SBIR Phase I: Hybrid surgical stapler with tissue sensing technology

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是改善手术订书机设备的现状。尽管订书机在外科实践中被广泛采用，但订书机故障或误用可导致严重的手术和术后并发症，包括出血、败血症和死亡。打火和切割错误是订书机故障的主要原因。本项目提出了一种半可重复使用的手术订书机，该订书机将为外科医生提供实时反馈以指导发射，从而减少订书机故障，提高手术成功率。拟议的解决方案结合了可重复使用的控制系统，这将减少医疗保健系统产生的有毒废物的数量（加起来填埋，占医疗保健支出的25%），和一次性把手，这将允许减少手术准备所需的成本和时间（节省40% /程序）。提出的解决方案将节省医院成本，提高手术性能，降低手术并发症的风险。此外，该项目将推动医疗行业智能设备领域的研究，有可能引领其他类型手术设备的创新。这个小企业创新研究（SBIR）第一阶段项目建议开发控制系统，以自动识别拟议的外科订书机的发射系统。订书机的工作参数必须根据组织的生物力学特性仔细选择。组织的内在特征因器官和个体而异，使放电参数的标准化复杂化。该系统将帮助外科医生提供有关组织的实时信息，并建议使用最佳的药筒。这个项目的特点是设计控制系统，能够感应夹中的组织，并确定最佳的短钉发射参数。首先，对控制系统的组成部分进行设计。随后，将在一个经验数据集上开发控制射击速度、能量消耗和衔接的算法。该项目将建立夹紧力与组织参数之间的相关性。所开发的手术订书机所产生的好处，将与商业解决方案在体外和离体进行基准测试。在第一期项目完成后，提议的创新将准备在体内进行测试。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 Small Business Innovation Research (SBIR) Phase I project is to improve the current state of the art of surgical stapler devices. Despite their widespread adoption in surgical practices, stapler malfunctioning or misuse can cause severe surgical and post-surgical complications which include bleeding, sepsis, and death. Misfiring and cutting errors are the main causes of staplers malfunctioning. This project proposes a semi-reusable surgical stapler which will provide real-time feedback to surgeons to guide the firing, thus reducing staplers malfunctioning and increasing surgeries success rates. The proposed solution combines a reusable control system, which will decrease the amount of toxic waste generated by the healthcare system (adding up to landfill and accounting for 25% of healthcare expenditures), and a disposable handle, which will allow to cut down the cost and time required for surgery preparation (40% savings/procedure). The proposed solution will save hospital costs and improve surgeries performances, decreasing the risks of complications during surgeries. Additionally, this project will bring forward research in the field of smart devices in medical industry, potentially leading to innovation for other types of surgical devices.This Small Business Innovation Research (SBIR) Phase I project proposes to develop the control system to automate the tissue recognition of the firing system of the proposed surgical stapler. The stapler working parameters must be carefully selected in accordance with the tissue’s biomechanical properties. Tissues' intrinsic characteristics vary among organs and individuals, complicating the standardization of firing parameters. The proposed system will assist surgeons by providing real-time information over the tissue to clamp and advising over the optimal cartridge to be used. This project will feature the design of the control system capable of sensing the tissue in the clamp and deciding optimal staple firing parameters. First, the components of the control system will be designed. Successively, the algorithm to control firing speed, energy consumption, and articulation will be developed on an empirical dataset. The project will establish the correlation between clamping forces and tissue parameters. The benefits yielded by the developed surgical stapler, will be benchmarked against commercial solutions both in vitro and ex vivo. At the completion of this Phase I project, the proposed innovation will be ready to be tested in vivo.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.