JP7804345B2 - Brain endoscopy training device - Google Patents

Description

The present invention relates to a cerebral model and training device that can be used for training in endoscopic surgical procedures for treating brain diseases. The present invention is particularly useful for training in procedures such as biopsies and resections for intracerebral tumors.

Until now, endoscopic surgery training has not involved the use of medical models to perform endoscopic procedures to treat brain diseases. From 2022, endoscopic brain biopsies and surgery to remove diseased areas will be covered by insurance in Japan, enabling a more practical approach and hopefully leading to safer and more accurate surgeries.

Surgery to treat brain diseases, particularly tumor removal, has traditionally involved craniotomy, which involves physically moving brain tissue to access and remove the tumor, placing a significant physical burden on the patient. Furthermore, biopsies for intracerebral diseases only involve the removal of a small amount of tissue from the target area using a needle-like surgical instrument, which carries a certain degree of risk of bleeding, etc.

In endoscopic surgery, a navigation system is used to identify the location of the tumor, and a cylindrical instrument is inserted through the skull to the tumor location. An endoscope is then inserted using this as a guide to perform a biopsy or resection. In particular, in surgery to remove a tumor, it is necessary to separate normal tissue and remove abnormal tissue.

This has created a need for more realistic surgical training models. Conventional models have limitations when it comes to simulating complex surgeries. Therefore, more sophisticated and realistic models are needed to practice tumor removal.

JP 2019-53264 A

https://madewithunity.jp/info/clip-sim/

While medical technology using intracerebral endoscopes is expected to become more widespread in the future, no suitable training models have been devised for endoscopic biopsies of intracerebral diseases or resections of diseased areas. Furthermore, while there are VR devices that use computer graphics and VR technology and are used in cerebral aneurysm surgery, they are unable to faithfully reproduce the movement and feel of actual surgical instruments.

After diligently studying the above-mentioned issues, the inventors were able to provide an endoscopic training device that recreates diseased areas inside a cerebral model, based on knowledge gained from manufacturing the medical model described in Patent Document 1.

The present invention therefore provides the following:

One embodiment of the present invention is an intracerebral endoscopy training device comprising: [1] a cerebral model made of synthetic resin; and a head model that detachably houses the cerebral model, with a simulated diseased area provided inside the cerebral model.

Another embodiment of the present invention is the intracerebral endoscopy training device described in [1], [2] in which the cerebral model portion includes regions corresponding to the frontal lobe, occipital lobe, temporal lobe, and occipital lobe, and the interior of the cerebral model portion has a space corresponding to the ventricular system.

Another embodiment of the present invention is the intracerebral endoscopy training device described in [1], [3] in which the cerebral model portion is divided horizontally into two equal parts, upper and lower.

In another embodiment of the present invention, [4] the cerebral model portion further comprises a groove corresponding to either or both of the lateral sulcus or the central sulcus,
[2] The brain endoscopy training device according to the present invention.

In another embodiment of the present invention, [5] the simulated disease area is formed by placing a disease model in a predetermined space of the cerebral model part,
[1] The brain endoscopy training device described in [1].

Another embodiment of the present invention is [6] a container containing a simulated normal portion and a simulated disease portion, and the shape of the container corresponds to at least a partial deletion portion of a region corresponding to the frontal lobe, parietal lobe, temporal lobe, and occipital lobe in the cerebral model portion.
[2] The brain endoscopy training device according to the present invention.

Another embodiment of the present invention is [7] the brain endoscopy training device described in [1], in which the head model portion has an opening for inserting an endoscope.

Another embodiment of the present invention is a method for detecting a patient's cerebral morphology, comprising: [8] collecting cerebral shape information including disease information in the cerebrum of the patient;
acquiring three-dimensional image data generated from the cerebral shape information;
identifying a diseased area in the three-dimensional image data;
A step of creating a mold of a cerebral model portion in which the identified diseased area is deleted as a missing portion;
The method includes a step of placing a simulated diseased area in the missing part of the cerebral model part.
This is a method for creating an intracerebral endoscopy training device.

The medical model of the present invention can specifically reproduce diseased areas of the cerebrum. This allows doctors to train in endoscopic operation using a more realistic brain model. Furthermore, this method of manufacturing the cerebrum model and the intracerebral endoscopic training device manufactured using it will also contribute to the planning of surgical strategies tailored to each patient's illness and the provision of sufficient information to patients (informed consent).

FIG. 1 is a schematic diagram of a training device described herein. FIG. 2 is a view of the training device of FIG. 1 as seen from the left side of the head. FIG. 2 is a perspective view of the training device of FIG. 1. FIG. 2 is a diagram showing the cerebral model portion of the training device of FIG. 1 installed. FIG. 1 is a schematic diagram of a portion of a brain model described herein. FIG. 1 is a schematic diagram of the interior of a portion of the brain phantom described herein. FIG. 1 shows the ventricular system of the brain phantom portion described herein. FIG. 1 shows a diseased area portion of a cerebral model described in this specification. FIG. 10 is a diagram showing another aspect of the diseased area portion of the cerebral model described in this specification. FIG. 10 is a diagram showing another aspect of the diseased area portion of the cerebral model described in this specification. FIG. 10 is a diagram showing another aspect of the diseased area portion of the cerebral model described in this specification. FIG. 10 is a diagram showing an endoscope inserted. 1A to 1C are diagrams illustrating the manufacturing process of the cerebral model part in the present invention.

In this disclosure, the cerebral model portion is used for training in endoscopic brain surgery and can reproduce conditions close to those used in actual surgery. The synthetic resin is preferably a material that can reproduce the texture of cerebral tissue and is easy to mold. Specifically, polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyurethane (PU), silicone (Si), ethylene propylene diene monomer (EPDM), etc., or combinations of these or materials with appropriate processing aids added, are preferred. Silicone is preferred from the standpoint of processability and texture.

In this disclosure, the head model refers to a head model that houses the cerebral model. Because intracranial endoscopic surgery is performed by penetrating the skull, a head model is required to simulate actual surgery. The head model is designed to detachably house the cerebral model. Materials used for the head model include acrylic (polymethyl methacrylate/PMMA), polycarbonate (PC), polyacetal (POM), polyethylene terephthalate (PET), acrylonitrile butadiene styrene (ABS), etc., or any combination of these. These materials are hard and easy to process, allowing for the creation of precise shapes. In this disclosure, the head model can be created using CNC machining, a 3D printer, or similar.

The intracerebral endoscopy training device disclosed herein has a simulated diseased area inside the cerebral model. This simulates a diseased area (e.g., a tumor or abnormal tissue) in a specific area of the cerebrum in order to simulate an actual surgical situation. During surgical training, doctors and trainees can use an endoscope to perform surgery on this simulated diseased area, enabling practical training.

In this disclosure, the cerebral model includes areas corresponding to the frontal lobe, temporal lobe, and occipital lobe, which are major parts of the brain. These areas control important brain functions, and surgical training can involve training in operations that take into account access to these areas.

In this disclosure, a space equivalent to the ventricular system is provided inside the cerebral model. The ventricular system is located inside the brain and is a space filled with cerebrospinal fluid, responsible for the production, circulation, and absorption of cerebrospinal fluid. The ventricular system is an important anatomical structure in endoscopic intracranial surgery, and is also an area that surgeons are likely to access when reaching important areas of the brain. Using the training device of the present invention makes it possible to train this complex structural area, contributing to improved surgical safety and efficiency.

In this disclosure, the cerebral model is divided into two halves, top and bottom, so that trainees can access the simulated diseased area, perform surgical procedures, and then separate the cerebral model to check the internal condition. Evaluating the internal changes and effects caused by procedures using surgical tools helps improve surgical effectiveness and techniques. Furthermore, this confirmation process allows trainees to strengthen their own surgical techniques and identify areas for improvement.

In the present disclosure, the cerebral model is divided into two halves, top and bottom, allowing for easy replacement of the simulated diseased part. The simulated diseased part simulates lesions and abnormalities within the brain and is an important training target area for trainees when performing surgery. By making the simulated diseased part interchangeable, training can be conducted on a variety of lesions, making it possible to accommodate a wide range of surgical scenarios. Furthermore, the use of interchangeable simulated diseased parts allows for effective and efficient training for a large number of trainees.

In the present disclosure, the simulated diseased area of the intracerebral endoscopic training device is configured so that the diseased area is placed in a predetermined space in the cerebral model. This diseased area mimics an actual pathological condition in intracerebral endoscopic surgery. Trainees can use an endoscope to perform surgery on this simulated diseased area, allowing for surgical training in a situation that closely resembles reality.

In the present disclosure, the simulated diseased area of the brain endoscopy training device may be configured as a container containing both a simulated normal portion and a simulated diseased portion. This container means that a portion simulating a diseased portion and a normal portion are arranged together in a specific area of the brain. That is, in this embodiment, the simulated diseased area is provided as a cartridge. This allows the trainee to perform surgical training on both the normal portion and the diseased portion within the simulated diseased area. In the present disclosure, the simulated diseased area can be configured to correspond to at least a partial missing portion of the area of the cerebral model that corresponds to the frontal lobe, parietal lobe, temporal lobe, and occipital lobe.

The present disclosure also provides a method for creating an intracerebral endoscopy training device. This method includes a step of first collecting cerebral shape information, including disease information for the patient's cerebrum. This step involves acquiring information such as the shape of the patient's brain, the location of the disease, and its magnification and reduction. Typically, medical imaging technology is used to acquire images such as MRI (magnetic resonance imaging) or CT (computed tomography), and the brain shape and disease information are analyzed.

Next, a process is performed to generate 3D image data based on the collected cerebral shape information. In this process, the 3D shape of the patient's cerebral cortex and disease information are acquired as digital data. Next, a process is performed to identify and specify specific diseased areas from the acquired 3D image data. This process obtains data including the location and extent of the disease within the patient's brain. A further process is performed to create a mold of the cerebral model in which the identified diseased area has been deleted as a missing part. This makes it possible to manufacture a mold of the cerebral model that does not include the diseased area within the brain as a missing part.

Next, a process is carried out in which a simulated diseased area that mimics a pathological condition similar to the identified diseased area is placed in the missing area of the manufactured cerebral model. This completes a cerebral model that resembles a real diseased state, making it usable for surgical training. Through these processes, it is possible to provide an intracerebral endoscopic training device in which a simulated diseased area is placed based on information about the shape of the patient's cerebral cortex. Trainees can use this device to conduct surgical training, improving their intracerebral endoscopic surgical skills and providing safer treatment to patients.

Below, an embodiment of an intracerebral endoscopy training device constructed in accordance with the present invention will be described with reference to the drawings.

Referring to Figure 1, one embodiment of the brain endoscopy training device according to the present invention is shown. Figure 1 is a schematic diagram of the brain endoscopy training device 1. This device consists of two main components: a hard head model 3 and an internal cerebral model 2. The head model 3 is preferably made of a material that is durable and suitable for maintaining its shape. In this embodiment, it is preferable to use a resin that can be manufactured using a 3D printer. Specifically, plastics such as acrylonitrile butadiene styrene (ABS) and polycarbonate are often used. These materials have high strength and impact resistance, and can be precisely shaped. In this embodiment, the head model is manufactured using polyamide resin by powder sintering additive manufacturing (PAS) based on 3D image data of a human head. In this embodiment, the head model 3 preferably has a hole near the top of the head. The trainee inserts a surgical tool through this hole to perform endoscopic training. In the present disclosure, such an opening in the head model is not necessarily required. If no opening is present, it is preferable to provide an area where a hole can be drilled. When providing such an opening, plastics that are particularly easy to process, such as polyethylene or polypropylene, are suitable. These materials are easy to mold and process using heat, allowing their flexibility and shape to resemble a real head, and users can even drill holes as needed during actual training.

Next, referring to Figure 2, the external appearance of the intracranial endoscopic training device of the present invention will be described. The head model 3 in the intracranial endoscopic training device 1 of the present invention has a shape in which the skull portion is cut transversely, and can be used by fastening the front surface 31 and rear surface 32 with fasteners 5. This configuration makes it possible to insert and remove the cerebrum model 2 into and from the head model 3. In this embodiment, a base 4 is provided on the rear surface 32 side. The installation location of this base 4 is one example, and the base 4 can be changed as appropriate depending on the purpose of the surgery.

Next, an overview of the intracerebral endoscopic training device of the present invention will be described with reference to Figures 3 and 4. A hole 6 for surgical training purposes is pre-formed in the head model portion 3 of the present invention. The position and size of the hole 6 in Figure 4 are exemplary for this embodiment and can be changed as appropriate depending on the purpose of the surgery for each individual patient. The manufacturing method for the intracerebral endoscopic training device of the present invention also makes it possible to provide an intracerebral endoscopic training device customized based on information about the inside of the brain of each individual patient. In this embodiment, the head model portion 3 is divided into a front and a back portion, and by separating these portions, the cerebrum model portion 2 can be inserted and removed.

Next, with reference to Figure 5, an overview of the cerebral model section 2 of the intracerebral endoscopy training device of the present invention will be described. Although not individually shown, the cerebral model section includes areas corresponding to the frontal lobe, occipital lobe, temporal lobe, and occipital lobe. These areas may be color-coded depending on the purpose. The interior of the cerebral model section 2 also has a space corresponding to the ventricular system. Preferably, the cerebral model section may be horizontally divided into upper and lower halves (21 and 22). The position of the bisection can be determined arbitrarily depending on the target disease for training or the state of the brain of the patient who is the surgical target. In this embodiment, the cerebral model section is divided into upper and lower halves horizontally at the position of the posterior horn of the lateral ventricle of the ventricular system. Optionally, a structure such as the pituitary stalk 23 may be added.

Such a cerebral model portion 2 can be manufactured, for example, by the following method. First, a human head is photographed using MRI, CT, or the like. Next, a mold for the cerebral model portion 2 is created using powder sintering additive manufacturing based on 3D image data generated from tomographic information of the human head. The cerebral model portion 2 can then be manufactured by pouring a suitable elastomer material into the mold for the created cerebral model portion 2. Elastomer materials are preferred as the material for manufacturing the cerebral model portion 2, and examples include thermoplastic elastomers such as ester-based, styrene-based, olefin-based, vinyl chloride-based, urethane-based, polyamide-based, fluororesin-based, and conjugated diene-based elastomers, as well as rubber-like elastic bodies such as silicone rubber.

Next, the interior of the cerebral model section 2 will be described with reference to Figure 6. In this disclosure, the cerebral model divided into two halves is referred to as the upper hemisphere 21 and the lower hemisphere 22. In this embodiment of the disclosure, the cerebral model 2 is divided horizontally into upper and lower halves at the position of the posterior horn of the ventricle in the human ventricular system. In Figure 6, the upper hemisphere 21 is composed of upper right ventricle sections 25 and 24 and upper left ventricle sections 27 and 26. This configuration allows the surgical target area to be confirmed in three dimensions, while easily replacing the model of the diseased area, as described below.

In Figure 6, by using the method of the present invention, a cerebral model can be created that mimics the inside of an actual patient's ventricle. Specifically, the choroid plexus 28, the third ventricle facing the back of it, and a tumor location 29 as a simulated diseased area can be created in a realistic form.

Next, the simulated disease area in the cerebral model section 22 will be described with reference to Figure 7. As mentioned above, the cerebral model section of the present invention can be manufactured by using a 3D printer to create a mold with a diseased area at a desired location as a simulated disease area based on image data from a patient's brain, and then pouring molten resin into this mold. In Figure 7, 29a and 29b are examples of simulated disease areas of the present invention. Surgical training can be performed by incorporating a model with the physical characteristics of the diseased area into such an area, combining it as shown in Figure 5, and incorporating it into the skull model as shown in Figure 4. Fixation devices can be locked as shown in Figure 3 or Figure 2, and surgical tools can be inserted as shown in Figure 12.

Next, referring to Figure 8, we will explain the model used for the diseased area of the cerebral model in this invention. In the example shown in Figure 8, a cherry tomato is incorporated as the simulated diseased area 29c. Cherry tomatoes are suitable as a brain tumor model due to their ease of availability, resistance to surgical tools, and hardness. Their internal structure also resembles necrotic tissue, making them a desirable model for brain tumor removal surgery training. In this invention, other models corresponding to the diseased area can be selected as appropriate. For example, in the case of tumor-related diseases, roughly spherical fruits (grapes, cherries, strawberries, blueberries, other berries, etc.) can be used depending on the size of the tumor. Silicone, elastomer, cellulose, clay, or any food material can also be blended and used, focusing on a weighing bag made of a thin resin film. Furthermore, they can be artificially created using synthetic resin.

Next, with reference to Figures 9 and 10, another embodiment of the diseased region of the cerebral model of the present invention will be described. In this embodiment, the cerebral model of the present invention is created by removing the surrounding area of the diseased region. Figure 9 shows an embodiment configured to replace a certain section of the periphery of the actual diseased region. Specifically, a roughly rectangular container made of plastic or the like is filled with a base material simulating normal brain tissue and a diseased region simulating the tissue of the diseased region, and is configured to be fitted into a portion of the cerebral model of the present invention. This configuration allows multiple trainees to train on the same diseased region by replacing the cartridge 29d. Furthermore, by changing the pattern of the diseased region model in the cartridge 29d, it is possible to use the same cerebral model to perform surgical training for different disease patterns. In Figure 10, a diseased region simulating the tissue of the diseased region is constructed at the bottom of the cartridge 29d, and a base material simulating normal brain tissue is layered on top of it. In Figure 10, the cartridge for the diseased region of the cerebral model of the present invention is inserted above the ear on the right side of the head. The size of the cartridge 29d and the insertion site of the cerebral model can be modified as appropriate.

Next, referring to Figure 11, a cartridge simulating a diseased area used in the cerebral model portion of the present invention will be described in detail. The cartridge described in Figure 11 is a roughly rectangular parallelepiped with a hollow interior formed in a shape corresponding to the missing area. The material used for such a cartridge is not particularly important, but it is preferable to form it from a transparent resin or the like, so that the diseased area and normal brain tissue are placed inside the cartridge as a base material. The size can be manufactured to match the area and size of the target disease to be trained, but it is preferable to ensure sufficient space for inserting the endoscope and sheath and for the trainee to operate the endoscope to treat the diseased area, such as a tumor.

The cerebral matrix filled into the cartridge is preferably a material similar in color and flexibility to cerebral tissue. Specifically, a matrix with a color and hardness similar to cerebral tissue can be created by appropriately mixing clay, tofu, jelly, agar, dietary fiber, cellulose, starch, etc. Brain matrixes can also be created by blending any thickener or pigment into a synthetic resin such as silicone. In one embodiment of the present invention, a paste can be used that is made by mixing approximately 5 g of cornstarch per 100 g of heated potato paste. Note that the hardness and viscoelasticity of the brain matrix are not particularly important in the present invention; it is sufficient that it allows for easy passage of surgical instruments such as sheaths and does not dissolve in water. In another embodiment of the present invention, a vascular model can be placed inside the cerebral tissue matrix or cartridge.

Furthermore, the cartridge contains a simulated normal area of cerebral tissue and a simulated diseased area to be treated using endoscopic tools. In the case of a brain tumor, as mentioned above, such a simulated diseased area can be arranged like a cherry tomato embedded in potato paste. In the present invention, other models corresponding to the diseased area can be selected as appropriate. For example, in the case of a brain tumor, depending on the size of the tumor, roughly spherical fruits (grapes, cherries, strawberries, blueberries, other berries, etc.) can be used. Silicone, elastomer, cellulose, clay, or any food material can also be blended and used, focusing on a weighing bag made of a thin resin film. Furthermore, it can also be artificially created using synthetic resin.

Next, referring to Figure 12, we will explain how to use the present invention. A sheath, which serves as a guide for inserting an endoscope, is inserted through the hole in the skull model shown in Figure 12. After the sheath reaches the diseased area, the endoscope is inserted into the tubular sheath. Furthermore, if a surgical tool is to be made operable, a cord-shaped counter electrode may be embedded in the cerebral model to simulate the use of an electric scalpel, for example.

In endoscopic brain surgery (e.g., brain tumor resection), sheaths create a path for guiding specific surgical instruments into the brain. Typically, surgeons use imaging techniques such as MRI or CT scans to plan the surgery and identify the location and size of the area to be operated on. Through navigation, a sheath is inserted into the brain, and then surgical instruments such as an endoscope or catheter are introduced into the brain, creating a path for treating the diseased area.

Sheaths used in brain surgery vary in shape and size depending on their intended use. They generally have a long, tubular structure, may be slender, and may have a tapered tip, designed to access tight spaces within the brain. Some sheaths have a smooth interior to allow for the easy passage of specific surgical instruments. Other sheaths are flexible and designed to pass through the tortuous pathways within the brain. By using the cartridge of the present invention, the compatibility of surgical instruments can be confirmed in advance in three dimensions.

Next, referring to Figure 13, one embodiment of the creation of an intracerebral endoscopic training device according to the present invention will be described. The intracerebral endoscopic training device according to the present invention can be used not only as a general-purpose medical model, but also as a pre-operative simulation and training device for patients who actually require surgery. Specifically, before a patient undergoes surgery, image processing technology is used to collect information about the inside of the brain and create a surgical plan. While MRI (magnetic resonance imaging) and CT (computed tomography) are typical means for identifying intracerebral tumors, bleeding, vascular disorders, etc., it is not intended that the present invention be limited to information obtained from these methods. In the present invention, three-dimensional data of the cerebrum is created using information collected for this purpose. It is preferable that this image data be two-dimensional tomographic images of a specific part of the patient's body.

The collected images are then preprocessed, including noise removal, contrast enhancement, and image scaling. The affected area or areas containing the affected area are then separated and extracted. 3D volume data is generated from the cross sections of each separated image. Typically, the images are aligned in one direction, and a 3D model is created using the spatial relationship between adjacent 2D images. This process is often performed using 3D drawing software. The created 3D model undergoes mesh optimization to smooth the model and hole repair, if necessary. This data is then converted into a common CAD format (e.g., STEP, IGES, STL, etc.). This data can then be opened in CAD software and used to create a cerebral model by 3D printing. Since the affected area has been identified in the cerebral model mold as described above, the cerebral model mold is created so that a portion of the cerebrum is missing. In another embodiment of the present invention, the affected area may be configured to be removed separately after the cerebral model is created.

Specifically, a cerebral model with a hollow ventricular system can be created from patient image data, divided into equal parts at predetermined locations, and the tumor can be carved out inside. Alternatively, the area surrounding the disease, which corresponds to the cartridge, can be excised from the cerebral model.

Next, synthetic resin is poured into the mold of the cerebral model created using a 3D printer, and the cerebral model is produced until it is ready for production.

By configuring it in this way, the method of the present invention makes it possible to create an endoscopic training device tailored to individual patients. Furthermore, by providing such a training device that simulates the disease area of an individual patient, it becomes easier to practice surgical strategies and procedures, which can contribute to improving doctors' medical skills and reducing surgical risks.

1: Brain endoscopy training device 2: Cerebral model section 3: Head model section 31: Cerebral model front surface 32: Cerebral model back surface 4: Base 5: Fastener 6: Head model opening 21: Cerebral model upper hemisphere 22: Cerebral model lower hemisphere 23: Pituitary gland 24: Right ventricle lower section 25: Right ventricle upper section 26: Left ventricle lower section 27: Left ventricle upper section 28: Choroid plexus 29 (29a and 29b): Simulated diseased area 29c: Simulated diseased area 29d: Diseased area cartridge 291: Simulated normal tissue section 292: Simulated diseased area

Claims (4)

A synthetic resin brain model,
a head model part that detachably houses the cerebral model part,
A simulated disease area is provided inside the cerebral model part,
An intracerebral endoscopy training device,
the cerebral model portion includes portions corresponding to the frontal lobe, the parietal lobe, the temporal lobe, and the occipital lobe;
the simulated disease area is formed by placing a disease model including a simulated normal portion and a simulated disease portion in a predetermined space of the cerebral model portion,
The disease model is a cartridge including at least a base material having a color and hardness similar to that of cerebral tissue and a material similar to that of tissue at a diseased site;
the shape of the cartridge corresponds to at least a partial missing portion of the region corresponding to the frontal lobe, parietal lobe, temporal lobe, and occipital lobe in the cerebral model portion;
Brain endoscopy training device. 2. The brain endoscopy training device according to claim 1, wherein the cerebral model portion is divided into two equal parts, upper and lower, in the horizontal direction. The cerebral model portion further includes a groove corresponding to either or both of the lateral sulcus and the central sulcus.
The brain endoscopy training device according to claim 1. The brain endoscopy training device according to claim 1 , wherein the head model portion is provided with an opening for inserting an endoscope.