DE1491218C3 - Blood vessel prosthesis and method for making the same - Google Patents

Blood vessel prosthesis and method for making the same

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Publication number
DE1491218C3
DE1491218C3 DE1491218A DE1491218A DE1491218C3 DE 1491218 C3 DE1491218 C3 DE 1491218C3 DE 1491218 A DE1491218 A DE 1491218A DE 1491218 A DE1491218 A DE 1491218A DE 1491218 C3 DE1491218 C3 DE 1491218C3
Authority
DE
Germany
Prior art keywords
blood vessel
prosthesis
collagen
tube
mass
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.)
Expired
Application number
DE1491218A
Other languages
German (de)
Other versions
DE1491218B2 (en
DE1491218A1 (en
Inventor
Miloslav Adam
Milosch Dr. Chvapil
Milan Dr. Krajitschek
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SPOFA SDRUZHENI PODNIKU PRO ZDRAVOTNICKOU VYROBU PRAG
Original Assignee
SPOFA SDRUZHENI PODNIKU PRO ZDRAVOTNICKOU VYROBU PRAG
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Application filed by SPOFA SDRUZHENI PODNIKU PRO ZDRAVOTNICKOU VYROBU PRAG filed Critical SPOFA SDRUZHENI PODNIKU PRO ZDRAVOTNICKOU VYROBU PRAG
Publication of DE1491218A1 publication Critical patent/DE1491218A1/en
Publication of DE1491218B2 publication Critical patent/DE1491218B2/en
Application granted granted Critical
Publication of DE1491218C3 publication Critical patent/DE1491218C3/en
Expired legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L33/00Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/0005Use of materials characterised by their function or physical properties
    • A61L33/0011Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
    • 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
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • 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
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/062Apparatus for the production of blood vessels made from natural tissue or with layers of living cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/22Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24Collagen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/34Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/507Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00365Proteins; Polypeptides; Degradation products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/23Carbohydrates
    • A61L2300/236Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404Biocides, antimicrobial agents, antiseptic agents
    • A61L2300/406Antibiotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/42Anti-thrombotic agents, anticoagulants, anti-platelet agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Materials Engineering (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Laminated Bodies (AREA)
  • Treatments For Attaching Organic Compounds To Fibrous Goods (AREA)

Description

5. Verfahren nach Anspruch 4, dadurch ge- kontrolle bei der Serienproduktion stellen weitere kennzeichnet, daß die zubereitete Kollagen- Nachteile dieser Methode dar.5. The method according to claim 4, thereby providing additional control during series production indicates that the prepared collagen is a disadvantage of this method.

masse bei der Homogenisierung mit Mucopoly- 40 Aufpibe der Erfindung ist demgegenüber die Hersacchariden und/oder mit Glycerin und/oder mit stellung einer Blutgefäßprothese, welche nach außen mindestens einem Antibiotikum vermischt wird. hin hochporös ist und ein Durchwachsen der um-In contrast, the mass in the homogenization with Mucopoly 40 Aufpibe of the invention is the Hersacchariden and / or with glycerine and / or with the position of a blood vessel prosthesis, which to the outside at least one antibiotic is mixed. is highly porous and a growth in the surrounding

6. Verfahren nach Anspruch 4 und 5, dadurch liegenden Blutgefäßzellgewebe relativ rasch gestattet, gekennzeichnet, daß die Kunstfasergeweberöhre welche aber im Inneren so aufgebaut ist, daß an der Kollagenröhre mit Hilfe einer durch Be- 45 Blutungen mit Sicherheit vermieden werden,
spritzen oder Anstreichen aufgetragenen Zwi- Die Erfindung besteht darin, daß der Kunstfaserschenschicht aus nativer Kollagenmasse fixiert gewebeschlauch mit einer Innenschicht aus einer wird. selbsttragenden, an sich bekannten Kollagenmasse
6. The method according to claim 4 and 5, characterized in that lying blood vessel cell tissue is allowed relatively quickly, characterized in that the synthetic fiber tube which, however, is constructed inside so that bleeding can be avoided with certainty on the collagen tube with the aid of a bleeding caused by bleeding,
The invention consists in that the synthetic fiber layer made of native collagen mass is fixed with a fabric tube with an inner layer made of a. self-supporting, known collagen mass

verbunden ist, die durch eine die Resorbierbarkeitis connected by an absorbability

50 modifizierende chemische Härtung unvollständig gehärtet ist und deren Innenfläche mit einem Antikoagulationsmittel behandelt ist. Mit dieser Blutgefäßprothese wurden sehr gute Erfahrungen ge-Die Erfindung betrifft eine Blutgefäßprothese mit macht.50 modifying chemical hardening incompletely hardened and the inner surface of which is treated with an anticoagulant. With this blood vessel prosthesis Very good experiences have been made. The invention relates to a blood vessel prosthesis with power.

einem physiologisch inerten Kunstfasergewebe- 55 Zur Erzielung einer stark verbesserten Haftfähigschlauch, der eine Wandporosität über 2000 ml H2O/ keit der Außensehicht an der Innenschicht ist es cm2min bei einem Innendruck von 120 mm Hg auf- zweckmäßig, wenn die beiden Schichten durch eine weist, sowie ein Verfahren zur Herstellung derselben. native Kollagenmasse miteinander verbunden sind. Bekannt ist es, Fäden, Schläuche und Filme aus Vorteilhaft ist es, wenn die Innenschicht mita physiologically inert synthetic fiber fabric- 55 To achieve a greatly improved adhesive hose, which has a wall porosity of over 2000 ml H 2 O / speed of the outer layer on the inner layer, it is advisable for cm 2 min at an internal pressure of 120 mm Hg for the two layers to pass through one has, and a method for making the same. native collagen masses are linked together. It is known to make threads, tubes and films from it is advantageous if the inner layer with

Dispersionen von tierischen Haut- und Sehnen- 60 Mucopolysacchariden und/oder mit Glycerin und/ Kollagen herzustellen. Hierzu wird nur geringfügig oder mit wenigstens einem Antibiotikum angereichert chemisch vorbehandeltes tierisches Kollagenmaterial ist. Hierdurch werden die Möglichkeiten eines Einzerkleinert und zerfasert und die erhaltene Masse Wachsens der Blutgefäßprothese verbessert,
unter Zusatz von Säuren, alkalisch reagierenden Hergestellt wird die Prothese dadurch, daß man
To produce dispersions of animal skin and tendon mucopolysaccharides and / or with glycerine and / collagen. For this purpose, chemically pretreated animal collagen material is only slightly or enriched with at least one antibiotic. As a result, the possibilities of crushing and fraying are improved and the mass of growth of the blood vessel prosthesis obtained is improved,
with the addition of alkaline acids, the prosthesis is produced by

Mitteln oder Salzen nach Quellung in einem 65 eine in an sich bekannter Weise durch alkalische wässerigen Milieu homogenisiert und dann die ge- Quellung des Rind-Leimgallertgewebes zubereitete quollene Masse unter Umständen mechanisch noch Kollagenmasse desintegriert und homogenisiert und weiter verfeinert, wobei das Material auf verhältnis- die Masse in Form einer selbsttragenden Röhre ge-Agents or salts after swelling in a 65 in a manner known per se by alkaline aqueous medium and then prepared the swelling of the beef glue jelly tissue swollen mass may be mechanically disintegrated and homogenized and collagen mass further refined, the material being proportioned to the mass in the form of a self-supporting tube

staltet, die man sodann mit der hochporösen Kunst- Ausf ührungsbeispielthat you can then use with the highly porous art design example

iasergeweberohre überzieht, worauf man die innere s v iaservergeweberohre covers, whereupon the inner s v

Oberfläche der Kollagenröhre durch Einwirkung Kollagenmasse, zubereitet durch alkalische Quel-Surface of collagen tube by exposure to collagen mass prepared by alkaline source

eines Gerbmittels teilweise härtet und nach Aus- lung des Rind-Leimgallertgewebes, wird desintegriertof a tanning agent partially hardens and after the beef glue gelatin has developed, it is disintegrated

waschen des Gerbmittels mit einem Antikoagulations- s und gründlich homogenisiert (z.B. 24 Stunden langwash the tanning agent with an anticoagulant and thoroughly homogenize (e.g. for 24 hours

mittel präpariert, trocknet und schließlich in einer in einem Homogenisator) und dann 24 Stunden langmedium prepared, dried and finally in one in a homogenizer) and then for 24 hours

luftdichten Hülle sterilisiert in einem Kühlschrank bei 0 bis 4° C sich selbst be-airtight envelope sterilizes itself in a refrigerator at 0 to 4 ° C

Dabei kann es zweckmäßig sein, daß die zu- lassen. Die st* behandelte Kollagenmasse kann manIt can be useful that they allow. The st * treated collagen mass can be

bereitete KoUagenmasse bei der Homogenisierung schon zur Erzeugung von resorbierbaren, selbst-prepared KoUagen mass during the homogenization for the production of resorbable, self-

mit Mucopolysacchariden und/oder mit Glycerin ίο tragenden Röhren, welche als Bestandteil einer kom-with mucopolysaccharides and / or with tubes carrying glycerin ίο, which are part of a com-

und/oder mit mindestens einem Antibiotikum ver- Dinierten hochporösen Blutgefäßprothese dienen,and / or are used with at least one antibiotic, highly porous blood vessel prosthesis,

mischt wird. Hierbei lassen sich die genannten Mittel verwenden,is mixed. The means mentioned can be used here,

am besten in die KoUagenmasse einbringen. Die KoUagenmasse kann man auch gegebenenfallsbest brought into the KoUagen mass. The KoUagenasse can also be used if necessary

Eine besonders feste Verbindung beider Röhren durch Vermischen mit Mucopolysacchariden, z. B. kann man dadurch erzielen, daß man die hoch- 15 vom Typus der Hyaluronsäure (0,5 bis 3,0%), mit poröse Geweberöhre an der KoUagenröhre mit Hilfe Glycerin (0,5 bis 5,0·/·) oder mit Antibiotika, z. B. einer durrh Bespritzen oder Anstreichen auf- mit CmOrtetracyklin (1 bis 5 g/100 g Masse), Neogetragenen Zwischenschicht aus amorpher, nativer, my ei η (0,5 bis 5 g/100 g Masse) oder Bacitracin chemisch nicht modifizierter Kollagenmasse fixiert. (10 000 bis 50 000 E/100 g Masse), anreichern. DieA particularly strong connection between the two tubes by mixing them with mucopolysaccharides, e.g. B. can be achieved that the high-15 of the type of hyaluronic acid (0.5 to 3.0%), with porous tissue tube on the KoUagenröhre with the help of glycerine (0.5 to 5.0 · / ·) or with antibiotics, e.g. B. a durrh spraying or painting with CmOrtetracyklin (1 to 5 g / 100 g mass), neo-worn intermediate layer of amorphous, native, my ei η (0.5 to 5 g / 100 g mass) or bacitracin chemically unmodified collagen mass fixed. (10,000 to 50,000 U / 100 g mass), enrich. the

Die auf vorstehendem Wege hergestellte hoch- ac genannten Komponenten kann man entweder einzeln poröse Blutgefäßprothese läßt sich ohne Gefahr oder in verschiedenen Kombinationen zusetzen,
einer unmittelbaren oder später auftretenden, lang Aus der auf diese Weise aufgearbeiteten Kollagendauernden Blutung durch die Prothesenwand im- masse wird dann in einer mit rotierendem Ziehkopf plantieren. Bei der klinischen Anwendung sind weder versehenen Preßmaschine durch Zusammenspinnen besondere Maßnahmen noch ein spezielles Arbeits- 35 und Verbindung einzelner Fasern eine Röhre mit gcverfahren bei der Operation erforderlich. Aus den wünschtem Durchmesser (z. B. 9 mm) und erforderbisherigen Forschungsergebnissen auf diesem Gebiet licher Wandstärke (z. B. 0,4 bis 0,6 mm) gezogen, geht hervor, daß die hohe Porosität des nicht und zwar unter gleichzeitigem Durchblasen von luft, resorbierbaren Bestandteils der erfindungsgemäßen z. B. unter 40 bis 150 mm Wassersäuledruck. Die Prothesen wesentlich bessere Resultate bei der Blut- 30 fertige Röhre trocknet man dann langsam bei einer gefäßrekonstruktion gewährleistet, als es mit dem Temperatur von 15 bis 25° C in mildem Luftstrom, bisher benutzten Ersatzmaterial .nöglieh war. Nach dem Trocknen überzieht man die Kollagen-
The components mentioned above can be used either individually. Porous blood vessel prosthesis can be added without risk or in various combinations,
an immediately or later occurring, long bleeding through the prosthesis wall that has been processed in this way is then planted in a rotating pulling head. In clinical use, neither a press machine equipped with a spinning technique nor a special work and connection of individual fibers with a tube with gc procedures are required during the operation. From the desired diameter (z. B. 9 mm) and the necessary previous research results in this area Licher wall thickness (z. B. 0.4 to 0.6 mm), it can be seen that the high porosity of the not and that with simultaneous blowing of air, absorbable component of the z. B. under 40 to 150 mm water column pressure. The prosthesis results in significantly better results with the blood-finished tube then slowly dried during a vascular reconstruction than was possible with the temperature of 15 to 25 ° C in a gentle stream of air, previously used replacement material. After drying, the collagen is coated

Das Anbringen der resorbierbaren selbsttragenden röhre mit Hilfe einer speziellen Vorrichtung mit derAttaching the resorbable self-supporting tube with the help of a special device with the

Röhre im Inneren der Kunstfasergeweberöhre läßt Kunstfasergeweberöhre, worauf man sie von innenTube inside the synthetic fiber fabric tube lets synthetic fiber fabric tube, whereupon you can see it from the inside

die Maschen des Gewibes relativ frei, so daß rasches 35 mit einer i°/oigen wässerigen 2,4,6-Trimethoxytriazin-the meshes of the fabric are relatively free, so that a 100% aqueous 2,4,6-trimethoxytriazine

Durchwachsen der umliegenden Blutgefäßzellgewebe lösung, nachher mit überschüssigem destilliertemThe surrounding blood vessel cell tissue solution grows through, afterwards with excess distilled

erfolgen kann, ohne daß ein vorheriger Abbau des Wasser und schließlich mit einer Lösung eines ge-can take place without a previous degradation of the water and finally with a solution of a

resorbierbaren Bestandteils notwendig wäre. Die eigneten Antikoagulationsmittels, z. B. mit einerabsorbable component would be necessary. Suitable anticoagulants, e.g. B. with a

blutgerinnungshemmende Wirksamkeit der inneren l°/oigen wässerigen Heparinlösung, durchwäscht. DieAnticoagulant effectiveness of the inner 10% aqueous heparin solution, washed through. the

Oberfläche verhindert die Bildung von Thromben. 40 Herstellung der Blutgefäßprothese beendigt manSurface prevents the formation of thrombi. 40 Manufacture of the blood vessel prosthesis is terminated

Ein weiterer Vorteil liegt darin, daß man die durch Trocknen unter bereits erwähnten Bedingun-Another advantage is that the drying under the aforementioned conditions

biologischen Eigenschaften des Materials zur Her- gen. Durch Luftüberdruck in der inneren Röhrebiological properties of the material used to produce it. By means of excess air pressure in the inner tube

stellung von Blutgefäßprothesen gemäß der Erfin- während des Trocknens wird eine feste VerbindungPosition of blood vessel prostheses according to the invention while drying becomes a solid connection

dung dank großer chemischer Reaktivität der beider Schichten erzielt Diese Verbindung kannThis connection can be achieved thanks to the great chemical reactivity of the two layers

KoUagenmasse je nach Bedarf neuen Forschungs- 45 man auch so verfestigen, daß uan zwischen beideDepending on the need for new research, the coagulation mass can also be solidified in such a way that there is between the two

ergebnissen anpassen kann. Das ist besonders für Schichten eine dünne Zwischenschicht aus amorpher,can adjust results. This is especially for layers a thin intermediate layer of amorphous,

das Einwachsen des nicht resorbierbaren Bestandteils nativer, chemisch nicht modifizierter KoUagenmassethe ingrowth of the non-resorbable component of native, chemically unmodified KoUagen mass

und für die Neubildung der Blutgefäßwand wichtig. aufträgt.and important for the formation of new blood vessel walls. applies.

Durch chemische Härtung der KoUagenröhre läßt Die fertige Blutgefäßprothese wird dann in einenBy chemical hardening of the KoUagenröhre the finished blood vessel prosthesis is then in a

sich auch ihre Resorptionsdauer beeinflussen und 50 luftdichten Umschlag, z. B. in eine Glasampulle,also affect their resorption time and 50 airtight envelope, z. B. in a glass ampoule,

standardisieren, so daß eine vorzeitige Resorption eingeschlossen und mit Gamma-Strahlung (z. B. instandardize so that premature absorption is included and treated with gamma radiation (e.g. in

dieser Röhre vermieden werden kann. einer Gabe von 2.10« r 5 Stunden lang) sterilisiert.this tube can be avoided. a dose of 2.10 «r for 5 hours).

Claims (4)

1 " 2 mäßig niedrigen Temperaturen gehalten wird. Patentansprüche: Schließlich wird die entstandene Dispersion zu ver schiedenen Gebilden verformt. Die erhaltenen End-1 "2 is kept at moderately low temperatures. Claims: Finally, the resulting dispersion is shaped into various structures. 1. Blutgefäßprothese nut einem physiologisch produkte haben sich in der Chirurgie in Form von inerten Kunstfasergewebeschlauch, der eine 5 Schläuchen oder Röhren als Gefäßersatz nicht be-Wandporosität über 2000 ml HgO/cnAviin bei währt. Die hergestellten Röhren sind sehr druckeinem Innendruck von 120 mm Hg aufweist, da- anfällig, weich und bergen die Gefahr einer Blutung durch gekennzeichnet, daß der Kunst- in sich, die geraume Zeit nach der Implantierung der fasergewebeschlauch mit einer Innenschiebt aus Röhre auftritt Aus diesem Grunde haben sich dereiner selbsttragenden, an sich bekannten Kollagen- ίο artige Röhren nicht in der Chirurgie mit Erfolg einmasse verbunden ist, die durch eine die Re- führen lassen.1. Blood vessel prosthesis is a physiological product that has been used in surgery in the form of Inert synthetic fiber hose, which does not contain 5 hoses or tubes as a vascular substitute - wall porosity over 2000 ml HgO / cnAviin lasts. The tubes produced are very pressurized Internal pressure of 120 mm Hg, they are susceptible, soft and harbor the risk of bleeding characterized by that the art in itself, the considerable time after the implantation of the Fiber fabric tube with an inner slide out of the tube occurs For this reason, the one Self-supporting, well-known collagen-like tubes are not used successfully in surgery is connected, who let the re-lead by one. sorbierbarkeit modifizierende chemische Härtung In der klinischen Praxis der BlutgefäßchirurgieSorbability-modifying chemical hardening In the clinical practice of blood vessel surgery unvollständig gehärtet ist und deren Innenfläche werden vielmehr zum Ersetzen von resezierten Blutmit einem Antikoagulationsmittel behandelt ist. gefäßen Prothesen, welche aus verschiedenen,is incompletely hardened and its inner surface is rather used to replace resected blood with treated with an anticoagulant. vascular prostheses, which are made of different, 2. Piothese nach Anspruch 1, dadurch gekenn- 15 physiologisch inerten Kunstfasergeweben (PolytetrazeicVmet, daß die beiden Schichten durch eine fluoräthylen, Polyäthylenterephthalat u. dgl.) hernative Kollagenmasse miteinander verbunden gestellt sind, verwendet. Die WandpoTosität solcher sind. Prothesen beträgt etwa 1500 bis 2000 ml H2O/cm*min2. Piothesis according to claim 1, characterized in that 15 physiologically inert synthetic fiber fabrics (PolytetrazeicVmet that the two layers are connected to each other by a fluoroethylene, polyethylene terephthalate and the like) hernative collagen mass are used. The wall poses are such. Prosthesis is around 1500 to 2000 ml H 2 O / cm * min 3. Prothese nach Anspruch 1, dadurch gekenn- bei einem Druck von 120 mm Hg. Die Konstruktion zeichnet, daß d:e Innenschicht mit Mucopoly- ao von Blutgefäßprothesen mit höherer Wandporosit;<t sacchariden und/oder mit Glycerin und'oder mit (5000 bis 10 000 ml HäO/cm-min), weiche gemäß wenigstens einem Antibiotikum angerc -hert ist. Forschungsergebnissen für das weitere Schicksal Jes. 3. A prosthesis according to claim 1, characterized marked at a pressure of 120 mm Hg, the construction is characterized in that d e inner layer with Mucopoly- ao of blood vessel prostheses with higher Wandporosit <t saccharides and / or with glycerol und'oder with ( 5000-10000 ml H ä O / cm-min), soft according to at least one antibiotic is -hert angerc. Research results for the further fate of Isa 4. Verfahren zur Herstellung von Blutgefäß- implantierten Blutgefäßersatzes von Grundbedeutung prothesen nach Anspruch 1 bis 3, dadurch ge- ist, wird durch Kombination eines resorbierbaren kennzeichnet, daß eine in ar. sich bekannter as Materials mit einer dünnen Gewebeprothese gelöst Weise durch alkalische Quellung des Rind-Leim- Das resorbierbare Material hat nämlich die Aufgabe gallertgewebes zubereitete Kollagenmasse des- während des Heilprozesses die Bli'tung durch die integriert und homogenisiert und die Masse in Maschen des Kunstfasergewebes zu verhindern.
Form einer selbsttragenden Röhre gestaltet wird. Als resorierbares Material wurden bisher Catgutdit sodann mit der hochporösen» Kunstfaser- 30 fasern, gegebenenfalls mit Kunstfasern zusammen geweberöhre überzogen wird, worauf die innere gewirkt oder -gewebt, amorphe Gelatine oder auch Oberfläche der Kollagenröhre durch Einwirkung Kollagenfilm, der in Form einer Röhre zusammeneines Gerbmittels teilweise gehärtet und nach genäht ist, benutzt. Die experimentelle Erprobung Auswaschen des Gerbmittels mit einem Anti- solcher Prothese war im wesentlichen erfolglos, da koagulationsmittel präpariert, getrocknet und 35 die Versuchstiere größtenteils (über 500O) ausschließlich in einer luftdichten Hülle sterilisiert geblutet waren. Ein kompliziertes Herstellungswird. verfahren und die Unmöglichkeit der Qualitäts-
4. A method for the production of blood vessel-implanted blood vessel replacement of basic meaning prostheses according to claim 1 to 3, characterized in that it is characterized by a combination of a resorbable one in ar. known as material is solved with a thin tissue prosthesis way by alkaline swelling of the beef glue - the resorbable material has the task of gelatinous tissue prepared collagen mass of the - during the healing process the blooming is integrated and homogenized and the mass in meshes of the synthetic fiber tissue impede.
Shape of a self-supporting tube is designed. As a resorbable material, catgutdit has hitherto been covered with the highly porous synthetic fiber, if necessary with synthetic fibers, on which the inner knitted or woven, amorphous gelatin or the surface of the collagen tube through the action of a collagen film, which is in the form of a tube together with a tanning agent partially hardened and after being sewn, used. The experimental trial washout of the tanning agent with an anti such prosthesis was substantially unsuccessful since coagulant prepared, dried and 35, the test animals were bled mostly sterilized (over 50 0 O) exclusively in an air-tight envelope. A complicated manufacturing process becomes. procedure and the impossibility of quality
DE1491218A 1963-06-15 1963-12-12 Blood vessel prosthesis and method for making the same Expired DE1491218C3 (en)

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GB1018288A (en) 1966-01-26
DE1491218B2 (en) 1972-06-08
US3425418A (en) 1969-02-04
DE1491218A1 (en) 1969-04-03
BR6355428D0 (en) 1973-07-19
CH472219A (en) 1969-05-15
BE649183A (en) 1964-10-01

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