Breast cancer inspection instrument, breast cancer inspection device, breast cancer inspection set, and breast cancer inspection system
The breast cancer inspection system allows subjects to perform self-measurements using a measurement sheet and inspection device, addressing the discomfort and accessibility issues of current examination methods by enabling easy and comfortable internal breast tissue measurement.
Patent Information
- Application Number
- JP2022526984
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-05-27
- Filing Date
- 2021-05-21
- Publication Date
- 2025-06-20
- Estimated Expiration
- 2041-05-21
AI Technical Summary
Current breast cancer examination methods, such as mammography and ultrasonography, often require subjects to visit medical institutions and may cause discomfort due to the need for manual scanning by examiners.
A breast cancer inspection system that includes a measurement sheet with a cover member and a fixing member, allowing subjects to attach the sheet to their breasts and perform self-measurements using a breast cancer inspection device that moves a probe along the surface of the breast to capture ultrasonic images.
Enables subjects to easily and comfortably measure their breast tissue internally without the need for external examination, improving accessibility and reducing psychological barriers to breast cancer screening.
Smart Images

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Abstract
Description
Technical Field
[0001] The present disclosure relates to a breast cancer examination instrument, a breast cancer examination apparatus, a breast cancer examination set, a chest measurement method, and a breast cancer examination system.
Background Art
[0002] In breast cancer screening, generally, methods such as visual and tactile examination, mammography, and ultrasonography are used. Visual and tactile examination is rarely used alone and is generally used in combination with mammography or ultrasonography. Mammography is recommended as a standard screening method, but since it strongly compresses the breast, it causes great pain to the subject. In this regard, ultrasonography causes less pain to the subject because the probe only needs to be scanned along the surface of the breast.
[0003] In ultrasonography, it is common for an examiner to hold the probe by hand and scan the entire breast without omission. Therefore, the accuracy of the examination greatly depends on the knowledge, experience, and skills of the examiner.
[0004] The following Patent Document 1 discloses a diagnostic apparatus that automatically scans a probe in order to solve this problem. In the examination using this diagnostic apparatus, the diagnostic apparatus is placed on the subject's breast while adjusting the subject's posture so as to keep the breast horizontal. The diagnostic apparatus rotates the probe around the nipple and acquires ultrasonic images of arbitrary cross-sections of the breast. Since the scanning of the probe is automatically performed, even an examiner who is not familiar with ultrasonography can easily measure the internal state of the breast.
[0005] However, the subject has to go to a medical institution such as a hospital or a clinic to undergo ultrasonography, which places a heavy burden on the subject. In addition, the subject often has psychological resistance to exposing their own breast to the examiner. It is expected that more women will undergo breast cancer screening if the subject can easily perform the measurement without exposing their own breast to others.
Prior Art Documents
Patent Document
[0006]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0007] The present disclosure provides a breast cancer inspection instrument, a breast cancer inspection apparatus, a breast cancer inspection set, a chest measurement method, and a breast cancer inspection system that enable a subject to measure the internal state of the breast by himself / herself.
Means for Solving the Problems
[0008] The breast cancer inspection instrument of the present disclosure includes a cover member that covers a region including a scanning region of a probe in a breast of a subject, and a fixing member that brings the cover member into close contact with the breast.
[0009] The breast cancer inspection apparatus of the present disclosure includes a measurement unit that moves a probe for irradiating an ultrasonic beam along the surface of a breast of a subject, a drive unit that drives the measurement unit, and a cover container that at least partially covers the breast and includes a support unit that supports the drive unit inside.
[0010] The chest measurement method of the present disclosure covers a region including a scanning region of a probe in a breast of a subject with a mesh member, applies a gel to the mesh member in a state where the mesh member is brought into close contact with the breast by a fixing member, and measures the inside of the breast while moving the probe for irradiating ultrasonic waves while being in contact with the mesh member.
[0011] The breast cancer inspection set of the present disclosure includes a breast cancer inspection instrument including a cover member that covers a region including a scanning region of a probe in a breast of a subject and a fixing member that brings the cover member into close contact with the breast, and a measurement unit that moves the probe for irradiating an ultrasonic beam while being in contact with the surface of the cover member.
[0012] The breast cancer inspection system of the present disclosure includes a measurement unit that moves a probe for irradiating an ultrasonic beam along the surface of a subject's breast, a driving unit that drives the measurement unit, a cover container that at least partially covers the breast and includes a support portion that supports the driving unit inside, a detection unit that detects whether the breast measured by the measurement unit is the left breast or the right breast, an image generation unit that generates image data based on a reflection signal of the ultrasonic beam, and a display unit that displays the information detected by the detection unit and the image data.
Brief Description of the Drawings
[0013]
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Embodiments for Carrying Out the Invention
[0014] 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 resulting combination is also part of the embodiments shown in the present disclosure.
[0015] FIG. 1 is a plan view of a breast cancer inspection instrument according to an embodiment of the present disclosure. FIG. 2 is a rear view of the breast cancer inspection instrument of FIG. 1. The breast cancer inspection instrument of FIG. 1 is a measurement sheet having a flat sheet shape. However, as shown in each modification described later, the breast cancer inspection instrument according to the present embodiment can have various shapes or structures.
[0016] The outline of the measurement sheet 10 shown in FIGS. 1 and 2 will be described. The measurement sheet 10 is capable of maintaining the breast in a shape suitable for measurement and allowing the probe to scan smoothly when the subject performs a measurement for breast cancer examination by himself / herself. The subject wears the measurement sheet on the breast in any posture, such as standing or sitting at home or the like. For example, the subject covers the back surface of the cover member (mesh member) 11 of the measurement sheet on the breast, and while adjusting the shape of the breast to a shape suitable for measurement (for example, a shape with the breast bulged), fixes the fixing member 12 of the measurement sheet to the breast or the peripheral part 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 parts 12A, 12B, and 12C, and the measurement sheet can be easily fixed to the breast by being adhered to predetermined positions in a predetermined order. In the state where the measurement sheet 10 is fixed, even if the subject releases the hand from 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 examination device (measurement device) 30 (see FIG. 4 described later) on the breast with the measurement sheet 10 attached, and operates the measurement unit 50 inside the cover container 40 (see FIG. 9 described later). The probe 52 scans the surface of the mesh member of the measurement sheet 10. That is, while moving, the probe 52 outputs an ultrasonic beam and receives the signal of the reflected wave as measurement data. Thereby, the internal state of the breast is measured. By using the measurement sheet 10 and the breast cancer examination device 30 according to the present embodiment in this way, the subject can easily perform the measurement for breast cancer examination at home or the like without exposing the breast to others. Hereinafter, the present embodiment will be described in more detail.
[0017] As shown in FIG. 1, the measurement sheet 10 includes a cover member (mesh member) 11 and a fixing member 12 coupled around the cover member 11.
[0018] The cover member 11 covers an area including at least the scanning area (measurement area) of the probe on the breast. The cover member 11 is a net-like member and has a circular or substantially circular shape. As an example, the material of the cover member 11 is a material having elasticity and capable of transmitting ultrasonic waves. For example, the cover member 11 includes a dielectric material such as nylon, polyurethane, or synthetic fiber. The cover member 11 may include a single material or a plurality of materials. In order to protect the skin of the breast, the cover member 11 may be constituted by a material having a low coefficient of friction. The cover member 11 is not limited to being net-like, and may be constituted by other shapes or other materials as long as it can transmit ultrasonic waves. When the cover member 11 is net-like, the subject can adjust the shape of the breast while observing the shape of the breast.
[0019] As shown in FIG. 2, a gel 21 containing moisture 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 being mixed 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 the gel is not essential. The gel may be applied in advance, or the subject may apply it when using the measurement sheet.
[0020] In FIG. 1, the fixing member 12 is attached to the cover member 11 outward so as to surround the periphery of the cover member 11. By fixing the fixing member 12 to the breast or the peripheral part of the breast, the measurement sheet can be fixed to the breast while maintaining the shape of the breast inside the cover member 11.
[0021] The fixing member 12 is constituted by a material harder than the cover member 11 as an example. For example, the fixing member 12 includes an elastomer. However, the fixing member 12 may be constituted by other materials 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 suppressing melting even in a high-humidity space such as a bathroom or a bathtub.
[0022] The fixing member 12 includes three major fixing parts, namely, a fixing part 12A (first fixing part), a fixing part 12B (second fixing part), and a fixing part 12C (third fixing part). The fixing parts 12A to 12C are attached to the cover member 11 outward. In the example of the figure, the fixing parts 12A to 12C are integrally formed, but may be attached to the cover member 11 in a separately separated state.
[0023] 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 parts 12A to 12C). That is, the back surface of the fixing member 12 (the back surfaces of the plurality of fixing parts 12A to 12C) serves as an adhesive surface. The subject can fix the fixing parts 12A to 12C to the body by pressing the fixing parts 12A to 12C against the body from the surface.
[0024] A seal may be attached to the adhesive surface of the fixing member 12 (the adhesive surfaces of the plurality of fixing parts 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, an adhesive material may be applied to the back surfaces of the plurality of fixing parts 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 high-humidity space such as a bathroom or a bathtub, the state where the fixing member 12 is fixed can be maintained.
[0025] The fixing parts 12A to 12C in FIG. 1 are fixed to predetermined positions around the breast in a predetermined order. More specifically, the fixing part 12A is fixed to the first position on the center side of the body along the lower edge of the breast. The first position is, for example, a position on the rib near the center of the body. The subject aligns the position of the fixing part 12A based on this position.
[0026] The fixing part 12B is fixed to the second position on the outer side opposite to the center side along the lower edge of the breast. The second position is, for example, a position that is generally symmetric with respect to the first position through the breast. A guide line 13 is provided in the portion between the fixing part 12B and the fixing part 12A. The guide line 13 is formed, for example, by printing. After the subject first fixes the fixing part 12A, the subject can easily position the fixing part 12B by pressing the fixing member 12 along the guide line up to the fixing part 12B. Note that the guide line 13 may be a part of the fixing part 12A or the fixing part 12B.
[0027] The fixing part 12C is fixed to the third position under the armpit or near the armpit on the side opposite to the center of the body along the lower edge of the breast. The fixing part 12C has a larger area than the fixing part 12A and the fixing part 12B. That is, the fixing part 12C has a wider width than the fixing part 12A and the fixing part 12B in the direction from the cover member 11 toward the outside. Thereby, the flesh under the breast or around it can be gathered under the armpit, and the shape of the breast can be easily adjusted.
[0028] Information indicating the order in which the fixing parts 12A to 12C are to be fixed is provided on the surfaces of the fixing parts 12A to 12C. For example, numbers are provided on the surfaces of the fixing parts 12A to 12C. "1" is provided on the fixing part 12A, "2" is provided on the fixing part 12B, and "3" is provided on the fixing part 12C. By fixing the fixing parts 12A to 12C in this order of numbers, the subject can easily attach the measurement sheet.
[0029] Specifically, first, with the back surface of the cover member 11 covering the breast, the subject presses the fixing part 12A and fixes it to the body. Next, the subject presses along the guide line in the figure toward the fixing part 12B and fixes the fixing part 12B. Next, while gathering the flesh under the breast or in the vicinity thereof under the armpit, the subject adjusts the shape of the breast and fixes the fixing part 12C to the body. Thereby, the breast can be adjusted to a shape suitable for measurement (for example, a bulging shape). Since the measurement sheet 10 is fixed by the fixing member 12, the shape of the breast is maintained even if the subject releases the measurement sheet 10 from the hand.
[0030] Figure 3 schematically shows the state in which the measurement sheet 10 is attached to the left breast of the subject. The fixing part 12A is fixed at the position of the rib near the center of the body. The fixing part 12B is fixed at a position substantially symmetric to the fixing part 12A through the breast. The fixing part 12C is fixed under the armpit or near the underarm. A part of the fixing part 12C is sandwiched between the left armpit.
[0031] The measurement sheet 10 is provided with a reference mark 14 for alignment with a breast cancer inspection device (measurement device). By aligning the alignment mark (sheet position adjustment part) 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 positioning of the breast cancer inspection device 30 can be easily performed. When the subject attaches the measurement sheet 10 to the breast, the reference mark 14 may be parallel to a predetermined direction (for example, in the height direction of the body). Thereby, the subject can attach the measurement sheet 10 more easily.
[0032] In FIGS. 1 and 2, a measurement sheet for the left breast is shown. However, the measurement sheet for the right breast has the same configuration as that of FIG. 1 except that the shape shown in FIG. 1 is made symmetric left and right.
[0033] 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 a measurement sheet corresponding to his / her bust size or bust shape.
[0034] Note that 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 repeatedly used by washing or the like.
[0035] FIG. 4(A) is a perspective view showing the overall appearance of a breast cancer inspection device (measurement device) 30 according to an embodiment of the present disclosure. FIG. 4(B) is a plan view of the breast cancer inspection device 30 viewed from directly above. FIG. 4(C) is an external perspective view of the breast cancer inspection device 30 viewed from the bottom. FIG. 4(D) is a side view of the breast cancer inspection device 30 viewed from the direction of arrow Y shown in FIG. 4(B).
[0036] The breast cancer inspection device 30 in FIG. 4 is configured to be commonly used for both the left breast and the right breast. The breast cancer inspection device 30 is a measurement device including a cover container 40, a measurement unit 50 (FIG. 4(C)) disposed in the cover container 40, and a drive control system (see FIG. 10 described later) that controls the measurement unit 50. The measurement unit 50 includes a main body portion 51, a probe (detector) 52, and an arm 53 (see FIG. 6 described later).
[0037] The cover container 40 has a cup shape with a concave side for accommodating the measurement unit 50. During measurement, at least a part of the breast with a measurement sheet attached is accommodated inside the cover container 40. The shape of the cover container 40 is not limited to a cup shape, and any shape may be used as long as the subject can grip it from the outside and rotatably support the inner measurement unit 50. For example, the cover container 40 may be formed in a flat disk shape. In this case, a grip portion (such as a handle or a knob) for the subject may be provided on the surface of the disk (opposite to the breast).
[0038] A drive control system 60 (see FIG. 10) that controls the measurement unit 50 is provided at an arbitrary position inside the cover container 40. For example, the drive control system 60 may be provided on the ceiling portion of the cover container 40 or in the vicinity thereof, or a part of the drive control system 60 may be provided inside the measurement unit 50 and the remaining part may be provided outside the measurement unit 50. The drive control system 60 may be provided inside the measurement 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.
[0039] FIG. 5 is a plan view showing the probe 52 and the main body 51 taken out from the breast cancer inspection apparatus 30. FIG. 6 is a side view of the probe 52 and the main body 51 shown in FIG. 5.
[0040] As shown in FIG. 5, the shaft 56 of the motor 58 (see FIG. 6) is coupled to the main body 51 of the measurement unit 50 directly or via a gear 57 or the like. The shaft 56 of the motor and the gear 57 or the like constitute 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 rotates integrally with the probe 52 about the shaft 56. That is, when the motor 58 is driven, the measurement unit 50 rotates about the shaft 56 of the motor (see the arrow in FIG. 5).
[0041] 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 as a convex portion into this concave portion 59. The shaft 56 of the motor 58 extending to the side opposite to the ceiling portion is coupled to the main body 51. Thereby, the measurement 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 measurement unit 50 and can control the measurement unit 50. The configuration described here is an example, and other configurations may be used as long as the measurement unit 50 can rotate within the cover container 40. A transmission mechanism (configured using, for example, gears, links, etc.) for pressing the main body 51 and the probe 52 in the breast direction using the driving force of the motor 58 may be provided. Thereby, the measurement unit 50 can be rotated while pressing the breast with the main body 51 and the probe 52. Also, a biasing portion (pressing portion) 55 such as a coil spring may be disposed in the space between the upper portion of the motor 58 and the concave portion 59. Thereby, when the subject presses the cover container 40 against 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 can be brought into close contact with the breast with an appropriate force.
[0042] The probe 52 in Fig. 6 is coupled to the main body 51 by the arm 53. The joint (articulation part) between the main body 51 and 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 can be brought into close contact with the breast. Further, the arm 53 is configured to be telescopic. For example, the arm 53 includes an outer arm and an inner arm enclosed within 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 (slidably) from the position in Fig. 6 in the radial direction of rotation, that is, in the direction away from the main body 51.
[0043] Fig. 7 is a bottom perspective view showing a state where the probe 52 is moved in a direction away from the main body 51 from the state shown in Fig. 4(C). The position of the probe 52 has, as an example, two states: a first state corresponding to the position in Fig. 4(C) and a second state corresponding to the position in Fig. 7. The measurement in this embodiment is performed, as an example, by setting the probe 52 in the first state and rotating the probe 52 once in the circumferential direction of the breast, and then setting the probe 52 in the second state and rotating the probe 52 one more time. That is, the measurement area of the breast is divided into an area close to the nipple and an area far from the nipple. In the first state, the area close to the nipple is measured, and in the second state, the area far from the nipple is measured. The area close to the nipple and the area far from the nipple may partially overlap each other. As a modification, the probe 52 may be configured to be long so as to cover both the area close to the nipple and the area far from the nipple, and the measurement may be performed by rotating the probe 52 once.
[0044] FIG. 8 is a diagram showing the plan view of FIG. 4(B) in more detail. The cover container 40 has a shape that is nearly circular when viewed in plan. The cover container 40 is made of a material such as a resin or a silicon material as an example. A part of the cover container 40 is a transmissive part 41. The transmissive part 41 is a transparent member or an opening. The transmissive part 41 is a part along the path where the probe 52 of the measurement unit 50 moves. Through the transmissive part 41, a part of the probe 52 and a part of the main body part 51 are visible. Through the transmissive part 41, the subject can visually recognize the state of the probe 52 scanning and confirm that the measurement unit 50 is operating normally. The light emitting part 44 is electrically connected to the drive control system 60 and is controlled to emit light according to the operating state of the measurement unit 50. For example, when the measurement unit 50 is measuring, it emits light in a predetermined color, and when it is not measuring, it emits light in another color or turns off. Thereby, the subject can easily confirm whether the measurement unit 50 is measuring or not.
[0045] The cover container 40 is provided with marks (sheet position adjustment parts) 42A and 42B for aligning with the measurement sheet 10 attached to the breast. The mark 42A is for the left breast, and the mark 42B is for the right breast. The marks 42A and 42B are transmissive members or openings. However, the marks 42A and 42B are not limited to being transmissive members or openings, and may be linear marks colored in a specific color. The marks 42A and 42B may be formed integrally with the transmissive part 41.
[0046] When measuring the left breast, attach the measurement sheet 10 for the left breast (see FIG. 1) to the left breast, and arrange the cover container 40 so that the mark 42A of the cover container 40 coincides with the reference mark 14 of the measurement sheet (see FIG. 1). When measuring the right breast, attach the measurement sheet for the right breast to the right breast, and arrange the cover container 40 so that the mark 42B of the cover container 40 coincides with the reference mark of the measurement sheet.
[0047] As described later, the drive control system 60 is equipped with a direction sensor (e.g., a gyro or a magnetic sensor, etc.) that detects the direction in which the breast cancer inspection device 30 is installed. When the mark 42A is arranged to face upward (to face the opposite direction to the ground), the drive control system 60 detects that the left breast is to be measured. When the mark 42B is arranged to face upward, the drive control system 60 detects that the right breast is to be measured. In this way, the drive control system 60 detects whether to perform an inspection on the left breast or the right breast based on the direction in which the breast cancer inspection device 30 is installed.
[0048] However, it may be determined based on the subject's operation input whether to perform an inspection on the left breast or the right breast. For example, based on the input instruction signal from the operation input unit, it may be determined whether to perform an inspection on the left breast or the right breast. The operation input unit may be a button or a touch panel that can be operated by the subject, or a receiving unit that receives a signal wirelessly or by wire from a terminal held by the subject.
[0049] FIG. 9 shows a state of measuring the left breast of a subject. The breast cancer inspection device 30 is placed over the left breast on which the measurement sheet 10 is attached. The mark 42A for the left breast (sheet position adjustment unit) of the measurement unit 50 is aligned with the reference mark 14 of the measurement sheet 10. The subject maintains a state of gently pressing the breast cancer inspection device 30 in the direction of the breast. The subject gives an instruction to start the measurement in this state. The start of the measurement is performed, for example, by manually inputting an instruction to start the measurement to the operation input unit or by giving an instruction signal from a terminal. In the inspection, first, the drive control system 60 sets the position of the probe to the first state and performs the first scan. Thereby, the area near the nipple is measured. Subsequently, the position of the probe is set to the second state, and the second scan is performed. Thereby, the distant area around the near area is measured. The drive control system 60 stores the data measured by the probe in the storage unit.
[0050] FIG. 10 is a block diagram of a breast cancer inspection system including a breast cancer inspection apparatus 30 according to the present embodiment, a terminal 101 which is a communication apparatus operated by a subject, and a diagnostic apparatus 201 installed in a medical institution. Illustration of a cover container 40 included in the breast cancer inspection apparatus 30 is omitted. 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 configured by, for example, an electronic circuit board (an electronic circuit board for ultrasonic diagnosis). The shape of the electronic circuit board may be determined according to, for example, the shape of the location where it is arranged. As an example, the electronic circuit board may have a substantially semicircular or crescent 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, for example, at locations visible to the subject in the cover container 40. The control unit 62 and the image generation unit 67 are realized by dedicated hardware circuits or software such as programs. The storage unit 66 includes an arbitrary storage medium such as a non-volatile or volatile memory, a hard disk, an optical disk, and a magnetic disk.
[0051] The drive unit 61 drives the measurement unit 50 (the main body unit 51 and the 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 unit 51 by the drive unit 61, the probe 52 coupled to the main body unit 51 via the arm 53 also rotates integrally.
[0052] The control unit 62 controls the entire drive control system 60. The control unit 62 controls each element within the drive control system 60. For example, when the control unit 62 receives a measurement start instruction from the subject, it starts the scanning of the probe 52. First, the control unit 62 sets the position of the probe 52 to the first state and performs the first scan of the probe 52. Then, it sets the position of the probe 52 to the second state and performs the second scan of the probe 52. In each scan, an ultrasonic beam is output from the probe 52, and data of the reflected signal of the ultrasonic beam is acquired at regular time intervals as measurement data.
[0053] The control unit 62 may perform control to press the probe 52 against the measurement sheet 10 so that the probe 52 is in close contact with the measurement sheet 10 during measurement. For example, when another motor is provided at the joint part (articulation part) between the main body part 51 and the arm 53, the angle of the arm 53 can be adjusted by controlling the motor. By detecting the contact state of the probe 52 with respect to the measurement sheet 10 using a pressure sensor or a distance sensor or the like, the angle of the arm 53 is determined. Thereby, the probe 52 is brought into close contact with the measurement sheet 10. Alternatively, the driving force of the driving unit 61 may be transmitted to the arm 53 by a predetermined transmission mechanism (for example, a combination of gears and rollers, etc.) to press the probe 52 against the measurement sheet 10. Thereby, 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, it is possible to prevent air from being mixed between the probe 52 and the breast and to perform highly accurate measurement.
[0054] Further, the control unit 62 may perform control to press the main body 51 itself against the measurement sheet 10 during measurement. For example, when the ceiling part in the cover container 40 and the motor are connected by a telescopic member, the length of the member is controlled to press the main body 51 against the measurement sheet 10. The length of the member may be determined by detecting the contact state of the main body 51 with respect to the measurement sheet using a pressure sensor, a distance sensor, or the like. By pressing the main body 51, breast regions other than the probe 52 are 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.
[0055] The sensor 63 includes a direction sensor that detects the orientation in which the breast cancer inspection device 30 is installed. As an example, the direction sensor includes an acceleration sensor, a magnetic sensor, or a gyroscope. Further, the sensor 63 may include a sensor (such as a pressure sensor, a distance sensor, etc.) that detects the contact state between the probe 52 or the main body 51 and the measurement sheet 10.
[0056] Further, the sensor 63 may include other sensors such as a biological sensor, an image sensor, a temperature sensor, a humidity sensor, etc. The control unit 62 may perform control using at least one of these sensors. For example, the health state of the subject may be detected using a biological sensor, and measurement may be permitted only when there is no problem with the health state of the subject. Also, the subject may be identified using an image sensor, and measurement may be permitted only for a pre-registered subject.
[0057] The battery 64 supplies the voltages necessary for operation to the measurement unit 50, each element 61 - 63, 65 - 68 in the drive control system 60, the light emitting unit 44, the speaker 48, and the display unit 49. The measurement unit 50 may separately include a battery different from the battery 64 and operate using the battery.
[0058] The operation input unit 65 is an interface through which the subject inputs various instructions or data. As an example, the operation input unit 65 is a touch panel, one or more buttons, or a receiving unit that receives instructions or data from the terminal 101 held by the subject. The receiving unit may perform reception either by wire or wirelessly. Also, the operation input unit 65 may be a voice input unit that acquires instructions or data by voice recognition of the voice signal spoken by the subject. Further, the operation input unit 65 may be a gesture input unit that detects the subject's gesture and acquires instructions or data corresponding to the gesture.
[0059] The storage unit 66 stores the measurement data acquired by the scanning of the probe 52 in association with additional information. The additional information includes an index, a measurement time, breast identification information for identifying 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.
[0060] 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 the scanning of the probe 52. The image data to be generated may be either 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 the measurement data or two-dimensional image data.
[0061] The storage unit 66 stores the image data generated by the image generation unit 67 in association with additional information. The additional information includes an index, an inspection time, a data size, breast identification information for identifying whether the inspected breast is the left breast or the right breast, and the like. In addition, the additional information may include information such as the resolution of the image and the file format.
[0062] The storage unit 66 is where the control unit 62 or the image generation unit 67, etc., such as a CPU (Central Processing Unit When implemented by a program executed by a processor such as [[ID=]], a program for causing the CPU to execute and parameters used for the execution of the program 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.
[0063] 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 communicable with the diagnostic device 201 by wire or wirelessly.
[0064] The light emitting unit 44 includes a light emitting element capable of emitting one or more colors. The light emitting unit 44 includes, for example, 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 inspection device 30, the subject can easily recognize the operating state of the breast cancer inspection device 30. As an example, while the breast is being measured by the probe 52, the light emitting unit 44 emits light in the first color. Thereby, the subject can be made to recognize that measurement is in progress. Also, while image data is being transmitted from the communication unit 68 to the terminal 101, the light emitting unit 44 emits light in the second color. Thereby, the subject can be made to recognize that image data is being transmitted.
[0065] The speaker 48 is a device that outputs sound. For example, the control unit 62 outputs the operating state of the breast cancer inspection device 30 from the speaker 48 by sound or outputs an instruction to the subject from the speaker 48 by sound. Examples of instructions by sound include messages such as "When the attachment of the measurement sheet is completed, align the mark on the measurement sheet with the mark on the cover container" and "When the alignment is completed, press the measurement start button".
[0066] 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 inspection device 30 or displays instructions to the subject. As examples of the operating state, messages such as "Measuring", "Measurement completed", "Transmitting image data" may be displayed. Also, the same messages as those output by the above-described voice messages may be displayed.
[0067] Based on the instructions of the subject, the breast cancer inspection device 30 transmits at least one of the left and right breast image data stored in the storage unit 66 and its additional information to the terminal 101. Also, based on the instructions of the subject, the breast cancer inspection device 30 may transmit at least one of the measurement data of the left and right breasts stored in the storage unit 66 and its additional information to the terminal 101.
[0068] The terminal 101 is a communication device used by the subject. Examples of the terminal 101 include smartphones, personal computers (such as notebook PCs and desktop PCs), tablet devices, or mobile phones. An application for breast cancer inspection (inspection app) is stored in the terminal 101. By starting the inspection app, the subject can transmit various instructions or data from the terminal 101 to the breast cancer inspection device 30. As an example, the subject instructs the start of measurement from the terminal 101. Also, the breast cancer inspection device 30 is made to transmit image data as an inspection result obtained by the breast cancer inspection device 30 to the terminal 101. The terminal 101 may display the image data and its additional information on the display unit of the terminal 101. Also, the terminal 101 may display the measurement data and its additional information on the display unit of the terminal 101.
[0069] The terminal 101 can communicate with the diagnostic device 201 via the communication network 200. The communication network 200 can be a local area network or a wide area network such as the Internet. The terminal 101 transmits diagnostic request information for requesting a diagnosis of at least one of the left and right breasts to the diagnostic device 201. The diagnostic request information includes information about the subject, image data of at least one of the breasts to be diagnosed, and additional information thereof. Alternatively, the diagnostic request information may include information about the subject, measurement data of at least one of the left and right breasts to be diagnosed, and additional information thereof. The information about the subject includes, for example, the ID of the subject, name, age, gender, etc.
[0070] The diagnostic device 201 is an information terminal installed in a medical institution such as a hospital or a clinic. The diagnostic device 201 is operated by medical staff such as doctors or nurses. The diagnostic device 201 may store an electronic medical record storing the medical information of the subject. The diagnostic device 201 can communicate with the terminal 101 via the communication network 200 and receives diagnostic request information from the terminal 101.
[0071] 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, etc. The management unit 212 manages information about the subject, image data, and additional information thereof based on the diagnostic 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 types of data and information to be managed. The storage unit 213 includes any recording medium such as a volatile or non-volatile memory, a hard disk, an optical disk, or a magnetic disk.
[0072] The diagnostic unit 211 diagnoses the breast of the subject based on the image data and additional information of the subject. The diagnosis is performed, for example, by executing a diagnostic program. The diagnostic program detects tumors by means such as image clustering and neural networks. The diagnostic unit 211 may display the diagnostic result on the display unit 214 to obtain confirmation from the doctor.
[0073] In addition, the diagnostic unit 211 may display information such as image data required by the doctor for diagnosis on the screen, and the doctor may perform examinations and diagnoses based on the displayed information. The diagnostic unit 211 may obtain the diagnostic result by the doctor from an operation input unit such as a touch panel, keyboard, mouse, or voice input unit.
[0074] The diagnostic unit 211 may store the diagnostic result in the storage unit 213 in association with the information of the subject.
[0075] The diagnostic unit 211 may generate a schematic diagram as part of the diagnostic result. The schematic diagram includes an image that schematically represents the breast image data. Information for identifying the location of the detected tumor may be superimposed on the image.
[0076] The diagnostic unit 211 generates response data including the diagnostic result of the subject. The response data includes, for example, information about the subject and the diagnostic result. The diagnostic device 201 may transmit the response data to the terminal 101 via the communication network 200. The response data is transmitted by a secure method such as encryption or password. Or the diagnostic device 201 may print the response data on paper. In this case, a medical staff member may send or hand over the diagnostic result form to the subject.
[0077] When the image data is a two-dimensional image, the management unit 212 may generate a three-dimensional image from the image data using a model such as a neural network. The display unit 214 may display the three-dimensional image. It is expected that the doctor can make a more appropriate diagnosis by checking the image of the breast examination results in three dimensions. The management unit 212 may include a three-dimensional image generation unit that generates three-dimensional image data based on two-dimensional image data or measurement data.
[0078] Figure 11 is a flowchart of an example of the chest measurement method according to the present embodiment. The cover member (mesh member) 11 of the measurement sheet 10 is placed over 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 fixing members 12A, 12B, and 12C are fixed to predetermined positions around the breast in this order to attach the measurement sheet 10 (see FIG. 3). When the gel is not applied to the mesh member 11, the subject applies a gel containing moisture to the mesh member 11. The application of the gel may be performed using an application device for applying the gel. The application device may be provided in the breast cancer inspection device 30, and after the installation of the breast cancer inspection device 30, the application device may apply the gel under the control of the control unit 62.
[0079] The subject installs the breast cancer inspection device 30 on the breast with the measurement sheet 10 attached (S12). The installation is performed such that at least a part of the breast with the measurement sheet 10 attached is included in the cover container 40. In the case of the left breast, alignment is performed so that the mark (sheet position adjustment unit) 42A of the cover container 40 matches the reference mark 14 of the measurement sheet 10. In the case of the right breast, alignment is performed so that the mark (sheet position adjustment unit) 42B of the cover container 40 matches the reference mark of the measurement sheet for the right breast. The subject may adjust the force application and reduction when 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.
[0080] When the breast cancer examination device 30 receives an instruction to start measurement from the subject, it starts the measurement. With the position of the probe 52 in the first state close to the nipple, the probe 52 is scanned (S13). The probe 52 is rotated 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. When the probe 52 has made one full rotation, with the position of the probe 52 in the second state far from the nipple, the probe 52 is scanned again (same S13). The breast cancer examination device 30 generates image data representing the internal state of the breast based on the measurement data acquired in two separate times (S14).
[0081] As described above, according to the present embodiment, by using the measurement sheet including the cover member and the fixing member that cover the breast, the subject can easily adjust and fix the breast into a shape suitable for measurement by himself / herself. Also, in a state where the measurement sheet is attached, by using the breast cancer examination device, the subject can easily measure the internal state of the breast by himself / herself. By using such a set of the measurement sheet and the breast cancer examination device (breast cancer examination set) in this way, the subject can easily perform the measurement of the breast with high precision at home or the like.
[0082] In the present embodiment, the breast is measured in a state where the measurement sheet is attached. However, depending on the shape of the breast, it is also possible to directly install the breast cancer examination device on the breast without attaching the measurement sheet and perform the measurement. At this time, gel may be directly applied to the breast and the probe may be scanned on the breast.
[0083] In this embodiment, it is assumed that the measurement is performed by the subject at home or the like, but the measurement may also be performed at a medical institution. For example, at a medical institution, in a space where there are no medical staff such as doctors or nurses, the measurement is performed using the measurement sheet and the breast cancer inspection device according to this embodiment. After the measurement, a medical staff member may directly read the image data and the like stored in the breast cancer inspection device into the diagnostic device 201. The reading is performed by wireless or wired communication. Alternatively, the image data and the like may be read from the breast cancer inspection device using a detachable memory device, and the read image data and the like may be written into the diagnostic device 201. According to this, since the subject can receive advice from a medical staff member on the spot regarding the usage method of the measurement sheet and the breast cancer inspection device, the measurement can be performed more easily.
[0084] (Modification Example 1) FIG. 12(A) is a perspective view showing the appearance of the breast cancer inspection instrument 70 according to Modification Example 1. FIG. 12(B) is a cross-sectional view taken along line L1-L2 of FIG. 12(A). The breast cancer inspection instrument 70 in FIG. 12 has a cup-like shape. The breast cancer inspection instrument 70 in FIG. 12 is referred to as a measurement cup 70. The measurement cup 70 includes a cover member 71 and a fixing member 72 coupled outwardly to the end of the cover member 71. The measurement cup 70 is prepared for the right breast and the left breast, respectively, as an example. The measurement 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 measurement cup according to the shape or size of his or her own breast.
[0085] The cover member 71 covers an area including the breast of the subject and at least the scanning area (measurement area) of the probe on the breast, and is for shaping the breast into 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 inner side of the cover member 71 contains a material having adhesiveness. This facilitates attachment and enhances the adhesion between the inner surface of the cover 71 and the breast. When a material having no adhesiveness or low adhesiveness is used, an adhesive material may be applied to the inner surface of the cover member 71. As long as the material of the cover member 71 can transmit ultrasonic waves, other materials may be used. A plurality of air holes including air holes 73A, 73B, 73C, and 73D are formed in the cover member 71. This can prevent or suppress the entry of air between the breast and the cover member 71 when the measurement cup 70 is attached.
[0086] 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 true semi-sphere. The inside of the cover member 71 has a shape adapted to the breast. For this reason, as shown in FIG. 12(B), the thickness of the cover member 71 varies depending on the location. The fact that the thickness of the cover member 71 varies depending on the location does not substantially affect the measurement data of the probe 52.
[0087] The various configurations described in the above-described embodiment are also applicable to this Modification 1. For example, a reference mark for alignment with the breast cancer inspection device may be provided on the measurement cup 70. Further, the fixing member 72 may include a plurality of fixing portions. Information indicating the order of fixing the plurality of fixing portions may be written on the plurality of fixing portions. Even when the measurement cup 70 of this Modification 1 is used, as in the above-described embodiment, measurement can be performed by the probe 52 using the breast cancer inspection device 30. In this Modification 1, the surface of the measurement cup 70 is scanned by the probe 52. A material such as gel may be applied to the surface of the measurement cup 70 to facilitate the scanning of the probe 52.
[0088] (Modification 2) FIG. 13(A) is a plan view showing an example of the breast cancer inspection instrument 80 according to Modification 2. FIG. 13(B) is a perspective view showing the assembled state of the breast cancer inspection instrument 80 in FIG. 13(A). The breast cancer inspection instrument 80 of this modification may be commonly used for both the left and right breasts, or may be configured for the right breast and the left breast respectively. Also, a plurality of sizes may be lined up, and the subject may use a measurement sheet according to the shape or size of their own breast.
[0089] The breast cancer inspection instrument 80 in FIG. 13(A) is a measurement sheet having a flat sheet shape. The measurement sheet 80 includes a material capable of retaining moisture, such as a paper material or a sponge. As an example, the measurement sheet 80 is a non-woven fabric. Gel has penetrated into the measurement sheet 80, and the gel is retained by a moisture retention mechanism. The front and back surfaces of the measurement sheet 80 are also covered with gel.
[0090] The measurement sheet 80 generally has a 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 hole 81 is continuous with the notches 82 and 83. The notch 82 reaches the outer end of the measurement sheet 80, and the notch 83 is formed up to the middle between the hole 81 and the outer end. Due to the notch 82, the measurement sheet 80 can be assembled into a generally trapezoidal conical shape as shown in FIG. 13(B). When the measurement sheet 80 is assembled into a trapezoidal conical shape, by overlapping the sheet portions on both sides of the notch 83, it is possible to prevent a gap from forming on the side surface. The region 84 is a region where the sheet portions on both sides of the notch 83 overlap each other.
[0091] The subject is positioned so that the nipple is included in the hole 81 at the upper part of the substantially trapezoidal cone, and the measurement sheet 80 is assembled so that the back surface of the measurement sheet 80 is in close contact with the scanning area (measurement area) of the probe around the nipple. At this time, the sheet portions on both sides of the notch 83 are overlapped so that no gap is generated in the measurement area. By adjusting the size of the overlapping area, the height of the substantially trapezoidal cone can also be adjusted. The measurement sheet 80 adheres to the breast by the gel on the back surface of the measurement sheet 80. In this modification, the non-woven fabric corresponds to the cover member, and the gel corresponds to the fixing member.
[0092] The various configurations described in the above-described embodiments are also applicable to this Modification 2. For example, a reference mark for alignment with the breast cancer inspection device may be provided on the measurement sheet. Similar to the above-described embodiment, the breast cancer inspection device 30 can be placed over the breast through the measurement sheet 80, and 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.
[0093] FIG. 14(A) is a plan view showing another example of the breast cancer inspection instrument (measurement sheet) 90 according to Modification 2. FIG. 14(B) is a perspective view showing a state in which the breast cancer inspection instrument 90 of FIG. 14(A) is assembled. The measurement sheet 90 in FIG. 14 contains the same material as the measurement sheet in FIG. 13 described above. The gel is permeated into the measurement sheet 90. Hereinafter, the description will focus on the parts different from the breast cancer inspection instrument 80 in FIG. 13, and the common parts will be omitted as appropriate.
[0094] 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 notch 92 reaches the outer end of the measurement sheet 90. The notch 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 notch 93 is 1 / 2 or less, 1 / 4 or less, or 1 / 3 or less of the length from the center of the hole 91 to the outer end. Further, a plurality of elongated notches 94 are formed in the measurement sheet 90 from the outer end toward the hole 91. As an example, the length of the notch 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.
[0095] The measurement sheet 90 of FIG. 14 can be assembled in the same manner as the measurement sheet of FIG. 13. In the configuration of FIG. 14, since short notches are formed on both the inner and outer sides, 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 steps is suppressed, and the probe 52 can be moved more smoothly.
[0096] FIG. 15(A) is a plan view showing still another example of the breast cancer inspection instrument (measurement sheet) according to Modification 2. In the breast cancer inspection instrument (measurement sheet) 110 of FIG. 15(A), a hole 111 is formed near the center, and a notch 112 reaching from the hole 111 to the outer end is formed. No notches are 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 occurring in the measurement region of the probe 52. Further, since there is only one location where the sheet portions can overlap each other, the probe 52 can be moved smoothly.
[0097] Figure 15(B) is a plan view showing still another example of the breast cancer inspection instrument (measurement sheet) according to Modification 2. In the breast cancer inspection instrument (measurement sheet) 120 of Figure 15(B), a hole 121 is formed near the center, and a notch 122 reaching from the hole 121 to the outer end is formed. Further, a plurality of elongated notches 123 are formed from the outer end toward the direction of the hole 121. The configuration of Figure 15(B) is the same as the configuration of the measurement sheet of Figure 14 described above when no inner notch is provided. With this configuration, when the measurement sheet 120 is attached to the breast, it is possible to prevent a gap from occurring in the measurement area of the probe 52. Further, since there is only one location where the sheet portions can overlap each other, the probe 52 can be smoothly moved.
[0098] As described above, according to this Modification 2, an assembled measurement sheet made of a non-woven fabric or the like can be realized.
[0099] (Modification 3) Figure 16(A) shows an example of a package structure in which the measurement sheet according to Modification 2 described above is packaged. Figure 16(A) shows an example of a package structure in which both surfaces of the measurement sheet 120 of Figure 15(B) are sandwiched between a film 131 and a 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 films, drying of the gel contained in the measurement sheet 120 can be prevented. The other measurement sheets of Figures 13, 14, and 15(A) can also be similarly sandwiched with films. Further, the measurement sheet of Figure 1 according to the above-described embodiment may also be similarly sandwiched with a film.
[0100] Figure 16(B) shows an example of taking out the measurement sheet 120 from the package structure of Figure 16(A). 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). Thereby, 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.
[0101] As described above, according to the third modification example, it is possible to realize a package structure in which the cover member can penetrate and hold the gel.
[0102] (Modification Example 4) FIG. 17 is a cross-sectional view schematically showing an example of a package structure in which a measurement sheet according to the fourth modification example is packaged.
[0103] FIG. 18 shows an example of a measurement sheet packaged in the package structure of FIG. 17. This measurement sheet has the same structure as that of FIG. 1. FIG. 17 schematically shows a cross-section taken along line L3-L4 of FIG. 18. In the cross-sectional view of FIG. 17, the scale in the vertical direction is made larger than the scale in the horizontal direction.
[0104] 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. A gel 302 is applied to a region including a portion of the back surface of the film 301 that faces 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 joined to the film 301, and the film 303 can be easily peeled off from the film 301. The method of joining may be any of an adhesive material, an adhesive tape, or a punched cut line. The portion of the back surface of the film 301 where the film 303 does not exist is joined to the surface of the fixing member 12. The method of joining may be any of an adhesive material or an adhesive tape. It is sufficient that the joining is made with a force that allows the subject to easily peel off the film 303.
[0105] On the back surface of the fixing member 12, an adhesive material 304 for adhesion to the breast is formed. 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 thin films and include a polymer compound such as cellulose as an example.
[0106] FIG. 19 is a diagram for explaining a method of taking out the measurement sheet from the package structure of FIG. 17. First, pinch one end of the film 301 on the front surface side of the measurement sheet 10, and peel off the film 301 with the other 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 together.
[0107] Next, peel off the film 303 on the back surface side of the film 301 (FIG. 19(2)) to expose the gel 302 (FIG. 19(3)). After the gel 302 is exposed, by returning the film 301 to its original position, the gel 302 is attached to the cover member (mesh member) 11 (FIG. 19(4)). The subject completely peels off the film 301 from the measurement sheet 10 while rubbing the film 301 against the cover member 11 so as to transfer the gel 302 to the cover member 11 (FIG. 19(5)). Next, peel off the film 305 attached to the back surface of the measurement sheet 10 to expose the adhesive material 304 on the back surface of the fixing member 12 (FIG. 19(6)). The subject attaches the measurement sheet taken out in this way to the breast by the method described in the above-described embodiment (see FIG. 3).
[0108] According to this modification 4, a package structure can be realized in which the gel can be applied to the cover member immediately before use.
[0109] Note that the above-described embodiments are merely examples 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. Forms with such modifications, substitutions, omissions, etc. are also included in the scope of the present disclosure, as well as in the scope of the invention described in the claims and the equivalent scope thereof.
[0110] In addition, the effects of the present disclosure described in this specification are merely examples, and there may be other effects.
[0111] Note that the present disclosure can also adopt the following configuration. [Item 1] A cover member that covers an area including a scanning region of a probe in a breast of a subject, A fixing member that brings the cover member into close contact with the breast, A breast cancer inspection instrument comprising the above. [Item 2] The fixing member has an adhesive surface that adheres to the breast or the periphery of the breast The breast cancer inspection instrument according to Item 1. [Item 3] The fixing member includes a plurality of fixing parts The breast cancer inspection instrument according to Item 1 or 2. [Item 4] The plurality of fixing parts are A first fixing part fixed to a first location on the central side of the body along the lower edge of the breast, A second fixing part fixed to a second location on the outer side opposite to the central side along the lower edge of the breast, A third fixing part fixed to a third location under the armpit or near the armpit on the side opposite to the central side along the lower edge of the breast, and include The breast cancer inspection instrument according to Item 3. [Item 5] The first fixing part, the second fixing part, and the third fixing part are numbered in the order of the first fixing part, the second fixing part, and the third fixing part to indicate the order of fixing the first fixing part, the second fixing part, and the third fixing part in this order. The breast cancer inspection instrument according to Item 4. [Item 6] The third fixing part has a wider width than the first fixing part and the second fixing part in the direction from the cover member toward the outside. The breast cancer inspection instrument according to Item 4. [Item 7] The cover member contains a dielectric material. The breast cancer inspection instrument according to any one of Items 1 to 6. [Item 8] The cover member is a sheet-like member. The breast cancer inspection instrument according to any one of Items 1 to 7. [Item 9] The cover member is a net-like member. The breast cancer inspection instrument according to any one of Items 1 to 8. [Item 10] The cover member contains an elastic material. The breast cancer inspection instrument according to any one of Items 1 to 9. [Item 11] Gel is applied to the surface of the cover member on the side covering the scanning area. The breast cancer inspection instrument according to any one of Items 1 to 10. [Item 12] The cover member is provided with a reference mark for alignment with a measuring device that measures the inside of the breast through the cover member. The breast cancer inspection instrument according to any one of Items 1 to 11. [Item 13] The fixing member contains a material harder than the cover member. The breast cancer inspection instrument according to any one of Items 1 to 12. [Item 14] The fixing member contains an elastomer. The breast cancer inspection device according to any one of Items 1 to 13. [Item 15] The cover member and the fixing member contain a dielectric material. At least one air hole is provided in the cover member. The breast cancer inspection device according to any one of Items 1 to 14. [Item 16] The cover member is a non-woven fabric. The fixing member is a gel infiltrated into the non-woven fabric. The non-woven fabric is provided with holes. A notch portion is provided that reaches the outer end of the non-woven fabric from the holes. The breast cancer inspection device according to any one of Items 1 to 15. [Item 17] At least one notch portion is provided that is formed radially from the holes and does not reach the outer end. The breast cancer inspection device according to Item 16. [Item 18] At least one notch portion is formed from the outer end toward the holes, and the at least one notch portion does not reach the holes. The breast cancer inspection device according to Item 16. [Item 19] A first film provided on the first surface of the non-woven fabric and covering the gel, A second film provided on the second surface of the non-woven fabric and covering the gel, The breast cancer inspection device according to Item 16, comprising: [Item 20] The breast cancer inspection device has a sheet-like shape. A third film that 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, A gel applied to a part of the third film facing the first surface of the cover member, A fourth film covering the gel, An adhesive material provided on the second surface of the fixing member, A fifth film covering the adhesive material The breast cancer inspection instrument according to any one of Items 1 to 19, comprising the above [Item 21] A measurement unit that moves a probe for irradiating an ultrasonic beam along the surface of the breast of a subject via an arm A drive unit that drives the measurement unit A cover container that at least partially covers the breast and includes a support portion that supports the drive unit inside A breast cancer inspection device comprising the above [Item 22] In the cover container, the portion along the path where the probe moves is formed of a transmissive member or is an opening The breast cancer inspection device according to Item 21 [Item 23] Comprising a battery that supplies an operating voltage to the drive unit The drive unit moves the probe in the scanning area of the breast The breast cancer inspection device according to Item 21 or 22 [Item 24] The drive unit moves the probe in a sheet adhered to the breast The cover container at least partially covers the breast via the sheet The cover container has a plurality of sheet position adjusters for aligning the cover container with the sheet, and the plurality of sheet position adjusters are formed of a transmissive member or are openings The breast cancer inspection device according to any one of Items 21 to 23 [Item 25] It can be commonly used for the left and right breasts of the subject The breast cancer inspection device according to Item 24 [Item 26] A detection unit that detects whether the breast measured by the measurement unit is the left breast or the right breast An image generation unit that generates image data based on the reflection signal of the ultrasonic beam A communication unit that transmits the information detected by the detection unit and the image data to a communication device; The breast cancer inspection apparatus according to any one of Items 21 to 25. [Item 27] The detection unit uses an azimuth sensor to identify the installation direction of the breast cancer inspection apparatus, 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 inspection apparatus according to Item 26. [Item 28] An image generation unit that generates image data based on the reflected signal of the ultrasonic beam; A storage unit that stores the image data The breast cancer inspection apparatus according to any one of Items 21 to 27, comprising the above. [Item 29] While moving the probe, press the probe against the breast The breast cancer inspection apparatus according to any one of Items 21 to 28. [Item 30] The cover container is disk-shaped, cup-shaped, or concave on the side of the breast The breast cancer inspection apparatus according to any one of Items 21 to 29. [Item 31] Comprising an electronic circuit board for ultrasonic diagnosis that electronically controls the measurement unit; The electronic circuit board for ultrasonic diagnosis has a substantially semicircular or crescent shape The breast cancer inspection apparatus according to Item 30, comprising the above. [Item 32] The breast cancer inspection apparatus is installed such that the cover container covers at least a part of the breast, Comprising a control unit that adjusts the angle of the arm according to the shape of the breast The breast cancer inspection apparatus according to any one of Items 21 to 31. [Item 33] The cover container is stretchable in the height direction and can be adjusted to a position suitable for the breast The breast cancer inspection apparatus according to any one of Items 21 to 32. [Item 34] A display unit or a light-emitting unit that represents the operating state of the measurement unit The breast cancer inspection apparatus according to any one of Items 21 to 33 including the same [Item 35] The cover container contains a silicon material The breast cancer inspection apparatus according to any one of Items 21 to 34 including the same [Item 36] A region including a scanning region of a probe in a subject's breast is covered with a mesh member, and while the mesh member is in close contact with the breast by a fixing member, gel is applied to the mesh member, A chest measurement method of measuring the inside of the breast while moving a probe that irradiates ultrasonic waves in a state of being in contact with the mesh member [Item 37] A breast cancer inspection instrument including a cover member that covers a region including a scanning region of a probe in a subject's breast, and a fixing member that brings the cover member into close contact with the breast, A measurement unit that moves a probe that irradiates an ultrasonic beam in a state of being in contact with the surface of the cover member via an arm A breast cancer inspection set including the same [Item 38] A measurement unit that moves a probe that irradiates an ultrasonic beam along the surface of a subject's breast via an arm, A drive unit that drives the measurement unit, A cover container that at least partially covers the breast and includes a support unit that supports the drive unit inside, A detection unit that detects whether the breast measured by the measurement unit is the left breast or the right breast, An image generation unit that generates image data based on a reflection signal of the ultrasonic beam, A display unit that displays information detected by the detection unit and the image data A breast cancer inspection system including the same [Item 39] A management unit that manages the information and the image data, A diagnosis unit that diagnoses the subject based on the information and the image data The breast cancer inspection system according to item 38, which includes [Item 40] The management unit normalizes the image data to a predetermined size and manages the normalized image data. The breast cancer inspection system according to item 39. [Item 41] The diagnosis unit generates a schematic diagram representing the diagnosis result of the subject for answering the diagnosis result to the subject. The breast cancer inspection system according to item 39. [Item 42] It includes a three-dimensional image generation unit that generates three-dimensional image data of the interior of the breast based on the image data or the reflection signal. The display unit displays the three-dimensional image data. The breast cancer inspection system according to any one of items 38 to 41.
Explanation of Signs
[0112] 10 Measurement sheet 11 Cover member (mesh member) 12 Fixing member 12A Fixing part 12B Fixing part 12C Fixing part 13 Guide line 14 Reference mark 21 Gel 22 Adhesive material 30 Breast cancer inspection device 40 Cover container 41 Transmission part 42A, 42B Marks (sheet position adjustment parts) 44 Light emitting part 48 Speaker 49 Display part 50 Measurement unit 51 Main body part 52 Probe (touch probe) 53 Arm 55 Biasing part (pressing part) 56 Shaft 57 Gear 58 Motor 59 Concave part 60 Drive control system 61 Driving unit 62 Control unit 63 Element 63 Sensor 64 Battery 65 Operation input unit 66 Memory unit 67 Image generation unit 68 Communication unit 70 Breast cancer examination instrument (measurement cup) 71 Cover member 72 Fixing member 73A - 73D Air holes 84 Region 101 Terminal 80, 90, 110, 120 Breast cancer examination instrument (measurement sheet) 81, 91, 111, 121 Holes 82, 83, 92, 93, 94, 112, 122, 123 Cut - out parts 131, 132 Films 200 Communication network 201 Diagnostic device 211 Diagnostic unit 212 Management unit 213 Memory unit 214 Display unit 301, 303 Films 302 Gel 304 Adhesive material 305 Film
Claims
1. A cover member that covers the scanning area of a probe on the breast of a subject, A fixing member that makes the cover member adhere closely to the breast, comprising, The fixing member includes a plurality of fixing parts, The plurality of fixing parts are, A first fixing part fixed to a first location on the central side of the body along the lower edge of the breast, A second fixing part fixed to a second location on the outer side opposite to the central side along the lower edge of the breast, A third fixing part fixed to a third location under the armpit or near the armpit on the side opposite to the central side along the lower edge of the breast, and includes A breast cancer inspection device.
2. The first fixing part, the second fixing part, and the third fixing part are numbered in the order of fixing the first fixing part, the second fixing part, and the third fixing part in the order of the first fixing part, the second fixing part, and the third fixing part to indicate the order of fixing the first fixing part, the second fixing part, and the third fixing part. The breast cancer inspection device according to Claim 1.
3. The third fixing part has a wider width than the first fixing part and the second fixing part in the direction from the cover member outward. The breast cancer inspection device according to Claim 1.
4. The cover member includes a dielectric material. The breast cancer inspection device according to Claim 1.
5. The cover member is a sheet-like member. The breast cancer inspection device according to Claim 1.
6. The cover member is a net-like member. The breast cancer inspection device according to Claim 1.
7. The cover member includes an elastic material. The breast cancer inspection device according to Claim 1.
8. Gel is applied to the surface of the cover member that covers the breast. The breast cancer inspection device according to claim 1.
9. The cover member is provided with a reference mark for alignment with a measuring device that measures the interior of the breast through the cover member. The breast cancer inspection device according to claim 1.
10. The fixing member contains a material harder than the cover member. The breast cancer inspection device according to claim 1.
11. The fixing member contains an elastomer. The breast cancer inspection device according to claim 1.
12. A cover member that covers the scanning area of the probe in the breast of the subject, A fixing member that makes the cover member adhere closely to the breast, comprising, The cover member and the fixing member contain a dielectric material, At least one air hole is provided in the cover member. Breast cancer inspection device.
13. A cover member that covers the scanning area of the probe in the breast of the subject, A fixing member that makes the cover member adhere closely to the breast, comprising, The cover member is a non-woven fabric, The fixing member is a gel permeated into the non-woven fabric, The non-woven fabric is provided with holes, A notch portion is provided that reaches from the holes to the outer end of the non-woven fabric. Breast cancer inspection device.
14. At least one notch portion is provided that is formed radially from the holes and does not reach the outer end. The breast cancer inspection device according to claim 13.
15. At least one notch is formed from the outer end toward the hole, and the at least one notch does not reach the hole. The breast cancer inspection instrument according to claim 13.
16. A first film provided on the first surface of the non-woven fabric and covering the gel; A second film provided on the second surface of the non-woven fabric and covering the gel; The breast cancer inspection instrument according to claim 13, comprising:
17. A cover member covering a scanning region of a probe on a breast of a subject; A fixing member for closely attaching the cover member to the breast; A breast cancer inspection instrument comprising: The breast cancer inspection instrument has a sheet-like shape; A third film covering 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; A gel applied to a part of the third film facing the first surface of the cover member; A fourth film covering the gel; An adhesive material provided on the second surface of the fixing member; A fifth film covering the adhesive material; A breast cancer inspection instrument comprising:
18. A measurement unit for moving a probe that irradiates an ultrasonic beam along the surface of a breast of a subject; A drive unit for driving the measurement unit; A cover container that at least partially covers the breast and includes a support portion that supports the drive unit inside; Comprising: A portion along the path where the probe moves in the cover container is formed of a transmissive member or is an opening. A breast cancer inspection device.
19. It is provided with a battery that supplies an operating voltage to the drive unit, The drive unit moves the probe in the scanning area of the breast The breast cancer inspection device according to claim 18.
20. An image generation unit that generates image data based on the reflected signal of the ultrasonic beam, A storage unit that stores the image data The breast cancer inspection device according to claim 18, which includes the above.
21. A display unit or a light emitting unit that represents the operating state of the measurement unit The breast cancer inspection device according to claim 18, which includes the above.
22. The cover container contains a silicon material The breast cancer inspection device according to claim 18.
23. A measurement unit that moves a probe that irradiates an ultrasonic beam along the surface of the breast of a subject, A drive unit that drives the measurement unit, A cover container that at least partially covers the breast and includes a support unit that supports the drive unit inside, It includes the above, The drive unit moves the probe on a sheet that is in close contact with the breast, The cover container at least partially covers the breast through the sheet, The cover container has a plurality of sheet position adjustment units for aligning the cover container with the sheet, and the plurality of sheet position adjustment units are formed of a transmissive member or are openings Breast cancer inspection device.
24. It can be commonly used for the left breast and the right breast of the subject The breast cancer inspection device according to claim 23.
25. A measurement unit that moves a probe that irradiates an ultrasonic beam along the surface of the breast of a subject, A drive unit that drives the measurement unit, A cover container that at least partially covers the breast and includes a support portion that supports the drive portion inside; A detection unit that detects whether the breast measured by the measurement unit is the left breast or the right breast; A breast cancer inspection device comprising: The detection unit specifies the installation direction of the breast cancer inspection device by means of an azimuth sensor, and detects whether the breast measured by the measurement unit is the left breast or the right breast according to the installation direction. Breast cancer inspection device.
26. An image generation unit that generates image data based on the reflected signal of the ultrasonic beam; A communication unit that transmits the information detected by the detection unit and the image data to a communication device; The breast cancer inspection device according to claim 25, further comprising:
27. A measurement unit that moves a probe for irradiating an ultrasonic beam along the surface of the breast of a subject; A drive unit that drives the measurement unit; A cover container that at least partially covers the breast and includes a support portion that supports the drive portion inside; Comprising: While moving the probe, pressing the probe against the breast Breast cancer inspection device.
28. A measurement unit that moves a probe for irradiating an ultrasonic beam along the surface of the breast of a subject; A drive unit that drives the measurement unit; A cover container that at least partially covers the breast and includes a support portion that supports the drive portion inside; Comprising: The cover container has a disk shape, a cup shape, or a concave shape on the side of the breast; Comprising an electronic circuit board for ultrasonic diagnosis that electronically controls the measurement unit; The electronic circuit board for ultrasonic diagnosis has a substantially semicircular or crescent shape Breast cancer inspection device.
29. A measurement unit that moves a probe for irradiating an ultrasonic beam along the surface of a subject's breast, a drive unit that drives the measurement unit, a cover container that at least partially covers the breast and includes a support portion that supports the drive unit inside, A breast cancer inspection device comprising: The breast cancer inspection device is installed such that the cover container covers at least a part of the breast, A breast cancer inspection device comprising a control unit that adjusts the angle of an arm that supports the probe according to the shape of the breast.
30. A measurement unit that moves a probe for irradiating an ultrasonic beam along the surface of a subject's breast, a drive unit that drives the measurement unit, a cover container that at least partially covers the breast and includes a support portion that supports the drive unit inside, A breast cancer inspection device comprising: The cover container is stretchable in the height direction and adjustable to a position suitable for the breast.
31. A breast cancer inspection instrument according to any one of Claims 1 to 17, and a measurement unit that moves the probe for irradiating the ultrasonic beam in contact with the surface of the cover member. A breast cancer inspection set comprising:
32. A breast cancer inspection device according to any one of Claims 18, 19, 21 to 25, 27 to 30, an image generation unit that generates image data based on a reflection signal of the ultrasonic beam, and a display unit that displays the image data. A breast cancer inspection system comprising:
33. A management unit that manages the image data, and a diagnosis unit that diagnoses the subject based on the image data. The breast cancer inspection system according to Claim 32, comprising:
34. The management unit normalizes the image data to a predetermined size and manages the normalized image data. The breast cancer inspection system according to claim 33.
35. The diagnosis unit generates a schematic diagram representing the diagnosis result of the subject for answering the diagnosis result to the subject. The breast cancer inspection system according to claim 33.
36. A three-dimensional image generation unit that generates three-dimensional image data of the interior of the breast based on the image data or the reflection signal is provided. The display unit displays the three-dimensional image data. The breast cancer inspection system according to claim 32.
Citation Information
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