Medical-Grade TPE Film for Wound Healing Applications

A custom extruded, medical-grade TPE film said to deliver a high level of patient support and treatment-friendly wound healing, has been developed by custom compounder of TPEs and TPE films United Soft Plastics (USP), Lawrenceville, Ga. Developed in conjunction with a Danish start-up under the brand name Impervious, the USP custom medical grade TPE is said to relieve patients of undue irritation and pain.

Patients who have been treated with wound dressings for injuries to their arms and legs must receive regular medical care to ensure the area of the wound dressing is clean and dry before any follow-up treatment or daily aftercare and at the same time to protect it from dangerous bacterial ingress. Previously, this has been done by covering the wound dressing with a medically protective film or protective bag (polybag), which is then affixed to the skin with an adhesive tape and sealed. However, the removal of the protective film by tearing off the tape from the skin usually causes unpleasant pain in connection with unwanted micro-injuries to the topmost skin layer.

The new TPE film is a latex-free alternative and does not have to be torn off because it is permanently welded to the polybag as a stretchable, flexible, and conical sealing strip. As a result, the use of adhesive tape can be completely eliminated. The TPE film product represents a significant relief in everyday treatment for patients and medical nursing staff, according to USP general manager for Europe Michael Bodmann.

“When we were approached by one of our European customers about this idea, we were initially not sure whether we would actually be able to develop a medical TPE grade that combines a multitude of partly contrary performance properties along with the need to meet strict customer and medical regulatory requirements,” said Bodmann.

The TPE grade exhibits a low Shore A hardness (25-35), high tear strength in connection with demanding transverse and longitudinal strain loads, and the indispensable requirement of a very thin wall thickness (0.2-0.4 mm). The company also addressed manufacturing issues so the medical-grade TPE could be produced in a cost-effective manner, said Bodmann.

The year-long joint development project is in a pre-commercialization phase and undergoing clinical trials. After initial commercialization in Europe, the new TPE film will be made available globally.