BASF and  Essentium, under its subsidiary brand  TriFusion Devices, bring the strongest 3D printed thermoplastic carbon fibre definitive prosthetic socket to market that is easily customized to ensure the most comfortable fit for patients.

The prosthetic, printed with BASF’s Ultramid polyamide reinforced with short carbon fibre, is lightweight, yet tough and more flexible than traditional carbon fibre sockets. The definitive socket is made with thermoplastic material that enables small adjustments in increments of 2-3mm without weakening as needed throughout the life cycle of the prosthetic, a crucial development as a patient’s body changes over time. While traditional sockets do not easily accommodate modifications, BASF’s material allows changes to be made directly to the socket to ensure it always fits a patient comfortably.

“It’s a rewarding process to develop the formulation in the lab with Essentium and then turn that resin into a real material, knowing it can impact prosthetic patients in a positive way,” said Oleksandra Korotchuk, New Market Development Scout, Performance Materials at BASF. “It’s a true validation of the partnership and we will continue to uncover new materials and techniques that will unlock advanced design and speed capabilities.”

To ensure the sockets meet clinicians and patients’ expectations, the companies enlisted  Anew Life Prosthetics and Orthotics, a Southeast Mich. based clinic, as a validation partner. BASF introduced Essentium to Chris Casteel, owner of Anew Life, to determine the fit and function of TriFusion 3D printed sockets. As a clinician, past manufacturing professional and amputee himself, Casteel works with patients to test the sockets and provide real-time feedback to Essentium and BASF on improvements to the 3D printing process and material selection. According to Casteel, patients shared that the test sockets fit like a glove and are overall more comfortable.

“Just like anything else, it’s one thing to hear about a product like this, but another thing to actually feel and touch it,” Casteel said. “We received extremely positive feedback from patients on the 3D printed test sockets and it is incredible to see and feel how well they fit. This is a huge success for the prosthetic industry and I look forward to seeing what comes next.”

Patient safety and satisfaction are of utmost importance, so while the development of 3D printed prosthetic devices is not yet regulated by the FDA, Essentium and BASF choose to follow the strict standards outlined in the regulatory body’s guidelines for Additive Manufacturing set forth December, 2017. Each of the 30-step manufacturing process is documented and the devices are hand inspected before being shipped to clinicians.

A traditional carbon fiber socket typically takes three days of labor by a technician to mold and cast. The 3D printed socket streamlines the time- and resource-intensive production process to less than 24 hours from scan to ship. This allows for efficient order fulfillment, increased patient interface and profitability for clinicians. It also eliminates human error as the scan ensures the socket fit is close to correct the first time.

“The materials used in these definitive sockets have the power to open up people’s lives to more mobility and more freedom,” said Blake Teipel, president and co-founder of Essentium, Inc. “As we propel 3D printing of functional parts, we’re proud to make a prosthetic that’s more customized, lightweight, affordable and comfortable for the patient, and make the production process easier and more efficient for the clinician.”

The companies are also actively pursuing the production of a multi-material 3D printed prosthetic with rigid and flexible TPU elements. The hard-soft socket would allow clinicians to implement soft material into the design for increased comfort on sensitive areas. It is expected to launch in 2018.

The 3D printed prosthetic leg, with the carbon fibre definitive socket and foot, will be on display at  NPE 2018.