Compounder Teknor Apex Co. has signed an agreement with PVC manufacturer Vestolit GmbH & Co., for exclusive global rights to a vinyl copolymer technology that provides inherent anti-clotting properties in extruded and injection molded parts.
Teknor will use the technology to develop and produce vinyl compounds for medical devices used in processing or storing living blood during procedures like surgery, transfusions, catheterization, wound drainage, and dialysis. The first grades may be commercial in two years, according to Bert Lederer, senior vp. of Teknor Apex, which is based in Pawtucket, RI.
The deal was announced at the Plastec West show in Anaheim, CA, in February.
The compounds will replace anti-clotting (also called anti-thrombogenic) techniques like coatings, which Peter M. Galland, Teknor’s industry manager for specialty compounds, says are expensive and non-permanent. The compounds can be coextruded as the inner layer of tubing or other profiles. They can also be used in injection molded parts. Galland notes that the compounds will be expensive, but at an expected use ratio of 20%, will be no more costly than current anti-thrombogenic methods. The compound’s anti-clotting property, moreover, will be permanent, he says.
The chemistry behind the technology incorporates anti-thrombogenic molecules within the vinyl compound. These mimic the effect of heparin, the body’s natural anti-clotting chemical. As Galland described it, “This is a copolymer of pvc that tells blood it is in the presence of heparin.”
Radu Bordeianu, research leader at Vestolit, Marl, Germany, notes that the copolymer can only be made from a few commercially available monomers. Teknor declines to reveal what these monomers are, but says the materials in use are patented. PVC compounds will be produced by reactive extrusion. The bioactive components of the Vestolit formulations are permanently attached to the PVC backbone and are non-extractable.
The science behind the process stems from research done at the University of Paris-Nord, though antecedent work in Germany dates to 1894. The process makes use of the J&J Principle, so named for the researchers that developed it at Paris-Nord (Prof. Marcel Jozefowicz and his wife, Prof. Jacqueline Jozefonvicz). This states that random copolymers containing the basic functional groups of heparin-like molecules, randomly distributed in the right proportions, will arrange themselves in the same architecture as active sites of heparin, rendering an application antithrombic.
Importantly, notes Radu Bordeianu, research leader at Vestolit, the molecules also prevent formation of filaments that serve as the site of clots. Bordeianu says there is some evidence that the chemistry has bacteriostatic properties, but this needs further study.
One clear benefit of bacteriostatic properties would be a decrease in the incidence of blood-stream infections from the use of central venous catheters. One result of the antithrombic copolymer is that it inhibits the proliferation of microorganisms that colonize catheters.
The deal takes advantage of Teknor’s expertise in medical compounding and pvc formulation. Teknor not only receives exclusive rights to the technology and the right to market grades as its own products, but a guaranteed supply of the anti-thrombogenic compound from Vestolit. “We needed a competent and experienced ally for further worldwide marketing,” Bordeianu says of the venture with Teknor.
Teknor is testing the material and has not yet begun discussions with oems about potential applications.