WO1998052489A1 - Biocompatible barrier membrane - Google Patents

Biocompatible barrier membrane Download PDF

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Publication number
WO1998052489A1
WO1998052489A1 PCT/EP1998/002955 EP9802955W WO9852489A1 WO 1998052489 A1 WO1998052489 A1 WO 1998052489A1 EP 9802955 W EP9802955 W EP 9802955W WO 9852489 A1 WO9852489 A1 WO 9852489A1
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WIPO (PCT)
Prior art keywords
membrane
perforations
biocompatible
barrier membrane
biocompatible barrier
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PCT/EP1998/002955
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German (de)
French (fr)
Inventor
Dusan Ristic
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Dusan Ristic
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Publication of WO1998052489A1 publication Critical patent/WO1998052489A1/en

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    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0003—Not used, see subgroups
    • A61C8/0004—Consolidating natural teeth
    • A61C8/0006—Periodontal tissue or bone regeneration

Definitions

  • the invention relates to a biocompatible barrier membrane for maintaining, improving, restoring and recreating the hard and / or soft tissue of parts of the human or animal body, in particular the mouth area.
  • non-absorbable, universal barrier membranes have developed into an important tool in periodontology and implantology. They are used in human medicine and oral surgery both for controlled tissue regeneration and for controlled bone regeneration, thereby - also for later implantation - usable bone profile in height and width is obtained.
  • Generic membranes have so far been made from PTFE (polytetrafluoroethylene). This material is microporous and can be removed from the human body after use.
  • a disadvantage of the known PTFE material is that the spontaneous opening of the sewn-on mucosal flap or the like. More bacteria can settle on the material, and that this triggers increased plaque formation.
  • the material is also relatively soft and not sufficiently rigid for some areas of application, so that attempts have already been made to reinforce it by inserting titanium strips.
  • the PTFE material is also difficult to distinguish optically from natural tissue. Membranes made of biocompatible metals or metal alloys, on the other hand, can be easily recognized and separated from human or animal tissue.
  • Films made of titanium are also known for controlled tissue regeneration, in particular for the treatment of the mouth area, for example from FR 2 713 090 and EP 0 622 052 and from DE-OS 196 05 485.
  • the bone-inductive properties of the Titans used through which a relatively rapid bone formation is achieved. With such titanium membranes, the defect area is shielded from the surrounding area.
  • a hard, tough, elastic, stretchable and polishable, rollable and forgeable metal or such a metal alloy such as titanium, tantalum, platinum, cobalt and / or their alloys, depending on the selection of the film thickness and / or corresponding stiffness or metal alloy, the desired rigidity can always be achieved.
  • the base metals mentioned also coat with a protective oxide layer and are extremely resistant to biological and chemical attacks. there is therefore no risk of increased or increased bacterial colonization with subsequent plaque formation.
  • the disadvantage with them so far is that they provide complete shielding and do not allow substances that are absolutely desirable for healing, such as bodily fluids and / or blood cells, to pass through.
  • the object of the invention is therefore to provide a solution in which an increased bacterial colonization with subsequent plaque formation is avoided, and in which at the same time a sufficient, higher rigidity of the membrane is achieved.
  • the body's own juices, especially blood cells should be able to pass through the membrane.
  • the membrane made of titanium, tantalum, platinum, cobalt and / or a titanium, tantalum, platinum or cobalt alloy is microperforated.
  • micro-perforated metal membrane is that unwanted bacteria or cells are kept away from the area to be covered, while for example body juices or blood cells can pass through the membrane.
  • microperforated metal foils according to the invention can be used indefinitely or are durable, since they can in particular also be resterilized and are not subject to natural decay.
  • the membrane preferably consists of the particularly suitable biocompatible metal alloy Syntacoben®, from which, among other things, hip joint prostheses and the like. getting produced. It is a ductile cobalt alloy (approx. 45% Co, 18% Ca, 3.8 Mo, 3.8 W, 5% Fe, 1% Ti, rest of nickel), which is shaped hot and cold and with different Strength levels can be produced. This material is standardized as a ductile colbalt-nickel-chrome-molybdenum-tungsten-iron alloy in Switzerland under SNV 056510- 1975 and in America under ASTM F 563/78 as a surgical implant material. An international standard (ISO) is also in preparation.
  • Syntacoben® is a ductile cobalt alloy (approx. 45% Co, 18% Ca, 3.8 Mo, 3.8 W, 5% Fe, 1% Ti, rest of nickel), which is shaped hot and cold and with different Strength levels can be produced.
  • This material is standardized as a ductile colbal
  • the material is characterized by high toughness, strength, ductility and corrosion resistance and is particularly suitable for the manufacture of small-sized implants that have to absorb high forces.
  • the crystallographic structure of Syntacoben® corresponds to that of stainless steel, but the corrosion resistance, fatigue strength, hardness and tensile strength of this cobalt alloy exceed the corresponding properties of even the best quality stainless steel of type V4A or AISI 316 L, whereby excellent ductility is guaranteed.
  • the membrane is microperforated with at least 100 perforations per mm, preferably with 12,000 perforations and more per mm 2 .
  • a barrier membrane is used between the bone and mucous membranes, it is possible for the membrane to grow well with soft tissue at about 100 perforations per mm 2 , so that entire skin lobes can then be pulled up adhering to the membrane and sewn by the surgeon. The rag and membrane can be lifted together. With 12,000 microperforations per mm 2 , on the other hand, it is impossible to grow through, a defect area covered with such material can be completely protected against undesired bacteria and cells.
  • the invention provides in a further embodiment that the membrane has perforations of ⁇ 50 micrometers, preferably ⁇ 5 micrometers. With this, the results described above can be achieved even better.
  • two treatment strategies can be seen: fewer and larger perforations per unit area enable the tissue to grow through the membrane according to the invention, so that this membrane can be used as a kind of reinforcement of soft tissue, that, for example, this tissue can be kept away from the surface of a tooth until there is enough slow has always formed growing bone.
  • This "soft tissue reinforcement" by the membrane according to the invention prevents this soft tissue from tearing and thereby supports the desired effect of the regrowth of, for example, bone substance.
  • the second effect can be seen in the fact that a large number of microperforations with a small diameter prevent the growth of tissue cells as well as the passage of bacteria, but nevertheless enable the passage of, for example, proteins. With perforations of ⁇ 1 micrometer, only the body's own juices and blood cells can pass through the membrane.
  • the invention also provides that the membrane can only be passed through by proteins, but not by bacteria or tissue cells. This enables the construction of the desired material, in particular the tissue or bone substance to be regenerated. Bacteria and soft tissue cells have to be kept away, for example, so that bone material develops. The formation of bone material, on the other hand, requires the addition of proteins.
  • the invention also proposes a method for producing a biocompatible barrier membrane.
  • the perforations are made mechanically and / or by bundled light energy, in particular lasers and / or by chemical processes, in particular etching or the like. , and / or produced by bombardment with protons or other particles. This enables particularly fine perforations of ⁇ 5 micrometers to be achieved. It has been found, for example, that with a perforation by laser light the size of the individual perforations on the processing side facing the laser is initially relatively large, but the laser can be adjusted so precisely that on the side facing away from the laser that is to be processed Membrane only a tiny opening remains, so that the desired values of ⁇ 5 micrometers per per perforation can be achieved in this way.
  • FIG. 1 shows a membrane according to the invention made of titanium, tantalum, platinum, cobalt or a corresponding metal alloy
  • FIG. 2 shows a biocompatible barrier membrane according to the invention in the application position.
  • a - greatly enlarged - generally designated 1 membrane of titanium, tantalum, platinum, cobalt or a corresponding metal alloy has a blank 2 with microperforations 3.
  • these microperforations 3 are generated mechanically and / or by bundled light energy, in particular lasers, and / or by chemical methods, in particular etching or the like. , and / or produced by bombardment with protons or other particles. It is possible, for example, to form at least 100, but preferably 12,000 perforations and more per mm 2 , so that the individual perforations are ⁇ 50 micrometers, but preferably ⁇ 5 micrometers.
  • Such micro perforations 3 have the advantage that they can only be passed by proteins 4, but not by bacteria 5 or tissue cells 6.
  • a defect region 7 covered with a corresponding membrane 2 is protected, and soft tissue 9 to be lifted is reinforced in order to prevent tearing, so that new, slower-growing bone material 8 can form underneath.
  • the membrane 2 thus forms, for example, a barrier between the gingival soft tissue 9 and the defect area (cavity) 7 above the root surface 10.
  • the gingival tissue 9 and the epithelium 11 no longer proliferate apically, which leads to the formation of new desmodonts, dental cement and bone tissue (inside the alveoli - cortical). In this way, a new attachment can be achieved. Is after a short time to recognize new cement or new bone. Experience has shown that it only takes a period of 2 to 6 months for the bone structure to improve significantly. After a period of 10 to 12 months, the necessary bone build-up is usually complete.
  • the membrane according to the invention can be used to achieve sufficient durability for newly inserted implants after the corresponding bone material has been built up.
  • the membrane 2 according to the invention has the function, if necessary, of growing the new, soft tissue in order to raise it with the surrounding flaps in order to make more space for the desired bone tissue.
  • the invention is not limited to the exemplary embodiments shown. Further configurations are possible without leaving the basic idea.

Abstract

The aim of the invention is to provide a biocompatible barrier membrane for maintaining, improving, reconstructing and recreating the hard and/or soft tissue of parts of the human or animal body, especially of the mouth region. To this end, the membrane consists of micro-perforated titanium, tantalum, platinum or cobalt, or a titanium, tantalum, platinum, or cobalt alloy.

Description

"Biokompatible Barrieremembran" "Biocompatible barrier membrane"
Die Erfindung betrifft eine biokompatible Barrieremembran zur Erhaltung, Verbesserung, Wiederherstellung und Neuschaffung des harten und/oder weichen Gewebes von Teilen des menschlichen oder tierischen Körpers, insbesondere des Mundbereiches .The invention relates to a biocompatible barrier membrane for maintaining, improving, restoring and recreating the hard and / or soft tissue of parts of the human or animal body, in particular the mouth area.
Nicht resorbierbare, universale Barrieremembrane haben sich in der Vergangenheit zu einem wichtigen Hilfsmittel in der Paradontologie und Implantologie entwickelt. Sie werden in der Humanmedizin und Oralchirurgie sowohl zur gesteuerten Geweberegeneration wie auch zur gesteuerten Knochenregeneration eingesetzt, dabei wird - auch für die spätere Implantation - verwendbares Knochenprofil in Höhe und Breite gewonnen. Gattungsbildende Membrane werden bislang aus PTFE ( Polytetrafluoräthylen) hergestellt. Dieses Material ist mikroporös und nach dem Einsatz wieder aus dem menschlichen Körper entfernbar.In the past, non-absorbable, universal barrier membranes have developed into an important tool in periodontology and implantology. They are used in human medicine and oral surgery both for controlled tissue regeneration and for controlled bone regeneration, thereby - also for later implantation - usable bone profile in height and width is obtained. Generic membranes have so far been made from PTFE (polytetrafluoroethylene). This material is microporous and can be removed from the human body after use.
Nachteilig bei dem bekannten PTFE-Material ist es jedoch, daß sich bei der spontanen Öffnung der angenähten Schleimhautlappen oder dergl . Bakterien auf dem Material vermehrt ansiedeln können, und daß hierdurch ausgelöst, es zu einer verstärkten Plaquebildung kommt. Auch ist das Material relativ weich, und für einige Anwendungsbereiche nicht ausreichend steif, so daß bereits versucht wurde, es durch Einlegung von Titanstreifen zu armieren. Auch ist das PTFE-Material optisch schwer von natürlichem Gewebe zu unterscheiden. Membrane aus biokompatiblen Metallen bzw. Metallegierungen sind hingegen gut zu erkennen und vom menschlichen bzw. tierischen Gewebe zu trennen.A disadvantage of the known PTFE material, however, is that the spontaneous opening of the sewn-on mucosal flap or the like. More bacteria can settle on the material, and that this triggers increased plaque formation. The material is also relatively soft and not sufficiently rigid for some areas of application, so that attempts have already been made to reinforce it by inserting titanium strips. The PTFE material is also difficult to distinguish optically from natural tissue. Membranes made of biocompatible metals or metal alloys, on the other hand, can be easily recognized and separated from human or animal tissue.
Auch sind bereits Folien aus Titan für die gesteuerte Geweberegeneration, insbesondere für die Behandlung des Mundbereiches, bekannt, so aus der FR 2 713 090 und der EP 0 622 052 sowie aus der DE-OS 196 05 485. Dabei werden insbesondere die knocheninduktiven Eigenschaften des Titans genutzt, durch die eine relativ rasche Knochenbildung erreicht wird. Mit derartigen Titanmembranen erfolgt eine Abschirmung des Defektbereiches gegenüber dem umgebenden Gebiet. Durch die Auswahl eines harten, zähen, elastischen, dehnbaren und polierbaren, walz- und schmiedbaren Metalls bzw. einer derartigen Metallegierung, wie z.B Titan, Tantal, Platin, Kobalt und/oder deren Legierungen, kann je nach Auswahl der Folienstärke und/oder des entsprechenden Metalls oder der Metallegierung immer die gewünschte Stei- figkeit erreicht werden. Dabei ist es z.B. möglich, über dem jeweiligen Defekt im menschlichen oder tierischen Körper ein Zelt zu bilden, was mit dem PTFE-Material ohne zusätzliche Armierungen nicht möglich ist. Auch überziehen sich die genannten unedlen Metalle unter anderem mit einer schützenden Oxidschicht und sind gegen biologische und chemische Angriffe außerordentlich widerstandsfähig, es be- steht bei ihnen daher nicht die Gefahr einer erhöhten oder vermehrten Bakterienansiedlung mit nachfolgender Plaquebil- dung. Allerdings besteht bei ihnen bisher der Nachteil, daß sie eine vollständige Abschirmung darstellen und auch für die Heilung durchaus erwünschte Stoffe, wie Körpersäfte und/oder Blutzellen, nicht durchlassen.Films made of titanium are also known for controlled tissue regeneration, in particular for the treatment of the mouth area, for example from FR 2 713 090 and EP 0 622 052 and from DE-OS 196 05 485. The bone-inductive properties of the Titans used, through which a relatively rapid bone formation is achieved. With such titanium membranes, the defect area is shielded from the surrounding area. Through the selection of a hard, tough, elastic, stretchable and polishable, rollable and forgeable metal or such a metal alloy, such as titanium, tantalum, platinum, cobalt and / or their alloys, depending on the selection of the film thickness and / or corresponding stiffness or metal alloy, the desired rigidity can always be achieved. It is possible, for example, to form a tent over the respective defect in the human or animal body, which is not possible with the PTFE material without additional reinforcements. The base metals mentioned also coat with a protective oxide layer and are extremely resistant to biological and chemical attacks. there is therefore no risk of increased or increased bacterial colonization with subsequent plaque formation. However, the disadvantage with them so far is that they provide complete shielding and do not allow substances that are absolutely desirable for healing, such as bodily fluids and / or blood cells, to pass through.
Aufgabe der Erfindung ist es daher, eine Lösung zu schaffen, bei der eine verstärkte Bakterienansiedlung mit nachfolgender Plaquebildung vermieden wird, und bei der gleichzeitig eine ausreichende, höhere Steifigkeit der Membran erreicht wird. Zugleich sollen körpereigene Säfte, insbesondere auch Blutzellen, die Membran passieren können.The object of the invention is therefore to provide a solution in which an increased bacterial colonization with subsequent plaque formation is avoided, and in which at the same time a sufficient, higher rigidity of the membrane is achieved. At the same time, the body's own juices, especially blood cells, should be able to pass through the membrane.
Diese Aufgabe wird gemäß der Erfindung dadurch gelöst, daß die Membran aus Titan, Tantal, Platin, Kobalt und/oder einer Titan-, Tantal-, Platin- oder Kobaltlegierung mikroperforiert ist.This object is achieved according to the invention in that the membrane made of titanium, tantalum, platinum, cobalt and / or a titanium, tantalum, platinum or cobalt alloy is microperforated.
Der wesentliche Vorteil einer derartigen mikroperforierten Metallmembran besteht darin, daß unerwünschte Bakterien oder Zellen von dem abzudeckenden Bereich abgehalten werden, während beispielsweise Körpersäfte oder Blutzellen die Membran passieren können. Ein weiterer Vorteil besteht darin, daß anders als bei PTFE-Materialien erfindungsge- mäße, mikroperforierte Metallfolien unbegrenzt anwendbar bzw. haltbar sind, da sie insbesondere auch resterilisier- bar sind und keinem natürlichen Verfall unterworfen sind.The main advantage of such a micro-perforated metal membrane is that unwanted bacteria or cells are kept away from the area to be covered, while for example body juices or blood cells can pass through the membrane. Another advantage is that, unlike PTFE materials, microperforated metal foils according to the invention can be used indefinitely or are durable, since they can in particular also be resterilized and are not subject to natural decay.
Vorzugsweise besteht die Membran aus der besonders geeigneten biokompatiblen Metallegierung Syntacoben®, aus der unter anderem auch Hüftgelenksprothesen und dergl . hergestellt werden. Es handelt sich dabei um eine duktile Kobaltlegierung (ca. 45 % Co, 18 % Ca, 3,8 Mo, 3,8 W, 5 % Fe, 1 % Ti, Rest Nickel), die sich warm und kalt umformen und mit verschiedenen Festigkeitsgraden herstellen läßt. Dieses Material ist als duktile Kolbalt-Nickel-Chrom-Molybdän- Wolfram-Eisen-Legierung in der Schweiz unter SNV 056510- 1975 und in Amerika unter ASTM F 563/78 als chirurgischer Implantatwerkstoff normiert. Auch eine internationale Norm (ISO) ist in Vorbereitung. Der Werkstoff zeichnet sich durch hohe Zähigkeit, Festigkeit, Duktilität und Korrosionsresistenz aus und ist besonders geeignet für die Herstellung von Implantaten kleiner Dimensionen, die hohe Kräfte aufnehmen müssen. Die kristallographische Struktur von Syntacoben® entspricht derjenigen des rostfreien Stahles, jedoch übertreffen Korrosionsfestigkeit, Ermüdungsfestigkeit, Härte und Zugfestigkeit dieser Kolbaltlegierung die entsprechenden Eigenschaften selbst des rostfreien Stahles vom Typ V4A oder AISI 316 L bester Qualität, wobei ausgezeichnete Duktilität gewährleistet ist. In Ausgestaltung ist vorgesehen, daß die Membran mikroper- foriert ist mit wenigstens 100 Perforationen pro mm , vorzugsweise mit 12.000 Perforationen und mehr pro mm2. Wird eine derartige Barrieremembran zwischen Knochen- und Schleimhaut eingesetzt, ist es möglich, daß die Membran bei etwa 100 Perforationen pro mm2 gut von weichem Gewebe durchwachsen wird, so daß anschließend ganze Hautläppen an der Membran haftend hochgezogen und vom Operateur vernäht werden können. Es kann der Lappen und die Membran geraeinsam gehoben werden. Bei 12.000 Mikroperforationen pro mm2 ist hingegen ein Durchwachsen unmöglich, es kann ein mit derartigem Material abgedeckter Defektbereich vollständig vor unerwünschten Bakterien und Zellen geschützt werden.The membrane preferably consists of the particularly suitable biocompatible metal alloy Syntacoben®, from which, among other things, hip joint prostheses and the like. getting produced. It is a ductile cobalt alloy (approx. 45% Co, 18% Ca, 3.8 Mo, 3.8 W, 5% Fe, 1% Ti, rest of nickel), which is shaped hot and cold and with different Strength levels can be produced. This material is standardized as a ductile colbalt-nickel-chrome-molybdenum-tungsten-iron alloy in Switzerland under SNV 056510- 1975 and in America under ASTM F 563/78 as a surgical implant material. An international standard (ISO) is also in preparation. The material is characterized by high toughness, strength, ductility and corrosion resistance and is particularly suitable for the manufacture of small-sized implants that have to absorb high forces. The crystallographic structure of Syntacoben® corresponds to that of stainless steel, but the corrosion resistance, fatigue strength, hardness and tensile strength of this cobalt alloy exceed the corresponding properties of even the best quality stainless steel of type V4A or AISI 316 L, whereby excellent ductility is guaranteed. One embodiment provides that the membrane is microperforated with at least 100 perforations per mm, preferably with 12,000 perforations and more per mm 2 . If such a barrier membrane is used between the bone and mucous membranes, it is possible for the membrane to grow well with soft tissue at about 100 perforations per mm 2 , so that entire skin lobes can then be pulled up adhering to the membrane and sewn by the surgeon. The rag and membrane can be lifted together. With 12,000 microperforations per mm 2 , on the other hand, it is impossible to grow through, a defect area covered with such material can be completely protected against undesired bacteria and cells.
Die Erfindung sieht in weiterer Ausgestaltung vor, daß die Membran Perforationen von < 50 Mikrometern, vorzugsweise < 5 Mikrometern aufweist. Hiermit können die vorstehend beschriebenen Ergebnisse noch besser erreicht werden. Erkennbar werden je nach Porenausbildung, wie oben schon angedeutet, zwei Behandlungsstrategien möglich: wenige und größere Perforationen pro Flächeneinheit ermöglichen es, daß das Gewebe durch die erfindungsgemäße Membran hindurchwachsen kann, so daß diese Membran als eine Art Armierung von Weichgewebe benutzt werden kann, derart, daß beispielsweise dieses Gewebe von der Oberfläche eines Zahnes solange abgehalten werden kann, bis sich darunter genügend viel langsa- mer wachsende Knochensubstanz gebildet hat. Diese "Weichgewebearmierung" durch die erfindungsgemäße Membran verhindert ein Einreißen dieses Weichgewebes und unterstützt dabei den gewünschten Effekt des Nachwachsens von beispielsweise Knochensubstanz. Wie oben angegeben, ist der zweite Effekt darin zu sehen, daß eine Vielzahl von Mikroperfora- tionen mit kleinem Durchmesser das Durchwachsen von Gewebezellen ebenso verhindert wie den Durchtritt von Bakterien, gleichwohl aber den Durchtritt von beispielsweise Proteinen ermöglicht. Bei Perforationen von < 1 Mikrometer können nur noch körpereigene Säfte und Blutzellen die Membran passieren .The invention provides in a further embodiment that the membrane has perforations of <50 micrometers, preferably <5 micrometers. With this, the results described above can be achieved even better. Depending on the pore formation, as already indicated above, two treatment strategies can be seen: fewer and larger perforations per unit area enable the tissue to grow through the membrane according to the invention, so that this membrane can be used as a kind of reinforcement of soft tissue, that, for example, this tissue can be kept away from the surface of a tooth until there is enough slow has always formed growing bone. This "soft tissue reinforcement" by the membrane according to the invention prevents this soft tissue from tearing and thereby supports the desired effect of the regrowth of, for example, bone substance. As stated above, the second effect can be seen in the fact that a large number of microperforations with a small diameter prevent the growth of tissue cells as well as the passage of bacteria, but nevertheless enable the passage of, for example, proteins. With perforations of <1 micrometer, only the body's own juices and blood cells can pass through the membrane.
So sieht die Erfindung auch vor, daß die Membran lediglich von Proteinen, nicht jedoch von Bakterien oder Gewebezellen passierbar ist. Dadurch wird der Aufbau des jeweils gewünschten Materials , insbesondere der zu regenerierenden Gewebe- oder Knochensubstanz, ermöglicht. Bakterien und weiche Gewebezellen müssen nämlich beispielsweise ferngehalten werden, damit sich Knochenmaterial entwickelt. Zur Bildung von Knochenmaterial bedarf es andererseits der Zuführung von Proteinen.The invention also provides that the membrane can only be passed through by proteins, but not by bacteria or tissue cells. This enables the construction of the desired material, in particular the tissue or bone substance to be regenerated. Bacteria and soft tissue cells have to be kept away, for example, so that bone material develops. The formation of bone material, on the other hand, requires the addition of proteins.
Die Erfindung schlägt auch ein Verfahren zur Herstellung einer biokompatiblen Barrieremembran vor. Die Perforationen werden mechanisch und/oder durch gebündelte Lichtenergie, insbesondere Laser und/oder durch chemische Verfahren, insbesondere Ätzen oder dergl . , und/oder durch Beschießen mit Protonen oder anderen Teilchen hergestellt. Hiermit können besonders feine Perforationen von < 5 Mikrometern erzielt werden. So hat sich beispielsweise herausgestellt, daß bei einer Perforation durch Laser-Licht zwar die Größe der einzelnen Perforationen auf der dem Laser zugewandten Bearbeitungsseite zunächst relativ groß ist, der Laser jedoch so genau justiert werden kann, daß auf der dem Laser abgewandten Seite der zu bearbeitenden Membran nur noch eine winzig kleine Öffnung verbleibt, so daß die angestrebten Werte von < 5 Mikrometern pro Perforation auf diese Weise erreichbar sind .The invention also proposes a method for producing a biocompatible barrier membrane. The perforations are made mechanically and / or by bundled light energy, in particular lasers and / or by chemical processes, in particular etching or the like. , and / or produced by bombardment with protons or other particles. This enables particularly fine perforations of <5 micrometers to be achieved. It has been found, for example, that with a perforation by laser light the size of the individual perforations on the processing side facing the laser is initially relatively large, but the laser can be adjusted so precisely that on the side facing away from the laser that is to be processed Membrane only a tiny opening remains, so that the desired values of <5 micrometers per perforation can be achieved in this way.
Die Erfindung ist nachstehend anhand der Zeichnung beispielsweise näher erläutert. Diese zeigt in:The invention is explained below with reference to the drawing, for example. This shows in:
Fig. 1 eine erfindungsgemäße Membran aus Titan, Tantal, Platin, Kobalt oder einer entsprechenden Metalllegierung,1 shows a membrane according to the invention made of titanium, tantalum, platinum, cobalt or a corresponding metal alloy,
Fig. 2 eine erfindungsgemäße biokompatible Barrieremembran in der Anwendungslage.2 shows a biocompatible barrier membrane according to the invention in the application position.
Eine - stark vergrößerte - allgemein mit 1 bezeichnete erfindungsgemäße Membran aus Titan, Tantal, Platin, Kobalt oder einer entsprechenden Metallegierung weist einen Zuschnitt 2 mit Mikroperforationen 3 auf . Diese Mikroperfora- tionen 3 werden erfindungsgemäß mechanisch, und/oder durch gebündelte Lichtenergie, insbesondere Laser, und/oder durch chemische Verfahren, insbesondere Ätzen oder dergl . , und/oder durch Beschießen mit Protonen oder anderen Teilchen hergestellt. Dabei ist es möglich, z.B. wenigstens 100, vorzugsweise jedoch 12.000 Perforationen und mehr pro mm2 auszubilden, so daß die einzelnen Perforationen < 50 Mikrometer, vorzugsweise jedoch < 5 Mikrometer groß sind. Derartige Mikroperforationen 3 bieten den Vorteil, daß sie lediglich von Proteinen 4, nicht jedoch von Bakterien 5 oder Gewebezellen 6 passierbar sind.A - greatly enlarged - generally designated 1 membrane of titanium, tantalum, platinum, cobalt or a corresponding metal alloy has a blank 2 with microperforations 3. According to the invention, these microperforations 3 are generated mechanically and / or by bundled light energy, in particular lasers, and / or by chemical methods, in particular etching or the like. , and / or produced by bombardment with protons or other particles. It is possible, for example, to form at least 100, but preferably 12,000 perforations and more per mm 2 , so that the individual perforations are <50 micrometers, but preferably <5 micrometers. Such micro perforations 3 have the advantage that they can only be passed by proteins 4, but not by bacteria 5 or tissue cells 6.
Bei einer anderen Anwendung wird ein mit einer entsprechenden Membran 2 abgedeckter Defektbereich 7 geschützt, und abzuhebendes Weichgewebe 9 armiert, um ein Zerreißen zu verhindern, so daß sich darunter neues, langsamer wachsendes Knochenmaterial 8 bilden kann. Die Membran 2 bildet so beispielsweise eine Barriere zwischen dem gingivalen Weichgewebe 9 und dem Defektbereich (Hohlraum) 7 über der Wurzeloberfläche 10. Das gingivale Gewebe 9 und das Epithel 11 proliferieren nicht mehr nach apikal, was die Bildung neuen Desmodonts, Zahnzements und Knochengewebes (Alveoleninnen- kortikalis) begünstigt. Auf diese Weise kann ein neues Attachement erreicht werden. Bereits nach kurzer Zeit ist neues Zement bzw. neuer Knochen zu erkennen. Erfahrungsgemäß vergeht nur ein Zeitraum von 2 bis 6 Monaten, bis der Knochenaufbau deutlich verbessert ist. Nach einem Zeitraum von 10 bis 12 Monaten ist der notwendige Knochenaufbau in der Regel vollständig abgeschlossen.In another application, a defect region 7 covered with a corresponding membrane 2 is protected, and soft tissue 9 to be lifted is reinforced in order to prevent tearing, so that new, slower-growing bone material 8 can form underneath. The membrane 2 thus forms, for example, a barrier between the gingival soft tissue 9 and the defect area (cavity) 7 above the root surface 10. The gingival tissue 9 and the epithelium 11 no longer proliferate apically, which leads to the formation of new desmodonts, dental cement and bone tissue (inside the alveoli - cortical). In this way, a new attachment can be achieved. Is after a short time to recognize new cement or new bone. Experience has shown that it only takes a period of 2 to 6 months for the bone structure to improve significantly. After a period of 10 to 12 months, the necessary bone build-up is usually complete.
Vor allem in der Implantologie kann die erfindungsgemäße Membran genutzt werden, um nach dem Aufbau entsprechenden Knochenmaterials eine ausreichende Haltbarkeit für neu eingesetzte Implantate zu erreichen.Above all in implantology, the membrane according to the invention can be used to achieve sufficient durability for newly inserted implants after the corresponding bone material has been built up.
Weitere Ausgestaltungen der Erfindung sind möglich, ohne den Grundgedanken zu verlassen. Wesentlich ist nur, die entsprechenden Flächen 10 bzw. Hohlräume 7 gegen die Anlagerung unerwünschter Gewebestrukturen zu schützen, damit sich dort Zellen selektiv ansiedeln, die beispielsweise Zement und desmodontales Bindegewebe bilden. Dagegen sollen das Epithel 11 und gingivales Bindegewebe 9 ebenso wie Bakterien 5 daran gehindert werden, die zu schützenden Flächen 11 bzw. Bereiche 7 zu besiedeln und dort zu wachsen. Im anderen Fall hat die erfindungsgemäße Membran 2 die Funktion, ggf ein Anwachsen des neuen, weichen Gewebes zu erreichen, um dieses mit den umgebenden Lappen anzuheben, um für das gewünschte Knochengewebe mehr Platz zu schaffen. Natürlich ist die Erfindung nicht auf die dargestellten Ausführungsbeispiele beschränkt. Weitere Ausgestaltungen sind möglich, ohne den Grundgedanken zu verlassen. Further refinements of the invention are possible without leaving the basic idea. It is only essential to protect the corresponding surfaces 10 or cavities 7 against the accumulation of undesired tissue structures, so that cells settle there selectively, which form cement and desmodontal connective tissue, for example. In contrast, the epithelium 11 and gingival connective tissue 9 as well as bacteria 5 are to be prevented from colonizing the areas 11 or regions 7 to be protected and from growing there. In the other case, the membrane 2 according to the invention has the function, if necessary, of growing the new, soft tissue in order to raise it with the surrounding flaps in order to make more space for the desired bone tissue. Of course, the invention is not limited to the exemplary embodiments shown. Further configurations are possible without leaving the basic idea.

Claims

Patentansprüche : Claims:
1. Biokompatible Barrieremembran zur Erhaltung, Verbesserung, Wiederherstellung und Neuschaffung des harten und/oder weichen Gewebes von Teilen des menschlichen oder tierischen Körpers, insbesondere des Mundbereiches, aus Titan, Tantal, Platin, Kobalt und/oder einer Titan-, Tantal-, Platin- oder Kobaltlegierung, dadurch gekennzeichnet, daß die Membran (1) mikroperforiert ist.1. Biocompatible barrier membrane for maintaining, improving, restoring and recreating the hard and / or soft tissue of parts of the human or animal body, in particular the mouth area, made of titanium, tantalum, platinum, cobalt and / or a titanium, tantalum, platinum - or cobalt alloy, characterized in that the membrane (1) is microperforated.
2. Biokompatible Barrieremembran nach Anspruch 1, dadurch gekennzeichnet, daß die Membran (1) aus der biokompatiblen Metallegierung Syntacoben® besteht.2. Biocompatible barrier membrane according to claim 1, characterized in that the membrane (1) consists of the biocompatible metal alloy Syntacoben®.
3. Biokompatible Barrieremembran nach Anspruch 1 oder 2 , dadurch gekennzeichnet, daß die Membran (1) mikroperforiert mit wenigstens 100, vorzugsweise 12.000 und mehr Perforationen (3) pro mm2 ausgebildet ist.3. Biocompatible barrier membrane according to claim 1 or 2, characterized in that the membrane (1) is microperforated with at least 100, preferably 12,000 and more perforations (3) per mm 2 .
4. Biokompatible Barrieremembran nach Anspruch 1 oder einem der folgenden, dadurch gekennzeichnet, daß die Membran (1) Perforationen (3) von < 50 Mikrometern, vorzugsweise < 5 Mikrometern aufweist.4. Biocompatible barrier membrane according to claim 1 or one of the following, characterized in that the membrane (1) perforations (3) of <50 microns, preferably has <5 micrometers.
5. Biokompatible Barrieremembran nach Anspruch 1 oder einem der folgenden, dadurch gekennzeichnet, daß die Membran (1) Perforationen (3) aufweist, die lediglich von Proteinen (4), nicht jedoch von Bakterien (5) oder Gewebezellen (6) passierbar sind.5. Biocompatible barrier membrane according to claim 1 or one of the following, characterized in that the membrane (1) has perforations (3) which are only passable by proteins (4), but not by bacteria (5) or tissue cells (6).
6. Verfahren zur Herstellung einer biokompatiblen Barrieremembran nach Anspruch 1 oder einem der folgenden, dadurch gekennzeichnet, daß die Perforationen (3) mechanisch und/oder durch gebündelte Lichtenergie, insbesondere Laser, und/oder durch chemische Verfahren, insbesondere Ätzen oder dergl . , und/oder durch Beschießen mit Protonen oder anderen Teilchen hergestellt werden. 6. A method for producing a biocompatible barrier membrane according to claim 1 or one of the following, characterized in that the perforations (3) mechanically and / or by bundled light energy, in particular laser, and / or by chemical methods, in particular etching or the like. , and / or by bombardment with protons or other particles.
PCT/EP1998/002955 1997-05-21 1998-05-20 Biocompatible barrier membrane WO1998052489A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19713011C2 (en) * 1997-03-27 1999-10-21 Friadent Gmbh Foil for medical technology
EP2062548B1 (en) * 2000-05-29 2016-05-04 CelGen AG Medicinal membrane for bone regeneration
DE10347232A1 (en) * 2003-10-10 2005-05-12 Bego Semados Gmbh & Co Kg Arrangement for the regression of a periodontosis-related bone defect

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US4219015A (en) * 1977-04-22 1980-08-26 Institut Straumann Ag Plates for osteosynthesis
US4842517A (en) * 1986-12-05 1989-06-27 Haruyuki Kawahara Endosseous implant having mesh pore structure
EP0621018A1 (en) * 1992-04-17 1994-10-26 Kyocera Corporation A prosthesis and a method of making the same
EP0622052A1 (en) 1993-04-28 1994-11-02 Ceka N.V. Method for manufacturing a membrane for controlled bone regeneration
FR2713090A1 (en) 1993-12-03 1995-06-09 Scortecci Gerard Bone tissue regeneration promotion device, esp. for dental surgery
DE19605485A1 (en) 1996-02-14 1997-08-21 Francesco Pedrazzini Use of malleable titanium@ membranes for controlled regeneration

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19713011C2 (en) * 1997-03-27 1999-10-21 Friadent Gmbh Foil for medical technology

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4219015A (en) * 1977-04-22 1980-08-26 Institut Straumann Ag Plates for osteosynthesis
US4842517A (en) * 1986-12-05 1989-06-27 Haruyuki Kawahara Endosseous implant having mesh pore structure
EP0621018A1 (en) * 1992-04-17 1994-10-26 Kyocera Corporation A prosthesis and a method of making the same
EP0622052A1 (en) 1993-04-28 1994-11-02 Ceka N.V. Method for manufacturing a membrane for controlled bone regeneration
FR2713090A1 (en) 1993-12-03 1995-06-09 Scortecci Gerard Bone tissue regeneration promotion device, esp. for dental surgery
DE19605485A1 (en) 1996-02-14 1997-08-21 Francesco Pedrazzini Use of malleable titanium@ membranes for controlled regeneration

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DE19721192A1 (en) 1998-12-03

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