Concept Laser medical implants
Additively manufactured implant, made with Concept Laser's M2 cusin machine
Concept Laser has revealed its LaserCUSING process has been leveraged by a leading player in the craniomaxillofacial (CMF) surgery field to produce patient-specific implants with titanium.
Synonymous with implants in craniomaxillofacial surgery for nearly 40 years, Karl Leibinger Medizintechnik, of the KLS Martin Group, has been additively manufacturing implants since 2013, using Concept Laser’s M2 cusing machine. The development of additive manufacturing techniques being used in surgical operations has seen the production of implants for correction through distraction and osteosynthesis significantly improved.
KLS Martin is one of the world’s leading suppliers of many of the essential items for operations in CMF surgery, ranging from plates, meshes, screws, pins, distractors, patient-specific implants through to lasers, HF equipment, surgical lights and sterilisation containers. Distraction osteogenesis involves the extension of bones – ‘reminding’ them to grow, if they have ‘forgotten’. For this reason, it is usually sufficient in the paediatric treatment of craniosynostosis, for example, to perform a one-off operation in order to open and distract the ossifying skull so that the brain has the required room to grow. Titanium osteosynthesis, the second key concept, involves giving the bone new stability, and is where the M2 cusing machine has made its impact.
Due to its excellent biocompatibility and its high resistance to corrosion, titanium has gained immense popularity and has successfully established itself as the material of choice in the medical field. It allows bone to grow and is therefore the perfect material for implants in combination with lattice structures made by additive manufacturing. Depending on the indication, titanium implants are likewise developed individually and manufactured conventionally as a mesh or as a high-strength solid reconstruction version.
Concept Laser medical implant
A craniomaxillofacial skull implant.
Frank Reinauer, Head of Innovation and Production of Biomaterials at KLM, now consistently relies on additively manufactured implants to perform successful surgeries in quick time, and printing in metal has also brought other benefits.
“This decision [purchasing Concept Laser machine], balancing the desire for innovation and the assessment of risk, proved to be a fruitful one: The complex part requirements for medical implants, even in light of very complicated rules and regulations, meant that the AM machine very quickly paid for itself,” said Reinauer. “Given the pressure of time for an operating room, the amount of time saved with tool-free manufacturing should also not be underestimated.
“But above all the strategic decision was an important driver because an additively manufactured titanium implant for an individual patient is a giant leap forward for clinical practice. The increasing spread of these implants around the world is also reflected in the fact that they are now a significant revenue driver for the company.
“From numerous aspects, we view titanium as providing the benchmark for implant technology. But there is another very important aspect in favour of additively manufactured titanium implants: the patient-specific geometry and precision fit. Ultimately this means a high level of functionality.”
Concept Laser surgical implant build plate
A build plate of craniomaxillofacial implants.
The KLS Martin Group long had its eye on adopting additive manufacturing. Though some doubts about how successful and costly it would be, KLS Martin’s management recongised the potential opportunities and gave the go ahead. It took the company around nine months to get through a preparatory phase because of the strict regulations and conditions in medical technology being extremely meticulous. Additionally, special regulations for different countries had to be considered.
Soon after KLS Martin’s adoption of metal 3D printing, they realised laser melting was the method of choice for titanium osteosynthesis. Able to produce large-scale reconstructions with complex geometries, LaserCUSING also offers sufficient geometric freedom, catering for specific aesthetic requirements. The parts also have high strength, and the material is biocompatible. Even those with allergies can receive titanium extremely well.
“Titanium has very high strength,” continued Reinauer. “Particularly with laser melting, we can tailor the construction very specifically to the patient’s anatomical structure, that is to say the optimum geometry, and incorporate the biological structure at the same time. We can define specific, including partial, surface roughness which help to ensure that the implant grows in well. Titanium, originally a material from the aerospace sector, has developed into a benchmark for medical technology. The material has set the standards in titanium osteosynthesis.”
