A 3D-printed customizable, lightweight definitive prosthetic socket that improves patient comfort and can be manufactured faster than conventional devices has been developed in a partnership between BASF (Florham Park, NJ) and 3D-printing and materials development company Essentium (College Station, TX). The prosthetic is printed using BASF’s Ultramid polyamide reinforced with short carbon fiber and is manufactured by Essentium subsidiary TriFusion Devices.
Described as the strongest 3D-printed thermoplastic carbon-fiber definitive prosthetic socket on the market, the device enables adjustments to be made in 2- to 3-mm increments without compromising its strength as needed throughout the life cycle of the prosthetic. Traditional sockets do not easily accommodate modifications, said BASF, and this feature considerably enhances patient comfort.
To ensure the sockets meet clinician and patient expectations, BASF and Essentium enlisted Anew Life Prosthetics and Orthotics, a clinic based in Detroit, MI, as a validation partner. Anew Life owner and clinician Chris Casteel, a past manufacturing professional and amputee, worked with patients to test the sockets and provide real-time feedback on improvements that could be made to the 3D-printing process and material selection. According to Casteel, patients said the test sockets fit like a glove and were overall more comfortable than other products.
By leveraging 3D printing, the companies also were able to accelerate the production process. A traditional carbon-fiber socket typically takes a technician three days to mold and cast, said BASF. By contrast, a 3D-printed socket can go from scan to ship in less than 24 hours. 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.
Although development of 3D-printed prosthetic devices is not yet regulated by FDA, Essentium and BASF chose to follow the strict standards outlined in the agency’s guidelines for additive manufacturing published in December 2017. Each part of the 30-step manufacturing process is documented, and the devices are hand inspected before being shipped to clinicians.
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 later this year.
The 3D printed prosthetic leg, with the carbon-fiber definitive socket and foot, will be on display at NPE2018 at the BASF booth (S15023).
Essentium is the developer of FlashFuse technology, which it claims can produce 3D-printed parts that match the strength of injection molded products. It also provides a line of 3D-printing materials. Prosthetics and orthotics company TriFusion was acquired by Essentium in February 2017.