RU2754181C1 - Gel for ultrasound examinations - Google Patents

Abstract

FIELD: ultrasound examinations.

SUBSTANCE: invention relates to a gel for ultrasound examinations. The gel contains a base, glycerin and purified water. As a basis, carboxymethyl cellulose, diethylene glycol and sodium hydroxide are used. Additionally, the gel contains flavoring, preservatives and 75% medical alcohol. The content of the components of the finished gel is: carboxymethyl cellulose 15.9-17.5 g; diethylene glycol 4.5-5.5 ml; sodium hydroxide 10-11 g; glycerin 5.8-6.5 ml; distilled water 50 ml; flavoring 4-4.5 ml; preservatives 5.4-6 ml; 75% medical alcohol 0.28-0.59 ml.

EFFECT: obtaining a composition with high performance characteristics, expanding the scope and the possibility of reusable use.

4 cl, 5 dwg, 1 tbl, 3 ex

Description

The invention relates to compositions that are applied to various surfaces, and can be used when conducting ultrasound examinations (ultrasound).

Known contact acoustic paste "SONOGEL" (see https://www.sonogel.de/ultraschallgel) containing carboxymethylcellulose and distilled water.

The specified composition absorbs moisture from the air, dries for a long time and has a neutral pH, approximate, but not equal to the optimal value (7). In addition, since This paste is produced in Germany, it has a relatively high cost and therefore is not entirely suitable for the educational process.

As the closest analogue, a gel for ultrasound studies was adopted, containing a base, glycerin and purified water (see RF patent No. 2225729, IPC A61K 49/22, A61K 9/06, publication date 03/20/2004).

The disadvantages of the closest analogue are the disposability and narrowness of the scope of its application - for the study of various organs it is necessary to create gels of different compositions. It should also be noted that the patent does not provide information on the use of the gel on surfaces other than skin.

The problem to be solved by the present invention is the development of a gel that can be used when conducting ultrasound studies.

The technical result, which is achieved when solving the problem, is expressed in obtaining a composition with high performance characteristics, expanding the scope and the possibility of reusable use.

The problem is solved by the fact that the gel for conducting ultrasound examinations, containing a base, glycerin and purified water, differs in that carboxymethyl cellulose, diethylene glycol and sodium hydroxide are used as the base, in addition, the gel additionally contains a flavoring agent, preservatives and 75% medical alcohol, the content of the components of the finished gel is:

carboxymethyl cellulose, g 15.9-17.5 diethylene glycol, ml 4.5-5.5 sodium hydroxide, g 10-11 glycerin, ml 5.8-6.5 distilled water, ml 50 flavoring, ml 4-4.5 preservatives, ml 5.4-6 75% medical alcohol, ml 0.28-0.59

In addition, a menthol flavoring agent 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, the gel additionally contains a dye in the amount of 3.5-4 ml.

In addition, gum arabic, dextrin, gum, bovine bile and 75% medical alcohol are used as a dye at a ratio in vol.% As 20-25: 23-30: 11-20: 25-35: 4-7.

Comparative analysis of the set of essential features of the proposed technical solution and the set of essential features of the prototype and analogues indicates its compliance with the criterion of "novelty".

In this case, the distinctive features of the claims solve the following functional problems.

The signs "use carboxymethyl cellulose, diethylene glycol and sodium hydroxide as a basis" describe the composition of the base, in which carboxymethyl cellulose is a structurant, diethylene glycol is a binder for components at the second stage of preparation and a plasticizer for carboxymethyl cellulose, and sodium hydroxide is a pH regulator of the mixture obtained at the first stage of preparation ...

The sign "the gel additionally contains a fragrance" and the sign of the first dependent claim of the formula allow to determine the presence of the gel and how long ago it was applied to the surface by the intensity of the aroma, and the fragrance also has a soothing effect when the gel is applied or accidentally hit the human skin.

The sign "the gel additionally contains preservatives" and the signs of the second dependent claim provide a shelf life of 2-3 years when closed.

The sign "the gel additionally contains 75% medical alcohol" makes it possible to obtain the fused mixture at the third stage of preparation.

Signs “the content of the components of the finished gel is:

carboxymethyl cellulose, g 15.9-17.5 diethylene glycol, ml 4.5-5.5 sodium hydroxide, g 10-11 glycerin, ml 5.8-6.5 distilled water, ml 50 flavoring, ml 4-4.5 preservatives, ml 5.4-6 75% medical alcohol, ml 0.28-0.59 "

describe the optimal ratio of components to each other.

The signs of the third and fourth dependent claims of the formula allow using color identification to highlight control points for students to memorize the anatomical and topographic areas of gel application necessary for ultrasound, with the achievement of the most effective clinical and diagnostic result.

Figure 1 shows a polybutadiene rubber ball as an object of interest.

In figure 2, the process of conducting ultrasound of a plastic container with water and a ball made of polybutadiene rubber.

Figure 3 shows ultrasound images of a plastic container with water and a polybutadiene rubber ball, the object of interest is highlighted in a red frame:

a - using Akugel Neo gel;

b - using the inventive gel.

Figure 4 shows ultrasound images in the lumbar region of the abdominal cavity of a person to visualize the kidneys and the pelvis-calyx system:

a - using Akugel Neo gel;

b - using the inventive gel.

Figure 5 shows a colored gel for ultrasound examinations applied to the inner surface of a plastic dummy of an organ, in particular a human larynx.

The drawings show a ball 1 made of polybutadiene rubber, a plastic container 2, a sensor 3 of an ultrasound machine 4, a gel 5 for conducting ultrasound examinations, a plastic dummy 6 of the human larynx.

When checking the presence of phonophoretic properties, the ball 1, which is the object of interest, simulates an organ / foreign body, and the plastic container 2 simulates human skin, and its wall thickness is comparable to the thickness of the walls printed with a 3D printer of dummies of organs.

The inventive gel is prepared in several stages using standard technology on standard equipment.

At the first stage, carboxymethyl cellulose is poured with a solution consisting of 98% of the total amount of distilled water and glycerin, and heated to 72 ° C until the mixture swells, then mixed thoroughly by adding sodium hydroxide.

The resulting solution is poured into 2/3 of the total amount of 75% medical alcohol and then insisted in a dark place for 2-3 days.

At the second stage, the technologies for preparing transparent and colored gels for ultrasound examinations differ.

To obtain a transparent gel, a mixture is prepared containing 2% of the total amount of distilled water and diethylene glycol.

To obtain a color gel, gum arabic is ground to a powdery state and dissolved in a mixture containing 2% of the total amount of distilled water, diethylene glycol and bovine bile, then dextrin and gum are added.

At the third stage, to obtain a colored or transparent gel, benzoic, lactic and citric acids with 1/3 of the total amount of 75% medical alcohol are stirred at 73 ° C until a fused mixture is obtained.

At the end, the results obtained in the previous stages are mixed with each other until a homogeneous mixture is obtained, with the addition of a flavoring agent.

Examples of gel formulations are shown in Table 1.

Table 1

Gel formulations

Component name, unit of measurement Amount, ratio, vol.% Example 1 Example 2 Example 3 Distilled water, ml 50 50 50 Carboxymethylcellulose, g 15.9 17.5 16.7 Glycerin, ml 6.5 6.15 5.8 Diethylene glycol, ml 5 4.5 5.5 Sodium hydroxide, g eleven ten 10.5 Menthol (flavoring), ml 4 4.25 4.5 Preservatives (benzoic, lactic and citric acids), ml 5.7
(22:47:31) 5.4
(32:42:26) 6
(27:37:36) 75% medical alcohol, ml 0.28 0.43 0.59 Dye (gum arabic, dextrin, gum, bovine bile, 75% medical alcohol), ml 4
(20: 30: 11: 35: 4) - 3.5
(25: 23: 20: 25: 7) Finished product yield, g 102.38 98.23 103.09

The result is a gel with the following properties:

- the ability to conduct ultrasound studies of both organs and systems of the body, and on plastic models or dummies of organs;

- high adhesion properties (with a surface energy of 97-108 J / m) - so that the gel does not quickly drain from the surface (within 1.5-3 hours);

- neutral pH level (6.8-7.2), so that it does not react with other substances and does not irritate the human skin;

- the presence of phonophoretic properties for ultrasound with a penetration depth of up to 5 cm;

- the possibility of easy removal of the gel, without the use of special substances or tools;

- average viscosity - Brookfield value 16.0-20.0 Pas, so that visible traces from the tool influence remain and remain;

- the gel must maintain its viscosity, i.e. do not harden for 1.5-2 hours - this time is generally enough to carry out manipulation or conduct 1 pair during training;

- the gel can be stored for at least 2 years in a closed state;

- until the gel has hardened, it can be reused, for which it is recommended to pre-stir it.

The obtained laboratory results were tested in the laboratory of ecology of microorganisms with the International Scientific and Educational Center for Biological Safety of the School of Biomedicine of the Far Eastern Federal University and the laboratory of virology of the Federal Research Center of Biodiversity of Terrestrial Biota of East Asia FEB RAS.

The presence of phonophoretic properties of the gel was checked as follows.

When the sensor 3 (for example, the convex abdominal sensor C344) of the ultrasound machine 4 (for example, SonoScape S6Pro), on the surface of which the gel is applied, is in contact with the object, ultrasound is performed using standard technology and images are obtained.

For comparison with the claimed gel used Akugel Neo, reg. beats No. RZN 2018/7296 dated 21.06.2018.

Studies were carried out on a plastic container with water and a polybutadiene rubber ball, which mimic the skin, blood / body environment and organ / foreign body in the abdominal space, respectively (see Fig. 3) in order to visualize the foreign body and determine its size, as well as in the lumbar areas of the human abdominal cavity to visualize the kidneys and the calyceal system (see Fig. 4), and the resulting images were compared.

As can be seen in Fig. 3, when using different gels, the contours of the object of interest are quite clearly visualized, its dimensions are determined (25.8 mm).

As can be seen in Fig. 4, when using different gels, the image quality in the images is comparable. On the images of the abdominal cavity obtained using the inventive gel (see Fig. 4b), the renal calyceal system was better visualized, as a result of which it can be concluded that this gel allows for more informative ultrasound studies of the body.

Thus, it can be concluded that the inventive gel has similar phonophoretic characteristics with gels used for ultrasound studies.

Claims (6)

1. Gel for ultrasound examinations, containing a base, glycerin and purified water, characterized in that carboxymethylcellulose, diethylene glycol and sodium hydroxide are used as the base, in addition, the gel additionally contains a flavoring agent, preservatives and 75% medical alcohol, while the content of the components of the finished gel is: carboxymethyl cellulose, g 15.9-17.5 diethylene glycol, ml 4.5-5.5 sodium hydroxide, g 10-11 glycerin, ml 5.8-6.5 distilled water, ml 50 flavoring, ml 4-4.5 preservatives, ml 5.4-6 75% medical alcohol, ml 0.28-0.59 2. A gel according to claim 1, characterized in that a menthol flavoring agent is used. 3. The gel according to claim 1, characterized in that benzoic, lactic and citric acids are used as preservatives at a ratio, vol.%, As 22-32: 37-47: 26-36. 4. The gel according to claim 1, characterized in that the gel additionally contains a dye in an amount of 3.5-4 ml. 5. The gel according to claim 4, characterized in that gum arabic, dextrin, gum, bovine bile and 75% medical alcohol are used as a dye at a ratio, vol.%, As 20-25: 23-30: 11-20: 25 -35: 4-7.

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