Development of a novel surgical implant to treat pelvic organ prolapse using advanced materials

盆腔器官脱垂（POP）是一种常见的疾病，是由于骨盆底的弱点导致内脏器官向下凸出阴道腔，并因年龄和分娩而加剧。聚丙烯材料制成的补片以前曾用于POP的手术治疗。由于越来越多的人担心该材料会导致骨盆慢性疼痛、继发于持续感染的慢性炎症和补片收缩导致的纤维瘢痕症状，因此已被禁止使用。**目前的选择：** POP的管理包括观察等待或插入硅胶阴道托以支撑突出的器官，通常因不适而停止。没有植入物的手术导致超过三分之一的病例复发。目前，尚无聚丙烯补片的竞争性替代品，因此临床需求未得到满足。**解决方案：** Hastalex（r）是由本公司开发的石墨烯基材料。该材料已获得专利，并且没有侵犯我们的自由经营权的现有知识产权（由剑桥的Stratagem IPM Ltd执行）。Hastalex利用石墨烯的上级特性，因为它的新配方。该材料的机械强度和弹性已经过调整，以匹配骨盆组织的特性。Hastalex和生物可降解版本BioHastalex（r）的其他应用包括心脏瓣膜、肌腱、人工尿道括约肌和作为卫生棉条样药物输送装置。2022年青年创新者奖为我提供了支持和资金，以进行Hastalex的体外和体内毒理学研究，证明它是无毒和生物相容的。我一直在与NanoRegMed合作，与帝国理工学院伦敦合作，设计一种用于脱垂手术的新型植入物。**当前提案：** 本提案的目的是进一步发展骨盆植入物。第一步包括设计和制造，通过两种制造方法进行比较。1)使用激光技术切割的Hastalex平板。2)该公司最近开发的Hastalex纤维针织膜。两种产品都将在临床前动物试验中进行疗效评估。我将与监管机构建立联系，以勾画临床可行性研究的途径。该项目的愿景是通过内部制造或通过大型医疗器械公司的支持，在POP手术中实施膜。我们的成功将对英国经济产生重大的积极影响。材料和制造都是环保的。

Pelvic organ prolapse (POP), a common condition, is the bulging of internal organs down the vaginal canal secondary to weaknesses in the pelvic floor, exacerbated by age and childbirth. A mesh made of polypropylene material was previously used for the surgical management of POP. It has since been banned due to rising concerns that, in the pelvis, the material causes symptoms of chronic pain, chronic inflammation secondary to persistent infection, and fibrous scarring as a result of mesh shrinkage.**Current options:** Management of POP includes watchful waiting or the insertion of a silicone-based pessary to hold up protruding organs, often discontinued due to discomfort. Surgery without an implant results in recurrence in over a third of cases. Currently, there is an unmet clinical need with no competitive alternative to the polypropylene mesh.**Solution:** Hastalex(r) is a trade registered graphene-based material, developed by our company. The material has been patented and with no existing intellectual property that infringes our Freedom to Operate (carried out by Stratagem IPM Ltd, Cambridge). Hastalex harnesses the superior properties of graphene due to its novel formulation. The mechanical strength and elasticity of the material have been tuned to match the properties of pelvic tissue. Other applications of Hastalex, and the biodegradable version BioHastalex(r), include heart valves, tendons, artificial urinary sphincters, and as a tampon-like drug delivery device.The Young Innovator award 2022 provided me with the support and funding to carry out in vitro and in vivo toxicology studies on Hastalex proving it to be non-toxic and biocompatible. I have been working with NanoRegMed, in collaboration with Imperial College London, on the design of a novel implant to be used in prolapse surgery.**Current Proposal:** The aim of this proposal is to further the development of the pelvic implant. The first step includes design and manufacturing via two fabrication methodologies for comparison. 1) Flat Hastalex sheet with patterns cut using laser technology. 2) Knitted membrane with Hastalex fibres, developed recently by the company. Both products will be assessed for treatment efficacy at preclinical animal trials.I will establish contacts with regulatory bodies to sketch the pathway toward clinical feasibility studies. The vision of this project is to implement the membrane in POP surgery with manufacturing either in-house or via the support of a larger medical devices company. Our success would have a major positive impact on the UK economy. The materials and manufacturing are environmentally friendly.