Table 1.
General design constraints and criteria for biodegradable metallic device applications (Reproduced with permissions from Ref. [95]).
| Criterion | Cardiovascular stent | Orthopedic internal fixation device |
|---|---|---|
| Biocompatibility | Non-toxic, non-inflammatory, hypoallergenic | Non-toxic, non-inflammatory, hypoallergenic No harmful release or retention of particulates Promote osteoblast and osteoclast attachment; avoid fibrous encapsulation |
| No harmful release or retention of particulates | ||
| Promote endothelial cell attachment; discourage smooth muscle cell attachment | ||
| Mechanical integrity and resorption during service | Mechanical integrity: 3–6 months | Mechanical integrity: Plates and screws <6 months Osteotomy staples <3 months Full absorption in 1–2 years |
| Full absorption in 1–2 years | ||
| Mechanical properties | Yield strength >200 MPa | Yield strength >230 MPa Tensile strength >300 MPa Elongation to failure >15–18% Elastic modulus approximates to that of cortical bone (10–20 GPa) |
| Tensile strength > 300 MPa | ||
| Elongation of failure > 15–18% | ||
| Elastic recoil on expansion < 4% | ||
| Corrosion behavior | Penetration rate < 20 μm year−1 | Plates and screws (0.5 mm year−1) Hydrogen evolution < 10 μL cm−2·day−1 |
| Hydrogen evolution < 10 μL cm−2 · day−1 |