Method for manufacturing an epithesis

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Breast prosthesis

Reexamination Certificate

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Details

C264S222000

Reexamination Certificate

active

06447541

ABSTRACT:

The invention relates to an epithesis, which is made up of a casing adapted to the body at the rear and at the front is assimilated to the desired body surface, and of a filling in the casing and furthermore to a kit for the performance of the method and for the production of such epitheses.
Epitheses for the compensation of innate or acquired defects of the body have long been known and copiously described. They are employed on a large scale to conceal the consequences of accidents or of surgical operations and to imitate a natural body surface. A frequent purpose of use is the imitation of the female breast after surgical amputation owing to malignant tumors.
In this respect epitheses serve on the one hand to protect the defective body surface against undesired external influences, that is to say for example to aid in wound healing and to improve hygiene. On the other hand epitheses are prescribed and worn more particularly for cosmetic reasons.
Having regard to the intended purpose it is necessary to adapt the epithesis in an optimum fashion to the body surface. This is so because it is only in this manner that basic medical and hygienic requisites may be fulfilled and because it is only so that optimum “wearing comfort” may be guaranteed. A further point is that it is only a well fitted epithesis that creates the desired appearance and allows the patient to move freely. Optimum imitation of the natural body surface, including imitation of the natural skin color, is in this case is an obvious requirement.
Conventional epitheses comprise an outer casing, which is adapted to the body surface and is filled with a liquid. The material of the casing normally consists of silicone rubber or also a polyurethane plastic, such substances having been shown to extremely compatible with the skin. Frequently, the filling consists of a liquid silicone.
Disadvantages encountered with such known epitheses are however the ability to flow and the poor dimensional stability of the filling. This leads to the necessity of appropriate measures for the attachment of the epithesis, which accordingly must be more complex than is compatible with wearer comfort. This, and the relatively high concomitant weight, leads to impairments as regards mobility and, in the case of vigorous movements, to a proneness of the epithesis to slip out of position. Moreover there is the danger of leakage following any damage to the casing. Air-filled epitheses collapse, if the casing is punctured.
A further disadvantage of known epitheses is their low degree of adaptation to individual needs. Standardized epitheses are only occasionally able to meet the requirements of an individual case. Optimum adaptation to the body surface and to the general appearance of the wearer are however essential for wearer comfort and acceptability.


REFERENCES:
patent: 4466936 (1984-08-01), Schapel
patent: 4600551 (1986-07-01), Erb
patent: 4906423 (1990-03-01), Frisch
patent: 5035758 (1991-07-01), Degler et al.
patent: 5370688 (1994-12-01), Schultz et al.
patent: 5733335 (1998-03-01), Ishikawa et al.
patent: 5824075 (1998-10-01), Thielbar
patent: 6042608 (2000-03-01), Ishikawa et al.
patent: 6086801 (2000-07-01), Eaton
patent: 6136027 (2000-10-01), Jackson

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