WO2021241438A1 - Breast cancer examination instrument, breast cancer examination device, breast cancer examination set, breast measurement method and breast cancer examination system - Google Patents

Abstract

In order to enable a subject to measure the internal state of a breast by herself/himself, a breast cancer examination instrument according to the present disclosure includes a cover member covering an area including a scanning area of a probe in the breast of the subject, and a fixing member that brings the cover member into close contact with the breast.

Description

Breast cancer testing equipment, breast cancer testing equipment, breast cancer testing set, breast measurement method and breast cancer testing system

This disclosure relates to breast cancer testing instruments, breast cancer testing devices, breast cancer testing sets, breast measurement methods and breast cancer testing systems.

In breast cancer screening, methods such as palpation, mammography, and ultrasonic diagnosis are generally used. Palpation is rarely used alone and is generally used in combination with mammography or ultrasonography. Mammography is recommended as the standard method of examination, but it causes great pain to the subject due to the strong pressure on the breast. In this respect, the ultrasonic diagnosis only requires scanning the probe (probe) along the surface of the breast, so that the subject is less distressed.

In ultrasonic diagnosis, it is common for the examiner to hold the probe and scan the probe all over the breast. Therefore, the accuracy of the inspection is greatly influenced by the inspector's knowledge, experience, and skill.

The following Patent Document 1 discloses a diagnostic device that automatically scans a probe in order to solve this problem. In the examination using this diagnostic device, the diagnostic device is installed on the subject's breast with the subject's position adjusted so as to keep the breast horizontal. The diagnostic device rotates the probe around the nipple and acquires an ultrasound image of any cross section of the breast. Since the probe is automatically scanned, even an examiner who is not familiar with ultrasonic diagnosis can easily measure the internal state of the breast.

However, the subject must go to a medical institution such as a hospital or clinic to receive an ultrasonic diagnosis, which imposes a heavy burden on the subject. Subjects also often have psychological resistance to exposing their breasts to the examiner. If subjects can easily make measurements without exposing their breasts to others, it is expected that more women will be tested for breast cancer.

Japanese Unexamined Patent Publication No. 2007-22233

The present disclosure provides a breast cancer test device, a breast cancer test device, a breast cancer test set, a breast measurement method, and a breast cancer test system that enable a subject to measure the internal condition of the breast by himself / herself.

The breast cancer testing instrument of the present disclosure includes a cover member that covers a region including a scanning region of a probe in the breast of a subject, and a fixing member that brings the cover member into close contact with the breast.

The breast cancer testing apparatus of the present disclosure covers a measuring unit that moves a probe that irradiates an ultrasonic beam along the surface of the breast of a subject, a driving unit that drives the measuring unit, and the breast at least partially. A cover container including a support portion for supporting the drive portion is provided inside.

In the chest measurement method of the present disclosure, a region including a scanning region of a probe in a subject's breast is covered with a mesh member, and the gel is applied to the mesh member in a state where the mesh member is brought into close contact with the breast by a fixing member. ,
The inside of the breast is measured while moving the probe to be irradiated with ultrasonic waves in contact with the reticulated member.

The breast cancer test set of the present disclosure comprises a breast cancer test device including a cover member covering a region including a scanning region of a probe in the breast of a subject, a fixing member for bringing the cover member into close contact with the breast, and an ultrasonic beam. A measuring unit for moving the probe to be irradiated in contact with the surface of the cover member is provided.

The breast cancer testing system of the present disclosure covers a measuring unit that moves a probe that irradiates an ultrasonic beam along the surface of the breast of a subject, a driving unit that drives the measuring unit, and the breast at least partially. A cover container including a support portion that supports the drive portion inside, a detection unit that detects whether the breast measured by the measurement unit is a left breast or a right breast, and a reflected signal of the ultrasonic beam. It includes an image generation unit that generates image data based on the above, and a display unit that displays information detected by the detection unit and the image data.

The plan view of the breast cancer examination instrument which concerns on embodiment of this disclosure. The back view of the breast cancer examination instrument of FIG. The figure which shows typically the state which attached the measurement sheet to the left breast of a subject. (A) is a perspective view showing the overall appearance of the breast cancer testing apparatus according to the embodiment of the present disclosure. (B) is a plan view of the breast cancer testing device as viewed from directly above. (C) is an external perspective view of the breast cancer inspection device as viewed from the bottom. (D) is a side view of a breast cancer testing device. Top view showing the probe and the main body taken out from the breast cancer inspection device. A side view of the probe and the main body shown in FIG. Bottom perspective view showing a state in which the probe is moved away from the main body. Detailed plan view of the breast cancer testing device. The figure which shows the state of performing the measurement of the left breast of a subject. The block diagram of the breast cancer examination system which concerns on this embodiment. The flowchart of an example of the operation using the chest measurement method which concerns on this embodiment. (A) is a perspective view showing the appearance of the breast cancer inspection device according to the modified example 1. (B) is a cross-sectional view taken along the line L1-L2. (A) is a plan view which shows an example of the breast cancer inspection instrument which concerns on modification 2. (B) is a perspective view showing a state in which a breast cancer test instrument is assembled. (A) is a plan view showing another example of the breast cancer testing instrument according to the modified example 2. (B) is a perspective view showing a state in which a breast cancer test instrument is assembled. FIG. 3 is a plan view showing still another example of the breast cancer testing instrument according to the second modification. (A) is a figure which shows an example of the package structure of the measurement sheet which concerns on modification 2. (B) is a diagram showing an example of taking out a measurement sheet from a package structure. FIG. 5 is a cross-sectional view schematically showing an example of a package structure of a measurement sheet according to a modified example 4. The figure which shows the example of the measurement sheet packaged in the package structure of FIG. The figure explaining the method of taking out the measurement sheet from the package structure of FIG.

Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. In one or more embodiments shown in the present disclosure, the elements included in each embodiment can be combined with each other, and the combined result is also part of the embodiments shown in the present disclosure.

FIG. 1 is a plan view of the breast cancer testing device according to the embodiment of the present disclosure. FIG. 2 is a back view of the breast cancer testing instrument of FIG. The breast cancer testing instrument of FIG. 1 is a measuring sheet having a flat sheet shape. However, as shown in each modification described later, the breast cancer testing device according to this embodiment can have various shapes or structures.

The outline of the measurement sheet 10 shown in FIGS. 1 and 2 will be described. The measurement sheet 10 enables the subject to maintain the breast in a shape suitable for the measurement and to smoothly scan the probe (probe) when the subject makes a measurement for breast cancer examination by himself / herself. Is. The subject attaches the measurement sheet to the breast in any posture such as standing or sitting in the house or the like. For example, the subject covers the back surface of the cover member (reticulated member) 11 of the measurement sheet with the breast, and adjusts the shape of the breast to a shape suitable for measurement (for example, a shape in which the breast is raised) of the measurement sheet. The fixing member 12 is fixed to the breast or the peripheral portion of the breast. The back surface of the fixing member 12 is an adhesive surface, and is fixed by being pressed against the body. More specifically, the fixing member 12 includes a plurality of fixing portions 12A, 12B, and 12C, each of which is adhered to a predetermined position in a predetermined order so that the measurement sheet can be easily fixed to the breast. In the state where the measurement sheet 10 is fixed, even if the subject releases the measurement sheet 10, the measurement sheet 10 does not separate and the shape of the breast is maintained. In this state, the subject covers the breast cancer testing device (measuring device) 30 (see FIG. 4 described later) on the breast to which the measuring sheet 10 is attached, and operates the measuring unit 50 inside the cover container 40 (described later). See FIG. 9). The probe 52 scans the surface of the mesh member of the measurement sheet 10. That is, the probe 52 outputs an ultrasonic beam while moving, and receives the reflected wave signal as measurement data. This measures the internal condition of the breast. As described above, by using the measurement sheet 10 and the breast cancer test device 30 according to the present embodiment, the subject can easily perform the measurement for breast cancer test at home or the like without exposing the breast to another person. Hereinafter, the present embodiment will be described in more detail.

As shown in FIG. 1, the measurement sheet 10 includes a cover member (net-like member) 11 and a fixing member 12 coupled around the cover member 11.

The cover member 11 covers at least a region including the scanning region (measurement region) of the probe in the breast. The cover member 11 is a net-like member and has a circular shape or a substantially circular shape. As an example, the material of the cover member 11 is a material that has elasticity and is capable of transmitting ultrasonic waves. For example, the cover member 11 contains a dielectric material such as nylon, polyurethane, or synthetic fiber. The cover member 11 may contain a single material or may contain a plurality of materials. In order to protect the skin of the breast, the cover member 11 may be made of a material having a low coefficient of friction. The cover member 11 is not limited to being reticulated, and may be made of another shape or other material as long as it can transmit ultrasonic waves. When the cover member 11 is reticulated, the subject can adjust the shape of the breast while observing the shape of the breast.

As shown in FIG. 2, a gel 21 containing water is applied to the back surface of the cover member (net-like member) 11. By applying the gel, it is possible to prevent or suppress air from entering between the cover member 11 and the breast when the measurement sheet 10 is attached to the breast. However, if the cover member 11 can be brought into close contact with the breast when the measurement sheet 10 is attached to the breast, that is, if air can be prevented or suppressed from being mixed between the cover member 11 and the breast, the application of gel is indispensable. No. The gel may be applied in advance, or may be applied when the subject uses the measurement sheet.

In FIG. 1, the fixing member 12 is attached to the cover member 11 toward the outside so as to surround the cover member 11. By fixing the fixing member 12 to the breast or the peripheral portion of the breast, the measurement sheet can be fixed to the breast while maintaining the shape of the breast inside the cover member 11.

As an example, the fixing member 12 is made of a material harder than the cover member 11. For example, the fixing member 12 contains an elastomer. However, the fixing member 12 may be made of another material such as rubber or a hard paper material. When a water-resistant material is used, the fixing member 12 can be maintained without melting or by suppressing the fixing member 12 even in a humid space such as a bathroom or a bathtub.

The fixing member 12 largely includes three fixing portions, that is, a fixing portion 12A (first fixing portion), a fixing portion 12B (second fixing portion), and a fixing portion 12C (third fixing portion). The fixing portions 12A to 12C are attached to the cover member 11 so as to face outward. In the example of the figure, the fixing portions 12A to 12C are integrally configured, but may be attached to the cover member 11 in a separately separated state.

As shown in FIG. 2, an adhesive material 22 such as an adhesive is applied to the back surface of the fixing member 12 (the back surfaces of the plurality of fixing portions 12A to 12C). That is, the back surface of the fixing member 12 (the back surface of the plurality of fixing portions 12A to 12C) is an adhesive surface. The subject can fix the fixed portions 12A to 12C to the body by pressing the fixed portions 12A to 12C against the body from the surface.

A sticker may be attached to the adhesive surface of the fixing member 12 (adhesive surface of a plurality of fixing portions 12A to 12C). In this case, the subject can expose the adhesive surface of the fixing member 12 by peeling off the seal when using the measurement sheet. Alternatively, when the subject uses the measurement sheet, the adhesive material may be applied to the back surfaces of the plurality of fixing portions 12A to 12C. A water resistant material may be used as the adhesive material. In this case, even when the measurement sheet is used in a humid space such as a bathroom or a bathtub, the fixing member 12 can be maintained in a fixed state.

The fixing portions 12A to 12C in FIG. 1 are fixed to predetermined locations around the breast in a predetermined order. More specifically, the fixation portion 12A is fixed to a first location on the central side of the body along the lower edge of the breast. The first location is, for example, a position on the ribs (ribs) near the center of the body. The subject aligns the fixed portion 12A with reference to this position.

The fixing portion 12B is fixed to the outer second place on the opposite side to the central side along the lower edge of the breast. The second location is approximately symmetrical with respect to the first location, for example via the breast. A guide wire 13 is provided in a portion between the fixed portion 12B and the fixed portion 12A. The guide line 13 is formed by printing, for example. The subject can easily position the fixing portion 12B by first fixing the fixing portion 12A and then pressing the fixing member 12 up to the fixing portion 12B along the guide line. The guide wire 13 may be a part of the fixed portion 12A or the fixed portion 12B.

The fixation portion 12C is fixed to a third location near the armpit or armpit on the opposite side of the center of the body along the lower edge of the breast. The fixed portion 12C has a larger area than the fixed portion 12A and the fixed portion 12B. That is, the fixing portion 12C has a wider width than the fixing portion 12A and the fixing portion 12B in the direction from the cover member 11 to the outside. As a result, the meat in or around the lower part of the breast can be collected under the armpit, and the shape of the breast can be easily adjusted.

Information indicating the order in which the fixing portions 12A to 12C are fixed is provided on the surface of the fixing portions 12A to 12C. For example, numbers are provided on the surfaces of the fixing portions 12A to 12C. The fixed portion 12A is provided with "1", the fixed portion 12B is provided with "2", and the fixed portion 12C is provided with "3". The subject can easily attach the measurement sheet by fixing the fixing portions 12A to 12C in the order of the numbers.

Specifically, first, the subject presses the fixing portion 12A with the back surface of the cover member 11 covering the breast to fix it to the body. Next, the fixing portion 12B is fixed by pressing it toward the fixing portion 12B along the guide line in the drawing. Then, while collecting the meat in or near the lower part of the breast under the armpit, the shape of the breast is adjusted and the fixing portion 12C is fixed to the body. This makes it possible to shape the breast into a shape suitable for measurement (for example, a raised shape). Since the measurement sheet 10 is fixed by the fixing member 12, the shape of the breast is maintained even if the subject takes the measurement sheet 10 away from his / her hand.

FIG. 3 schematically shows a state in which the measurement sheet 10 is attached to the left breast of the subject. The fixation portion 12A is fixed at the position of the ribs (ribs) near the center of the body. The fixing portion 12B is fixed at a position substantially symmetrical to the fixing portion 12A via the breast. The fixing portion 12C is fixed to the armpit or the vicinity of the armpit. A part of the fixed portion 12C is sandwiched between the left armpits.

The measurement sheet 10 is provided with a reference mark 14 for alignment with the breast cancer testing device (measuring device). By aligning the alignment mark (seat position adjustment unit) provided on the cover container of the breast cancer inspection device 30 (see FIG. 4) with the reference mark 14 of the measurement sheet 10, the breast cancer inspection device 30 can be easily positioned. Can be done. When the measurement sheet 10 is attached to the breast, the subject may make the reference mark 14 parallel to a predetermined direction (for example, in the height direction of the body). As a result, the subject can more easily attach the measurement sheet 10.

Although the measurement sheet for the left breast is shown in FIGS. 1 and 2, the measurement sheet for the right breast also has the same configuration as that of FIG. 1 except that the shape shown in FIG. 1 is symmetrical.

The measurement sheets shown in FIGS. 1 and 2 may be prepared in a plurality of sizes (for example, small, large, medium, etc.). In this case, the subject can easily attach the measurement sheet by using the measurement sheet according to his / her bust size or bust shape.

Depending on the configuration of the measurement sheet, the measurement sheet can be either a disposable type that is replaced for each measurement or a type that can be used repeatedly by cleaning or the like.

FIG. 4A is a perspective view showing the overall appearance of the breast cancer testing device (measuring device) 30 according to the embodiment of the present disclosure. FIG. 4B is a plan view of the breast cancer inspection device 30 as viewed from directly above. FIG. 4C is an external perspective view of the breast cancer inspection device 30 as viewed from the bottom surface. FIG. 4D is a side view of the breast cancer testing apparatus 30 viewed from the direction of arrow Y shown in FIG. 4B.

The breast cancer testing device 30 shown in FIG. 4 is configured to be commonly used for the left breast and the right breast. The breast cancer inspection device 30 includes a cover container 40, a measurement unit 50 (FIG. 4 (C)) arranged in the cover container 40, and a drive control system (see FIG. 10 described later) for controlling the measurement unit 50. It is a measuring device. The measuring unit 50 includes a main body 51, a probe (probe) 52, and an arm 53 (see FIG. 6 to be described later).

The cover container 40 has a cup shape with a concave side for accommodating the measurement unit 50. At the time of measurement, at least a part of the breast to which the measurement sheet is attached is housed inside the cover container 40. The shape of the cover container 40 is not limited to the cup shape, and may be any shape as long as it can be grasped from the outside and the inner measuring unit 50 can be rotatably supported. For example, the cover container 40 may be formed in the shape of a flat disk. In this case, a grip portion (handle, knob, etc.) of the subject may be provided on the surface of the disk (opposite to the breast).

A drive control system 60 (see FIG. 10) that controls the measurement unit 50 is provided at an arbitrary location in the cover container 40. For example, the drive control system 60 may be provided at or near the ceiling of the cover container 40, a part of the drive control system 60 is provided inside the measurement unit 50, and a part of the drive control system 60 is provided outside the measurement unit 50. May be done. The drive control system 60 may be provided in the measuring unit 50. As will be described later, the drive control system 60 includes a battery, a drive unit (including, for example, a motor), a control unit, a communication unit that communicates with an external device, and the like.

FIG. 5 is a plan view showing the probe 52 and the main body 51 taken out from the breast cancer inspection device 30. FIG. 6 is a side view of the probe 52 and the main body 51 shown in FIG.

As shown in FIG. 5, the shaft 56 of the motor 58 (see FIG. 6) is coupled to the main body 51 of the measuring unit 50 directly or via a gear 57 or the like. The shaft 56 of the motor, the gear 57, and the like form a transmission mechanism. Through this transmission mechanism, the driving force of the motor is transmitted to the main body 51, and the main body 51 is integrated with the probe 52 and rotates about the shaft 56. That is, when the motor 58 is driven, the measuring unit 50 rotates about the shaft 56 of the motor (see the arrow in FIG. 5).

As shown in FIG. 6, a concave portion 59 is provided in the ceiling portion inside the cover container 40 or in the vicinity thereof, and a housing for storing the motor 58 is inserted into the concave portion 59 as a convex portion. The shaft 56 of the motor 58 extending to the opposite side of the ceiling portion is coupled to the main body portion 51. As a result, the measuring unit 50 can be rotated while the motor 58 is fixed and supported by the ceiling portion. The motor 58 constitutes a part of the drive control system 60. The drive control system 60 is electrically connected to the measuring unit 50 and can control the measuring unit 50. The configuration described here is an example, and other configurations may be used as long as the measuring unit 50 is rotatable in the cover container 40. A transmission mechanism (for example, configured by using a gear, a link, etc.) that presses the main body 51 and the probe 52 in the breast direction by using the driving force of the motor 58 may be provided. As a result, the measuring unit 50 can be rotated while pressing the breast with the main body 51 and the probe 52. Further, an urging portion (pressing portion) 55 such as a coil spring may be arranged in the space between the upper portion of the motor 58 and the concave portion 59. As a result, when the subject presses the cover container 40 toward the breast side, the height of the cover container 40 is adjusted according to the shape and size of the breast, and the probe 52 and the main body 51 are pressed with an appropriate force. Can be in close contact with the breast.

The probe 52 in FIG. 6 is connected to the main body 51 by an arm 53. The joint portion (joint portion) of the main body portion 51 with the arm 53 may be controllable by the drive control system 60. Thereby, the angle of the arm 53 may be adjusted. By adjusting the angle of the arm 53, the probe 52 and the breast can be brought into close contact with each other. Further, the arm 53 is configured to be expandable and contractible. For example, the arm 53 includes an outer arm and an inner arm included in the outer arm, and the length of the arm 53 can be adjusted by moving the inner arm. The drive control system 60 controls the adjustment of the length of the arm 53. By adjusting the length of the arm 53, the position of the probe 52 can be moved (sliding) from the position shown in FIG. 6 in the radial direction of rotation, that is, in the direction away from the main body 51.

FIG. 7 is a bottom perspective view showing a state in which the probe 52 is moved away from the main body 51 from the state shown in FIG. 4 (C). As an example, the position of the probe 52 has two states, a first state corresponding to the position shown in FIG. 4C and a second state corresponding to the position shown in FIG. 7. The measurement of the present embodiment is performed, for example, by setting the probe 52 in the first state and rotating the probe 52 once in the circumferential direction of the breast, and further setting the probe 52 in the second state and rotating the probe 52 once more. That is, the measurement region of the breast is divided into a region close to the nipple and a region distant from the nipple, the region close to the nipple is measured in the first state, and the region distant from the nipple is measured in the second state. The region near and far from the nipple may partially overlap each other. As a modification, the probe 52 may be long so as to cover both the region near the papilla and the region far from the papilla, and the probe 52 may be rotated once to perform the measurement.

FIG. 8 is a diagram showing the plan view of FIG. 4 (B) in more detail. The cover container 40 has a shape close to a circle when viewed in a plane. As an example, the cover container 40 is made of a material such as a resin or a silicon material. A part of the cover container 40 is a transmission portion 41. The transmission portion 41 is a transparent member or an opening. The transmission unit 41 is a portion along the path through which the probe 52 of the measurement unit 50 moves. A part of the probe 52 and a part of the main body 51 are visible through the transmission portion 41. Through the transmission unit 41, the subject can visually check how the probe 52 scans and confirm that the measurement unit 50 is operating normally. The light emitting unit 44 is electrically connected to the drive control system 60, and is controlled to emit light according to the operating state of the measuring unit 50. For example, the measuring unit 50 emits light in a predetermined color during measurement, and emits light or turns off in another color during non-measurement. As a result, the subject can easily confirm whether or not the measurement unit 50 is being measured.

The cover container 40 is provided with marks (seat position adjusting portions) 42A and 42B for aligning with the measurement sheet 10 attached to the breast. Mark 42A is for the left breast and Mark 42B is for the right breast. The marks 42A and 42B are transparent members or openings. However, the marks 42A and 42B are not limited to being transparent members or openings, and may be linear marks colored with a specific color. The marks 42A and 42B may be integrally formed with the transmission portion 41.

When measuring the left breast, the measurement sheet 10 for the left breast (see FIG. 1) is attached to the left breast, and the mark 42A of the cover container 40 coincides with the reference mark 14 of the measurement sheet (see FIG. 1). As such, the cover container 40 is arranged. When measuring the right breast, the measurement sheet for the right breast is attached to the right breast, and the cover container 40 is arranged so that the mark 42B of the cover container 40 coincides with the reference mark of the measurement sheet.

As will be described later, the drive control system 60 is equipped with a direction sensor (for example, a gyro or a magnetic sensor) that detects the direction in which the breast cancer inspection device 30 is installed. The drive control system 60 detects that when the mark 42A is placed facing up (facing opposite to the ground), it makes a measurement of the left breast. The drive control system 60 detects that the measurement of the right breast is performed when the mark 42B is arranged so as to face upward. In this way, the drive control system 60 detects whether to inspect the left breast or the right breast based on the orientation in which the breast cancer inspection device 30 is installed.

However, it may be decided whether to perform the examination of the left breast or the right breast based on the operation input of the subject. For example, it may be determined whether to perform the examination of the left breast or the right breast based on the input instruction signal from the operation input unit. The operation input unit may be a button or a touch panel that can be operated by the subject, or may be a receiving unit that receives a signal wirelessly or by wire from a terminal held by the subject.

FIG. 9 shows how the left breast of the subject is measured. A breast cancer inspection device 30 is placed on the left breast to which the measurement sheet 10 is attached. The mark (seat position adjusting portion) 42A for the left breast of the measuring unit 50 is aligned with the reference mark 14 of the measuring sheet 10. The subject maintains a state in which the breast cancer testing device 30 is lightly pressed toward the breast. The subject instructs the start of the measurement in this state. The measurement is started, for example, by manually inputting the measurement start instruction to the operation input unit or by giving an instruction signal from the terminal. In the inspection, the drive control system 60 first sets the position of the probe to the first state and scans the first lap. This measures the area near the nipple. Subsequently, the position of the probe is set to the second state, and the second round of scanning is performed. As a result, the distant region around the neighboring region is measured. The drive control system 60 stores the data measured by the probe in the storage unit.

FIG. 10 is a block diagram of a breast cancer testing system including a breast cancer testing device 30 according to the present embodiment, a terminal 101 which is a communication device operated by a subject, and a diagnostic device 201 installed in a medical institution. The cover container 40 included in the breast cancer testing device 30 is not shown. The drive control system 60 includes a drive unit 61, a control unit 62, a sensor 63, a battery 64, an operation input unit 65, a storage unit 66, an image generation unit 67, and a communication unit 68. At least a part of the drive control system 60 is composed of an electronic circuit board (electronic circuit board for ultrasonic diagnosis) as an example. The shape of the electronic circuit board may be determined according to, for example, the shape of the place where the electronic circuit board is arranged. As an example, the electronic circuit board may have a substantially semicircular or crescent-shaped shape. A light emitting unit 44, a speaker 48, and a display unit 49 are connected to the drive control system 60 via wiring. The light emitting unit 44 and the display unit 49 are arranged at a position visible to the subject, for example, in the cover container 40. The control unit 62 and the image generation unit 67 are realized by software such as a dedicated hardware circuit or a program. The storage unit 66 includes any storage medium such as a non-volatile or volatile memory, a hard disk, an optical disk, and a magnetic disk.

The drive unit 61 drives the measurement unit 50 (main body unit 51 and probe 52). For example, the drive unit 61 includes a motor 58 (see FIG. 6) and rotates the measurement unit 50 around the shaft 56 of the motor 58. More specifically, by rotating the main body 51 by the drive unit 61, the probe 52 coupled to the main body 51 via the arm 53 also rotates integrally.

The control unit 62 controls the entire drive control system 60. The control unit 62 controls each element in the drive control system 60. For example, the control unit 62 starts scanning the probe 52 when it receives a measurement start instruction from the subject. First, the control unit 62 sets the position of the probe 52 in the first state and performs the first scan of the probe 52, and then sets the position of the probe 52 in the second state and performs the second scan of the probe 52. conduct. In each scan, an ultrasonic beam is output from the probe 52, and the reflected signal data of the ultrasonic beam is acquired as measurement data at regular time intervals.

The control unit 62 may control the probe 52 to be pressed against the measurement sheet 10 so that the probe 52 is in close contact with the measurement sheet 10 at the time of measurement. For example, when another motor is provided at the joint portion (joint portion) between the main body portion 51 and the arm 53, the angle of the arm 53 can be adjusted by controlling the motor. The angle of the arm 53 is determined by detecting the contact state of the probe 52 with the measuring sheet 10 by a pressure sensor, a distance sensor, or the like. As a result, the probe 52 is brought into close contact with the measurement sheet 10. Alternatively, the probe 52 may be pressed against the measurement sheet 10 by transmitting the driving force of the driving unit 61 to the arm 53 by a predetermined transmission mechanism (for example, a combination of gears, rollers, or the like). As a result, the probe 52 is brought into close contact with the measurement sheet 10. By bringing the probe 52 into close contact with the measurement sheet 10, air can be prevented from being mixed between the probe 52 and the breast, and high-precision measurement can be performed.

Further, the control unit 62 may control the main body 51 itself to be pressed against the measurement sheet 10 at the time of measurement. For example, when the ceiling portion in the cover container 40 and the motor are connected by a stretchable member, the main body portion 51 is pressed against the measurement sheet 10 by controlling the length of the member. The length of the member may be determined by detecting the contact state of the main body 51 with the measuring sheet using a pressure sensor, a distance sensor, or the like. By pressing the main body 51, the breast region other than the probe 52 is also pressed, so that the shape of the breast is stabilized and more accurate measurement becomes possible. The method of pressing the probe 52 and the main body 51 described here is an example, and other methods may be used.

The sensor 63 includes a direction sensor that detects the direction in which the breast cancer inspection device 30 is installed. Directional sensors include, for example, accelerometers, magnetic sensors or gyroscopes. Further, the sensor 63 may include a sensor (for example, a pressure sensor, a distance sensor, etc.) that detects a contact state between the probe 52 or the main body 51 and the measurement sheet 10.

Further, the sensor 63 may include other sensors such as a biological sensor, an image sensor, a temperature sensor, and a humidity sensor. The control unit 62 may perform control using at least one of these sensors. For example, a biosensor may be used to detect the health condition of the subject, and the measurement may be permitted only when there is no problem in the health condition of the subject. Further, the subject may be identified by using an image sensor, and the measurement may be permitted only in the case of a pre-registered subject.

The battery 64 supplies the voltage required for operation to the measurement unit 50, the elements 61 to 63, 65 to 68 in the drive control system 60, the light emitting unit 44, the speaker 48, and the display unit 49. The measuring unit 50 may separately include a battery different from the battery 64 and operate using the battery.

The operation input unit 65 is an interface for the subject to input various instructions or data. As an example, the operation input unit 65 is a receiving unit that receives instructions or data from a touch panel, one or more buttons, or a terminal 101 held by a subject. The receiving unit may receive either by wire or wirelessly. Further, the operation input unit 65 may be a voice input unit that acquires instructions or data by voice recognition of a voice signal spoken by the subject. Further, the operation input unit 65 may be a gesture input unit that detects the gesture of the subject and acquires instructions or data according to the gesture.

The storage unit 66 stores the measurement data acquired by scanning the probe 52 in association with the additional information. Additional information includes index, measurement time, breast identification information that identifies whether the measured breast is the left breast or the right breast, and the like. The measurement time is, for example, a sampling time at regular intervals.

The image generation unit 67 generates image data representing the internal state of the breast based on the measurement data (data of the reflected signal of the ultrasonic beam) acquired by scanning the probe 52. The image data to be generated may be two-dimensional image data or three-dimensional image data. The image generation unit 67 may include a three-dimensional image generation unit that generates three-dimensional image data based on measurement data or two-dimensional image data.

The storage unit 66 stores additional information in association with the image data generated by the image generation unit 67. Additional information includes index, examination time, data size, breast identification information that identifies whether the examined breast is the left breast or the right breast. In addition, the additional information may include information such as image resolution and file format.

The storage unit 66 is used for a program to be executed by the CPU and execution of the program when the control unit 62 or the image generation unit 67 or the like is realized by a program executed by a processor such as a CPU (Central Processing Unit). The parameters may be stored. In addition, the storage unit 66 may store instructions or data input by the operation input unit 65, data or information used in the drive control system 60, data received from an external device such as the terminal 101, and the like.

The communication unit 68 communicates with the subject's terminal 101 by wire or wirelessly. For example, communication is performed by wireless LAN, Bluetooth, infrared communication, USB (Universal Serial Bus), mobile line, or the like. Further, the communication unit 68 may similarly be able to communicate with the diagnostic device 201 by wire or wirelessly.

The light emitting unit 44 includes a light emitting element capable of emitting one or more colors. The light emitting unit 44 includes one or more LEDs (Light Emission Diodes) as an example. By causing the light emitting unit 44 to emit a color corresponding to the operating state of the breast cancer testing device 30, the subject can easily recognize the operating state of the breast cancer testing device 30. As an example, while the breast is being measured by the probe 52, the light emitting unit 44 is made to emit light in the first color. This makes it possible for the subject to recognize that the measurement is in progress. Further, while the image data is being transmitted from the communication unit 68 to the terminal 101, the light emitting unit 44 is made to emit light in the second color. This makes it possible for the subject to recognize that the image data is being transmitted.

The speaker 48 is a device that outputs sound. For example, the control unit 62 outputs the operating state of the breast cancer examination device 30 by voice from the speaker 48, or outputs an instruction to the subject by voice from the speaker 48. As examples of voice instructions, "When the measurement sheet is installed, align the mark on the measurement sheet with the mark on the cover container", "When the alignment is complete, press the start button for measurement", etc. There is a message of.

The display unit 49 is a device that displays various instructions or data. The display unit 49 is, for example, a liquid crystal display device, an organic EL display device, or the like. The control unit 62 displays the operating state of the breast cancer testing device 30 and displays instructions to the subject. As an example of the operating state, a message such as "Measuring", "Measuring completed", or "Sending image data" may be displayed. Further, the same message as in the case of outputting the above-mentioned voice message may be displayed.

The breast cancer examination device 30 transmits at least one image data of the left and right breasts stored in the storage unit 66 and additional information thereof to the terminal 101 based on the instruction of the subject. Further, the breast cancer examination device 30 may transmit measurement data of at least one of the left and right breasts stored in the storage unit 66 and additional information thereof to the terminal 101 based on the instruction of the subject.

The terminal 101 is a communication device used by the subject. Examples of the terminal 101 include a smartphone, a personal computer (notebook PC, desktop PC, etc.), a tablet device, or a mobile phone. A breast cancer test application (test application) is stored in the terminal 101. By activating the test application, the subject can transmit various instructions or data from the terminal 101 to the breast cancer test device 30. As an example, the terminal 101 instructs the start of measurement. Further, the image data is transmitted to the terminal 101 as the test result acquired by the breast cancer test device 30. The terminal 101 may display the image data and its additional information on the display unit of the terminal 101. Further, the terminal 101 may display the measurement data and its additional information on the display unit of the terminal 101.

The terminal 101 can communicate with the diagnostic device 201 via the communication network 200. The communication network 200 may be a local area network or a wide area network such as the Internet. The terminal 101 transmits the diagnosis request information requesting the diagnosis of at least one of the left and right breasts to the diagnosis device 201. The diagnosis request information includes information about the subject, image data of at least one breast for which a diagnosis is requested, and additional information thereof. Alternatively, the diagnosis request information may include information about the subject, measurement data of at least one of the left and right breasts for which the diagnosis is requested, and additional information thereof. The information about the subject includes, for example, the subject's ID, name, age, gender, and the like.

The diagnostic device 201 is an information terminal installed in a medical institution such as a hospital or clinic. The diagnostic device 201 is operated by a medical worker such as a doctor or a nurse. The diagnostic device 201 may store an electronic medical record that stores medical information of the subject. The diagnostic device 201 can communicate with the terminal 101 via the communication network 200, and receives the diagnosis request information from the terminal 101.

The diagnostic device 201 includes a diagnostic unit 211, a management unit 212, and a display unit 214. In addition, the diagnostic device 201 includes an operation input unit, a communication unit, and the like. The management unit 212 manages information about the subject, image data, and additional information thereof based on the diagnosis request information. The management unit 212 may normalize the image data to a predetermined size and use the normalized image data as diagnostic image data. The diagnostic device 201 includes a storage unit 213 that stores various data and information to be managed. The storage unit 213 includes an arbitrary recording medium such as a volatile or non-volatile memory, a hard disk, an optical disk, or a magnetic disk.

The diagnosis unit 211 diagnoses the breast of the subject based on the image data and additional information of the subject. Diagnosis is performed, for example, by executing a diagnostic program. The diagnostic program detects tumors by methods such as image clustering and neural networks. The diagnosis unit 211 may display the diagnosis result on the display unit 214 and obtain confirmation from a doctor.

Further, the diagnosis unit 211 may display information such as image data required for the diagnosis by the doctor on the screen, and the doctor may perform the examination and the diagnosis based on the displayed information. The diagnosis unit 211 may acquire the diagnosis result by the doctor from an operation input unit such as a touch panel, a keyboard, a mouse, or a voice input unit.

The diagnosis unit 211 may store the diagnosis result in the storage unit 213 in association with the information of the subject.

The diagnosis unit 211 may generate a schematic diagram as a part of the diagnosis result. The schematic diagram includes an image schematically showing the image data of the breast. Information identifying the location of the detected tumor may be superimposed on the image.

The diagnosis unit 211 generates response data including the diagnosis result of the subject. The response data includes, for example, information about the subject, diagnosis results, and the like. The diagnostic device 201 may transmit the response data to the terminal 101 via the communication network 200. Answer data will be sent by a secure method such as encryption or password. Alternatively, the diagnostic device 201 may print the response data on paper. In this case, the medical staff may send or hand the diagnosis result table to the subject.

When the image data is a two-dimensional image, the management unit 212 may generate a three-dimensional image from the image data by using a model such as a neural network. The display unit 214 may display a three-dimensional image. Doctors can expect to make a more appropriate diagnosis by checking the images of breast test results in three dimensions. The management unit 212 may include a three-dimensional image generation unit that generates three-dimensional image data based on the two-dimensional image data or the measurement data.

FIG. 11 is a flowchart of an example of the chest measurement method according to the present embodiment. The cover member (reticulated member) 11 of the measurement sheet 10 is put on the breast (left breast or right breast) of the subject, and the fixing member 12 of the measurement sheet 10 is fixed around the breast (S11). As an example, the measurement sheet 10 is attached by fixing the fixing portions 12A, 12B, and 12C at predetermined positions around the breast in this order (see FIG. 3). When the gel is not applied to the reticulated member 11, the subject applies the gel containing water to the reticulated member 11. The gel may be applied using a coating device for applying the gel. The application device may be provided in the breast cancer inspection device 30, and after the breast cancer inspection device 30 is installed, the application device may apply the gel under the control of the control unit 62.

The subject installs the breast cancer examination device 30 on the breast to which the measurement sheet 10 is attached (S12). The installation is performed so that the cover container 40 contains at least a part of the breast to which the measurement sheet 10 is attached. In the case of the left breast, the alignment is performed so that the mark (seat position adjusting portion) 42A of the cover container 40 matches the reference mark 14 of the measurement sheet 10. In the case of the right breast, the mark (seat position adjusting portion) 42B of the cover container 40 is aligned so as to match the reference mark of the measurement sheet for the right breast. The subject may adjust the force for pressing the breast cancer inspection device 30 so that the probe 52 and the main body 51 are in close contact with the measurement sheet 10.

The breast cancer testing device 30 starts the measurement when the subject gives an instruction to start the measurement. The probe 52 is scanned with the position of the probe 52 as the first state close to the papilla (S13). The probe 52 is made to go around the breast while irradiating ultrasonic waves in a state of being in close contact with the mesh member 11 of the measurement sheet 10, and the signal of the reflected wave is acquired as measurement data. After the probe 52 makes one round, the position of the probe 52 is set to the second state far from the papilla, and the probe 52 is scanned again (S13). The breast cancer examination device 30 generates image data showing the internal state of the breast based on the measurement data acquired in two steps (S14).

As described above, according to the present embodiment, the subject can easily adjust and fix the breast in a shape suitable for measurement by himself / herself by using the measurement sheet including the cover member covering the breast and the fixing member. .. In addition, by using the breast cancer testing device with the measurement sheet attached, the internal condition of the breast can be easily measured by itself. By using the set of the measurement sheet and the breast cancer test device (breast cancer test set) in this way, the subject can easily measure the breast at home or the like with high accuracy.

In the present embodiment, the breast is measured with the measurement sheet attached, but depending on the shape of the breast, it is also possible to directly install the breast cancer inspection device on the breast without attaching the measurement sheet to perform the measurement. Is. At this time, the gel may be applied directly to the breast to scan the probe on the breast.

In this embodiment, it is assumed that the subject performs the measurement at home or the like, but the measurement may be performed at a medical institution. For example, in a medical institution, in a space where there are no medical personnel such as doctors and nurses, measurement is performed using the measurement sheet and the breast cancer inspection device according to the present embodiment. After the measurement, the medical worker may directly read the image data or the like stored in the breast cancer testing device into the diagnostic device 201. Reading is performed by wireless or wired communication. Alternatively, an image data or the like may be read from the breast cancer inspection device by a removable memory device, and the read image data or the like may be written to the diagnostic device 201. According to this, the subject can receive advice from the medical staff on the spot about how to use the measurement sheet and the breast cancer testing device, so that the measurement can be performed more easily.

(Modification 1)
FIG. 12A is a perspective view showing the appearance of the breast cancer testing instrument 70 according to the first modification. 12 (B) is a cross-sectional view taken along the line L1-L2 of FIG. 12 (A). The breast cancer testing instrument 70 of FIG. 12 has a cup-shaped shape. The breast cancer testing instrument 70 of FIG. 12 is referred to as a measuring cup 70. The measuring cup 70 includes a cover member 71 and a fixing member 72 coupled outward to the end of the cover member 71. The measuring cup 70 is prepared for the right breast and the left breast, respectively, as an example. The measuring cup 70 may be made to order for an individual, or a plurality of sizes may be lined up, and the subject may use a measuring cup according to the shape or size of his / her breast.

The cover member 71 covers the breast of the subject, at least the region including the scanning region (measurement region) of the probe in the breast, and adjusts the shape of the breast to a shape suitable for measurement. The cover member 71 contains a dielectric material. The cover member 71 has elasticity such as silicon as an example. At least the inside of the cover member 71 contains a sticky material. This facilitates mounting and enhances the adhesion between the inner surface of the cover portion 71 and the breast. When a material having no adhesiveness or low adhesiveness is used, the adhesive material may be applied to the inner surface of the cover member 71. The material of the cover member 71 may be another material as long as it can transmit ultrasonic waves. The cover member 71 is formed with a plurality of air holes including air holes 73A, 73B, 73C, and 73D. This makes it possible to prevent or suppress air from entering between the breast and the cover member 71 when the measuring cup 70 is attached.

The outer shape of the cover member 71 has a hemispherical shape or a substantially hemispherical shape. As an example, the outer shape of the cover member 71 is a perfect semicircle. The inside of the cover member 71 has a shape that matches the breast. Therefore, as shown in FIG. 12B, the thickness of the cover member 71 differs depending on the location. The fact that the thickness of the cover member 71 varies from place to place does not substantially affect the measurement data of the probe 52.

The various configurations described in the present embodiment described above can also be applied to the present modification 1. For example, the measuring cup 70 may be provided with a reference mark for alignment with the breast cancer testing device. Further, the fixing member 72 may include a plurality of fixing portions. Information indicating the order in which the plurality of fixed portions are fixed may be described in the plurality of fixed portions. Also when the measurement cup 70 of the present modification 1 is used, the measurement by the probe 52 can be performed by using the breast cancer inspection device 30 as in the above-described embodiment. In the first modification, the probe 52 is scanned on the surface of the measuring cup 70. A material such as gel may be applied to the surface of the measuring cup 70 to facilitate scanning of the probe 52.

(Modification 2)
FIG. 13A is a plan view showing an example of the breast cancer testing instrument 80 according to the modified example 2. 13 (B) is a perspective view showing a state in which the breast cancer testing instrument 80 of FIG. 13 (A) is assembled. The breast cancer test device 80 of this variant may be commonly used for both the left and right breasts, or may be configured for the right breast and the left breast, respectively. In addition, a plurality of sizes may be lined up, and the subject may use a measurement sheet according to the shape or size of his / her breast.

The breast cancer test instrument 80 in FIG. 13 (A) is a measurement sheet having a flat sheet shape. The measuring sheet 80 includes a material capable of retaining water such as a paper material or a sponge. As an example, the measurement sheet 80 is a non-woven fabric. The gel has penetrated into the measuring sheet 80, and the gel is held by the water retention mechanism. The front surface and the back surface of the measurement sheet 80 are also covered with gel.

The measurement sheet 80 has a substantially flat circular shape. The center of the measurement sheet 80 is a hole 81, and one notch 82 and a plurality of elongated notches 83 are formed radially from the hole 81. The holes 81 and the notches 82 and 83 are continuous. The notch 82 reaches the outer end of the measurement sheet 80, and the notch 83 is formed halfway between the hole 81 and the outer end. The notch 82 allows the measurement sheet 80 to be assembled into a substantially trapezoidal conical shape, as shown in FIG. 13 (B). When the measurement sheet 80 is assembled into a trapezoidal conical shape, it is possible to prevent a gap from being left on the side surface by overlapping the sheet portions on both sides of the notch portion 83. The area 84 is an area in which the sheet portions on both sides of the cutout portion 83 are overlapped with each other.

The subject aligns the hole 81 at the top of the substantially trapezoidal cone so that the papilla is included, and the back surface of the measurement sheet 80 is brought into close contact with the scanning region (measurement region) of the probe around the papilla. Assemble the measuring sheet 80. At this time, the sheet portions on both sides of the cutout portion 83 are overlapped with each other so that no gap is formed in the measurement area. By adjusting the size of the overlapping area, the height of the substantially trapezoidal cone can also be adjusted. The gel on the back surface of the measuring sheet 80 causes the measuring sheet 80 to come into close contact with the breast. In this modification, the non-woven fabric corresponds to the cover member, and the gel corresponds to the fixing member.

The various configurations described in the above-described embodiment can also be applied to the present modification 2. For example, the measurement sheet may be provided with a reference mark for alignment with the breast cancer testing device. Similar to the above-described embodiment, the breast cancer inspection device 30 can be placed on the breast via the measurement sheet 80, and the measurement can be performed by the probe 52. Since the gel is applied to the surface of the measurement sheet 80, the probe 52 can be smoothly moved while being in close contact with the probe 52.

FIG. 14 (A) is a plan view showing another example of the breast cancer test instrument (measurement sheet) 90 according to the modified example 2. 14 (B) is a perspective view showing a state in which the breast cancer testing instrument 90 of FIG. 14 (A) is assembled. The measurement sheet 90 of FIG. 14 contains the same material as the measurement sheet of FIG. 13 described above. The measuring sheet 90 is impregnated with gel. Hereinafter, the parts different from the breast cancer test instrument 80 in FIG. 13 will be mainly described, and the common parts will be omitted as appropriate.

A hole 91 is formed near the center of the measurement sheet 90, and a notch 92 and a plurality of elongated notches 93 are formed radially from the hole 91. The cutout portion 92 reaches the outer end of the measuring sheet 90. The cutout portion 93 does not reach the outer end of the measurement sheet 90, and is shorter than the configuration of FIG. 13 described above. As an example, the length of the cutout portion 93 is 1/2 or less, 1/4 or less, or 1/3 or less of the length from the center to the outer end of the hole 91. Further, the measuring sheet 90 is formed with a plurality of elongated notched portions 94 from the outer end toward the hole 91. As an example, the length of the notch portion 94 is 1/2 or less, 1/4 or less, or 1/3 or less of the length from the outer end to the center of the hole 91.

The measurement sheet 90 of FIG. 14 can be assembled in the same manner as the measurement sheet of FIG. In the configuration of FIG. 14, since short notches are formed on the inside and the outside, the measurement sheet 90 can be brought into close contact with the breast without generating an overlapping region of the sheet portions. Therefore, the generation of a step is suppressed, and the probe 52 can be moved more smoothly.

FIG. 15A is a plan view showing still another example of the breast cancer test instrument (measurement sheet) according to the modified example 2. In the breast cancer test instrument (measurement sheet) 110 of FIG. 15A, a hole 111 is formed in the vicinity of the center, and a notch 112 extending from the hole 111 to the outer end is formed. No notch is formed other than the notch 112. When the measurement sheet 110 is attached to the breast, it is possible to more reliably prevent a gap from being generated in the measurement area of the probe 52. Further, since there is only one place where the sheet portions can overlap with each other, the probe 52 can be moved smoothly.

FIG. 15B is a plan view showing still another example of the breast cancer test instrument (measurement sheet) according to the modified example 2. In the breast cancer test instrument (measurement sheet) 120 of FIG. 15B, a hole 121 is formed in the vicinity of the center, and a notch 122 extending from the hole 121 to the outer end is formed. Further, a plurality of elongated notched portions 123 are formed from the outer end toward the hole 121. The configuration of FIG. 15B is the same as that of the above-mentioned measurement sheet of FIG. 14 in which the inner notch is not provided. With this configuration, it is possible to prevent a gap from being generated in the measurement area of the probe 52 when the measurement sheet 120 is attached to the breast. Further, since there is only one place where the sheet portions can overlap with each other, the probe 52 can be moved smoothly.

As described above, according to the present modification 2, an assembly-type measurement sheet made of a non-woven fabric or the like can be realized.

(Modification 3)
FIG. 16A shows an example of a package structure in which the measurement sheet according to the above-mentioned modification 2 is packaged. FIG. 16A shows an example of a package structure in which both sides of the measurement sheet 120 of FIG. 15B are sandwiched between the film 131 and the film 132. One surface (first surface) of the measurement sheet 120 is covered with the film 131 (first film), and the other surface (second surface) is covered with the film 132 (second film). By sandwiching the measurement sheet 120 with a film, it is possible to prevent the gel contained in the measurement sheet 120 from drying out. The other measurement sheets of FIGS. 13, 14 and 15 (A) can be sandwiched between the films in the same manner. Further, the measurement sheet of FIG. 1 according to the above-described embodiment may be sandwiched between films in the same manner.

FIG. 16B shows an example of taking out the measurement sheet 120 from the package structure of FIG. 16A. The film 131 (first film) is peeled off from one surface (first surface) of the measurement sheet 120, and the film 132 (second film) is peeled off from the other surface (second surface). As a result, the measurement sheet 120 can be taken out. Since the gel is held on the taken-out measurement sheet 120, the subject can easily attach the measurement sheet to the breast as it is.

As described above, according to the present modification 3, it is possible to realize a package structure in which the gel can be permeated and held in the cover member.

(Modification example 4)
FIG. 17 is a cross-sectional view schematically showing an example of a package structure in which the measurement sheet according to the modified example 4 is packaged.

FIG. 18 shows an example of a measurement sheet packaged in the package structure of FIG. This measurement sheet has a structure similar to that in FIG. FIG. 17 schematically shows a cross section taken along the line L3-L4 of FIG. In the cross-sectional view of FIG. 17, the vertical scale is larger than the horizontal scale.

In FIG. 17, the surface of the measurement sheet 10 is covered with a film 301 (third film). That is, the film 301 covers the surface of the fixing member 12 and the surface of the cover member 11 on the same side as the surface of the fixing member. The gel 302 is applied to the region of the back surface of the film 301 including the portion facing the surface of the cover member 11. The gel 302 is covered with a film 303 (fourth film). The outer peripheral portion of the film 303 is bonded to the film 301, and the film 303 can be easily peeled off from the film 301. The method of bonding may be any, such as an adhesive material, an adhesive tape, or a punched cut line. Of the back surface of the film 301, the portion where the film 303 does not exist is bonded to the front surface of the fixing member 12. The bonding method may be any adhesive material, adhesive tape, or the like. It suffices if the film 303 is bonded with such a force that the subject can easily peel it off.

An adhesive material 304 for adhesion to the breast is formed on the back surface of the fixing member 12. The back surface of the measurement sheet 10 is covered with a film 305 (fifth film), and the film 305 has a role of sealing the adhesive material 304. By peeling off the film 305, the adhesive material 304 is exposed. In this example, the entire back surface of the measurement sheet 10 is covered with the film 305, but only the portion where the adhesive material 304 is formed may be covered. The films 301, 303, and 305 are members formed of a thin film, and include, as an example, a polymer compound such as cellulose.

FIG. 19 is a diagram illustrating a method of taking out a measurement sheet from the package structure of FIG. First, the film 301 on the front side of the measurement sheet 10 is pinched on one end, and the film 301 is peeled off using the opposite end of the film 301 as a fulcrum until the film 303 on the back side of the film 301 is exposed. (1)). At this time, since the film 303 on the back surface side of the film 301 is bonded to the film 301, the film 303 also separates from the measurement sheet 10.

Next, the film 303 on the back surface side of the film 301 is peeled off (FIG. 19 (2)) to expose the gel 302 (FIG. 19 (3)). After the gel 302 is exposed, the film 301 is returned to its original position to attach the gel 302 to the cover member (reticulated member) 11 (FIG. 19 (4)). The subject completely peels off the film 301 from the measurement sheet 10 while rubbing the film 301 on the cover member 11 so as to transfer the gel 302 to the cover member 11 (FIG. 19 (5)). Next, the film 305 attached to the back surface of the measurement sheet 10 is peeled off to expose the adhesive material 304 on the back surface of the fixing member 12 (FIG. 19 (6)). The measurement sheet thus taken out is attached to the breast by the subject by the method described in the above-described embodiment (see FIG. 3).

According to this modification 4, it is possible to realize a package structure in which the gel can be applied to the cover member immediately before use.

It should be noted that the above-described embodiment shows an example for embodying the present disclosure, and the present disclosure can be implemented in various other forms. For example, various modifications, substitutions, omissions, or combinations thereof are possible without departing from the gist of the present disclosure. The forms in which such modifications, substitutions, omissions, etc. are made are also included in the scope of the invention described in the claims and the equivalent scope thereof, as are included in the scope of the present disclosure.

Further, the effects of the present disclosure described in the present specification are merely examples, and other effects may be obtained.

The present disclosure may also have the following structure.
[Item 1]
A cover member covering the area including the scanning area of the probe in the breast of the subject,
A fixing member that brings the cover member into close contact with the breast,
Breast cancer testing device equipped with.
[Item 2]
The breast cancer testing instrument according to item 1, wherein the fixing member has an adhesive surface that adheres to the breast or a peripheral portion of the breast.
[Item 3]
The breast cancer testing instrument according to item 1 or 2, wherein the fixing member includes a plurality of fixing portions.
[Item 4]
The plurality of fixing portions are
A first fixation portion fixed to a first location on the central side of the body along the lower edge of the breast.
A second fixation portion fixed to a second location on the outer side opposite to the center side along the lower edge of the breast.
The breast cancer testing instrument according to item 3, comprising a third fixation portion fixed to a third location along the lower edge of the breast at or near the armpit on the opposite side of the center.
[Item 5]
In the first fixing portion, the second fixing portion, and the third fixing portion, the first fixing portion, the second fixing portion, and the third fixing portion are in this order, the first fixing portion, and the second fixing portion. The breast cancer test device according to item 4, which is numbered in the order of fixing the first fixing portion, the second fixing portion, and the third fixing portion, which indicates that the third fixing portion is fixed.
[Item 6]
Item 4. The breast cancer testing instrument according to Item 4, wherein the third fixing portion has a wider width than the first fixing portion and the second fixing portion in a direction outward from the cover member.
[Item 7]
The breast cancer testing device according to any one of items 1 to 6, wherein the cover member includes a dielectric material.
[Item 8]
The breast cancer testing device according to any one of items 1 to 7, wherein the cover member is a sheet-shaped member.
[Item 9]
The breast cancer testing device according to any one of items 1 to 8, wherein the cover member is a mesh member.
[Item 10]
The breast cancer testing device according to any one of items 1 to 9, wherein the cover member includes an elastic material.
[Item 11]
The breast cancer testing instrument according to any one of items 1 to 10, wherein a gel is applied to the surface of the cover member on the side covering the scanning region.
[Item 12]
The cover member is provided with a reference mark for alignment with a measuring device that measures the inside of the breast via the cover member.
The breast cancer testing device according to any one of items 1 to 11.
[Item 13]
The breast cancer testing instrument according to any one of items 1 to 12, wherein the fixing member contains a material harder than the cover member.
[Item 14]
The breast cancer testing device according to any one of items 1 to 13, wherein the fixing member contains an elastomer.
[Item 15]
The cover member and the fixing member include a dielectric material, and the cover member and the fixing member include a dielectric material.
The breast cancer testing instrument according to any one of items 1 to 14, wherein the cover member is provided with at least one air hole.
[Item 16]
The cover member is a non-woven fabric and is
The fixing member is a gel impregnated into the non-woven fabric.
The non-woven fabric is provided with holes.
A notch is provided from the hole to reach the outer end of the nonwoven fabric.
The breast cancer testing device according to any one of items 1 to 15.
[Item 17]
The breast cancer testing instrument according to item 16, wherein the breast cancer testing instrument is formed radially from the hole and is provided with at least one notch that does not reach the outer end.
[Item 18]
The breast cancer testing instrument according to item 16, wherein at least one notch is formed from the outer end toward the hole, and the at least one notch does not reach the hole.
[Item 19]
A first film provided on the first surface of the nonwoven fabric and covering the gel,
A second fill provided on the second surface of the nonwoven fabric and covering the gel,
16. The breast cancer testing instrument according to item 16.
[Item 20]
The breast cancer test instrument has a sheet-like shape and has a sheet-like shape.
It covers the first surface of the fixing member and the first surface of the cover member on the same side as the first surface of the fixing member, and a part of the third film is fixed to the first surface of the fixing member. With the third film
A gel applied to a part of the third film facing the first surface of the cover member, and
The fourth film covering the gel and
The adhesive material provided on the second surface of the fixing member and
A fifth film covering the adhesive material and
The breast cancer testing device according to any one of items 1 to 19, comprising the above.
[Item 21]
A measurement unit that moves a probe that irradiates an ultrasonic beam along the surface of the subject's breast via an arm.
The drive unit that drives the measurement unit and
A cover container containing a support portion that covers the breast at least partially and supports the drive portion inside.
Breast cancer testing device equipped with.
[Item 22]
The breast cancer testing apparatus according to item 21, wherein the portion of the cover container along the path through which the probe moves is formed of a permeation member or has an opening.
[Item 23]
A battery that supplies an operating voltage to the drive unit is provided.
The breast cancer testing apparatus according to item 21 or 22, wherein the driving unit moves the probe in the scanning region of the breast.
[Item 24]
The drive unit moves the probe in a sheet in close contact with the breast, and the cover container covers the breast at least partially via the sheet.
The cover container has a plurality of seat position adjusting portions for aligning the cover container with the seat, and the plurality of seat position adjusting portions are formed of a transmissive member or serve as an opening. The breast cancer testing apparatus according to any one of 23.
[Item 25]
The breast cancer testing apparatus according to item 24, which can be commonly used for the left breast and the right breast of the subject.
[Item 26]
A detection unit that detects whether the breast measured by the measuring unit is a left breast or a right breast.
An image generation unit that generates image data based on the reflected signal of the ultrasonic beam, and an image generation unit.
The breast cancer testing device according to any one of items 21 to 25, the communication unit that transmits the information detected by the detection unit and the image data to the communication device.
[Item 27]
The detection unit identifies the installation direction of the breast cancer inspection device by the orientation sensor, and detects whether the breast measured by the measurement unit is the left breast or the right breast according to the installation direction.
Item 26. The breast cancer testing apparatus.
[Item 28]
An image generation unit that generates image data based on the reflected signal of the ultrasonic beam, and an image generation unit.
The breast cancer testing apparatus according to any one of items 21 to 27, comprising a storage unit for storing the image data.
[Item 29]
The breast cancer testing apparatus according to any one of items 21 to 28, wherein the probe is pressed against the breast while the probe is being moved.
[Item 30]
The breast cancer testing apparatus according to any one of items 21 to 29, wherein the cover container has a disk shape, a cup shape, or a concave shape on the side of the breast.
[Item 31]
An electronic circuit board for ultrasonic diagnosis that electronically controls the measurement unit is provided.
The breast cancer testing apparatus according to item 30, wherein the electronic circuit board for ultrasonic diagnosis has a shape of a substantially semicircle or a crescent shape.
[Item 32]
The breast cancer testing device is installed so that the cover container covers at least a part of the breast.
The breast cancer testing apparatus according to any one of items 21 to 31, further comprising a control unit for adjusting the angle of the arm according to the shape of the breast.
[Item 33]
The breast cancer testing apparatus according to any one of items 21 to 32, wherein the cover container is expandable and contractible in the height direction and can be adjusted to a position suitable for the breast.
[Item 34]
The breast cancer testing apparatus according to any one of items 21 to 33, which comprises a display unit or a light emitting unit indicating an operating state of the measurement unit.
[Item 35]
The breast cancer testing apparatus according to any one of items 21 to 34, wherein the cover container contains a silicon material.
[Item 36]
The area including the scanning region of the probe in the breast of the subject is covered with a reticulated member, and the gel is applied to the reticulated member in a state where the reticulated member is in close contact with the breast by the fixing member.
A chest measurement method for measuring the inside of the breast while moving the probe to be irradiated with ultrasonic waves in contact with the reticulated member.
[Item 37]
A breast cancer testing instrument including a cover member covering the area including the scanning area of the probe in the breast of the subject and a fixing member for bringing the cover member into close contact with the breast.
A breast cancer examination set including a measurement unit that moves the probe that irradiates an ultrasonic beam in contact with the surface of the cover member via an arm.
[Item 38]
A measurement unit that moves a probe that irradiates an ultrasonic beam along the surface of the subject's breast via an arm.
The drive unit that drives the measurement unit and
A cover container containing a support portion that covers the breast at least partially and supports the drive portion inside.
A detection unit that detects whether the breast measured by the measuring unit is a left breast or a right breast.
An image generation unit that generates image data based on the reflected signal of the ultrasonic beam, and an image generation unit.
A breast cancer examination system including a display unit that displays information detected by the detection unit and the image data.
[Item 39]
A management unit that manages the information and the image data,
A diagnostic unit that diagnoses the subject based on the information and the image data,
38. The breast cancer testing system according to item 38.
[Item 40]
The breast cancer examination system according to item 39, wherein the management unit normalizes the image data to a predetermined size and manages the normalized image data.
[Item 41]
The breast cancer testing system according to item 39, wherein the diagnostic unit generates a schematic diagram showing a diagnostic result of the subject for answering the diagnostic result to the subject.
[Item 42]
A three-dimensional image generation unit that generates three-dimensional image data inside the breast based on the image data or the reflection signal is provided.
The breast cancer inspection system according to any one of items 38 to 41, wherein the display unit displays the three-dimensional image data.

10 Measurement sheet 11 Cover member (mesh member)
12 Fixing member 12A Fixing part 12B Fixing part 12C Fixing part 13 Guide wire 14 Reference mark 21 Gel 22 Adhesive material 30 Breast cancer inspection device 40 Cover container 41 Permeation part 42A, 42B mark (Sheet position adjustment part)
44 Light emitting unit 48 Speaker 49 Display unit 50 Measuring unit 51 Main unit 52 Probe (probe)
53 Arm 55 Bounce part (pressing part)
56 Axis 57 Gear 58 Motor 59 Concave part 60 Drive control system 61 Drive unit 62 Control unit 63 Element 63 Sensor 64 Battery 65 Operation input unit 66 Storage unit 67 Image generation unit 68 Communication unit 70 Breast cancer inspection device (measurement cup)
71 Cover member 72 Fixing member 73A-73D Air hole 84 Area 101 Terminal 80, 90, 110, 120 Breast cancer inspection instrument (measurement sheet)
81, 91, 111, 121 Holes 82, 83, 92, 93, 94, 112, 122, 123 Notch 131, 132 Film 200 Communication Network 201 Diagnostic Device 211 Diagnostic Unit 212 Management Unit 213 Storage Unit 214 Display Unit 301, 303 Film 302 Gel 304 Adhesive Material 305 Film

Claims (42)

1. A cover member that covers the scanning area of the probe in the subject's breast,
   A fixing member that brings the cover member into close contact with the breast,
   Breast cancer testing device equipped with.
2. The breast cancer testing instrument according to claim 1, wherein the fixing member is attached to the cover member outward and has an adhesive surface that adheres to the breast or a peripheral portion of the breast.
3. The breast cancer testing device according to claim 2, wherein the fixing member includes a plurality of fixing portions.
4. The plurality of fixing portions are
   A first fixation portion fixed to a first location on the central side of the body along the lower edge of the breast.
   A second fixation portion fixed to a second location on the outer side opposite to the center side along the lower edge of the breast.
   The breast cancer testing instrument according to claim 3, further comprising a third fixation portion fixed to a third location along the lower edge of the breast in the armpit opposite the center or in the vicinity of the armpit.
5. In the first fixing portion, the second fixing portion, and the third fixing portion, the first fixing portion, the second fixing portion, and the third fixing portion are in this order, the first fixing portion, and the second fixing portion. The breast cancer test device according to claim 4, wherein the first fixing portion, the second fixing portion, and the third fixing portion are numbered in the order of fixing the third fixing portion.
6. The breast cancer testing instrument according to claim 4, wherein the third fixing portion has a wider width than the first fixing portion and the second fixing portion in a direction outward from the cover member.
7. The breast cancer testing device according to claim 1, wherein the cover member includes a dielectric material.
8. The breast cancer testing device according to claim 1, wherein the cover member is a sheet-shaped member.
9. The breast cancer testing device according to claim 1, wherein the cover member is a mesh member.
10. The breast cancer testing device according to claim 1, wherein the cover member includes an elastic material.
11. The breast cancer testing device according to claim 1, wherein a gel is applied to the surface of the cover member on the side covering the breast.
12. The cover member is provided with a reference mark for alignment with a measuring device that measures the inside of the breast via the cover member.
    The breast cancer testing device according to claim 1.
13. The breast cancer testing device according to claim 1, wherein the fixing member contains a material harder than the cover member.
14. The breast cancer testing device according to claim 1, wherein the fixing member contains an elastomer.
15. The cover member and the fixing member include a dielectric material, and the cover member and the fixing member include a dielectric material.
    The breast cancer testing device according to claim 1, wherein the cover member is provided with at least one air hole.
16. The cover member is a non-woven fabric and is
    The fixing member is a gel impregnated into the non-woven fabric.
    The non-woven fabric is provided with holes.
    A notch is provided from the hole to reach the outer end of the nonwoven fabric.
    The breast cancer testing device according to claim 1.
17. The breast cancer testing instrument according to claim 16, wherein the breast cancer testing instrument is formed radially from the hole and is provided with at least one notch portion that does not reach the outer end.
18. The breast cancer testing instrument according to claim 16, wherein at least one notch is formed from the outer end toward the hole, and the at least one notch does not reach the hole.
19. A first film provided on the first surface of the nonwoven fabric and covering the gel,
    A second fill provided on the second surface of the nonwoven fabric and covering the gel,
    16. The breast cancer testing device according to claim 16.
20. The breast cancer test instrument has a sheet-like shape and has a sheet-like shape.
    It covers the first surface of the fixing member and the first surface of the cover member on the same side as the first surface of the fixing member, and a part of the third film is fixed to the first surface of the fixing member. With the third film
    A gel applied to a part of the third film facing the first surface of the cover member, and
    The fourth film covering the gel and
    The adhesive material provided on the second surface of the fixing member and
    A fifth film covering the adhesive material and
    The breast cancer testing device according to claim 1.
21. A measurement unit that moves a probe that irradiates an ultrasonic beam along the surface of the subject's breast,
    The drive unit that drives the measurement unit and
    A cover container containing a support portion that covers the breast at least partially and supports the drive portion inside.
    Breast cancer testing device equipped with.
22. The breast cancer testing apparatus according to claim 21, wherein the portion of the cover container along the path through which the probe moves is formed of a permeation member or has an opening.
23. A battery that supplies an operating voltage to the drive unit is provided.
    The breast cancer testing apparatus according to claim 21, wherein the driving unit moves the probe in the scanning region of the breast.
24. The drive unit moves the probe in a sheet in close contact with the breast, and the cover container covers the breast at least partially via the sheet.
    21. The cover container has a plurality of seat position adjusting portions for aligning the cover container with the seat, and the plurality of seat position adjusting portions are formed of a transmission member or have an opening. The breast cancer testing device described in.
25. The breast cancer testing apparatus according to claim 24, which can be commonly used for the left breast and the right breast of the subject.
26. A detection unit that detects whether the breast measured by the measuring unit is a left breast or a right breast.
    An image generation unit that generates image data based on the reflected signal of the ultrasonic beam, and an image generation unit.
    The breast cancer testing device according to claim 21, wherein the communication unit transmits the information detected by the detection unit and the image data to the communication device.
27. The detection unit identifies the installation direction of the breast cancer inspection device by the orientation sensor, and detects whether the breast measured by the measurement unit is the left breast or the right breast according to the installation direction.
    The breast cancer testing apparatus according to claim 26.
28. An image generation unit that generates image data based on the reflected signal of the ultrasonic beam, and an image generation unit.
    The breast cancer testing apparatus according to claim 21, further comprising a storage unit for storing the image data.
29. The breast cancer testing apparatus according to claim 21, wherein the probe is pressed against the breast while the probe is being moved.
30. The breast cancer testing apparatus according to claim 21, wherein the cover container has a disk shape, a cup shape, or a concave shape on the side of the breast.
31. An electronic circuit board for ultrasonic diagnosis that electronically controls the measurement unit is provided.
    The breast cancer testing apparatus according to claim 30, wherein the electronic circuit board for ultrasonic diagnosis has a shape of a substantially semicircle or a crescent shape.
32. The breast cancer testing device is installed so that the cover container covers at least a part of the breast.
    21. The breast cancer testing apparatus according to claim 21, further comprising a control unit that adjusts the angle of an arm that supports the probe according to the shape of the breast.
33. The breast cancer testing apparatus according to claim 21, wherein the cover container is expandable and contractible in the height direction and can be adjusted to a position suitable for the breast.
34. The breast cancer testing apparatus according to claim 21, further comprising a display unit or a light emitting unit indicating an operating state of the measuring unit.
35. The breast cancer testing apparatus according to claim 21, wherein the cover container contains a silicon material.
36. The scanning area of the probe in the breast of the subject is covered with a mesh member, and the gel is applied to the mesh member in a state where the mesh member is in close contact with the breast by the fixing member.
    A chest measurement method for measuring the inside of the breast while moving the probe to be irradiated with ultrasonic waves in contact with the reticulated member.
37. A breast cancer testing instrument including a cover member covering the area including the scanning area of the probe in the breast of the subject and a fixing member for bringing the cover member into close contact with the breast.
    A breast cancer examination set including a measurement unit that moves the probe that irradiates an ultrasonic beam in contact with the surface of the cover member.
38. A measurement unit that moves a probe that irradiates an ultrasonic beam along the surface of the subject's breast,
    The drive unit that drives the measurement unit and
    A cover container containing a support portion that covers the breast at least partially and supports the drive portion inside.
    A detection unit that detects whether the breast measured by the measuring unit is a left breast or a right breast.
    An image generation unit that generates image data based on the reflected signal of the ultrasonic beam, and an image generation unit.
    A breast cancer examination system including a display unit that displays information detected by the detection unit and the image data.
39. A management unit that manages the information and the image data,
    A diagnostic unit that diagnoses the subject based on the information and the image data,
    38. The breast cancer testing system according to claim 38.
40. The breast cancer testing system according to claim 39, wherein the management unit normalizes the image data to a predetermined size and manages the normalized image data.
41. The breast cancer testing system according to claim 39, wherein the diagnostic unit generates a schematic diagram showing a diagnostic result of the subject for answering the diagnostic result to the subject.
42. A three-dimensional image generation unit that generates three-dimensional image data inside the breast based on the image data or the reflection signal is provided.
    The breast cancer examination system according to claim 38, wherein the display unit displays the three-dimensional image data.

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