Detailed Description
Reference will now be made in detail to the present application, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the same or similar parts or parts having the same or similar functions throughout. In addition, if a detailed description of the known art is not necessary for illustrating the features of the present application, it is omitted. The embodiments described below with reference to the drawings are exemplary only for the purpose of explaining the present application and are not to be construed as limiting the present application.
It will be understood by those within the art that, unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the prior art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
As used herein, the singular forms "a", "an", "the" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. It will be understood that when an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements may also be present. Further, "connected" or "coupled" as used herein may include wirelessly connected or wirelessly coupled. As used herein, the term "and/or" includes all or any element and all combinations of one or more of the associated listed items.
The inventor of the application researches and discovers that in the process of tumor electric field treatment, a patient needs to wear the electrode patch for a long time, and an electrode structure in the electrode patch can continuously generate heat in work, so that the temperature of the skin of the patient, which is in contact with or close to the electrode structure, is increased, and the skin of the patient is extremely easy to burn and the like.
In order to ensure the safety of the tumor electric field treatment process, the temperature rise phenomenon needs to be controlled, and the following two ways can be generally adopted:
mode 1: by reducing the output power of the electrode structure, the heat productivity of the electrode structure is reduced, thereby reducing the damage to the skin of a patient. However, lowering the output power of the electrode structure can reduce the therapeutic effect, even result in no therapeutic effect.
Mode 2: the protection capability of the patient skin is maintained by continuously changing the application position of the electrode patch, but the optimal position of the treatment, namely the optimal field intensity of the target is lost when the position is changed, so that the treatment effect is weakened, and even the treatment effect is completely absent.
Therefore, the existing tumor electric field treatment has the defects of easily injuring the skin of a patient, influencing the treatment effect and the like.
The application provides an electrode patch and a cell division suppression device, which aim to solve the technical problems in the prior art.
The following describes the technical solutions of the present application and how to solve the above technical problems with specific embodiments.
An embodiment of the present application provides an electrode patch, a schematic structural diagram of which is shown in fig. 1 to 4, including: patch 110, electrode assembly 120, and active heat sink assembly 130.
The patch 110 is adapted to be at least partially applied to a surface of a biological tissue.
The electrode assembly 120 is connected to the patch 110 for applying a set electric field to the biological tissue.
Active heat sink assembly 130 is in thermally conductive connection with at least a portion of electrode assembly 120 for conducting heat at electrode assembly 120 to the external environment.
In the present embodiment, the patch 110 may serve as a structural basis for the entire electrode patch, and the electrode assembly 120 and the active heat dissipation assembly 130 may be connected to the patch 110 in a direct or indirect manner, respectively.
The active heat dissipation assembly 130 in the electrode patch is in heat conduction connection with at least part of the electrode assembly 120, and the active heat dissipation assembly 130 can actively and timely conduct heat generated by the electrode assembly 120 to the external environment, so that the heat accumulation on the surface of a biological tissue is effectively reduced, the safety and the comfort of a patient in the tumor electric field treatment process can be further improved, the electrode assembly 120 can work with the optimal output power, and the optimal treatment effect can be favorably realized; in the tumor electric field treatment process, the application position of the electrode patch does not need to be changed, so that the electrode assembly 120 can continuously work at the optimal treatment position, the targeted optimal field intensity is provided for the focal zone, and the optimal treatment effect is favorably realized; is suitable for patients with sensitive skin, and is favorable for expanding the application range of tumor electric field treatment.
Alternatively, the patch 110 is a medical grade nonwoven. The medical non-woven fabric has stickiness on one side, so that the electrode assembly 120 is favorably pasted on the surface of biological tissues, and the stability between the medical non-woven fabric and the biological tissues is improved; the medical non-woven fabric also has good air permeability, is beneficial to removing partial moisture and keeping the surface of the biological tissue dry.
Alternatively, the electrode assembly 120 may be disposed on a side of the patch 110 for facing the surface of the biological tissue with an electric field output end of the electrode assembly 120 facing the surface of the biological tissue.
Alternatively, the electrode assembly 120 may be disposed on a side of the patch 110 that faces away from the surface of the biological tissue, with the electric field output end of the electrode assembly 120 facing the surface of the biological tissue.
Alternatively, the set electric field may comprise a pulsed electric field to disrupt mitosis preventing cancer cells from completing rapid divisions.
Alternatively, the mechanism of action of the set electric field may be: tubulin is influenced to be aggregated into clusters in the metaphase of the electric field, so that the formation of a spindle body in a diseased cell is prevented, and chromosomes cannot be separated normally, thereby inhibiting the normal division of the diseased cell.
Alternatively, the mechanism of action of the set electric field may be: at the end stage of the division of the diseased cell, electric charges are pushed to the neck of the dividing cell by an electric field, and the structure of the diseased cell is damaged, so that the normal division of the diseased cell is inhibited.
The inventors of the present application considered that the smaller the distance between the electrode assembly 120 and the surface of the biological tissue, the more advantageous the utilization of the output power of the electrode assembly 120 is, but the more the influence of the heat generated from the electrode assembly 120 on the surface of the biological tissue is. Therefore, the application provides the following possible implementation modes for the electrode patch:
as shown in fig. 1, the electrode patch of the embodiment of the present application includes the following features:
the patch 110 has a through hole 110 a.
Electrode assembly 120 is located on the side of patch 110 that is intended to face the surface of biological tissue.
A portion of active heat sink assembly 130 is positioned between patch 110 and electrode assembly 120.
Another portion of active heat sink assembly 130 passes through-hole 110a and is located on a side of patch 110 away from electrode assembly 120.
In the present embodiment, the electrode assembly 120 is located on the side of the patch 110 facing the surface of the biological tissue, so that the electrode assembly 120 can directly contact the surface of the biological tissue, that is, the distance between the electrode assembly 120 and the surface of the biological tissue is greatly reduced, which can effectively improve the utilization rate of the output power of the electrode assembly 120.
Furthermore, a portion of the active heat dissipation assembly 130 is located between the patch 110 and the electrode assembly 120, and the other portion passes through the through hole 110a and is located on a side of the patch 110 away from the electrode assembly 120, so that the active heat dissipation assembly 130 can actively and timely conduct heat generated by the electrode assembly 120 to an external environment away from the surface of the biological tissue, and negative effects caused by too small distance between the electrode assembly 120 and the surface of the biological tissue can be effectively overcome, thereby improving safety and comfort of a patient in an electric field treatment process of a tumor, and facilitating realization of an optimal treatment effect.
In some possible embodiments, the active heat dissipation assembly 130 includes: an active heat dissipation structure 131 and a passive heat dissipation structure 132.
The active heat dissipation structure 131 is located between the patch 110 and the electrode assembly 120, and a heat absorption side of the active heat dissipation structure 131 is thermally connected to the electrode assembly 120.
The passive heat dissipation structure 132 is located at a side of the patch 110 away from the electrode assembly 120, a heat absorption side of the passive heat dissipation structure 132 passes through the through hole 110a to be thermally conductively connected with a heat dissipation side of the active heat dissipation structure 131, and a heat dissipation side of the passive heat dissipation structure 132 is used for thermally conductive connection with an external environment.
The heat absorbing side of the passive heat dissipating structure 132 is conductively connected to the heat dissipating side of the active heat dissipating structure 131.
Alternatively, the heat absorption side of the passive heat dissipation structure 132 passes through the through hole 110a and the heat emission side of the active heat dissipation structure 131, and a heat conduction connection may be implemented by using a heat conductive silicone.
Optionally, the active heat dissipation structure 131 includes: at least one of a semiconductor radiator, an air-cooled radiator and a water-cooled radiator.
In one example, the active heat dissipation structure 131 is a semiconductor cooling plate, and the size can be selected from 20 mm long, 20 mm wide and 1 mm thick, and the heat dissipation power can be selected from 30W (watts). The temperature of the electrode assembly 120 is reduced to below 26 ℃, so that the patient can be comfortable in the tumor electric field treatment process, and the patient is not prone to sweating.
The semiconductor refrigerating sheet, also called thermoelectric refrigerating sheet, is a heat pump. Its advantages are no slide part, limited space, high reliability and no pollution of refrigerant. By means of the Peltier effect of semiconductor material, when current passes through the loop comprising different conductors, irreversible Joule heat is produced, and heat absorption and heat release phenomena appear at the joints of different conductors along with the difference of current directions, so as to realize the purpose of refrigeration. The semiconductor refrigeration is a refrigeration technology generating negative thermal resistance, and is characterized by no moving parts and higher reliability.
Optionally, the passive heat dissipation structure 132 includes: metal heat conduction structure and graphite alkene heat-conducting layer. The graphene heat conduction layer is coated on the surface of the metal conductive structure.
Alternatively, the metal heat conducting structure may adopt any one of aluminum, iron, copper, or any alloy mixed.
In one example, the passive heat dissipation structure 132 is made of an aluminum sheet, and the size can be selected from 20 mm long, 20 mm wide and 1 mm high. The surface of the aluminum sheet is covered with a graphene coating with the thickness of 100 microns, so that the heat dissipation efficiency is effectively improved.
The inventors of the present application consider that the electrode assembly 120 needs to achieve a set electric field application to biological tissue. To this end, the present application provides one possible implementation of the following for the electrode assembly 120:
as shown in fig. 1, an electrode assembly 120 of the present embodiment includes a stacked electrode structure 121 and a dielectric structure 122.
The electrode structure 121 is thermally conductively connected to the active heat sink 130.
The dielectric structure 122 is connected to a side of the electrode structure 121 away from the active heat sink 130.
In this embodiment, the dielectric structure 122 is an electrical signal application medium, which is not conductive in itself and may be in direct contact with the surface of the biological tissue. But due to the property of the dielectric structure 122 having a relatively high dielectric constant, it is suitable for applying an alternating electrical signal, resulting in a capacitive effect.
The electrode structure 121 transmits an electrical signal to the dielectric structure 122, thereby forming a set electric field at the focal zone.
Optionally, the dielectric structure 122 has a dielectric constant of at least 10000 square coulombs per newton square meter.
In one example, the dielectric structure 122 may be a ceramic wafer having a size of 20 mm in diameter and a thickness of 1 mm.
Optionally, the periphery of the dielectric structure 122 has rounded corners. The smooth chamfer can effectively reduce the risk of point discharge.
Optionally, the radius of curvature of the rounded chamfer is no greater than 0.3 mm.
Optionally, the junction of the dielectric structure 122 and the electrode structure 121 has a silver plating layer. The charges are transmitted to the high-dielectric constant material through the silver layer and are collected, so that a capacitance effect is formed between every two electrodes, and an electric field is generated.
Optionally, the edge between the dielectric structure 122 and the electrode structure 121 may be sealed by an underfill process, so as to seal a gap that may exist at the edge between the dielectric structure 122 and the electrode structure 121, thereby avoiding the risk of tip discharge.
In some possible embodiments, the electrode structure 121 includes at least one pad portion 121a, and a conductive portion 121b connecting two adjacent pad portions 121 a.
One side of each pad portion 121a is connected to the dielectric structure 122.
The other side of the at least one pad portion 121a is directly thermally and conductively connected to the active heat sink assembly 130.
In the present embodiment, the pad portions 121a in the electrode structure 121 are used to output an electric field, and the conductive portions 121b are used to supply charges for forming the electric field to the corresponding pad portions 121 a.
The active heat sink 130 may actively remove heat from the at least one pad portion 121a that is directly thermally conductively connected. The other pad portions 121a not directly connected to the active heat sink 130 by thermal conduction may be conducted to the pad portions 121a directly connected to the active heat sink 130 by thermal conduction inside the electrode structure 121, thereby achieving heat dissipation. Specifically, the other pad portions 121a, which are not directly thermally conductively connected to the active heat sink 130, conduct heat to the pad portions 121a, which are directly thermally conductively connected to the active heat sink 130, through the conductive portions 121 b.
Alternatively, the pad parts 121a are arranged in an array. This is beneficial to improving the coverage area of the electric field and is also beneficial to forming a more uniform electric field.
In one example, the electrode structure 121 has 4 pad portions 121a, and is arranged in an array of 2 rows and 2 columns.
In one example, as shown in fig. 1, the electrode structure 121 has 9 pad portions 121a, and is arranged in an array of 3 rows and 3 columns.
In one example, the electrode structure 121 has 24 pad portions 121a, and the pad portions are arranged in an array of 4 rows and 6 columns, or 6 rows and 4 columns, or 3 rows and 8 columns.
Alternatively, the pad portion 121a located at the middle of each column is thermally conductively connected to the active heat sink 130. This is beneficial to relatively uniform heat transfer inside the electrode structure 121, and improves the heat dissipation effect of the electrode structure 121.
Alternatively, the pad portion 121a located at the middle of each row is thermally conductively connected to the active heat sink 130. This is beneficial to relatively uniform heat transfer inside the electrode structure 121, and improves the heat dissipation effect of the electrode structure 121.
Optionally, the pad portion 121a located at the middle of each row and at the middle of each column is thermally conductive connected to the active heat sink assembly 130. This is beneficial to relatively uniform heat transfer inside the electrode structure 121, and improves the heat dissipation effect of the electrode structure 121.
In some possible embodiments, the electrode assembly 120 further includes at least one support sheet 123.
The other side of the pad, which is not directly thermally conductively connected to the active heat sink 130, is connected to the support plate 123.
In the embodiment, the supporting sheet 123 may provide a support for the bonding pad to protect the bonding pad from being damaged by bending, and the supporting sheet 123 may also provide a support for the dielectric structure 122 to protect the dielectric structure 122 from being damaged by bending.
The pads directly connected to the active heat spreader 130 by thermal conduction can be supported by the active heat spreader 130, so that the support plate 123 is not required.
In one example, the support plate 123 may be made of plastic, and is a disc with a diameter of 20 mm and a thickness of 1 mm.
Optionally, the support sheet 123 is attached to the side of the pad facing the patch 110 by a thermally conductive silicone.
The inventor of the present application considers that, in the electric field treatment process of tumor, the patient needs to wear the electrode patch for a long time, and if the air permeability of the electrode patch is insufficient, adverse reaction on the surface of the biological tissue is caused. Therefore, the application provides the following possible implementation modes for the electrode patch:
as shown in fig. 1 and 4, the electrode patch of the embodiment of the present application further includes: a moisture absorbing structure 140.
The moisture absorption structure 140 has fitting holes adapted to the electrode assembly 120, and the moisture absorption structure 140 is nested with the electrode assembly 120 through the fitting holes.
In this embodiment, the moisture absorption structure 140 can absorb moisture possibly existing near the electrode assembly 120 and diffuse out through the medical nonwoven fabric, thereby improving the dryness of the surface of the biological tissue near the electrode patch, reducing the adverse reaction on the surface of the biological tissue, and improving the comfort of the patient during the tumor electric field treatment.
Alternatively, the moisture absorbing structure 140 may be made of foam.
Alternatively, the moisture absorption structure 140 has fitting holes adapted to a portion of each of the electrode assembly 120 and the active heat dissipation assembly 130, and the moisture absorption structure 140 is nested with a portion of each of the electrode assembly 120 and the active heat dissipation assembly 130 through the fitting holes.
In one example, the moisture absorption structure 140 has a shape as shown in fig. 1, has a thickness of 2 mm, is embedded in the electrode assembly 120 outside the dielectric structure 122, absorbs moisture, and diffuses out through the medical non-woven fabric 110. The active heat sink 130 is square, and the moisture absorption structure 140 has a square fitting hole corresponding to the active heat sink 130, so that the moisture absorption structure 140 can reduce the contact with the active heat sink 130.
The inventor of the application considers that in the tumor electric field treatment process, the patient needs to wear the electrode patch for a long time, and the comfort of the patient is directly affected by the material in direct contact with the patient. Therefore, the application provides the following possible implementation modes for the electrode patch:
as shown in fig. 1 and 4, the electrode patch of the embodiment of the present application further includes: hydrogel structure 150. Hydrogel structure 150 is attached to the side of electrode assembly 120 remote from patch 110.
In the present embodiment, the hydrogel structure 150 serves as a coupling material between the dielectric structure 122 and the surface of the biological tissue, which not only improves the comfort of the patient, but also increases the conduction efficiency of the electric field.
Optionally, the hydrogel structure 150 has a thickness of 1 millimeter.
Based on the same inventive concept, the embodiments of the present application provide a cell division inhibiting device, including: any of the electrode patches set forth in the above-described embodiments.
In this embodiment, since the cell division suppressing device employs any one of the electrode patches provided in the foregoing embodiments, the principle and technical effects thereof are referred to the foregoing embodiments and will not be described herein again.
Optionally, the cell-division inhibiting device further comprises a power source electrically connected to the electrode patch. The power supply may provide electrical energy to the electrode structures 121 in the electrode patch such that the electrode structures 121 are capable of generating the required electric field.
Optionally, the power supply is an alternating current power supply. The alternating current provided by the alternating current source can cause the electrode structure 121 in the electrode patch to generate a desired alternating electric field.
Optionally, the power supply is a pulsed power supply. The pulsed current provided by the pulsed power supply enables the electrode structure 121 in the electrode patch to generate the required pulsed electric field.
By applying the embodiment of the application, at least the following beneficial effects can be realized:
1. the active heat dissipation assembly 130 in the electrode patch is in heat conduction connection with at least part of the electrode assembly 120, and the active heat dissipation assembly 130 can actively and timely conduct heat generated by the electrode assembly 120 to the external environment, so that the heat accumulation on the surface of a biological tissue is effectively reduced, the safety and the comfort of a patient in the tumor electric field treatment process can be further improved, the electrode assembly 120 can work with the optimal output power, and the optimal treatment effect can be favorably realized; in the tumor electric field treatment process, the application position of the electrode patch does not need to be changed, so that the electrode assembly 120 can continuously work at the optimal treatment position, the targeted optimal field intensity is provided for the focal zone, and the optimal treatment effect is favorably realized; is suitable for patients with sensitive skin, and is favorable for expanding the application range of tumor electric field treatment.
2. The electrode assembly 120 is located at a side of the patch 110 for facing the surface of the biological tissue, so that the electrode assembly 120 can directly contact the surface of the biological tissue, that is, the distance between the electrode assembly 120 and the surface of the biological tissue is greatly reduced, which can effectively improve the utilization rate of the output power of the electrode assembly 120.
3. One part of the active heat dissipation assembly 130 is located between the patch 110 and the electrode assembly 120, and the other part passes through the through hole 110a and is located on one side of the patch 110 far away from the electrode assembly 120, so that the active heat dissipation assembly 130 can actively and timely conduct heat generated by the electrode assembly 120 to an external environment far away from the surface of the biological tissue, and negative effects caused by too small distance between the electrode assembly 120 and the surface of the biological tissue can be effectively overcome, thereby improving safety and comfort of patients in the tumor electric field treatment process, and being beneficial to realizing optimal treatment effects.
4. The pad portions 121a in the electrode structure 121 are used to output an electric field, and the conductive portions 121b are used to supply charges for forming the electric field to the corresponding pad portions 121 a. The pad portions 121a are arranged in an array, which is beneficial to improving the coverage area of the electric field and forming a relatively uniform electric field.
5. The support piece 123 may provide support for the bonding pad and protect the bonding pad from bending damage, and the support piece 123 may also provide support for the dielectric structure 122 and protect the dielectric structure 122 from bending damage.
6. The moisture absorption structure 140 can absorb moisture possibly existing near the electrode assembly 120 and diffuse out through the medical non-woven fabric, thereby improving the dryness of the surface of the biological tissue near the electrode patch, reducing the adverse reaction on the surface of the biological tissue, and improving the comfort of the patient in the tumor electric field treatment process.
7. The hydrogel structure 150 serves as a coupling material between the dielectric structure 122 and the surface of the biological tissue, which not only improves patient comfort, but also increases the conduction efficiency of the electric field.
In the description of the present application, it is to be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the present application and simplifying the description, but do not indicate or imply that the referred device or element must have a particular orientation, be constructed in a particular orientation, and be operated, and thus should not be construed as limiting the present application.
The terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless otherwise specified.
In the description of the present application, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.
In the description herein, particular features, structures, materials, or characteristics may be combined in any suitable manner in any one or more embodiments or examples.
The foregoing is only a partial embodiment of the present application, and it should be noted that, for those skilled in the art, several modifications and decorations can be made without departing from the principle of the present application, and these modifications and decorations should also be regarded as the protection scope of the present application.