Development of a Pullback Device for Intravascular Ultrasound and Photoacoustic Catheter Imaging

Abstract

Introduction – Cardiovascular diseases are the leading cause of death in the world with one in three succumbing to the disease. The most common cardiovascular disease is coronary artery disease, caused by atherosclerosis resulting in a build-up of plaque within the arteries. This plaque can progress into a vulnerable plaque, which has been linked to an increase in major adverse cardiac events. Identification of a vulnerable plaque can lead to more precise treatment, better patient outcomes, and fewer reinterventions. A technique currently in development is intravascular photoacoustic catheter imaging combined with intravascular ultrasound, which can detect both the composition and the structure of a plaque. Current pullback devices – a device for driving the catheter – don’t exist for a clinical setting for this application and are used for research purposes only. This project is a design study looking into the different aspects that go into the development of such a product with the aim of usability, divided into two goals: Exploring the catheter connection to the pullback device that is suitable for users of the product, and the redesign of the pullback device.
Methods and Materials – The first part concerns the design of the catheter connection to the pullback device for users of the product. The users are interventional cardiologists and anyone who interacts with the device in a clinical setting. Catheter connector designs are prototyped and central to a short user experience study. The design space for current catheter connector devices is explored and four connectors are designed. A user experience study is made with the aim of obtaining feedback on different design aspects and what this user group prefers in catheter connector devices. The second part concerns the redesign of the system. A system design is proposed within the set requirements.
Results – Catheter connector designs are designed and 3D printed, assembled and placed in mock-up pullback devices as prototypes. These have been shown to users of the product during a user experience study. This study has shown that users (n=5) have clear preference for some design aspects, such as a twisting connection, relatively small connection devices, automatic signal connection parts, among others. A redesign of the system is performed within the set requirements, where design aspects and their consequences are considered. This is done through an iterative design process to enquire feedback from technicians, until a satisfactory system is proposed. This includes the signal transfer to the catheter and back, the rotation of the catheter, the pullback of the catheter, and its housing.
Discussion – Catheter connection design aspects have been explored after which a system redesign is proposed. This redesign lacks the connection between the signal connectors of the catheter and the pullback device. This connection is highly dependent on the disconnection method, which is non-trivial and infeasible to explore in this user experience study. The catheter connector could encompass a project in itself. The system redesign originally was aimed at the manufacture of the device, but was deemed infeasible for this project. Instead the project was aimed to be a design study of the development of such a device. As it stand, the current device is larger than preferred by users, which could be scaled down in collaboration with parts manufacturers. This can also downscale the motor for rotation, which is implemented to work at the devices maximum expected power requirements.
Conclusion – This thesis focused on the design study of a pullback device for intravascular photoacoustic and ultrasound catheter imaging for users of such a device. Catheter connection design aspects have been explored after which a system redesign is proposed considering the many different aspects that go into such a design. All designs have been handed over to Kaminari Medical