EXTERNAL BREAST PROSTHESIS

Abstract

Disclosed is an external breast prosthesis (1), including an envelope (2) of flexible material with a breast shape, the envelope defining an internal cavity (6) closed by a protective lid (3) of which one face, called the external face (4), is designed to be pressed against the chest of a person, the cavity enclosing a filler and a weighted element intended to adjust the weight of the prosthesis. The weighted element is in the form of a plurality of ballast elements (7) which are distributed along a sagittal axis of the prosthesis substantially perpendicular to the plane of the protective lid.

Claims

1. An external breast prosthesis (1) comprising a shell (2) in a flexible material having a breast shape, said shell defining an internal cavity (6) formed by a lid (3), a face of which, called external face (4), is adapted so as to be pressed against the chest of a person, said cavity containing a filling and a weighted element intended for adjusting the weight of the prosthesis, wherein the weighted element is made as a plurality of ballast elements (7, 10) distributed along a sagittal axis of the prosthesis substantially orthogonal to the plane of the lid.

2. The prosthesis according to claim 1, wherein the internal cavity (6) has an interior shape, the contour of which along a section through a front plane is curvilinear, notably a substantially circular, elliptical or oval contour.

3. The prosthesis according to claim 1, wherein the cavity (6) is adapted for containing from three to five ballast elements (7, 10) of staged sizes, decreasing from the lid (3) to the distal end of the cavity.

4. The prosthesis according to claim 3, wherein, for each size of a ballast element (7, 10), there exists a plurality of ballast elements having different weights.

5. The prosthesis according to claim 1, wherein the ballast elements are weighted discs (10) inserted into parallel slots (12) made in a foam filling (11) adjusted to the shape of the internal cavity (6).

6. The prosthesis according to claim 1, wherein the ballast elements are ballast pads (7) with a substantially lenticular shape, the main median plane of which is substantially parallel to the plane of the lid (3).

7. The prosthesis according to claim 6, wherein each ballast pad (7) comprises an external flexible wall with a pouch shape (8) filled with a deformable load (9).

8. The prosthesis according to claim 7, wherein the deformable load (9) consists of a divided solid with a specific density adapted to the sought weight.

9. The prosthesis according to claim 7, wherein the deformable load (9) consists of a polymeric gel including a load, the density of which depends on the sought weight.

10. The prosthesis according to claim 6, wherein the ballast pads (7) include attachment means (13) placed on a sagittal axis of the prosthesis and adapted for making faces secured to each other facing two adjacent pads.

11. The prosthesis according to claim 6, further comprising a filling buffer (14) in elastic material suitable for being placed between the lid (3) and the ballast pads (7) in order to maintain the latter in compression.

12. The prosthesis according to claim 1, wherein the shell (2) is made in a thermoformed thermoplastic foam, notably selected from among polyolefin foams, in particular in thermoformed polyethylene foam.

13. The prosthesis according to claim 1, wherein the shell (2) is tinted in the bulk and includes an added nipple (5).

14. The prosthesis according to claim 1, wherein the shell (2) includes at least one opening (15) of the cavity (6) allowing introduction of the ballast elements (7; 10).

15. The prosthesis according to claim 1, wherein the lid (3) includes, on its external face (4) an attachment strip (17) covered with a plurality of juxtaposed detachable protective films (18) so as to allow the selection of at least one area for adhesive bonding on the chest.

16. The prosthesis according to claim 2, wherein the cavity (6) is adapted for containing from three to five ballast elements (7, 10) of staged sizes, decreasing from the lid (3) to the distal end of the cavity.

17. The prosthesis according to claim 2, wherein the ballast elements are weighted discs (10) inserted into parallel slots (12) made in a foam filling (11) adjusted to the shape of the internal cavity (6).

18. The prosthesis according to claim 3, wherein the ballast elements are weighted discs (10) inserted into parallel slots (12) made in a foam filling (11) adjusted to the shape of the internal cavity (6).

19. The prosthesis according to claim 4, wherein the ballast elements are weighted discs (10) inserted into parallel slots (12) made in a foam filling (11) adjusted to the shape of the internal cavity (6).

20. The prosthesis according to claim 2, wherein the ballast elements are ballast pads (7) with a substantially lenticular shape, the main median plane of which is substantially parallel to the plane of the lid (3).

Description

[0027] Other objects, features and advantages of the invention will become apparent considering the description which follows and the appended drawings wherein:

[0028] FIG. 1 is a schematic sectional view through a median sagittal plane of an external breast prosthesis according to a preferential embodiment of the invention,

[0029] FIG. 2 is a sectional view along the same plane as FIG. 1 of a prosthesis according to another embodiment,

[0030] FIG. 3 is a view along the vertical axis of a breast of a laid-down person comprising a natural breast and a prosthesis according to the invention, illustrating the static and dynamic reality mechanism of the prosthesis, and

[0031] FIG. 4 is a perspective three-quarter rear view showing the external face of the lid and the adhesive tape allowing attachment of the prosthesis according to the invention on the chest of a person.

[0032] The external breast prosthesis 1 illustrated in FIG. 1 includes a shell 2 with the shape of a breast made in a supple and flexible material, preferentially in low density polyethylene foam with a thickness varying between 3 mm and 10 mm.

[0033] The shell 2 defines an internal cavity 6 closed by a substantially plane lid 3. The lid 3 may be made in a single piece with the shell 2 or else be stuck or welded on the contour of the shell 2 in order to close the cavity 6. In one case like in the other, an opening 15 of the cavity is made in the upper portion of the contour of the shell in order to allow the introduction of ballast elements and of the filling elements into the cavity. The opening 15 is obtained by separating a portion 3a (illustrated in dash lines in FIG. 1) of the lid 3 from the contour of the shell 2. It may be closed by adhesive bonding by means of a reusable adhesive closure 16.

[0034] In the preferential embodiment illustrated in FIG. 1, the cavity 6 contains five ballast elements as ballast pads 7 of a lenticular shape and with staged sizes. The pads 7 are positioned so that their median plane is substantially orthogonal to the sagittal axis of the prosthesis 1, parallel to the lid 3. Each pad 7 is of a suitable size (in this case a diameter) in order to correspond to the internal diameter of the cavity 6 depending on its position on the sagittal axis. For example, the pad 7 placed at the distal end of the cavity 6 has the smallest diameter.

[0035] The ballast pads 7 include an external wall forming a flexible pouch 8 containing a deformable load 9. The pouch 8 may be produced by joining along their edge, two discs of flexible synthetic material, for example in elastomer. Before complete joining, the pouch 8 is filled with a load 9 which gives it its thickness and therefore its lenticular shape. The load 9 may consist of a powder or of granules, for example glass beads, which, in combination with the elasticity of the pouch 8, give a viscoelastic consistency to the pad 7, the consistency being related to the natural consistency of the breast. Alternatively, the pouches 8 may be filled with a polymeric gel, for example a silicone hydrogel alone or being used as a binder to a granular load.

[0036] According to the invention, for each pad size 7, there exists a plurality of pads 7 having a different weight in order to give the possibility, for a given total weight corresponding to the weight of the replaced breast, of having several solutions for distributing the weight along the sagittal axis. For a same pad size, the different weights may be obtained by acting on the density of the gel, on the density (real or apparent) of the granular load, on the load proportion in the gel, etc. For example, a granular load formed with hollow glass microbeads may have an apparent density ranging from 0.2 to 1.5. Greater densities may be obtained with microbeads of another material, for example metal microbeads. Depending on the size and therefore on the volume of the pad, all the ranges of weights may be obtained by producing if required mixtures of different loads. Of course, the different loads are not limited to the mentioned microbeads but may comprise talcs or any other type of load known to one skilled in the art.

[0037] The pads 7 further include means for attachment between adjacent pads. In the example illustrated in FIG. 1, these attachment means are adhesive tabs 13, positioned along the sagittal axis. These adhesive tabs 13 are of course reusable for allowing changes in the pads depending on the intention of the user. These adhesive tabs have a diameter less than the diameter of the pads which they connect in order to leave clear a ring shaped area of each face of the pouch 8 in order to allow a lateral displacement of each pad relatively to the adjacent pads by deformation of this ring shaped area of the pouch.

[0038] In order to maintain the ballast pads 7 in the cavity 6, a filling buffer 14, in an elastic material of a suitable shape, for example a cylinder in elastic foam, ends the stacking of the pads and is used as a spring between the lid 3 and the largest pad in order to retain the pads in compression.

[0039] The shell 2 of the prosthesis 1 may be made in a single piece. However, according to the invention, it may be preferable to provide addition of an insert 5 forming the nipple and the peripheral areolar area for allowing a suitable change in tint on the one hand, the nipple and the areola being generally of a darker complexion than the remainder of the breast and using a material more resistant to abrasion on the other hand, taking into account that this area is much more subject to friction stresses. The added nipple may be attached by adhesive bonding or else by cooperation of conjugate shapes during the thermoforming of the shell 2.

[0040] Reference is made to FIG. 3 for detailing one of the advantages of the prosthesis according to the invention. In this figure, a chest comprising a natural breast 20 and a prosthesis 1 in a laid-down position, seen along an axis corresponding to the vertical axis of the body is illustrated in this figure. In the laid-down position, the natural breast 20 tends to move outwards relatively to the chest 19 (a movement illustrated by the arrow F), and to form a curve 21. In the prosthesis of the prior art, the filling with a constant density and the place of the weight as close as possible to the chest cause that the prosthesis remains immobile and rigid. For the prosthesis 1 according to the invention, the inventors noticed that the whole of the pads 7 behaves like a flexible viscoelastic mass by means of the distribution of weight along the sagittal axis and of the deformation of each pad 7, the anterior and posterior faces of which of the pouch laterally sliding relatively to each other while being maintained with the adhesive tab 13 respectively to the corresponding face of the adjacent pad. This relative sliding of the pads 7, illustrated by the arrows f in FIG. 3, causes a deformation of the shell 2 along an arrow F similar to that of the natural breast and causes a similar curve. Also, many movements of the chest are made possible by the prosthesis according to the invention and the comfort feeling of the user is reinforced.

[0041] Another embodiment of the prosthesis 1 is illustrated in FIG. 2. In this embodiment, the cavity 6 of the shell 2 is filled with a foam fill 11 adjusted to the shape of the cavity. The ballast elements appear as weighted discs 10 inserted into slots made in the filling 11. Each slot 12 has, depending on its rank on the sagittal axis, a contour corresponding to the contour of the disc 10 corresponding to this rank, except for the area for inserting the disc in the upper portion of the filling. The size of the discs 10 is adapted for allowing a foam thickness right around the disc so as not to have any influence on the tactile sensation. The foam forming the filling 11 is sufficiently flexible for allowing a relative lateral movement of the disc 10 with respect to each other, thereby allowing dynamics of the prosthesis similar to those obtained with the pads.

[0042] For each disc size, a plurality of discs 10 of different weights is provided thereby allowing modulation of the torque exerted on the shell 2 depending on the cantilever of the prosthesis. In this embodiment, the shell 2 also includes an opening allowing insertion of the filling 11 and of the discs 10 into the cavity, an opening closed by an adhesive closure 16. The shell 2 may also include an added nipple 5.

[0043] Regardless of the embodiment of the prosthesis according to the invention, the latter includes means for attaching the prosthesis on the chest of a user. These means are illustrated in FIG. 4 and in include, on the external face 4 of the lid 3 an attachment strip 17, for example consisting of a biocompatible double-sided adhesive. This attachment strip 17 has a suitable shape for following the contour of the lid 3 and a sufficient width for allowing adapted attachment of the prosthesis on the chest of the user. Advantageously, this attachment strip is covered with a plurality of detachable protective films 18 juxtaposed covering the whole surface of the attachment strip 17. This advantageous arrangement allows the user to select the area for adhesively bonding the prosthesis on her chest so as to avoid areas of particular sensitivity such as scars, etc. The attachment strip 17 may be advantageously water-resistant and resistant to current washroom products so as to be able to be permanently worn.

[0044] Of course, this description is given only as an illustrative example and one skilled in the art may provide thereto many modifications without departing from the scope of the invention, such as for example modifying the location of the opening 15 of the shell 2 in any area of the contour of the lid 3 or even at the center of the latter. Also, the filling buffer 14 in the embodiment of FIG. 1 may be equivalently placed at the distal end of the cavity 6 while ensuring its spring function.

[0045] This listing of claims which follows on the next page will replace all prior versions, and listings of claims in the application: