External breast prosthesis with integrated bra

Abstract

The invention relates to an external breast prosthesis comprising a shell having a breast shape and a lingerie item attached to said shell, said breast prosthesis having a folded conformation, in which the lingerie item is housed in an internal compartment of the shell and an unfolded conformation, in which the lingerie item is unfolded out of the internal compartment of the shell and in which the shell is positioned in a cup of said lingerie item.

Description

Title of the invention: External breast prosthesis with integrated bra Technical field

[0001] The present invention relates to the field of external breast prostheses and lingerie, in particular bras, brassieres and swimsuits, in particular suitable for women who have undergone a mastectomy. TECHNOLOGICAL BACKGROUND

[0002] Breast cancer is the most common cancer in women, affecting 1 in 8 women worldwide. Different types of treatments can be used to treat breast cancer: surgery, radiotherapy, hormone therapy, chemotherapy, and / or targeted therapies. Mastectomy, the total or partial removal of the breast to remove the tumor, is the most commonly used treatment and affects approximately 60,000 women in France each year.

[0003] To replace the missing breast(s), or part of a missing breast, patients can use external breast prostheses. Generally, the breast prosthesis is held in position by a specific bra, equipped with a pocket to house the prosthesis. However, current bras are not very satisfactory. Indeed, beyond the aesthetic aspect, they do not allow the prosthesis to be held in position correctly. It often happens that the prosthesis slips out of its housing when the woman performs simple daily movements (doing her hair, carrying a load, playing sports, etc.). In addition, the cost of such a bra is added to that of the prosthesis, making this solution particularly expensive.

[0004] The temporary, definitive or specific prosthesis is also unsatisfactory. Generally, it cannot be used alone, without a suitable bra. Its weight is problematic: the temporary textile prosthesis, too light, does not allow the bra to be held in place. The definitive silicone prostheses, whose weight is only supported by the bra strap, are often uncomfortable for patients.

[0005] There is therefore a need for an alternative solution, allowing a woman who has undergone a mastectomy to be able to use an external breast prosthesis, without the disadvantages mentioned above. Summary of the invention

[0006] The present invention proposes to solve at least partially the problems mentioned above by providing a 2 in 1 product. More precisely, the device according to the invention comprises a lingerie item, such as a bra, integrating a prosthesis at the level of one of the two cups, said lingerie item being able to be folded inside said prosthesis which can then be used as a conventional removable prosthesis. The device according to the invention is designed so that the volume of the missing breast is entirely integrated into the lingerie item (when the device according to the invention is in the deployed conformation) or into the prosthesis (when the device according to the invention is in the folded conformation). The volume therefore remains in place regardless of the movements of the woman wearing said item in the deployed conformation.Advantageously, the device according to the invention comprises padding, capable of compacting in an internal volume of the prosthesis in the folded conformation, and of expanding in the lingerie item in the deployed conformation, in such a way that not only the volume, but also the density of the prosthesis is substantially the same in the folded and deployed conformation, so as to replace the missing breast in an equivalent manner when the device is used in the form of a conventional prosthesis (folded conformation) or in the form of a prosthesis integrated into a lingerie item (deployed conformation). DETAILED DESCRIPTION OF THE INVENTION

[0007] The present invention relates to an external breast prosthesis configured for post-surgical use, and in particular post-mastectomy. According to the invention, said prosthesis can be used to replace a total breast, following a total mastectomy, or a portion of a breast removed, following a partial mastectomy.

[0008] As used herein, the term "mastectomy" refers to a procedure in which breast tissue is removed. This term may refer to a total mastectomy, in which an entire breast is removed, or a partial mastectomy, in which a portion of a breast is removed. A mastectomy may also refer to a radical mastectomy, in which an entire breast, lymph nodes under the arms, and the chest wall muscles under the breast are removed; a modified radical mastectomy, in which an entire breast and a portion of the underarm lymph nodes are removed; or a nippleless mastectomy, in which all breast tissue is removed without removal of the nipple. Preferably, the mastectomy involves only one of the two breasts.

[0009] The invention particularly relates to an external breast prosthesis comprising a shell having a breast shape and a lingerie item secured to said shell, said breast prosthesis having:

[0010] - a folded conformation, in which the lingerie item is housed in a internal housing of the hull; and

[0011] - a deployed conformation, in which the lingerie item is deployed outside the internal housing of the shell and in which the shell is positioned in a bonnet said lingerie item.

[0012] According to the invention, the internal housing, in the folded conformation, also comprises padding made of material capable of compacting to be entirely contained in said housing. In the deployed conformation, when the lingerie item is removed from the housing, said housing is turned over, so that the padding is no longer compressed in the housing and can expand.

[0013] Thus, in a folded conformation, the device forms a breast prosthesis making it possible to compensate for the volume, and advantageously the density, of a missing breast (or part of a missing breast) via the shell, the walls of which can be padded and the internal housing of which is padded by the lingerie item folded inside said housing and by the padding capable of compacting.

[0014] To move from the folded conformation to the deployed conformation, the user removes the lingerie item from the housing of the shell, then turns the shell over on itself. Advantageously, the padding of the internal housing is then released from the pressure which was applied by the presence of the lingerie item in the housing and can expand, so as to occupy all the space in the cup of said lingerie item.

[0015] This reversibility of the device according to the invention makes it possible to easily switch from a prosthesis (folded conformation) to an item of lingerie incorporating a prosthesis having the volume, shape and advantageously the density of a breast (deployed conformation). The volume and density of a breast are in fact maintained whatever the intended use.

[0016] As used herein, the term "lingerie item" refers to a clothing item configured to be worn on at least the upper portion of a wearer's torso, and in particular, to support at least one of the wearer's two breasts. Also, in the context of the invention, the term lingerie item is used to refer to a bra, a swimsuit, a bralette, or any other lingerie item intended to support a breast, whether natural, prosthetic, or partially prosthetic.

[0017] The invention therefore particularly relates to an external breast prosthesis comprising a shell having a breast shape and a bra secured to said shell, said breast prosthesis having:

[0018] - a folded conformation, in which the bra is housed in a housing internal hull; and

[0019] - a deployed conformation, in which the bra is deployed out of the internal housing of the shell and in which the shell is positioned in a cup of said bra.

[0020] By "positioned in a cup of the bra" is meant that the shell constitutes all or part of said cup, or fills all or part of said cup.

[0021] A bra typically comprises a bust section and a back section. The bust section is intended to receive two cups of the bra. The bra generally comprises two possibly adjustable straps. The bra band is generally closed at the back or front by one or more closure means, such as hooks and eyes, and generally comprises two parts called "bra sides" or "wings". A bra may further comprise stiffening or reinforcing elements, such as stays placed under the cups of the bra. The stiffening element may also be a reinforced seam or a rib made of plastic or metallic material. The bra is configured for post-surgical use, and in particular post-mastectomy use.

[0022] According to one embodiment, the bra is a non-wired bra. Indeed, an underwired bra can rub against the skin and irritate it.

[0023] When the device according to the invention is in the folded conformation, the lingerie item is entirely contained in the internal housing of the shell. The lingerie item, such as a bra, is not visible and the shell can then be used as an external breast prosthesis.

[0024] When the device according to the invention is in the deployed or unfolded conformation, the lingerie item extends entirely outside the shell. The shell is then positioned in one of the cups of the lingerie item, so as to fill the void left by the mastectomy, in particular to give the appearance and advantageously the density of a breast, the second cup remaining empty, so as to receive and support the remaining breast.

[0025] Advantageously, the shell comprises padding capable of compacting in the folded conformation and expanding in the deployed conformation. Thus, in the folded conformation, the padding present in the housing of the shell is compressed to make room for the lingerie item placed in the internal housing. When the lingerie item is removed from the shell (unfolded conformation), the internal surface of the housing in the folded conformation is found facing outwards. The padding is no longer compressed in the housing and can then expand freely, such that the volume and density of the prosthesis remain substantially identical in the folded and deployed conformation.

[0026] According to the invention, the shell and the lingerie item are integral with each other, that is to say they are physically connected to each other. Advantageously, the connection between the shell and the lingerie item is non-removable, so that the lingerie item cannot be detached from the shell, which advantageously forms the volume of a cup of said lingerie item in the deployed configuration. In one embodiment, the shell is integral with a cup of the lingerie item. Thus, in the deployed configuration, said shell is automatically found in said cup, of which it is an integral part. Furthermore, this ensures that in the deployed conformation the padding of the shell perfectly fills the volume of the missing breast. In addition, the padding is advantageously in a material that allows the density of the missing breast to be reproduced.

[0027] In one embodiment, the shell is made of compressible material, so as to facilitate the transition from the folded conformation to the deployed conformation.

[0028] For example, the shell is made of a “second skin” material. In particular, the shell may be made of a non-adherent textile, such as cotton, for example 100% pure cotton, wadding, mesh fabrics, nylon, spandex, polyester, and combinations thereof. In another embodiment, the shell is made of silicone, adhesive or non-adherent.

[0029] According to the invention, the internal housing of the shell is delimited by an internal surface in a folded conformation, said internal surface being returnable to form an external surface of the shell in a deployed conformation. Indeed, according to the invention, the internal housing of the shell encloses the lingerie item. In a first mode of use, the shell is used as a conventional external breast prosthesis, the lingerie item remaining enclosed in the internal housing of the shell. The volume and density of the compacted padding and the bra folded in the housing advantageously allow the prosthesis in a folded conformation to replace the volume and density of the missing breast.

[0030] In a second mode of use, the device according to the invention is used as an item of lingerie incorporating a breast prosthesis: the item of lingerie is extracted from the internal housing, which once emptied is completely turned over, and forms a padding for one of the two cups of the item of lingerie. The volume and density of the prosthesis integrated into the item of lingerie are then ensured by the padding which expands, thus making it possible to replace the volume and density of the missing breast.

[0031] In one embodiment, the shell comprises a flat face intended and capable of being pressed against the torso of a user, in direct or indirect contact with the user's skin, and a curved face intended and capable of being housed in a bra cup, or the like.

[0032] Advantageously, if direct contact with the user's skin is envisaged, the external flat face of the shell, or more generally the face intended to be in contact with the user's skin, comprises a hydrogel material. For example, the external flat face is covered with a layer of hydrogel material. Of course, any other compatible material, and in particular any second skin material, can be used.

[0033] In another embodiment, when the device is in the folded conformation, the external flat face of the shell intended to be in contact with the patient's skin is made of thermochromic material. The use of such a material makes it possible, for example, to identify inflammation of the user's skin tissues, in particular caused by poor healing.

[0034] In one embodiment, the shell further comprises massaging nubs and / or a silicone nipple, in particular in its folded conformation.

[0035] In particular, the massaging nubs can be placed on the flat external face of the shell, which comes into contact with the user's skin.

[0036] Conversely, the silicone nipple is placed on the curved face of the shell, opposite the one that comes into contact with the user's skin.

[0037] Advantageously, the massaging studs and / or the nipple are fixed to the external surface of the shell in folded conformation, by a reversible fixing means, preferably chosen from the group consisting of press studs, clips, or loop and hook strips (Velcro®).

[0038] In one embodiment, an additional reversible attachment means is attached to the inner surface of the shell in the folded conformation. Thus, the massaging nubs and / or the nipple can be attached to the outer surface of the shell in the unfolded conformation, when the lingerie item is removed from the shell or to the outer surface of the shell in the folded conformation, when the device is used in the form of a prosthesis.

[0039] According to the invention, the housing of the shell in the folded conformation comprises padding. Advantageously, said padding is integrated into the walls of the shell. Alternatively, the padding can be fixed, preferably in a non-removable manner, to the walls of the shell. It is also possible to provide removable padding, in particular in addition to the non-removable padding. This can be particularly advantageous for adapting the volume and density of the prosthesis in the case of a partial mastectomy of a breast.

[0040] Said padding is capable of compacting in the folded conformation to be entirely housed in the internal housing of the shell, with the lingerie item, and of expanding outside the housing in the deployed conformation. Thus, said padding advantageously makes it possible to give a shape, a volume and a density to the prosthesis, whether it is used as a conventional external breast prosthesis, or in combination with the lingerie item fixed to the shell. Advantageously, the padding is capable of compacting and expanding in such a way that the volume and density of the prosthesis in the folded conformation are substantially identical to the volume and density of the shell returned to the deployed conformation.

[0041] The type of compressible / expandable material that can be used as padding in the context of the present invention is well known to those skilled in the art. The padding may in particular be made of dacron or foam, such as polyurethane or polyethylene foam.

[0042] In one embodiment, the padding is made of a textile material, such as dacron, wool, down, feathers, microfiber, etc., or a mixture of all or part of these materials In another embodiment, the padding is silicone, hydrogel material, or other material allowing to provide a texture and a hold (density) approaching that of a breast.

[0043] In one embodiment, the padding is made of hydrogel material. This allows for a cooling action on the user's skin, in particular during a radiotherapy session. Advantageously, the padding is a shape memory material, in particular a shape memory textile, capable of compacting in the folded conformation and expanding in the deployed conformation. Advantageously, said padding also makes it possible, in the folded conformation, to form a flexible and protective barrier which isolates the user from the hard parts possibly constituting the lingerie item (straps, closures, etc.).

[0044] In one embodiment, the breast prosthesis according to the invention comprises a shell and / or padding made of flexible material, preferably a textile material, preferably a shape memory material.

[0045] The material(s) forming the prosthesis and the bra are preferably washable.

[0046] Advantageously, the materials used for the production of the prosthesis, and in particular for the parts in contact with the skin and the padding, comply with standard NF EN ISO 10993-5 (relating to the biological evaluation of medical devices - part 5: in vitro cytotoxicity) in order to guarantee their skin tolerance and their non-toxicity, and to be washable.

[0047] The prosthesis and the lingerie item can be made in different sizes and dimensions. The cup of the lingerie item can in particular be sized according to known sizes such as A, D, C, D, E, F, G etc., or XS, S, M, L, XL, etc. The shell can also be sized to fit the desired cup size. If necessary, it is also possible in the deployed conformation, to add padding in the housing of the shell.

[0048] In one embodiment, the shell comprises an opening for accessing the internal housing, allowing the entry and exit of the lingerie item. The opening of the housing is preferably made on an upper part of the contour of the shell, so as not to hinder the user when she uses the shell as a conventional external breast prosthesis (i.e. in folded conformation). Of course, it is possible to position this opening in another location, in particular on a front lateral face of the shell in folded conformation. By front lateral face, generally curved, is meant the face of the prosthesis in folded conformation intended to be in contact with the cup of a lingerie item, as opposed to the rear lateral face, generally flat, intended to be in contact with the user's body. Advantageously, the opening is closed by a fixing means reversible, preferably chosen from the group consisting of snap fasteners, clips, clasps, a zipper or hook and loop fasteners (Velcro®). DESCRIPTION OF DRAWINGS

[0049] [Fig.l] represents a front view, in perspective, of an external breast prosthesis according to the invention, in folded conformation;

[0050] [Fig.2] represents a lateral side view of the external breast prosthesis, in folded position, with the access opening to the internal housing closed;

[0051] [Fig.3] represents a frontal side view of the external breast prosthesis, in folded position, with the access opening to the internal housing open;

[0052] [Fig.4] represents the external breast prosthesis according to the invention, in conformation partially deployed;

[0053] [Fig.5] represents a partial view of the external breast prosthesis, in position deployed, in which a bra is fully extended from the internal housing, not yet turned inside out;

[0054] [Fig.6] represents a partial view of the external breast prosthesis, in position deployed, in which the bra is fully extended from the internal housing which has been turned inside out;

[0055] [Fig.7] represents the external breast prosthesis, in the deployed position, in which the bra is fully deployed, seen from behind;

[0056] [Fig.8] is an enlargement of [Fig.7] at the level of the opening of the housing returned and closed;

[0057] [Fig.9] represents the external breast prosthesis, in the deployed position, in which the bra is fully deployed, front view.

[0058] DETAILED DESCRIPTION OF AN EMBODIMENT OF THE INVENTION

[0059] The invention will be better understood upon reading the following description of a particular embodiment of the invention and upon examining the accompanying figures. These are presented for illustrative purposes and in no way limit the invention. In the figures, the same references indicate the same elements. In this embodiment, the lingerie item is a bra. Those skilled in the art will readily understand that any other lingerie item intended to support a chest can replace the bra.

[0060] As can be seen in [Fig.l], the device according to the invention consists of a breast prosthesis 1, formed by a shell 2, which in folded conformation has a general breast shape. It is thus possible to use it like a prosthesis of the state of the art with a suitable bra, by sliding it into a dedicated housing of the bra. In this conformation, the bra of the device is entirely contained in a housing (not visible in [Fig.l]). The prosthesis 1, in its folded conformation, is formed by the shell 2, which has a flat face 9 and a curved face 10, so as to have a general breast shape.

[0061] An opening 3, provided on an upper external edge 4 of the shell 2 ([Fig.2]), provides access to the housing. In the example shown, the opening 3 is closed reversibly by press studs 5 ([Fig.3]). Of course, any other suitable closing means can be envisaged. As can be seen in [Fig.3], the opening 3 provides access to an internal housing 6, in which the bra 20 is housed.

[0062] When the user wants to use the prosthesis 1 according to the invention in the deployed conformation, she pulls on the bra 20 located in the housing 6 to remove it from said housing ([Fig.4]). Once the bra 20 is completely removed from the housing 6, the shell 2 is empty ([Fig.5]) and can be turned inwards ([Fig.6]). An external wall 7 of the shell 2 in the folded conformation is found, in the deployed conformation, inside. In this embodiment, the shell 2 is integral with one of the cups 21 of the bra 20. More precisely, in the deployed position, the shell 2 is integrated into the cup 21, which makes it possible to guarantee its correct positioning in said cup 21. The wall of the shell 2 advantageously has a certain thickness (thanks to padding), making it possible to give volume to the cup 21 of the bra 20 in which said shell 2 is positioned ([Fig.9]).Indeed, said padding contained in the wall of the shell 21 is compressed in the housing with the bra, when the prosthesis is in the folded conformation. When the bra is removed and the shell turned over, the padding expands in such a way that the volume and density of the prosthesis remain substantially identical in the folded and deployed conformation. It is also possible to provide over-padding if necessary. As can be seen in [Fig.9], the first cup 21 has the volume and shape of a breast and the second cup 22 remains empty and can thus receive a breast of the user.

[0063] Once the bra 20 has been completely removed from the internal housing 6 and the shell 2 has been turned over and positioned in the dedicated cup 21, the opening 3 is closed ([Fig.8]), to ensure better hold of the assembly in the deployed configuration.

Claims

Claims

1. External breast prosthesis (1) comprising a shell (2) having a breast shape, said shell being provided with an internal housing (6) comprising padding, and a lingerie item (20) secured to said shell, said breast prosthesis having: - a folded conformation, in which the lingerie item is housed in the internal housing (6) of the shell; - a deployed conformation, in which the lingerie item is deployed outside the internal housing of the shell and in which the shell is positioned in a cup (21) of said lingerie item; and said padding being capable of compacting in the folded conformation and expanding in the deployed conformation.

2. Breast prosthesis according to claim 1, in which the shell is integral with a cup of the lingerie item.

3. A breast prosthesis according to claim 1 or 2, wherein the internal housing is delimited by an internal surface in a folded conformation, said internal surface being returnable to form an external surface of the shell in a deployed conformation.

4. A breast prosthesis according to any one of claims 1 to 3, wherein padding is integrated into a wall of the shell.

5. Breast prosthesis according to claim 1 to 4, in which the shell and / or the padding is made of flexible material, preferably a textile material, preferably a shape memory material.

6. Breast prosthesis according to any one of claims 1 to 5, in which the shell comprises a flat face (9) capable of being pressed against the torso of a person, and a curved face (10) capable of being housed in a cup (21) of the lingerie item (20).

7. A breast prosthesis according to claim 6, wherein the planar face of the shell comprises a hydrogel material.

8. A breast prosthesis according to any preceding claim, wherein said shell comprises an opening (3) allowing access to the internal housing.

9. Breast prosthesis according to claim 8, wherein the opening is closed by a reversible fastening means (5), preferably chosen from the group consisting of snap fasteners, clips, clasps, a zipper or hook and loop strips (Velcro®).

10. Breast prosthesis according to any one of the preceding claims, in which the lingerie item is a bra, a swimsuit or a brassiere, preferably a bra.

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