Method for the manufacture of breast prostheses

Details Method for the manufacture of breast prostheses Method for the manufacture of breast prostheses

2000-07-21

2001-10-02

Kuhns, Allan R. (Department: 1732)

Plastic and nonmetallic article shaping or treating: processes

Mechanical shaping or molding to form or reform shaped article

To produce composite, plural part or multilayered article

C264S046600, C264S320000, C264SDIG006

Reexamination Certificate

active

06296800

ABSTRACT:

The invention relates to a method for the manufacture of breast prostheses consisting of a shell-shaped body made from an addition-vulcanising two-components silicone rubber mass, which body is contained in plastic films enveloping it, where a filler of low density consisting of hollow spheres or microspheres is added to the two-component silicone rubber mass, the mixture is poured into a sheath of plastic films and cured in a mould under the effect of heat.
Breast prostheses of this type are known from DE 92 01 918 U. Such breast prostheses are manufactured using the conventional method, in which the two components of the silicone rubber are set with regard to their viscosity so that they can be pumped together with the filler and guided through a mixer to fill the plastic films already welded together to prosthesis sheaths. To be pumpable, the two components or the mixture must have a relatively low viscosity which leads to the lighter filler spheres, which have a density of <0.1 g/cm
3
, floating in the pouch-shaped plastic sheaths inserted in the mould before their curing so that the uniform distribution of the filler in the silicone rubber mass is lost and the filler migrates from the lower regions of the mixture to the top and collects in the upper region of the pouch-shaped plastic sheaths.
Further problems with the processing of the mixture of the two-component silicone rubber with the filler spheres arise in particular during the pumping of said mixture. The fillers consisting of the hollow spheres or microspheres form a compressible component in the mixture so that the total mixture no longer behaves like a liquid, but can lead to different volume discharges as the result of pressure differences in the pump operation. This is particularly problematic when filling the plastic films welded together into the prosthesis sheaths.
Various proposals are known from DE 44 13 076 A1 which are intended to prevent the problem of the unwanted floating of the filler spheres or microspheres. However, these proposals do not lead to a remedy for the problems in the processing of the mixture of hollow spheres or microspheres with the still unvulcanised two-component silicone rubber mass.


REFERENCES:
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patent: 4955907 (1990-09-01), Ledergerber
patent: 5549671 (1996-08-01), Waybright et al.
patent: 5738812 (1998-04-01), Wild
patent: 92 01 918 (1992-07-01), None
patent: 44 13 076 (1995-10-01), None
patent: 295 19 283 (1996-04-01), None
patent: 295 16 281 (1997-03-01), None
patent: 197 54 144 (1998-11-01), None
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