SBIR Phase I: Hybrid surgical stapler with tissue sensing technology

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是改善外科吻合器器械的当前技术水平。尽管在外科实践中广泛采用，但吻合器故障或误用可能导致严重的手术和术后并发症，包括出血、败血症和死亡。误击发和切割错误是吻合器故障的主要原因。该项目提出了一种半可重复使用的手术吻合器，该吻合器将为外科医生提供实时反馈以指导击发，从而减少吻合器故障并提高手术成功率。所提出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量（加起来填埋并占医疗保健支出的25%），以及一次性手柄，这将允许减少手术准备所需的成本和时间（节省40%/程序）。所提出的解决方案将节省医院成本，提高手术性能，降低手术期间并发症的风险。此外，该项目还将推进医疗行业智能设备领域的研究，并有可能导致其他类型手术设备的创新。该小型企业创新研究（SBIR）I期项目提出开发控制系统，以自动识别拟议手术吻合器击发系统的组织。必须根据组织的生物力学特性仔细选择吻合器工作参数。组织的内在特征在器官和个体之间是不同的，这使得发射参数的标准化变得复杂。所提出的系统将通过提供待夹紧组织的实时信息并建议使用最佳钉仓来帮助外科医生。本项目将设计能够感知夹钳中的组织并决定最佳缝钉击发参数的控制系统。首先，将设计控制系统的组成部分。接下来，将在经验数据集上开发控制发射速度、能量消耗和接合的算法。该项目将建立夹紧力和组织参数之间的相关性。所开发的外科吻合器产生的受益将与体外和离体商业解决方案进行基准比较。该奖项反映了NSF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.