JP7636044B2 - Human body model for puncture technique training and puncture technique training method using the same - Google Patents

Description

This invention relates to a simulator device for medical skill training, and a training method, for training doctors and other medical personnel in puncture procedures using injection needles, etc.

Simulator devices for medical skill training have been available for some time.

This simulator device for medical skills training is a simulator that acts as a substitute for a patient, allowing doctors, nurses, and other medical professionals to train the skills required for diagnosis and treatment.

One medical procedure that can be the subject of training is a puncture procedure that is routinely performed with high frequency, such as injections. In emergency medical care, when a patient's condition suddenly changes or they go into shock, a catheter or cannula is urgently inserted into the femoral artery or femoral vein to assist circulation. The specific steps for catheter insertion are as follows. First, the blood vessel is secured with a puncture needle (injection needle), and then a guidewire is inserted. The puncture needle is removed while leaving the guidewire in place. Unlike normal injections, puncturing a deep blood vessel to insert a catheter or cannula over the guidewire is highly urgent and difficult because the target blood vessel is located deep inside. For example, it is generally considered necessary to insert a catheter within one minute.

One type of simulator for training injection techniques is one that places a blood vessel model made of vinyl tubes inside an arm model made of elastic resin such as urethane. Injection training simulators are popular primarily in educational institutions for medical and nursing students.

Injection technique simulators come in two types: those that contain simulated blood inside the embedded blood vessel model, and those that do not. Those that contain simulated blood can be used for training in blood collection. By drawing up the simulated blood with a syringe, the results of the blood collection technique can be evaluated in real time. When training using a simulator, emphasis is placed on the reproducibility of the model as well as the evaluation function.

However, there are several issues with using injection training simulators to train puncture techniques for catheter and cannula placement.

First, conventional simulators have a structure in which a blood vessel model is embedded inside a single elastic structure made of urethane or hydrogel, which results in little change in the physical properties of the blood vessel wall and the surrounding tissue, and is unable to reproduce the minute "pop" reaction force that occurs when the front wall of the blood vessel is pierced, making it difficult to achieve realistic training. In the first place, when puncturing a blood vessel, since the blood vessel has a closed cylindrical structure, only the front wall of the blood vessel that comes into contact first must be pierced, and the rear wall on the opposite side must not be damaged or pierced. However, with a structure in which a simulated blood vessel model made of elastic material is simply embedded in a single elastic material, it is difficult to distinguish the difference between the reaction force that the needle receives from the blood vessel wall and the reaction force from the surrounding tissue.

Next, puncture training using a simulator requires a function that allows the trainee to instantly determine whether or not the target blood vessel was properly punctured and whether the technique was appropriate. However, with conventional injection simulators that mimic the arm, it is not possible to know which part the puncture needle has touched, or where inside the subcutaneous tissue the needle is located. The inability to make an immediate evaluation limits the effectiveness of learning the technique.

Furthermore, there was no function or method for adjusting the difficulty of the puncture procedure, so there was a problem in that it was not possible to provide a training model and environment that matched the trainee's level.

Therefore, the object of this invention is to provide a simulator device for medical skill training that can easily achieve the tactile reproducibility required for puncture technique training, the ability to evaluate the technique, and the ability to adjust the level of difficulty, which were not possible with conventional simulators.

In order to achieve the above object, according to a first aspect of the present invention,
(1) A human body model for puncture technique training, comprising:
a body having one surface and another surface;
and a puncture target artificial organ disposed at a predetermined position within the main body,
The human body model is characterized in that the main body is configured such that the puncture target artificial organ cannot be seen from one side, but can be seen from the other side.

(2) In the human body model described in (1) above,
The body includes:
a base layer formed of a light-transmitting elastic material, the base layer having the target artificial organ placed or embedded in a predetermined position on one side of the base layer;
a non-translucent simulated fat layer that is placed on one surface of the base material and covers the organ model;
A human body model configured so that a puncture procedure can be performed on the simulated organ through the simulated fat layer.

(3) In the human body model described in (1) above,
A human body model, comprising: a fibrous member disposed around the target artificial organ within the main body.

(4) In the human body model described in (1) above,
The human body model, wherein the target artificial organ has an outer surface and an inner surface, the inner surface being lubricated.

According to a second aspect of the present invention,
(5) A method for training a puncture technique using a human body model,
Providing a human body model,
This human body model is
a body having one surface and another surface;
and a puncture target artificial organ disposed at a predetermined position within the main body,
the main body is configured so that the puncture target artificial organ cannot be seen from one side, but can be seen from the other side;
A step of performing a puncture procedure from one side of the human body model, using the puncture target artificial organ as a target;
and after performing the puncture procedure, confirming a result of the puncture procedure from the other surface side of the human body model.
is provided.

Features other than those mentioned above are disclosed in the following embodiment section and drawings.

FIG. 1 is a schematic diagram of an artificial organ model showing a first embodiment of the present invention. FIG. 2 is a schematic diagram showing puncture procedure training using the artificial organ model according to the first embodiment of the present invention.

FIG. 3 is a schematic diagram of an example of use of the artificial organ model according to the first embodiment of the present invention.

FIG. 4 is a schematic diagram of an example of use of the artificial organ model according to the first embodiment of the present invention.

FIG. 5 is a schematic diagram of an example of use of the artificial organ model according to the first embodiment of the present invention.

The following describes an embodiment of the invention with reference to the drawings.

Figure 1 is a cross-sectional view of the puncture simulator, which is a human body model of this embodiment, and Figure 2 is a perspective view showing its appearance.

(Basic configuration)
As shown in FIG. 1, the structure of the puncture simulator (the human body model of the present invention) is as follows:
First, the device has a multi-layer structure consisting of 1) a skin layer, 2) a fat layer, 3) a fiber layer (filling member), 4) a blood vessel model (target artificial organ), and 5) a bottom support layer. Here, the skin layer 1, the fat layer 2, and the bottom support layer 5 constitute the main body of the present invention, and these may be an inseparable integrated structure.

The thickness of the fat layer 2 is preferably at least 1 mm and at most 20 mm. The thickness of the fat layer is proportional to the difficulty of the puncture procedure, and by adjusting the thickness of the fat layer, it is possible to reproduce training using a puncture simulator with a higher level of difficulty. A thickness of 10 mm is suitable for training general medical trainees and clinical engineers.

Silicone rubber is a suitable material for the fat layer, but it is important that it is elastic, that the needle surface friction resistance during puncture is not too high, and that the physical properties are stable with little change over time. For a typical needle, puncture is performed with a load of about 0.05-1.0 N. Therefore, a resistance value that allows the surgeon to maintain a load resolution of at least 0.01 N is desirable.

It is preferable that the fiber layer 3 and the blood vessel model 4 are connected continuously or nearly continuously to each other. If the surgeon makes a mistake in penetrating the blood vessel during puncture, the fiber layer becomes entangled with the needle 6, creating a large resistance. In other words, the fiber layer is a necessary structure for realizing an immediate evaluation function that indicates to the surgeon the failure of the puncture procedure. In particular, by creating a boundary between the elastic structure and the fiber structure, it becomes possible to distinguish between areas where puncture is permitted and areas where puncture is prohibited during the puncture procedure.

The blood vessel models 4 are divided into arterial and venous models. Generally, punctures for inserting catheters or cannulas are performed on the femoral artery and femoral vein in the thigh. The arterial model simulating the femoral artery is made of silicone, and is preferably 6 mm in inner diameter and 8 mm in outer diameter. It is desirable that the model has a shape retention ability to the extent that it has a lumen space inside in the natural state. In other words, it has an elastic structure. On the other hand, the vein model is made of silicone and is a cylindrical structure with an inner diameter of 10 mm and an outer diameter of 11 mm, but it has poor structural shape retention and is suitable for a model in which the lumen shape is crushed under its own weight. By applying silicone oil to the inside of these blood vessel models in advance, it is possible to clearly let the operator recognize that the puncture into the blood vessel lumen has been successful due to the low frictional resistance value when puncturing with needle 6 and inserting the guide wire.

Next, the bottom support layer 5 for supporting the vascular model at its bottom must be transparent or semi-transparent. Its transparency must be such that the needle 6 and guide wire that were unable to capture the lumen of the target blood vessel during puncture can be visually recognized, and ideally it should be completely transparent. By making the bottom support layer transparent, the surgeon can instantly determine whether the puncture procedure was successful by turning the entire simulator upside down and visually inspecting the bottom during or after the puncture procedure. In other words, making the bottom support layer transparent can provide the simulator body with an instantaneous evaluation function.

This bottom support layer 5 is a layer structure connected to the outside of the posterior wall of the blood vessel model 4, and it is desirable for this to be a flexible structure with an elastic modulus close to that of 1 and 2, and it must not be a rigid body that does not have rubber-like elasticity. For example, if the bottom support layer 5) is made of a rigid material such as an acrylic plate or polycarbonate, which is transparent and has excellent workability and availability, the surgeon will not be able to detect the reaction force from the wall of the blood vessel model by touch when puncturing (this is evident from experiments).

That is, the bottom support layer 5 must be elastic and have a transparent or translucent structure.

In other words, the important points are 1 to 5 below.
1. Artificial fat layer on top of blood vessel model Thickness: 0-20 mm, optimal thickness is 10 mm
2. Transparent bottom plate 3. Elasticity of blood vessel fixing base 4. Fibrous tissue around the periphery of the blood vessel model (The fibrous tissue becomes entangled, allowing you to recognize that something other than a blood vessel has been pierced.)
5. Lubrication of the blood vessel lumen (difference between resistance of the outer wall and resistance of the inner wall)
According to this configuration, a simulator simulating a human thigh or the like can be reproduced, and puncture procedures for inserting a catheter or cannula can be efficiently and effectively trained. That is, the difficulty of the procedure can be adjusted by adjusting the thickness of the fat layer structure, failure when a site other than a blood vessel is punctured can be detected or evaluated by arranging and connecting fibrous tissue around the periphery of the blood vessel model, success or failure of puncturing the inside of the blood vessel can be appropriately evaluated by lubricating the inside of the blood vessel, evaluation can be performed as necessary by making the bottom support layer transparent, and the minute reaction force of the blood vessel wall can be recognized by making the bottom support layer an elastic body.

This allows the user to efficiently learn the delicate sensation of puncturing a blood vessel in the same way as a human.

(Production method)
The skin layer is made of silicone rubber and shaped to have dimensions of 400 mm x 100 mm x 3 mm thickness. Next, the fat layer is shaped to have dimensions of 350 mm x 60 mm x 10 mm.

Next, a tube-shaped artery model and vein model are formed. The artery model has an inner diameter of 6 mm, an outer diameter of 8 mm, and a length of 350 mm. The vein model has an inner diameter of 10 mm, an outer diameter of 11 mm, and a length of 350 mm. 2 cc of silicone oil is dripped into the artery model and vein model, and applied to the entire inner lumen surface.
A bottom support layer of 400mm x 100mm x 3mm thickness is then molded using clear silicone resin.

The assembly procedure is as follows: first, lay down the bottom support layer, and then glue and fix the blood vessel model to the surface of the bottom support layer. Next, place polyester fiber with a thickness of about 10 mm around the blood vessel.

The fat model is placed so that it covers the top of the blood vessels.

Next, the entire structure is covered with a skin layer, and the outer periphery is attached to the bottom support layer with a glue margin of about 3 mm, fixing the entire structure and enclosing all of the structures.

(evaluation)
The product of the present invention was evaluated by a specialist doctor who has experience in performing many puncture procedures on dialysis patients and in emergency medical care. When a puncture was performed using a 17.5 gauge needle, the artery model was punctured on the first try (as shown in Figure 3). Next, the vein model was punctured, and the first attempt pierced the back wall of the blood vessel, and the entire simulator was turned over to visually check the transparent bottom support layer, allowing the puncture failure to be evaluated (as shown in Figure 4). In the second puncture, a location where a blood vessel other than the target vessel was not present was punctured, so after the fat layer was penetrated, a significant increase in resistance due to the fibrous layer was felt, allowing the puncture procedure to be evaluated as a failure (as shown in Figure 5).

On the third attempt, the blood vessel lumen was successfully punctured, and when the guide wire was inserted into the blood vessel lumen through the puncture needle, a smooth insertion sensation was obtained due to the lubrication. This allowed the success of the puncture to be evaluated.

The above experiments enable accurate reproduction of failure and success modes in clinical practice, and provide the effect of enabling immediate self-evaluation of the success or failure of the puncture procedure.

This invention is not limited to the above embodiment, and various modifications are possible without departing from the spirit of the invention.

For example, in the above embodiment, the target artificial organ was a blood vessel model, but it may be another artificial organ model. The filling material is not limited to fibrous materials, and any material that provides a different feel from the artificial organ may be used.

Claims (2)

A human body model for training a trainee in puncture surgery, comprising:
a body having one surface and another surface;
and a puncture target artificial organ disposed at a predetermined position within the main body,
The body includes:
a base layer provided on the other surface side of the main body and made of a light-transmitting elastic material;
The puncture target artificial organ is configured to be visible from the other surface of the main body through the base layer,
The puncture target artificial organ is
A hollow portion having a lubricated inner surface is defined within the main body , and the change in puncture resistance provided by the lubricity of the inner surface of the hollow portion is configured to allow the trainee to detect the puncture of the puncture target artificial organ.
A human body model characterized by: A method for training a trainee in puncture surgery using a human body model,
Providing a human body model,
This human body model is
a body having one surface and another surface;
and a puncture target artificial organ disposed at a predetermined position within the main body,
The body includes:
a base layer provided on the other surface side of the main body and made of a light-transmitting elastic material;
The puncture target artificial organ is configured to be visible from the other surface of the main body through the base layer,
The puncture target artificial organ is
defining a hollow portion within the body, the inner surface of which is lubricated ;
a step of performing a puncture surgical procedure from one side of the human body model using the target artificial organ as a target, and having the trainee detect the puncture of the puncture target artificial organ based on a change in puncture resistance provided by the lubricity of the inner surface of the hollow portion;
and after performing the surgical procedure, visually checking a result of the surgical procedure on the target artificial organ from the other side of the human body model.

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