WO2024048067A1

WO2024048067A1 - Blood vessel model

Info

Publication number: WO2024048067A1
Application number: PCT/JP2023/024917
Authority: WO
Inventors: 信圭山中; 明日香関下
Original assignee: 朝日インテック株式会社
Priority date: 2022-09-02
Filing date: 2023-07-05
Publication date: 2024-03-07
Also published as: JP2024035348A

Abstract

The purpose of the present invention is to provide a blood vessel model that enables easy and reliable observation of a fluid leaking outward from a pseudo vessel through a perforated hole.　The blood vessel model 1 is provided with a pseudo vessel 11 having a lumen 11h and simulating a blood vessel and a support member 21 placed to cover the outer circumference of the pseudo vessel 11, wherein a liquid leak detection region R, in which the outer circumference surface 11s of the pseudo vessel 11 and the support member 21 are placed in contact in a separable manner, is formed on at least a part of the outer circumference along the longitudinal direction of the pseudo vessel 11.

Description

blood vessel model

The present invention relates to a blood vessel model.

For example, there are thin, curved, soft blood vessels in the body, such as collateral channels that bypass coronary arteries. During a procedure such as inserting an instrument such as a guide wire into such a blood vessel, the risk of accidentally penetrating the blood vessel increases. Therefore, in order to perform the above-mentioned procedures, it is necessary to acquire advanced and skilled techniques in advance.

As a measure to acquire the above-mentioned techniques, for example, a training blood vessel model that simulates blood vessels in the body has been proposed (see, for example, Patent Document 1).

JP2017-53897A

In the conventional blood vessel model as described above, a blood vessel itself having a texture similar to an actual blood vessel can be reproduced. However, in order to experience a more realistic procedure, a model that can simulate the texture of tissues surrounding blood vessels is more preferable.

The present invention has been made based on the above-mentioned circumstances, and its purpose is to provide a blood vessel model that allows easy and reliable observation of liquid leaking from a pseudo blood vessel to the outside through a perforation. be.

Some aspects of this disclosure include:
(1) A blood vessel model comprising a pseudo blood vessel having a lumen simulating a blood vessel, and a support member disposed to cover the outer periphery of the pseudo blood vessel,
A liquid leak detection area is provided on at least a portion of the outer periphery along the longitudinal direction of the pseudo blood vessel, in which the outer circumferential surface of the pseudo blood vessel and the support member are arranged in contact with each other so that they can be separated from each other. blood vessel model,
(2) The blood vessel model according to (1) above, wherein a liquid having a pressure higher than the pressure applied to the outer peripheral surface of the pseudo blood vessel is contained in the inner lumen of the pseudo blood vessel, and (3) the support member, or The blood vessel model according to (1) or (2), wherein the support member and the pseudo blood vessel are made of a material transparent to visible light.

The present invention can provide a blood vessel model that allows easy and reliable observation of liquid leaking from a pseudo blood vessel to the outside through a perforation.

FIG. 1 is a schematic cross-sectional view showing one embodiment of a blood vessel model. FIG. 2 is a schematic cross-sectional view showing a state in which the blood vessel model of FIG. 1 is used. FIG. 2 is a schematic cross-sectional view showing a state in which the blood vessel model of FIG. 1 is used.

A blood vessel model of the present disclosure includes a pseudo blood vessel having a lumen simulating a blood vessel, and a support member disposed to cover the outer periphery of the pseudo blood vessel, the blood vessel model comprising: a pseudo blood vessel having a lumen simulating a blood vessel; A liquid leakage detection region is provided on at least a portion of the outer circumference along the direction, in which the outer circumferential surface of the pseudo blood vessel and the support member are arranged in contact with each other so as to be able to separate from each other.

Hereinafter, one embodiment of the present invention will be described with reference to the drawings, but the present invention is not limited only to the embodiment described in the drawings. Further, the dimensions of each part shown in the drawings are shown to facilitate understanding of the implementation details, and do not necessarily correspond to actual dimensions.

FIG. 1 is a schematic cross-sectional view showing one embodiment of a blood vessel model. As shown in FIG. 1, the blood vessel model 1 is roughly composed of a pseudo blood vessel 11 and a support member 21.

The pseudo blood vessel 11 is a member having a lumen 11h that simulates a blood vessel. The configuration of the pseudo blood vessel 11 is not particularly limited as long as it has a texture (flexibility, strength, etc.) comparable to that of an actual blood vessel. A liquid, which will be described later, can flow through the lumen 11h of the pseudo blood vessel 11. The pseudo blood vessel 11 of this embodiment is exemplified as a pseudo blood vessel that is composed of a tubular inner layer and a tubular outer layer that is laminated to cover the outer periphery of the inner layer.

Examples of the materials constituting the inner layer and outer layer of the pseudo blood vessel 11 include silicone, polyvinyl alcohol, and the like. Note that the inner layer may be configured by physical crosslinking. The outer layer may be composed of physical crosslinks and chemical crosslinks. Since the outer layer contains chemical crosslinking (crosslinking using a crosslinking agent), stress that causes the pseudo blood vessel 11 to contract in the circumferential direction is generated. Thereby, since the inner layer receives compressive stress, for example, when penetrating the pseudo blood vessel 11, it is possible to obtain a texture that is closer to that of an actual blood vessel.

The liquid contained in the lumen 11h of the pseudo blood vessel 11 is not particularly limited as long as it can flow through the lumen 11h. Examples of the liquid include a blood imitation that simulates blood, a medicinal solution such as physiological saline, and the like.

Note that the inner lumen 11h of the pseudo blood vessel 11 may contain a liquid with a pressure higher than the pressure applied to the outer circumferential surface 11s of the pseudo blood vessel 11. That is, the pressure of the liquid within the pseudo blood vessel 11 may be set to a pressure higher than atmospheric pressure (1 atm). In this case, for example, if a perforation occurs in the pseudo blood vessel 11 for some reason, liquid can be reliably leaked from the pseudo blood vessel 11 to the outside through the perforation, just like in an actual blood vessel. Further, it is possible to check whether or not there is a leakage of liquid based on the presence or absence of a drop in the pressure of the liquid.

The support member 21 is a member arranged to cover the outer periphery of the pseudo blood vessel 11. The support member 21 simulates the area around which the blood vessel penetrates (for example, tissues such as subcutaneous tissue and muscle tissue). The hardness of the support member 21 can be appropriately selected depending on the part to be simulated.

Examples of the material constituting the support member 21 include silicone rubber, acrylic rubber, olefin rubber, polyurethane, and the like. Among these, silicone rubber is preferred, and a mixture of silicone rubber and silicone oil that is heat-cured is more preferred. This makes it possible to obtain a texture close to the actual tissue surrounding the blood vessel. Note that the mixing ratio of silicone rubber and silicone oil, heating conditions, etc. can be appropriately selected depending on the hardness of the part to be simulated.

Furthermore, the support member 21 or the support member 21 and the pseudo blood vessel 11 may be formed of a material that is transparent to visible light. Thereby, the liquid leaked from the pseudo blood vessel 11 can be visually observed through the support member 21.

In such a case, examples of the transparent material forming the support member 21 include silicone resin, urethane resin, polyvinyl alcohol (PVA) resin, and the like. Examples of the transparent material forming the pseudo blood vessel 11 include polyvinyl alcohol (PVA) resin.

Here, a liquid leakage detection region R is provided on at least a part of the outer circumference along the longitudinal direction of the pseudo blood vessel 11, in which the outer circumferential surface 11s of the pseudo blood vessel 11 and the support member 21 are arranged in contact with each other in a separable state. There is. Note that the pseudo blood vessel 11 in the area other than the liquid leakage detection area R and the support member 21 may be fixed to each other.

The portion where the liquid leak detection region R is provided may be provided along the entire length of the pseudo blood vessel 11, or may be provided along a part of the length of the pseudo blood vessel 11. The liquid leakage detection region R of this embodiment is provided so as to include the entire curved portion W of the pseudo blood vessel 11 that curves into an S-shape (the region indicated by the arrow R in FIG. 1).

Here, the contact state between the outer circumferential surface 11s of the pseudo blood vessel 11 and the support member 21 in the liquid leakage detection region R is simply a physical condition as long as it can be easily separated by leakage of liquid from the pseudo blood vessel 11. They may be in contact with each other or may be bonded with weak bonding force (for example, weak adhesive, weak chemical bond, etc.).

For example, suppose that a perforation 11p occurs in the pseudo blood vessel 11, and the liquid L leaks to the outside of the pseudo blood vessel 11 through the perforation 11p, as shown in FIG. 3, which will be described later. In this case, in the liquid leakage detection region R, the outer circumferential surface 11s of the pseudo blood vessel 11 and the support member 21 are arranged in contact with each other in a separable state, so that the leaked liquid L may cause the outer circumferential surface 11s of the pseudo blood vessel 11 and the support member 21 can be easily pushed out. As a result, a storage space C filled with the liquid L is formed around the pseudo blood vessel 11.

The formed storage space C can be observed from the outside of the blood vessel model 1. Examples of observation methods include an observation method using an imaging device that uses an X-ray transmission image, an ultrasound reflection image, an MRI, etc., a support member 21 made of a material transparent to visible light, or a pseudo A visual observation method such as observation through the blood vessel 11 with the naked eye or an optical microscope can be adopted.

Next, how the blood vessel model 1 is used will be explained with reference to FIGS. 2 and 3. Here, as the liquid L, pseudo blood L1 having a viscosity comparable to that of blood is exemplified.

FIG. 2 is a schematic cross-sectional view of an apparatus for use in the blood vessel model 1. The blood vessel model 1 may be used while being placed in a container 51, for example, as shown in FIG. The container 51 is provided with a connector 61, a connector 71, and a pressure gauge 81.

The connector 61 is connected to one end of the pseudo blood vessel 11 and has a lumen 61h that communicates with the lumen 11h of the pseudo blood vessel 11. The inner cavity 61h of the connector 61 is branched into two. The pseudo blood L1 is injected into one lumen 61h1 from a pump for injecting pseudo blood (not shown) via the hemostasis valve V1. A medical instrument such as a guide wire GW is inserted into the other lumen 61h2 via the hemostasis valve V2.

The connector 71 is connected to the other end of the pseudo blood vessel 11 and has a lumen 71h that communicates with the lumen 11h of the pseudo blood vessel 11. In this embodiment, the end of the connector 71 is closed with a hemostatic valve V3.

The pressure gauge 81 is connected to the connector 71 and measures the pressure of the pseudo blood L1 within the pseudo blood vessel 11. As the pressure gauge 81, for example, a pressure gauge having the same degree of accuracy as a blood pressure monitor that can measure the pressure of blood flowing in an actual blood vessel may be used.

When using the blood vessel model 1, first, pseudo blood L1 is poured into the pseudo blood vessel 11. Specifically, the pseudo blood L1 is injected from the pump into the lumen 11h of the pseudo blood vessel 11 via the lumen 61h1 of the connector 61 so as to maintain a predetermined pressure while watching the pressure gauge 81. Note that the predetermined pressure can be set to a pressure at which the pseudo blood L1 leaks from the pseudo blood vessel 11 to the outside through the perforation 11p formed in the wall of the pseudo blood vessel 11. The predetermined pressure may be set to a pressure (actual blood pressure) that will result in a desired leakage state (bleeding state).

Next, the guide wire GW is inserted into the pseudo blood vessel 11. Specifically, after inserting the guide wire GW into the lumen 11h of the pseudo blood vessel 11 via the lumen 61h2 of the connector 61, the distal end of the guide wire GW is advanced to the site to be treated.

Here, it is assumed that during operation of the guide wire GW, the tip of the guide wire GW penetrates the blood vessel wall of the pseudo blood vessel 11, and a perforation 11p is formed in the blood vessel wall of the pseudo blood vessel 11. At this time, as shown in FIG. 3, in the liquid leakage detection region R of the blood vessel model 1, the pseudo blood L1 leaks to the outside of the pseudo blood vessel 11 through the perforation 11p. When the leaked pseudo blood L1 reaches the boundary between the outer circumferential surface 11s of the pseudo blood vessel 11 and the support member 21, the pressure of the pseudo blood L1 pushes the boundary apart, and the area around the pseudo blood vessel 11 is filled with the pseudo blood L1. A storage space C is formed.

While the blood vessel model 1 is in use, it is constantly observed whether the storage space C is formed or not. The presence or absence of the storage space C and its position may be observed, for example, using the above-mentioned visual observation method. Thereby, while the blood vessel model 1 is in use, it is possible to visually confirm the presence or absence of leakage of the pseudo blood L1 from the perforation 11p caused by the penetration of the guide wire GW, and the position of the leakage. The presence or absence of leakage of the pseudo blood L1 is confirmed based on the presence or absence of a decrease in the pressure of the pseudo blood L1 accommodated in the pseudo blood vessel 11, for example, by tracking the pressure of the pseudo blood L1 obtained with the pressure gauge 81. You can also do that.

As described above, since the blood vessel model 1 has the above configuration, it is possible to easily and reliably observe the pseudo blood L1 (liquid L) leaked from the pseudo blood vessel 11 to the outside through the perforation 11p in the liquid leakage detection region R. can. Therefore, the blood vessel model 1 can be suitably used, for example, for training to acquire advanced and skilled techniques using the guide wire GW.

The present disclosure is not limited to the configuration of the embodiments described above, but is indicated by the scope of the claims, and is intended to include all changes within the scope and meanings equivalent to the scope of the claims. be done. Some of the configurations of the embodiments described above may be deleted or replaced with other configurations, or other configurations may be added to the configurations of the embodiments described above.

For example, in the embodiment described above, the blood vessel model 1 was described in which the liquid leakage detection region R was provided so that the entire curved portion W of the pseudo blood vessel 11 was included. However, the liquid leakage detection region R only needs to be provided so that at least a portion of the pseudo blood vessel 11 is included. The liquid leak detection region R may be provided on the entire outer peripheral surface 11s of the pseudo blood vessel 11 along the longitudinal direction of the pseudo blood vessel 11. The liquid leak detection region R may be provided at two or more independent parts of the outer peripheral surface of the pseudo blood vessel 11 along the longitudinal direction of the pseudo blood vessel 11.

Furthermore, in the above-described embodiment, the blood vessel model 1 including the two-layer (inner layer and outer layer) pseudo blood vessel 11 formed of a specific material has been described. However, the pseudo blood vessel may be any known pseudo blood vessel as long as it does not impair the effects of the present invention.

Furthermore, in the embodiment described above, the liquid L is exemplified by the pseudo blood L1. However, as the liquid L, a liquid other than the pseudo blood L1, such as a medical solution, may be appropriately selected depending on the purpose.

1 Blood vessel model 11 Pseudo blood vessel 11s Outer peripheral surface 21 Support member R Liquid leak detection region L Liquid L1 Pseudo blood

Claims

A blood vessel model comprising a pseudo blood vessel having a lumen simulating a blood vessel, and a support member disposed to cover the outer periphery of the pseudo blood vessel,
A liquid leak detection area is provided on at least a portion of the outer periphery along the longitudinal direction of the pseudo blood vessel, in which the outer circumferential surface of the pseudo blood vessel and the support member are arranged in contact with each other so that they can be separated from each other. Blood vessel model.
The blood vessel model according to claim 1, wherein a liquid having a higher pressure than the pressure applied to the outer peripheral surface of the pseudo blood vessel is contained in the inner lumen of the pseudo blood vessel.
The blood vessel model according to claim 1 or 2, wherein the support member, or the support member and the pseudo blood vessel are made of a material that is transparent to visible light.