Abstract

This paper presents the first try to fabricate degradable polylactic acid (PLA) biomedical stents with round edges by the multi-axis micro-milling process. Conventionally biomedical stents are produced by laser processing. Post-processing operations are usually required to handle sharp edges and thermal defects of the stent due to laser processing. A computer graphics software package was used to design the strut structures with round corners of the PLA stent. A PLA tube was first created using injection molding, and a degradable biomedical stent was then fabricated through micro-milling by using a five-axis computer numerical control (CNC) machine tool. This study investigated the error in the rotation center that can occur during five-axis micro-milling. Data obtained from experiments on center-of-rotation errors were substituted into homogeneous coordinate conversion formulas. Center-of-rotation errors in the five-axis machine tool were compensated for improving the milling precision (A and C axes) to be within 5 μ m. Furthermore, milling parameter optimization experiments were conducted, which determined the optimal conditions for milling PLA to be a spindle speed of 60,000 rpm, feed per tooth of 0.005 mm, and feed rate of 600 mm/min, and achieved the minimum burr 0.01 mm and the average surface roughness (Ra) 0.4 μ m. These optimal cutting parameters will be used in the following actual stent processing experiments. Finally, the error compensation and optimal parameters were combined in a CAM software package and layered spiral micromilling to machine the actual stent. The experimental results revealed that the combination of five-axis micro-milling led to the successful fabrication of a degradable biomedical stent (stent diameter = 6 mm, strut width = 0.3 mm, and radius at round corners = 0.1 mm). The machined actual stent had cross-section height and width errors within 0.01 mm, and arc depth of cut variation within 6 μ m. In addition, the PLA stent machining results indicated a rebound of approximately 33% at the strut round edge machining. This work may also open up future possibilities for complex three-dimensionally structured biomedical stents for better performance and special functionality.

Highlights

  • Traditional biomedical stents are made from stainless steel and nickel–titanium alloy [1,2], and their grid structure is fabricated through laser processing [3], which, often results in problems including residual thermal stress, poor surface roughness, and sharp corners of the structure

  • The five-axis machining-based milling process proposed in this study, which is a continual and one-time process, can achieve the fabrication of degradable polylactic acid (PLA) stents with high surface quality and smooth geometric shape, thereby overcoming the numerous problems with biomedical stents that are produced through laser processing

  • The error compensation and optimal cutting parameters were combined in a Computer-Aided Manufacturing (CAM) software package and layered spiral micromilling to machine the actual stent

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Summary

Introduction

Traditional biomedical stents are made from stainless steel and nickel–titanium alloy [1,2], and their grid structure is fabricated through laser processing [3], which, often results in problems including residual thermal stress, poor surface roughness, and sharp corners of the structure. Eckman et al [23] investigated the resilience of polymer materials, using a micro-end mill (the edge of which had a radius of 48 μm) to conduct an undercut experiment on acrylic materials They discovered that, under various cutting depths, when the springback direction was vertical to the cutting tool feed direction and the cutting depth was smaller than 15 μm, the springback rate was. PLA, a biodegradable polymer material, was employed as a stent material to develop a degradable biomedical stent through micromilling using a five-axis machine tool. The five-axis machining-based milling process proposed in this study, which is a continual and one-time process, can achieve the fabrication of degradable PLA stents with high surface quality and smooth geometric shape (i.e., no sharp corners in the stent structure), thereby overcoming the numerous problems with biomedical stents that are produced through laser processing

Material and Design of the PLA Biomedical Stent
Experiment on PLA Cutting Parameter Optimization
Center-of-Rotation Error Compensation
Compensation for Center-of-Rotation Errors
Cutting-Path Planning in Five-Axis CAM of Stents and Actual Stent Machining
Cross-Section Height of the Stent
Cross-Section Width of the Stent
Stent Arc Homogeneity
Arc Dimension Errors
Conclusions
Full Text
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