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CN114099958B - Electric field therapeutic instrument and electrode patch thereof - Google Patents

Electric field therapeutic instrument and electrode patch thereof
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Publication number
CN114099958B
CN114099958BCN202111580039.1ACN202111580039ACN114099958BCN 114099958 BCN114099958 BCN 114099958BCN 202111580039 ACN202111580039 ACN 202111580039ACN 114099958 BCN114099958 BCN 114099958B
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CN
China
Prior art keywords
main body
electrode
electric field
electrode units
adjacent
Prior art date
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CN202111580039.1A
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Chinese (zh)
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CN114099958A (en
Inventor
陈晟
孙虎
沈琪超
于晶
张军
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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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Application filed by Jiangsu Hailai Xinchuang Medical Technology Co LtdfiledCriticalJiangsu Hailai Xinchuang Medical Technology Co Ltd
Priority to CN202111580039.1ApriorityCriticalpatent/CN114099958B/en
Publication of CN114099958ApublicationCriticalpatent/CN114099958A/en
Priority to PCT/CN2022/134717prioritypatent/WO2023051846A1/en
Priority to PCT/CN2022/134677prioritypatent/WO2023051845A1/en
Priority to US18/696,568prioritypatent/US20250229084A1/en
Priority to PCT/CN2022/137451prioritypatent/WO2023116448A1/en
Priority to PCT/CN2022/138105prioritypatent/WO2023116473A1/en
Priority to PCT/CN2022/140141prioritypatent/WO2023116644A1/en
Priority to US18/723,196prioritypatent/US20250177743A1/en
Priority to PCT/CN2022/140412prioritypatent/WO2023116708A1/en
Priority to PCT/CN2022/140432prioritypatent/WO2023116714A1/en
Application grantedgrantedCritical
Publication of CN114099958BpublicationCriticalpatent/CN114099958B/en
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Abstract

The invention provides an electric field therapeutic apparatus and an electrode patch thereof, wherein the electrode patch comprises a flexible circuit board which is arranged in a grid shape, and a plurality of dielectric elements which are arranged on grid points of the flexible circuit board at intervals and apply alternating electric fields to tumor parts of a patient, the dielectric elements are at least distributed in three rows and four columns, the flexible circuit board is provided with a plurality of connecting parts for connecting two adjacent dielectric elements and a wiring part connected with the connecting parts, the dielectric elements are at least connected with two connecting parts, the number of the dielectric elements is at least 10, and the number of the dielectric elements in each row or each column is not identical. The electrode patch applies an alternating electric field to the tumor part of a patient through at least 10 dielectric elements arranged on the electrode patch to treat the tumor, so that the influence of insufficient electric field treatment caused by the difference of the size, the part and the position of the tumor on the treatment effect can be avoided, the coverage area of an electrode unit of the electrode patch is increased, the intensity of the electric field is enhanced, the range of the alternating electric field covering the tumor part is enlarged, and the treatment effect is improved.

Description

Electric field therapeutic instrument and electrode patch thereof
Technical Field
The invention relates to an electric field therapeutic apparatus and an electrode patch thereof, belonging to the technical field of medical appliances.
Background
At present, the treatment modes of tumors mainly comprise operation, radiotherapy, chemotherapy and the like, but have corresponding defects, such as side effects caused by radiotherapy and chemotherapy, and normal cells can be killed. The use of electric fields to treat tumors is also one of the leading edges of current research and development, and tumor electric field treatment generates a tumor treatment method which interferes with the mitotic process of tumor cells through a low-intensity, medium-high-frequency and alternating electric field by a special electric field generating device. Research shows that the electric field treatment has obvious effect in treating glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and other diseases, and the electric field applied by the treatment method can influence the aggregation of tubulin, prevent spindle body formation, inhibit mitosis process and induce cancer cell apoptosis.
The electric field therapeutic apparatus for curing tumor mainly includes electric field generating device, electrode patch and adapter connected between the electric field generating device and electrode patch, and the electrode patch is applied on the skin of correspondent focus of human body so as to apply alternating electric field to tissue region where tumor is positioned. Because of the difference of the body of the patient, the tumor position and the tumor size are different, when the traditional electrode patch disclosed in the patent publication No. 112717272 is adopted for treatment, the problem that the intensity of the electric field applied to the tumor position by the electrode patch is insufficient for treatment or the treatment effect is affected because the electric field does not cover partial areas of the tumor exists.
Accordingly, there is a need for an improved electrode patch and electric field therapeutic apparatus that overcomes the problems associated with electrode patches of electric field therapeutic apparatus.
Disclosure of Invention
The invention provides an electrode patch and an electric field therapeutic apparatus, which can strengthen the electric field intensity of tumor treatment and improve the area covered by an electric field.
The electrode patch is realized by the following technical scheme: the utility model provides an electrode paster, is applicable to tumour electric field treatment, its includes a flexible circuit board that latticed set up, a plurality of dielectric elements of locating on the grid point of flexible circuit board and applying alternating electric field to patient's tumour position at intervals, a plurality of dielectric elements are three row four at least and are arranged, flexible circuit board has a plurality of connecting portions of connecting adjacent two dielectric elements and a wiring portion of being connected with connecting portion, two connecting portions are all connected at least to every dielectric element, dielectric element is at least 10, the dielectric element quantity of each row or each row is not the same.
Further, the number of the dielectric elements is 20, and the dielectric elements are distributed in an array area which is surrounded by four rows and six columns.
Further, at least one of the plurality of dielectric elements is disposed in a disconnected state between two adjacent dielectric elements in the same row or column.
Further, a space is formed between two adjacent dielectric elements arranged in a disconnected mode, and the wiring part passes through the space.
Further, the connection portions are provided by extending a connection portion in the direction of the interval.
Furthermore, the wiring part and the connecting part are arranged in a vertical mode, and the wiring part is approximately in a straight-line shape.
Further, the connection part bridge is arranged between two connection parts respectively connected with two adjacent dielectric elements which are arranged in a disconnected mode.
Further, the wiring portion is arranged in a substantially T-shaped configuration.
Further, the spacing between the adjacent two dielectric elements arranged in rows is the same, and the plurality of connection portions connecting the adjacent two dielectric elements arranged in rows have the same length.
Further, the spacing between the adjacent two dielectric elements arranged in the column is the same, and the connection portions of the plurality of adjacent two dielectric elements connected in the column have the same length.
Further, at least two adjacent dielectric elements arranged in a row in the plurality of dielectric elements are arranged in a spacing column, and the intervals between the two adjacent dielectric elements arranged in the row are not identical.
Further, at least two adjacent dielectric elements arranged in a row are arranged in a spacing manner, and the intervals between the adjacent dielectric elements arranged in a row are not identical.
Further, the adjacent two dielectric elements arranged in rows are arranged in adjacent columns, and the intervals between the adjacent dielectric elements arranged in rows are the same.
Further, the adjacent two dielectric elements arranged in the column are arranged in adjacent rows, and the intervals between the adjacent dielectric elements arranged in the column are the same.
Further, the spacing between the adjacent two dielectric elements arranged in rows is the same, and the spacing between the adjacent two dielectric elements arranged in columns is the same.
Further, the dielectric elements are distributed in the array area of four rows and six columns in a manner that two dielectric elements are arranged in each of the first row and the last row, and four dielectric elements are arranged in each of the middle four rows and four columns.
Further, the plurality of dielectric elements located at the periphery of the array are connected in pairs through the connecting portions.
Further, at least one adjacent two dielectric elements among the plurality of dielectric elements in the array inner layer are arranged in a disconnected mode, and a space C for the wiring part to pass through is formed between the adjacent two dielectric elements in the disconnected mode.
Further, the flexible circuit board also comprises a wire electrically connected with the flexible circuit board, and the wire is welded with the wiring part.
Further, the flexible circuit board also comprises a back lining for supporting the corresponding part of the flexible circuit board, and the back lining is provided with a threading hole for the lead to pass through.
Further, the connection portion has conductive pads provided at opposite ends thereof, and the dielectric element is soldered to the corresponding conductive pad.
Further, the temperature sensor is arranged on the dielectric element, and the dielectric element is provided with perforations corresponding to the temperature sensors.
Further, the temperature sensor is selectively arranged at the tail end of part of the connecting part.
The electric field therapeutic apparatus is realized by the following technical scheme: an electric field therapeutic apparatus for treating tumor by electric field is composed of electric field generator and said electrode patch electrically connected to said electric field generator.
The electrode patch of the invention applies alternating electric field to the tumor part of a patient through at least 10 dielectric elements arranged on the electrode patch to treat the tumor, so that the influence of insufficient electric field treatment caused by the difference of the size, the part and the position of the tumor on the treatment effect can be avoided, the coverage area of an electrode unit of the electrode patch is increased, the electric field intensity applied to the tumor part to treat the tumor is enhanced, the range of the alternating electric field covering the tumor part is enlarged, and the treatment effect is improved.
Drawings
Fig. 1 is a perspective view showing an electrode patch according to an embodiment of the electric field therapeutic apparatus of the present invention.
Fig. 2 is a bottom plan view of the electrode patch of fig. 1.
Fig. 3 is an exploded perspective view of the electrode patch of fig. 1.
Fig. 4 is an exploded perspective view of the electrode array and leads of fig. 3.
Fig. 5 is a schematic plan view of a dielectric element of the electrode array of fig. 4.
Reference numerals illustrate:
electrode patch 100, electrode array 1, electrode unit 10, peripheral electrode unit 10A, center electrode unit 10B, flexible circuit board 11, main body portion 111, connection portion 112, wiring portion 113, gold finger 1130, conductive pad 114, conductive core 1140, insulating plate 12, dielectric element 13, metal layer 131, perforation 132, temperature sensor 14, backing 2, threading hole 21, support 3, support unit 30, through hole 31, wire 4, heat shrinkage bush 41, plug 42, adhesive 5, insulating substrate B, interval C.
Detailed Description
Reference will now be made in detail to exemplary embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, the same numbers in different drawings refer to the same or similar elements, unless otherwise indicated. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples of apparatus, systems, devices, and methods that are consistent with aspects of the invention.
An electric field therapeutic apparatus (not shown) for treating tumors according to the present invention includes an electric field generator (not shown) and an electrode patch 100 connected to the electric field generator (not shown), wherein the electrode patch 100 is applied to the skin surface of a human body, and a therapeutic electric field generated by the electric field generator (not shown) is applied to the human body. The electrode patch 100 according to an embodiment of the present invention is applied to a trunk area of a human body to assist in treating tumors at the corresponding area.
Referring to fig. 1 to 5, the electrode patch 100 includes a backing 2, an electrode array 1 adhered to the backing 2, a support 3 adhered to the backing 2, an adhesive member 5 covering a portion of the support 3 corresponding to the electrode array 1, and a wire 4 electrically connected to the electrode array 1. The electrode patch 100 is attached to the body surface corresponding to the tumor part of the patient through the back lining 2, and an alternating electric field is applied to the tumor part of the patient through the electrode array 1 so as to interfere or prevent the mitosis of tumor cells of the patient, thereby achieving the purpose of treating the tumor.
The electrode array 1 is disposed in a grid shape, and includes a plurality of electrode units 10 arranged in an array, a plurality of connection portions 112 connecting two adjacent electrode units 10, and a wire connection portion 113 welded with the wire 4. The plurality of electrode units 10 are distributed at intervals on grid points of the electrode array 1. Each electrode unit 10 is connected to at least two electrode units 10 adjacent thereto through a connection portion 112. Each electrode unit 10 is connected to at least two connection parts 112. The number of the electrode units 10 is at least ten, and the electrode units 10 are distributed in an array area with at least three rows and four columns, so that the coverage area of the electrode units 10 of the electrode patch 100 can be increased, the electric field intensity applied to a tumor part for tumor electric field treatment can be enhanced, the range of the alternating electric field covering the tumor part can be increased, and the treatment effect can be improved.
Preferably, each electrode unit 10 is connected to at least three electrode units 10 adjacent thereto through a connection part 112. Each of the electrode units 10 is connected to at least three connection parts 112. The plurality of electrode units 10 are twenty and distributed in an array area of four rows and six columns. The number of electrode units 10 per column is not exactly the same. The number of the electrode units 10 in each row may or may not be identical. At least one adjacent two electrode units 10 among the plurality of electrode units 10 are arranged in a disconnected form, and a space C is formed between the adjacent two electrode units 10 arranged in the disconnected form for the wire connection part 113 to pass through. The connection portion 113 is provided to extend laterally from the connection portion 112 opposite to the space C. The connection portion 112 of the extending connection portion 113 is disposed perpendicular to the connection portion 113, and both are disposed in a substantially T-shape. The connection portion 113 is substantially in a straight shape. Alternatively, the connection portion 113 is provided in a T shape, and is installed between two connection portions 112 connected to the adjacent two electrode units 10 provided in a disconnected shape. The wiring portion 113 is located between the plurality of electrode units 10 and is disposed in a space surrounded by the plurality of electrode units 10, so that an increase in manufacturing cost due to an excessive overall size of the electrode array 1 can be avoided.
The twenty electrode units 10 are arranged in an array area of four rows and six columns in a manner of two electrode units 10 are arranged in each of two columns, and four electrode units are arranged in each of the other four columns. Specifically, the twenty electrode units 10 are distributed in an array area with four rows and six columns in a manner that four columns with four electrode units 10 are adjacent to each other. The spacing between two adjacent electrode units 10 arranged in a row is the same. The plurality of connection parts 112 connecting the adjacent two electrode units 10 arranged in a row have the same length. Specifically, the electrode units 10 in each of the two columns provided with only two electrode units 10 are arranged in adjacent rows, the spacing between the adjacent two electrode units 10 arranged in columns is the same, and the connecting portions 112 of the plurality of adjacent two electrode units 10 connected in columns have the same length. The four electrode units 10 in the two columns may be arranged in a row-wise alignment, respectively; or can be respectively arranged in a staggered manner in the row direction; one of the two can be arranged in a row direction alignment mode, and the other can be arranged in a row direction staggered mode. Alternatively, the two electrode units 10 of at least one of the two columns provided with only two electrode units 10 are arranged in a row at intervals, the spacing between the electrode units 10 arranged in the columns is different, and the plurality of connection portions 112 connected to the adjacent two electrode units 10 in the columns have different lengths.
Optionally, the twenty electrode units are distributed in an array area of four rows and six columns at intervals in at least two of four columns provided with four electrode units 10. The spacing between the adjacent two electrode units 10 arranged in a row is different, and the plurality of connection parts 112 between the adjacent two electrode units 10 connected in a row have different lengths. Specifically, the two electrode units 10 of at least one of the two columns of only two electrode units 10 are arranged in a row at intervals, the spacing between the adjacent two electrode units 10 arranged in a column is different, and the connecting portions 112 between the adjacent two electrode units 10 connected in a column have different lengths. Alternatively, when only two electrode units 10 in each of two columns of two electrode units 10 are arranged in adjacent rows, the spacing between the adjacent two electrode units 10 arranged in the columns is the same, and the connecting portions 112 between the adjacent two electrode units 10 connected in the columns have the same length.
The twenty electrode units 10 in the present embodiment are distributed in an array area of four rows and six columns in such a manner that four electrode units 10 are provided in each of the first row and the last row, and six electrode units 10 are provided in each of the middle two rows. From the view of column arrangement, two electrode units 10 are arranged in each of the first column and the sixth column, and four electrode units 10 are arranged in each of the middle four columns. The electrode units 10 in the first column and the sixth column are arranged adjacently in the row direction, and the electrode units 10 in the two columns are arranged in the row direction in alignment. Specifically, the four electrode units 10 of the first row are respectively located in each of the second column to the fifth column, the six electrode units 10 of each of the two middle rows are respectively located in each of the first column to the sixth column, and the four electrode units 10 of the last row are respectively located in each of the second column to the fifth column. The plurality of electrode units 10 of the electrode array 1 are arranged in an axisymmetric manner. The plurality of electrode units 10 of the electrode array 1 are arranged in a line-wise axisymmetric manner and a column-wise axisymmetric manner. Twenty electrode units 10 are arranged in an octagonal shape.
The connection portion 112 connects all two adjacent electrode units 10 located at the periphery of the array, and at least one adjacent two electrode units 10 in the two adjacent electrode units 10 located at the inner layer of the array are disposed in a disconnected manner. Specifically, the connection portion 112 is provided between all adjacent two electrode units 10 except for two electrode units 10 located in the third column of the second row and the fourth column of the second row and two electrode units 10 located in the third column of the third row and the fourth column of the third row. The connection portions 112 connecting the adjacent two electrode units 10 arranged in a row are equal in length. The connecting portions 112 of the adjacent two electrode units 10 connected in a row have the same length. The connection part 112 is located between two adjacent electrode units 10 arranged in rows, between two electrode units 10 arranged in columns, at the periphery of the array, and between two adjacent electrode units 10 arranged diagonally in adjacent rows and adjacent columns.
The plurality of electrode units 10 may be divided into a plurality of peripheral electrode units 10A located at the periphery and a plurality of central electrode units 10B surrounded by the peripheral electrode units 10A, as viewed from the distribution positions of the electrode units 10 in the array. In this embodiment, the number of the peripheral electrode units 10A is 12, and the number of the central electrode units 10B is 8. All the peripheral electrode units 10A are connected in pairs by the connection portions 112. That is, the connection portion 112 is provided between all adjacent two peripheral electrode units 10A. At least two of the plurality of center electrode units 10B are disposed in a disconnected state between the center electrode units 10B adjacent to each other in the same row or adjacent to each other in the same column, and a space C is formed therebetween for the wire connection portion 113 to pass through.
The interval C is provided between two adjacent center electrode units 10B located in the second row, the third column and the second row, the fourth column and between two adjacent center electrode units 10B located in the third row, the third column and the third row, the fourth column. The wiring portion 113 is disposed in a substantially T-shape, penetrates through the space C, and bridges the connection portion 112 between the two adjacent center electrode units 10B in the middle of the third column and the connection portion 112 between the two adjacent center electrode units 10B in the middle of the fourth column. The connection portion 113 and two adjacent connection portions 112 connected thereto are disposed in an axisymmetric manner. Alternatively, the wiring portion 113 is arranged in a straight shape and is laterally extended toward the space C by the connection portion 112 corresponding to the space C.
The wiring portion 113 of the electrode array 1 is electrically connected to the lead wire 4. In the present embodiment, a pair of golden fingers 1130 welded to the wire 4 are provided on both side surfaces of the wire connecting portion 113, which are far from one end of the connecting portion 112 to which the wire connecting portion is connected, in a staggered manner. One end of the wire 4 is electrically connected to the golden finger 1130 of the wiring portion 113; the other end is electrically connected to an electric field generator (not shown) through a plug 42 provided at the end thereof to supply ac power to the electrode patch 100 during electric field therapy of tumors. The welding part between the wire 4 and the golden finger 1130 of the wire connection part 113 is covered with a heat-shrinkable sleeve 41. The heat shrinkage sleeve 41 insulates and protects the connection part of the lead 4 and the connection part 113 of the electrode array 1, provides support, prevents the connection part of the lead 4 and the connection part 113 of the electrode array 1 from breaking, and can prevent dust and water.
The electrode unit 10 includes a main body 111 provided at opposite ends of the connection portion 112, an insulating plate 12 provided at a side of the main body 111 remote from the skin of the human body, a dielectric element 13 provided at a side of the main body 111 facing the skin of the human body, and a temperature sensor 14 selectively provided at the main body 111 and located at the same side as the dielectric element 13. The main body 111, the insulating plate 12, and the dielectric element 13 are all circular sheet-like structures. The insulating plate 12, the main body 111 and the dielectric element 13 are arranged in one-to-one correspondence, and the centers of the three are positioned on the same straight line. In other embodiments, the main body 111 may also have a cross-point configuration extending from the end of the corresponding connecting portion 112.
The side of the main body 111 facing the dielectric element 13 is provided with a conductive pad 114. The conductive pad 114 of the main body 111 can be completely covered by the dielectric element 13, so that the conductive pad 114 and the dielectric element 13 are soldered by solder (not shown). The conductive pad 114 of the main body 111 includes a plurality of conductive cores 1140 arranged in a central symmetry manner, so that the dielectric element 13 is effectively prevented from being displaced due to stacking of solder (not shown) during the soldering process. The conductive pad 114 of the body portion 111 is centered on the centerline of the body portion 111. The top surfaces of the plurality of conductive cores 1140 of the conductive pad 114 are located on the same plane, so as to avoid the occurrence of a solder joint cold joint between the conductive cores 1140 and the dielectric element 13. The center of the conductive pad 114 is also located on the center line of the dielectric element 13.
In this embodiment, the conductive pads 114 of the same main body 111 include 4 conductive cores 1140 arranged at intervals and in a central symmetry shape. The conductive core 1140 is arranged in a multi-point interval manner, so that the use amount of copper foil for manufacturing the conductive core 1140 can be reduced, and the material cost is reduced; at the same time, the amount of solder (not shown) used for soldering the conductive core 1140 and the dielectric element 13 can be reduced, thereby further reducing the material cost. The 4 conductive cores 1140 of the same conductive pad 114 are all of a petal-shaped configuration. Each of the conductive cores 1140 includes an inner arc (not numbered) and an outer arc (not numbered) connected end to end. The inner arc (not numbered) and the outer arc (not numbered) of the conductive core 1140 are disposed in axisymmetric form. Inner arcs (not numbered) of the 4 conductive cores 1140 of the same conductive pad 114 are each recessed toward the center of the conductive pad 114. Outer arcs (not numbered) of the 4 conductive cores 1140 of the same conductive pad 114 each protrude in a direction away from the center of the conductive pad 114. The 4 conductive cores 1140 forming the conductive disc 114 are arranged in a central symmetry manner and an axial symmetry manner, and each conductive core 1140 is also arranged in an axial symmetry manner, so that when the 4 conductive cores 1140 of the conductive disc 114 of the main body 111 are welded with the dielectric element 13, stress balance of each welding point between the conductive disc 114 and the dielectric element 13 is ensured, integral welding balance of the dielectric element 13 is ensured, welding quality is improved, and the phenomenon that the welding point on the side with a larger interval between the dielectric element 13 and the main body 111 is weak in strength and easy to break due to inclination of the dielectric element 13 caused by unbalanced welding stress is avoided; while also avoiding affecting the fit of electrode patch 100.
The insulating plate 12 is made of an insulating material. Preferably, the insulating board 12 is an epoxy glass cloth laminated board. The insulating plate 12 is adhered to the surface of the main body 111 away from the skin of the human body by a sealant (not shown), so that the strength of the main body 111 can be enhanced, a flat welding plane is provided for the welding operation between the main body 111 and the dielectric element 13, and the product yield is improved. Meanwhile, the insulating plate 12 can also isolate the moisture in the air of the electrode patch 100 far away from the skin from contacting with the solder (not shown) between the main body 111 and the dielectric element 13, so as to prevent the moisture from corroding the solder (not shown) between the main body 111 and the dielectric element 13 and affecting the electrical connection between the main body 111 and the dielectric element 13.
The size of the insulating plate 12 is the same as that of the main body 111, so as to avoid that when the insulating plate 12 is adhered to the main body 111 away from the skin of the human body by the sealant (not shown), the sealant (not shown) climbs to the side of the main body 111 facing the skin of the human body by capillary effect, and the filling of the sealant (not shown) in a gap (not shown) formed by welding the dielectric element 13 and the main body 111 is affected, so that a cavity exists in the sealant (not shown), and further, the phenomena of bursting and popcorn are avoided due to rapid expansion of the steam caused by large difference of thermal expansion coefficients of the steam in the cavity and the sealant (not shown) when the sealant (not shown) is cured at high temperature, and the product is damaged.
The dielectric element 13 is made of a high dielectric constant material, and has conductive characteristics of blocking the conduction of direct current and allowing the alternating current to pass through, so that the safety of a human body can be ensured. Preferably, the dielectric element 13 is a dielectric ceramic sheet. The dielectric element 13 has a ring-shaped structure, and a through hole 132 is formed in the middle of the dielectric element for accommodating the temperature sensor 14. The dielectric element 13 has a ring-shaped metal layer 131 attached to a surface thereof facing the main body 111. The metal layer 131 of the dielectric element 13 and the conductive core 1140 of the conductive disc 114 of the main body 111 form point-to-face welding, which does not require higher welding alignment precision and is more convenient. A gap (not shown) formed by welding the dielectric element 13 and the main body 111 is filled with a sealant (not shown) to protect solder (not shown) between the dielectric element 13 and the main body 111, so as to prevent the dielectric element 13 from being broken at the welding position due to the influence of external force, and further prevent the alternating electric field from being applied to the tumor part of the patient through the dielectric element 13; while also ensuring that the dielectric element 13 is secured to the body portion 111 by a sealant (not shown). The inner ring of the metal layer 131 of the dielectric element 13 is spaced from the edge of the through hole 132 of the dielectric element 13, so that the solder (not shown) between the metal layer 131 of the dielectric element 13 and the main body 111 is prevented from diffusing in the direction of the through hole 132 of the dielectric element 13 when being melted by heat, thereby preventing the temperature sensor 14 from being shorted. The outer ring of the metal layer 131 of the dielectric element 13 is also spaced from the outer edge of the dielectric element 13, so that solder (not shown) disposed between the metal layer 131 of the dielectric element 13 and the main body 111 is prevented from overflowing to the outside of the main body 111 when being melted by heat, and direct current which is not hindered by the dielectric element 13 is prevented from passing through and acting on the surface of the patient when the electrode patch 100 is applied to the surface of the tumor part of the patient.
The outer diameter of the dielectric element 13 is slightly smaller than the diameter of the main body 111, and the sealant (not shown) fills the gap (not shown) along the edge of the main body 111 outside the dielectric element 13 by capillary phenomenon, so as to facilitate the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 13 and the main body 111. When the sealant (not shown) is filled in the gap (not shown) formed by welding the dielectric element 13 and the main body 111 in combination with the through hole 132 of the dielectric element 13, air in the gap (not shown) can be discharged from the through hole 132 of the dielectric element 13, so that the void is prevented from being generated in the sealant (not shown) filled in the gap (not shown), and the product quality is improved.
The temperature sensor 14 is provided with a plurality of through holes 132 respectively accommodated in the corresponding dielectric elements 13. In the present embodiment, the number of the temperature sensors 14 is eight, and the temperature sensors are respectively disposed on eight electrode units 10 disposed in the first row, the fourth row, the last row, the fourth row, the second row, the fifth row, the third row, the second column, and the fifth row. The eight temperature sensors 14 are provided at the center of the main body portion 111 of the corresponding electrode unit 10, respectively. The temperature sensor 14 is used for monitoring the temperature of the adhesive member 5 covering the side of the dielectric element 13 of the electrode array 1 facing the skin of the human body, and further detecting the temperature of the skin of the human body attached to the adhesive member 5. When the temperature detected by the temperature sensor 14 exceeds the upper limit of the safe temperature of the human body, the electric field generator (not shown) timely reduces or turns off the alternating current, so that the human body is prevented from being scalded at low temperature. The temperature sensor 14 is welded to the main body 111 and then sealed with a sealant (not shown) to reliably fix the temperature sensor 14 while preventing the temperature sensor 14 from being damaged by moisture and causing the temperature sensor 14 to fail. The temperature sensor 14 has a signal terminal (not shown) and a ground terminal (not shown). In other embodiments, the specific number of temperature sensors 14 may be set as desired. The temperature sensor 14 is preferably a thermistor.
Referring to fig. 4, the main body 111 of the electrode unit 10, the connection portions 112 connecting two adjacent electrode units, and the connection portions 113 connecting two adjacent connection portions 112 together constitute the flexible circuit board 11 of the electrode array 1. The flexible circuit board 11 is arranged in a grid shape. The dielectric element 13 is provided on the grid points of the flexible circuit board 11. It is understood that the main body 111 is a grid point of the flexible circuit board 11. From the view point of forming the electrode unit 10, the insulating plate 12 is disposed on the side of the main body 111 of the flexible circuit board 11 facing away from the skin of the human body, the dielectric element 13 is disposed on the side of the main body 111 of the flexible circuit board 11 facing the skin of the human body, and the temperature sensor 14 is selectively disposed on the side of the main body 111 of the flexible circuit board 11 facing the skin of the human body. The arrangement of the main body 111 of the flexible circuit board 11 is consistent with the arrangement of the electrode units 10.
The flexible circuit board 11 is composed of an insulating substrate B and a plurality of conductive traces (not shown) embedded in the insulating substrate B. The conductive trace (not shown) embedded in the insulating substrate B of the main body 111, the conductive trace (not shown) embedded in the insulating substrate B of the connecting portion 112, and the conductive trace (not shown) embedded in the insulating substrate B of the connecting portion 113 are electrically connected. The insulating substrate B of the portion of the connection portion 112 is embedded with conductive traces (not shown), and the remaining connection portion 112 only includes the insulating substrate B to strengthen the strength of the flexible circuit board 11. The conductive core 1140 is exposed or protrudes from the insulating substrate B of the main body 111. The insulating substrate B of the flexible circuit board 11 can isolate the moisture in the air around the electrode patch 100 from the solder (not shown) between the conductive core 1140 of the conductive pad 114 of the main body 111 of the flexible circuit board 11 and the dielectric element 13, so as to avoid the moisture in the air far from the skin from corroding the solder (not shown) between the main body 111 and the dielectric element 13 of the flexible circuit board 11. The insulating substrate B of the flexible circuit board 11 and the insulating board 12 have a double isolation function, so that the service life of the electrode patch 100 can be prolonged. The golden finger 1130 of the wiring portion 113 is exposed on the insulating substrate B.
The conductive traces (not shown) of the flexible circuit board 11 include a conductive trace (not shown) connecting all the conductive cores 1140 of the conductive pads 114 of the respective main body portions 111 in series, a conductive trace (not shown) connecting the ground terminals (not shown) of the respective temperature sensors 14 of the respective main body portions 111 in series, and a plurality of conductive traces (not shown) electrically connected to the signal terminals (not shown) of the temperature sensors 14 of the respective main body portions 111, respectively. The conductive traces (not shown) are electrically connected to the plurality of fingers 1130 of the wiring portion 113 in a one-to-one correspondence.
The backing 2 is provided in the form of a sheet, which is mainly made of a flexible, breathable, insulating material. The backing 2 is a mesh fabric. Specifically, the back lining 2 is a net-shaped non-woven fabric, has the characteristics of softness, thinness, moisture resistance and ventilation, and can be applied to the surface of a patient for a long time to keep the surface of the skin of the patient dry. The surface of the back lining 2 facing the body surface of the patient is also coated with a biocompatible adhesive (not shown) for tightly attaching the back lining 2 to the body surface corresponding to the tumor part of the patient. The electrode array 1 is centrally adhered to the backing 2 by a biocompatible adhesive (not shown). As shown in fig. 2, the back lining 2 is provided with a threading hole 21 corresponding to the wiring portion 113. The threading hole 21 may allow one end of the lead 4 to pass through and be electrically connected with the connection portion 113 inside the flexible circuit board 11, so as to prevent the lead 4 from being applied between the backing 2 and the skin to affect the electrode patch 100 to be tightly attached to the skin, and further prevent air from entering between the electrode array 1 and the skin of a human body to increase the impedance between the electrode array 1 and the skin, so that the heat generation of the electrode array 1 is increased to cause low-temperature scald.
The supporting piece 3 is made of soft materials, and can be made of Polyethylene (PE) materials, PET materials, heat-conducting silica gel sheets, or insulating materials which are compounded by polyurethane, polyethylene, dispersing agents, flame retardants, carbon fibers and the like, are soft, stable in chemical performance, light in weight, not easy to deform and nontoxic. The support 3 is preferably foam. The support 3 has a plurality of through holes 31 provided therethrough, the through holes 31 corresponding to the electrode units 10. The support 3 may be of an integral sheet-like construction, which may increase the overall strength of the electrode patch 100. The plurality of through holes 31 are arranged at intervals and are respectively arranged on the support 3 in a surrounding manner of the corresponding electrode units 10. In the present embodiment, the supporting member 3 is composed of a plurality of supporting units 30 which are identical in structure and independent. The plurality of support units 30 are disposed at intervals. Each of the support units 30 surrounds the corresponding plurality of electrode units 10. Each supporting unit 30 has two through holes 31 penetrating therethrough for receiving two electrode units 10 of adjacent rows in the same column, respectively. The support 3 is composed of 10 support units 30. The thickness of the support 3 is substantially identical to the thickness of the electrode unit 10, and the upper surfaces of the support 3 and the electrode unit 10 are substantially flush after the support 3 and the electrode array 1 are applied to the backing 2. In other embodiments, each of the support units 30 may be provided with a single through hole 31 having a larger size, surrounding a plurality of electrode units 10 located in the same column.
The adhesive means 5 is applied to the support 3 and the side of the electrode unit 10 remote from the backing 2. The adhesive element 5 has double-sided adhesive properties, and contact with the skin keeps the skin surface moist and relieves local pressure. The adhesive means 5 are preferably conductive gel. The shape of the adhesive element 5 is substantially the same as the shape of the support element 3. Since the upper surfaces of the support 3 and the electrode unit 10 are flush so that the adhesive member 5 covers the support 3 and the electrode unit 10 smoothly.
In other embodiments, twenty electrode units 10 of the electrode patch 100 of the present invention are distributed in an array region of four rows and six columns in a manner that one electrode unit 10 is provided in one column, three electrode units 10 are provided in one column, and four electrode units 10 are provided in each of the remaining four columns. Specifically, twenty electrode units 10 are distributed in an array area of four rows and six columns in a manner of arranging one electrode unit 10 in the first column, arranging four electrode units 10 in each of the middle four columns, arranging three adjacent electrode units 10 in the last column, wherein the spacing between the adjacent electrode units 10 arranged in the rows is the same, and the spacing between the adjacent electrode units 10 arranged in the columns is the same. That is, the plurality of connection portions 112 connecting adjacent electrode units 10 in the same row have the same length. The plurality of connection parts 112 connecting the two electrode units 10 adjacent to each other in the same column have the same length.
Optionally, twenty electrode units 10 are distributed in an array area of four rows and six columns in a mode that one electrode unit 10 is arranged in the first column, four electrode units 10 are arranged in each of the middle four columns, and one adjacent two electrode units 10 in the last column are arranged in a spacing row mode, the spacing between the adjacent two electrode units 10 arranged in the rows is the same, and the spacing between the adjacent two electrode units 10 arranged in the columns is different. That is, the plurality of connection portions 112 connecting adjacent electrode units 10 in the same row have the same length. The plurality of connection parts 112 connecting the two electrode units 10 adjacent to each other in the same column have different lengths.
Optionally, twenty electrode units 10 are distributed in an array area of four rows and six columns in a manner that four electrode units 10 are arranged in each of the first to fourth columns, three electrode units 10 are arranged in the fifth column, and only one electrode unit 10 is arranged in the last column. The electrode units 10 in the last column are aligned with one of the three electrode units 10 in the fifth column in a row direction, and the three electrode units 10 in the fifth column are all arranged adjacently in a row direction, the intervals between the adjacent two electrode units 10 arranged in the row are the same, the intervals between the adjacent two electrode units 10 arranged in the column are the same, the connecting parts 112 connected with the adjacent electrode units 10 arranged in the row have the same length, and the connecting parts 112 connected with the adjacent electrode units 10 arranged in the column have the same length. Optionally, the electrode units 10 in the last column and the three electrode units 10 in the fifth column are arranged in a staggered manner in a row direction, and the three electrode units 10 in the fifth column are all arranged in an adjacent manner in a row direction, the intervals between the adjacent two electrode units 10 arranged in a row are different, the intervals between the adjacent two electrode units 10 arranged in a column are the same, the connecting portions 112 of the adjacent two electrode units 10 connected in a row have different lengths, and the connecting portions of the adjacent two electrode units 10 connected in a column have the same length. Optionally, the electrode units 10 in the last column are staggered with the three electrode units 10 in the fifth column in a row direction, and two adjacent electrode units 10 in the three electrode units 10 in the fifth column are arranged in a row at intervals, the spacing between the two adjacent electrode units 10 arranged in the row is different, the spacing between the two adjacent electrode units 10 arranged in the column is different, the connecting portions 112 of the two adjacent electrode units 10 connected in the row have different lengths, and the connecting portions 112 of the two adjacent electrode units 10 connected in the column have different lengths.
Optionally, at least two of four columns of the twenty electrode units 10, each of which is provided with four electrode units 10, are distributed in an array area of four rows and six columns at intervals, the spacing between the adjacent two electrode units 10 arranged in the rows is different, and the connecting portions 112 connecting the adjacent two electrode units 10 arranged in the rows have different lengths. The spacing between adjacent electrode units 10 arranged in a row may be the same or different. The connection portions 112 between the plurality of adjacent electrode units 10 connected in a column arrangement may have the same length or may have different lengths.
The electrode patch 100 of the invention applies an alternating electric field to a tumor part of a patient through at least 10 electrode units 10 arranged on the electrode patch to treat the tumor, so that the influence of insufficient electric field treatment caused by the size, the part and the position difference of the tumor on the treatment effect can be avoided, the coverage area of the electrode units 10 of the electrode patch 100 is increased, the electric field intensity applied to the tumor part to treat the tumor is enhanced, the range of the alternating electric field covering the tumor part is enlarged, and the treatment effect is improved.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, alternatives, and improvements that fall within the spirit and scope of the invention.

Claims (7)

1. The utility model provides an electrode paster, is applicable to tumour electric field treatment, includes a flexible circuit board, a plurality of dielectric elements, one with flexible circuit board electric connection's wire and support the back lining in the corresponding position of flexible circuit board, dielectric elements locate flexible circuit board with interval and apply alternating electric field to patient's tumour position, its characterized in that: the flexible circuit board mainly comprises an insulating substrate and a plurality of paths of conductive traces embedded in the insulating substrate, and comprises a plurality of main body parts, a plurality of connecting parts for connecting two adjacent main body parts and wiring parts connected with the connecting parts, wherein the conductive traces are embedded in part of the insulating substrate of the connecting parts, and the rest of the connecting parts only comprise the insulating substrate for reinforcing the strength of the flexible circuit board; the dielectric element is arranged corresponding to the main body part and is welded with the conductive disc, each main body part is connected with at least three main body parts around the main body part through corresponding connecting parts, the main body parts are divided into a plurality of main body parts positioned at the periphery and a plurality of main body parts positioned at the center according to the distribution positions of the main body parts, the main body parts positioned at the center are all surrounded by the main body parts positioned at the periphery, the main body parts positioned at the periphery are connected into an annular structure through the connecting parts, the wiring parts are arranged in the annular structure surrounded by the main body parts positioned at the periphery, and at least two main body parts positioned at the same row or column adjacent to the wiring parts at the center form intervals for the wiring parts to pass through; the wire is welded with the wiring part, and the back lining is provided with a threading hole for the wire to pass through.
CN202111580039.1A2021-09-282021-12-22Electric field therapeutic instrument and electrode patch thereofActiveCN114099958B (en)

Priority Applications (10)

Application NumberPriority DateFiling DateTitle
CN202111580039.1ACN114099958B (en)2021-12-222021-12-22Electric field therapeutic instrument and electrode patch thereof
PCT/CN2022/134677WO2023051845A1 (en)2021-09-282022-11-28Tumor electric field treatment system
PCT/CN2022/134717WO2023051846A1 (en)2021-09-282022-11-28Tumor electric field treatment system
US18/696,568US20250229084A1 (en)2021-09-282022-11-28Tumor Electric Field Treatment System
PCT/CN2022/137451WO2023116448A1 (en)2021-12-222022-12-08Insulation electrode for electric field-based tumor treatment, and manufacturing method therefor
PCT/CN2022/138105WO2023116473A1 (en)2021-12-222022-12-09Electrode slice air tightness test device, system and method
PCT/CN2022/140141WO2023116644A1 (en)2021-12-222022-12-19Tumor treating fields system and alternating current electrical signal application method thereof
US18/723,196US20250177743A1 (en)2021-12-222022-12-19Tumor treating fields system and alternating current signal application method thereof
PCT/CN2022/140412WO2023116708A1 (en)2021-12-222022-12-20Electrode array detection device, system and method for tumor electric field therapy
PCT/CN2022/140432WO2023116714A1 (en)2021-12-222022-12-20Method for manufacturing electrode patch for tumor-treating fields

Applications Claiming Priority (1)

Application NumberPriority DateFiling DateTitle
CN202111580039.1ACN114099958B (en)2021-12-222021-12-22Electric field therapeutic instrument and electrode patch thereof

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CN114099958A CN114099958A (en)2022-03-01
CN114099958Btrue CN114099958B (en)2023-10-13

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WO2023116448A1 (en)*2021-12-222023-06-29江苏海莱新创医疗科技有限公司Insulation electrode for electric field-based tumor treatment, and manufacturing method therefor
WO2023116714A1 (en)*2021-12-222023-06-29江苏海莱新创医疗科技有限公司Method for manufacturing electrode patch for tumor-treating fields
CN119212621A (en)*2022-11-282024-12-27深圳市韶音科技有限公司 Electrode structure and wearable device
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