CN112755385A - Electrode for defected skull - Google Patents

Electrode for defected skull Download PDF

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Publication number
CN112755385A
CN112755385A CN202110101086.7A CN202110101086A CN112755385A CN 112755385 A CN112755385 A CN 112755385A CN 202110101086 A CN202110101086 A CN 202110101086A CN 112755385 A CN112755385 A CN 112755385A
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CN
China
Prior art keywords
electrode
insulating layer
skull
circuit board
dielectric layer
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Pending
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CN202110101086.7A
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Chinese (zh)
Inventor
赵宇
孙崇然
王艳城
黄勇
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Jiangsu Hailai Xinchuang Medical Technology Co Ltd
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Jiangsu Hailai Xinchuang Medical Technology Co Ltd
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Priority to CN202110101086.7A priority Critical patent/CN112755385A/en
Publication of CN112755385A publication Critical patent/CN112755385A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0472Structure-related aspects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/40Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

The invention provides an electrode for a defective skull, which comprises: the flexible printed circuit board comprises a flexible printed circuit board 1, a bonding pad 2 and a dielectric layer 4, wherein the bonding pad 2 is attached to the surface of the flexible printed circuit board 1 facing the skin of a human body and is electrically connected with the flexible printed circuit board 1; the first surface of the dielectric layer 4 is attached to the pad 2, and the second surface of the dielectric layer 4 is attached to the insulating layer 5; the insulating layer 5 is between the dielectric layer 4 and the human skin. The insulating layer 5 is added between the dielectric layer 4 and the skin of the human body, so that the electric field intensity can be ensured and the heat generation can be reduced under the condition of not reducing the applied voltage, the situation that the applied voltage cannot be tolerated by a patient due to the rapid rise of the skin surface temperature is avoided, and the patient with the skull defect glioblastoma multiforme is brought into the application range of tumor electric field treatment.

Description

Electrode for defected skull
Technical Field
The invention relates to the field of tumor electric field treatment, in particular to an electrode for defected skull.
Background
Tumor electric field therapy (TTFields) is an antimitotic, noninvasive tumor therapy with broad anti-tumor properties. TTFields exhibit the ability to disrupt tumor cell division, inhibit tumor cell proliferation, interfere with tumor cell migration and invasion, and reduce tumor DNA repair in vitro and in vivo experiments on a variety of tumor cell lines by delivering low intensity, medium frequency, alternating electric fields to solid tumor sites through an externally applied transducer array. The clinical test results show that: compared with the control group of the primary glioblastoma, the total survival rate of patients treated by TTfields is greatly improved, and the test result of patients with unresectable malignant pleural mesothelioma is better.
When treating a patient, TTFields couples an electric field into the patient through a transducer array made of multiple ceramic plates with high dielectric constants. Reconstructing a head model of a patient with glioblastoma according to a head nuclear magnetic resonance image of the patient, laying out electrodes on two sides of the outer surface of the skin of the head according to a standard attachment scheme of an existing electrode slice, and establishing a COMSOL simulation model as shown in figure 1.
FIG. 2 shows a skull incision made during surgery on a patient with glioblastoma, the skull not being replaced due to the high intracranial pressure.
At present, the electrical signal simulation is respectively carried out on the complete skull and the defect skull of a patient with the glioblastoma multiforme, and the difference of the distribution of an electric field on the head is observed. Mainly focuses on the electric field intensity of the tumor position and the heat generation of hydrogel attached to the skull defect position electrode. The applied electrical signal is a voltage: 160Vp-p, frequency: 200 kHz.
Fig. 3 shows the electric field distribution of the head cross-section for both the intact (left) and defective (right) skull conditions when the electrodes do not include an insulating layer, with the tumor area circled. Here, since the difference in the electric field intensity is large in each portion of the head, the regions having the electric field intensity of more than 5V/cm are all shown as 5V/cm. As can be seen from fig. 3, the electric field strength at the interface of the tumor core and the outer shell is significantly enhanced in case of skull defects.
Figure 4 shows the electric field intensity distribution on the head tumor for both the cranial integrity (left) and cranial defect (right) cases when the electrodes do not include an insulating layer. It can be seen from fig. 4 that the electric field strength on the tumor is significantly increased in the case of a skull defect. Through calculation, the mean electric field intensity of the tumor shell under the condition of complete skull is 1.74V/cm, and the mean electric field intensity of the tumor shell under the condition of skull defect is 2.09V/cm.
Geometrically it can be seen that the skull defect site covered the first two pieces of electrodes on the right side. The heat generation power of the hydrogel attached to the lower surfaces of the two electrodes when the electrodes do not comprise insulating layers under the two conditions of skull integrity and skull defect is calculated respectively. Under the condition of complete skull, the heat generation power of the two pieces of hydrogel is 5.23e 5W/m respectively3And 1.99e 5W/m3. Under the condition of skull defect, the heat generation power of the two pieces of hydrogel is 1.41e 6W/m respectively3And 7.26e 5W/m3
A large increase in the heat-generating power causes a rapid increase in the skin surface temperature, resulting in the patient being unable to withstand the applied voltage. Since all electrodes on one side are connected in series, the voltage is the same for all electrodes. The reduced voltage results in a significantly reduced therapeutic effect, which is one of the reasons why the current electric field therapy is not applied to the patient with the skull defect.
Disclosure of Invention
In order to overcome the defects of the existing electrode, an electric field treatment electrode suitable for a patient with glioblastoma multiforme with a defective skull is provided, and the purpose of the electric field treatment electrode is to expand the application range of tumor electric field treatment.
According to one aspect of the present invention, there is provided an electrode for a defective skull, comprising: the flexible printed circuit board comprises a flexible printed circuit board 1, a bonding pad 2 and a dielectric layer 4, wherein the bonding pad 2 is attached to the surface of the flexible printed circuit board 1 facing the skin of a human body and is electrically connected with the flexible printed circuit board 1; the first surface of the dielectric layer 4 is attached to the pad 2, and the second surface of the dielectric layer 4 is attached to the insulating layer 5; the insulating layer 5 is between the dielectric layer 4 and the human skin.
According to one aspect of the invention, the electrode for defective skull further comprises a conductive gel 6, the conductive gel 6 being between the insulating layer 5 and the human skin.
According to one aspect of the invention, the dielectric constant of the insulating layer 5 in the electrode for defective skull is lower than 100 and the thickness is less than 100 μm.
According to one aspect of the present invention, the dielectric constant of the insulating layer 5 in the electrode for defective skull is 2 to 20 and the thickness is 0.5 to 10 μm.
According to one aspect of the invention, the insulating layer 5 in the electrode for defective skull has a dielectric constant of 2.5 and a thickness of 2 μm.
According to one aspect of the invention, the pads 2 in the electrode for defective skull are soldered on the flexible circuit board 1.
According to one aspect of the invention, the pad 2 in the electrode for the defective skull is a partially exposed conductive portion on the flexible circuit board 1.
According to one aspect of the invention, the electrode for defective skull further comprises a conductive layer 3, said conductive layer 3 being between the pad 2 and the dielectric layer 4 and being electrically connected to said pad 2.
According to an aspect of the present invention, the dielectric constant of the dielectric layer 4 in the electrode for defective skull is 1000 or more and 50000 or less.
According to one aspect of the invention, the dielectric layer 4 in the electrode for defective skull has a dielectric constant of 24000.
According to one aspect of the invention, the electrically conductive gel 6 in the electrode for defective skull is a hydrogel.
The invention has the technical effects that:
the invention provides an electrode for a defective skull, which comprises: the flexible printed circuit board comprises a flexible printed circuit board 1, a bonding pad 2 and a dielectric layer 4, wherein the bonding pad 2 is attached to the surface of the flexible printed circuit board 1 facing the skin of a human body and is electrically connected with the flexible printed circuit board 1; the first surface of the dielectric layer 4 is attached to the pad 2, and the second surface of the dielectric layer 4 is attached to the insulating layer 5; the insulating layer 5 is between the dielectric layer 4 and the human skin. The insulating layer 5 is added between the dielectric layer 4 and the skin of the human body, so that the electric field intensity can be ensured and the heat generation can be reduced under the condition of not reducing the applied voltage, the situation that the applied voltage cannot be tolerated by a patient due to the rapid rise of the skin surface temperature is avoided, and the patient with the skull defect glioblastoma multiforme is brought into the application range of tumor electric field treatment.
Drawings
FIG. 1 shows a schematic diagram of TTfields coupling an electric field into a patient's body through a transducer array made of multiple ceramic plates with high dielectric constants when treating the patient;
FIG. 2 shows a schematic representation of a skull incision made during surgery on a glioblastoma patient;
FIG. 3 shows a schematic representation of the electric field distribution of a cross-section of a head, both in the case of intact skull (left) and in the case of a defective skull (right), when the electrodes do not comprise an insulating layer;
FIG. 4 shows a schematic of the electric field intensity distribution over a head tumor when the electrodes do not include an insulating layer, for both cases of skull integrity (left) and skull defect (right);
FIG. 5 shows a layered perspective view of an electrode for a defective skull, according to an embodiment of the invention;
FIG. 6 shows a perspective view of an electrode for a defective skull, according to an embodiment of the invention;
FIG. 7 is a schematic diagram showing the distribution of tumor electric field intensity after an insulating layer 5 is added on two electrodes at the skull defect of the original COMSOL simulation model according to the embodiment of the present invention;
FIG. 8 is a graph showing the relationship between the thickness of the insulating layer 5 and the average electric field intensity at a tumor site when the dielectric constant of the insulating layer 5 is 2.5 according to an embodiment of the present invention;
FIG. 9 shows a schematic representation of the thickness of the insulation layer 5 as a function of the heat generation power of the hydrogel at two electrodes at the center and at the edge of the defective skull for an insulation layer 5 with a dielectric constant of 2.5 according to an embodiment of the invention;
FIG. 10 is a graph showing the relationship between the dielectric constant of the insulating layer 5 and the average electric field intensity at a tumor site when the thickness of the insulating layer 5 is 2 μm according to an embodiment of the present invention; and
fig. 11 shows a schematic representation of the dielectric constant of the insulating layer 5 as a function of the heat generation power of the hydrogel at both electrodes at the center and at the edge of the defective skull, for an insulating layer 5 with a thickness of 2 μm according to an embodiment of the invention.
Detailed Description
In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of one or more embodiments. It may be evident, however, that such embodiment(s) may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form in order to facilitate describing one or more embodiments.
Various embodiments according to the present invention will be described in detail below with reference to the accompanying drawings.
FIG. 5 shows an electrode for a defective skull, according to an embodiment of the invention, comprising: the flexible printed circuit board comprises a flexible printed circuit board 1, a bonding pad 2 and a dielectric layer 4, wherein the bonding pad 2 is attached to the surface of the flexible printed circuit board 1 facing the skin of a human body and is electrically connected with the flexible printed circuit board 1; the first surface of the dielectric layer 4 is attached to the pad 2, and the second surface of the dielectric layer 4 is attached to the insulating layer 5; the insulating layer 5 is between the dielectric layer 4 and the human skin.
According to one embodiment, the electrode for defective skull further comprises a conductive gel 6, the conductive gel 6 being between the insulating layer 5 and the human skin.
Specifically, the hydrogel 6 is in the shape of a circle with a diameter of 20mm and a thickness of 1mm, and is attached to the insulating layer 5.
According to one embodiment, the electrode for defective skull further comprises a conductive layer 3, said conductive layer 3 being between the pad 2 and the dielectric layer 4 and being electrically connected with said pad 2.
Specifically, as shown in fig. 5, the flexible circuit board 1 may be an FPC flexible circuit board 1, which is in the shape of a table tennis bat, the circular portion is a circle with a diameter of 20mm, a solder joint is left at the center of the circle, the handle portion is customized according to specific requirements, and the internal lead can transmit an electrical signal to the solder joint.
According to one embodiment, the pads 2 may be soldered on the flexible circuit board 1.
Specifically, the bonding pad 2 is a circular copper layer with the diameter of 20mm and the thickness of 0.1mm, and is welded at the welding point of the FPC flexible circuit board 1 and completely matched with the circular part of the FPC flexible circuit board.
According to one embodiment, the pads 2 may be partially exposed conductive portions on the flexible circuit board 1.
Specifically, as shown in fig. 5, the conductive layer 3 may be a silver layer in the shape of a circle with a diameter of 20mm and a thickness of 0.01 mm. The dielectric layer 4 may be a high dielectric constant ceramic sheet. The silver layer 3 can be plated on the surface of the high-dielectric-constant ceramic plate 4 and is clamped between the bonding pad 2 and the high-dielectric-constant ceramic plate 4.
According to one embodiment, the dielectric constant of the dielectric layer 4 is 1000 or more and 50000 or less.
According to one embodiment, the dielectric layer 4 has a dielectric constant of 24000.
Specifically, the high-dielectric-constant ceramic sheet 4 has a diameter of 20mm, a thickness of 1mm, and a dielectric constant of 24000.
According to one embodiment, the dielectric constant of the insulating layer 5 is lower than 100 and the thickness is less than 100 μm.
According to one embodiment, the dielectric constant of the insulating layer 5 is between 2 and 20 and the thickness is between 0.5 and 10 μm.
According to one embodiment, the dielectric constant of the insulating layer 5 is 2.5 and the thickness is 2 μm.
According to one embodiment, the electrically conductive gel 6 is a hydrogel.
Specifically, the insulating layer 5 has a dielectric constant of 2.5 and a thickness of 2 μm, and is deposited on the other surface of the high-dielectric-constant ceramic sheet 4. Sandwiched between a high dielectric constant ceramic sheet 4 and a hydrogel 6.
FIG. 6 shows a perspective view of an electrode for a defective skull, according to an embodiment of the present invention. As shown in fig. 6, the FPC flexible circuit board 1, the bonding pad 2, the silver layer 3, the high-dielectric-constant ceramic sheet 4, and the insulating layer 5 are sequentially stacked, sealed by an underfil process, and then attached with the hydrogel 6.
After the insulating layer 5 is added to the two electrodes at the skull defect position of the original COMSOL simulation model, the heat generation power of the two hydrogels is calculated to be 2.56e 5W/m respectively3And 2.68e 5W/m3. Compared with the case of a complete skull, the total heat production is obviously reduced.
Fig. 7 shows a schematic diagram of tumor electric field intensity distribution after an insulating layer 5 is added on two electrodes at the skull defect of the original COMSOL simulation model according to the embodiment of the invention. After the insulating layer 5 is added on the two electrodes at the skull defect position of the original COMSOL simulation model, the intensity distribution of tumor electric field is shown in figure 7. The mean electric field intensity of the tumor shell is 1.82V/cm, which is still higher than that of the tumor shell under the condition of a complete skull. Therefore, the method for depositing the insulating material on the interface of the ceramic plate and the hydrogel can ensure that the skull defect patient obtains the treatment effect which is not inferior to that of the complete skull patient, and the application range of the tumor electric field treatment is expanded.
The following studies are made regarding the choice of material properties and dimensions of the insulating layer 5:
the thin layer attached to the high dielectric material needs to be an insulating material in consideration of the fact that if it is a conductive substance, it itself generates heat under the action of an electric field. We can select the range of dielectric constant and thickness of suitable materials by means of simulation.
A dielectric constant value (2.5) is selected because most polymeric materials have dielectric constants close to this value. The average electric field intensity of the tumor part and the change of the heat generation power of the two pieces of hydrogel along with the thickness can be obtained by calculation, as shown in figures 8 and 9. Fig. 8 shows a schematic diagram of the relationship between the thickness of the insulating layer 5 and the average electric field intensity at the tumor site when the dielectric constant of the insulating layer 5 is 2.5 according to an embodiment of the present invention. Fig. 9 shows a schematic representation of the thickness of the insulation 5 at two electrodes missing the center and edge of the skull when the dielectric constant of the insulation 5 is 2.5 as a function of the heat generation power of the hydrogel (P1 and P2, respectively) according to an embodiment of the invention.
As can be seen from fig. 8 and 9, when the thickness reaches 2 μm, the electric field intensity and the rate of decrease in the heat generation power of the hydrogel of the two pieces of electrodes are significantly reduced; the electric field intensity and the heat generating power are basically stable when the thickness reaches 10 mu m. Therefore, 0.5 to 10 μm is a preferable thickness range for the dielectric constant value (2.5). The benefit of the reduction of the heat generation power obtained by increasing the thickness of the thin insulating layer 5 on this basis is not significant.
Fig. 10 shows a schematic diagram of the dielectric constant of the insulating layer 5 in relation to the average electric field intensity at the tumor site when the thickness of the insulating layer 5 is 2 μm according to an embodiment of the present invention. Fig. 11 shows a schematic representation of the dielectric constant of the insulating layer 5 as a function of the heat generation power of the hydrogel (P1 and P2, respectively) at two electrodes of the defective skull, central and peripheral, with a thickness of 2 μm of the insulating layer 5, according to an embodiment of the invention.
For a given layer thickness (2 μm), it can be seen that the electric field strength of the tumor increases somewhat when the dielectric constant is raised from 2.5 to 1000, as shown in fig. 10. But at the same time there was a significant increase in the heat production of the hydrogel, as shown in figure 11. Considering that our main objective is to reduce the heat generation power of the hydrogel substantially while ensuring that the electric field is not significantly reduced, a lower dielectric constant is a more preferred choice. In addition, the dielectric constant of most insulating materials is between 2 and 20, so 2 to 20 is a preferable range of the dielectric constant. Particularly, when the dielectric constant of the insulating layer 5 is 2.5 and the thickness is 2 μm, a strong electric field can be ensured under the condition of applying the same voltage, heat generation can be reduced, the phenomenon that the applied voltage cannot be tolerated by a patient due to rapid rise of the skin surface temperature is avoided, and a good effect of tumor electric field treatment on a patient with the glioblastoma multiforme with skull defect is achieved.
In summary, the thin layer material with dielectric constant of 2-20 and thickness of 0.5-10 μm, especially with dielectric constant of 2.5 and thickness of 2 μm, of the insulating layer given in the examples is the better solution obtained after analysis.
The invention provides an electrode for a defective skull, which comprises: the flexible printed circuit board comprises a flexible printed circuit board 1, a bonding pad 2 and a dielectric layer 4, wherein the bonding pad 2 is attached to the surface of the flexible printed circuit board 1 facing the skin of a human body and is electrically connected with the flexible printed circuit board 1; the first surface of the dielectric layer 4 is attached to the pad 2, and the second surface of the dielectric layer 4 is attached to the insulating layer 5; the insulating layer 5 is between the dielectric layer 4 and the human skin. The insulating layer 5 is added between the dielectric layer 4 and the skin of the human body, so that the electric field intensity can be ensured and the heat generation can be reduced under the condition of not reducing the applied voltage, the situation that the applied voltage cannot be tolerated by a patient due to the rapid rise of the skin surface temperature is avoided, and the patient with the skull defect glioblastoma multiforme is brought into the application range of tumor electric field treatment.
While the foregoing disclosure shows illustrative embodiments of the invention, it should be noted that various changes and modifications could be made herein without departing from the scope of the invention as defined by the appended claims. Furthermore, although elements of the invention may be described or claimed in the singular, the plural is contemplated unless limitation to a single element is explicitly stated.
Finally, it should be noted that: although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that changes may be made in the embodiments and/or equivalents thereof without departing from the spirit and scope of the invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (11)

1. An electrode for a defective skull, comprising: a flexible circuit board (1), a bonding pad (2) and a dielectric layer (4),
the welding plate (2) is attached to the surface of the flexible circuit board (1) facing the skin of a human body and is electrically connected with the flexible circuit board (1);
the first surface of the dielectric layer (4) is attached to the pad (2), and the second surface of the dielectric layer (4) is attached to the insulating layer (5);
the insulating layer (5) is between the dielectric layer (4) and the human skin.
2. The electrode for defective skull according to claim 1, characterized in that it further comprises a conductive gel (6), said conductive gel (6) being between said insulating layer (5) and the human skin.
3. The electrode for defective skull according to claim 1 characterized in that the dielectric constant of the insulating layer (5) is lower than 100 and the thickness is less than 100 μm.
4. The electrode for defective skull according to claim 3 characterized in that the dielectric constant of the insulating layer (5) is comprised between 2 and 20 and the thickness is comprised between 0.5 and 10 μm.
5. The electrode for defective skull according to claim 4 characterized in that the dielectric constant of the insulating layer (5) is 2.5 and the thickness is 2 μm.
6. The electrode for defective skull according to claim 1 characterized in that said pad (2) is soldered on said flexible circuit board (1).
7. The electrode for defective skull according to claim 1 characterized in that the pad (2) is a partially exposed conductive part on the flexible circuit board (1).
8. The electrode for defective skull according to claim 1, characterized in that it further comprises a conductive layer (3), said conductive layer (3) being between the pad (2) and the dielectric layer (4) and being electrically connected with said pad (2).
9. The electrode for defective skull according to claim 1 characterized in that the dielectric constant of the dielectric layer (4) is 1000 or more and 50000 or less.
10. The electrode for defective skull according to claim 9 characterized in that the dielectric constant of the dielectric layer (4) is 24000.
11. The electrode for defective skull according to claim 2 characterized in that said electrically conductive gel (6) is a hydrogel.
CN202110101086.7A 2021-01-26 2021-01-26 Electrode for defected skull Pending CN112755385A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202110101086.7A CN112755385A (en) 2021-01-26 2021-01-26 Electrode for defected skull

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202110101086.7A CN112755385A (en) 2021-01-26 2021-01-26 Electrode for defected skull

Publications (1)

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CN112755385A true CN112755385A (en) 2021-05-07

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CN202110101086.7A Pending CN112755385A (en) 2021-01-26 2021-01-26 Electrode for defected skull

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115970155A (en) * 2023-03-22 2023-04-18 深圳奥派森生物电磁科技有限公司 Metal substrate electrode, tumor electric field treatment electrode and system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115970155A (en) * 2023-03-22 2023-04-18 深圳奥派森生物电磁科技有限公司 Metal substrate electrode, tumor electric field treatment electrode and system
CN115970155B (en) * 2023-03-22 2023-08-22 深圳奥派森生物电磁科技有限公司 Metal substrate electrode, tumor electric field treatment electrode and system

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