WO2015151939A1 - Inner limiting membrane detachment model - Google Patents

Abstract

Provided is an internal boundary film detachment model which can be used suitably in technical training in detaching an inner limiting membrane. This inner limiting membrane detachment model (10) is equipped with an artificial retina (30) and an artificial inner limiting membrane (20) laminated on at least one surface of the artificial retina (30). This inner limiting membrane detachment model (10) is characterized in that the detachability when forceps are used to detach the artificial inner limiting membrane (20) from the top of the artificial retina (30) approximates the detachability when forceps are used to detach the inner limiting membrane in a human eye.

Description

Inner boundary membrane peeling model

The present invention relates to an inner boundary membrane separation model used for training of inner boundary membrane separation techniques.
Note that this application claims priority based on Japanese Patent Application No. 2014-074694 filed on March 31, 2014, the entire contents of which are incorporated herein by reference. ing.

The retina is a tissue that exists on the back of the eye, and the light that passes through the pupil and enters the eyeball connects the images. The retina has a multi-layered structure, roughly speaking, from the vitreous side (hereinafter, the vitreous side is understood as the “inside” of the eyeball) to the inner limiting membrane (Inner limiting membrane, ILM), sensory nerve retina, retinal pigment epithelium. Etc. In the retina, there is a portion that is slightly depressed from the surrounding retina called the central fovea, and a circular region with a diameter of about 1.5 to 2.0 mm that can be confirmed dark yellow on the fundus photograph around the central fovea Exists. Such a deep yellow region is called “macular”. The fovea and the macula are areas where the center of the visual field forms an image, and are the most sensitive areas in the retina.

Retinal damage (typically exfoliation and hiatus) may cause vision loss, visual field distortion, visual field loss, etc., and may lead to blindness as it progresses. In particular, damage to the macula (fovea) causes significant visual loss or central vision loss. Since the above-mentioned visual abnormalities lead to a marked QOL (Quality of Life), treatment of the retinal (macular) damage is important.

An example of the retinal damage is a macular hole with a hole in the macula. Macular foramen are generally treated by vitreous surgery. Specifically, posterior vitreous detachment, inner boundary film detachment, and liquid gas replacement are performed. Inner boundary membrane detachment is not an indispensable treatment for the above-mentioned macular hole treatment, but by performing inner boundary membrane detachment, the retina developability (flexibility) around the hole is increased and the hole is easily closed ( That is, it is known that the therapeutic effect is improved. Therefore, there are an increasing number of cases where internal boundary membrane detachment is performed in macular hole surgery. In addition, inner boundary membrane detachment has been reported not only for the above-mentioned macular hole but also for the superiority of adaptation to the macular epithelium, retinal vein occlusion, etc., and is positioned as one of the important techniques in vitrectomy.

Vitreous surgery is a surgery that is difficult and requires delicate techniques because it treats the deepest part of the eyeball. In particular, the inner limiting membrane is a very thin membrane (the thickness of the inner limiting membrane of the human eye is about 3 μm), and since the retina exists immediately below the inner limiting membrane, the inner limiting membrane is a particularly delicate technique. One of the necessary surgeries. If the retina is accidentally damaged when the inner boundary membrane is peeled off, there is a risk of serious visual impairment due to the damage. Further, depending on the peeling speed and peeling direction at the time of peeling of the inner boundary membrane, there is a possibility that the retinal detachment portion may be widened in the macular hole or the like, or a new cause of retinal detachment or retinal tear may occur. As described above, the inner boundary membrane separation requires a very delicate procedure, and the operation by an unskilled operator (doctor or practitioner) is a difficult operation that may lead to blindness.

International Publication No. WO2010 / 084595

Proceedings of the 5th Annual Conference of the Japanese Virtual Reality Society, Volume 5, 2000, pp. 421-424

A great deal of experience is required to learn and improve inner boundary membrane separation. Conventionally, in general techniques for ophthalmic surgery, training has been performed using an isolated animal eye (typically a pig eye). However, since advanced eye surgery requires grasping of the eye structure peculiar to the human eye, alternative training using the isolated animal eye is unsuitable for the procedure training of inner boundary membrane peeling. Recently, Non-Patent Document 1 reported an eye surgery simulator system that realized a surgery simulator for premacular membrane disease with virtual reality technology. However, both the premacular delamination and the inner boundary membrane separation have a common part as a technique to remove the thin film near the macula, but the inner boundary membrane is extremely thin, and the nerve tissue is directly under the inner boundary membrane. Because of the fact that the inner boundary membrane is composed of a series of membrane tissues and the formation of an exfoliation end is necessary, the premacular membrane disease surgery simulator is used as the inner boundary membrane exfoliation surgery simulator. It is unknown whether it can be used. In addition, it is considered difficult to accurately evaluate the proficiency level of the surgical technique for detachment of the inner limiting membrane, which differs in the target site of surgery, using a premacular surgery simulator. In addition, since the surgical simulator system for the premacular membrane disease requires the introduction of various state-of-the-art devices, there are cost and place restrictions on the introduction of the system. Above all, there is an extremely high demand from the medical field for a model for procedure training (for example, a pseudo arm for blood collection or a skin for suture) that faithfully reproduces an actual anatomy. For example, Patent Document 1 describes an artificial eye device used for practicing cataract surgery.
Therefore, the present invention is an invention created for the purpose of providing an inner boundary membrane peeling model that can be used for technique training of inner boundary membrane peeling, evaluation of proficiency of surgical techniques, and the like.

In order to achieve the above object, according to the present invention, there is provided an inner boundary membrane peeling model comprising a pseudo retina and a pseudo inner boundary membrane laminated on at least one surface of the pseudo retina, An inner boundary membrane peeling model is provided in which the peelability when peeling the membrane from the pseudo retina using the insulator is similar to the peelability when peeling the inner boundary membrane using the insulator in the human eye. .

The above-mentioned inner boundary membrane peeling model having peelability can be suitably used for technique training of inner boundary membrane peeling, evaluation of proficiency of surgical technique, and the like. By performing the inner boundary membrane peeling technique training using the inner boundary membrane peeling model, it becomes possible to acquire advanced techniques and to accurately evaluate the proficiency level of the surgical technique. In particular, since the inner boundary membrane peeling can be reproduced without relying on a surgical simulator, it is possible to respond to a high demand for a procedure training model from a medical field.
In addition, by using the above-described inner boundary membrane peeling model, it is possible to easily and inexpensively and easily perform technique training for inner boundary membrane peeling and evaluation of proficiency of surgical techniques. In particular, it is important to provide highly efficient techniques and high-quality medical care to an operator who is technically inexperienced in the technique of peeling the inner limiting membrane before he / she can actually perform the procedure on the patient. Social contributions are extremely high from all aspects such as providing health care and reducing human risks associated with surgery. Furthermore, since the skill level of the operator can be objectively evaluated, it is possible to contribute to the uniformization and improvement of the quality of the medical service (inner boundary film peeling).

In this specification, “the peelability when peeling the pseudo inner boundary membrane from the pseudo retina using the insulator is similar to the peelability when peeling the inner boundary membrane using the insulator in the human eye” Means that a doctor who is a person skilled in the art who has mastered the technique of exfoliating the inner boundary film in the human eye (ie, a person skilled in the art) can perform an evaluation by conducting a sensory test that removes the pseudo inner boundary film from the pseudo retina. it can.
Specifically, with respect to the inner boundary membrane exfoliation model to be evaluated, a plurality of doctors (at least 2 or more, preferably 3 or more) are simulated from above the pseudo retina using an actual surgical instrument (eg, insulator). We conducted a test to peel the inner boundary membrane, and compared the sensation of peeling the pseudo inner boundary membrane from the pseudo retina with the sensation when peeling the inner boundary membrane of the actual human eye, so Peelability when peeling the membrane (for example, ease of grasping, tearing, hardness, thickness, strength, elongation and adhesiveness of the pseudo inner boundary membrane, adhesion between the pseudo retina and the pseudo inner boundary membrane, and Various properties such as ease of peeling, particularly mechanical properties such as strength, elongation, and adhesiveness of the pseudo inner boundary film, and ease of peeling of the pseudo retina and pseudo inner boundary film can be evaluated. Typically, the peelability of the inner boundary film peeling model can be evaluated by measuring the breaking strength and breaking elongation of the inner boundary film peeling model, or the peeling strength, etc. by the method described later.
In this specification, the majority of doctors who perform sensory tests (for example, the majority of 2 to 5 doctors) feel that the sensation when peeling the pseudointimal membrane from the pseudoretina is an actual person. An inner boundary membrane peeling model that was judged to be close to the sensation of peeling the inner boundary membrane in the eye was expressed as `` The peelability when peeling the pseudo inner boundary membrane from the pseudo retina using an insulator is the inner boundary in the human eye. It is similar to the peelability when the film is peeled off using an insulator. Here, the sensory test is performed by a plurality of doctors (ophthalmologists) (at least 2 or more, preferably 3 or more) who have acquired a surgical technique for peeling the inner boundary membrane in the human eye.

In a preferred embodiment of the inner boundary membrane peeling model disclosed herein, the film thickness of the pseudo inner boundary membrane is 1 μm or more and 10 μm or less.

The film thickness of the pseudo inner boundary membrane is felt as a thickness (typically the same) as when the inner boundary membrane of the human eye is gripped when the pseudo inner boundary membrane is gripped with a surgical instrument such as an insulator. The film thickness is in the range. That is, by setting the thickness of the inner boundary film within the above range, the thickness of the inner boundary film of the human eye can be reproduced.

Preferably, the pseudo inner boundary film is a vinyl polymer such as polyvinylidene chloride, polyvinyl chloride or polyvinyl alcohol, a polyolefin such as polyethylene, polypropylene or polymethylpentene, a polyester such as polyethylene terephthalate, a polyamide, a cellophane or other cellulose. A polymer material selected from the group consisting of a series polymer and a combination thereof is included as a main component. In particular, a film made of a vinyl polymer or polyolefin used for production of a food packaging film is suitable.

By using these polymer materials as the main component of the quasi-inner boundary membrane, an inner boundary membrane peeling model having a peelability approximate to the peelability when peeling the inner boundary membrane with the human eye described above is realized at a high level. be able to. In particular, the use of such a polymer material reproduces the characteristics of the quasi-inner boundary membrane (for example, ease of grasping the quasi-inner boundary membrane, ease of tearing (easy to tear), hardness, thickness, strength, elongation, etc.). It is effective. In addition, a thin film can be formed from the above-described polymer material by a conventionally known method. In addition, all of the above-described polymer materials are materials used for medical instruments and pharmaceutical packaging (for example, syringes, drug containers, catheters, etc.). Therefore, the compatibility with a living body is high. Since the present invention is not directly used for treatment of patients (surgical instruments, etc.), having high biocompatibility is not an essential requirement, but it is possible to use surgical instruments and equipment used for actual surgery. Therefore, it is preferable to use a material having high biocompatibility. By using materials with high biocompatibility, it is possible to prevent the patient, such as trainers and surgical instruments, from being contaminated with materials with low biocompatibility (typically adversely affecting the living body). it can.

In particular, a pseudo inner boundary film containing polyvinylidene chloride as a main component can achieve a high level of peelability (peeling similar to the human eye) of the inner boundary film peeling model described above. For example, it is suitable for realizing a pseudo inner boundary film whose breaking strength and breaking elongation are within appropriate numerical ranges. Moreover, it is particularly suitable for the implementation of the present invention from the viewpoints of film-formability and biocompatibility. The polyvinylidene chloride film is preferable because it is highly transparent and looks similar to an actual inner boundary film. Polyvinylidene chloride is also a suitable material from the viewpoint of manufacturing cost.

Preferably, the pseudo retina is selected from the group consisting of rubber materials (elastomers) such as silicone rubber, butadiene rubber, isoprene rubber, butyl rubber, fluororubber, ethylene propylene rubber, nitrile rubber, natural rubber, and combinations thereof. As a main component.

By using such a polymer material (typically, a thermosetting resin-based elastomer such as silicone rubber or fluororubber) as the main component of the pseudo retina, the releasability of the inner boundary membrane exfoliation model described above (approximate to the human eye) (Peeling) can be realized to a high degree. Specifically, it is possible to reproduce a sensation close to the retinal sensation (for example, hardness, elasticity, etc.) grasped when the inner boundary membrane is peeled from the retina of an actual human eye. The pseudo retina is made of a material having characteristics similar to those of the actual human retina (for example, hardness, elasticity, etc.). This is effective for learning the magnitude of force applied to the inner boundary film when forming the peeling start end of the boundary film peeling. In addition, the above-described polymer materials are all materials used for medical instruments, pharmaceutical packaging, and the like (for example, catheters, tubes, gloves, hoses, drug containers, blood collection tube seals, syringe seals, etc.). Therefore, it is highly compatible with a living body and is suitable for the implementation of the present invention.

In particular, silicone rubber mainly composed of dimethylpolysiloxane is suitable for the practice of the present invention. Such silicone rubber is also used for medical materials such as artificial blood vessels and artificial joints, and surgical instruments, and is a material with high biocompatibility. Moreover, it is excellent from the viewpoints of realizing the characteristics (hardness and the like) of the pseudo retina, moldability, and handleability. Moreover, since such silicone rubber is inexpensive and readily available, it is effective for reducing manufacturing costs.

Further, in a preferred aspect of the inner boundary membrane peeling model disclosed herein, at least one surface of the pseudo retina is subjected to a hydrophilic treatment, and the hydrophilic treatment surface is opposed to the pseudo inner boundary membrane. Are stacked.
The hydrophilic treatment of the pseudo retina improves the adhesion (adhesiveness) between the pseudo retina and the pseudo inner boundary membrane, thus contributing to the realization of the above-mentioned inner boundary membrane peeling model (peeling that approximates the human eye). obtain. In particular, it is suitable for adjusting the peel strength when peeling the pseudo inner boundary membrane from the pseudo retina. In addition, depending on the material forming the pseudo retina, a material that repels the material constituting the pseudo inner boundary membrane may be included, but by performing the above hydrophilic treatment, the configuration of the pseudo inner boundary membrane on the pseudo inner retina It is possible to reduce the repelling of the component. That is, familiarity between the pseudo retina and the pseudo inner boundary membrane is improved. Therefore, when the inner boundary membrane peeling model is formed by the method of directly forming the pseudo inner boundary membrane on the pseudo retina, the film formation property of the pseudo inner boundary membrane can be improved by performing the hydrophilic treatment. .

In a preferred embodiment of the inner boundary membrane peeling model disclosed herein, fine particles (typically, microbeads) are dispersed in the pseudo inner boundary membrane, which is based on a laser diffraction / light scattering method. The average particle diameter (D ₅₀ ) of the fine particles (typically microbeads) measured by particle size distribution measurement is 40% to 120% of the film thickness of the pseudo inner boundary film.

By dispersing microbeads as fine particles having the above-mentioned particle diameter in the pseudo inner boundary film, the micro particles (microbeads) can be a break point when breaking the pseudo inner boundary film. As a result, it is possible to realize the characteristics of the simulated inner boundary film (for example, the ease of tearing, the strength, and the elongation of the simulated inner boundary film) similar to the peelability of the human eye. For example, the breaking strength and breaking elongation of the pseudo inner boundary film can be reduced. In addition, depending on the configuration of the inner boundary membrane peeling model, the tensile force required to break the pseudo inner boundary membrane may change depending on the tensile angle and direction of the pseudo inner boundary membrane (having the direction dependency of the fracture), By dispersing fine particles (microbeads) that can function as a break point when the pseudo inner boundary film is broken, the direction dependency of the break can be reduced. As a result, it is possible to highly realize an inner boundary film peeling model having a peelability approximate to the peelability when peeling the inner boundary film with the human eye.
In addition, by dispersing fine particles (typically microbeads) in the simulated inner boundary film, it becomes easier to visually recognize the boundary between the simulated inner boundary film and the simulated retina. Thereby, the peeling location of the pseudo inner boundary film can be easily grasped.

In the present specification, the effects of fine particles (microbeads) dispersed in the pseudo inner boundary film, that is, the effect of reducing the breaking strength, the effect of reducing the breaking elongation, and the effect of reducing the direction dependency of the breaking are collectively referred to. This is referred to as “perforation effect of microparticles”, and microparticles (microbeads) that can exert at least one of the effects are recognized as microparticles (microbeads) having perforation effect. I will do it.

In a preferred embodiment of the inner boundary membrane peeling model disclosed herein, the microbeads constituting the fine particles are 1 × 10 ⁸ pieces / cm ³ to 10 × 10 ⁸ pieces / cm in the pseudo inner boundary membrane. ³ contained.

By setting the density of the microbeads contained in the pseudo inner boundary film in such a range, the perforation effect of the microbeads can be exhibited to a high degree. By setting the density of the microbeads contained in the pseudo inner boundary film to 1 × 10 ⁸ pieces / cm ³ or more, the perforation effect of the microbeads can be exhibited at a high level. Further, by setting the density of the microbeads contained in the simulated inner boundary film to 10 × 10 ⁸ pieces / cm ³ or less (for example, 5 × 10 ⁸ pieces / cm ³ or less), the fracture strength and fracture of the simulated inner boundary film The elongation can be kept at an appropriate level without being excessively reduced. That is, by setting the density of the microbeads in the pseudo inner boundary membrane within the above range, the above-described inner boundary membrane peeling model peelability (peeling similar to the human eye) can be highly realized.

Preferably, the inner boundary membrane peeling model has one or a plurality of marks including a circular shape having a diameter of 1 mm to 10 mm and / or a scale.
The macular of the human eye has a substantially circular shape with a diameter of about 1.5 mm to 2.0 mm. In the case of peeling of the inner boundary film in the human eye, the inner boundary film on the macula is very often peeled off, and the range of about 3 mm to 5 mm in diameter is often peeled depending on symptoms. By attaching a mark including a circular shape (including a perfect circle shape and an elliptical shape) or a scale as described above to an inner boundary membrane peeling model (typically, a pseudo retina and a supporting base material), a pseudo inner boundary membrane is attached. It is possible to accurately grasp the region where the film should be peeled off. Therefore, the circular mark or the like is effective in acquiring a technique for peeling the inner boundary film in an appropriate range. In addition, by giving a plurality of such marks at appropriate intervals, it is possible to repeatedly perform high-level inner boundary film peeling training and the like using one inner boundary film peeling model.

Moreover, the suitable one aspect | mode of the inner boundary film peeling model disclosed here is characterized by the said pseudo | simulation inner boundary film being colored.
When the inner boundary membrane is actually peeled off by the human eye, the inner boundary membrane can be colored with a pigment to distinguish the inner boundary membrane from the retina so that the inner boundary membrane can be peeled off reliably and safely. In many situations. Therefore, by coloring the pseudo inner boundary film of the inner boundary peeling model, it becomes possible to perform a technique training for inner boundary film peeling under conditions close to the inner boundary film peeling in an actual human eye.

Moreover, as a suitable aspect of the inner boundary film peeling model disclosed here, it may be an inner boundary film peeling model that satisfies both the following features (1) and (2).
(1) The fracture strength of the pseudo inner boundary membrane is as follows:
The strip-shaped test piece is pulled under the tension condition of 20 mm between chucks and a tensile speed of 12 mm / min;
The tensile force (kgf) applied per unit area (mm ² ) of the cross section perpendicular to the tensile direction of the test piece before tension is defined as tensile stress (kgf / mm ² ); The tensile stress (kgf / mm ² ) at the time of breaking is defined as the breaking strength (kgf / mm ² );
In as ^measured, it is 0.05kgf / mm 2 ~ 1.2kgf / mm 2.
(2) The fracture elongation (%) of the pseudo inner boundary membrane is as follows:
The strip-shaped test piece is pulled until the test piece breaks at a tensile distance of 20 mm and a tensile speed of 12 mm / min until the test piece breaks; and the test piece leads to a break with respect to the chuck distance (mm) before tension. The rate of increase (%) in the distance between chucks (mm) at the time of breaking is defined as the elongation at break (%);
0.1% to 5.0% when measured by.

The pseudo inner boundary film showing the breaking strength of (1) above is broken by pulling with the same (typically the same) force as when the inner boundary film is broken in the actual inner eye peeling. be able to. Therefore, the inner boundary film peeling model provided with such a pseudo inner boundary film is particularly suitable for learning such as formation of a peeling start end in inner boundary film peeling, adjustment of force for pulling the inner boundary film, and evaluation of the procedure.
In addition, by setting the rupture elongation of the pseudo inner boundary membrane within the numerical range of (2) above, the degree of elongation is reproduced to the same extent (typically the same) as when the inner boundary membrane is ruptured in the actual human eye. can do. Therefore, the inner boundary film peeling model provided with such a pseudo inner boundary film is particularly suitable for learning the fracture characteristics of the inner boundary film in the inner boundary film peeling and evaluating the technique.

The inner boundary membrane exfoliation model having such a configuration, that is, the inner boundary membrane exfoliation model having (1) breaking strength and (2) breaking elongation of the pseudo inner boundary membrane in the above range, It can approximate the structure and properties of the boundary membrane. That is, the peelability when peeling the pseudo inner boundary membrane from the pseudo retina using the insulator can be an inner boundary membrane peeling model that approximates the peelability when peeling the inner boundary membrane using the insulator in the human eye. . Therefore, when training of inner boundary membrane peeling is performed using such an inner boundary membrane peeling model, the training has the same feeling as if an actual procedure (that is, inner boundary membrane peeling in the human eye) was performed. Obtainable. Therefore, such an inner boundary membrane peeling model can be suitably used for learning the inner boundary membrane peeling technique, evaluating the proficiency level of the surgical technique, and the like.

In the present specification, the breaking strength of the pseudo inner boundary film (1) can be measured, for example, by the following method. A pseudo inner boundary film to be used for measurement is cut into a strip shape having a short side of 8 mm and a long side longer than 20 mm to prepare a test piece. The test piece is set in a tensile tester so that the longitudinal direction thereof coincides with the tensile direction and the distance between chucks is 20 mm. As the tensile tester, for example, trade name “AGS-X” manufactured by Shimadzu Corporation or trade name “Tensilon” manufactured by Orientec Co., Ltd. can be used. The test piece was pulled under the conditions of 25 ° C. and 50% RH under the conditions of a tensile speed of 12 mm / min, and the tensile stress (kgf / mm ² ; 1 kgf was about 9 .8N.).
In this specification, the tensile stress (kgf / mm ^2), refers to a unit area of a cross section perpendicular to the pulling direction of the tensile test piece before (mm ²⁾ tensile force applied per (kgf). That is, the breaking strength is expressed by the following formula: breaking strength (kgf / mm ² ) = tensile force at break (kgf) ÷ {length of short side of test piece (mm) × thickness of test piece (mm)} ;

In the present specification, the breaking elongation of the pseudo inner boundary membrane of the above (2) can be measured, for example, by the following method. The pseudo inner boundary film is pulled by the same method as the measurement of the peel strength described above, and the distance between chucks (mm) when the test piece is broken is measured. Then, the increase rate (%) of the inter-chuck distance (mm) when the test piece reaches the rupture with respect to the inter-chuck distance (mm) before tension is calculated as the rupture elongation (%). That is, the elongation at break is the following formula: Break elongation (%) = {Distance between chucks at break (mm) −Distance between chucks before tension (mm)} ÷ Distance between chucks before tension (mm) × 100;

Moreover, in a preferable aspect of the inner boundary membrane peeling model disclosed herein, the inner boundary membrane peeling model may satisfy the following feature (3).
(3) The peel strength (N / mm) for peeling the pseudo inner boundary membrane from the pseudo retina is as follows:
Using a strip-shaped inner boundary membrane exfoliation model as a test piece, the pseudo retina and the pseudo inner boundary membrane are T-shaped exfoliated in the longitudinal direction under an exfoliation condition of 6 mm / min;
The average of the peel force (N) measured at a peel length of 15 mm or more excluding from the peel start end to 10 mm and from the peel end end to 5 mm is defined as the average peel force (N);
Peel strength (N / mm) is the average peel force (N) required to peel the pseudo inner boundary membrane per unit width (mm) from the pseudo retina;
It is 0.001 N / mm to 0.1 N / mm when measured by.

The inner boundary membrane peeling model showing the peeling strength in (3) above is pulled by a force similar to (typically the same as) when peeling the pseudo inner boundary membrane from the pseudo retina in the actual human eye, The pseudo inner limiting membrane can be peeled off from the pseudo retina. Therefore, the inner boundary film peeling model provided with such a pseudo inner boundary film is particularly suitable for learning such as formation of a peeling start end in inner boundary film peeling, force adjustment for peeling the inner boundary film, evaluation of the technique, and the like.
The inner boundary membrane detachment model having such a configuration, that is, the inner boundary membrane detachment model having a separation strength for detaching the pseudo inner boundary membrane from the above-described range (3) on the pseudo retina, the retina and inner boundary membrane in an actual human eye. Can be very close to the structure and characteristics of That is, the peelability when peeling the pseudo inner boundary membrane from the pseudo retina using the insulator can be an inner boundary membrane peeling model that approximates the peelability when peeling the inner boundary membrane using the insulator in the human eye. . More preferably, (1) breaking strength and (2) breaking elongation in the above range are combined with (3) peel strength in the above range. Such an inner boundary membrane exfoliation model is extremely suitable for use in learning the inner boundary membrane exfoliation technique and evaluating the proficiency level of the surgical technique.

In the present specification, the peel strength when the pseudo inner boundary membrane is peeled from the pseudo retina (3) above can be measured, for example, by the following method. A test piece is prepared by cutting an inner boundary membrane peeling model to be used for measurement into a 20 mm × 30 mm rectangular shape. At the one end in the longitudinal direction of the test piece, a peeling start end is formed by peeling the pseudo inner boundary membrane from the pseudo retina by about 5 mm, and the test piece is subjected to the peeling rate of 6 mm / min in a 25 ° C., 50% RH environment. The pseudo retina and the pseudo inner boundary membrane are pulled so that the pseudo inner boundary membrane and the pseudo retina are separated in a T-shape along the longitudinal direction from the peeling end, and the tensile force (N), that is, the peeling force (N) is measured. . For example, the trade name “AGS-X” manufactured by Shimadzu Corporation or the product name “Tensilon” manufactured by Orientec Co., Ltd. can be used for tensioning the pseudo inner boundary membrane. Then, the average peel force (N) is calculated from the peel force (N) measured with a peel length of 15 mm excluding from the peel start end to 10 mm and from the peel end end to 5 mm. The average peeling force (N) can be obtained from a force-grasping movement distance curve in accordance with, for example, a calculation method in JIS K 6854-2. Then, the average peel force (N) required to peel the pseudo inner boundary film and the pseudo retina per unit width (mm) is calculated as the peel strength (N / mm). That is, the peel strength can be determined by the following formula: peel strength (N / mm) = average peel force (N) ÷ length of the short side of the test piece (mm).

Moreover, according to the present invention, as another aspect, there is provided an inner boundary film peeling training apparatus used for inner boundary film peeling training or the like, and an apparatus having the following characteristics. That is, the inner boundary membrane peeling training apparatus includes an inner boundary membrane peeling model of any aspect disclosed herein, and an inner boundary membrane peeling model setting unit for setting the inner boundary membrane peeling model. The inner boundary membrane peeling model set portion includes a fixing portion that fixes the inner boundary membrane peeling model and a main body portion in which an insertion port for inserting a surgical instrument is formed.
In the inner boundary membrane peeling, a surgical instrument is inserted from an insertion port (so-called cannula) of a surgical instrument provided on the eyeball, and the inner boundary membrane existing in the deep part of the eyeball is peeled off. Therefore, there is a limitation in the range of motion of the surgical instrument. By using the inner boundary membrane peeling training apparatus having the above-described configuration, it is possible to implement training in an environment close to that in the case of operating an actual eyeball.

FIG. 1 is a cross-sectional view schematically showing a typical configuration example of an inner boundary film peeling model according to the present invention. FIG. 2 is a cross-sectional view schematically showing another configuration example of the inner boundary film peeling model according to the present invention. FIG. 3 is a cross-sectional view schematically showing another configuration example of the inner boundary film peeling model according to the present invention. FIG. 4 is a cross-sectional view schematically showing another configuration example of the inner boundary film peeling model according to the present invention. FIG. 5 is an optical micrograph of an inner boundary film peeling model (an inner boundary film peeling model including a pseudo inner boundary film containing microbeads) according to an embodiment of the present invention, taken from the simulated inner boundary film side. Note that the microbeads in the pseudo inner boundary membrane are grasped as black dots in the figure. FIG. 6 shows a state in which the pseudo inner boundary membrane is peeled off from the pseudo retina with respect to the inner border membrane peeling model (an inner boundary membrane peeling model including a pseudo inner boundary membrane containing microbeads) according to an embodiment of the present invention. It is a photograph taken. In the figure, the area where many white spots are dispersed is the area where the pseudo inner boundary film has not been peeled off (that is, the pseudo inner boundary film is photographed), and there is almost no white spot near the center of the figure (blackish) The visible part) is a region where the pseudo inner boundary membrane is peeled off from the pseudo retina (that is, the pseudo retina is photographed). In addition, the circular and straight marks in the figure are the same as the marks in FIG. 7 described later. FIG. 7 is a photograph of a support substrate (a support substrate with a mark) according to an embodiment of the present invention. The circular mark in the figure is a mark (typically a mark imitating the macula or a mark indicating the peeling range) used for grasping the peeling range when the inner boundary film is peeled off. Moreover, the straight line in the figure is a mark (scale line) used for grasping the dimension of the peeling range. FIG. 8 is an explanatory view schematically showing the configuration of the inner boundary membrane peeling training apparatus of the present invention.

Hereinafter, preferred embodiments of the present invention will be described. Matters necessary for the implementation of the present invention other than matters specifically mentioned in the present specification can be grasped as design matters of those skilled in the art based on the prior art in this field. The present invention can be carried out based on the contents disclosed in this specification and common technical knowledge in the field. In addition, in the following drawings, the same code | symbol is attached | subjected and demonstrated to the member and site | part which show | plays the same effect | action, and the overlapping description may be abbreviate | omitted or simplified. Further, the dimensional relationship (length, width, thickness, etc.) in each drawing does not necessarily reflect the actual dimensional relationship.
In addition, the entire contents of all documents cited in this specification are incorporated herein by reference.

The inner boundary membrane detachment model disclosed here includes a pseudo retina and a pseudo inner boundary membrane laminated on at least one surface of the pseudo retina. The shape of the inner boundary membrane peeling model is not particularly limited, and may be, for example, a sheet shape, a plate shape, or a chip shape having an appropriate size.

A typical configuration example of such an inner boundary film peeling model is schematically shown in FIG. This inner boundary membrane peeling model 10 includes a sheet-like pseudo retina 30 and a film-like (sheet-like) pseudo inner boundary membrane 20 laminated on one surface (one surface) thereof. The inner boundary membrane detachment model is typically used for an inner boundary membrane detachment technique training for detaching the inner boundary membrane from the retina. The model of inner boundary membrane peeling before use (ie, before being used for the training of inner boundary membrane peeling, typically during storage) is typically the case where the pseudo inner boundary membrane surface is protected by a protective sheet. It can be in form.
Further, as shown in FIG. 2, the inner boundary membrane peeling model is a form in which the other surface of the pseudo retina 30 (the back surface of the surface on which the pseudo inner boundary membrane is laminated) is laminated on the support substrate 40. Also good. Alternatively, as shown in FIG. 3, the pseudo inner boundary film 20 may be formed on each side (both sides) of the pseudo retina 30. Alternatively, as shown in FIG. 4, the pseudo retina 30 is provided on each surface (both sides) of the support base material 40, and the pseudo inner boundary film is further provided on the surface of the pseudo retina 30 (the back side of the surface in contact with the support base material). 20 may be provided. The inner boundary membrane peeling model 10 having the support substrate 40 is preferable because it is excellent in maintaining the shape. Further, the inner boundary film peeling model 10 having the pseudo inner boundary film 20 on both surfaces is preferable because the area of the pseudo inner boundary film per unit area of the inner boundary film peeling model increases (typically doubles).

Further, in the inner boundary membrane peeling model disclosed here, the peelability when peeling the pseudo inner boundary membrane from the pseudo retina is similar to the peelability when peeling the inner boundary membrane with the human eye.
It should be noted that the peelability when peeling the pseudo inner boundary membrane from the pseudo retina is similar to the peelability when peeling the inner border membrane in the human eye. The evaluation can be performed by a sensory test in which a master doctor (that is, a person skilled in the art) learns to peel off the pseudo inner boundary membrane from the pseudo retina. For example, the evaluation can be performed by adopting an evaluation method shown in Examples described later. Alternatively, it can be evaluated by measuring the breaking strength, breaking elongation, peeling strength, etc. of the inner boundary membrane peeling model.

The peelability of the inner boundary membrane exfoliation model can be determined, for example, by appropriately selecting the constituent materials constituting the pseudo inner boundary membrane and the pseudo retina, and the molecular weight and molecular structure (crystallinity, etc.) of the constituent materials. It can be adjusted by dispersing fine particles (typically microbeads) in the film. In addition, the above-described peelability can be adjusted by appropriately surface-treating the surface of the pseudo retina facing the pseudo inner boundary membrane (typically hydrophilic treatment).

Pseudo within the boundary layer as disclosed herein is typically a distance between chucks 20 mm, tensile strength measured at a tensile rate of 12 mm / min condition 0.05 kgf / mm ² or more (preferably 0.08kgf / mm ² or more, more preferably 0.1 kgf / mm ² or higher), and 1.2 kgf / mm ² or less (preferably 1.0 kgf / mm ² or less, more preferably 0.8 kgf / mm ² or less, more preferably 0 .6 kgf / mm ² or less).

The breaking strength of the quasi-inner boundary film can be adjusted, for example, by appropriately selecting the constituent material constituting the quasi-inner boundary film and the molecular weight and molecular structure (crystallinity, etc.) of the constituent material. Although details will be described later, the breaking strength of the simulated inner boundary film can also be adjusted by dispersing fine particles (typically, microbeads) in the simulated inner boundary film.

Further, the pseudo inner boundary film disclosed herein typically has a breaking elongation measured at a distance between chucks of 20 mm and a tensile speed of 12 mm / min of 0.1% or more (preferably 0.3% or more). , More preferably 0.5% or more) and 5.0% or less (preferably 3.0% or less, more preferably 2.0% or less, and further preferably 1.5% or less).

The breaking elongation of the pseudo inner boundary film can be adjusted, for example, by appropriately selecting the constituent material constituting the pseudo inner boundary film and the molecular weight or molecular structure (crystallinity, etc.) of the constituent material. As will be described in detail later, the breaking elongation of the simulated inner boundary film can also be adjusted by dispersing fine particles (typically microbeads) in the simulated inner boundary film.

The inner boundary membrane peeling model disclosed here typically has a peeling strength of 0.001 N / mm measured at a peeling speed of 6 mm / min and a T-type peeling condition between the pseudo retina and the pseudo inner boundary membrane. It can be above (preferably 0.003 N / mm or more, more preferably 0.005 N or more), 0.1 N / mm or less (preferably 0.05 N / mm or less, more preferably 0.02 N / mm or less).

The peeling strength when peeling the pseudo inner boundary membrane from the pseudo retina is selected by appropriately selecting, for example, the constituent materials constituting the pseudo inner boundary membrane and the pseudo retina, and the molecular weight and molecular structure (crystallinity, etc.) of the constituent materials. It can be adjusted by combining. The peel strength can also be adjusted by appropriately surface-treating the surface of the pseudo retina facing the pseudo inner boundary membrane (typically hydrophilic treatment).

The surface shape of the pseudo inner boundary membrane of the inner boundary membrane peeling model may be a flat surface or a curve simulating the concave surface of the fundus sphere of the human eye. Since the range of the inner boundary membrane to be peeled in the case of the inner boundary membrane peeling by the human eye is narrow (for example, the size of a circle with a diameter of about 3 mm to 5 mm), The present invention can be suitably implemented with any of the boundary peeling models. From the viewpoint of production efficiency and storage, a flat-plate inner boundary membrane peeling model is preferable.

The thickness of the pseudo inner boundary film is not particularly limited, but peelability similar to the peelability of the inner boundary film peeling by the human eye (typically gripping ability of the pseudo inner boundary film, breaking strength, breaking elongation, etc.) From the viewpoint of highly reproducing the thickness, the thickness of the pseudo inner boundary membrane is preferably 1 μm or more (for example, 2 μm or more, typically 4 μm or more), and preferably 10 μm or less (for example, 8 μm or less, typically 5 μm or less). preferable.

Here, the present inventors have found that when the film thickness is increased, the pseudo inner boundary film is easily detached from the pseudo retina, and when the film thickness is decreased, it is difficult to exfoliate the pseudo inner boundary film from the pseudo retina. It became clear by. In other words, by adjusting the film thickness of the simulated inner boundary film, the difficulty level when peeling the simulated inner boundary film from the pseudo retina can be changed. For example, an inner boundary membrane peeling model having a different thickness of the pseudo inner boundary membrane is provided with a pseudo inner boundary membrane having a thickness of about 6 μm or more according to the difficulty level when peeling the pseudo inner boundary membrane from the pseudo retina. The inner boundary membrane peeling model is a low difficulty model. When the film thickness of the pseudo inner boundary film is 3 μm or more and less than 6 μm, the medium difficulty level (general purpose) model, and the film thickness of the pseudo inner boundary film is less than 3 μm. The case can be classified as a highly difficult inner boundary membrane peeling model.
In the present specification, “film thickness” and “thickness” mean an average film thickness and an average thickness, and preferably 95% or more of the entire region shows the film thickness or thickness shown here. Within the range of.

By changing the difficulty level when peeling the pseudo inner boundary membrane, it is possible to create an inner boundary membrane peeling model according to the skill level of the inner boundary membrane peeling technique (technique) of the operator (for example, a trainee) it can. For example, an inner boundary film peeling model (typically, an inner boundary film peeling model having a thicker pseudo inner boundary film) in which peeling of the pseudo inner boundary film is less difficult is technically related to inner boundary film peeling. It can be used more suitably when an unskilled operator (typically a beginner) learns the technique of inner boundary membrane separation. On the other hand, an inner boundary film peeling model (typically an inner boundary film peeling model with a thinner inner inner film) having a medium difficulty level and a high difficulty level. Therefore, the present invention can be suitably used for the purpose of acquiring a more practical technique for peeling the inner boundary film and evaluating the skill level of the technique. Of the inner boundary film peeling models classified into three stages according to the difficulty level (film thickness) as described above, the inner boundary film peeling model (typically the simulated inner The inner boundary membrane peeling model with a boundary membrane thickness of approximately 3 μm or more and less than 6 μm is suitable for use by surgeons (trainers, doctors) with the widest range of technical proficiency. high.

The simulated inner boundary membrane of the inner boundary membrane peeling model realizes peelability (typically the above breaking strength, breaking elongation, peeling strength, etc.) similar to the peeling properties of the inner boundary membrane peeling in the human eye described above. As long as it can be obtained, it is not particularly limited by the constituent components of the pseudo inner boundary membrane. For example, it may be a material containing a thermoplastic resin, a UV curable resin, a thermosetting resin or the like as a main component (for example, a component exceeding 50% by mass in the constituent components of the pseudo inner boundary film). Examples of the pseudo inner boundary film include vinyl polymers such as polyvinylidene chloride, polyvinyl chloride, and polyvinyl alcohol, polyolefins such as polyethylene, polypropylene, and polymethylpentene, polyesters such as polyethylene terephthalate, polyamide, cellophane, and other cellulose polymers. And a polymer material selected from the group consisting of these as a main component. In particular, a film made of a vinyl polymer or polyolefin used for production of a food packaging film is suitable. Polymer materials (typical) such as polyvinylidene chloride, polyvinyl chloride, polyethylene (low density polyethylene, linear low density polyethylene, high density polyethylene, etc.), polypropylene, polymethylpentene, polyethylene terephthalate, polyamide, polyvinyl alcohol, cellophane Can be made of a material containing a resin material as a main component. These polymer materials may be used alone or in combination of two or more.

In a preferred embodiment, the pseudo inner boundary film is made of a material containing polyvinylidene chloride. The proportion of polyvinylidene chloride as a constituent component of the pseudo inner boundary membrane is preferably more than 50% by mass, more preferably 75% by mass or more, and further preferably 90% by mass or more. The constituent component of the pseudo inner boundary membrane may be substantially polyvinylidene chloride.

As polyvinylidene chloride, vinylidene chloride is a main component (main constituent monomer, main monomer, that is, a component exceeding 50% by mass of the whole monomer constituting the polyvinylidene chloride), and can be copolymerized with this. A vinylidene chloride copolymer (vinylidene chloride copolymer) which is a copolymer with a monomer is preferable. Alternatively, it may be a vinylidene chloride homopolymer (vinylidene chloride homopolymer) in which the monomer constituting polyvinylidene chloride is only vinylidene chloride. Examples of the monomer that can be copolymerized with vinylidene chloride include, for example, vinyl chloride; acrylic acid esters such as methyl acrylate, butyl acrylate, and 2-ethylhexyl acrylate; and methacrylates such as methyl methacrylate and butyl methacrylate. Acrylic acid ester, acrylonitrile, etc. are mentioned. In particular, vinyl chloride, methyl acrylate, butyl acrylate, and 2-ethylhexyl acrylate are preferable. Only one monomer may be copolymerized with vinylidene chloride, or two or more monomers may be used.

The proportion of vinylidene chloride in the monomer (monomer) constituting the vinylidene chloride copolymer is, for example, preferably 70% by mass or more and 98% by mass or less, and more preferably 80% by mass or more and 97% by mass or less. More preferred. A vinylidene chloride copolymer in which the proportion of vinylidene chloride is within such a range is suitable for the practice of the present invention because of its high film formability when forming a pseudo inner boundary film.

The vinylidene chloride copolymer can be synthesized by a technique such as an emulsion polymerization method, a solution polymerization method, or a suspension polymerization method.

The weight average molecular weight of the vinylidene chloride copolymer is not particularly limited, but is 4 × 10 ⁴ or more and 18 × 10 ⁴ or less (preferably 6 × 10 ⁴ or more and 16 × 10 ⁴ or less, more preferably 8 × 10 ⁴ or more and 14 × or less. 10 ⁴ or less). In addition, you may adjust so that it may become an appropriate weight average molecular weight by mixing 2 or more types of vinylidene chloride copolymers from which a weight average molecular weight differs in arbitrary ratios.
Here, the weight average molecular weight can be measured, for example, by gel permeation chromatography (GPC).

The vinylidene chloride copolymer includes a heat stabilizer, a plasticizer, a lubricant, an antioxidant, a dispersion aid, a filler, an ultraviolet absorber, a surfactant, other stabilizers, a pH adjuster, a colorant ( Various additives such as dyes and pigments may be included as necessary.

In a preferred embodiment of the technology disclosed herein, fine particles (typically microbeads) can be included in the pseudo inner boundary film. FIG. 5 shows an optical micrograph of an inner boundary membrane peeling model including a simulated inner boundary membrane containing microbeads taken from the simulated inner boundary membrane side. In FIG. 5, microbeads are grasped as black spots. As shown in FIG. 5, a pseudo inner boundary membrane in which the microbeads are dispersed almost uniformly in the pseudo inner boundary membrane is preferable. FIG. 6 shows a photograph of an inner boundary membrane peeling model having a pseudo inner boundary membrane containing microbeads peeled off from the pseudo retina. In FIG. 6, microbeads are grasped as white spots. As shown in FIG. 6, since the microbeads (white dots in FIG. 6) are removed at the same time as the pseudo inner boundary membrane is peeled off from the pseudo retina, when using the pseudo inner boundary membrane in which the micro beads are dispersed, It is possible to easily discriminate the place where the pseudo inner boundary membrane is peeled off from the pseudo retina.

The average particle diameter (M _D50 ) of the fine particles (typically microbeads) can be 40% or more and 120% or less of the average film thickness (Lt) of the pseudo inner boundary film. By containing fine particles (microbeads) having such an average particle diameter in the pseudo inner boundary film, the fine particles (microbeads) can preferably act as break points (that is, the perforation effect can be effectively exhibited). . For example, _MD50 is 40% or more (preferably 50% or more, more preferably 85% or more, more preferably 90% or more) of the film thickness of the pseudo inner boundary film 100% or less (preferably 99% or less, more preferably May be 98% or less). Alternatively, _{MD 50} is larger than the film thickness of the pseudo inner boundary film (that is, larger than 100% of the film thickness, preferably 101% or more, more preferably 102% or more, and further preferably 105% or more) 120% Or less (preferably 115% or less, more preferably 110% or less). Alternatively, the film thickness of the pseudo inner boundary film and the average particle diameter (M _D50 ) of the fine particles (microbeads) may be the same. In other words, Lt × 0.4 (μm) ≦ M _D50 ≦ Lt × 1 (μm), or Lt × 1 (μm) <M _D50 ≦ Lt × 1.2 (μm).
The pseudo inner boundary film in which the average particle size of the fine particles (typically microbeads) is smaller than the film thickness of the pseudo inner boundary film can increase the surface smoothness. As a result, it is possible to reduce a sense of incongruity that is felt when an insulator or the like is unnaturally caught on a convex surface derived from fine particles (microbeads) when the pseudo inner boundary film is gripped using the insulator or the like. In the pseudo inner boundary film in which the average particle diameter of the fine particles (microbeads) is larger than the film thickness of the pseudo inner boundary film, the perforation effect of the microparticles (microbeads) is exhibited at a high level. A pseudo inner boundary film in which the average particle size of the microparticles (microbeads) is the same as the film thickness is preferable because both the effect of eliminating the sense of incongruity and the perforation effect can be achieved at a high level.

In this specification, “average particle size” means a particle corresponding to a cumulative frequency of 50% by volume from the fine particle side in a volume-based particle size distribution measured by particle size distribution measurement based on a general laser diffraction / light scattering method. Diameter (D ₅₀ , also referred to as median diameter).

The shape of the fine particles (microbeads) is not particularly limited, and may be a true sphere, an ellipsoid, a hollow, a bowl, or the like. In particular, spherical fine particles (microbeads) are particularly suitable for practicing the present invention because they are easily dispersed uniformly in the quasi-inner boundary film and exhibit a high effect as a breaking point.

The number of fine particles (typically microbeads) dispersed in the unit volume of the pseudo inner boundary membrane is, for example, 1 × 10 ⁸ particles / cm ³ or more (preferably 2 × 10 ⁸ particles / cm ³ or more), 10 × 10 ⁸ pieces / cm ³ or less (preferably 8 × 10 ⁸ pieces / cm ³ or less, more preferably 5 × 10 ⁸ pieces / cm ³ or less).

The material of the fine particles (typically microbeads) is not particularly limited. For example, polystyrene, low density polyethylene (LDPE), linear low density polyethylene (LLDPE), polypropylene (PP), polyvinylidene chloride, polyvinyl chloride. , Polyamide, polyurethane, polyacrylate, polyacrylonitrile, ABS, polytetrafluoroethylene (PTFE), polymethyl methacrylate (PMMA), hard wax, silica, glass, aluminum oxide and the like, and mixtures and copolymers thereof. . Alternatively, an arbitrary material (typically, the above material) or the like may be used as a core, and the surface thereof may be covered with another material (the above material) or the like. The fine particles (microbeads) may be appropriately subjected to surface treatment (for example, hydrophilic treatment or functional group treatment).

Further, in a preferable aspect of the technology disclosed herein, the pseudo inner boundary film is transparent (preferably transparent). Specifically, it is preferable that the color or mark under the pseudo inner boundary film is more transparent than visible. By using such a pseudo inner boundary membrane, when observing the inner boundary membrane peeling model from the pseudo inner boundary membrane side, the pseudo retina under the inner boundary membrane can be visually recognized, so that it is close to the actual inner boundary membrane of the human eye It becomes. Furthermore, although details will be described later, such a pseudo inner boundary membrane is suitable for exerting the effect of an inner boundary membrane peeling model in which a pseudo retina or the like is marked.

Further, in a preferred aspect of the technology disclosed herein, the pseudo inner boundary film is colored. Since such a pseudo inner boundary membrane can be easily distinguished from the pseudo retina, it is easy to confirm the separation of the pseudo inner border membrane from the pseudo retina. It should be noted that a technique for peeling the inner boundary film after staining the inner boundary film with a dye or the like is also known for peeling the inner boundary film in an actual human eye.

The coloring of the pseudo inner boundary film can be performed, for example, by adding an appropriate colorant (dye, pigment) to the pseudo inner boundary film. Specifically, a method of mixing (dispersing) a colorant in the constituent material of the simulated inner boundary film in advance and molding the simulated inner boundary film using the constituent material can be mentioned. Alternatively, a coloring agent may be applied (for example, applied) on the pseudo inner boundary film after molding.

The colorant (dye, pigment) used for coloring the pseudo inner boundary film is known to be used for coloring the main component of the pseudo inner boundary film (typically, the above polymer material). For example, conventionally known ones can be used as appropriate. Although not particularly limited, pigments (for example, azo pigments, phthalocyanine pigments, anthraquinone pigments, etc.) are widely used as colorants when the above-described polymer is colored.

As a method for providing the pseudo inner boundary film on the pseudo retina, any method known in the art can be used as long as it can create a pseudo inner boundary film having a peelability similar to the peelability of the inner boundary film peeling in the human eye. Can be adopted. For example, there is a method (hereinafter referred to as a direct method) in which a liquid composition for forming a quasi-inner boundary film containing a constituent component of the quasi-inner boundary film is directly applied (typically applied) onto the pseudo retina and then cured (hereinafter referred to as a direct method). It is done. Alternatively, a pseudo inner boundary film produced by a general film (sheet) formation method (for example, extrusion molding method, inflation molding method, etc.) may be laminated (for example, pasted together) on the pseudo retina. From the viewpoint of workability, the direct method is preferable.

Here, the liquid composition for forming the quasi-inner boundary film is, for example, a main component of the quasi-inner boundary film (typically, the above-described polymer material such as a polyvinylidene chloride copolymer). It can be dissolved in a solvent (such as an organic solvent or water), or can be one in which the main component of the pseudo inner boundary film is dispersed in an appropriate solvent (for example, an emulsion). Alternatively, a liquid composition for forming a pseudo inner boundary film may be prepared by heating and melting constituent components of the pseudo inner boundary film.
When components (insoluble components) that are not soluble in the solvent constituting the simulated inner boundary membrane composition, such as fine particles (microbeads) or pigments, are used as the constituent components of the simulated inner boundary membrane, the insoluble components are conventionally known. In this way, it is preferable that the liquid composition for forming the quasi-inner boundary film is uniformly dispersed and used. For example, a composition for forming a pseudo inner boundary film by a method such as a method of mixing the above insoluble components using a stirrer (for example, a propeller stirrer) or the like into a composition for forming a pseudo inner boundary film before the formation of the pseudo inner boundary film, or a method such as emulsification Examples thereof include a method of dispersing the insoluble component in a product.

For example, fine particles (microbeads), coloring agents, and other additives are added to a commercially available emulsion in which the main component of the pseudo inner boundary film is stably dispersed in water (for example, a vinylidene chloride copolymer emulsion). The liquid composition for quasi-inner boundary film composition can be prepared by mixing. As a commercially available vinylidene chloride copolymer emulsion, the brand name "Saran latex (trademark)" by Asahi Kasei Chemicals Co., Ltd. etc. are mentioned, for example.

The application of the composition for forming the pseudo inner boundary film (typically, application) can be performed using, for example, a spin coater, spray coater, gravure coater, capillary coater (a coating apparatus using a capillary phenomenon), or the like. it can. In particular, the coating using a spin coater (that is, the spin coating method) can form a thin film having a uniform film thickness with high accuracy and is excellent in workability, and thus is preferable for the implementation of the present invention.

The curing treatment may be one or more treatments selected from drying (heating), cooling, crosslinking, aging, additional copolymerization reaction, and the like. For example, a process that only dries a composition for forming a simulated inner boundary film containing a solvent (such as a heat treatment) or a process that only cools (solidifies) a composition for forming a simulated inner boundary film in a heated and melted state. , And can be included in the curing treatment here.

In a preferred embodiment disclosed herein, a liquid composition for forming a quasi-inner boundary film in which the main component of the quasi-inner boundary film is dissolved or dispersed in an appropriate solvent is directly applied onto the pseudo retina and heated. By drying the solvent, a pseudo inner boundary film can be formed on the pseudo retina. The drying temperature can be about 40 ° C. to 150 ° C., for example. After drying, an aging treatment in which the temperature is maintained at about 35 ° C. to 60 ° C. (for example, 40 ° C. to 50 ° C.) may be performed. The aging time can be appropriately selected depending on the material used and the purpose of aging, and can be, for example, about 12 to 120 hours (typically 24 to 90 hours, preferably 36 to 60 hours). .

For example, when a vinylidene chloride copolymer is used as the main component of the pseudo inner boundary film, the crystallinity of the copolymer is adjusted (typically high crystallization) by performing the aging treatment. Can do. By increasing the crystallinity (high crystallization) of the vinylidene chloride copolymer by aging treatment, the fracture strength and elongation at break of the pseudo inner boundary film containing the highly crystalline vinylidene chloride copolymer are lowered. be able to.

The pseudo retina is not particularly limited as long as it realizes peelability (typically, the above-mentioned breaking strength, breaking elongation, peeling strength, etc.) similar to the peeling property of the inner boundary membrane peeling in the human eye. . The pseudo retina may be a single layer or a laminated structure of two or more layers. The thickness of the pseudo retina is not particularly limited, and can be set as appropriate from the viewpoints of productivity, cost, storage stability, and the like. For example, the thickness of the pseudo retina (the thickness in the case of a single layer structure, the thickness of the layer facing the pseudo inner boundary membrane in the case of a laminated structure) is 10 μm or more (for example, 50 μm or more), 1000 μm or less (for example, 500 μm or less) , Typically 100 μm or less).

The material of the pseudo retina used for the inner boundary membrane exfoliation model is not particularly limited. For example, elastomer (silicone rubber, natural rubber, etc.), metal (aluminum, etc.), or synthetic resin is the main component (in the constituent components of the pseudo retina). The component may be included as a component exceeding 50% by mass). In particular, a material containing an elastic material (typically an elastomer) as a main component can be suitably used because it easily achieves a peelability that is close to the peelability of the inner boundary film peeling in the actual human eye. . The pseudo retina can be made of a material mainly composed of a polymer material such as silicone rubber, butadiene rubber, isoprene rubber, butyl rubber, fluorine rubber, ethylene propylene rubber, nitrile rubber, natural rubber, and the like. Such polymer materials may be used alone or in combination of two or more.

In a preferred embodiment of the present invention, the pseudo retina is made of a material containing silicone rubber. The proportion of the silicone rubber in the constituent components of the pseudo retina is preferably more than 50% by mass (that is, the main component), more preferably 75% by mass or more, and 90% by mass or more. Further preferred. The constituent component of the pseudo retina may be substantially silicone rubber.

In the case of using a pseudo retina having a laminated structure, a pseudo retina in which the surface facing the pseudo inner boundary membrane is made of the above-described polymer material (preferably silicone rubber) as a main component is preferable. In particular, a pseudo retina in which a surface facing the pseudo inner boundary film is made of the polymer material (preferably silicone rubber) is preferable.

The silicone rubber is not particularly limited as long as it is a polysiloxane having a crosslinked structure and rubber-like properties. Usually, silicone rubber is produced by crosslinking polysiloxane. The polysiloxane may be linear, branched or cyclic. One of these polysiloxanes may be used alone, or two or more may be used in combination.

As the silicone rubber, for example, a dimethyl silicone rubber composed of polydimethylsiloxane (typically both end-modified polydimethylsiloxane) in which all side chains of polysiloxane, which is a main component of silicone rubber, are methyl groups is used. Can do. Alternatively, one or more methyl groups in the side chain of the polydimethylsiloxane are alkenyl groups such as vinyl groups, fluoroalkyl groups such as fluoro groups and trifluoromethyl groups, alkyl groups such as ethyl groups, and / or phenyls. Silicone rubber substituted with an aryl group such as a group may be used. Specifically, vinyl methyl silicone rubber in which one or more methyl groups in the side chain of polydimethylsiloxane are substituted with vinyl groups, phenylmethyl silicone rubber substituted with phenyl groups, vinyl groups and phenyl groups. Examples thereof include substituted phenylvinylmethyl silicone rubber, fluorosilicone rubber substituted with a trifluoropropyl group, and the like. These silicone rubbers may be used alone or in combination of two or more.

Polydimethylsiloxane, whose side chains are all methyl groups, is used as an intraocular filling material and gastrointestinal gas-releasing agent in retinal detachment surgery, and is a highly biocompatible substance. Therefore, a silicone rubber crosslinked with polydimethylsiloxane (typically both end-modified polydimethylsiloxane) as the main component, that is, polydimethylsiloxane exceeds 50% by mass of the polysiloxane constituting the silicone rubber (preferably Silicone rubber is preferred (75% by mass or more, more preferably 85% by mass or more, and still more preferably 95% by mass or more). A silicone rubber in which the polysiloxane constituting the silicone rubber is substantially polydimethylsiloxane (typically both end-modified polydimethylsiloxane), that is, dimethyl silicone rubber is suitable for the practice of the present invention.

Silicone rubber can be classified in various ways according to curing conditions, curing reaction mode, and the like. The silicone rubber used for the pseudo retina is a thermosetting silicone rubber that cures (or accelerates curing) by applying heat, ionizing radiation (ultraviolet rays, α rays, β rays, γ rays, neutron rays, Ionizing radiation curable silicone rubber (typically UV curable silicone rubber) that cures when irradiated with electron beam, etc., or heat / ionizing radiation curable that cures by applying either heat or ionizing radiation Silicone rubber, moisture curable silicone rubber (typically condensation-reactive silicone rubber) in which a curing reaction (typically a condensation reaction) proceeds by reacting with moisture in the air, and the like can be used. These silicone rubbers may be used alone or in combination of two or more. From the viewpoints of economy and productivity, thermosetting silicone rubber, ultraviolet curable silicone rubber, or heat / ultraviolet curable silicone rubber is preferable. In particular, thermosetting silicone rubber is preferable from the viewpoint of simplicity of an apparatus used for forming the pseudo retina.

A preferred example of the thermosetting silicone rubber is a heat addition reaction curable silicone rubber that is cured by crosslinking by an addition reaction. The curing temperature of the heat addition reaction curable silicone rubber is not particularly limited, and may be either a room temperature curable silicone rubber that cures at room temperature or a heat curable silicone rubber that cures by heating. From the viewpoint of easy management of the curing rate (curing time) and improvement in productivity, a heat-curable silicone rubber that undergoes an addition reaction by heating is preferable. For example, a thermosetting silicone rubber having a curing temperature of about 80 ° C. to 180 ° C. (for example, 90 ° C. to 160 ° C.) can be used.

Also, a catalyst for advancing the crosslinking reaction can be added to the above heat addition reaction curable silicone rubber. Examples of such a catalyst include platinum-based catalysts such as platinum fine particles, chloroplatinic acid and derivatives thereof. The amount of the catalyst to be added is not particularly limited, but can be, for example, about 0.1 to 10,000 ppm (more preferably 1 to 100 ppm) in terms of platinum weight with respect to polysiloxane constituting the silicone rubber.

Also, the silicone rubber used for the pseudo retina may be blended with an inorganic filler for the purpose of adjusting the hardness (hardness) of the silicone rubber, improving the weather resistance, or as an extender. By adjusting the blending amount of such an inorganic filler, it is possible to adjust the silicone rubber to an appropriate hardness (typically the same hardness as the retina of the human eye). As such an inorganic filler, various fillers known to be used for silicone rubber can be used, and examples thereof include powders such as fumed silica, precipitated silica, diatomaceous earth, quartz, and clay.

In addition to the polysiloxane as described above, the silicone rubber used for the pseudo retina includes, for example, a catalyst, a filler, an antioxidant, an ultraviolet absorber, a plasticizer, a colorant (dye, pigment), if necessary. Other known additives such as reaction aids and reaction inhibitors can be added as appropriate. By adjusting the addition amount of a catalyst, a filler, a plasticizer, etc., the hardness etc. of silicone rubber can be adjusted suitably. As such silicone rubber, those prepared by appropriately mixing or obtaining the above-mentioned components, or commercially available products containing the above-described components can be used.

As a method of forming the pseudo retina, a conventionally known method suitable for the material to be used can be employed. For example, in the case of an inner boundary membrane in a form in which a pseudo retina composed of a material containing the polymer material as a main component is laminated on a support base material, a liquid containing constituent components of the pseudo retina is provided on the support base material. The pseudo retina can be formed by directly applying (typically applying) the composition for forming a pseudo retina, followed by curing. Specifically, the composition for forming a pseudo retinal can be applied onto a support substrate using a gravure coater, roll coater, die coater, spin coater, spray coater or the like. In particular, the coating using a spin coater (that is, the spin coating method) can form a thin film having a uniform film thickness with high accuracy and is excellent in workability, and thus is preferable for the implementation of the present invention.
Or you may shape | mold by the general film (sheet | seat) shaping | molding method (For example, extrusion molding method or inflation molding method), for example using the material which contains the said polymeric material as a main component. Such a method is suitable for forming a pseudo retina in an inner boundary membrane exfoliation model having no support base material. Moreover, you may use the pseudo retina shape | molded by this method fixed on a support base material using an adhesive agent etc.

The curing treatment may be one or more treatments selected from drying (heating), cooling, crosslinking, aging, additional copolymerization reaction, and the like. For example, it includes a treatment (such as heat treatment) for simply drying the composition for forming a pseudo retina containing a solvent, heating as a crosslinking reaction, UV irradiation, or the like.

In a preferred aspect of the technology disclosed herein, the surface of the pseudo retina facing the pseudo inner boundary membrane is subjected to a hydrophilic treatment. By performing such a hydrophilic treatment, it is possible to adjust the peelability (typically, the above-mentioned peel strength, etc.) that is close to the peelability of the inner boundary film peeling by the human eye. In addition, some of the above-described polymeric materials (particularly silicone rubber) as the main component have high hydrophobicity (water repellency). When forming a pseudo inner boundary film on such a highly water-repellent pseudo retina, There is a possibility that the formability (thickness uniformity, etc.) may decrease. By performing hydrophilic treatment on the pseudo retina, the formability of the pseudo inner boundary film on the pseudo retina can be improved. In particular, the hydrophilic treatment can exert a high effect when the pseudo inner boundary film is formed on the pseudo inner boundary film by a direct method.
As the above-mentioned hydrophilic treatment, plasma treatment, etching treatment, surfactant application, hydrophilic resin application (coat), inorganic coating agent (for example, alkali silicate) application, photocatalyst (titanium oxide) were used. Surface treatment etc. are mentioned. Among these, since the plasma treatment is a dry treatment, it is preferable because it is less affected by a chemical agent (hydrophilic treatment agent) and the like and can exhibit a high hydrophilic treatment effect. Plasma treatment is a treatment method frequently used in the hydrophilic treatment of medical instruments such as contact lenses, and can be suitably employed in the practice of the present invention.

The plasma treatment method can be performed by a conventionally known method. For example, atmospheric pressure plasma (normal pressure plasma) processing, low temperature plasma processing, and the like can be given. As the source gas used for the plasma treatment, a conventionally known gas can be used, and the gas can be appropriately selected from the characteristics of the material used for the pseudo retina, the combination of the pseudo retina and the pseudo inner boundary film, and the like. For example, oxygen, argon, nitrogen, hydrogen, or a mixed gas thereof can be used. Typically, oxygen gas can be used.

As a suitable example of the supporting base material used for the inner boundary membrane, a plate-like base material having an appropriate strength can be appropriately selected and used. The material of the substrate is not particularly limited. For example, a substrate formed of metal, glass, resin, ceramic, paper or the like can be used. Such a supporting substrate may be a single layer or a laminated structure of two or more layers. Further, surface treatment such as hydrophilic treatment may be performed. Further, the thickness of the support substrate is not particularly limited and can be set as appropriate. For example, it can be 0.25 mm or more and 0.35 mm or less.

In addition, an inner boundary membrane exfoliation model (typically, a pseudo retina or a supporting base material) according to a preferred embodiment of the technology disclosed herein is a circular shape having a diameter of 1 mm to 10 mm (preferably 2 to 8 mm, for example, 6 mm) ( One or a plurality of marks such as a perfect circle shape and an elliptical shape) and / or a scale (including a straight line) are provided. The macular of the human eye has a substantially circular shape with a diameter of about 1.5 mm to 2.0 mm. In the case of peeling of the inner boundary film in the human eye, the inner boundary film on the macula is very often peeled off, and the range of about 3 mm to 5 mm in diameter is often peeled depending on symptoms. By detaching the pseudo inner boundary film while observing the above-mentioned circular mark or the like, it is possible to carry out training or the like in consideration of the separation range of the inner boundary film in the actual human eye. The color of the mark is not particularly limited, but a color that allows the mark to be visually recognized when the inner boundary film peeling model is observed from the pseudo inner boundary film side is preferable. In particular, dark yellow is preferable because it approximates the color of the macular of the human eye, and visibility close to that of actual surgery can be obtained.

The above mark may be attached to any of the pseudo inner boundary film, the pseudo retina, and the supporting substrate as long as the mark can be visually recognized when the inner boundary film peeling model is observed from the pseudo inner boundary film side. From the viewpoint of reproducing the macular portion of the human eye to a higher degree, a model attached to a pseudo retina or a supporting substrate is preferable. For example, it can be attached to the opposite surface of the pseudo retina to the pseudo inner boundary membrane, the back surface of the opposite surface (the surface that does not face the inner boundary membrane), the opposite surface of the support base material to the pseudo retina, or the back surface of the opposite surface. . In addition, when a pseudo retina having a laminated structure is used, it may be attached to either the outermost layer or the inner layer. When the hydrophilic treatment is performed on the pseudo retina, it is easy to apply the mark by the hydrophilic treatment. Therefore, it is preferable to apply the hydrophilic treatment surface of the pseudo retina (that is, the surface facing the pseudo inner boundary film). is there.

The method for giving the mark is not particularly limited. If it is applied on the retina, it can be printed by, for example, a silk screen method or an ink jet method. The colorant (ink) used for such printing is not particularly limited, and can be appropriately selected from conventionally known dyes and pigments. Moreover, if it is a case where the said mark is provided on a support base material, it can provide by sputtering etc., for example. A film forming material for sputtering is not particularly limited, and for example, chromium, copper, titanium, silver, platinum, gold, or the like can be used. FIG. 7 shows a photograph of a glass support substrate provided with a mark by chromium sputtering.

Further, as another aspect of the invention disclosed herein, an inner boundary film peeling training including the inner boundary film peeling model 10 and the inner boundary film peeling model set unit 110 as schematically shown in FIG. An apparatus 100 is provided. As shown in the drawing, the inner boundary membrane exfoliation model set unit 110 includes a main body (model) in which a fixing unit 120 for fixing the inner boundary membrane exfoliation model 10 and an insertion port 131 for inserting a surgical instrument 133 are formed. Set body portion) 130. The shape of the model set main body 130 is not particularly limited, and may be, for example, a box shape, a cylindrical shape, a spherical shape, or the like. In particular, a shape simulating an eyeball (for example, a spherical shape or a hemispherical shape) is preferable because the actual surgical environment for peeling the inner boundary membrane can be reproduced at a higher level.
Hereinafter, although not intended to be particularly limited, the inner boundary film peeling training apparatus 100 of the present invention will be described in detail by taking an apparatus having a spherical model set main body 130 shown in FIG. 8 as an example.

The inner boundary membrane exfoliation model 10 in the fixing part 120 attached to the model set main body 130 may be fixed in a non-detachable state by bonding or the like, or fixed in a removable state by a clip or the like. May be. Since the used inner boundary membrane peeling model 10 can be replaced and the inner boundary membrane peeling model 10 can be repeatedly trained with one training apparatus 100, the inner boundary membrane peeling model 10 is fixed in a state where it can be removed from the fixing portion 120. It is preferable to do. The shape of the fixing part 120 is not particularly limited as long as the inner boundary film peeling model can be fixed without moving (without shifting) during the training of inner boundary film peeling. For example, as shown in FIG. 8, a shape having a clip 121 or the like for fixing the inner boundary membrane peeling model 10 sandwiched therebetween, or a shape having a recess 122 for fitting and fixing the inner boundary membrane peeling model 10 Etc. Alternatively, if the inner boundary membrane peeling model 10 provided with an appropriate hole (or recess) is used, the shape or the like having a protrusion for inserting and fixing the hole (or recess) may be used. Good. Or the shape which combined these shapes (shape provided with the clip, the recessed part, the convex part, etc.) may be sufficient.

The shape of the insertion port 131 for inserting the surgical instrument 133 is not particularly limited, and may be, for example, a circular shape. The size of the insertion port 131 can be appropriately set depending on the surgical instrument 133 used for training, and the surgical instrument 133 can be inserted and preferably as small as possible. For example, the insertion port 131 can have a circular shape with a diameter of about 0.4 to 1.5 mm, preferably about 0.5 to 1.1 mm. Specifically, when a 20 G (outer diameter 0.9 mm) instrument is used, the inner diameter of the insertion port 131 is about 0.9 mm, and when a 23 G (outer diameter 0.65 mm) instrument is used, the inner diameter of the insertion port 131 is set. Can be set to about 0.65 mm and the inner diameter of the insertion port 131 can be set to about 0.5 mm. The insertion port 131 having such a shape can be formed, for example, by providing a through hole at an appropriate location of the model set main body 130. As the insertion port forming member, a member (typically a cannula or a cannula) used for forming an insertion port into which a surgical instrument is inserted in actual inner boundary membrane peeling can be used.

The insertion port 131 is a pseudo inner boundary film of an inner boundary film peeling model fixed to the fixing portion 120 (in the case of an inner boundary film peeling model having a pseudo inner boundary film on both surfaces, a pseudo inner boundary film on a peeling side) The distance from the surface (typically the peeled portion) to the insertion port 131 can be set to be 11.5 mm or more (preferably 16 mm or more) and 30 mm or less (preferably 26 mm or less). In addition, the mode in which the insertion port 131 is disposed on a sphere having a diameter of 16 mm or more and 30 mm or less that is in contact with the peeled portion of the pseudo inner boundary membrane is suitable for the implementation of the present invention. In particular, the insertion port 131 is disposed on the hemisphere on the counter electrode (B pole 135) side when the point where the sphere on which the insertion port 131 is disposed contacts the pseudo inner boundary film 20 is one pole (A pole 134). The embodiment is preferred. The diameter of the eyeball is about 25 mm for adults (about 16.5 mm for newborns). A surgical instrument insertion port 131 (typically a cannula or cannula) provided on the human eye in actual surgery by setting the distance from the pseudo inner boundary membrane surface to the insertion port 131 and the arrangement of the insertion port 131 as described above. The sensation of performing an operation through the computer can be highly reproduced.

Specifically, as shown in FIG. 8, the insertion port 131 is formed in the hollow and spherical model set main body 130, and one point (A pole 134) of the main body 130 is the surface of the pseudo inner boundary membrane 20. By arranging the main body part 130 so as to be in a position in contact with (typically a peeling site), the model set part 110 in which the insertion port 131 is arranged on the sphere can be constructed. The A pole 134 of the model set main body 130 is preferably provided with an opening (peeling port 136) for peeling the inner boundary film. At this time, the A pole 134 and the pseudo inner boundary film 20 do not actually contact each other. The peeling port 136 may be, for example, a circular hole having a diameter of 5 mm or more and a diameter of the equatorial plane of the model set main body. Preferably, the peeling port 136 can be provided in parallel with the pseudo inner boundary film. In FIG. 8, as a preferred example, the diameter of the peeling port 136 is the same as the diameter of the equatorial plane of the model set main body 130, that is, the model set main body 130 is a hemisphere, and the peeling port 136 is a pseudo inner boundary membrane. 10 shows an aspect of being provided so as to be in parallel with 10. The model set main body 130 can be arranged (fixed) at a desired position using an appropriate support member 140.

The number of insertion openings 131 provided in the model set main body 130 can be appropriately set depending on the number of surgical instruments 133 to be used. For example, two, three, or four or more (typical) per model set main body 130 (typical). 3).

Further, the model set main body 130 of the inner boundary membrane peeling training apparatus 100 may be provided with a viewing portion 137 for visually recognizing the inner boundary membrane peeling training. Preferably, the viewing portion 137 can be provided so as to be parallel to the pseudo inner boundary film. For example, as shown in FIG. 8, an opening is provided in the upper part (typically, the B pole 135) of the model set main body 130 provided on the fixed part 120, or the part is formed by a transparent member. The peeping portion 137 can be formed. The viewing portion 137 preferably has a circular shape having a diameter of 7 mm or more (for example, 8 mm or more) and 12 mm or less (for example, 11 mm or less). In particular, it can be a circular shape having a diameter of 9 mm. Since the diameter of the lens of the human eye (typically an adult eye) is about 9 mm, it is possible to secure (limit) the visual field close to the actual inner boundary membrane separation by making the peeping portion into the shape described above. it can.

Hereinafter, some examples relating to the present invention will be described. However, the present invention is not intended to be limited to the examples shown in the examples.

<Test Example 1: Production of inner boundary membrane peeling model>
The inner boundary film exfoliation model according to Examples 1 to 16 shown in Table 1 was produced by the following materials and processes. In addition, the abbreviations and symbols in the column “Structure of inner boundary membrane peeling model” in Table 1 are as follows.
“PDMS-1” is a product name “DOW CORNING TORAY SILPOT 184 W / C” manufactured by Toray Dow Corning Co., Ltd. as a silicone rubber material mainly composed of polydimethylsiloxane. Rubber) and a silicone rubber (silicone rubber paint) in which a curing catalyst is mixed at a ratio of 1 part by mass with respect to 10 parts by mass of the main agent.
“PDMS-2” means a silicone rubber (silicone rubber paint) in which the same silicone rubber material as that of PDMS-1 is used and a curing catalyst is mixed at a ratio of 1 part by mass with respect to 30 parts by mass of the main agent.
“PVDC-1” is a polyvinylidene chloride emulsion mainly composed of polyvinylidene chloride (PVDC emulsion), a trade name “Saran Latex (registered trademark) L549B” (a vinylidene chloride copolymer) manufactured by Asahi Kasei Chemicals Corporation. Emulsion).
“PVDC-2” is a polyvinylidene chloride emulsion (PVDC emulsion) having a main component of polyvinylidene chloride, a trade name “Saran Latex (registered trademark) L509” (vinylidene chloride copolymer) manufactured by Asahi Kasei Chemicals Corporation. Emulsion).
“+” In the “aging” column indicates that the aging process described later has been performed, and “−” indicates that the aging process has not been performed.
“+” In the “microbeads” column indicates that microbeads are included as fine particles in the simulated inner boundary membrane, and “−” indicates that microbeads are not included in the simulated inner boundary membrane.
The “film thickness (μm) of the simulated inner boundary film” in the table indicates the simulated inner boundary after the aging process (when the aging process is not performed, after the simulated inner boundary film is dried or cured). It is the average film thickness of the film.

A method for producing the inner boundary film peeling model according to Example 1 will be described.
First, a glass plate having a thickness of 0.25 mm was prepared as a supporting substrate. And the pseudo retina which consists of silicone rubber which has polydimethylsiloxane as a main component was formed in one side of this support base material as follows. First, the “PDMS-1” (that is, silicone rubber paint) was applied by spin coating (rotation speed: 1000 rpm, rotation time: 30 seconds). The glass plate coated with the silicone rubber paint was heated on a hot plate at 90 ° C. for about 10 minutes to dry and cure the silicone rubber. At this time, the average thickness of the pseudo retina was 90 μm.

Next, the surface of the pseudo retina formed as described above was subjected to a hydrophilic treatment by plasma treatment using oxygen gas. Specifically, plasma treatment was performed for 5 minutes under the following conditions using an LF plasma cleaner “CUTE 1MP / R” manufactured by FEMTO Science.
Output: 100W
Gas (air) flow rate: 0.169 Pa · m ³ / sec (100 sccm)
Degree of vacuum: 666.61 Pa (500 × 10 ⁻² Torr)

Then, a pseudo inner boundary film mainly composed of polyvinylidene chloride was formed on the plasma-treated pseudo retina as follows. First, “PVDC-1” (that is, PVDC emulsion) was applied onto the pseudo retina by a spin coating method (rotation speed: 4500 rpm, rotation time: 3 seconds). And the said PVDC emulsion coating amount was dried by heating on a 145 degreeC hotplate for 1 minute. At this time, the average thickness of the pseudo inner boundary film was 3 μm. Thus, the inner boundary film peeling model according to this example was created.

An inner boundary membrane peeling model according to Example 2 was created in the same manner as in Example 1 except that the pseudo inner boundary membrane was formed using a PVDC emulsion in which microbeads were dispersed. As the microbeads, a trade name “Duke Standard A4203” manufactured by Thermo Scientific was used. Such microbeads are polystyrene beads having an average particle diameter of 3 μm. The microbeads were mixed in the PVDC emulsion so that the microbeads were dispersed at a density of 5.0 × 10 ⁸ pieces / cm ³ in the pseudo inner boundary membrane after drying.

A plate having a pseudo retina on one side of the supporting base material and a pseudo inner boundary membrane on the surface of the pseudo retina was produced using the same material and process as those of the inner boundary membrane exfoliation model according to Example 1. Further, the plate was subjected to an aging treatment under the condition of being left in a constant temperature bath at 40 ° C. for 4 days, and an inner boundary film peeling model according to Example 3 was created.

A plate having a pseudo retina on one side of a supporting substrate and a pseudo inner boundary film including microbeads on the surface of the pseudo retina, using the same material and process as the inner boundary membrane exfoliation model according to Example 2 Produced. Further, the plate was subjected to an aging treatment under the condition of standing in a constant temperature bath at 40 ° C. for 4 days, and an inner boundary film peeling model according to Example 4 was created. At this time, the mixed amount of microbeads was prepared so that the microbeads were dispersed at a density of 5.0 × 10 ⁸ pieces / cm ³ in the pseudo inner boundary film after the aging treatment.

Example 4 except that a pseudo inner boundary film having an average film thickness after aging of 7.5 μm was formed by changing the conditions for spin-coating the PVDC emulsion in which microbeads were dispersed to a rotation speed of 1000 rpm and a rotation time of 3 seconds. Similarly, an inner boundary membrane peeling model according to Example 5 was created.

An inner boundary membrane exfoliation model according to Example 6 was produced in the same manner as in Example 4 except that the above “PDMS-2” was used as a material for forming the pseudo retina.

An inner boundary membrane peeling model according to Examples 7 to 10 was produced in the same manner as in Examples 1 to 4, except that the above “PVDC-2” was used as a material for forming the pseudo inner boundary membrane.

Using the trade name “Human Skin (Registered Trademark) Gel (Product No .: Hardness 5)” manufactured by EXCIAL Corporation, which is a material mainly composed of polyurethane, as a material for forming the pseudo inner boundary film, the pseudo inner boundary film is formed. An inner boundary film peeling model according to Example 11 was prepared in the same manner as in Example 1 except that the material was spin-coated under the conditions of a rotation speed of 4000 rpm and a rotation time of 3 seconds.

Except that the above-mentioned “PDMS-2” was used as a material for forming the quasi-inner boundary film, and the quasi-inner boundary film forming material was spin-coated under the conditions of a rotation speed of 7000 rpm and a rotation time of 30 seconds, An inner boundary membrane peeling model according to Example 12 was prepared.

As the material for forming the pseudo retina, the above-mentioned “human skin (registered trademark) gel (product number: hardness 5)” (material having polyurethane as a main component) is used, and the pseudo retina forming material is rotated at 1000 rpm and the rotation time is 30 seconds. An inner boundary film peeling model according to Example 13 was produced in the same manner as in Example 12 except that spin coating was performed under the conditions described above.

As a material for forming the pseudo retina, a silicon wafer made by Matsuzaki Seisakusho Co., Ltd. (CZ method, crystal axis <100>, thickness 525 ± 25 μm, resistivity 1 to 20 Ωcm, finish: single side An inner boundary membrane peeling model according to Example 14 was produced in the same manner as Example 12 except that Mirror / Etched) was used.

An inner boundary membrane exfoliation model according to Example 15 was produced in the same manner as Example 12 except that the pseudo retina was formed of agarose gel by the following method. The pseudo retina formed by the agarose gel was prepared by the following method. First, agarose powder (Agarose 36GU) manufactured by Funakoshi Co., Ltd. was stirred in water (typically ion-exchanged water) and then heated to prepare an agarose solution in which the agarose powder was dissolved. The agarose solution was spin-coated on a glass substrate under the conditions of a rotation speed of 1000 rpm and a rotation time of 30 seconds, and then cured by cooling to form a pseudo retina formed by an agarose gel. At this time, it set so that the density | concentration (final density | concentration) of the agarose contained in this agarose gel might be 2 mass%.

Example 12 except that the plasma treatment was directly performed on the surface of the glass serving as the support substrate in the same manner as in Example 1 above, and a pseudo inner boundary film was formed on the plasma treatment surface using the glass as a pseudo retina. Similarly, an inner boundary film peeling model according to Example 16 was produced.

<Test Example 2: Evaluation of peelability of inner boundary film peeling model>
For the inner boundary film peeling model according to each example produced as in Test Example 1, an inner boundary film peeling test was performed by the following method.
Specifically, two doctors (ophthalmologists) who are persons skilled in the art once peeled off the pseudo inner boundary membrane from the pseudo retina for the inner border membrane peeling model according to each example using the insulator used for actual surgery. . In conducting such a test, in a state where the test specimen (inner boundary membrane exfoliation model) is not clarified to which example the inner perimeter membrane exfoliation model is disclosed to the doctor who is the test operator (ie, single-blind test) The inner boundary membrane peeling model of each example was tested in a random order. FIG. 6 shows a photograph of the inner limiting membrane peeling model according to Example 3 when the pseudo inner limiting membrane is peeled from the pseudo retina.
The doctors who conducted this study (referred to here as doctors A and B) are both ophthalmologists at the University of Tokyo Medical Hospital, who are highly skilled in the technique of exfoliating the inner limiting membrane (typically In particular, it is an ophthalmologist who has experienced 10 or more cases of endocardial surgery.

The peel test was evaluated based on the following criteria.
◎: Very close to the peelability when peeling the inner boundary membrane of the human eye 〇: Similar to the peelability when peeling the inner boundary membrane of the human eye ×: When peeling the inner boundary membrane of the human eye It is judged that the inner boundary membrane peeling model evaluated in the above ◎ and ○ is suitable for use for the purpose of training the inner boundary membrane peeling or evaluating the proficiency level of the technique. This is an inner boundary membrane peeling model. The evaluation of the peelability (result of the sensory test) of the inner boundary membrane peel model according to each example made by each doctor (tester) is shown in the “Removability” column of Table 1.

As shown in Table 1, each of the models 3-6, 9 and 10 has an inner boundary membrane exfoliation model in which both the test performer (ophthalmologist) exfoliates when the inner limiting membrane of the human eye is exfoliated. This is an inner boundary film peeling model determined to have an approximate peelability, which is a suitable example as an embodiment of the present invention. Moreover, these inner boundary membrane peeling models were evaluated by the test operator as being suitable for use for the purpose of, for example, training of inner boundary membrane peeling and evaluation of proficiency of techniques.
In particular, the inner boundary membrane peeling model according to Examples 4 and 5 is judged to have a peelability very close to the peelability when the test practitioner (ophthalmologist) peels the inner boundary membrane of the human eye. Therefore, such an inner boundary membrane peeling model was evaluated by a test operator as an inner boundary membrane peeling model that is extremely suitable for use for the purpose of, for example, technique training of inner boundary film peeling and evaluation of proficiency level of techniques.
On the other hand, at least one of the testers (in this case, two people) of the inner boundary membrane detachment model according to Examples 1, 2, 7, 8, and 11 to 16 was simulated from the pseudo retina on the inner boundary membrane detachment model. It is judged that the peelability when peeling the inner boundary film is different from the peelability when peeling the inner boundary film of the human eye, which is an example that is not suitable as an embodiment of the present invention.

In addition, the inner boundary membrane separation model according to Examples 2, 4 and 5 is affected by the tensile angle and the tensile direction of the pseudo inner boundary membrane as compared with the inner boundary membrane separation model according to Examples 1 and 3. The pseudo inner boundary film could be peeled off and fractured. This confirms that by dispersing fine particles (typically microbeads) in the simulated inner boundary film, the dependence on the tensile angle and the tensile direction when the simulated inner boundary film is broken can be reduced. It was.

Further, the inner boundary film peeling model according to Example 5 was able to peel the pseudo inner boundary film more easily than the inner boundary film peeling model according to Example 4. At this time, the peelability of the inner boundary film peeling model according to Example 5 and Example 4 is very close to the peelability of the inner boundary film peeling in the human eye, and there is a difference in the peelability between the models according to the above two examples. There wasn't. Thereby, it was confirmed that the difficulty level of the inner boundary film peeling can be changed while maintaining the peelability by adjusting the film thickness of the pseudo inner boundary film.

Although detailed data are not shown here, several more inner boundary film peeling models were produced in which only the film thicknesses of the inner boundary film peeling models according to Example 4 and Example 5 were changed. The thickness (average film thickness) was compared with the difficulty level when peeling the pseudo inner boundary film. As a result, according to the test practitioner (that is, a person skilled in the art) of this test, it was evaluated that the film thickness of the pseudo inner boundary film and the difficulty level were proportional. In addition, the inner boundary membrane peeling model with different film thicknesses has a low difficulty level when the pseudo inner boundary film thickness is about 6 μm or more, a medium difficulty level (general purpose) when the thickness is about 3 μm to less than 6 μm, and less than about 3 μm. In the case of, it was evaluated as a highly difficult inner boundary membrane exfoliation model.

For example, according to a test practitioner (that is, a person skilled in the art) of this test, an inner boundary membrane peeling model according to Example 5 in which the pseudo inner boundary membrane is thicker is an operator who is technically immature with respect to inner boundary membrane peeling ( It was evaluated that it can be used more favorably when a beginner (typically a beginner) learns the technique of inner boundary membrane separation. On the other hand, the inner boundary membrane peeling model according to Example 4 was evaluated to be more suitable for use for the purpose of more technical acquisition of inner boundary membrane peeling and evaluation of the skill level of the technology. When Example 4 and Example 5 are compared, the inner boundary film peeling model according to Example 4 (typically the inner boundary film peeling model in which the film thickness of the pseudo inner boundary film is approximately 3 μm or more and less than 6 μm) is wider. It was suitable for use by an operator (trainer) of technical proficiency and was evaluated as a versatile inner boundary membrane peeling model.

<Test Example 3: Physical property evaluation of inner boundary membrane peeling model>
For the inner boundary membrane peeling models according to Examples 1 to 5 in Test Example 1, the breaking strength and breaking elongation of the simulated inner boundary membrane and the peeling strength when peeling the simulated inner boundary membrane from the pseudo retina were measured. .

First, as the simulated inner boundary membrane test piece for measuring the breaking strength and measuring the breaking elongation, simulated inner boundary membranes according to the above Examples 1 to 5 that were not laminated on the pseudo retina were prepared by the following method. Except for the matters specifically mentioned, test pieces were prepared using the same materials and processes as those used for preparing the inner boundary film exfoliation models according to Examples 1 to 5 in Test Example 1 described above.
First, an aluminum foil was pasted on a pseudo retina produced by the same method as in Example 1 in Test Example 1, and the surface of the aluminum foil was plasma treated. On the aluminum foil, pseudo inner boundary films according to Examples 1 to 5 were formed, respectively. Then, the pseudo inner boundary film was peeled off from the aluminum foil and cut into an appropriate size to prepare a test piece. For the simulated inner boundary films according to Examples 3 to 5, the cut specimens were subjected to an aging treatment under the condition that they were left in a constant temperature bath at 40 ° C. for 4 days.

Further, as an inner boundary membrane peeling model for measuring peel strength, inner boundary membrane peeling models according to Examples 1 to 5 in Test Example 1 in a state without a supporting base material were prepared by the following method. Except for the matters to be mentioned in particular, the same materials and processes as those for the production of the inner boundary film peeling model according to Examples 1 to 5 in Test Example 1 described above were performed.
Specifically, first, a pseudo retina was formed on a glass plate on which a resist film (sacrificial film) had been formed in advance by spin coating (rotation speed: 1000 rpm, rotation time: 30 seconds). Here, the resist film was formed by spin coating (rotation speed: 2000 rpm, rotation time: 30 seconds) with a trade name “LOR5B” manufactured by Micro Chem. The glass plate on which the pseudo retina was formed in this manner was immersed in ethanol to dissolve the protective film (sacrificial film), thereby creating a pseudo retina having no support base material. The pseudo retina is fixed on an aluminum foil (it can be easily fixed by the self-adhesive force of the pseudo retina), the surface of the pseudo retina is subjected to plasma treatment, and then the pseudo inner boundary film is spin-coated (rotation speed: 3000 rpm, rotation) Time 5 seconds). The pseudo retina and the pseudo inner boundary film were peeled off from the aluminum foil and cut into an appropriate size. For the inner boundary membrane peeling model according to Examples 3 to 5, aging treatment (40 ° C., 4 days) was performed.

The breaking strength of the simulated inner boundary membrane test pieces for breaking strength measurement according to Examples 1 to 5 obtained as described above was measured by the following method.
That is, the quasi-inner boundary film according to each example was cut into a strip shape having a short side of 8 mm and a long side of 40 mm to prepare a test piece. The test piece was set in a tensile tester so that the longitudinal direction thereof coincided with the tensile direction and the distance between chucks was 20 mm. The test piece was pulled under conditions of 25 ° C. and 50% RH under the condition of a tensile speed of 12 mm / min, and the tensile force (kgf) when the test piece was broken was measured. The tensile tester includes a load cell (LTS-500GA) manufactured by Kyowa Denki Co., Ltd., an automatic linear motion stage (KS303-100) manufactured by Suruga Seiki Co., Ltd., and a stepping motor controller (D220 manufactured by Suruga Seiki Co., Ltd.). ) And a chuck (gripping tool) produced in accordance with the size of the sample was used. And the following formula: breaking strength (kgf / mm ² ) = tensile force at break (kgf) ÷ {length of short side of test piece before tension (mm) × thickness of test piece before tension (mm) }; Rupture strength was calculated.
The results are shown in the “Break strength” column of Table 2.

The rupture elongation of the pseudo inner boundary film for measuring the rupture elongation according to Examples 1 to 5 obtained as described above was measured by the following method.
That is, the quasi-inner boundary film according to each example was cut into a strip shape having a short side of 8 mm and a long side of 40 mm to prepare a test piece. The test piece was set in a tensile tester so that the longitudinal direction thereof coincided with the tensile direction and the distance between chucks was 20 mm. Then, the test piece was pulled under the conditions of 25 ° C. and 50% RH under the condition of a tensile speed of 12 mm / min, and the distance between the chucks when the test piece was broken was measured. In addition, as the tensile tester, the same one as that used in the test for the breaking strength was used. Then, the elongation at break (%) = {Distance between chucks at break (mm) −Distance between chucks before tension (mm)} ÷ Distance between chucks before tension (mm) × 100; Was calculated.
The results are shown in the “breaking elongation” column of Table 2.

The peeling strength of the inner boundary film peeling model for peeling strength measurement according to Examples 1 to 5 obtained as described above was measured by the following method.
That is, the inner boundary membrane peeling model according to each example was cut into a rectangular shape of 20 mm × 30 mm to prepare a test piece. At one end in the longitudinal direction of such a test piece, a peeling start end is formed by peeling the pseudo inner boundary membrane from the pseudo retina by about 5 mm, and simulated under a peeling speed of 6 mm / min in an environment of 25 ° C. and 50% RH. The pseudo inner boundary membrane and the pseudo retina are pulled so that the inner boundary membrane and the pseudo retina are T-shaped peeled from the peeling end along the longitudinal direction of the test piece, and the tensile force (N), that is, the peeling force (N ) Was measured. A tensile tester similar to the one used for the above-mentioned breaking strength test was used for tensioning the pseudo inner boundary membrane. Next, the average peel force (N) is calculated from JIS K 6854-2 based on the peel force (N) measured at a peel length of 15 mm excluding the distance from the peel start end to 10 mm and the peel end end to 5 mm. Calculated in conformity. Then, the peel strength was calculated by the following formula: peel strength (N / mm) = average peel force (N) ÷ length of short side of test piece (mm).
The results are shown in the “Peel strength” column of Table 2.

In the above test example 2 (peelability test), the inner boundary film peeling model according to examples 3 to 5 determined by a person skilled in the art to have peelability similar to that when peeling the inner boundary film of the human eye things, breaking strength of the pseudo within the boundary layer is at 0.05 kgf / mm ² or more 1.2 kgf / mm ² or less, where and elongation at break of the pseudo within the boundary film satisfies 5.0% or less than 0.1% Met.
Further, in Test Example 2 (Peelability Test) described above, the inner boundaries according to Examples 4 and 5 that were determined by those skilled in the art to have peelability that was very similar to the peelability when peeling the inner boundary membrane of the human eye. delamination model, breaking strength of the pseudo within the boundary layer is at 0.05 kgf / mm ² or more 0.6 kgf / mm ² or less, and elongation at break of the pseudo within the boundary layer is 5.0% or less than 0.1% It met. The inner boundary film peeling models according to Examples 1 to 5 all had a peeling strength of 0.001 N / mm or more and 0.1 N / mm or less.

In addition, from the results shown in Table 2, it was confirmed that the value of the breaking strength greatly changes depending on the presence or absence of the aging treatment. Further, it was confirmed that the value of the elongation at break greatly changes depending on the presence or absence of fine particles (typically microbeads) in the pseudo inner boundary film.

<Test Example 4: Production of inner boundary membrane peeling training apparatus>
Using the inner boundary film peeling model according to Examples 3 to 5, an inner boundary film peeling training apparatus as shown in FIG. 8 was produced. Specifically, the inner boundary film peeling models according to Examples 2 and 3 were each fixed on an acrylic plate using a clip. Thus, an inner boundary membrane peeling model and a fixing portion for fixing it were prepared.
Next, polypropylene hollow spheres (hollow balls) having a diameter (outer diameter) of 25.4 mm (1 inch) constituting the model set main body according to this example were purchased from Humanity Co., Ltd. and prepared. An arbitrary point on the hollow sphere was designated as the A pole, and the counter electrode of the A pole was designated as the B pole. The hollow sphere was cut at the equator plane that bisects the A pole and the B pole. Here, the equator plane (cut plane) is grasped as a peeling port. Hereinafter, the hemisphere on the B pole side was used for manufacturing the model main body. Part of the hemisphere was cut out so that the cut surface had a circular shape with a diameter of 9 mm, and an opening (view portion) was produced. Here, the center of the circle of the peeping part is located on a straight line connecting the A pole and the B pole, and the cut surface of the peeping part is parallel to the equator plane (peeling opening). With respect to such a hemisphere, three holes having a diameter of about 0.7 mm were formed at regular intervals at a position about 3 mm in a straight line from the circumference of the viewing portion. The 3G cannula for 23G system (manufactured by Doruk Co., Ltd., 23G cannula system) was inserted through these three holes to produce a model set main body, and the inner boundary membrane fixed on the acrylic plate The surface of the quasi-inner boundary film of the exfoliation model was arranged and fixed so that the viewing portion and the exfoliation port of the model set main body were parallel to each other. At this time, the insertion port holding member was arranged so that the equator plane (equatorial plane that bisects the A pole and the B pole) was 12.7 mm away from the pseudo inner boundary membrane.
As a result, a model set portion having a model set main body portion having three insertion ports (typically cannulas) on a 25.4 mm sphere in contact with the surface of the pseudo inner boundary membrane and the fixing portion, and an inner boundary An inner boundary membrane peeling training apparatus equipped with a membrane peeling model was produced.

As described above, according to the present invention, it is possible to provide an inner boundary membrane exfoliation model that highly reproduces the sensation when the inner boundary membrane is exfoliated by the human eye. By training the inner boundary membrane separation for such an inner boundary membrane separation model, the experience of inner boundary membrane separation can be repeated without performing actual surgery. In other words, the inner boundary membrane peeling model disclosed herein can be used to learn the technique of inner boundary membrane peeling for an actual human eye and improve the skill.

DESCRIPTION OF SYMBOLS 10 Inner boundary membrane peeling model 20 Pseudo inner boundary membrane 30 Pseudo retina 40 Support base material 100 Inner boundary membrane peeling training apparatus 110 Model set part 120 Fixing part 121 Clip 122 Recess 130 Model set main part 131 Insertion port 133 Surgical instrument 134 A pole 135 B-Pole 136 Peeling Port 137 Viewing Portion

Claims (12)

An inner boundary membrane detachment model comprising a pseudo retina and a pseudo inner boundary membrane laminated on at least one surface on the pseudo retina,
An inner boundary membrane peeling model in which the peelability when peeling the pseudo inner boundary membrane from the pseudo retina using an insulator is similar to the peelability when peeling the inner boundary membrane using an insulator in the human eye . The inner boundary membrane peeling model according to claim 1, wherein the pseudo inner boundary membrane has a thickness of 1 μm or more and 10 μm or less. The inner boundary according to claim 1 or 2, wherein the pseudo inner boundary film includes, as a main component, a polymer material selected from the group consisting of vinyl polymers, polyolefins, polyesters, polyamides, cellulose polymers, and combinations thereof. Membrane peeling model. The inner boundary membrane peeling model according to claim 3, wherein the polymer material is polyvinylidene chloride. The pseudo retina includes, as a main component, a polymer material selected from the group consisting of silicone rubber, butadiene rubber, isoprene rubber, butyl rubber, fluorine rubber, ethylene propylene rubber, nitrile rubber, natural rubber, and combinations thereof. The inner boundary membrane exfoliation model according to any one of 1 to 4. The inner boundary film peeling model according to claim 5, wherein the polymer material is composed of silicone rubber containing dimethylpolysiloxane as a main component. The inner boundary according to any one of claims 1 to 6, wherein at least one surface of the pseudo retina is subjected to a hydrophilic treatment, and the hydrophilic treatment surface is laminated so as to face the inner boundary membrane. Membrane peeling model. Fine particles are dispersed in the quasi-inner boundary film, and the fine particles have an average particle diameter (D ₅₀ ) corresponding to a cumulative frequency of 50 vol% from the fine particle side in the particle size distribution based on the laser diffraction / light scattering method. The inner boundary membrane peeling model according to any one of claims 1 to 7, which is 40% to 120% of an average film thickness of the pseudo inner boundary membrane. The inner boundary film peeling according to claim 8, wherein the microbeads constituting the fine particles are contained in the pseudo inner boundary film at a density of 1 × 10 ⁸ particles / cm ³ to 10 × 10 ⁸ particles / cm ^3. model. The inner boundary membrane exfoliation model according to any one of claims 1 to 9, which has one or a plurality of marks having a circular shape and / or a scale having a diameter of 1 mm to 10 mm. The inner boundary film peeling model according to any one of claims 1 to 10, wherein the inner boundary film is colored. An inner boundary membrane peeling training device used for inner boundary membrane peeling training,
An inner boundary membrane peeling model set unit, and the inner boundary membrane peeling model according to any one of claims 1 to 11 set in the set portion,
The inner boundary membrane detachment model set unit includes an inner boundary membrane detachment training apparatus having a fixing portion for fixing the inner boundary membrane detachment model and a main body portion in which an insertion port for inserting a surgical instrument is formed.

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