Iker Principe, Cikautxo Medical outlines the company’s latest R&D developments in leaching / non-leaching antimicrobial solutions for its vascular access catheter portfolio.
Iker Principe, Cikautxo Medical
It is well known that endovascular catheters are exposed to a risk factor of biofilm growth along its surface and, in those cases, infections may sometimes occur causing to patients an extra damage and to hospitals an extra cost. For this reason, in the US market, approximately two third parts of the catheters purchased have some anti-microbial and/or anti-thrombogenic performance. Unfortunately Europe has not the same legislation but some European hospitals have made their balance and started to increase the percentage of catheters purchased with those performances.
How does the anti-microbial technology work? There are two main methods to kill bacteria: method one or ‘leaching’, involves adding a substance to the catheter that is released inside the vascular system attacking the bacteria growing colony being created on its biofilm surface. There are in the market catheters with different substances to be leached, the best known are silver ions, antibiotics and even chlorhexidine. Heparin is also used as anti-thrombotic agent.
The main constraint of this first method is that the principle used is based on a release of a substance into the vascular system of the patient with secondary effects that might counterbalance its antimicrobial or its antithrombotic benefit. For this reason the R&D developments are focused to release the minimum quantity of substance capable of keeping the effect during the target period.
A second method has also been developed: the ‘non leaching method’. In those catheters, the surface is treated with a non-leaching substance that kills the bacteria when it approaches and with no contact. This method does not release any substance along the vascular system of the patient and no secondary effect occurs.
What anti-microbial technologies are offering the manufacturers? Some European Contract manufacturers are offering non-leaching catheters to European branded manufacturers. This is the case with Cikautxo Medical. Our customers, the big catheter branded manufacturers, select different technologies in order to differentiate themselves in the market: some of them give priority to the time-to-market aspect and choose a simple silver ion technology that we manufacture embedded into the catheter tube and accept this ‘leaching’ option that releases a small (always under the regulatory limits) silver quantity into the vascular system. Some other customers prefer a longer term anti-microbial / anti-thrombogenic solutions based on chlorhexidine and accept the potential downsides of this second ‘leaching’ method (perhaps a remote allergic anaphylactic risk). Although we also have a solution based on a cocktail of antibiotics, today we are focusing our efforts in new generation technologies, especially in our latest development, a ‘non leaching’ natural polymer anti-microbial coating and its anti-thrombogenic version based on heparin.
How does this last generation of anti-microbial technology work? The natural polymer acting as a ‘selective non-contact bacteria killer’ is linked into the catheter surface after a special surface activation treatment is done to the catheter. Once the complete process is finished, we cure the catheters to eliminate any possible volatile agent. The bacteria attack is made by a technology called ‘positive charge’ which is an ionization killing activity that emits no leaching substance into the vascular system. In addition, combining this natural polymer with heparin obtains an excellent last generation catheter that has both anti-microbial and anti-thrombogenic activity.