Polypropylene-Based Polymer Locking Ligation System Manufacturing by the Ultrasonic Micromolding Process

Abstract

In recent years, there has been a growing demand for biocompatible medical devices on the microscale. However, the manufacturing of certain microfeatures has posed a significant challenge. To address this limitation, a new process called ultrasonic injection molding or ultrasonic molding (USM) has emerged as a potential solution. In this study, we focused on the production of a specific microdevice known as Hem-O-Lok, which is designed for ligation and tissue repair during laparoscopic surgery. Utilizing USM technology, we successfully manufactured the microdevice using a nonabsorbable biopolymer that offers the necessary flexibility for easy handling and use. To ensure high-quality microdevices, we extensively investigated various processing parameters such as vibration amplitude, temperature, and injection velocity. Through careful experimentation, we determined that the microdevice achieved optimal quality when manufactured under conditions of maximum vibrational amplitude and temperatures of 50 and 60 °C. This conclusion was supported by measurements of critical microfeatures. Additionally, our materials characterization efforts revealed the presence of a carbonyl (C=O) group resulting from the thermo-oxidation of air in the plasticizing chamber. This finding contributes to the enhanced thermal stability of the microdevices within a temperature range of 429–437 °C.