RU2789406C1 - Removable plastic compound that transmits ultrasonic waves to simulate living tissues in mock-ups - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, in particular to a removable plastic composition that transmits ultrasonic waves to simulate living tissues in mock-ups. This plastic composition includes the following components: sodium bicarbonate, starch, distilled water, flavor, preservatives, dye, which are used in the stated amounts.

EFFECT: implementation of the invention makes it possible to reliably simulate living tissues in models, including in the form of shape-retaining objects, including volumetric ones, which can also be filled with liquids; in addition, it is possible to conduct an objective assessment of the correctness of performing manipulations with surgical and/or diagnostic instruments by a student on mock-ups of organs, including under ultrasound control.

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Description

The invention relates to compositions applied to the surfaces of various materials for use as a plastic agent in modeling body tissues, and / or as an additional means of visualization and assessment of the correctness of performing manipulations with surgical and / or diagnostic instruments by a student on mock-ups of organs.

Known compositions of gels used to assess the correctness of the impact of the instrument on models or dummies of human body organs (see RF patent No. 2746244, IPC A61K 9/06, G09B 23/28, A61L 31/00, A61B 90/00, publication date 09.04. 2021) or performing ultrasound examinations (see RF patent No. 2754181, IPC A61K 49/22, A61K 9/06, A61B 8/00, publication date 08/30/2021).

As disadvantages of analogues, it can be indicated that these compositions:

- are not intended for volumetric modeling, since they are made in the form of gels with a relatively viscous consistency;

- water-soluble, and therefore the cavities of models with gel applied to their surface cannot be filled with liquids.

As the closest analogue, a plasticine composition was adopted containing a base in the form of a salt of carbonic acid and a dye (see RF patent No. 2635258, IPC C08L 91/06, C08L 91/00, C08L 3/02, C08K 13/02, publication date 09.11. 2017).

The disadvantage of the closest analogue is its lack of phonophoretic properties, which significantly reduces the effectiveness and objectivity of assessing the results of performing manipulations with surgical and/or diagnostic instruments by a student on mock-ups of organs.

The task to be solved by the claimed invention is the development of a removable and reusable composition for modeling body tissues and assessing the correctness of performing manipulations with surgical and/or diagnostic instruments of a student on mock-ups of organs, including under ultrasound control.

Also, the specified composition is suitable for bonding plastic surfaces together.

The technical result achieved in solving the problem is expressed in the possibility of reliable modeling of living tissues in models, including in the form of shape-retaining objects, including volumetric ones, which can also be filled with liquids, and the possibility of an objective assessment of the correctness of performing manipulations with surgical and / or diagnostic tools of the student on mock-ups of organs, including those under ultrasound control.

The problem is solved by the fact that the removable plastic composition that transmits ultrasonic waves to simulate living tissues in mock-ups, containing a base in the form of a carbonic acid salt and a dye, differs in that it additionally contains distilled water, preservatives and flavoring, and sodium bicarbonate is used as the base and starch in the following ratio of components per 100 g of the finished product:

sodium bicarbonate, g 31.4-32.3 starch, g 14.2-15.6 distilled water, ml 47.5 flavor, ml 0.8-1.2 preservatives, ml 1.7-2.4 dye, ml 3.0-3.2

In addition, the flavoring "menthol" is used.

In addition, benzoic, lactic and citric acids are used as preservatives at a ratio in vol.% as 22-32:37-47:26-36.

In addition, gum arabic, dextrin, gum, ox bile, 75% medical alcohol and distilled water are used as a dye at a ratio in vol.% as 1.7-3.4:3.4-5.1:1, 36-3.06:4.25-5.95:2.04-3.74:83.

Comparative analysis of the features of the proposed solution with the features of the prototype and analogues indicates the compliance of the claimed solution with the criterion of "novelty".

At the same time, the features of the claims provide a solution to the following functional problems.

The sign "removable plastic composition ... additionally contains distilled water" allows you to connect the components together and achieve the desired consistency.

The sign "removable plastic composition ... additionally contains preservatives" and the signs of the second dependent claim provide a shelf life of 2-3 years in the closed state and non-hardening of the plastic composition for six months.

The sign "removable plastic composition ... additionally contains a flavor" and the sign of the first dependent claim make it possible to reduce the level of contamination by microorganisms of the surface of the composition itself and the surface on which it is applied, with the reusable use of surgical and / or diagnostic instruments, and by the level of reduction in concentration in the air to judge the time of application of the composition.

Also, in connection with direct contact with the surface of the hands and / or protective gloves, this feature allows students to judge the correctness of the impact of the tool.

The features “sodium bicarbonate and starch are used as the base” describe the composition of the base, in which sodium bicarbonate is a structurant, and starch is a binder for components in the second stage of preparation and a plasticizer for sodium bicarbonate.

The signs of the third dependent claim make it possible to distinguish and demarcate zones of "interest" and "errors" and objectify in assessing the correctness of the impact of the tool on the layouts by determining the level of deformation of the composition.

In FIG. 1 shows a general view of the model of the pelvic organs in men.

In FIG. 2 shows a side view of the main elements with the contour of the pelvic bones.

In FIG. 3 shows an instrument that affects the layout of the pelvic organs in men.

In FIG. 4 illustrates the insertion of the instrument into the model of the small pelvic organs in men.

In FIG. 5 shows the instrument after its correct introduction into the model of the small pelvic organs in men.

In FIG. 6 shows the instrument after its incorrect insertion into the model of the small pelvic organs in men.

In FIG. 7 shows the removable plastic composition in the form of a layer 1-2 mm thick in two projections.

In FIG. 8 shows an object of interest in the form of a polybutadiene rubber ball in different colors.

In FIG. 9-11 shows the study of the phonophoretic properties of the plastic composition applied to the ultrasound sensor, with the object of interest (marked with a red frame in the ultrasound images) immersed in a plastic container with water:

in fig. 9 - when the object of interest is located in the immediate vicinity of the ultrasonic sensor:

a - research methodology;

b - ultrasound image;

in fig. 10 - when the object of interest is located at a distance of about 4 cm from the ultrasound sensor:

a - research methodology;

b - ultrasound image;

in fig. 11 - when the object of interest is located at a distance of about 8 cm from the ultrasound sensor:

a - research methodology;

b - ultrasound image.

In FIG. 12-13 shows a study of the phonophoretic properties of a plastic composition applied to the outer surface of the wall of a container with water in which an object of interest is immersed:

in fig. 12 - when the object of interest is located at a distance of about 4 cm from the ultrasound sensor:

a - research methodology;

b - ultrasound image;

in fig. 13 - when the object of interest is located at a distance of about 8 cm from the ultrasound sensor:

a - research methodology;

b - ultrasound image.

The drawings show the bones 1 of the pelvis, the base 2, the bladder 3, the prostate 4 and its cavity 5, communicated with through holes 6, the ampulla 7 of the rectum and its cavity 8, communicated with through holes 9 and 10, the gap 11 between facing each other each other with the surfaces of the ampoule 7 of the rectum and the prostate 4, the removable indicator composition 12, 13 and 14 applied to the surfaces of the cavities 5 and 8 of the prostate 4 and the ampoule 7 of the rectum, respectively, as well as in the gap 11 between the ampoule 7 of the rectum and the prostate 4, the tool 15.

To study the phonophoretic properties of the removed plastic composition 16, an object of interest 17, a plastic container 18 with water, and an ultrasonic sensor 19 were used.

The layout contains the bones 1 of the pelvis, placed on the base 2 and forming a closed contour in plan.

Inside the contour of the bones 1 of the pelvis, the bladder 3, the prostate 4 and the ampulla 7 of the rectum are placed, and the bladder 3 is attached to the inner surface of the front part of the contour of the bones 1 of the pelvis facing it, and on the inner surface of the rear part of the contour of the bones 1 of the pelvis one of the side parts of the ampoule 7 of the rectum, which are removable connected to each other, and the lower end of the ampoule 7 of the rectum is placed below the bones 1 of the pelvis.

At the same time, on the back surface of the lower part of the bladder 3, one of the lateral parts of the prostate 4 is fixed, which are removably connected to each other.

Ampoule 7 of the rectum and prostate 4 are located with the formation of a gap 11 between their facing surfaces, provided with through holes 10 and 6, respectively, which are made with the possibility of communicating with each other.

On the surface of the cavities 5 and 8 of the prostate 4 and the ampoule 7 of the rectum, respectively, as well as in the gap 11 between the ampoule 7 of the rectum and the prostate 4, a removable indicator composition 12, 13 and 14, respectively, is applied.

The inventive plastic composition is prepared in several stages according to standard technology on standard equipment.

At the first stage, sodium bicarbonate is poured with a solution consisting of 95% of the amount of distilled water intended for the manufacture of a plastic composition at a temperature of +2±1°C and starch.

At the second stage, gum arabic is crushed to a powder and dissolved in a mixture containing distilled water and ox bile, then dextrin, gum and 75% medical alcohol are added, stirring to a homogeneous substance.

In the third stage, benzoic, lactic and citric acids are stirred at a temperature of 50°C until a solution is obtained.

At the end, the results obtained in the previous steps are mixed together, then thoroughly mixed and heated to 75 ° C until the mixture acquires the shape of a ball, with the addition of flavor and 5% of the amount of distilled water intended for the manufacture of a plastic composition.

Examples of the compositions of the removed plastic composition are presented in table 1.

Table 1
The compositions of the removed plastic composition Component name, unit of measurement Amount per 100 g of removed plastic composition, ratio in vol. % Example 1 Example 2 Example 3 Distilled water, ml 47.5 47.5 47.5 Sodium bicarbonate, g 31.4 32.3 31.9 Starch, g 15.6 14.6 14.2 Menthol (flavor), ml 1.0 0.8 1.2 Preservatives (benzoic, lactic and citric acids), ml 2.2
(22:47:31) 1.7
(32:42:26) 2.4
(27:37:36) Dye (gum arabic, dextrin, gum, ox bile, 75% medical alcohol, distilled water), ml 3.2
(1.7:5.1:2.21:5.95:2.04:83) 3.1
(3.4:4.25:1.36:5.1:2.89:83) 3.0
(2.55:3.4:3.06:4.25:3.74:83)

The result is a removable plastic composition with the following characteristics:

- stable amorphous consistency at room temperature (the atomic structure must have a short-range order and no long-range order, determined by electron microscopy or X-rays), so that the composition has resistance to shear deformations;

- the composition must be chemically neutral (6.0 < pH < 8.0) so as not to react with other substances and not cause an allergic reaction in humans;

- the basic consistency of the composition is colorless, with the possibility of coloring it by adding dyes;

- the possibility of free application and removal of the composition from the surfaces of the organ model without the use of specific materials;

- the composition must have plastic properties with the possibility of its deformation and change depending on the tasks being solved;

- water tightness and good miscibility;

- the presence of high adhesive properties with a surface energy of 194-216 J/m for a strong adhesion of the composition (as an adhesive) to plastic parts (as a substrate).

The obtained laboratory results were tested in the Laboratory of Microbial Ecology with the International Scientific and Educational Center for Biological Safety of the School of Medicine of the Far Eastern Federal University and the Laboratory of Virology of the Federal Scientific Center for Biodiversity of Terrestrial Biota of East Asia, Far Eastern Branch of the Russian Academy of Sciences.

An objective assessment of the correctness of manipulations with surgical and/or diagnostic instruments on mock-ups of organs is carried out as follows.

1. A removable plastic composition is applied to the surfaces of mock-ups of organs to simulate the surface tissue structures of the body (mucous and submucosal, mesenchyme and adventitia, etc.).

With regard to the model of the pelvic organs in men, shown in Fig. 1, a removable indicator compound 12, 13 is applied to the surfaces of the cavities 5 and 8 of the prostate 4 and rectal ampule 7, respectively.

2. If necessary, carry out activities for the assembly / modification of mock-ups of organs.

In this case, the indicator composition 14 to be removed can be preliminarily applied to the surface of the ampoule 7 of the rectum or prostate 4, or placed in the gap 11 between the ampoule 7 of the rectum and the prostate 4 of the already assembled model.

The layout is installed by resting it on the back or side plane of the base.

At the same time, the implementation of the layout elements, on which the removable plastic composition is applied, from PLA plastic or acrylonitrile butadiene styrene increases the efficiency and visibility of exposure to ultrasonic waves.

3. Tool 15 is inserted into the layout with simultaneous exposure to ultrasonic radiation (see Fig. 4).

The tool 15 is inserted through the inlet through hole 9 into the cavity 8 of the ampoule 7 of the rectum and through the through hole 10 is directed through the removable indicator composition 14 and then through the removable indicator composition 12, placed in the through hole 6, into the cavity 5 of the prostate 4.

As an example of instrument 15 (see Fig. 3) can be a biopsy needle attached to a Sonoscape 6V3 intracavitary microconvex probe (radiating surface radius 10 mm).

4. Perform the necessary manipulations with surgical and / or diagnostic instruments, as an example for the model of the small pelvic organs in men, you can take an operation to conduct a multifocal biopsy of the prostate (PZ) under ultrasound control or transrectal ultrasound (TRUS).

5. Dismantle the model of the pelvic organs in men.

6. Examine the results of exposure to the tool.

This action is performed by examining the removed indicator composition 12-14 for the presence of deformations and damages with an assessment of the depth, trajectory of movement and location of the impact with the tool 15.

The use of a removable indicator composition 12-14 of different colors on the surfaces of the prostate 4 and ampoule 7 of the rectum, made of plastic, makes it possible to demonstrate the residual composition 12-14 on the instrument 15 (see Fig. 5, 6), which allows the specialist to objectively detect areas and evaluate the topography of the impact of the instrument.

Moreover, the student has the opportunity to conduct individual self-control of the quality of the performed instrument manipulations without the direct participation of a specialist (for example, a teacher), as well as directly observe the accuracy of the manipulation.

7. The plastic color composition 12-14 is removed from the surface of the mock organs (for example, manually) with cleaning and/or replacement of the tool 15.

To study the phonophoretic properties of plastic composition 16, Akugel Neoreg ultrasound gel was used. beats No. РЗН 2018/7296 dated 06/21/2018, ultrasonic transducer 19 convex abdominal C344 for ultrasound apparatus SonoScape S6Pro, plastic container 18, the wall thickness of which is comparable to the wall thickness of the layout elements, on which the removable plastic composition is applied.

Water and an object of interest 17 in the form of a ball are added to the plastic container 18, thus simulating, for example, blood or pus (with an abscess) or glandular secretion, the prostate wall (plastic) and an abscess inside the cavity (ball).

Next, a removable plastic composition 16 is applied, a gel is applied to the ultrasound sensor 19, after which ultrasound is performed to visualize the object of interest 17 as a foreign body and determine its size.

Based on Fig.9-13, it can be concluded that regardless of where the removable plastic composition 16 is applied (US sensor 19/plastic container wall 18):

- removable plastic composition for application to plastic objects with a thickness of 1-2 mm has the ability to conduct ultrasound;

- when the object of interest approaches the transabdominal ultrasound sensor 19, signal suppression is observed (see Fig. 9);

- the zone of acoustic visibility of the object starts from 4 cm, at a distance (about >4 cm) the contours of the object begin to appear (see Fig. 10 and 12), at a distance of about >6 cm, the contours of the object of interest become quite clearly visualized with the possibility of determining its size (25.8 mm), and the maximum resolution is achieved at a distance of 8 cm (see Fig. 11 and 13);

- the presence of air layers between the wall of the plastic container 18 and the removed plastic composition sharply worsens the sensitivity of the ultrasonic sensor 19 to reflected ultrasonic waves and, accordingly, the quality of the ultrasonic-assisted manipulation.

Thus, the inventive removable plastic color composition can be used not only for modeling body tissues or as an indicator composition when assessing the correctness of performing manipulations with surgical and / or diagnostic instruments on mock-ups of organs, but also while implementing the mentioned manipulations with ultrasound (ultrasound) in the event that the layout elements, on which the removable plastic composition is applied, are made of plastic that is permeable to ultrasonic waves.

The attributes under consideration make it possible to objectify the evaluation of specialists in the analysis of the results of the implementation of the actions of students and better conduct of practical classes.

Claims (5)

1. A removable plastic composition that transmits ultrasonic waves to simulate living tissues in mockups, containing a base in the form of a carbonic acid salt and a dye, characterized in that it additionally contains distilled water, preservatives and flavoring, and sodium bicarbonate and starch are used as the base when the following ratio of components per 100 g of the finished product: Sodium bicarbonate, g 31.4-32.3 Starch, g 14.2-15.6 Distilled water, ml 47.5 Flavor, ml 0.8-1.2 Preservatives, ml 1.7-2.4 Dye, ml 3.0-3.2 2. Removable plastic composition according to claim 1, characterized in that the flavor "menthol" is used. 3. Removable plastic composition according to claim 1, characterized in that benzoic, lactic and citric acids are used as preservatives at a ratio in vol.% as 22-32:37-47:26-36. 4. Removable plastic composition according to claim 1, characterized in that gum arabic, dextrin, gum, ox bile, 75% medical alcohol and distilled water are used as a dye at a ratio in vol.% as 1.7-3.4 :3.4-5.1:1.36-3.06:4.25-5.95:2.04-3.74:83.

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