Apparatus and method for early evaluation of lymphedema occurrence by determining regularity of lymphatic contractions

Abstract

The present disclosure relates to an apparatus and method for early evaluation of lymphedema occurrence by determining the regularity of lymphatic contractions, the apparatus comprising a memory for storing at least one instruction for early evaluation of lymphedema occurrence, and a processor for performing operations according to the instruction, wherein the processor: monitors, by using indocyanine green lymphography, the occurrence of lymphedema in an animal model in which lymph nodes have been resected to disconnect lymphatic circulation in an upper limb from the proximal region; measures lymphatic contraction signals at a distal site to detect the onset of and changes in lymphatic circulation disorder; compares the measured lymphatic contraction signals with the lymphatic contraction signals from a normal site; monitors changes in the lymphatic contraction signals at the distal site; and determines the presence of lymphedema on the basis of the monitoring results.

Description

Device and method for early assessment of lymphedema occurrence by determining the normality of lymphatic contraction

[0001] The present disclosure relates to a device and method for early evaluation of lymphedema occurrence through determination of the regularity of lymphatic contraction, and more specifically, to a device and method for early evaluation of lymphedema occurrence that determines the regularity of lymphatic contraction in a normal body in a diseased state and thereby early evaluates lymphedema.

[0002] The matters described in this section are not prior art to the claims of this application, and their inclusion in this section does not constitute an admission that they are prior art.

[0003] The circulatory system, including the vascular and lymphatic systems, maintains a constant production and excretion of body fluids in the absence of external stimuli. This creates a constant fluid flow through homeostasis. In the vascular system, blood moves through blood vessels driven by the contraction and relaxation of the heart, so the heartbeat cycle can be examined to assess the condition. For example, an electrocardiogram (ECG) device that measures a constant heart rate and pulse within normal limits can be used to determine a normal state.

[0004] In the lymphatic system, there is a unit called a lymphangion between each valve, and the movement of lymph fluid occurs according to the contraction and relaxation of the smooth muscles surrounding this unit. The vascular system relies on the heart as the central organ as the driving force for blood flow, so the entire system shows a pattern of movement that is almost similar. In contrast, the lymphatic system has a distributed driving force in a localized form, as illustrated in Figure 1, which shows normal and abnormal signals of the electrocardiogram and lymph, so the corresponding biological area is greatly influenced by the environment.

[0005] Meanwhile, lymphatic circulatory disorders are conditions that disrupt the normal functioning of the lymphatic system. These disorders can arise from abnormalities in lymphatic vessels, lymph nodes, lymphatic valves, or lymphatic tissue itself. Because the lymphatic system plays a crucial role in the circulation of body fluids and the immune system, early diagnosis of circulatory disorders, such as edema, is crucial. However, conventional methods for diagnosing lymphedema, such as analyzing lymphatic drainage patterns, rely on assessing and observing the functioning of the lymphatic system, making early diagnosis of lymphedema difficult.

[0006] An early assessment device and method for lymphedema occurrence through determination of the normality of lymphatic contraction according to an embodiment predict and diagnose the occurrence of lymphedema at an early stage by observing changes in the normality of lymphatic contraction.

[0007] In this example, lymph nodes in an animal model were removed to sever lymphatic circulation in the upper limb proximally. The development of lymphedema in the animal model was assessed using indocyanine green lymphography to assess lymphatic drainage. To determine whether lymphatic circulatory disturbances occur distally, lymphatic contraction signals were measured distally, and changes in abnormal lymphatic contraction signals compared to normal levels were observed over time.

[0008] However, the problems to be solved according to one embodiment are not limited to those mentioned above.

[0009] In order to achieve the above-described technical task, the present disclosure provides a device for early evaluation of lymphedema occurrence through determination of the normality of lymphatic contraction, comprising: a memory storing at least one command for early evaluation of lymphedema occurrence; and a processor performing an operation according to the command, wherein the processor monitors whether lymphedema occurs in an animal model in which lymphatic circulation in the upper limb is cut off from the proximal portion by resecting a lymph node using indocyanine green lymphography, measures a lymphatic contraction signal at a distal portion to confirm the occurrence and change of lymphatic circulation disorder, compares the measured lymphatic contraction signal with a lymphatic contraction signal at a normal portion, monitors a change in the lymphatic contraction signal at the distal portion, and determines lymphedema based on the monitoring result.

[0010] At this time, the processor can monitor changes in abnormal lymph contraction signals of the distal portion by using a Fourier transform (FFT) that converts a time-axis signal into a frequency-axis signal to determine the regularity of a constant contraction cycle of the lymph contraction signal.

[0011] Additionally, the processor can identify a signal peak indicating normality in the abnormal lymphatic contraction signal of the distal portion, and if the signal peak is not identified, it can be determined that the onset of lymphatic circulation disorder is in the early stage.

[0012] In addition, the processor can monitor changes in abnormal lymphatic contraction signals of the distal portion by using wavelet transform (CWT, Continues Wavelet Transform), a signal processing method capable of confirming changes in frequency over time.

[0013] In addition, the processor can check for a signal of a certain period including a signal peak indicating regularity in the lymphatic contraction signal of the distal portion, and if the signal of the certain period is not checked, it can be determined that the occurrence of a lymphatic circulation disorder is in the early stage.

[0014] Additionally, the processor can determine whether there is lymphedema based on the size of the peak value of the lymph contraction signal of the distal portion compared to the peak value of a specific frequency band in a normal state.

[0015] In addition, the processor can determine lymphedema based on the color distribution around a reference value of a specific frequency when the time domain and frequency domain are displayed together when using the CWT.

[0016] In addition, the processor can set a factor for determining whether the condition is normal or lymphedema, and determine normality including whether the condition of lymphedema has changed and the possibility of lymphedema based on the set factor.

[0017] Additionally, the processor can determine lymphedema based on the results of component analysis including the periodicity, frequency composition, and frequency band of the Fourier-transformed lymph contraction signal of the distal portion.

[0018] Additionally, the processor can determine lymphedema based on the results of component analysis including energy increase, periodicity variation, and singularity in a specific frequency band in the results of the CWT.

[0019] In addition, a method for early evaluation of lymphedema occurrence through determination of normality of lymphatic contraction performed by a device according to the present disclosure for achieving the above-described technical task may include the steps of: monitoring the occurrence of lymphedema in an animal model in which lymphatic circulation in the upper limb is cut off proximal to the lymph node by resecting the animal model using indocyanine green lymphography; measuring a lymphatic contraction signal at a distal site to confirm the occurrence and change of lymphatic circulation disorder, and comparing the measured lymphatic contraction signal with a lymphatic contraction signal at a normal site; and monitoring a change in the lymphatic contraction signal at the distal site and determining lymphedema based on the monitoring result.

[0020] The device and method for early evaluation of lymphedema occurrence through determination of the normality of lymphatic contraction as described above overcomes the limitations of existing lymphedema diagnosis methods and enables early diagnosis by directly detecting lymphatic circulation disorder, which is the fundamental cause of lymphedema.

[0021] Most of the treatment methods currently used in clinical practice are known to be effective in the early stages of lymphedema, and there is no method to predict and continuously monitor the occurrence of lymphedema. Therefore, the device and method for early evaluation of lymphedema occurrence through determination of the normality of lymphatic contraction according to the embodiment dramatically improve the efficiency of lymphedema management and the accuracy of prediction.

[0022] The device and method for early assessment of lymphedema development by determining the normality of lymphatic contraction according to the embodiment can be applied to any methodology capable of measuring the movement of lymphatic contraction over time. Furthermore, the embodiment presents a signal processing method that facilitates clinical evaluation of lymphatic contraction signals and enables meaningful judgment, thereby demonstrating high expandability.

[0023] The effects of the present invention are not limited to the effects described above, and should be understood to include all effects that can be inferred from the detailed description of the present invention or the composition of the invention described in the claims.

[0024] Figure 1 is a diagram showing normal and abnormal signals of lymph and electrocardiogram.

[0025] Figure 2 is a drawing showing an animal model processing process according to an embodiment.

[0026] Figure 3 is a diagram showing the results of indocyanine green (ICG) lymphography in normal and lymphedema models.

[0027] Figure 4 is a diagram showing the normalized intensity values ​​of ICG versus time for normal and lymphedema signals.

[0028] Figure 5 is a diagram showing the results of monitoring the frequency of lymphatic contraction in normal and lymphedema states.

[0029] Figure 6 is a block diagram of a device for early evaluation of lymphedema occurrence through determination of normality of lymphatic contraction according to an embodiment.

[0030] Figure 7 is a diagram showing the waveform of the lymph contraction signal monitored according to an embodiment as FFT and CWT.

[0031] Figure 8 is a diagram showing the results of determining lymphedema based on the signal analysis results of an early lymphedema occurrence evaluation device according to an embodiment and the presence or absence of lymphedema based on analysis of the lymphatic drainage pattern.

[0032] Figure 9 is a diagram showing a method for early evaluation of lymphedema occurrence through determination of normality of lymphatic contraction according to an embodiment.

[0033] Hereinafter, the embodiments disclosed in this specification will be described in detail with reference to the attached drawings. Regardless of the drawing numbers, identical or similar components will be given the same reference numbers, and redundant descriptions thereof will be omitted. The suffixes "module" and "part" used for components in the following description are assigned or used interchangeably only for the convenience of writing the specification, and do not in themselves have distinct meanings or roles. In addition, when describing the embodiments disclosed in this specification, if it is determined that a specific description of a related known technology may obscure the gist of the embodiments disclosed in this specification, a detailed description thereof will be omitted. In addition, the attached drawings are only intended to facilitate easy understanding of the embodiments disclosed in this specification, and the technical ideas disclosed in this specification are not limited by the attached drawings, and should be understood to include all modifications, equivalents, and substitutes included in the spirit and technical scope of the present invention.

[0034] Terms that include ordinal numbers, such as first, second, etc., may be used to describe various components, but the components are not limited by these terms. These terms are used solely to distinguish one component from another.

[0035] When a component is referred to as being "connected" or "connected" to another component, it should be understood that it may be directly connected or connected to that other component, but that there may be other components intervening. Conversely, when a component is referred to as being "directly connected" or "connected" to another component, it should be understood that there are no other components intervening.

[0036] In this application, terms such as “include” or “have” are intended to specify the presence of a feature, number, step, operation, component, part or combination thereof described in the specification, but should be understood not to exclude in advance the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts or combinations thereof.

[0037] In this specification, the term "unit" includes a unit realized by hardware, a unit realized by software, and a unit realized using both. Furthermore, a single unit may be realized using two or more pieces of hardware, and two or more units may be realized by a single piece of hardware.

[0038] Some of the operations or functions described herein as being performed by a terminal, apparatus, or device may instead be performed by a server connected to the terminal, apparatus, or device. Similarly, some of the operations or functions described herein as being performed by a server may also be performed by a terminal, apparatus, or device connected to the server.

[0039] Hereinafter, the present invention will be described in detail with reference to the attached drawings.

[0040] The embodiment provides a method for early diagnosis of lymphedema by determining the regularity of lymphatic contraction. The method for early diagnosis of lymphedema provided in the embodiment is not limited to a method and device for measuring the movement of lymphatic contraction and may include all equipment and methods capable of deriving a contraction signal. The device and method for early evaluation of lymphedema occurrence by determining the regularity of lymphatic contraction according to the embodiment can be applied to all methodologies capable of measuring the movement of lymphatic contraction over time. In addition, the embodiment presents a signal processing method that can easily and meaningfully judge the clinical evaluation of the lymphatic contraction signal, so that the expandability is very wide.

[0041] The circulatory system, including the vascular and lymphatic systems, maintains a constant fluid production and discharge rate in the absence of external stimuli, thus maintaining a constant fluid flow through homeostasis. In the vascular system, blood moves through blood vessels driven by the contraction and relaxation of the heart. Therefore, a steady heart rate and pulse within a normal range can be determined as normal by examining the heart's rhythm, similar to an electrocardiogram. In the lymphatic system, lymph fluid moves according to the contraction and relaxation of the smooth muscle surrounding the lymphatic unit, a unit between each valve. The vascular system relies on the heart as the central driving force for blood flow, demonstrating a nearly uniform pattern of movement throughout the entire system. In contrast, the lymphatic system operates on a distributed, peripheral driving force, making it highly susceptible to environmental influences within the respective biomechanical region.

[0042] Figure 1 is a diagram illustrating normal and abnormal lymphatic and electrocardiographic signals. Referring to Figure 1, it can be confirmed that if lymphatic circulation disturbance occurs before the visible symptoms of lymphedema, such as lymph fluid accumulation, the onset of lymphedema can be predicted and diagnosed by observing changes in the regularity of lymphatic contraction.

[0043] Figure 2 is a drawing showing an animal model processing process according to an embodiment.

[0044] Referring to Fig. 2, in the examples, an animal model is used to prove that the occurrence of lymphedema can be predicted by observing changes in the regularity of lymphatic contraction. In the examples, an animal model is created in which lymphatic circulation is artificially impeded in an animal experiment, and lymph nodes are resected to cut off lymphatic circulation in the upper limb from the proximal part. The surgical trauma is completely healed after one week, and since external interventions other than the lymph nodes are minimized, except for the lymphatic circulation impediment, it is physiologically identical to a normal part. The occurrence of lymphedema in the animal model used in the examples can be observed by evaluating lymphatic drainage using indocyanine green lymphography.

[0045] Figures 3 to 5 are diagrams showing the process and results of monitoring the occurrence of lymphedema in animal models. Figure 3 is a diagram showing the results of tracking indocyanine green (ICG) lymphography in normal and lymphedema models, and Figure 4 is a diagram showing the normalized intensity values ​​of ICG versus time for normal and lymphedema signals. Figure 5 is a diagram showing the results of monitoring the frequency of lymphatic contraction in normal and lymphedema states.

[0046] Referring to Figure 3, the results of tracking indocyanine green (ICG) lymphography show that the proximal part shows an abnormal drainage pattern (A) due to lymphatic circulation disruption, but the distal part shows a pattern that is not much different from the normal part.

[0047] The early evaluation device for lymphedema occurrence through determination of normality of lymphatic contraction according to an embodiment measures lymphatic contraction signals at the distal end to determine whether lymphatic circulation disorder at the proximal end causes changes at the distal end, and monitors changes in abnormal lymphatic contraction signals compared to the normal end along the time axis.

[0048] Fig. 6 is a block diagram of a device for early assessment of lymphedema occurrence by determining the normality of lymphatic contraction according to an embodiment. The configuration of the device for early assessment of lymphedema occurrence (100) illustrated in Fig. 6 is merely a simplified example.

[0049] The configuration of the early lymphedema occurrence evaluation device (100) illustrated in FIG. 6 is merely a simplified example. The communication module (110) may be configured regardless of the communication mode, such as wired or wireless, and may be configured with various communication networks, such as a personal area network (PAN) and a wide area network (WAN). In addition, the communication module (110) may operate based on the known World Wide Web (WWW), and may also utilize wireless transmission technologies used for short-distance communication, such as infrared (IrDA: Infrared Data Association) or Bluetooth. For example, the communication module (110) may be responsible for transmitting and receiving data required to perform a technique according to an embodiment of the present disclosure.

[0050] The memory (120) may refer to any type of storage medium. For example, the memory (120) may include at least one type of storage medium among a flash memory type, a hard disk type, a multimedia card micro type, a card type memory (e.g., SD or XD memory, etc.), a RAM (Random Access Memory), a SRAM (Static Random Access Memory), a ROM (Read-Only Memory), an EEPROM (Electrically Erasable Programmable Read-Only Memory), a PROM (Programmable Read-Only Memory), a magnetic memory, a magnetic disk, and an optical disk. Such a memory (120) may also constitute a database as illustrated in FIG. 1.

[0051] The memory (120) can store at least one instruction that can be executed by the processor (130). In addition, the memory (120) can store any type of information generated or determined by the processor (130) and any type of information received by the server (200). In addition, the memory (120) stores various types of modules, instruction sets, or models.

[0052] The processor (130) may perform technical features according to embodiments of the present disclosure, which will be described later, by executing at least one instruction stored in the memory (120). In one embodiment, the processor (130) may be configured with at least one core and may include a processor for data analysis and / or processing, such as a central processing unit (CPU), a general purpose graphics processing unit (GPGPU), or a tensor processing unit (TPU) of a computer device.

[0053] The processor (130) monitors the occurrence of lymphedema in an animal model in which lymphatic circulation in the upper limb is severed proximally by resecting the lymph nodes using indocyanine green lymphography. In addition, the processor (130) measures a lymphatic contraction signal at a distal site to identify the occurrence and changes in lymphatic circulation disorders, and compares the measured lymphatic contraction signal with a normal lymphatic contraction signal. In an embodiment, the processor (130) monitors changes in an abnormal lymphatic contraction signal at a distal site along a time axis.

[0054] In the embodiment, the processor (130) monitors changes in abnormal lymph contraction signals in the distal region using a Fast Fourier Transform (FFT) that converts a time-axis signal into a frequency-axis signal to determine the normality of a constant contraction cycle of the lymph contraction signal.

[0055] In addition, the processor (130) monitors changes in abnormal lymphatic contraction signals in the distal region using wavelet transform (CWT, Continues Wavelet Transform), a signal processing method that can check changes in frequency over time.

[0056] Fig. 7 is a diagram showing the waveform of a lymph contraction signal monitored according to an embodiment in FFT and CWT.

[0057] As illustrated in FIG. 7, in the embodiment, changes in an abnormal lymphatic contraction signal compared to a normal portion are monitored along the time axis. In the embodiment, the processor (130) converts the time axis signal into a frequency axis signal through the fast Fourier transform (FFT) of mathematical expression 1 to determine the normality of a certain contraction cycle.

[0058]

[0059] Afterwards, the transformed signal was observed, and as shown in Fig. 7, the Fourier transform signal (e) of the affected side (lymphedema) was monitored to have disappeared from the signal peak indicating normality. In addition, in the embodiment, the wavelet transform (CWT, Continues Wavelet Transform), a signal processing method capable of confirming frequency changes over time, is performed using mathematical expression 2.

[0060]

[0061] Referring to FIG. 7, the processor (130) can confirm that, based on the wavelet transform result (f), a signal with a constant cycle disappears during signal measurement. This change indicates that lymphatic circulation disorder occurs almost immediately and can be observed before lymphedema worsens.

[0062] Accordingly, the processor (130) checks for a signal peak indicating regularity in the abnormal lymphatic contraction signal of the distal portion in the Fourier transform signal, and if no signal peak is found, it determines that the occurrence of lymphatic circulation disorder is in the early stage. In addition, the processor (130) checks for a signal of a certain period including a signal peak indicating regularity in the abnormal lymphatic contraction signal of the distal portion in the wavelet transform signal, and if no signal of a certain period is found, it determines that the occurrence of lymphatic circulation disorder is in the early stage.

[0063] In addition, the processor (130) can determine whether lymphedema exists based on the size of the peak value of the abnormal lymph contraction signal of the distal portion compared to the peak value of a specific frequency band in a normal state in the Fourier transform signal. In the embodiment, the processor (130) determines lymphedema based on the results of component analysis including the periodicity, frequency composition, and frequency band of the Fourier transformed lymph contraction signal of the distal portion.

[0064] For example, the processor (130) measures a peak value in the frequency band of a lymphatic contraction signal occurring in a normal state. In an embodiment, the processor (130) can measure a peak value and a frequency, which are frequency components corresponding to a normal lymphatic contraction cycle. Thereafter, the peak value of the lymphatic contraction signal at the distal end is measured. When lymphedema occurs, the peak value of an abnormal frequency band in the lymphatic contraction signal may be large, so the peak value of the lymphatic contraction signal at the distal end is measured. Thereafter, the peak values ​​of the frequency bands measured in the normal state and at the distal end are compared. In an embodiment, the processor (130) can determine that lymphedema has occurred if the peak value of the frequency band of the lymphatic contraction signal at the distal end is large by a certain level or more.

[0065] Additionally, the processor (130) determines the periodicity in the converted signal and analyzes which frequency components appear in the frequency domain. At this time, the processor (130) determines the difference in frequency between the normal state and the lymphedema state.

[0066] Thereafter, the processor (130) analyzes components in a specific frequency band. In an embodiment, the processor (130) identifies changes in a specific frequency band associated with lymphedema and uses this as a judgment criterion. Thereafter, the processor (130) synthesizes the analysis results of components such as periodicity, frequency composition, and frequency band to determine the presence or absence of lymphedema. This judgment can be made by detecting changes in specific patterns or frequency components associated with lymphedema.

[0067] Additionally, when using CWT, the processor (130) determines lymphedema based on the color distribution around a reference value of a specific frequency, with both the time domain and frequency domain displayed. In an embodiment, the processor (130) sets a reference value of a specific frequency for which lymphedema is to be determined. The reference value may include an average value in a normal state.

[0068] Thereafter, the processor (130) analyzes the color distribution around the set reference value to determine the signal intensity or characteristics in the monitored frequency band. Thereafter, the processor (130) detects patterns or changes associated with lymphedema based on the analyzed color distribution. In an embodiment, the processor (130) may determine that a change in the color distribution exceeding the reference value is lymphedema.

[0069] Additionally, the processor (130) sets factors for determining whether lymphedema is normal or lymphedema through CWT, and determines normality based on the set factors. In an embodiment, normality may include whether the status of lymphedema has changed and the possibility of lymphedema.

[0070] To this end, the processor (130) sets factors that can determine normal and lymphedema states. For example, signal characteristics including peak values ​​of specific frequencies and color distributions can be set as factors. Thereafter, the processor (130) evaluates the normality of the lymphatic contraction signal based on the set factors. In an embodiment, the normality evaluation process includes a process of confirming normality by comparing the signal with factors expected for normal lymphatic contraction.

[0071] Thereafter, the processor (130) evaluates the normality of the lymphatic contraction signal to determine whether there is a change in the state of lymphedema. In an embodiment, the processor (130) determines that there may be a change in lymphedema if the signal deviates from a set factor. In addition, the possibility of lymphedema is assessed based on the normality of the lymphatic contraction signal. For example, the processor (130) can estimate the possibility of lymphedema based on the monitoring results of specific factors associated with lymphedema.

[0072] Additionally, the processor (130) determines lymphedema based on component analysis results including energy increases in specific frequency bands, periodic fluctuations, and singularities in the CWT results. For example, the processor (130) analyzes energy increases in specific frequency bands in the CWT results and detects a pattern of energy increases in frequency bands associated with lymphedema.

[0073] In addition, the CWT results are checked for periodic fluctuations. The processor (130) detects cases where the periodicity in a specific frequency band fluctuates above a certain level compared to the normal state. In addition, the processor (130) analyzes singularities in the CWT results. In an embodiment, singularities include unusual changes or peaks in the frequency domain. Thereafter, the processor (130) determines whether lymphedema exists by synthesizing the results of component analysis such as energy increase, periodic fluctuation, and singularity. In an embodiment, the processor (130) can determine that the possibility of lymphedema is above a certain level when the energy increase and periodic fluctuation in a specific frequency band are prominent.

[0074] Figure 8 is a diagram showing the results of determining lymphedema based on the signal analysis results of an early lymphedema occurrence evaluation device according to an embodiment and the presence or absence of lymphedema based on analysis of a lymph drainage pattern.

[0075] As shown in Fig. 8, it can be confirmed that the early evaluation device for lymphedema occurrence through determination of normality of lymphatic contraction according to an embodiment can preemptively detect lymphedema and enable early diagnosis of lymphedema compared to other measurement methods including a lymph drainage pattern analysis method.

[0076] Below, a method for early assessment of lymphedema occurrence through determination of the normality of lymphatic contraction is sequentially described. The function of the method for early assessment of lymphedema occurrence through determination of the normality of lymphatic contraction according to the embodiment is essentially the same as the function of the device for early assessment of lymphedema occurrence through determination of the normality of lymphatic contraction, so any description overlapping with that in FIGS. 1 to 8 will be omitted.

[0077] Figure 9 is a diagram illustrating a method for early evaluation of lymphedema occurrence through determination of normality of lymphatic contraction according to an embodiment.

[0078] Referring to Figure 9, in step S100, in an animal model in which lymphatic circulation in the upper limb is severed proximally by resecting the lymph nodes, the occurrence of lymphedema in the animal model is monitored using indocyanine green lymphography. In step S200, to confirm the occurrence and change of lymphatic circulation disorder, the lymphatic contraction signal is measured distally, and the measured lymphatic contraction signal is compared with the lymphatic contraction signal of the normal part. In step S300, the change in the lymphatic contraction signal of the distal part is monitored, and the presence or absence of lymphedema is determined (diagnosed).

[0079] The device and method for early evaluation of lymphedema occurrence through determination of the normality of lymphatic contraction as described above overcomes the limitations of existing lymphedema diagnosis methods and enables early diagnosis by directly detecting lymphatic circulation disorder, which is the fundamental cause of lymphedema.

[0080] Most of the treatment methods currently used in clinical practice are known to be effective in the early stages of lymphedema, and there is no method to predict and continuously monitor the occurrence of lymphedema. Therefore, the device and method for early evaluation of lymphedema occurrence through determination of the normality of lymphatic contraction according to the embodiment dramatically improve the efficiency of lymphedema management and the accuracy of prediction.

[0081] The device and method for early assessment of lymphedema development by determining the normality of lymphatic contraction according to the embodiment can be applied to any methodology capable of measuring the movement of lymphatic contraction over time. Furthermore, the embodiment presents a signal processing method that facilitates clinical evaluation of lymphatic contraction signals and enables meaningful judgment, thereby demonstrating high expandability.

[0082] The disclosed content is merely an example, and various modifications and implementations can be made by a person skilled in the art without departing from the gist of the claims claimed in the patent, so the scope of protection of the disclosed content is not limited to the specific embodiments described above.

Claims

1. In the early evaluation device for lymphedema occurrence through determination of the normality of lymphatic contraction, A memory storing at least one command for early assessment of lymphedema development; and A processor comprising: a processor that performs an operation according to the above command; The above processor, To monitor the occurrence of lymphedema in an animal model in which lymph nodes were removed to cut off the lymphatic circulation in the upper limb proximally using indocyanine green lymphography. To identify the occurrence and changes of lymphatic circulation disorders, lymphatic contraction signals are measured distally. The measured lymphatic contraction signal is compared with the normal lymphatic contraction signal, Monitor changes in the lymphatic contraction signal of the above distal part, A device for determining lymphedema based on the above monitoring results.

2. In the first paragraph, the processor, A device for monitoring changes in abnormal lymphatic contraction signals of the distal portion by using a Fast Fourier Transform (FFT) that converts a time-axis signal into a frequency-axis signal to determine the regularity of a constant contraction cycle of the lymphatic contraction signal.

3. In the second paragraph, the processor, Identify the signal peaks that indicate normality in the abnormal lymphatic contraction signals in the distal region above, If the above signal peak is not confirmed, the device judges that it is the initial stage of lymphatic circulation disorder.

4. In the second paragraph, the processor, A device that monitors changes in abnormal lymphatic contraction signals of the distal portion using wavelet transform (CWT, Continues Wavelet Transform), a signal processing method capable of confirming changes in frequency over time.

5. In the fourth paragraph, the processor, Identify a signal of a regular period that includes a signal peak indicating regularity in the lymphatic contraction signal of the distal portion, A device that determines that the onset of lymphatic circulation disorder is in the early stages when the above-mentioned regular periodic signal is not confirmed.

6. In the second paragraph, the processor, A device for determining whether there is lymphedema based on the size of the peak value of the lymph contraction signal of the distal part compared to the peak value of a specific frequency band in a normal state.

7. In the fourth paragraph, the processor, A device for determining lymphedema based on the color distribution around a reference value of a specific frequency, in a state where the time domain and frequency domain are displayed together when using the above CWT.

8. In the 7th paragraph, the processor, Establish factors to determine whether it is normal or lymphedema, A device for determining whether there is a change in the status of lymphedema and normality including the possibility of lymphedema based on the above-set factors.

9. In paragraph 6, the processor, A device for determining lymphedema based on the results of component analysis including the periodicity, frequency composition and frequency band of the Fourier-transformed lymph contraction signal of the distal portion.

10. In the fourth paragraph, the processor, A device for determining lymphedema based on component analysis results including energy increase, periodicity variation, and singularity in a specific frequency band in the results of the above CWT.

11. In a method for early evaluation of lymphedema occurrence through determination of the normality of lymphatic contraction performed by a device, A step of monitoring the occurrence of lymphedema in an animal model in which lymphatic circulation in the upper limb is severed proximally by resecting the lymph nodes using indocyanine green lymphography; A step of measuring a lymphatic contraction signal at a distal site to confirm the occurrence and change of lymphatic circulation disorder and comparing the measured lymphatic contraction signal with a lymphatic contraction signal at a normal site; and A method comprising the step of monitoring changes in the lymphatic contraction signal of the distal portion and determining lymphedema based on the monitoring results.

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