Breast cancer diagnosis device and method

Abstract

A breast cancer diagnosis device according to the present invention includes: a memory for storing a breast cancer diagnosis program; a processor for executing the breast cancer diagnosis program; and a display. The breast cancer diagnosis program obtains output light received by a probe after being output from an object in response to incident light, of at least one wavelength in the near-infrared region, output to the object through the probe; calculates the concentration of a chromophore material in the object for each chromophore on the basis of data on the output light received by the probe; and generates a chromophore image showing the distribution of the calculated value of the concentration of each chromophore material and outputs the chromophore image through a diagnosis interface displayed on the display. The diagnosis interface outputs a first chromophore image showing the ratio between the distribution of the chromophore material in a control scan region and the distribution of the chromophore material in a diagnosis target scan region.

Description

Breast cancer diagnosis device and method

[0001] The present invention relates to a device and method for diagnosing breast cancer using ultrasound and near-infrared rays.

[0002] Early diagnosis and treatment of disease are crucial for leading a healthy life. Among various diseases, cancer is a serious and potentially life-threatening condition, and interest in its early diagnosis and treatment is growing.

[0003] Meanwhile, among women, breast cancer has the highest incidence rate among cancers such as breast, thyroid, stomach, colon, and lung. Therefore, there is growing interest in finding effective methods for early diagnosis and effective treatment of breast cancer. Conventional techniques for diagnosing breast cancer include mammography, breast ultrasound, and breast MRI, which use X-rays to detect lesions within the breast.

[0004] However, mammography has the problem of being difficult to screen for cancer from breast tissue because the difference in X-ray absorption rates between breast tissue and cancer is very small, and there are problems such as pain due to compression of the breast during the scan and exposure to radiation during the examination.

[0005] Furthermore, breast ultrasound is expensive, and it is difficult to clearly distinguish between breast and benign tumors based on ultrasound images alone. Results vary depending on the examiner's skill. Breast MRI is also expensive and has low specificity, sometimes leading to benign tumors being classified as cancer.

[0006] To solve these problems, a method for diagnosing breast cancer is known by analyzing chromophore substances in the tissues inside the breast using near-infrared wavelengths.

[0007] For example, Korean Patent No. 10-2444393 (Title: Breast Cancer Diagnosis System) held by the applicant of the present invention discloses a system for diagnosing breast cancer by irradiating multiple wavelengths in the near-infrared region and using the output light from the target object.

[0008] Specifically, Korean Patent Publication No. 10-2019-0048249 discloses a device for diagnosing breast cancer by converting an infrared ray detected on a diagnostic target using an optical signal and an optical signal into a digital signal, and calculating the signal size difference and phase difference of each converted digital signal.

[0009] An object of the present invention is to provide a breast cancer diagnosis device and method capable of outputting a chromophore image representing the ratio between the concentration of a chromophore material in a contrast scan area and the concentration of a chromophore material in a diagnosis target scan area.

[0010] The tasks of the present invention are not limited to the tasks mentioned above, and other tasks not mentioned will be clearly understood by those skilled in the art from the description below.

[0011] As a technical means for achieving the above-described technical task, a breast cancer diagnosis device according to an embodiment of the present invention comprises: a memory for storing a breast cancer diagnosis program; a processor for executing the breast cancer diagnosis program; and a display, wherein the breast cancer diagnosis program acquires output light received by the probe after being output from the object in response to incident light of at least one wavelength in the near-infrared region output to the object through a probe, calculates the chromophore concentration of the object for each chromophore substance based on data of the output light received by the probe, and generates a chromophore image representing the distribution of the concentration value of each calculated chromophore substance and outputs the chromophore image through a diagnostic interface displayed on the display, wherein the diagnostic interface outputs a first chromophore image representing the ratio between the distribution of the chromophore substance in a control scan area and the distribution of the chromophore substance in a diagnosis target scan area.

[0012] A method for operating a breast cancer diagnosis device according to one embodiment of the present invention comprises the steps of: (a) allowing a near-infrared probe to receive output light output from a target object in response to incident light of at least one wavelength in the near-infrared region output to the target object through the probe, and allowing the control unit to receive output light from the near-infrared probe; (b) calculating the concentration of a chromophore substance of the target object for each chromophore substance based on data of the output light received by the probe; and (c) generating a chromophore image representing a distribution of the concentration values ​​of each chromophore substance and outputting the image through a diagnostic interface displayed on a display, wherein step (c) outputs a first chromophore image representing a ratio between a distribution of a chromophore substance in a control scan area and a distribution of a chromophore substance in a diagnosis target scan area.

[0013] According to the above-described problem-solving means of the present invention, the breast cancer diagnosis device according to the present invention outputs a chromophore image representing the ratio between the concentration of a chromophore substance included in the output light collected through a scan of a diagnosis area and the output light collected through a scan of a control area, thereby providing an effect of easily diagnosing breast cancer.

[0014] FIG. 1 is a block diagram schematically showing a breast cancer diagnosis device according to one embodiment of the present invention.

[0015] Figure 2 is a conceptual diagram schematically showing the configuration of the near-infrared probe illustrated in Figure 1.

[0016] Figure 3 is a block diagram schematically showing the configuration of the control unit illustrated in Figure 1.

[0017] Figure 4 is an example diagram of a user UI.

[0018] Figure 5 is an example diagram of a shooting guide interface.

[0019] Figures 6 and 7 are examples of a scanning guide interface.

[0020] Figure 8 is an example diagram of a diagnostic interface.

[0021] Figure 9 is a flowchart for explaining an operation method of a breast cancer diagnosis device according to one embodiment of the present invention.

[0022] Below, with reference to the attached drawings, embodiments of the present invention are described in detail to facilitate easy implementation by those skilled in the art. However, the present invention can be implemented in various different forms and is not limited to the embodiments described herein. In the drawings, irrelevant parts have been omitted for clarity, and similar reference numerals have been used throughout the specification to indicate similar elements.

[0023] Throughout this specification, when a part is said to be "connected" to another part, this includes not only cases where it is "directly connected" but also cases where it is "electrically connected" with another element in between.

[0024] Throughout this specification, when it is said that an element is "on" another element, this includes not only cases where the element is in contact with the other element, but also cases where another element exists between the two elements.

[0025] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the attached drawings and the following description. However, the present invention is not limited to the embodiments described herein and may be embodied in other forms. Like reference numbers designate like elements throughout the specification.

[0026] Hereinafter, the configuration of a breast cancer diagnosis device according to an embodiment of the present invention will be described.

[0027] FIG. 1 is a block diagram schematically showing a breast cancer diagnosis device according to one embodiment of the present invention.

[0028] Referring to FIG. 1, the breast cancer diagnosis device (1000) of the present invention includes an ultrasound probe (100), a near-infrared probe (200), a display (300), and a control unit (400).

[0029] An ultrasonic probe (100) outputs ultrasonic waves to a target object and receives ultrasonic waves output from the target object. A near-infrared probe (200) outputs incident light of at least one wavelength in the near-infrared region to a target object and receives and processes output light output from the target object.

[0030] In the ultrasonic operation mode, the control unit (400) outputs an ultrasonic image generated based on ultrasonic waves received from the ultrasonic probe (100) to the display (300) and sets an area selected by the user from the ultrasonic image as an area of ​​interest. Thereafter, in the near-infrared operation mode, the control unit (400) displays an area of ​​interest on the display (300) and guides the output light to be collected from the area of ​​interest through the near-infrared probe (200).

[0031] In addition, the control unit (400) calculates the concentration of the chromophore material of the target object for each chromophore material based on the optical data of the output light received by the near-infrared probe (200), and generates a chromophore image representing the distribution of the concentration values ​​of each chromophore material, and outputs the image through a diagnostic interface displayed on the display (300). Here, the diagnostic interface outputs a first chromophore image representing the ratio between the distribution of the chromophore material in the contrast scan area and the distribution of the chromophore material in the diagnostic area.

[0032] Fig. 2 is an exemplary diagram of the near-infrared probe illustrated in Fig. 1. The detailed configuration of the near-infrared probe (200) will be described with reference to Fig. 2.

[0033] Referring to FIG. 2, the near-infrared probe (200) sequentially irradiates light of multiple wavelengths in the near-infrared region to a target object, and receives output light output from the target object according to the irradiation of the light. To this end, the near-infrared probe (200) includes multiple channel signal processing units (210). The channel signal processing units (210) may be arranged in N units (N is a natural number greater than or equal to 1), and include optical element pairs composed of a light-emitting element (211) and a light-receiving element (212). The channel signal processing unit (210) sequentially irradiates light of multiple wavelengths in the near-infrared region to a target object through the light-receiving element (212), and signals-processes the measured values ​​(hereinafter referred to as “optical data”) of the output light output from the target object according to the irradiation of the light through the light-receiving element (212). At this time, near-infrared light incident on the target may be reflected, absorbed, or scattered by biological tissue, and by analyzing the output light from the target, the state of reflection, absorption, or scattering in the biological tissue can be analyzed.

[0034] The light-emitting element (211) may be configured to include a light-emitting element such as a laser diode (LD), a light emitting diode (LED), or a vertical cavity surface emitting laser (VCSEL) that can output incident light having different wavelengths within the near infrared ray region.

[0035] For example, the light emitting element (211) may be configured to output light classified into eight types according to the length of the wavelength. At this time, if one light output element constituting the light emitting element (211) can output light having eight types of wavelengths, the light emitting element (211) may be configured as one light output element. In addition, if one light output element constituting the light emitting element (211) can output light having four types of wavelengths, the light emitting element (211) may be configured as two light output elements each of which outputs light having a different wavelength.

[0036] Meanwhile, the number of types of incident light by wavelength output by the light-emitting element (211) can be determined based on the number of types of chromophore materials present inside the breast. Since chromophore materials effectively absorb light having a wavelength of a specific length depending on the type, by irradiating the breast with incident light having a wavelength effectively absorbed by each chromophore material and collecting and analyzing the output light, the concentration of each type of chromophore material present inside the breast can be measured.

[0037] The light receiving element (212) may be configured to include a light collecting element such as a photodiode, a photo transistor, a photo multiplier tube (PMT), a photo cell, etc., which can receive light and collect light data. The light data of the output light collected by the light receiving element (212) is transmitted to the control unit (400) so that the concentration of the chromophore material is calculated, and is used to produce a chromophore image for the concentration of the chromophore material.

[0038] The light emitting element (211) and the light receiving element (212) are installed in the near-infrared probe (200) so as to be exposed to the contact surface of the near-infrared probe (200) that comes into contact with a target object such as a breast, so that the light emitting element (211) and the light receiving element (212) can come into contact with the target object.

[0039] The near-infrared probe (200) may include a plurality of channel signal processing units (210) including optical element pairs composed of light-emitting elements (211) and light-receiving elements (212), and may include a channel signal processing group (220) in which the plurality of channel signal processing units (210) are arranged in a horizontal direction. In addition, the near-infrared probe (200) may have a plurality of channel signal processing groups (220) that receive output light for different areas of a target object arranged adjacent to each other so that optical data for a predetermined area of ​​the breast can be acquired through a single measurement. For example, as illustrated in FIG. 2, the near-infrared probe (200) may have a plurality of channel signal processing units (210) arranged in a row on one surface to form a channel signal processing group (220), and the plurality of channel signal processing groups (220) may also be arranged in a plurality of columns.

[0040] At this time, the penetration depth of the near-infrared light can be adjusted by the separation distance between the light-receiving element (212) and the light-emitting element (211), and accordingly, the measurement depth in the measurement target can be adjusted. For example, the penetration depth of the near-infrared light is about half the separation distance. Therefore, by setting an appropriate separation distance for the light-receiving element (212) and the light-emitting element (211), the optimal measurement depth can be set.

[0041] In other words, the distance between the light emitting elements (211) and the light receiving elements (212) included in each channel signal processing unit (210) is configured to be the same, so that a plurality of light emitting elements (211) can be arranged in a row in a first direction at the contact surface of the near-infrared probe (200), and a plurality of light receiving elements (212) can be arranged in a row in a second direction parallel to the first direction at the contact surface of the near-infrared probe (200). In this way, since the near-infrared probe (200) includes one or more channel signal processing units (210), the near-infrared probe (200) can collect light data of a wide area of ​​the object with a single contact when collecting light data by contacting the object.

[0042] In addition, the light-emitting element (211) emits near-infrared light at different times for each wavelength, and accordingly, the light-receiving element (212) collects light data for different wavelengths from the target object, which may include information about the wavelength, intensity, etc. of the output light.

[0043] Meanwhile, each channel signal processing unit (210) may further include a driving chip (not shown) that sequentially outputs a driving signal for driving the light-emitting element (211).

[0044] In addition, the near-infrared probe (200) may further be equipped with a notification unit such as a blinking LED, a liquid crystal display, etc. on the outer housing of the main body. The notification unit performs a function of notifying the user of the operating status of the near-infrared probe (200), etc. For example, when the near-infrared probe (200) completes collecting optical data from a target object, the notification unit may notify the user of the completion of optical data collection by blinking the blinking LED or displaying information about the completion of optical data collection on the liquid crystal display.

[0045] Meanwhile, the near-infrared probe (200) is held by the user of the breast cancer diagnostic device (1000) and may have various small shapes for easy holding. In addition, it is connected to the control unit (400) via wired or wireless communication, so that it can receive a control signal from the control unit (400) and transmit data on the output light for each wavelength to the control unit (400).

[0046] Figure 3 is a block diagram schematically showing the configuration of the control unit illustrated in Figure 1.

[0047] Referring to FIG. 3, the control unit (400) includes a memory (410) in which a breast cancer diagnosis program is stored, a processor (420) that executes the breast cancer diagnosis program, and an interface module (430).

[0048] The memory (410) stores a breast cancer diagnosis program that generates a chromophore image. The memory (410) should be interpreted as a general term for a non-volatile storage device that maintains stored information even when power is not supplied and a volatile storage device that requires power to maintain the stored information. The memory (410) may perform a function of temporarily or permanently storing data processed by the processor (420). In addition to a volatile storage device that requires power to maintain the stored information, the memory (410) may include a magnetic storage media or a flash storage media, but the scope of the present invention is not limited thereto.

[0049] The processor (420) executes a breast cancer diagnosis program stored in the memory (410). The processor (420) may refer to a data processing device built into hardware, for example, having a physically structured circuit to perform a function expressed by a code or command included in the program. Examples of such data processing devices built into hardware include processing devices such as a microprocessor, a central processing unit (CPU), a processor core, a multiprocessor, an application-specific integrated circuit (ASIC), and a field programmable gate array (FPGA), but the scope of the present invention is not limited thereto.

[0050] The interface module (430) can communicate with external devices or various computing devices. The interface module (430) may be a device including hardware and software necessary to transmit and receive signals, such as control signals or data signals, with an external device via a wired or wireless connection. For example, the interface module (430) can communicate with an external device via a local area network (LAN), a wide area network (WAN), the Internet (WWW), a wired or wireless data communication network, etc.

[0051] For reference, the components illustrated in FIG. 3 according to an embodiment of the present invention refer to software or hardware components such as FPGAs (Field Programmable Gate Arrays) or ASICs (Application Specific Integrated Circuits), and perform predetermined roles. However, the term "components" is not limited to software or hardware, and each component may be configured to reside on an addressable storage medium or configured to execute one or more processors. Accordingly, as an example, the components include components such as software components, object-oriented software components, class components, and task components, as well as processes, functions, properties, procedures, subroutines, segments of program code, drivers, firmware, microcode, circuits, data, databases, data structures, tables, arrays, and variables. The components and the functions provided within the components may be combined into a smaller number of components or further separated into additional components.

[0052] Next, the operation of the breast cancer diagnosis program is described in detail.

[0053] First, the case where the breast cancer diagnosis program operates in ultrasound mode will be described. The breast cancer diagnosis program outputs an ultrasound image generated based on ultrasound received from an ultrasound probe (100) to the display (300). Then, when outputting the ultrasound image to the display (300), the breast cancer diagnosis program outputs a user UI that collects information on a region of interest, and sets a region selected by the user through the user UI as the region of interest. Here, the region of interest is set to include location information using the nipple or areola of the breast to be diagnosed as a reference point. The location information may be the distance and angle from the reference point. At this time, the user may select the region of interest through an input device (not shown), such as a mouse, connected to the breast cancer diagnosis device (1000), or, if the display (300) has a touch screen function, may select the region of interest through a touch pen input or direct touch input.

[0054] Fig. 4 is an example of a user UI. An example configuration for setting a region of interest will be described with reference to Fig. 4. As illustrated in Fig. 4, a breast cancer diagnosis program displays a left breast and a right breast on a user UI (440), receives a predetermined region from the user, and sets a region of interest (10) where a lesion (11) is estimated to be located. The region of interest (10) may include location information using a nipple (20) of the breast as a reference point. Here, the location information may include information about a distance (r) from the nipple (20) of the breast to be diagnosed as a reference point and an angle (θ) from a reference line (30).

[0055] In addition, the breast cancer diagnosis program can receive information on a region of interest from the user through the user UI (440) and set a region of interest (10) based on the information on the region of interest. The breast cancer diagnosis program can receive at least one of information on the location of a point where a lesion (11) is estimated to be located, information on the depth at which the lesion (11) is estimated to be located, or information on the size of the expected lesion (11) from the user through the user UI (440) to set a region of interest (10). Here, the location information may be a distance (r) from the nipple (20) as a reference point and an angle (θ) from a reference line (30). In addition, the user can input information on the region of interest through an input device (not shown) such as a mouse and a keyboard connected to the breast cancer diagnosis device (1000).

[0056] Information about the region of interest input by the user in this way can be helpful when performing analysis on the inside of a tissue using a near-infrared probe (200). Since the near-infrared probe (200) is capable of analyzing the inside of a tissue, the depth information of the region of interest input by the user can be used when the near-infrared probe (200) detects a lesion. In addition, information about the size of the lesion input by the user can also be helpful in detecting the lesion.

[0057] Fig. 5 is an example diagram of a shooting guide interface, and Figs. 6 and 7 are example diagrams of a scanning guide interface. Referring to Figs. 5 to 7, a case where a breast cancer diagnosis program operates in a near-infrared mode will be described. When the breast cancer diagnosis program operates in the near-infrared mode, a shooting guide interface (450) indicating a left breast area and a right breast area is output on the display (300), and a diagnosis target scan area (451) and a control scan area (452) are displayed on the shooting guide interface (450) in accordance with information on a region of interest (10) set in the ultrasound mode. The diagnosis target scan area (451) is an area corresponding to the region of interest (10), and the control scan area (452) is an area to be compared among the breast areas facing the diagnosis target scan area (451).

[0058] At this time, the breast cancer diagnosis program can output a scanning guide interface (460) indicating the status of acquisition of unit scan data of the near-infrared probe (200) in the diagnosis target scan area (451) or the control scan area (452).

[0059] Referring to FIG. 6, the breast cancer diagnosis program acquires N unit scan data corresponding to the number of scans of the channel signal processing group (220) of the near-infrared probe (200) as the near-infrared probe (200) is moved in the vertical direction and scanned N times, and can display the acquisition status (461) of the unit scan data through the scanning guide interface (460).

[0060] Referring to FIG. 7, when the near-infrared probe (200) includes five channel signal processing units (210), the breast cancer diagnosis program can display each coordinate (indicated by a circle) (461) corresponding to the channel signal processing units (210) on the scanning guide interface (460) and indicate whether or not optical data is collected for each coordinate (461). Here, each coordinate (461) can include coordinate information of a position where each channel signal processing unit (210) of the near-infrared probe (200) comes into contact. In the case of FIG. 7, unit scan data is acquired up to the third coordinate (461) of the first row, and when acquisition of unit scan data for the first row is completed, the near-infrared probe (200) moves to a position corresponding to the second row to perform an operation of acquiring unit scan data.

[0061] The breast cancer diagnosis program calculates the concentration of each of the plurality of chromophore substances for the diagnosis target scan area and the control scan area using the unit scan data acquired in this way. The breast cancer diagnosis program analyzes the unit scan data acquired from the near-infrared probe (200) to calculate the absorption coefficient and the scattering coefficient, and quantitatively calculates the concentration of the chromophore substance using the absorption coefficient and the scattering coefficient. Here, the breast cancer diagnosis program can calculate the concentration of the chromophore substance of the target by inputting the wavelength-specific measurement values ​​of the output light into a machine-learned learning model based on training data in which the wavelength-specific measurement values ​​of light and the concentrations of the plurality of chromophore substances are respectively matched.

[0062] Thereafter, the breast cancer diagnosis program generates a first chromophore image representing the ratio of the concentration values ​​of the chromophore material in the diagnosis area (Lesion) and the control area (Normal) based on the concentration of the produced chromophore material, and outputs the first chromophore image to the display (300). The first chromophore image may be generated based on a value obtained by dividing the concentration value of the chromophore material in the control scan area by the concentration value of the chromophore material in the diagnosis target scan area, or conversely, may be generated based on a value obtained by dividing the concentration value of the chromophore material in the diagnosis target scan area by the concentration value of the chromophore material in the control scan area, and this may be expressed as a breast cancer diagnosis index.

[0063] Here, examples of chromophore substances include water (H2O), lipid, oxy-hemoglobin (HbO2), deoxy-hemoglobin (HHb), total hemoglobin (THC), and oxygen saturation (StO2).

[0064] The breast cancer diagnostic index represents the concentration ratio of the lesion area (diagnostic area) to the normal area (control area) based on the concentration of such chromophore substances, and can be calculated based on the ratio of the average concentration value of the chromophore substance for each of the multiple areas included in the diagnostic area and the average value of the chromophore substance for each of the multiple areas included in the control area. Examples of the breast cancer diagnostic index include the oxyhemoglobin comparison index, the deoxyhemoglobin comparison index, the water comparison index, the lipid comparison index, and the oxygen saturation comparison index, and can be calculated in the form of mathematical equation 1.

[0065] [Mathematical Formula 1]

[0066]

[0067] The oxyhemoglobin comparison index, deoxyhemoglobin comparison index, water comparison index, and lipid comparison index are calculated from the concentrations of oxyhemoglobin, deoxyhemoglobin, water, and lipid in the diagnostic and control areas, respectively. Additionally, the total hemoglobin comparison index is calculated from the total hemoglobin concentration, which is the sum of the oxyhemoglobin and deoxyhemoglobin concentrations.

[0068] And, the oxygen saturation comparison index is calculated by dividing the concentration value of total hemoglobin by the concentration value of oxyhemoglobin to calculate the oxygen saturation for each of the diagnostic area and the control area, and is calculated through the oxygen saturation for each of the diagnostic area and the control area.

[0069] At this time, the breast cancer diagnostic index is classified into a strong index or a weak index depending on the correlation between the calculated value and abnormal tissue (such as a malignant tumor). Specifically, the strong index indicates a strong correlation between the breast cancer diagnostic index and abnormal tissue (such as a malignant tumor). According to the test results, the oxyhemoglobin comparison index, deoxyhemoglobin comparison index, water comparison index, and total hemoglobin comparison index were analyzed to have values ​​ranging from 0.8 to 4.5 in abnormal tissue.

[0070] In addition, the correlation between the fragility index and the strength index was weaker or negative, and according to the test results, the lipid comparison index and oxygen saturation comparison index were analyzed to have values ​​of 0.8 to 1.5.

[0071] That is, among the chromophore substances, oxyhemoglobin, deoxyhemoglobin, and water increase in value in tumor tissue compared to normal tissue due to angiogenesis, so the oxyhemoglobin comparison index, deoxyhemoglobin comparison index, and water comparison index that utilize these can be classified as strong indices, and the lipid and oxygen saturation comparison indices that decrease in value or have a small change range in tumor tissue compared to normal tissue can be classified as weak indices.

[0072] Meanwhile, theoretically, the stiffness index should exceed 1 in malignant tumor tissue, but in the process of specifying the diagnostic area, cases where normal tissue is also included in the diagnostic area inevitably occur, and errors in the actual measurement process may cause the stiffness index to not exceed 1. Similarly, the fragility index should be less than 1 in malignant tumor tissue, but cases where it exceeds 1 may occur. In this way, there is a possibility that the stiffness index or fragility index may not clearly distinguish malignant tumor tissue.

[0073] Accordingly, the control unit (400) can use the optical index (TOI: Tissue Optical Index) calculated by the operation using the stiffness index or the weakness index as a breast cancer diagnosis index. The optical index can be classified into a first optical index obtained by multiplying two or more of a plurality of stiffness indices and dividing the result by one of the weakness indices, or a second optical index obtained by dividing one of the weakness indices by a value obtained by multiplying two or more of the plurality of stiffness indices.

[0074] For example, the first optical index can be defined as the product of the total hemoglobin comparison index and the water comparison index, divided by the lipid comparison index. Since malignant tumor tissue increases hemoglobin (both oxyhemoglobin and deoxyhemoglobin) and water and decreases lipids compared to normal tissue due to angiogenesis, the first optical index in malignant tumor tissue shows a value that increases compared to normal tissue. Depending on the configuration, the first optical index is designed to be strengthened so that its value is greater than the stiffness index in malignant tumor tissue, so that malignant tumor tissue can be more clearly distinguished.

[0075] In contrast, the second optical index can be defined as the lipid comparison index divided by the product of the total hemoglobin comparison index and the water comparison index. In this case, the second optical index in malignant tissue exhibits a decreased value compared to normal tissue. Depending on the configuration, the second optical index is designed to have a smaller value in malignant tissue compared to the weak index, allowing for more clear identification of malignant tissue.

[0076] Additionally, the breast cancer diagnosis program can generate first to third chromophore images, including an estimated image. The estimated image can be generated using an interpolation algorithm as image data corresponding to some locations where optical data was not collected. That is, the estimated image data estimated through the interpolation algorithm can be inserted into the empty space between coordinates to generate a chromophore image. Here, the interpolation algorithm can be linear interpolation, bilinear interpolation, cubic interpolation, or bicubic interpolation.

[0077] Figure 8 is an example diagram of a diagnostic interface. Referring to Figure 8, the operation of the breast cancer diagnostic program outputting the first chromophore image is described.

[0078] Referring to FIG. 8, the breast cancer diagnosis program outputs a first chromophore image (471) representing the ratio between the distribution of chromophore material in the control scan area and the distribution of chromophore material in the diagnosis target scan area through a diagnosis interface (470) displayed on a display (300).

[0079] In addition, the breast cancer diagnosis program can display the concentration value of the chromophore material analyzed in units of output light collected by each channel signal processing unit (210) on a two-dimensional coordinate plane corresponding to the position of each channel signal processing unit (210) to generate a second chromophore image (472) representing the concentration distribution of the chromophore material for the diagnosis area and a third chromophore image (473) representing the concentration distribution of the chromophore material for the control area, and can additionally output the second chromophore image (472) and the third chromophore image (473) together with the first chromophore image (471) through the diagnosis interface (470).

[0080] Additionally, the diagnostic interface (470) may include a material selection interface (474) that allows the user to select one of multiple chromophore materials. This allows the user to select a desired chromophore material and view first to third chromophore images for the selected chromophore material. This allows the user to quickly and accurately determine a breast cancer diagnosis for the diagnostic area.

[0081] For example, the material selection interface (474) is implemented in the form of multiple tabs that display multiple chromophore materials, and when a specific tab is selected, first to third chromophore images for the chromophore materials matching the corresponding tab can be output. Meanwhile, the material selection interface (474) can be implemented in various forms of material selection interfaces in addition to the tab method. The chromophore materials displayed in the material selection interface (474) can include materials such as water (H2O), lipid, oxy-hemoglobin (HbO2), deoxy-hemoglobin (HHb), total hemoglobin (THC), and oxygen saturation (StO2).

[0082] Figure 9 is a flowchart for explaining an operation method of a breast cancer diagnosis device according to one embodiment of the present invention.

[0083] Referring to FIGS. 1 and 9, an operation method (S100) of a breast cancer diagnosis device (1000) according to an embodiment of the present invention will be described. In response to incident light of at least one wavelength in the near-infrared region output to the target through the near-infrared probe (200), the near-infrared probe (200) receives output light output from the target, and the control unit (400) receives the received output light through the near-infrared probe (200) (step S110). The control unit (400) calculates the concentration of the chromophore material of the target based on the output light received from the near-infrared probe (200) for each chromophore material (step S120), and generates a first chromophore image based on the distribution of the concentration values ​​of each calculated chromophore material and outputs it through a diagnostic interface displayed on the display (300) (step S130). Here, the first chromophore image represents the ratio between the concentration distribution of the chromophore material in the contrast scan area and the concentration distribution of the chromophore material in the diagnostic scan area.

[0084] Hereinafter, each process of the operation method (S100) of the breast cancer diagnosis device (1000) will be described in detail.

[0085] First, the process (step S110) in which the control unit (400) receives output light through the near-infrared probe (200) is described.

[0086] Referring to FIG. 5, when the near-infrared probe (200) performs an operation of receiving output light, the control unit (400) outputs a shooting guide interface (450) indicating a left chest area and a right chest area on the display (300), and displays a diagnosis target scan area (451) and a control scan area (452) on the shooting guide interface (450). The diagnosis target scan area (451) is an area corresponding to an area of ​​interest set by the user, and the control scan area (452) is an area to be compared among the chest areas facing the diagnosis target scan area (451).

[0087] At this time, the control unit (400) can output a scanning guide interface (460) indicating the acquisition status of the unit scan data of the near-infrared probe (200) in the diagnosis target scan area (451) or the control scan area (452) as illustrated in Fig. 6. As the near-infrared probe (200) moves in the vertical direction and scans the target object N times, the control unit (400) can acquire N pieces of unit scan data corresponding to the number of scans of the near-infrared probe (200), and display the acquisition status of the unit scan data through the scanning guide interface (460).

[0088] Referring to FIG. 7, when the near-infrared probe (200) includes a channel signal processing unit that processes five pieces of optical data, the scanning guide interface (460) can display each coordinate (indicated by a circle) (461) corresponding to the channel signal processing unit and indicate whether optical data is collected for each coordinate (461). Here, each coordinate (461) can include coordinate information of a position where each channel signal processing unit of the near-infrared probe (200) comes into contact. In the case of FIG. 7, unit scan data is acquired up to the third coordinate (461) of the first row, and when acquisition of unit scan data for the first row is completed, the near-infrared probe (200) moves to a position corresponding to the second row to perform an operation of acquiring unit scan data.

[0089] Next, the process (step S130) in which the control unit (400) outputs a chromophore image through a diagnostic interface is described.

[0090] The control unit (400) calculates the concentration of a plurality of chromophore materials for each of the diagnosis area and the control area using the unit scan data thus acquired, and generates a first chromophore image based on the calculated concentration of the chromophore material and outputs it to the display (300). Here, the first chromophore image may be generated based on a value obtained by dividing the concentration value of the chromophore material in the control scan area by the concentration value of the chromophore material in the diagnosis target scan area, or conversely, may be generated based on a value obtained by dividing the concentration value of the chromophore material in the diagnosis target scan area by the concentration value of the chromophore material in the control scan area, and this may be expressed as a breast cancer diagnosis index.

[0091] Fig. 8 is an example diagram of a diagnostic interface. Referring to Fig. 8, the operation of the control unit (400) to output the first chromophore image will be described.

[0092] Referring to FIG. 8, the control unit (400) outputs a first chromophore image (471) representing the ratio between the distribution of chromophore material in the contrast scan area and the distribution of chromophore material in the diagnosis target scan area through the diagnostic interface (470) displayed on the display (300).

[0093] In addition, the control unit (400) can display the chromophore concentration value analyzed by the output light unit collected by each channel signal processing unit (210) on a two-dimensional coordinate plane corresponding to the position of each channel signal processing unit (210) to generate a second chromophore image (472) representing the concentration distribution of the chromophore material for the diagnosis area and a third chromophore image (473) representing the concentration distribution of the chromophore material for the control area, and can additionally output the second chromophore image (472) and the third chromophore image (473) together with the first chromophore image (471) through the diagnosis interface (470).

[0094] Additionally, the diagnostic interface (470) may include a material selection interface (474) that allows the user to select one of a plurality of chromophore materials. When the user selects a desired chromophore material, the control unit (400) may output first to third chromophore images for the selected chromophore material. This allows the user to quickly and accurately determine a breast cancer diagnosis for the diagnostic area.

[0095] In addition, the control unit (400) can generate the first to third chromophore images, including the estimated image. The estimated image can be generated using an interpolation algorithm as image data corresponding to some positions where optical data is not collected. That is, the chromophore image can be generated by inserting the estimated image data estimated through the interpolation algorithm into the empty space between the coordinates. Here, the interpolation algorithm can be linear interpolation, bilinear interpolation, cubic interpolation, bicubic interpolation, etc.

[0096] The method for diagnosing breast cancer according to one embodiment of the present invention may also be implemented in the form of a recording medium containing computer-executable instructions, such as program modules executed by a computer. Computer-readable media may be any available media that can be accessed by a computer, and includes both volatile and nonvolatile media, removable and non-removable media. Computer-readable media may also include computer storage media. Computer storage media includes both volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storing information, such as computer-readable instructions, data structures, program modules, or other data. Although the methods and systems of the present invention have been described with respect to specific embodiments, some or all of their components or operations may be implemented using a computer system having a general-purpose hardware architecture.

[0097] The foregoing description of the present invention is for illustrative purposes only, and those skilled in the art will readily appreciate that the present invention can be readily modified into other specific forms without altering the technical spirit or essential characteristics of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single entity may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined manner.

[0098] The scope of the present invention is indicated by the claims described below rather than the detailed description above, and all changes or modifications derived from the meaning and scope of the claims and their equivalent concepts should be interpreted as being included in the scope of the present invention.

Claims

1. In a breast cancer diagnosis device, Memory storing the breast cancer diagnosis program; A processor executing the above breast cancer diagnosis program; and Including the display, The above breast cancer diagnosis program is, In response to incident light of at least one wavelength in the near-infrared region output to the target through the probe, the output light output from the target and received by the probe is acquired, and based on the data of the output light received by the probe, the concentration of the chromophore material of the target is calculated for each chromophore material, and a chromophore image representing the distribution of the concentration value of each calculated chromophore material is generated and output through a diagnostic interface displayed on the display. A breast cancer diagnostic device, wherein the above diagnostic interface outputs a first chromophore image representing a ratio between the distribution of chromophore material in a contrast scan area and the distribution of chromophore material in a diagnostic scan area.

2. In paragraph 1, The above breast cancer diagnosis program is, A breast cancer diagnostic device, which outputs, together with the first chromophore image, a second chromophore image showing the distribution of chromophore material in a scan area to be diagnosed through the diagnostic interface, and a third chromophore image showing the distribution of chromophore material in a control scan area to be compared and facing the scan area to be diagnosed.

3. In paragraph 1, The above breast cancer diagnosis program is, The first chromophore image is output based on the value obtained by dividing the distribution value of the chromophore material of the above contrast scan area by the distribution value of the chromophore material of the above diagnosis target scan area, or A breast cancer diagnosis device, which outputs the first chromophore image based on a value obtained by dividing the distribution value of the chromophore material of the above diagnosis target scan area by the distribution value of the chromophore material of the above control scan area.

4. In paragraph 1, The above breast cancer diagnosis program is, A breast cancer diagnosis device, wherein the wavelength-specific measurement values ​​of the output light are input into a machine-learned learning model based on training data in which the wavelength-specific measurement values ​​of light and the concentrations of multiple chromophore substances are respectively matched, to calculate the concentration of the chromophore substance of the target object.

5. In paragraph 1, The above breast cancer diagnosis program is, Output a shooting guide interface indicating the left chest area and the right chest area on the above display, The above diagnostic scan area and the contrast scan area are displayed on the above shooting guide interface. A breast cancer diagnosis device, wherein the above diagnostic target scan area corresponds to an area of ​​interest set by a user, and the above control scan area is set to an area of ​​the chest facing the above diagnostic target scan area to be compared.

6. In paragraph 5, The above breast cancer diagnosis program is, A breast cancer diagnosis device that outputs a scanning guide interface that indicates the status of acquiring unit scan data of the probe in the above diagnosis target scan area or control scan area.

7. In paragraph 1, The above probe, A photodiode comprising a plurality of photodiode pairs including a light-emitting element and a light-receiving element, and comprising at least one group of photodiode pairs arranged in a horizontal direction, The above breast cancer diagnosis program is, As the probe is moved in the vertical direction and scanned N times, N unit scan data corresponding to the number of scans of the optical element pair group are acquired, A breast cancer diagnostic device, wherein the concentration value of the chromophore material analyzed for each output light unit collected by each optical element pair is displayed on a two-dimensional coordinate plane corresponding to the position of each optical element pair for each unit scan data, thereby generating the chromophore image.

8. In paragraph 6, The above breast cancer diagnosis program is, The concentration value of the chromophore material is displayed on a two-dimensional coordinate plane corresponding to the position of each of the above optical element pairs, A breast cancer diagnostic device in which data for each coordinate and the blank space between the coordinates display an estimated value through an interpolation algorithm.

9. In paragraph 1, The above breast cancer diagnosis program is, A breast cancer diagnostic device that generates at least one chromophore image distinguished by the chromophore substance to be analyzed.

10. In paragraph 1, The above diagnostic interface is, A material selection interface comprising a selection input for selecting one of a plurality of target chromophore materials, The above breast cancer diagnosis program is, A breast cancer diagnostic device that generates and outputs the first to third chromophore images for each of the analysis target chromophore materials selected by the material selection interface.

11. In the operating method of a breast cancer diagnosis device, (a) a step in which a near-infrared probe receives output light output from a target object in response to incident light of at least one wavelength in the near-infrared region output to the target object through the probe, and a control unit receives output light from the near-infrared probe; (b) a step of calculating the concentration of the chromophore material of the target object for each chromophore material based on the data of the output light received by the probe; and (c) a step of generating a chromophore image representing the distribution of the concentration values ​​of each chromophore substance produced above and outputting it through a diagnostic interface displayed on a display; Step (c) above, A method of operating a breast cancer diagnosis device, wherein a first chromophore image is output, which represents a ratio between the distribution of chromophore material in a contrast scan area and the distribution of chromophore material in a diagnosis target scan area.

12. In paragraph 11, Step (c) above, A method for operating a breast cancer diagnosis device, wherein a second chromophore image representing the distribution of chromophore material in a scan area to be diagnosed and a third chromophore image representing the distribution of chromophore material in a control scan area to be compared and facing the scan area to be diagnosed are output together with the first chromophore image.

13. In paragraph 11, Step (c) above, The first chromophore image is output based on the value obtained by dividing the distribution value of the chromophore material of the above contrast scan area by the distribution value of the chromophore material of the above diagnosis target scan area, or A method of operating a breast cancer diagnosis device, wherein the first chromophore image is output based on a value obtained by dividing the distribution value of the chromophore material of the above diagnosis target scan area by the distribution value of the chromophore material of the above control scan area.

14. In paragraph 11, Step (b) above, A method for operating a breast cancer diagnosis device, wherein the wavelength-specific measurement values ​​of the output light are input into a machine-learned learning model based on training data in which the wavelength-specific measurement values ​​of light and the concentrations of multiple chromophore substances are respectively matched, to thereby calculate the concentration of the chromophore substance of the target object.

15. In paragraph 13, Step (a) above, The above display outputs a shooting guide interface indicating the left chest area and the right chest area, and displays the diagnostic scan area and the contrast scan area on the shooting guide interface. A method of operating a breast cancer diagnosis device, wherein the above diagnostic target scan area corresponds to an area of ​​interest set by a user, and the above control scan area is set to an area of ​​the chest facing the above diagnostic target scan area to be compared.

16. In paragraph 15, Step (a) above, An operating method of a breast cancer diagnosis device, wherein a scanning guide interface is output to indicate the acquisition status of unit scan data of the probe in the diagnosis target scan area or the control scan area.

17. In paragraph 11, The above probe, A photodiode comprising a plurality of photodiode pairs including a light-emitting element and a light-receiving element, and comprising at least one group of photodiode pairs arranged in a horizontal direction, Step (a) above, As the probe is moved in the vertical direction and scanned N times, N unit scan data corresponding to the number of scans of the optical element pair group are acquired, Step (c) above, A method for operating a breast cancer diagnosis device, wherein the concentration value of a chromophore material analyzed for each output light unit collected by each optical element pair is displayed on a two-dimensional coordinate plane corresponding to the position of each optical element pair for each unit scan data, thereby generating the chromophore image.

18. In paragraph 17, Step (c) above, The concentration value of the chromophore material is displayed on a two-dimensional coordinate plane corresponding to the position of each of the above optical element pairs, A method of operating a breast cancer diagnosis device, wherein data in the blank space between each coordinate and the coordinates displays an estimated value through an interpolation algorithm.

19. In paragraph 11, Step (c) above, A method of operating a breast cancer diagnostic device, wherein at least one chromophore image is generated according to a chromophore substance to be analyzed.

20. In paragraph 11, Step (c) above, Outputting a material selection interface that receives a selection input for selecting one of a plurality of analysis target chromophore materials from the above diagnostic interface, A method for operating a breast cancer diagnosis device, wherein the first to third chromophore images are generated and output for each of the analysis target chromophore materials selected by the material selection interface.

21. A non-transitory computer-readable recording medium having recorded thereon a computer program for performing a method of operating a breast cancer diagnosis device according to any one of claims 11 to 20.

Images