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WO1986001997A1 - Breast prosthesis - Google Patents

Breast prosthesis Download PDF

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Publication number
WO1986001997A1
WO1986001997A1 PCT/DE1984/000196 DE8400196W WO8601997A1 WO 1986001997 A1 WO1986001997 A1 WO 1986001997A1 DE 8400196 W DE8400196 W DE 8400196W WO 8601997 A1 WO8601997 A1 WO 8601997A1
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WO
WIPO (PCT)
Prior art keywords
breast prosthesis
prosthesis according
long
breast
chain polyether
Prior art date
Application number
PCT/DE1984/000196
Other languages
German (de)
French (fr)
Inventor
Tertulin Eberl
Original Assignee
Tertulin Eberl
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 Tertulin Eberl filed Critical Tertulin Eberl
Priority to PCT/DE1984/000196 priority Critical patent/WO1986001997A1/en
Priority to EP19840903625 priority patent/EP0195001A1/en
Publication of WO1986001997A1 publication Critical patent/WO1986001997A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/502—Plasticizers
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials

Definitions

  • the invention relates to a breast prosthesis consisting of a soft plastic body modeled on the natural breast shape with an elastic outer skin.
  • breast prostheses of this type are required by women after the breast has been removed by surgery. They are usually placed in a brassiere. The consistency and the weight of the breast prosthesis must correspond approximately to the natural conditions. This applies in particular to the weight so that posture damage is avoided at the wearer.
  • a breast prosthesis of the type specified in the introduction is known from DE-AS 26 05 148.
  • the plastic body consists of a silicone rubber compound, while a polyurethane film is used for the covering.
  • Silicone rubber compositions are used because they can easily be adjusted to a consistency that corresponds to that of the female breast.
  • silicone rubber bodies with the necessary softness have the disadvantage that they have a sticky and slightly oily character, which is why they are incorporated into a polyurethane film which forms a barrier layer which prevents sticky substances from migrating out of the silicone rubber body. Both silicone rubber and polyurethane are physiologically harmless.
  • a disadvantage of such breast prostheses is the rather high price of the silicone rubber compound.
  • silicone rubber takes a relatively long time to process.
  • the mass is usually cured using a platinum-containing catalyst, which significantly increases the cost of producing breast prostheses with a silicone rubber body.
  • the object of the invention was to create a breast prosthesis of the type specified in the introduction, in which the silicone rubber composition is replaced by another, easier to process and cheaper composition.
  • the object can be achieved with a breast prosthesis in which the plastic body consists of uncrosslinked or of low crosslinked polyurethane containing an external plasticizer.
  • polyurethanes can be produced in hard or elastic form.
  • the elastic known polyurethane forms are all unsuitable for producing a plastic body which approximately corresponds to the female breast in terms of its softness.
  • a conventional external plasticizer to the Production of an uncrosslinked or low-crosslinked polymethane body can achieve a consistency that corresponds exactly to the consistency of the silicone rubber compositions previously used for this purpose.
  • the polyurethane component of the plastic body preferably consists of a polyurethane, which is the reaction product of an aromatic diisocyanate and a long-chain polyether with a hydroxyl functionality between 2 and 3.
  • Aromatic diisocyanates which can be used are those customary in polyurethane technology, in particular diphenyl ethane diisocyanate.
  • the long-chain polyether can -3- z. B. have a molecular weight in the range of 180 to 8000, preferably 500 to 1000. Polypropylene glycol with a molecular weight in the ranges mentioned has proven to be particularly suitable.
  • the external plasticizer In order to achieve a suitable consistency of the breast prosthesis, larger amounts of the external plasticizer are preferably used, such as e.g. B. at least 30% by weight and in particular at least 50% by weight
  • the proportion of the external plasticizer can go up to 90% by weight.
  • the proportions of the * outer plasticizer are based on the total mass, that is to say on polyurethane and outer plasticizer.
  • a polyurethane film is preferred for the outer skin. However, it can also consist of a silicone layer.
  • a polyurethane film a long-chain polyether, in particular polypropylene glycol, has proven to be particularly advantageous as an external plasticizer, since many of the customary plasticizers migrate into the polyurethane film and can make it sticky. Such phenomena were not observed when using a polyurethane film as the outer skin and a long-chain polyether as a plasticizer.
  • the breast prosthesis can be produced in a manner known per se. For example, one * two flat elasti ⁇ specific polyurethane films they aufventlegen'und along a line corresponding to the subsequent edge of the prosthesis, from a filling opening welded together * '. This film can then be introduced into a corresponding two-part shape, the welded edge being clamped between the molded parts. By pouring a flowable starting mass between the foils, these are pressed against the inner wall of the hollow body. The mass is cured by heating. The prosthesis can then be removed from the mold.
  • a breast prosthesis with a silicone outer layer can be produced by first producing a silicone layer on the inner surface of the mold, which is relatively highly cross-linked, but which still has the necessary elasticity. Highly cross-linked silicone is required so that the outer layer is not sticky. Further processing then takes place in that a mass is poured into the closed mold and polycondensed by heating into a plasticized polyurethane.
  • Cold-curing starting materials can of course also be used if appropriately reactive catalysts are used.
  • auxiliaries can be incorporated into the starting mass, in particular dyes, catalysts, accelerators and the like.
  • Fig. 1 is a plan view of the breast prosthesis
  • the breast prosthesis 1 consists of a body 2 modeled on the breast shape, which consists of a polyurethane containing an external plasticizer.
  • the top and bottom of the body is covered with a polyurethane film 3, 4 of sufficient strength and elasticity. They are connected to one another by a weld seam 5 along the edge of the molded body 2.
  • the body 2 has a cavity on its back. Such cavities are common so that the breast prosthesis does not lie against the entire surface of the body, particularly in the area of surgical scars.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The breast prosthesis is comprised of a soft plastic body having the shape of a natural breast with an elastic skin (3, 4) on the outside. The plastic body consists of noncross-linked or little linked polyurethane including a plastifier. Preferably, the plastifier is polypropylenglycol for at least 30% by weight, and preferably at least 50% by weight. The outer skin is preferably comprised of a polyurethane sheet.

Description

-1 - -1 -
B R U S T P R O T H E S EB R U S T P R O T H E S E
Die Erfindung bezieht sich auf eine Brustprothese, bestehend aus einem der natürlichen Brustform nachgebildeten weichen Kunststoffkörper mit einer elastischen Außenhaut.The invention relates to a breast prosthesis consisting of a soft plastic body modeled on the natural breast shape with an elastic outer skin.
Brustprothesen dieser Art werden von Frauen nach einer Ent- fernung der Brust durch Operation benötigt. Sie rden üb¬ licherweise in einen Büstenhalter eingelegt. Die Konsistenz und das Gewicht der Brustprothese muß in etwa den natürli¬ chen Gegebenheiten entsprechen. Dies gilt insbesondere für das Gewicht, damit bei der Trägerin Haltungsschäden ver- mieden werden.Breast prostheses of this type are required by women after the breast has been removed by surgery. They are usually placed in a brassiere. The consistency and the weight of the breast prosthesis must correspond approximately to the natural conditions. This applies in particular to the weight so that posture damage is avoided at the wearer.
Eine Brustprothese der eingangs näher bezeichneten Art ist aus der DE-AS 26 05 148 bekannt. Dabei besteht der Kunst- stoffkörper aus einer Silikonkautschukmasse, während für die Umhüllung eine Polyurethanfolie verwendet wird. Silikon¬ kautschukmassen werden deshalb verwendet, weil sie sich leicht auf eine Konsistenz einstellen lassen, die derjeni¬ gen der weiblichen Brust entspricht. Silikonkautschukkörper mit der nötigen Weichheit haben aber den Nachteil, daß sie einen klebrigen und leicht öligen Charakter besitzen, wes¬ halb sie in eine Polyurethanfolie einverleibt werden, die eine Sperrschicht bildet, die das Auswandern von klebrigen Substanzen aus dem Silikonkautschukkörper verhindert. Sowohl Silikonkautschuk als auch Polyurethan sind physio- logisch unbedenklich.A breast prosthesis of the type specified in the introduction is known from DE-AS 26 05 148. The plastic body consists of a silicone rubber compound, while a polyurethane film is used for the covering. Silicone rubber compositions are used because they can easily be adjusted to a consistency that corresponds to that of the female breast. However, silicone rubber bodies with the necessary softness have the disadvantage that they have a sticky and slightly oily character, which is why they are incorporated into a polyurethane film which forms a barrier layer which prevents sticky substances from migrating out of the silicone rubber body. Both silicone rubber and polyurethane are physiologically harmless.
Nachteilig an solchen Brustprothesen ist der ziemlich hohe Preis der Silikonkautschukmasse. Außerdem benötigt Silikon¬ kautschuk für seine Verarbeitung verhältnismäßig lange Zeiten. Die Aushärtung der Masse wird üblicherweise mit einem platinhaltigen Katalysator durchgeführt, der die Kosten der Herstellung von Brustprothesen mit einem Silikonkautschukkörper erheblich steigert.A disadvantage of such breast prostheses is the rather high price of the silicone rubber compound. In addition, silicone rubber takes a relatively long time to process. The mass is usually cured using a platinum-containing catalyst, which significantly increases the cost of producing breast prostheses with a silicone rubber body.
Figure imgf000003_0001
-2- Der Erfindung lag die Aufgabe zugrunde-, eine Brustprothese der eingangs näher bezeichneten Art zu schaffen, bei der die Silikonkautschukmasse durch eine andere, leichter zu verarbeitende und billigere Masse ersetzt ist.
Figure imgf000003_0001
The object of the invention was to create a breast prosthesis of the type specified in the introduction, in which the silicone rubber composition is replaced by another, easier to process and cheaper composition.
Es wurde gefunden, daß sich die Aufgabe mit einer Brust¬ prothese lösen läßt, bei der der Kunststof körper aus un¬ vernetztem oder aus niedervernetztem, einen äußeren Weich¬ macher enthaltendem Polyurethan besteht.It has been found that the object can be achieved with a breast prosthesis in which the plastic body consists of uncrosslinked or of low crosslinked polyurethane containing an external plasticizer.
Es ist bekannt, daß man Polyurethane in harter oder elasti¬ scher Form herstellen kann. Die elastischen bekannten Poly¬ urethanformen sind aber samt und sonders nicht geeignet, um einen Kunststoffkörper herzustellen, der in seiner Weich- heit in etwa der weiblichen Brust entspricht, überraschen¬ derweise wurde aber festgestellt, daß man durch den Zusatz eines üblichen äußeren Weichmachers bei der Herstellung eines unvernetzten oder niedervernetzten Polymethankörpers eine Konsistenz erreichen kann, die genau der Konsistenz der bisher für diesen Zweck verwendeten Silikonkautschuk¬ massen entspricht.It is known that polyurethanes can be produced in hard or elastic form. The elastic known polyurethane forms, however, are all unsuitable for producing a plastic body which approximately corresponds to the female breast in terms of its softness. Surprisingly, however, it was found that the addition of a conventional external plasticizer to the Production of an uncrosslinked or low-crosslinked polymethane body can achieve a consistency that corresponds exactly to the consistency of the silicone rubber compositions previously used for this purpose.
Die Verwendung von äußeren Weichmachern in Polyurethanen ist ganz.und gär unüblich. So wird in Ulimanns Enzyklopädie der- chemischen Technik, 3. Auflage, unter dem Stichwort Weichmacher auf Seite 567 ausgeführt: "Bei den Poly¬ urethanen wird die gewünschte Elastifizierung nicht durch äußere Weichmachung sondern durch Auswahl der Reaktions¬ komponenten (Polyester bzw. Polyäther und Polyisocyanate) erreicht.".The use of external plasticizers in polyurethanes is quite unusual. For example, in Ulimann's Encyclopedia of Chemical Technology, 3rd edition, under the key word plasticizer on page 567: "In the case of polyurethanes, the desired elasticization is not achieved by external plasticization but by the choice of the reaction components (polyester or polyether and Polyisocyanates). "
Vorzugsweise besteht der Polyurethanbestandteil des Kunst¬ stoffkörpers aus einem Polyurethan, das das Umsetzungspro¬ dukt aus einem aromatischen Diisocyanat und einem lang- kettigen Polyäther mit einer Hydroxylfunktionalität zwi¬ schen 2 und 3 ist. Als aromatische Diisocyanate kommen die in der Polyurethantechnik üblichen in Frage, insbesondere Diphenyl ethandiiscyanat. Der langkettige Polyäther kann -3- z. B. ein Molekulargewicht im Bereich von 180 bis 8000, vor¬ zugsweise 500 bis 1000, aufweisen. Polypropylenglycol mit einem Molekulargewicht in den erwähnten Bereichen hat sich als besonders geeignet erwiesen.The polyurethane component of the plastic body preferably consists of a polyurethane, which is the reaction product of an aromatic diisocyanate and a long-chain polyether with a hydroxyl functionality between 2 and 3. Aromatic diisocyanates which can be used are those customary in polyurethane technology, in particular diphenyl ethane diisocyanate. The long-chain polyether can -3- z. B. have a molecular weight in the range of 180 to 8000, preferably 500 to 1000. Polypropylene glycol with a molecular weight in the ranges mentioned has proven to be particularly suitable.
Zur Erzielung einer geeigneten Konsistenz der Brustprothese werden vorzugsweise größere Mengen des äußeren Weichmachers verwendet, wie z. B. mindestens 30 Gew.% und insbesondere mindestens 50 Gew.%.Der Anteil des äußeren Weichmachers kann bis zu 90 Gew.% gehen. In den Ansprüchen und in dieser Beschreibung sind die Anteile des* äußeren Weichmachers auf die Gesamtmasse bezogen, das heißt also auf Polyurethan und äußeren Weichmacher.In order to achieve a suitable consistency of the breast prosthesis, larger amounts of the external plasticizer are preferably used, such as e.g. B. at least 30% by weight and in particular at least 50% by weight The proportion of the external plasticizer can go up to 90% by weight. In the claims and in this description, the proportions of the * outer plasticizer are based on the total mass, that is to say on polyurethane and outer plasticizer.
Als äußere Weichmacher kommen alle üblichen äußeren Weich¬ macher, die in der Kunststoff echnik bekannt sind, in Be¬ tracht, wie z. B. Dibutylphthalat und Dioctylphthalat. Be¬ sonders geeignet als äußere Weichmacher haben sich aber langkettige Polyäther solcher Art erwiesen, wie sie auch für die Herstellung des Polyurethanbestandteils der Brustr prothese verwendet werden. Besonders günstig ist es, wenn der Polyätherbestandteil des Polyurethans und der Weich- macherbestandteil der Brustprothese identisch sind. In einem solchen Fall braucht man lediglich bei der Herstellung des' Polyurethans einen entsprechenden Überschuß an lang- kettigem Polyäther zu verwenden.All conventional external plasticizers known in plastics technology come into consideration as external plasticizers, such as, for. B. dibutyl phthalate and dioctyl phthalate. Long-chain polyethers of the type which are also used for the production of the polyurethane component of the breast prosthesis have proven particularly suitable as external plasticizers. It is particularly favorable if the polyether component of the polyurethane and the plasticizer component of the breast prosthesis are identical. In such a case, it is only necessary to use an appropriate excess of long-chain polyether in the production of the polyurethane.
Für die Außenhaut wird eine Polyurethanfolie bevorzugt. Sie kann aber auch aus einer Silikonschicht bestehen.Bei Ver- wendung einer Polyurethanfolie hat sich ein langkettiger Polyäther, insbesondere Polypropylenglycol, als äußerer Weichmacher besonders günstig erwiesen, da viele der üb¬ lichen Weichmacher in die Polyurethanfolie hineinwandern und diese klebrig machen können. Bei Verwendung einer Poly- urethanfolie als Außenhaut und eines langkettigen Poly- äthers als Weichmacher wurden solche Erscheinungen nicht beobachtet.A polyurethane film is preferred for the outer skin. However, it can also consist of a silicone layer. When using a polyurethane film, a long-chain polyether, in particular polypropylene glycol, has proven to be particularly advantageous as an external plasticizer, since many of the customary plasticizers migrate into the polyurethane film and can make it sticky. Such phenomena were not observed when using a polyurethane film as the outer skin and a long-chain polyether as a plasticizer.
Figure imgf000005_0001
-4 - Die Herstellung der Brustprothese kann in an sich bekannter Weise erfolgen. Beispielsweise kann man* zwei flache elasti¬ sche Polyurethanfolien aufeinanderlegen'und sie entlang einer Linie, die dem späteren Rand der Prothese entspricht, bis auf eine Einfüllöffnung miteinander*' verschweißen. Hier¬ auf kann man diese Folie in eine entsprechende zweiteilige Form einbringen, wobei der verschweißte Rand zwischen die Formteile eingeklemmt wird. Durch Einfüllen einer flie߬ fähigen Ausgangsmasse zwischen die Folien werden diese an die Innenwandung des Hohlkörpers angedrückt. Durch Er¬ hitzen wird die Masse ausgehärtet. Die Prothese kann dann aus der Form entnommen werden.
Figure imgf000005_0001
-4 - The breast prosthesis can be produced in a manner known per se. For example, one * two flat elasti¬ specific polyurethane films they aufeinanderlegen'und along a line corresponding to the subsequent edge of the prosthesis, from a filling opening welded together * '. This film can then be introduced into a corresponding two-part shape, the welded edge being clamped between the molded parts. By pouring a flowable starting mass between the foils, these are pressed against the inner wall of the hollow body. The mass is cured by heating. The prosthesis can then be removed from the mold.
Eine Brustprothese mit einer Silikonaußenschicht kann man dadurch herstellen, daß man zunächst auf der inneren Ober¬ fläche der Form eine Silikonschicht herstellt, die verhält¬ nismäßig hoch vernetzt ist, die aber noch die nötige Elasti¬ zität aufweist. Hochvernetztes Silikon ist erforderlich, damit die Außenschicht nicht klebrig ist. Die weitere Ver- arbeitung erfolgt dann dadurch, daß man in die geschlossene Form eine Masse einfüllt, die durch Erwärmen in ein weich¬ gemachtes Polyurethan polykondensiert.A breast prosthesis with a silicone outer layer can be produced by first producing a silicone layer on the inner surface of the mold, which is relatively highly cross-linked, but which still has the necessary elasticity. Highly cross-linked silicone is required so that the outer layer is not sticky. Further processing then takes place in that a mass is poured into the closed mold and polycondensed by heating into a plasticized polyurethane.
Natürlich können auch kalthärtende Ausgangsmassen verwendet werden, wenn entsprechend reaktive Katalysatoren zur Ver¬ wendung gelangen.Cold-curing starting materials can of course also be used if appropriately reactive catalysts are used.
In die Ausgangsmasse können die verschiedensten Hilfsstoffe einverleibt werden, und zwar insbesondere Farbstoffe, Kata- lysatoren, Beschleuniger und dergleichen.A wide variety of auxiliaries can be incorporated into the starting mass, in particular dyes, catalysts, accelerators and the like.
Eine erfindungsgemäße Brustprothese wird nun anhand der beigefügten Zeichnungen näher erläutert. In den Zeichnungen zeigen:A breast prosthesis according to the invention will now be explained in more detail with reference to the accompanying drawings. The drawings show:
Fig. 1 eine Draufsicht auf die Brustprothese undFig. 1 is a plan view of the breast prosthesis and
Fig. 2 einen Schnitt an der Linie II-II in Fig. 1. Die Brustprothese 1 besteht aus einem der Brustform nachge¬ bildeten Körper 2, der aus einem einen äußeren Weichmacher enthaltendem Polyurethan besteht. Der Körper ist auf seiner Ober- und Unterseite mit einer Polyurethanfolie 3, 4 von ausreichender Festigkeit und Elastizität bedeckt. Entlang des Randes des Formkörpers 2 sind sie durch eine Schwei߬ naht 5 miteinander verbunden. Der Körper 2 weist auf seiner Rückseite eine Höhlung auf. Solche Höhlungen sind üblich, damit die Brustprothese nicht über ihre gesamte Grundfläche am Körper, insbesondere im Bereich von Operationsnarben, anliegt.2 shows a section on the line II-II in FIG. 1st The breast prosthesis 1 consists of a body 2 modeled on the breast shape, which consists of a polyurethane containing an external plasticizer. The top and bottom of the body is covered with a polyurethane film 3, 4 of sufficient strength and elasticity. They are connected to one another by a weld seam 5 along the edge of the molded body 2. The body 2 has a cavity on its back. Such cavities are common so that the breast prosthesis does not lie against the entire surface of the body, particularly in the area of surgical scars.
Figure imgf000007_0001
Figure imgf000007_0001

Claims

P A T E N T A N S P R Ü C H E 1. Brustprothese, bestehend aus einem der natürlichen Brustform nachgebildeten weichen Kunststoffkörper mit einer elastischen Außenhaut, dadurch gekennzeichnet, daß der Kunststoffkörper aus unvernetztem oder niedervernetz- te , einen äußeren Weichmacher enthaltendem Polyurethan besteht. P A T E N T A N S P R Ü C H E 1. Breast prosthesis, consisting of a soft plastic body modeled on the natural breast shape with an elastic outer skin, characterized in that the plastic body consists of uncrosslinked or low-crosslinked polyurethane containing an external plasticizer.
2. Brustprothese nach Anspruch 1, dadurch gekennzeichnet, daß das Polyurethan ein Umsetzungsprodukt aus einem aro- matischen Diisocyanat und einem langkettigen Polyäther mit einer Hydroxylfunktionalität zwischen 2 und 3 ist.2. Breast prosthesis according to claim 1, characterized in that the polyurethane is a reaction product of an aromatic diisocyanate and a long-chain polyether with a hydroxyl functionality between 2 and 3.
3. Brustprothese nach Anspruch 2, dadurch gekennzeichnet, daß das Diisocyanat aus Diphenylmethandiisocyanat besteht.3. Breast prosthesis according to claim 2, characterized in that the diisocyanate consists of diphenylmethane diisocyanate.
4. Brustprothese nach Anspruch 2 oder 3 , dadurch gekenn¬ zeichnet, daß der langkettige Polyäther ein Molekularge¬ wicht zwischen 180 und 8000 aufweist.4. Breast prosthesis according to claim 2 or 3, characterized gekenn¬ characterized in that the long-chain polyether has a molecular weight between 180 and 8000.
5. Brustprothese nach Anspruch 4, dadurch gekennzeichnet, daß der langkettige Polyäther ein Molekulargewicht zwischen 500 und 1000 aufweist.5. Breast prosthesis according to claim 4, characterized in that the long-chain polyether has a molecular weight between 500 and 1000.
6. Brustprothese nach einem der Ansprüche 4 oder 5, dadurch gekennzeichnet, daß der langkettige Polyäther aus Polypropylenglycol besteht.6. Breast prosthesis according to one of claims 4 or 5, characterized in that the long-chain polyether consists of polypropylene glycol.
7. Brustprothese nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, daß der äußere Weichmacher in einer Menge von mindestens 30 Gew.% vorliegt.7. Breast prosthesis according to one of claims 1 to 6, characterized in that the external plasticizer is present in an amount of at least 30% by weight.
8. Brύstprothese nach Anspruch 7, dadurch gekennzeichnet, daß der äußere Weichmacher in einer Menge von mindestens8. breast prosthesis according to claim 7, characterized in that the outer plasticizer in an amount of at least
50 Gew.% vorliegt.50% by weight is present.
9. Brustprothese nach einem der Ansprüche 1 bis 8 , dadurch gekennzeichnet, daß der Weichmacher aus einem -7- Phthalat;, insbesondere Dibutyl- oder Dioctylphthalat, besteht.9. Breast prosthesis according to one of claims 1 to 8, characterized in that the plasticizer from one -7- phthalate; especially dibutyl or dioctyl phthalate.
10. Brustprothese nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß der Weichmacher aus einem langkettigen Polyäther mit einer Hydroxylfunktionalität von 2 bis 3 besteht.10. Breast prosthesis according to one of claims 1 to 8, characterized in that the plasticizer consists of a long-chain polyether with a hydroxyl functionality of 2 to 3.
11. Brustprothese nach Anspruch 10, dadurch gekenn- zeichnet, daß der langkettige Polyäther ein Molekular¬ gewicht zwischen 180 und 8000 aufweist.11. Breast prosthesis according to claim 10, characterized in that the long-chain polyether has a molecular weight between 180 and 8000.
12. Brustprothese nach Anspruch 11, dadurch gekenn¬ zeichnet, daß der langkettige Polyäther ein Molekular- gewicht zwischen 500 und 1000 aufweist.12. Breast prosthesis according to claim 11, characterized gekenn¬ characterized in that the long-chain polyether has a molecular weight between 500 and 1000.
13. Brustprothese nach Anspruch 11 oder 12, dadurch ge¬ kennzeichnet, daß der langkettige Polyäther aus Poly¬ propylenglycol besteht.13. Breast prosthesis according to claim 11 or 12, characterized in that the long-chain polyether consists of poly propylene glycol.
14. Brustprothese nach Anspruch 2 und einem der Ansprüche 10 bis 13, dadurch gekennzeichnet, daß der im Polyurethan vorliegende langkettige Polyäther und der als äußerer Weichmacher dienende Polyäther identisch sind.14. Breast prosthesis according to claim 2 and one of claims 10 to 13, characterized in that the long-chain polyether present in the polyurethane and the polyether serving as an external plasticizer are identical.
15. Brustprothese nach einem der Ansprüche 1 bis 14, dadurch gekennzeichnet, daß die Außenhaut aus einer Poly¬ urethanfolie besteht.15. Breast prosthesis according to one of claims 1 to 14, characterized in that the outer skin consists of a poly urethane film.
16. Brustprothese nach einem der Ansprüche 1 bis 14, dadurch gekennzeichnet, daß die Außenhaut aus einer Silikonschicht besteht.16. Breast prosthesis according to one of claims 1 to 14, characterized in that the outer skin consists of a silicone layer.
Figure imgf000009_0001
Figure imgf000009_0001
PCT/DE1984/000196 1984-09-26 1984-09-26 Breast prosthesis WO1986001997A1 (en)

Priority Applications (2)

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PCT/DE1984/000196 WO1986001997A1 (en) 1984-09-26 1984-09-26 Breast prosthesis
EP19840903625 EP0195001A1 (en) 1984-09-26 1984-09-26 Breast prosthesis

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PCT/DE1984/000196 WO1986001997A1 (en) 1984-09-26 1984-09-26 Breast prosthesis

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5092881A (en) * 1989-02-27 1992-03-03 Anita Spezialmiederfabrik Dr. Helbig Ges.M. B. H & Co. Kg Artificial breast
EP0600239A1 (en) * 1992-10-30 1994-06-08 DEKUMED Gesellschaft für Kunststoff- und Medizintechnik mbH Bust correction device
US5370688A (en) * 1993-03-30 1994-12-06 Spenco Medical Corporation Encapsulated gel breast prosthesis and method of making
WO1996003940A1 (en) * 1994-08-05 1996-02-15 Innovative Technologies Limited Mammary prostheses

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3189921A (en) * 1962-04-11 1965-06-22 William J Pangman Compound prosthesis
US3366975A (en) * 1965-06-04 1968-02-06 William J. Pangman Compound prosthesis
US3683424A (en) * 1970-01-30 1972-08-15 William J Pangman Surgically implantable compound breast prosthesis
DE2605148A1 (en) * 1976-02-10 1977-08-11 Cornelius Rechenberg Artificial breast with flexible air-free dish-shaped body - made of addition-crosslinking two-component silicone rubber compsn.
FR2410472A1 (en) * 1977-12-01 1979-06-29 Arlaud Gaston Artificial breast partly filled with small glass balls - to react to movement in partly elastic and partly fluid manner

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3189921A (en) * 1962-04-11 1965-06-22 William J Pangman Compound prosthesis
US3366975A (en) * 1965-06-04 1968-02-06 William J. Pangman Compound prosthesis
US3683424A (en) * 1970-01-30 1972-08-15 William J Pangman Surgically implantable compound breast prosthesis
DE2605148A1 (en) * 1976-02-10 1977-08-11 Cornelius Rechenberg Artificial breast with flexible air-free dish-shaped body - made of addition-crosslinking two-component silicone rubber compsn.
FR2410472A1 (en) * 1977-12-01 1979-06-29 Arlaud Gaston Artificial breast partly filled with small glass balls - to react to movement in partly elastic and partly fluid manner

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
M. Szycher and W.J. Robinson: 'Synthetic Biomedical Polymers. Concepts and Applications' US, Westport, Technomic, 1980 ULRICH H. et al.: 'Synthesis and Biomedical Applications of Polyurethanes', pages 29-38, see page 29, lines 12-15; page 30, lines 8-10; page 31, lines 1,2 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5092881A (en) * 1989-02-27 1992-03-03 Anita Spezialmiederfabrik Dr. Helbig Ges.M. B. H & Co. Kg Artificial breast
EP0600239A1 (en) * 1992-10-30 1994-06-08 DEKUMED Gesellschaft für Kunststoff- und Medizintechnik mbH Bust correction device
US6022375A (en) * 1992-10-30 2000-02-08 Dekumed Gesellschaft Fur Kunststoff- Und Medizintechnik Mbh Breast prosthesis
US5370688A (en) * 1993-03-30 1994-12-06 Spenco Medical Corporation Encapsulated gel breast prosthesis and method of making
WO1996003940A1 (en) * 1994-08-05 1996-02-15 Innovative Technologies Limited Mammary prostheses

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