EP1087725A1 - Plastic part with shape memory (also partially) used in implant applications with minimal invasiveness - Google Patents

Plastic part with shape memory (also partially) used in implant applications with minimal invasiveness

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Publication number
EP1087725A1
EP1087725A1 EP98964384A EP98964384A EP1087725A1 EP 1087725 A1 EP1087725 A1 EP 1087725A1 EP 98964384 A EP98964384 A EP 98964384A EP 98964384 A EP98964384 A EP 98964384A EP 1087725 A1 EP1087725 A1 EP 1087725A1
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EP
European Patent Office
Prior art keywords
shape memory
molded part
organism
shape
plastic part
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.)
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Application number
EP98964384A
Other languages
German (de)
French (fr)
Inventor
Thomas Müller
Helmut O. KÄUFER
Gregor Krings
Peter Ewert
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Individual
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Individual
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Publication of EP1087725A1 publication Critical patent/EP1087725A1/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0023Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply

Definitions

  • Plastic part with shape memory also partially as a minimally invasive implant application
  • the invention uses a method for producing a plastic part, which has a shape memory impressed on it and which is reset by the supply of energy.
  • This can be an elongated, possibly branched tube or hose element made of thermoplastic material, this element being given a shape memory.
  • the hose element is reset until it has reached its original shape, if possible.
  • This element is produced in one basic shape by one of the known methods, for example by extrusion or injection molding, and then forcibly brought into a second shape, for example by stretching, in order to impart its shape memory.
  • the mold is frozen at the freezing temperature, which can be as high as the stretching temperature. If necessary, the freezing temperature is then reached by supplying energy, for example by heat, and the shape memory is thus activated, so that the molded part strives to regain its original shape as far as possible.
  • the molded part can first be produced as a preform in an extrusion or injection molding tool and, after it has been cooled to a fixing temperature, it can be immediately deformed into the shrinkable shape under tension or pressure by reaction in the same device.
  • molecular orientations are compulsory, which establish the shape memory.
  • the finished part is ejected and, as a shrinking element, can be at least approximately deformed or shrunk back into its original shape by a corresponding supply of energy.
  • preforms are first produced, which are only later or in one shape memory is imposed on the corresponding second shaping device.
  • this requires a tempering phase beforehand to bring the preforms to the required temperature.
  • this separately produced preform is then introduced into the forming machine and subjected to the forming process already described.
  • the preform was conventionally manufactured and directionally cooled, while in a later second sub-process the actual stretching process, the shaping of the preform into the finished part, takes place.
  • preforms which have been worked out, for example, from extruded or cast semifinished products. Depending on the pre-history of the preform, this enables the finished part properties to be influenced in a targeted manner.
  • the preform is formed into a shrinkable finished part.
  • this reshaping that is to say a change in the shape of the molded part with an approximately constant molded part volume
  • high molecular orientations in the finished part arise at least in partial areas as a result of flow and stretching processes.
  • These highly oriented areas not only lead to a significant increase in mechanical strength, but also to a targeted and increased shrinkage in these areas.
  • This entropy-elastic effect can be explained by the memory of aligned molecular clusters which, when reheated, cause a disordered, i.e. strive for more likely condition.
  • the method now makes it possible to optimize the molded parts with regard to their shrinking behavior in such a way that a shrinking element with a predetermined shrinking behavior can be produced.
  • fixation of the introduced molecular orientations required for the shrinkage behavior takes place depending on the material used and depending on the later required temperature range under defined tension or pressure at a correspondingly chosen fixing temperature, which in any case, however, at or below the crystallite melting point or softening range of the one used thermoplastic lies.
  • the shape of the plastic part with shape memory must be designed by means of a suitable procedure so that the designed part allows a minimally invasive introduction into an organism by means of a catheter, a probe or other suitable aids or without aids and an activation of the by means of minimally invasive or non-invasive techniques Shape memory is possible. (Photo 121)
  • the combination of shrinking parts with film areas within the cross section, which are stretched by the shrinking may be necessary.
  • the combination of shrinking parts with film areas within the cross-section, which are stretched by the shrinking enable the shrinking element with film areas as a vascular prosthesis with the help of the film areas to take over a valve function for circulating liquids within a vascular system or cavity.
  • the biocompatibility of the plastics used must be fully guaranteed before and after shrinking. The process must therefore be carried out in such a way that the biocompatibility of the shrunk part with respect to the preform does not significantly deteriorate due to the interim molecular orientations.
  • the (heat) energy required to activate the restoring forces to cancel the molecular orientation must be adapted to the regions of the body in which shrinkage is to be carried out in such a way that it does not damage the organism or can be applied by the body itself.
  • the type of temperature control and its precision must therefore be carried out specifically in comparison with conventional process parameters.
  • a special procedure is necessary for the stretching speed in such a way that both the type of stretching speed (it appears to be extremely slow stretching) and the constancy of the stretching speed must be specially designed.

Abstract

The invention relates to a method for producing or treating plastic parts in such a way that a shape memory is imposed on said plastic parts. The plastic part can have a shape suitable for an implant. The shape of the plastic part can be changed by applying energy, including the heat energy of an organism, so that it can be used for special functions in an organism.

Description

Kunststoffteil mit Formgedächtnis (auch partiell) als minimalinvasiv zu applizierende ImplantatanwendungPlastic part with shape memory (also partially) as a minimally invasive implant application
Beschreibung:Description:
Die Erfindung bedient sich eines Verfahrens zur Herstellung eines Kunststoffteils, dem ein Formgedächtnis eingeprägt wird und das durch Energiezufuhr zurückgestellt wird.The invention uses a method for producing a plastic part, which has a shape memory impressed on it and which is reset by the supply of energy.
Es kann sich hierbei um ein längliches, ggf. verzweigtes Rohr- oder Schlauchelement aus thermoplastischen Kunststoff handeln, wobei diesem Element ein Formgedächtmis verliehen ist. Bei Energiezufuhr wird das Schlauchelement zurückgestellt bis es, wenn möglich, seine Ursprungsform erreicht hat.This can be an elongated, possibly branched tube or hose element made of thermoplastic material, this element being given a shape memory. When energy is supplied, the hose element is reset until it has reached its original shape, if possible.
Dieses Element wird nach einem der bekannten Verfahren, zum Beispiel durch Extrusion oder Spritzguß, in einer Grundform hergestellt und dann zur Verleihung seines Formgedächtnisses zwangsweise in eine zweite Form, zum Beispiel durch Reckung, gebracht. In diesem Zustand wird die Form bei der Einfriertemperatur, die so hoch wie die Recktemperatur sein kann, eingefroren. Bei Bedarf wird dann durch Energiezufuhr, zum Beispiel durch Wärme, die Einfriertemperatur erreicht und damit das Formgedächtnis aktiviert, so daß das Formteil bestrebt ist, seine ursprüngliche Form soweit wie möglich wieder zu erlangen.This element is produced in one basic shape by one of the known methods, for example by extrusion or injection molding, and then forcibly brought into a second shape, for example by stretching, in order to impart its shape memory. In this state, the mold is frozen at the freezing temperature, which can be as high as the stretching temperature. If necessary, the freezing temperature is then reached by supplying energy, for example by heat, and the shape memory is thus activated, so that the molded part strives to regain its original shape as far as possible.
Vorteile am Verfahren sind nun darin zu sehen, daß der Gegenstand bis zur Verleihung der Formgedächtnisses in einem Verfahrenszug hergestellt werden kann, wobei es jedoch ebenso einfach ist, den Herstellungsvorgang in mehere einzelne Verfahrensschritte zu zerlegen.Advantages of the process can now be seen in the fact that the object can be produced in one process until the shape memory is imparted, although it is just as easy to divide the production process into several individual process steps.
So kann beispielsweise das Formteil zunächst als Vorformling im Extrusions- oder Spritzgußwerkzeug gefertigt werden und nach einer entsprechenden Abkühlung auf eine Fixiertemperatur sofort durch Umsetzen in der gleichen Vorrichtung zwangsweise in die schrumpfbare Form unter Zug oder Druck verformt werden. Hierbei erfolgen zwangsweise Molekülorientierungen, die das Formgedächtnis begründen. Nach einer jeweils festzulegenden Fixierzeit wird das fertige Teil ausgeworfen und kann als Schrumpfelement durch entsprechende Energiezufuhr in seine Ursprungsform zumindest annähernd zurückverformt bzw. geschrumpft werden.For example, the molded part can first be produced as a preform in an extrusion or injection molding tool and, after it has been cooled to a fixing temperature, it can be immediately deformed into the shrinkable shape under tension or pressure by reaction in the same device. Here, molecular orientations are compulsory, which establish the shape memory. After a fixing time to be determined in each case, the finished part is ejected and, as a shrinking element, can be at least approximately deformed or shrunk back into its original shape by a corresponding supply of energy.
Die Verfahrensschritte können auch aufgeteilt werden. So ist es beispielsweise möglich, daß zunächst Vorformlinge hergestellt werden, denen dann erst später oder auch in einer entsprechenden zweiten Formvorrichtung das Formgedächtnis auferlegt wird. Hierzu bedarf es dann jedoch vorher einer Temperierphase, um die Vorformlinge auf die erforderliche Temperatur zu bringen. Im temperierten Zustand wird dieser separat hergestellte Vorformling dann in die Umformmaschine eingebracht und dem bereits beschriebenen Umformprozeß unterzogen. So ist also in einem ersten Teilprozeß der Vorformling konventionell gefertigt und gerichtet abgekühlt worden, während in einem späteren zweiten Teilprozeß der eigentliche Reckvorgang, das Umformen des Vorformlings in das Fertigteil, stattfindet. Bei diesem Verfahren ist es auch möglich, Vorformlinge zu verwenden, die zum Beispiel aus extrudierten oder gegossenen Halbzeugen herausgearbeitet wurden. Damit besteht die Möglichkeit, je nach Vorgeschichte des Vorformlings die Fertigteileigenschaften gezielt beeinflussen zu können.The process steps can also be divided. So it is possible, for example, that preforms are first produced, which are only later or in one shape memory is imposed on the corresponding second shaping device. However, this requires a tempering phase beforehand to bring the preforms to the required temperature. In the tempered state, this separately produced preform is then introduced into the forming machine and subjected to the forming process already described. Thus, in a first sub-process the preform was conventionally manufactured and directionally cooled, while in a later second sub-process the actual stretching process, the shaping of the preform into the finished part, takes place. With this method it is also possible to use preforms which have been worked out, for example, from extruded or cast semifinished products. Depending on the pre-history of the preform, this enables the finished part properties to be influenced in a targeted manner.
Bei beiden Verfahren ist jedoch gleich, daß die Umformung eines Vorformlings in ein schrumpfbares Fertigteil erfolgt. Während dieser Umformung, das heißt Änderung der Formteilgeometrie bei annähernd konstantem Formteilvolumen, entstehen durch Fließ- und Reckprozesse zumindest in partiellen Bereichen hohe Molekülorientierungen im Fertigteil. Diese hochorientierten Bereiche führen nicht nur zu einer deutlichen Steigerung der mechanischen Festigkeit, sondern auch zu einer ebenso gezielten wie erhöhten Schrumpfung in diesen Bereichen. Dieser entropie-elastische Effekt läßt sich mit dem Rückerinnerungsvermögen ausgerichteter Molekülknäuel erklären, die bei Wiedererwärmung einem ungeordneten, d.h. wahrscheinlicheren Zustand anstreben. Durch die Verfahren wird es nun möglich, die Formteile hinsichtlich ihres Schrumpfverhaltens so zu optimieren, daß ein Schrumpfelement mit vorher festgelegtem Schrumpfverhalten hergestellt werden kann.In both methods, however, it is the same that the preform is formed into a shrinkable finished part. During this reshaping, that is to say a change in the shape of the molded part with an approximately constant molded part volume, high molecular orientations in the finished part arise at least in partial areas as a result of flow and stretching processes. These highly oriented areas not only lead to a significant increase in mechanical strength, but also to a targeted and increased shrinkage in these areas. This entropy-elastic effect can be explained by the memory of aligned molecular clusters which, when reheated, cause a disordered, i.e. strive for more likely condition. The method now makes it possible to optimize the molded parts with regard to their shrinking behavior in such a way that a shrinking element with a predetermined shrinking behavior can be produced.
Die für das Schrumpfverhalten erforderliche Fixierung der eingebrachten Molekülorientierungen, erfolgt je nach verwendetem Material und je nach später erforderlichem Temperaturbereich unter definiertem Zug bzw. Druck bei einer entsprechend zu wählenden Fixiertemperatur, die in jedem Fall jedoch am bzw. unterhalb des Kristallitschmelzpunktes bzw. Erweichungsbereiches des verwendeten thermoplastischen Kunststoffes liegt.The fixation of the introduced molecular orientations required for the shrinkage behavior takes place depending on the material used and depending on the later required temperature range under defined tension or pressure at a correspondingly chosen fixing temperature, which in any case, however, at or below the crystallite melting point or softening range of the one used thermoplastic lies.
Die Verformung während des Umformungsvorganges, das bedeutet die Umformgeschwindigkeit zum Verformen der Vorformlinge und damit zum Einbringen der zwangsweisen Molekülorientierung erfolgt je nach Material und später erforderlichem Rückstellverhalten (Höhe und Richtung der Rückstellkräfte). Bei der erfindungsgemäßen Anwendung dieses Verfahrens auf dem medizintechnischen Sektor, speziell dem Gebiet der Implantologie sind mehrere prinzipielle Hindernisse zu überwinden, die den erfindungsgemäßen Maßnahmen einer sehr definierten Verfahrensführung bedürfen. Im Speziellen werden diese im Folgenden erläutert.Deformation during the reshaping process, that means the reshaping speed for reshaping the preforms and thus for introducing the compulsory molecular orientation takes place depending on the material and later required restoring behavior (amount and direction of the restoring forces). When using this method according to the invention in the medical technology sector, especially in the field of implantology, several fundamental obstacles have to be overcome which require the measures according to the invention to be carried out in a very defined manner. These are specifically explained below.
• Die Endform nach dem Schrumpfen des Teiles muß in dem Sinne der Problematik der Implantologie angepaßt sein, daß das Kunststoffteil als Implantat eine Funktion als Prothese im Gefäßsystem oder anderen Hohlorganen zu übernehmen in der Lage ist. (Bild 1 1)• The final shape after shrinking the part must be adapted in the sense of the problem of implantology that the plastic part as an implant is able to take on a function as a prosthesis in the vascular system or other hollow organs. (Photo 1 1)
• Die Form des Kunststoffteils mit Formgedächtnis muß durch geeignete Verfahrensführung so gestaltet sein, daß das gestaltete Teil es erlaubt mittels eines Katheters, einer Sonde oder anderer geeigneter Hilfsmittel oder ohne Hilfsmittel in einen Organismus minimalinvasiv eingebracht zu werden und mittels minimalinvasiver oder nichtinvasiver Techniken eine Aktivierung des Formgedächtnisses möglich ist. (Bild 121)• The shape of the plastic part with shape memory must be designed by means of a suitable procedure so that the designed part allows a minimally invasive introduction into an organism by means of a catheter, a probe or other suitable aids or without aids and an activation of the by means of minimally invasive or non-invasive techniques Shape memory is possible. (Photo 121)
• Die Kombination von schrumpfenden Teilen mit Folienbereichen innerhalb des Querschnittes, die durch das Schrumpfen aufgespannt werden, kann erforderlich sein. Die Kombination von schrumpfenden Teilen mit Folienbereichen innerhalb des Querschnittes, die durch das Schrumpfen aufgespannt werden, ermöglichen es dem Schrumpfelement mit Folienbereichen als Gefäßprothese mit Hilfe der Folienbereiche eine Ventlifunktion für zirkulierende Flüssigkeiten innerhalb eines Gefäßsystems oder Hohlraums zu übernehmen.• The combination of shrinking parts with film areas within the cross section, which are stretched by the shrinking, may be necessary. The combination of shrinking parts with film areas within the cross-section, which are stretched by the shrinking, enable the shrinking element with film areas as a vascular prosthesis with the help of the film areas to take over a valve function for circulating liquids within a vascular system or cavity.
• Die Biokompatibilität der angewendeten Kunststoffe muß vor und nach dem Schrumpfen uneingeschränkt gewährleistet sein. Das Verfahren muß also derart geführt werden, daß sich aufgrund der zwischenzeitlichen Molekülumorientierungen die Biokompatibilität des geschrumpften Teils gegenüber dem Vorformling nicht wesentlich verschlechtert. • Die zur Aktivierung der Rückstellkräfte zur Aufhebung der Molekülorientierung nötige (Wärme-) Energie muß den Körperregionen in denen eine Schrumpfung vorgenommen werden soll so angepaßt werden, daß diese den Organismus nicht schädigt, oder von ihm selber aufgebracht werden kann. Die Art der Temperaturführung und deren Präzision ist daher im Vergleich mit herkömmlichen Verfahrensparametern speziell auszuführen. Desweiteren ist bei der Reckgeschwindigkeit eine spezielle Verfahrensführung notwendig in der Art, daß sowohl die Art der Reckgeschwindigkeit (es scheint sich ein extrem langsames Recken anzubieten) als auch die Konstantheit der Reckgeschwindigkeit speziell ausgeführt sein müssen.• The biocompatibility of the plastics used must be fully guaranteed before and after shrinking. The process must therefore be carried out in such a way that the biocompatibility of the shrunk part with respect to the preform does not significantly deteriorate due to the interim molecular orientations. • The (heat) energy required to activate the restoring forces to cancel the molecular orientation must be adapted to the regions of the body in which shrinkage is to be carried out in such a way that it does not damage the organism or can be applied by the body itself. The type of temperature control and its precision must therefore be carried out specifically in comparison with conventional process parameters. Furthermore, a special procedure is necessary for the stretching speed in such a way that both the type of stretching speed (it appears to be extremely slow stretching) and the constancy of the stretching speed must be specially designed.
Das Prinzip der möglichen Anwendung des Kunststoffteils als Implantat in Gefäßsystemen oder Hohlorganen ist in den Bildern IM -III dargestellt. The principle of the possible use of the plastic part as an implant in vascular systems or hollow organs is shown in Figures IM-III.

Claims

Patentansprüche: Claims:
1. Verfahren zur Herstellung eines Kunststoffteils das Biokompatibilität aufweist und auf, dem durch Verformen im festen Aggregatzustand ein Formgedächtnis eingeprägt wird, dadurch gekennzeichnet, daß das Teil mit Formgedächtnis minimalinvasiv zu applizieren ist, ein Schrumpfen, auch partiell, innerhalb von Gefäßsystemen oder anderen Hohlräumen lebender Organismen möglich ist ohne diesen zu schädigen und die Endform nach dem Schrumpfen des Teiles Funktionen im Kontakt mit Blut und/oder Gewebe ausführen kann, und/oder Gewebeteile ersetzen kann. (Bilder IM, 121, 131)1. A method for producing a plastic part which has biocompatibility and on which a shape memory is impressed by deforming in the solid state, characterized in that the part with shape memory is to be applied in a minimally invasive manner, shrinkage, also partially, living within vascular systems or other cavities Organisms are possible without damaging them and after shrinking the part the final shape can perform functions in contact with blood and / or tissue, and / or can replace tissue parts. (Pictures IM, 121, 131)
2. Verfahren nach Anspruch 1, dadurch gekennzeichent, daß die Form des Kunststoffteils mit Formgedächtnis durch geeignete Verfahrensführung so gestaltet ist, daß das gestaltete Teil es erlaubt mittels eines Katheters, einer Sonde oder anderer geeigneter Hilfsmittel oder ohne Hilfsmittel in einen Organismus minimalinvasiv eingebracht zu werden und mittels minimalinvasiver oder nichtinvasiver Techniken eine Aktivierung des Formgedächtnisses möglich ist.2. The method according to claim 1, characterized in that the shape of the plastic part with shape memory is designed by suitable process control so that the designed part allows a minimally invasive to be introduced into an organism by means of a catheter, a probe or other suitable aids or without aids and activation of the shape memory is possible using minimally invasive or non-invasive techniques.
3. Verfahren nach Anspruch 1 - 2, dadurch gekennzeichent, daß die Wärme des menschlichen Organismus ausreicht um die Rückstellkräfte zur Aufhebung der eingebrachten Molekülorientierungen zu aktivieren.3. The method according to claim 1-2, characterized gekennzeichent that the heat of the human organism is sufficient to activate the restoring forces to cancel the introduced molecular orientations.
4. Verfahren nach Anspruch 1 - 2, dadurch gekennzeichent, daß die Energie die zur Aktivierung der Rückstellkräfte zur Aufhebung der eingebrachten Molekülorientierungen nötig ist, innerhalb des menschlichen Organismis mittels geeigneter Methoden (z.B. Heizelemente, Ultraschall, etc.) an das Formteil appliziert werden kann, ohne den Organismus zu schädigen. 4. The method according to claim 1-2, characterized gekennzeichent that the energy required to activate the restoring forces to cancel the introduced molecular orientations, can be applied to the molded part within the human organism by means of suitable methods (eg heating elements, ultrasound, etc.) without harming the organism.
5. Verfahren nach Anspruch 1 - 4, dadurch gekennzeichent, daß sich aufgrund der zwischenzeitlichen Molekülumorientierungen die Biokompatibilität des geschrumpften Teils gegenüber dem Vorformling nicht wesentlich verschlechtert.5. The method according to claim 1-4, characterized in that the biocompatibility of the shrunk part compared to the preform does not deteriorate significantly due to the intermediate molecular orientations.
6. Schrumpfbares Formteil, hergestellt nach den unter 1 - 5 genannten Verfahren, dadurch gekennzeichnet, daß sich innerhalb des Formteils Elemente befinden, die nach erfolgter Rückstellung des Formteils innerhalb des menschlichen Organismus aufgespannt werden können und dort dem Schrumpfelement mit Folienbereichen eine Funktion als (Blut-) Gefäßprothese erlauben, die mit Hilfe der Folienbereiche eine Ventlifunktion für zirkulierende Flüssigkeiten innerhalb eines (Blut-) Gefäßes übernehmen kann.6. Shrinkable molded part, produced by the methods mentioned under 1-5, characterized in that there are elements within the molded part that can be clamped after the molded part has been reset within the human organism and there the shrinking element with film areas a function as (blood -) Allow vascular prosthesis, which with the help of the foil areas can perform a ventilating function for circulating liquids within a (blood) vessel.
7. Schrumpfbares Formteil, hergestellt nach den unter 1 - 5 genannten Verfahren, dadurch gekennzeichnet,7. Shrinkable molded part, produced according to the methods mentioned under 1-5, characterized in that
daß zur Verbesserung der Biokompatibilität angewendete Oberflächenmodifizierungsverfahren oder Oberflächenfibrillierungsverfahren durch das Einbringen des Formgedächtnisses und/oder das anschließende Rückstellen in Ihrer Wirkung nicht beeinträchtigt werden. that the surface modification methods or surface fibrillation methods used to improve the biocompatibility are not impaired in their effect by the introduction of the shape memory and / or the subsequent resetting.
EP98964384A 1997-12-04 1998-12-03 Plastic part with shape memory (also partially) used in implant applications with minimal invasiveness Withdrawn EP1087725A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19755872 1997-12-04
DE1997155872 DE19755872A1 (en) 1997-12-04 1997-12-04 Plastic part with shape memory (also partially) as a minimally invasive implant application
PCT/DE1998/003605 WO1999029263A1 (en) 1997-12-04 1998-12-03 Plastic part with shape memory (also partially) used in implant applications with minimal invasiveness

Publications (1)

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EP98964384A Withdrawn EP1087725A1 (en) 1997-12-04 1998-12-03 Plastic part with shape memory (also partially) used in implant applications with minimal invasiveness

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AU2002218995A1 (en) 2000-11-21 2002-06-03 Schering A.G. Tubular vascular implants (stents) and methods for producing the same
US7087078B2 (en) 2000-11-21 2006-08-08 Schering Ag Tubular vascular implants (stents) and methods for producing the same
DE102009025293A1 (en) 2009-06-15 2010-12-16 Adolf Pfaff & Dr. Karl-Friedrich Reichenbach GbR (vertretungsberechtigter Gesellschafter: Adolf Pfaff, 79183 Waldkirch) Radioopaque shape memory polymers
US20160114077A1 (en) * 2013-05-31 2016-04-28 University Of Massachusetts Medical School Elastomeric and degradable polymer scaffolds and high-mineral content polymer composites, and in vivo applications thereof

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WO1999029263A1 (en) 1999-06-17

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