Lesion model and biological model having lesion model

JPWO2024157323A5Pending Publication Date: 2025-10-01
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Patent Information

Application Number
JP2024572542
Authority / Receiving Office
JP · JP
Patent Type
Applications
Filing Date
2025-06-24
Publication Date
2025-10-01

AI Technical Summary

Technical Problem

Conventional lesion models used for training and evaluating medical devices struggle to accurately determine the position of lesions in images captured by imaging devices, such as ultrasound diagnostic imaging devices, making it difficult to properly train techniques and evaluate device performance, especially for penetrability tests.

Method used

A marker-equipped lesion model with a longitudinal shape, featuring a marker made of a resin material and a powdered material with different acoustic impedance, embedded or as a membrane covering the end surface, allowing clear identification in images and facilitating the recognition of the lesion's position and edge.

Benefits of technology

Enables easy and reliable determination of the positional relationship between medical devices and lesions in images, enhancing the accuracy of training and performance evaluation of medical devices, particularly for procedures involving guide wires.

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Abstract

The purpose of the present invention is to provide a lesion model with which it is possible to easily and reliably grasp the positional relationship between a medical device and the lesion model in an image imaged using an imaging device. The purpose is also to provide a biological model having the lesion model. This lesion model (1) comprises: a lesion model (11) simulating a lesion; and a marker (21) which is disposed to an end (P) of the lesion model (11) and can be differentiated in an image obtained by imaging the lesion model (11). Additionally, the biological model (10) having the lesion model comprises the lesion model (1) with the marker, and a biological model (31) simulating tubular tissue of a body. The lesion model (1) with the marker is disposed in a lumen (31h) of the biological model (31).
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Description

Lesion models and biological models with lesion models

[0001] The present invention relates to a lesion model and a biological model with a lesion model.

[0002] In the medical field, lesion models that artificially mimic lesions in living organisms are sometimes used to train practitioners or evaluate the performance of medical devices.

[0003] As such a lesion model, for example, a lesion model that faithfully reproduces the appearance and physical properties of a lesion has been proposed so that training tailored to the condition of each patient and accurate evaluation of medical devices can be performed (see, for example, Patent Document 1).

[0004] JP 2010-187878 A

[0005] However, with the conventional lesion models described above, it is difficult to accurately determine the location of the lesion in an image captured using an imaging device such as an ultrasound diagnostic imaging device, which tends to make it difficult to appropriately train procedures using a medical device on the lesion and to accurately evaluate the performance of the medical device (e.g., the penetrability of a guidewire).

[0006] The present invention has been made based on the above circumstances, and its purpose is to provide a lesion model and a biological model with a lesion model that make it possible to easily and reliably grasp the positional relationship between a medical device and a lesion model in an image captured using an imaging device.

[0007] Some aspects of the present disclosure include: (1) a marker-equipped lesion model comprising: a lesion model simulating a lesion; and a marker disposed at an end of the lesion model and discernible in an image obtained by photographing the lesion model; (2) the marker-equipped lesion model according to (1), wherein the lesion model is longitudinal, and the marker is disposed at an end of the lesion model in the longitudinal direction; (3) the marker-equipped lesion model according to (1) or (2), wherein the marker is at least one of a granular marker embedded in the lesion model and a membrane-like marker covering an end face of the lesion model; (4) the marker-equipped lesion model according to (3), wherein the marker comprises a first material and a second material, wherein the first material is a resin material, and the second material is a powdered material that has an acoustic impedance different from the acoustic impedance of the resin material or is radiopaque; (5) the marker comprises a first material and a second material, (6) The lesion model with a marker according to (3), wherein the first material is made of a resin material, the second material is made of a powdered material having an acoustic impedance different from that of the resin material, and a portion adjacent to the marker does not contain the second material or contains the second material at a content rate lower than that of the second material contained in the marker; (7) The lesion model with a marker according to any one of (4) to (6), wherein the content rate of the second material in the marker is 1% by mass or more and 70% by mass or less; (8) The lesion model with a marker according to any one of (1) to (7), wherein the first material is made of a resin material, the second material is made of a powdered material having radiopaque properties, and a portion adjacent to the marker does not contain the second material or contains the second material at a content rate lower than that of the second material contained in the marker; a biological model simulating a tubular tissue of a body, wherein the lesion model with markers is disposed in the lumen of the biological model; and(9) The biological model with a lesion model according to (8), wherein the marker is arranged at an end of the lesion model in the tube axis direction of the biological model.

[0008] In this specification, the term "end portion" refers to a region consisting of the end surface of a member and the interior (adjacent portion) of the member adjacent to the end surface.

[0009] In addition, in this specification, a typical example of an "image obtained by photographing a lesion model" is "an image created by irradiating a lesion model with ultrasound or radiation and based on the ultrasound or radiation reflected by or transmitted through the lesion model."

[0010] The present invention can provide a lesion model and a biological model with a lesion model that allow the positional relationship between a medical device and a lesion model to be easily and reliably grasped in an image captured using an imaging device.

[0011] 1 is a schematic cross-sectional view showing a first embodiment; FIG. 2 is a schematic cross-sectional view showing a second embodiment; FIG. 3 is a schematic cross-sectional view showing a third embodiment; FIG. 4 is a schematic cross-sectional view showing a modified example; FIG.

[0012] <Lesion model with marker> The lesion model with marker of the present disclosure includes a lesion model that simulates a lesion area, and a marker that is placed at the end of the lesion model and can be distinguished in an image obtained by photographing the lesion model.

[0013] <Biological model with lesion model> The present disclosure comprises the above-mentioned lesion model with markers and a biological model simulating tubular tissue of the body, and the above-mentioned lesion model with markers includes a biological model with lesion model placed in the lumen of the above-mentioned biological model.

[0014] The lesions simulated by the marker-attached lesion model and the living body simulated by the lesion-attached biological model are not limited to specific tissues, as long as they respectively simulate a lesion in the body and a living body. Examples of lesions include occlusions and stenoses. Examples of living bodies include blood vessels and the digestive tract.

[0015] First to third embodiments of the present invention will be described below with reference to the drawings. However, the present invention is not limited to the embodiments shown in the drawings. The dimensions of each part shown in the drawings are shown to facilitate understanding of the implementation and do not necessarily correspond to the actual dimensions. The imaginary lines in the drawings indicate an example of a medical device (guidewire) used in the procedure. In each drawing, the left side of the drawing indicates the proximal side (hand side) operated by the operator, and the right side indicates the distal side.

[0016] In the first to third embodiments, a lesion model that simulates an occlusion is exemplified, and all of the embodiments include an embodiment of a lesion model with markers and an embodiment of a biological model with a lesion model.

[0017] [First Embodiment] Fig. 1 is a schematic cross-sectional view showing a first embodiment. As shown in Fig. 1, in the first embodiment, a marker-attached lesion model 1 is generally composed of a lesion model 11 and a marker 21, and is placed in a lumen 31h of a biological model 31. Furthermore, a lesion-attached biological model 10 is composed of the marker-attached lesion model 1 and a biological model 31.

[0018] The lesion model 11 is a component that simulates a lesion. The shape of the lesion model is not particularly limited. In this embodiment, a longitudinal lesion model 11 is exemplified. Such a longitudinal lesion model 11 simulates an occlusion formed in a living body, such as a blood vessel or a digestive tract.

[0019] The material constituting the lesion model 11 may be, for example, a gel-like material. Examples of gel-like materials include gels of polysaccharides such as agarose and cellulose, and gels of polyvinyl alcohol. The hardness of the lesion model 11 may be adjusted depending on the tissue to be simulated, for example, by adjusting the water content of the gelled polysaccharides or by combining multiple materials. The lesion model 11 can be formed using known techniques. Gelded agarose will hereinafter also be referred to as "agarose gel."

[0020] Marker 21 is disposed at end P of lesion model 11, i.e., in a region consisting of end surface 11a of lesion model 11 and the interior (adjacent portion) 11b of lesion model 11 adjacent to end surface 11a, and is a component that can be distinguished in an image obtained by capturing an image of lesion model 11. The method for capturing the image is not particularly limited as long as it does not impair the effects of the present invention. Examples of the capturing method include a method that uses reflected ultrasound (a capturing method using an ultrasound imaging diagnostic device) and a method that uses penetrating radiation (a capturing method using a radiation imaging diagnostic device).

[0021] The shape of the markers 21 is not particularly limited as long as they can be distinguished in the captured image. The shape of the markers 21 may be, for example, a granular marker embedded in the interior 11b of the lesion model 11 (hereinafter also referred to as a "granular marker 21"), or a membrane-like marker covering the end face of the lesion model 11 (hereinafter also referred to as a "membrane marker 22," described below). In this embodiment, a granular marker 21 embedded in the lesion model 11 is used.

[0022] The marker 21 may be placed at only one end of the lesion model, at both the one end and the other end opposite the one end, or on the entire end of the lesion model (the entire surface of the lesion model). In this embodiment, the marker 21 is placed at the longitudinal end of the lesion model 11, more specifically, at the proximal end P of the lesion model 11 in the tube axis Z direction of the biological model 31 (the interior 11b of the lesion model 11 adjacent to the end face 11a). This allows, for example, the proximal end and / or distal end of the lesion model 11 in the biological model 31 simulating an occlusion or stenosis to be easily identified, thereby enabling accurate training in procedures and performance tests of medical devices.

[0023] The material constituting the marker 21 is selected based on the imaging device and is distinguishable in an image. Specifically, the marker 21 may include, for example, a first material and a second material, where the first material is a resin material and the second material is a powdered material having an acoustic impedance different from that of the resin material. The form (particle shape, average particle size, particle size distribution, etc.) of the powder constituting the second material is not particularly limited as long as it can identify the edge of the lesion model 11. It is preferable that the powder be uniformly dispersible in the resin material.

[0024] Examples of the resin material include agarose gel, etc. Examples of the second material include metal oxides such as bismuth trioxide, barium sulfate, iodine compounds, and metals such as tungsten.

[0025] In this way, the marker 21 comprises a first material and a second material, the first material being a resin material, and the second material being a powdered material. Since the resin material is soft and has the property of being easily penetrated by a medical device (such as a guidewire GW), the progress of the medical device can be prevented from being hindered by the marker 21 when the medical device passes through the lesion model 11.

[0026] A member (hereinafter also referred to as an "adjacent member") having an acoustic impedance different from that of the second material may be disposed in a region (hereinafter also referred to as an "adjacent region") adjacent to the marker 21. The adjacent region may include, for example, at least one of a region of the lesion model, a region of the biological model, and a region other than the lesion model and the biological model.

[0027] In this embodiment, the portion of the lesion model 11 surrounding the marker 21 is the adjacent region, and the portion adjacent to the marker 21 is composed of an adjacent member that does not contain the second material or that contains the second material at a content rate lower than the content rate of the second material contained in the marker 21.

[0028] In this embodiment, as described above, an adjacent member having an acoustic impedance different from the acoustic impedance of the second material in the marker 21 is arranged in the adjacent region, so an ultrasound imaging diagnostic device is preferred as the imaging device.

[0029] The adjacent member may be, for example, a material such as agarose gel that does not contain the second material.

[0030] In this way, by arranging an adjacent member in the area adjacent to the marker 21 (adjacent region) that does not contain the second material or that contains the second material at a content rate lower than the content rate of the second material contained in the marker 21, the contrast between the marker 21 and the adjacent region in the image can be increased, and the marker 21, i.e., the proximal end P of the lesion model 11, can be reliably recognized.

[0031] The lower limit of the content of the second material (a powdered material having an acoustic impedance different from that of the resin material in the marker 21) in the marker 21 is preferably 0.1% by mass or more, more preferably 0.5% by mass or more, and even more preferably 1% by mass or more. This effectively improves the identifiability of the marker 21. The upper limit of the content of the second material in the marker 21 is preferably 90% by mass or less, more preferably 80% by mass or less, and even more preferably 70% by mass or less. This effectively improves the flexibility and penetrability of the resin material. The content of the second material in the marker 21 is also preferably 1% by mass or more and 70% by mass or less. This effectively improves, for example, the flexibility and penetrability of the resin material and the identifiability of the marker 21.

[0032] The biological model 31 is a member that simulates tubular tissue of the body. Specifically, the biological model 31 can be configured, for example, as a tubular member having a lumen 31 h. In this embodiment, a blood vessel model (hereinafter also referred to as the "blood vessel model 31") is exemplified as the biological model 31, and the marker-equipped lesion model 1 is placed in the lumen 31 h of the blood vessel model 31.

[0033] The material constituting the biological model 31 is not particularly limited as long as it has the same texture (flexibility, strength, etc.) as that of a living body. Examples of such materials include gels of silicone, polyvinyl alcohol, urethane, etc. The hardness of the biological model 31 may be adjusted depending on the tissue to be simulated, for example, by adjusting the water content of the gelled material or by combining multiple materials. The biological model 31 can be formed using known techniques.

[0034] Next, we will explain how to use the marker-equipped lesion model 1 and the lesion-equipped biological model 10. Here, we will explain the procedure of using a metal guidewire GW as a medical device and penetrating the marker-equipped lesion model 1 placed in the lumen 31h of a blood vessel model 31 that simulates a blood vessel as shown in Figure 1. In addition, we will use an ultrasound imaging diagnostic device as the imaging device.

[0035] Here, the acoustic impedance of the metallic guidewire GW is different from the acoustic impedance of the blood vessel model 31 and the lesion model 11. Furthermore, a member having an acoustic impedance different from the acoustic impedance of the second material contained in the marker 21 is disposed in the adjacent region. Therefore, in an ultrasound echo image obtained using an ultrasound imaging diagnostic device, the guidewire GW, the lesion model 11, and the marker 21 are clearly distinguishable from one another, and the positional relationship between the end P of the lesion model 11, on which the marker 21 is provided, and the tip of the guidewire GW can be grasped.

[0036] In the procedure, first, a guidewire GW (shown by a virtual line in FIG. 1 ) is inserted into the blood vessel model 31. Specifically, the tip of the guidewire GW is inserted into the opening of the blood vessel model 31, and while observing an echo image of ultrasound emitted by an ultrasound imaging diagnostic device (not shown), the guidewire GW is advanced until the tip reaches the vicinity of the end face 11a on the end P side of the lesion model 11 where the granular markers 21 are provided. Next, while observing the echo image, the tip of the guidewire GW is brought into contact with the end face 11a of the lesion model 11, using the granular markers 21 as a guide. This completes preparations for puncturing the lesion model 11 with the guidewire GW.

[0037] Next, the guidewire GW is passed through the lesion model 11. Specifically, while observing the echo image to confirm the positional relationship between the tip of the guidewire GW and the marker 21, the tip of the guidewire GW punctures the end surface 11a of the lesion model 11, and the tip of the guidewire GW passes through the lesion model 11. The shape of the tip of the guidewire GW when passing through may be straight or may be shaped into a J-shape or the like (FIG. 1 illustrates a guidewire GW with a straight tip).

[0038] Next, the guidewire GW is pushed further distally into the lesion model 11. Specifically, while observing the echo image, the guidewire GW is pushed to a predetermined position within the blood vessel model 31. At this time, even if the tip of the guidewire GW comes into contact with the marker 21, the two may avoid each other or the guidewire GW may advance while penetrating the resin material in the marker 21. The guidewire GW may be pushed until its tip penetrates the lesion model 11, or may be stopped midway through the lesion model 11. The method of pushing the guidewire GW into the lesion model 11 can be selected appropriately depending on the purpose of the procedure (e.g., procedure training, performance testing of a medical device, etc.).

[0039] As described above, since the marker-equipped lesion model 1 and the lesion-equipped biological model 10 have the above-described configurations, it is possible to easily and reliably grasp, for example, in a captured echo image, the positional relationship between the guidewire GW and the lesion model 11. As a result, medical devices can be appropriately used with the lesion model 11 and the lesion-equipped biological model 10 depending on the purpose of the procedure.

[0040] Furthermore, by placing marker 21 at end P of lesion model 11, it is possible to grasp the position of the end of the lesion, rather than the overall position of the lesion, in an image obtained by imaging lesion model 11 while irradiated with ultrasound or radiation. Therefore, when a medical device (e.g., a guidewire) reaches marker 21, the operator of the medical device can reliably recognize the presence of a lesion after passing through marker 21. Additionally, after the medical device passes marker 21, the appearance and tactile sensation of the lesion can be accurately reproduced, similar to those during actual treatment. Therefore, by using lesion model 1 with marker 21, the operator of the medical device can accurately evaluate the medical device while recognizing that the device is present inside lesion model 11, or can perform training to reliably master the feel of operating the medical device within lesion model 11.

[0041] Furthermore, since the markers 21 are granular and embedded in the lesion model 11, the granular markers 21 can effectively prevent the progress of the guidewire GW from being obstructed when the guidewire GW passes through the lesion model 11.

[0042] Second Embodiment Figure 2 is a schematic cross-sectional view showing a second embodiment. As shown in Figure 2, in the second embodiment, a marker-attached lesion model 2 is generally composed of a lesion model 12 and a marker 22, and is placed in a lumen 31h of a biological model 31. Furthermore, a lesion-attached biological model 20 is composed of a marker-attached lesion model 2 and a biological model 31. The second embodiment differs from the first embodiment in that it includes a marker-attached lesion model 2. Note that the configuration of the biological model 31 is similar to that of the first embodiment, and therefore, the same parts are designated by the same reference numerals and detailed description thereof will be omitted. Furthermore, the configuration of the marker-attached lesion model 2 is similar to that of the first embodiment, except as described below.

[0043] Lesion model 12 is a member that simulates a lesion. In this embodiment, a longitudinal lesion model 12 that simulates an occlusion is exemplified.

[0044] Marker 22 is a component that is placed at the end of the lesion model and is distinguishable in an image obtained by photographing the lesion model. In this embodiment, a membrane-like marker 22 that covers end surface 12 a of lesion model 12 is used as marker 22. Marker 22 is placed at end P in the longitudinal direction of lesion model 12, more specifically, at end P (on end surface 12 a of lesion model 12) on the proximal side of lesion model 12 in the tubular axis direction of biological model 31.

[0045] The thickness of the membrane marker 22 is not particularly limited as long as it allows accurate recognition of the end surface 12a of the lesion model 12 in an image captured using an imaging device. Furthermore, the membrane marker 22 may cover only a portion of the end surface of the lesion model, or may cover the entire end surface. In this embodiment, the membrane marker 22 is disposed only at one end of the lesion model 12, covering the entire end surface 12a at that end.

[0046] The marker 22 includes a first material and a second material, the first material being made of a resin material, and the second material being made of a powdered material having radiopaque properties (hereinafter also referred to as "radiopaque material").

[0047] Examples of the resin material include agarose gel, etc. Examples of the second material include metal oxides such as bismuth trioxide, barium sulfate, iodine compounds, and metals such as tungsten.

[0048] In this embodiment, a radiolucent member (hereinafter also referred to as a "radiotransmitting member") is disposed in a region adjacent to the marker 22 (adjacent region). The adjacent region includes, for example, at least one of a region of the lesion model, a region of the biological model, and a region other than the lesion model and the biological model.

[0049] In this embodiment, the areas of the lesion model 12 and the biological model 31 that contact the marker 22 are adjacent regions, and the areas adjacent to the marker 22 are made of a radiolucent material that does not contain the second material or that contains the second material at a content lower than the content of the second material contained in the marker 22.

[0050] In this embodiment, as described above, the marker 22 contains a radiopaque material, and a radiotransparent member having a radiotransmission performance different from that of the marker 22 is disposed in the adjacent region, and therefore a radiological imaging diagnostic device is preferred as the imaging device.

[0051] The adjacent member may be, for example, a material such as agarose gel that does not contain the second material.

[0052] In this way, by arranging a radiolucent material in the area adjacent to the marker 22 (adjacent area) that does not contain the second material or that contains the second material at a content lower than the content of the second material contained in the marker 22, the contrast between the marker 22 and the adjacent area can be increased in the image, and the marker 22, i.e., the proximal end P of the lesion model 12, can be reliably recognized.

[0053] The lower limit of the content of the second material (radiopaque material) in the marker 22 is preferably 0.1% by mass or more, more preferably 0.5% by mass or more, and even more preferably 1% by mass or more. This effectively improves the distinguishability of the marker 22. The upper limit of the content of the second material in the marker 22 is preferably 90% by mass or less, more preferably 80% by mass or less, and even more preferably 70% by mass or less. This effectively improves the flexibility and penetrability of the resin material. The content of the second material in the marker 22 is also preferably 1% by mass or more and 70% by mass or less. This effectively achieves both the flexibility and penetrability of the resin material and the distinguishability of the marker 22, for example.

[0054] The manner of use of the marker-equipped lesion model 2 and the lesion-equipped biological model 20 in this embodiment is the same as that described in the first embodiment, except that a radiological imaging diagnostic device is used as the imaging device, and therefore a description thereof will be omitted here.

[0055] As described above, since the marker-equipped lesion model 2 and the lesion-equipped biological model 20 each have the above-mentioned configuration, it is possible to easily and reliably grasp the positional relationship between the guide wire GW and the lesion model 12, for example, in a captured radiographic image.

[0056] Furthermore, since the shape of the marker 22 is a membrane that covers the end face of the lesion model 12, the membrane-like marker 22 can accurately recognize the end face of the lesion model 12, and for example, the timing when the guide wire GW enters the lesion model 12 can be reliably grasped.

[0057] [Third Embodiment] Figure 3 is a schematic cross-sectional view showing the second embodiment. As shown in Figure 3, in the third embodiment, the marker-attached lesion model 3 is generally composed of a lesion model 13 and a marker 23, and is disposed in the lumen 31h of the biological model 31. The lesion-attached biological model 30 is composed of the marker-attached lesion model 3 and the biological model 31. The third embodiment differs from the first embodiment in that it includes the marker-attached lesion model 3. Note that the configuration of the biological model 31 is similar to that of the first embodiment, and therefore, the same components are designated by the same reference numerals and detailed description thereof will be omitted. Other than as described below, the configuration of the marker-attached lesion model 3 and the usage modes of the marker-attached lesion model 3 and the lesion-attached biological model 30 are similar to those of the first and second embodiments.

[0058] Lesion model 13 is a member that simulates a lesion. In this embodiment, lesion model 13 having a longitudinal shape that simulates an occlusion is exemplified.

[0059] Markers 23 are components arranged at the ends of the lesion model and distinguishable in images obtained by photographing the lesion model. In this embodiment, markers 23 are employed, which include granular markers 231 embedded in lesion model 13 and a membrane-like marker 232 covering end surface 13a of lesion model 13. Granular markers 231 and membrane-like marker 232 are each arranged at the longitudinal ends of lesion model 13, more specifically, at end P on the proximal side of lesion model 13 in the tubular axis direction of biological model 31 (end surface 13a of lesion model 13 and interior 13b of lesion model 13 adjacent to end surface 13a).

[0060] The first material (resin material) and second material constituting the granular marker 231 and the film-like marker 232 may be the same or different. In this embodiment, the granular marker 231 and the film-like marker 232 contain the same first material (resin material), the second material in the granular marker 231 is composed of a powdered material having an acoustic impedance different from the acoustic impedance of the resin material, and the second material in the film-like marker 232 is composed of a powdered material having radiopacity.

[0061] As described above, the lesion model 3 with markers and the biological model 30 with lesion model are each configured as described above, so that, for example, in the captured echo images and radiographic images, the positional relationship between the guide wire GW and the lesion model 13 can be easily and reliably grasped.

[0062] Furthermore, markers 23 include granular markers 231 and film-like markers 232, with granular marker 231 containing a material with an acoustic impedance different from that of the resin material, and film-like marker 232 containing a material with radiopaque properties. Therefore, by using an ultrasound imaging diagnostic device and a radiological imaging diagnostic device in combination as the imaging devices, end P of lesion model 13 can be more accurately identified based on the echo images and radiological images captured by the respective imaging devices. Alternatively, end P of lesion model 13 can be accurately identified regardless of whether an ultrasound imaging diagnostic device or a radiological imaging diagnostic device is used.

[0063] The present disclosure is not limited to the configurations of the above-described embodiments, but is intended to include all modifications within the scope and meaning equivalent to the claims, as defined by the claims. Part of the configurations of the above-described embodiments may be deleted or replaced with other configurations, or other configurations may be added to the configurations of the above-described embodiments.

[0064] For example, in the above-described embodiment, the lesion models 11, 12, and 13 that simulate an occlusion have been described. However, as shown in Fig. 5 , the lesion model may be a lesion model that simulates a lesion other than an occlusion, such as lesion model 15 that simulates a stenosis.

[0065] In the above-described embodiment, the end faces 11a, 12a, and 13a of the lesion models 11, 12, and 13, on which the markers 21, 22, and 23 are arranged, are illustrated as planes perpendicular to the longitudinal direction (the Z-axis direction) of the lesion models 11, 12, and 13. However, the shape of the end faces is not particularly limited. For example, as shown in FIG. 4 , the end faces may have various irregular shapes, such as the lesion model 14 having a recess on the end face 14a. When the end face has a recess, the deepest part (distal end) of the recess may be located near the Z-axis of the biological model. This allows for easy and reliable centering of the tip of a medical device (e.g., a guidewire GW) relative to the lumen 31h of the biological model 31.

[0066] In the above-described embodiment, the markers 21, 22, and 23 are placed only at the proximal ends of the lesion models 11, 12, and 13. However, the markers may be placed only at the distal ends, at both the proximal and distal ends, or on the entire periphery of the lesion model.

[0067] In the above-described embodiment, the longitudinal lesion models 11, 12, and 13 have been described. However, the shape of the lesion model is not limited to this. The shape of the lesion model may be, for example, spherical, plate-like, or irregular.

[0068] In the above-described embodiment, the markers 21, 22, and 23 include a first material (resin material) and a second material. However, the material of the marker is not particularly limited as long as the marker can be distinguished in an image obtained by capturing an image of the lesion model.

[0069] Furthermore, in the first to third embodiments described above, a model has been exemplified in which a member having an acoustic impedance different from that of the second material and / or a member having radiotransparency is disposed in a region adjacent to the markers 21, 22, and 23. However, as long as the markers can be identified, the acoustic impedance characteristics and the presence or absence of radiotransparency of the region adjacent to the marker are not particularly limited.

[0070] 1, 2, 3, 4, 5 Lesion model with marker 10, 20, 30, 40, 50 Biological model with lesion model 11, 12, 13, 14, 15 Lesion model 11a, 12a, 13a, 14a End surface 21, 22, 23, 24, 25, 231, 232, 241, 242 Marker 31 Biological model 31h Lumen P End GW Guide wire

Claims

1. A lesion model that simulates a lesion area, a marker disposed at an end of the lesion model and distinguishable in an image obtained by photographing the lesion model;

2. The lesion model has a longitudinal shape; The marked lesion model according to claim 1 , wherein the markers are arranged at longitudinal ends of the lesion model.

3. The lesion model with markers according to claim 1 , wherein the markers are at least either granular markers embedded in the lesion model or film-like markers covering an end surface of the lesion model.

4. the marker includes a first material and a second material; the first material is made of a resin material, The lesion model with markers according to claim 3 , wherein the second material is made of a powdered material that has an acoustic impedance different from that of the resin material or that is radiopaque.

5. the marker includes a first material and a second material; the first material is made of a resin material, the second material is a powdered material having an acoustic impedance different from that of the resin material, The marked lesion model according to claim 3 , wherein the area adjacent to the marker does not contain the second material or contains the second material at a content lower than the content of the second material contained in the marker.

6. the marker includes a first material and a second material; the first material is made of a resin material, the second material is a powdered material having radiopacity; The marked lesion model according to claim 3 , wherein the area adjacent to the marker does not contain the second material or contains the second material at a content lower than the content of the second material contained in the marker.

7. The marked lesion model according to claim 4 , wherein the content of the second material in the marker is 1% by mass or more and 70% by mass or less.

8. A lesion model with markers according to any one of claims 1 to 7; a biological model simulating a tubular tissue of a body; The marker-attached lesion model is a biological model with a lesion model that is placed in the lumen of the biological model.

9. The biological model has an opening through which a medical device is inserted, 9. The biological model with a lesion model according to claim 8, wherein the marker is a granular marker embedded in the lesion model and is arranged at an end of the lesion model on the opening side.

10. The markers are a plurality of granular markers embedded in the lesion model, The marked lesion model according to claim 1 , wherein the markers are arranged along a radial direction of the lesion model, and adjacent markers in the radial direction are spaced apart from each other.

11. A lesion model with markers as described in Claim 10, wherein multiple markers are arranged along the longitudinal direction of the lesion model, and adjacent markers in the longitudinal direction are spaced apart.

12. A lesion model with markers as described in claim 1, wherein the markers are multiple granular markers embedded in the lesion model, and all of the markers are positioned at a distance from the outer surface of the lesion model.

13. The lesion model has a longitudinal shape, The marked lesion model according to claim 1 , wherein there is a linear region extending from one end of the lesion model to the other end, the linear region being free of the markers.

14. A lesion model with a marker as described in claim 1, wherein the marker is a granular marker embedded in the lesion model that avoids a medical device inserted into the lesion model when it comes into contact with the medical device.