WO2008052650A1 - Method for the production of a breast prosthesis - Google Patents

Method for the production of a breast prosthesis Download PDF

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Publication number
WO2008052650A1
WO2008052650A1 PCT/EP2007/008934 EP2007008934W WO2008052650A1 WO 2008052650 A1 WO2008052650 A1 WO 2008052650A1 EP 2007008934 W EP2007008934 W EP 2007008934W WO 2008052650 A1 WO2008052650 A1 WO 2008052650A1
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WO
WIPO (PCT)
Prior art keywords
silicone rubber
plastic films
microwaves
heating
vulcanization
Prior art date
Application number
PCT/EP2007/008934
Other languages
German (de)
French (fr)
Inventor
Johann Stuffer
Original Assignee
Amoena Medizin-Orthopädie-Technik GmbH
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Publication of WO2008052650A1 publication Critical patent/WO2008052650A1/en

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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
    • 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
    • A61F2/5044—Designing or manufacturing processes
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30451—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
    • 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
    • A61F2/5044—Designing or manufacturing processes
    • A61F2002/5056—Laminates, i.e. layered products
    • 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
    • A61F2/76—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
    • A61F2002/7605—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means for assembling by heating
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
    • B29C35/08—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation
    • B29C35/0805—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using electromagnetic radiation
    • B29C2035/0855—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using electromagnetic radiation using microwave

Definitions

  • the invention relates to a method for producing an extracorporeal breast prosthesis according to the preamble of claim 1.
  • the edge welding of the plastic films is usually carried out in a contact welding system. This means that a separate tool must be made for each contour. Due to the necessary tool changes, additional set-up times must be planned during production. Another time requirement is that the respective tools must be heated up to the welding temperature. Finally, the tools take up a high storage capacity.
  • the films loaded in the molds are usually thermally drawn to thereby form the bag-shaped pockets for heating the silicone rubber.
  • This heating takes place indirectly via the molding tool.
  • the mold is placed for this purpose in corresponding circulating air ovens.
  • the circulating air ovens provide the necessary temperature.
  • the heating takes place here via heat conduction and convection, resulting in a decreasing from outside to inside temperature profile. This is particularly important in terms of accelerating the vulcanization of the silicone rubber.
  • the resulting temperature profile has the consequence that high core temperatures can only be achieved by high outside temperatures or faster longer soak times.
  • both are disadvantageous in the production of breast prostheses since, on the one hand, the plastic film (TPU film) must not be overheated and, on the other hand, the lowest possible cycle times are sought.
  • the high energy consumption is disadvantageous, since of course the convection oven as such and all molds located in the oven must be heated.
  • the object of the invention is to further develop the manufacturing process for breast prostheses such that the manufacturing process can be accelerated.
  • the film contours of the plastic films are welded to a laser outside the mold.
  • laser welding eliminates the previously required in the contact welding system tool, the Tool change, tool heating and tool storage. It can be achieved here in a very flexible manner high quality welds.
  • the vulcanization of individual components of the silicone rubber can be accelerated by direct heating of the silicone rubber.
  • the direct heating of the silicone rubber can be carried out by induction.
  • the direct heating of the silicone rubber by a high frequency field, in particular by microwaves, take place.
  • the energy for accelerating the vulcanization of individual components of the silicone rubber and for the thermal stretching of the plastic film by direct heating of the material can be introduced.
  • the direct heating can be done by microwaves. According to another embodiment of the invention, the direct heating can be done by induction or high frequency technology.
  • the welded plastic films are preferably placed in a mold.
  • the insertion of the prefabricated bag in the tool is complicated and time-consuming, since it must be fixed in the tool so that the contour of the bag coincides as closely as possible with the geometry of the tool.
  • the welding of the plastic films can also be done directly in the mold, thereby eliminating the costly application of the bag.
  • the unwelded film webs are clamped one above the other in the mold and the contour welded by laser.
  • the plastic films can be thermally stretched after filling with the components of the silicone rubber and heated to accelerate the vulcanization with the molds in convection ovens. The heating with the molds in convection ovens corresponds to the prior art.
  • the plastic films After filling with the components of the silicone rubber, the plastic films can be thermally drawn by means of microwaves. After filling the appropriate silicone rubber components, it is possible to wait at room temperature until they are cross-linked. This process variant is energetically favorable, but has disadvantages in the timing due to the relatively long reaction time. Therefore, vulcanization of the silicone rubber in the process flow can also be accelerated by microwave heating.
  • plastic films are thermally drawn by means of microwaves prior to filling with the components of the silicone rubber. Again, after filling the silicone rubber, it is first possible to wait at room temperature until the individual components are crosslinked. Alternatively, to accelerate the vulcanization of the silicone rubber, heating by means of microwaves may take place.
  • the heating of the components of the silicone rubber to be crosslinked takes place directly in the silicone rubber to be crosslinked, resulting in a temperature profile quasi inverse to that in the case of indirect heating.
  • the direct heating can be generated here, as stated above, by induction, a high-frequency field or especially by microwaves.
  • the transparent films are therefore clamped between a transparent solid and underlaid with a flat absorber.
  • the flat absorber is advantageous to an absorber film.
  • the laser beam penetrates the solid and the films and is absorbed by the absorber film. Heat conduction from the absorber foil into the foils leads to melting and welding of the foils.
  • a glass plate or even a glass ball can be used as the transparent solid.

Abstract

The invention relates to a method for the production of a breast prosthesis which consists essentially of the following sequence of steps: stacking of at least two sheets of synthetic material, bonding of the stacked sheets of synthetic material during formation of one of several chambers, filling of the at least one chamber with primarily silicone rubber, and complete vulcanization of the silicone rubber. According to the invention, the borders of the sheet of synthetic material are bonded by means of a laser. Finally, heat is introduced for the thermal stretching of the sheet and also for the acceleration of the vulcanization of the silicone rubber, completely or partly, through direct heating, particularly by means of microwaves.

Description

Verfahren zur Herstellung einer Brustprothese Method of making a breast prosthesis
Die Erfindung betrifft ein Verfahren zur Herstellung einer extrakorporalen Brustprothese nach dem Obergriff des Anspruchs 1.The invention relates to a method for producing an extracorporeal breast prosthesis according to the preamble of claim 1.
Es sind bereits Verfahren zur Herstellung etwa schalenförmiger extra korporalen Brustprothesen bekannt. In der Regel werden zwei oder mehr Kunststofffolien aufeinandergelegt, um eine oder mehrere Kammern zu bilden. Hierzu werden die aneinanderliegenden Kunststofffolien entsprechend ihrem Rand verschweißt. Anschließend werden sie mit einem Elastomer, insbesondere Silikonkautschuk, gefüllt. Beim Befüllen sind die beuteiförmigen Kunststoffkammern in ein Formwerkzeug eingelegt. Dort vernetzen die einzelnen Bestandteile des Elastomers, das heißt insbesondere des Silikonkautschuks. Anschließend kann die soweit fertiggestellte Brustprothese entnommen und noch nachbearbeitet werden. Bei der Nachbearbeitung werden überstehende Folienränder abgeschnitten.There are already known methods for producing about cup-shaped extracorporeal breast prostheses. Typically, two or more plastic films are stacked to form one or more chambers. For this purpose, the adjacent plastic films are welded according to their edge. They are then filled with an elastomer, in particular silicone rubber. When filling the bag-shaped plastic chambers are inserted into a mold. There, the individual constituents of the elastomer crosslink, that is to say, in particular, of the silicone rubber. Subsequently, the breast prosthesis completed so far can be removed and reworked. During finishing, protruding edges of the film are cut off.
Während des vorgenannten Herstellprozesses wird üblicherweise die Randver- schweißung der Kunststofffolien in einer Kontaktschweißanlage vorgenommen. Dies bedeutet, daß für jede Kontur ein eigenes Werkzeug angefertigt werden muß. Aufgrund der notwendigen Werkzeugwechsel sind zusätzlich Rüstzeiten bei der Produktion einzuplanen. Ein weiterer Zeitbedarf besteht darin, daß die jeweiligen Werkzeuge bis zur Schweißtemperatur aufgeheizt werden müssen. Schließlich nehmen die Werkzeuge eine hohe Lagerkapazität in Anspruch.During the abovementioned production process, the edge welding of the plastic films is usually carried out in a contact welding system. This means that a separate tool must be made for each contour. Due to the necessary tool changes, additional set-up times must be planned during production. Another time requirement is that the respective tools must be heated up to the welding temperature. Finally, the tools take up a high storage capacity.
Die in die Formwerkzeuge eingelegten Folien werden üblicherweise thermisch verstreckt, um hierdurch die beuteiförmigen Taschen zur Aufwärmung des Silikonkautschuks zu bilden. Diese Erwärmung erfolgt mittelbar über das Formwerkzeug. Das Formwerkzeug wird hierzu in entsprechende Umluftöfen gestellt. Die Umluftöfen stellen die notwendige Temperatur zur Verfügung. Die Erwärmung erfolgt hier also über Wärmeleitung und Konvektion, woraus sich ein von außen nach innen abnehmendes Temperaturprofil ergibt. Dies ist insbesondere hinsichtlich der Beschleunigung der Vulkanisation des Silikonkautschuks von Bedeutung. Das sich bildende Temperaturprofil hat nämlich zur Folge, daß hohe Kerntemperaturen nur durch hohe Außentemperaturen oder schnellere längere Durchwärmzeiten erzielt werden können. Beides ist aber bei der Fertigung von Brustprothesen von Nachteil, da einerseits die Kunststofffolie (TPU-Folie) nicht überhitzt werden darf und andererseits möglichst geringe Zykluszeiten angestrebt werden. Neben der langen Durchwärmzeit ist auch der hohe Energieverbrauch nachteilig, da natürlich der Umluftofen als solches und sämtliche im Ofen befindlichen Formwerkzeuge erhitzt werden müssen.The films loaded in the molds are usually thermally drawn to thereby form the bag-shaped pockets for heating the silicone rubber. This heating takes place indirectly via the molding tool. The mold is placed for this purpose in corresponding circulating air ovens. The circulating air ovens provide the necessary temperature. The heating takes place here via heat conduction and convection, resulting in a decreasing from outside to inside temperature profile. This is particularly important in terms of accelerating the vulcanization of the silicone rubber. The resulting temperature profile has the consequence that high core temperatures can only be achieved by high outside temperatures or faster longer soak times. However, both are disadvantageous in the production of breast prostheses since, on the one hand, the plastic film (TPU film) must not be overheated and, on the other hand, the lowest possible cycle times are sought. In addition to the long soak time, the high energy consumption is disadvantageous, since of course the convection oven as such and all molds located in the oven must be heated.
Aufgabe der Erfindung ist es, das Herstellverfahren für Brustprothesen derart weiterzubilden, daß das Fertigungsverfahren beschleunigt werden kann.The object of the invention is to further develop the manufacturing process for breast prostheses such that the manufacturing process can be accelerated.
Diese Aufgabe wird zunächst durch die Kombination der Merkmale des Anspruchs 1 gelöst.This object is first achieved by the combination of the features of claim 1.
Erfindungsgemäß werden hier die Folienkonturen der Kunststofffolien mit einem Laser außerhalb des Formwerkzeugs verschweißt. Durch die Laserverschweißung entfällt der bei der Kontaktschweißanlage bislang notwendige Werkzeugbau, der Werkzeugwechsel, die Werkzeugerwärmung und die Werkzeuglagerung. Es können hier in sehr flexibler Weise hochwertige Schweißnähte erzielt werden.According to the invention, the film contours of the plastic films are welded to a laser outside the mold. By laser welding eliminates the previously required in the contact welding system tool, the Tool change, tool heating and tool storage. It can be achieved here in a very flexible manner high quality welds.
Bevorzugte Ausgestaltungen der Erfindung, die das Verfahren weiter vereinfachen und effizienter gestalten, ergeben sich aus den sich an den Hauptanspruch anschließenden Unteransprüchen.Preferred embodiments of the invention, which further simplify the process and make it more efficient, result from the dependent claims that follow the main claim.
Demnach kann die Vulkanisation einzelner Komponenten des Silikonkautschuks durch unmittelbare Erwärmung des Silikonkautschuks beschleunigt werden.Accordingly, the vulcanization of individual components of the silicone rubber can be accelerated by direct heating of the silicone rubber.
Die unmittelbare Erwärmung des Silikonkautschuks kann dabei durch Induktion erfolgen. Gemäß einer anderen Ausgestaltung der Erfindung kann die unmittelbare Erwärmung des Silikonkautschuks durch ein Hochfrequenzfeld, insbesondere durch Mikrowellen, erfolgen.The direct heating of the silicone rubber can be carried out by induction. According to another embodiment of the invention, the direct heating of the silicone rubber by a high frequency field, in particular by microwaves, take place.
Demnach kann die Energie zur Beschleunigung der Vulkanisation einzelner Komponenten des Silikonkautschuks und zur thermischen Verstreckung der Kunststofffolie durch unmittelbare Erwärmung des Gutes eingebracht werden.Accordingly, the energy for accelerating the vulcanization of individual components of the silicone rubber and for the thermal stretching of the plastic film by direct heating of the material can be introduced.
Die unmittelbare Erwärmung kann dabei durch Mikrowellen erfolgen. Gemäß einer anderen Ausgestaltung der Erfindung kann die unmittelbare Erwärmung durch Induktion oder Hochfrequenztechnik erfolgen.The direct heating can be done by microwaves. According to another embodiment of the invention, the direct heating can be done by induction or high frequency technology.
Nach dem Schweißen der Konturen mittels Laser werden die verschweißten Kunststofffolien vorzugsweise in ein Formwerkzeug gelegt. Das Einlegen des vorgefertigten Beutels in das Werkzeug gestaltet sich dabei kompliziert und zeitaufwendig, da dieser so im Werkzeug fixiert werden muss, dass sich die Kontur des Beutels möglichst genau mit der Geometrie des Werkzeugs deckt.After welding the contours by means of laser, the welded plastic films are preferably placed in a mold. The insertion of the prefabricated bag in the tool is complicated and time-consuming, since it must be fixed in the tool so that the contour of the bag coincides as closely as possible with the geometry of the tool.
Die Verschweißung der Kunststofffolien kann jedoch auch direkt im Formwerkzeug erfolgen, wodurch das aufwendige Auflegen des Beutels entfällt. Dabei werden die unverschweißten Folienbahnen übereinander in das Formwerkzeug eingespannt und die Kontur mittels Laser verschweißt. Hier können die Kunststofffolien nach dem Befüllen mit den Komponenten des Silikonkautschuks thermisch verstreckt werden und zur Beschleunigung der Vulkanisation mit den Formwerkzeugen in Umluftöfen erwärmt werden. Die Erwärmung mit den Formwerkzeugen in Umluftöfen entspricht dabei dem Stand der Technik.However, the welding of the plastic films can also be done directly in the mold, thereby eliminating the costly application of the bag. The unwelded film webs are clamped one above the other in the mold and the contour welded by laser. Here, the plastic films can be thermally stretched after filling with the components of the silicone rubber and heated to accelerate the vulcanization with the molds in convection ovens. The heating with the molds in convection ovens corresponds to the prior art.
Die Kunststofffolien können nach dem Befüllen mit den Komponenten des Silikonkautschuks mittels Mikrowellen thermisch verstreckt werden. Nach dem Einfüllen der entsprechenden Silikonkautschukkomponenten kann bei Raumtemperatur zugewartet werden, bis diese vernetzt sind. Diese Verfahrensvariante ist energetisch günstig, weist allerdings im zeitlichen Ablauf aufgrund der verhältnismäßig langen Reaktionszeit Nachteile auf. Daher kann die Vulkanisation des Silikonkautschuks in dem Verfahrensablauf auch durch Erwärmung mittels Mikrowellen beschleunigt werden.After filling with the components of the silicone rubber, the plastic films can be thermally drawn by means of microwaves. After filling the appropriate silicone rubber components, it is possible to wait at room temperature until they are cross-linked. This process variant is energetically favorable, but has disadvantages in the timing due to the relatively long reaction time. Therefore, vulcanization of the silicone rubber in the process flow can also be accelerated by microwave heating.
Eine andere Verfahrensvariante kann darin bestehen, daß die Kunststofffolien vor dem Befüllen mit den Komponenten des Silikonkautschuks mittels Mikrowellen thermisch verstreckt werden. Auch hier kann nach Einfüllen des Silikonkautschuks zunächst bei Raumtermperatur gewartet werden, bis die einzelnen Komponenten vernetzt sind. Alternativ kann zur Beschleunigung der Vulkanisation des Silikonkautschuks eine Erwärmung mittels Mikrowellen erfolgen.Another variant of the method may be that the plastic films are thermally drawn by means of microwaves prior to filling with the components of the silicone rubber. Again, after filling the silicone rubber, it is first possible to wait at room temperature until the individual components are crosslinked. Alternatively, to accelerate the vulcanization of the silicone rubber, heating by means of microwaves may take place.
Entsprechend einem bevorzugten Gedanken der Erfindung erfolgt die Erwärmung der zu vernetzenden Komponenten des Silikonkautschuks unmittelbar indem zu vernetzenden Silikonkautschuk, woraus sich ein Temperaturprofil quasi invers zu demjenigen bei einer mittelbaren Erwärmung ergibt. Die unmittelbar Erwärmung kann hier, wie zuvor ausgeführt, durch Induktion, ein Hochfrequenzfeld oder speziell durch Mikrowellen erzeugt werden.According to a preferred aspect of the invention, the heating of the components of the silicone rubber to be crosslinked takes place directly in the silicone rubber to be crosslinked, resulting in a temperature profile quasi inverse to that in the case of indirect heating. The direct heating can be generated here, as stated above, by induction, a high-frequency field or especially by microwaves.
Besondere Vorteile der unmittelbaren Erwärmung sind zunächst einmal die kürzere Durchwärmzeit und zum anderen der geringere Energieaufwand zu nennen. Darüber hinaus kann das zu erwärmende Gut, das heißt die zu vernetzenden Silikon- kautschukkomponenten, gezielt erwärmt werden, so daß durch geschickte Werkstoffauswahl die zu vernetzenden Komponenten des Silikonkautschuks erwärmt werden und nicht das Werkzeug selbst.Special advantages of direct heating are first of all the shorter soaking time and secondly the lower energy consumption. In addition, the material to be heated, that is to say the silicone rubber components, are heated selectively, so that by skillful choice of materials, the components to be crosslinked of the silicone rubber are heated and not the tool itself.
Bei der Verwendung optisch transparenter Kunststofffolien ergibt sich das Problem, dass beim Laserschweißen mittels Diodenlaser die Laserenergie von den Folien nicht absorbiert wird. Gemäß einer besonders vorteilhaften Ausgestaltung der Erfindung werden die transparenten Folien daher zwischen einem transparenten Festkörper eingespannt und mit einem flächigen Absorber unterlegt. Bei dem flächigen Absorber handelt sich um vorteilhaft um eine Absorberfolie.When optically transparent plastic films are used, the problem arises that the laser energy is not absorbed by the films during laser welding by means of diode lasers. According to a particularly advantageous embodiment of the invention, the transparent films are therefore clamped between a transparent solid and underlaid with a flat absorber. In the flat absorber is advantageous to an absorber film.
Der Laserstrahl durchdringt den Festkörper und die Folien und wird von der Absorberfolie absorbiert. Über Wärmeleitung von der Absorberfolie in die Folien kommt es zum Aufschmelzen und Verschweißen der Folien. Als transparenter Festkörper läßt sich grundsätzlich eine Glasplatte oder auch eine Glaskugel einsetzen. The laser beam penetrates the solid and the films and is absorbed by the absorber film. Heat conduction from the absorber foil into the foils leads to melting and welding of the foils. In principle, a glass plate or even a glass ball can be used as the transparent solid.

Claims

Patentansprüche claims
1. Verfahren zur Herstellung einer Brustprothese im wesentlichen bestehend aus folgenden Schritten:1. A method for producing a breast prosthesis consisting essentially of the following steps:
- Aufeinanderlegen von wenigstens zwei Kunststofffolien,- placing at least two plastic films on top of each other,
- Verschweißen der aufeinandergelegten Kunststofffolien unter Bildung einer oder mehrerer Kammern,Welding the superimposed plastic films to form one or more chambers,
- Befüllen der mindestens einen Kammer mit vorwiegend Silikonkautschuk und- Filling the at least one chamber with predominantly silicone rubber and
- Ausvulkanisieren des Silikonkautschuks,Vulcanizing the silicone rubber,
dadurch gekennzeichnet,characterized,
dass die Folienkonturen der Kunststofffolien mit einem Laser verschweißt wer den. that the foil contours of the plastic films welded to a laser who the.
2. Verfahren nach Anspruch 1 , dadurch gekennzeichnet, dass die Vulkanisation des Silikonkautschuks durch unmittelbare Erwärmung des Silikonkautschuks beschleunigt wird.2. The method according to claim 1, characterized in that the vulcanization of the silicone rubber is accelerated by direct heating of the silicone rubber.
3. Verfahren nach Anspruch 2, dadurch gekennzeichnet, dass die unmittelbare Erwärmung des Silikonkautschuks durch Mikrowellen erfolgt.3. The method according to claim 2, characterized in that the immediate heating of the silicone rubber is effected by microwaves.
4. Verfahren nach Anspruch 2, dadurch gekennzeichnet, dass die unmittelbare Erwärmung des Kautschuks durch Induktion erfolgt.4. The method according to claim 2, characterized in that the immediate heating of the rubber is carried out by induction.
5. Verfahren nach Anspruch 2, dadurch gekennzeichnet, dass die unmittelbare Erwärmung des Silikonkautschuks durch ein Hochfrequenzfeld erfolgt.5. The method according to claim 2, characterized in that the immediate heating of the silicone rubber is effected by a high-frequency field.
6. Verfahren nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass nach Schweißen der Folienkonturen mittels Laser die verschweißten Kunststofffolien in ein Formwerkzeug gelegt werden.6. The method according to any one of claims 1 to 5, characterized in that after welding the foil contours by means of laser, the welded plastic films are placed in a mold.
7. Verfahren nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass das Schweißen der Folienkonturen mittels Laser direkt im Formwerkzeug erfolgt.7. The method according to any one of claims 1 to 5, characterized in that the welding of the foil contours by means of laser is carried out directly in the mold.
8. Verfahren nach Anspruch 6 und 7, dadurch gekennzeichnet, dass die Kunststofffolien nach dem Befüllen mit den Komponenten des Silikonkautschuks thermisch verstreckt werden und zur Beschleunigung der Vulkanisation mit den Formwerkzeugen in Umluftöfen erwärmt werden.8. The method according to claim 6 and 7, characterized in that the plastic films are thermally stretched after filling with the components of the silicone rubber and are heated to accelerate the vulcanization with the molds in convection ovens.
9. Verfahren nach Anspruch 6 und 7, dadurch gekennzeichnet, dass die Kunststofffolien nach dem Befüllen mit den Komponenten des Silikonkautschuks mittels Mikrowellen thermisch verstreckt werden. 9. The method according to claim 6 and 7, characterized in that the plastic films are thermally stretched after filling with the components of the silicone rubber by means of microwaves.
10. Verfahren nach Anspruch 9, dadurch gekennzeichnet, dass gewartet wird, bis der Silikonkautschuk bei Raumtemperatur vernetzt ist.10. The method according to claim 9, characterized in that it is waited until the silicone rubber is crosslinked at room temperature.
11. Verfahren nach Anspruch 9, dadurch gekennzeichnet, dass die Vulkanisation des Silikonkautschuks durch Erwärmung mittels Mikrowellen beschleunigt wird.11. The method according to claim 9, characterized in that the vulcanization of the silicone rubber is accelerated by heating by means of microwaves.
12. Verfahren nach Anspruch 6 und 7, dadurch gekennzeichnet, dass die Kunststofffolien vor dem Befüllen mit den Komponenten des Silikonkautschuks mittels Mikrowellen thermisch verstreckt werden.12. The method according to claim 6 and 7, characterized in that the plastic films are thermally stretched by means of microwaves prior to filling with the components of the silicone rubber.
13. Verfahren nach Anspruch 12, dadurch gekennzeichnet, dass gewartet wird, bis der Silikonkautschuk bei Raumtemperatur vernetzt ist.13. The method according to claim 12, characterized in that it is waited until the silicone rubber is crosslinked at room temperature.
14. Verfahren nach Anspruch 12, dadurch gekennzeichnet, dass die Vulkanisation des Silikonkautschuks durch Erwärmung mittels Mikrowellen beschleunigt wird.14. The method according to claim 12, characterized in that the vulcanization of the silicone rubber is accelerated by heating by means of microwaves.
15. Verfahren nach einem der Ansprüche 1 bis 14, dadurch gekennzeichnet, dass zum Verschweißen optisch transparenter Folie die optisch transparenten Folien zwischen einem transparenten Festkörper und einem flächigen Absorber eingespannt werden.15. The method according to any one of claims 1 to 14, characterized in that for welding optically transparent film, the optically transparent films between a transparent solid and a flat absorber are clamped.
16. Verfahren nach Anspruch 15, dadurch gekennzeichnet, dass als Laser Diodenlaser eingesetzt werden.16. The method according to claim 15, characterized in that are used as a laser diode laser.
17. Verfahren nach einem der Ansprüche 14 oder 15, dadurch gekennzeichnet, dass der Absorber aus einer Absorberfolie besteht. 17. The method according to any one of claims 14 or 15, characterized in that the absorber consists of an absorber film.
PCT/EP2007/008934 2006-10-31 2007-10-15 Method for the production of a breast prosthesis WO2008052650A1 (en)

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EP2177237A1 (en) 2008-10-20 2010-04-21 Hoc Age CTA Core fillings for prostheses

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Publication number Priority date Publication date Assignee Title
US4249975A (en) * 1978-08-14 1981-02-10 Cornelius Rechenberg Process of manufacturing artificial breasts
DE3742352A1 (en) * 1987-12-14 1989-06-29 Amoena Med Orthopaedie Tech CHEST PROSTHESIS
EP0880951A2 (en) * 1997-05-03 1998-12-02 Thämert Orthopädische Hilfsmittel GmbH & Co. Method of producing a prosthesis for the female breast

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4249975A (en) * 1978-08-14 1981-02-10 Cornelius Rechenberg Process of manufacturing artificial breasts
US4249975B1 (en) * 1978-08-14 1988-04-05
DE3742352A1 (en) * 1987-12-14 1989-06-29 Amoena Med Orthopaedie Tech CHEST PROSTHESIS
EP0880951A2 (en) * 1997-05-03 1998-12-02 Thämert Orthopädische Hilfsmittel GmbH & Co. Method of producing a prosthesis for the female breast

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2177237A1 (en) 2008-10-20 2010-04-21 Hoc Age CTA Core fillings for prostheses

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