TekniPlex Healthcare, which utilises advanced materials science expertise to help deliver better patient outcomes, will bring an eclectic mix of solutions for medical device applications to the China International Medical Equipment Fair (CMEF), April 8-11 in Shanghai. At Hall 8.1, Booth U47, the company’s highlights will include radiation-sterilisable PVC compounds, tracheal tube balloon PVC compounds, and PTA/PTCA balloon catheter tubing capabilities – all of which draw upon TekniPlex Healthcare’s nearly 60 years of experience in medical-grade materials science.
Radiation-sterilisable PVC Compounds
To accommodate radiation sterilisation – a technique increasingly favoured for its residue-free efficiency – at CMEF TekniPlex Healthcare will feature its recently developed series of radiation-resistant PVC compounds. Formulated to minimise yellowing and maintain material integrity, the compounds were designed to overcome the discolouration and brittleness that conventional PVC can experience when exposed to sterilisation radiation.
In comparative studies, TekniPlex Healthcare’s radiation-resistant PVC compounds exhibited minimal colour change post-irradiation, substantially outperforming other PVC products in both aesthetics and performance stability. Ideal for single-use medical devices, the compounds are compatible with several sterilisation methods – including gamma, electron beam (E-beam) and X-ray – and their high thermal stability reduces risks of degradation during processing.
Tracheal Tube Balloon PVC Compounds: soft and elastic for enhanced comfort
Suitable for both single- and multi-lumen tracheal tubes, TekniPlex Healthcare’s tracheal tube balloon PVC compounds stand out for high elasticity, low friction and exceptional stability. Combined with optimised low-adhesion properties, the PVC compounds’ low durometer helps yield soft-textured tracheal tubing that minimises patient discomfort. From a manufacturability standpoint, compatibility with various solvents facilitates easy bonding and assembly.
TekniPlex Healthcare’s tracheal tube balloon PVC compounds are sterilisable via gamma, e-beam & ETO processes, affording compliance with stringent medical sterilisation standards. The company’s multi-continent production sites, combined with localised production at its Suzhou, China facility, helps ensure stable supply and abbreviated lead times.
PTA/PTCA Balloon Catheter Tubing capabilities
For coronary and non-coronary angioplasty applications, TekniPlex Healthcare also will showcase samples of its PTA/PTCA Balloon Catheter Tubing solutions, which are ISO 13485-certified and manufactured at the company’s aforementioned Suzhou facility. Ranging in balloon size from 1 to 30mm, the customised balloon catheter tubing is manufactured at tight tolerances (± .0005”) with concentricity of over 90%. The tubing’s controlled elongation rate provides blown balloons with uniform wall thickness, improving overall yield and substantially reducing bursting risk.
TekniPlex Healthcare’s tri-layer inner tubing constructs are particularly sophisticated. The solutions consist of polyamide (nylon) or polyether block amide copolymer (PEBA) outer layers with high-density polyethylene (HDPE) inner layers. The small-diameter, thin-wall, tight-tolerance configurations are required for use in interventional vascular apparatuses to allow diagnostic and therapeutic devices – for example, balloon catheters for coronary, peripheral and neurovascular intervention – to more easily advance over guide wires.
The inner tubing’s HDPE inner layer reduces friction on the wire, while the outer layer is bondable to balloon catheter tubing of similar materials; the middle layer is an extremely thin adhesive ‘tie layer’. The thickness of the inner and outer layers can be customised to suit various applications.