TW201946590A - Breast ultrasound phantom, method of manufacturing the same, and storage box for containing the same - Google Patents

Abstract

This phantom (10) is equipped with: a pectoralis major muscle simulation layer (21) that simulates the pectoralis major muscle of the human body in terms of the ultrasonic propagation characteristics; and a retromammary space fat simulation layer (22) that simulates the adipose layer of the retromammary space of the human body in terms of the ultrasonic propagation characteristics, the retromammary space fat simulation layer being layered on the pectoralis major muscle simulation layer. The phantom is also equipped with: a skin simulation layer (23) that simulates the surface skin layer of the breast in terms of the ultrasonic propagation characteristics; a subcutaneous fat simulation layer (24) that simulates the subcutaneous fat of the breast, the subcutaneous fat simulation layer being attached to the inside of the skin simulation layer; and a plurality of glandular lobe simulators (25) that simulate the glandular lobes of the breast at least in terms of the ultrasonic propagation characteristics, the glandular lobe simulators being arranged between the retromammary space fat simulation layer and the subcutaneous fat simulation layer. At least one lesion simulation portion (T1 (T2-T4)) that simulates a breast lesion in terms of the ultrasonic propagation characteristics is provided in the plurality of glandular lobe simulators (25).

Description

Breast ultrasound phantom, manufacturing method of breast ultrasound phantom, and storage box for storing breast ultrasound phantom

The invention relates to a breast ultrasound phantom that simulates a subject, especially a human breast, and particularly relates to a breast ultrasound phantom that has at least a plurality of glandular lobes and a diseased phantom. Ultrasound characteristics, even when the ultrasound probe touches it, it is close to the actual breast. It is suitable for the breasts of medical staff (hereinafter referred to as doctors and technicians) engaged in breast ultrasound examinations, such as doctors, medical examiners, and medical radiologists. Ultrasound training.

In recent years, all parties have said that breast cancer must be detected early. One of the important diagnostic methods for early detection of breast cancer is breast ultrasound.

However, it is not easy for doctors and technicians to distinguish malignant lesions from normal tissues while interpreting the tomographic images obtained immediately by touching the ultrasound probe against the breast, and it requires a lot of experience. In order to improve its experience, it is useful to use breast ultrasound phantom cumulative training.

In order to accumulate this training, it is necessary to have a breast ultrasound phantom as close as possible to the actual breast (with individual differences). Specifically, the requirements are: the penetration characteristics of the ultrasound beam are close to the actual breast; the simulated body that simulates the lesion, especially the lesion that is difficult to understand only by the lecture, is hidden inside; the elasticity (softness) that is as close to the actual breast as possible : There are individual differences), according to the subtle changes in the touch form of the ultrasonic probe, its internal structure will also change, and an image reflecting the change will be obtained.

At present, some breast ultrasound phantoms for breast ultrasound examinations have been proposed, and some of them can be used for training.

As an example, a phantom described in Patent Document 1 is known. The phantom of Patent Document 1 presents a layer structure (but not a glandular lobe) that can easily change characteristics. The phantom is formed so as to simulate a lesion and is buried in a layered structure.

In addition, Patent Document 2 discloses an example of a breast ultrasound phantom having a composite structure for medical training. According to this phantom, a breast is composed of a plurality of different layers using an elastic body.

In addition, Patent Document 3 proposes a mimic called a SIMULATOR DEVICE. This phantom is configured to embed various pathological elements in a breast having elasticity.
[Prior technical literature]
[Patent Literature]

[Patent Document 1] Japanese Patent Laid-Open No. 2016-202835
[Patent Document 2] EP02977977A
[Patent Document 3] EP001166253A

[Problems to be solved by the invention]

However, the breast ultrasound phantoms described in the previous bulletins are not necessarily suitable for the training of physicians and technicians to improve the experience value of breast ultrasound. For example, the phantom described in Patent Document 1 is not for training, it is a phantom having a plurality of layers with different ultrasonic transmission characteristics, but it is not based on the premise that the glandular lobes are present in an actual breast. Therefore, the phantom described in Patent Document 1 is not suitable for training of physicians and technicians. In addition, although the case of the composite structure described in Patent Document 2 discloses a layered structure having different thicknesses, it is similar to the above, and does not simulate a glandular structure. In addition, the device described in Patent Document 3 is also a case in which training for exploring pathological elements can be performed, but because it is not a simulation of the glandular lobe structure, it is lack of realism for a simulated breast body, and it is not sufficient to cultivate the Scanning feel.

As such, a breast ultrasound phantom that has the necessary ultrasonic characteristics to accumulate the experience of breast ultrasound examinations in order to allow physicians and technicians to use it for training, and is close to the actual breasts in touch is not yet provided.

Therefore, in the present invention, in view of this situation, the object is to provide a breast ultrasound phantom suitable for training, which is close to the actual breast in terms of ultrasonic transmission characteristics and tactile sensation during operation of the ultrasound probe. And as a basic structure, it has a glandular lobular structure in which a simulated body simulating a lesion is hidden in a glandular lobes to obtain an ultrasound image close to the actual breast, and provides a method for manufacturing the breast ultrasound phantom, and storing the Storage box for breast ultrasound implants.

[Technical means to solve the problem]

In order to achieve the above object, the breast ultrasound phantom provided by the present invention simulates the human breast based on the shape and hardness of the physical object and the ultrasonic transmission characteristics including the attenuation and reflection of the ultrasound, and is used by the examiner An ultrasound diagnostic device touches the probe and is used as a training phantom for breast ultrasound diagnosis. The breast ultrasound phantom, as a basic structure thereof, has at least: a pectoralis major muscle simulation layer that simulates the pectoralis major muscle of the human body at least in terms of ultrasonic transmission characteristics (acoustic impedance, sound attenuation rate, etc.); and is laminated on the chest The large muscle simulation layer simulates the posterior mammary interstitial fat simulation layer of the human body's posterior mammary interstitial fat layer from the aspect of the aforementioned ultrasound transmission characteristics; the ultrasound transmission characteristic simulates the surface of the breast's surface skin layer of the skin A simulation layer; a subcutaneous fat simulation layer that is attached to the inside of the skin simulation layer and simulates the subcutaneous fat of the breast; and is disposed between the post-mammary space fat simulation layer and the subcutaneous fat simulation layer, and at least from the super The aspect of the sonic transmission characteristics simulates a plurality of glandular lobe mimics of the glandular lobe of the aforementioned breast. The plurality of glandular leaf simulation bodies are provided with at least one lesion simulation section simulating a lesion of the breast from the aspect and morphological characteristics of the ultrasonic transmission characteristics.

The breast of the human body referred to here is an artificial breast having a predetermined shape, size, hardness, and ultrasonic transmission characteristics including attenuation and reflection of ultrasound, imitating actual breasts.

According to this basic structure, the pectoralis major muscle, the posterior mammary gland fat layer, a plurality of glandular lobes, the subcutaneous fat layer, and the skin layer are sequentially provided from the thoracic side. It has these elements, and has the softness and ultrasonic transmission characteristics (acoustic impedance, sound attenuation rate, etc.) of an actual breast. Therefore, doctors and technicians can obtain a probe scanning sense closer to the real thing. At the same time, the ultrasound image obtained by the probe scanning has a delicate internal structure closer to the actual one, especially because of the simulation of glandular lobes, based on this, a scanning feeling closer to the solid can also be obtained. Furthermore, because the lesions are simulated in the glandular lobes in the same way as the actual symptoms, the breast ultrasound training can be accumulated by exploring the lesions.

For example, the lesion simulation part is a mock body for simulating the lesion, which is formed of the same material as the gland leaf mock body, and the mock body is preferably formed by a different process from the gland leaf mock body. In this way, a sound boundary can be generated inside the glandular leaf simulation body around the simulation body, so that the physician or technician can accumulate the training of moving the ultrasound probe on the surface of the body in a manner that makes the boundary more clear.

Furthermore, according to another aspect of the present invention, a method for manufacturing a breast ultrasound phantom is provided. The breast ultrasound phantom is based on the physical shape, hardness, and ultrasonic transmission characteristics including attenuation and reflection of the ultrasound This method simulates the breast of a human body and is used by the examiner to touch the probe of the ultrasonic diagnostic device for training of breast ultrasound. This manufacturing method prepares a template that simulates the shape of the breast, and sequentially arranges the template: a subcutaneous fat simulation layer that simulates the subcutaneous fat of the breast, and simulates the glandular lobes of the breast from the transmission characteristics of the ultrasound The plurality of glandular leaf simulators include at least one lesion simulation unit that simulates a lesion of the breast from the aspect of the ultrasonic transmission characteristics.

According to this manufacturing method, the subcutaneous fat is also made by the simulation layer, and then a plurality of glandular leaf simulation bodies are arranged, and the operation is easier to understand and simplified than in the case of the opposite production process.

Various other features of the present invention will be apparent from the embodiments described later with reference to the accompanying drawings.

Hereinafter, a breast ultrasound phantom of a human body according to an embodiment of the present invention will be described with reference to the accompanying drawings.

FIG. 1 is a perspective view showing the appearance of the breast ultrasound phantom 10, and FIG. 2 is a cross-sectional view taken along the line II-II in FIG. In addition, FIG. 3 shows a cross section and a surface viewed along an imaginary line III-III line in FIG. 2.

This breast ultrasound phantom 10 (hereinafter, simply referred to as a phantom 10 if necessary) is produced for a doctor or a technician to accumulate training for performing a breast ultrasound. Therefore, the imitation body 10 simulates the breast of an actual human body in a state as close as possible to the actual shape, size, and touch (softness) of the surface when the ultrasound probe touches it, and sends and receives information from the ultrasound. In terms of characteristics (acoustic impedance, acoustic attenuation rate, etc.), the internal structure of the breast of an actual human body is simulated as close to the actual state as possible. That is, the breast of the human body in this embodiment is an artificial breast that imitates an actual breast. It has a predetermined shape, size, and hardness, and is provided with pectoralis major muscle, a posterior mammary gland fat layer, a plurality of glandular lobes, The internal structures such as the subcutaneous fat layer and the skin layer include ultrasonic transmission characteristics including attenuation and reflection of ultrasonic waves.

In this phantom 10, in simulating the actual internal structure, various elements are carefully made in a state close to reality, and one of the basic elements is a plurality of glandular lobes. That is, its basic feature is that it does not adopt a layered structure that takes only ultrasonic characteristics into consideration, as in the past. In addition to this feature, various elements are carefully crafted as described later.

In addition, because the training is to find a lesion including cancer, a mock body of such a lesion is buried inside. Of course, because there are individual differences in the overall shape, size, elasticity, etc. of the breast itself, in this embodiment, the phantom 10 is made by imitating general numerical values obtained statistically. Of course, in order to obtain closer to the actual ultrasonic image, the shape, size, elasticity, etc. of the internal structure are also made as much as possible to imitate the actual person.

Physicians and technicians, during training, are the same as the actual clinical scene. They touch the phantom 10 with the probe of the ultrasonic diagnostic device and interpret the B-mode tomographic images obtained immediately while visually observing. Of course, if necessary, the attention tomographic image can be recorded as a static image or animation, which is the same as the clinical scene.

Therefore, the phantom 10 requires the same degree of softness and ultrasonic transmission characteristics as the actual breast. The breast surface and internal structure can be deformed according to the probe's contact force, direction (scanning direction), and angle (scanning angle). It is important that the corresponding B-mode tomographic image can be taken. Embedded in the phantom 10: a phantom that simulates a lesion including a cancer, and a phantom that simulates normal tissue as a comparison. In addition, similar to an actual breast, it is a mock body including a plurality of glandular lobes with breasts inside, and the glandular lobes with lesions such as breast cancer. Of course, because it is used repeatedly, the surface of the phantom is preferably maintained at a certain strength, and more preferably, it has a strength that can withstand the normal shaking during transportation.

Since the phantom 10 of this embodiment is manufactured so as to satisfy these requirements as much as possible, its basic structure includes a pedestal 11 (frame) and a phantom body 12 formed on the pedestal 11.

The pedestal 11 is, as shown in FIG. 1 and FIG. 2, a plate-like member made of resin with a certain thickness.

The phantom body 12 is imagined to imagine the actual breast (left breast) of the patient, simulate its size and shape, and simulate its internal structure from the viewpoint of ultrasonic transmission characteristics (acoustic impedance, acoustic attenuation rate, etc.) model. The phantom body 12 is formed to have elasticity (softness when touched with an ultrasonic probe) using a polymer hydrogel or the like as a whole. Various unique structures (simulation bodies) are embedded in the phantom body 12.

As the basic structure of the structure, as shown in Figs. 2 and 3, at least: the pectoralis major simulation layer 21 that simulates the pectoralis major muscle of the human body at least in terms of ultrasonic transmission characteristics (acoustic impedance, sound attenuation rate, etc.); Laminated on the pectoralis major muscle simulation layer 21, and simulates the posterior mammary interstitial fat layer 22 of the human posterior mammary interstitial fat layer from the aspect of ultrasound transmission characteristics; the ultrasound layer simulates the skin layer of the skin from the surface of the breast Simulation layer 23; subcutaneous fat simulation layer 24 attached to the inside of the skin simulation layer 23 and simulating subcutaneous fat of the breast; disposed between the post-mammary space fat simulation layer 22 and the subcutaneous fat simulation layer 24, and at least from the super In terms of sonic transmission characteristics, a plurality of glandular leaf simulating bodies 25 which simulate the glandular lobes of the breast; and the gap between the glandular leaf simulating bodies 25 and the posterior mammary gland fat modeling layer 22 are filled inside the phantom body 12 Way of filling the substrate 26.

At least one lesion simulation part T1 (~ T4) (target) is embedded in the plurality of glandular leaf simulators 25. The lesion simulation part T1 (~ T4) is simulated from the characteristics of transmission characteristics and morphology of ultrasound Breast-derived cancerous lesions, and simulated lesions with structures similar to the lesions.

An example of the structure of the phantom 10 will be described in detail below. As shown in FIG. 2, a spacer 13 is placed on the pedestal 11, and the phantom body 12 is formed on the pedestal 11 so as to cover the spacer 13. The spacer 13 is a member made of, for example, a urethane resin, and the central portion of the cross section has a raised shape. Therefore, the spacer 13 pushes the pectoralis major muscle simulation layer 21 toward the front of the chest to simulate the curvature of the thorax of the actual human body, thereby preventing the tomographic body 12 itself and the tomographic images obtained by scanning the phantom 10 from unnaturally changing. thick.

＜ Glandular body structure ＞
Each of the plurality of glandular leaf mimics 25 is a simulation in which a glandular leaf (each constituting a breast tissue) constituted by a milk duct and a plurality of leaflets is regarded as a substantially eggplant-shaped organ. Specifically, a polymer material (for example, a polymer hydrogel) is formed into a substantially eggplant shape by using a net-like member. An additive is contained in the polymer material, so that the transmission characteristics of the ultrasonic signal show a certain allowable range close to the reflection characteristics of the real object.

In the present embodiment, a total of five glandular leaf simulating bodies 25 are provided in the phantom 10, but not necessarily five, as if there are individual differences, as long as there are a plurality of them. Each of the five glandular leaf mimics 25 is formed into a substantially eggplant-like shape by using a mesh material of a polymer material, and as shown in FIG. 4, the vertexes (that is, the tops in contact with the nipples) are formed by In a manner of contacting each other, for example, the silk ST is bundled to form one glandular leaf mimic unit 25U in which five glandular leaf mimics 25 are arranged radially.

The glandular leaf mimic body unit 25U, as shown in FIGS. 2 and 5, is placed inside the phantom body 12. In the actual human body, the glandular lobe is connected to the pectoralis major muscle and the subcutaneous tissue through the breast ligament to maintain the softness of the entire breast and maintain the spatial position in the breast. Therefore, the phantom 10 also has a structure that mimics the physical structure as much as possible in terms of flexibility and maintenance of the spatial position. In this way, the palpation feeling when a doctor or a technician touches the phantom 10 with an ultrasonic probe is close to the actual diagnosis.

Compared with such a previous phantom, the phantom 10 of this embodiment has a plurality of glandular leaf mimics 25 (25 ₁ to 25 ₅ ), which is an advantageous feature. The reason is that because the actual breast has a plurality of mammary gland leaf tissues connected to the nipple, by faithfully simulating it as much as possible, you can get a sense of using an ultrasonic probe that is close to the diagnosis of the actual breast, and you can understand the structural characteristics. This helps the training of physicians and technicians.

In addition, another feature of this embodiment is that each of the four glandular leaf mimics 25 (25 ₁ to 25 ₅ ) among the five glandular leaf mimics 25 (25 ₁ to 25 ₄ ) is embedded to simulate the onset of disease. Various lesion simulation sections T1 to T4 (hereinafter, referred to as targets) of the lesions or structures similar to the lesions. Most lesions such as tumors occur along the site of the ducts belonging to the respective glandular lobes. Therefore, it is reasonable to adopt such a structure for each glandular leaf mimic 25. A physician or technician touches the phantom 10 with an ultrasonic probe, and visually displays a B-mode tomographic image displayed on a monitor in real time to perform training to find the target. In this training, a lesion is found and recorded on a tomographic image, and the type of the lesion is interpreted.

＜ Various targets ＞
In order to perform this training, it is preferable to prepare different kinds of targets in a plurality of glandular leaf mimics 25. Based on this viewpoint, in this embodiment, there are four types of targets: benign lumps, malignant lumps, regional lesions suggestive of malignancy, and structural distortion that is also commonly referred to as structural distortion (Architectural distortion). T1 ~ T4. In the present embodiment, in which 25 of a lobe mimetibody five lobe mimetibody target ₂₅₅ is not embedded, but as mimetibody gland disease is not normally used for the reference.

As will be described later, the relationship between the type and number of targets embedded in the phantom 10 and the number of gland leaf mimics embedded in the target can be implemented in various forms.

As shown schematically in FIG. 3, among the five glandular leaf mocks 25 (25 ₁ to 25 ₅ ), a benign mass is simulated inside the first glandular leaf mocks 25 ₁ or inside contact with the outer surface. An example of the benign mass target T1 (equivalent to lesion simulation, tumor and tumor simulation, and benign tumor simulation). The benign mass target T1 is a tumor with a simulated oval or leaf-like shape and smooth edges, and is composed of a polymer material having a lower ultrasonic reflection characteristic than a glandular leaf simulated body material.

In addition, the second gland lobe mimic 25 _{2 is} provided with a malignant tumor target T2 (corresponding to a lesion simulation section, a tumor and tumor simulation section, and a malignant tumor simulation section), which is an example of a malignant mass. The malignant mass target T2 is a tumor that simulates polygonal or irregular shapes and has rough edges. Similarly, it is composed of a polymer material with lower ultrasonic reflection characteristics than that of a glandular leaf simulated body. This malignant mass target T2, in this embodiment, simulates a state in which the front boundary line is broken. As shown schematically in Fig. 5, it penetrates the surface of the second gland leaf mimic body 25 ₂ and penetrates into the subcutaneous fat mimic layer. 24.

Therefore, in the production of the phantom 10, when it is regarded as a malignant tumor target T2, a part of the malignant tumor target T2 is embedded in the subcutaneous fat simulation layer 24 (refer to the figure) 6). Then, the second glandular leaf mimic 25 ₂ is pushed in such a way that the remainder of the malignant mass target T2 sinks into a part of the second glandular leaf mimic 25 ₂ , thereby fixing the malignant mass target T2 to the second gland. Leaf mimicry 25 ₂ . In this way, the simulation produced a state where the front boundary line was broken.

Furthermore, a plurality of regional lesion targets T3 (corresponding to the disease simulation) composed of a plurality of small tumors with irregular shapes and rough edges that simulate regional lesions are arranged in the third gland leaf mimic 25 ₃ . Department, regional lesion simulation department). The plurality of regional lesion targets T3 are made of a high-molecular material with a lower ultrasonic reflectance than the glandular leaf simulated body.

Furthermore, a structural distortion target T4 (which is an example of a lesion simulation section and a structural abnormality simulation section) is arranged in the fourth gland leaf mimic 25 ₄ in a form that simulates the structural abnormality (structural distortion) of the tissue. This structure twist target T4 is made by weaving three-dimensionally a wire in a flower shape as shown in FIG. 7, and burying the braid in a glandular leaf mimic.

Also in this embodiment, the third gland leaf mock body 25 ₃ and the fourth gland leaf mock body 25 ₄ are mixed with a moderate amount of thin non-woven fabric pieces in a suitable amount. This mixing prevents the position of the regional lesion target T3 from being excessively moved in the simulated body during manufacture. The structural distortion target T4 is improved in visual confirmation of the state where the structural distortion is formed by the incorporation of the non-woven fabric. In other glandular leaf simulants, the non-woven piece can be mixed or not mixed. Because it is a small piece of non-woven fabric, it has almost no effect on the transmission characteristics of ultrasound and the elastic modulus (or softness) of the glandular leaf mimic.

The fifth gland leaf mimic 25 _{5 is} not provided with a target, but is used as a reference. The fifth glandular leaf mimic 25 ₅ without lesions plays an important training function in comparison with other glandular leaf mimics.

＜ Manufacturing of phantoms ＞
The phantom 10 of this embodiment is manufactured in the following procedure. However, the following procedure is only an example, and various modifications such as use or non-use of the mold can be performed.

First, the pedestal 11 and the spacer 13 are prepared (step S1), and the base portion of the phantom body is set (made) on the upper surface 11A of the pedestal 11 (step S2). At least the upper surface 11A of the pedestal 11 is formed of a material (for example, a silicon-based resin) having good adhesion to a polymer material constituting the skin simulation layer 23 described later.

Of course, the manufacturing processes of these steps S1 and S2 can also be performed at a suitable point in time, such as a gap in the manufacturing process of a phantom body described later.

If the basal part is made, the aforementioned five glandular leaf mimics 25 ₁ to 25 _{5 are prepared} as described above (FIG. 8: step S11). In this step, four targets T1 to T4 are arranged as described above for each of the four gland leaf mock bodies 25 ₁ to 25 ₄ .

Next, the end portions on the nipple side of the five glandular leaf simulants 25 ₁ to 25 _{5 are} centered toward each other, and each gland leaf simulative body 25 ₁ to 25 _{5 is} radially expanded from the center, and the center The five end portions on the sides are connected to each other by a connecting portion 25X to form a glandular leaf mimic unit 25U (see FIG. 4) (step S12). This glandular leaf mimic body unit 25U is produced by inserting and filling five glandular leaf mimics 25 ₁ to 25 ₅ and a member serving as a connecting portion 25X into a mold. After the phantom body is made, as shown in FIG. 2, the connection portion 25X is located directly below the nipple 28. The connecting portion 25X is made of the same material as the glandular leaf mimic. By making this glandular leaf mimic body unit 25U, compared with the case where the glandular leaf mimics 25 ₁ to 25 _{5 are} separately arranged, the five glandular leaf mimicry 25 ₁ to 25 ₅ described below can be simplified to be arranged in the subcutaneous fat. Work on layer 24 is simulated.

In addition, the glandular lobe mimics are not connected by the connecting portion 25X, and only the five distal ends are sutured to each other with a silk thread, and the same function can be performed.

Next, an appropriate amount of a high-molecular material constituting the subcutaneous fat simulation layer 24 is filled into a template (not shown) that has been prepared in advance as an internal shape of a bowl-shaped depression in the entire breast, and the filled high-molecular material is filled. Then, a mold for molding the subcutaneous fat simulation layer 24 (the surface of the fat layer having simulated unevenness) is tightly pressed to form the subcutaneous fat simulation layer 24 with unevenness (step S13). A skin-colored pigment is mixed into the polymer material. In this template, instead of being formed into a simple bowl-shaped depression shape, it is formed so as to form a breast surface that simulates the shape of the inferior sulcus 10A (see FIGS. 1,2) that an actual breast has.

Next, a part of the malignant mass target T2 is pushed into a predetermined position fixed to the subcutaneous fat simulation layer 24 (step S14: see FIG. 6).

Next, a glandular leaf mimic body unit 25U is placed on the subcutaneous fat mimic layer 24 formed in the internal space of the template (step S15). During deployment, the connecting portion 25X of the central portion of the glandular leaf mimic body unit 25U is located at the substantially bowl-shaped bottom center of the subcutaneous fat mimicry layer 24, and the other end portion of the malignant tumor target T2 abuts against the second gland A part of the mock body 25 ₂ is aligned. Then, the second gland leaf mock body 25 _{2 is} slightly pressed, and a part of the other end portion of the malignant mass target T2 is penetrated into the second gland leaf mock body 25 ₂ . In this way, it is possible to achieve a state in which a part of the malignant lump target T2 runs out from the second gland leaf mock body 25 ₂ to infiltrate a part of the subcutaneous fat mock layer 24.

After completion, the same polymer material as the glandular leaf mimic 25 is used as the base material 26 to be poured into the template, and the gap between the structures in the template is filled (step S16).

Then, it is left for a certain period of time (step S17). A posterior mammary interstitial fat simulation layer 22 is laminated on the surface of the substrate 26 filled in the template (step S18), and a plurality of pectoralis major muscle simulation layers 21 are laminated thereon (step S19).

After the phantom body 12 is formed as described above, the phantom body 12 is taken out from the template, and the phantom body 12 is placed while being aligned with the prepared spacer 13 (step S20). Next, the entire phantom body 12 placed on the spacer is placed while being aligned with the base portion of the prepared stand 11 (step S21). In this way, the phantom body 12 placed on the upper surface 11A of the pedestal 11 is completed.

Then, the areola 27 and the nipple 28 formed by the red silicon-based polymer material are adhered and fixed on the top of the phantom body 12 (step S22). The areola 27 may be used to color only a predetermined portion of the surface of the subcutaneous fat simulating layer.

After completion, the transparent polymer material serving as the skin simulation layer 23 is applied to the entire body of the phantom body 12 (including areola 27 and nipple 28) with a thickness of about 1 to 3 mm (step S23). At this time, as shown in FIG. 2, it is coated so as to cover the ends of the posterior breast interstitial fat simulation layer 22 and the pectoralis major muscle simulation layer 21 and extend and abut on the surface of the pedestal 11. In this way, the phantom body 12 is integrated with the areola 27 and the nipple 28 by the skin simulation layer 23, and the phantom body 12 is fixed on the upper surface 11A of the pedestal 11. In this way, a phantom 10 having a length and a length of 15 to 18 cm and a weight of about 3 to 4 kg, respectively, is simulated.

Although the end portion 23A of the skin simulation layer 23 is substantially integrally welded to the upper surface 11A of the pedestal 11 to seal the inside of the phantom body 12, if necessary, the end portion 23A of the skin simulation layer 23 may The entire skin simulating layer 23 is removed. In this way, it is convenient when the body 10 is to be repaired or the like.

In the above-mentioned manufacturing process, although drying time, standby time between processes, degassing time, temperature control, etc. are not mentioned, of course, such time and temperature management can be performed in an appropriate state.

＜ Training ＞
Therefore, as shown in FIG. 9, if the ultrasound probe 42 of the ultrasound diagnostic device 41 touches the phantom 10, the ultrasound pulse is transmitted from the transmitting and receiving circuit 43 in the device to the phantom 10 in the order of B-mode photography. . The reflected pulse waves reflected by the boundary surfaces with different acoustic impedances in the phantom 10 are received by the ultrasonic probe 42. This received wave is signal-processed by the transmitting / receiving circuit 43 and is displayed on the monitor 44 as a B-mode tomographic image.

Therefore, as long as the physician or technician uses the phantom 10 of this embodiment, he can obtain the B-mode tomographic images shown in FIGS. 10 (A) to (F). FIG 10 (A) are, for example: non-target configuration of a fifth lobe ₂₅₅ mimetibody, or arranged by the first to the fourth targets gland mimetibody claims 25 ₁ to 25 ₄ of a target of B-mode tomographic image of the scanning section. In this tomographic image, of course, the target cannot be illuminated, but the subcutaneous fat simulation layer 24, the glandular leaf simulation body 25, and the like are presented. Therefore, the examiner who sees this image can judge that there is no part that is a lesion or a similar lesion.

FIG. 10 (B) shows an example of a B-mode tomographic image scanned through a section below the nipple 28. In this case, the silicon-based polymer materials used in the areola 27 and the nipple 28 may have a high ultrasonic attenuation, and therefore a dark shadow portion along the width is present below the areola 27 and the nipple 28. Of course, this shaded part is difficult to interpret, and the actual breasts are the same. Because even the shadow portion is simulated, the inspector who sees the shadow portion must carefully observe the shadow portion, and if necessary, must change the scanning profile and observe the portion directly below it several times. In this way, training can be performed in order to avoid overlooking the lumps and the like that occur on the lower side of the nipple 28.

In addition, FIG. 10 (C), (D), (E), and (F) respectively show that a benign tumor target T1 and a malignant tumor that pass through the first to fourth gland lobe mimics 25 ₁ to 25 ₄ are scanned. B-mode tomographic images of target T2, regional lesion target T3, and structurally distorted target T4 profile. In particular, a part of the malignant mass target T2 penetrates into the subcutaneous fat simulation layer 24. By reading this image, it is easy to determine that it is a malignant mass during training.

Furthermore, Fig. 11 and Fig. 12 show that when the ultrasound probe is used to scan the phantom 10, the different angles of the probe on the phantom 10 have an impact on the ultrasound image. Sex comparison example. FIG. 11 is an example of a glandular leaf mimic 25 ₅ . The image (A) on the left side of FIG. 11 shows an example in which the probe scans the phantom 10 at an angle as close to 90 ° as possible; on the other hand, FIG. 10 (B) shows that the probe tilts (more accurately, An example in which scanning is performed at an angle of reclining (inclined more than the angle of FIG. 10 (A)). FIG. 12 shows an example of the same difference regarding the glandular leaf mimic 25 ₁ of the target T1 containing a benign mass.

In both the cases of FIGS. 11 and 12, the right-side image (B) has a glandular leaf simulating body 25 compared with the left-side image (A).₅ , 25₁ And the outline of the target T1 is not clear, and the sharpness of the pectoralis major muscle simulation layer 21 also deteriorates. These comparative examples show that by touching the ultrasonic probe at 90 ° (upright) with respect to the breast contact surface as much as possible, by adjusting the angle of the ultrasonic probe with respect to the structure to be presented, a sufficient ultrasonic reflection pulse can be received To make the picture quality better. This shows again that the examiners such as doctors and technicians can realize the importance of adjusting the angle of the probe.

As described above, the phantom 10 of this embodiment is based on the viewpoints of the physical shape, hardness, and shape, and the ultrasonic transmission characteristics including ultrasonic attenuation and reflection, and simulates the malignant and benign characteristics unique to human breasts and breasts. Lesions. Therefore, it becomes an appropriate breast ultrasound phantom for training breast doctors and other technicians to perform breast ultrasound examination by touching the probe of the ultrasound diagnostic apparatus. In particular, it is different from the previous prosthesis (only the shape of the entire breast) because it has a plurality of glandular leaf mimics 25 (25 ₁ to 25 ₄ ) equipped with targets T1 (~ T4) as at least one lesion simulation part. It is simulated with a polymer material and a target is embedded in it). Not only can it obtain the same scanning sensation as the actual breast, but also the target can be understood and retrieved in the tomographic lobe-centric tomographic image obtained from the actual breast ultrasound. Target morphology. This is suitable for training.

The present inventors tested a breast ultrasound phantom based on the structure of this embodiment, and measured the hardness (elastic modulus) of the main part. As a result, the following measured values were obtained.


In addition, the phantom 10 is manufactured so that it may conform to the specification requested by JIS standard (JIS T 0601-2-37: 2005).

According to the above data, when the examiner touches the phantom 10 with the ultrasonic probe, the scanning feeling is not to move the probe across a hard object, but to press and rotate the probe to the phantom 10 The surface of S is slightly sunken and has a state of moderate flexibility (see FIG. 9). In this way, it has a scanning feeling with the same difficulty of movement as a probe operation on an actual breast, and thus helps the examiner's proficiency in scanning techniques for exploring targets.

That is, because it is a phantom 10 with a moderate softness close to the real thing, the position and angle of the probe must be well maintained in order to place the surface of the four glandular leaf mimics 25 (25 ₁ ~ 25 ₄ ) in the interior. Targets T1 ~ T4 are clearly displayed. This is because as long as the angle and position of the probe are slightly changed, the target T1 (~ T4) cannot be presented on the monitor screen, or a characteristic tomographic image cannot be captured, requiring subtle scanning techniques.

In addition, the plurality of targets T1 to T4 are not simply buried in the breast, but have the size, hardness, and ultrasonic reflection characteristics close to the actual lesion. Therefore, if it is not read carefully, the benign and malignant masses will be mistaken, or the boundary surface of the presented tissue will be mistaken for structural distortion, and training can also be accumulated at this point.

In addition, there are several types of targets, not only to determine whether there is a mass (tumor), but also: targets with benign or malignant characteristics in shape and distribution, scanning with a probe like a twisted structure, and monitoring on a monitor Targets that can be recognized in the moving images shown above. Therefore, physicians, technicians, and even such subtle structural changes can accumulate training.

Moreover, as illustrated in FIG. 11 and FIG. 12, even when the ultrasonic probe 42 touches the phantom 10, the angle difference can be reflected in the image. That is, because the difference in scanning angles will change the sharpness of the image, especially the sharpness of the boundaries of tissues and structures, it is also possible to accumulate the following training, that is, make the scanning angle as upright as possible on the contact surface with the breast, and observe the location. Adjust the angle of the probe by rendering the image.

Furthermore, in this embodiment, since the spacer 13 having a raised cross section is provided on the pedestal 11, the breast enlargement can be scanned without difficulty with a depth of field of view (about 4 to 6 cm) from the ultrasonic probe close to the real object. The muscle simulates the layer, and can improve the realism of scanning.

Furthermore, since the application of the skin simulation layer 23 is performed at the time of final manufacture, the end of the base portion surrounding the phantom body 12 and the base 11 can be fixed. In this way, during the transportation of the phantom, the durability of the skin layer, that is, the surface of the phantom body 12 can be improved, which can help prevent damage inside the phantom.

In the phantom body 12, since the connection portion 25X is arranged below the central portion thereof, the density of the structures inside the phantom body 12 is increased. Therefore, even if the suspensory ligament is not arranged, the plurality of glandular leaf simulating bodies 25 can be positioned substantially along the chest side of the subcutaneous fat simulating layer 24 as much as possible.

In addition, because the areola 27 and the nipple 28 are provided as simulation bodies, the scanning feeling is closer to the entity, and it is also easy to understand the scanning feeling of the portion with high ultrasonic attenuation directly below the nipple.

Furthermore, in the process of manufacturing the phantom 10, a template is used, and a fat layer is first prepared from the open side of the template. Then, the glandular leaf simulating body 25 is arranged, and after the base material 26 is filled, the skin simulating layer 23 is applied by turning it over, and is produced in this order. In this way, unlike the procedure of simply making from the nipple side or the chest side, even the sealing structure of the skin simulation layer 23 and the pedestal 11 can be produced at once, which contributes to the simplification and efficiency of the manufacturing process.

Furthermore, due to changes over time, friction during use, damage, and the like, the surface of the phantom 10 may have to be repaired. In particular, between the skin simulating layer 23 and the subcutaneous fat simulating layer 24 below it, there may be cases where bubbles generated from the subcutaneous fat simulating layer 24 change over time. Such bubbles become noise in the ultrasonic image. Therefore, when this situation is reached, the skin simulation layer 23 can be completely peeled off from the end portion 23A, the areola 27 and the nipple 28 can be replaced again, and the skin simulation layer 23 can be coated, so that the surface of the phantom can be easily repaired.

Further, among the entire surface of the phantom 10 that is touched by the ultrasonic probe, that is, the skin simulation layer 23, a submammary groove 10A is formed in a curved portion located on the diagonally lower side of the patient's foot side. Generally, the vicinity of the inferior sulcus 10A is a portion where the ultrasonic probe is difficult to touch the breast upright. In the vicinity of the inferior sulcus 10A, when the ultrasonic probe is floating or the contact surface cannot be uprightly touched, the tissue boundary (including the boundary of the lesion) on the B-mode tomographic image is often unclear ( (See Fig. 11 and Fig. 12 (B)). Therefore, a physician or a technician can scan an ultrasound probe in such a manner that the boundary of the tissue is clearly displayed while observing the image on a B-mode tomographic image. In this way, not only the target is found, but also the training of a basic operation of the ultrasonic probe.

On the other hand, the phantom 10 of this embodiment uses a template (not shown) to create a subcutaneous fat simulation layer 24, and a plurality of glandular leaf simulation bodies 25 are arranged so as to be wrapped inside, and postmammary interstitial fat is provided. The simulation layer 22 and the pectoralis major muscle simulation layer 21 are sequentially laminated. After mounting such a laminated body on the base portion including the spacer on the upper surface 11A of the pedestal 11, a skin simulation layer is prepared. Different from the manufacturing method in which the pectoralis major muscle simulation layer is sequentially laminated on the pedestal, the production process can be switched while the production state of each production process can be observed in detail while operating. In this way, the working process is simplified, and the yield in the production of phantoms can be improved.

Although the phantom 10 of this embodiment uses a template or a stamper, most of the steps can be manufactured by hand. In the case of manual manufacturing, of course, products that meet the specifications and tolerances required by the phantom are of course made. Of course, individual differences are inevitable. However, the actual breasts also have individual differences in size, structure, softness, etc. The individual differences actually help to take such personal differences into consideration for training. Of course, mechanized manufacturing using a 3D printer or the like is also possible.

(Storage box for storage and transportation of phantom)
In this embodiment, a storage box 90 for storing and transporting the phantom 10 is also provided. Therefore, the phantom 10 is preferably stored in the dedicated storage box 90 for storage and transportation.

As shown in FIG. 13, the storage box 90 is a box-shaped box. When the cover 91 is opened, a plurality of partitions 92 are provided inside the storage box 90. The partition 92 has a structure that prevents the base 11 made of plastic of the phantom 10 from rolling in a rectangular shape in plan view. During storage, as shown in FIG. 13 (A), a substantially bowl-shaped cover 93 made of, for example, polyurethane is applied to the outer surface of the phantom body 12 (see FIGS. 13 (B) and (C)). The cover 93 has a bowl-shaped portion 92B bulging from the rectangular substrate portion 93A, and the bowl-shaped portion 92B has an internal volume that matches the size, height, and shape of the phantom body 12, and the bowl-shaped portion 93B is formed to be open at the bottom. After covering, the cover 93 is detachably fixed to the edge of the base 11 by a suitable locking means. As shown in the figure, the cover 93 is provided with, for example, a narrow slit 93C so as to avoid the areola 27 (the nipple 28). Therefore, the cover 93 is formed so as not to come into direct contact with the nipple 28. At the same time, the bowl-shaped portion 93B covering 93 has a moderate hardness (softness) that fits on the phantom body 12 and can cover the phantom body 12 while contacting or substantially contacting the outer surface of the phantom body 12, The vibration of the phantom body 12 on the pedestal 11 can be suppressed.

Then, as shown in FIG. 13 (D), the phantom 10 covered with the cover 93 is stored along the partition 92 of the storage box 90. Next, when the cover 91 is closed, the pressing portion 91A fixed on the back side of the cover 91 abuts a rectangular edge portion (that is, an edge portion of the pedestal 11) of the substrate portion 93A covering the 93. In this manner, in the storage box 90, the phantom body 12 is restricted in movement by covering 93 on the surface of the pedestal 11, and the pedestal 11 is fixed in the storage box 90 through the edge portion of the cover 93 and the pressing portion 91A. .

Therefore, even if vibration is transmitted from the outside during storage and transportation, the swing and vibration of the body body 12 can be limited by the cover 93, and the vibration can be appropriately absorbed by the softness of the cover 93. Therefore, it is possible to prevent the body 10 from being damaged during transportation.

The cover 93 is not a closed type, but a slit 93C is formed. Therefore, it can also function as a vent during long-term storage or transportation, and it is useful for managing the temperature and humidity of the phantom body 10 by providing a moderate ventilation port in the storage box 90. In this way, the deterioration of various materials constituting the phantom 10 can be prevented or suppressed, and the durability can also be improved.

＜ Modifications ＞
The breast ultrasound phantom for breast ultrasound examination training according to the present invention is not necessarily limited to the structure described in the above embodiment, and can be further changed to various aspects as long as it does not depart from the gist of the constituent elements described in the scope of the patent application. To implement.

In particular, the present invention is characterized in that it simulates an actual glandular lobe, and has a simulated part on the surface or inside of the structure that simulates a lesion or a similar lesion. Therefore, the lesion simulation unit is not only a structural abnormality (structural distortion) of the tissues constituting the glandular lobes of the breast, but also a mild bundling or concentration (not shown) that is limited only to local changes in the tissues that exhibit the abnormality. These clusters and concentrated parts constitute other examples of the structural abnormality simulation unit.

The tumor and tumor simulation unit may be a tumor simulation unit that simulates a benign morphology in forming a tumor mass, or a tumor simulation unit that simulates a malignant morphology. That is, the size, shape, ultrasonic reflectance, and the like of the simulation body can be set so that it is difficult to clearly determine whether it is benign or malignant, but it is in a form suggesting benign or a form suggesting malignancy. For the size and shape, it is only necessary to shape the simulation body itself, and the ultrasonic reflectance can be adjusted by the type and amount of additives added to the polymer material.

Furthermore, the tumor target Te having the same or substantially the same level of reflection characteristics as the glandular leaflet 25 (25 ₁ to 25 ₅ ) may be arranged in the glandular leaflet 25. According to such a configuration, when the angle at which the probe of the ultrasound diagnostic device touches the breast ultrasound phantom is not appropriate, the boundary of the tumor target Te becomes unclear on the breast ultrasound image, resulting in a decrease in visual confirmation. . Therefore, physicians and technicians can accumulate and train the angle (scanning angle) that the ultrasound probe touches on the image so that the boundary of the tumor target Te can be more clearly visually confirmed.

FIG. 14 illustrates how the tumor target Te and the visual confirmation change depending on the scanning angle of the ultrasonic probe. In FIGS. 14 (A) and (B), a tumor target Te is arranged at a desired position inside a mold or a member for forming a gland leaf mimic 25 (arrangement step), and the glands are filled with the mold and the member to form a gland. Polymer material of leaf mimic 25 (filling step). Therefore, even if the same macromolecular material is used inside the gland leaf mimic 25, a boundary between the tumor target Te and the material containing the gland leaf mimic 25 will have different acoustic impedance. Therefore, as shown in FIG. 14 (A), when the scanning angle of the ultrasonic probe is correct, a white (high-echo) linear boundary is present between the surrounding gland leaf mimic 25 and the tumor target Te. WY and the line-shaped boundary BY that exhibits a black color (presented with low or no echo) can be clearly visually confirmed. However, if the scanning angle of the ultrasonic probe is incorrect as shown in Figure 14 (B), the linear boundaries WY and BY of white (high echo) and 黒 (low echo or no echo) can only be visually obscured. confirm. This is because the touch method of the ultrasonic probe is incorrect, so the touch method of the ultrasonic probe is trained in such a way that the boundaries WY, BY can be clearly imaged.

The structure in which the tumor target Te is embedded can be implemented not only in the aforementioned embodiment, but also in various modifications thereof.

Furthermore, in the phantom 10 of this embodiment, the type and number of targets, and the number of gland leaf mimics in which the target is buried can be further developed in various aspects.

First, the target is not limited to the above four types, and may be any one type of target, any two types of targets, or any three types of targets. Of course, the type of the target itself is not limited to the target (mimic) of the four types of lesions described above, and five or more types of targets may be provided. For example, when simulating a benign mass, a plurality of types of targets can be formed which differentiate characteristics such as the reflectivity of an ultrasonic wave. In this way, targets that are also benign masses can be further subdivided by setting the brightness difference. For example, five types of targets can be buried.

It should be noted that the phantom 10 is not limited to a structure in which one target is provided for each target. It is also possible to arrange a plurality of targets of the same or different type in one gland leaf mimic 25.

Furthermore, in the example shown in the foregoing embodiment, there is only one single glandular lobe mimictor 25 ₅ in which the target is arranged, but it is not necessarily limited to such a structure. It is also possible to set two or more glandular leaf simulators without targets to change the difficulty of training.

Furthermore, for example, by setting only one or a plurality of structurally twisted targets T4 as training for finding a lesion with difficulty in recognition, it is possible to provide a phantom suitable for advanced persons.

As such, the phantom 10 of this embodiment can adopt a structure in which any one or a plurality of types of targets are buried in various forms.

In addition, even if a phantom with the same structure is used, by changing the size of the target or molding the phantom without a target at all, it is possible to provide phantoms of various difficulties.

By combining the various aspects described above, it is possible to provide training phantoms of various levels from beginners to advanced ones.

As a further modification, the phantoms of the above embodiments and modifications can also be developed as follows.

By changing the size, height, hardness, and / or the proportion of the fat portion and the breast portion of the phantom 10 described above, it is possible to simulate large breasts, small breasts, hard breasts, soft breasts, and young or elderly breasts. In this way, it is possible to provide a phantom that takes into consideration even individual differences and gender differences and implements a variety of the present invention for training.
In addition, the size and height of the nipples of the above-mentioned phantom 10 can be appropriately increased, and thus a phantom that can increase the difficulty of training can be provided.
Furthermore, in the aforementioned phantom 10, the echo intensity of a considerable portion of the breast can be increased or decreased, or high echoes and low echoes can be mixed irregularly, thereby attenuating the ultrasonic waves in a considerable portion of the breasts. Improve, reduce the visual confirmation of the target and make training more difficult. Such a phantom reproduces the state of a lactation period and a highly dense breast (so-called dense breast). Furthermore, as for male breasts, a breast ultrasound phantom that can reproduce normal conditions, feminized breasts, and male breast cancer, etc. can be provided.

Furthermore, in the breast, the inferior sulcus of the breast, which is particularly difficult to scan by the probe, or the glandular leaf mimics located near or near the nipple, can also be equipped with smaller targets and targets that are difficult to find.

The overall shape of the breast is different from the shape of the end portion of the phantom as shown in FIGS. 1 and 2, and the end portion is formed to be more smoothly arranged on the upper surface 11A of the pedestal 11. That is, even the root part of the breast is presented, and the probe touch method of this part can be trained.

In addition, as an example of further development of the foregoing embodiment, the skin simulation layer may be provided instead of the subcutaneous fat simulation layer, or the skin simulation layer and the subcutaneous fat simulation layer may be integrated into one.

10‧‧‧ Breast Ultrasound (Body)

10A‧‧‧ Inferior sulcus

11‧‧‧ pedestal

11A‧‧‧ Top surface

12‧‧‧ body

13‧‧‧ spacer

21‧‧‧ Pectoralis major muscle simulation layer

22‧‧‧ Postmammary Gland Fat Simulating Layer

23‧‧‧Skin simulation layer

23A‧‧‧End

24‧‧‧ Subcutaneous fat simulation layer

25 (25 ₁ ~ 25 ₅ ) ‧‧‧Gland Leaf Simulator

26‧‧‧ Substrate

27‧‧‧areola

28‧‧‧ Nipple

90‧‧‧Storage Box

91A‧‧‧Pressing section

92‧‧‧ Division

93‧‧‧ coverage

93C‧‧‧Slit

T1 ~ T4, Te‧‧‧ target (Disease Simulation Department)

FIG. 1 is a perspective view showing an example of a breast ultrasound phantom according to one embodiment.

FIG. 2 is a cross-sectional view showing a schematic cross-section taken along a line II-II in FIG. 1.

FIG. 3 is a plan view showing a partial cross-section and a schematic plane along line III-III in FIG. 2.

Fig. 4 is a perspective view showing a glandular lobe structure composed of five glandular leaf mimics.

FIG. 5 illustrates a partially omitted paraffin section view of a benign mass target and a malignant mass target disposed on a glandular leaf mimic.

FIG. 6 is an explanatory diagram of a procedure for preparing a malignant mass target.

FIG. 7 is an explanatory diagram of a knitting example of a structure twist target line embedded in a gland leaf mimic.

FIG. 8 is a process diagram illustrating an outline of a manufacturing procedure of a phantom.

FIG. 9 is an explanatory diagram of the appearance of a scan for training using a phantom.

Figures 10 (A) ~ (F) are examples of B-mode tomographic images of nipples, glandular lobes, and targets collected during training using phantoms.

11 (A) and (B) are explanatory diagrams of image changes of a glandular leaf mimic (no target) caused by different scanning angles of the ultrasonic probe's contact surface with the breast.

Figures 12 (A) and (B) are explanatory diagrams of changes in the image of a benign mass target caused by different scanning angles of the ultrasound probe's contact surface with the breast.

FIGS. 13 (A) to (D) are explanatory diagrams of a special storage box structure and a storage sequence for storing and transporting a breast ultrasound phantom used in the embodiment.

Figures 14 (A) and (B) are explanatory diagrams of image changes of other targets with different scanning angles of the ultrasonic probe's contact surface to the breast.

Claims (22)

A breast ultrasound phantom, which simulates a human breast based on the physical shape, hardness, and ultrasonic transmission characteristics including the attenuation and reflection of ultrasound, and is used as a probe of an ultrasonic diagnostic device for an examiner to touch. Training for breast ultrasound, characterized by, This breast ultrasound phantom has at least: A pectoralis major muscle simulation layer for simulating the pectoralis major muscle of the human body at least from the aforementioned ultrasonic transmission characteristics, Laminar posterior space fat simulation layer laminated on the pectoralis major muscle simulation layer and simulating the fat layer of the posterior space of the human body from the aspect of the ultrasonic transmission characteristics, A skin simulation layer that simulates the skin layer on the surface of the breast from the ultrasonic transmission characteristics, A subcutaneous fat simulation layer attached to the inside of the skin simulation layer and simulating the subcutaneous fat of the breast, and A plurality of glandular leaf simulants arranged between the post-mammary space fat simulation layer and the subcutaneous fat simulating layer and simulating the glandular lobes of the breast at least in terms of the ultrasonic transmission characteristics The plurality of glandular leaf simulators are provided: at least one lesion simulation unit that simulates a lesion of the breast from the aspect of the ultrasonic transmission characteristics. The breast ultrasound phantom according to claim 1, wherein: The lesion simulation section is a structural abnormality simulation section that simulates a structural abnormality of a tissue constituting the glandular lobes of the breast, and the structural abnormality is a lesion expressed in at least one of structural distortion, bunching and concentration. The breast ultrasound phantom according to claim 1 or claim 2, wherein: The plurality of glandular lobes are further provided with a mass and a tumor simulating part as the simulating part of the lesion, The tumor cum tumor simulation section simulates a tumor-forming lesion among the aforementioned tumors in the breast. The breast ultrasound phantom according to claim 3, wherein, The aforementioned tumor and tumor simulation section includes two types: a benign tumor simulation section and a malignant tumor simulation section. The benign tumor simulation section and the malignant tumor simulation section are simulated as a benign tumor and a malignant tumor forming a tumor mass. The breast ultrasound phantom according to claim 3, wherein, The tumor and tumor simulation unit is a tumor simulation unit that simulates a benign morphology in the tumor forming tumor. The breast ultrasound phantom according to claim 3, wherein, The tumor and tumor simulation unit is a tumor simulation unit that simulates a malignant shape in the tumor forming tumor. The breast ultrasound phantom according to claim 3, wherein, The simulation of the mass and tumor simulation section is to simulate the formation of the tumor mass in the tumor, which is a tumor simulation section that has benign and malignant characteristics in the shape, hardness, and location of the gland lobe mimic body. The breast ultrasound phantom according to claim 4, wherein: A regional lesion simulation section serving as the lesion simulation section is provided in the plurality of glandular leaf simulation bodies, and the regional lesion simulation section is a simulation of a regional lesion occurring in the breast. The breast ultrasound phantom according to claim 1, wherein: Further providing a regional lesion simulation section as the lesion simulation section on the plurality of glandular leaf simulation bodies, The regional lesion simulation section simulates a lesion that does not form an obvious tumor among the aforementioned breast-onset tumors, or simulates a lesion in which a small tumor exists in a specific gland lobe region. The breast ultrasound phantom according to claim 8, wherein: The at least one lesion simulation unit includes: the structural abnormality simulation unit, the benign mass simulation unit, the malignant mass simulation unit, and the regional lesion simulation unit, The plurality of glandular leaf mimics are at least four glandular leaf mimics which include the structural abnormality simulation part, the malignant mass simulation part, and the regional lesion simulation part individually or in plurality. The breast ultrasound phantom according to claim 1, wherein: The at least one lesion simulation unit is composed of at least two lesion simulation units. The aforementioned plurality of lesion simulation sections are composed of at least two simulation sections among the structural abnormality simulation section, the tumor and tumor simulation section, and the regional lesion simulation section. The structural abnormality simulation unit simulates a structural abnormality of a tissue constituting the glandular lobes of the breast, and the structural abnormality is a lesion represented by at least one of structural distortion, clustering, and concentration. The aforementioned tumor and tumor simulation unit simulates a tumor-forming lesion among the aforementioned tumors in the breast, The regional lesion simulation section simulates a lesion that does not form a significant tumor among the breast-onset tumors, or simulates a lesion in which a small tumor exists in a specific gland lobe region. The breast ultrasound phantom according to claim 1 or claim 2, wherein: A nipple simulation body that simulates a nipple of the breast is formed on the top of the breast. The breast ultrasound phantom according to claim 12, wherein: The attenuation rate of the ultrasonic wave of the nipple simulation body is set to be larger than a peripheral portion of the nipple simulation body. The breast ultrasound phantom according to claim 13, wherein: The subcutaneous fat simulating layer is a shape that simulates the shape of the subcutaneous fat layer of the human body and has a paving stone-like surface, and simulates the softness of the subcutaneous fat layer. The breast ultrasound phantom according to claim 1 or claim 2, wherein: The skin simulation layer is formed so as to be removable from the subcutaneous fat simulation layer. The breast ultrasound phantom according to claim 1 or claim 2, wherein: The aforementioned breast ultrasound phantom is placed on the upper surface of the pedestal, The skin simulating layer covers the subcutaneous fat simulating layer and has an end portion substantially integrated with the upper surface of the pedestal. The breast ultrasound phantom according to claim 1 or claim 2, wherein: The shape of the breast surface formed by the skin simulating layer has a submammary sulcus in a state where the breast ultrasound phantom is placed horizontally. The breast ultrasound phantom according to claim 1 or claim 2, wherein: The lesion simulation part is a simulation body for simulating the lesion, which is formed of the same material as that of the gland leaf simulation body, and the simulation body is formed by a different process from the gland leaf simulation body. A method for manufacturing a breast ultrasound phantom. The breast ultrasound phantom simulates a human breast based on the shape and hardness of the physical object, and the viewpoint of ultrasonic transmission characteristics including attenuation and reflection of the ultrasound. The probe of the sonic diagnostic device is used for training for breast ultrasound examination when it touches the probe, which is characterized in that: Prepare a template that simulates the shape of the aforementioned breast, The templates are sequentially arranged: a subcutaneous fat simulation layer that simulates the subcutaneous fat of the breast, and a plurality of gland leaf simulators that simulate the glandular lobes of the breast from the ultrasonic transmission characteristics. The method includes at least one lesion simulation unit that simulates a lesion of the breast from the aspect of the ultrasonic transmission characteristics. The method for manufacturing a breast ultrasound phantom according to claim 19, wherein, Take out the part of the arrangement from the template, and place the part of the arrangement on the stand through the spacer, On the top of the part of the aforementioned configuration, at least a nipple simulation body that simulates a nipple from the aforementioned ultrasonic transmission characteristics is fixed, A skin simulation layer that simulates the skin layer of the breast from the ultrasonic transmission characteristics is applied to the entire surface of the breast on which the nipple simulation body is fixed, so as to fill the gap between the breast and the pedestal. The method for manufacturing a breast ultrasound phantom according to claim 20, wherein, At least before the above-mentioned arranging step, layering on the part of the pedestal for placing the arranging part: a spacer which bulges more gently than the peripheral part, simulates the pectoralis major muscle of the human body from the aspect of the ultrasonic transmission characteristics, The pectoralis major muscle simulation layer covering the aforementioned spacer. A storage box for storing a breast ultrasound phantom according to claim 1 or claim 2, characterized in that: cover, A pressing part fixed on the back side of the cover, Forming a resinous covering along the surface of the breast ultrasound phantom so as to cover the size and shape of the surface; and A partition that is formed inside the storage box and puts the breast breast ultrasound phantom stored therein, After the covered breast ultrasound phantom is stored in the storage box and placed in the partition, and the cover is closed, the cover and the breast ultrasound phantom are fixed to the cover by the pressing part. The interior of the storage box.