I-Corps: On-line Monitoring of a Tissue Welding Process

这个I-Corps项目的更广泛的影响/商业潜力是，拟议的技术为目前广泛应用于许多医学专业（如神经外科）的电外科问题提供了急需的解决方案。电手术速度快，术后恢复时间短；然而，主要的问题，如侧支神经损伤和密封失败仍然存在，有时致命的后果。提出的技术通过用声信号监测电手术过程，帮助消除这些问题。它将为外科医生提供一种辅助设备，使他们能够做出精确的决定，从而确保手术质量。它将减少外科医生的疲劳、手术室时间和医疗成本，同时改善患者的整体体验。该项目允许广泛的客户发现和市场分析，从中开发商业产品以满足患者、外科医生和医院的需求。预计到2021年，全球电外科手术设备市场将达到51.7亿美元，该技术将具有巨大的商业潜力。应用于该项目的监测方法为精确外科手术领域带来了工程原理的进步。这个I-Corps项目的重点是开发一种实时声信号监测系统，以保证电外科手术过程的质量。首先，在手术过程中捕获的声音信号与加热组织中的水沸腾和蛋白质变性过程相关。然后，提出了一种基于信号强度和气泡破裂事件数量的决策算法。以往对电手术过程的研究提供了基本的认识，并表明声监测方法明显优于现有的方法。在之前的研究中，实验是用离体猪组织进行的，并证明了使用低姿态传感器所提出的技术的可行性。这份I-Corps合同将为技术改进提供与客户面谈的机会。将确定产品开发的一组功能需求，以支持拟议技术的商业化。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。

The broader impact/commercial potential of this I-Corps project is that the proposed technology provides a much-needed solution to the current problems in electrosurgery that is widely used in many medical specialties such as neurological surgery. Electrosurgery is fast and requires short post-surgery recovery time; however, major problems such as collateral nerve damage and seal failure still exist, sometimes with fatal consequences. The proposed technology helps eliminate those problems by monitoring the electrosurgical process with an acoustic signal. It will enable an assistive device for surgeons to make precise decisions that will ensure the surgical quality. It will reduce surgeon fatigue, time in the operating room, and healthcare cost, while improving the overall patient experience. This project allows extensive customer discovery and market analysis, from which commercial products will be developed to satisfy the needs of patients, surgeons, and hospitals. With the projected $5.17B global market for electrosurgical equipment by 2021, the proposed technology will have a significant commercial potential. The monitoring methodology applied to this project brings advances to the field of precision surgery with engineering principles. This I-Corps project focuses on developing a real-time acoustic signal monitoring system for quality assurance of the electrosurgical process. First, sound signals captured during the surgery is correlated to the water boiling and protein denaturing process in heated tissue. Then, a decision-making algorithm is developed based on the signal strength and number of bubble bursting events. Previous research on the electrosurgical process has provided fundamental understanding and suggested that the acoustic monitoring method is dramatically better than existing ones. In the previous study, experiments was conducted with ex-vivo porcine tissue and the feasibility of the proposed technology using a low-profile sensor was demonstrated. This I-Corps award will provide opportunities to conduct customer interviews for technology refinement. A set of functional requirements for product development will be identified to support commercialization of the proposed technology.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.