DE1617330B1 - Process for the production of tubular and smooth prostheses from biological tissue - Google Patents

Process for the production of tubular and smooth prostheses from biological tissue

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Publication number
DE1617330B1
DE1617330B1 DE1966B0089013 DEB0089013A DE1617330B1 DE 1617330 B1 DE1617330 B1 DE 1617330B1 DE 1966B0089013 DE1966B0089013 DE 1966B0089013 DE B0089013 A DEB0089013 A DE B0089013A DE 1617330 B1 DE1617330 B1 DE 1617330B1
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Germany
Prior art keywords
tissue
layers
thread
layer
prostheses
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Pending
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DE1966B0089013
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German (de)
Inventor
Bernd Dipl-Chem Dr Med Braun
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B Braun International GmbH
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B Braun International GmbH
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Publication date
Application filed by B Braun International GmbH filed Critical B Braun International GmbH
Publication of DE1617330B1 publication Critical patent/DE1617330B1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3629—Intestinal tissue, e.g. small intestinal submucosa
    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1348—Cellular material derived from plant or animal source [e.g., wood, cotton, wool, leather, etc.]

Landscapes

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

Description

1 21 2

Die Erfindung betrifft ein Verfahren zur Herstellung Bei der Durchführung des erfindungsgemäßen Ver-The invention relates to a method for the production. When carrying out the inventive method

von röhrenförmigen und glatten Prothesen aus biolo- fahrens kann beispielsweise ein röhrenförmiger KernTubular and smooth prostheses from biolofahrens can, for example, be a tubular core

gischem Gewebe, das dadurch gekennzeichnet ist, daß oder eine Platte aus Glas oder Kunststoff als festeChemical fabric, which is characterized in that or a plate made of glass or plastic as a solid

man auf eine feste Unterlage ein erstes Stück Gewebe- Unteilage verwendet werden. Diese Unterlage wirda first piece of fabric support can be used on a firm surface. This document will

schlauch oder -schicht aufbringt, diese Schicht mit 5 vorher zweckmäßig mit einem Gleitmittel, z. B.hose or layer applies, this layer with 5 beforehand appropriately with a lubricant such. B.

einer Bindemittelpaste bestreicht oder oberflächlich Glyzerin oder Siliconöl, behandelt. Sodann bringt mancoated with a binder paste or treated with glycerine or silicone oil on the surface. Then one brings

quillt, auf diese Schicht ein zweites Stück Gewebe und ein gut gereinigtes und gegebenenfalls mit Wasser-swells, on this layer a second piece of tissue and a well-cleaned and if necessary with water

bis zur gewünschten Wandstärke in der gleichen Weise stoffsuperoxyd gebleichtes, schlauchförmiges oderup to the desired wall thickness in the same way fabric superoxide bleached, tubular or

weitere Gewebeschichten aufbringt, die mehrschichtige glattes Stück biologisches Gewebe, z. B. Submucosa-applies further layers of tissue, the multilayered smooth piece of biological tissue, e.g. B. Submucosal

Prothese sodann trocknet und von der Unterlage io oder Serosagewebe auf die Unterlage. Darauf bestreichtProsthesis then dries and from the pad io or serosa tissue to the pad. Smeared on it

entfernt. man die Gewebeschicht mit einer Bindemittelpaste,removed. the fabric layer with a binder paste,

Die erfindungsgemäß herstellbaren Prothesenkönnen vorzugsweise aus Kollagenfasern, und läßt dieseThe prostheses that can be produced according to the invention can preferably be made from collagen fibers, and leave these

z. B. als Gefäß-, Oesophagus-, Bronchus-, Darm-, Harn- gegebenenfalls leicht antrocknen. Auf die Pastez. B. as vascular, esophageal, bronchial, intestinal, urinary if necessary slightly dry. On the paste

leiter- und Herzklappenprothesen eingesetzt weiden. bringt man sodann ein weiteres Stück Gewebe undLadder and heart valve prostheses are used. then bring another piece of tissue and

In der Gefäß- und Herzchirurgie werden seit 15 wiederholt diese Arbeitsweise beliebig oft, bis die eimgen Jahren aus Polytetrafluoräthylen- oder Poly- gewünschte Wandstärke erreicht ist. Die fertige Proesterfäden gewebte, gestrickte oder nach deinem Web- these kann z. B. etwa acht Gewebeschichten enthalten. Strick-Verfahren hergestellte Schläuche und Gewebe Um eine zu frühe Resorption der erfindungsgemäß als Ersatz für erkrankte Blutgefäße bzw. Herzteile herstellbaren Implantate im Körper zu verhindern, verwendet. Die klinischen Ergebnisse mit diesen 20 kann man sie einer Gerbung unterziehen. Als Gerb-Prothesen waren zwar anfänglich befriedigend und mittel können sowohl pflanzliche als auch synthetische, vielversprechend, verschlechterten sich, jedoch nach physiologisch unbedenkliche Gerbmittel, wie beispielslängeren Zeiten (vgl. Materia Medica Nordmark, 16 weise Formaldehyd, zur Anwendung kommen. Je nach [1964], S. 245, sowie »Der Internist«, 6 [1965], H. 5, der Konzentration des Geibmittels kann man jeden S. 216). Ein weiterer Nachteil bestand z. B. darin, 25 gewünschten Resorptionsgrad erzielen,
daß die Kunststoffgewebe nicht gut in das natürliche Die Gerbung wird vorzugsweise durchgeführt, nachGewebe einwachsen. Um diesen Nachteil auszu- dem die letzte Gewebeschicht aufgebracht wurde. Man schalten, hat man zwar versucht, die Kunststoff- . kann aber auch die einzelnen Gewebeschichten gerben, gewebe lockerer zu gestalten; dadurch wurden jedoch bevor sie aufgebracht werden. Bei dieser Arbeitsweise andere Eigenschaften der Prothesen, z. B. die Festig- 30 kann man die einzelnen Gewebeschichten unterschiedkeit, beeinträchtigt. Ein weiterer Nachteil bestand Hch stark gerben und dadurch eine unterschiedliche darin, daß die Kunststoffgewebe nahttechnische Resorbierbarkeit der einzelnen Schichten erreichen. Schwierigkeiten boten, da sie leicht ausrissen und die So kann man bei Verwendung eines röhrenförmigen Löcher sich nicht wieder schlossen. Kerns als Unterlage die untersten GewebeschichtenIn vascular and cardiac surgery, this method of operation has been repeated as often as required for the last 15 years until the wall thickness required for polytetrafluoroethylene or poly is reached. The finished Proesterfäden woven, knitted or according to your woven thesis can z. B. contain about eight layers of tissue. Hoses and fabrics produced by knitting process To prevent premature absorption of the implants which can be produced according to the invention as a replacement for diseased blood vessels or heart parts in the body, used. The clinical results obtained with these 20 can be tanned. Both herbal and synthetic tanning prostheses were initially satisfactory and medium, but they worsened, but after physiologically harmless tanning agents, such as for example longer periods of time (cf. Materia Medica Nordmark, 16 weise formaldehyde), they can be used. Depending on [1964 ], P. 245, as well as "Der Internist", 6 [1965], no. 5, the concentration of the gelling agent can be found on p. 216). Another disadvantage was z. B. in achieving 25 desired degree of absorption,
The tanning is preferably carried out after the fabric has grown into it. To avoid this disadvantage the last layer of fabric was applied. You switch, you tried the plastic. but can also tan the individual layers of tissue to make the tissue looser; however, this was done before they were applied. In this way of working, other properties of the prosthesis, e.g. B. the strength 30 can be the individual tissue layers difference, impaired. Another disadvantage was that the individual layers were highly tanned and therefore a different one in that the synthetic fabrics were capable of being absorbed by the seams. Difficulties presented because they tore out easily and the use of a tubular hole cannot be closed again. Core as a base the lowest layers of fabric

Die vorstehenden Nachteile werden erfindungs- 35 stärker gerben, um einen resistenten Kern zu erhalten,The above disadvantages are tanned more strongly according to the invention in order to obtain a resistant core,

gemäß dadurch vermieden, daß man an Stelle von und die äußeren Gewebeschichten nur leicht gerben,accordingly avoided by only slightly tanning the outer fabric layers instead of and,

Kunststoffgeweben biologische Gewebe einsetzt. um eine bestimmte Resorbierbarkeit dieser SchichtenSynthetic tissue uses biological tissue. a certain resorbability of these layers

Nach dem erfindungsgemäßen Verfahren eignet sich zu erreichen.The method according to the invention is suitable to achieve.

für die Herstellung derartiger Prothesen besonders Nach Entfernung der Unterlage und gegebenenfallsfor the production of such prostheses, especially after removing the support and if necessary

die Submucosa, die man in reiner Form aus dem 40 nach Aufschneiden des Schlauches erhält man Fascien-the submucosa, which is obtained in pure form from the 40 after cutting the tube, one obtains fascia

Dünndarm von Schafen, Ziegen und anderen Tieren prothesen, die als sogenannte »Patches« zum Vei-Small intestines of sheep, goats and other animals prostheses, which are used as so-called "patches" for feeding

gewinnen kann, sowie das sogenannte »Goldschläger- schließen von Trommelfell-, Herwanddefekten, Hohl-can win, as well as the so-called »Goldschläger- closing of eardrum, heart wall defects, hollow

häutchen«, das aus der Serosa von Rinderdärmen wandorganen oder als Herzklappen dienen können,skin «, which from the serosa of beef intestines can serve as wall organs or as heart valves,

besteht. Die Submucosa, die als feiner Widerstands- Durch Zuschneiden der Folien sind aus dem gleichenconsists. The submucosa, which acts as a finer resistance, by cutting the foils are made of the same

fähiger Schlauch gewonnen wird, weist eine diagonale 45 Material auch Bänder für chirurgische Zwecke, z, B.able tubing is obtained, has a diagonal 45 material also tapes for surgical purposes, e.g.

Kollagenfaserstruktur auf. Die noch anhaftenden zum Aufhängen von Wandernieren und bei der Opera-Collagen fiber structure. Those that are still sticking for hanging up hiking kidneys and during surgery

Mucosa- und Muscularis-Anteile können wie bei der tion der Incontinentia vesicae, herstellbar.Mucosa and muscularis parts can be produced as in the case of the incontinentia vesicae.

Katgutherstellung leicht entfernt werden. Außer Folien und Bändern können nach dem erfin-Catgut can be easily removed. In addition to foils and tapes, according to the invention

Da eine einzelne Submucosaschicht eine viel zu dungsgemäßen Verfahren auch röhrenförmige, glatteSince a single submucosal layer is a much too appropriate method, it is also tubular, smooth

geringe Festigkeit aufweist — sie ist etwa 15 μ dick —, 50 oder geriffelte Prothesen hergestellt werden. Diesehas low strength - it is about 15 μ thick - 50 or corrugated prostheses can be produced. These

hat es sich als zweckmäßig erwiesen, mehrere Gewebe- röhrenförmigen Prothesen können von gleichmäßigemit has proven to be useful, several tissue-tubular prostheses can be of uniform

schichten mit HiKe eines Bindemittels, z. B. von Durchmesser sein oder sich konisch erweitern oderlayers with HiKe of a binder, e.g. B. be of diameter or widen conically or

Kollagenfaserbrei, zu verbinden. Der Kollagenfaser- verjüngen.Collagen pulp, to connect. The collagen fiber rejuvenate.

brei kann beispielsweise nach der deutschen Patent- Die F i g. 1 und 2 erläutern die Herstellung von schrift 659 490 hergestellt werden. Durch diese 55 röhrenförmigen, formbeständigen, nicht abknickbaren Kollagenfaserschicht erreicht man außerdem, daß Gefäßprothesen mit Schraubenprofil,
irgendwelche Löcher, Risse u. dgl. der Gewebeschicht, Ein Kunststoffrohr a, beispielsweise aus Polyäthylen die bei der Herstellung, im Verlauf der Operation oder Polypropylen, das mit einem Gewinde b versehen oder später eintreten können, sich leicht wieder ist, wird gründlich gereinigt und gegebenenfalls mit schließen können. Dadurch können Blutungen, die 60 Siliconöl behandelt. Anschließend zieht man einen gut bisher äußerst gefährlich waren, vermieden werden. Ein gereinigten und gegebenenfallsmit Wasserstoff superweiterer Vorteil des Kollagenfaserbreies besteht darin, oxyd gebleichten Gewebeschlauch, vorzugsweise aus daß man diesem Bindemittel therapeutische Zusätze Submucosa, über das Polyäthylenrohr, läßt ihn zufügen kann. So kann man dem Faserbrei z. B. gegebenenfalls leicht antrocknen und umwickelt ihn Heparin zusetzen, um die Blutgerinnung zu hemmen, 65 mit einem Kunststoffaden jeweils in den Vertiefungen oder Knorpelpulver bzw. Chondroitinsulfat, um die des Gewindes und trocknet ihn. Danach kann man den Bildung neuer Kollagenfasern für die Gefäßintima Faden wieder abwickeln, und die Submucosa c ist anzuregen, sowie andere Substanzen mehr. somit schraubenförmig gestaltet und kalibriert. Als-porridge can, for example, according to the German patent Die F i g. 1 and 2 explain the production of font 659 490. This 55 tubular, dimensionally stable, non-kinkable collagen fiber layer also ensures that vascular prostheses with a screw profile,
any holes, tears and the like in the fabric layer, a plastic tube a, for example made of polyethylene which is easy to recover during manufacture, during the operation or polypropylene, which is provided with a thread b or can later enter, is thoroughly cleaned and can close with if necessary. This can prevent bleeding, which 60 silicone oil treats. Then one pulls a well so far extremely dangerous were to be avoided. Another advantage of the collagen fiber pulp, which has been purified and, if necessary, supplemented with hydrogen, is that it can be oxide-bleached fabric tube, preferably from the fact that therapeutic additives submucosa can be added to this binding agent via the polyethylene tube. So you can z. B. if necessary, slightly dry it and wrap it with heparin to inhibit blood clotting, 65 with a plastic thread in each of the depressions or cartilage powder or chondroitin sulfate around that of the thread and dry it. Then you can unwind the formation of new collagen fibers for the vascular intima thread again, and the submucosa c is to be stimulated, as well as other substances. thus designed and calibrated helically. As-

dann bestreicht man das Gewebe mit einer Bindemittelpaste, vorzugsweise aus Kollagenfasern, laß diese leicht antrocknen und zieht einen weiteren Gewebeschlauch darüber, bei dem man die Umwicklung und Trocknung in gleicher Weise wie vorstehend beschrieben vornimmt. Diese Arbeitsweise kann beliebig oft wiederholt werden, bis die gewünschte Wandstärke erreicht ist. Die mehrfachen Gewebeschlauchschichten d werden dabei durch das Bindemittel fest miteinander verklebt. Um dann den aus diesen Gewebeschichten gebildeten Schlauch von seinem Kunststoffkern zu befreien, kann man durch das Innere des Kunststoffrohres einen warmen Luftstrom leiten, der das Kunststoffrohr etwas plastisch werden läßt, kann sodann an beiden Enden des Kunststoffrohres ziehen, bis es sich streckt, am Anfang des Gewindes einreißt und sich dann als plastischer Faden e aus dem Submucosaschlauch herausziehen läßt, ohne daß letzterer haften bleibt oder verletzt wird. Je nach der Steigung des Gewindes, Tiefe des Gewindeganges und Anzahl der Windungen kann man den unterschiedlichen Verwendungszwecken angepaßte Prothesen erhalten.then the fabric is coated with a binder paste, preferably made of collagen fibers, allowed to dry slightly and another fabric tube is pulled over it, in which the wrapping and drying are carried out in the same way as described above. This procedure can be repeated as often as required until the desired wall thickness is reached. The multiple fabric hose layers d are firmly glued to one another by the binding agent. In order to free the tube formed from these layers of fabric from its plastic core, you can pass a stream of warm air through the inside of the plastic tube, which makes the plastic tube a little plastic, then pull on both ends of the plastic tube until it stretches, at the beginning of the thread tears and can then be pulled out of the submucosal tube as a plastic thread e without the latter sticking or being injured. Depending on the pitch of the thread, the depth of the thread and the number of turns, prostheses adapted to the different purposes can be obtained.

Der so hergestellte schraubenartige Gewebeschlauch entspricht den an die gewünschte Gefäßprothese gestellten Anforderungen betreffs Festigkeit, Dichte, Elastizität, Vernähbarkeit und Stichfestigkeit. Durch seine Schraubengänge wird verhindert, daß der Schlauch bei Bewegung nach der Implantation im Körper abknickt und den Blutstrom behindert. Andererseits ist er in seiner Länge dehnbar.The screw-like fabric tube produced in this way corresponds to that of the desired vascular prosthesis requirements regarding strength, density, elasticity, sewability and puncture resistance. By its screw threads prevent the tube from moving in the Body kinks and obstructs blood flow. On the other hand, it is stretchable in its length.

Will man dahingegen glatte röhrenförmige Prothesen ohne jede Riffelung herstellen, wie sie z. B. als Ersatz für Gallengänge, Harnleiter oder Speiseröhren infrage kommen, so kann man das gleiche Verfahren mit den schraubenförmigen Kunststoffrohren anwenden, das Gewebe darf dann jedoch nicht mit einem Faden umwickelt und dem schraubenförmigen Gewinde entsprechend geformt werden, sondern man zieht den elastischen Gewebeschlauch über das Kunststoffrohr und bindet ihn an beiden Enden gestrafft fest ab, so daß er sich dem äußeren Umfang des Kunststoffrohres voll angleicht, ohne den Riffelungen zu entsprechen.If, on the other hand, you want to produce smooth tubular prostheses without any corrugation, as z. B. as a replacement for bile ducts, ureters or esophagus come into question, so one can do the same procedure with the Use helical plastic pipes, but then do not allow the fabric to be tied with a thread wrapped around and corresponding to the helical thread be shaped, but one pulls the elastic fabric hose over the plastic tube and binds it tightly at both ends so that it fits the outer circumference of the plastic pipe fully aligns without conforming to the corrugations.

Auf die beschriebene Weise können z. B. Prothesen für die Speiseröhre, Luftröhre sowie Darm unter Berücksichtigung der entsprechenden anatomischen Anforderungen, des Durchmessers und der Wandstärke hergestellt werden. Um bei diesen Prothesen die Festigkeit noch wesentlich zu verbessern, kann man zwischen die einzelnen Schichten noch synthetische oder natürliche Gewebeschichten einarbeiten. Als Kunststoffgewebe kommen z. B. Gewebe aus Polyamid- oder Polyesterfasern in Frage. Als natürliche Gewebeschichten können z. B. biologische Gewebe wie Serosagewebe oder natürliche Fasergewebe eingesetzt werden. Die Serosagewebe können einmal von links nach rechts diagonal und beim nächsten Mal von rechts nach links diagonal gewickelt werden. Diese Gewebeschichten können gegebenenfalls vorbehandelt, z. B. gereckt werden.In the manner described, for. B. Prostheses for the esophagus, trachea and intestines under Consideration of the corresponding anatomical requirements, the diameter and the wall thickness getting produced. In order to significantly improve the strength of these prostheses, you can choose between work in the individual layers with synthetic or natural layers of fabric. As a synthetic fabric come z. B. fabrics made of polyamide or polyester fibers in question. As natural layers of tissue can e.g. B. biological tissue such as serosa tissue or natural fiber tissue can be used. The serosa tissues can be diagonal from left to right once and from right to left the next time be wound diagonally. These fabric layers can optionally be pretreated, e.g. B. stretched will.

Es besteht auch die Möglichkeit, die Verklebung der Gewebeschichten dadurch zu erzielen, daß man •die Schläuche oder die glatten Gewebestücke in einem sauren oder alkalischen Medium zur Aufquellung bringt. Dabei werden die oberen Schichten der Kollagenfasern leicht anhydrolysiert bzw. in ein Tropokollagen übergeführt, das beim Antrocknen auch leimähnliche Klebeeffekte zeigt. Hierbei tritt bei der nativen Beschaffenheit der Kollagenfaser betreffs ihrer physikalischen Eigenschaften eine negative Beeinflussung ein und es ist eine nachträgliche Neutralisation und eine Auswaschung der bei der Neutralisation gebildeten Salze notwendig.There is also the possibility of gluing the fabric layers to achieve that one • the tubes or the smooth pieces of fabric in one acidic or alkaline medium to swell. This is where the top layers of collagen fibers become slightly partially hydrolyzed or converted into a tropocollagen, which also resembles glue when it dries Shows glue effects. This occurs when the natural constitution of the collagen fiber is concerned with regard to its physical Properties a negative influence and there is a subsequent neutralization and a It is necessary to wash out the salts formed during neutralization.

Die Sterilisation der so hergestellten Prothesen kann durch y-Bestrahlung vorgenommen werden, die neben dem sterilisierenden Effekt noch den Vorteil hat, daß sie die antigenen Eigenschaften des Kollagens herabsetzt.The prostheses produced in this way can be sterilized by γ-irradiation, which in addition to the sterilizing effect, it also has the advantage that it retains the antigenic properties of collagen degrades.

Claims (9)

Patentansprüche:Patent claims: 1. Verfahren zur Herstellung von röhrenförmigen und glatten Prothesen aus biologischem Gewebe, dadurch gekennzeichnet, daß man auf eine feste Unterlage ein erstes Stück Gewebeschlauch oder -schicht aufbringt, diese Schicht mit einer Bindemittelpaste bestreicht oder oberflächlich quillt, auf diese Schicht ein zweites Stück Gewebe und bis zur gewünschten Wandstärke in der gleichen Weise weitere Gewebeschichten aufbringt, die mehrschichtige Prothese sodann trocknet und von der Unterlage entfernt.1. Process for the production of tubular and smooth prostheses from biological tissue, characterized in that a first piece of fabric tube is placed on a solid base or layer applies, this layer is coated with a binder paste or superficially swells, on this layer a second piece of tissue and up to the desired wall thickness in the same Way, further layers of tissue are applied, the multi-layer prosthesis is then dried and removed removed from the pad. 2. Verfahren nach Anspruch 1, dadurch gekennzeichnet, daß die Wandung der Prothese aus Submucosagewebe besteht und durch Einarbeiten einer oder mehrerer Serosabandschichten oder Schichten aus synthetischem oder natürlichem Gewebe verstärkt wird.2. The method according to claim 1, characterized in that that the wall of the prosthesis consists of submucosal tissue and by incorporating a or multiple layers of serosa tape or layers of synthetic or natural tissue are reinforced will. 3. Verfahren nach Anspruch 1 und 2, dadurch gekennzeichnet, daß man als Unterlage einen röhrenförmigen Kern oder eine Platte verwendet.3. The method according to claim 1 and 2, characterized in that one is used as a base tubular core or plate used. 4. Verfahren nach Anspruch 1 und 2, dadurch gekennzeichnet, daß man als Unterlage einen mit Gewinde versehenen Kern und als Gewebeschichten Submucosaschläuche verwendet, um jeden Submucosaschlauch im halbtrockenen Zustand einen Faden wickelt und den Faden nach Trocknung entfernt.4. The method according to claim 1 and 2, characterized in that there is one with as a base Threaded core and submucosal tubes used as layers of tissue around each submucosal tube wind a thread in the semi-dry state and remove the thread after drying. 5. Verfahren nach Anspruch 1, 2 und 4, dadurch gekennzeichnet, daß man als mit Gewinde versehenen Kern ein Polyäthylenrohr verwendet, in den ein Gewinde so eingefräst worden ist, daß sich das Polyäthylenrohr leicht fadenförmig auftrennen, und entfernen läßt.5. The method according to claim 1, 2 and 4, characterized characterized in that a polyethylene tube is used as the threaded core, in a thread has been milled in such a way that the polyethylene pipe can be easily separated in the form of a thread, and can be removed. 6. Verfahren nach Anspruch 1 bis 3, dadurch gekennzeichnet, daß die Prothese nach ihrer Herstellung gegerbt wird.6. The method according to claim 1 to 3, characterized in that the prosthesis after its manufacture is tanned. 7. Verfahren nach Anspruch 1 bis 3, dadurch gekennzeichnet, daß die einzelnen Gewebeschichten vor dem Aufbringen gegerbt werden.7. The method according to claim 1 to 3, characterized in that the individual fabric layers be tanned before application. 8. Verfahren nach Anspruch 1 bis 7, dadurch gekennzeichnet, daß man dem Bindemittel Therapeutica-Zusätze hinzufügt.8. The method according to claim 1 to 7, characterized in that the binder Therapeutica additives adds. 9. Verfahren nach Anspruch 1 bis 8, dadurch gekennzeichnet, daß man als Bindemittel Kollagenfaserbrei verwendet.9. The method according to claim 1 to 8, characterized in that the binder is collagen fiber pulp used. Hierzu 1 Blatt Zeichnungen1 sheet of drawings
DE1966B0089013 1966-08-22 1966-09-20 Process for the production of tubular and smooth prostheses from biological tissue Pending DE1617330B1 (en)

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GB1195992A (en) 1970-06-24
AT261800B (en) 1968-05-10
US3562820A (en) 1971-02-16

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