Affordable bionic semi-patient-specific cranial implants for low- and middle-income countries and conflict zones

Abstract

Background: Expensive-to-treat conditions in low-income and low-to-middle-income countries (LMICs) are generally unmitigated, as the world’s health aid is mainly focused on transmissible diseases whose treatment costs are low. Cranioplasty is a neurosurgical procedure to reconstruct cranial defects. In LMICs, the most common reconstruction material is the autologous bone, although the complication rate is high. Other treatment modalities are often too expensive. Therefore, an affordable solution is needed to raise a standard for cranial reconstructions in emergency cases, conflict zones, developing countries and/or rural areas.

Objective: The objectives of this thesis are to formulate a design of a set for the creation of modular cranial semi-patient specific implant (semi-PSI) and demonstrate its clinical potential as an affordable solution for on-the-spot cranial reconstructions in LMICs and conflict zones.

Materials and Methods: As the main approach, this thesis project employs a Concurrent Engineering. The thesis is combining empirical and experimental research in every iteration phase of the workflow.

Results: In this thesis, a design concept of a set for the creation of a modular cranial semi-PSI is formulated together with the group of prominent Finnish neurosurgeons. This concept is based on a set of stackable geometrical modules, which can be clicked together akin to LEGO and placed in different configurations to match the shape of various cranial defects. In mechanical testing, the prototypes of the modular cranial semi-PSI did not disintegrate and were capable of mechanical performance in line with the Food and Drug Administration requirements in the United States. Clinical potential is successfully demonstrated by applying the prototypes of the modular cranial semi-PSI to artificial anonymized skulls produced by additive manufacturing.