BG4297U1 - Realistic simulation model of a female breast allowing biopsy and excision of nonpalpable tumor formations under ultrasonographic control - Google Patents

Abstract

A realistic simulation model of a female breast enables both diagnostic and therapeutic procedures to be performed, namely excision of a nonpalpable tumor formation under ultrasonographic control. The aim is to remove the lesion with clean resection lines and secondly to preserve more healthy glandular tissue. Achieving the latter guarantees oncological accuracy and a better postoperative aesthetic outcome, reflecting on the patients' life. The simulation model has the following properties: texture and resistance similar to human tissue; the tissue of the simulation model does not allow the tumor formations to be touched; the necessary ultrasound penetration to allow identification and localization of structures in depth; the tissue allows performing fine-needle biopsy; the tissue allows performing wide-needle biopsy; the tissue allows performing sectoral excision of the tumor formation under ultrasonographic control; the simulation model allows intratissue manipulation; the tissue is easily repairable or replaceable upon manipulation; the targets are ultrasonographically distinguishable from the surrounding tissue; cost-effective; does not create a predisposition to infection; easy to transport; offers different levels of complexity that can be modified; can be easily manufactured; after exploitation, the material can be reused to reproduce the simulation model of a female breast.

Description

Field of technique

The present utility model relates to a realistic simulation model of a female breast, enabling the biopsy and excision of non-palpable tumor formations under ultrasound guidance, and finds application in the training of specialists and trainees in general surgery, as well as those in imaging diagnostics.

Prior art

During surgical specialization, worldwide, simulation training is gradually entering. The use of simulators to perform both non-invasive and invasive methods of research and treatment is gaining more and more popularity. It is the use of such tools that guarantees the patient's safety in the first place. The methodology can be practiced repeatedly until reaching certain achievements and minimal risk of error in real conditions. A similar type of simulators would also have potential in training imaging specialists and specialists. These simulation models must meet different requirements and be manufactured or purchased, depending on their financial availability.

In the 21st century, breast cancer represents the disease with the highest morbidity and mortality worldwide of all oncological diseases in women. Advances in diagnostic research and the introduction of screening programs lead to the diagnosis of more and more tumor formations at an early stage. Most often, these tumors are under 2, and in some cases under 1 st. The small size of this type of lesions is often related to the fact that they are non-palpable, or in other words, cannot be touched through the skin.

The new oncological recommendations and trends are developing towards closer resection lines and targeted preservation of a larger volume of healthy glandular tissue, which significantly affects the quality of life of breast cancer patients.

This necessitates the use of different methods for intraoperative navigation during excision. Among those used in the literature, the method of intraoperative ultrasound stands out with many advantages. One of its disadvantages is that it is directly dependent on the ability and experience of the surgeon in working with ultrasound. This is where simulation medicine comes into play.

A number of papers have been published in scientific databases describing the necessary supplies and methods for making palpation phantoms, ultrasound-positive simulation models for fine-needle, punch biopsy, insertion of a fixed needle hook, and aspiration of simple cysts of the female breast.

In their articles, McNamara and Sisney [1, 2] present the creation of an ultrasound-positive biopsy simulation model, without commenting on its handling qualities. Their simulation models are mostly based on gelatin. Their transparency and instability under pressure compromises the goal of excising a lesion that is "invisible" to the human eye and hand.

For his simulation model, Nicholson [3] used latex layers, which, however, would have prevented the use of a scalpel and removal of the "tumor".

Ustbas and his team [4] present a simulation model based on silicone and polydimethylsiloxane, which has good ultrasound permeability and an appearance similar to a real female breast. The substances used for the simulation model do not allow their reuse, and after the final operation, it must be destroyed.

Morehouse [5] presented a gelatin simulation model to which metamucil was added for better echographic properties, and the resulting mixture was stored in envelopes. Experience has shown that such a mixture could break down and not allow manipulation of an ultrasound transducer in the simulation model itself.

Various simulation models are known from the patent literature, for example the one disclosed in patent application CN 104658388 A, Breast operation training model. The simulator makes it possible to perform operative interventions or acupuncture on a breast simulation model equipped with certain sensors and alarm systems. There is no data indicating that the pattern is sonographically positive, nor whether the tumor formations are palpable or not.

In patent application CN 102477191 A, Preparation method for breast self-inspection model, a simulation model suitable for self-examination training for breast tumor formations is described. There is no evidence that the simulation model is suitable for performing operative techniques or ultrasound diagnostics.

The simulation model described in patent application JP 2014095869 A, Breast cancer palpation training model is only suitable for performing palpation of tumor formations on a female breast. The simulation model does not allow excision to be performed under ultrasound control. The focus of our proposed invention is precisely the inability to feel (palpate) or visualize the tumor formation. It is necessary that the consistency of the simulation model makes it possible to perform both biopsy and "operative removal of the finding under ultrasound control.

The breast lump operation model disclosed in registered utility model CN 210535151 U, Breast lump operation model, consists of an entire operating table on which the breast itself is placed. The authors report that any type of biopsy can be performed on the model - fine-needle, broad-needle, vacuum-assisted, and open. No information is available on whether the model is suitable for performing ultrasound, whether the available "tumor formations" are ultrasound positive and whether the invention allows multiple reproduction of the simulation model from the matrix and the reuse of the material from which the simulation model is made after its exploitation .

In international patent application WO 2019221188 A1, "Breast ultrasound phantom, method for producing breast ultrasound phantom, and accommodating box for accommodating said breast ultrasound phantom, an extremely detailed and one-of-a-kind breast ultrasound diagnostic simulator is proposed, which comprises all layers of the female breast to the chest wall itself, as well as tumor formations. It is not described whether the simulator is suitable for performing operative techniques as well as diagnostic ones. The tissue complexity of the phantom implies the impossibility of reproduction after operation.

The simulation model described in patent application CN 109859600 A, Ultrasound-guided breast neoplasm puncture model and preparation method thereof is suitable for performing different types of biopsies. There are no 4 data whether the same is possible to reproduce from an available matrix and whether it allows manipulation of the ultrasound transducer during excision.

In patent application US 2016180745 A1, Ultrasound Phantom Models, Materials, and Methods, an ultrasound phantom of a female breast enabling ultrasound diagnosis of various tumor formations is disclosed. It is not described whether they can be biopsied or excised.

Patent US 4867686 A, Breast Cancer Detection Model and Method for Using Same discloses a female breast model for teaching breast examination, the model including an opaque, elastomeric membrane simulating the skin, a transparent support member connected to the opaque membrane to define a camera between them, simulating adipose tissue located within the chamber and simulating also a tumor within the chamber and opacifiers covering and movably attached to the transparent support member. The invention is directed to a method of training individuals to detect breast tumors by palpation of said pattern.

In contrast to the invention subject to the present application, the invention subject to patent protection US 4867686 A demonstrates a model for tactile detection of tumor formations of the mammary gland, which is not the subject of the present proposal for a simulation model of a female breast. On the contrary, an aim of the claimed invention is precisely such formations not to be detected by touch. The collective referred to in patent US 4867686 A does not comment on whether the material from which the invention is made, as well as the tumor formations, are subject to biopsy examination. It is also not commented on whether the model is sonographically positive and whether the tissue from which it is made is suitable for operative manipulation. There is also no comment on whether the material is suitable for self-reproduction after exploitation.

No simulation model of a female breast is known which combines at the same time adequate ultrasound permeability, i.e. possessing a heteroechoic ultrasound structure, allowing fine-needle or wide-needle biopsy training of non-palpable tumor formations, allowing their excision under ultrasound guidance, and which be repeatedly reproduced from a matrix when reusing the material to make the simulation model.

The task of the present utility model is to create a realistic simulation model of a female breast with the necessary consistency, which does not allow both visualization and palpation of the tumor formations placed in it. It should provide the possibility of performing both a fine-needle or wide-needle biopsy, as well as performing the simulated excision of the lesion under ultrasound control. At the same time, the simulation model should allow placement of the high-frequency transducer in the operative wound itself and manipulation in all necessary axes without tearing it to a state in which it becomes unusable. In this, the simulation model can be repeatedly reproduced from a matrix, and the material to make it can be reused after the use of the model is finished.

Technical nature of the utility model

The task was solved by developing a realistic simulation model of a female breast, allowing biopsy and excision of non-palpable tumor formations under ultrasound control, with a structure that does not allow visualization and palpation of the tumor formations placed in it.

The same allows for a biopsy examination of the lesions, as well as their surgical removal under ultrasound control. The extra-realistic simulation model can be repeatedly reproduced from a die, and the material to make it can be reused after the model's service life.

The realistic simulation model of a female breast, allowing biopsy and excision of non-palpable tumor formations under ultrasound control, is made of a material representing a mixture of water, pharmacopoeial glycerin (C3H8O3), finely powdered psyllium and pork gelatin in a ratio of approximately 20: 10:1:3, whose visual density was achieved with the addition of ½ part titanium dioxide (T1O2) and 1/10 part flesh-colored dye, such as the areolamammillary complex, was further stained with 1/20 part water-soluble pink dye. The realistic female breast model cast in a breast matrix has a diameter of the base of the breast between 18 cm and 21 cm and a height of 9.5 cm to 10.5 cm, with a total volume of 1100 ml to 1500 ml, and the diameter of the areolamammillary complex is in the range of 4.5 cm to 5.3 cm, with a mamilla height of 0.9 cm to 1.5 cm. Inside the material of the breast model are placed simulating different tumor formations from vegetable grains selected from the group consisting of chickpea and/or pea and/or bean and/or corn and/or grape, as well as a small balloon with fluid mimicking a cyst.

Explanations of the attached figures

Figure 1 and 2. Top and side views of modeling clay mold models for making a realistic female breast simulation model

Figure 3 and 4. Top and side views of a urethane resin mold for fabricating a realistic simulation model of a female breast.

Figure 5. Sonographic characterization of a realistic female breast simulation model made according to the proposed utility model.

Figure 6, 7 and 8. Ultrasound images of "tumor masses" located in the simulation model constructed according to the proposed utility model.

Figures 9 and 10. Top and side views of uncolored realistic female breast models obtained according to the proposed utility model.

Figure 11 and 12. Top (left) and top (right) views of a realistic model of a female breast according to the proposed utility model, during ultrasound.

Figure 13. Performing a biopsy examination - puncture of the cyst, using a syringe, under ultrasound control.

Figure 14 and 15. Broad-needle biopsy needle with biopsy material.

Figure 16 and 17. Performing excision under ultrasound control.

Figure 18. Removed tumor mass (representing a grape seed), with resection margin.

Figure 19. Simulation model of female breast during excision.

The creation of a realistic simulation model of a female breast, allowing biopsy and excision of non-palpable tumor formations under ultrasound control, consists of several stages.

The first stage is the creation of a model for a matrix of a simulation model (Figs. 1 and 2), with realistic shape and dimensions, from modeling clay, polymer clay or plaster. The matrix model should recreate a breast with a base diameter between 18 cm and 21 cm and a height of 9.5 cm to 10.5 cm with a total volume of 1100 ml to 1500 ml. In accordance with the proportions of the human body, the diameter of the areolomammillary complex is in the range of 4.5 cm to 5.3 cm, and the height of the mammilla is 0.9 cm to 1.5 cm.

The second stage represents the creation of a matrix from the matrix model obtained in the first stage (Figs. 3 and 4). For this purpose, a sufficiently high board is made, covering the matrix model by more than 1 cm and a distance of 1.5 cm from it. A two-component urethane resin is used to create the matrix.

The third stage is the creation of a realistic simulation model of a female breast from the obtained matrix. The capacity of the matrix varies depending on the size of the model from 1100 ml to 1500 ml.

The material for making the realistic simulation model is a mixture of water, pharmacopoeial glycerin (C3HvO3), finely powdered psyllium and pork gelatin in a ratio of approximately 20:10:1:3. In a water bath, at a water temperature above 100°C, the mixture is heated to homogenization, after which it is colored with ½ part of titanium dioxide (TU ₂ ) until a solid white color is achieved and 1/10 part of flesh color dye is added.

The flesh-colored mixture cools and thickens under the influence of gelatin. From the slightly cooled and colored liquid in a separate container, a small amount is separated, sufficient for the production of the areolamammillary complex, which is additionally colored with 1/20 part of water-soluble pink dye. The additional colored mixture is poured into the created matrix so as to cover the impression of the areolamammillary complex. Pour 1/2 of the remaining flesh-colored mixture on top. The half-filled mold is cooled to a temperature below 10°C for a period of at least 1 h. At this stage, on the surface of the mixture, scattered, various objects of plant grains are added, imitating various tumor formations, as well as a balloon filled with a red-colored liquid, imitating a cyst. About an hour later, on top of the already cooled mixture with the added objects, the remaining colored mixture is cast, in such a way that the mimic tumor objects remain in the middle of the simulation model. The filled matrix is cooled at a temperature below 10°C for a period of 8 h, after which the realistic simulation model is ready for operation (Figs. 11. and 12). The storage of the finished simulation model should be carried out at a temperature below 10°С, and the time for its operation at room temperature exceeds 168 h. After performing all the manipulations, even if divided into separate parts, the simulator allows repeated reproduction, as well as the reuse of the material after it is melted in a water bath at a temperature above 100°C and placed in the above-described manner in the matrix. It is observed that after each subsequent remelting of the material to make the simulation model, it decreases in its quantity and is gradually depleted, but it can be replenished or completely replaced in the matrix.

The operation of the simulation model can be carried out in several stages, according to the principles of modern oncological surgery.

First, a manual inspection is performed, where it is determined that the formations cannot be touched.

Second, an ultrasound examination is performed, which proves the presence, characteristics and size of the formations, since they cannot be felt or seen with the naked eye. The simulator is constructed in such a way that the lesions are located approximately in the middle of the model and its consistency does not allow tactile sensitivity of the tumors.

Third, a biopsy is performed. In the presence of a cystic formation, the red liquid contained in the balloon is aspirated (Fig. 13). When a solid formation is diagnosed, it can be biopsied with a wide-needle biopsy under ultrasound guidance (Figures 5, 6, 7 and 8). When performing a cyst puncture, a red secretion is aspirated using a syringe (Fig. 13). When a solid formation is established, a wide-needle biopsy is applied, in which, after extraction of the needle, a different tissue than that of the simulation model is found, which proves the entry into the tumor (Figs. 14 and 15).

Fourth, after detecting the tumor, it should be excised under ultrasound control (Fig. 16, Fig. 18), with the main goal being to remove it all, with the necessary resection distance, and at the same time to preserve more healthy glandular parenchyma (Fig. 17).

After removing the excised area, it can be measured and compared according to certain indicators, thus demonstrating the course of the training curve of the trainees.

Examples of implementation of the utility model

The examples presented are not exhaustive of possible exemplary embodiments.

Example 1: Making a model for a matrix with a base diameter of 18 cm and a capacity of 1100 ml

Modeling clay or plaster of choice is used to create a mold model. The resulting female breast shape differs from the real one to allow for biopsy and excision in all quadrants of the female breast. The reason for this is the changes in the shape of the breast when the patient is lying down, the presence or absence of posture and the changes in the structure of the mammary gland, varying over the years. It is preferred that with a diameter of the matrix model base of 18 cm, its height is 9.5 cm and the diameter of the areolomammillary complex is 5.3 cm, of which the height of the mammilla is 1.4 cm. The die model is sculpted from a sufficient amount of modeling clay or plaster, and the material is cured at room temperature for 24 h.

Example 2: Making a model for a matrix with a base diameter of 21 cm and a capacity of 1500 ml

Polymer clay is used to create a matrix model. The proportion that is used to make the pattern for the matrix assumes that the diameter of the breast to its height are in a ratio of approximately 2:1. It is preferred that with a matrix model base diameter of 21 cm, its height is 10.5 cm and the diameter of the areolomammillary complex is 5.3 cm, of which the mamilla height is 1.5 cm. The matrix model is sculpted from a sufficient amount of polymer clay, which hardens when heated in accordance with the instructions, use of the corresponding polymer clay.

Example 3: Making a matrix for a realistic simulation model of a female breast with a base diameter of 18 cm

The matrix model obtained according to Example 1 with a base diameter of 18 cm and a total volume of 1100 ml is used to make the matrix, the preferred material being a two-component urethane resin. Equal amounts of the two resin components are mixed in a vessel until a thermal reaction occurs, after which the urethane resin is ready for use. The matrix model obtained according to example 1 is placed in a mold with dimensions exceeding its own, as follows: diameter 19 cm, height 11 cm. The ready-to-use urethane resin is poured onto the die model to fill the dimensions described above. The two-component urethane resin cures in about 3 min, but is completely ready to release from the mold after 1 h. The finished mold can be used repeatedly to cast realistic female breast simulation models.

Example 4: Making a matrix for a realistic simulation model of a female breast with a base diameter of 21 cm

The matrix model obtained according to Example 2 with a base diameter of 21 cm and a total volume of 1500 ml was used to make the matrix, the preferred material being a two-component urethane resin. Equal amounts of the two resin components are mixed in a vessel until a thermal reaction occurs, after which the urethane resin is ready for use. The matrix model obtained according to example 2 is placed in a mold with dimensions exceeding its own, as follows: diameter 22 cm, height 12 cm. The ready-to-use urethane resin is poured onto the die model to fill the dimensions described above. The two-component urethane resin cures in about 3 min, but is completely ready to release from the mold after 1 h. The finished mold can be used repeatedly to cast realistic female breast simulation models.

Example 5: A realistic simulation model of a female breast, allowing biopsy and excision of non-palpable tumor formations under ultrasound guidance

A realistic simulation model of a female breast, allowing biopsy and excision of non-palpable tumor formations under ultrasound control, prepared from a material consisting of a mixture of 20 parts water, 10 parts pharmacopoeial glycerin, 1 part finely powdered psyllium and 3 parts porcine gelatin. The resulting mixture is colored with ½ part titanium dioxide to a solid white color and 1/10 part flesh colorant. 1 part of the body-colored mixture was separated, which was additionally colored with 1/20 part of water-soluble pink dye. Added to the flesh-colored mixture are various objects mimicking different tumor formations from plant grains (chickpea, pea, bean, corn, and grape), as well as a small bubble of fluid (water and red dye) mimicking a cyst.

Example 6: Creation of a realistic simulation model of a female breast, allowing excision of non-palpable tumor formations under ultrasound control

To create a realistic simulation model of a female breast, allowing excision of non-palpable tumor formations under ultrasound control, 20 parts of water are used, which are mixed with 10 parts of pharmacopoeial glycerin. 1 part of finely powdered psyllium and 3 parts of pork gelatin are added to them. The mixture is heated in a water bath, at a temperature above 100°C, until it is homogenized. The resulting mixture is colored with ½ part of titanium dioxide to achieve a solid white color and 1/10 part of flesh color dye, to achieve a realistic look of the simulation model. In addition to achieving a realistic appearance, the main purpose of using titanium dioxide and other dyes is precisely "to hide the tumor formation, 9 which, apart from being non-palpable, cannot be visualized. After the mixture has cooled and thickened, 1 to 2 parts of it is poured into a separate container and additionally colored with 1/20 part of water-soluble pink dye. The additional colored mixture is poured first into the created matrix so that it covers the impression of the areolamammillary complex, then half of the remaining flesh-colored mixture is poured. The half-filled matrix is cooled for 1 h at a temperature below 10°C.

Different objects mimicking different tumor formations are added to the mixture cooled in the matrix. The matrix, together with the obtained mixture, is again placed in a cooler and after another 1 h, the remaining mixture is poured into it, in such a way that the added objects imitating tumor formations remain in the middle of the obtained mass. The filled mold is cooled for 8 h at a temperature below 10°C, after which the realistic simulation model can be removed from the mold and is ready to work.

Example 7: Operation of the simulation model - first stage

In the first stage of operation of the simulation model, inspection and palpation of the same is carried out in order to establish signs of "tumor formation". An ultrasound examination of the simulation model is then performed. The location, number, type and distance from the "skin" and the areolamammillary complex of non-palpable "tumor formations" is determined.

Example 8: Operation of the simulation model - second stage

After specifying the type of "tumor formations", in the presence of a cystic one, a fine-needle aspiration biopsy is performed, which is positive after aspiration of secretion (fig. 13).

When a solid formation is detected, the student's task is to perform a wide-needle biopsy under ultrasound control. It is validated when there is excised material from the suspected tumor formation in the biopsy needle itself (Fig. 14, Fig. 15).

Example 9: Operation of the simulation model-third stage

After the diagnostic specification of the "tumor formation", the same should be "operated". For this purpose, an ultrasound apparatus is used for continuous monitoring of the location of the "tumor" during the excision. A sheet-like incision is made in the "skin" over the formation, and by means of ecarding and manipulation of the high-frequency ultrasound transducer in the "wound" itself, the aim is to remove the formation in clean resection lines and preserve more healthy parenchyma (Fig. 16, Fig. 17, Fig. 18).

Example 10: Reuse of the material for a realistic female breast simulation model after operation of the simulation model.

To reuse the material for a realistic simulation model of a female breast, after exploitation and violation of its integrity, the objects imitating the tumor formations and the cyst are removed. The thus cleaned material is placed again at a temperature above 100°C in a water bath for melting. The process of building the model according to example 6 is then repeated.

Claims (1)

A realistic simulation model of a female breast, allowing biopsy and excision of non-palpable tumor formations under ultrasound control, characterized by the fact that the material for its manufacture is a mixture of water, pharmacopoeial glycerin (C3H8O3), finely powdered psyllium and pork gelatin in a ratio of approximately 20:10:1:3, the visual density of which was achieved with the addition of 1/2 part titanium dioxide (TiO2) and 1/10 part flesh-colored colorant, such as the areolamammillary complex, was additionally colored with 1/20 part water-soluble pink dye in which the realistic female breast model cast in a breast mold has a diameter at the base of the breast between 18 cm and 21 cm and a height of 9.5 cm to 10.5 cm, with a total volume of 1100 ml to 1500 ml , and the diameter of the areolamammillary complex is in the range of 4.5 cm to 5.3 cm, with a height of the mammilla from 0.9 cm to 1.5 cm, inside the material of the breast model are plant seeds selected from the group containing chickpeas and/or peas h grain and/or bean grain and/or corn grain and/or grape grain imitating various tumor formations, as well as a fluid bubble imitating a cyst