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<p>A key yet often overlooked factor in the unpredictable failure of degradable systems is “acquired”; heterogeneity—a spatially and temporally evolving unevenness of degradation that emerges and aggravates during service, rather than originating from manufacturing defects. Controlling this inherent randomness is particularly critical for biodegradable implants, where corrodible metals offer the necessary strength but are susceptible to such unpredictable localized weakness throughout the therapeutic window. Herein, we propose that the reliability of a biodegradable device is highly dependent upon the extent of such “acquired”; heterogeneity. We derive an equation set of random degradation inspired by the Poisson raindrop question, and employ them to quantify the acquired heterogeneity of biometals with and without polymer coatings. We find that coating iron with polylactide increases the corrosion rate by 3-fold but reduces the inhomogeneity by 4,000-fold in a blood-mimetic medium, surprisingly leading to later device fracture despite faster degradation. The resulting biodegradation-controlled metal-polymer composite stents for interventional treatment prevent high-risk early and random fractures. Preclinical studies in pigs, clinical trials involving 1108 patients across multiple cohorts, and 5-year outcomes of 45 first-in-human implantations illustrate that the biodegradation-controlled metal-polymer composite stents are safe, durable, and reliable. Our theoretical framework is relevant to any discipline in which random tempospatial variability undermines system performance.</p>

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A set of equations for random degradation quantifies the role of polymer coatings in mitigating the acquired heterogeneity of corrodible metals for biodegradable stents

  • 期刊论文

  • 发表日期：

    2026年6月22日

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  • Xin Li,
  • Wenjie Wu,
  • Wanqian Zhang,
  • Hong Qiu,
  • Xun Ma,
  • Hongjie Zhang,
  • Yongli Qi,
  • Haiping Qi,
  • Ye Fu,
  • Lei Song,
  • Ying Xia,
  • Xiaoye Yu,
  • Qunsong Wang,
  • Gui Zhang,
  • Jie Qian,
  • Deyuan Zhang,
  • Runlin Gao,
  • Jiandong Ding

摘要

A key yet often overlooked factor in the unpredictable failure of degradable systems is “acquired”; heterogeneity—a spatially and temporally evolving unevenness of degradation that emerges and aggravates during service, rather than originating from manufacturing defects. Controlling this inherent randomness is particularly critical for biodegradable implants, where corrodible metals offer the necessary strength but are susceptible to such unpredictable localized weakness throughout the therapeutic window. Herein, we propose that the reliability of a biodegradable device is highly dependent upon the extent of such “acquired”; heterogeneity. We derive an equation set of random degradation inspired by the Poisson raindrop question, and employ them to quantify the acquired heterogeneity of biometals with and without polymer coatings. We find that coating iron with polylactide increases the corrosion rate by 3-fold but reduces the inhomogeneity by 4,000-fold in a blood-mimetic medium, surprisingly leading to later device fracture despite faster degradation. The resulting biodegradation-controlled metal-polymer composite stents for interventional treatment prevent high-risk early and random fractures. Preclinical studies in pigs, clinical trials involving 1108 patients across multiple cohorts, and 5-year outcomes of 45 first-in-human implantations illustrate that the biodegradation-controlled metal-polymer composite stents are safe, durable, and reliable. Our theoretical framework is relevant to any discipline in which random tempospatial variability undermines system performance.