3D printing industry is so fascinating as well as creating new milestone every day. Another new breakthrough has been achieved by the MedTech industry BellaSeno GmbH, an ISO 13485 certified company. They are developing resorbable scaffolds using additive manufacturing technologies. They have compared their results and presented it at the 24th EFORT Congress in Vienna, Austria. The polycaprolactone/hydroxyapatite bone reconstruction scaffolds made by them possess longer stress cycles and withstand higher loads than those produced by competing technologies.
Current technology
In the treatment of large bone defects and non-unions, the insertion of an osteoconductive structure (scaffold) to guide bone regeneration is involved. There are several companies which have used additive manufacturing to construct new and customized scaffolds as per the requirement of patients. Often, these scaffolds are printed from resorbable materials like polycaprolactone (PCL), polylactic acid, or composites of PCL and hydroxyapatite (HA) and are meant to secure the autologous bone graft. These scaffolds are created by selective laser sintering (SLS) or fused deposition modelling (FDM). BellaSeno working on both technique to tailor and fine-tune the manufacturing process.
Results: SLS vs FDM
They have tested the biomechanical properties of polycaprolactone/hydroxylapatite (PCL/HA) scaffolds produced for bone regeneration developed by both the processes. For this testing, standard lattice design triangular scaffolds (30mm x 30mm) were fabricated under optimized conditions. After that, a mechanical testing apparatus was used to perform high-precision axial compression-deformation tests on the scaffolds. The specimens were subjected to an increasing axial load for 1,000 cycles at 500, 700, 1,000, and 1,100 N. The amount of strain was expressed as a percentage of the applied force. They have found that FDM scaffold could easily withstand up to 1000 N load while SLS developed scaffold resulted in immediate failure on the application of 700 N.
Conclusive Remark
“The data clearly demonstrate that our proprietary FDM-based technology has a decisive impact on the axial mechanical stability of the final product,” said Dr. Med. Tobias Grossner, Chief Medical Officer of BellaSeno. “PCL/HA composite scaffolds produced by selective laser sintering have much lower mechanical integrity. Moreover, the overall waste of raw material is less for FDM compared to SLS.” “To our knowledge, this is the first time such a comparison has been published,” said Mohit Chhaya, CEO of BellaSeno. “We are very pleased that our approach using FDM can be considered the more robust and more economical technology to produce scaffolds for bone reconstruction. However, SLS still is an option for applications where we need higher design freedom, e.g., when overhanging structures are necessary. In these cases, it is superior to FDM.”
BellaSeno’s resorbable implants are safe, well-tolerated, and stimulate natural tissue growth, according to preliminary results from current Phase I research. However fully developed scaffold used in the treatment of large bone defects may take time…