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Medical Devices Are Both A Challenge and An Opportunity for Plastics Manufacturers.

On the one hand, medical devices provide chemical engineers with the opportunity to push the limits of polymer formulations. Promote the development of new materials to meet a variety of application requirements, such as one-time or reusable, hard or flexible, transparent or opaque, small or large. There are plastics designed for lubrication, plastics can be used for good grip, plastics contain antibacterial agents, plastics to eliminate static electricity, and plastics to replace knees and other joints. There are even absorbable plastics for temporary implantation of organisms.

On the other hand, because of the particularity of medical devices, engineers have to deal with some of the original in the automotive or home appliance industry has not encountered problems. The materials of medical devices must be kept clean and need to be disinfected. These materials may need to be biologically compatible and must pass a number of regulatory hurdles.

Here we talk about these special materials.

Sturdy but flexible

DuPont Hytrel is a thermoplastic-free thermoplastic polyester elastomer (TPC-ET) for products that require greater flexibility. This elastic material has excellent fatigue resistance and spring-like properties. It can be used over a wide temperature range while maintaining its flexibility and mechanical properties. The material is designed with a wide range of parts and products with the best properties of high-performance rubber and flexible plastics.

Hytrel's Shore hardness ranges from 30 to 82 Shore D, and the material can be processed using a variety of molding or extrusion processes.

One company that takes advantage of the unique properties of this material is Niagara Pross and Orthotics International in St. Catherine, Ontario. In 2012, the company launched Niagara Foot, an affordable, high-performance prosthetic foot designed for people with an active lifestyle and walking on rough terrain. The foot design is a natural movement that mimics the ankle. Prosthetists can customize Niagara Foot based on customer weight, foot size, activity level and personal preferences.

A key component of the prosthetic foot is its keel , an S-shaped component molded from hytrel 8238. When a person walks, it stores and releases energy like a spring. "The energy recovery mechanism incorporated into the Niagara Foot design allows users to walk more naturally than traditional designs," explains Rob Gabourie, founder of Niagara And Orthotics and inventor of Niagara Foot. "Patients like the performance of the device, which reduces the muscle strength required to walk."

The combination of low flex fatigue and high stress resistance provided by Hytrel materials is essential to this concept. In fact, Gabourie is confident that his design does not apply to any other material, including polyformaldehyde (POM) and polyamide, and cannot pass 2 million cycle load tests due to deformation or structural failure in some cases. Hytrel passed the ISO 10328 test requirement.

Hytrel's easy-to-process features also contribute to the manufacture of prosthetic feet. Hole defects are common in POM or polyamide molded parts, but do not exist in hytrel-molded parts. "The geometry of the current design requires an unusually thick portion," explains Helga Plishka, DuPont Canada's senior technical representative. "Because Hytrel is easy to flow, the hole defect is eliminated. This is essential for achieving high flex fatigue. "

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