CN114852947A - MEMS electrode device for cardiac pulse field ablation and preparation method thereof - Google Patents
MEMS electrode device for cardiac pulse field ablation and preparation method thereof Download PDFInfo
- Publication number
- CN114852947A CN114852947A CN202210422714.6A CN202210422714A CN114852947A CN 114852947 A CN114852947 A CN 114852947A CN 202210422714 A CN202210422714 A CN 202210422714A CN 114852947 A CN114852947 A CN 114852947A
- Authority
- CN
- China
- Prior art keywords
- electrode
- layer
- insulating layer
- ablation
- cardiac
- 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.)
- Pending
Links
- 238000002679 ablation Methods 0.000 title claims abstract description 73
- 230000000747 cardiac effect Effects 0.000 title claims abstract description 31
- 238000002360 preparation method Methods 0.000 title abstract description 8
- 238000000034 method Methods 0.000 claims abstract description 24
- 230000004048 modification Effects 0.000 claims abstract description 17
- 238000012986 modification Methods 0.000 claims abstract description 17
- 210000005003 heart tissue Anatomy 0.000 claims abstract description 15
- 238000011065 in-situ storage Methods 0.000 claims abstract description 8
- 230000008569 process Effects 0.000 claims abstract description 7
- 229910052751 metal Inorganic materials 0.000 claims description 34
- 239000002184 metal Substances 0.000 claims description 34
- 229920002120 photoresistant polymer Polymers 0.000 claims description 32
- 238000004544 sputter deposition Methods 0.000 claims description 24
- 238000000059 patterning Methods 0.000 claims description 17
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims description 12
- 238000004519 manufacturing process Methods 0.000 claims description 11
- 239000000463 material Substances 0.000 claims description 11
- 230000005684 electric field Effects 0.000 claims description 9
- 238000004528 spin coating Methods 0.000 claims description 8
- 238000001312 dry etching Methods 0.000 claims description 5
- 238000001259 photo etching Methods 0.000 claims description 5
- 238000003860 storage Methods 0.000 claims description 4
- 239000004698 Polyethylene Substances 0.000 claims description 3
- HTXDPTMKBJXEOW-UHFFFAOYSA-N dioxoiridium Chemical compound O=[Ir]=O HTXDPTMKBJXEOW-UHFFFAOYSA-N 0.000 claims description 3
- 238000009713 electroplating Methods 0.000 claims description 3
- 238000005530 etching Methods 0.000 claims description 3
- 229910000457 iridium oxide Inorganic materials 0.000 claims description 3
- 229920000172 poly(styrenesulfonic acid) Polymers 0.000 claims description 3
- -1 polyethylene Polymers 0.000 claims description 3
- 229920000573 polyethylene Polymers 0.000 claims description 3
- 229940005642 polystyrene sulfonic acid Drugs 0.000 claims description 3
- 239000000758 substrate Substances 0.000 claims description 3
- VYZAMTAEIAYCRO-UHFFFAOYSA-N Chromium Chemical compound [Cr] VYZAMTAEIAYCRO-UHFFFAOYSA-N 0.000 description 7
- VRBFTYUMFJWSJY-UHFFFAOYSA-N 28804-46-8 Chemical compound ClC1CC(C=C2)=CC=C2C(Cl)CC2=CC=C1C=C2 VRBFTYUMFJWSJY-UHFFFAOYSA-N 0.000 description 6
- 229910052804 chromium Inorganic materials 0.000 description 6
- 239000011651 chromium Substances 0.000 description 6
- 238000010586 diagram Methods 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 6
- 229910052737 gold Inorganic materials 0.000 description 6
- 239000010931 gold Substances 0.000 description 6
- 238000004088 simulation Methods 0.000 description 6
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 4
- WYTGDNHDOZPMIW-RCBQFDQVSA-N alstonine Natural products C1=CC2=C3C=CC=CC3=NC2=C2N1C[C@H]1[C@H](C)OC=C(C(=O)OC)[C@H]1C2 WYTGDNHDOZPMIW-RCBQFDQVSA-N 0.000 description 4
- 238000013153 catheter ablation Methods 0.000 description 4
- 238000009826 distribution Methods 0.000 description 4
- 238000000206 photolithography Methods 0.000 description 4
- 229910052697 platinum Inorganic materials 0.000 description 4
- 210000003492 pulmonary vein Anatomy 0.000 description 4
- 210000001519 tissue Anatomy 0.000 description 4
- 238000001039 wet etching Methods 0.000 description 4
- 206010003658 Atrial Fibrillation Diseases 0.000 description 3
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 3
- 230000030833 cell death Effects 0.000 description 3
- 238000005229 chemical vapour deposition Methods 0.000 description 3
- 238000000151 deposition Methods 0.000 description 3
- 238000001514 detection method Methods 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000007674 radiofrequency ablation Methods 0.000 description 3
- 229910052719 titanium Inorganic materials 0.000 description 3
- 239000010936 titanium Substances 0.000 description 3
- 241001391944 Commicarpus scandens Species 0.000 description 2
- 239000004642 Polyimide Substances 0.000 description 2
- 239000003364 biologic glue Substances 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 238000004520 electroporation Methods 0.000 description 2
- 230000002427 irreversible effect Effects 0.000 description 2
- 238000002955 isolation Methods 0.000 description 2
- 229920000052 poly(p-xylylene) Polymers 0.000 description 2
- 229920001721 polyimide Polymers 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 238000002791 soaking Methods 0.000 description 2
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 208000028389 Nerve injury Diseases 0.000 description 1
- 206010049171 Pulmonary vein stenosis Diseases 0.000 description 1
- 229920001486 SU-8 photoresist Polymers 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000002651 drug therapy Methods 0.000 description 1
- 210000002837 heart atrium Anatomy 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000013152 interventional procedure Methods 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 230000008764 nerve damage Effects 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 210000003105 phrenic nerve Anatomy 0.000 description 1
- 238000001020 plasma etching Methods 0.000 description 1
- 239000003507 refrigerant Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
Images
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B81—MICROSTRUCTURAL TECHNOLOGY
- B81B—MICROSTRUCTURAL DEVICES OR SYSTEMS, e.g. MICROMECHANICAL DEVICES
- B81B7/00—Microstructural systems; Auxiliary parts of microstructural devices or systems
- B81B7/02—Microstructural systems; Auxiliary parts of microstructural devices or systems containing distinct electrical or optical devices of particular relevance for their function, e.g. microelectro-mechanical systems [MEMS]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B81—MICROSTRUCTURAL TECHNOLOGY
- B81C—PROCESSES OR APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OR TREATMENT OF MICROSTRUCTURAL DEVICES OR SYSTEMS
- B81C1/00—Manufacture or treatment of devices or systems in or on a substrate
- B81C1/00015—Manufacture or treatment of devices or systems in or on a substrate for manufacturing microsystems
- B81C1/00134—Manufacture or treatment of devices or systems in or on a substrate for manufacturing microsystems comprising flexible or deformable structures
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B81—MICROSTRUCTURAL TECHNOLOGY
- B81C—PROCESSES OR APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OR TREATMENT OF MICROSTRUCTURAL DEVICES OR SYSTEMS
- B81C1/00—Manufacture or treatment of devices or systems in or on a substrate
- B81C1/00015—Manufacture or treatment of devices or systems in or on a substrate for manufacturing microsystems
- B81C1/00134—Manufacture or treatment of devices or systems in or on a substrate for manufacturing microsystems comprising flexible or deformable structures
- B81C1/00166—Electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
- A61B2018/00375—Ostium, e.g. ostium of pulmonary vein or artery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00613—Irreversible electroporation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00875—Resistance or impedance
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B81—MICROSTRUCTURAL TECHNOLOGY
- B81B—MICROSTRUCTURAL DEVICES OR SYSTEMS, e.g. MICROMECHANICAL DEVICES
- B81B2201/00—Specific applications of microelectromechanical systems
- B81B2201/06—Bio-MEMS
Landscapes
- Engineering & Computer Science (AREA)
- Manufacturing & Machinery (AREA)
- Health & Medical Sciences (AREA)
- Microelectronics & Electronic Packaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Medical Informatics (AREA)
- Otolaryngology (AREA)
- Computer Hardware Design (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Abstract
The invention provides an MEMS electrode device for cardiac pulse field ablation and a preparation method thereof, wherein the electrode device comprises a lower insulating layer, a temperature sensing layer, a middle insulating layer, an electrode layer, an upper insulating layer and an electrode modification layer which are sequentially arranged from bottom to top; the electrode layer is used for applying a pulse electrical signal to the cardiac tissue, simultaneously recording the electrical impedance of the cardiac tissue before and after ablation in each pulse field, and also used for recording the electrocardiosignal of the cardiac tissue before and after ablation; the temperature sensing layer is used for in-situ recording of dynamic temperature changes in the ablation process. The invention can improve the safety and efficiency of the cardiac pulse field ablation.
Description
Technical Field
The invention relates to the technical field of electrophysiological instruments, in particular to an MEMS electrode device for cardiac pulse field ablation and a preparation method thereof.
Background
Atrial fibrillation is the most common persistent arrhythmia in the clinic, it has high morbidity and mortality, and the risk of morbidity increases with age, affecting 1-2% of the population. Approximately 90% of atrial fibrillation is due to abnormal electrical signals entering the atrium via the pulmonary veins, resulting in irregular electrocardiographic signals. Heretofore, pulmonary vein isolation using catheter ablation techniques has been the cornerstone of interventional procedures for atrial fibrillation. Compared with the drug therapy, the catheter ablation is the preferred treatment method due to high safety, high efficiency and good effect.
Currently, catheter ablation techniques generally employ radiofrequency ablation or cryoablation to achieve pulmonary vein isolation. The former causes cell death in the target area by applying radio frequency energy, and the latter causes cell death by using a refrigerant such as N2O. Both of these techniques have significant disadvantages. First, they are not specific for the damage of various tissues and cells at the pulmonary veins. Secondly, many surgical complications such as pulmonary vein stenosis, phrenic nerve injury, etc. are generated. In addition, the radio frequency ablation has high requirements on operators and long operation time. Therefore, there is a strong need to find a new ablation method that avoids the above problems.
Recently, a new and promising ablation technique, known as pulsed field ablation, has emerged. It shows significant advantages over conventional radiofrequency ablation and cryoablation, including tissue-specific and non-thermal properties. Pulsed field ablation effectively induces nanoporosity in cell membranes using narrow pulses and high voltages, resulting in cell death, i.e., irreversible electroporation. Various shapes of ablation electrodes have been developed by several medical companies, such as the ring 9 electrode ablation catheter of medtronic, usa, the basket 20 electrode ablation catheter and lasso epicardial ablation catheter of farapule, usa, and the lattice-tip catheter ablation system of Affera. However, there are still some common problems: (1) the ablation electrode can not perform point ablation on a target point of heart tissue to obtain an ablation point with accurate size, usually the whole area is damaged, and thus the tissue of a non-target area is inevitably damaged; (2) high voltages of 1000-; (3) the ablation effect cannot be evaluated quickly, the changes of the tissue layer before and after ablation cannot be evaluated effectively by CT, MRI and ultrasonic examination, and if the ablation is unsuccessful, a second operation is required; (4) the adopted electrodes have large sizes and insufficient flexibility, and cannot be in close and common contact with the surface of the heart; (5) the ability of a single catheter to integrate multiple sensors is insufficient, and multiple physical parameters such as temperature, impedance and the like cannot be detected simultaneously.
Based on the technology and the improvement direction, the MEMS electrode device for cardiac pulse field ablation and the preparation method thereof have important scientific research and clinical application values and have very important significance for popularization and application of pulse field ablation.
Disclosure of Invention
In view of the defects in the prior art, the invention aims to provide a MEMS electrode device for cardiac pulse field ablation and a preparation method thereof.
According to one aspect of the invention, an MEMS electrode device for cardiac pulse field ablation is provided, which comprises a lower insulating layer, a temperature sensing layer, a middle insulating layer, an electrode layer, an upper insulating layer and an electrode modification layer, wherein the lower insulating layer, the temperature sensing layer, the middle insulating layer, the electrode layer, the upper insulating layer and the electrode modification layer are sequentially arranged from bottom to top; wherein the electrode modification layer is used for reducing the electrochemical impedance of the electrode and improving the charge storage capacity; the electrode layer is used for applying pulse electrical signals to the cardiac tissue, simultaneously recording the electrical impedance of the cardiac tissue before and after each pulse field ablation, and also used for recording the electrocardiosignals of the cardiac tissue before and after the ablation; the temperature sensing layer is used for in-situ recording of dynamic temperature changes in the ablation process.
Further, the electrode layer comprises a circular electrode and a ring electrode positioned around the circular electrode, and the circular electrode and the ring electrode form a central radial electric field.
Further, the radius of the circular electrode is 50-500 μm; the inner radius of the annular electrode is 100-; the distance between the circumference of the circular electrode and the inner ring circumference of the annular electrode is less than 1 mm.
Furthermore, the circular electrode and the annular electrode are respectively used for connecting with two electrodes for transmitting pulse electric signals; the pulsed electrical signal applied to the electrode device satisfies the following condition: the pulse waveform is a unipolar pulse square wave or a bipolar pulse square wave; the voltage is 10-500V; the pulse width is 1-100 mus; the pulse frequency is 1-10 Hz; the number of pulses is 50-120.
Further, the temperature sensing layer includes a temperature sensitive metal in a serpentine shape.
Further, the temperature sensing layer and the electrode layer are stacked up and down at the electrode end.
Further, the thickness of the temperature sensing layer is 100-500 nm.
Further, the lower insulating layer, the middle insulating layer and the upper insulating layer are formed of the same material, and the thickness of the lower insulating layer, the thickness of the middle insulating layer and the thickness of the upper insulating layer are 1-200 μm.
Further, the electrode modification layer is formed in an electroplating mode, and the material of the electrode modification layer is any one of platinum black, iridium oxide and polyethylene dioxythiophene-polystyrene sulfonic acid.
According to another aspect of the present invention, there is provided a method for preparing the MEMS electrode device for cardiac pulsed field ablation, the method comprising:
manufacturing a lower insulating layer on a substrate;
sputtering an adhesion layer on the lower insulating layer, sputtering a first metal layer, and patterning the first metal layer by adopting a photoresist mode to form a temperature sensing layer lead;
forming the outline of the temperature sensitive metal in the temperature sensing layer by adopting a photoresist mode above the temperature sensing layer lead;
sputtering an adhesion layer and then sputtering temperature sensitive metal;
removing the photoresist, and leaving the temperature sensitive metal with the designated profile to form a temperature sensing layer;
manufacturing a middle insulating layer above the temperature sensing layer;
sputtering an adhesion layer on the middle insulating layer, sputtering a second metal layer, and patterning the second metal layer by adopting a photoresist mode to form an electrode layer;
manufacturing an upper insulating layer on the electrode layer;
spin-coating a photoresist, patterning the photoresist by photoetching, and etching and exposing the electrode part, the pad part and the whole outline of the electrode device by using a dry etching method;
releasing the electrode device.
Compared with the prior art, the invention has the following beneficial effects:
1. the invention utilizes MEMS technology for processing, can be used for cardiac pulse field ablation under lower voltage, has the functions of impedance detection and electrocardiosignal recording to evaluate the ablation effect, and the temperature sensing layer can accurately measure the temperature in situ; the invention can improve the safety and efficiency of the cardiac pulse field ablation.
2. The electrode is flexible as a whole, can be directly attached to the surface of the heart, and can also be attached to the end part of a medical catheter by using biological glue for ablation by means of interventional operation.
Drawings
Other features, objects and advantages of the invention will become more apparent upon reading of the detailed description of non-limiting embodiments with reference to the following drawings:
FIG. 1 is an exploded schematic view of a MEMS electrode device for cardiac pulsed field ablation in an embodiment of the present invention;
FIG. 2 is a schematic structural diagram of an electrode layer according to an embodiment of the present invention;
FIG. 3 is a schematic diagram of a pulsed electrical signal applied in an embodiment of the present invention;
FIG. 4 is a schematic diagram illustrating simulation of electric fields of electrodes according to an embodiment of the present invention;
FIG. 5 is a schematic structural diagram of a temperature sensitive metal in a temperature sensing layer according to an embodiment of the present invention;
fig. 6 is a schematic flow chart of a method for manufacturing a MEMS electrode device for cardiac pulsed field ablation in an embodiment of the present invention.
In the figure: 1 is a lower insulating layer, 2 is a temperature sensing layer, 21 is a temperature sensitive metal, 3 is a middle insulating layer, 4 is an electrode layer, 41 is a circular electrode, 42 is an annular electrode, 5 is an upper insulating layer, and 6 is an electrode modification layer; a represents a potential distribution simulation result, and B represents an electric field intensity distribution simulation result.
Detailed Description
The present invention will be described in detail with reference to specific examples. The following examples will assist those skilled in the art in further understanding the invention, but are not intended to limit the invention in any way. It should be noted that variations and modifications can be made by persons skilled in the art without departing from the spirit of the invention. All falling within the scope of the present invention. In the description of the embodiments of the present invention, it should be noted that the terms "first", "second", and the like in the description and the claims of the present invention and the drawings described above are used for distinguishing similar objects and not necessarily for describing a particular order or sequence. It is to be understood that the data so used is interchangeable under appropriate circumstances such that the embodiments of the invention described herein are capable of operation in sequences other than those illustrated or described herein.
The embodiment of the invention provides an MEMS electrode device for cardiac pulse field ablation, which comprises a lower insulating layer 1, a temperature sensing layer 2, a middle insulating layer 3, an electrode layer 4, an upper insulating layer 5 and an electrode modification layer 6 which are sequentially arranged from bottom to top, wherein the temperature sensing layer 2 is arranged on the lower insulating layer; wherein, the electrode modification layer 6 is used for reducing the electrochemical impedance of the electrode and improving the charge storage capacity; the electrode layer 4 is used for applying a pulse electrical signal to the heart tissue, enabling the myocardial cells to generate irreversible electroporation, simultaneously recording the electrical impedance of the heart tissue before and after ablation in each pulse field, and also recording the electrocardiosignals of the heart tissue before and after ablation for evaluating the ablation effect; the temperature sensing layer 2 is used to record the dynamic temperature change during the ablation process in situ to obtain the optimal ablation parameters.
The electrode device in the embodiment of the invention can be used for cardiac pulse field ablation, and has an impedance detection function and an electrocardiosignal recording function so as to evaluate the ablation effect, and the temperature sensing layer 2 can accurately measure the temperature in situ; the invention can improve the safety and efficiency of the cardiac pulse field ablation.
Referring to fig. 2, in some preferred embodiments, the electrode layer 4 comprises a circular electrode 41 at the center and a ring electrode 42 around the circular electrode 41, the circular electrode 41 and the ring electrode 42 form a central radial electric field, so as to limit the energy within the electrode, and the structure can perform precise point-like ablation on the heart tissue. The electrode layer 4 further includes electrode layer leads respectively connecting the circular electrode 41 and the ring electrode 42, and preferably, the electrode layer leads are serpentine to prevent the leads from being easily broken during deformation of the device.
The material of the electrode layer 4 needs to have good biocompatibility, the thickness of the electrode layer 4 needs to be within the range that the MEMS process can process, and in some preferred embodiments, the material of the electrode layer 4 is gold, platinum or carbon, etc., and the thickness is 100-500 nm. The radius of the circular electrode 41 and the inner radius and the outer radius of the annular electrode 42 are set according to the size of a designed single ablation point, so that the size of the ablation point with accurate size is ensured. Preferably, the radius of the circular electrode 41 is 50-500 μm; the inner radius of the annular electrode 42 is 100-; the distance between the circumference of the circular electrode 41 and the inner ring circumference of the annular electrode 42 is less than 1mm, the small distance between the electrodes can realize low-voltage pulse field ablation, and the high electric field intensity required by the pulse field ablation can be formed by applying low voltage.
The circular electrode 41 and the ring electrode 42 are used for connection with two electrodes, i.e. an anode and a cathode, respectively, which deliver a pulsed electrical signal. The pulsed electrical signal applied to the electrode device satisfies the following condition: the pulse waveform (i.e. the shape of the pulse voltage signal) is a unipolar pulse square wave or a bipolar pulse square wave; the voltage (namely the peak value of the pulse voltage signal) is 10-500V, and is used for realizing low-voltage pulse field ablation; pulse widths (i.e., the duration of each pulse) are 1-100 μ s; the pulse frequency (namely the repetition frequency of the pulse voltage signal) is 1-10 Hz; the number of pulses (i.e., the number of pulses applied per ablation site) is 50-120.
Preferably, with reference to fig. 3, the following conditions are satisfied for a schematic diagram of the applied pulsed electrical signal: the pulse waveform is a unipolar pulse square wave; the voltage is 100V; the pulse width is 100 mus; the pulse frequency is 1 Hz; the number of pulses was 99.
Referring to fig. 4, which is an electrode electric field simulation diagram, after a pulse electric signal is applied to a circular electrode 41 located at the center and a ring electrode 42 located at the periphery, an electric potential distribution simulation result a and an electric field intensity distribution simulation result B show that the two can form an electric field with a radial center, so that energy is limited in the range of the electrode, and the structure can perform accurate point-like ablation on cardiac tissue.
In some preferred embodiments, referring to fig. 5, the temperature sensing layer 2 comprises a temperature sensitive metal 21 in a serpentine shape (i.e. a serpentine line shape) to achieve an increase in its effective length in a limited area, resulting in a larger amount of resistance change. The temperature sensitive metal 21 is made of a metal with a large resistance temperature coefficient, such as platinum or gold, to obtain a large sensitivity. The temperature sensing layer 2 further includes temperature sensing layer leads extending from the temperature sensitive metal 21, and preferably the temperature sensing layer leads are serpentine (i.e., serpentine) to prevent the leads from being easily broken during device deformation. The thickness of the temperature sensing layer 2 is 100-500nm, when the thickness of the temperature sensing layer 2 is too small, the temperature sensing layer is easy to break and break, and when the thickness is too large, the resistance value is reduced. The temperature sensing layer 2 and the electrode layer 4 are stacked up and down at an electrode end, and the electrode end and the lead end are respectively positioned at two ends of the temperature sensing layer 2 or the electrode layer 4; preferably, the temperature sensing layer 2 is stacked up and down in position with the ends of the electrode layer 3 formed by the circular electrode 41 and the ring electrode 42, separated by only the middle insulating layer 3, to achieve accurate measurement of temperature in situ.
In some preferred embodiments, the electrode modification layer 6 is formed by electroplating, and the material of the electrode modification layer 6 is any one of platinum black, iridium oxide and polyethylene dioxythiophene-polystyrene sulfonic acid, preferably platinum black, so as to reduce the electrochemical impedance of the electrode and improve the charge storage capacity.
In order to ensure the overall flexibility of the electrode, in some preferred embodiments, the lower insulating layer 1, the middle insulating layer 3 and the upper insulating layer 5 are made of the same material, and are convenient to process by using the same material, and have good compatibility with the same material, good bonding force and sealing performance, the insulating layer is made of a biocompatible material such as Parylene (Parylene), Polyimide (Polyimide) or SU-8 photoresist, the thickness of the lower insulating layer 1, the middle insulating layer 3 and the upper insulating layer 5 is 1-200 μm, if the thickness of the insulating layer is too small, the device is easy to break, and if the thickness is too large, the flexibility of the device is reduced. The electrode device in the embodiment of the invention is flexible as a whole, can be directly attached to the surface of the heart, and can also be attached to the end part of a medical catheter by using biological glue for ablation by means of interventional operation.
The embodiment of the invention also provides a preparation method of the above MEMS electrode device for cardiac pulse field ablation, which includes:
s1, manufacturing a lower insulating layer on the substrate;
s2, sputtering an adhesion layer on the lower insulating layer, wherein the adhesion layer can be made of titanium or chromium, sputtering a first metal layer, patterning the first metal layer by adopting a photoresist mode, specifically, spin-coating photoresist, patterning the photoresist by photoetching, and patterning the metal layer by wet etching or dry etching to form a temperature sensing layer lead;
s3, forming the outline of the temperature sensitive metal in the temperature sensing layer by adopting a photoresist mode above the temperature sensing layer lead;
s4, sputtering an adhesion layer, wherein the material of the adhesion layer can be titanium or chromium, and then sputtering temperature sensitive metal;
s5, removing the photoresist, leaving the temperature sensitive metal with the designated outline, specifically, soaking in hot acetone, and removing the photoresist through ultrasonic vibration to form a temperature sensing layer;
s6, manufacturing a middle insulating layer above the temperature sensing layer;
s7, sputtering an adhesion layer on the middle insulating layer, wherein the adhesion layer can be made of titanium or chromium, sputtering a second metal layer, patterning the second metal layer by adopting a photoresist mode, specifically, spin-coating photoresist, patterning the photoresist by photoetching, and patterning the metal layer by wet etching or dry etching to form an electrode layer;
s8, manufacturing an upper insulating layer on the electrode layer;
s9, spin-coating photoresist, patterning the photoresist through photoetching, and etching and exposing the electrode part, the pad part and the whole outline of the electrode device by using a dry etching method;
s10, releasing the electrode device.
Preferably, referring to fig. 6, the method for preparing the MEMS electrode device for cardiac pulsed field ablation comprises the steps of:
s1, as shown in fig. 6 (a), depositing Parylene-C (Parylene-C) with a thickness of 5 μm as a lower insulating layer on a 4-inch silicon wafer by using a chemical vapor deposition method;
s2, as shown in fig. 6 (b), sputtering a layer of chromium with a thickness of 20nm as an adhesion layer on the lower insulating layer, and then sputtering gold with a thickness of 400 nm; as shown in fig. 6 (c), spin-coating a photoresist, patterning the photoresist by photolithography, and patterning chrome/gold by wet etching to form a temperature sensing layer lead;
s3, as shown in fig. 6 (d), spin-coating a photoresist, and patterning the photoresist by photolithography to form a profile of the temperature-sensitive metal in the temperature sensing layer;
s4, as shown in fig. 6 (e), sputtering a layer of chromium with a thickness of 20nm as an adhesion layer, and then sputtering platinum with a thickness of 400nm as a temperature-sensitive metal;
s5, as shown in fig. 6 (f), soaking in hot acetone, and removing the photoresist by ultrasonic vibration, leaving the temperature sensitive metal platinum with a specific profile;
s6, as shown in fig. 6 (g), depositing Parylene-C (Parylene-C) with a thickness of 5 μm by using a chemical vapor deposition method as a middle insulating layer;
s7, as shown in (h) of FIG. 6, sputtering a layer of chromium with the thickness of 20nm as an adhesion layer on the middle insulating layer, and then sputtering gold with the thickness of 400 nm; as shown in fig. 6 (i), a photoresist is spin-coated, the photoresist is patterned by photolithography, and gold is patterned by wet etching to form an electrode layer;
s8, as shown in (j) of fig. 6, depositing Parylene-C (Parylene-C) with a thickness of 5 μm by using a chemical vapor deposition method as an upper insulating layer;
s9, as shown in fig. 6 (k), spin-coating a photoresist, and patterning the photoresist by photolithography; as shown in (l) of fig. 6, the electrode part, the pad part and the overall profile of the electrode device are etched and exposed using a reactive ion etching method;
s10, as shown in fig. 6 (m), releasing the electrode device.
The MEMS electrode device for cardiac pulse field ablation and the preparation method thereof in the embodiment of the invention utilize the MEMS technology for processing, can be used for cardiac pulse field ablation under lower voltage, and has the impedance detection function and the electrocardiosignal recording function so as to evaluate the ablation effect, and the temperature sensing layer can accurately measure the temperature in situ; the invention can improve the safety and efficiency of the cardiac pulse field ablation.
The foregoing description of specific embodiments of the present invention has been presented. It is to be understood that the present invention is not limited to the specific embodiments described above, and that various changes and modifications may be made by one skilled in the art within the scope of the appended claims without departing from the spirit of the invention. The above-described preferred features may be used in any combination without conflict with each other.
Claims (10)
1. An MEMS electrode device for cardiac pulse field ablation is characterized by comprising a lower insulating layer, a temperature sensing layer, a middle insulating layer, an electrode layer, an upper insulating layer and an electrode modification layer which are sequentially arranged from bottom to top;
the electrode modification layer is used for reducing the electrochemical impedance of the electrode and improving the charge storage capacity;
the electrode layer is used for applying pulse electrical signals to the cardiac tissue, simultaneously recording the electrical impedance of the cardiac tissue before and after each pulse field ablation, and also used for recording the electrocardiosignals of the cardiac tissue before and after the ablation;
the temperature sensing layer is used for in-situ recording of dynamic temperature changes in the ablation process.
2. The MEMS electrode device for cardiac pulsed field ablation of claim 1, wherein the electrode layer comprises a circular electrode and a ring electrode located around the circular electrode, the circular electrode and the ring electrode forming a central radial electric field.
3. The MEMS electrode device for cardiac pulsed field ablation of claim 1, wherein the radius of the circular electrode is 50-500 μ ι η; the inner radius of the annular electrode is 100-; the distance between the circumference of the circular electrode and the inner ring circumference of the annular electrode is less than 1 mm.
4. The MEMS electrode device for cardiac pulsed field ablation of claim 1, wherein the circular electrode and the ring electrode are for connection with two electrodes, respectively, that deliver pulsed electrical signals; the pulsed electrical signal applied to the electrode device satisfies the following condition: the pulse waveform is a unipolar pulse square wave or a bipolar pulse square wave; the voltage is 10-500V; the pulse width is 1-100 mus; the pulse frequency is 1-10 Hz; the number of pulses is 50-120.
5. The MEMS electrode device for cardiac pulsed field ablation of claim 1, wherein the temperature sensing layer comprises a temperature sensitive metal in a serpentine shape.
6. The MEMS electrode device for cardiac pulsed field ablation of claim 1, wherein the temperature sensing layer and the electrode layer are stacked one on top of the other at an electrode end.
7. The MEMS electrode device for cardiac pulsed field ablation of claim 1, wherein the thickness of the temperature sensing layer is 100-500 nm.
8. The MEMS electrode device for cardiac pulsed field ablation of claim 1, wherein the lower insulating layer, the middle insulating layer and the upper insulating layer are formed of the same material, and the thickness of the lower insulating layer, the middle insulating layer and the upper insulating layer is 1-200 μm.
9. The MEMS electrode device for cardiac pulse field ablation according to claim 1, wherein the electrode modification layer is formed by electroplating, and the material of the electrode modification layer is any one of platinum black, iridium oxide and polyethylene dioxythiophene-polystyrene sulfonic acid.
10. A method of making a MEMS electrode device for cardiac pulsed field ablation according to any of claims 1-9, comprising:
manufacturing a lower insulating layer on a substrate;
sputtering an adhesion layer on the lower insulating layer, sputtering a first metal layer, and patterning the first metal layer by adopting a photoresist mode to form a temperature sensing layer lead;
forming the outline of the temperature sensitive metal in the temperature sensing layer by adopting a photoresist mode above the temperature sensing layer lead;
sputtering an adhesion layer and then sputtering temperature sensitive metal;
removing the photoresist, and leaving the temperature sensitive metal with the designated profile to form a temperature sensing layer;
manufacturing a middle insulating layer above the temperature sensing layer;
sputtering an adhesion layer on the middle insulating layer, sputtering a second metal layer, and patterning the second metal layer by adopting a photoresist mode to form an electrode layer;
manufacturing an upper insulating layer on the electrode layer;
spin-coating a photoresist, patterning the photoresist by photoetching, and etching and exposing the electrode part, the pad part and the whole outline of the electrode device by using a dry etching method;
releasing the electrode device.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210422714.6A CN114852947A (en) | 2022-04-21 | 2022-04-21 | MEMS electrode device for cardiac pulse field ablation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210422714.6A CN114852947A (en) | 2022-04-21 | 2022-04-21 | MEMS electrode device for cardiac pulse field ablation and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN114852947A true CN114852947A (en) | 2022-08-05 |
Family
ID=82632037
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210422714.6A Pending CN114852947A (en) | 2022-04-21 | 2022-04-21 | MEMS electrode device for cardiac pulse field ablation and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN114852947A (en) |
Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060089637A1 (en) * | 2004-10-14 | 2006-04-27 | Werneth Randell L | Ablation catheter |
| US20120265069A1 (en) * | 2011-04-13 | 2012-10-18 | St. Jude Medical, Inc. | Acoustic transducer for pulse-echo monitoring and control of thermally ablative lesioning in layered and nonlayered tissues, catheter contact monitoring, tissue thickness measurement and pre-pop warning |
| US20160113712A1 (en) * | 2014-10-24 | 2016-04-28 | Boston Scientific Scimed Inc. | Medical devices with a flexible electrode assembly coupled to an ablation tip |
| CN106999151A (en) * | 2014-11-25 | 2017-08-01 | 皇家飞利浦有限公司 | ultrasonic system and method |
| CN112932648A (en) * | 2021-04-07 | 2021-06-11 | 上海宏桐实业有限公司 | Method for improving electroporation effect and preheating pulse ablation system |
| CN113017819A (en) * | 2019-12-24 | 2021-06-25 | 深圳市赛诺思医疗科技有限公司 | Pulse ablation device |
| CN113768616A (en) * | 2021-10-20 | 2021-12-10 | 四川锦江电子科技有限公司 | Integrated system for cardiac ablation |
| CN114052890A (en) * | 2020-08-07 | 2022-02-18 | 上海微创电生理医疗科技股份有限公司 | Impulse ablation device, system, parameter setting method and readable storage medium |
-
2022
- 2022-04-21 CN CN202210422714.6A patent/CN114852947A/en active Pending
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060089637A1 (en) * | 2004-10-14 | 2006-04-27 | Werneth Randell L | Ablation catheter |
| US20120265069A1 (en) * | 2011-04-13 | 2012-10-18 | St. Jude Medical, Inc. | Acoustic transducer for pulse-echo monitoring and control of thermally ablative lesioning in layered and nonlayered tissues, catheter contact monitoring, tissue thickness measurement and pre-pop warning |
| US20160113712A1 (en) * | 2014-10-24 | 2016-04-28 | Boston Scientific Scimed Inc. | Medical devices with a flexible electrode assembly coupled to an ablation tip |
| CN106999151A (en) * | 2014-11-25 | 2017-08-01 | 皇家飞利浦有限公司 | ultrasonic system and method |
| CN113017819A (en) * | 2019-12-24 | 2021-06-25 | 深圳市赛诺思医疗科技有限公司 | Pulse ablation device |
| CN114052890A (en) * | 2020-08-07 | 2022-02-18 | 上海微创电生理医疗科技股份有限公司 | Impulse ablation device, system, parameter setting method and readable storage medium |
| CN112932648A (en) * | 2021-04-07 | 2021-06-11 | 上海宏桐实业有限公司 | Method for improving electroporation effect and preheating pulse ablation system |
| CN113768616A (en) * | 2021-10-20 | 2021-12-10 | 四川锦江电子科技有限公司 | Integrated system for cardiac ablation |
Non-Patent Citations (3)
| Title |
|---|
| MENGFEI XU等: "FRACTAL MICROELECTRODES INTEGRATED WITH THE CATHETER FOR LOW-VOLTAGE PULSED FIELD ABLATION", 2023 IEEE 36TH INTERNATIONAL CONFERENCE ON MICRO ELECTRO MECHANICAL SYSTEMS, 3 June 2023 (2023-06-03), pages 405 - 408 * |
| 余锂镭等: "脉冲电场消融治疗阵发性心房颤动的初步临床应用", 中国心脏起搏与心电生理杂志, vol. 35, no. 5, 25 October 2021 (2021-10-25), pages 434 - 438 * |
| 唐龙军等: "用于心血管介入治疗的柔性MEMS电化学阻抗传感器", 中国科技论文, vol. 12, no. 8, 30 April 2017 (2017-04-30), pages 957 - 961 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US20210161453A1 (en) | Electrophysiology catheter design | |
| US9848795B2 (en) | Electrode assembly | |
| US11647935B2 (en) | Masked ring electrodes | |
| US8655427B1 (en) | Catheter systems for measuring electrical properties of tissue and methods of use | |
| JPH06507797A (en) | Single-phase action potential/ablation combination catheter and high-performance filter system | |
| US20040073110A1 (en) | Transseptal access tissue thickness sensing dilator devices and methods for fabricating and using same | |
| JP2014012174A (en) | High resolution electrophysiology catheter | |
| US10758144B2 (en) | Flexible electrode for cardiac sensing and method for making | |
| Berte et al. | Impact of micro-, mini-and multi-electrode mapping on ventricular substrate characterisation | |
| CN114852947A (en) | MEMS electrode device for cardiac pulse field ablation and preparation method thereof | |
| CN115568938A (en) | Fractal structure microelectrode, preparation method thereof and catheter | |
| US20130190586A1 (en) | Multi-Terminal Nanoelectrode Array | |
| CN112353484B (en) | Flexible microsensor system, extensible flexible device and preparation method | |
| Xu et al. | Low-voltage flexible interdigital electrode for pulsed field ablation with effect evaluation | |
| KR101010925B1 (en) | One point detection of electrocardiography using MEMS based electrode module | |
| CN117503318A (en) | MEMS device for irreversible electroporation treatment of heart tissue and preparation method thereof | |
| JPH01204647A (en) | Sticking needle | |
| JP2023531437A (en) | Devices and methods for delivering electroporation therapy | |
| CN116264987A (en) | High frequency tissue ablation using coated electrodes |
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 |