FR2675049A1 - Implantable mammary prosthesis - Google Patents

Implantable mammary prosthesis Download PDF

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Publication number
FR2675049A1
FR2675049A1 FR9104602A FR9104602A FR2675049A1 FR 2675049 A1 FR2675049 A1 FR 2675049A1 FR 9104602 A FR9104602 A FR 9104602A FR 9104602 A FR9104602 A FR 9104602A FR 2675049 A1 FR2675049 A1 FR 2675049A1
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FR
France
Prior art keywords
polyether
envelope
silicone
polyurethane
layer
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Withdrawn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
FR9104602A
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French (fr)
Inventor
Mas Jean-Claude
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.)
MAS JEAN CLAUDE
Original Assignee
MAS JEAN CLAUDE
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
Application filed by MAS JEAN CLAUDE filed Critical MAS JEAN CLAUDE
Priority to FR9104602A priority Critical patent/FR2675049A1/en
Publication of FR2675049A1 publication Critical patent/FR2675049A1/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/34Macromolecular materials

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The present invention relates to an implantable mammary prosthesis. It consists of a closed silicone envelope, pre-filled during manufacture with silicone gel and covered by a layer of polyurethane, in polyether form, glued on the said silicone envelope in such a way as to render it completely inseparable from the latter. It is intended to be used both in reparative surgery for patients who have undergone mastectomy and in cosmetic surgery.

Description

PROTHESE MAMMAIRE IMPLANTABLE
La présente invention a pour objet une prothèse mammaire implantable.
IMPLANTABLE BREAST PROSTHESIS
The present invention relates to an implantable breast prosthesis.

Elle est destinée à être utilisée aussi bien en chirurgie réparatrice pour les patientes ayant subi une mastectomie, qu'en chirurgie esthétique. It is intended to be used both in reconstructive surgery for patients who have undergone a mastectomy, and in cosmetic surgery.

Les prothèses mammaires sont le plus souvent constituées d'une poche en élastomère de silicone ou autre, gonfable ou remplie de sérum physiologique après implantation, grâce à un système de valve. Ces prothèses ont non seulement une texture très éloignées du sein naturel, mais elles ont de plus tendance à se déformer avec le temps et les tissus organiques adhérent très mal sur leur enveloppe externe. Breast prostheses are most often made up of a silicone elastomer or other bag, inflatable or filled with physiological saline after implantation, thanks to a valve system. These prostheses not only have a texture very distant from the natural breast, but they also tend to deform over time and the organic tissues adhere very poorly to their outer shell.

Des améliorations sensibles ont été réalisées par certains fabricants qui proposent des prothèses formées d'une enveloppe en élastomère vulcanisé à froid ou à chaud, préalablement remplie de gel silicone lors de sa fabrication, et recouvertes de polyuréthane polyester, toutefois les articles ainsi obtenus présentent une décollement du polyuréthane si l'on exerce une pression normale pour l'implantation, et surtout laissent apparaltre un silicone insuffisamment polymérisé lorsque l'on décolle le polyuréthane. Significant improvements have been made by certain manufacturers who offer prostheses formed from an envelope of cold or hot vulcanized elastomer, previously filled with silicone gel during its manufacture, and covered with polyester polyurethane, however the articles thus obtained have a polyurethane detachment if normal pressure is applied for implantation, and above all reveal insufficiently polymerized silicone when the polyurethane is detached.

Le dispositif selon la présente invention supprime tous ces inconvénients. En effet, il permet d'obtenir des prothèses indéformables, ayant une consistance voisine de celle des tissus naturels et dont l'enveloppe externe ne peut être décollée de la poche en élastomère contenant le gel de silicone. The device according to the present invention eliminates all these drawbacks. Indeed, it makes it possible to obtain non-deformable prostheses, having a consistency close to that of natural tissues and the external envelope of which cannot be detached from the elastomer pocket containing the silicone gel.

Il est constitué d'une enveloppe de silicone fermée, préremplie en cours de fabrication de gel de silicone et recouverte d'une couche de polyuréthane sous forme de polyéther collée sur ladite enveloppe de silicone de manière à la rendre parfaitement indissociable de cette dernière. It consists of a closed silicone envelope, pre-filled during the manufacture of silicone gel and covered with a layer of polyurethane in the form of polyether bonded to said silicone envelope so as to make it perfectly inseparable from the latter.

La description détaillée ci-après se rapporte à un exemple non limitatif d'une des formes de réalisation de l'objet de 1 'invention.  The detailed description below relates to a nonlimiting example of one of the embodiments of the subject of the invention.

La prothèse mammaire selon l'invention est réalisée à partir d'une enveloppe en élastomère de silicone de forme et dimension adéquates, remplie durant la fabrication d ' un gel de silicone dont la viscosité est adaptée de manière à donner au produit terminé une consistance aussi proche que possible de celle d'un véritable sein. L'ensemble est ensuite recouvert d'une couche externe de polyuréthane sous forme de polyether et non sous forme de polyester comme la plupart des polyuréthanes, cette couche externe étant collée sur l'enveloppe de telle façon qu ' elle soit intimément liée à celle-ci. The breast prosthesis according to the invention is produced from an envelope of silicone elastomer of suitable shape and size, filled during the manufacture of a silicone gel, the viscosity of which is adapted so as to give the finished product also a consistency as close as possible to that of a real breast. The assembly is then covered with an external layer of polyurethane in the form of polyether and not in the form of polyester like most polyurethanes, this external layer being bonded to the envelope in such a way that it is intimately bonded to it. this.

L'enveloppe peut avantageusement être fabriquée par trempage d'élastomères bi-composants diméthyl polysiloxane vynil, catalisés par des platines. The envelope can advantageously be manufactured by dipping two-component elastomers dimethyl polysiloxane vynil, catalyzed by plates.

La couche externe est obtenue en faisant réagir un prépolymère de polyuréthane polyéther hydrophile expansible, dérivé du toluène diisocyanate (TDI), avec un composé contenant de l'hydrogène actif et comportant des groupes hydroxyles. Le composé à groupes hydroxyles est avantageusement constitué par de l ' eau contenant éventuellement des additifs en suspension. The outer layer is obtained by reacting a prepolymer of expandable hydrophilic polyether polyether, derived from toluene diisocyanate (TDI), with a compound containing active hydrogen and containing hydroxyl groups. The compound with hydroxyl groups advantageously consists of water optionally containing additives in suspension.

Un très bon résultat est obtenu en utilisant un poids sensiblement égal de prépolymère et d'eau. Le type de produit employé permet d ' avoir une polymération en quelques minutes, sans catalyseur, ce qui permet de garantir une qualité médicale pour le produit fini.  A very good result is obtained by using a substantially equal weight of prepolymer and water. The type of product used allows polymerization in a few minutes, without catalyst, which guarantees medical quality for the finished product.

Le positionnement des divers éléments constitutifs donne à l'objet de l'invention un maximum d'effets utiles qui n ' avaient pas été, à ce jour, obtenus par des dispositifs similaires.  The positioning of the various constituent elements gives the object of the invention a maximum of useful effects which had not, to date, been obtained by similar devices.

Claims (3)

REVENDICATIONS 10 Prothèse mammaire implantable, utilisable aussi bien en chirurgie réparatrice en cas de mastectomie, qu'en chirurgie esthétique, caractérisé par la combinaison d'une enveloppe de silicone fermée, pré-remplie en cours de fabrication d ' un gel de silicone dont la viscosité est adaptée de manière à donner au produit terminé une consistance aussi proche que possible de celle d'un véritable sein, et recouverte d'une couche de polyuréthane sous forme de polyéther collée sur ladite enveloppe de manière à la rendre parfaitement indissociable de cette dernière.CLAIMS 10 Implantable breast prosthesis, usable both in reconstructive surgery in case of mastectomy, as in cosmetic surgery, characterized by the combination of a closed silicone envelope, pre-filled during the manufacture of a silicone gel, the viscosity is adapted so as to give the finished product a consistency as close as possible to that of a real breast, and covered with a layer of polyurethane in the form of polyether bonded to said envelope so as to make it perfectly inseparable from the latter . 20 Dispositif selon la revendication 1, se caractérisant par le fait que la couche externe est cbtenue en faisant réagir un prépolymère de polyuréthane polyéther hydrophile expansible, dérivé du toluène diisocyanate, avec un composé à groupes hydroxyles contenant de l'hydrogène actif. 20 Device according to claim 1, characterized in that the outer layer is cbtenue by reacting a prepolymer of hydrophilic polyether polyether expandable, derived from toluene diisocyanate, with a compound with hydroxyl groups containing active hydrogen. 30 Dispositif selon l'une quelconque des revendications précédentes, se caractérisant par le fait que la couche extérieure est réalisée en utilisant un poids sensiblement égal d'eau et de prépolymère de polyuréthane polyéther hydrophile expansible. 30 Device according to any one of the preceding claims, characterized in that the outer layer is produced using a substantially equal weight of water and of hydrophilic polyether expandable polyurethane prepolymer. 40 Dispositif selon la revendication 3, se caractérisant par le fait que la polymérisation est cbtenue sans catalyseur.  40 Device according to claim 3, characterized in that the polymerization is carried out without a catalyst.
FR9104602A 1991-04-09 1991-04-09 Implantable mammary prosthesis Withdrawn FR2675049A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
FR9104602A FR2675049A1 (en) 1991-04-09 1991-04-09 Implantable mammary prosthesis

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR9104602A FR2675049A1 (en) 1991-04-09 1991-04-09 Implantable mammary prosthesis

Publications (1)

Publication Number Publication Date
FR2675049A1 true FR2675049A1 (en) 1992-10-16

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
FR9104602A Withdrawn FR2675049A1 (en) 1991-04-09 1991-04-09 Implantable mammary prosthesis

Country Status (1)

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FR (1) FR2675049A1 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0693910A4 (en) * 1992-09-29 1995-08-03 Lipomatrix Inc Breast implant with radiolucent shell
WO1998029056A1 (en) * 1996-12-31 1998-07-09 Dominique Lucciardi Abrasionproof treatment for breast implants and resulting products
EP2581193A1 (en) 2011-10-14 2013-04-17 Polytech Health&Aesthetics GmbH Process for the manufacture of implants or intermediate products of such implants as well as implants and intermediate products obtained by such process
CZ309442B6 (en) * 2019-11-11 2023-01-18 Richtr Patrik MUDr., Ph.D. Silicone breast implant

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0693910A4 (en) * 1992-09-29 1995-08-03 Lipomatrix Inc Breast implant with radiolucent shell
EP0693910A1 (en) * 1992-09-29 1996-01-31 Lipomatrix Incorporated Breast implant with radiolucent shell
WO1998029056A1 (en) * 1996-12-31 1998-07-09 Dominique Lucciardi Abrasionproof treatment for breast implants and resulting products
EP2581193A1 (en) 2011-10-14 2013-04-17 Polytech Health&Aesthetics GmbH Process for the manufacture of implants or intermediate products of such implants as well as implants and intermediate products obtained by such process
EP3002101A1 (en) 2011-10-14 2016-04-06 Polytech Health&Aesthetics GmbH Process for the manufacture of implants or intermediate products of such implants as well as implants and intermediate products obtained by such process
US10307945B2 (en) 2011-10-14 2019-06-04 Polytech Health & Aesthetics Gmbh Process or the manufacture of implants or intermediate products of such implants as well as implants and intermediate products obtained by such process
CZ309442B6 (en) * 2019-11-11 2023-01-18 Richtr Patrik MUDr., Ph.D. Silicone breast implant

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