Field of the invention

The invention generally relates to constructing special clothing, namely brassieres for women who had mastectomy (breast removal). This brassiere is constructed for use with a breast prosthesis and designed for daily wear with any type of breast prosthesis; it can also be used as an element of rehabilitation.

Background of the invention

Mastectomy (from Greek Mostds meaning "breast" and ek tome "I remove") is a surgery for breast removal. Its goal is to excise a breast and fatty tissue containing lymph nodes (possible targets for metastases); depending on the mastectomy variant chosen, greater and/or smaller pectoral muscle can also be removed. Mastectomy is performed when needed after identifying a breast cancer tumor, a sarcoma, a purulent inflammation, or other diseases of the breast.

Doctors recommend women who had their breast removed to wear a special brassiere and a prosthesis. The prosthesis creates additional load on the body and is designed to decrease the probability of spinal curvature due to uneven load distribution. A silicone-made breast prosthesis is the most popular. A standard post-mastectomy brassiere has two cups: one for the breast and the other for placing the prosthesis, an adjustable belt and straps to fix the brassiere's position on the body; the reverse side of the cup is fitted with a pocked to fix the prosthesis inside. However, the construction of standard post-mastectomy brassiere does not take into account the special needs of female body after cancer and surgery. Using a classical brassiere with a pocket inside the cup where the prosthesis is placed can cause additional diseases to emerge, namely the following:

1) Spinal curvature: this is a problem that cannot be solved by wearing a prosthesis in a post-mastectomy brassiere with a pocket on the inside of the cup as the load on the back is not balanced. Breast weight is not a constant value; it depends on many factors, and identically sized breasts of different women have different weight. It is impossible to create a one-size-fits-all prosthesis for all women that would have the weight and volume identical to the amputated breast. Therefore, balancing the loads on the body from the breast and the prosthesis is a task for a post-mastectomy brassiere. Classical post-mastectomy brassieres differ in construction from regular ones only by harboring a pocket for the prosthesis. The brassiere belt is designed to take and distribute the load from cups over the chest. The prosthesis is fixed without any attachment to the body, so the prosthesis weight is passed fully onto the belt and the strap, which increases the difference in loads on the spine. The forces are applied in different points; therefore, the belt becomes deformed and loses its ability to evenly distribute the load over the chest. As a result, the load from the prosthesis is mostly passed via the strap onto the shoulder girdle. Therefore, using a prosthesis in the brassiere with a pocket on the reverse side of the cup increases the probability of spine curvature, which in its turn may lead to other diseases;

2) Impaired circulation may emerge due to the strap's pressure on the shoulder girdle where important vessels are located. To even out the positioning of a heavy silicone prosthesis to the level of own breast it is necessary to increase the strap pull. The load on the shoulder girdle can lead to the occlusion of muscles, blood or lymphatic vessels ensuring normal circulation of blood and lymph in the arm. The disruption of blood vessels functioning might lead to numb feeling in the arm;

3) Heating of post-op area. When wearing a silicone prosthesis in a classical brassiere with a pocket on the reverse side of the cup, the prosthesis adheres to the post-op area of the body with just the pocket cloth between them. The silicone prosthesis is inert; it heats to the ambient temperature and does not let the air in.

A greenhouse effect emerges: the prosthesis heats and the body temperature under the prosthesis rises, the air is not supplied so the body sweats. Doctors recommend cancer patients to avoid exposure to increased temperatures. Therefore, putting a prosthesis in a brassiere pocket on the reverse side of the cup and wearing it in this way may be dangerous for the woman's health;

4) Prosthesis deflection. A regular brassiere with a pocket for breast prosthesis on the reverse side of the cup is unable to normally take and distribute static load from the breast's and the prosthesis' weight. With each movement, dynamic loads emerge, and the brassiere's construction is unable to reliably fix the prosthesis' positioning in relation to own breast. Constant checks on the prosthesis only remind the woman about her disease, become a source of stress and may cause depression.

Prior art

From prior art, there are post-mastectomy brassieres for women described in DE8321007U1 of 19 July 1984 and in DE3305096A1 of 16 August 1984. The construction of such brassiere has two symmetrical halves with the external and internal sides. Each symmetrical half is formed by a cup the upper part of which is connected to the strap with adjustable length, and the lower part, with the belt. Each cup (or at least one, depending on the woman's needs) is equipped with a pocket to place and fix the prosthesis from the internal side of the cavity. The pocket is formed by two valves placed with reciprocal closure of their ends. The pocket has an aperture through which the prosthesis is freely placed and fixed in the cup's internal cavity. Such placement of the prosthesis on the reverse side of the cup does not ensure the fixation of prosthesis positioning on the body, does not solve the problem of post-op area heating under the prosthesis and does not create an even distribution of unequal load from the prosthesis and the breast on the woman's body. The brassiere in DE8321007U1 has an elastic strap from the cup to the belt and a Velcro strap connecting the ends of the valves and closing the aperture for the prosthesis. These elements are needed to improve the fixation of prosthesis positioning in the cup's cavity but they are not enough to improve the prosthesis' use.

The brassiere for use with breast prosthesis described in DE19530686C1 of 7 May 1997 was adopted as a prototype. The brassiere according to the prototype has two symmetrical halves with the external side and the internal side. Each symmetrical half is formed by a cup the upper part of which is connected to the strap with adjustable length and the lower part, with the belt along its own lower edge. The belt has fasteners on its ends which ensure better adherence of the belt to the chest. The brassiere also has a pocket on the internal side of the cup, which creates an internal cavity to place a prosthesis in. The external part of the cup turned to the body is formed from a lawyer of microfiber cloth or yarn. The brassiere according to the prototype has the construction of a classical post mastectomy brassiere; therefore, its use has drawbacks described above: namely, it is unable to balance the load from the prosthesis and the breast passed to the spine; the weight of the prosthesis puts too much pressure on muscles and vessels in the shoulder girdle; the body under the prosthesis is exposed to high temperatures; and the prosthesis has no reliable fixation during the movement. Invention summary

The invention was based on the task to create a brassiere construction for use with breast prosthesis, equipped with thermal regulation to remove excessive heating of the body under the prosthesis and ensuring more rational distribution of load from the prosthesis and the healthy breast on the woman's shoulders and spine, thereby decreasing the probability of circulation impairment and prosthesis deflection during movement.

The task is solved in the following way: the post-mastectomy brassiere, which has two cups, connects the lower part of each cup to the belt designed to fix the positioning of cups in the horizontal plane; the fasteners are located on both ends of the belt to fix it on the body; the upper part of each cup is connected to the strap of adjustable length, and the other end of the strap is connected to one of the halves of the belt; there is a pocket to place the breast prosthesis in; according to the invention, the construction has a new element, the brace; the abovementioned pocket is located on the surface of the brace and oriented towards the cup; the brace is located from the internal surface of the brassiere on one of the symmetrical halves and connected to the internal part of the brassiere at least in three places; one lower end of the brace is connected to the belt along the symmetry line of brassiere halves; the second lower end of the brace is connected to one of the belt ends in the area of the fastener; and the upper end of the brace is attached in the area of strap connection to the upper part of one of the cups. The technical results from using the said construction of the brassiere are the following:

- balancing uneven loads from the prosthesis and the breast on the woman's body;

- decreasing the load applied on the shoulder girdle via the straps; - minimizing post-op area heat exposure, which is possible under a silicone prosthesis;

- reliably fixing the prosthesis positioning during movement.

According to one of the prevailing options for brassiere manufacturing, the brace is made from a more elastic material than the brassiere itself. As another option, the brace may be made of two or more different materials, e.g. textiles like underwear foam.

According to one more prevailing option for brassiere manufacturing, the portion of the brace located under the internal side of the prosthesis is made of material with low heat conductivity; it can be porous material allowing air to pass through, e.g. underwear foam.

According to one more prevailing option for brassiere manufacturing, the brace with the pocket is a removable element attached to the internal surface of the brassiere along the symmetry line located between the cups. Due to this the brace with the pocket can be placed from one or the other half of the brassiere depending on the woman's individual needs.

According to one more prevailing option for brassiere manufacturing, the brace is permanently attached to the belt along the symmetry line. In such form the brassiere can have two braces one of which can be removed depending on the woman's needs.

According to one more prevailing option for brassiere manufacturing, the brace with the pocket is a universal element attached permanently to the brassiere along the symmetry line, and the same brace with the pocket can be used either on the left or the right side depending on woman's needs.

The developed brassiere construction has the following main elements: two cups, a belt with the fixation system (fasteners attached to the end of the belt), two straps with adjustable length, a brace, and a pocket. Over the middle of the brassiere a symmetry line is formed along which the brassiere is divided into two symmetrical halves. Each symmetrical half has the cup described above (for the breast or the prosthesis). The upper part of the cup is attached to the abovementioned strap with adjustable length (to fix the positioning along the vertical plane). Along the lower edge the cup is attached to the belt, which wraps up the woman's chest; on the back, the belt has the abovementioned fixing system with fasteners located on both ends of the belt symmetrically in relation to the symmetry line. Unlike classical post-mastectomy brassieres, the pocket for prosthesis according to the invention is located on an additional construction element, the brace. The brace is an element the shape of which replicates the projection of one brassiere half on the body. This element is located from the internal side of the brassiere, adheres closely to the woman's chest from the side of removed breath, covers the chest from the middle of the breastbone along the ribs to the spine and forms a "mono-bodice". The brace is connected to the brassiere along the symmetry line by one end, and the other end of the brace is attached to the belt fixing system on its posterior part, which ensures its full adherence to the body and formation of a "mono-bodice". The upper part of the brace is attached to the strap, in the area where the strap is connected to the upper part of a cup.

The brace is a new element of the construction developed to solve the problems of existing post-mastectomy brassiere models. In its shape, the brace replicates the projection of one of the brassiere halves on the body. It adheres tightly to the woman's chest from the side of the removed breast and forms a "mono-bodice". The "mono-bodice" is a brassiere with one cup which fits close to the chest and adheres to it. Such construction ensures reliable fixing of brassiere positioning on the body. For brace, material with low heat conductivity and high elasticity has been used. The elastic material of the brace forms a rigid frame next to the chest; on the external side of the brace a pocket for breast prosthesis is located. Placing the prosthesis in the brace pocket allows to pass most of the load from the prosthesis to the brace which thanks to its elastic material is able to take it and distribute it over the chest. As the brace material is deformation-resistant, this ensures reliable fixing of prosthesis positioning during movement. The placement of prosthesis in the pocket on the brace prevents heat exposure as a result of silicone prosthesis interaction with the body. On the outside, the brace and pocket with the prosthesis are covered and hidden by the second half of the brassiere. Description of acting forces emerging in static vertical position of the body and their distribution.

Using a regular brassiere. In the vertical position of the body, the breasts are impacted by gravity, i.e. mass multiplied by free-fall velocity (mg) most of which is taken by the body via muscles and breast tissue. The rest of the load impacts the cup and is transmitted to the belt and the strap. The belt wraps the woman's chest, adheres to it tightly and transmits the load in the horizontal plane over the whole chest. The strap ensures normal vertical positioning of the brassiere. When necessary, its length can be adjusted; it also takes the load and transmits it to the shoulder girdle (Fig. 7).

Using a classical post-mastectomy brassiere with the prosthesis placed in the pocket on the reverse side of the cup. In the vertical position of the body the prosthesis placed in the pocket on the cup is impacted by the gravity (mg); the load from the prosthesis is transmitted to the belt and the strap via the cup. The brassiere belt is made from textile, non-woven fabric and elastics; its construction due to the impact of differing loads (own breast on the one side and prosthesis on the other) becomes deformed. The belt stretches out and hangs, unable to fix the prosthesis positioning and to distribute the load from the prosthesis over the chest. Most part of the load from the prosthesis goes to the strap, which increases the load on the shoulder girdle from the side of the prosthesis. Because of its shape prosthesis has a shifted center of gravity due to which a force moment emerges, turning the heaviest part of the prosthesis down (Fig. 8).

Using a specially developed post-mastectomy brassiere with the prosthesis placed in the pocket on the brace. In the vertical position of the body the prosthesis placed in the pocket on the brace is impacted by gravity (mg). Most part of the gravity is absorbed by the brace. Thanks to its elastic material the brace forms a reliable corset from the middle of the breastbone along ribs towards the spine and passes the load from the prosthesis onto the chest. Because of its shape the prosthesis has a shifted center of gravity due to which a force moment emerges, turning the heaviest part of the prosthesis down. The pocket covers the prosthesis' center of weight and takes the moment of force impacting it. On the outside, the pocket with the prosthesis and the brace are covered by a respective half of the brassiere. In this way the prosthesis positioning is additionally fixed, and the rest of the load is distributed (Fig. 9.). The constructive solution placing the prosthesis on the brace pocket makes the distribution of the load more similar to the way acting forces from the healthy breast are taken by the body, balancing the load.

The developed brassiere construction balances the load from the prosthesis and the breast, distributes weight over the chest, decreases the load on the shoulder girdle, provides rigid fixing of the prosthesis position, and prevents temperature impact of the prosthesis on the post-op area of the body.

List of figures

- Fig. 1- external view of the brassiere when worn;

- Fig. 2 - general view of the brassiere when worn;

- Fig. 3 - general view of brassiere elements forming a "mono-bodice"; brassiere half for the healthy breast and a brace with the pocket to put prosthesis in;

- Fig. 4 - brassiere in unwrapped state, view from the outside;

- Fig. 5 - part of the brassiere forming a "mono-bodice" in the unwrapped state, view from the outside (brace and the other half of the brassiere);

- Fig. 6 - brassiere in the unwrapped state, view from the inside;

- Fig. 7 - a schematic illustration of the load from the breast in static vertical body positioning and counter-forces emerging in the brassiere;

- Fig. 8 - a schematic illustration of the load from the breast prosthesis in static vertical body positioning and counter-forces emerging in the classical post-mastectomy brassiere with a pocket on the reverse side of the cup;

- Fig. 9 - a schematic illustration of the load from the breast prosthesis in static vertical body positioning and counter-forces emerging in the brassiere with a pocket located on the surface of the brace according to the invention.

Description of elements used on Figs. 1-9 1- breast cup;

2- adjustable strap;

3- belt;

4- fasteners (a system for fixing the belt); 5- brace;

6- pocket;

7- fastener for fixing the brace to form a “mono-bodice";

8- symmetry line;

9- breast prosthesis. Description of acting forces displayed on Figs. 7-9: mgi - gravity force of the breasts;

R b _ody - body reaction to gravity impact;

R i _res - resistance reaction taken by the belt (3),

R 2 _res - resistance reaction taken by the lower part of the cup (1); F i _tens - tension force of the upper part of the cup (1);

F 2 _tens - tension force of the strap (2);

M - moment of force.

The provided examples and illustrations do not limit other possible embodiments of the invention and only explain itsessential. Detailed description of the preferred embodiments

The post-mastectomy brassiere has two symmetrical halves with the external and internal side. Each symmetrical half is formed by a breast cup (1). The upper part of the cup (1) is attached to the strap (2) of adjustable length. The lower part of the cup (1) is attached to the belt (3). The belt (3) has two ends with fasteners (4) attached to both, which together form a system of belt fixing. The brassiere also contains a brace (5) and a pocket (6). The brace (5) is attached to the internal side of the brassiere in at least three places. One lower end of the brace (5) is attached to the belt (3) along the symmetry line (8) of the brassiere halves. The other lower end of the brace (5) is connected by fasteners (7) to one of the belt ends (3) in the area where its fastener (4) is located. The upper end of the brace (5) is attached in the area of strap (2) connection to the upper part of one of the breast cup (1). The pocket (6) is located from the internal side of the brassiere on the surface of the brace (5). The breast prosthesis (9) is fixed on the brace (5) by means of the pocket (6) it is placed in.

Therefore, through the use of the invention the post-mastectomy brassiere can be achieved that ensures more rational load distribution from the prosthesis and the healthy breast on the woman's shoulders and spine, and hereby decreases the probability of circulation disruption in the shoulder joint and prosthesis deflection during movement; this brassiere also has a thermal regulation function and removes excessive heating of the body area under the prosthesis.