Temporary Pacing Leads - Scoping and Mitigating Environmental Impact

许多人没有意识到，心内直视手术后，患者往往会经历心律紊乱，这可能会导致康复过程中的严重并发症。因此，患者通常在手术后安装临时起搏系统1-2周，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，并通过手术中安装的电线连接到心脏，穿过胸部。然后将这些电线连接到与起搏器接口的延长电缆上。如果临时起搏器可重复使用，则临时起搏线和延长电缆通常在一次使用后被焚烧。虽然起搏导线被植入，但起搏延长电缆并不是，只是用来固定和屏蔽导线和起搏器之间的连接。由于每个程序通常需要两套延长电缆(每个心腔一根)，而且在英国每年大约进行3.4万次心脏外科手术，估计每年有6.8万根电缆被烧毁(相当于3.6公吨的浪费)[1]。在美国和欧洲，每年进行的手术数量超过140万次，相当于大约280万根电缆(或150吨塑料垃圾)[2]。起搏电缆通常是由聚氯乙烯(PVC)制成的，聚氯乙烯(PVC)在焚烧时会产生氯化氢和二恶英--持久性有机毒素是剧毒的。心脏技术公司开发了一种新型医疗设备，有望给临时起搏带来革命性的变化(参见IUK项目10042881和10051092)。通过这项技术，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，心脏技术公司将与PD-m国际有限公司合作，后者是一家专门从事可持续发展的产品设计机构；监管机构和利益相关者，评估产品生命周期和临时起搏电缆使用的材料，并确定和评估对更可持续的商业模式、实践和/或产品的兴趣。这将包括评估电缆再加工和再消毒的障碍(包括改变监管途径的机会)，以及考虑对环境影响较小的制造电缆的材料，如基于植物的塑料。通过该项目，合作伙伴将在设计过程中纳入利益相关者，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

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