In the past, FDM 3D printing solutions have been primarily used for surgical planning. The added benefit is one can perform surgical planning digitally in preparation for surgical procedures, create mock up operations physically with the usage of trustworthy full-scale printed parts and test implants prior to inserting them into the body.
Example: A pre-surgical bone model printed on the Raise3D Pro2 Plus 3D Printer
But today with the use of metal 3D printing, the Russian company CML AT Medical of the North-West Nanocenter in collaboration with the Russian Scientific Research Institute of Traumatology and Orthopedics named after R.R. Vreden developed a custom 3D printed endoprosthesis (implanted prosthesis) for a knee joint replacement, as well as a part of a femur replacement.
The medical device is a full-metal implant that can not be taken apart. It is used to replace affected parts of a femur. Unlike common modular endoprostheses, this device offers improved density and longevity thanks to keeping the number of connecting parts as low as possible. The concept was developed by the scientists at the RSRI of T.O. named after R.R. Vreden and was later sent to CML AT Medical for further refinement. The engineers optimized the shape of the endoprosthesis, calculated the size and found where to place the cellular structures inside the implant, they also managed to reduce the costs of manufacturing without compromising on required properties.
The product was modeled using the CT scans of a patient, which allowed the engineers to consider the individual anatomical characteristics during the design process. The implant was produced using 3D printing with a biocompatible titanium alloy.
The first surgery involving this prosthesis was done at the beginning of 2021. The workers highlighted the convenience of the device using the surgery, as well as high levels of osseointegration and articular congruence post-surgery.
“Using a custom-made implant to replace a femur part with a serious defect resulted in a reliable primary implant fixation of an articular knee joint endoprosthesis of a standard design. This allowed a patient to quickly restore a lower limb support ability and functions of a knee joint without changing the standard rehabilitation program. Control radiological examinations done after three and six months demonstrated osseointegration of the implant to the bone,” commented Nikolay Kornilov, a professor of orthopedics and traumatology and lead researcher at the RSRI of T.O. named after R.R. Vreden.
CML AT Medical and RSRI of T.O. named after R.R. Vreden working together to develop an endoprosthesis for a knee joint and a femur is not a single example of a successful collaboration between this startup and medical institutions. Over the course of two years, the experts at this engineering company managed to develop medical devices for Tomsk National Research Medical Center of the Russian Academy of Sciences, Clinical Hospital no. 122 named after L.G. Sokolov of the FMBA, as well as the National Center for Neurosurgery in Nur-Sultan, Kazakhstan. According to Yana Chekryzhova, the General Director of ML AT Medical, the expertise of their team provides the best adaptation of the concepts designed by medical specialists for modeling and 3D printing of implants. Moreover, collaborations with leading medical centers increase the share of competitive products on the Russian medical devices market.
According to the calculation, the Russian market of medical implants has high prospects of growth. According to the numbers by the Centre for Innovative Technology in Orthopaedics (FGUP CITO) of Russia's Ministry of Industry and Trade, 1.216 million surgeries related to orthopaedics and trauma are performed annually in Russia. More than 250 thousand of them involve joints. An annual demand for medical devices for musculoskeletal disorders treatment in Russia is 3 million. The share of the Russian-made devices is lower than 15%. The development of the local market of 3D printed implants will fulfill the demand for medical devices and provide import substitution.
About the North-West Nanocenter
North-West Technology Transfer Center (North-West Nanocenter) is a part of the investment network of the Fund for Infrastructure and Educational Programs of the RUSNANO GROUP It aims to commercialize the solutions in the nanotechnology industry, based on unifying laboratory and technological equipment, as well as providing the services of marketing support for small innovative companies. North-West Nanocenter provides the full cycle of venture building.
CML AT Medical designs the products using both medical and engineering knowledge, meeting medical requirements and keeping in mind the peculiarities of manufacturing. The company’s portfolio includes development of individual endoprostheses with improved osseointegration based on CT scans, actuators and plates, serial medical devices and tools. Thanks to the network of partners with experience in 3D printing, mechanical processing, distribution and registration, the company can provide fast and efficient manufacturing of medical devices made from various materials.