DE1491218A1 - Highly porous collagen tissue blood vessel prosthesis and method for producing the same - Google Patents

Description

Patent attorney Dipl.-Ing. A. SPRp ER Göttingen, Groner Str. 37 Fernruf 59923 · Postal checking account: KSIn 86838 · Bank account: Kreissparkasse GöHingen 5254 Private: KJeperweg 6 ■ Telephone 59923 1 A 9 1 2 1 8

I - '-'; ι; pötti.-igen, 9.12.1963

My files »9566 s /

'SPO? A, Sji3? U2fenf podniKu pro zdravotniGkoUjTyrobu, Praiia (0S3R)

High-porous Kollajjen tissue blood-catching protneae and Verfauron to -rierotstellung the same.

The experience concerns a high porous collagen-Gevvebe-Blood-Feet-Prot-iQse and, a process for making the same

As is well known in clinical practice, the blood vessel surgeon ^ jie to replace resected blood vessels prostheses, which are made of different, physiologically inert synthetic fiber fabrics (Teflon, Dacron, etc.), used »The wall

porosity of such prostheses is about 150-2000 ml Hg "in. at a pressure of 12o mm Hg. The construction of 31ut- ^ eXässprothesen with higher V / andporöaität / 5ooo - lo.ooo ml ii ^ O / om ^ / i.in. /, which according to Forsohungser ^ ebniiisen for the further The fate of the implanted blood vessel set from Grundl »euGutun {ä is solved by combining a resorbable hatorial with a thin tissue protlieoe. The re-absorbable The task of the tutorial is during the healing process the lutung dui * cii to prevent the meshes of the synthetic fiber ^ ewebes.

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The following substances have been used as absorbable material * Catgut fiber, possibly combined or woven with synthetic fibers, amorphous gelatin, collagen film in the form of a Tube sewn together * The experimental testing of such The prosthesis was essentially unsuccessful considering that the test animals mostly bled out (over 50 #) - was. A complicated manufacturing process and the impossibility of continuous quality control in series production represent a further part of this method.

The present invention succeeded in achieving the aforementioned Deficiency due to the construction of a highly porous collagen-tissue-blood vessel prosthesis according to the invention and by eliminating a process for the production of the same «,

This prosthesis, consisting of a tube, made of a non-resorbable, physiologically inert synthetic fiber fabric, with a wall porosity of over 2000 ml . / Min. at a pressure of 12o mm Hg _f combined with a resorbable substance such as catgut, gelatine or collagen, is characterized essentially by the fact that the tube made of a non-resorbable, physiologically inert synthetic fiber fabric is the outer surface of the blood vessel prosthesis and a self-supporting one Tube made of a collagen mass, the absorbability of which is modified by partially ohemisous hardening, forms the inner gohioht, the inner surface of the collagen tube being prepared with an anticoagulant.

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This Blutgefässprotheae features SiOH further that · "their inner Sohiaht forms a conduit _f which is fabricated from a with Muoopolysaoohariden and / or Glyoerin and / or with one or more Antibiotioa angereioherten collagen mass, where these components can either be added individually or in various combinations can _e

Another embodiment of the invention consists in that sioh between the outer synthetic fiber fabric layer and the inner, made of a chemically modified collagen mass, an intermediate layer made of an amorphous, native one chemically unmodified collagen mass is located

In the production of the hooliporous blood vessel prostheses _{according to the invention, ZeB 0} can be done in such a way that initially disintegrated and homogenized collagen mass, prepared by alkaline swelling of the beef glue gelatinous tissue, optionally mixed with muoopolysaoohariden and / or glycerin and / or with one or more antibiotics In the form of a tube, which is then covered in a wet or dry state with a porous O-tissue tube, whereupon the inner surface of the collagen tube is modified ohemisoh by the action of a hardening agent and, after washing out the hardening agent, is prepared with an anticoagulant

A particularly firm connection between the two tubes can be achieved achieve that the high-porous tissue tube on the collagen

tube with the help of a duroh spray or paint applied Fixed intermediate layer of amorphous, native, chemically unmodified collagen mass.

The high-porous blood vessel prosthesis manufactured in the above way can be carried out through the wall of the prosthesis without the risk of immediate or later occurring permanent bleeding implant. In clinical use, neither special measures nor a special working procedure are required Surgery required. The previous analogical research results in this area show that the high porosity of the non-absorbable component of the invention Prostheses ensure significantly better results in blood vessel reconstruction than with the previously used one Replacement material was possible ·.

The attachment of the absorbable self-supporting tube in the Inside the synthetic fiber fabric tube leaves the meshes of the fabric relatively free, so that the surrounding area can be swiftly expanded Blood vessel cell tissue can take place without prior degradation of the absorbable component would be necessary

• Prevents the inner surface from having an anti-coagulant effect the formation of thrombi. Another advantage is that it has biological properties of the material for its manufacture of blood vessel prostheses according to the invention thanks to great ohemieoher Collagen mass reactivity as required by new research * - can adjust results. This is special for waxing of the niohi absorbable component and for the new formation

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the. Blood vessel walls are important. By chemical hardening of the collagen tubes lets si'Oh also influence their absorption duration and standardize so that no premature resorption of this tube can occur

The naousteilende example will illustrate the invention _f without it. be so offended.

The following example clearly describes the invention an execution form of the invention "

Collagen mass, prepared by alkaline uellu g of beef XeiKigallertgev / ebes, is disintegrated and thoroughly homogenized ^ e.g. 'B.' In a homogenizer for 24 hours) and then for 24- otuhden in a refrigerator at 0-4 0 itself seibot burden «This KoI-lageiiKariije treated in the above way can sonon be used to produce absorbable, self-supporting tubes, which serve as a component of a combined iioohporous blood vessel prosthesis, are used "

i ^ ^ oI-l'a enaia'.se ', .ann one also ge _t: e ^ Θΐ _£ «ηΓί Ils by Vermis'j: .f: i tiit Iiucopolyn ^ cchariden, eg ^ from Typuis dor tl; ^r aluronic acid (0.5 - 3.0; i), with glycerine (0.5 - 5.055>) or with / -ntibiotioa, J4 »B. enrich with chlortetracycline (1 - 5 g / 100 g of mouse), tieomyoin (0.5 - 5 g / 10% g mass) or baoitracin (10,000 - 50,000 E. lic. c Tanse). The component η mentioned can be added either individually or in cross-linked combinations.

Au "χ ν -'luf serve Vieiee reclaimed Kollageniaanse is

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then provided in a iuit rotating pulling head Presämaschine duroli Sußarai-; ii '·. in ": s and connecting individual Pas-rn a tube with ^wt: nscutiuu major comes, he (z _o ß _o 9 now) and wall thickness (for example, 0 , 4- - 0.6 now) - ^ ezojbn, and zv;? R while blowing air through it, ZoBo under 40-150 mm water column pressure. The finished tube is then dried for a long time, generally at a temperature of 15-25 ° O in After drying, the collagen tube is covered with the synthetic fiber tube using a special device, whereupon it is covered from the inside with an aqueous 2, 4, 6-trimethoxytriazine solution, then with excess distilled water and finally with a solution of a .Antikoagulationsmittels suitable, for example, strength with a Vi'o aqueous lieparinlösung by wipes _o> manufacturing of Blutgefassprotiiese to quit by drying under conditions already mentioned "by air pressure in the inner tube during drying, a de3 A firm connection between sohicxites is achieved, This connection can also be strengthened by applying a thin intermediate layer of amorphous, natural, chemically unmodified Follt'gen-1U..1 a .: e between the two layers.

Dio is finished Blutgefässprotuese Dunn .. included in eirtfhluftdiehten UmSOiLLa ₁ Y, ζ.Γ in a glass ampoule and G-amma-radiation sterilized (for example in a dose of 2 <.1O r 5 'hours 1 ng).

ORIGINAL

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Claims (2)

Ρ A Ly Highly porous collagenous vascular prosthesis, 'consisting of a tube made of a non-absorbable, physiological inert synthetic fiber fabric with a wall porosity 2000 ml HpO / cm / min at a pressure of 120 ram Eg combined with an absorbable substance such as catgut, gelatine or collagen, characterized in that the non-■ Resox'bable, physiologically inert synthetic fiber fabric produced Tube forms the outer layer of the blood vessel prosthesis and that is a self-supporting tube made from a Collagen mass, whose absorbability is partly due to chemical Hardening is modified, which forms the inner layer, vfobei the inner surface of the egg tube with an anticoagulant is prepared ' 2. High-porous collagen tissue blood vessel prosthesis according to claim 1, characterized in that the inner layer forms a tube made from a collagen mass enriched with muoopolysaooharides and / or glycerol and / or with one or more antibiotics, these components either individually or i & various combinations can be added. 5 · Highly porous colleague tissue blood vessel prosthesis naoh Aiispruoh 1, _f or 2, characterized by the fact that the outer esophageal tissue is ow often and the inner, ohemisoh modified 8 Ö 9 8 H / 0 0 5 7 bad original a layer made of delicate collagen mass, an intermediate layer made of amorphous, native, chemically unmodified collagen mass, " Method for the production of blood vessel prostheses according to claim 1 or 2 or 3, characterized in that the first disinfected and homogenized collagen mills, prepared by alkaline swelling of the glue gelatinous tissue, if necessary mixed with muo © polysaccharides and / or glycerine and / or with one or more / ntibiotica, divided in the form of a tube, -die one afterwards in a wet or dry state with a The highly porous tube of tissue is coated, whereupon the inner surface of the follagen tube is covered by the action of a hardening agent chemically modified and prepared after washing out the hardener with an anticoagulant Method according to claim 4, characterized in that the highly porous Gevveberöhre on the iCollagenröhre with the help of a Spraying or painting applied intermediate layer of amorphous, native, chemically unmodified collagen mass fixed. 9098 U / 005 7 BAD ORiGINAL