CN115429414B - Apparatus for transmitting electric field energy to human body and control circuit thereof - Google Patents
Apparatus for transmitting electric field energy to human body and control circuit thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
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- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00666—Sensing and controlling the application of energy using a threshold value
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Abstract
The invention relates to an apparatus device for transmitting electric field to human body and control circuit thereof, the apparatus device comprises: the device comprises a power adapter, an electric field generator, a visual manual operator and at least two pairs of electrode patches adhered to a human body; the electric field generator comprises: the system comprises a signal generation module, a pressure regulating module, an algorithm control module and a feedback monitoring module, wherein the algorithm control module is respectively connected with the feedback monitoring module and the pressure regulating module; the signal generating module is internally provided with a control circuit which is respectively connected with the voltage regulating module and the electrode patches, the control circuit is used for generating switching signals with the period of 2 seconds, the switching signals are input into at least two pairs of electrode patches, and under the regulating action of the voltage regulating module, a local electric field with the frequency of 1kHz-300kHz, the frequency of 1-300V and the frequency of 0-2000mA and the frequency of 1V-20V/cm can be formed between any pair of electrode patches. The intelligent degree is high.
Description
Technical Field
The present invention relates to surgical instruments for delivering energy to the human body in non-mechanical forms, and more particularly to an instrument device for delivering an electric field to the human body and a control circuit therefor.
Background
In the related art, an electric field may be applied to a target tissue region such that the electric field radiates through the target tissue region to effect ablation of cancerous cells. For example: chinese patent publication No. CN 101553180a discloses an apparatus and method for destroying cancer cells by applying an electric field to abnormally proliferating cells or cells exhibiting irregular growth (e.g., cancer cells) through electrode positioning, achieving selective cancer cell ablation or destruction while leaving normal cells or tissues substantially intact.
The apparatus for transmitting electric field energy to human body can utilize the above-mentioned principle to utilize alternating electric field to prevent the formation of spindle body microtubule in the course of mitosis of some tumor cells, inhibit the separation of intracellular organelles in the cell division period and induce the cell apoptosis in the mitosis period, and its patent can be referred to the Chinese patent invention whose patent number is 201820261308.5. However, the currently used instrument devices have low intelligence degree and narrow application range.
Disclosure of Invention
The invention aims to solve the technical problem of providing a control circuit of a medical electric field generator and the electric field generator comprising the same.
In order to solve the problems, the technical scheme adopted by the invention is as follows:
in one aspect, an apparatus for delivering electric field energy to a human body is provided, comprising: the electric field generator is respectively connected with the power adapter, the visual manual operator and the electrode patches;
the electric field generator includes: the system comprises a signal generating module, a pressure regulating module, an algorithm control module and a feedback monitoring module, wherein the algorithm control module is respectively connected with the feedback monitoring module and the pressure regulating module, and the pressure regulating module is connected with the signal generating module;
be provided with in the signal generation module respectively with the control circuit that pressure regulating module and electrode paster are connected, control circuit is including connecting gradually: the device comprises a signal generator, an H-bridge driver, an H-bridge power MOS (metal oxide semiconductor) tube, a transformer, a filter and a voltage regulating power supply, wherein the filter is connected with an electrode patch, and the voltage regulating power supply is connected with a voltage regulating module;
the signal generator controls and generates a first pulse width modulation signal PWM1 and a second pulse width modulation signal PWM2 with fixed frequency and fixed duty ratio, and the frequency and the duty ratio of the PWM1 and the PWM2 are the same;
the PWM1 and the PWM2 respectively form a square wave with the frequency of 1kHz-300kHz and the duty ratio of 56% -72% after sequentially passing through the H-bridge driver and the H-bridge power MOS tube;
the square wave forms a switching signal with a period of 2 seconds after passing through a transformer and a filter, and after the switching signal is input into at least two pairs of electrode patches, a local electric field with a frequency of 1kHz-300kHz, an adjustable output voltage of 1-300V, a load current of 0-2000mA and a strength of 1V-20V/cm can be formed between the pair of electrode patches under the adjusting action of a voltage-adjusting power supply;
each of the electrode patches includes: the flexible printed circuit board is provided with a plurality of connecting plates, a first surface of each connecting plate is connected with the corresponding ceramic electrode plate, a second surface of each connecting plate is provided with a supporting plate, and the ceramic electrode plates, the connecting plates and the supporting plates are all arranged in positioning holes in the corresponding positioning plates.
As an implementation mode of the invention, each electrode patch is provided with a temperature sensor for collecting the temperature of the electrode patch in real time; the feedback monitoring module further comprises: the current output control device comprises a voltage monitoring unit for acquiring current output voltage in real time and a current monitoring unit for acquiring current output current in real time, wherein the voltage monitoring unit, the current monitoring unit and a temperature sensor are all connected with an algorithm control module;
the algorithm control module is used for calculating the output intensity at the next moment based on the current temperature sent by the temperature sensor, the current output voltage sent by the voltage monitoring unit and the current output current sent by the current monitoring unit, and sending the output intensity to the voltage regulating module to regulate the voltage at the next moment.
As an embodiment of the invention, the algorithm control module calculates the output intensity at the next time by using the following method:
inputting the current temperature, the current output voltage and the current output current into an electric field intensity model, outputting an optimal electric field intensity value serving as the output intensity of the next moment, and obtaining the electric field intensity model through deep learning;
when the current output current is determined not to reach the preset current threshold value and all the current temperatures are determined not to reach the temperature threshold value, the optimal electric field strength value is higher than the strength value corresponding to the current output voltage, and when any one current temperature is determined to reach the temperature threshold value, the optimal electric field strength value is lower than the strength value corresponding to the current output voltage, and the temperature threshold value range is 37-44 ℃;
the electric field intensity model is obtained by training by adopting the following method:
acquiring original sample data, wherein the original sample data comprises historical output voltage, historical output current, historical output intensity and historical temperatures of a plurality of electrode patches at a plurality of electric field transmission moments;
training to obtain an electric field strength model based on the original sample data;
dividing original sample data into a first class data set and a second class data set according to a historical output current intensity value and a historical electrode plate temperature value, wherein the historical output current intensity value in the first class data set does not reach the preset current threshold value and the historical electrode plate temperature value does not reach the temperature threshold value, and the historical output current intensity value in the second class data set does not reach the preset current threshold value and the historical electrode plate temperature value reaches the temperature threshold value;
obtaining a space vector load submodel for outputting an optimal electric field strength value under the condition of a first transmission electric field according to the first type of data set;
and training according to the second type of data set to obtain an electric field intensity sub-model for outputting the optimal electric field intensity value under the second transmission electric field condition.
As an embodiment of the invention, each of the temperature sensors includes a plurality of temperature sensing elements connected to the algorithm control module, all the temperature sensing elements are divided into a groups of B, preferably a = B; each group of temperature sensing elements is connected with the algorithm control module through a controlled analog switch, and the on/off of each controlled analog switch is controlled by an I/O line;
the current temperature and/or the historical temperature of each temperature sensor is obtained by the following method:
when the temperature sent by all the temperature sensing elements corresponding to the temperature sensor is lower than the temperature threshold value, taking the temperature mean value of all the temperature sensing elements as the current temperature and/or the historical temperature of the temperature sensor;
and when the temperature sent by all the temperature sensing elements corresponding to the temperature sensor is determined to have the temperature greater than the temperature threshold, taking the sent highest temperature as the current temperature and/or the historical temperature of the temperature sensor.
As an embodiment of the invention, the visual hand-operated device comprises:
the input module is used for receiving user identification information input by a user;
the calling module is used for calling electrode patch position information corresponding to the user identification information in a database;
the display module is used for displaying the position information of the electrode patch so that a user can paste the electrode patch based on the position information of the electrode patch;
wherein the database is obtained by the following method:
generating a plurality of brain tissue structure models in a three-dimensional simulation mode;
calculating the field intensity distribution of each brain tissue structure model;
and calculating the positioning position of the electrode patch corresponding to each brain tissue structure model based on the field intensity distribution.
As an embodiment of the invention, a through hole is formed in the middle of each ceramic electrode plate, a temperature sensing element for acquiring the temperature of the ceramic electrode plate is arranged in each through hole, a shadowless glue for encapsulating the temperature sensing element is filled in each through hole, and the shadowless glue is flush with the upper surface of the ceramic electrode plate after being cured.
As an embodiment of the invention, each ceramic electrode plate is connected with a signal generation module through an electric control switch, and the electric control switch is also connected with an algorithm control module;
each electronically controlled switch is configured to control a switch-on signal sent by the module according to the algorithm so that current can flow between the corresponding ceramic electrode sheet and the signal generating module; and (c) a second step of,
and according to the cutting signal sent by the algorithm control module, cutting current flows between the corresponding ceramic electrode plate and the signal generation module.
As an embodiment of the invention, the supporting plate is a bakelite plate, the thickness of the supporting plate is 0.4-0.6mm, and the supporting plate is of a circular structure with the same outer diameter as the ceramic electrode plate.
The edge of each notch of the flexible circuit board is provided with an embedded reinforcing line, and the embedded reinforcing lines extend along the shape of the notch of the flexible circuit board;
and a plurality of circular open spaces with the diameter of 0.1-3cm are arranged in the area of the patch substrate not covered by the flexible circuit board and the positioning sheet.
The flexible circuit board is connected with a lead, the lead is connected with the electric field generator, a sleeve pipe which plays a role in strengthening protection is arranged at the joint of the flexible circuit board and the lead, the sleeve pipe adopts a heat shrinkage pipe, and shadowless glue is filled in the heat shrinkage pipe for heating shrinkage to realize packaging.
In one embodiment of the invention, the ceramic electrode sheet is made of a ferroelectric ceramic material having a relative dielectric constant in the range of 5000 to 20000 and a dielectric loss of less than 0.04; the ferroelectric ceramic material is prepared by a one-step method or a two-step method.
As an embodiment of the invention, the preparation method of the ferroelectric ceramic material comprises the following steps:
1) Adopting a solid phase method to synthesize in one step
a[0.67Bi 0.995 Ce 0.005 FeO 3 -0.33BaTiO 3 ]-b[Sr 1-x Pb x Ti 1-y Zr y O 3 ]-c[Pb(Mg 1/3 Nb 2/3 )O 3 ]：
With Bi 2 O 3 ，CeO 2 ，Fe 2 O 3 ，BaCO 3 ，TiO 2 ，SrCO 3 ，Pb 3 O 4 ，ZrO 2 ，MgO，Nb 2 O 5 As raw materials, keeping the temperature at 750-850 ℃ for 4 hours, and synthesizing
a[0.67Bi 0.995 Ce 0.005 FeO 3 -0.33BaTiO 3 ]-b[Sr 1-x Pb x Ti 1-y Zr y O 3 ]-c[Pb(Mg 1/3 Nb 2/3 )O 3 ]Powder; wherein, 0<a<0.06，0.05<b<0.18，a+b+c=1； 0.6≤x≤0.8，0<y<0.2；
2) For the synthesized in the step 1)
a[0.67Bi 0.995 Ce 0.005 FeO 3 -0.33BaTiO 3 ]-b[Sr 1-x Pb x Ti 1-y Zr y O 3 ]-c[Pb(Mg 1/3 Nb 2/3 )O 3 ]Finely grinding the powder, adding a binder for granulation after fine grinding, and performing compression molding to obtain a biscuit;
3) Performing plastic removal to remove organic substances in the biscuit;
4) And sintering the biscuit to obtain the ceramic material.
As an implementation manner of the invention, release paper is arranged on one side of the back adhesive layer of the electrode patch, the release paper comprises first release paper and second release paper, the first release paper and the second release paper are intersected, and hand tearing parts are arranged at the intersection of the first release paper and the second release paper, so that the first release paper and the second release paper can be torn off conveniently, and the hand tearing parts are overlapped or intersected with each other.
In another aspect, there is provided a control circuit of an apparatus for delivering electric field energy to a human body, which is disposed in the signal generating module according to the first aspect, the control circuit comprising, connected in sequence: the device comprises a signal generator, an H-bridge driver, an H-bridge power MOS (metal oxide semiconductor) tube, a transformer, a filter and a voltage regulating power supply, wherein the filter is connected with an electrode patch, and the voltage regulating power supply is connected with a voltage regulating module;
the signal generator is used for controlling and generating a first pulse width modulation signal PWM1 and a second pulse width modulation signal PWM2 with fixed frequency and fixed duty ratio, and the frequency and the duty ratio of the PWM1 and the PWM2 are the same;
the PWM1 and the PWM2 respectively form a square wave with the frequency of 1kHz-300kHz and the duty ratio of 56% -72% after sequentially passing through the H-bridge driver and the H-bridge power MOS tube;
the square waves form switching signals with the period of 2 seconds after passing through a transformer and a filter, the switching signals are input into at least two pairs of electrode patches, and under the adjusting action of a voltage adjusting module, a local electric field with the frequency of 1kHz-300kHz, the adjustable output voltage of 1-300V, the adjustable load current of 0-2000mA and the intensity of 1V-20V/cm can be formed between any pair of electrode patches.
Adopt the produced beneficial effect of above-mentioned technical scheme to lie in:
the apparatus for transferring electric field energy to a human body provided by the invention is provided with the power adapter, the electric field generator, the visual manual operator and at least two pairs of electrode patches which are oppositely pasted on the human body, and the electric field generator is respectively connected with the power adapter, the visual manual operator and the electrode patches, so that non-mechanical energy can be transferred to the human body through the electric field generator and the electrode patches, and the apparatus is simple in structure and convenient to popularize in a large range.
In addition, an electric field intensity model is obtained through training, so that an algorithm module in the electric field generator can adjust the voltage in real time based on the current temperature sent by the temperature sensor, the current output voltage sent by the voltage monitoring unit and the current output current sent by the current monitoring unit; the user can also know the pasting position of the electrode patch through a visual manual operator, the operation is simple, convenient and fast, and the intelligent degree is high.
According to the invention, the temperature sensing elements are divided into A groups, each group comprises B temperature sensing elements, each group of temperature sensing elements is connected with the feedback monitoring module through one controlled analog switch, and the on/off of each controlled switch is controlled by one I/O line, so that the number of the I/O lines is greatly reduced, and the whole device is cleaner and tidier.
Drawings
Fig. 1 is a schematic diagram of a connection between a temperature sensing element and an electric field generator according to an embodiment of the present invention.
Fig. 2 is a schematic structural diagram of an electrode patch according to an embodiment of the present invention.
Fig. 3 is a schematic structural diagram of a flexible circuit board according to an embodiment of the present invention.
Fig. 4 is a side view of an electrode patch provided by an embodiment of the invention.
Fig. 5 is a schematic structural diagram of a release paper and an electrode patch according to an embodiment of the present invention.
Fig. 6 is an exploded view of fig. 5.
Fig. 7 is a schematic structural diagram of another release paper and electrode patch according to an embodiment of the present invention.
Fig. 8 is a schematic connection diagram of a control circuit of an apparatus for delivering electric field energy to a human body according to an embodiment of the present invention.
FIG. 9 is a schematic connection diagram of the control circuit of another apparatus for delivering electric field energy to a body according to an embodiment of the present invention.
Wherein: 1-a signal generator, a 2-H bridge driver, a 3-H bridge power MOS tube, a 4-transformer and a 5-voltage-regulating power supply;
101-a patch base body, 102-a positioning sheet, 103-a ceramic electrode sheet, 104-a positioning hole, 105-a flexible circuit board, 106-a connecting plate, 107-a supporting plate, 108-an embedded reinforcing wire, 109-a temperature sensing element, 110-a circular open space, 111-a sleeve, 112-a conducting wire, 200-release paper, 201-first release paper, 201-1-a first tearing part, 202-second release paper and 202-1-a second tearing part.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in detail and fully with reference to the following embodiments.
Example 1
The embodiment of the invention provides an apparatus device for transmitting electric field energy to a human body, which comprises: the electric field generator is respectively connected with the power adapter, the visual manual operator and the electrode patches;
the electric field generator includes: the system comprises a signal generation module, a pressure regulating module, an algorithm control module and a feedback monitoring module, wherein the algorithm control module is respectively connected with the feedback monitoring module and the pressure regulating module, and the pressure regulating module is connected with the signal generation module;
a local electric field with the frequency of 1kHz-300kHz, adjustable output voltage of 1-300V, load current of 0-2000mA and the strength of 1V-20V/cm can be generated between each pair of electrode patches.
Specifically, be provided with in the signal generation module respectively with the control circuit that pressure regulating module and electrode paster are connected, control circuit is including connecting gradually: the device comprises a signal generator, an H-bridge driver, an H-bridge power MOS (metal oxide semiconductor) tube, a transformer, a filter and a voltage regulating power supply, wherein the filter is connected with an electrode patch, and the voltage regulating power supply is connected with a voltage regulating module;
the signal generator is used for controlling and generating a first pulse width modulation signal PWM1 and a second pulse width modulation signal PWM2 with fixed frequency and fixed duty ratio, and the frequency and the duty ratio of the PWM1 and the PWM2 are the same;
the PWM1 and the PWM2 respectively form square waves with the frequency of 1kHz-300kHz and the duty ratio of 56% -72% after sequentially passing through the H-bridge driver and the H-bridge power MOS tube;
the square wave forms a switching signal with the period of 2 seconds after passing through a transformer and a filter, and after the switching signal is input into at least two pairs of electrode patches, a local electric field with the frequency of 1kHz-300kHz, the output voltage of 1-300V adjustable, the load current of 0-2000mA and the intensity of 1V-20V/cm can be formed between the pair of electrode patches under the adjusting action of a voltage-regulating power supply.
The switching signal comprises a plurality of sine wave sub-signals, and the number of the sine wave sub-signals is equal to the logarithm of the electrode patches; each sine wave sub-signal is used for acting on a pair of electrode patches, so that a local electric field is generated between the pair of electrode patches, and due to the fact that the directions of the local electric fields generated by each pair of electrode patches are different, the switching signals can enable at least two pairs of electrode patches to generate local electric fields in at least two directions, and the effect of transmitting electric field energy to a human body is improved. Specifically, when the electrode patches are set in two pairs, electric fields in different directions are generated between the two pairs of electrode patches, and the electrode patches are replaced every 1 second.
Certainly, the apparatus device also comprises an electric field charging seat, a portable backpack, a multifunctional nursing box, a standby manual operator and an electric field manual operator connecting wire.
Wherein, produce the electric field in order to realize transmitting electric field energy to the human body at electric field generator through the electrode paster, in-process, for improving its intelligent degree, electric field generator still can carry out real-time regulation and control based on the parameter of transmission electric field in-process.
In one possible implementation mode, each electrode patch is provided with a temperature sensor for acquiring the temperature of the electrode patch in real time; the feedback monitoring module further comprises: the current output control device comprises a voltage monitoring unit for acquiring current output voltage in real time and a current monitoring unit for acquiring current output current in real time, wherein the voltage monitoring unit, the current monitoring unit and a temperature sensor are all connected with an algorithm control module; the algorithm is embedded in the cpu of the signal generation module.
The algorithm control module is used for calculating the output intensity at the next moment based on the current temperature sent by the temperature sensor, the current output voltage sent by the voltage monitoring unit and the current output current sent by the current monitoring unit, and sending the output intensity to the voltage regulating module to regulate the voltage at the next moment.
The specific method comprises the following steps:
s1, taking the head of a human body as an electric field space, outputting electric energy to an electrode slice to form an electric field at the head of the human brain, and collecting the current temperature, the current output voltage and the current output current of an electrode patch in the electric field transmission process in real time;
the current output voltage and the current output current can be acquired through the Hall element.
And S2, inputting the current temperature, the current output voltage and the current output current of the electrode patch into an electric field intensity model, and outputting an optimal electric field intensity value, wherein the electric field intensity model is obtained through deep learning.
When the current output current is determined to be smaller than the preset current threshold and the current electrode plate temperature is lower than the temperature threshold, the optimal electric field strength value is larger than the strength value corresponding to the current output voltage; when the current output current is determined to be smaller than the preset current threshold and the current electrode plate temperature is determined to be higher than the temperature threshold, the optimal electric field strength value is lower than the strength value corresponding to the current output voltage;
in addition, the preset current threshold may be determined by a maximum current value which does not affect the progress in the electric field transmission process and can achieve the best effect, and exemplarily, the current threshold is 2000mA; further, the temperature threshold may be determined by the highest temperature that the human body can bear, which may be preset by the staff as a fixed temperature, or may be determined by the staff according to the degree of bearing of the patient, and the temperature threshold may be in a range of 37 ℃ to 44 ℃, for example.
And S3, adjusting the output voltage at the next moment according to the optimal electric field intensity value.
The algorithm control module calculates the output intensity at the next moment by adopting the following method:
inputting the current temperature, the current output voltage and the current output current into an electric field intensity model, outputting an optimal electric field intensity value serving as the output intensity of the next moment, and obtaining the electric field intensity model through deep learning;
when the current output current is determined not to reach the preset current threshold value and all the current temperatures are determined not to reach the temperature threshold value, the optimal electric field strength value is higher than the strength value corresponding to the current output voltage, and when any one current temperature is determined to reach the temperature threshold value, the optimal electric field strength value is lower than the strength value corresponding to the current output voltage, and the temperature threshold value range is 37-44 ℃;
the electric field intensity model is obtained by training by adopting the following method:
acquiring original sample data, wherein the original sample data comprises historical output voltage, historical output current, historical output intensity and historical temperatures of a plurality of electrode patches at a plurality of electric field transmission moments;
training to obtain an electric field strength model based on the original sample data;
dividing original sample data into a first class data set and a second class data set according to a historical output current intensity value and a historical electrode plate temperature value, wherein the historical output current intensity value in the first class data set does not reach the preset current threshold value and the historical electrode plate temperature value does not reach the temperature threshold value, and the historical output current intensity value in the second class data set does not reach the preset current threshold value and the historical electrode plate temperature value reaches the temperature threshold value;
obtaining a space vector load submodel for outputting an optimal electric field strength value under the condition of a first transmission electric field according to the first type of data set;
and training according to the second type of data set to obtain an electric field intensity sub-model for outputting the optimal electric field intensity value under the second transmission electric field condition.
It should be noted that, since the temperature sensor provided on each electrode patch includes a plurality of electrode elements, the current temperature and/or the historical temperature of the temperature sensor is obtained by:
when the temperature sent by all the temperature sensing elements corresponding to the temperature sensor is lower than the temperature threshold value, taking the temperature mean value of all the temperature sensing elements as the current temperature and/or the historical temperature of the temperature sensor;
and when the temperature sent by all the temperature sensing elements corresponding to the temperature sensor is determined to have the temperature larger than the temperature threshold, taking the sent highest temperature as the current temperature and/or the historical temperature of the temperature sensor.
In addition, to facilitate the control of the temperature sensing elements, in one possible implementation, as shown in fig. 1, all the temperature sensing elements are divided into a groups, each group is B, preferably a = B, the next case a = B ± 1 is also possible, and when the total amount is a prime number, there may be a group whose number is inconsistent with that of other groups, and the total amount is determined in software, without affecting the acquisition effect.
Each group of temperature sensing elements is connected with the algorithm control module through a controlled analog switch, and the on/off of each controlled analog switch is controlled by an I/O line; the controlled analog switch may be a mos transistor or an integrated analog switch, such as CD4051 or CD4052.
Illustratively, there are 9 electrode patches on each electrode patch, and when there are 4 electrodes in total, of all the temperature sensing elements (9 × 4= 36), every 6 temperature sensing elements are divided into one group, each group of the temperature sensing elements is connected with an electric field generator through a controlled analog switch, and the on and off of each controlled switch is controlled by an I/O line.
That is, the temperature sensing elements may be divided into 6 groups of 6 each. When the temperature sensing elements are represented by Rt, rt 1-Rt 6 are a first group, the controlled switch sw1 controls loading of the measuring signals, rt 7-Rt 13 are a second group, the sw2 controls loading of the measuring signals … …, and the like. The single chip microcomputer is controlled by a program to only conduct one path and read out corresponding information within a certain time, six paths are read out in sequence, and a temperature acquisition process is completed. Only 6+6, that is, 12I/O lines, are used to read in the information of 36 temperature sensors, compared with the original connection mode, 37-12= 25I/O lines are saved, it is seen that the effect of saving the I/O lines is significant, in addition, the time of collecting once in actual work is about 0.1ms, the collection time is divided into 6 groups, the time of reading for 6 times is only 0.6ms, and the signal collection speed is high (fig. 1 is an example performed by 16 temperature sensing elements, which is specifically connected with an algorithm control module in an electric field transmitter, and when the temperature sensing elements are set to 36, the connection mode is similar to that, and is not repeated here).
To further increase its intelligence level, in one possible implementation, the visual hand operator comprises:
the input module is used for receiving user identification information input by a user;
the calling module is used for calling electrode patch position information corresponding to the user identification information in a database;
the display module is used for displaying the position information of the electrode patch so that a user can paste the electrode patch based on the position information of the electrode patch;
wherein the database is obtained by the following method:
generating a plurality of brain tissue structure models in a three-dimensional simulation mode;
calculating the field intensity distribution of each brain tissue structure model;
and calculating the positioning position of the electrode patch corresponding to each brain tissue structure model based on the field intensity distribution.
Furthermore, the operator or the medical staff can paste a plurality of electrode patches on the body of the patient according to the content displayed by the visual hand operator (each electrode patch corresponds to one label), and then the labels of each pair of electrode patches are manually set to realize the grouping of the two pairs of electrode patches. The electrode patches may be arranged in two pairs, with different directions of electric field generated between the two pairs of electrode patches, and the electrode patches may be replaced every 1 second, and there may be two, or three, or more electrode patches per pair, so that an electric field may be applied to any one tumor tissue.
Alternatively, the database may be pre-stored in the electric field generator in a manner known in the art, and the present invention will not be described in detail herein.
The electrode patch will be further described below.
1. Function of electrode patch
In one possible implementation, the electrode patches are provided in two pairs; each electrode patch has an area of 22.5cm 2 When all the electrode patches (two pairs) are attached to the skull, 4 electrode patches can cover 75% of the area of the human brain, the purpose of transmitting an electric field is realized through two pairs of electrode patches which are respectively oppositely arranged under the action of the electric field, and the arrangement directions of the two pairs of electrode patches are different:
the alternating rectangular wave signal is a periodic control signal with a first output state and a second output state;
the first pair of electrode patches is used for generating a first local electric field with the frequency of 1kHz-300kHz, adjustable output voltage of 1-300V, load current of 0-2000mA and strength of 1V-20V/cm when the alternating rectangular wave signal is in a first output state; the second pair of electrode patches is used for generating a second local electric field with the frequency of 1kHz-300kHz, adjustable output voltage of 1-300V, load current of 0-2000mA and strength of 1V-20V/cm when the alternating rectangular wave signal is in a second output state;
the direction of the first local electric field is different from the direction of the second local electric field, and the first local electric field and the second local electric field both penetrate through the tissue to be subjected to electric field transmission.
2. Connection mode of electrode patch
In one possible implementation manner, each ceramic electrode plate is connected with a signal generation module through an electric control switch, and the electric control switch is further connected with an algorithm control module;
each electronically controlled switch is configured to control the on signal sent by the module according to the algorithm so that current can flow between the corresponding ceramic electrode sheet and the signal generating module; and the number of the first and second groups,
and according to the cutting signal sent by the algorithm control module, cutting current flows between the corresponding ceramic electrode plate and the signal generation module.
Therefore, when the algorithm calculation module determines that the current output temperature of any one ceramic electrode reaches or exceeds a preset threshold value, the algorithm calculation module can perform independent regulation and control on the ceramic electrode in time, sends a cutting signal to the ceramic electrode, achieves accurate control on the ceramic electrode, and improves efficiency.
3. Electrode skin structure
1. For facilitating the pasting and fixing of the electrode patch
In one possible implementation, as shown in fig. 2-4, each of the electrode patches includes:
the adhesive tape comprises a chip substrate 101, wherein a back adhesive layer is arranged on one surface of the chip substrate 101;
the positioning pieces 102 are arranged on one side of the back adhesive layer of the patch base body 101 in an array mode, and a plurality of positioning holes 104 are uniformly distributed on the positioning pieces;
a plurality of ceramic electrode plates 103, wherein the ceramic electrode plates 103 are placed in the positioning holes 104;
the flexible circuit board 105 is arranged on one side of the back glue layer of the chip substrate 101, the first side of the flexible circuit board is provided with bonding pads which correspond to the ceramic electrode plates 103 one by one, the ceramic electrode plates 103 are welded on the bonding pads, and the second side of the flexible circuit board is provided with a supporting plate 107; the edge of each notch of the flexible circuit board is provided with an embedded reinforcing line 108, the embedded reinforcing lines 108 extend along the shape of the notch of the flexible circuit board 105, and the embedded reinforcing lines 108 are n-shaped, n-shaped or w-shaped, so that the flexible circuit is prevented from being damaged when being pulled;
the ceramic electrode plate 103, the connecting plate 106 and the supporting plate 107 are all arranged in the positioning hole 104 on the positioning plate 102.
The thickness and material of the supporting plate 107 are not particularly limited, and the supporting plate only needs to be ensured to play a supporting role, for example: the thickness of the support plate 107 is 0.5mm; the material of the bakelite plate is epoxy resin material, or the bakelite plate can also be made of metal material to increase heat dissipation; in addition, the supporting plate 107 has a circular structure with the same outer diameter as the ceramic electrode sheet 103 to improve the supporting effect.
In addition, a through hole is formed in the middle of each ceramic electrode plate 103, a temperature sensing element used for acquiring the temperature of the ceramic electrode plate is arranged in each through hole, shadowless glue used for embedding the temperature sensing element is filled in each through hole, and the shadowless glue is flush with the upper surface of the electrode patch after being cured.
Further, in the invention, considering that the whole electrode patch is required to be adhered to the outer side of the skin of a human body through medical adhesive cloth and worn continuously for at least about 10 hours in the process of transmitting an electric field, the existing medical adhesive cloth is rectangular, has a large contact area with the skin of the human body, and is often subjected to pruritus and even ulceration after being adhered for a long time, and a plurality of circular open spaces 110 with the diameter of 0.1-3 cm are arranged in the area of the patch base body 101 which is not covered by the flexible circuit board and the positioning sheet. The open space may be set at the time of factory shipment or may be set by a family member of the patient according to the requirement of the patient, which is not particularly limited in the embodiment of the present invention.
2. To ensure the electrode paste can play a role after being pasted
In a possible implementation manner, the flexible circuit board 105 is connected with a lead 112, the lead 112 is connected with an electric field generator, a sleeve 111 for reinforcing protection is arranged at the connection position of the flexible circuit board 105 and the lead 112, the sleeve 111 is a heat shrinkable tube, and shadowless glue is filled in the heat shrinkable tube to heat and shrink to realize encapsulation. The ceramic electrode plate is made of ferroelectric ceramic material with relative dielectric constant of 5000-20000 and dielectric loss less than 0.04; the ferroelectric ceramic material is prepared by a one-step method or a two-step method.
Illustratively, the preparation method of the ferroelectric ceramic material comprises the following steps:
1) Adopting a solid phase method to synthesize in one step
a[0.67Bi 0.995 Ce 0.005 FeO 3 -0.33BaTiO 3 ]-b[Sr 1-x Pb x Ti 1-y Zr y O 3 ]-c[Pb(Mg 1/3 Nb 2/3 )O 3 ]：
With Bi 2 O 3 ，CeO 2 ，Fe 2 O 3 ，BaCO 3 ，TiO 2 ，SrCO 3 ，Pb 3 O 4 ，ZrO 2 ，MgO，Nb 2 O 5 As raw materials, keeping the temperature at 750-850 ℃ for 4 hours, and synthesizing
a[0.67Bi 0.995 Ce 0.005 FeO 3 -0.33BaTiO 3 ]-b[Sr 1-x Pb x Ti 1-y Zr y O 3 ]-c[Pb(Mg 1/3 Nb 2/3 )O 3 ]Powder; wherein, 0<a<0.06，0.05<b<0.18，a+b+c=1； 0.6≤x≤0.8，0<y<0.2；
2) For the synthesized in the step 1)
a[0.67Bi 0.995 Ce 0.005 FeO 3 -0.33BaTiO 3 ]-b[Sr 1-x Pb x Ti 1-y Zr y O 3 ]-c[Pb(Mg 1/3 Nb 2/3 )O 3 ]Finely grinding the powder, adding a binder for granulation after fine grinding, and performing compression molding to obtain a biscuit;
3) Performing plastic removal to remove organic substances in the biscuit;
4) And sintering the biscuit to obtain the ceramic material.
3. Electrode patch convenient for user to use
In a possible implementation manner, in order to facilitate the user to tear off the release paper, as shown in fig. 5-7, one side of the back adhesive layer of the electrode patch is provided with the release paper 200, the release paper includes a first release paper 201 and a second release paper 202, the first release paper 201 and the second release paper 202 intersect, and the first release paper 201 and the second release paper 202 are both provided with a hand tearing portion at the intersection (the first release paper is provided with a first hand tearing portion 201-1, the second release paper is provided with a second hand tearing portion 202-1), so as to facilitate the tearing off of the first release paper 201 and the second release paper 202, and the hand tearing portions are overlapped or crossed with each other. When not in use, the medical sticky cloth is covered by the two pieces of release paper to protect the medical sticky cloth, so that sticky failure is prevented.
Example 2
An embodiment of the present invention provides a control circuit of an apparatus device for delivering electric field energy to a human body, as shown in fig. 8, which includes, connected in sequence: the device comprises a signal generator 1, an H bridge driver 2, an H bridge power MOS tube 3, a transformer 4, a filter and a voltage-regulating power supply 5; the filter is connected with the electrode patch, and the voltage regulating power supply is connected with the voltage regulating module;
the signal generator 1 controls and generates a first pulse width modulation signal PWM1 and a second pulse width modulation signal PWM2 with fixed frequency and fixed duty ratio, and the frequency and the duty ratio of the PWM1 and the PWM2 are the same;
the PWM1 and the PWM2 respectively form square waves with the frequency of 1kHz-300kHz, the high level duration of 320 ms-627 ms and the duty ratio of 56% -72% after sequentially passing through the H bridge driver 2 and the H bridge power MOS tube 3;
the square waves form switching signals with a period of 2 seconds after passing through a transformer and a filter, the switching signals are input into at least two pairs of electrode patches, and under the adjusting action of a voltage adjusting module, a local electric field with the frequency of 1kHz-300kHz, the adjustable output voltage of 1-300V, the adjustable load current of 0-2000mA and the intensity of 1V-20V/cm can be formed between any pair of electrode patches.
Selecting different electric field frequencies according to the aimed tumors and diseases, wherein the electric field frequency for transmitting the electric field to the intracranial tumors is 170-230kHz; the electric field frequency for transmitting the electric field to the intestinal tumor is 30-70kHz; the electric field frequency for transmitting the electric field to the small cell lung cancer is 170-230kHz; the frequency of an electric field for transmitting the electric field to the non-small cell lung cancer is 120-170kHz; the electric field frequency for delivering an electric field to breast cancer is 100-180kHz; the frequency of the electric field used to deliver the electric field to the bladder cancer is 100-180kHz; the frequency of the electric field used to deliver the electric field to ovarian cancer is 170-230kHz.
As shown in fig. 9, the H-bridge driver 2 includes a first half-bridge driver and a second half-bridge driver, the H-bridge power MOS transistor 3 includes a high-end MOS transistor M1, a low-end MOS transistor M2, a high-end MOS transistor M3, and a low-end MOS transistor M4, and the 4 MOS transistors M1, M2, M3, and M4 form a differential H-bridge power MOS transistor 3.
The first pulse width modulation signal PWM1 generates high-end driving signals PWM1-H and low-end driving signals PWM1-L through a half-bridge driver I, and drives the high-end MOS tube M1 and the low-end MOS tube M2 respectively, wherein the high-end driving signals PWM1-H and the low-end driving signals PWM1-L are complementary;
the second pulse width modulation signal PWM2 generates a high-side driving signal PWM2-H and a low-side driving signal PWM2-L through the second half-bridge driver, and drives the high-side MOS transistor M3 and the low-side MOS transistor M4, respectively, wherein the high-side driving signal PWM2-H and the low-side driving signal PWM2-L are complementary to each other. It should be noted that the first half-bridge driver and the second half-bridge driver may adopt chips meeting requirements in the prior art, so as to drive the four MOS transistors by using the chips in the foregoing manner.
In addition, the high-end MOS transistor M1 and the low-end MOS transistor M2 are both connected to a VOA output terminal, the high-end MOS transistor M3 and the low-end MOS transistor M4 are both connected to a VOB output terminal, and the VOA output terminal and the VOB output terminal are both connected to an input terminal of the output transformer 4;
after the output signals of the VOA output end and the VOB output end are converged (according to the voltage difference between the VOA output end and the VOB output end), a square wave with the frequency of 1kHz-300kHz and the duty ratio of 56% -72% is formed; the square wave passes through a subsequent transformer and a filter to obtain a switching signal with the period of 2 seconds.
Claims (11)
1. An apparatus for delivering electric field energy to a human body, comprising: the electric field generator is respectively connected with the power adapter, the visual manual operator and the electrode patches;
the electric field generator includes: the system comprises a signal generating module, a pressure regulating module, an algorithm control module and a feedback monitoring module, wherein the algorithm control module is respectively connected with the feedback monitoring module and the pressure regulating module, and the pressure regulating module is connected with the signal generating module;
the signal generating module is internally provided with a control circuit which is respectively connected with the voltage regulating module and the electrode patches, the control circuit is used for generating switching signals with the period of 2 seconds, the switching signals are input into at least two pairs of electrode patches, and under the regulation action of the voltage regulating module, a local electric field with the frequency of 1kHz-300kHz, the output voltage of 1-300V, the load current of 0-2000mA and the strength of 1V-20V/cm can be formed between any pair of electrode patches;
each of the electrode patches includes: the flexible circuit board is provided with a plurality of connecting plates, the first surfaces of the connecting plates are connected with the ceramic electrode plates, the second surfaces of the connecting plates are provided with supporting plates, and the ceramic electrode plates, the connecting plates and the supporting plates are all arranged in positioning holes in the positioning plates;
the visual manual operator comprises:
the input module is used for receiving user identification information input by a user;
the calling module is used for calling electrode patch position information corresponding to the user identification information in a database;
the display module is used for displaying the position information of the electrode patch so that a user can paste the electrode patch based on the position information of the electrode patch;
wherein the database is obtained by the following method:
generating a plurality of brain tissue structure models in a three-dimensional simulation mode;
calculating the field intensity distribution of each brain tissue structure model;
and calculating the positioning position of the electrode patch corresponding to each brain tissue structure model based on the field intensity distribution.
2. The apparatus according to claim 1, wherein each electrode patch is provided with a temperature sensor for real-time temperature acquisition; the feedback monitoring module further comprises: the current output control device comprises a voltage monitoring unit for acquiring current output voltage in real time and a current monitoring unit for acquiring current output current in real time, wherein the voltage monitoring unit, the current monitoring unit and a temperature sensor are all connected with an algorithm control module;
the algorithm control module is used for calculating the output intensity at the next moment based on the current temperature sent by the temperature sensor, the current output voltage sent by the voltage monitoring unit and the current output current sent by the current monitoring unit, and sending the output intensity to the voltage regulating module to regulate the voltage at the next moment.
3. The apparatus according to claim 2, wherein the algorithm control module calculates the output intensity at the next time by:
inputting the current temperature, the current output voltage and the current output current into an electric field intensity model, outputting an optimal electric field intensity value serving as an output intensity at the next moment, and obtaining the electric field intensity model through deep learning;
when the current output current is determined not to reach the preset current threshold value and all the current temperatures are determined not to reach the temperature threshold value, the optimal electric field strength value is higher than the strength value corresponding to the current output voltage, and when any one current temperature is determined to reach the temperature threshold value, the optimal electric field strength value is lower than the strength value corresponding to the current output voltage, and the temperature threshold value range is 37-44 ℃;
the electric field intensity model is obtained by training by adopting the following method:
acquiring original sample data, wherein the original sample data comprises historical output voltage, historical output current, historical output intensity and historical temperatures of a plurality of electrode patches at a plurality of electric field transmission moments;
training to obtain an electric field strength model based on the original sample data;
dividing original sample data into a first class data set and a second class data set according to a historical output current intensity value and a historical electrode plate temperature value, wherein the historical output current intensity value in the first class data set does not reach the preset current threshold value and the historical electrode plate temperature value does not reach the temperature threshold value, and the historical output current intensity value in the second class data set does not reach the preset current threshold value and the historical electrode plate temperature value reaches the temperature threshold value;
obtaining a space vector load submodel for outputting an optimal electric field strength value under the condition of a first transmission electric field according to the first type of data set;
and training according to the second type of data set to obtain an electric field intensity sub-model for outputting the optimal electric field intensity value under the second transmission electric field condition.
4. The apparatus according to claim 3, wherein each of said temperature sensors comprises a plurality of temperature sensing elements connected to said algorithm control module, all of said temperature sensing elements being divided into A groups of B, where A = B; each group of temperature sensing elements is connected with the algorithm control module through a controlled analog switch, and the on/off of each controlled analog switch is controlled by an I/O line;
the current temperature and/or the historical temperature of each temperature sensor is obtained by the following method:
when the temperature sent by all the temperature sensing elements corresponding to the temperature sensor is lower than the temperature threshold value, taking the temperature mean value of all the temperature sensing elements as the current temperature and/or the historical temperature of the temperature sensor;
and when the temperature sent by all the temperature sensing elements corresponding to the temperature sensor is determined to have the temperature greater than the temperature threshold, taking the sent highest temperature as the current temperature and/or the historical temperature of the temperature sensor.
5. The apparatus for transferring electric field energy to a human body according to claim 1, wherein a through hole is formed in the middle of each ceramic electrode plate, a temperature sensing element for acquiring the temperature of the ceramic electrode plate is arranged in each through hole, a shadowless glue for embedding the temperature sensing element is filled in each through hole, and the shadowless glue is flush with the upper surface of the ceramic electrode plate after being cured.
6. The apparatus for delivering electric field energy to a human body according to claim 1, wherein each of said ceramic electrode plates is connected to a signal generating module via an electronic control switch, said electronic control switch being further connected to an algorithm control module;
each electronically controlled switch is configured to control a switch-on signal sent by the module according to the algorithm so that current can flow between the corresponding ceramic electrode sheet and the signal generating module; and the number of the first and second groups,
and according to the cutting-off signal sent by the algorithm control module, cutting off the current flowing between the corresponding ceramic electrode plate and the signal generation module.
7. The apparatus for transmitting electric field energy to human body according to claim 1, wherein said supporting plate is a bakelite plate with a thickness of 0.4-0.6mm, and is a circular structure having the same outer diameter as the ceramic electrode plate;
the edge of each notch of the flexible circuit board is provided with an embedded reinforcing line, and the embedded reinforcing lines extend along the shape of the notch of the flexible circuit board;
a plurality of circular open spaces with the diameter of 0.1-3cm are arranged in the area of the patch substrate not covered by the flexible circuit board and the positioning sheet;
the flexible circuit board is connected with a lead, the lead is connected with the electric field generator, a sleeve pipe which plays a role in strengthening protection is arranged at the joint of the flexible circuit board and the lead, the sleeve pipe adopts a heat shrinkage pipe, and shadowless glue is filled in the heat shrinkage pipe for heating shrinkage to realize packaging.
8. The apparatus according to claim 1, wherein the ceramic electrode sheet is made of a ferroelectric ceramic material having a relative dielectric constant in the range of 5000-20000 and a dielectric loss of less than 0.04; the ferroelectric ceramic material is prepared by a one-step method or a two-step method.
9. The apparatus according to claim 8, wherein said ferroelectric ceramic material is prepared by a method comprising the steps of:
1) One-step synthesis by solid phase method
a[0.67Bi 0.995 Ce 0.005 FeO 3 -0.33BaTiO 3 ]-b[Sr 1-x Pb x Ti 1-y Zr y O 3 ]-c[Pb(Mg 1/3 Nb 2/3 )O 3 ]：
With Bi 2 O 3 ，CeO 2 ，Fe 2 O 3 ，BaCO 3 ，TiO 2 ，SrCO 3 ，Pb 3 O 4 ，ZrO 2 ，MgO，Nb 2 O 5 As raw materials, keeping the temperature at 750-850 ℃ for 4 hours, and synthesizing
a[0.67Bi 0.995 Ce 0.005 FeO 3 -0.33BaTiO 3 ]-b[Sr 1-x Pb x Ti 1-y Zr y O 3 ]-c[Pb(Mg 1/3 Nb 2/3 )O 3 ]Powder; wherein, 0<a<0.06，0.05<b<0.18，a+b+c=1； 0.6≤x≤0.8，0<y<0.2；
2) For the synthesized in the step 1)
a[0.67Bi 0.995 Ce 0.005 FeO 3 -0.33BaTiO 3 ]-b[Sr 1-x Pb x Ti 1-y Zr y O 3 ]-c[Pb(Mg 1/3 Nb 2/3 )O 3 ]Finely grinding the powder, adding a binder for granulation after fine grinding, and performing compression molding to obtain a biscuit;
3) Performing plastic removal to remove organic substances in the biscuit;
4) And sintering the biscuit to obtain the ceramic material.
10. The apparatus for transmitting electric field energy to human body according to claim 1, wherein the back adhesive layer of the electrode patch is provided with release paper on one side, the release paper includes a first release paper and a second release paper, the first release paper and the second release paper intersect with each other, and both the first release paper and the second release paper are provided with hand tearing portions at the intersection of the two, so as to facilitate tearing off the first release paper and the second release paper, and the hand tearing portions are overlapped or crossed with each other.
11. An apparatus according to any one of claims 1 to 10, wherein the control circuit comprises, connected in series: the device comprises a signal generator, an H-bridge driver, an H-bridge power MOS (metal oxide semiconductor) tube, a transformer, a filter and a voltage regulating power supply, wherein the filter is connected with an electrode patch, and the voltage regulating power supply is connected with a voltage regulating module;
the signal generator is used for controlling and generating a first pulse width modulation signal PWM1 and a second pulse width modulation signal PWM2 with fixed frequency and fixed duty ratio, and the frequency and the duty ratio of the PWM1 and the PWM2 are the same;
the PWM1 and the PWM2 respectively form a square wave with the frequency of 1kHz-300kHz and the duty ratio of 56% -72% after sequentially passing through the H-bridge driver and the H-bridge power MOS tube;
the square wave forms a switching signal with the period of 2 seconds after passing through a transformer and a filter.
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| US7128741B1 (en) * | 2003-04-04 | 2006-10-31 | Megadyne Medical Products, Inc. | Methods, systems, and devices for performing electrosurgical procedures |
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