissue. When the current from the pulse generator increases, only a reversible electrochemical reaction occurs. In the event of a reversible electrochemical reaction, the charge carriers do not permanently leave the metal surface, and therefore the balance of charge in the metal and the tissue can be maintained. In this embodiment, no significant tissue damage and/or electrode erosion at the electrode-tissue interface is caused when the electrical pulse stimulus is applied by the pulse generator.
In addition, after the coating layer 22 is disposed in the electrode contact 20 of the implantable lead electrode 100, the current density of the electrode contact 20 will increase. The electrode contacts 20 will significantly change (decrease) the output parameters of the pulse generator operating at the controlled current. For example, a conventional implantable lead electrode would require a pulse generator to output 10 units of voltage to achieve a current level of 10 units. With the implantable lead electrode 100 provided in the present embodiment, however, the impedance of the electrode contact 20 can be reduced by a factor of 10 due to the coating layer 22 provided on the electrode contact 20. Therefore, with the implantable lead electrode 100 provided in the present embodiment, 10 unit current intensities can be achieved at 1 unit voltage output from the pulse generator. In other words, with the implanted lead electrode 100 provided in the present embodiment, the pulse generator can be made to operate at a lower maximum voltage, and thus it is not necessary to provide a circuit for boosting the voltage from 3V (typical value of lithium ion battery) to 30V. Moreover, the pulse generator can operate with lower losses, since the efficiency of the boosting process is less than 100%.
With the implantable lead electrode 100 provided in this embodiment, the same maximum current level and maximum voltage level can still be achieved with an appropriate reduction in electrode size (e.g., a 10-fold reduction in electrode size). Thus, the electrode contacts 20 in the implantable lead electrode 100 provided in this embodiment occupy less surface area on the lead and may be more densely packed. The higher packing density of the electrode contacts 20 allows more localized stimulation of the tissue and better current control. The electrode contacts 20 are also configured to prevent tissue damage, deliver large currents to tissue, locally deliver currents to tissue surrounding areas, and shape currents in tissue surrounding the implantable lead electrode 100.
In one embodiment, the coating layer 22 includes at least one of platinum, iridium oxide, titanium nitride, titanium carbide, ruthenium oxide, tantalum oxide, carbon nanotubes, nanocrystalline diamond, graphene, conductive polymers, or conductive hydrogels. Nanocrystalline diamond generally has a hardness that exceeds that of single crystal diamond. Conductive polymers include conductive polymer materials, which are generally a class of polymer materials that are chemically or electrochemically "doped" with polymers having conjugated pi-bonds to convert them from an insulator to a conductor.
In this embodiment, the coating layer 22 may be selected from one of the above materials. Or the coating layer 22 may be a mixture of two or more of the above materials. The thickness of the coating layer 22 and the length of the coating layer 22 in the direction of the first electrode lead 10 may be set according to actual needs. In this embodiment, the material of the coating layer 22 is a material with reversible electrochemical reaction capability, so that the electrode contact 20 can be prevented from being damaged by the tissue and/or corroded by the electrode during the use of the implantable lead electrode 100.
In one embodiment, the coating layer 22 is a smooth conductive coating or a roughened conductive coating. In this embodiment, reference is specifically made to fig. 2 and 3. In fig. 2, a smooth conductive coating is provided on the outer side wall of the first conductive layer 21. In fig. 3, it is schematically shown that a rough conductive coating is provided on the outer side wall of the first conductive layer 21. In this embodiment, the coating layer 22 is a smooth conductive coating or a rough conductive coating, which can increase the occurrence of reversible electrochemical reaction during the use of the implantable lead electrode 100, and prevent significant tissue damage and/or electrode erosion at the interface of the electrode contact 20 and tissue.
In one embodiment, the thickness of the coating layer 22 in the direction of coating the first conductive layer 21 is 10nm to 1000nm. As shown in fig. 2, the thickness of the smooth conductive coating, i.e., the coating layer 22, may be 20nm, 50nm, 130nm, 240nm, 510nm, 630nm, 740nm, 890nm, 950nm, or 980nm. The coating layer 22 in fig. 3 is a roughened conductive coating, i.e. the thickness of the coating layer 22 may be composed of a plurality of peaks in the range of 10nm to 1000nm, each peak having a different height. For example, the height of each peak may be selected between 20nm, 70nm, 140nm, 260nm, 500nm, 650nm, 730nm, 880nm, 940nm or 990 nm.
In one embodiment, the first electrode lead 10 includes a second portion 12 and a third portion 13. The second portion 12 and the third portion 13 are contiguous. The third portion 13 is remote from the first portion 11. In use, the implantable electrode 100 is implanted in a living body in the first portion 11. The second part 12 is re-implanted with the living body. The third portion 13 is finally implanted into the living body. In the above embodiment, one or more of the electrode contacts 20 are disposed at intervals on the first portion 11 of the first electrode lead 10.
The implantable lead electrode 100 further includes: a second conductive layer 121 and a first insulating layer 122. The second conductive layer 121 is coated on the outer sidewalls of the second portion 12 and the third portion 13 of the first electrode lead 10. The second conductive layer 121 may include a plurality of conductive filaments. Specifically, the number of conductive wires included in the second conductive layer 121 may be determined according to the number of the electrode contacts 20. The first insulating layer 122 is coated on the outer side wall of the second conductive layer 121. The material of the first insulating layer 122 may be a polymer material. In one embodiment, the material of the first insulating layer 122 is at least one of polyurethane, silicone, polytetrafluoroethylene, fluorine-containing polymer, parylene, or polyimide.
In this embodiment, the second conductive layer 121 and the first insulating layer 122 are coated on the outer side walls of the second portion 12 and the third portion 13 of the first electrode lead 10. The second portion 12 and the third portion 13 after the first insulating layer 122 is coated may be referred to as a lead body.
In one embodiment, the implantable lead electrode 100 further comprises: the fixing member 131. The fixing elements 131 are disposed at intervals on the third portion 13 of the first electrode lead 10. The fixation element 131 is selected from a polymeric material having shape memory properties such as: one or more of polyurethane, silicone, polytetrafluoroethylene, or parylene.
In this embodiment, the fixing element 131 may perform a fixing function to limit the movement of the implantable lead electrode 100 after implantation into a living body, which affects normal examination or treatment.
Referring to fig. 1 of the present application in detail, the first portion 11 of fig. 1 schematically includes the first electrode wire 10, the first conductive layer 21 and the coating layer 22 in an enlarged view of a dotted line. Since the second electrode contact 20 (counted starting from the direction of the first portion 11 towards the second portion 12) is shown in the enlarged dashed line in fig. 1, two layers of conductive filaments are included in the first conductive layer 21. The outer wall of the conductive wire is provided with an insulating substance. The adjacent conductive wires are not conductive. If the third electrode contact is shown enlarged in dashed lines in fig. 1, three layers of conductive filaments should be included in the first conductive layer 21. The outer wall of the conductive wire is provided with an insulating substance. The adjacent conductive wires are not conductive. An enlarged view of the dashed line in the second portion 12 in fig. 1 schematically comprises the first electrode lead 10, the second conductive layer 121 and the first insulating layer 122. The second conductive layer 121 includes four layers of the conductive wires. The enlarged view of the broken line in the third portion 13 in fig. 1 schematically comprises the first electrode lead 10, the second conductive layer 121, the first insulating layer 122 and the fixing element 131. Four layers of the conductive wires are also included in the second conductive layer 121. In this embodiment, only 4 electrode contacts 20 are illustrated, and if more electrode contacts 20 are included in the implantable lead electrode 100, more conductive filaments in the first conductive layer 21 may be provided.
Referring to fig. 4, the embodiment of the present application further provides a method for preparing an implantable lead electrode 100, which includes:
s10, a first electrode lead 10 is provided. The first electrode lead 10 comprises a first portion 11. The first portion 11 is the portion that is first to be accessed when a living body is implanted along the implantable lead electrode 100. The material of the first electrode lead 10 may be at least one of a metal, a metal alloy, or a conductive polymer. The length and thickness of the first electrode wire 10 are not particularly limited, and may be arbitrarily adjusted according to the design requirements of the implantable lead electrode 100.
And S20, one or more electrode contacts 20 are arranged on the outer side wall of the first electrode wire 10 at intervals. The electrode contact 20 includes a first conductive layer 21 and a coating layer 22. The first conductive layer 21 is coated on the outer sidewall of the first portion 11 of the first electrode lead 10, and the coating layer 22 is coated on the outer sidewall of the first conductive layer 21. The material of the coating layer 22 is a reversible electrochemical reaction material. The coating layer 22 is prepared by any one of electrodeposition, chemical vapor deposition, plasma enhanced chemical vapor deposition, physical vapor deposition, or atomic layer deposition.
For example, physical vapor deposition (Physical Vapour Deposition, PVD), which means that under vacuum conditions, a physical method is used to gasify the surface of a material source (solid or liquid) into gaseous atoms, molecules or partially ionize them into ions, and a thin film with a specific function is deposited on the surface of a substrate by a low-pressure gas (or plasma) process. Physical vapor deposition further comprises: vacuum evaporation, sputter coating, arc plasma plating, ion plating, and molecular beam epitaxy.
In this embodiment, the implantable lead electrode 100 is prepared, the coating layer 22 is disposed on the outer sidewall of the electrode contact 20, and the material of the coating layer 22 is a reversible electrochemical reaction material. The implantable lead electrode 100 has the coating layer 22 in direct contact with the tissue interface when the electrode contact 20 is in contact with the tissue interface, and only a reversible electrochemical reaction exists between the electrode contact 20 and the tissue. When the current from the pulse generator increases, only a reversible electrochemical reaction occurs. In the event of a reversible electrochemical reaction, the charge carriers do not permanently leave the metal surface, and therefore the balance of charge in the metal and the tissue can be maintained. In this embodiment, no significant tissue damage and/or electrode erosion at the electrode-tissue interface is caused when the electrical pulse stimulus is applied by the pulse generator.
In addition, after the coating layer 22 is disposed in the electrode contact 20 of the implantable lead electrode 100, the current density of the electrode contact 20 will increase. The electrode contacts 20 will significantly change (decrease) the output parameters of the pulse generator operating at the controlled current. For example, a conventional implantable lead electrode would require a pulse generator to output 10 units of voltage to achieve a current level of 10 units. With the implantable lead electrode 100 provided in the present embodiment, however, the impedance of the electrode contact 20 can be reduced by a factor of 10 due to the coating layer 22 provided on the electrode contact 20. Therefore, the implantable lead electrode 100 obtained by the preparation method of the implantable lead electrode 100 provided in this embodiment can achieve 10 current densities when the pulse generator outputs 1 unit voltage. In other words, the implantable lead electrode 100 obtained by the method for manufacturing the implantable lead electrode 100 according to the present embodiment can enable the pulser to operate at a lower maximum voltage, so that it is not necessary to provide a circuit for boosting the voltage from 3V (typical value of lithium ion battery) to 30V. Moreover, the pulse generator can operate with lower losses, since the efficiency of the boosting process is less than 100%.
In one embodiment, referring to fig. 5 and 6, fig. 5 is a flow chart of steps of a preparation method. Fig. 6 is a schematic diagram of the preparation process. The step of preparing the coating layer 22 by the electrodeposition method includes:
s210, providing an electrodeposition cell, and introducing an electrolyte solution 101 into the electrodeposition cell.
S220, providing a pre-fabricated implantable lead electrode 200 and a return electrode 106, and placing the pre-fabricated implantable lead electrode 200 and the return electrode 106 in the electrolyte solution 101, respectively. A reference electrode 107 may also be provided in this step. Meanwhile, the reference electrode 107 is placed in the electrolyte solution 101. In this step, the prefabricated implantable lead electrode 200 includes a first electrode lead 10 (the first electrode lead 10 has a first portion 11, a second portion 12, and a third portion 13), the first conductive layer 21 provided at the first portion 11, the second conductive layer 121 and the first insulating layer 122 provided at the second portion 12 and the third portion 13, and the fixing element 131 provided at the third portion 13.
At S230, with the prefabricated lead electrode 200 as a cathode and the return electrode 106 as an anode, the return electrode 106 may be platinum with a larger surface area. The pre-fabricated implantable lead electrode 200 and the return electrode 106 are energized and the electrolyte solution 101 is continuously stirred. In this step, if the reference electrode 107 is provided, the reference electrode 107 may be an electrode made of silver and silver chloride.
In particular this step, a current may be passed between the pre-fabricated implantable lead electrode 200 and the return electrode 106, the current being passed in an amount such that the pre-fabricated implantable lead electrode 200 and the return electrode 106 have a voltage of-3V to +3v relative to the reference electrode 107. A continuous direct current or pulsed direct current may be applied between the pre-fabricated implantable lead electrode 200 and the return electrode 106 at a frequency of 10Hz to 400 kHz.
During electrodeposition, the electrolyte solution 101 may be continuously stirred using a magnetic stirrer 110, an ultrasonic tank, or a dispersion of an inert gas (e.g., argon or nitrogen). During electrodeposition, the electrodeposition cell may be at atmospheric or high pressure. During electrodeposition, the electrolyte solution 101 may be heated at room temperature or to a temperature below the boiling point of the electrolyte solution. The duration of the electrodeposition process may be in the range of 1 hour to 168 hours. For example, for electrodepositing iridium oxide, the electrolyte solution 101 is prepared by adding ammonium hexachloroplatinate and sodium hexachloroiridium acid electrolyte to water or chloric acid. Depending on the details of the electrodeposition process, the coating layer 22 may be made smooth or roughened. The thickness of the smooth coating layer may be between 10nm and 1000nm. The roughened coating layer may comprise a plurality of peaks having a height in the range of 10nm to 1000nm. In particular, in preparing the coating layer 22 by using the electrodeposition method, the roughness of the coating layer may be increased by appropriately modifying the electrodeposition voltage, the electrodeposition time, or adding a salt (e.g., potassium sulfate) to the electrolyte solution 101.
Continuing to agitate the electrolyte solution 101 may increase the movement of electrolyte in the electrolyte solution 101 to create a current between the first conductive layer 21 and the return electrode 106. Energizing the pre-fabricated implantable lead electrode 200 and the return electrode 106, and continuing to agitate the electrolyte solution 101, may cause the electrolyte material in the electrolyte solution 101 to form the coating layer 22 on the outer sidewall of the first conductive layer 21.
As shown in fig. 6, 3 openings are opened at the top of the electrodeposition cell. To prevent evaporation of the electrolyte solution 101 from the electrodeposition cell, the 3 openings may be sealed with a piston 109 made of a polymer material (e.g., rubber, polyurethane, silicone). The lead 108 in fig. 6 is used to transmit electrical signals to the reference electrode 107 and the return electrode 106.
In this embodiment, a method for preparing the coating layer 22 is specifically provided. In this embodiment, the electrodeposition method is used to prepare the coating layer 22, and the crystal growth of the coating layer 22 is fast and the crystal grains are more uniform. And the diffusion rate and the charge transfer reaction rate of the adsorption surface of the coating layer 22 are more easily controlled, facilitating uniform growth of crystal grains in the coating layer 22.
In one embodiment, the coating layer 22 is prepared using a vacuum evaporation method. The specific steps for preparing the coating layer 22 include:
providing the prefabricated implantable lead electrode 200, a metal target material platinum and a reaction cavity;
the prefabricated implanted lead electrode 200 is placed in a reaction cavity, and the reaction cavity is vacuumized, wherein the general vacuum degree is 10 -4 Pa to 10 -5 Pa. In order to prevent other reactions from affecting the purity of vapor deposition, an appropriate amount of inert gas may be filled under vacuum conditions for protection.
And under the vacuum condition, adopting a pulse laser deposition method to carry out vacuum evaporation on the metal target platinum. The deposition thickness of the coating layer 22 can be adjusted by setting parameters such as the light output power and the light output frequency of the laser during the evaporation process.
Or under vacuum condition, the metal target platinum is irradiated by a deposition method of magnetron sputtering, and is sputtered onto the surface of the first conductive layer 21 in the prefabricated implanted lead electrode 200, so as to form the coating layer 22.
In this embodiment, the coating layer 22 is prepared by a vacuum evaporation method, and specifically, the thickness of the coating layer 22 in the direction of coating the first conductive layer 21 may be controlled by parameters in the evaporation process.
The present application also provides a sacral nerve stimulator, comprising: a pulse stimulation generator and a sacral nerve stimulation electrode. The pulse stimulation generator is used for generating stimulation pulses. The sacral nerve stimulation electrode is electrically connected with the pulse stimulation generator. The sacral nerve stimulation electrode is the implantable lead electrode 100 described in any one of the preceding claims.
Finally, electrical stimulation using the sacral nerve stimulation electrodes provided in the above-described embodiments of the present application can prevent tissue damage by reducing the rate of irreversible electrochemical reactions.
With the sacral nerve stimulation electrode provided in the above-described embodiments of the application, electrical stimulation can be performed by increasing the current density at the electrode contact 20-tissue interface from 0.1mC/cm 2 to 0.4mC/cm 2 (when the coating layer 22 is roughened platinum) or 1-50mC/cm 2 (when the coating layer 22 is iridium oxide and/or titanium nitride).
With the sacral nerve stimulation electrode provided in the above embodiments of the present application, more local current can be provided to the tissue.
With the sacral nerve stimulation electrode (the electrode contacts 20 having a smaller size) provided in the above-described embodiments of the application, electrical current can be established in the tissue surrounding the sacral nerve stimulation electrode. Preventing tissue damage, greater current delivery to tissue, localized current delivery to tissue, and current shaping in tissue surrounding the sacral nerve lead can provide more effective, safer sacral nerve treatment.
Electrographic recording using the sacral nerve stimulation electrodes provided in the above-described embodiments of the application can provide stronger electrical signals and lower electrical noise.
Electrochemical recordings using the sacral nerve stimulation electrodes provided in the above-described embodiments of the application can provide stronger electrochemical signals and lower electrochemical noise.
With the sacral nerve stimulation electrode provided in the above embodiments of the present application, electrical and electrochemical recordings with stronger signals and lower noise can be obtained, thereby providing information about physiological status, disease symptoms, and efficacy of sacral nerve treatment.
In one embodiment, the fluid injection is performed on a test mouse, and the implanted lead electrode 100 provided in the above embodiments of the present application is used to detect the sacral nerve data change of the test mouse and obtain the comparison test result. Fig. 7 and 8 show examples of electrographic results from the sacral nerve before and after different fluids are injected into the gut in a test mouse. FIG. 7 is a graph showing an example of electrographic results before and after injection of a non-inflammatory liquid (phosphate buffer) into a test mouse. FIG. 8 is a graph showing an example of electrographic results before and after injection of an inflammatory fluid (1 mM capsaicin in phosphate buffer) into a test mouse.
The upper graph of fig. 7 shows the raw electrogram and the lower graph of fig. 7 shows the calculated spike frequency in Hz from the raw electrogram, indicating the nerve activation level. The vertical boundaries in fig. 7 represent the injection time of the non-inflammatory fluid (phosphate buffered saline).
The upper graph of fig. 8 shows the raw electrogram and the lower graph of fig. 8 shows the calculated spike frequency in Hz from the raw electrogram, indicating the nerve activation level. The vertical boundaries in fig. 8 represent the injection time of inflammatory fluid (1 mM capsaicin in phosphate buffer).
The noise (including biological noise and electrical noise) recorded in fig. 7 and 8 is indicated by two arrows on the right side. As is evident from fig. 8: after injection of the inflammatory fluid, the frequency of spikes increases significantly compared to the pre-injection phase.
In another specific embodiment, fig. 9, 10 and 11 show examples of electrochemical signal changes in the sacral nerve at different nerve activation levels and with different coating layers for the electrodes. Fig. 9 records the small nerve activation process using an electrode with a surface not coated with the coating. Fig. 10 records the large nerve activation process using an electrode with a surface not coated with the coating layer. Fig. 11 records the process of large nerve activation using an electrode with an iridium oxide coated surface. In this example, FIGS. 9-11 each use cyclic voltammetry to measure electrochemical signals. Alternatively, cyclic voltammetry or impedance spectroscopy may also be used to measure electrochemical signals.
In fig. 9, 10 and 11, the vertical scale shows the percentage change in electrochemical signal compared to the case without nerve activation, and the horizontal scale shows the time after nerve activation in milliseconds. In fig. 9, using an electrode with a surface not coated with the coating layer, no significant change in electrochemical signal was observed during small nerve activation. In fig. 10, a small change in electrochemical signal can be seen during activation of the large nerve using an electrode whose surface is not coated with the coating layer. In fig. 11, electrochemical signals are greatly changed during activation of large nerves using an electrode coated with an iridium oxide coating layer.
Sacral nerve stimulation may be triggered by detecting a significant increase in spike frequency or a significant change in electrochemical signal. When a coating is applied to the electrode of the sacral nerve stimulation lead, the impedance of the electrode can be greatly reduced, and electrical and electrochemical noise can be greatly reduced. The use of a coating on the electrodes of the sacral nerve stimulation lead helps to accurately calculate the frequency of spikes and electrochemical signals and results in more accurate detection of increased nerve activity during intestinal inflammation.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples merely represent a few embodiments of the present application, which are described in more detail and are not to be construed as limiting the scope of the invention. It should be noted that it would be apparent to those skilled in the art that various modifications and improvements could be made without departing from the spirit of the present application, which would be within the scope of the present application. Accordingly, the scope of protection of the present application is to be determined by the claims appended hereto.
Claims (2)
1. A method of making an implantable lead electrode, comprising:
providing a first electrode lead comprising a first portion; the first portion is a portion that first enters when a living body is implanted along the implanted lead electrode;
one or more electrode contacts are arranged on the outer side wall of the first part at intervals; the electrode contact comprises a first conductive layer and a coating layer, wherein the first conductive layer is coated on the outer side wall of the first electrode wire, and the coating layer is coated on the outer side wall of the first conductive layer; the material of the coating layer is a reversible electrochemical reaction material; the coating layer is prepared by any one of electrodeposition, chemical vapor deposition, plasma enhanced chemical vapor deposition, physical vapor deposition or atomic layer deposition;
the step of preparing the coating layer by an electrodeposition method includes:
providing an electrodeposition cell and introducing an electrolyte solution into the electrodeposition cell;
providing a pre-fabricated implantable lead electrode and a return electrode, respectively placing the pre-fabricated implantable lead electrode and the return electrode in the electrolyte solution;
electrifying the prefabricated implanted lead electrode and the reflux electrode by taking the prefabricated implanted lead electrode as a cathode and taking the reflux electrode as an anode, and continuously stirring the electrolyte solution so that the electrolyte material in the electrolyte solution forms the coating layer on the outer side wall of the first conductive layer;
during electrodeposition, the electrolyte solution is continuously stirred using a magnetic stirrer, an ultrasonic tank, or a dispersion of inert gas; continuously stirring the electrolyte solution to increase movement of electrolyte in the electrolyte solution to form an electrical current between the first conductive layer and the return electrode;
3 openings are formed in the top of the electrodeposition cell and used for preventing the electrolyte solution from evaporating from the electrodeposition cell;
the method for preparing the coating layer by adopting the vacuum evaporation method comprises the following specific steps of:
providing the prefabricated implantable lead electrode, a metal target material platinum and a reaction cavity;
placing the prefabricated implanted lead electrode in a reaction cavity, and vacuumizing the reaction cavity, wherein the general vacuum degree is 10 -4 Pa to 10 -5 Pa, in order to prevent other reactions from affecting the purity of evaporation, filling a proper amount of inert gas under vacuum condition for protection;
under vacuum condition, adopting pulse laser deposition method to implement vacuum evaporation plating on the metal target platinum, and adjusting deposition thickness of the coating layer by setting light-emitting power and light-emitting frequency parameters of the laser in the evaporation plating process;
or under the vacuum condition, the metal target platinum is irradiated by adopting a deposition method of magnetron sputtering, and is sputtered to the surface of the first conductive layer in the prefabricated implanted lead electrode, so as to form the coating layer.
2. The method of claim 1, wherein the coating layer is an iridium oxide layer; the electrolyte solution is formed by adding ammonium hexachloroplatinate and sodium hexachloroiridium into an aqueous solution or a chloric acid solution.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010365555.1A CN113577536B (en) | 2020-04-30 | 2020-04-30 | Implantable lead electrode, preparation method and sacral nerve stimulator |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010365555.1A CN113577536B (en) | 2020-04-30 | 2020-04-30 | Implantable lead electrode, preparation method and sacral nerve stimulator |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN113577536A CN113577536A (en) | 2021-11-02 |
| CN113577536B true CN113577536B (en) | 2024-02-27 |
Family
ID=78237438
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010365555.1A Active CN113577536B (en) | 2020-04-30 | 2020-04-30 | Implantable lead electrode, preparation method and sacral nerve stimulator |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113577536B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN118880300B (en) * | 2024-08-05 | 2025-07-15 | 重庆立道新材料科技有限公司 | A nano-carbon material assisted chemical platinum plating composite coating and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103726090A (en) * | 2012-10-11 | 2014-04-16 | 中国科学院大连化学物理研究所 | A preparation method of α-Fe2O3 photoanode for photoelectrolysis |
| CN104353181A (en) * | 2014-11-06 | 2015-02-18 | 北京品驰医疗设备有限公司 | Implanted spiral electrode and manufacturing method thereof |
| CN205055188U (en) * | 2015-09-18 | 2016-03-02 | 清华大学 | Neural electric stimulating electrode subassembly of implanted and electrode pipe thereof |
-
2020
- 2020-04-30 CN CN202010365555.1A patent/CN113577536B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103726090A (en) * | 2012-10-11 | 2014-04-16 | 中国科学院大连化学物理研究所 | A preparation method of α-Fe2O3 photoanode for photoelectrolysis |
| CN104353181A (en) * | 2014-11-06 | 2015-02-18 | 北京品驰医疗设备有限公司 | Implanted spiral electrode and manufacturing method thereof |
| CN205055188U (en) * | 2015-09-18 | 2016-03-02 | 清华大学 | Neural electric stimulating electrode subassembly of implanted and electrode pipe thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN113577536A (en) | 2021-11-02 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Venkatraman et al. | In vitro and in vivo evaluation of PEDOT microelectrodes for neural stimulation and recording | |
| US4679572A (en) | Low threshold cardiac pacing electrodes | |
| AU2019299334B2 (en) | Systems and methods for nerve conduction block | |
| US4762136A (en) | Low polarization pacing electrodes for capture verification | |
| Cui et al. | Poly (3, 4-ethylenedioxythiophene) for chronic neural stimulation | |
| CA1173114A (en) | Body implantable lead with improved dcd electrode | |
| AU2006315285B2 (en) | Implantable stimulator configured to be implanted within a patient in a pre-determined orientation | |
| US7256982B2 (en) | Electrolytic capacitor | |
| US8738144B2 (en) | Bioelectric implant and method | |
| EP1750798A1 (en) | Electrodes for sustained delivery of energy | |
| US7177680B2 (en) | Field stimulation about a discontinuity of the myocardium to capture the heart at reduced pacing thresholds | |
| US20100055570A1 (en) | Biobattery with nanocrystalline material anode | |
| US7142928B2 (en) | Field stimulation about a discontinuity of the myocardium to capture the heart at reduced pacing thresholds | |
| Shah et al. | Improved chronic neural stimulation using high surface area platinum electrodes | |
| US20210345928A1 (en) | Recessed electrodes for flexible substrates | |
| CN113577536B (en) | Implantable lead electrode, preparation method and sacral nerve stimulator | |
| Petrossians et al. | Improved electrode material for deep brain stimulation | |
| EP0596589A1 (en) | Method for reducing the polarization of bioelectrical stimulation leads using surface enhancement and product made thereby | |
| Ali et al. | An in-vitro study of electrodes impedance in deep brain stimulation | |
| US7459369B2 (en) | High capacitance low resistance electrode | |
| Schiavone et al. | Dimensional scaling of thin-film stimulation electrode systems in translational research | |
| CA1305528C (en) | Low threshold cardiac pacing electrodes | |
| CN218187546U (en) | Biological nerve regulation and control electrode | |
| EP2968957B1 (en) | Medical leads and techniques for manufacturing the same | |
| Abbott et al. | In vitro electrochemical properties of titanium nitride neural stimulating and recording electrodes as a function of film thickness and voltage biasing |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |