Apparatus and method for validating ultrasound cavitation signal

Abstract

According to one embodiment of the present invention, the invention may include an ultrasonic generating and cavitation sensing module that generates ultrasonic waves, a tank that receives a medium through which the ultrasonic waves are transmitted, a membrane disposed between the ultrasonic generating and cavitation sensing module and the medium of the tank to transmit the ultrasonic waves into the medium, tubing that communicates with the tank and provides a fluid passage for injecting microbubbles, a sound-absorbing material that absorbs interference components of the ultrasonic waves generated within the tank, and a signal processing module that converts the cavitation signal generated by the microbubbles into an electrical signal for analysis and evaluates the reproducibility of the cavitation signal based on the analysis results.

Description

Technology Field

[0001] The present invention relates to an ultrasonic cavitation signal validation device and method. Background Technology

[0002] Ultrasound technology is being utilized in various fields such as medical imaging, treatment, and drug delivery, and its scope of application is continuously expanding.

[0003] In particular, ultrasonic application technology using microbubbles is attracting attention for its high spatial precision and energy control capabilities, and accordingly, research to elucidate the relationship between ultrasonic signal characteristics and device performance is actively underway. Furthermore, there is an increasing trend of attempts to analyze physical phenomena by measuring the frequency components of ultrasonic signals and to incorporate this into the evaluation of device performance.

[0004] However, conventional technology is often limited primarily to simple signal observation or verification of output conditions, which has limitations as results vary significantly depending on changes in the measurement environment or medium conditions. Furthermore, even when repeated experiments are performed under identical conditions, signal characteristics are inconsistent, leading to a problem where the reliability of device performance is degraded.

[0005] In particular, changes in nonlinear components occurring across various frequency bands directly affect the consistency of device performance, but a system capable of comprehensively validating them has not yet been sufficiently established.

[0006] Therefore, for ultrasound-based devices to operate stably and consistently in actual application environments, technology is required that goes beyond simple signal measurement to quantitatively analyze performance fluctuations occurring throughout the operation process and ensure stability. The problem to be solved

[0007] The problem that the present invention aims to solve is to provide an evaluation and verification technology that quantitatively analyzes cavitation signals generated by ultrasound and ensures stable and consistent signal characteristics even when repeated under the same conditions.

[0008] Furthermore, the problem that the present invention aims to solve is to verify the operating status of a device based on specific frequency components of an ultrasonic signal. In particular, it provides a method to ensure stability by verifying the performance of the device in advance before applying it to an object, and furthermore, to guarantee the reproducibility of the device's performance based on these verification results. means of solving the problem

[0009] According to one embodiment of the present invention, the invention may include an ultrasonic generating and cavitation sensing module that generates ultrasonic waves, a tank that receives a medium through which the ultrasonic waves are transmitted, a membrane disposed between the ultrasonic generating and cavitation sensing module and the medium of the tank to transmit the ultrasonic waves into the medium, tubing that communicates with the tank and provides a fluid passage for injecting microbubbles, a sound-absorbing material that absorbs interference components of the ultrasonic waves generated within the tank, and a signal processing module that converts the cavitation signal generated by the microbubbles into an electrical signal for analysis and evaluates the reproducibility of the cavitation signal based on the analysis results.

[0010] According to one embodiment of the present invention, the microbubbles may be injected directly through the tubing by a user or continuously injected through the tubing by a fluid supply module.

[0011] According to one embodiment of the present invention, the sound-absorbing material may be placed in the path of the ultrasonic waves within the water tank. Accordingly, it can absorb ultrasonic waves formed by reflection or scattering from other structures within the water tank, excluding the cavitation signal generated by the microbubbles.

[0012] According to one embodiment of the present invention, the device may further include an ultrasonic transmission characteristic simulating member disposed on the path of the ultrasonic waves between the ultrasonic wave generating and cavitation sensing module and the tubing, and simulating the transmission characteristics of the ultrasonic waves.

[0013] According to one embodiment of the present invention, the signal processing module can perform frequency analysis on the cavitation signal to extract a preset frequency component. Accordingly, the reproducibility of the cavitation signal can be evaluated based on the extracted frequency component.

[0014] According to one embodiment of the present invention, the preset frequency component may be at least one of a subharmonic component, a harmonic component, and an ultraharmonic component.

[0015] According to one embodiment of the present invention, the signal processing module can calculate variability by analyzing multiple measurement data of the cavitation signal. Accordingly, the reproducibility can be evaluated based on the variability.

[0016] According to one embodiment of the present invention, the method may include the steps of: degassing a tank containing a medium; measuring the dissolved oxygen concentration of the medium; injecting microbubbles through tubing provided in the tank and providing a fluid passage; setting the ultrasonic output level of an ultrasonic generation and cavitation sensing module and generating ultrasonic waves; collecting a cavitation signal generated by the microbubbles and converting it into an electrical signal; and analyzing the electrical signal and evaluating the reproducibility of the cavitation signal based on the analysis results.

[0017] According to one embodiment of the present invention, the step of evaluating the reproducibility may include a step of evaluating that the reproducibility is secured when the magnitude of the electrical signal is greater than or equal to a preset reference value and the variability of the electrical signal is within a predetermined range.

[0018] According to one embodiment of the present invention, the step of analyzing the electrical signal may include the step of performing frequency analysis on the electrical signal to extract a preset frequency component. The preset frequency component may be at least one of a subharmonic component, a harmonic component, and an ultraharmonic component.

[0019] According to one embodiment of the present invention, a computer-readable non-transient recording medium for executing the ultrasonic cavitation signal validation method may be included. Through this configuration, the method can be executed by computer. Effects of the invention

[0020] According to the present invention, since the cavitation signal generated by ultrasound can be quantitatively evaluated through frequency analysis and variability analysis, consistency of signal characteristics can be ensured even when repeated under the same conditions. As a result, signal fluctuations that may occur during the operation of the device are minimized, and the reproducibility of performance is improved, thereby providing reliable analysis results.

[0021] Furthermore, according to the present invention, interference signals within the water tank can be absorbed and specific frequency components can be selectively extracted, thereby effectively reducing the influence of unnecessary noise. This allows for increased analysis accuracy of core cavitation signals, stable verification of device performance, and improved reliability of result interpretation.

[0022] Furthermore, according to the present invention, since reproducibility can be evaluated by simultaneously considering the magnitude and variability criteria of the cavitation signal, an objective and clear judgment is possible from the user's perspective. Consequently, the evaluation process is simplified and efficiency is enhanced, and performance can be stably managed in the actual application environment of the device. Brief explanation of the drawing

[0023] FIG. 1 is a schematic diagram of an ultrasonic cavitation signal validation device according to one embodiment of the present disclosure. FIG. 2 is a drawing illustrating various arrangement structures of sound-absorbing material and tubing according to one embodiment of the present disclosure. FIG. 3 is a schematic diagram of an ultrasonic cavitation signal validation device according to another embodiment of the present disclosure. FIG. 4 is a drawing illustrating the results of a performance evaluation of a sound-absorbing material according to one embodiment of the present disclosure. FIG. 5 is a diagram illustrating the results of an evaluation of cavitation reactivity according to a microbubble injection method according to one embodiment of the present disclosure. FIG. 6 is a diagram illustrating the results of an evaluation of the reproducibility of a cavitation signal according to an ultrasonic output level and repeated experiments according to one embodiment of the present disclosure. FIG. 7 is a flowchart of an ultrasonic cavitation signal validation method according to one embodiment of the present disclosure. Specific details for implementing the invention

[0024] Various embodiments of the present invention will be described in detail below with reference to the accompanying drawings. This is intended to enable those skilled in the art to easily implement the invention, and the present invention is not limited to the embodiments below but can be implemented in various forms.

[0025] To clearly explain the invention, unnecessary parts have been omitted, and the same reference numerals are assigned to identical or similar components throughout the specification. Accordingly, the reference numerals described above may be used identically in other drawings.

[0026] Furthermore, the size or thickness of each component depicted in the drawings is arbitrarily expressed for the convenience of explanation, and thus the present invention is not necessarily limited to the depicted proportions. In particular, the thickness of multiple layers or regions may be exaggerated to aid understanding.

[0027] In the description, the expression "identical" may be used to include the meaning of "substantially identical." That is, it refers to similarity within the scope that a person skilled in the art would accept as identical. Similarly, other expressions in the specification may also imply the meaning of "substantially."

[0028] In addition, where it is stated that a specific component 'includes' another component, this does not exclude the possibility of additional inclusion of other components unless there is a special statement explicitly excluding them.

[0029] As used in this specification, "~part" refers to a unit that performs at least one function or operation, and may be, for example, software, an FPGA, or a hardware component. The function may be performed by being separated into multiple components or by being integrated with other components. Accordingly, "~part" is not limited to software or hardware and may be implemented in an addressable storage medium or configured to execute one or more processors.

[0030] Hereinafter, embodiments of the present invention will be described in detail with reference to the attached drawings.

[0031] FIG. 1 is a schematic diagram of an ultrasonic cavitation signal validation device according to one embodiment of the present disclosure.

[0032] Referring to FIG. 1, the ultrasonic cavitation signal validation device (1) according to the present embodiment may include an ultrasonic generation and cavitation sensing module (10), a water tank (20), a membrane (30), tubing (40), a sound-absorbing material (50), and a signal processing module (60). Each component (10, 20, 30, 40, 50, 60) may be functionally combined to enable the generation of ultrasonic waves, the injection of microbubbles, and the collection and analysis of cavitation signals to be performed continuously and stably.

[0033] Meanwhile, the ultrasonic cavitation signal validation device (1) may have some of the components shown in FIG. 1 omitted or added, which means that various modifications are possible within the scope of the technical concept of the present invention.

[0034] The ultrasonic generation and cavitation sensing module (10) can convert an electrical input into ultrasonic waves that can be transmitted to a medium and emit them. The ultrasonic generation and cavitation sensing module (10) can be driven by including a piezoelectric element and can generate ultrasonic waves of various frequency bands depending on the applied voltage.

[0035] The ultrasonic generation and cavitation sensing module (10) may be placed outside or installed inside the water tank (20), and the generated ultrasonic waves may be transmitted to the medium of the water tank (20) through the membrane (30).

[0036] The ultrasonic generation and cavitation sensing module (10) can be configured to adjust the output intensity and frequency range, and can be controlled to conditions suitable for the purpose of operation according to the user's settings. Accordingly, various cavitation characteristics can be implemented, enabling the collection of a wide range of data for reproducibility evaluation.

[0037] In addition, the ultrasonic generation and cavitation sensing module (10) can be linked with a control circuit to stably maintain the output voltage, current, and frequency within a set range. The control circuit can monitor parameter changes in real time to ensure consistency of conditions during repeated operation.

[0038] The ultrasonic generation and cavitation sensing module (10) may further include a cooling device (not shown) to control heat generated during long-term operation. The cooling device may be implemented as a water-cooled or air-cooled type, thereby suppressing output drift and improving durability and reliability.

[0039] The tank (20) may be a structure that accommodates a medium to ensure stable transmission of ultrasound. The tank (20) may be designed to have a certain volume and internal shape so that the distribution and flow of the medium are maintained uniformly.

[0040] The material of the water tank (20) can be formed from, for example, glass, acrylic, polycarbonate, or a composite thereof, and if a transparent or translucent material is used, the internal condition can be checked with the naked eye.

[0041] The tank (20) can accommodate a degassing-treated medium, and the dissolved oxygen concentration can be measured by a dedicated sensor and maintained within a predetermined range. Through such management, the reproducibility and stability of the cavitation signal can be ensured when operating under the same conditions.

[0042] The water tank (20) can be combined with a membrane (30), tubing (40), and sound-absorbing material (50), and may be provided with a dedicated mounting structure so that each component (30, 40, 50) is securely fixed. For example, a membrane insertion part may be formed on the front, a tubing connection part on the side or top, and a sound-absorbing material mounting part on the bottom.

[0043] Additionally, the water tank (20) may include temperature and pressure control functions to maintain a constant internal environment. For example, the temperature of the medium may be maintained within a set range through a temperature sensor (not shown) and a heater (not shown), and the internal pressure may be controlled through a pressure sensor (not shown) and a valve (not shown). Such control functions can contribute to stably maintaining cavitation reaction conditions.

[0044] The membrane (30) can be positioned between the ultrasonic generating and cavitation sensing module (10) and the tank (20) (e.g., boundary) to substantially minimize ultrasonic transmission loss and distortion. The membrane (30) can be formed from a polymer film, a thin metal film, or a composite material, and its thickness and material characteristics can be optimized to match the frequency band and output conditions.

[0045] The membrane (30) can reduce distortion of the main frequency components transmitted to the medium by suppressing unnecessary reflected waves. Furthermore, the media placed on both sides of the membrane (30), such as the medium inside the membrane (30) and the medium inside the tank (20), can be provided differently from each other.

[0046] By applying different medium conditions as described above, changes in the propagation characteristics of the ultrasonic signal can be detected, and by utilizing this, the performance of the device (1) or whether cavitation occurs can be measured and evaluated more precisely.

[0047] In addition, the membrane (30) can be implemented to be easily replaceable in response to changes in the usage environment or frequency conditions, and can be selectively applied as a polymer film, ceramic thin film, metal-polymer composite, etc.

[0048] The tubing (40) can be connected to the water tank (20) to provide a fluid passage for injecting microbubbles. The tubing (40) can be connected to an external fluid supply module to control the injection pressure, flow rate, and injection speed, allowing for fine adjustment of injection conditions.

[0049] Additionally, the tubing (40) can be implemented with various inner diameters, materials, and shapes, and, for example, can be designed to mimic a three-dimensional blood vessel structure. Through such modifications, flow characteristics similar to those of a real biological environment can be implemented, or differences in cavitation reactions depending on injection conditions can be simulated.

[0050] The tubing (40) can support both manual injection and continuous injection, and may include variations configured with a single path or branch structure for simultaneous injection at multiple locations. Accordingly, a uniform distribution can be formed within the medium to increase the stability of the cavitation reaction.

[0051] The sound-absorbing material (50) is placed on the ultrasonic travel path inside the tank (20) to absorb reflected and scattered waves, thereby reducing unnecessary signal components during the analysis process. As a result, only the cavitation signal generated by microbubbles is selectively transmitted, and noise can be minimized.

[0052] The sound-absorbing material (50) may be composed of a porous material or a polymer composite and can effectively block the reflection and scattering of ultrasound. The installation location and area of ​​the sound-absorbing material (50) may be adjusted according to experimental conditions and may be concentrated in a specific reflection area.

[0053] The sound-absorbing material (50) is manufactured with a replaceable structure, allowing it to be replaced with various materials depending on frequency conditions or medium characteristics. This allows for maintaining optimal sound absorption performance during repeated processes and increasing the utility of the device (1).

[0054] The signal processing module (60) can convert the cavitation signal generated by the microbubble into an electrical signal. The electrical signal can be processed through frequency analysis and variability analysis, and the results can be used to evaluate the reproducibility of the cavitation signal.

[0055] The signal processing module (60) can extract subharmonic, harmonic, and ultraharmonic components through frequency analysis functions. These components can represent the characteristics of the cavitation reaction and the performance of the device (1) can be evaluated.

[0056] The signal processing module (60) may calculate variability by accumulating data from multiple trials. Variability can be compared with a pre-set reference value, and if it is within a certain range, it can be determined that reproducibility is ensured. Through this, consistency can be maintained during the repetition process.

[0057] The signal processing module (60) can evaluate the magnitude and variability of an electrical signal by considering them simultaneously. If the magnitude of the signal is above a standard and the variability is within a predetermined range, it can be determined as a stable cavitation signal. Through this, a clear and objective result can be provided to the user.

[0058] The signal processing module (60) can transmit digitized data through an external storage device or network. The data can be analyzed in real time in conjunction with a software algorithm and can be visually displayed through a user interface (not shown).

[0059] The signal processing module (60) can record long-term data and build a database. This allows tracking of changes in the device's performance and can be utilized for long-term reliability verification and system optimization.

[0060] Meanwhile, the signal processing module (60) can be linked with an artificial intelligence-based analysis algorithm as needed, thereby enabling an automatic judgment function that minimizes user intervention. This automation can increase efficiency and reduce subjective deviations that may occur during the evaluation process.

[0061] FIG. 2 is a drawing illustrating various arrangement structures of sound-absorbing material and tubing according to one embodiment of the present disclosure.

[0062] As shown in FIG. 2, the sound-absorbing material (50) can be placed at a location that does not directly block the main output path through which the ultrasonic waves emitted from the ultrasonic generation and cavitation sensing module (10) are transmitted to the medium of the water tank (20) via the membrane (30).

[0063] This is because when the main propagation path of the ultrasound is maintained smoothly, the microbubbles can stably generate cavitation, and as a result, a consistent signal can be secured. Therefore, the sound-absorbing material (50) can be selectively installed in an area outside the main output path of the ultrasound, that is, at a location where reflected or scattered waves are mainly formed.

[0064] For example, the sound-absorbing material (50) may be installed on the inner wall of the water tank (20), in which case the reflected waves generated when ultrasonic waves reach the side wall can be effectively suppressed. The arrangement of the inner wall may be advantageous when the water tank (20) has a rectangular or cubic structure, and the effect of the reflected waves can be uniformly reduced by symmetrically arranging the sound-absorbing material (50) on the left and right inner sides.

[0065] Additionally, the sound-absorbing material (50) may be installed on the inner bottom of the water tank (20), and the bottom arrangement may be effective in suppressing the reflection component that is strongly formed, especially when driving low-frequency ultrasonic waves.

[0066] Furthermore, the sound-absorbing material (50) may be placed on the inner rear side of the water tank (20), which may be useful for suppressing the phenomenon where ultrasonic waves passing through the membrane (30) reach the rear wall and are reflected. Rear placement is effective in reducing interference waves that occur at a position directly facing the main output axis of the ultrasonic waves.

[0067] Depending on the installation location and shape of the tubing (40), the arrangement of the sound-absorbing material (50) may also vary.

[0068] The tubing (40) performs the function of injecting microbubbles, but the ultrasound may be scattered or partially reflected by the surface of the tubing (40).

[0069] In this case, the sound-absorbing material (50) may be selectively placed around the tubing (40) to absorb unnecessary interference components originating from the tubing (40). For example, when the tubing (40) is inserted through the top of the water tank (20), the sound-absorbing material (50) may be placed near the tubing (40) or on the side wall to effectively suppress scattering components.

[0070] However, since the microbubbles injected from the tubing (40) must be distributed along the main path of the ultrasound, the sound-absorbing material (50) can be placed in a position that does not directly block the microbubble injection area.

[0071] That is, the installation position of the tubing (40) can be varied according to the characteristics of the ultrasound emitted from the ultrasound generation and cavitation sensing module (10). For example, the tubing (40) can be positioned at a location where the ultrasound output is maximized or focused, in which case the microbubbles can interact directly with the ultrasound to induce a cavitation reaction more efficiently.

[0072] This arrangement is advantageous for increasing the cavitation signal strength and ensuring uniformity of the cavitation response, and furthermore, can improve the quality of the data input to the signal processing module (60).

[0073] The shape of the sound-absorbing material (50) can be implemented in various forms, such as plate-shaped, block-shaped, or curved shapes. A plate-shaped structure can be installed in close contact with the wall of the water tank (20), and a block-shaped structure can be concentrated in a specific area to suppress local reflection.

[0074] A curved structure can be advantageous for controlling scattered waves that spread out in a curved shape or at specific points where reflected waves gather. In some cases, the sound-absorbing material (50) may be formed into a multilayer structure to have different absorption bands, and may be effective against low-frequency and high-frequency ultrasound simultaneously.

[0075] The area and arrangement ratio of the sound-absorbing material (50) may vary depending on environmental conditions.

[0076] For example, when using high-output ultrasound, a strong reflection component is formed, so a large proportion of the internal area of ​​the tank (20) can be covered with sound-absorbing material (50). Conversely, under low-output conditions, it may be sufficient to place only a minimal area.

[0077] In addition, the sound-absorbing material (50) may be concentrated in a specific area or distributed throughout the entire tank (20), and may be implemented as a replaceable structure as needed to respond to changes in conditions.

[0078] The arrangement of the tubing (40) can have a single path or a multiple branch structure, and accordingly, the arrangement method of the sound-absorbing material (50) can also be different.

[0079] For example, when multiple tubings (40) inject microbubbles at different locations, scattered waves can be controlled by placing sound-absorbing material (50) locally around each tubing (40). On the other hand, when only a single tubing (40) is used, it may be effective to place sound-absorbing material (50) on the wall or floor opposite the tubing (40).

[0080] Through such various arrangement structures, the sound-absorbing material (50) can effectively absorb unnecessary reflected and scattered waves without obstructing the main propagation path of the ultrasound. This increases the purity of the cavitation signal and improves the reliability of the data input to the signal processing module (60), thereby enabling a more stable reproducibility evaluation.

[0081] FIG. 3 is a schematic diagram of an ultrasonic cavitation signal validation device according to another embodiment of the present disclosure.

[0082] The device (1) of the present disclosure has a basic structure comprising the components of FIG. 1, namely, an ultrasonic generation and cavitation sensing module (10), a water tank (20), a membrane (30), tubing (40), a sound-absorbing material (50), and a signal processing module (60), and may additionally include an ultrasonic transmission characteristic simulation member (70).

[0083] An ultrasonic transmission characteristic simulation member (70) is placed on the ultrasonic travel path between the ultrasonic generation and cavitation sensing module (10) and the tubing (40) to induce changes in transmission characteristics such as ultrasonic intensity attenuation, phase delay, refraction, and multiple scattering at a stage prior to the ultrasonics interacting with microbubbles in the tubing (40).

[0084] The ultrasonic transmission characteristic mock member (70) can be designed to implement acoustic impedance and transmission loss characteristics similar to a skull and can be composed of various materials such as composite polymers, ceramic-polymer composites, structures containing porous fillers, and synthetic hard tissue materials.

[0085] In addition, it may be implemented as a multilayer structure (e.g., high-attenuation layer / intermediate impedance layer / surface protection layer) as needed, or reflection and scattering characteristics may be controlled by forming an acoustic coupling layer or micro-pattern on the surface.

[0086] Even in this embodiment, the tubing (40) can be positioned so as to be aligned with the location where the ultrasonic output is maximized or focused. That is, the injection location of the tubing (40) is designed so that the maximum acoustic intensity region formed within the tank (20) by the ultrasonic waves passing through the ultrasonic transmission characteristic mock member (70) coincides with the injection location of the tubing (40), thereby causing the injected microbubbles to be distributed along the region where the ultrasonic output is maximized or focused. When aligned in this way, the microbubbles can interact directly with the ultrasonic waves to induce a more stable and consistent cavitation reaction.

[0087] The position of the tubing (40) can be adjusted based on various arrangement embodiments described in FIG. 2, and the reproducibility of experimental conditions can be ensured by repeatedly implementing such arrangements identically. As a result, the variability of the collected cavitation signal is reduced, and the reliability of the data transmitted to the signal processing module (60) can be further improved.

[0088] In other words, the reproducibility and analytical reliability of cavitation signals are improved, and furthermore, it can be usefully applied to the preliminary evaluation and verification of various medical applications, such as ultrasound control, drug delivery, and blood-brain barrier opening.

[0089] FIG. 4 is a drawing illustrating the results of a performance evaluation of a sound-absorbing material according to one embodiment of the present disclosure.

[0090] FIGS. 4a and FIGS. 4b show the experimental results performed to evaluate the performance of a sound-absorbing material (50) according to one embodiment of the present invention.

[0091] Specifically, FIG. 4a illustrates a case where an ultrasonic signal is measured when the sound-absorbing material (50) is not installed inside the water tank (20), and FIG. 4b illustrates a case where the signal is measured under the same conditions when the sound-absorbing material (50) is placed directly on the main path of the ultrasonic waves.

[0092] The two drawings are configured to allow comparison of how the propagation characteristics of the ultrasonic signal differ depending on whether the sound-absorbing material (50) is installed and the placement location under the same experimental conditions.

[0093] As illustrated in FIGS. 4a and 4b, the ultrasonic generation and cavitation sensing module (10) according to the present invention may include a transmitter (T:101), a receiver (R:102), and a pulser / receiver (103), and the signal processing module (60) may include an RF OUT (104), a Trig (105), a CH1 (106), a CH2 (107), an oscilloscope (108), etc.

[0094] The hydrophone (109) functions as an independent sensor that directly receives ultrasonic waves transmitted to the medium inside the tank (20) and converts them into electrical signals.

[0095] The ultrasonic generation and cavitation sensing module (10) generates ultrasonic waves through the transmitter (T:101) according to the driving signal of the Pulser / Receiver (103), and the generated ultrasonic waves are transmitted to the water tank (20) through the membrane (30).

[0096] The signal passing through the medium is converted into an electrical signal by the hydrophone (109), input to the Pulser / Receiver (103) via the receiver (R:102), and then transmitted to the oscilloscope (108) via Trig (105) and CH2 (107).

[0097] The oscilloscope (108) can visually display the waveform of the input signal and simultaneously measure quantitative characteristics such as peak-to-peak voltage, signal amplitude change, and time delay.

[0098] In the case of FIG. 4a, an ultrasonic signal was measured without the sound-absorbing material (50) installed. In this case, the ultrasonic waves propagate along the medium of the water tank (20) without significant loss and reach the hydrophone (109).

[0099] Therefore, the detected signal may include not only the direct wave but also reflected or scattered waves caused by the walls of the tank (20), tubing (40), and the heterogeneity of the medium. As a result of the experiment, the peak-to-peak voltage measured at this time was found to be approximately 565.1 mV.

[0100] This indicates that the ultrasound was transmitted without attenuation, while also meaning that it includes unnecessary reflection and interference components.

[0101] On the other hand, FIG. 4b shows a case where the sound-absorbing material (50) is placed directly on the main path of the ultrasound.

[0102] Ultrasound generated under the same conditions passes through the membrane (30), enters the water tank (20), and then reaches the sound-absorbing material (50). Since the sound-absorbing material (50) is composed of a porous material and effectively absorbs ultrasonic energy, the signal component reaching the hydrophone (109) can be significantly reduced.

[0103] As a result of the experiment, the peak-to-peak voltage measured at the hydrophone (109) was found to be about 17.1 mV, which is about 30 dB (about 30.38 dB) lower than that of FIG. 4a. These results demonstrate that the sound-absorbing material (50) not only suppresses reflected waves but can also strongly absorb ultrasonic energy along the main path.

[0104] In particular, the result of FIG. 4b indicates that even when the sound-absorbing material (50) is installed in the main path, it is possible to minimize ultrasonic leakage and remove unnecessary components reaching the hydrophone (109). That is, the sound-absorbing material (50) can be considered an essential component for improving signal purity and ensuring the reliability of analysis, going beyond being an auxiliary element for suppressing interference waves.

[0105] Therefore, the comparative experiment of FIG. 4a and FIG. 4b clearly shows that the sound-absorbing material (50) according to one embodiment of the present invention plays a key role in ensuring the performance and reliability of the ultrasonic cavitation signal validation device (1).

[0106] In other words, the sound-absorbing material (50) enables precise analysis of the cavitation signal and ensures consistent signal characteristics even in experiments repeated under the same conditions, thereby enabling a highly reproducible evaluation.

[0107] FIG. 5 is a diagram illustrating the results of an evaluation of cavitation reactivity according to a microbubble injection method according to one embodiment of the present disclosure.

[0108] FIG. 5a is a diagram illustrating a microbubble injection method according to an embodiment of the present invention. In order to quantitatively and reproducibly secure ultrasonic cavitation signals, the present invention may include various methods of injecting microbubbles into a water tank (20), and representative examples include a quantitative injection method using a syringe pump and a manual filling method.

[0109] The upper drawing of FIG. 5a illustrates a method of injecting microbubbles into tubing (40) using a syringe pump.

[0110] This method allows for precise control of micro-flow rates and pressures based on the syringe pump's control signal, making it advantageous for repeatedly implementing constant injection conditions.

[0111] Particularly when repeatability is required, the ability to reliably reproduce identical injection rates and pressure conditions minimizes variability in ultrasonic cavitation signals. Furthermore, since the injection volume of microbubbles can be controlled down to the microscopic level, it can be effective for inducing cavitation reactions under specific concentration conditions or evaluating reactivity at specific critical energy levels.

[0112] However, since this method necessarily requires external devices (e.g., syringe pumps), it is difficult to apply in the same way in clinical trials or actual medical environments. In particular, additional issues such as limitations on installation space, equipment purchase costs, and maintenance hassles may arise.

[0113] In contrast, the lower drawing of FIG. 5a illustrates a manual filling method.

[0114] The manual filling method is a method in which a user directly fills the inside of the tubing (40) with microbubbles using an injector without using a separate driving device, and then inserts it into the water tank (20).

[0115] This method has the advantage of minimizing equipment dependency and allowing the same experiment to be performed with only a simple configuration. In particular, in clinical application environments, it is often difficult to keep expensive syringe pumps readily available; therefore, the manual filling method according to the present invention can function as a practical alternative to overcome such limitations.

[0116] In addition, when microbubbles are filled inside the tubing (40), ultrasound emitted from the ultrasound generation and cavitation sensing module (10) passes through the membrane (30) and through the medium of the water tank (20) to interact with the microbubbles inside the tubing (40), thereby inducing a local cavitation reaction. At this time, experiments can be performed repeatedly under the same measurement conditions, and consequently, it is advantageous for quantitatively analyzing the variability of the signal.

[0117] In common with the upper and lower drawings of FIG. 5a, the hydrophone (109) can convert an ultrasonic cavitation signal generated inside the water tank (20) into an electrical signal and transmit it to the signal processing module (60).

[0118] The signal processing module (60) can quantitatively evaluate cavitation responsiveness by performing frequency analysis on the input signal, extracting harmonic, subharmonic, and ultraharmonic components, and calculating signal variability.

[0119] For example, when using a syringe pump, the standard deviation of the signal may appear small because the infusion conditions are maintained stably, whereas in the case of a manual filling method, the variance of the signal magnitude may increase depending on variations in the infusion volume; however, this can be useful for verifying device performance in an actual clinical setting.

[0120] Therefore, the present invention includes both a quantitative injection method using a syringe pump and a manual filling method. The former can ensure consistency and precision during the research and performance verification process, while the latter can maintain signal reproducibility while overcoming equipment limitations in actual application environments.

[0121] By implementing both methods in this way, the ultrasonic cavitation signal validation device (1) according to the present invention can be operated stably regardless of the environment, and as a result, the reliability of signal analysis can be maximized.

[0122] FIG. 5b is a diagram illustrating the results of an evaluation of cavitation reactivity according to a microbubble (MB) injection method according to one embodiment of the present invention.

[0123] This drawing shows the results obtained by comparing the Saline-only condition and the Microbubble injection condition, respectively, under the same experimental environment and injection conditions using an ultrasonic cavitation signal validation device (1) to clearly demonstrate the effect of the presence of microbubbles on cavitation reactivity.

[0124] First, the upper graph of Fig. 5b illustrates the frequency response spectrum under conditions of Saline alone. Here, Saline is generally defined as a 0.9% aqueous sodium chloride solution, i.e., physiological saline, and is an isothermal solution having the same osmotic pressure as human body fluids.

[0125] In this embodiment, the inside of the tubing (40) is filled only with Saline to create a state in which no microbubbles exist at all. This Saline-only condition has significant meaning as a reference signal, i.e., baseline reference data, indicating a case where ultrasound propagates only through the medium without a non-linear reaction caused by bubbles.

[0126] It can be confirmed that the frequency response measured under Saline-only conditions mainly detects the fundamental frequency component generated from the ultrasonic generation and cavitation sensing module (10), and that non-linear components such as harmonic, subharmonic, and ultraharmonic components are hardly present.

[0127] This shows that the ultrasound was transmitted along a purely linear path within the tank (20), and at the same time provides an important comparison point for verifying background noise and reference signal levels during the signal analysis process of the present invention.

[0128] In other words, the saline-only condition functions as a control group to determine whether specific reactions caused by microbubbles occur. With this baseline data secured, it can be definitively verified that all nonlinear components detected in subsequent experiments are attributed to the presence of microbubbles.

[0129] On the other hand, the lower graph of Fig. 5b shows the frequency response spectrum when microbubbles are injected under the same conditions.

[0130] In this embodiment, the microbubble concentration was maintained at, for example, about 25%, and the flow rate was set at, for example, about 2.1 mL / min, and supplied continuously to the water tank (20) through the tubing (40).

[0131] Under these conditions, ultrasound emitted from the ultrasound generation and cavitation sensing module (10) passes through the membrane (30) to reach the tubing (40) and interacts with the injected microbubbles. As the microbubbles receive ultrasonic stimulation, they vibrate by repeatedly compressing and expanding, and above certain sound pressure conditions, they generate strong nonlinear resonance and collapse phenomena.

[0132] As a result of this nonlinear reaction, under microbubble injection conditions, distinct harmonic, subharmonic, and ultraharmonic components are formed in addition to the fundamental frequency component.

[0133] In fact, in the lower graph of Fig. 5b, clear peaks are observed in the bands of multiples of the fundamental frequency, such as 250 kHz, 500 kHz, 750 kHz, and 1000 kHz, which indicates that this is a specific response caused by the nonlinear vibration of microbubbles. Furthermore, it is proven that this signal is not merely noise, but a unique spectrum generated by microbubbles responding to ultrasonic energy.

[0134] Therefore, the frequency response under microbubble injection conditions exhibits a pattern significantly distinct from that under saline-only conditions. This experimentally proves that microbubbles are the key medium for the cavitation phenomenon.

[0135] Furthermore, through comparison with a reference signal obtained under Saline-only conditions, it can be clearly confirmed that the nonlinear component occurring under MB conditions is not attributed to medium characteristics or system noise, but is solely a reaction caused by microbubbles.

[0136] The result of FIG. 5b presented in the present invention provides various important technical effects.

[0137] First, the saline-only condition provides a baseline for quantitatively defining the background signal, thereby establishing an objective point of comparison for all subsequent data analysis. Second, the microbubble injection condition can play a decisive role in verifying microbubble reactivity by clearly demonstrating the harmonic and nonlinear components expected in the ultrasonic cavitation signal. Third, signal reproducibility can be ensured through repeated comparisons between the saline condition and the microbubble injection condition, which supports the stable application of the device according to the present invention in various environments.

[0138] In conclusion, FIG. 5b experimentally demonstrates that the ultrasonic cavitation signal validation device (1) proposed in the present invention goes beyond simply collecting signals and quantitatively determines the reactivity based on the presence or absence of microbubbles, thereby providing a core technical basis for maximizing the reliability and objectivity of signal analysis.

[0139] In particular, saline-only conditions are essential for securing the device's baseline signal, while microbubble injection conditions serve as key evidence in demonstrating cavitation reactivity.

[0140] FIGS. 5C and FIGS. 5D are drawings illustrating the results of evaluating cavitation reactivity under microbubble (MB) injection conditions according to one embodiment of the present invention.

[0141] Specifically, FIGS. 5C and 5D show frequency response spectra measured by applying ultrasound for 10 seconds under fixed output levels (400 Level and 800 Level) while microbubbles are contained in tubing (40). This experiment was performed to verify how the responsiveness of microbubbles changes over time when they are exposed to ultrasonic stimulation for a certain period of time.

[0142] The graph in FIG. 5c shows the result of measuring the cavitation signal for about 10 seconds with the output level set to 400 Level while the microbubbles are filled into the tubing (40).

[0143] During the initial approximately 3 seconds after sonication began, harmonic and subharmonic components were clearly observed, but as time passed, a phenomenon was confirmed in which the signal intensity decreased rapidly. This is interpreted as a result of the microbubbles failing to continuously maintain cavitation responsiveness as they rapidly collapsed or diffused into the surrounding medium due to ultrasonic stimulation.

[0144] In other words, a limitation was revealed in that it is difficult to maintain stable cavitation even if initial reactivity appears under conditions where the effective concentration of microbubbles decreases rapidly.

[0145] The graph in Fig. 5d illustrates the case where the output level is increased to 800 levels in the same environment.

[0146] At this time, the nonlinear spectral components observed during the initial approximately 3 seconds appeared relatively stronger than under the 400 Level condition, and several distinct peaks were formed in the band of multiples of the fundamental frequency.

[0147] However, similarly, after 3 seconds, the signal strength decreased significantly due to the rapid disappearance of microbubbles, and by the time 10 seconds were reached, the initial responsiveness had almost disappeared. This means that under high power conditions, the collapse of microbubbles accelerates, making it difficult to secure stable responsiveness for a long time.

[0148] The results of FIGS. 5c and 5d experimentally demonstrate that under conditions where microbubbles are simply kept in a stationary state within the tubing (40), the distribution of microbubbles changes very rapidly, making it difficult to maintain cavitation reactivity for a long time.

[0149] In other words, microbubbles are continuously collapsed or lose their aggregate structure due to ultrasonic stimulation, which makes it difficult to sustain acoustic cavitation (AC) responsiveness for more than a certain period of time.

[0150] Therefore, in the present invention, rather than keeping the microbubbles in a stationary state within the tubing (40), it is essential to have a technical configuration that maintains a constant concentration of microbubbles through a continuous injection method using a syringe pump or a manual injection method that allows the user to repeatedly replenish them.

[0151] In particular, the results observed in FIGS. 5c and 5d provide important design grounds for the present invention. First, under microbubble loading conditions, even if initial reactivity is secured, signal persistence is significantly degraded, making it difficult to ensure reliability in device performance evaluation. Second, compared to continuous injection conditions, the loading condition is disadvantageous for obtaining reproducible data because the rate of microbubble loss is excessively fast. Third, these results support the necessity of considering various microbubble injection methods proposed in the present invention, and strongly suggest the need for an injection method capable of stably maintaining a cavitation reaction, particularly in clinical application environments.

[0152] Accordingly, FIGS. 5C and 5D show that the ultrasonic cavitation signal validation device (1) of the present invention can go beyond simple signal collection and quantitatively analyze differences in reactivity according to microbubble injection and maintenance conditions.

[0153] This can be considered a result that empirically proves that the technical means proposed by the present invention can secure a stable and consistent cavitation response not only in a laboratory environment but also in an actual clinical environment.

[0154] FIG. 6 is a diagram illustrating the results of an evaluation of the reproducibility of a cavitation signal according to an ultrasonic output level and repeated experiments according to one embodiment of the present disclosure.

[0155] FIG. 6a is a diagram showing the results of four independent experiments performed repeatedly under conditions where the ultrasonic output level was set to 400 using an ultrasonic cavitation signal validation device (1) according to one embodiment of the present invention.

[0156] This drawing serves as important data for verifying reliability and reproducibility, given that each experiment was conducted independently despite the results being performed under the same device configuration, experimental protocol, and environmental conditions.

[0157] The four graphs are each classified as #1, #2, #3, and #4, and the frequency response spectrum shown in each graph is the result of analysis by the signal processing module (60) based on the collected signal after the ultrasound emitted from the ultrasound generation and cavitation sensing module (10) interacts with the microbubbles (MB) distributed inside the tubing (40).

[0158] A common feature observed in all graphs of Fig. 6a is that the fundamental frequency component is clearly detected.

[0159] A strong peak appears around 250 kHz, which means that the signal output from the ultrasonic generation and cavitation sensing module (10) is transmitted to the medium without loss and measured stably. Such consistent detection of the fundamental frequency component is fundamental evidence showing that the device (1) according to the present invention can stably control the output conditions.

[0160] However, a more important aspect of the present invention is whether non-linear components, rather than basic components, are detected, and in this regard, Fig. 6a shows the same trend in all four independent experiments.

[0161] In other words, clear harmonic components were detected in the integer multiples of the fundamental frequency in all experimental results, which experimentally proves that microbubbles generated nonlinear vibrations in response to ultrasonic stimulation.

[0162] For example, distinct peaks observed in the 500 kHz, 750 kHz, and 1000 kHz bands show that microbubbles induced nonlinear acoustic phenomena rather than simple linear propagation through repetitive compression and expansion.

[0163] In addition, subharmonic components were observed in each graph at approximately 125 kHz, which is half the fundamental frequency. This is a phenomenon that is characteristic when the stability of the cavitation reaction is ensured, and it strongly proves that the interaction between ultrasound and microbubbles is not due to simple scattering or noise.

[0164] In addition, ultraharmonic components were identified in regions such as 375 kHz and 625 kHz, indicating that microbubbles are forming complex vibration modes beyond linear responses.

[0165] These results are clearly distinguishable from conventional simple scattering signals that respond only in a single frequency range, and demonstrate that the device (1) according to the present invention has the performance essential for quantitatively verifying cavitation reactivity.

[0166] Of particular note is the fact that although all four experiments were conducted independently, harmonic, subharmonic, and ultraharmonic components were detected in all of them.

[0167] This means that while minute differences in signal intensity may occur depending on the instantaneous distribution or local concentration of microbubbles in the experimental environment, or the injection route, the intrinsic characteristics of the cavitation reaction remain unchanged and appear reproducibly.

[0168] In other words, the fact that non-linear components are always clearly detected when microbubbles are present, and that the pattern does not change even when the experiment is repeated, strongly supports the technical reliability provided by the present invention.

[0169] In addition, the results of Fig. 6a are significant in that they go beyond simply proving the reproducibility of the experiment and provide a criterion for distinguishing between noise and the actual response in the analysis of ultrasonic cavitation signals.

[0170] The consistent peaks appearing in the fundamental frequency component and its multiple bands clearly prove that the signal is due to a microbubble reaction, and the repeated observation of the same pattern allows for the exclusion of the influence of accidental noise that may occur during the analysis process.

[0171] This means that it can be said that the signal processing module (60) according to the present invention has been experimentally verified to be able to produce stable and reliable results even in various environments.

[0172] In conclusion, Figure 6a shows that harmonic, subharmonic, and ultraharmonic components were clearly observed in all four independent experiments conducted under conditions of an ultrasonic output level of 400, thereby empirically proving that the microbubble-based cavitation reaction is a specific and reproducible phenomenon.

[0173] Furthermore, these results indicate that the ultrasonic cavitation signal validation device (1) according to the present invention can provide consistent data despite the repetition of experimental conditions, thereby maximizing the reliability of signal analysis and technical effects.

[0174] FIG. 6b is a diagram showing the results of four independent experiments performed repeatedly under conditions where the ultrasonic output level was set to 800 using an ultrasonic cavitation signal validation device (1) according to one embodiment of the present invention.

[0175] This figure is the result of a study conducted by increasing only the output level while maintaining the same device configuration, the same environmental conditions, and the same experimental protocol as the 400 level condition presented in Figure 6a, and clearly verifies the difference in cavitation reactivity according to changes in output intensity.

[0176] The four graphs are classified as #1, #2, #3, and #4, respectively, and common characteristics and trends are confirmed despite all experiments being conducted independently.

[0177] A common feature in all graphs of Fig. 6b is that a very distinct and strong peak is detected in the fundamental frequency band of about 250 kHz.

[0178] This means that the signal output from the ultrasonic generation and cavitation sensing module (10) is stably transmitted through the medium without loss, and at the same time, the device (1) according to the present invention has secured technical reliability that enables it to stably generate and transmit signals even under high-output conditions.

[0179] However, in Fig. 6b, the clarity and intensity of the nonlinear component observed in the region other than the fundamental frequency are more pronounced compared to Fig. 6a.

[0180] As the output level increases from 400 to 800, the microbubbles (MB) respond more vigorously to ultrasonic stimulation, and as a result, harmonic, subharmonic, and ultraharmonic components become more distinct.

[0181] In fact, very distinct peaks were formed in each graph at integer multiples of the fundamental frequency, such as 500 kHz, 750 kHz, 1000 kHz, and 1250 kHz, which is characteristic of the typical nonlinear response generated by microbubbles through repeated expansion and contraction.

[0182] In addition, at around 125 kHz, a subharmonic component corresponding to half the fundamental frequency was consistently detected, which means that the microbubbles have reached a stable resonance state and that this is an intrinsic cavitation reaction that cannot be explained by simple scattering or noise.

[0183] In addition, ultra-harmonic components were identified in fractional multiple bands such as 375 kHz, 625 kHz, and 875 kHz, which shows that microbubbles form more complex vibration modes as the output intensity increases.

[0184] These results experimentally demonstrate that, beyond a mere increase in signal intensity, the spectral diversity of the cavitation response expands along with the rise in output level.

[0185] In other words, as the output intensity increases, the microbubbles do not remain in a simple primary reaction but cause a complex reaction accompanied by various frequency components, which shows that the device (1) proposed in the present invention can quantitatively detect and interpret such changes.

[0186] In particular, despite the fact that all four experiments were conducted independently, not only the fundamental frequency but also harmonic, subharmonic, and ultraharmonic components were consistently detected. This implies that while there may be some variation in the intensity of individual peaks depending on the instantaneous distribution of microbubbles or differences in local concentrations in the experimental environment, the essential characteristics of the reaction remain unchanged and appear reproducibly.

[0187] In other words, the technical reliability provided by the present invention is supported by the fact that even under conditions where the output level is set to 800, the cavitation reaction is always accompanied by a distinct non-linear component, and this pattern is consistently observed even through repeated experiments.

[0188] In conclusion, Figure 6b clearly shows harmonic, subharmonic, and ultraharmonic components in repeated experiments performed under conditions where the output level was set to 800, which experimentally proves that the microbubble-based cavitation reaction is a stable and reproducible phenomenon even under high-output conditions.

[0189] Furthermore, the ultrasonic cavitation signal validation device (1) according to the present invention demonstrates that it can provide consistent data despite changes in output conditions, thereby presenting an important basis for maximizing the reliability and technical effect of cavitation signal analysis.

[0190] FIG. 6c is a diagram showing the results of statistically analyzing repeated experimental data performed under conditions where the ultrasonic output level is set to 400 using an ultrasonic cavitation signal validation device (1) according to one embodiment of the present invention.

[0191] Based on the four independent experiments presented in Fig. 6a, the mean and standard deviation were calculated by performing a total of 40 repeated measurements under each experimental condition, and furthermore, the results of the analysis by integrating the entire data set of 160 times (n=160) were presented, thereby verifying the reproducibility and reliability of the experiment from various angles.

[0192] First, looking at the average and standard deviation results for each experiment, it can be seen that the frequency response, confirmed in the form of individual graphs in Figure 6a, is not a simple one-time phenomenon but is maintained statistically consistently through repeated experiments. For each experiment, the fundamental frequency component showed the highest average value in the band of approximately 250 kHz, and the standard deviation was also maintained at an extremely low level.

[0193] This means that the signal output from the ultrasonic generation and cavitation sensing module (10) is stably transmitted through the medium without loss, so that the basic component is always detected at a constant level. These results empirically support the fact that the device (1) according to the present invention can ensure the stability of signal generation under the same conditions.

[0194] In addition, in each experiment, harmonic components were repeatedly detected in the bands of integer multiples of the fundamental frequency, such as 500 kHz, 750 kHz, and 1000 kHz, and subharmonic and ultraharmonic components also appeared in some frequency ranges.

[0195] In particular, the average value of the harmonic component was clearly observed in all four experiments, and the fact that the standard deviation was not excessively large confirms that microbubbles (MB) exhibit a constant non-linear response to ultrasonic stimulation.

[0196] This statistically proves that the nonlinear pattern intuitively identified through the individual graphs in Fig. 6a is not simple noise but a characteristic that is reproducible even in repeated measurements.

[0197] In particular, the results of integrating the entire data (n=160) further clearly demonstrate the technical effects of the present invention. Based on the overall average value, the fundamental frequency component around 250 kHz maintained the highest signal strength, and distinct peaks were detected on average in the harmonic bands of 500 kHz, 750 kHz, and 1000 kHz.

[0198] At the same time, the magnitude of the standard deviation observed in each frequency band remained within a relatively limited range, which implies that the reactivity of microbubbles is not dependent on minute differences in experimental conditions and is inherently stable and reproducible.

[0199] In addition, at around 125 kHz, a subharmonic component corresponding to half the fundamental frequency consistently appeared, which serves as an indicator that the microbubble has reached a critical point of a stable resonance state.

[0200] In addition, ultra-harmonic components were detected in non-integer multiple bands such as 375 kHz, 625 kHz, and 875 kHz, which statistically proves that microbubbles form vibrations of complex modes beyond simple linear vibrations.

[0201] The co-detection of these various frequency components demonstrates that the device (1) of the present invention can go beyond the level of recording simple energy transfer phenomena and can precisely capture the characteristics of the actual cavitation reaction.

[0202] Figure 6a showed that the fundamental component and non-linear component were repeatedly observed in four individual experiments, and Figure 6c further objectively verified this through statistical verification.

[0203] In other words, it clearly demonstrated that the harmonic, subharmonic, and ultraharmonic components observed in individual experiments are not due to chance or local conditions, but are universal phenomena that are always reproducible when repeated experiments are performed under identical output conditions.

[0204] Accordingly, it is experimentally proven that the ultrasonic cavitation signal validation device (1) according to the present invention can provide consistent results even with repetitive and large amounts of data, going beyond simply stably generating and measuring a signal under an output level of 400. This means that it is a key foundation for maximizing the technical effects provided by the present invention, namely the reproducibility and reliability of the cavitation response signal.

[0205] FIG. 6d is a diagram showing the results of statistically analyzing repeated experimental data performed under conditions where the ultrasonic output level is set to 800 using an ultrasonic cavitation signal validation device (1) according to one embodiment of the present invention.

[0206] This figure is based on the independent experimental data presented in Figure 6b, and involves performing repeated measurements 40 times under each experimental condition and calculating the mean and standard deviation, and further includes the results of integrating and analyzing the total data of 160 times (n=160).

[0207] This drawing goes beyond merely verifying individual experimental results and can serve as important supporting data for quantitatively proving the reproducibility and reliability of cavitation reactions under high-power conditions by statistically processing large-scale repeated data.

[0208] If we look specifically at the average and standard deviation results, we can see that the frequency response pattern visually observed in Fig. 6b is not due to a simple transient phenomenon or deviations in the individual experimental environment.

[0209] The fundamental frequency component in the 250 kHz band formed the most distinct peak in all experiments, and the average value was consistently high while the standard deviation remained within an extremely limited range.

[0210] This means that the signal output from the ultrasonic generation and cavitation sensing module (10) is stably transmitted through the medium without loss, and also means that the device (1) of the present invention can consistently control output parameters even under high-output conditions.

[0211] In addition, harmonic components were clearly detected on average at 500 kHz, 750 kHz, and 1000 kHz, which are integer multiples of the fundamental frequency, and their magnitude increased overall compared to the 400 level condition in Fig. 6c. This means that the increase in output intensity acts as a direct factor in strengthening the nonlinear vibration response of microbubbles (MB).

[0212] In particular, the fact that the standard deviation of each harmonic component did not become excessively large and maintained a limited level supports the fact that the reactivity of the microbubbles is essentially reproducible without unstable fluctuations even when the output intensity increases. In other words, the device (1) according to the present invention can function as a stable verification platform capable of ensuring signal consistency and repeatability despite changes in output conditions.

[0213] When analyzed in more detail by frequency band, a subharmonic component corresponding to half the fundamental frequency is consistently observed on average in all four experiments around 125 kHz.

[0214] Subharmonics are a characteristic indicator that generally appears when microbubbles reach a stable resonance state, which statistically proves that the cavitation response of microbubbles is an inherent physical phenomenon rather than unstable scattering or noise, even when the output level is raised to 800.

[0215] In addition, ultraharmonic components were detected in non-integer multiple bands such as 375 kHz, 625 kHz, and 875 kHz, which indicates that microbubbles form higher-order and complex vibration modes beyond simple linear vibrations. These ultraharmonic components became more pronounced as the output intensity increased, which is a clearly enhanced feature compared to Fig. 6c.

[0216] The results of the integrated analysis of the entire dataset (n=160) support the technical reliability of the present invention. According to the overall average values, the fundamental frequency component is observed to have the highest intensity, and the harmonic component also consistently maintains a high average value.

[0217] At the same time, the fact that the standard deviation of each component remains within a limited range implies that the intrinsic characteristics of the microbubble reaction do not significantly depend on local environmental differences or the number of repetitions.

[0218] In other words, the device (1) according to the present invention can ensure statistical consistency of the cavitation reaction even under high power conditions, which means that it can be used as a stable verification tool in various experimental environments.

[0219] Comparing Fig. 6c and Fig. 6d, significant differences due to differences in output levels are clearly evident. In Fig. 6c (output level 400), the fundamental frequency and harmonic, subharmonic, and ultra-harmonic components are repeatedly observed and reproducible, but their intensity is relatively limited.

[0220] On the other hand, at Fig. 6d (output level 800), the same pattern is maintained while the signal strength increases overall, and the detection frequency and average value of the ultra-harmonic component increase more distinctly.

[0221] This experimentally proves that an increase in output intensity does not merely amplify the signal size, but rather expands the vibration modes of microbubbles to induce responses across a wider range of frequency bands.

[0222] Accordingly, FIG. 6d clearly indicates that the ultrasonic cavitation signal validation device (1) according to the present invention can provide consistent and reproducible data despite changes in output conditions, and can also be utilized as a tool to quantitatively evaluate the intensity and spectral diversity of the microbubble reaction through the control of output intensity.

[0223] Furthermore, these results empirically support the fact that the device of the present invention goes beyond a simple signal detection device to systematically characterize the properties of cavitation reactions and provides a core technical foundation that can be applied to various medical and industrial applications.

[0224] FIG. 6e is a diagram showing the results of setting a frequency band to finally determine the ACV conditions based on data established by repeated experiments and statistical analysis using an ultrasonic cavitation signal validation device (1) according to one embodiment of the present invention.

[0225] The term 'ACV (Acoustic Cavitation Validation) condition' as used in this specification refers to a case where, through repeated experiments and statistical analysis, the cavitation response signal in a specific frequency band satisfies the average value and standard deviation criteria and is consistently maintained, for example, within a range of ±5 dB.

[0226] In other words, the ACV condition is established when at least one non-linear component among harmonics, subharmonics, and ultraharmonics simultaneously satisfies a sufficient signal-to-noise ratio and limited variability. The results in Figures 6c and 6d above provide the data basis for establishing such an ACV condition.

[0227] This drawing reflects the results of a comprehensive analysis of data from repeated experiments (n=160) under 400 level and 800 level conditions presented in Figures 6c and 6d, and defines a frequency range that can be used for actual cavitation verification by selecting a frequency band that satisfies statistical criteria for signal strength and reproducibility.

[0228] Specifically, in the present invention, a frequency band in which the average signal strength in the frequency response spectrum is stably derived at 10 dB or higher is set as the ACV candidate band. This is because if it is less than 10 dB, it lacks discriminative power and is susceptible to the influence of experimental noise, making it difficult to adopt as a reliable standard.

[0229] In addition, the fundamental frequency component in the approximately 250 kHz band was excluded from the ACV condition setting because it is more likely to be influenced by the output characteristics of the ultrasound generation itself rather than fluctuations caused by microbubble reactivity. This criterion can be said to be the result of comprehensively considering not only the magnitude of the signal strength but also statistical consistency through repeated experiments and the specificity of reactivity relative to noise.

[0230] Accordingly, under the condition of an output level of 400, bands of approximately 500 kHz, 750 kHz, and 1000 kHz were established as ACV frequency bands. This is based on the fact that, as confirmed in Fig. 6c, the bands were observed to have stable harmonic components as a result of repeated experiments (n=160), and both the mean value and standard deviation met the criteria.

[0231] On the other hand, under the condition of an output level of 800, the response intensity and spectral diversity were further enhanced as shown in the results of Fig. 6d, and accordingly, bands of 125 kHz (subharmonic), 375 kHz, 500 kHz, 750 kHz, 875 kHz, 1000 kHz, ... were established as ACV frequency bands. In particular, under the 800 level condition, subharmonic and ultra-harmonic components were observed statistically significantly, allowing for the presentation of extended conditions that reflect the complexity and stability of the cavitation reaction.

[0232] The two graphs shown in Fig. 6e display the results of the average and standard deviation of the entire data at 400 levels (n=160) and 800 levels (n=160), respectively, thereby providing a quantitative basis for the ACV condition setting process.

[0233] Under 400 level conditions, it was confirmed that stable responsiveness of more than 10 dB was obtained in the 500 kHz, 750 kHz, and 1000 kHz bands, and under 800 level conditions, responsiveness meeting the criteria was observed in a wider frequency band.

[0234] This experimentally proves that the increase in output intensity does not merely amplify the signal size but expands the vibration modes of microbubbles to induce specific responses across various frequency bands.

[0235] This is further clarified by comparing it with Fig. 6c and Fig. 6d. In Fig. 6c, the fundamental component and harmonic component were stably detected under the condition of an output level of 400, but the response intensity was limited, and accordingly, the ACV frequency band was limited to some harmonic components. On the other hand, in Fig. 6d, while the same pattern was maintained under the condition of an output level of 800, the response intensity increased significantly, and as ultra-harmonic and sub-harmonic components were observed statistically significantly, the ACV frequency band could be further expanded.

[0236] That is, Fig. 6e is not simply a result of combining data from two conditions, but corresponds to the stage of finally establishing the ACV condition band based on the iterative and statistical verification process accumulated in Figs. 6c and 6d.

[0237] In conclusion, the ultrasonic cavitation signal validation device (1) of the present invention can derive reliable ACV conditions based on repetitive and large-scale experimental data.

[0238] Furthermore, the ACV frequency band, which is selectively set according to output level and frequency conditions, can function as a standardization criterion for verifying the cavitation reaction, and thereby the device (1) of the present invention can be utilized as a consistent and objective evaluation tool in various application environments.

[0239] FIG. 6f is a diagram illustrating the results of setting pass conditions by frequency band to finally establish ACV conditions using an ultrasonic cavitation signal validation device (1) according to one embodiment of the present invention.

[0240] Based on the ACV frequency band setting results presented in Fig. 6e above, the process of calculating the average value and standard deviation derived from each frequency band and quantitatively analyzing them to finally establish an applicable acceptance condition is shown in detail.

[0241] In the present invention, the ACV pass condition is set to an average value of ±5 dB based on the average value and standard deviation of the signal derived from the frequency response spectrum. This is to prevent the problem of reduced discriminability caused by an excessively wide allowable range if this is applied as is, even though statistically about 95% of the total data falls within the ±10 dB range.

[0242] Such condition settings function as a key criterion for excluding accidental signal fluctuations caused by noise and selectively verifying only the specific response of microbubbles (MB).

[0243] The table shown at the top displays the results by frequency band under the condition of an output level of 400. The three bands of 500 kHz, 750 kHz, and 1000 kHz are the bands established as ACV frequency conditions in Fig. 6c, and the statistical distribution for them is specifically presented in Fig. 6f.

[0244] The 500 kHz band has an average of 27.3 dB and a standard deviation of 5.6 dB, the 750 kHz band has an average of 13.5 dB and a standard deviation of 4.3 dB, and the 1000 kHz band has an average of 20.1 dB and a standard deviation of 4.1 dB. In particular, the overall average standard deviation of these bands is only about 4.7 dB, demonstrating that the signal converges stably within a range of ±5 dB.

[0245] This is important evidence proving that, under the output level 400 condition, non-linear components are not merely present but are statistically consistently detected and can be utilized as ACV conditions.

[0246] The table below shows the results by frequency band under the condition of an output level of 800. Under this condition, as shown in FIGS. 6d and 6e, the subharmonic (125 kHz), harmonic (500 kHz, 750 kHz, 1000 kHz, ...), and ultraharmonic (375 kHz, 625 kHz, 875 kHz, ...) components were all established in the ACV band.

[0247] In Figure 6f, the mean and standard deviation of each frequency band are as follows. 11.2±4.5 dB at 125 kHz, 17.1±5.5 dB at 375 kHz, 41.6±2.1 dB at 500 kHz, 16.5±5.9 dB at 625 kHz, 26.0±4.4 dB at 750 kHz, 17.1±6.0 dB at 875 kHz, and 31.1±4.1 dB at 1000 kHz were obtained.

[0248] Among these, the 500 kHz, 750 kHz, and 1000 kHz bands show high signal strength and the most limited standard deviation, confirming that they are the most stable indicators for ACV verification under high power conditions.

[0249] On the other hand, subharmonic (125 kHz) and some ultraharmonic components (375 kHz, 625 kHz, 875 kHz) maintain consistency within a ±5 dB range despite having relatively low average intensity, showing that they can function as auxiliary indicators of the cavitation response.

[0250] In addition, despite changes in output level, the average standard deviation remains similar at 4.7 dB at 400 levels and 4.6 dB at 800 levels. This means that while an increase in output intensity expands signal strength and spectral diversity, it does not increase data variance but rather maintains it at a stable level. In other words, the device (1) of the present invention has been experimentally proven to be able to establish consistent and reproducible ACV conditions regardless of changes in output conditions.

[0251] In conclusion, the ultrasonic cavitation signal validation device (1) of the present invention calculates the average and standard deviation for each frequency band based on repetitive and large-scale experimental data, and based on this, can establish strict ACV passing conditions within the ±5 dB range.

[0252] This represents a key achievement that goes beyond simply measuring signals to quantitatively guaranteeing the specificity and reproducibility of microbubble-based cavitation reactions, signifying that the device of the present invention can be utilized as a standardized verification tool in various medical and industrial applications.

[0253] FIG. 7 is a flowchart of an ultrasonic cavitation signal validation method according to one embodiment of the present disclosure.

[0254] This method consists of a series of procedures extending from the pretreatment of the medium to microbubble injection, ultrasound generation, signal acquisition and analysis, and final reproducibility evaluation; each step is organically interconnected to reliably verify the cavitation reaction.

[0255] In step (S10), degassing treatment is performed on the tank (20) containing the medium and the membrane (30).

[0256] This step corresponds to a preparatory process to remove dissolved gases, particularly oxygen, contained in the medium within the tank (20) to suppress the generation of unnecessary natural bubbles and to stably secure the reactivity of the microbubbles subsequently injected. The degassing medium provides a basic environment that ensures the accuracy and reproducibility of the cavitation signal.

[0257] In step (S20), the dissolved oxygen concentration of the medium in the tank (20) is measured. This is a process to quantitatively verify the effect of the degassing treatment, and by confirming that the oxygen concentration of the medium is maintained below a certain standard, the cavitation experiment can be performed under uniform environmental conditions.

[0258] In step (S30), microbubbles are injected through tubing (40) installed in the water tank (20).

[0259] The tubing (40) provides a passage for fluid flow, and microbubbles injected along this passage act as a key medium to induce a cavitation reaction by interacting with ultrasound. The injected microbubbles then repeatedly compress and expand according to the ultrasound output, generating a characteristic non-linear reaction.

[0260] In step (S40), the output level of the ultrasonic generation and cavitation sensing module (10) is set, and ultrasonic waves are generated according to the set conditions.

[0261] The output level can be adjusted according to the purpose and environment, and the generated ultrasound stimulates microbubbles as it passes through the medium inside the tank (20). In this process, the microbubbles cause various non-linear vibrations beyond a linear response, and as a result, various cavitation signals are generated.

[0262] In step (S50), cavitation signals generated by microbubbles are collected and converted into electrical signals. A collection sensor placed in the water tank (20) detects acoustic signals, converts them into electrical waveforms, and transmits them to a signal processing module (60). This step corresponds to a key procedure for quantitatively recording the phenomenon occurring from the interaction between ultrasound and microbubbles.

[0263] In step (S60), the electrical signal is analyzed, and the reproducibility of the cavitation signal is evaluated based on the results.

[0264] In this process, the signal processing module (60) performs frequency analysis on the collected signal to extract not only the fundamental frequency but also unique non-linear components such as harmonics, subharmonics, and ultraharmonics.

[0265] In particular, if a response of a certain magnitude or greater is stably detected in a specific frequency band and signal variability is maintained within an acceptable range, the cavitation response is determined to be reproducible.

[0266] This procedure goes beyond simply confirming whether a signal is generated; by comprehensively considering the signal magnitude and consistency, as well as the presence of specific components, it enables the precise verification of only the actual cavitation reaction.

[0267] In conclusion, the method illustrated in Fig. 7 consists of a process for systematically evaluating the reproducibility of a cavitation reaction through pretreatment of the medium, injection of microbubbles, generation of ultrasound, signal acquisition, and frequency analysis.

[0268] Through such a procedure, the method of the present invention provides reliable data even under various experimental conditions and further realizes the effect of quantitatively and objectively verifying the characteristics of the cavitation reaction.

[0269] The drawings and detailed descriptions in this specification are merely illustrative embodiments of the invention and are not intended to limit the meaning of the invention or the scope of the invention as defined in the claims. Accordingly, those skilled in the art will understand that various modifications and equivalent alternative embodiments are possible from the invention. Ultimately, the true scope of protection of the invention must be determined by the technical spirit of the appended claims.

[0270] The above embodiments may be implemented as hardware components, software components, or a combination thereof. For example, the device, method, and components of the present invention may be implemented through a general-purpose computer or a special-purpose computer capable of executing and responding to instructions, such as a processor, a controller, an arithmetic logic unit (ALU), a digital signal processor (DSP), a microcomputer, an FPGA, a PLU, a microprocessor, etc.

[0271] The processing unit may execute an operating system and one or more software applications running thereon, thereby accessing, storing, manipulating, processing, and generating data. Although a single processing unit has been exemplified in this specification, a person skilled in the art will understand that the processing unit may include multiple processing elements or various types of processing elements. For example, various processing configurations are possible, such as multiple processors, a combination of processors and controllers, or parallel processors.

[0272] Software may be represented as computer programs, code, instructions, or a combination thereof, which may configure a processing unit to perform a desired operation or control it independently or in combination. Additionally, software and / or data may be embodied in machines, components, physical or virtual devices, computer storage media, etc., and may be distributed, stored, and executed on networked systems. These may be stored on one or more computer-readable recording media.

[0273] The method of the present invention may be implemented in the form of program instructions and recorded on a computer-readable medium, and the medium may include program instructions, data files, data structures, etc., either individually or in combination. In this case, the program instructions may be specially written for the present invention or may be instructions known to a person skilled in software.

[0274] Examples of computer-readable media include magnetic media such as hard disks, floppy disks, and magnetic tapes; optical recording media such as CD-ROMs and DVDs; and hardware devices configured to store and execute program instructions, such as ROM, RAM, and flash memory. Program instructions may include not only machine code but also high-level language code executable through an interpreter. The hardware devices may be configured to operate as one or more software modules, and vice versa.

[0275] Although the embodiments described above have been described with reference to specific embodiments and drawings, those skilled in the art will understand that various modifications and variations are possible from the description of the present invention. For example, appropriate effects can be obtained even if the described techniques are performed in a different order, components such as systems, devices, and circuits are combined or assembled in different forms, or are replaced with other components or equivalents. Accordingly, the claims set forth below and their equivalents are also included within the scope of the present invention. Explanation of the symbols

[0276] 1: Ultrasonic cavitation signal validation device 10: Ultrasonic generation and cavitation sensing module 20: Water tank 30: Membrane 40: Tubing 50: Sound-absorbing material 60: Signal processing module

Claims

Claim 1 An ultrasonic cavitation signal validation device comprising: an ultrasonic generation and cavitation sensing module for generating ultrasonic waves; a tank for receiving a medium through which the ultrasonic waves are transmitted; a membrane disposed between the ultrasonic generation and cavitation sensing module and the medium of the tank to transmit the ultrasonic waves into the medium; tubing communicating with the tank to provide a fluid passage for injecting microbubbles; a sound-absorbing material for absorbing interference components of the ultrasonic waves generated within the tank; a signal processing module for converting and analyzing a cavitation signal generated by the microbubbles into an electrical signal and evaluating the reproducibility of the cavitation signal based on the analysis results; and an ultrasonic transmission characteristic simulation member disposed on the path of the ultrasonic waves between the ultrasonic generation and cavitation sensing module and the tubing to form the transmission characteristics of the ultrasonic waves. Claim 2 An ultrasonic cavitation signal validation device according to claim 1, wherein the microbubbles are injected directly through the tubing by a user or continuously injected through the tubing by a fluid supply module. Claim 3 An ultrasonic cavitation signal validation device according to claim 1, wherein the sound-absorbing material is disposed in the path of the ultrasonic waves within the water tank and absorbs ultrasonic waves formed by reflection or scattering from other structures within the water tank, excluding the cavitation signal generated by the microbubbles. Claim 4 delete Claim 5 An ultrasonic cavitation signal validation device according to claim 3, wherein the signal processing module is configured to perform frequency analysis on the cavitation signal to extract a preset frequency component and to evaluate the reproducibility of the cavitation signal based on the extracted frequency component. Claim 6 An ultrasonic cavitation signal validation device according to claim 5, wherein the preset frequency component is at least one of a subharmonic component, a harmonic component, and an ultraharmonic component. Claim 7 An ultrasonic cavitation signal validation device according to claim 5, wherein the signal processing module is configured to calculate variability by analyzing multiple measurement data of the cavitation signal and to evaluate reproducibility based on the variability. Claim 8 A method for validating an ultrasonic cavitation signal, comprising: a step of degassing a tank containing a medium; a step of measuring the dissolved oxygen concentration of the medium; a step of injecting microbubbles through tubing provided within the tank and providing a fluid passage; a step of setting the ultrasonic output level of an ultrasonic generation and cavitation sensing module and generating ultrasonics; a step of collecting a cavitation signal generated by the microbubbles and converting it into an electrical signal; and a step of analyzing the electrical signal and evaluating the reproducibility of the cavitation signal based on the analysis result; wherein the step of generating ultrasonics includes generating ultrasonics in a state in which the transmission characteristics of the ultrasonics are formed by an ultrasonic transmission characteristic simulation member disposed on the travel path of the ultrasonics between the ultrasonic generation and cavitation sensing module and the tubing. Claim 9 In claim 8, the step of evaluating the reproducibility includes evaluating that the reproducibility is secured when the magnitude of the electrical signal is greater than or equal to a preset reference value and the variability of the electrical signal is within a predetermined range. Claim 10 In claim 8, the step of analyzing the electrical signal comprises the step of performing frequency analysis on the electrical signal to extract a preset frequency component, wherein the preset frequency component is at least one of a subharmonic component, a harmonic component, and an ultraharmonic component, an ultrasonic cavitation signal validation method. Claim 11 A computer-readable, non-transient recording medium having a program recorded thereon for executing the ultrasonic cavitation signal validation method of claim 8.

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