CN113576652A

CN113576652A - Composite steep pulse treatment equipment for automatically monitoring and adjusting ablation parameters

Info

Publication number: CN113576652A
Application number: CN202110779185.0A
Authority: CN
Inventors: 王海峰; 罗中宝; 林汉字; 高玉富
Original assignee: Shanghai Remedicine Co ltd
Current assignee: Shanghai Remedicine Co ltd
Priority date: 2021-06-04
Filing date: 2021-07-09
Publication date: 2021-11-02
Also published as: CN216221635U

Abstract

The invention relates to a compound steep pulse treatment device for automatically monitoring and adjusting ablation parameters, comprising: the upper computer is used for judging whether ablation parameters need to be adjusted or not based on the ablation target and sending an instruction when the ablation parameters need to be adjusted; the control unit is coupled to the upper computer and used for receiving the instruction and generating control information according to the instruction; the ablation parameter adjusting unit is coupled to the control unit and used for adjusting the ablation parameters according to the control information; and the acquisition unit is respectively coupled to the ablation parameter adjusting unit and the control unit and is used for acquiring the ablation parameters output by the ablation parameter adjusting unit and sending the acquired data to the upper computer through the control unit. The composite steep pulse treatment equipment for automatically monitoring and adjusting the ablation parameters can automatically monitor and adjust the ablation parameters when judging that the ablation target is not reached, thereby not only accelerating the ablation efficiency, but also reducing the operation time.

Description

Composite steep pulse treatment equipment for automatically monitoring and adjusting ablation parameters

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to composite steep pulse treatment equipment for automatically monitoring and adjusting ablation parameters.

Background

Tumors, especially malignant tumors, are major diseases that endanger human health. Traditional and more recently developed therapies for tumors are thermal ablation physiotherapy characterized by minimally invasive ablation. The clinical application of the traditional Chinese medicine composition has certain limitations due to the limitation of factors such as adaptability, contraindications, side effects of treatment, heat effect and the like. In recent years, with the continuous development of pulsed bioelectricity, the electric field pulse attracts the attention of researchers due to the non-thermal and minimally invasive biomedical effects thereof, and the irreversible electroporation therapy of tumors among them attracts the extensive attention of researchers in the bioelectricity field at home and abroad due to the advantages and characteristics of rapidness, controllability, visibility, selectivity, non-thermal mechanism and the like, and is gradually applied to the clinical treatment of tumors.

The composite steep pulse treatment equipment is one of equipment for treating tumors by adopting an irreversible electroporation technology, and in the process of treating tumors by using the composite steep pulse treatment equipment, when voltage is not changed, the resistance value of focal tissues is changed due to ablation of the focal tissues, and treatment current is changed accordingly, so that whether ablation reaches an ablation target or not can be judged by observing whether the current change of the focal tissues reaches a preset threshold or not. However, in the prior art, when the current change of the focal tissue is found to be small during the treatment process and the ablation target is not reached, the operator is usually required to return to the operation interface for operation, so as to continue to ablate the tumor tissue, and the operator returns to the operation interface for operation, which not only causes troublesome process, but also increases operation time.

Disclosure of Invention

In order to solve the technical problem that the operation time is increased due to the fact that an operator returns to an operation interface to operate, the embodiment of the invention provides the composite steep pulse treatment equipment for automatically monitoring and adjusting the ablation parameters.

The invention provides a composite steep pulse treatment device for automatically monitoring and adjusting ablation parameters, which comprises:

the upper computer is used for judging whether ablation parameters need to be adjusted or not based on the ablation target and sending an instruction when the ablation parameters need to be adjusted;

the control unit is coupled to the upper computer and used for receiving the instruction and generating control information according to the instruction;

an ablation parameter adjusting unit coupled to the control unit for adjusting the ablation parameter according to the control information;

and the acquisition unit is respectively coupled to the ablation parameter adjusting unit and the control unit and is used for acquiring the ablation parameters output by the ablation parameter adjusting unit and sending the acquired data to the upper computer through the control unit.

In some embodiments, the ablation parameter adjustment unit comprises at least a high voltage power supply unit and a pulse unit;

the high-voltage power supply unit is respectively coupled to the control unit and the pulse unit and used for generating required voltage according to the control information received from the control unit;

the pulse unit is respectively coupled to the high-voltage power supply unit, the acquisition unit and the control unit and is used for converting the voltage into the required pulse according to the control information.

In some embodiments, when the control information is for instructing to adjust the voltage, the control unit is configured to send the control information to the high-voltage power supply unit; when the control information is used for indicating to adjust the pulse parameters, the control unit is used for sending the control information to the pulse unit, and the pulse unit adjusts the pulse parameters according to the control information.

In certain embodiments, the acquisition unit comprises:

the current sensor is used for collecting the current value of the pulse output by the pulse unit and sending the current value to the upper computer through the control unit;

and the voltage dividing unit is used for collecting the voltage value of the pulse output by the pulse unit and sending the voltage value to the upper computer through the control unit.

In some embodiments, the ablation target is that after a preset number of bursts are emitted, the value of change of the current value reaches a preset threshold value and the current value is within a preset range.

In some embodiments, the upper computer is further configured to obtain, via the control unit, a first current value at the start of transmitting the preset number of pulse trains from the acquisition unit, and further configured to obtain, via the control unit, a second current value at the end of transmitting the preset number of pulse trains from the acquisition unit, and determine a change value of the current value within the preset time period according to the first current value and the second current value, and if the change value is smaller than the preset threshold, determine that the ablation parameter needs to be adjusted.

In some embodiments, the predetermined threshold is 5A and the predetermined range is 40A-45A.

In certain embodiments, further comprising: and the analog-to-digital conversion unit is arranged between the acquisition unit and the control unit and is used for converting the analog signal data acquired by the acquisition unit into digital signal data.

In certain embodiments, further comprising: and the switching unit is respectively coupled to the pulse unit, the control unit and the electrode needle unit and is used for selectively switching the pulse of the pulse unit among the electrode needles in the electrode needle unit according to the control signal of the control unit.

In certain embodiments, the control unit is comprised of a processor and an FPGA processor;

the processor is respectively coupled to the upper computer and the high-voltage output unit, and the FPGA processor is respectively coupled to the processor, the pulse unit and the acquisition unit.

The invention has the beneficial effects that: according to the composite steep pulse treatment equipment for automatically monitoring and adjusting the ablation parameters, provided by the embodiment of the invention, when the ablation target is judged not to be reached in the treatment process, the ablation parameters can be automatically monitored and adjusted, so that an operator does not need to return to an operation interface for operation in the treatment process, the ablation efficiency can be accelerated, and the operation time can be reduced.

Drawings

Fig. 1 is a schematic structural diagram of a composite steep pulse treatment device for automatically monitoring and adjusting ablation parameters according to an embodiment of the present invention;

fig. 2 is another schematic structural diagram of a composite steep pulse treatment device for automatically monitoring and adjusting ablation parameters according to an embodiment of the present invention;

fig. 3 is a schematic structural diagram of a composite steep pulse treatment device for automatically monitoring and adjusting ablation parameters according to an embodiment of the present invention;

fig. 4 is a schematic structural diagram of a composite steep pulse treatment device for automatically monitoring and adjusting ablation parameters, which comprises an analog-to-digital conversion unit;

fig. 5 is a schematic structural diagram of a composite steep pulse treatment device for automatically monitoring and adjusting ablation parameters, which comprises a processor and an FPGA processor according to an embodiment of the present invention;

fig. 6 is a flow chart of a method that can be performed by the composite steep pulse treatment device for automatically monitoring and adjusting ablation parameters according to an embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to specific embodiments and the accompanying drawings. Those skilled in the art will appreciate that the present invention is not limited to the drawings and the following examples.

As used herein, the term "include" and its various variants are to be understood as open-ended terms, which mean "including, but not limited to. The term "based on" may be understood as "based at least in part on". The term "one embodiment" may be understood as "at least one embodiment". The term "another embodiment" may be understood as "at least one other embodiment". The terms "first", "second", and the like herein are used merely for distinguishing technical features and have no essential meaning.

As described above, in the process of treating tumor lesion tissue by ablation, when it is found that the current change of the lesion tissue is small and it is determined that the current change does not reach the ablation target, the operator is usually required to return to the operation interface to perform the operation, which not only causes a troublesome procedure, but also increases the operation time. Based on the above, the embodiment of the invention provides a composite steep pulse treatment device for automatically monitoring and adjusting ablation parameters, which sends an instruction when the ablation parameters need to be adjusted based on an ablation target, and automatically monitors and adjusts the ablation parameters according to the instruction, so that the adjustment of the ablation parameters can be completed without returning an operator to an operation interface for operation, the ablation efficiency can be accelerated, and the operation time can be reduced.

Embodiments of the present invention are further described below with reference to the accompanying drawings. Fig. 1 shows a schematic structural diagram of a composite steep pulse treatment device 10 for automatically monitoring and adjusting ablation parameters according to one embodiment of the present invention. Referring to fig. 1, a composite steep pulse treatment apparatus 10 for automatically monitoring and adjusting ablation parameters according to an embodiment of the present invention includes: the device comprises an upper computer 1, a control unit 2, an ablation parameter adjusting unit 3, a collecting unit 4, a switching unit 5 and an electrode needle unit 6. Wherein:

the upper computer 1 is used for judging whether ablation parameters need to be adjusted or not based on the ablation target, and sending an instruction to the control unit 2 when the ablation parameters need to be adjusted.

In particular, the host computer may be a computing device such as a computer or tablet.

And the control unit 2 is coupled to the upper computer 1 and used for receiving the instruction from the upper computer 1 and generating control information according to the instruction.

And the ablation parameter adjusting unit 3 is coupled to the control unit 2 and used for receiving the control information from the control unit 2 and adjusting the ablation parameters according to the control information.

And the acquisition unit 4 is respectively coupled to the control unit 2 and the ablation parameter adjusting unit 3, and is used for acquiring the ablation parameters output by the ablation parameter adjusting unit 3 and sending the acquired data to the upper computer 1 through the control unit 2.

And a switching unit 5 for switching the electrode needles in the electrode needle unit 6 by means of the switches and connecting the electrode needles to the pulse unit by means of the switches, thereby forming a high-voltage electric field between the electrode needles.

And the electrode needle unit 6 consists of electrode needles and is used for selectively switching the pulses emitted by the parameter adjusting unit 3 among the electrode needles according to the control signals of the control unit 2.

In practice, the number of electrode needles may be selected based on the type, shape, size, malignancy of the tumor to be treated, for example, the electrode needle unit may be composed of 4 electrode needles including two electrode needles having a high potential and two electrode needles having a low potential. In another example, the electrode needle unit may be composed of 5, 7, or 8 electrode needles, and the potential of each electrode needle may be different.

In practice, ablation parameters may also be set based on factors such as the type of tumor to be treated, shape, size, malignancy, and the like. For example, in one example, the ablation parameter may be set to a voltage, in which case adjusting the ablation parameter refers to adjusting the voltage; in another example, the ablation parameter may be set to a burst frequency, in which case adjusting the ablation parameter refers to adjusting the burst frequency; in yet another example, the ablation parameter may be set as a combination of voltage and burst frequency, in which case adjusting the ablation parameter may be adjusting the voltage first, then adjusting the burst frequency, and then adjusting the voltage interval, adjusting the burst frequency first, then adjusting the voltage interval, and then adjusting the burst frequency interval, or adjusting the voltage first until the voltage cannot be adjusted again, and then adjusting the burst frequency.

In the process of treating tumors by using the irreversible electroporation technology, a plurality of nano-scale micropores are required to be generated on a cell membrane where cells in an ablation tissue are located in an ultrashort time, so that the balance inside and outside the cells is irreversibly damaged, the cells are induced to die, and the current of the lesion tissue is correspondingly changed along with the ablation of the lesion tissue in the treatment process. Therefore, the change of the current and the value range of the current in the ablation process can be considered as the ablation target, that is, a single item or a combination of the change of the current and the value range of the current in the ablation process can be considered as the ablation target.

Thus, in an alternative embodiment, the ablation targets may be set to: after a preset number (e.g., 10) of bursts are transmitted, the change in the required current value reaches a preset threshold (e.g., 5A). In this case, if the change in the current value reaches the preset threshold value after the emission of the preset number of pulse trains, it is judged that the ablation target is reached, otherwise it is judged that the ablation target is not reached. In another alternative embodiment, the ablation targets may be set to: in addition to requiring that the current value change reaches a preset threshold (e.g., 5A) after a preset number of bursts are transmitted, the present current value is also required to be within a preset threshold range (e.g., 40A-45A). In this case, even after a preset number of pulse trains are emitted, if the change in the current value does not reach the preset threshold value, it cannot be judged that the ablation target is reached, and it must be judged that the ablation target is reached when the current value is also within the preset threshold value range.

For example, in one alternative embodiment, the ablation targets may be set to: after transmitting 10 pulse trains, the rising change of the required current value reaches 5A. In this case, if the rising change of the current value does not reach 5A after the firing of 10 pulse trains, the upper computer judges that the ablation target is not reached, otherwise, judges that the ablation target is reached. In another alternative embodiment, the ablation targets may be set to: after transmitting 10 bursts, not only the current is required to rise to 5A, but also the present current value is required to be in the range of 40A-45A. In this case, if the rising change of the current value reaches 5A even after the transmission of 10 pulse trains, the upper computer cannot judge that the ablation target is reached if the current value is not within the range of 40A-45A, such as the current value of 35A. Only after 10 pulse trains are transmitted, the upper computer can judge that the ablation target is reached, wherein the rising change of the current value reaches 5A, and the current value is in the range of 40A-45A (for example, the current value is 42A).

It should be noted that, in an optional embodiment, the transmitting of the preset number of pulse trains may be completed by the pulse unit, the acquisition unit 4 may acquire a first current value at the start of transmitting the preset number of pulse trains and a second current value at the end of transmitting the preset number of pulse trains, after the acquisition unit 4 acquires the first current value and the second current value, the control unit 2 sends the first current value and the second current value to the upper computer 1, then the upper computer 1 determines a change value of the current value according to the first current value and the second current value, and if the change value is smaller than a preset threshold, it is determined that the ablation parameter needs to be adjusted. In another alternative embodiment, when the ablation target is set to: in addition to the requirement that the change of the current value reaches the preset threshold value after the preset number of pulse trains are transmitted, and the requirement that the current value is within the preset threshold value range, the upper computer 1 determines whether the change of the current value reaches the preset threshold value, and also determines whether the ablation parameters need to be adjusted after determining whether the current value, i.e., the second current value, is within the preset threshold value range.

It should be noted that, in one example, a pulse train may refer to a pulse train with a pulse width of 5 μ s and a number of sub-pulses of 20. In another example, a pulse train may refer to a pulse train having a pulse width of 50 μ s and a number of sub-pulses of 2. In particular implementations, the width and number of bursts may be set based on the type of tumor to be treated, shape, size, malignancy, and the like. However, it is necessary to ensure that the product of the sub-pulse width and the number of pulses in the pulse train is a fixed value, and the fixed value may be set according to an industry requirement or an industry specification, for example, 100, and in this case, if the width of the sub-pulse is represented by W and the number of pulses in the pulse train is represented by n, W × n is 100.

Based on clinical experience, there is an upper limit to the number of bursts that can be transmitted per unit time when adjusting the burst frequency. For example, for a pulse train having a pulse width of 5 μ s and the number of sub-pulses of 20, 5 pulse trains can be transmitted at most in 1 second.

Furthermore, since the type, shape, size, and malignancy of the tumor to be treated are different for different patients, different starting voltages can be set for different patients, but regardless of the setting of the starting voltage, when the ablation target is reached by increasing the voltage, the single increase of the voltage should not exceed 30V-50V and the total increase of the voltage should not exceed 20% -30% of the starting voltage based on clinical experience. For example, if the initial voltage of a patient is set to 1500V based on the type, shape, size, malignancy of a tumor to be treated, a single rise of the voltage should not exceed 30V-50V and the total rise of the voltage should not exceed 1800V-1950V in reaching an ablation target by raising the voltage.

In particular, the adjustment of the ablation parameters is performed by the ablation parameter adjustment unit 3. In an alternative embodiment, the ablation parameter adjustment unit 3 may comprise a high voltage power supply unit 31, a conversion unit 32 and a pulse unit 33, see fig. 2. A first end of the high voltage power supply unit 31 is coupled to the control unit 2, and a second end of the high voltage power supply unit 31 is coupled to the conversion unit 32, and is configured to generate a required high voltage dc voltage according to control information received from the control unit 2; a first end of the converting unit 32 is coupled to the high-voltage power supply unit 31, and a second end of the converting unit 32 is coupled to the pulse unit 33, for converting the high-voltage dc voltage from the high-voltage power supply unit 31 into a required standard pulse; the pulse unit 33 is coupled to the control unit 2, the conversion unit 32 and the acquisition unit 4, respectively, and is configured to modulate the standard pulse according to the control information received from the control unit 2. In yet another alternative embodiment, the ablation parameter adjustment unit 3 may only include a high voltage power supply unit 31 and a pulse unit 33, wherein a first end of the high voltage power supply unit 31 is coupled to the control unit 2, and a second end of the high voltage power supply unit 31 is coupled to the pulse unit 33, for generating the required high voltage dc voltage according to the control information received from the control unit 2; the pulse unit 33 is coupled to the high voltage power supply unit 31, the control unit 2 and the acquisition unit 4, respectively, for converting the high voltage dc voltage provided by the high voltage power supply 31 into a required pulse according to the control information received from the control unit 2.

In one example, when the high voltage power supply unit 31 may generate a required dc voltage based on the control information from the control unit 2, the high voltage power supply unit 31 may convert the 220V ac mains voltage into a dc voltage of 800V to 3000V based on the control information from the control unit 2. In other examples, the high voltage power supply unit 31 may convert 220V of ac mains into a dc voltage lower than 800V, such as 300V, 400V, 500V, 600V or 700V, based on the control information from the control unit 2. In yet another example, the high voltage power supply unit 31 may convert 220V of ac mains power into a dc voltage higher than 3000V, such as 3100V, 3300V, 3500V, 3700V, or 4000V, based on the control information from the control unit 2.

Specifically, when the conversion unit 32 converts the direct-current voltage from the high-voltage power supply 31 into the pulse voltage, the pulse voltage may be a unipolar pulse voltage, and in another example, the pulse voltage may be a bipolar pulse voltage. By using the bipolar pulse voltage, the problems of non-uniform electric field, ablation blind area, poor ablation effect and the like caused by unipolar pulse voltage can be solved, and the problems of muscular atrophy, treatment pain and the like can be avoided.

For example, the pulse voltage may be a bipolar pulse voltage having an amplitude of 800V and a frequency of 100 Hz. In another example, the pulsed voltage may be a bipolar pulsed voltage with an amplitude of 1500V and a frequency of 500 Hz. In yet another example, the pulsed voltage may also be a bipolar pulsed voltage with an amplitude of 3000V and a frequency of 1000 Hz. Furthermore, in an alternative embodiment, a storage capacitor (not shown) may be further disposed between the high voltage power supply unit 31 and the converting unit 32 so that the converting unit 32 can obtain stable power.

It should be noted that, during the specific implementation, the ablation parameter can be set to be the voltage, and the ablation parameter can be set to be the pulse train frequency, so that when the upper computer judges that the ablation parameter needs to be adjusted based on the ablation target, different instructions can be sent to the control unit.

In an optional embodiment, when determining that the ablation parameters need to be adjusted based on the ablation target, the upper computer 1 may send a first instruction to the control unit 2, where the first instruction is used to instruct to adjust the voltage, for example, the first instruction is used to instruct the control unit to adjust the voltage from 1500V to 1530V, and after receiving the first instruction, the control unit 2 sends first control information to the high-voltage power supply unit 31, where the first control information is used to control the high-voltage power supply unit 31 to adjust the voltage, for example, control the high-voltage power supply 31 to adjust the voltage from 1500V to 1530V.

In another optional embodiment, when it is determined that the ablation parameter needs to be adjusted based on the ablation target, the upper computer 1 may send a second instruction to the control unit 2, where the second instruction includes adjusting the pulse train frequency, for example, the second instruction is used to instruct the pulse unit to adjust the pulse train transmission frequency from 1 pulse train transmission 1 second to 1 pulse train transmission 2 second, and after receiving the second instruction, the control unit 2 sends second control information to the pulse unit 33, where the second control information is used to control the pulse unit 33 to perform the adjustment of the pulse transmission frequency from 1 pulse transmission 1 second to 1 pulse transmission 2 second.

In yet another alternative embodiment, when the ablation parameter is set to the combination of the voltage and the burst frequency, and the upper computer 1 determines that the ablation parameter needs to be adjusted based on the ablation target, the upper computer 1 may send a third instruction to the control unit 2, where the third instruction includes both the adjustment voltage and the adjustment burst frequency, for example, the third instruction is used for instructing the control unit to adjust the voltage from 1500V to 1530V and instructing the burst unit to adjust the burst transmission frequency from 1 burst transmission frequency to 1 burst transmission frequency in 1 second. After receiving the third instruction, the control unit 2 needs to send not only third control information for controlling the high-voltage power supply unit 31 to perform voltage adjustment but also fourth control information for controlling the pulse unit 33 to perform pulse transmission frequency adjustment to the high-voltage power supply unit 31.

In the implementation, the collecting unit 4 can collect both the current of the pulse emitted by the pulse unit 33 and the voltage of the pulse emitted by the pulse unit 33. Thus, in an alternative embodiment, the acquisition unit 4 may comprise a current sensor 41 and a voltage dividing unit 42, see fig. 3. A first end of the current sensor 41 is coupled to the pulse unit 33, and a second end of the current sensor 41 is coupled to the control unit 2, and is configured to collect a current value of the pulse output by the pulse unit 33 and send the current value to the upper computer 1 via the control unit 2. The first end of the voltage dividing unit 42 is coupled to the pulse unit 33, and the second end of the voltage dividing unit 42 is coupled to the control unit 2, and is configured to collect a voltage value of a pulse output by the pulse unit 33 and send the voltage value to the upper computer 1 via the control unit 2.

Specifically, the current sensor 41 can send a first current value when the emission of the preset number of pulse trains starts to the upper computer 1 through the control unit 2, the current sensor 41 can also send a second current value when the emission of the preset number of pulse trains ends to the upper computer 1 through the control unit 2, then the upper computer 1 determines a change value of the current value according to the first current value and the second current value, and if the change value is smaller than a preset threshold value, it is determined that the ablation parameters need to be adjusted. In another alternative embodiment, when the ablation target is set to: in addition to the requirement that the change of the current value reaches the preset threshold value after the preset number of pulse trains are transmitted, and the requirement that the current value is within the preset threshold value range, the upper computer 1 determines whether the change of the current value reaches the preset threshold value, and also determines whether the ablation parameters need to be adjusted after determining whether the current value, i.e., the second current value, is within the preset threshold value range.

For example, in an example, assuming that the preset threshold is 5A, it is further assumed that the current sensor sends the acquired first current value 30A at the beginning of transmitting the 10 pulse trains and the acquired second current value 36A at the end of transmitting the 10 pulse trains to the upper computer 1 via the control unit 2, and then the upper computer determines that the variation value of the current value is 6A according to the first current value 30A and the second current value 36A, and since the variation value of the current value 6A is greater than 5A, the variation threshold of the current value is reached, the upper computer determines not to adjust the ablation parameter. In yet another example, when the ablation target is set to: in addition to the requirement that the change value of the current value reaches 5A after the transmission of 10 bursts, the current sensor transmits the acquired first current value 30A at the start of the transmission of 10 bursts and the acquired second current value 36A at the end of the transmission of 10 bursts to the upper computer via the control unit 2 when the current value is within the range of 40A-45A, and then the upper computer determines the change value of the current value to be 6A based on the first current value 30A and the second current value 36A. Although the change in the current value reaches the change threshold 5A, the upper computer determines that an adjustment to the ablation parameter is required because the current value, i.e., the second current value 36A, is not within the range of 40A-45A.

When the current value rises too fast or when the current value is larger than the preset threshold range, the current value can be adjusted in a voltage reduction mode, so that the current value is within the preset threshold range, and in specific implementation, when the rising value of the current is higher than 50% of the ablation target on the basis of reaching the ablation target, the current can be judged to rise too fast. Here, the magnitude of the voltage decrease may be set based on the magnitude of the voltage rise, but for the sake of patient safety, the magnitude of the voltage decrease needs to be larger than the magnitude of the voltage rise in general, and for example, when the magnitude of the voltage rise is set to 30V, the magnitude of the voltage decrease may be set to 50V.

However, it should be noted that, based on clinical experience, when the current value is greater than 60A, the complex steep pulse treatment device needs to be shut down, that is, when the current acquired by the upper computer from the current sensor is greater than 60A, the upper computer sends an instruction to the control unit to instruct the stop of the operation of the complex steep pulse treatment device.

In order to facilitate the calculation of the current value of the pulse collected by the current sensor 41 and the voltage value of the pulse collected by the voltage dividing unit, in an alternative embodiment, an analog-to-digital conversion unit 7 may be further included between the collecting unit 4 and the control unit 2, see fig. 4. Of course, in practical implementation, the analog-to-digital conversion unit may also be disposed in the control unit 2. And the analog-to-digital conversion unit 7 is used for converting the analog signal data acquired by the acquisition unit 4 into digital signal data. Specifically, the analog-to-digital conversion unit 7 is configured to convert an analog current collected by the current sensor 41 into a digital current, and convert an analog voltage collected by the voltage division unit 42 into a digital voltage.

As the processing power of the processor increases, the control unit 2 may therefore, in an alternative embodiment, consist of a processor only. In another alternative embodiment, the control unit may also be composed of a processor and an FPGA processor, see fig. 5.

In fig. 5, the control unit 2 is composed of a processor 21 and an FPGA processor 22, a first end of the processor 21 is coupled to the upper computer 1, and a second end of the processor 21 is coupled to the high-voltage power supply unit 31, and is configured to receive an instruction from the upper computer, generate control information, and send the control information to the high-voltage power supply unit 31; the first end of the FPGA processor 22 is coupled to the upper computer 1, the second end of the PGA processor 22 is coupled to the processor 21, the pulse unit 33, and the acquisition unit 4, respectively, and is configured to receive an instruction from the upper computer 1, generate corresponding control information according to the instruction, and send the control information to the high-voltage power supply unit 31, and the FPGA processor 22 may be further configured to selectively switch pulses output by the pulse unit 33 between electrode needles in the electrode needle unit 6. In addition, in an alternative embodiment, the processor 21 and the FPGA processor 22 may communicate with each other through the FSMC protocol, and of course, the processor 21 and the FPGA processor 22 may also communicate with each other through other protocols, and the present invention does not limit the communication manner between the processor 21 and the FPGA processor 22.

In some examples, the control unit 2 may also be referred to as a lower circuit or a lower board as opposed to an upper computer. The control unit 2 may be coupled to each component in the composite steep pulse device in a wired or wireless manner as required to receive, process and transmit data signals, thereby controlling each component in the composite steep pulse device.

It should be noted that, when the control unit 2 is composed of only a processor, the analog-to-digital conversion unit 7 may be provided in the processor. When the control unit 2 is composed of a processor and an FPGA processor, the analog-to-digital conversion unit may be provided in the FPGA processor.

The composite steep pulse treatment device for automatically monitoring and adjusting ablation parameters 10 described above in detail with reference to fig. 1 to 5 can perform the following method for automatically monitoring and adjusting ablation parameters, as shown in fig. 6, which can include:

and S100, judging whether the ablation parameters need to be adjusted or not by the upper computer based on the ablation target, if so, turning to the step S200, and otherwise, ending the process.

In particular implementations, ablation parameters may be set and ablation targets formulated based on the type of tumor to be treated, shape, size, malignancy, and the like. The setting of ablation parameters and the formulation of ablation targets have been described in the above embodiments, and will not be described in detail here.

And S200, the upper computer sends an instruction to the control unit, and the instruction is used for instructing the control unit to adjust the ablation parameters.

In a specific implementation, the upper computer may send different instructions to the control unit. Several cases of sending different instructions to the control unit by the upper computer have been described in the above embodiments, and are not described herein again.

And S300, the control unit generates control information according to the instruction and sends the control information to the ablation parameter adjusting unit.

And S400, the ablation parameter adjusting unit executes the adjustment of the ablation parameters according to the control information. After the ablation parameter adjustment unit performs adjustment of the ablation parameter according to the control information, it goes to step S100.

The application of the above-described composite steep pulse treatment device for automatically monitoring and adjusting ablation parameters is briefly explained below by way of several specific embodiments.

Example one

In this embodiment, the ablation parameter is set to voltage, assuming that the object of treatment is a patient a, and based on the tumor type, shape, size, malignancy of the patient a, the starting voltage is set to 1500V, and the voltage rise amplitude is set to 30V and the total rise amplitude of the voltage does not exceed 300V, further assuming that the ablation target is set to: after transmitting 10 pulse trains (for example, a pulse train having a pulse width of 5 μ s and a number of sub-pulses of 20), the rising change of the current is required to reach 5A. In this case, if the voltage dividing unit detects that the present voltage is 1500V, the present current is 30A, and it is found that the current rise change does not reach 5A after transmitting 10 pulse trains during the treatment, the upper computer sends an instruction to the control unit for instructing the control unit to adjust the voltage from 1500V to 1530V, the control unit generates control information upon receiving the instruction, and the control unit sends the control information to the high voltage power supply unit for controlling the high voltage power supply unit to perform the voltage rise from 1500V to 1530V. After the high-voltage power supply unit raises the voltage from 1500V to 1530V, the control unit continuously monitors whether the rising change of the current reaches 5A after 10 pulse trains are transmitted again, if the rising change of the current reaches 5A, the rising voltage is stopped, and if not, the upper computer continuously sends an instruction to indicate the rising voltage. However, it should be noted that in this embodiment, since the initial voltage is 1500V, and since the total rising amplitude of the voltage is set not to exceed 300V, if the voltage rises to 1800V, the upper computer does not continue to send the instruction to continue to rise the voltage.

Example two

In this embodiment, the ablation parameter is set to voltage, assuming that the object of treatment is patient B, and based on the tumor type, shape, size, malignancy of patient B, the starting voltage is set to 1600V, and the voltage rise amplitude is set to 35V and the total rise amplitude of the voltage should not exceed 320V, further assuming that the ablation target is set to: after transmitting 10 pulse trains (for example, a pulse train having a pulse width of 5 μ s and a number of sub-pulses of 20), not only the current rise change is required to be 5A, but also the current value is required to be in the range of 40A to 45A. In this case, if during the treatment, when the voltage dividing unit detects that the present voltage is 1600V, the present current is 31A, and after transmitting 10 pulse trains, the current is found to rise from 31A to 38A. Although the current rises from 31A to 38A after the 10 pulse trains are transmitted, and the current change value 7A reaches the preset threshold value 5A, because the current value 38A is not within the preset threshold value range, the upper computer can still send a command to the control unit for instructing to raise the voltage from 1600V to 1635V, the control unit sends control information to the high-voltage power supply unit after receiving the command, controls the high-voltage power supply unit to execute the raising of the voltage from 1600V to 1635V, after the high-voltage power supply unit raises the voltage from 1600V to 1635V, the control unit continues to monitor and send 10 pulse trains, and then continues to collect the current value by the current sensor, and if the current value is found to be 42A, the upper computer can judge that the ablation target is reached and does not send any command any more. If the current value is still not within the preset threshold range, such as 39A, the upper computer may continue to indicate the voltage rise, but it should be noted that when the voltage continues to rise from 1635V to 1920V according to the above cycle, the voltage rises 320V due to the rise from 1600V to 1920V, and at this time, if the current value is still not within the preset range, the upper computer does not continue to send the instruction to indicate that the voltage continues to rise.

EXAMPLE III

In this embodiment, the ablation parameters are set to adjust the burst frequency, assuming that the subject being treated is patient C, and based on factors such as the tumor type, shape, size, malignancy of patient C, the starting burst frequency may be set to transmit 1 burst of pulses (e.g., a burst with a pulse width of 5 μ s and a number of sub-pulses of 20) for 1 second and the upper limit of the burst transmission frequency may be set to transmit 5 bursts for 1 second, further assuming that the ablation target is set to: after transmitting 10 bursts, the current is required to rise by 5A. In this case, if, during the treatment, the current sensor detects that the present current is 30A and, after transmitting 10 pulse trains, it is found that the current rise change does not reach 5A, the upper computer sends an instruction to the control unit for instructing the control unit to adjust the pulse train transmission frequency from 1 pulse train transmission for 1 second to 2 pulse trains transmission for 1 second, the control unit generates control information upon receiving the instruction, and the control unit sends the control information to the pulse unit, the pulse unit performs the adjustment of the pulse train frequency from 1 pulse train transmission for 1 second to 2 pulse trains transmission for 1 second, based on the control information. After the pulse unit adjusts the pulse transmission frequency from 1 pulse string transmitted in 1 second to 2 pulse strings transmitted in 1 second, the control unit continuously monitors whether the rising change of the current reaches 5A after 10 pulse strings are transmitted again, if the rising change of the current reaches 5A, the voltage rising is stopped, and if not, the upper computer continuously sends an instruction to adjust the pulse transmission frequency. However, it should be noted that since the upper limit of the transmission frequency of the burst is set to 1 second for transmitting 5 bursts, after the transmission frequency of the burst is adjusted from 1 burst transmission in 1 second to 5 bursts transmission in 1 second, the upper computer does not continue to send the instruction indicating that the burst frequency is adjusted.

Example four

In this embodiment, the ablation adjustment parameters are set to voltage and pulse train frequency, and the manner in which the ablation parameters are adjusted is set to: the pulse train is adjusted first and then the voltage is adjusted. Assume that the subject of treatment is a patient D, and based on the tumor type, shape, size, malignancy of the patient D, the starting voltage is set to 1500V, the voltage rise amplitude is set to 30V and the total rise amplitude of the voltage should not exceed 300V, and the transmission frequency of the starting pulse train is set to 1 train of pulses (for example, a pulse train having a pulse width of 5 μ s and a number of sub-pulses of 20) transmitted for 1 second, and the upper limit of the transmission frequency of the pulse train is set to 1 second to transmit 5 trains of pulses. Further assume that the ablation targets are set to: after transmitting 10 bursts, the rising change in current reaches 5A. In this case, if, during the treatment, the voltage dividing unit detects that the present voltage is 1500V, the present current is 30A, and after transmitting 10 pulse trains, it is found that the current rise change does not reach 5A, the upper computer sends an instruction to the control unit for instructing the control unit to adjust the pulse train transmission frequency from 1 pulse train transmission for 1 second to 2 pulse trains transmission for 1 second, the control unit generates control information upon receiving the instruction, and the control unit sends the control information to the pulse unit, the pulse unit performs the adjustment of the pulse train frequency from 1 pulse train transmission for 1 second to 2 pulse trains transmission for 1 second, based on the control information. And then, continuously monitoring whether the rising change of the current reaches 5A or not after the 10 pulse trains are transmitted by the control unit, if the rising change of the current does not reach 5A, sending an instruction to the control unit by the upper computer for instructing the control unit to adjust the voltage from 1500V to 1530V, generating control information after receiving the instruction by the control unit, and sending the control information to the high-voltage power supply unit by the control unit for controlling the high-voltage power supply unit to execute the voltage rising from 1500V to 1530V. After the high-voltage power supply unit raises the voltage from 1500V to 1530V, the control unit continuously monitors whether the rising change of the current reaches 5A after 10 pulse trains are transmitted again, if the rising change of the current reaches 5A, the command is stopped to be transmitted, and if not, the upper computer continuously transmits a command instruction to adjust the transmission frequency of the pulse trains and indicate the rising voltage. However, it should be noted that in this embodiment, since the initial voltage is 1500V, and since the total rising amplitude of the voltage is set not to exceed 300V, if the voltage rises to 1800V, the upper computer does not send any instruction to continue rising the voltage; and because the upper limit of the transmitting frequency of the pulse train is set as 1 second to transmit 5 pulse trains, after the transmitting frequency of the pulse train is adjusted from 1 pulse train transmitting in 1 second to 5 pulse trains transmitting in 1 second, the upper computer does not continuously send instructions to indicate that the frequency of the pulse train is adjusted.

EXAMPLE five

In this embodiment, the ablation parameter is set to voltage, assuming that the object of treatment is a patient E, and based on the tumor type, shape, size, malignancy of the patient E, the starting voltage is set to 1500V, and the voltage rise amplitude is set to 30V and the total rise amplitude of the voltage does not exceed 300V, the voltage fall amplitude is set to 50V, further assuming that the ablation target is set to: after transmitting 10 pulse trains (for example, a pulse train having a pulse width of 5 μ s and a number of sub-pulses of 20), the rising change of the current is required to reach 5A. Further, if the current rise value is higher than 50% of the ablation target after reaching the ablation target, it can be determined that the current rises too fast, that is, if the current rise value is higher than 7.5V, it can be determined that the current rises too fast. In this case, if during the treatment, when the voltage dividing unit detects that the present voltage is 1500V, the present current is 30A, and after transmitting 10 pulse trains, the current value at this time reaches 34A, it can be determined that the current rise change does not reach 5A, the upper computer sends an instruction to the control unit for instructing the control unit to adjust the voltage from 1500V to 1530V, the control unit generates control information upon receiving the instruction, and the control unit sends the control information to the high voltage power supply unit for controlling the high voltage power supply unit to perform the voltage rise from 1500V to 1530V. After the high voltage power supply unit raises the voltage from 1500V to 1530V, the control unit continues to monitor the 10 pulse trains for emission, if the current value reaches 42A at this time, the current value rises from 34A to 42A, and rises by 8A, and since 8A is greater than 7.5A, it can be judged that the current rises too fast. In this case, the upper computer may transmit an instruction to the control unit for instructing the control unit to adjust the voltage from 1530V to 1480V, generate control information upon receiving the instruction, and transmit the control information to the high voltage power supply unit for controlling the high voltage power supply unit to perform the voltage drop from 1530V to 1480V.

EXAMPLE six

In this embodiment, the ablation parameter is set to voltage, assuming that the object of treatment is a patient F, and based on the tumor type, shape, size, malignancy of the patient F, the starting voltage is set to 1600V, and the voltage rise amplitude is set to 35V and the total voltage rise amplitude should not exceed 320V, the voltage fall amplitude is set to 50V, further assuming that the ablation target is set to: after transmitting 10 pulse trains (for example, a pulse train having a pulse width of 5 μ s and a number of sub-pulses of 20), not only the current rise change is required to be 5A, but also the current value is required to be in the range of 40A to 45A. Further, if the current rise value is higher than 50% of the ablation target after reaching the ablation target, it can be determined that the current rises too fast, that is, if the current rise value is higher than 7.5V, it can be determined that the current rises too fast. In this case, if during the treatment, when the voltage dividing unit detects that the present voltage is 1600V, the present current is 33A, and after transmitting 10 pulse trains, the current is found to rise from 33A to 39A. Although the current rises from 33A to 39A and the current variation value 6A reaches the preset threshold value 5A after the 10 pulse trains are transmitted, because the current value 39A is not within the preset threshold value range, the upper computer can still send a command to the control unit for instructing to raise the voltage from 1600V to 1635V, the control unit sends control information to the high-voltage power supply unit after receiving the command, controls the high-voltage power supply unit to execute the raising of the voltage from 1600V to 1635V, after the high-voltage power supply unit raises the voltage from 1600V to 1635V, the control unit continues to monitor and transmit 10 pulse trains, and then continues to collect the current value by the current sensor, if the current value is found to be 46A, although the current value rises from 39A to 46A after the 10 pulse trains are transmitted, the current value rises by 7A, and is not higher than 7.5A, it cannot be judged that the current value rises too fast, but because the current value 46A is not within the range of 40A-45A, the current value can still be adjusted by reducing the voltage for safety of the patient F, that is, in this case, the upper computer may send an instruction to the control unit for instructing the control unit to adjust the voltage from 1635V to 1585V, the control unit generates control information after receiving the instruction, and the control unit sends the control information to the high-voltage power supply unit for controlling the high-voltage power supply unit to execute the reduction of the voltage from 1635V to 1585V.

It should be noted that although various components or circuits are schematically illustrated in fig. 1-5, it should be understood that this is merely an illustration and not a limitation on the scope of the disclosure. For example, in the embodiment of FIG. 1, some other components may be added between various components, or some components may be subtracted from the embodiment of FIG. 1.

Those of skill in the art will understand that the logic and/or steps represented in the flowcharts or otherwise described herein, e.g., an ordered listing of executable instructions that can be viewed as implementing logical functions, can be embodied in any computer-readable medium for use by or in connection with an instruction execution system, apparatus, or device, such as a computer-based system, processor-containing system, or other system that can fetch the instructions from the instruction execution system, apparatus, or device and execute the instructions. For the purposes of this description, a "computer-readable medium" can be any means that can contain, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device.

More specific examples (a non-exhaustive list) of the computer-readable medium would include the following: an electrical connection (electronic device) having one or more wires, a portable computer diskette (magnetic device), a Random Access Memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber device, and a portable compact disc read-only memory (CDROM). Additionally, the computer-readable medium could even be paper or another suitable medium upon which the program is printed, as the program can be electronically captured, via for instance optical scanning of the paper or other medium, then compiled, interpreted or otherwise processed in a suitable manner if necessary, and then stored in a computer memory.

It should be understood that portions or modules of the present invention may be implemented in hardware, software, firmware, or a combination thereof. In the above embodiments, the various steps or methods may be implemented in software or firmware stored in memory and executed by a suitable instruction execution system. For example, if implemented in hardware, as in another embodiment, any one or combination of the following techniques, which are known in the art, may be used: a discrete logic circuit having a logic gate circuit for implementing a logic function on a data signal, an application specific integrated circuit having an appropriate combinational logic gate circuit, a Programmable Gate Array (PGA), a Field Programmable Gate Array (FPGA), or the like.

In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiment. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A compound steep pulse therapy device for automatically monitoring and adjusting ablation parameters, comprising:

2. The composite steep pulse treatment apparatus according to claim 1, wherein the ablation parameter adjusting unit includes at least a high voltage power supply unit and a pulse unit;

3. The compound steep pulse treatment apparatus according to claim 1, wherein when the control information is for controlling the adjustment of the voltage, the control unit is for sending the control information to the high voltage power supply unit; when the control information is used for controlling and adjusting the pulse parameters, the control unit is used for sending the control information to the pulse unit, and the pulse unit adjusts the pulse parameters according to the control information.

4. The composite steep pulse treatment apparatus according to claim 1, wherein the acquisition unit comprises:

5. The composite steep pulse treatment apparatus according to claim 4, wherein the ablation target is that a change value of the current value reaches a preset threshold value and a present current value is within a preset range after a preset number of pulse trains are fired.

6. The composite steep pulse treatment device according to claim 5, wherein the upper computer is further configured to obtain, via the control unit, a first current value at the beginning of the emission of the preset number of pulse trains from the acquisition unit, and further configured to obtain, via the control unit, a second current value at the end of the emission of the preset number of pulse trains from the acquisition unit, and determine a change value of the current value within the preset time period according to the first current value and the second current value, and if the change value is smaller than the preset threshold, determine that the ablation parameter needs to be adjusted.

7. The composite steep pulse treatment apparatus according to claim 6, wherein the preset threshold value is 5A and the preset range is 40A-45A.

8. The composite steep pulse treatment apparatus according to claim 4, further comprising: and the analog-to-digital conversion unit is arranged between the acquisition unit and the control unit and is used for converting the analog signal data acquired by the acquisition unit into digital signal data.

9. The composite steep pulse treatment apparatus according to claim 2, further comprising: and the switching unit is respectively coupled to the pulse unit, the control unit and the electrode needle unit and is used for selectively switching the pulse of the pulse unit among the electrode needles in the electrode needle unit according to the control signal of the control unit.

10. The composite steep pulse treatment device according to any one of claims 1 to 9, characterized in that the control unit is comprised of a processor and an FPGA processor;