Method for manufacturing a simulated animal organ, method for manufacturing a simulated animal organ kit, method for manufacturing a medical device evaluation kit

Abstract

This simulated animal organ production method comprises a molding step for mixing mannan that is used as a main component, a microcapsule-type discoloring agent that changes color depending on temperature and water, gelatinizing the resultant mixture and molding the same to give a molded body. Subsequently, this molded body is frozen to form a fibrous or mesh structure. Thus, the fibrous or mesh structure can hold the discoloring agent, which makes it possible to provide a simulated animal organ that enables the evaluation of heating effects thereon on the basis of the discoloration state thereof and that is highly similar to an actual animal organ.

Description

Technical Field

[0001] The present invention relates to a simulated animal organ that can be used for practicing surgery on animals such as humans and for other purposes.

Background Art

[0002] Surgery is widely performed on animals including humans. For example, surgeries such as removing tumors or the like from organs, excising a part of an organ, transplanting an organ, and suturing an organ are known.

[0003] In this type of surgery, in the incision work using a scalpel (including an electric scalpel) and the needle work in suturing or anastomosis, etc., a corresponding technique is required for the surgeon. Therefore, it is normal to practice these techniques before actually performing the surgery.

[0004] Conventionally, biological models (simulated animal organs) have been used for medical education practice, surgical technique training, etc. These simulated animal organs are generally made of silicone resin or polyurethane, but in addition, biological models using polymer resin have also been proposed (see Japanese Patent No. 4126374). Further, the applicant of the present application has proposed a biological model using mannan as a material for a simulated animal organ (International Publication WO2017 / 010190).

[0005] Also, in a conventional biological model using polymer resin, in order to confirm a cauterized site using a high-frequency scalpel or the like, a technique has been proposed in which a microcapsule pigment is contained in a molded article to confirm the heating of the cauterized site by a color change (Japanese Patent Application Laid-Open No. 2018-49166).

Summary of the Invention

Problems to be Solved by the Invention

[0006] However, as disclosed in JP-A-2018-49166, in the case of a biological model in which a synthetic resin contains microcapsule pigments, when the biological model is cauterized with a high-frequency scalpel or the like for skill practice, harmful substances and bad odors may be generated, and there is a problem that it is difficult to use in a medical institution (especially in an operating room). In addition, in the case of a synthetic resin, since the material itself melts with a high-frequency scalpel, there is a problem that it is difficult to accurately reproduce the heat diffusion state in which the heat during cauterization propagates around the biological model by a change in color.

[0007] In addition, in the medical field, a large amount of simulated animal organs used for practice purposes will be discarded after use. However, in the case of chemical component materials such as silicone resin and polymer resin, there is a problem that they tend to have an adverse impact on the environment during disposal.

[0008] The present invention has been made in view of the above problems, and an object of the present invention is to provide a simulated animal organ that can visually confirm the influence of heat when performing educational training or surgical practice in a state close to that of an actual animal organ.

Means for Solving the Problems

[0009] The present invention for achieving the above object includes a molding step of mixing a main component of mannan, a microcapsule-shaped discolorant that changes color depending on temperature, and water, gelatinizing them, and molding them to obtain a molded body, and a freezing step of freezing the molded body to form a fiber structure or a mesh structure. It is a method for manufacturing a simulated animal organ, characterized by having

[0010] In relation to the method for manufacturing the simulated animal organ, in the freezing step, the discolorant is carried in a state by the fiber structure or the mesh structure.

[0011] In relation to the method for manufacturing the simulated animal organ, the particle size of the discolorant is characterized by being 5.0 μm or less.

[0012] In relation to the method for manufacturing the simulated animal organ, the particle size of the discolorant is characterized by being 2.0 μm or less.

[0013] In relation to the method for manufacturing the above-described simulated animal organ, the discoloring agent is characterized in that it starts to change color to a first hue when the temperature exceeds a first temperature during a temperature rise, and starts to change color to a second hue when the temperature drops below a second temperature lower than the first temperature in the state of the first hue.

[0014] In relation to the method for manufacturing the above-described simulated animal organ, after the freezing step, a heating step of heating the molded body to a temperature higher than the first temperature to make the discoloring agent in a first hue state, and after the heating step, a cooling step of cooling the molded body to a temperature lower than the second temperature to make the discoloring agent in a second hue state.

[0015] In relation to the method for manufacturing the above-described simulated animal organ, in the heating step, the molded body is heated to 75 degrees or more, in the cooling step, the molded body is cooled to less than -5 degrees, the first temperature of the discoloring agent is set higher than 30°C and lower than 75 degrees, and the second temperature of the discoloring agent is set lower than 20°C and higher than or equal to -5 degrees.

[0016] In relation to the method for manufacturing the above-described simulated animal organ, the first hue is white or transparent, and the second hue is red, pink, brown or tan.

[0017] In relation to the method for manufacturing the above-described simulated animal organ, the molded body in the molding step contains 1.0% by weight or more of the discoloring agent.

[0018] In relation to the method for manufacturing the above-described simulated animal organ, at the final product stage after the freezing step, the water content of the molded body is 95% or less.

[0019] In relation to the method for manufacturing the above-described simulated animal organ, at the final product stage after the freezing step, the water content of the molded body is 80% or more.

[0020] In relation to the method for manufacturing the above-described simulated animal organ, after the freezing step, the compression elastic modulus of the formed body is 0.015 N / mm2 or less, which is characterized by this.

[0021] In relation to the method for manufacturing the above-described simulated animal organ, after the freezing step, the compression elastic modulus of the formed body is 0.011 N / mm2 or less, which is characterized by this.

[0022] The present invention for achieving the above object includes a forming step of mixing a raw material mainly composed of mannan, water, and a microcapsule-shaped discoloring agent that changes color depending on temperature, gelatinizing them, and forming them into a formed body. The discoloring agent has a property that when the temperature rises, the discoloration to a first hue starts at a first temperature, and when the temperature drops in the state of the first hue, the discoloration to a second hue starts at a second temperature lower than the first temperature. The method for manufacturing a simulated animal organ is characterized by having a heating step of heating the formed body to a temperature higher than the first temperature to make the discoloring agent in a first hue state, and a cooling step of cooling the formed body to a temperature lower than the second temperature after the heating step to make the discoloring agent in a second hue state.

[0023] In relation to the method for manufacturing the above-described simulated animal organ, in the forming step, it is characterized by mixing an electrolyte into the water.

[0024] In relation to the method for manufacturing the above-described simulated animal organ, the formed body in the forming step contains the electrolyte at 1.0% by weight or less, which is characterized by this.

[0025] The present invention for achieving the above object is a simulated animal organ characterized by being manufactured by any of the above manufacturing methods.

[0026] The present invention for achieving the above object includes the above-described simulated animal organ formed in a sheet shape and a three-dimensional organ model formed of resin or metal, and is characterized in that the simulated animal organ is fixed to a part of the wall surface of the organ model, which is a simulated animal organ kit.

[0027] To achieve the above object, the present invention provides a medical device evaluation kit, comprising a first surface composed of the above-described simulated animal organ, a second surface provided in a direction orthogonal to the first surface and having a property of changing color by heat, and a third surface provided in a direction orthogonal to the first surface, spaced apart from the second surface, and having a property of changing color by heat.

[0028] In relation to the above medical device evaluation kit, the second surface and the third surface are characterized by being composed of paper or a resin film.

[0029] In relation to the above medical device evaluation kit, the second surface and the second surface are characterized by being composed of the simulated animal organ described in claim 13.

[0030] To achieve the above object, the present invention provides a simulated animal organ containing mannan as a main component, an electrolyte, water, and a microcapsule-shaped discolorant that changes color depending on temperature, wherein the discolorant is supported by the fiber structure or mesh structure of the mannan.

[0031] In relation to the above simulated animal organ, the discolorant is characterized by being supported in a filamentous shape along the fiber structure or mesh structure of the mannan.

[0032] In relation to the above simulated animal organ, recesses are formed by the fiber structure or mesh structure of the mannan, and the discolorant is accommodated in the recesses.

[0033] In relation to the above simulated animal organ, the water content is characterized by being 95% or less and 80% or more.

[0034] In relation to the above simulated animal organ, the compression elastic modulus is characterized by being 0.015 N / mm2 or less.

Advantages of the Invention

[0035] According to the present invention, it is possible to evaluate the heating effect based on the discoloration state, and it is possible to obtain a simulated animal organ in a state extremely close to an actual animal organ, which exhibits an excellent effect.

Brief Description of the Drawings

[0036]

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Embodiments for Carrying Out the Invention

[0037] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings.

[0038] FIG. 1 shows a manufacturing process of a simulated animal organ according to a first embodiment of the present invention.

[0039] <Kneading and Gelatinization Step (S110)> In the kneading and gelatinization step S110, first, mannan as a main component, an electrolyte, a thickening agent, a microcapsule-shaped discoloring agent that changes color depending on temperature, and water are mixed and kneaded to obtain a stock solution. Mannan is a polysaccharide having mannose as a main constituent unit, and for example, glucomannan, galactomannan, konjac flour (a kind of glucomannan), etc. can be used. Glucomannan is a polymer in which glucose and mannose are polymerized at a ratio of approximately 2:3 to 1:2. Galactomannan is a polymer of mannose and galactose.

[0040] An electrolyte is a substance that conducts electricity when dissolved in water. Specifically, it exhibits the property of conducting electricity as ions charged in water. Ions of the electrolyte include, for example, sodium ions, potassium ions, calcium ions, magnesium ions, chloride ions, phosphate ions, and hydrogen carbonate ions, but other ionic substances may also be used. In this embodiment, sodium chloride (common salt) is adopted as the electrolyte. That is, physiological saline is used as the electrolyte aqueous solution.

[0041] A thickener is a substance that increases the viscosity of the stock solution or gives it a thickening property, and can enhance the stability of konjac glue and prevent its separation. Thickeners include animal-based ones (such as gelatin) and plant-based ones (such as polysaccharides and chemical derivatives of cellulose). Specific examples of thickeners include pectin, guar gum, xanthan gum, tamarind gum, carrageenan, propylene glycol, carboxymethyl cellulose, starch, crystalline cellulose, trehalose, dextrin, etc., and these can be used alone or in combination. For example, a mixture of dextrin, starch, and thickening polysaccharides can be used.

[0042] The microcapsule-shaped discoloring agent starts to change color and gradually becomes the first hue when it exceeds the first temperature (discoloration start temperature during heating) which is higher than the daily living environment temperature (room temperature). Furthermore, when it exceeds the first fixing temperature (fixing temperature during heating) which is higher than this first temperature, this first hue is fixed. Note that this first temperature is, for example, within the range of 30°C to 40°C, the first fixing temperature is set within the range of, for example, 30°C to 80°C, preferably set at 50°C or higher, and also preferably set at less than 7°C. The first hue may be different from the second hue described later, but for example, it is preferably white or transparent (colorless).

[0043] Furthermore, when this discoloring agent drops below the second temperature (discoloration start temperature during cooling) which is lower than the daily living environment temperature (room temperature), it starts to change color and gradually becomes the second hue. Furthermore, when it exceeds the second preparation completion temperature (preparation completion temperature during cooling) which is lower than this second temperature, the whole becomes the second hue, and the color development preparation for the first hue during the next heating is completed. Note that this second temperature is, for example, within the range of -5 to 20 degrees, more preferably within the range of 0°C to 10°C. Also, the second preparation completion temperature is set within the range of, for example, -5°C to -20°C. The second hue is preferably any one of red, pink, brown, or brown that approximates an organ. Note that this coloring agent has a heat-resistant temperature. This heat-resistant temperature is higher than the first fixing temperature and is, for example, 100°C or higher.

[0044] This discoloring agent preferably includes those with a particle size of 5.0 μm or less, more preferably those with a particle size of 2.0 μm or less. Therefore, when selecting the discoloring agent, those with a median diameter of 5.0 μm or less are preferred, and more preferably those with a median diameter of 2.0 μm or less. As will be described in detail later, the smaller the particle size, the easier it is to be carried by the fiber structure or mesh structure of mannan, and the easier it is to aggregate in a bunchy shape. As a result, the outflow of the discoloring agent during the manufacturing process and the outflow of the discoloring agent accompanying moisture leakage during actual use can be suppressed.

[0045] The mixing ratio of mannan, electrolyte, thickener, discoloring agent, and water is, for example, 8:2:3:1:340. Specifically, while stirring, mannan, thickener, and discoloring agent are gradually added to the aqueous electrolyte solution obtained by mixing the electrolyte and water. The mixing ratio of the total weight of mannan, electrolyte, thickener, and water to the weight of the discoloring agent is, for example, 99:1. The content ratio of the electrolyte (sodium chloride) in the whole stock solution thus prepared is preferably 1.0 wt% or less, more preferably 0.7 wt% or less, and 0.01 wt% or more. Also, the weight content ratio of the thickener in the whole stock solution is preferably 5.0 wt% or less, more preferably 3.0 wt% or less, and 0.5 wt% or more. The weight content ratio of the discoloring agent in the whole stock solution is preferably 0.5 wt% or more, more preferably 1.0 wt% or more. The stock solution thus prepared is left standing for a while.

[0046] Thereafter, an alkaline substance such as calcium hydroxide or calcium carbonate is further added and the stock solution is further stirred to be gelatinized. Thereby, a so-called konjac paste can be obtained.

[0047] <Forming step (S120)> In the shaping process S120, the konjac paste is shaped into the same shape as the target animal organ. For example, in the case of an organ, the konjac paste is poured into a mold imitating the shape of the organ and three-dimensionally shaped. In the case of the skin, the konjac paste is poured into a plate-shaped mold and shaped into a sheet. In the case of blood vessels, the konjac paste may be continuously extruded from round holes or annular holes and shaped into a string or tube. Of course, instead of extrusion molding, blood vessels, intestinal tracts, esophagi, lungs, tongues, etc. may be molded using a mold. As a result, a molded body in which the konjac paste is shaped into a desired shape can be obtained.

[0048] <Freezing process (S130)> In the freezing process S130, the molded body is maintained in a low-temperature environment below 0°C for a certain period of time. As a result, the molded body changes into a fiber structure or a mesh structure, and a discoloring agent is carried on this fiber structure or mesh structure. That is, even after thawing, the discoloring agent is strongly retained inside and around the fiber structure or mesh structure, and as a result, the outflow of the discoloring agent to the moisture side (drip side) is suppressed. Note that the fiber structure or mesh structure leads to an increase in the tensile strength and tear strength of the molded body. For example, when practicing a procedure on an organ, there are cases where the organ is incised with a scalpel and forceps are inserted into the incision to pinch the inside of the organ. This is because it is necessary to further incise the deeper side while pinching the inside of the organ with forceps, or to perform peeling or extraction surgery while pulling the inside of the organ with forceps. Therefore, the freezing process provides an environment for practicing such procedures by increasing the tensile strength and tear strength inside the molded body.

[0049] In the freezing step S130, at least a part of the molded body is frozen. When frozen, the fiber structure or mesh structure develops, strengthening the bonding state between the konjac pastes, and appropriately reducing the situation where the molded body is crushed or torn even when pinched with forceps, resulting in an internal state extremely close to that of an actual organ. To freeze efficiently, it is preferably maintained in an environment of, for example, -10°C or lower, more desirably, -20°C or lower. For example, it can be maintained at about -27°C for 30 minutes to several hours. When a thickening agent is mixed, it is preferably maintained between, for example, -5°C or lower and -15°C or higher. Appropriate fiberization progresses, suppressing the amount of water leakage during cutting with an electric scalpel while ensuring appropriate strength. For example, it is maintained at about -8°C for 10 hours. Note that when freezing at less than -15°C (for example, -20°C), fiberization may progress too much, the water retention capacity may decrease, and the amount of water leakage during cutting with an electric scalpel may instead increase.

[0050] Also, in this freezing step S130, it is also preferable to keep the center in a non-frozen state while freezing the outer surface side of the molded body. By doing so, a mock animal organ can be obtained in which the tensile strength on the surface side is strong and gradually becomes softer toward the center side. Also, due to the difference in characteristic values between the frozen parts and the non-frozen parts, it becomes possible to form a boundary, and it becomes possible to practice the peeling technique along that boundary. Since many actual organs also have such a structure, it is an extremely preferable mode for practice.

[0051] Note that drips may occur from the molded body after thawing. It is preferable to set the final water content to 80% - 95% in a state where drips are deliberately caused from the molded body after thawing.

[0052] <Drying step (S140)> In the drying step S140, the moisture of the formed body is evaporated and dried. It is sufficient to dry the vicinity of the outer surface of the formed body in this drying step S140, whereby it becomes possible to increase the tensile strength of only the outer surface. Depending on the type of organ, it may be closer to practice if the epidermis (or outer bag) is present, and the epidermis can be simulatedly formed by this drying step S140. When the epidermis is unnecessary, this drying step S140 can be omitted.

[0053] On the other hand, if the formed body is dried too much in the drying step S140, it will be in a state like so-called jerky, the tensile strength will become too strong, and the reproducibility of the actual living body may deteriorate. Also, it is difficult to dry the inside of the formed body. If an attempt is made to dry deep inside, the surface will dry too much. Therefore, for the reproduction of organs, the freezing step S130 that produces an appropriate strength is prioritized, and by combining the drying step S140 therewith, it is preferable to appropriately control the tensile strength inside the formed body and the tensile strength of the outer surface. At this time, the drying step S140 is preferably performed after the freezing step S130, but depending on the purpose of the organ to be reproduced, it may be better to execute the drying step S140 before the freezing step S130.

[0054] Note that it is also possible to perform the freezing step S130 and the drying step S140 simultaneously by so-called vacuum freeze-drying.

[0055] For example, if the freezing step S130 is performed before the drying step S140, both the outer surface and the inside change slightly into a mesh-like (fibrous) state, and the tensile strength can be increased as a whole. Although the hardness of the outer surface increases by the subsequent drying step S140, the mesh-like composition does not change particularly.

[0056] On the one hand, if the drying process S140 is carried out before the freezing process S130, the outer surface becomes smooth (in a dense state), and the strength of this outer surface can be locally increased. By the subsequent freezing process S130, only the inside becomes slightly mesh-like, and the tensile strength inside can be enhanced. Therefore, for example, an organ produced by carrying out the drying process S140 before the freezing process S130 has the advantage that even if an operation such as injecting a liquid into the inside with an injection needle from the outer surface is performed, the liquid is less likely to leak out from the outer surface.

[0057] <Packaging process (S145)> In the packaging process S145, the molded body is accommodated in a desired container or bag while being immersed in a strong alkaline solution. For example, it is preferable to use a vacuum packaging machine to accommodate the molded body in a state where the inside of a resin bag is evacuated and then perform heat sealing. As the packaging bag, for example, it is preferable to use a composite film material with a nylon outer surface and a polyethylene inner surface, which can achieve both heat resistance, heat sealability, and oxygen non-permeability. It is also desirable to adopt retort-compatible packaging. Note that the packaging process (S145) can also be carried out in the storage process (S160) described later.

[0058] <Heating process (S150)> In the heating step S150, the packaged molded body is heated until it exceeds the first temperature of the discoloring agent. More preferably, it is heated until it exceeds the first fixed temperature. By this heating step S150, the discoloring agent is once discolored to the first hue. Also, the elasticity of the molded body can be enhanced by this heating step S150. Thus, by the heating step S150, by once starting or fixing the discoloration of the discoloring agent, it becomes possible to visually confirm whether the discoloring agent is homogeneously dispersed. Specifically, it is preferably heated to 50 degrees or more, more preferably 60 degrees or more. For example, the molded body may be placed in boiling water that is at or above the first fixed temperature and heated for several tens of minutes. Depending on the type of organ, elasticity may not be required. In that case, the heating time can be shortened, the heating temperature can be lowered within the range of room temperature or higher, or the heating step S150 can be omitted. However, since this heating step S150 can also serve as a sterilization step, it is preferable to perform heating at or above the sterilization temperature (for example, 75 degrees) as needed. Of course, sterilization can also be performed by methods other than heat sterilization.

[0059] This heating step S150 is preferably performed after the freezing step S130 and the drying step S140. If the heating step S150 is performed first to give elasticity, it is difficult to obtain the desired tensile strength even if the freezing step S130 or the drying step S140 is performed thereafter. Through the above steps, the simulated animal organ 10 is completed.

[0060] <Re-cooling step (S155)> In the cooling step S155, the molded body heated in the heating step S150 is maintained in a low-temperature environment lower than the second temperature of the discoloring agent for a certain period of time. Thereby, the discoloring agent that was discolored to the first hue in the heating step S150 is returned to the second hue state. Preferably, it is cooled to 5°C or lower, more preferably 0°C or lower. Particularly preferably, it is -5°C or lower, and it is also preferable to re-freeze the molded body in this cooling step S155. In this embodiment, for example, the molded body is held in a state of -10°C or lower for 1 hour or more.

[0061] <Storage step (S160)>

[0062] In the preservation step S160, the simulated animal organ 10 after the above plurality of steps are completed is preserved. At this timing, the packaging step (S145) may be executed. Thereby, preservation at normal temperature or refrigeration for several months to several years can be realized.

[0063] Note that in the state immediately before the preservation step (S160) or the packaging step (S145), it is preferable that the water content rate of the simulated animal organ 10 is 95% or less. Thereby, the amount of water leakage during cutting with an electric scalpel can be suppressed. On the other hand, it is preferable that the water content rate of the simulated animal organ 10 is 80% or more. When the water content rate becomes 80% or less, the difference from a human organ during skill practice becomes large, and a sense of discomfort is likely to occur. Desirably, the water content rate is 94% or less. Note that this water content rate can be calculated by the relational expression (final product weight - raw material weight) / (final product weight).

[0064] Furthermore, in the state immediately before the preservation step (S160) or the packaging step (S145), it is preferable that the compression (tensile) elastic modulus of the simulated animal organ 10 is set to 0.015 N / mm2 or less. More desirably, the compression (tensile) elastic modulus is set to 0.011 N / mm2 or less. By setting such a low elastic modulus, an appropriate sense of stretch can be obtained when pinching with forceps. Note that this compression (tensile) elastic modulus is preferably set to 0.001 N / mm2 or more.

[0065] As described above, in the above manufacturing process, while adjusting the water content rate of the simulated animal organ 10 to be low, the elastic modulus is lowered to ensure a highly flexible and stretchable state. Moreover, since the discoloring agent is carried along the internal fibers, when the simulated animal organ 10 is stretched or contracted, the discoloring agent follows it.

[0066] FIG. 2 shows the simulated animal organ 10 manufactured by the above process. This simulated animal organ 10 has high reproducibility of actual organs such as internal organs. Specifically, it has the following advantages.

[0067] (1) Management of temperature change This simulated animal organ 10 contains a discoloring agent that is temporarily fixed to the second color phase in the unused state. Therefore, for example, as shown in Fig. 3(A), when practicing the procedure using the electrosurgical knife 40, the degree of thermal damage to the simulated animal organ 10 by the electrosurgical knife can also be visually confirmed by the discoloration state to the first color phase (for example, white). Also, in the practice of procedures such as catheter ablation, the degree of thermal cauterization of the simulated animal organ 10 can be visually confirmed by the discoloration state to the first color phase. Furthermore, whether the heat generated by the electrosurgical knife or catheter propagates through the simulated animal organ 10 or in the air and affects the area outside the cutting site can also be visually confirmed by its discoloration state.

[0068] (2) Electrical conductivity This simulated animal organ 10 has electrical conductivity. Therefore, as shown in Fig. 3(A), it becomes possible to practice the procedure using the electrosurgical knife 40, and the cutting feeling of the simulated animal organ 10 by the electrosurgical knife can also obtain a feeling very close to that of an actual organ. In particular, since this simulated animal organ contains an electrolyte, its electrical conductivity can be further enhanced. Therefore, for example, during the procedure using a monopolar electrosurgical knife using a counter electrode plate, it becomes possible to stabilize the cutting condition of the simulated animal organ. In particular, the content ratio of the electrolyte (sodium chloride) in the stock solution is preferably 1.0% by weight or less, more preferably 0.7% by weight or less, and 0.01% by weight or more, so that a cutting feeling close to that of an actual animal organ can be created. Note that if the content ratio of the electrolyte is too high, an abnormal alarm may be issued from the electrosurgical knife device.

[0069] (3) Storage stability This simulated animal organ 10 can be stored for a long time. If the package is unopened, it can be stored at room temperature for more than one year, and even after opening, it can be stored for several days.

[0070] (4) Disposability Since this simulated animal organ 10 has natural-derived components (food) as the main components, it can be easily discarded in the same way as food waste. Also, no substances that destroy the environment are generated during the disposal after discarding (for example, during incineration or landfill).

[0071] (5) Low cost and hygienic The simulated animal organ 10 can be mass-produced at extremely low cost. As a result, it can be frequently replaced (discarded), and as a result, it is possible to practice techniques in a hygienic environment at all times.

[0072] (6) Utilization of forceps The internal part of the simulated animal organ 10 also has appropriate tensile strength. Therefore, as shown in Fig. 3(B), it is possible to practice techniques such as picking up and holding or pulling the meat inside the organ after incision with forceps 50. If the freezing process S130 is omitted during manufacturing, the inside becomes soft, and the material will be torn apart when picked up with forceps 50.

[0073] (7) Suture characteristics As shown in Fig. 3(C), the cut part of the simulated animal organ 10 can be sutured using a surgical needle 90 and a surgical thread 92. When performing suture practice, it is preferable to increase the surface tensile strength by the freezing process S130 or the drying process S140.

[0074] (8) Ultrasonic examination The simulated animal organ 10 can obtain an output state similar to that of an actual organ even in an echo (ultrasonic examination device) examination. Therefore, it can also be used for echo practice, and a series of practices combining echo and surgical operation can also be performed with a single simulated animal organ 10. The same applies to various imaging diagnostic devices (X-ray, CT, MRI, etc.).

[0075] (9) Drip suppression Since the simulated animal organ 10 contains a thickening agent, it can retain moisture. As a result, when cutting with an electric scalpel, the amount of moisture leakage occurring simultaneously with the cutting can be suppressed (appropriately controlled). This also leads to creating a cutting edge similar to that of an actual animal organ. Also, since the discoloring agent is carried on the side of the fiber structure or mesh structure of mannan, the content of the discoloring agent on the moisture side retained by the thickening agent can be suppressed. As a result, the outflow of the discoloring agent together with the moisture leaking out when cutting with an electric scalpel is suppressed, and the thermal effect on the fiber structure or mesh structure of mannan rather than the moisture can be correctly evaluated. Incidentally, when the amount of the thickening agent is too small (or not contained), the amount of moisture leakage during cutting becomes too large, and in some cases, an abnormal alarm (alarm) may be issued from the electric scalpel device due to the moisture. Note that since the simulated animal organ 10 is performing the freezing step S130 in a state where the thickening agent is mixed, it is possible to achieve both appropriate strength and drip suppression.

[0076] In the above-described first embodiment, the case of manufacturing with a single stock solution or a single molding step S120 has been illustrated, but the present invention is not limited to this. For example, a plurality of types of stock solutions can be prepared and poured separately into a mold to form a multilayer state. As shown in FIG. 4(A), by laminating a plurality of types of stock solutions 70A, 70B, and 70C on a mold 60 on a flat plate, a simulated animal organ 10 having a multilayer structure can be obtained so that different characteristics are produced in the subsequent freezing step S130, drying step S140, and heating step S150. Also, it is preferable to appropriately select and perform the freezing step S130, drying step S140, and heating step S150 after laminating the first stock solution 70A, then laminate the second stock solution 70B and appropriately select and perform the freezing step S130, drying step S140, and heating step S150, and finally laminate the third stock solution 70C and appropriately select and perform the freezing step S130, drying step S140, and heating step S150. When performing in such a plurality of steps, even if the compositions of the first to third stock solutions 70A, 70B, and 70C are the same, a time difference occurs in the subsequent freezing step S130, drying step S140, and heating step S150, so different characteristics can be produced between the laminations.

[0077] As shown in FIG. 4(B), a mold may be used to form a bag-shaped first simulated animal organ 10A, and then a raw material may be poured into the mold to form a second simulated animal organ 10B inside the first simulated animal organ 10A, thereby producing an integrated simulated animal organ 10. Conversely, as shown in FIG. 4(C), a mold may be used to form a block of the first simulated animal organ 10A, and then a mold (not shown) may be used to pour raw material around the block to form a second simulated animal organ 10B, thereby producing an integrated simulated animal organ 10. In this case, as shown by the dotted line, for example, the simulated animal organ 10 may be produced by embedding a foreign body 10C that is created to simulate a tumor or the like inside the organ. In this way, it is possible to practice the procedure of removing a tumor or the like, or to practice an echo examination to detect a foreign body.

[0078] As shown in Fig. 4(D), a string-like or tubular simulated blood vessel K simulating a blood vessel (which may become a foreign body) can be formed by the manufacturing method of the first embodiment or other manufacturing methods, and this simulated blood vessel K can be embedded inside the simulated animal organ 10. In this way, it is possible to practice the procedure of cutting the simulated animal organ 10 with a scalpel or the like, extracting the internal blood vessel K, and anastomosis (connecting blood vessels together) of the blood vessel K inside.

[0079] <Example>

[0080] The simulated animal organ 1 was fabricated according to the manufacturing method of the first embodiment. Specifically, in the kneading and gelatinization step (S110), mannan, electrolyte, thickening agent, discoloring agent, and water were kneaded to obtain a stock solution. The discoloring agent had a particle size (median diameter) of 0.9 to 1.3 μm, with the first hue being white and the second hue being brown. As the discoloring agent material, one with a first temperature of 60°C, a first fixed temperature of 95°C, a second temperature of 0°C, and a second preparation completion temperature of -18°C was used. Specifically, the Memory Type thermochromic material of NCC was used. Before kneading, the discoloring agent was in the second hue state. Then, calcium carbonate was added to the stock solution and further stirred to gelatinize it. In the molding step (S120), the gelatinized stock solution was molded into a sheet shape. Next, in the freezing step (S130), the molded body was stored in a frozen state. After confirming that the water content after freezing completion was 80% to 95%, it was packaged in the packaging step (S145), and then in the heating step (S150), the molded body was stored at room temperature for 10 hours. Next, in the re-cooling step (S155), the molded body was held at -18°C for 24 hours to fix the discoloring agent to the second hue (brown), and then returned to room temperature to complete the simulated animal organ 1.

[0081] (Verification 1)

[0082] As a verification, after the molding step (S120) and before performing the freezing step (S130), the molded body was compressed to squeeze out the drip, and its color was confirmed. As a result, as shown in Fig. 5(A), a red drip D1 flowed out. Next, for the same molded body, after performing the freezing step (S130), the molded body was compressed to squeeze out the drip, and its color was confirmed. As a result, as shown in Fig. 5(B), a transparent or light yellow drip D2 flowed out. That is, even after the molding step (S120) and before the freezing step (S130), since the holding power of the discoloring agent by the molded body is weak, when an external force is applied to compress the molded body, it was confirmed that a part of the discoloring agent easily flows out together with the moisture. On the other hand, when the freezing step (S130) is performed, it was confirmed that most of the discoloring agent is carried by the molded body, and even when an external force is applied to compress the molded body, the outflow of the discoloring agent is significantly suppressed. That is, it became clear that the holding power or holding rate (holding amount) of the discolored body by the molded body increases due to the freezing step (S130). Note that Fig. 5(C) shows a photograph directly taken of only the discoloring agent G before kneading.

[0083] (Verification 2)

[0084] Next, the tissue state of the completed simulated animal organ 1 was observed. Specifically, after freezing the simulated animal organ 1 with liquid nitrogen, it was dried by freeze-drying to prepare an observation sample, and confirmed with a desktop microscope. The freeze-drying apparatus used was the FDU-1200 manufactured by EYELA, and as the drying conditions, the temperature was set at -45°C and the pressure was set at 20 Pa, and the treatment was performed for 20 hours. The desktop microscope used was the TM-1000 manufactured by Hitachi High-Technologies Corporation, and as the observation conditions, the acceleration voltage was set at 15000 V, the emission current was set at 53.3 mA, the vacuum degree was set at 15.0 kV, and the working distance was set at 5.56 mm.

[0085] In the observation results of FIGS. 6(A) and (B), it was confirmed that the microcapsule-like discoloring agent R was held in the fiber structure or mesh structure generated by the freezing step (S130). In particular, as can be seen from FIG. 6(B), it was confirmed that the discoloring agent R with a particle diameter of 2.0 μm or less was carried in the fiber structure or mesh structure. As shown in the observation results of FIG. 7, 50% or more of the microcapsule-like discoloring agent R (alone) was incorporated (embedded) in the fiber structure or mesh structure, and a state in which a part of the discoloring agent R was exposed from the surface of the fiber structure or mesh structure was confirmed. This loading mode means that the holding power of the discoloring agent R is increased and the discoloring mode is in a state that is easy to visually recognize from the outside.

[0086] Also, as shown in the observation results of FIGS. 8(A) and (B), it was confirmed that the microcapsule-like discoloring agent R was held in a bundle (cluster) shape along the fibers of the fiber structure or mesh structure generated by the freezing step (S130). In particular, as can be seen from FIG. 8(B), it was confirmed that the discoloring agent R with a particle diameter of 2.0 μm or less was carried in the fiber structure or mesh structure in an aggregated state. It was confirmed that these bundles of the discoloring agent R were carried by the fiber structure or mesh structure T having a fiber diameter or film thickness of 0.3 μm or less.

[0087] Furthermore, as shown in FIGS. 9(A) and (B), pocket-shaped recesses P were formed in the fiber structure or mesh structure generated by the freezing step (S130), and it was confirmed that the microcapsule-like discoloring agent R was accommodated in a bundle (cluster) shape in the recesses P. That is, it was confirmed that the fiber structure or mesh structure functioned as a container for accommodating the discoloring agent R.

[0088] As described above, according to the simulated animal organ 1 of the present embodiment, since the discoloring agent R is surely supported by the fiber structure or mesh structure of the main component mannan, even if external force or vibration acts during long-term storage or transportation, the outflow of the discoloring agent R is suppressed. In particular, due to the fiber structure or mesh structure, the discoloring agent R can be supported in a bundle shape or a large amount of the discoloring agent R can be held in the concave portion P, so that the visibility at the time of discoloration can be enhanced.

[0089] (Verification 3)

[0090] Next, the elastic modulus of the completed simulated animal organ 1 was measured. Specifically, using a small desktop compression / tension tester (EZ-SX) manufactured by Shimadzu Corporation, the simulated animal organ 1 was processed into a cylindrical shape with a diameter of 10 mm and a length of 10 mm as a test piece, and the stress when compressed at a speed of 10 mm / min was measured with a load cell to calculate the elastic modulus at 10% deformation. Three test pieces were prepared, and the measurement results were 0.01303 N / mm2, 0.00849 N / mm2, and 0.1076 N / mm2. Incidentally, when a general edible konjac was measured by the same method, the result was 0.0160 N / mm2.

[0091] Next, an application example regarding the usage method of the present simulated animal organ 10 is shown.

[0092] As shown in FIG. 10, the simulated animal organ kit 300 according to the second embodiment of the present invention includes the simulated animal organ 10 of the first embodiment and a three-dimensional organ model 310 formed of resin or metal. The simulated animal organ 10 is formed in a sheet shape here. The organ model 310 is a heart organ model 310 made of plastic, silicone or rubber here. An opening 310A is formed in a part of the wall surface of the organ model 310, and the simulated animal organ 10 is fixed to the organ model 310 so as to cover the opening 310A. As a result, a part of the wall surface of the organ model 310 is replaced by the simulated animal organ 10. In the present embodiment, the case where the simulated animal organ 10 is fixed to the organ model 310 by a fixing pin or a fixing screw 320 is illustrated, but the simulated animal organ 10 may be arranged in the opening 310A by a clip or other holding structure.

[0093] For example, when practicing the atrial fibrillation catheter ablation technique of the ablation device 900 which is a medical device using this simulated animal organ kit 300, the counter electrode plate 902 is placed in contact with the outside of the simulated animal organ 10, and the electrode catheter 901 is inserted into the organ model 310 via a vein or an artery. After the tip electrode of the electrode catheter 901 is brought into contact with the inside of the simulated animal organ 10 through the opening 310A of the organ model 310, a high-frequency current is passed to electrically burn the contact portion. As a result, since the discoloring agent of the simulated animal organ 10 changes color to the first color phase, the ablation range can be visually confirmed.

[0094] Here, the heart organ model 310 is illustrated, but the present invention is not limited thereto, and a three-dimensional model of other organs such as the stomach, esophagus, lung, liver, kidney, large intestine, and small intestine may be used. Further, here, the sheet-shaped simulated animal organ 10 is illustrated, but it may have a tubular or other shape.

[0095] As shown in FIG. 11, the medical device evaluation kit 400 according to the third embodiment of the present invention includes the simulated animal organ 10 of the first embodiment, a discoloring sheet 410 composed of paper or a resin film, a base 450, and a fixing jig 470. The simulated animal organ 10 is formed in a strip shape.

[0096] The discoloration sheet 410 is bent in a V shape to form a pair of opposing surfaces (the second surface 412 and the third surface 413). These opposing surfaces (the second surface 412 and the third surface 413) change color due to heat. The discoloration sheet 410 is formed with slits 410A extending from the vertex of the V shape toward both ends, and the simulated animal organ 10 is inserted into these slits 410A. The discoloration sensitivity of the opposing surfaces (the second surface 412 and the third surface 413) is preferably set higher than that of the simulated animal organ 10. That is, it is preferable that the discoloration starts at a temperature lower than the first temperature (the discoloration start temperature during heating) of the simulated animal organ 10 and the discoloration is fixed at a temperature lower than the first fixed temperature.

[0097] The base 450 is in the shape of a rectangular parallelepiped pedestal, and the simulated animal organ 10 is placed on the placement surface 452 which is the upper surface thereof. Since the belt length of the simulated animal organ 10 is longer than that of the placement surface 452, both ends of the simulated animal organ 10 protrude from the placement surface 452 and bend toward the lower side of the side surface of the base 450. A recess 454 is formed in the placement surface 452, and a part of the recess 454 is open to the side surface of the base 450. As a result, a medical device can be inserted behind the simulated animal organ 10 using the recess 454. In the base 450, a holding portion 458 for holding a medical device is protrudingly provided on the side surface where a part of the recess 454 is open. The recess 455 is V-shaped in plan view, and the V-shaped discoloration sheet 410 is held by a pair of opposing inner walls 456 thereof. A groove 460 is formed on the back surface of the base 450 to hold the fixing jig 470.

[0098] The fixing jig 470 has a structure in which a pair of clips are arranged at both ends of, for example, a rubber-like elastic material. While aligning the elastic material along the groove 460 of the base 450, both ends of the simulated animal organ 10 placed on the placement surface 452 are held by the clips at both ends thereof. As a result, as shown in FIG. 12(A), the simulated animal organ 10 is fixed to the placement surface 452 so as to wrap around the base 450. The V-shaped discoloring sheet 410 is inserted into the recess 454 from the side surface of the recess 454 of the base 450. As a result, the discoloring sheet 410 is fixed to the recess 454 with the simulated animal organ 10 inserted into the slit 410A.

[0099] The medical device evaluation kit 400 assembled by the above procedure includes a first surface 411 composed of the simulated animal organ 10, a second surface 412 provided in a direction orthogonal to the first surface 411 and discolored by heat, and a third surface 413 provided in a direction orthogonal to the first surface 411 and having a space from the second surface 412 and discolored by heat. The space surrounded by the first surface 411, the second surface 412, and the third surface 413 becomes a heat evaluation space. This heat evaluation space is a triangular prism-shaped space extending in the up-and-down dual directions orthogonal to the surface with the first surface 411 as a boundary.

[0100] Fig. 12(B) shows a mode of thermally evaluating the bipolar type electric scalpel 910, which is a medical device, using this medical device evaluation kit 400. The electric scalpel 910 is held by the holding part 458, and the first surface 411 of the simulated animal organ 10 is cut by sandwiching it with the forceps-like electrode at the tip. At this time, due to the temperature rise of the forceps-like electrode, the temperature rise of the simulated animal organ 10, water vapor generated from the simulated animal organ 10, etc., a temperature rise occurs in the thermal evaluation space, and the heat is also transmitted to the second surface 412 and the third surface 413 to cause discoloration. As a result, in addition to the first surface 411, the thermal effects on the surrounding second surface 412 and third surface 413 can be visually confirmed. Generally, in the case of the electric scalpel 910, the thermal effect on the cutting part (here, the first surface 411) during surgery is naturally tolerated, but it is not preferable to have a thermal effect on the surrounding area that has nothing to do with the cutting part. By using this medical device evaluation kit 410, the electric scalpel 910 with a small thermal effect on the second surface 412 and the third surface 413 can be evaluated as having high performance from the perspective of thermal effect, while the electric scalpel 910 with a large thermal effect on the second surface 412 and the third surface 413 can be evaluated as having low performance from the perspective of thermal effect.

[0101] In this medical device evaluation kit 400, a triangular prism-shaped space is exemplified as the thermal evaluation space, but the present invention is not limited to this, and other shapes such as a quadrangular prism, a hexagonal prism, a polygonal prism space (including a partial cylindrical space that is a partial arc), a cylindrical space, a spherical space, a cone, and a polygonal pyramid may be adopted. Also, although the upper surface of this thermal evaluation space is shown as being open, the upper surface may be closed.

[0102] Fig. 13 shows a medical device evaluation kit 400 according to a modification of the third embodiment. In this medical device evaluation kit 400, four holding rods 460 serving as holders are erected on the placement surface 452 of the base 450. A belt-shaped first simulated animal organ 11 corresponding to the first embodiment is wound around the holding rod 460, and both ends thereof are clamped by clips 472. As a result, a surrounding wall surface that is rectangular in plan view is formed by the first simulated animal organ 11.

[0103] On one hand, as already described, the strip-shaped second simulated animal organ 12 is fixed to the mounting surface 452 of the base 450 by the fixing jig 470. This second simulated animal organ 12 is configured to form the bottom surface of the range surrounded by the first simulated animal organ 11.

[0104] As shown in FIG. 14, if one of the peripheral walls of the first simulated animal organ 11 is defined as the first surface 411, the remaining three peripheral walls of the same first simulated animal organ 11 form a second surface 412 and a third surface 413 that are orthogonal to each other and opposed to the first surface 411, and a fourth surface 414 opposed to the first surface 411. Further, the second simulated animal organ 12 forms a fifth surface 415 orthogonal to all of the first surface 411 to the fourth surface 414. A cubic (quadrangular prism-shaped) evaluation space is secured by these five surfaces.

[0105] In this medical device evaluation kit 400, the first surface 411 of the first simulated animal organ 11 is cut by sandwiching it with the forceps-shaped electrode at the tip of the scalpel 910. At this time, due to the temperature rise of the forceps-shaped electrode, the temperature rise of the first simulated animal organ 11, water vapor generated from the first simulated animal organ 11, etc., a temperature rise occurs in the thermal evaluation space, and the heat is transmitted to the second surface 412 to the fourth surface 414 and the fifth surface 415 of the second simulated animal organ 12 to cause discoloration. As a result, in addition to the first surface 411, the thermal influence around it can be visually confirmed.

[0106] In the above embodiment, the case where both the electrolyte and the thickener are contained in the simulated animal organ is exemplified, but the present invention is not limited thereto. For example, in order to enhance the stability during cutting using a scalpel, only the electrolyte may be contained to enhance the electrical conductivity. Similarly, in order to suppress the water drip during cutting using a scalpel, only the thickener may be contained. The above embodiment mainly exemplifies the case of manufacturing the internal organs of an animal, but the present invention is not limited thereto, and it is also possible to manufacture organs such as skin, arms, mouth, nose, ears, legs, and fingers.

[0107] In addition, in the above-described embodiment, it was exemplified that when the microcapsule-shaped discoloring agent exceeds a first temperature (discoloration start temperature during temperature rise) higher than the daily living environment temperature (room temperature), it starts to discolor and gradually becomes a first hue, and further, when it exceeds a first fixing temperature (fixing temperature during temperature rise) higher than this first temperature, this first hue is fixed. However, the opposite is also possible. Specifically, when it falls below a first temperature (discoloration start temperature during temperature drop) lower than the daily living environment temperature (room temperature), it starts to discolor and gradually becomes a first hue, and further, when it falls below a first fixing temperature (fixing temperature during temperature drop) lower than this first temperature, this first hue is fixed. At the same time, when the discoloring agent exceeds a second temperature (discoloration start temperature during temperature rise) higher than the daily living environment temperature (room temperature), it starts to discolor and gradually becomes a second hue, and when it exceeds a second preparation completion temperature (preparation completion temperature during temperature rise) higher than this second temperature, the whole becomes the second hue, and the color development preparation for the first hue during the next temperature drop is completed. By using such a temperature drop-sensitive discoloring agent, for example, practice and simulation of cryoablation techniques for atrial fibrillation can be realized.

[0108] Note that the present invention is not limited to the above-described embodiments, and it goes without saying that various modifications can be made without departing from the gist of the present invention.

[0109] Furthermore, regarding all of the above inventions and embodiments, it goes without saying that even when the discolored body is omitted, a simulated animal organ that can be used for practicing normal medical procedures can be obtained.

[0110] That is, by a method for manufacturing a simulated animal organ, which comprises a molding step of mixing and gelatinizing mannan as a main component and water and then molding to obtain a molded body, and a freezing step of freezing the molded body to form a fiber structure or a mesh structure, a non-discoloring type of simulated animal organ can be obtained. At this time, similar to the above-described embodiment, it is preferably characterized in that the water content of the molded body is 95% or less at the final product stage, and more preferably, it can be characterized in that the water content of the molded body is 80% or more. Furthermore, after the freezing step, it may be characterized in that the compression elastic modulus of the molded body is 0.015 N / mm2 or less, and more preferably, the compression elastic modulus of the molded body is adjusted to be 0.011 N / mm2 or less.

Claims

1. A forming step of obtaining a formed body by mixing mannan as a main component, microcapsule-shaped discoloring agent that changes color depending on temperature, and water, followed by gelatinization and forming; A freezing step of forming a fibrous structure or a mesh structure by freezing the formed body; characterized by comprising: After undergoing the forming step and the freezing step, a part of the microcapsules serving as the discoloring agent is naturally embedded in the fibrous structure or the mesh structure, and the remaining part of the microcapsules is exposed from the surface of the fibrous structure or the mesh structure; A method for manufacturing a simulated animal organ, wherein the particle size of the discoloring agent is 2.0 μm or less.

2. A forming step of obtaining a formed body by mixing mannan as a main component, microcapsule-shaped discoloring agent that changes color depending on temperature, and water, followed by gelatinization and forming; A freezing step of forming a fibrous structure or a mesh structure by freezing the formed body; characterized by comprising: After undergoing the forming step and the freezing step, the microcapsules serving as the discoloring agent are naturally aggregated in a bundle shape around the fibrous structure or the mesh structure; A method for manufacturing a simulated animal organ, wherein the particle size of the discoloring agent is 2.0 μm or less.

3. A forming step of obtaining a formed body by mixing mannan as a main component, microcapsule-shaped discoloring agent that changes color depending on temperature, and water, followed by gelatinization and forming; A freezing step of forming a fibrous structure or a mesh structure by freezing the formed body; characterized by comprising: After undergoing the forming step and the freezing step, pocket-shaped recesses are naturally formed on the surface of the fibrous structure or the mesh structure, and the microcapsules serving as the discoloring agent are aggregated in the recesses; A method for manufacturing a simulated animal organ, wherein the particle size of the discoloring agent is 2.0 μm or less.

4. The discoloring agent has the property that when the temperature rises and exceeds a first temperature, discoloration to a first hue starts, and when the temperature drops in the first hue state and falls below a second temperature lower than the first temperature, discoloration to a second hue starts; A method for manufacturing a simulated animal organ according to any one of Claims 1 to 3.

5. After the freezing step, a heating step of heating the formed body to a temperature higher than the first temperature to make the discoloring agent in a first hue state; After the heating step, a cooling step of cooling the molded body to a temperature lower than the second temperature to bring the discoloring agent into a second hue state; characterized by comprising The method for manufacturing a simulated animal organ according to claim 4.

6. In the heating step, the molded body is heated to 75 degrees or higher, In the cooling step, the molded body is cooled to lower than -5 degrees, The first temperature of the discoloring agent is set higher than 30°C and lower than 75 degrees, The second temperature of the discoloring agent is set lower than 20°C and higher than or equal to -5 degrees, characterized in that The method for manufacturing a simulated animal organ according to claim 5.

7. The first hue is white or transparent, and the second hue is red, pink, brown or tan, characterized in that The method for manufacturing a simulated animal organ according to any one of claims 4 to 6.

8. The molded body in the molding step contains 1.0% by weight or more of the discoloring agent, characterized in that The method for manufacturing a simulated animal organ according to any one of claims 1 to 7.

9. In the final product stage after the freezing step, the water content of the molded body is 95% or less, characterized in that The method for manufacturing a simulated animal organ according to any one of claims 1 to 8.

10. In the final product stage after the freezing step, the water content of the molded body is 80% or more, characterized in that The method for manufacturing a simulated animal organ according to any one of claims 1 to 9.

11. After the freezing step, the compression elastic modulus of the molded body is 0.015 N / mm2 or less, characterized in that The method for manufacturing a simulated animal organ according to any one of claims 1 to 10.

12. After the freezing step, the compression elastic modulus of the molded body is 0.011 N / mm2 or less, characterized in that The method for manufacturing a simulated animal organ according to claim 11.

13. In the molding step, an electrolyte is mixed with the water, characterized in that The method for manufacturing a simulated animal organ according to any one of claims 1 to 12.

14. The molded body in the molding step contains the electrolyte at 1.0% by weight or less, characterized in that The method for manufacturing a simulated animal organ according to claim 13.

15. A simulated animal organ manufactured by the manufacturing method according to any one of claims 1 to 14 and formed in a sheet shape, A three-dimensional organ model formed of resin or metal, and is provided with The simulated animal organ is fixed to a part of the wall surface of the organ model, characterized in that Method for manufacturing a simulated animal organ kit.

16. A first surface composed of a simulated animal organ, A second surface provided in a direction orthogonal to the first surface and having a property of changing color by heat, A third surface provided in a direction orthogonal to the first surface and spaced from the second surface and having a property of changing color by heat, having, The simulated animal organ, A forming step of mixing mannan as a main component, a microcapsule-shaped discoloring agent that changes color depending on temperature, and water, gelatinizing them, and forming them into a formed body; and a freezing step of freezing the formed body to obtain a fiber structure or a mesh structure. It is characterized by being manufactured by Method for manufacturing a medical device evaluation kit.

17. The discoloring agent has a property that when the temperature rises, discoloration to a first hue starts at a first temperature, and when the temperature drops in the first hue state, discoloration to a second hue starts at a second temperature lower than the first temperature. Furthermore, the simulated animal organ A heating step of heating the formed body to a temperature higher than the first temperature to make the discoloring agent in a first hue state, After the heating step, a cooling step of cooling the formed body to a temperature lower than the second temperature to make the discoloring agent in a second hue state, , characterized by being manufactured by The method for manufacturing a medical device evaluation kit according to claim 16.

18. The second surface and the third surface are composed of paper or a resin film, characterized by The method for manufacturing a medical device evaluation kit according to claim 16 or 17.

19. The second surface and the third surface are composed of the simulated animal organ, characterized by The method for manufacturing a medical device evaluation kit according to claim 16 or 17.

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