Design of a Minimally Invasive Surgical Instrument Set
For an Innovative Titanium Implantable Vertebral Augmentation Device
D.C. Sarwin (TU Delft - Mechanical Engineering)
Johan M.F. Molenbroek – Mentor (TU Delft - Human Factors)
J Zhou – Mentor (TU Delft - Biomaterials & Tissue Biomechanics)
Y Song – Mentor (TU Delft - Industrial Design Engineering)
T. Horeman-Franse – Coach (TU Delft - Medical Instruments & Bio-Inspired Technology)
S. Aarts – Coach (Amber Implants B.V.)
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Abstract
Purpose
As a result of the worldwide aging population, Vertebral Compression Fractures (VCF) are commonly detected in osteoporotic patients; these can originate from traumatic events or occur spontaneously. The existing VCF devices and their corresponding surgical instruments have their limitations in terms of short- and long-term performance, efficiency, safety, and complications. Amber Implants has developed an innovative new Titanium Implantable Vertebral Augmentation Device (TIVAD) that overcomes the shortcomings of the available state-of-the-art VCF devices. However, the specific surgical instruments required for the insertion and deployment of the TIVAD are yet to be developed.
Methods
A knowledge-driven iterative design process that includes extensive theoretical and empirical research together with spine surgeons, concept development, and experimental verification phases has been executed.
Results
The outcomes of the experiments have shown that the final TIVAD inserter and expander met the predefined requirements regarding efficiency, mechanical properties, and usability. These results lead to a significant contribution to the overall TIVAD procedure.
Conclusions
To summarize, it can be stated that the essential surgical instruments, the TIVAD inserter, and expander, enable the surgeon to insert and deploy the TIVAD to relieve the patient from its pain sensation and to restore the adequate spine curve while reducing the number of surgical steps, the overall surgery time, and thus costs. Additionally, the risk of infection and pulmonary embolisms is decreased significantly due to the TIVAD’s non-PMMA minimally invasive surgical procedure.