The Haermonic Flush. Designing the next Pericardial Flushing Device

Abstract

The goal of this graduation project was to design the next pericardial flushing device. The whole “Post Pericardial Flushing project (PPF)” was initiated by Dave Koolbergen and Johan Manshanden as a clinical study to introduce a new technique to actively flush the pericardial section of the human body after open heart surgery. The key functionality of the device is to flush an infusion fluid through the space around the heart sack to make sure the unwanted body fluids and clots are safely drained. Therfore, they will not cause any inflammatory reactions inside the pericardial area in a post-operative state. Within this project several clinical studies and trials are involved. At this stage there was a need for technical development of the experimental prototype which was built by the AMC itself. After a selection procedure I got the opportunity to work on designing the next generation of the pericardial flushing device. The designing project consisted out of three main phases: the Analysis, the Concept and the Embodiment phase. First, in the Analysis phase an internal and external analysis was performed to formulate a final design scope. The result from this analysis phase was a visual with possible design directions. After a selection of the possible design directions the final scope of this project is described as follows: 1. Design a casing to increase the safety and hygiene of the device 2. Increase the user friendliness of the device 3. Reduce the dimensions of the device The design project was carried out with great attention for the user; User Centred Design. The current prototype of the AMC was functioning, but minimal attention was paid to the user experience of the device: the IC-nurses, the surgeons, the OR-staff and of course the patient itself. The introduction of this new vision created a lot of “positive buzz” inside the AMC. Everyone knew about the developments and people were getting more and more enthusiastic. Subsequently, in the Concept phase many ideas were generated and a final concept was designed. It all started with brainstorm sessions with several stakeholders so the total spectrum of wishes was carefully analysed. Next, the iterative process of creating concepts started: start with a great variety of idea sketches and conclude with one feasible concept. Major outcome was the transformation of the 1.80 meters tall stand-alone AMC prototype to an integrated device into the back of the IC-bed without using any unnecessary space. The result is an almost invisible medical device on the back of the IC-bed for the patient and an intuitive medical assisting device for the medical professionals to work with. Finally, in the Embodiment phase a prototype was created. Extensive optimizations were made to make the step from feasible concept to feasible prototype. Aspects such as materials and production methods greatly influence the manufacturability of the prototype. After this engineering step the prototype was produced and evaluated in several clinical lessons given by Johan and myself. The development of the design can be found in the timetable of the design.