EP0057721A1 - Prothese mammaire et procede pour sa fabrication - Google Patents

Prothese mammaire et procede pour sa fabrication

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
breast
prosthesis
edge
hardener
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Withdrawn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)
English (en)
Inventor
Bodo Knoche
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 claimed from DE19803031223 external-priority patent/DE3031223A1/de
Application filed by Individual filed Critical Individual
Publication of EP0057721A1 publication Critical patent/EP0057721A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/52—Mammary prostheses

Definitions

  • the invention relates to a breast prosthesis intended for insertion or insertion into a brassiere, made by molding, made of soft-elastic, porous, adhesive, skin-colored silicone rubber cross-linked with hardener, consisting essentially of a central part surrounded by an edge, the convex outer surface of which has the shape of a female breast with wart and areola and its concave inner wall is arched in a bosom shape while maintaining the desired prosthesis wall thickness and deepened in the top area to reduce the prosthesis wall thickness.
  • the middle part is hollow and consequently compresses when pressure is applied to it.
  • the weight distribution of these prostheses does not correspond to that of a natural breast.
  • the invention has for its object to limit the compression of the breast prosthesis when subjected to pressure to the given size in a natural breast with the greatest possible approximation of the elastomechanical behavior of the prosthesis to that of a natural breast.
  • a similar weight distribution has been striven for, among other things, to enable natural sagging and rocking of the breast prosthesis.
  • the invention consists in that the middle part of the prosthesis in the dome area having the depression is filled with a (semolina) mush-like mixture of silicone jelly and vulcanized silicone crumbs (silicon grits) and by a flexible protective layer vulcanized on the edge of the depression made of very tough , hardened with cross-linked silicone rubber.
  • a (semolina) mush-like mixture of silicone jelly and vulcanized silicone crumbs (silicon grits) and by a flexible protective layer vulcanized on the edge of the depression made of very tough , hardened with cross-linked silicone rubber.
  • Fig. 1 a plan view of the front
  • the prosthesis which is produced as a casting from a soft silicone rubber compound crosslinked with hardener, has a central part 1, the convex outer surface of which has the shape of a female breast with wart 2 and areola 3, while its concave inner surface consists of two, merge into each other through a step-shaped paragraph 7 the areas li and lii.
  • the surfaces of both areas li and lii are bent like a bush, the area of area li being at a greater distance from the outer surface la than the surface area lii.
  • the prosthesis wall thickness is accordingly reduced in the area lii, to a wall thickness of approximately 1.5 mm.
  • the layer la-lii approximately obtains the elastic properties of the human skin.
  • the wall area li merges with a constant curvature ie the rear wall of a spur-like, thin, flexible edge part 5 surrounding the middle part, which is extended on the armpit-side prosthesis side to an extension 6 which is intended for sealing the armpit-lymphatic gland area.
  • the area forming the areola 3 with wart 2 consists of a very soft silicone rubber compound (crosslinked with hardener). It is made from a mixture of hardener with silicone rubber that gives a greater degree of softness than the rest of the prosthesis body.
  • a protective layer 8 consisting of a very tough silicone rubber compound is vulcanized, which is approximately 1 mm thick and air-and liquid-tightly sealed between the surface lii, the shoulder 7 and the layer 8 completes.
  • This space is filled with a mass 9, which consists of a mixture of gelatinous silicone jelly and vulcanized silicone crumbs.
  • the individual crumbs are roughly the size of a semolina and are mixed with the jelly with a 30% share, so that the mixture has a semolina-like consistency.
  • a preferably round PVC plate 11 of about 25 mm in diameter is vulcanized into a corresponding recess in the lower surface of the edge, slightly below the edge sheet located at the top when the prosthesis is worn, on the edge strip lying towards the center of the body, which is used to attach a double-sided Adhesive plate is used, with the help of which the prosthesis edge 5 can be glued to the body.
  • the mass from which the middle part 1, the edge part 5 with extension 6, the filling 9 and the protective layer 8 and the plate 11 are formed is colored skin-colored.
  • the mass from which areola 3 with wart 2 is made is colored in the color of a natural areola with wart.
  • the edge part la-li of the middle part 1 forms a so-called static frame for the soft, rocking upper dome part, which keeps the prosthesis in shape.
  • the jelly filling 9 prevents the prosthesis from being compressed when pressure is exerted on the areola area or in another direction and, at the same time, causes pressure compensation in conjunction with the protective layer 8, so that the middle part of the prosthesis reacts resiliently to the effects of pressure.
  • the elastic properties of the prosthesis have thus been optimally matched to those of the natural breast.
  • the prosthesis weight also corresponds to that of a natural breast.
  • the breast prosthesis according to the invention is manufactured as follows:
  • the areola area is first cast with wart from a mixture of silicone rubber and hardener which gives a high degree of softness and allowed to vulcanize at approx. 120 ° C.
  • the middle part 1 with edge 5 and extension 6 is then cast from a silicone-rubber hardener mixture which results in a lower degree of softness, followed by a vulcanization process at about 120 ° C.
  • the upper part of the mold is removed and the dome part up to the upper edge of the step 7 poured with silicone "semolina porridge".
  • the mass to form the very tough final layer 8 is spread onto the surface of the filling, with the edge of step 7 also being coated.
  • the through holes 10 can be formed by pins inserted into the mold. After vulcanization of the plate 11, the prosthesis is completed.

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. 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. 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.
EP19810902388 1980-08-19 1981-08-17 Prothese mammaire et procede pour sa fabrication Withdrawn EP0057721A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE8022099 1980-08-19
DE3031223 1980-08-19
DE8022099U 1980-08-19
DE19803031223 DE3031223A1 (de) 1980-08-19 1980-08-19 Brustprothese und verfahren zu ihrer herstellung

Publications (1)

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

Family

ID=25787310

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19810902388 Withdrawn EP0057721A1 (fr) 1980-08-19 1981-08-17 Prothese mammaire et procede pour sa fabrication

Country Status (2)

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

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3440960A1 (de) * 1984-10-13 1986-04-24 S + G Implants GmbH, 2400 Lübeck Prothese als ersatzfuer eine amputierte brust
DE3615726C1 (de) * 1986-05-09 1987-08-27 S & G Implants Gmbh Brustprothese
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 (fr) * 1976-05-27 1981-02-24 Alfred P. Brill, Iii Articles en silicone souple contenant un gel et gels a cet effet
DE2742140A1 (de) * 1977-09-19 1979-03-29 Bodo Knoche Brustprothese sowie verfahren und form zu ihrer herstellung
DE2742394A1 (de) * 1977-09-21 1979-03-29 Maria Lohse Brustprothese

Non-Patent Citations (1)

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

Also Published As

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

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Legal Events

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PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

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AK Designated contracting states

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Effective date: 19821025