INK-BASED HYBRID MULTI-MATERIAL FABRICATION OF NEXT GENERATION IMPLANTS

Project Information

INKplant

Grant agreement ID: 953134

DOI

10.3030/953134

Project closed

EC signature date 16 December 2020

Start date 1 January 2021

End date 30 June 2024

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies

Total cost

€ 5 988 155,00

EU contribution

€ 5 988 155,00

Coordinated by

PROFACTOR GMBH
Austria

Periodic Reporting for period 2 - INKplant (INK-BASED HYBRID MULTI-MATERIAL FABRICATION OF NEXT GENERATION IMPLANTS)

Reporting period: 2022-07-01 to 2024-06-30

Summary of the context and overall objectives of the project

The vision of INKplant was to combine different new biomaterials, high resolution 3D-printing technologies (bi-material lithography-based ceramic manufacturing - LCM, multi-material inkjet printing) with new simulation & modelling and biological evaluation methods. This allows the design and fabrication of multi-material biomimetic scaffolds with appropriate composition and microstructure that induce tissue-specific regeneration, addressing the complexity of different tissues in the human body and consideration of the individual variations to patient´s requirements.
INKplant prepared implants for use cases that provide solutions to patients suffering from chronic defects of joints or dental tissues who have severely decreased life quality and depend continuously on health care. As 22% of the European population will be aged over 65 by the year 2025, rising to almost 30% by 2050, regenerative approaches become more important to sustainably heal and avoid further treatments.
INKplant aimed at the future incorporation of 3D-printed scaffolds into the daily routine of medical practice to foster personalized regenerative therapies for the whole society (concept shown in Figure1).
These overall objectives are set:

• To develop innovative manufacturing technologies for affordable patient-specific scaffolds;
• To create a workflow for the design optimization of 3D printed scaffolds,
• To demonstrate the INKplant approach in clinically relevant use cases,
• To assure the future translation of the technology to clinical application, via European regulatory approval and commercialization.

The INKplant project revolutionized medical implants by combining advanced 3D printing with biomedical materials to improve bone and cartilage repair. This was achieved through the successful development of a bi-material Lithography Ceramic Manufacturing process, a hybrid printing process combining ceramics and degradable photopolymers, and several inkjet printing processes including a 5-Axis multi-material printing module.
Within INKplant, the challenge of using regenerative biomaterials in high-resolution multi-material printing was solved and a new generation of high-performance printers constructed. New standards were developed and disseminated to accompany these processes with adequate validation and quality control measures that go beyond the specific application.
INKplant actively engaged stakeholders through various initiatives, including publications in biomaterials, additive manufacturing, and tissue engineering journals. The project also organized stakeholder and lead user workshops in collaboration with the external advisory board, focusing on design, materials and fixation techniques for implants. Additionally, INKplant promoted education and outreach by offering trainings for children, launching several new courses at universities, and incorporating project designs and prototypes as case studies in university courses. The ethics of the novel regenerative implants was explored and communication with patients realized in workshops. In an art project, the INKplant use cases were the base for an intuitive approach to communicate this new era of medical treatment.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

INKplant has achieved exceptional results by printing customizable implants and demonstrators tailored to individual defect sizes, anatomical features, and material composition. With a world's first 3D-printed ceramic subperiosteal implant in a clinical use case, award-winning CWA standards including a scaffold library that has already gained global popularity, improved solutions for surgical handling and implant fixation, and a flagship AM certification project for medical devices, INKplant's results were exceeding expectations. The INKplant approach provides biomechanical properties suitable for Meniscus, Osteochondral defects, Palatal clefts, Bone augmentation, and Subperiosteal implants.
User acceptance studies, including feedback from patients and clinicians, underscored the high demand for innovative solutions in customized implants. Moreover, the interactive art project “Intimate Implant” aimed to reflect on the impact of regenerative implants and their relationship with our bodies, and to engage a broader public in this reflection.
Advanced simulation and modeling methods enabled a novel design workflow that integrates pre-operative patient imaging, clinicians' experience, biomechanical characterization of multi-materials, and an optimization process for patient-specific implants.
We contributed significantly to standards for “Implants for Surgery,” published three CEN Workshop Agreements (CWAs) that may become new EN standards including design workflow for patient-specific implants, establishing a systematic procedure for personalized tissue engineering and minimizing errors throughout the design and manufacturing process. Further INKplant has developed and made publicly available the most comprehensive open-source library of tissue engineering scaffold designs, through e.g. Zenodo, Ubora, and Thingiverse, promoting collaborative innovation in research.
Commercialization of solutions for bone augmentation, subperiosteal implants, palatal cleft, and osteochondral defect implants will be managed by partners and have started their journey to registered medical products in a new spin-off company. Some materials will be further optimized in follow-up projects. Printer sales for lithographic ceramic manufacturing bi-material and GMP-compliant 5-axis multi-material printers are prepared, alongside with support for ink development, quality management consulting, and additive manufacturing services in dental medicine. Spin-off and start-up companies, such as Agensmed GmbH for subperiosteal and other implants, 3Dtive S.L. for dental AM solutions, and Resorbink for biodegradable polymers, will commercialize INKplant results.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

INKplant advanced beyond state of the art by developing innovative ceramic ink formulations and bi-material co-processing techniques, new inkjet printable formulations for soft materials, and a 5-axis multi-material printer that is already appreciated by future users in the AM community. In addition, optimised software and workflows for fabricating hybrid implants were introduced and new standards for modelling, design and characterisation methods were set, supporting the successful development of the integrated workflow from image data to printable files and the open scaffold libraries.
The clinical use case showed that the novel implants can minimize trauma to the patient and potentially reduce healthcare costs through faster rehabilitation compared to conventional therapies.
The technical and ethical advances have already been disseminated in lectures and workshops at renowned institutions across Europe.
The exchange of expertise between project partners, H2020 projects and external institutions in areas such as regulatory aspects, certification, AM technologies, manufacturing, ethics, material development and biological testing has increased understanding and improved the efficiency of research. By increasing interdisciplinary technology transfer, INKplant has contributed to strengthening the EU's competitiveness in the biomaterials and biomedical industries.

INKplant's concept: from medical imaging to optimized patient-specific biological scaffolds