EP0057721A1 - Mammary prosthesis and process for the manufacture thereof - Google Patents

Mammary prosthesis and process for the manufacture thereof

Info

Publication number
EP0057721A1
EP0057721A1 EP19810902388 EP81902388A EP0057721A1 EP 0057721 A1 EP0057721 A1 EP 0057721A1 EP 19810902388 EP19810902388 EP 19810902388 EP 81902388 A EP81902388 A EP 81902388A EP 0057721 A1 EP0057721 A1 EP 0057721A1
Authority
EP
European Patent Office
Prior art keywords
silicone
prosthesis
breast
edge
characterized
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP19810902388
Other languages
German (de)
French (fr)
Inventor
Bodo Knoche
Original Assignee
KNOCHE, Bodo
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to DE19803031223 priority Critical patent/DE3031223C2/de
Priority to DE8022099 priority
Priority to DE8022099U priority
Priority to DE3031223 priority
Application filed by KNOCHE, Bodo filed Critical KNOCHE, Bodo
Publication of EP0057721A1 publication Critical patent/EP0057721A1/en
Application status is Withdrawn legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/52Mammary prostheses

Abstract

Prothese mammaire constituee par une forme coulee, destinee a etre posee ou introduite dans un soutien-gorge, en caoutchouc au silicone reticule avec durcisseur, elastique, mou, poreux, adherant, de la couleur de la peau, qui se compose en particulier d'une partie centrale entouree d'un bord, dont la surface exterieure couvexe presente la forme d'un sein avec mamelon et areole et dont la paroi interieure concave est galbee sans porter atteinte a l'epaisseur de la paroi de la forme de sein souhaitee de la prothese et est creusee dans la zone arrondie afin de diminuer l'epaisseur de la paroi de la prothese. Breast prosthesis constituted by a casting form, intended to be placed or introduced into a bra, in rubber cross-linked silicone with hardener, elastic, soft, porous, adhering, color of the skin, which consists in particular of a central section surrounded by an edge, whose couvexe outer surface has the shape of a breast with the nipple and areola and the concave inner wall is Galbee without affecting the thickness of the wall of the shaped desired within the prosthesis and is dug in the rounded zone to reduce the thickness of the wall of the prosthesis. Pour limiter la deformation de la prothese a celui d'un sein naturel, cause par des effets de pression en tenant compte au mieux du comportement elasto-mecanique de la prothese en comparaison d'un sein naturel et pour atteindre avant tout une repartition de poids egale qui permet entre autre l'affaissement naturel du sein, la partie centrale de la prothese (1) est remplie dans la zone arrondie comportant un creux avec un melange (9) pateux de gelee de silicone et de miettes de silicone vulcanisees (granule de silicone) et fermee par une couche (8) de protection souple en caoutchouc au silicone avec durcisseur soudee au bord du creux. To limit the deformation of the prosthesis is that of a natural breast, caused by pressure effects, taking into account the most of elasto-mechanical behavior of the prosthesis compared to a natural breast and achieve primarily a weight distribution equal which allows, among other natural sagging of the breast, the central portion of the prosthesis (1) is met in the rounded zone comprising a hollow with a mixture (9) pasty silicone jelly and vulcanized silicone crumbs (granule silicone) and closed by a layer (8) of flexible protective silicone rubber with welded hardener edge of the hollow. Dans le procede de fabrication d'une telle prothese, on confectionne par coulage, respectivement remplissage avec un melange de caoutchouc au silicone et durcisseur ou gelee de silicone et miettes de silicone, l'areole avec mamelon, la paroi de la partie centrale (1) avec bord (5) et prolongement (6), la masse de remplissage (9) de la partie centrale (1) et la couche de protection (8) l'une apres l'autre. In the method of manufacturing such a prosthesis, it manufactures by casting, respectively filled with a mixture of silicone rubber and curing agent or jelly silicone and silicone crumbs, the areola to the nipple, the wall of the central portion (1 ) with edge (5) and extension (6), the filler (9) of the central portion (1) and the protective layer (8) one after the other.

Description

A breast prosthesis and process for their preparation

The invention relates to a breast prosthesis intended for inserting or insertion into a brassiere made by molding from soft-elastic, pored, adhering, skin-colored, cross-linked with hardener silicone rubber consisting essentially of an area surrounded by an edge of the middle part, the convex outer surface has the shape of a female breast and areola and nipple with the concave inner wall is bosom shaped curved in compliance with the desired prosthesis wall thickness and deepens in the tip region in order to reduce the prosthesis wall thickness.

In breast prostheses of the type mentioned above, the central part is hollow and is reflected accordingly in Druckein effects on it together. The weight distribution of these prostheses does not correspond to a natural breast.

The invention aims underlain to limit the compression of the breast prosthesis at the effects of pressure on the given at a natural breast measure, taking utmost approach of elastomechanisehen behavior of the prosthesis to the natural breast. wherein especially a similar weight distribution has been desired to allow, among other things also a natural sagging and rockers of the breast prosthesis.

The invention consists in that the prosthesis central portion in the filled, the recess having the tip region having a (Griesheim) pasty mixture of silicone jelly and fully vulcanized silicone crumbs (silicone-Gries) and very tough by the recess edge vulcanized flexible protective layer of is terminated with hardener cross-linked silicone rubber.

Further features of the invention are subject of the subclaims.

An exemplary embodiment of a breast prosthesis according to the invention is described below with reference to the drawings. Show it:

Fig. 1 is a plan view of the front side and

Fig. 2 is a plan view of the back of the Brustpro synthesis and Fig. 3 shows a section along the line III-III of Fig. 1.

The prosthesis manufactured as a cast piece of a crosslinked with hardeners, soft silicone rubber compound comprises a center part 1, whose convex outer surface has the shape of a female breast with wart 2 and areola 3, while its concave inner surface li is made up of two by a step-shaped shoulder 7 merge the fields of li and composed lii. The surfaces of both areas and li lii are bent büsenförmig, wherein the area of ​​the region li a greater distance from the outer face la having, as the surface area lii. The graft wall thickness is reduced accordingly in the range lii, on a wall thickness of about 1.5 mm. Characterized the layer la-lii obtained as a result of elastomechanisehen properties of the silicone rubber composition used in about the elastic properties of human skin. The wall region li goes with constant curvature ie the rear wall of the center portion surrounding, streamer-like, thin, flexible edge portion 5 which is extended at the shoulder prosthesis-side to an extension 6, which is intended for Abdeichen the armpit -Lymphdrüsen-Be kingdom.

Of the areola 3 forming with wart area 2 consists of a very soft silicone rubber composition (crosslinked with hardener). It is resulting from a greater degree of softness, another mixture of curing agent prepared with silicone rubber as the remaining prosthesis body.

Am adjacent to the inner surface of left edge of the shoulder 7 is a made of a very viscous silicone rubber composition of protective layer 8 is vulcanized, which is about 1mm thick and between the surface lii, the shoulder 7 and the layer 8 space formed air- and liquid keitsdτcht concludes. This space is filled with a mass 9, which consists of a mixture of gelatinous silicone jelly and fully vulcanized silicone crumbs. The individual crumbs have approximately the size of a grain and semolina are mixed with a 30% share the shots, so that the mixture has a consistency griessbreiähnliche. In the wall la-li of the central part are through holes 10 for the passage of air.

At the bottom of the skirt portion 5 just below the while wearing de r prosthesis uppermost located edge arc at-facing middle of the body edge strip, a preferably round PVC plate 11 vulcanized of about 25 mm diameter in a corresponding recess of the rim bottom surface, which a double-sided for attaching adhesive wafer is used, by means of which the prosthesis edge is 5-adhered to the body.

The composition from which the central part 1, the edge portion 5 with the extension 6, the filling 9 and the protective layer 8 and the plate 11 are formed is colored skin color. Likewise, the mass from which the areola 3 is made with wart 2, colored in the color of a natural areola with wart.

The edge part la-li of the central part 1 forms a so-called. Static frame for the soft, bouncing upper tip portion that holds the prosthesis in the form of comparatively outlined. The jelly filling 9 prevents compression of the prosthesis under pressure to the areola or in any other direction and effected simultaneously in connection with the protective layer 8 pressure equalization, so that the prosthesis central part on the effects of pressure responsive resilient. So that the elastic properties of the prosthesis have been adjusted in an optimal manner to those of the natural breast. Also the prosthesis weight corresponds to that of a natural breast. This has a very positive effect on the physical sensation and the mental situation of the prosthesis wearer, which can make the difference between the natural breast and the prosthesis hardly notice, especially the support of the brassiere not according to the weight difference between natural breast and breast prosthesis must adjust differently and can therefore easily forget their condition as when wearing the known prostheses.

The breast prosthesis according to the invention is prepared as follows:

In one of the prosthesis corresponding to the shape, consisting of upper and lower part of the mold is first warts yard gegössen with wart from a high degree of softness resulting mixture of silicone rubber and curing agent, and at about 120 ° C allowed to vulcanization. Then, from a lower degree of softness resulting silicone rubber curing agent mixture of the central part 1 with the edge 5 and extension 6 cast with subsequent Ausvulkanisierungsprozess at about 120 ° C. Thereafter, the molded shell is removed and the dome portion to the upper edge of the step 7 filled with silicone "semolina". the mass is spread to form the very viscous Prom uss-layer 8 on the surface of the filling, also the edge of the step 7 is coated. By vulcanization the result is a tight closure of the hilltops-interior with the Jelly Silicon porridge filling. The through holes 10 may be formed by pins inserted into the mold. After vulcanization of the plate 11, the prosthesis is completed.

Claims

claims
1. A breast prosthesis manufactured by molding of soft, pored, adhering, skin-colored cross-linked with hardener silicone rubber consisting essentially of a from an edge (5) surrounding the central part (1), whose convex outer surface (1a) takes the form of a female having breast with Wärze and areola and the concave inner wall (lii) is bosom shaped curved and recessed in the tip region in order to reduce the prosthesis wall thickness, characterized in that the prosthesis central part (1) in which the recess having the tip region (la-LII) with a ( semolina) pasty mixture of silicone jelly and fully vulcanized silicone crumbs (silicone Griess) (9) filled and very resistant (by the recess edge anvul karrisierte, flexible protective layer 8), cross-linked with hardener silicone rubber is completed.
2. A breast prosthesis according to claim 1, characterized in that the areola (3) with wart (2) of a very soft crosslinked with curing silicone rubber is formed, in a corresponding recess of the harder central part (1) is vulcanised.
3. A breast prosthesis according to claim 1 and / or 2, characterized by vent holes (10) in the carrier edge (la li) of the central part (1).
4. A breast prosthesis according to any one of the preceding claims, characterized in that the central part (1) in the region of the inner recess (la-li) has a wall thickness of about 1.5 mm.
5. A breast prosthesis according to at least one of the preceding claims, characterized in that the protective layer (8) has a wall thickness of about 1mm.
6. A breast prosthesis according to at least one of the preceding claims, characterized in that the mass (9) Silicone-jelly and silicone Griess is flesh-colored dyed.
7. A breast prosthesis according to at least one of the preceding claims, characterized by a 30% - stake of silicone Griess in jelly-slurry.
8. A breast prosthesis according to at least one of the preceding claims, characterized by at least one anvulkanisiertes PVC plate (11) on the underside of the edge portion (5) for Anrbingen a double-sided pressure-sensitive adhesive lamina.
9. The method for producing the breast prosthesis according to the preceding claims by molding in a group consisting of upper and lower parts Giess form, characterized by the following process steps:
a) pouring the recess for the casting of areola (3) with wart (2) in the mold with a very high degree of softness resulting mixture of silicone rubber and curing agent with ansschliessendem Ausvulkanisierungsprozess at 120 ° C, b) casting of the central part (1) with the edge (5) and extension (6) from a lower softness degree resulting mixture of silicone rubber and curing agent with final plenty of running Ausvul kanisierungs process at 120 ° C, c) filling of the coupling member to the upper edge of the step (7) with a mixture of silicone jelly and fully vulcanized silicone crumbs (silicone Griess) (9). d) coating the filling compound (9) (with a very high degree of toughness resulting silicone chewing Schuk-curing agent mixture including the edge of the stage 7).
10. The method according to claim 9, characterized in that on the underside of the edge portion (5), a PVC plate (11) is vulcanized for attaching a double-sided adhesive Haftplättcheαs.
EP19810902388 1980-08-19 1981-08-17 Mammary prosthesis and process for the manufacture thereof Withdrawn EP0057721A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
DE19803031223 DE3031223C2 (en) 1980-08-19 1980-08-19
DE8022099 1980-08-19
DE8022099U 1980-08-19
DE3031223 1980-08-19

Publications (1)

Publication Number Publication Date
EP0057721A1 true EP0057721A1 (en) 1982-08-18

Family

ID=25787310

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19810902388 Withdrawn EP0057721A1 (en) 1980-08-19 1981-08-17 Mammary prosthesis and process for the manufacture thereof

Country Status (2)

Country Link
EP (1) EP0057721A1 (en)
WO (1) WO1982000583A1 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3440960C2 (en) * 1984-10-13 1987-01-08 S + G Implants Gmbh, 2400 Luebeck, De
DE3615726C1 (en) * 1986-05-09 1987-08-27 S & G Implants Gmbh breast prosthesis
GB2344273A (en) * 2000-02-12 2000-06-07 Mjm International Limited Foundation garment with silicone fluid bag

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2066503A (en) * 1935-09-24 1937-01-05 Blanche E Wiggers Breast adapter
US2636182A (en) * 1951-08-23 1953-04-28 Freedman Ruth Artificial body bulge
US3986213A (en) * 1975-05-27 1976-10-19 Medical Engineering Corporation Gel filled medical devices
CA1096529A (en) * 1976-05-27 1981-02-24 Alfred P. Brill, Iii Low oiling silicone gel filled flexible articles and gels therefor
DE2742140A1 (en) * 1977-09-19 1979-03-29 Bodo Knoche Plastics foam rubber prosthesis simulating a woman's breast - has flange along base to protect the wearer's lymphatic glands
DE2742394A1 (en) * 1977-09-21 1979-03-29 Maria Lohse Woman's breast plastics prosthesis - has radially extending adhesive lugs to stick it to wearer's skin

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO8200583A1 *

Also Published As

Publication number Publication date
WO1982000583A1 (en) 1982-03-04

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Legal Events

Date Code Title Description
AK Designated contracting states:

Designated state(s): AT CH FR GB LU NL SE

18D Deemed to be withdrawn

Effective date: 19821025