Extrusion Characteristics of Thin Walled Tubes for Catheters Using Thermoplastic Elastomer.

Soonmo Cho,Gyu Man Kim,Woojin Kim,Seunggi Jo,Euntaek Lee

doi:10.3390/polym12081628

Abstract

As the market for minimally invasive surgery has grown, the demand for high-precision and high-performance catheters has increased. Catheters for the diagnosis and treatment of cardiovascular or cerebrovascular disease mainly use a braided wire tube with a polymer inner liner and outer jacket to improve the pushability and trackability. The outer jacket should have an accurate inner and outer diameter and while maintaining a wall thickness of 150 µm or less. In this study, we designed and manufactured a tip and die capable of extruding an outer jacket with a wall thickness of 150 µm or less using a medical thermoplastic elastomer for manufacturing 8Fr (2.64 mm diameter) thin-walled tubes. The ovality and inner/outer diameters of the tube were studied according to changes in the screw speed (mass flow rate), puller speed, air pressure applied to the lumen, and distance between the quench and head, which are the main variables of microextrusion processes. The screw speed (mass flow rate), puller speed, and air pressure affected the inner/outer diameter of the tube, with screw speed and puller speed having the largest influence on diameter. The air pressure and distance between quench and head had the greatest influence on ovality. The results show the effect of different processing parameters on the characteristics of the extruded tube, which will help to establish a stable extrusion process for the manufacture of outer jackets for braided catheter shafts.

Highlights

IntroductionCatheters are minimally invasive interventional medical devices actively used in numerous procedures, including stent delivery, drug and contrast injection, imaging guide diagnosis, and ablation [1,2,3]
Catheters are minimally invasive interventional medical devices actively used in numerous procedures, including stent delivery, drug and contrast injection, imaging guide diagnosis, and ablation [1,2,3].These thin tubes are generally 300–2000 mm long, with a single-lumen or multi-lumen cross-section and a braided or coiled shaft to meet the demands of the application
The puller speed was varied between 5.3 and 9.3 m/min, and the flow rate of polymer melts was fixed at 15.84 g/min which is the flow rate at screw speed of 11 rpm

Summary

Introduction

Catheters are minimally invasive interventional medical devices actively used in numerous procedures, including stent delivery, drug and contrast injection, imaging guide diagnosis, and ablation [1,2,3]. These thin tubes are generally 300–2000 mm long, with a single-lumen (cavity in the tube) or multi-lumen cross-section and a braided or coiled shaft to meet the demands of the application. In the medical device industry, the outer diameter of the catheter shaft is typically less than 3 mm, while the interventional catheters used in cardiovascular and cerebrovascular fields have outer diameters of 1 mm or less [15,16,17]. Extrusion systems have many components, including a dryer and dehumidifier, hopper, screw and barrel, tip and die, quenching system, vacuum water tank, measurement device, puller, cutter, and conveyor system

Methods

Results

Conclusion