RU2645621C2 - Method of individual manufacture of exoprothesis of a nipple-areolar complex - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medical prostheses and can be used to compensate for tissue deficiency in the region of the remote nipple-areolar complex (NAC) in patients who underwent surgery for the mammary gland. Method includes manufacturing of NAC from silicone. Before the operation to remove the mammary gland, a color scale in tone with the NAC is selected for the patient, a NAC cast is made, the cast is removed and, after complete drying, a two-component soft silicon on a platinum base is poured into its cavity step by step. At the first stage, the nipple cavity is cast and colored in a selected tone. On the second stage, the areolar cavity is filled and colored. Silicone filled mold is dried at room temperature for 30 minutes. Before fixing to the skin, the fixing side of the NAC exoprosthesis is covered with latex and silicone glue.

EFFECT: invention makes it possible to provide a long fixation of the prosthesis to the body and to improve the quality of life of the patient.

1 cl, 10 dwg

Description

The present invention relates to medical prostheses and can be used to compensate for tissue deficiency in the area of the remote nipple-areolar complex (hereinafter - SAK) in patients who underwent surgery on the mammary gland.

Often, women who have had breast surgery experience depression, which is a problem for many patients. Depression can make it difficult for a patient to recover from surgery and increase fatigue after chemotherapy and radiation. It may take time for patients to get used to breast loss. For psycho-emotional recovery and cosmetic appearance, patients can use nipple exoprostheses.

The self-adhesive prosthesis of the company Silima® is known, which is made of self-adhesive silicone and can be fixed both on a silicone exoprosthesis and on the skin (http://wvvw.silima.su/catalog/exo/soski.php).

The disadvantages of this exoprosthesis are an unnatural appearance that does not correspond to the anatomical appearance of the nipple, a short fixation period and the absence of a variety of models.

Also known is the MedProm exoprosthesis (International Quality Certificate TUV N I 60014004. 02/27/2006), which has the same drawbacks as the Silima® exoprosthesis.

There are a large number of exoprostheses of NAO produced outside the Russian Federation, in particular in China, Korea and Taiwan, which have the same drawbacks as the above exoprostheses and do not have official registration in the Russian Federation. Delivery of these products to patients is carried out by mail.

The closest analogue to the claimed invention is a silicone nipple prosthesis that is glued to the chest with medical glue (Pink Perfect USA, not officially registered in the Russian Federation, http://www.pink-perfect.com/). Adopted for the prototype.

The disadvantages of this prosthesis are the high cost (about 280 cu), the lack of a representative office in the Russian Federation.

The task to which the invention is directed is to improve the quality of life of patients undergoing surgery on the mammary gland, reduce the cost of the exoprosthesis, improve its appearance, taking into account the individual approach to each patient, as well as a longer fixation period.

The specified technical result during the implementation of the invention is achieved due to the fact that, just as in the known analogue, the exoprosthesis of NAO is made of silicone.

A feature of the proposed method lies in the fact that before the operation to remove the mammary gland, the patient is selected with a color scheme in tone with NAO, make an impression of NAO from the impression mass based on alginate powder, the impression is taken and, after complete drying, two-component soft platinum-based silicone is gradually poured into its cavity , at the first stage, the nipple cavity is poured and stained in the selected tone, at the second stage, the areola cavity is poured and stained, then the silicone cast cast is dried at room temperature for 30 minutes, As a fixation to the skin, the attachment side of the exoprosthesis of the NAO is covered with latex and silicone glue. To stain the exoprosthesis of NAO in the required tone, use dye for silicone makeup.

The method is illustrated by a detailed description, clinical examples and illustrations, which depict:

FIG. 1 - cast of the nipple-areal complex of alginate powder.

FIG. 2 - filling the nipple with two-component soft silicone on a platinum basis.

FIG. 3 - a) coloring the nipple in tone using special dyes; b) filling the areola and staining to the desired tone.

FIG. 4 - a) separation of the silicone form from the alginate cast; b) the type of finished exoprosthesis.

FIG. 5 - view of patient I., before surgery.

FIG. 6 - view of patient I., 2 months after surgery.

FIG. 7 (a, b) - view of patient I., after attachment of an exoprosthesis of SAH.

FIG. 8 - view of patient P., before surgery.

FIG. 9 - view of patient P., after surgery: subcutaneous mastectomy.

FIG. 10 is a view of patient P., after attachment of an exoprosthesis of SAH.

The method is as follows.

Before or after the operation to remove the mammary gland, the patient is made an NAP cast and a color tone is selected for the manufacture of an exoprosthesis. When making an impression, medical alginate powder is used to take impressions (for example, Phase Plus Zhermack clinical, made in Italy). After complete drying, the mold cavity (Fig. 1) is gradually filled with a two-component soft platinum-based silicone for makeup (for example, Smooth-On Ecoflex 00-30). At the first stage, the nipple is filled (Fig. 2) and stained in the required tone with a special dye for silicone makeup (for example, Smooth-On Silc Pig) (Fig. 3, a). The second stage isola filling and stained in the desired tone with the above dyes (Fig. 3, b). The cast mold forms dry at room temperature for 30 minutes. The exoprosthesis of NAO is separated from the alginate cast (Fig. 4, a). The finished exoprosthesis completely imitates the nipple, areola, and Mantgomery tubercles (Fig. 4, b). The side of attachment of the SAK exoprosthesis before fixing to the skin is covered with latex and silicone glue for long-term mobile makeup (for example, Smooth-On Skin Tite).

To illustrate the method, we present clinical examples:

Example 1. Patient I., 41 years old (Fig. 5). Operation performed: subcutaneous mastectomy.

Before a mastectomy, the patient was made a cast of NAO and selected a color tone for the manufacture of an exoprosthesis. When performing the impression, medical alginate powder was used to take impressions (Phase Plus Zhermack clinical, made in Italy). After complete drying, the mold cavity was filled in two stages using two-component soft platinum-based silicone for makeup Smooth-On Ecoflex 00-30. At the first stage, the nipple was filled (Fig. 2), painted in the selected tone using dyes for silicone makeup Smooth-On Silc Pig (Fig. 3a), then, at the second stage, the areola was filled and painted (Fig. 3, b) . At the request of the patient, the areal of the nipple was made smaller. The flooded form of NAO was allowed to dry at room temperature for 30 minutes. After drying, the silicone form (exoprosthesis of NAO) was separated from the alginate cast (Fig. 4, a). The finished exoprosthesis is fully consistent with the removed SAH (Fig. 4, b).

Two months after surgery, the patient came to the reception (Fig. 6). After examination, an exoprosthesis of SAH (Fig. 46) was attached to the skin. To do this, latex was coated on the attachment side of the exoprosthesis and fixed to the skin with silicone glue for long-term mobile makeup Smooth-On Skin Tite (Fig. 7). The patient was given recommendations on the use of an exoprosthesis of SAH.

The long-term result two months after using the exoprosthesis of NAO: the patient is satisfied, leads an active lifestyle (swims, tans), does not experience inconvenience in intimate life.

Example 2

Patient P., 47 years old (Fig. 8). The patient underwent surgery: subcutaneous mastectomy (Fig. 9).

Before the operation, an impression was made on the standard sizes of the breast. An exogenous prosthesis was prepared according to the above procedure. After complete drying, the exoprosthesis SAK was attached to the skin using latex and silicone glue for long-term mobile makeup Smooth-On Skin Tite (Fig. 10).

The long-term result 2.5 months after using the exoprosthesis of NAO: the patient is completely satisfied, socially adapted, leads an active lifestyle.

This invention can be introduced into the practice of oncological institutions, where the removal of SAH is most often performed in patients with breast cancer, as rehabilitation in the late postoperative period. An exoprosthesis is simple to manufacture, cost-effective than its counterpart, and avoids the difficulty of ordering such products in foreign firms. In addition, in case of loss, an exoprosthesis can always be made according to the finished cast.

Using the claimed method in medical practice will achieve the following technical and therapeutic results:

- economic efficiency;

- improve the appearance of the exoprosthesis, taking into account the individual approach to each patient;

- increase the period of fixation, given the possibility of using the prosthesis in water;

- improve the quality of life of patients who underwent breast surgery with the removal of SAH.

Claims (2)

1. A method for the individual manufacture of an exoprosthesis of the nipple-areolar complex (SAC), including the manufacture of SAC from silicone, characterized in that before the operation to remove the mammary gland, the patient selects a color scheme in tone of SAC, makes a cast of SAC, the cast is taken and after it has completely dried the cavity is gradually filled with two-component soft silicone on a platinum basis, at the first stage, the nipple cavity is filled and painted in the selected tone, at the second, the areola cavity is filled and painted, then the mold cast with silicone is dried at room temperature for 30 minutes, before fixing to the skin integument, the attachment side of the exoprosthesis of NAO is covered with latex and silicone glue. 2. The method according to p. 1, characterized in that for staining the exoprosthesis of NAO in the required tone, use a dye for silicone makeup.

Images