TekniPlex Healthcare, which utilizes advanced materials science expertise to help deliver better patient outcomes, will emphasize its substantially expanded capabilities for the design and manufacture of Class III implantable devices and delivery systems at MD&M Minneapolis, October 16-17. At its Booth 3926, the company will highlight its status as a full-fledged CDMO in these niches, one capable of partnering with startups and established entities alike on everything from initial concepting, prototyping and pilot production through larger-scale manufacturing and commercialization.
TekniPlex Healthcare is among the few medical device CDMOs offering comprehensive, ideation-to-completion product creation across a wide range of categories including endovascular stents, heart valves and delivery systems. Among other points of distinction, the company offers high-precision, tight-tolerance development and prototyping for a broad array of miniscule metal components typical not only in cardiovascular settings but also pulmonary, gastrointestinal, laparoscopic and other endoscopic applications – including devices for delivering chemotherapy drugs.
TekniPlex Healthcare’s enhanced stature reflects its significantly expanded upstream capabilities. A longstanding leader in medical tubing solutions, the company now offers an array of services supporting customers from early ideation stages through product development, prototyping, testing and full production of catheter-based systems and other tubing-related solutions. This includes an array of precision secondary processes, as well as clean room assembly of Class II and Class III devices such as stents, heart valves, catheter-based devices and delivery systems.
Among the specific solutions TekniPlex Healthcare will feature at MD&M Minneapolis is its PTA/PTCA Balloon Catheter Tubing for coronary and non-coronary angioplasty applications. Ranging in balloon size from 1 to 30mm, the company’s customized 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, high-precision 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 guidewires.
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 customized to suit various applications.
TekniPlex Healthcare is also dedicated to developing custom solutions to unique problems in the medical and bioprocess fields. At MD&M Minneapolis, the company also will showcase its paratubing, which it can produce in up to eight custom-colored, textured, or striped tube formations to distinguish between flow paths. Other examples include patented multilayer tubing configurations that offer extremely low absorption properties to help extend the usable life of insulin and other unstable drug products, such as chemotherapy drugs. Another patented configuration, designed for fluid transfer of DMSO and other solvent suspensions, allows for safe product delivery in dual hormone delivery systems and advanced cell & gene therapy processes.
Finally, TekniPlex Healthcare will showcase samples of its medical device packaging offerings, including a variety of grid lacquer-coated paper specifications and coated Tyvek® options. Later this year, TekniPlex Healthcare also will open a new facility in Madison, WI. Commencing with state-of-the-art air knife capabilities for coated Tyvek® and reinforced paper, the plant will subsequently showcase a seven-color extended gamut flexographic printing press utilizing both water- and solvent-based inks. The high-definition printer features fast changeover to help expedite customer delivery times and minimize waste compared to previous technologies in the production environment.
