Static molds – Having surface shaped to simulate a product of nature
Patent
1996-06-21
1999-07-20
Crispino, Richard
Static molds
Having surface shaped to simulate a product of nature
249170, 249171, 425521, A61F 262, B29K 5110
Patent
active
059252820
DESCRIPTION:
BRIEF SUMMARY
The invention relates to a method of manufacturing a foil-wrapped breast prosthesis with a filling consisting of a curable compound, preferably a silicone compound, by which producing a prosthesis bag, leaving at the joint a filling opening, filling opening is sealed after air bubbles have been expelled, with an open mould cavity corresponding to the desired shape of the front of the prosthesis, the bag being positioned with respect to the mould cavity and secured to the mould, the mould.
The invention also relates to a shaping tool for use in performing the method.
From DE-C2-33 36 279 and U.S. Pat. No. 4,249,975 methods of manufacturing breast prostheses are known by which injection of the silicone compound used as filling is performed under pressure during the actual curing process, which is performed in a closed mould. In this connection, it is known from said DE publication to bring the walls of the prosthesis bag into contact with the walls of the mould cavity by applying vacuum before injecting the silicone compound.
To avoid the disadvantages by injecting the silicone compound under pressure during the actual curing process, a manufacturing method of the above mentioned kind is suggested in GB-A-2 257 387, by which the prosthesis bag is filled before being placed in the curing mould, which also in this case is closed, the actual mounting taking place under application of vacuum.
In a method of the above mentioned kind, the manufacturing can be performed in practice e.g. by welding together two sheets of polyurethane foil, which have been pre-shaped for forming the front and the rear side, respectively, of the prosthesis, into a prosthesis bag by means of a contour welding tool, thereby leaving a gate for use in filling the curable prosthesis mass, which usually consists of a vulcanizable silicone compound. By the filling, a predetermined volume of the filling compound is admitted to the prosthesis bag by means of conventional mixing and dosing equipment, whereafter the gate is sealed by high-frequency or hot welding, possibly after having expelled air bubbles.
However, for the method according to the above mentioned GB patent application, an over-charging of the prosthesis bag is required to obtain a fully moulded front with an intended anatomic shape with a nipple, which generally results in an unintentional thickening of the prosthesis edge, the prosthesis thus not fitting tightly to the body.
The purpose of the invention is to provide a method by which the above mentioned problem can be avoided, and a shaping tool which to a considerable extent eases the handling of a prosthesis bag by placing and fixing it in a mould or a curing shell.
In this respect, according to the invention a method of the above mentioned kind is characterized in that the curing is performed without closing the mould cavity and while maintaining vacuum therein, at least in the beginning of the curing.
As the front of the prosthesis bag is kept in close contact with the wall of the mould cavity until the filling, or at least the part of it which is close to the wall, has cured, a considerably improved certainty is obtained for a fully moulded front with the desired shape corresponding to the mould cavity in the generally replaceable first mould part and with thin edge parts, making the prosthesis fit well to the body.
At the same time, greater freedom in the elaboration of the rear side of the prosthesis is obtained, as an expansion of the prosthesis mass, as a result of thermal expansion during the curing, can be routed to the areas of the rear side which are less important to the appearance and function of the prosthesis.
As such method according to the invention can be performed without using a rear block, although such a rear block is applied in most cases to obtain a desired shaping of parts of the rear side of the prosthesis. The shaping of the rear side can also be utilized for adjusting the flexibility and elasticity of the prosthesis and, in case of large prostheses, possibly for adjusting the weight of the prosthe
REFERENCES:
patent: 4247351 (1981-01-01), Rechenberg
patent: 4249975 (1981-02-01), Rechenberg
patent: 4401492 (1983-08-01), Pfrommer
patent: 4701230 (1987-10-01), Loi
Coloplast A/S
Crispino Richard
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