Breast cancer diagnosis device and method using ultrasonic waves and near-infrared light

Abstract

The breast cancer diagnosis device according to the present invention comprises: an ultrasound probe configured to output ultrasonic waves toward a subject and receive ultrasound waves outputted from the subject; a near-infrared probe configured to output incident light of at least one wavelength in a near-infrared region toward the subject and receive and process output light outputted from the subject; a display; and a control unit configured, in an ultrasound operation mode, to output, to the display, an ultrasound image generated based on the ultrasonic weaves received from the ultrasound probe and set, as a region of interest, a region selected by a user from the ultrasound image, and configured, in a near-infrared operation mode, to display the region of interest on the display and guide the output light to be collected through the near-infrared probe from the region of interest.

Description

Device and method for diagnosing breast cancer using ultrasound and near-infrared rays

[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, in the case of women, the incidence of breast cancer is the highest among cancers such as breast cancer, thyroid cancer, stomach cancer, colon cancer, and lung cancer. Therefore, interest is focused on finding ways to effectively diagnose breast cancer at an early stage in order to treat it effectively. Conventional techniques for diagnosing breast cancer include mammography, breast ultrasound, and breast MRI, which use X-rays to detect lesions inside the breast. To guide these quarantine management facilities, there are means to measure disinfection time and record and provide alarms, such as loop sensors, cameras, and entrance sensors, but the installation and operation costs are high and on-site managers are required, so they are not being properly utilized.

[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 pressure on 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] However, since breast cancer diagnosis using ultrasound and breast cancer diagnosis using multi-wavelength near-infrared are performed on separate devices, diagnostic experts have the inconvenience of having to use them separately.

[0010] An object of the present invention is to provide a breast cancer diagnosis device and method that can perform ultrasound analysis and multi-wavelength near-infrared analysis together by including an ultrasound module and a multi-wavelength near-infrared module (DMW-NIRS (Discrete Multi Wavelength Near Infra-Red Spectroscopy)).

[0011] 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.

[0012] As a technical means for achieving the above technical task, a breast cancer diagnosis device according to an embodiment of the present invention includes: an ultrasound probe that outputs ultrasound to a target object and receives ultrasound output from the target object; a near-infrared probe that outputs incident light of at least one wavelength in the near-infrared region to the target object and receives and processes the output light output from the target object; a display; and a control unit that, in an ultrasound operation mode, outputs an ultrasound image generated based on ultrasound received from the ultrasound probe to the display, sets a region selected by a user from the ultrasound image as a region of interest, and, in a near-infrared operation mode, displays the region of interest on the display and guides output light to be collected through the near-infrared probe in the region of interest.

[0013] A method for diagnosing breast cancer using a breast cancer diagnosis device according to one embodiment of the present invention comprises the steps of: (a) allowing the ultrasound probe to receive ultrasound output from an object in response to ultrasound output to the object through the ultrasound probe, and allowing a control unit to receive the ultrasound received from the ultrasound probe; (b) allowing the control unit to output an ultrasound image generated based on the ultrasound received, and setting an area selected by a user from the ultrasound image as a area of ​​interest; (c) allowing the control unit to display the area of ​​interest on the display; and (d) allowing the near-infrared probe to receive output light output from the object in response to incident light of at least one wavelength in the near-infrared region output to the object through the near-infrared probe, and allowing the control unit to receive output light from the near-infrared probe.

[0014] According to the above-described problem solving means of the present invention, the breast cancer diagnosis device according to the present invention can efficiently provide breast cancer diagnosis results by integrating an ultrasound diagnosis method and a multi-wavelength near-infrared diagnosis method, including an ultrasound probe and a near-infrared probe.

[0015] FIG. 1 is a block diagram schematically showing the configuration of a breast cancer diagnosis device according to one embodiment of the present invention.

[0016] Figure 2 is an example diagram of the near-infrared probe illustrated in Figure 1.

[0017] Figure 3 is an example of a user UI.

[0018] Figure 4 is an example diagram of a shooting guide interface.

[0019] Figures 5 and 6 are examples of a scanning guide interface.

[0020] Figure 7 is an example diagram of a diagnostic interface.

[0021] Figure 8 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] 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.

[0032] 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 the 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.

[0033] 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.

[0034] 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.

[0035] 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 their 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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).

[0043] 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.

[0044] 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).

[0045] Next, the operation of the control unit (400) will be described in detail.

[0046] First, the case where the control unit (400) operates in the ultrasound mode will be described. The control unit (400) outputs an ultrasound image generated based on ultrasound received from the ultrasound probe (100) to the display (300). Then, when the control unit (400) outputs the ultrasound image to the display (300), it 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 position information using the nipple or areola of the breast to be diagnosed as a reference point. The position 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 may select the region of interest through a touch pen input or direct touch input when the display (300) has a touch screen function.

[0047] Fig. 3 is an example of a user UI. Referring to Fig. 3, a configuration for setting a region of interest will be described as an example. As illustrated in Fig. 2, the control unit (400) displays the left breast and the right breast on the user UI (410), 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 the nipple (20) of the breast as a reference point. Here, the location information may include information on the distance (r) separated from the nipple (20) of the breast to be diagnosed as a reference point and the angle (θ) from the reference line (30).

[0048] In addition, the control unit (400) can receive information on a region of interest from a user through a user UI (410) and set a region of interest (10) based on the information on the region of interest. The control unit (400) can receive information on the location of a point where a lesion (11) is estimated to be located, the depth where the lesion (11) is estimated to be located, or the size of the expected lesion (11) from a user through the user UI (410) and set a region of interest (10).

[0049] Here, the location information may be the distance (r) from the nipple (20) as a reference point and the angle (θ) from the reference line (30). In addition, the user may 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). The information on the region of interest input by the user in this way may be helpful when performing analysis on the inside of the tissue through the near-infrared probe (200). Since the near-infrared probe (200) is capable of analyzing the inside of the tissue, the depth information on the region of interest input by the user may be used in the process of the near-infrared probe (200) detecting a lesion. In addition, information on the size of the lesion input by the user may also be helpful information in detecting the lesion.

[0050] Fig. 4 is an example diagram of a shooting guide interface, and Figs. 5 and 6 are example diagrams of a scanning guide interface. Referring to Figs. 4 to 6, a case where the control unit (400) operates in a near-infrared mode will be described. When the control unit (400) operates in the near-infrared mode, the control unit (400) outputs a shooting guide interface (420) indicating a left chest area and a right chest area on the display (300), and displays a diagnosis target scan area (421) and a control scan area (422) on the shooting guide interface (420) in accordance with information on a region of interest (10) set in the ultrasound mode. The diagnosis target scan area (421) is an area corresponding to the region of interest (10), and the control scan area (422) is an area to be compared among the chest areas facing the diagnosis target scan area (421).

[0051] At this time, the control unit (400) can output a scanning guide interface (430) indicating the status of acquisition of unit scan data of the near-infrared probe (200) in the diagnostic target scan area (421) or the control scan area (422).

[0052] The control unit (400) 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 of the unit scan data through the scanning guide interface (430).

[0053] Referring to FIG. 6, when the near-infrared probe (200) includes five channel signal processing units (210), the scanning guide interface (430) can display each coordinate (indicated by a circle) (431) corresponding to the channel signal processing units (210) and indicate whether optical data is collected for each coordinate (431). Here, each coordinate (431) 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. 6, unit scan data is acquired up to the third coordinate (431) 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.

[0054] The control unit (400) calculates the concentration of each of a plurality of chromophore substances for the target object using the unit scan data thus acquired, and generates a chromophore image based on the calculated concentration of the chromophore substance and outputs it to the display (300). Here, the chromophore image may represent the distribution of the concentration of the chromophore substance or the distribution of the breast cancer diagnosis index calculated based on the concentration of the plurality of chromophore substances.

[0055] Fig. 7 is an example diagram of a diagnostic interface. Referring to Fig. 7, the operation of the control unit (400) to output a chromophore image will be described.

[0056] Referring to FIG. 7, the control unit (400) calculates the concentration of the chromophore material of the target object for each chromophore material based on the output light included in the unit scan data, and outputs a chromophore image representing the distribution of the concentration values ​​of each chromophore material through the diagnostic interface (440) displayed on the display (300). The control unit (400) generates a chromophore image by displaying the concentration values ​​of the chromophore material analyzed for each 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) for each unit scan data, and outputs a chromophore image (441) for the diagnosis target scan area and a chromophore image (442) for the control scan area through the diagnostic interface (440).

[0057] The control unit (400) can simultaneously output a chromophore image (441) for the diagnostic area and a chromophore image (442) for the control area to the diagnostic interface (440). This allows a user to easily compare the two images, thereby enabling a rapid and accurate diagnosis of breast cancer in the diagnostic area.

[0058] In addition, the control unit (400) can generate a chromophore image (441) for the diagnostic area and a chromophore image (442) for the control area, including an 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, a chromophore image can be generated by inserting estimated image data estimated through an interpolation algorithm into a blank space between coordinates. Here, linear interpolation, bilinear interpolation, cubic interpolation, bicubic interpolation, etc. can be used as the interpolation algorithm.

[0059] Next, the chromophore materials and breast cancer diagnostic indices used to generate the above chromophore images are described. The chromophore materials include water (H2O), lipid, oxy-hemoglobin (HbO2), and deoxy-hemoglobin (HHb), and the breast cancer diagnostic indices may include oxy-hemoglobin comparison index (HbO2-L / N), deoxy-hemoglobin comparison index (HHbL / N), water comparison index (waterL / N), lipid comparison index (lipidL / N), total hemoglobin comparison index (THCL / N), and oxygen saturation comparison index (StO2-L / N).

[0060] 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 multiple chromophore substances. The breast cancer diagnostic index is calculated by dividing the average concentration value of the chromophore substances for each of the multiple areas included in the diagnostic area by the average value of the chromophore substances for each of the multiple areas included in the control area. The control unit (400) calculates the breast cancer diagnostic index using mathematical expression 1.

[0061] [Mathematical Formula 1]

[0062]

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] Figure 8 is a flowchart for explaining an operation method of a breast cancer diagnosis device according to one embodiment of the present invention.

[0073] Referring to FIGS. 1 and 8, 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 the ultrasound output to the object through the ultrasound probe (100), the ultrasound probe (100) receives the ultrasound output from the object, and the control unit (400) receives the ultrasound received from the ultrasound probe (100) (step S110). The control unit (400) generates an ultrasound image based on the received ultrasound and outputs it to the display (300), sets an area selected by the user in the ultrasound image as an area of ​​interest (step S120), and outputs the area of ​​interest to the display (300) (step S130).

[0074] And, in response to the 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 the output light output from the target, and the control unit (400) receives the received output light through the near-infrared probe (200) (step S140). At this time, the control unit (400) outputs a scanning guide interface indicating the acquisition status of unit scan data of the near-infrared probe (200) in the diagnosis target scan area or the control scan area (step S150).

[0075] And, the control unit (400) calculates the concentration of the chromophore material of the target object for each chromophore material based on the output light received from the near-infrared probe (200), and outputs a chromophore image representing the distribution of the concentration value of each chromophore material calculated through a diagnostic interface displayed on the display (300) (step S160).

[0076] Hereinafter, each process of the operation method (S100) of the breast cancer diagnosis device (1000) will be described in detail.

[0077] First, the process (step S120) in which the control unit (400) sets the area of ​​interest will be described.

[0078] When the control unit (400) outputs an ultrasound image generated based on ultrasound received from the ultrasound probe (100) to the display (300), it outputs a user UI for collecting information on a region of interest to the display (300) 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 position information using the nipple of the breast to be diagnosed as a reference point. The position 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 may select the region of interest through a touch pen or direct touch input when the display (300) is provided with a touch screen.

[0079] A configuration for setting a region of interest is described as an example with reference to FIG. 3. As illustrated in FIG. 3, the control unit (400) displays a left breast and a right breast on a user UI (410), 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 the nipple (20) of the breast as a reference point. Here, the location information may include information on the distance (r) and angle (θ) separated from the nipple (20) of the breast to be diagnosed as a reference point.

[0080] In addition, the control unit (400) can receive information on a region of interest from the user through the user UI (410) and set the region of interest (10) based on the information on the region of interest. The control unit (400) 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 (410) to set the region of interest (10). Here, the location information can be the distance (r) and angle (θ) separated from the nipple (20) as a reference point. In addition, the user can input the region of interest information through an input device (not shown) such as a mouse and a keyboard connected to the breast cancer diagnosis device (1000).

[0081] Referring to FIG. 4, the process (S130) in which the control unit (400) displays the region of interest on the display (300) will be described. The control unit (400) outputs a shooting guide interface (420) indicating a left chest region and a right chest region on the display (300), and displays a diagnosis target scan region (421) and a control scan region (422) on the shooting guide interface (420) in accordance with information about the region of interest (10) set in the ultrasound mode. The diagnosis target scan region (421) is an area corresponding to the region of interest (10), and the control scan region (422) is an area to be compared among the chest regions facing the diagnosis target scan region (421).

[0082] Next, referring to FIG. 5, a process (step S150) in which the control unit (400) outputs a state in which the near-infrared probe (200) acquires unit scan data through the scanning guide interface is described. The control unit (400) can output a scanning guide interface (430) indicating a state in which the near-infrared probe (200) acquires unit scan data for the diagnosis target scan area (421) or the control scan area (422) simultaneously with the process of receiving output light from the near-infrared probe (200) (step S140).

[0083] The control unit (400) 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 of the unit scan data through the scanning guide interface (430).

[0084] Referring to FIG. 6, when the near-infrared probe (200) includes five channel signal processing units (210), the scanning guide interface (430) can display each coordinate (indicated by a circle) (431) corresponding to the channel signal processing units (210) and indicate whether optical data is collected for each coordinate (431). Here, each coordinate (431) 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. 6, unit scan data is acquired up to the third coordinate (431) 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.

[0085] Next, the process (step S160) in which the control unit (400) outputs a diagnostic interface is described with reference to FIG. 7.

[0086] Referring to FIG. 7, the control unit (400) calculates the concentration of the chromophore material of the target object for each chromophore material based on the output light included in the unit scan data, and outputs a chromophore image representing the distribution of the concentration values ​​of each chromophore material through the diagnostic interface (440) displayed on the display (300). The control unit (400) generates a chromophore image by displaying the concentration values ​​of the chromophore material analyzed for each 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) for each unit scan data, and outputs a chromophore image (441) for the diagnosis target scan area and a chromophore image (442) for the control scan area through the diagnostic interface (440).

[0087] The control unit (400) can simultaneously output a chromophore image (441) for the diagnostic area and a chromophore image (442) for the control area to the diagnostic interface (440). This allows a user to easily compare the two images, thereby enabling a rapid and accurate diagnosis of breast cancer in the diagnostic area.

[0088] In addition, the control unit (400) can generate a chromophore image (441) for the diagnostic area and a chromophore image (442) for the control area, including an 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, a chromophore image can be generated by inserting estimated image data estimated through an interpolation algorithm into a blank space between coordinates. Here, linear interpolation, bilinear interpolation, cubic interpolation, bicubic interpolation, etc. can be used as the interpolation algorithm.

[0089] 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.

[0090] 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.

[0091] 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, A breast cancer diagnosis device comprising: an ultrasound probe which outputs ultrasound to a target object and receives ultrasound output from the target object; a near-infrared probe which outputs incident light of at least one wavelength in the near-infrared region to the target object and receives and processes the output light output from the target object; a display; and a control unit which, in an ultrasound operation mode, outputs an ultrasound image generated based on the ultrasound received from the ultrasound probe to the display, sets a region selected by a user from the ultrasound image as a region of interest, and, in a near-infrared operation mode, displays the region of interest on the display and guides output light to be collected through the near-infrared probe in the region of interest.

2. In paragraph 1, A breast cancer diagnosis device, wherein the control unit, when outputting the ultrasound image, outputs a user UI for collecting information about the region of interest on the display, and sets the region selected by the user through the user UI as the region of interest, wherein the information about the region of interest is set to include location information spaced from the reference point, with the nipple of the breast to be diagnosed as the reference point.

3. In paragraph 1, A breast cancer diagnosis device, wherein the control unit, when outputting the ultrasound image, outputs a user UI that collects information about the region of interest on the display, and sets the region of interest based on information input by the user through the user UI, wherein the user UI collects information about the location of the point where the lesion is estimated to be located, the depth where the lesion is estimated to be located, or the expected size of the lesion.

4. In paragraph 1, A breast cancer diagnosis device, wherein the control unit outputs a shooting guide interface indicating a left breast area and a right breast area on the display during the near-infrared operation mode, and displays a diagnosis target scan area and a comparison scan area on the shooting guide interface in accordance with information about the area of ​​interest, wherein the diagnosis target scan area corresponds to the area of ​​interest, and the comparison scan area is set to an area to be compared among the breast areas facing the diagnosis target scan area.

5. In paragraph 4, A breast cancer diagnosis device, wherein the control unit outputs a scanning guide interface indicating the acquisition status of unit scan data of the near-infrared probe in the diagnosis target scan area or the control scan area.

6. In paragraph 5, A breast cancer diagnostic device, wherein the near-infrared probe includes a plurality of optical element pairs including a light-emitting element and a light-receiving element, and includes at least one group of optical element pairs arranged in a plurality of horizontal directions, and the control unit acquires N unit scan data corresponding to the number of scans of the optical element pair groups as the near-infrared probe is moved in the vertical direction and scanned N times, and displays the acquisition status of the unit scan data through the scanning guide interface.

7. In paragraph 1, A breast cancer diagnosis device, wherein the control unit calculates the concentration of the chromophore material of the target object for each chromophore material based on the output light, and outputs a chromophore image representing the distribution of the concentration values ​​of each chromophore material calculated through a diagnostic interface displayed on the display.

8. In paragraph 7, A breast cancer diagnosis device, wherein the control unit outputs a chromophore image for a diagnosis target scan area and a chromophore image for a control scan area through the diagnosis interface.

9. In paragraph 7, A breast cancer diagnostic device, wherein the control unit generates the chromophore image by displaying the concentration value of the chromophore material analyzed for each output light unit collected by each optical element pair for each unit scan data on a two-dimensional coordinate plane corresponding to the position of each optical element pair.

10. In paragraph 9, A breast cancer diagnosis device, wherein the control unit displays the concentration value of the chromophore material on a two-dimensional coordinate plane corresponding to the position of each optical element pair, and data of empty space between each coordinate displays a value estimated through an interpolation algorithm.

11. In paragraph 7, A breast cancer diagnosis device, wherein the control unit generates at least one chromophore image classified by the chromophore substance to be analyzed.

12. In the operating method of a breast cancer diagnosis device, (a) a step in which the ultrasonic probe receives ultrasonic waves output from the object in response to ultrasonic waves output to the object through the ultrasonic probe, and the control unit receives ultrasonic waves received from the ultrasonic probe; (b) a step of outputting an ultrasound image generated based on the ultrasound received by the control unit to a display and setting an area selected by the user from the ultrasound image as a area of ​​interest; (c) a step in which the control unit displays the region of interest on the display; and (d) A method for operating a breast cancer diagnosis device, comprising a step of the near-infrared probe receiving output light output from the target object in response to incident light of at least one wavelength in the near-infrared region output to the target object through the near-infrared probe, and the control unit receiving output light from the near-infrared probe.

13. In paragraph 12, The step (b) is a method for operating a breast cancer diagnosis device, wherein, when outputting the ultrasound image, a user UI for collecting information about the region of interest is output to the display, and the region selected by the user through the user UI is set as the region of interest, wherein the information about the region of interest is set to include location information spaced from the reference point, with the nipple of the breast to be diagnosed as the reference point.

14. In paragraph 12, The step (b) is a method for operating a breast cancer diagnosis device, wherein, when outputting the ultrasound image, a user UI for collecting information about the region of interest is output to the display, and the region of interest is set based on information input by the user through the user UI, wherein the user UI collects information about the location of the point where the lesion is estimated to be located, the depth where the lesion is estimated to be located, or the expected size of the lesion.

15. In paragraph 12, The step (c) above is a method for operating a breast cancer diagnosis device, wherein a shooting guide interface indicating a left breast area and a right breast area is output to the display, and a diagnosis target scan area and a comparison scan area are displayed on the shooting guide interface in a manner matching the information on the area of ​​interest, wherein the diagnosis target scan area corresponds to the area of ​​interest, and the comparison scan area is set to an area to be compared among the breast areas facing the diagnosis target scan area.

16. In paragraph 12, (e) A method for operating a breast cancer diagnosis device, further comprising the step of outputting a scanning guide interface indicating the acquisition status of unit scan data of the near-infrared probe in the diagnosis target scan area or the control scan area.

17. In paragraph 16, The near-infrared probe includes a plurality of optical element pairs including light-emitting elements and light-receiving elements, and includes at least one group of optical element pairs arranged in a plurality of horizontal directions, and in the step (e), the breast cancer diagnosis device acquires N unit scan data corresponding to the number of scans of the optical element pair groups as the near-infrared probe is moved in the vertical direction and scanned N times, and displays the acquisition status of the unit scan data through the scanning guide interface. A method for operating a breast cancer diagnosis device.

18. In paragraph 12, (f) A method for operating a breast cancer diagnosis device, further comprising the step of calculating the concentration of the chromophore material of the target object for each chromophore material based on the output light, and outputting a chromophore image representing the distribution of the concentration values ​​of each chromophore material calculated through a diagnostic interface displayed on the display.

19. In Article 18, The above step (f) is a method for operating a breast cancer diagnosis device, wherein the method outputs a chromophore image for a diagnosis target scan area and a chromophore image for a control scan area through the diagnosis interface.

20. In paragraph 18, The above step (f) is a method for operating a breast cancer diagnosis device, wherein the concentration value of the chromophore material analyzed for each output light unit collected by each optical element pair for each unit scan data is displayed on a two-dimensional coordinate plane corresponding to the position of each optical element pair to generate the chromophore image.

21. In paragraph 20, The step (f) above displays the concentration value of the chromophore material on a two-dimensional coordinate plane corresponding to the position of each optical element pair, and the data of the empty space between each coordinate displays a value estimated through an interpolation algorithm. The method of the breast cancer diagnosis device.

22. In paragraph 18, A method for operating a breast cancer diagnosis device, wherein the step (f) generates at least one chromophore image distinguished by the chromophore substance to be analyzed.

23. A non-transitory computer-readable recording medium having recorded thereon a computer program for performing an operating method of a breast cancer diagnosis device according to any one of claims 12 to 22.

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