New materials and complications of prostheses in humans: situation in Spain.

M Vallet-Regí, A De Alarcón, E Gómez Barrena, J A Planell, J Silva, E Bouza
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Abstract

Prostheses or implantable medical devices (IMDs) are parts made of natural or artificial materials intended to replace a body structure and therefore must be well tolerated by living tissues. The types of IMDs currently available and usable are very varied and capable of replacing almost any human organ. A high but imprecise percentage of Spaniards are carriers of one or more IMDs to which they often owe their quality of life or survival. IMDs are constructed with different types of materials that are often combined in the same prosthesis. These materials must combine harmlessness to human tissues with high wear resistance. Their durability depends on many factors both on the host and the type of prosthesis, but the vast majority last for more than 10-15 years or remain in function for the lifetime of the patient. The most frequently implanted IMDs are placed in the heart or great vessels, joints, dental arches or breast and their most frequent complications are classified as non-infectious, particularly loosening or intolerance, and infectious. Complications, when they occur, lead to a significant increase in morbidity, their repair or replacement multiplies the health care cost and, on occasions, can cause the death of the patient. The fight against IMD complications is currently focused on the design of new materials that are more resistant to wear and infection and the use of antimicrobial substances that are released from these materials. Their production requires multidisciplinary technical teams, but also a willingness on the part of industry and health authorities that is not often found in Spain or in most European nations. Scientific production on prostheses and IMD in Spain is estimated to be less than 2% of the world total, and probably below what corresponds to our level of socio-economic development. The future of IMDs involves, among other factors, examining the potential role of Artificial Intelligence in their design, knowledge of tissue regeneration, greater efficiency in preventing infections and taking alternative treatments beyond antimicrobials, such as phage therapy. For these and other reasons, the Ramón Areces Foundation convened a series of experts in different fields related to prostheses and IMDs who answered and discussed a series of questions previously formulated by the Scientific Council. The following lines are the written testimony of these questions and the answers to them.

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人体假体的新材料和并发症:西班牙的情况。
假体或植入式医疗器械(IMD)是由天然或人工材料制成的部件,旨在替代人体结构,因此必须能被活体组织很好地耐受。目前可用的植入式医疗器械种类繁多,几乎可以替代任何人体器官。西班牙人中有很高但不精确的比例是一种或多种 IMD 的携带者,他们的生活或生存质量往往得益于这些 IMD。综合器官置换系统由不同类型的材料构成,这些材料经常被组合在同一个假体中。这些材料必须兼具对人体组织无害性和高耐磨性。它们的耐用性取决于宿主和假体类型等多种因素,但绝大多数假体都能使用 10-15 年以上,或在患者的一生中都能发挥作用。最常植入的 IMD 位于心脏或大血管、关节、牙弓或乳房,其最常见的并发症分为非感染性(尤其是松动或不耐受)和感染性两种。并发症一旦发生,会导致发病率大幅上升,其修复或更换会使医疗费用成倍增加,有时甚至会导致患者死亡。目前,应对 IMD 并发症的重点是设计出更耐磨、更抗感染的新材料,并使用这些材料释放出的抗菌物质。这些材料的生产需要多学科的技术团队,同时也需要工业界和卫生当局的意愿,而这在西班牙和大多数欧洲国家并不常见。据估计,西班牙的假肢和 IMD 科研生产不足世界总量的 2%,可能也低于我们的社会经济发展水平。除其他因素外,综合医疗设备的未来还包括研究人工智能在其设计中的潜在作用、组织再生知识、提高预防感染的效率以及采取抗菌剂以外的替代疗法,如噬菌体疗法。出于这些原因和其他原因,拉蒙-阿雷斯基金会召集了一系列与假肢和 IMD 相关的不同领域的专家,他们回答并讨论了科学委员会之前提出的一系列问题。以下是对这些问题的书面证明和答复。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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