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

I-Corps：血肿减少加压装置和伤口美容改善接受心脏装置植入的患者

• 批准号: 2150327
• 负责人: Nishaki Mehta
• 金额: $ 5万
• 依托单位: Oakland University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2150327&HistoricalAwards=false
• 关键词: Corps; Hematoma; Reduction; Compression; Device

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.

I-Corps项目更广泛的影响/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，并降低心脏植入式电子设备（CIED）手术的医疗成本。随着心脏病患者寿命的延长，植入cied的频率也越来越高。血肿是CIED植入手术后常见的并发症，发生率高达9%。这些患者中的大多数都在服用血液稀释剂，这进一步加剧了风险。血肿不仅会给患者带来痛苦和毁容，而且是发生CIED感染的最大危险因素，因为它们会使感染风险增加20倍。CIED感染与高发病率/死亡率相关，每次感染的医疗费用高达50,000美元。全球每年有超过300万个cied植入，减少血肿和随后的感染可能会节省医疗费用并降低医院的风险。需要每6-10年更换一次电池和发电机的患者在胸壁上有额外的切口疤痕。伤口愈合和疤痕美容的改善可能会提高患者的满意度和生活质量。I-Corps的这个项目是基于开发一种非侵入性、外敷的气动压缩装置，该装置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容。该装置术后在恢复室应用于手术部位2-4小时。该设计是一个气动压缩系统，由一个透明的空气膨胀机构、一个充气手术球囊和一个放气阀组成。压缩系统通过四周应用的粘接垫固定在手术部位。气囊被充气到~40毫米汞柱，这个压力在临床试验中被很好地耐受，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磨损期间直接评估伤口。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。