LV14915B - An article for determining limits of an artificial tumor on the artificial skin and a method of ultrasonic investigation - Google Patents

Abstract

The invention relates to medicine, oncology in particular, and applies in detection of noninvasive signs in the border between malignant tumour tissue and healthy skin to perform radical surgery in case of basal cell skin cancer.A construction for detecting borders of tumour consists of straight aluminium wire with straight edges, the lenght of the wire is 3.0 – 10.0 cm and diameter is 0.06 – 0.1 cm.The invention relates also to a new method of ultrasonographic investigation, where the said construction is used.

Description

DESCRIPTION OF THE INVENTION

The invention relates to medicine, in particular to oncology, and may be used to determine non-invasive features at the borderline between tumor tissue and healthy tissue for radical surgery in basal cell cancer of the skin.

TECHNICAL LEVEL

An increase in the number of malignant neoplasms is observed: the incidence of skin cancer ranges from 50-60 to 140 (middle-aged, sick) per 100,000 population. A patient with suspected skin lesions undergoes surgical excision (biopsy) and histological examination. An excisional biopsy is performed in dermatology, in which case the entire tumor is excised. There is a known technique for the indication of surgical excision in the case of facial skin basal cell carcinoma (BCC): the patient undergoes tumor excision with 2 to 4 mm intact skin tissue. When planning tumor excision in cosmetically sensitive areas, especially on the face, the surgeon must consider 2 essential factors before surgery - eliminate the entire tumor without leaving malignant cells and maintain a cosmetically acceptable appearance with a minimal deviation in healthy tissues. The surgeon focuses on the empirical conditions at the time of the excision, correcting for the intraocular lesion about 3-4 mm from the visually visible edge of the BCC.

In the case of basal cell carcinoma of the skin, where the tumor is located on the face and neck, from a cosmetic point of view, such extensive coverage of healthy skin can have negative consequences. Prior to surgery, it would be desirable to determine certain specific parameters for the borderline between the tumor tissue and the healthy tissue.

Qualitative ultrasound scanners are used for visualization of the damaged skin, which allows to determine the size, shape, depth and degree of the damaged skin before the surgical excision [1-4]. However, after the examination, there is no mark on the surface of the skin by the surgeon who will perform the excision of this tumor. This assessment of tumor boundaries is very important because the presence of malignant cells in the deeper tissues - the dermis and the hypoderm - does not coincide with its visually visible boundaries on the epidermis.

The details of the difficulty in developing an informative, non-invasive, easy-to-repeat, harmless technique for determining the need for surgical intervention in the presence of cutaneous basal cell tumor are well known to surgeons, dermatologists, and oncologists. It is therefore important that during the ultrasound examination of the skin, the doctor can immediately mark the excision lines on the surface of the skin.

Ultrasonographic scanners of various designs are known [5-13]. All known ultrasound scanners use the probe head of the apparatus and the size of the ultrasound box is too large and during the examination it is not possible to determine the exact border of the tumors on the skin surface just below the probe head.

There is no known product design that would allow the ultrasonographic (US) examination to accurately mark the border of basal cells on the skin surface just below the probe head of the apparatus.

Investigating the issue:

Research into the design of the new product required an artificial skin tumor model. It was important for the artificial skin to be less deformed during the examination due to its elasticity, its offset areas being distorted, distorting the real distance between the tumor and the location of the surrounding tissue. It was necessary to fabricate the product and develop a new ultrasound imaging technique that would allow for the marking of tumor excision lines on the skin surface by performing a hyperehogenous acoustic high frequency ultrasonographic examination.

The object of the invention is to produce a product design and to develop a new ultrasonographic examination technique which, by means of ultrasonographic examination, would enable to accurately mark the border of the artificial tumor on the surface of the artificial skin. The new design and the new technique could solve all the above and stated tasks.

The aim is achieved by making a product consisting of straight aluminum wire (AB) with straight edges, wire length 3.0-10.0 cm and diameter 0.06-0.1 cm.

In ultrasound examination, a gel is applied over the artificial tumor, on the surface of the artificial skin, over which the ultrasonographic probe head (G) is placed, under the head, on the skin, and the product is placed on both sides of the visible artificial tumor mark the ends (AB), place the wire (AB) on the artificial skin surface (3, 3), around the artificial tumor (E) and look for the hyperehogenous "shadow" on the skin surface of the tumor, mark the dots (C, D, F) around the edge of the tumor (E), dots connected to the line (CDF), and specifying the border of the artificial tumor on the surface of the artificial skin.

Artificial tumor boundary product and ultrasonographic examination technique allow to accurately mark the artificial tumor boundaries on the artificial skin surface, moreover, the artificial tissues were made of material similar to human skin.

A hyperehogenous acoustic product was experimentally investigated and used with a CORTEX Dermoscan C Ver.3 20 MHz Ultrasound (CORTEX TECHNOLOGY, Denmark) [14]. Ultrasound imaging results from different tissue densities. Hypoehogenic structures in the image are visualized as dark areas, hyperehogenic as light areas, but they cast a dark shadow underneath the tissues because the ultrasound wave is fully reflected and does not spread under the hyperehogenous structures.

For experimental studies, a model of artificial skin tumor tissue was made. The model was made of silicone, which is similar in texture and resistance to human skin.

The material for the production of the wire of the article was also selected during the experimental research process. Copper and aluminum wires were used. During the ultrasound examination, a much brighter acoustic "shadow" at the depth of the tissue was obtained using aluminum wire. Therefore, aluminum wire was used in further experimental studies.

Experimental high-frequency ultrasonography studies have shown that the material meeting the above criteria for ultrasonographic examination is soft metal aluminum - hypoallergenic, chemically neutral, easy to repeat vertical skin pattern, circular in cross section, unchanged in probe diameter along its entire length.

The length of the aluminum wire should be within the range of 3.0 to 10.0 cm. If the wire length was less than 3.0 cm, the wire was not visible under the probe head of the ultrasound machine. If the wire length exceeded 10.0 cm, it was not possible to place it on a variety of difficult terrain.

The aluminum wire should have a diameter of 0.06-0.1 cm. If the wire diameter was less than 0.06 cm, then the acoustic "shadow" at the depth of the tissue was obscure. If the wire diameter was greater than 0.1 cm, then the acoustic "shadow" at the tissue depth was diffused.

The wire edges should be straight to obtain accurate acoustic "shadow" depth.

High-frequency ultrasound studies using an artificial skin tumor model and a new ultrasound technique have shown that they provide the following markings:

• which allows for accurate marking of the border of the artificial tumor on the surface of the artificial skin during the examination, • which is well visualized against the background of surrounding tissues and identifiable against the background of various skin structures and artefacts, • prevents skin deformities due to skin elasticity it is possible to move the skin over a period of time without distorting the overall ultrasonographic image, which • gives an accurate acoustic “shadow” depth to the tissue, • whose perpendicular cut dimensions are within the horisontal resolution, • whose geometric dimensions allow accurate topographical markings complex skin areas, including the face, • which are neutral to the artificial skin and to the gel used in the ultrasound examination.

The product and method are explained in the following diagrams:

Fig. 1 - side view of the product;

Fig. 2 - positioning of the product under the head of the ultrasound machine, side view;

Fig. 3 - ultrasound examination image showing the product on the tumor, top view;

Fig. 4 - ultrasound examination image of the product on the tumor, side view.

Product description in statics

The hyperehogenous acoustic product consists of a straight aluminum wire (AB,

Fig. 1) with straight edges (Figs. 1, 2, 1), wire length 3.0-10.0 cm (AB, Fig. 1) and diameter 06-0.1 cm (CD) , Figure 1).

Ultrasonographic examination technique

A gel is applied over the artificial tumor, on the surface of the artificial skin, over which the head of the ultrasonographic probe (G, Fig. 2) is placed, and aluminum wire (AB, Fig. 2) and wire (AB, ) on the visible artificial tumor (E,

2) the edges of the border, the wire at both ends mark the dots (AB, Fig. 2). Wire (AB,

Fig. 3) is placed on the surface of the artificial skin (Figs. 3, 3, 3), around the artificial tumor (E, Fig. 3), and looks for the hyperehogenous "shadow" on the surface of the skin, repeatedly looking for it. edge (E, Fig. 3), mark with dots (C, D, F) around the edge of the tumor (Fig. 3), connect the dots with a line (CDF, Fig. 3) and specify the border of the artificial tumor on the surface of artificial leather. From point C located on the edge of the tumor to the surface of the skin (Figures 3, 3, 4), a perpendicular line specifies the depth of the artificial tumor size (Figure 4.4).

After the measurement, the scanner probe is removed and the wire (AB) remains on the skin. The stylus marks the lines on the outer edge of the skin with the 'shadow' (CDF) of hyperehogenous wire that was visible beneath the scanner. The procedure lines indicate the excision margins of the artificial surface of the skin (CDF, Fig. 3). Cutting along these lines can allow accurate tumor excision. The examination is carried out in 5-7 minutes.

The high-frequency ultrasonographic measurements showed that using the new product and ultrasonographic technique, the excision lines of the artificial tumor (E) can be immediately marked on the artificial skin surface (CDF, Fig. 3) and a perpendicular section of the artificial skin tumor can be performed (C, 4). Fig. 4), which can be determined by using a wire (AB) applied to the tissues by a "shadow" (C, Fig. 4.4).

INDUSTRIAL USE

After carefully performed experimental measurements using silicone artificial skin tumor for 6 months (12 series of experiments, 20 experiments in each series), clinical measurements were made at the Clinic of the Department of Infectology and Dermatology, Riga Stradins University. High-frequency ultrasonography (HFUS, 22 MHz) measurements were made using the new product and the new hyperehogenous acoustic ultrasonography. In clinical trials, high-frequency ultrasonography was used to determine certain specific parameters that show the boundary between the tumor tissue BCC and healthy tissue on the skin surface. 3 patients with BCC of facial skin basal cell tumors were studied. In all 3 cases, the echograms clearly depicted the wire's hyperehogenous "shadow", which was distinctly different from tissue shadows and artifacts. Positioning the wire at high frequency ultrasonography showed the borders of the tumor with healthy skin on the screen. Markers were applied along the outer edge of the wire with a felt-tip pen, which was connected to the ruler after removal of the probe from the skin. For the first time, an excision line was obtained using the new product and the new ultrasound technique, which clearly visualized on the surface of the face for all three patients. By making cuts along these lines, the surgeon can perform accurate tumor excision, which is important in cosmetically sensitive areas.

Sources of information

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Claims (2)

An article for determining the border of an artificial tumor on the surface of an artificial skin, characterized in that it consists of a straight aluminum wire (AB) with straight edges, a wire length of 3.0-10.0 cm and a diameter of 0.06-0.1 cm. Ultrasonographic examination method characterized in that a gel is applied over the artificial tumor, on the surface of the artificial skin, over which the ultrasonographic probe head (G) is placed, under the head, on the skin, and the article according to claim 1 is placed border of artificial tumor (E), dots (AB) on both ends of article wire, places wire (AB) on artificial skin surface (3, 3), around artificial tumor (E) and looks for hyperehogenous "shadow" on skin surface ', Mark the dots (C, D, F) around the edge of the tumor (E) with a stylus, connect the dots to the line (CDF) and specify the border of the artificial tumor on the surface of the artificial skin.