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INTRODUCTION

Extra-uterine life support technology could provide a more physiologic alternative for the treatment of extremely premature infants, as it allows further fetal growth and development ex utero. Animal studies have been carried out which involved placing fetuses in a liquid-filled incubator, with oxygen supplied through an oxygenator connected to the umbilical vessels. Hence, by delaying lung exposure to air, further lung development and maturation can take place. This medical intervention requires adjustments to current obstetric procedures to maintain liquid-filled lungs through a so-called transfer procedure.

METHODS

Our objective was to develop obstetric device prototypes that allow clinicians to simulate this birth procedure to safely transfer the infant from the mother's uterus to an extra-uterine life support system. To facilitate a user-centered design, implementation of medical simulation during early phase design of the prototype development was used. First, the requirements for the procedure and devices were established, by reviewing the literature and through interviewing direct stakeholders. The initial transfer device prototypes were tested on maternal and fetal manikins in participatory simulations with clinicians.

RESULTS & DISCUSSION: Through analysis of recordings of the simulations, the prototypes were evaluated on effectiveness, safety and usability with latent conditions being identified and improved. This medical simulation-based design process resulted in the development of a set of surgical prototypes and allowed for knowledge building on obstetric care in an extra-uterine life support context.

INTRODUCTION

METHODS

引言

宫外生命支持技术可为治疗极早产儿提供一种更符合生理的替代方法，因为它能使胎儿在宫外进一步生长发育。已经开展了动物研究，即将胎儿置于充满液体的培养箱中，并通过连接到脐血管的氧合器供应氧气。因此，通过延迟肺部暴露于空气中，肺部可以进一步发育和成熟。这种医疗干预需要调整当前的产科程序，通过所谓的转运程序来维持肺部充满液体。

方法

我们的目标是开发产科设备原型，使临床医生能够模拟这种分娩程序，将婴儿从母亲子宫安全转运至宫外生命支持系统。为便于以用户为中心进行设计，在原型开发的早期设计阶段采用了医学模拟。首先，通过查阅文献和采访直接利益相关者，确定了该程序和设备的要求。最初的转运设备原型在与临床医生进行的参与性模拟中，在母体和胎儿人体模型上进行了测试。