Female breast cage

p0001The present invention relates to a breast shell of the type having a wall deformable polymeric material elastically.

p0002Plastic or reconstructive surgery, surgeons are brought to breast implants.

p0003Known prostheses comprise a flexible closed bag made of silicone within which is confined a filling liquid such as saline or silicone gel. The filling fluid guarantees a visual appearance and a touchdown to close the initial prosthetic mammary gland.

p0004However, some prostheses have risk of breakages which can lead to a release of the filling fluid in the body, which is not desirable. Further, oozing of the fluid through the casing can get older.

p0005Moreover, it is common during the procedure and before the establishment of the final breast implant, surgeons use templates, also referred to as "simulators" or "ghosts" to evaluate the final aesthetic result before insertion of the definitive prosthesis. These templates are temporarily implanted and then removed to allow the implementation of the final prosthesis.

p0006The templates have a volume identical to that of the final prosthesis.

p0007Thus, the surgeon can assess the fit between the patient and the final breast implant even before it is in place.

p0008Sometimes several tests of different sized jigs are necessary to achieve a satisfactory result.

p0009Discloses that templates are in fact simple breast prosthesis made of a flexible clause envelope containing a fill material such as a gel or saline. The templates are generally downgraded prostheses, which are colored to attract the eye of the surgeon and thus prevent it from being confused with the final prosthesis.

p0010These templates from mammary prosthesis have the drawback of being expensive. They are therefore used several times after washing and re-sterilization. However, the process of re-sterilization significantly deteriorates the quality of the gel contained in the prosthesis. These sterilizations and successive uses thus of inadmissible risk to the patient.

p0011Otherwise, <patcit id="pcit0001" dnum="US6210439B"><text>US. 6210439</text></patcit> discloses a hull according to the preamble of claim 1.

p0012The invention aims to provide a reliable and inexpensive equipment to use for interventions of breast surgery, aesthetic or reconstructive.

p0013To this end, the invention relates to a hull according to claim 1.

p0014According to particular embodiments, the shell comprises one or more of the features of the dependent claims.

p0015The invention will be better understood from reading the description which follows, given by way of example and with reference to the drawings, in which:<ul><li>the <figref idrefs="f0001">figure 1</figref> is a perspective view of a first embodiment of a hull according to the invention;</li><li>the <figref idrefs="f0001">2</figref> is a sectional view of the shell of the <figref idrefs="f0001">figure 1</figref> ;</li><li>the <figref idrefs="f0002">2A</figref> is a view identical to that of the <figref idrefs="f0001">2</figref> of an alternative embodiment of the shell of <figref idrefs="f0001">Figures 1 and 2</figref> ;</li><li>the <figref idrefs="f0002">3</figref> is a sectional view of an alternative embodiment of the shell illustrated in <figref idrefs="f0001">Figures 1 and 2</figref> ; and</li><li>the <figref idrefs="f0002">4</figref> is a perspective view of another embodiment of the hull according to the invention.</li></ul>

p0016The 10 illustrated in FIGS hulls are designed to either form of implantable breast implants or breast implant templates. Therefore, they will be referred to below by the generic term "shell".

p0017An implantable breast prosthesis is intended to be implanted permanently by a surgeon or under the pectoral muscle or directly under the mammary gland.

p0018In contrast, a breast prosthesis template is intended to be temporarily placed by a surgeon or under the chest muscle or directly in the mammary gland can be extracted and replaced by a final mammary prosthesis may or may not be of the same structure.

p0019The shell 10 has a generally bell-shaped. Specifically, it has a hemispherical shape. Thus, it presents externally a convex surface 12 and a concave inner surface 14 defining a recess 16 devoid of any filler.

p0020Thus, the shell 10 is formed by a wall 17 of polymer material of a constant thickness of between 0.5 and 10 mm and preferably between 2 and 5 mm. This wall has a peripheral support edge 18 defining the opening through which opens the recess 16. The edge 18 extends substantially in a same plane. From the edge 18, the shell has a cross section taken parallel to the plane of edge 18 which is gradually decreasing from the edge 18 to the noted top 20 of the shell.

p0021The height of the shell measured between its base 18 and the top 20 is between 15 and 100 mm.

p0022The diameter of the base 18 is between 70 and 200 mm.

p0023The structure of the hull is such that it can be elastically deformed, by crushing its open edge so that the edge 18 can be flattened on itself.

p0024Alternatively, the shell is rolled around the edge 18.

p0025The structure of the shell is sufficiently flexible and elastic so that the deformation of the hull, leading to the disappearance of the recess 16 by bringing the opposing portions of the wall 17 can be performed manually. In this folded position, the hull can be inserted under the skin of the patient.

p0026Alternatively, the shell is wrapped around the edge 18.

p0027In addition, the material is sufficiently elastic and the structure is such that the shell resumes its shape when released under the action of the elasticity of the wall 17, even when it is constrained by the pressure applied by the skin and optionally the pre-existing mammary gland of the patient.

p0028To ensure stiffening of the hull, the edge 18 advantageously has a peripheral rim rim 22 best seen <figref idrefs="f0001">2</figref>. This flange is integral with the rest of the wall 17. It forms a rib and has a thickness substantially equal to the average thickness of the wall 17. It extends radially over a distance less than the radius of the base, of so that it remains open. This distance is in particular between 1 mm and the radius of the base decreased by 5 mm.

p0029Advantageously, the flange 22 is slightly tapered and is curved inwardly of the shell. Thus it defines a concave bearing surface adapted to exactly conform to the body surface to which it is applied after implantation.

p0030In order to also increase the rigidity of the hull, it preferably comprises on the inner surface 14, two ribs of semi-equatorial stiffener 24, 26 offset with respect to each other of about 90 ° and intersecting adjacent the top 20 of the shell.

p0031Its ribs extend from two diametrically opposite points of the edge 18. They have a height between 1 and 5 mm.

p0032Preferably, the ribs 22, 24 and 26 are integral with the wall 17. However, they may be formed in another so that the shell material is bi-material.

p0033Semi-equatorial stiffener formed for example of deformable metal rods are alternatively integrated into the wall 17.

p0034Moreover, advantageously, the shell has, in its wall 17 a gripping profile allowing the surgeon to grasp it easily for removal of the breast lodge.

p0035In the embodiment of <figref idrefs="f0001">Figures 1 and 2</figref>This gripping profile is formed by a lumen 28 passing through the wall 17 from one side. This light has a sufficient diameter for the introduction of a collecting member. Thus, the light 28 is formed, for example, a circular through hole having a diameter greater than 8 mm. This diameter is preferably between 8 mm and 20 mm.

p0036In the embodiment illustrated in <figref idrefs="f0002">2A</figref>, The lumen 28 is replaced by a gripping tab 29 projecting from the outer surface of the wall 17. This forms a grip tab easily graspable projection by the practitioner when the hull is in the breast box. This lug is integral with the wall 17 or added. It is formed preferably in one of the materials mentioned for the wall 17.

p0037Such a shell is formed by molding, dipping, casting or injection of polymers.

p0038In the case of an implantable mammary prosthesis, the material used to form the wall 17 and any other possible components of the prosthesis is a material meeting the regulatory requirements specific implantable breast prostheses. The material is particularly adapted to be maintained for at least ten years in the body.

p0039Whether a prosthesis or a jig, the material for forming the shell is, for example low density polyethylene, polyvinyl chloride (PVC), polyurethane, silicone, or any other polymer semi- rigid. This polymer can be sterilized so that during commercialization, the hull is sterile and packaged in a leaktight packaging. Thus, before any intervention, the hull is supplied sterile and packed in its sealed packaging.

p0040It is understood that the bell shape of the hull that it consists of little material and is thus an extremely reduced cost.

p0041In addition, the absence of material in the recess 16, allows the shell can be easily folded for insertion under the skin of the patient. The own elasticity to form the shell of bell allows easy deployment thereof after insertion under the skin.

p0042Finally, the shell being formed only by a deformable wall, it does not involve gel or any other filling liquid, which eliminates the risks of seepage and unintended release of fluid in the body, particularly in the a prosthesis.

p0043On the <figref idrefs="f0002">3</figref> is schematically shown another embodiment of the hull. To facilitate deployment, the wall 17 has in the apex region 20 an inner protrusion 30 protruding to the inner surface 14 of the shell. This protrusion 30 is for example hemispherical and has a height between 1 and 10 mm.

p0044In yet another embodiment illustrated in <figref idrefs="f0002">4</figref>, The shell 40 has not a hemispherical form but a so-called anatomical shape, that is to say that the top of the shell is eccentric with respect to the base 18, which is generally more elongated.

p0045Thus, the shell has a teardrop shape may be asymmetrical with respect to its vertical axis.

p0046In the case where the shell is a template, it can be used by the patient on the skin, so as to enjoy the selected volume, at a pre-operative consultation.