I-Corps: Hematoma Reduction Compression Device and Wound Cosmesis Improvement in Patients Undergoing Cardiac Device Implants

这个i-Corps项目的更广泛的影响/商业潜力是开发一种干预措施，可以提高患者的安全性和满意度，并降低心脏可植入电子设备(CIED)程序的医疗成本。随着心脏病患者寿命的延长，植入CIED的频率越来越高。血肿是CIED植入手术后的常见并发症，发生在高达9%的患者中。这些患者中的大多数都在服用血液稀释剂的组合，这进一步增加了风险。血肿不仅使患者痛苦和毁容，而且是发展为CIED感染的最大风险因素，因为它们将感染风险增加20倍。CIED感染与高发病率/死亡率有关，每次感染的医疗费用超过5万美元。全球每年植入300多万个CIED，减少血肿和随后的感染可能会为医院节省医疗保健和降低风险。对于需要每6-10年进行一次电池和发电机更换程序的患者，胸壁上还有额外的切口疤痕。伤口愈合和疤痕美容的改善可能会导致患者满意度和生活质量的提高。I-Corps的这个项目是基于开发一种非侵入性的外部应用的气动压缩设备，该设备可以减少血肿的发生率，并改善接受CIED植入手术的患者的伤口美观。术后在恢复室将该装置应用于手术部位2-4小时。该设计是一种气动压缩系统，由一个带有充气外科气球的透明空气充气机构和一个空气释放阀组成。该加压系统通过四个周向应用的粘合垫固定在手术部位。球囊被充气到~40毫米汞，这一压力在临床试验中已经被很好地耐受，并足以对抗静脉压力以减少出血。该设备的透明材料允许在设备佩戴期间进行直接伤口评估。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the development of an intervention that may improve patient safety and satisfaction and reduce healthcare costs for cardiac implantable electronic device (CIED) procedures. CIEDs are being implanted more frequently as patients are living longer with cardiac disease. Hematomas are a common complication following CIED implant procedures, occurring in up to 9% of patients. Most of these patients are on a combination of blood thinners, which further compounds the risk. Hematomas are not only painful and disfiguring for patients, but they are the greatest risk factor for developing CIED infections as they increase the risk of infection by 20-fold. CIED infection is associated with high morbiditiy/mortality with an upwards of $50,000 in healthcare costs per infection. With over 3 million CIEDs implanted annually worldwide, reducing hematomas and subsequent infection may result in healthcare savings and risk mitigation for the hospital. There is additional incisional scarring on the chest wall for patients requiring battery and generator exchange procedures occurring every 6-10 years. Improvements in wound healing and scar cosmesis may result in improved patient satisfaction and quality of life. This I-Corps project is based on the development of a non-invasive, externally applied, pneumatic compression device that reduces the incidence of hematomas and improves wound cosmesis for patients undergoing CIED implant procedures. The proposed device is applied post-operatively to the surgical site for 2-4 hours in the recovery room. The design is a pneumatic compression system that consists of a transparent air inflation mechanism with an inflatable surgical balloon and an air release valve. The compression system is fixated to the surgical site via four circumferentially applied adhesive pads. The balloon is inflated to ~40 mmHg, a pressure that has been well tolerated in a clinical trial and sufficient to combat venous pressure to reduce bleeding. The device’s transparent material allows for direct wound assessment during device wear.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.