• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The invention relates to an external mammary prosthesis (1), comprising a casing (2) made of flexible material having a breast shape, said casing defining an internal cavity (6) closed by a lid (3), one face of which is called an external face. (4), is adapted to be pressed against the torso of a person, said cavity containing a padding and a weight element for adjusting the weight of the prosthesis, characterized in that the weight element is in the form of a a plurality of ballast elements (7) distributed along a sagittal axis of the prosthesis substantially orthogonal to the plane of the cap.
    公开号:FR3022451A1
    申请号:FR1455791
    申请日:2014-06-23
    公开日:2015-12-25
    发明作者:Christine Valdiserra；Nee Sanchez Leonarda Comte
    申请人:New Team；
    IPC主号:
    专利说明:

    [0001] The invention relates to an external mammary prosthesis, and more particularly to such a non-functional prosthesis, intended to temporarily replace an ablated breast whose appearance and dynamic behavior is as close as possible to the breast. original. External breast prostheses are generally used after mastectomy, after scarring and before surgical reconstruction of the breast, for a period of two years in general. An external breast prosthesis may be custom-made for a given patient, which generally involves a significant cost, or may be selected from an assortment of standard, more economical prostheses. However, in this case, certain adjustments, such as the weight of the prosthesis which must be substantially equal to the weight of the remaining breast (in the case of a unilateral mastectomy) are not realized and may eventually cause complications such as scoliotic attitudes or generate discomfort for the patient. US Pat. No. 3,811,133 discloses an external mammary prosthesis comprising a hollow plastic envelope, for example a flexible breast-shaped vinyl, a fibrous padding and a variable weight element consisting of metal granules, for example lead. bound in a block of synthetic material or in a sewn felt container. This weight is placed closest to the torso of the patient, fixed or immobilized on a rear wall of the envelope pressed against the torso of the patient. This type of prosthesis, which is similar to custom prostheses nevertheless has many disadvantages. For example, the padding used does not allow the prosthesis to exhibit a dynamic behavior comparable to that of a natural breast, which can be particularly noticeable when using the prosthesis with light clothing such as flexible throat. The present invention therefore aims to provide an external breast prosthesis which does not have the disadvantages of known prostheses of the prior art. In particular, the invention aims to provide such a prosthesis whose weight is adjustable by the user. The invention also relates to such a prosthesis which has a dynamic behavior closer to a natural breast.
    [0002] The invention also aims at such a prosthesis whose cantilever torque is adjustable. The invention also relates to such a prosthesis whose production cost is close to that of a standard prosthesis while offering the comfort and aesthetics of a custom prosthesis.
    [0003] To do this, the invention relates to an external mammary prosthesis, comprising a flexible material envelope having a breast shape, said envelope defining an internal cavity closed by a lid having a face, said external face, is adapted to be pressed against the torso of a person, said cavity enclosing a padding and a weight element for adjusting the weight of the prosthesis, characterized in that the weight element is made in the form of a plurality of weight elements distributed along a sagittal axis of the prosthesis substantially orthogonal to the plane of the operculum. In the present description, the terms conventionally used in the medical field in physiology are used to define the different orientations in space with respect to the body of a patient, in this case the planes (frontal, sagittal, horizontal) or axes. (sagittal or anteroposterior axis orthogonal to the frontal plane, transverse axis orthogonal to the sagittal plane and vertical axis orthogonal to the horizontal plane). These terms refer to the body of a patient, the horizontal plane relative to the body may be vertical relative to the earth's surface if the body is in a supine position. By using a plurality of weight elements distributed in the sagittal axis of the person wearing the prosthesis, it is possible not only to adjust the total weight of the prosthesis to match that of the missing breast or the other breast, but also to modify its cantilever torque so as to maintain a feeling closer to the original in the movements of the body, even if this pair is compensated by the bra. Similarly, the displacement and / or the shape modification of the prosthesis during these movements are closer to those of a natural breast whose dynamic behavior depends on the distribution of its mass in all directions, in particular according to the sagittal axis.
    [0004] Advantageously and according to the invention, the internal cavity has an inner shape whose contour in a section through a frontal plane is curvilinear, in particular a substantially circular contour, elliptical or oval. For example, the internal cavity has a substantially frustoconical shape, height oriented along a sagittal axis. This form makes it possible to use weight elements having a form of disks (or discoids) placed orthogonally to the sagittal axis of the prosthesis. It is also possible to choose an internal cavity having a spherical cap shape which has similar advantages. Advantageously and according to the invention, the cavity is adapted to contain from three to five weight elements of staggered, decreasing size of the lid at the distal end of the cavity. In order to obtain a good distribution of the cantilever torque of the prosthesis, it is advantageous to provide that the cavity can contain enough ballast elements and that these elements can be ordered in the cavity. The inventors have found that a satisfactory result is obtained with three to five elements whose sizes (in this case the diameters) are stepped so that their edge comes into contact with or near the cavity wall, according to a predetermined order (the smallest at the distal end of the cavity). Advantageously and according to the invention, for each size of ballast element, there is a plurality of ballast elements having different weights. In this way it is possible for the user to achieve the optimum distribution of the cantilever torque by choosing the weight of each ballast element according to its position along the sagittal axis of the prosthesis. It is thus possible to play by means of the elasticity of the envelope and by an appropriate choice of the ballast elements, on the general shape of the breast in a vertical sagittal plane, for example to obtain a "heavy" breast by choosing elements of weight of greater weight in distal position or a breast headed by placing the heaviest weight elements in the proximal position.
    [0005] Advantageously and according to a first embodiment of the invention, the ballast elements are heavy discs inserted in parallel slots formed in a foam padding adjusted to the shape of the internal cavity. Thanks to the use of a foam padding, preferably very flexible, provided with parallel slots and orthogonal to the sagittal axis of the prosthesis, each section of the padding, on either side of a slot, can move relative to the adjacent sections under the effect of static or dynamic stresses related to the weight of the weight disk inserted in the slot. These discs may be metal discs of different densities or plastic discs 10 loaded with particles of different densities or particles of the same density in different proportions. Preferably, the weight disks are immobilized in their slot, either by suitable reliefs, or by the shape of the slot which closes over the disc once it is inserted. Advantageously and according to a second preferred embodiment of the invention, the ballast elements are substantially lenticular shaped ball bearings whose main median plane is substantially parallel to the plane of the cap. By thus using lenticular pads, i.e. having a tangible thickness, preferably corresponding to a fraction of the depth of the cavity, it is possible to dispense with the foam padding of the foregoing embodiment. thickness of each of the pads contributing to the filling of the cavity of the prosthesis. The size (for example the diameter for a circular-shaped pad) is adapted, as previously seen, to come into contact with the inner wall of the cavity as a function of the rank of the pad on the sagittal axis of the prosthesis.
    [0006] Advantageously and according to the invention, each ballast pad comprises an outer wall in the form of a flexible bag filled with a deformable load. Each bag may be formed by joining two sheets of flexible synthetic material, for example elastomer, welded together by their facing edges in a substantially circular, elliptical or oval contour depending on the shape of the cavity of the prosthesis (orthogonally to the sagittal axis thereof). Inside each sachet, a filling charge makes it possible to give its lenticular shape to the sachet. The filler is preferably plastic, that is to say deformable and has reduced or no elasticity. Advantageously and according to the invention, the deformable load consists of a solid divided by a density adapted to the desired weight.
    [0007] For example, the deformable filler can be formed of a granulate of solid material, for example, microspheres with a diameter of 10 .mu.m to 500 .mu.m. Such glass microbeads may have a bulk density ranging from 0.2 kg / dm3 for hollow beads up to 1.5 kg / dm3 for solid beads. For higher weight pads, it is possible to use metal microspheres with higher densities, or mixtures of different types of aggregates. Advantageously and according to the invention, the deformable filler consists of a polymer gel comprising a filler whose density is a function of the desired weight. Preferably, to improve the felt sensation felt, it is possible to integrate the divided solid charge in a binder such as a polymer gel to obtain a single-piece viscoelastic charge. The density of this deformable filler is then determined by the density of the gel, that of the solid filler and by the proportion of solid filler in the gel. Advantageously and according to the invention, the ballast pads comprise fastening means placed on a sagittal axis of the prosthesis and adapted to make integral faces facing two adjacent pads. Thus each ballast pad can be made integral with the adjacent pads while retaining some mobility provided by the relative movement of the two sheets constituting the sides of the bag. In this way, the set of pads 25 behaves as a flexible viscoelastic mass having the ability to tilt on both sides of the sagittal axis depending on the movements of the bust of the user, as of a natural breast. Advantageously and according to the invention, the prosthesis further comprises a disc of elastic material adapted to be placed between the cap and the ball pads to maintain the latter in compression. Depending on the desired weight and dynamic behavior, it is not necessary to use all the pads of a prosthesis. For example, it is possible to use only three ballast pads on the five that can accommodate the envelope of the prosthesis. It is then possible to use a synthetic foam filling pad placed between the pads and the cover forming the back side of the prosthesis to hold the pads in place, with a minimum of compression to avoid any displacement of the pads. weighting that could result in an unsightly form of the prosthesis. Advantageously and according to the invention, the envelope is made of thermoformed thermoplastic foam, in particular chosen from foams of polyolefins, in particular of thermoformed polyethylene foam. In addition to the flexible synthetic materials commonly used to make external prostheses, such as silicone, latex or vinyl, the invention proposes to use a polyethylene envelope, preferably low density polyethylene for its flexibility. Even more advantageously, the casing may be made of polyethylene foam which has the advantage of being very light and of being able to be thermoformed to the desired shape by more economical production operations than those used for the other materials. In addition, such a thermoformed polyethylene foam has the advantage of providing a surface with a very soft feel, much closer to the tactile sensation of the skin than other materials.
    [0008] Advantageously and according to the invention, the casing is tinted in the mass and has an attached nipple. In addition, the polyethylene foam has the advantage of being tinted in the mass and to have at least one face a "skin" appearance. In addition, in order to take into account the different hues of complexion, it is possible to make a nipple and its areola adjacent to another shade of foam and report it for example by gluing on the envelope. Advantageously, in this case, the foam used may have a higher density to provide better resistance to abrasion in this area highly stressed to friction. Advantageously and according to the invention, the envelope comprises at least one opening of the cavity allowing the introduction of the ballast elements. The opening of the cavity is preferably performed by separation between the edge 3022451 7 of the lid and that of the envelope, on an upper portion of the contour thereof in the frontal plane of the prosthesis. For example, one of the two surfaces opposite the edge of the lid or envelope comprises a double-sided adhesive tape, reusable if necessary, to close the cavity after introduction of the 5 ballast elements. Advantageously and according to the invention, the lid has, on its outer face, a fastening strip covered with a plurality of detachable protective films juxtaposed so as to allow the choice of at least one bonding zone on the torso. Although the external breast prosthesis according to the invention is intended to be worn inside a bra, it is however preferable that it be attached to the wearer's torso. To this end, the invention provides that the lid, on its outer face in contact with the torso, comprises an adhesive tape, for example a biocompatible double-sided adhesive tape resistant to water and other common toilet products. The adhesive strip is originally attached to the outer face of the cap and has a plurality of protective films facing the wearer's torso that can be removed to provide a bond on the torso. The protective films are arranged to allow the user to choose the bonding areas of the prosthesis according to the arrangement of particular areas of sensitivity (eg scars, etc.). The invention also relates to an external breast prosthesis. characterized in combination by all or some of the features mentioned above or hereinafter. Other objects, features and advantages of the invention will become apparent from the following description and the accompanying drawings in which: - Figure 1 is a schematic sectional view through a median sagittal plane of an external breast prosthesis according to a preferred embodiment of the invention, - Figure 2 is a sectional view along the same plane as Figure 1 1 of a prosthesis according to another embodiment, 3022451 8 - Figure 3 is a view according to the vertical axis of a breast of a supine person comprising a natural breast and a prosthesis according to the invention, illustrating the mechanism of static and dynamic realism of the prosthesis, and - Figure 4 is a perspective view of three quarters. rear 5 showing the outer face of the lid and the adhesive tape for fixing the prosthesis according to the invention on the torso of a person. The external mammary prosthesis 1 shown in FIG. 1 comprises a breast-shaped envelope 2 made of a flexible and flexible material, preferably of low density polyethylene foam with a thickness varying between 3 mm and 10 mm. The casing 2 defines an internal cavity 6 closed by a substantially planar lid 3. The cover 3 can be made in one piece with the casing 2 or be glued or welded on the contour of the casing 2 to close the cavity 6. In one case as in the other, an opening 15 of the cavity is formed in the upper part of the envelope contour to allow the introduction of ballast and padding elements into the cavity. The opening 15 is obtained by separating a portion 3a (shown in dashed lines in FIG. 1) of the cover 3 of the contour of the casing 2. It can be closed by gluing by means of a reusable adhesive closure 16.
    [0009] In the preferred embodiment illustrated in FIG. 1, the cavity 6 contains five ballast elements in the form of pitch-like ball pads 7 and stepped sizes. The pads 7 are arranged so that their median plane is substantially orthogonal to the sagittal axis of the prosthesis 1, parallel to the cap 3. Each pad 7 is one size (in this case 25 diameter) adapted to correspond to the internal diameter of the cavity 6 as a function of its position on the sagittal axis. For example, the pad 7 placed at the distal end of the cavity 6 has the smallest diameter. The bearing pads 7 comprise an outer wall forming a flexible bag 8 containing a deformable load 9. The bag 8 can be made by joining, according to their edge, two plastics flexible discs, for example elastomer. Before complete joining, the bag 8 is filled 3022451 9 with a load 9 which gives it its thickness and therefore its lenticular shape. The filler 9 may consist of a powder or granules, for example glass beads, which, in combination with the elasticity of the bag 8, give a viscoelastic consistency to the pad 7, a consistency resembling the natural consistency of the 5 breast. Alternatively, the sachets 8 may be filled with a polymer gel, for example a silicone hydrogel alone or as a binder for a granular filler. According to the invention, for each size of cushion 7, there is a plurality of pads 7 having a different weight in order to allow, for a given total weight corresponding to the weight of the breast replaced, to have several weight distribution solutions. along the sagittal axis. For the same size of pad, the different weights can be obtained by adjusting the density of the gel, the density (actual or apparent) of the granular charge, the proportion of charge in the gel, etc. For example a granular filler formed of hollow glass microbeads may have a bulk density of 0.2 to 1.5. Higher densities can be obtained with microbeads of another material, for example metal microbeads. Depending on the size and therefore the volume of the pad, all the weight ranges can be obtained by carrying out, if necessary, mixtures of different fillers. Of course, the different charges are not limited to the microbeads mentioned but may include talcs or any other type of charge known to those skilled in the art. The pads 7 further comprise means for fixing between adjacent pads. In the example shown in Figure 1, these fixing means are adhesive pads 13, arranged along the sagittal axis. These adhesive pads 13 are of course reusable to allow pad changes to the will of the user. These adhesive pads have a diameter smaller than the diameter of the pads they connect so as to leave a crown of each side of the bag 8 free to allow lateral displacement of each pad relative to the adjacent pads by deformation of this ring of the bag.
    [0010] In order to maintain the ball pads 7 in the cavity 6, a filling pad 14 made of a suitably shaped elastic material, for example an elastic foam cylinder, terminates the stacking of the pads and acts as a spring between the operculum 3 and the larger pad to keep the pads in compression. The casing 2 of the prosthesis 1 can be made in one piece. However, according to the invention, it may be preferable to provide an insert 5 forming the nipple and the peripheral areolar zone to allow a suitable change of color, the nipple and the areola being generally of a complexion. more sustained than the rest of the breast and secondly use a material more resistant to abrasion, given that this area is much more subject to frictional stresses. The reported nipple can be fixed by gluing or by cooperation of conjugate forms during the thermoforming of the envelope 2. Referring to Figure 3 to detail one of the advantages of the prosthesis according to the invention. This figure shows, in the supine position, a breast comprising a natural breast 20 and a prosthesis 1 seen along an axis corresponding to the vertical axis of the body. In the supine position, the natural breast 20 tends to move outwardly relative to the torso 19 (movement illustrated by the arrow F) and to form a curve 21. In the prostheses of the prior art, the constant density padding and the place of weight closer to the torso make the prosthesis still and rigid. For the prosthesis 1 according to the invention, the inventors have found that the set of pads 7 behaves like a flexible viscoelastic mass thanks to the weight distribution along the sagittal axis and to the deformation of each pad 7 whose The front and rear sides of the bag slide laterally relative to each other while being held respectively by the adhesive patch 13 to the corresponding face of the adjacent pad. This relative sliding of the pads 7, illustrated by the arrows f in Figure 3, causes a deformation of the casing 2 according to an arrow F similar to that of the natural breast and causes a similar curve. Likewise, many breast movements are made possible by the prosthesis according to the invention and the feeling of comfort of the user is enhanced.
    [0011] Another embodiment of the prosthesis 1 is illustrated in FIG. 2. In this embodiment, the cavity 6 of the casing 2 is filled with a foam padding 11 fitted to the shape of the cavity. The ballast elements are in the form of heavy discs inserted into slots 12 in the padding 11. Each slot 12 has, according to its rank on the sagittal axis, a contour corresponding to the contour of the corresponding disk 10. at this rank, with the exception of the disc insertion area in the upper part of the padding. The size of the discs 10 is adapted to leave a thickness of foam all around the disc so as not to affect the tactile sensation. The foam forming the padding 11 is sufficiently flexible to allow relative lateral movement of the discs 10 relative to each other, thus allowing a dynamic prosthesis similar to that obtained with the pads. For each disc size 10, there is provided a plurality of discs 10 of different weights thereby modulating the torque exerted on the envelope 2 as a function of the overhang of the prosthesis. In this embodiment, the casing 2 also includes an opening allowing the padding 11 and the disks 10 to be inserted into the cavity, the opening being closed by an adhesive closure 16. The casing 2 may also include an attached nipple.
    [0012] Whatever the embodiment of the prosthesis according to the invention, it comprises means for fixing the prosthesis on the torso of a user. These means are shown in Figure 4 and comprise, on the outer face 4 of the lid 3 a fastening strip 17, for example composed of a double-sided adhesive biocompatible. This fastening strip 17 has a shape 25 adapted to follow the contour of the lid 3 and a width sufficient to allow a suitable attachment of the prosthesis on the torso of the user. Advantageously, this fastening strip is covered with a plurality of juxtaposed detachable protective films 18 covering the entire surface of the fastening strip 17. This advantageous arrangement allows the user to choose the bonding zone 30 of the prosthesis on his torso. so as to avoid areas of particular sensitivity such as scars, etc. The fastening strip 17 may be advantageously resistant to water and to common toiletry products so that it can be worn continuously. Of course, this description is given by way of illustrative example only and the person skilled in the art may make numerous modifications without departing from the scope of the invention, such as for example modifying the location of the opening 15 of the invention. the envelope 2 in any area of the contour of the lid 3 or even in the center thereof. Likewise, the filling pad 14 in the embodiment of FIG. 1 could be placed equivalently at the distal end of the cavity 6 while ensuring its spring function. 10
    权利要求:
    Claims (5)
    [0001]
    CLAIMS1 / - Prosthesis (1) external mammary, comprising a casing (2) of flexible material having a breast shape, said casing defining an internal cavity (6) closed by a lid (3), one side, said outer face (4). ), is adapted to be pressed against the torso of a person, said cavity containing a padding and a weight element for adjusting the weight of the prosthesis, characterized in that the weight element is made in the form of a plurality of ballast elements (7, 10) distributed along a sagittal axis of the prosthesis substantially orthogonal to the plane of the lid.
    [0002]
    2 / - prosthesis according to claim 1, characterized in that the cavity (6) internal has an inner shape whose contour in a section through a frontal plane is curvilinear, including a substantially circular contour, elliptical or oval.
    [0003]
    3 / - Prosthesis according to one of claims 1 or 2, characterized in that the cavity (6) is adapted to contain three to five weight elements (7, 10) of stepped, decreasing sizes of the lid ( 3) at the distal end of the cavity.
    [0004]
    4 / - Prosthesis according to claim 3, characterized in that, for each ballast element size (7, 10), there is a plurality of ballast elements 20 having different weights.
    [0005]
    5 / - Prosthesis according to one of claims 1 to 4, characterized in that the ballast elements are heavy discs (10) inserted into slots (12) parallel formed in a foam padding (11) adjusted to the shape of the internal cavity (6). 6 / - Prosthesis according to one of claims 1 to 4, characterized in that the ballast elements are bearing pads (7) of substantially lenticular shape whose main median plane is substantially parallel to the plane of the cap ( 3). 7 / - Prosthesis according to claim 6, characterized in that each bearing pad (7) comprises a flexible bag-shaped outer wall (8) filled with a deformable charge (9). 8 / - Prosthesis according to claim 7, characterized in that the load (9) deformable consists of a divided solid of a density adapted to the desired weight. 9 / - Prosthesis according to claim 7, characterized in that the load (9) deformable consists of a polymer gel having a load whose density is a function of the desired weight. 10 / - Prosthesis according to one of claims 6 to 9, characterized in that the bearing pads (7) comprise means (13) for fixing placed on a sagittal axis of the prosthesis and adapted to make integral 10 faces look of two adjacent pads. 11 / - Prosthesis according to one of claims 6 to 10, characterized in that it further comprises a buffer (14) for filling elastic material adapted to be placed between the lid (3) and the pads (7) ballast to maintain these in compression. 12 / - Prosthesis according to one of claims 1 to 11, characterized in that the casing (2) is made of thermoformed thermoplastic foam, especially selected from foams of polyolefins, in particular thermoformed polyethylene foam. 13 / - Prosthesis according to one of claims 1 to 12, characterized in that the casing (2) is tinted in the mass and comprises a nipple (5) reported. 14 / - Prosthesis according to one of claims 1 to 13, characterized in that the casing (2) comprises at least one opening (15) of the cavity (6) for introducing the elements (7; 10) of ballast. 30 / - Prosthesis according to one of claims 1 to 14, characterized in that the cover (3) comprises, on its outer face (4), a fastening strip (17) covered with a plurality of detachable protective films (18) juxtaposed so as to allow the choice of at least one bonding area on the torso.
    类似技术:
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    同族专利:
    公开号 | 公开日
    RU2017101874A|2018-07-23|
    RU2734866C2|2020-10-23|
    FR3022451B1|2016-07-01|
    EP3157472B1|2018-05-16|
    WO2015197938A1|2015-12-30|
    ES2676046T3|2018-07-16|
    EP3157472A1|2017-04-26|
    US10583016B2|2020-03-10|
    RU2017101874A3|2018-11-28|
    US20170189208A1|2017-07-06|
    引用文献:
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    RU2233644C1|2002-12-09|2004-08-10|Федеральное государственное унитарное предприятие "Федеральный научно-практический центр медико-социальной экспертизы и реабилитации инвалидов"|Method for manufacturing mammary exoprosthesis|
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    IT201900014193A1|2019-08-08|2021-02-08|Gardelli Manuela|breast implant container device in reconstructive breast surgery|
    法律状态:
    2015-06-23| PLFP| Fee payment|Year of fee payment: 2 |
    2015-12-25| PLSC| Search report ready|Effective date: 20151225 |
    2016-06-23| PLFP| Fee payment|Year of fee payment: 3 |
    2017-06-22| PLFP| Fee payment|Year of fee payment: 4 |
    2018-06-28| PLFP| Fee payment|Year of fee payment: 5 |
    2020-06-29| PLFP| Fee payment|Year of fee payment: 7 |
    2021-06-30| PLFP| Fee payment|Year of fee payment: 8 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1455791A|FR3022451B1|2014-06-23|2014-06-23|EXTERNAL BREAST PROSTHESIS|FR1455791A| FR3022451B1|2014-06-23|2014-06-23|EXTERNAL BREAST PROSTHESIS|
    EP15732867.5A| EP3157472B1|2014-06-23|2015-06-11|External breast prosthesis|
    RU2017101874A| RU2734866C2|2014-06-23|2015-06-11|Exoprosthesis of mammary gland|
    ES15732867.5T| ES2676046T3|2014-06-23|2015-06-11|External breast prosthesis|
    US15/321,239| US10583016B2|2014-06-23|2015-06-11|External breast prosthesis|
    PCT/FR2015/051554| WO2015197938A1|2014-06-23|2015-06-11|External breast prosthesis|
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