Department of Research and Development, Surgi Box Inc, Cambridge, MA 02139, USA.
Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
Mil Med. 2021 Jan 25;186(Suppl 1):295-299. doi: 10.1093/milmed/usaa311.
Scarcity of operating rooms and personal protective equipment in far-forward field settings make surgical infections a potential concern for combat mortality and morbidity. Surgical and transport personnel also face infectious risks from bodily fluid exposures. Our study aimed to describe the serial, proof-of-concept testing of the SurgiBox technology: an inflatable sterile environment that addresses the aforementioned problems, fits on gurneys and backpacks, and drapes over incisions.
The SurgiBox environmental control unit and inflatable enclosure were optimized over five generations based on iterative feedback from stakeholders experienced in surgery in austere settings. The airflow system was developed by analytic modeling, verified through in silico modeling in SOLIDWORKS, and confirmed with prototype smoke-trail checking. Particulate counts evaluated the enclosure's ability to control and mitigate users' exposures to potentially infectious contaminants from the surgical field in various settings. SurgiBox enclosures were setup over a mannequin's torso, in a configuration and position for either thoracic or abdominal surgery. A particle counter was serially positioned in sternotomy and laparotomy positions, as well as bilateral flank positions. This setup was repeated with open ports exposing the enclosure to the external environment. To simulate stress scenarios, sampling was repeated with enclosure measurements during an increase in external particulate concentration.
The airflow technology effectively kept contaminants away from the incision and maintained a pressure differential to reduce particle entry. Benchtop testing demonstrated that even when ports were opened or the external environment had high contaminant burden, the enclosed surgical field consistently registered 0 particle count in all positions. Time from kit opening to incision averaged 54.5 seconds, with the rate-limiting step being connecting the environmental control unit to the enclosure. The portable kit weighted 5.9 lbs.
Analytic, in silico, and mechanical airflow modeling and benchtop testing have helped to quantify the SurgiBox system's reliability in creating and maintaining an operating room-quality surgical field within the enclosure as well as protecting the surgical team outside the enclosure. More recent and ongoing work has focused on specifying optimal use settings in the casualty chain of care, expanding support for circumferential procedures, automating airflow control, and accelerating system setup. SurgiBox's ultimate goal is to take timely, safe surgery to patients in even the most austere of settings.
在远前沿战场环境中，手术室和个人防护设备的短缺使得手术感染成为战斗死亡率和发病率的潜在问题。手术和运输人员也面临着因体液暴露而感染的风险。我们的研究旨在描述 SurgiBox 技术的连续、概念验证测试：一种充气式无菌环境，可解决上述问题，适合放在轮床和背包上，并覆盖切口。
根据在艰苦环境中进行手术的利益相关者的反复反馈，对 SurgiBox 环境控制单元和充气式外壳进行了五轮优化。气流系统通过分析建模开发，通过 SOLIDWORKS 中的计算机模拟进行验证，并通过原型烟雾轨迹检查确认。颗粒计数评估了外壳在各种设置下控制和减轻手术区域内潜在传染性污染物对使用者暴露的能力。SurgiBox 外壳在人体模型的躯干上进行设置，配置和位置适合进行胸部或腹部手术。一个粒子计数器被连续放置在胸骨切开术和剖腹术位置，以及双侧侧腹部位置。在向外部环境暴露外壳的情况下，重复打开端口的设置。为了模拟压力情况，在外部颗粒浓度增加时，重复进行外壳测量的采样。
气流技术有效地将污染物挡在切口外，并保持压差以减少颗粒进入。台式测试表明，即使打开端口或外部环境有很高的污染物负荷，封闭的手术区域始终在所有位置记录到 0 颗粒计数。从套件打开到切口的平均时间为 54.5 秒，限制步骤是将环境控制单元连接到外壳。便携式套件重 5.9 磅。
分析、计算机模拟和机械气流建模以及台式测试有助于量化 SurgiBox 系统在外壳内创建和维持手术室质量手术区域的可靠性，以及保护外壳外的手术团队。最近和正在进行的工作重点是在伤员救治链中指定最佳使用设置，扩大对环形手术的支持，实现气流控制自动化，并加快系统设置。SurgiBox 的最终目标是在最艰苦的环境中为患者提供及时、安全的手术。
