An Evaluation Of The Use Of 3D Technologies In Developing Patient Specific Medical Devices For Interventional Radiology, And Its Potential Use For Producing A Personalised Embolic Coil for Peripheral Vasculature Embolization.
In this study it was shown that patient specific embolic coils for peripheral intervention can be produced utilising 3D patient scans and current materials and industry standard processes.The use of patient specific medical devices is growing since the invention of 3D technologies. This study investigated using this same technology to design a patient specific embolic coil. A key objective of the research was to establish if a patient specific coil could address complications and issues that are encountered with Off The Shelf (OTS) embolic coils. Literature on patient specific medical devices, 3D imaging, and embolization were reviewed to map the current landscape of embolic coiling, patient specific medical devices, costs, and regulatory considerations. There was a gap in the literature regarding patient specific embolic coils. Primary Research was conducted via individual interviews with 13 subject matter experts (SMEs) from the fields ofInterventional Radiology, Research & Development, Marketing, 3D Design and Process Development Engineering. The research found that there was no barrier to rendering a 3D anatomical scan into a patient specific embolic coil. Opinion of the SMEs was that current materials and standard manufacturing processes can be used to fabricate the same. The necessity for secondary devices, such as stents, can be overcome by producing a coil tailored to the patient’s anatomy. Prolonged procedure time can be reduced by delivering coils with a patient specific length. A wide range of OTS coils and liquid embolics exist, which provide the Interventional radiologist with a level of customization for each patient. It was found that a patient specific coil could be produced but that there may be only niche use for peripheral vascular treatment. The emergent nature of peripheral embolization procedures was deemed incompatible with the planning, design and manufacture required to produce a patient specific device. It was recommended the study be carried out in the field of Neuro Interventional Radiology as the level of planning, risk-reward and the specificity of tools required were greater than in Peripheral Vascular field. Also, it was recommended that research be conducted into the development of resorbable coils for Musculoskeletal (MSK) conditions.