Temporary Pacing Leads - Scoping and Mitigating Environmental Impact

临时起搏导联 - 界定和减轻环境影响

• 批准号: 10086805
• 金额: $ 9.76万
• 依托单位: CARDIAC-TECH LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10086805
• 关键词: Temporary; Pacing; Leads; Scoping; Mitigating

Many people are unaware that after open-heart surgery, patients often experience rhythm disturbances that can lead to serious complications during recovery. Patients are therefore normally fitted with a temporary pacing system for 1-2 weeks after their procedure to ensure a near-normal rhythm is maintained.Unlike permanent (implanted) pacing systems, temporary pacemakers sit externally at the patient's bedside and are connected to the heart with wires that are fitted during surgery and which pass through the chest. These wires are then connected to extension cables that interface with the pacing device.Whereas temporary pacemakers are re-usable, temporary pacing wires and extension cables are typically incinerated after a single use. Although pacing wires are implanted, pacing extension cables are not and serve only to secure and shield the connection between the wires and pacemaker.Since two sets of extension cables are normally required per procedure (one for each heart chamber) and around 34,000 cardiac surgical procedures are performed each year in the U.K., an estimated 68,000 cables are burned annually (representing over 3.6 metric tonnes of waste)\[1\]. In the U.S. and Europe, the number of procedures performed annually exceeds 1.4m., representing around 2.8m cables (or 150 tonnes of plastic waste)\[2\].In addition to contributing to CO2 emissions, pacing cables are commonly formed from polyvinyl chloride (PVC), which produces hydrogen chloride and dioxins upon incineration - persistent organic toxins that are highly toxic.Cardiac Tech has developed a novel medical device that is anticipated to revolutionise, temporary pacing (see IUK projects 10042881 and 10051092). Through this technology, the Company has the opportunity to disrupt the market for temporary pacing equipment, and plans to exploit this opportunity in a more sustainable manner.In this project, Cardiac Tech will work with Pd-m International Ltd., a product design agency with a specialism in sustainability; regulators and stakeholders, to evaluate the product lifecycle and materials used in temporary pacing cables, and to identify and assess the appetite for more sustainable business models, practices and/or products. This will include assessing the barriers to cable reprocessing and re-sterilisation (including opportunities to change regulatory pathways), as well consideration of less environmentally impactful materials from which cables could be manufactured, such as plant-based plastics.Throughout the project, the partners will include stakeholders in the design process to ensure that realistic and viable design or business model alternatives are proposed, and strong design foundations are established.1\. https://www.nicor.org.uk/wp-content/uploads/2020/12/National-Adult-Cardiac-Surgery-Audit-NACSA-FINAL.pdf[][0]2\. https://idataresearch.com/over-900000-cardiac-surgeries-performed-every-year-in-the-united-states/[0]: https://www.nicor.org.uk/wp-content/uploads/2020/12/National-Adult-Cardiac-Surgery-Audit-NACSA-FINAL.pdf

许多人都不知道，在心内直视手术后，患者经常会经历心律失常，这可能会导致恢复过程中的严重并发症。因此，患者通常在手术后1-2周内安装临时起搏系统，以确保维持接近正常的心律。与永久性（植入式）起搏系统不同，临时起搏器位于患者床边的外部，通过手术时安装的导线穿过胸部与心脏相连。然后将这些导线连接到与起搏装置相连的延长线上。虽然临时起搏器是可重复使用的，但临时起搏导线和延长线通常在使用一次后被焚烧。虽然植入了起搏器导线，但起搏器延长线并没有植入，只是起到保护导线与起搏器之间连接的作用。由于每次手术通常需要两套延长电缆（每个心脏腔一套），每年在英国进行大约34,000例心脏手术，估计每年燃烧68,000根电缆（代表超过3.6公吨的废物）\[1\]。在美国和欧洲，每年进行的处理次数超过140万次，相当于280万根电缆（或150吨塑料垃圾）\[2\]。除二氧化碳排放外，起搏电缆通常由聚氯乙烯（PVC）制成，在焚烧时产生氯化氢和二恶英-剧毒的持久性有机毒素。Cardiac Tech已经开发出一种新的医疗设备，预计将彻底改变临时起搏（见IUK项目10042881和10051092）。通过这项技术，该公司有机会颠覆临时起搏设备市场，并计划以更可持续的方式利用这一机会。在这个项目中，Cardiac Tech将与Pd-m International Ltd.合作，这是一家专注于可持续发展的产品设计机构；监管机构和利益相关者，评估临时起搏电缆的产品生命周期和材料，并确定和评估对更可持续的商业模式、实践和/或产品的需求。这将包括评估电缆再加工和再灭菌的障碍（包括改变监管途径的机会），以及考虑制造电缆的环境影响较小的材料，如植物性塑料。在整个项目中，合作伙伴将在设计过程中包括利益相关者，以确保提出现实可行的设计或商业模式替代方案，并建立坚实的设计基础。https://www.nicor.org.uk/wp-content/uploads/2020/12/National-Adult-Cardiac-Surgery-Audit-NACSA-FINAL.pdf[][0]2\。https://idataresearch.com/over-900000-cardiac-surgeries-performed-every-year-in-the-united-states/[0]: https://www.nicor.org.uk/wp-content/uploads/2020/12/National-Adult-Cardiac-Surgery-Audit-NACSA-FINAL.pdf