An ultrasonic scalpel system and its control method

Abstract

The present disclosure relates to an ultrasonic scalpel system and a control method thereof. The ultrasonic scalpel system includes an ultrasonic transducer and a processor, wherein the processor is configured to obtain a scanning frequency that maximizes the admittance of the equivalent circuit of the ultrasonic transducer during the frequency scanning process as a scanning characteristic parameter; calculate a first tissue damage factor associated with the degree of composite damage to the tissue based on a first deviation of the scanning characteristic parameter relative to a corresponding first reference range of the scanning characteristic parameter; and when the first tissue damage factor exceeds a first threshold range, suppress the driving signal of the ultrasonic transducer, and / or provide an acoustic and optical prompt for suppressing the driving signal of the ultrasonic transducer. The present disclosure can obtain characteristic parameters that characterize composite damage to the tissue, including thermal damage and vibration damage, at each working stage of the ultrasonic scalpel system, and timely and accurately suppress the composite damage that may be caused to the tissue without relying on the measurement of sensor devices including temperature sensors.

Description

Technical Field

[0001] The present disclosure belongs to the field of medical devices, and relates to the field of ultrasonic scalpel technology, and more specifically, to an ultrasonic scalpel system and a control method thereof. Background Art

[0002] An ultrasonic scalpel is an energy device that uses an ultrasonic transducer in surgical settings. It typically consists of a main unit, an ultrasonic transducer, and a blade. Its operating principle is as follows: the main unit generates high-frequency electrical energy and transmits it to the ultrasonic transducer. The piezoelectric ceramic in the ultrasonic transducer converts the electrical energy into mechanical vibration energy, which is amplified and transmitted to the blade via a horn. The blade generates vibrations at approximately 55.5kHz with an amplitude of approximately 50-100μm. The vibrating blade contacts tissue, disrupting protein hydrogen bonds due to mechanical impact. Simultaneously, due to heat generation and rising temperature, the tissue protein cells eventually denature to form a viscous coagulant, thereby achieving the purpose of cutting or coagulation.

[0003] During the operation of an ultrasonic scalpel, damage to the tissue may be caused due to overheating of the blade or undesirable vibration modes. For example, when the ultrasonic scalpel is cutting tissue, the vibration friction between the blade and the tissue will cause the blade temperature to rise, which may cause carbonized eschar at the tissue cutting site. In addition, when the temperature of the ultrasonic scalpel tip is high, it takes a long time to cool down naturally. If the surgeon operates other normal tissues without cooling the blade during the operation, it will also cause undesirable thermal damage to the normal tissue. When an ultrasonic scalpel is working, for example, whose conventional vibration mode is longitudinal vibration, lateral vibration and axial swing will also cause undesirable vibration damage during the cutting process.

[0004] In the existing technology, people usually only focus on thermal damage to tissues, and usually perform corresponding energy control by estimating the temperature of the ultrasonic scalpel head. However, the temperature sensor is generally far away from the ultrasonic scalpel head, resulting in a large error in the estimated head temperature and an inability to implement the corresponding energy control strategy well. Summary of the Invention

[0005] In view of the deficiencies in the prior art, the present disclosure is provided to solve the above-mentioned problems existing in the prior art.

[0006] An ultrasonic scalpel system and a control method thereof are needed, which can obtain corresponding characteristic parameters in each working stage of a single excitation process of the ultrasonic scalpel system including frequency scanning and frequency tracking, without relying on the setting and measurement of various sensor devices including temperature sensors, so that the characteristic parameters can characterize the composite damage of the tissue including both thermal damage and vibration damage, and determine the composite damage status of the tissue based on the obtained characteristic parameters, and implement targeted drive control of the ultrasonic transducer, so that in the working process of each stage of the ultrasonic scalpel system, the composite damage that may be caused to the tissue can be kept within an acceptable range in a timely and accurate manner.

[0007] According to a first embodiment of the present disclosure, an ultrasonic scalpel system is provided, comprising an ultrasonic transducer, the ultrasonic scalpel system further comprising a processor, the processor being configured to obtain a scanning frequency that maximizes the admittance of an equivalent circuit of the ultrasonic transducer during a frequency scanning process as a scanning characteristic parameter; calculate a first tissue damage factor associated with a composite degree of damage to the tissue based on a first deviation of the scanning characteristic parameter relative to a corresponding first reference range of the scanning characteristic parameter; and suppress a driving signal of the ultrasonic transducer and / or provide an acoustic and visual prompt for suppressing the driving signal of the ultrasonic transducer when the first tissue damage factor exceeds a first threshold range.

[0008] According to a second embodiment of the present disclosure, an ultrasonic scalpel system is provided, comprising an ultrasonic transducer, the ultrasonic scalpel system further comprising a processor, the processor being configured to, during a frequency tracking process: obtain the impedance of the equivalent circuit of the ultrasonic transducer, the matching parameters of the series branch in the equivalent circuit of the ultrasonic transducer, the excitation power and the excitation time as tracking characteristic parameters; calculate a second tissue damage factor associated with the composite damage degree of the tissue based on a second deviation of the tracking characteristic parameter relative to a corresponding second reference range of the tracking characteristic parameter; and when the second tissue damage factor exceeds a third threshold range, or the change trend of the second tissue damage factor exceeds a fourth threshold range, suppress the driving signal of the ultrasonic transducer, and / or provide an acoustic and visual prompt for suppressing the driving signal of the ultrasonic transducer.

[0009] According to a third embodiment of the present disclosure, a control method for an ultrasonic scalpel system is provided, wherein the ultrasonic scalpel system includes an ultrasonic transducer, and the control method includes: obtaining a scanning frequency that maximizes the admittance of an equivalent circuit of the ultrasonic transducer during a frequency scanning process as a scanning characteristic parameter; calculating a first tissue damage factor associated with a composite degree of damage to the tissue based on a first deviation of the scanning characteristic parameter relative to a corresponding first reference range of the scanning characteristic parameter; and when the first tissue damage factor exceeds a first threshold range, suppressing the driving signal of the ultrasonic transducer, and / or providing an acoustic and visual prompt for suppressing the driving signal of the ultrasonic transducer.

[0010] According to a fourth embodiment of the present disclosure, a control method for an ultrasonic scalpel system is provided, wherein the ultrasonic scalpel system includes an ultrasonic transducer, and the control method includes, during a frequency tracking process: obtaining the impedance of an equivalent circuit of the ultrasonic transducer, the matching parameters of the series branch in the equivalent circuit of the ultrasonic transducer, the excitation power and the excitation time as tracking characteristic parameters; calculating a second tissue damage factor associated with the composite damage degree of the tissue based on a second deviation of the tracking characteristic parameter relative to a corresponding second reference range of the tracking characteristic parameter; and when the second tissue damage factor exceeds a third threshold range, or the change trend of the second tissue damage factor exceeds a fourth threshold range, suppressing the driving signal of the ultrasonic transducer, and / or providing an acoustic and visual prompt for suppressing the driving signal of the ultrasonic transducer.

[0011] According to a fifth aspect of the present disclosure, there is provided a non-transitory computer-readable storage medium storing a program, wherein the program causes a processor to execute the control method of the ultrasonic knife system according to various embodiments of the present disclosure.

[0012] According to the ultrasonic scalpel system and its control method in various embodiments of the present disclosure, it can obtain corresponding characteristic parameters in various working stages of the ultrasonic scalpel without relying on the setting and measurement of various sensor devices including temperature sensors, so that the characteristic parameters can characterize the composite damage of the tissue including both thermal damage and vibration damage, and determine the composite damage status of the tissue based on the acquired characteristic parameters, and implement targeted drive control of the ultrasonic transducer, so as to timely and accurately control the composite damage that may be caused to the tissue within an acceptable range. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In the drawings, which are not necessarily drawn to scale, like reference numerals may describe similar components in different views. The drawings illustrate various embodiments generally by way of example and not limitation, and together with the description and claims, serve to illustrate the disclosed embodiments. Where appropriate, like reference numerals are used throughout the drawings to refer to like or similar parts. Such embodiments are illustrative and are not intended to be exhaustive or exclusive of the embodiments of the present apparatus or method.

[0014] Figure 1 A schematic diagram showing an equivalent circuit of an ultrasonic transducer according to an embodiment of the present disclosure.

[0015] Figure 2 A schematic block diagram of an ultrasonic knife system according to an embodiment of the present disclosure is shown.

[0016] Figure 3 A flowchart illustrating a first example of a method for controlling an ultrasonic knife system according to an embodiment of the present disclosure.

[0017] Figure 4 A flowchart illustrating a second example of a method for controlling an ultrasonic knife system according to an embodiment of the present disclosure.

[0018] Figure 5 A flowchart illustrating a third example of a method for controlling an ultrasonic knife system according to an embodiment of the present disclosure.

[0019] Figure 6 A diagram illustrating an admittance circle for calculating scanning feature parameters during a scanning process according to an embodiment of the present disclosure.

[0020] Figure 7 A diagram illustrating an impedance-frequency characteristic curve of an equivalent circuit of an ultrasonic transducer in an ultrasonic blade system according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0021] In order to enable those skilled in the art to better understand the technical solution of the present disclosure, the present disclosure is described in detail below in conjunction with the accompanying drawings and specific embodiments. The embodiments of the present disclosure are further described in detail below in conjunction with the accompanying drawings and specific embodiments, but they are not intended to limit the present disclosure. For the various steps described herein, if there is no necessity for a contextual relationship between each other, the order in which they are described as examples herein should not be regarded as a limitation. Those skilled in the art should know that they can be adjusted in order as long as the logic between them is not destroyed, resulting in the inability to implement the entire process.

[0022] The cutting process of the ultrasonic knife system can be performed by multiple excitations of the ultrasonic transducer. For each excitation, it is generally divided into two stages: frequency scanning and frequency tracking. After the excitation starts, the ultrasonic knife is processed in the frequency scanning stage and then in the frequency tracking stage. In the frequency tracking stage, the cutting operation on the target tissue can be performed, and after the cutting operation of this excitation is completed, the excitation can be ended. Among them, for the frequency scanning stage, a low driving current gear can be set, and the frequency can be gradually swept from a low frequency point to a high frequency point. During the frequency tracking process, as the cutting operation proceeds, the temperature will rise, and the series resonant frequency Fs of the ultrasonic transducer (that is, the desired operating frequency of the ultrasonic transducer) will gradually decrease.

[0023] In some embodiments of the present disclosure, during a frequency sweep, the admittance of the ultrasonic transducer's equivalent circuit can be measured, and the sweep frequency that maximizes the admittance can be obtained and used as one of the sweep characteristic parameters. The inventors have creatively discovered that, for a frequency sweep, the sweep characteristic parameters, including the sweep frequency that maximizes the admittance of the ultrasonic transducer's equivalent circuit, can accurately characterize the combined damage condition of the tissue, including both thermal and mechanical damage. Specifically, when the sweep characteristic parameters, including the sweep frequency that maximizes the admittance of the ultrasonic transducer's equivalent circuit (hereinafter referred to as the "maximum admittance frequency"), are within a corresponding reference range, the combined damage degree of the tissue, including both thermal and mechanical damage, is acceptable as verified by a physician. Furthermore, the proximity of the actual value of the sweep characteristic parameter to its reference range characterizes the acceptability of the combined damage degree of the tissue. The lower the proximity, that is, the greater the deviation from the reference range, the more severe and unacceptable the combined damage degree of the tissue. The maximum admittance frequency is the main component of the scanning characteristic parameters. In some embodiments, in addition to the maximum admittance frequency, the scanning characteristic parameters may also include at least one of half-power point frequency 1 and half-power point frequency 2 (which will be specifically explained below in conjunction with the admittance circle).

[0024] In some embodiments of the present disclosure, during the frequency tracking process, four parameters can be obtained: the impedance of the ultrasonic transducer's equivalent circuit, the matching parameters of the series branch in the ultrasonic transducer's equivalent circuit, the excitation power, and the excitation time, and these parameters can be used together as tracking characteristic parameters. The inventors have creatively discovered that, during the frequency tracking process, these tracking characteristic parameters can work together to accurately characterize the combined damage condition of tissue, including thermal and mechanical damage. Specifically, when the tracking characteristic parameters, including these four parameters, are within the corresponding reference range, the degree of combined damage to the tissue, including both thermal and mechanical damage, is physician-verified as acceptable. Furthermore, the proximity of the actual value of the tracking characteristic parameter to its reference range represents the acceptability of the combined damage degree of the tissue. The lower the proximity, that is, the greater the deviation from the reference range, the more severe and unacceptable the combined damage degree of the tissue.

[0025] The following will specifically describe how to obtain these scanning characteristic parameters and tracking characteristic parameters, and their correlation with the complex damage status of tissues, in conjunction with the structure of the equivalent circuit of the ultrasonic transducer.

[0026] Figure 1 FIG2 is a schematic diagram showing an equivalent circuit of an ultrasonic transducer according to an embodiment of the present disclosure, wherein the equivalent circuit is formed by modeling the ultrasonic transducer. Note that Figure 1 The equivalent circuit shown in , including the series branches, does not exist physically. The parameters of each analog component in each branch can be obtained through modeling and simulation.

[0027] like Figure 1 As shown in Figure 1, the equivalent circuit of the ultrasonic transducer can include two parallel branches, one branch is the static capacitor C0, and the other branch is a series branch (also called a dynamic branch) composed of inductor L1, capacitor C1 and resistor R1 in series. The voltage loaded on both ends of the ultrasonic transducer is U1, and the current flowing through the static capacitor C0 is I C , the current flowing through the series branch is I1.

[0028] During the frequency scanning stage, the overall admittance of the equivalent circuit of the ultrasonic transducer at different frequencies can be measured in the process of gradually sweeping from a low frequency point to a high frequency point, and different admittances correspond to different frequencies. The inventors have found that there is a reference range of maximum admittance frequency. When the first deviation of the maximum admittance frequency relative to the reference range is below a predetermined threshold, it is confirmed that the degree of composite damage to the tissue is acceptable. Accordingly, the first tissue damage factor associated with the degree of composite damage to the tissue can be calculated based on the first deviation of the scanning characteristic parameter relative to the corresponding reference range of the scanning characteristic parameter. The further the first deviation exceeds the predetermined threshold, the more severe the degree of composite damage to the tissue.

[0029] Note that the acceptability of the "composite damage degree of tissue" in the present disclosure is subject to comprehensive consideration and evaluation by the doctor. The "composite damage degree of tissue" is acceptable, which means that not only the thermal damage degree of the tissue is acceptable, the mechanical damage degree of the tissue is acceptable, but also the composite damage effect of the thermal damage and the mechanical damage of the tissue is acceptable. Furthermore, mechanical damage and thermal damage are related to each other and will interact with each other, which is reflected in the tissue as composite damage. When considering tissue damage, mechanical damage and thermal damage can be integrated to evaluate the overall damage condition of the tissue. For example, a composite tissue damage factor that characterizes tissue damage including thermal damage and vibration damage can be calculated, and the ultrasonic transducer can be controlled to output energy accordingly based on the calculated composite tissue damage factor, so as to suppress the overall damage to the tissue as much as possible.

[0030] From the above, the total admittance of the equivalent circuit at different frequencies can be conveniently measured. This measurement can be achieved through a simple impedance measurement without setting up various sensor devices including temperature sensors. The maximum admittance frequency can be obtained as a scanning characteristic parameter. Figure 7 FIG2 is a diagram showing an impedance frequency characteristic curve of an equivalent circuit of an ultrasonic transducer in an ultrasonic knife system according to an embodiment of the present disclosure. Figure 7 As shown, as the scanning frequency increases, the frequency point corresponding to the minimum impedance obtained by measuring the impedance of the equivalent circuit is the maximum admittance frequency (labeled as Fm in the figure). Similarly, the frequency point less than the maximum admittance frequency and with an impedance value half of the maximum impedance value is the half-power point frequency 1 (labeled as F1 in the figure), and the frequency point greater than the maximum admittance frequency and with an impedance value half of the maximum impedance value is the half-power point frequency 2 (labeled as F2 in the figure). In other embodiments, other required characteristic parameters such as the minimum admittance frequency (corresponding to the frequency at which the impedance is maximum, labeled as Fn in the figure) can also be obtained by measuring the impedance.

[0031] Simply comparing the actual value of the maximum admittance frequency with its corresponding reference range can meet the clinical practice of physicians monitoring tissue damage when operating an ultrasonic scalpel system, ensuring acceptable damage assessment results at both the thermal and mechanical levels of the tissue, as well as the combined level. Note that in addition to the maximum admittance frequency as a primary component, the scanning characteristic parameters can also incorporate other characteristic frequencies determined by the admittance circle based on the equivalent circuit as auxiliary components, such as, but not limited to, at least one of the half-power point frequency 1 and the half-power point frequency 2.

[0032] During frequency tracking, it is desirable for the ultrasonic transducer to maintain its ideal operating state as much as possible while performing tissue cutting. When the ultrasonic transducer operates in its ideal state, the impedance amplitude in its equivalent circuit is minimized, the ultrasonic transducer's vibration mode is also in the desired state, the power factor is high, and the ultrasonic scalpel's cutting and coagulation effects are optimal, with minimal tissue damage.

[0033] like Figure 1As shown, due to the presence of static capacitance C0 in the static branch, the entire ultrasonic transducer behaves as a partial capacitive load. During tissue cutting, the temperature will rise, causing the operating frequency of the series branch to be in an undesirable state, resulting in a phase difference between the voltage U1 loaded on both ends of the ultrasonic transducer and the current I1 flowing through the series branch, thereby increasing the useless power of the ultrasonic transducer, increasing heat generation, and reducing the power factor. The inventors found that the phase difference between the voltage U1 and the current I1 flowing through the series branch is closely related to the heat generation of the ultrasonic transducer, and in turn, closely related to thermal damage to the tissue. By adjusting the frequency of the output signal so that the phase difference Φ between U1 and I1 is zero, the series branch can be placed in an ideal working state, thereby achieving accurate frequency tracking. Note that in the present disclosure, the phase difference between the voltage U1 and the current I1 flowing through the series branch characterizes the matching degree of the series branch to some extent (which can also be referred to as an example of a "matching parameter"). The closer the phase difference is to its reference range (for example, but not limited to, the phase difference is close to 0), the higher the matching degree, which means that the useless power of the ultrasonic transducer is lower, the heat generation is smaller, and the power factor is increased. In addition to using the phase difference as a matching parameter, the operating frequency of the ultrasonic transducer can also be used. The closer the operating frequency is to its reference range (for example, but not limited to, the operating frequency is close to the expected operating frequency - series resonant frequency Fs), the higher the matching degree. The inventors have discovered that the synergistic use of the impedance of the equivalent circuit of the ultrasonic transducer, the matching parameters of the series branch in the equivalent circuit, the excitation power, and the excitation time can characterize the cumulative effect of composite damage, including both thermal damage and mechanical damage, during the frequency tracking process. Specifically, the inventors have confirmed that when the four parameters of the impedance of the equivalent circuit, the matching parameters of the series branches in the equivalent circuit, the excitation power, and the excitation time are close to their corresponding reference ranges, it can be basically ensured that the cumulative effect of the composite damage including thermal damage and mechanical damage during the frequency tracking process is acceptable to doctors.

[0034] The mechanism of action of these four parameters is as follows. The impedance of the equivalent circuit of the ultrasonic transducer, the operating frequency of the series branch in the equivalent circuit, and the matching parameters such as the phase difference between U1 and I1 can well characterize the risk of the ultrasonic scalpel system causing composite damage to the tissue, including thermal damage (via the correlation between the operating frequency and temperature) and mechanical damage (via the correlation between the operating frequency and mechanical vibration) from the level of the ultrasonic transducer equivalent circuit. The degree of deviation from the reference range can also well characterize the degree of composite damage that may occur under a given energy source and a given action time. In addition, the excitation power and excitation time are also introduced in the tracking characteristic parameters. The excitation power is actually the energy source of the composite damage, and the excitation time reflects the action time of the composite damage. Therefore, in the frequency tracking process, the coordinated use of these four parameters as tracking characteristic parameters can conveniently and accurately monitor the synergistic cumulative effect of the composite damage, including thermal damage and mechanical damage, on the tissue under actual energy supply and within an actual duration, thereby ensuring that the synergistic cumulative composite damage is acceptable.

[0035] Figure 2 FIG1 shows a schematic block diagram of an ultrasonic scalpel system according to an embodiment of the present disclosure. As an example, the ultrasonic scalpel system 1 includes at least an ultrasonic transducer 10, a processor 11, and a memory 12. When the ultrasonic scalpel system 1 is actually working, it may also include a scalpel head, a scalpel rod, a handle, a foot pedal, etc. that work in conjunction with the ultrasonic transducer 10, the processor 11, the memory 12, etc., which are not shown in FIG1. Figure 2 Shown in.

[0036] In the embodiments of the present disclosure, the ultrasonic scalpel system 1 can be activated in stages. Each activation step can include at least a frequency scanning phase and a frequency tracking phase. The frequency scanning phase can be performed during the system power-on self-test or at other times. During the frequency scanning phase, the ultrasonic scalpel system 1 does not perform actual operations on tissue, such as cutting. However, the aforementioned tissue cutting and coagulation operations are performed during the frequency tracking phase.

[0037] In some embodiments, the processor 11 can be implemented as a processing device including one or more general-purpose processing devices, such as a microprocessor, a central processing unit (CPU), a graphics processing unit (GPU), etc. More specifically, the processor can be a complex instruction set computing (CISC) microprocessor, a reduced instruction set computing (RISC) microprocessor, a very long instruction word (VLIW) microprocessor, a processor that runs other instruction sets, or a processor that runs a combination of instruction sets. The processor can also be one or more special-purpose processing devices, such as an application-specific integrated circuit (ASIC), a field programmable gate array (FPGA), a digital signal processor (DSP), a system on a chip (SoC), etc. The processor 11 can be communicatively coupled to the memory 12 and configured to execute computer-executable instructions stored thereon to perform, for example, the control method of the ultrasonic knife system according to each embodiment of the present disclosure.

[0038] The memory 12 may include a read-only memory (ROM), a flash memory, a random access memory (RAM), a dynamic random access memory (DRAM) such as a synchronous DRAM (SDRAM) or a Rambus DRAM, a static memory (e.g., a flash memory, a static random access memory), etc., on which computer executable instructions are stored in any format. In some embodiments, the computer executable instructions can be accessed by the processor 11, read from the ROM or any other suitable storage location, and loaded into the RAM for execution by the processor 11 to implement the control method of the ultrasonic knife system according to various embodiments of the present disclosure. In some embodiments, the processor 11 and the storage area 12 can be located in the host or integrated in the blade rod housing of the ultrasonic knife system, corresponding to different ultrasonic knife configurations.

[0039] The processor 11 can be configured to perform different operations in different working stages of the ultrasonic knife system 1, which will be described later in conjunction with Figure 3 and Figure 4 The memory 12 can also be configured to store records of the frequency scanning process during the frequency scanning phase of the ultrasonic scalpel system 1 during power-on self-test, records of tracking characteristic parameters acquired during the initial phase of the frequency tracking process, and other historical parameters of the ultrasonic scalpel system that can be used as reference ranges and frequency tracking process information, etc., so as to be subsequently called and used individually or in combination as reference ranges for characteristic parameters of the corresponding process.

[0040] For example, when the ultrasonic knife system 1 is powered on for self-test, no significant thermal damage and mechanical damage has occurred during the frequency scanning stage. At this time, the scanning characteristic parameters recorded in the record of the frequency scanning process, such as the maximum admittance frequency (other auxiliary characteristic parameters may also be added), can be regarded as relatively ideal scanning characteristic parameters, and can then be used as the corresponding reference range of the scanning characteristic parameters.

[0041] For another example, similarly, in the initial stage of the frequency tracking process, the tracking characteristic parameters are also relatively ideal, and the recorded tracking characteristic parameters can also be used as a reference range for the tracking characteristic parameters.

[0042] For another example, the historical parameters of the ultrasonic scalpel system represent the history of various operating parameters actually used by the physician to operate the ultrasonic scalpel system. These operating parameters include, but are not limited to, scanning characteristic parameters during the frequency scanning process and tracking characteristic parameters during the frequency tracking process. It is understood that the operating history actually performed and saved by the physician may be an ideal operating history in the physician's opinion, indicating that at least the complex injury is acceptable under the physician's monitoring. Therefore, the scanning characteristic parameters and tracking characteristic parameters used in these ideal operating histories can also be used as reference ranges for each.

[0043] Figure 3 A flowchart illustrating a first example of a method for controlling an ultrasonic knife system according to an embodiment of the present disclosure. Figure 3 The control method of the ultrasonic scalpel system shown is used in the frequency scanning stage of one excitation of the ultrasonic scalpel system.

[0044] In step 301, a scanning frequency (also referred to as the maximum admittance frequency, F ) at which the admittance of the equivalent circuit of the ultrasonic transducer is maximized during the frequency scanning process is obtained. m ), as the scanning feature parameter.

[0045] During the frequency sweep of the ultrasonic transducer, the admittance of its equivalent circuit can be directly measured or calculated by measuring other parameters. In some embodiments, the admittance parameters of the ultrasonic transducer are measured using the transmission line method, for example, but not limited to, with the aid of general or dedicated instruments and auxiliary measurement circuits. In other embodiments, the F of the equivalent circuit of the ultrasonic transducer can be determined by recording a series of waveform parameters of the equivalent circuit of the ultrasonic transducer during the frequency sweep, calculating and drawing an admittance circle diagram. m , and F m Recorded and stored as scanning characteristic parameters.

[0046] Figure 6 A diagram illustrating an admittance circle for calculating scanning characteristic parameters during a scanning process according to an embodiment of the present disclosure. By measuring the parameters of the ultrasonic transducer equivalent circuit during a scanning process, an admittance circle can be drawn, which can then be used to calculate a wide variety of frequency characteristic parameters.

[0047] The diameter is 1 / R1, and the center is located at (1 / 2R 1, ω sC01), R1 is the resistance of the series branch of the ultrasonic transducer equivalent circuit, C0 is the static capacitance of the parallel branch, ω s is the resonant frequency of the series branch (also called the series resonant frequency).

[0048] From the admittance circle diagram, remove F m In addition, for example, at least one of the half power point frequency 1 (F1) and the half power point frequency 2 (F2) may be obtained and used as a scanning characteristic parameter. Figure 6 In the admittance circle diagram shown, the real part of admittance is equal to the maximum power (G max ), that is, G max The frequencies corresponding to / 2 are F1 and F2, which are easy to determine. F1 and F2 indicate the -3dB frequency of the ultrasonic transducer, which is commonly known as the bandwidth. Whether the parameter values of F1 and F2 are within their corresponding first reference ranges characterizes whether the energy output of the ultrasonic transducer and its controlled state are normal. Therefore, once F1 and F2 deviate from the corresponding first reference ranges, it indicates that undesirable tissue damage may be caused. Therefore, in some embodiments, parameters such as F1 and F2 are used as auxiliary scanning feature parameters, and their first deviation from the corresponding first reference range is used to calculate the first tissue damage factor associated with the degree of composite damage to the tissue. This can more comprehensively consider factors that may cause composite damage such as thermal damage and mechanical damage to the tissue from different perspectives, and can prevent or inhibit the occurrence of composite damage to the tissue in a comprehensive, timely and more accurate manner.

[0049] Next, in step 302, based on the data including F obtained in step 301, m A series of scanning characteristic parameters including the first reference range are determined to determine the first deviation of each scanning characteristic parameter relative to the corresponding first reference range to calculate the first tissue damage factor associated with the composite damage degree of the tissue.

[0050] In some embodiments, when a scanning characteristic parameter is within a first reference range, it is considered that no undesirable tissue damage will occur. Conversely, when a first deviation of a scanning characteristic parameter from the first reference range exceeds a predetermined threshold, it is considered that varying degrees of undesirable tissue damage (tissue damage that is unacceptable to a physician) may result. Therefore, a first tissue damage factor associated with the composite degree of tissue damage can be calculated based on the first deviation of each scanning characteristic parameter from the corresponding first reference range.

[0051] In the embodiment of the present disclosure, using the first reference range rather than a fixed parameter value as the basis for calculating the first deviation has two beneficial effects. On the one hand, the "tolerance" range of the parameter can be taken into account, making the calculation of the first tissue damage factor more accurate, and not causing undesirable jump-like over-control due to disturbances within the normal range. Generally, although a specific ultrasonic transducer has relatively stable device parameters, it is affected by the working conditions of the device, and the actual working parameters of the device may not be exactly the same under different operating times and working scenarios. Taking the F of the equivalent circuit of the ultrasonic transducer as an example, m For example, each time the frequency is scanned, F m They are not exactly the same. There is usually a "tolerance" range. In some embodiments, this range can be set as the first reference range corresponding to the scanning characteristic parameter. On the other hand, the beneficial effect is that for some scanning characteristic parameters, they are not unidirectionally associated with the degree of tissue damage. For these scanning characteristic parameters, by setting the first reference range, their impact on tissue damage can be more efficiently reflected. As an example, consider F as a scanning characteristic parameter m In relation to mechanical damage in complex injuries, in practical applications, if the frequency is too large or too small, it may cause undesirable mechanical damage. Therefore, the relationship between this parameter and tissue damage is not based on a specific point and presents a monotonically positive or negative correlation. In this case, defining a reference range and using the deviation from the reference range to calculate the first tissue damage factor can conveniently and accurately reflect the characteristics of such parameters, and the existence of such a reference range has also been confirmed in actual clinical experiments.

[0052] In the disclosed embodiments, the first reference range corresponding to each scanning characteristic parameter can be determined through theoretical analysis, simulation, measurement experiments, and the use of historical data recorded during actual operation of the device. In some embodiments, the first reference range corresponding to each scanning characteristic parameter can directly use historical parameters pre-stored in the memory of the ultrasonic scalpel system, or use records of the frequency scanning phase recorded and stored in the memory during the power-on self-test of the ultrasonic scalpel system. The above records and historical parameters can also be fused according to certain criteria, such as time-ordered priority or data quality level, through weighted summation, and the fused data is used as the first reference range corresponding to the scanning characteristic parameter for calculation of the first deviation.

[0053] The inventors found that, for the frequency scanning stage, the frequency range selected in the embodiment of the present disclosure includes F m The difference (first deviation) between the scanning characteristic parameters including and the first reference range corresponding to the scanning characteristic parameters representing a good working state can well characterize the complex damage to tissues that may be caused by the ultrasonic scalpel system during operation.

[0054] Based on the first deviation (BS) between each scanning characteristic parameter (FS) and the corresponding first reference range (RR1), a preset polynomial function can be used to calculate a first tissue damage factor (CS) associated with the composite damage degree of the tissue. In some embodiments, a pre-frequency scanning process can be performed, in which multiple sets of first experimental data of the FS and corresponding second experimental data of the composite damage degree of the tissue are collected, and the multiple sets of first experimental data and second experimental data are fitted to obtain the coefficients of the above-mentioned polynomial function. In some embodiments, the coefficients of the polynomial function can be presented in the form of a coefficient matrix, which includes coefficients of various orders.

[0055] In some embodiments, when determining the coefficients of the polynomial function by fitting experimental data, the specific application scenarios of the ultrasonic scalpel system and other implementation conditions for controlling tissue damage can be given particular consideration. For example, when the real-time performance of controlling the ultrasonic scalpel system is the primary optimization goal, a first-order polynomial function can be used for fitting. In this case, CS can be calculated as shown in formula (1):

[0056] CS=∑[K i *BS i +b i ], among which, BS i =‖FS i -RR1 i ‖ Formula (1)

[0057] Among them, FS i To calculate the i-th scanning characteristic parameter used by CS, RR1 i For FS i Corresponding first reference range, BS i =‖FS i -RR1 i ‖ represents the FS obtained according to certain calculation rules i With RR1 i As an example, when RR1 i When the value range of [a,b] is defined, the distance FS can be selected i Closer to a or b, |FS i -a|or|FS i -b| (|·| is an absolute value operator) The smaller value is used as BS i In some other embodiments, BS i The calculation method of K is not limited to this and can be set as needed based on the physical meaning of the scanning characteristic parameters and the actual impact on CS evaluation. i and bi They are respectively the polynomial function and BS i The corresponding coefficients are given below. i and b i The solution method.

[0058] In a specific embodiment, based on a series of laboratory measurement parameters, multiple evaluation equations as shown in formula (2) can be obtained:

[0059] CS j =∑[K i *bs ij +b i ], where bs ij =||fs ij -RR i Formula (2)

[0060] Its meaning is that in the jth group of laboratory measurement parameters, the value of the first tissue damage factor is CS j ;fs ij For the jth group of laboratory measurement parameters, i Corresponding measurement value; RR1 i For FS i The corresponding first reference range, for the convenience of solution, for the same FS i For example, when multiple measurements are performed, RR1 i Can take the same value; bs ij is the jth group of laboratory measurement parameters based on fs ij and RR1 i Calculated BS i The measured value of K i and b i is the polynomial coefficient to be determined. In the actual system, K i and b i For example, it may include but is not limited to a series of evaluation parameters such as correction parameters and weight parameters.

[0061] Based on the measurement parameters obtained from multiple laboratories, a set of equations consisting of multiple evaluation equations can be obtained under the condition of preset initial values. i and b i The corresponding numerical solution is obtained and applied to the next CS evaluation calculation. Thus, in this embodiment, the CS calculation method defined in formula (1) can be used to obtain K in formula (1) through iterative fitting based on laboratory measurement evaluation data. i and b i The specific range or specific value of the coefficient (such as K as described above) is obtained. i and b i), combined with the specific scanning characteristic parameters obtained in the actual operation of the ultrasonic knife system, the CS value that characterizes the degree of composite damage of the tissue is calculated and predicted.

[0062] The CS calculation method set according to equation (1) has the advantages of fast calculation speed and easy control implementation. However, it should be noted that the CS calculation method is not limited to the first-order polynomial described above. In different application scenarios, higher-order polynomials can also be used to obtain higher approximation accuracy or faster control response, etc., which can achieve beneficial technical effects.

[0063] In some embodiments, the RR1 corresponding to each FS can be directly obtained by reading and using historical parameters of the ultrasonic scalpel system pre-stored in memory, or by recording the frequency scanning process during the ultrasonic scalpel system's power-on self-test, including each FS. In other embodiments, these records and historical parameters can be fused using a weighted summation or other fusion process based on specific criteria, such as time-ordered priority or data quality level. The fused data is used as the corresponding RR1 for subsequent CS calculation.

[0064] Next, in step 303, the calculated CS may be further judged. When it is judged that it exceeds the first threshold range, the driving signal of the ultrasonic transducer will be suppressed, and / or an acoustic and visual prompt for suppressing the driving signal of the ultrasonic transducer will be provided. Note that providing an acoustic and visual prompt for suppressing the driving signal of the ultrasonic transducer may include an acoustic and visual prompt that informs the user of the automatic suppression of the driving signal of the ultrasonic transducer, and may also include an acoustic and visual prompt that prompts the user to manually adjust and suppress the driving signal of the ultrasonic transducer. In the present disclosure, the technical term "acoustic and visual prompt" is intended to indicate a prompt that uses acoustic stimulation and / or optical stimulation, for example, it may be a pure acoustic prompt, a pure optical prompt, or an acoustic prompt combined with an optical prompt.

[0065] For ultrasonic scalpel systems of different models and different usage states (aging degrees), a specific first threshold range can be measured and / or simulated in advance, so that the composite damage to the tissue corresponding to the first tissue damage factor within the first threshold range is acceptable. Figure 3 The process shown in can ensure that the CS obtained after taking the inhibitory measures does not exceed the first threshold range, thereby ensuring that the composite damage to the tissue is within the level acceptable to the doctor.

[0066] In some embodiments, the driving signal of the ultrasonic transducer includes but is not limited to at least one of a driving current, a driving voltage, and a driving power. As an example, for a current-driven ultrasonic transducer, energy control of the ultrasonic transducer can be implemented by suppressing the driving current.

[0067] In other embodiments, it is further possible to determine whether the first tissue damage factor exceeds a second threshold range. Once exceeded, the ultrasonic transducer's energy output is stopped, and / or an acoustic and visual prompt signal is provided to indicate the forced stop of the ultrasonic transducer's energy output. Note that providing an acoustic and visual prompt signal to indicate the forced stop of the ultrasonic transducer's energy output may include an acoustic and visual prompt signal notifying the user of an automatic forced stop, or an acoustic and visual prompt signal instructing the user to manually perform a forced stop. Wherein, if the second threshold range exceeds the first threshold range, in this case, it generally indicates that the ultrasonic scalpel system may cause a risk of complex damage to the tissue, the rate of damage accumulation is also increased, and / or once damage is caused, the extent of the damage may also be greater. Therefore, more stringent measures will be taken in terms of energy control of the ultrasonic transducer, including the forced stop of the ultrasonic transducer's energy output. In this way, the energy supply to the ultrasonic transducer can be quickly cut off, new mechanical damage can be avoided, and further accumulation of complex tissue damage can be prevented.

[0068] Refer to the following Figure 4 , a flowchart describing in detail a second example of a control method for an ultrasonic knife system according to an embodiment of the present disclosure. Figure 4 The control method of the ultrasonic scalpel system shown is used in the frequency tracking stage of the ultrasonic scalpel system in one excitation. Figure 4 In the frequency tracking stage, the ultrasonic knife system controls the knife head to operate on the tissue under the coordinated work of the ultrasonic transducer, processor, memory, etc., and uses the following methods during the operation: Figure 4 The control method of the ultrasonic knife system according to the embodiment of the present disclosure is shown to control the energy output of the ultrasonic transducer in real time.

[0069] In step 401, the impedance of the equivalent circuit of the ultrasonic transducer during the frequency tracking process, the matching parameters of the series branch in the equivalent circuit of the ultrasonic transducer, the excitation power (EP) and the excitation time (ET) can be obtained as tracking characteristic parameters.

[0070] In other embodiments, the matching parameters of the series branch in the equivalent circuit may include one or more of the operating frequency (ω2) and the phase difference (Φ) between the voltage U1 across the series branch and the current I1 flowing therethrough. Similarly, because the series branch does not physically exist, it is necessary to indirectly determine the required physical quantities of the series branch, such as the current I1 flowing therethrough, by measuring the entire equivalent circuit and / or other circuits within the equivalent circuit of the ultrasonic transducer. When the series branch is in an ideal operating state, the impedance (Z) of the equivalent circuit also has a relatively small magnitude.

[0071] After the ultrasonic scalpel system passes through the frequency scanning phase, when the ultrasonic transducer enters the initial phase of frequency tracking, the series branch typically operates within an ideal operating state, and the temperature has not significantly deviated. The ultrasonic scalpel system is in a favorable state with a low risk of causing combined tissue damage. Therefore, the tracking characteristic parameters acquired during the initial phase of frequency tracking can be stored in memory and used as a second reference range corresponding to the tracking characteristic parameters for subsequent calculation of a second deviation. As the scalpel head cuts tissue, the temperature of the ultrasonic scalpel system rises, and the series branch also deviates from the ideal operating state. At this point, if the ultrasonic transducer is not controlled appropriately, combined tissue damage, including thermal and vibration damage, may occur.

[0072] In step 402, a second tissue damage factor associated with the composite damage degree of the tissue can be calculated based on the real-time acquired tracking characteristic parameters, such as, but not limited to, the second deviation of one or more of the aforementioned Z, ω2, Φ, EP, and ET relative to their corresponding second reference ranges. Specifically, the second deviation (BT) between each tracking characteristic parameter (FT) and the corresponding second reference range (RR2) is first calculated, and then a preset polynomial function is used to calculate the second tissue damage factor (CT) associated with the composite damage degree of the tissue during the frequency tracking phase. In some embodiments, a pre-frequency tracking process can be performed, in which multiple sets of third experimental data of FT and corresponding fourth experimental data of the composite damage degree of the tissue are collected; the multiple sets of third experimental data and fourth experimental data are fitted to obtain a coefficient matrix of the polynomial function.

[0073] In some embodiments, when determining the coefficient matrix of the polynomial function by fitting experimental data, the specific application scenario of the ultrasonic scalpel system and other implementation conditions for controlling tissue damage can be given particular consideration. For example, when the ultrasonic scalpel system takes control accuracy as the main optimization goal, a higher-order polynomial function can be used for fitting. As an example, when the real-time control of the ultrasonic scalpel system is the main optimization goal, a first-order polynomial function can be used for fitting. In this case, CT can be calculated as shown in formula (3):

[0074] CT=∑[K i *BT i +b i ], among which, BT i =‖FT i -RR2 i ‖ Formula (3)

[0075] Among them, FT i To calculate the i-th tracking characteristic parameter used by CT, RR2 i For FTi The corresponding second reference range, BT i =‖FT i -RR2 i ‖ represents the FT obtained according to certain calculation rules i With RR2 i As an example, when RR2 i When the value range of [a,b] is defined, the distance FT can be selected i The closer a or b is, the more |FT i -a|or|FT i -b| (|·| is an absolute value operator) The smaller value is used as BT i In some other embodiments, BT i The calculation method of K is not limited to this and can be set as needed based on the physical meaning of the scanning characteristic parameters and the actual impact on CT evaluation. i and b i They are respectively the polynomial functions and BT i The corresponding coefficient. About K i and b i The solution method has been combined with Figure 3 A detailed description has been given and will not be repeated here.

[0076] The CT calculation method set according to equation (3) has the advantages of fast calculation speed and easy control implementation. However, it should be noted that the CT calculation method is not limited to the first-order polynomial described above. In different application scenarios, higher-order polynomials can also be used to obtain higher approximation accuracy or faster control response, etc., which can achieve beneficial technical effects.

[0077] In some embodiments, the value of CT in the frequency tracking phase may also be calculated as shown in formula (4):

[0078] ct(t)=∏[K i *BT i (t)+b i ], among which, BT i (t) = ‖FT i (t)-RR2 i (t)‖

[0079] CT = ∑ct(t) Formula (4)

[0080] Where ct(t) is the instantaneous value of the second tissue damage factor expressed as a first-order polynomial function at time t in the frequency tracking phase, FT i (t) is the i-th tracking characteristic parameter used to calculate ct(t), RR2 i (t) is the same as FT i(t) corresponds to the second reference range, BT i (t) = ‖FT i (t)-RR2 i (t)‖ represents the FT obtained according to certain calculation rules i (t) and RR2 i The difference in (t), BT i The calculation method of (t) can be similar to that of formula (3), which will not be repeated here. i and b i They are respectively the polynomial functions and BT i (t) The corresponding coefficient, about K i and b i The solution method of CT is not described here. The value of CT is the accumulation of ct(t) in the time domain, for example, it can be the accumulation of values at multiple discrete sampling moments.

[0081] In some embodiments, the RR2 corresponding to each FT can be directly derived by reading and utilizing historical parameters of the ultrasonic scalpel system pre-stored in memory, a record of the frequency scanning process during the ultrasonic scalpel system's power-on self-test, including the aforementioned scanning characteristic parameters, or a record of frequency characteristic parameters from the initial phase of the frequency tracking process stored in real time in memory. In other embodiments, these records and historical parameters can be fused, such as by weighted summation, based on specific criteria, such as time-ordered priority or data quality level. The fused data can then be used as the corresponding RR2 for subsequent CT calculations.

[0082] Next, in step 403, the calculated CT may be further evaluated. If it is determined that the CT exceeds a third threshold range, or the CT's trend of change exceeds a fourth threshold range, the ultrasonic transducer drive signal may be suppressed, and / or an acoustic or visual prompt for suppressing the ultrasonic transducer drive signal may be provided. In addition to the CT's own magnitude, monitoring the CT's trend of change allows for "preventative" suppression measures. This allows for preemptive suppression of drive energy when unacceptable composite damage has not yet occurred but the risk has significantly increased. This provides ample margin for composite damage suppression and allows for early preventive intervention when the risk significantly increases.

[0083] The drive signal of the ultrasonic transducer includes, but is not limited to, at least one of a drive current, a drive voltage, and a drive power. For example, for a current-driven ultrasonic transducer, energy control of the ultrasonic transducer can be implemented by suppressing the drive current. In some embodiments, the acoustic and visual prompts are configured as various types of prompt signals that prompt a user to adjust the drive signal of the ultrasonic transducer.

[0084] In other embodiments, it may be further determined whether the second tissue damage factor exceeds a seventh threshold range, or whether the trend of change in the second tissue damage factor exceeds an eighth threshold range. If so, the ultrasonic transducer's energy output is stopped, and / or an acoustic and visual prompt signal is provided to instruct the user to forcibly stop the ultrasonic transducer's energy output. Where the seventh threshold range exceeds the third threshold range, and the eighth threshold range exceeds the fourth threshold range, this generally indicates that the ultrasonic scalpel system may increase the risk of causing complex tissue damage, and / or that once damage is caused, the extent of the damage may be greater. Therefore, more rapid and mandatory measures will be taken to control the ultrasonic transducer's energy, including providing an acoustic and visual prompt signal to instruct the user to forcibly stop the ultrasonic transducer's energy output.

[0085] The details and effectiveness of the energy output suppression measures and mandatory stop measures based on the second tissue damage factor in the frequency tracking phase are combined with the above description of the frequency scanning phase. Figure 3 The description is similar to that of , and is combined here without further details.

[0086] Refer to the following Figure 5 , the process of the third example of the control method of the ultrasonic knife system according to the embodiment of the present disclosure is described in detail. Figure 5 In the illustrated embodiment, the operation process of the ultrasonic scalpel system is a complete excitation, including two stages: frequency scanning and frequency tracking.

[0087] First, a frequency scanning process is performed. Under normal circumstances, the frequency tracking stage begins after the frequency scanning stage. In the frequency tracking stage, the ultrasonic knife system cuts the tissue. The specific application of each embodiment of the present disclosure in the above process will be described.

[0088] In some embodiments, the ultrasonic transducer in the ultrasonic scalpel system is current driven. Figure 5 In step 501, a lower driving current ( Figure 5 The ultrasonic transducer is driven with the sweep current in the frequency sweep mode and a lower initial frequency to start the frequency sweep process.

[0089] In steps 502-504, a scan is performed across all frequency points within the preset frequency sweep range, and sweep parameter information associated with the sweep frequency is measured, calculated, and recorded. In step 502, parameter information at the current sweep frequency, including but not limited to the admittance value, is measured and recorded. In step 503, the sweep frequency is incremented at a predetermined frequency interval, switching to the next predetermined frequency point. In step 504, a determination is made as to whether the frequency exceeds the preset frequency sweep range.

[0090] After all frequency points within the preset frequency scanning range are scanned, in step 505, the scanning characteristic parameters are determined based on the parameter information associated with the scanning frequency obtained in the previous steps 502 to 504, including but not limited to the scanning frequency F that maximizes the admittance of the equivalent circuit of the ultrasonic transducer. m In other embodiments, the frequency characteristic parameters may further include F1 and / or F2, etc. In some embodiments, when the frequency scan performed is a frequency scan process during the power-on self-test of the ultrasonic scalpel system, the scanning characteristic parameters obtained in the above step 505 may be stored in a memory in the ultrasonic scalpel system as a first reference range of the corresponding scanning characteristic parameters representing a good working state.

[0091] In step 506, the record of the frequency scanning phase during the power-on self-test of the ultrasonic scalpel system and the historical parameters of the ultrasonic scalpel system are obtained from the memory of the ultrasonic scalpel system and directly used as the first reference range of the corresponding scanning characteristic parameters. Alternatively, in some embodiments, the record of the frequency scanning process during the power-on self-test of the ultrasonic scalpel system, including the various scanning characteristic parameters, can also be used. In other embodiments, the above records and historical parameters can also be fused according to certain criteria, such as time-ordered priority or data quality level, through weighted summation, and the fused data is used as the corresponding first reference range for calculation of the first tissue damage factor in subsequent steps.

[0092] In step 507, based on the scanning characteristic parameters calculated in step 505 and the first reference range obtained in step 506, a first tissue damage factor associated with the composite damage degree of the tissue is calculated. The specific calculation method has been combined with Figure 3 A detailed description has been given and will not be repeated here.

[0093] In steps 508 and 509, based on the determination of the first tissue damage factor, it is determined whether and what measures should be taken to control the energy output of the ultrasonic transducer. In some embodiments, when it is determined in step 508 that the first tissue damage factor exceeds a first threshold range, the ultrasonic transducer energy output is controlled in step 509, for example, by suppressing the ultrasonic transducer drive signal and / or providing an acoustic and visual prompt for suppressing the ultrasonic transducer drive signal. In other embodiments, when it is determined that the first tissue damage factor further exceeds a second threshold range, the ultrasonic transducer energy output is stopped and / or an acoustic and visual prompt signal is provided to indicate the forced cessation of the ultrasonic transducer energy output, wherein the second threshold range exceeds the first threshold range. If the result of the determination in step 508 is "no", that is, the first tissue damage factor does not exceed the first threshold range, it indicates that the current state of the ultrasonic scalpel system has a low risk and / or degree of complex tissue damage, and the frequency tracking process can then be entered.

[0094] At step 510, the frequency tracking process of the ultrasonic scalpel system is started. First, the frequency tracking current and the initial tracking frequency can be set. As an example, the initial tracking frequency can refer to the F as the scanning characteristic parameter determined in the above frequency scanning process. m Make the settings.

[0095] In steps 511 to 516 , the working state of the ultrasonic scalpel system during the frequency tracking process, especially the state in which the ultrasonic scalpel system may cause complex tissue damage, is monitored and controlled.

[0096] In step 511, tracking characteristic parameters of the frequency tracking process are acquired. In some embodiments, the tracking characteristic parameters may include, but are not limited to, the impedance of the ultrasonic transducer's equivalent circuit, the operating frequency, the phase difference between the voltage across the series branch and the current flowing therethrough, the excitation power, and the excitation time. In some embodiments, the tracking characteristic parameters acquired during the initial phase of the frequency tracking process may be stored for use in calculating the second reference range in subsequent steps.

[0097] In step 512, the records of the frequency scanning process during the power-on self-test of the ultrasonic knife system, the historical parameters of the ultrasonic knife system, and the records of the tracking characteristic parameters in the initial stage of the frequency tracking process are read from the memory of the ultrasonic knife system, or the above records, historical parameters and frequency tracking characteristic parameters are integrated according to certain criteria to obtain the second reference range corresponding to each tracking characteristic parameter.

[0098] In step 513, based on the second deviation of the tracking characteristic parameters including at least the impedance of the equivalent circuit of the ultrasonic transducer, the matching parameters of the series branch in the equivalent circuit of the ultrasonic transducer, the excitation power and the excitation time relative to the corresponding second reference range of the tracking characteristic parameters, a second tissue damage factor associated with the composite damage degree of the tissue is calculated. The specific calculation method has been combined with Figure 4Detailed descriptions have been provided and will not be repeated here. In step 513, a third tissue damage factor is further calculated. Unlike the first and second examples already described, in this example, for a complete excitation process, including a frequency sweep process and a frequency tracking process, characteristic parameters from both processes are comprehensively considered. Specifically, the first deviation calculated based on the sweep characteristic parameters and their first reference range during the frequency sweep process is combined with the second deviation calculated based on the tracking characteristic parameters and their second reference range during the frequency tracking process to calculate a third tissue damage factor associated with the composite degree of tissue damage. In some embodiments, a similar calculation method as used for the first and second tissue damage factors can be used to fit a polynomial function including the first and second deviations to experimental data to obtain the third tissue damage factor. In other embodiments, other calculation methods can also be used. For example, a piecewise function can be used to calculate the third tissue damage factor. The first deviation serves as the boundary value of the piecewise function. Within different numerical ranges, different calculation methods or algorithm parameters are used to calculate the third tissue damage factor using the second deviation.

[0099] In steps 514 and 515 , based on the determination of the second or third tissue damage factor or its changing trend, it is determined whether and what measures should be taken to control the energy output of the ultrasonic transducer.

[0100] In step 514, if it is determined that the second tissue damage factor exceeds the third threshold range, or its trend exceeds the fourth threshold range, or the third tissue damage factor exceeds the fifth threshold range, or the trend of the third tissue damage factor exceeds the sixth threshold range, the drive signal of the ultrasonic transducer is suppressed in step 515, and / or an acoustic and visual prompt for suppressing the drive signal of the ultrasonic transducer is provided. In other embodiments, if it is determined in step 514 that the second tissue damage factor exceeds the seventh threshold range, or its trend exceeds the eighth threshold range, the energy output of the ultrasonic transducer is stopped in step 515, and / or an acoustic and visual prompt signal is provided to instruct the forced cessation of the energy output of the ultrasonic transducer, wherein the seventh threshold range exceeds the third threshold range, and the eighth threshold range exceeds the fourth threshold range.

[0101] When the result determined in step 514 is "no", that is, the second / third tissue damage factor does not exceed the threshold range, it indicates that the current state of the ultrasonic knife system has a low risk and / or degree of complex damage to the tissue. At this time, there is no need to control the energy output of the ultrasonic transducer, and frequency tracking can be performed normally. In step 516, the ultrasonic transducer is adjusted to the next frequency point of the preset frequency interval to continue frequency tracking.

[0102] Furthermore, although exemplary embodiments have been described herein, the scope includes any and all embodiments based on the present disclosure with equivalent elements, modifications, omissions, combinations (e.g., solutions that intersect various embodiments), adaptations, or changes. The elements in the claims are to be interpreted broadly based on the language employed in the claims and are not limited to the examples described in this specification or during the prosecution of this application, which examples are to be interpreted as non-exclusive. Therefore, this specification and examples are intended to be considered as examples only, with the true scope and spirit being indicated by the following claims and the full scope of their equivalents.

[0103] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more schemes thereof) can be used in combination with each other. For example, a person of ordinary skill in the art may use other embodiments when reading the above description. In addition, in the above-mentioned specific embodiments, various features can be grouped together to simplify the present disclosure. This should not be interpreted as an intention that a disclosed feature that is not required to be protected is necessary for any claim. On the contrary, the subject matter of the present invention may be less than all the features of a specific disclosed embodiment. Thus, the following claims are incorporated into the specific embodiments as examples or embodiments, wherein each claim is independently a separate embodiment, and it is considered that these embodiments can be combined with each other in various combinations or arrangements. The scope of the present invention should be determined with reference to the appended claims and the full scope of equivalents to which these claims are entitled.

Claims

1. An ultrasonic scalpel system, comprising an ultrasonic transducer, characterized in that: The ultrasonic scalpel system further includes a processor, and the processor is configured to: Acquiring a scanning frequency that maximizes the admittance of the equivalent circuit of the ultrasonic transducer during the frequency scanning process as a scanning characteristic parameter; calculating a first tissue damage factor associated with a composite damage degree of tissue based on a first deviation of the scanning characteristic parameter relative to a corresponding first reference range of the scanning characteristic parameter, the composite damage including thermal damage and vibration damage; and When the first tissue damage factor exceeds a first threshold range, the driving signal of the ultrasonic transducer is suppressed, and / or an acoustic and optical prompt for suppressing the driving signal of the ultrasonic transducer is provided.

2. The ultrasonic scalpel system according to claim 1, characterized in that: The driving signal of the ultrasonic transducer includes at least one of a driving current, a driving voltage, and a driving power; and the sound and light prompt is configured to prompt a user to adjust the driving signal of the ultrasonic transducer.

3. The ultrasonic scalpel system according to claim 1 or 2, characterized in that: There are multiple scanning characteristic parameters, and the processor is further configured to: measure the admittance circle of the equivalent circuit of the ultrasonic transducer during the frequency scanning process; Based on the measured admittance circle, the multiple scanning characteristic parameters are determined. In addition to the scanning frequency that maximizes the admittance of the equivalent circuit of the ultrasonic transducer, the multiple scanning characteristic parameters also include at least one of half-power point frequency 1 and half-power point frequency 2; the half-power point frequency 1 is a frequency point less than the maximum admittance frequency and whose impedance value is half of the maximum impedance value, and the half-power point frequency 2 is a frequency point greater than the maximum admittance frequency and whose impedance value is half of the maximum impedance value.

4. The ultrasonic scalpel system according to claim 1 or 2, characterized in that: The first tissue damage factor is calculated based on the first deviation between the scanning characteristic parameter and the corresponding first reference range and using a preset polynomial function. The coefficients of the polynomial function are obtained through the following steps: performing a preliminary frequency scanning process; in this preliminary frequency scanning process, collecting multiple groups of first experimental data of the scanning characteristic parameters and second experimental data of the corresponding composite damage degree of the tissue; and fitting the multiple groups of first experimental data and second experimental data.

5. The ultrasonic scalpel system according to claim 1 or 2, characterized in that: The processor is further configured to: when it is determined that the first tissue damage factor exceeds a second threshold range, stop the energy output of the ultrasonic transducer, and / or provide an acoustic and visual prompt signal indicating the forced cessation of the energy output of the ultrasonic transducer, wherein the second threshold range exceeds the first threshold range.

6. The ultrasonic scalpel system according to claim 1 or 2, characterized in that: The ultrasonic scalpel system further includes a memory, wherein the memory stores historical parameters of the ultrasonic scalpel system, and the processor is further configured to: storing a record of the frequency scanning process including the scanning characteristic parameters during the power-on self-test of the ultrasonic scalpel system in the memory; The first reference range is obtained by reading the record of the frequency scanning process during the power-on self-test of the ultrasonic scalpel system in the memory, the historical parameters of the ultrasonic scalpel system, or by fusing the record and the historical parameters.

7. The ultrasonic scalpel system according to claim 1, characterized in that: The processor is further configured to, during frequency tracking: Acquiring the impedance of the equivalent circuit of the ultrasonic transducer, the matching parameters of the series branch in the equivalent circuit of the ultrasonic transducer, the excitation power, and the excitation time during the frequency tracking process as tracking characteristic parameters; calculating a second tissue damage factor associated with a composite degree of damage to the tissue based on a second deviation of the tracking characteristic parameter from a corresponding second reference range of the tracking characteristic parameter; as well as When the second tissue damage factor exceeds a third threshold range, or the change trend of the second tissue damage factor exceeds a fourth threshold range, the driving signal of the ultrasonic transducer is suppressed, and / or an acoustic and visual prompt is provided for suppressing the driving signal of the ultrasonic transducer.

8. The ultrasonic scalpel system according to claim 7, characterized in that: The matching parameter of the series branch in the equivalent circuit includes at least one of an operating frequency and a phase difference between a voltage across the series branch and a current flowing therethrough.

9. The ultrasonic scalpel system according to claim 7 or 8, characterized in that: The processor is further configured to, for each excitation: Calculating a third tissue damage factor associated with a composite damage degree of the tissue based on the first deviation in the frequency scanning process and the second deviation in the frequency tracking process; as well as When the third tissue damage factor exceeds the fifth threshold range, or the change trend of the third tissue damage factor exceeds the sixth threshold range, the driving signal of the ultrasonic transducer is suppressed, and / or an acoustic and visual prompt is provided for suppressing the driving signal of the ultrasonic transducer.

10. An ultrasonic scalpel system, comprising an ultrasonic transducer, characterized in that: The ultrasonic scalpel system further includes a processor, wherein the processor is configured to, during the frequency tracking process: Acquiring the impedance of the equivalent circuit of the ultrasonic transducer, the matching parameters of the series branch in the equivalent circuit of the ultrasonic transducer, the excitation power, and the excitation time during the frequency tracking process as tracking characteristic parameters; calculating a second tissue damage factor associated with a composite damage degree of tissue based on a second deviation of the tracking characteristic parameter from a corresponding second reference range of the tracking characteristic parameter, the composite damage including thermal damage and vibration damage; as well as When the second tissue damage factor exceeds a third threshold range, or the change trend of the second tissue damage factor exceeds a fourth threshold range, the driving signal of the ultrasonic transducer is suppressed, and / or an acoustic and visual prompt is provided for suppressing the driving signal of the ultrasonic transducer.

11. The ultrasonic scalpel system according to claim 10, characterized in that: The driving signal of the ultrasonic transducer includes at least one of a driving current, a driving voltage, and a driving power; and the sound and light prompt is configured to prompt a user to adjust the driving signal of the ultrasonic transducer.

12. The ultrasonic scalpel system according to claim 10 or 11, characterized in that: The matching parameter of the series branch in the equivalent circuit includes at least one of an operating frequency and a phase difference between a voltage across the series branch and a current flowing therethrough.

13. The ultrasonic scalpel system according to claim 10 or 11, characterized in that: The second tissue damage factor is calculated based on the second deviation between the tracking characteristic parameter and the corresponding second reference range and using a preset polynomial function. The coefficients of the polynomial function are obtained through the following steps: performing a preliminary frequency tracking process; in this preliminary frequency tracking process, collecting multiple groups of third experimental data of the tracking characteristic parameters and fourth experimental data of the corresponding composite damage degree of the tissue; and fitting the multiple groups of third experimental data and fourth experimental data.

14. The ultrasonic scalpel system according to claim 10 or 11, characterized in that: The processor is further configured to: when it is determined that the second tissue damage factor exceeds the seventh threshold range, or the change trend of the second tissue damage factor exceeds the eighth threshold range, stop the energy output of the ultrasonic transducer, and / or provide an audible and visual prompt signal indicating the forced stop of the energy output of the ultrasonic transducer, wherein the seventh threshold range exceeds the third threshold range, and the eighth threshold range exceeds the fourth threshold range.

15. The ultrasonic scalpel system according to claim 10 or 11, characterized in that: The ultrasonic scalpel system further includes a memory, wherein the memory stores historical parameters of the ultrasonic scalpel system, and the processor is further configured to: storing in the memory a record including the tracking characteristic parameters acquired during an initial phase of a frequency tracking process; The second reference range is obtained by reading the historical parameters of the ultrasonic knife system in the memory, the record of the tracking characteristic parameters in the initial stage of the frequency tracking process, or by fusing the records of the historical parameters and the tracking characteristic parameters.

16. A non-transitory computer-readable storage medium storing a program, wherein the program causes a processor to execute a method for controlling an ultrasonic scalpel system, wherein the ultrasonic scalpel system includes an ultrasonic transducer, wherein: The control method includes: Acquiring a scanning frequency that maximizes the admittance of the equivalent circuit of the ultrasonic transducer during the frequency scanning process as a scanning characteristic parameter; calculating a first tissue damage factor associated with a composite damage degree of tissue based on a first deviation of the scanning characteristic parameter relative to a corresponding first reference range of the scanning characteristic parameter, the composite damage including thermal damage and vibration damage; and When the first tissue damage factor exceeds a first threshold range, the driving signal of the ultrasonic transducer is suppressed, and / or an acoustic and optical prompt for suppressing the driving signal of the ultrasonic transducer is provided.

17. The non-transitory computer-readable storage medium storing a program according to claim 16, wherein: The driving signal of the ultrasonic transducer includes at least one of a driving current, a driving voltage, and a driving power; and the sound and light prompt is configured to prompt a user to adjust the driving signal of the ultrasonic transducer.

18. The non-transitory computer-readable storage medium storing a program according to claim 16 or 17, wherein: There are multiple scanning characteristic parameters, and the control method further includes: measuring the admittance circle of the equivalent circuit of the ultrasonic transducer during the frequency scanning process; Based on the measured admittance circle, the multiple scanning characteristic parameters are determined. In addition to the scanning frequency that maximizes the admittance of the equivalent circuit of the ultrasonic transducer, the multiple scanning characteristic parameters also include at least one of half-power point frequency 1 and half-power point frequency 2; the half-power point frequency 1 is a frequency point less than the maximum admittance frequency and whose impedance value is half of the maximum impedance value, and the half-power point frequency 2 is a frequency point greater than the maximum admittance frequency and whose impedance value is half of the maximum impedance value.

19. The non-transitory computer-readable storage medium storing a program according to claim 16 or 17, wherein: The first tissue damage factor is calculated based on the first deviation between the scanning characteristic parameter and the corresponding first reference range and using a preset polynomial function. The coefficients of the polynomial function are obtained through the following steps: performing a preliminary frequency scanning process; in this preliminary frequency scanning process, collecting multiple groups of first experimental data of the scanning characteristic parameters and second experimental data of the corresponding composite damage degree of the tissue; and fitting the multiple groups of first experimental data and second experimental data.

20. The non-transitory computer-readable storage medium storing a program according to claim 16 or 17, wherein: When it is determined that the first tissue damage factor exceeds a second threshold range, the energy output of the ultrasonic transducer is stopped, and / or an acoustic and visual prompt signal is provided to indicate the forced stop of the energy output of the ultrasonic transducer, wherein the second threshold range exceeds the first threshold range.

21. The non-transitory computer-readable storage medium storing a program according to claim 16 or 17, wherein: The ultrasonic scalpel system further includes a memory, wherein the memory stores historical parameters of the ultrasonic scalpel system. The control method further includes: storing a record of the frequency scanning process including the scanning characteristic parameters during the power-on self-test of the ultrasonic scalpel system in the memory; The first reference range is obtained by reading the record of the frequency scanning process during the power-on self-test of the ultrasonic scalpel system in the memory, the historical parameters of the ultrasonic scalpel system, or by fusing the record and the historical parameters.

22. The non-transitory computer-readable storage medium storing a program according to claim 16, wherein: The control method further comprises, during the frequency tracking process: Acquiring the impedance of the equivalent circuit of the ultrasonic transducer, the matching parameters of the series branch in the equivalent circuit of the ultrasonic transducer, the excitation power, and the excitation time during the frequency tracking process as tracking characteristic parameters; calculating a second tissue damage factor associated with a composite degree of damage to the tissue based on a second deviation of the tracking characteristic parameter from a corresponding second reference range of the tracking characteristic parameter; as well as When the second tissue damage factor exceeds a third threshold range, or the change trend of the second tissue damage factor exceeds a fourth threshold range, the driving signal of the ultrasonic transducer is suppressed, and / or an acoustic and visual prompt is provided for suppressing the driving signal of the ultrasonic transducer.

23. The non-transitory computer-readable storage medium storing a program according to claim 22, wherein: The matching parameter of the series branch in the equivalent circuit includes at least one of an operating frequency and a phase difference between a voltage across the series branch and a current flowing therethrough.

24. The non-transitory computer-readable storage medium storing a program according to claim 22 or 23, wherein: The control method further comprises, for each excitation: The first deviation of the frequency scanning process is combined with the second deviation of the frequency tracking process to calculate a third tissue damage factor associated with the composite damage degree of the tissue; as well as When the third tissue damage factor exceeds the fifth threshold range, or the change trend of the third tissue damage factor exceeds the sixth threshold range, the driving signal of the ultrasonic transducer is suppressed, and / or an acoustic and visual prompt is provided for suppressing the driving signal of the ultrasonic transducer.

25. A non-transitory computer-readable storage medium storing a program, wherein the program causes a processor to execute a method for controlling an ultrasonic scalpel system, wherein the ultrasonic scalpel system includes an ultrasonic transducer, wherein: The control method includes, during the frequency tracking process: Acquiring the impedance of the equivalent circuit of the ultrasonic transducer, the matching parameters of the series branch in the equivalent circuit of the ultrasonic transducer, the excitation power, and the excitation time during the frequency tracking process as tracking characteristic parameters; calculating a second tissue damage factor associated with a composite damage degree of tissue based on a second deviation of the tracking characteristic parameter from a corresponding second reference range of the tracking characteristic parameter, the composite damage including thermal damage and vibration damage; as well as When the second tissue damage factor exceeds a third threshold range, or the change trend of the second tissue damage factor exceeds a fourth threshold range, the driving signal of the ultrasonic transducer is suppressed, and / or an acoustic and visual prompt is provided for suppressing the driving signal of the ultrasonic transducer.

26. The non-transitory computer-readable storage medium storing a program according to claim 25, wherein: The driving signal of the ultrasonic transducer includes at least one of a driving current, a driving voltage, and a driving power; and the sound and light prompt is configured to prompt a user to adjust the driving signal of the ultrasonic transducer.

27. The non-transitory computer-readable storage medium storing a program according to claim 25 or 26, wherein: The matching parameter of the series branch in the equivalent circuit includes at least one of an operating frequency and a phase difference between a voltage across the series branch and a current flowing therethrough.

28. The non-transitory computer-readable storage medium storing a program according to claim 25 or 26, wherein: The second tissue damage factor is calculated based on the second deviation between the tracking characteristic parameter and the corresponding second reference range and using a preset polynomial function. The coefficients of the polynomial function are obtained through the following steps: performing a preliminary frequency tracking process; in this preliminary frequency tracking process, collecting multiple groups of third experimental data of the tracking characteristic parameters and fourth experimental data of the corresponding composite damage degree of the tissue; and fitting the multiple groups of third experimental data and fourth experimental data.

29. The non-transitory computer-readable storage medium storing a program according to claim 25 or 26, wherein: When it is determined that the second tissue damage factor exceeds the seventh threshold range, or the change trend of the second tissue damage factor exceeds the eighth threshold range, the energy output of the ultrasonic transducer is stopped, and / or an acoustic and visual prompt signal is provided to indicate the forced stop of the energy output of the ultrasonic transducer, wherein the seventh threshold range exceeds the third threshold range, and the eighth threshold range exceeds the fourth threshold range.

30. The non-transitory computer-readable storage medium storing a program according to claim 25 or 26, wherein: The ultrasonic scalpel system further includes a memory, wherein the memory stores historical parameters of the ultrasonic scalpel system. The control method further includes: storing in the memory a record including the tracking characteristic parameters acquired during an initial phase of a frequency tracking process; The second reference range is obtained by reading the historical parameters of the ultrasonic knife system in the memory, the record of the tracking characteristic parameters in the initial stage of the frequency tracking process, or by fusing the record of the historical parameters and the tracking characteristic parameters.

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