FR2564728A1 - Solidified and coloured silicone elastomer-based moulded external mammary prosthesis - Google Patents

Abstract

The invention relates to an external mammary prosthesis usable for reconstructing or improving the plastics of people who have undergone a mastectomy. The material used is a solidified and coloured silicone elastomer which is rigorously neutral and because of this may be placed in direct contact with the skin. The method of manufacture, which is very particular, employs mixing, moulding and baking treatments which are well determined and often novel. The prosthesis is marketed with a double envelope made of materials with different natures, avoiding transpiration of the material and allergies of the wearer.

Description

 The present invention relates to a device intended to be used as an external breast prosthesis in order to restore a pleasing silhouette to women before undergoing a surgical or total ablation of the chest, following an accident or disease.

 The essential element of the prosthesis is a breast-shaped molding using a material which will best restore the appearance and the apparent characteristics of the natural orane.

This material is a cold or low temperature crosslinkable elastomer, with two comnosants and a SiH-Si crosslinking system.
Vinyl.

Before crosslinking, this elastomer is in the form of two components which are mixed at the time of use
Part A generally containing
- methylsiloxane oils and resins
- traces of catalyst based on chioroplatinic acid
- Possible charges and mineral nutrients
(silicone, calcium carbonate ...)
Part B generally containing
- grinding polymethylsiloxane oils and resins
Sih
- Optionally, polymethylsiloxanes and pigment pigments
minerals.

 The crosslinking is cold-pressed or temperature-controlled by mixing parts A and B laughing in appropriate proportions.

The principle of this crosslinking is absent on the reaction of the CH bonds on the i-vinyl bonds catalyzed by the platinum complex = SiH + CH2 = CH-S; ---- #) = Si. CH2. CH2Si =
The product obtained is a silicone rubber.

Platinum obviously remains the finished product.

 A particularly interesting material for this operation is the product designated under the name DTV. L. D. 2082 and marketed by the RHONE POULENC Company.

 The modalities of the crosslinking treatment must be precisely defined to give a finished product which presents a correct resemblance to the natural organ.

 The mixing of products A and B is advantageously carried out at @@ biante temperature Without a turbine jet nar mixer for twice five minutes.

 L @ Proportion of component A in the mixture is between 25% and 35% of the weight of the total mixture and, preferably, between 29% and 32, 3.1 ideal lying at 31.5.

 That of component B is between 65 and 75% by weight of the total mixture, and preferably between 68 and 71 ", the ideal being reached at 68.5%.

 After kneading, the mixture is poured into a preheated mold (700C) and coated with release agent (non-oil based soap) then placed in an oven whose temperature is between -80 and 100 degrees centigrade and at 900 rie reference during a Juror which is between 30 and 60 minutes depending on the size and mass of the mold.

 The mold is made of LAB 508 enoxy resin reinforced with 302 aluminum filings and undergoes, before being put into service, a thermal treatment that; makes it stable.

 To facilitate adaptation, the prosthesis on the subject, but also to lighten and make flexible the material, the internal face of the prosthesis, the closest to the skin must be of concave shape and the concavity can be characterized by the distance between the point of the deep nude and a plane resting on the external periphery of the prosthesis, this distance varying according to the size of the prosthesis is between 8mm and 15mm.

 Figure 1 shows a perspective view of the mold. Figure 2 a sectional view along the plane AA.

Figures 3a 36
4a 4b
5a 5b 6a 6b
7a 7b
8a 8b show in plans and sections the various realizations currently envisaged.

 The moile is produced in niece sets, a base (1) recessing in hollow the shape of a breast and a cover (2) in a convex shape which comes to plunge into the base to ensure the internal concauity of the prosthesis.

 The cover rests on the base via 3 'bridges (3,4,5,6) integral with the cover and coming to fit together with the recesses (7,8,9,10) in the base.

 The space (11) provided between the cover and the base allows the processed product to expand freely.

 Although the prosthesis can be used naked, it is delivered enclosed in sets in fabric envelopes.

 The first envelope intended to absorb a possible seepage and to let breathe the elastomer consists of a fabric in synthetic fiber ANTRON III Je "upont rie NEuOURS.

 The drawback of this fabric is that it sometimes produces irritation on contact with the skin on certain allergic foods.

 To avoid this drawback, the assembly formed by the prosthesis and the first envelope is placed again @ u Arns a second envelope 1002 cotton which gives no skin reaction.

 The seams of the envelopes made by means of a shaving serger are turned towards the inside of the device, thus producing no discomfort or irritation on the skin and goronti are total comfort, reinforced by the profile in studied curves of the prosthesis.

 After demoulding, the prosthesis is coated with officinal talc to absorb oily residues and to honor the best appearance of the product.

Claims (9)

 1) External breast prosthesis used following mastectomy, characterized by the nature of the constituent material which is a solidified and tinted silicone elastomer, crosslinkable at low temperature, with two components, with SiH - Si crosslinking system Vinyl, presented before crosslinking in the form of two constituents which are mixed at the time of use a. A constituent A containing  methylsiloxane oils and resins  traces of catalyst based on chloroplatinic acid  fillers or pigments.  polymethysiloxane oils and resins containing an SiH group. b. A constituent B containing  minerals.  Optionally, polymethylvinylsiloxanes and pigments  These various components known to be allergenic allow direct, occasional or repeated contact with the skin. Constituent A - between 25S and 35S of the total mixture by weight.  Components A and B used in the following proportions Constituent B - between 65% and 75% by weight of the total mixture.  2) Prosthesis according to Claim 1 characterized by the proportions of the mixture Constituent A - between 28 and 32t Constituent B - between 68S and 712.  3) Prosthesis according to Claim 1 characterized by the concave shape of the posterior surface in direct or indirect contact with the skin.  The concavity characterized by the distance between the deepest point and a plane resting: on the external periphery of the prosthesis between Bmm and 15mm depending on the sizes.  4) Prosthesis according to Claims 1 or 2 characterized by a covering made up of two fabric envelopes.  The first envelope is formed of a flesh-colored fabric, responsible for absorbing any exudations of silicone oil while letting the prosthesis "breathe" which will thus be able to modulate and distribute the pressures undergone.  This fabric known as a'ANTRON III is marketed by Du Pont de NEOURS.  The second envelope, in contact with the skin, is made with a 100% cotton fabric of flesh color also giving no allergic reaction. Its removal for cleaning purposes is facilitated by a vertical rear opening with no visible seams.  5) Droth according to one of the preceding claims characterized by the arrangement Its seams which are produced with an overlock shaver and turned and returned towards the interior of the device in order to guarantee comfort free of any roughness, reinforced by the messin in studied curves of the prosthesis. (fig. 3 to 8)  6) Method for manufacturing a breast prosthesis according to one of the preceding claims, characterized by the following operations - @ mixing of the old components at a temperature between 200 and 280. (degrees centigrade)  In a device of type: mixer by turbine head  During a period of: 2 times 5 minutes. - Treatment of the mixture, poured into a mold, in an oven brought to a temperature between 80 and 100 degrees centigrade for a period between 30 and 60 minutes.  7) Method according to pevendication 5 characterized by the execution of the heat treatment in an oven carried between 85 and 95 degrees centigrade during a period of between 35 and 45 minutes incorporating operations preheating the mold facilitating the installation of a layer of release agent and better polymerization in order to obtain constant flexibility of the finished product.  8) Method according to the kevendicot; on 6 characterized by the use of a mold made of epoxy resin LAB 508, reinforced by the addition of aluminum filings and stabilized by heat treatment Fig. 1 board 1/7. In addition to its characteristic and pprticular hollow shape, this mold has a removable sun nartie which ensures the posterior concavity of the prosthesis, the originality consisting in creating this hollow without enclosing the silicone (11) in an enclosed space giving it thus all facilities for expansion and vulcanization huron heat treatment.  9) Process according to Claims 6, 7 and 8 chargctérisé by the use of talc officinal fnvorisant llabsorption e oily residues while satinizing the external part of the prosthesis.