ADDITIVE MANUFACTURING
MEDICAL MARVEL
E
ver since inventor Chuck Hull fi led the fi rst patent for stereolithography (SLA) in the late 1980s, 3D printing has
evolved signifi cantly. Today, tailored pharmaceuticals and even the potential for organs crafted from living cells are possible to the imagination, with the potential of 3D printing promising further groundbreaking developments in medicine. In fact, this April, the Food and
Drug Administration (FDA) gave additive manufacturing solutions provider 3D Systems – which Hull also co-founded – 510(k) clearance for its 3D-printed, patient-specifi c cranial implant solution: VSP PEEK Cranial Implant. Such clearance enables widespread adoption of the company’s self-contained, cleanroom environment-based printing system, the EXT 220 MED, with implant- grade PEEK (polyetheretherketone) materials to deliver patient-specifi c cranial reconstruction solutions.
According to the Director of
Medical Devices at 3D Systems, Stefan Leonhardt, the technology can produce patient-specifi c cranial implants with up to 85% less material than similar implants produced by traditional machining, which can lead to signifi cant cost savings for expensive raw materials such as implantable PEEK. The cleanroom- based architecture of the printer, combined with simplifi ed post- processing workfl ows, also makes it an ideal technology for producing patient- specifi c medical devices at the hospital site with faster turnaround, while keeping the overall cost under control.
PEEK PERFORMANCE The VSP PEEK Cranial Implant is the fi rst FDA-cleared, additively manufactured patient-specifi c PEEK implant intended for cranioplasty procedures to restore defects in the skull. This implant-grade, high- performance polymer has a well- known clinical history in medical device applications as it possesses properties close to that of the human bone. In addition, PEEK has great biocompatibility, resistance to bodily fl uids, and stability in a wide range of temperatures, making it an ideal choice for many medical device applications. Moreover, the durability and
strength of the material and the implant’s contoured fi t make it an ideal choice for reconstruction. 3D printing in PEEK is also quicker than using traditional milling processes and is more compatible with diagnostic imaging. Meanwhile, the material is lightweight and eliminates temperature sensitivity, improving patient comfort.
The EXT 220 MED is the only extrusion platform that features an integrated clean room and is validated by leading medical device manufacturers and hospitals worldwide
12
www.engineerlive.com
A novel 3D printed implant solution has emerged, poised to enhance patient care in the fi eld of neurosurgery. By Siobhan Doyle
THE PRINTING PROCESS Leonhardt explains the process in creating the implant, stating that it all starts with a CT scan. “Based off that CT scan done at a hospital, the next workfl ow step is segmentation,” he says. “Here, we use software called D2P to create a three-dimensional model of the skull and the defect. In a second software called Freeform the implant is designed to fi ll the patient’s skull defect.” 3D Systems also off ers guidelines to help users of the system design an implant to ensure it perfectly fi ts the patient at the end of the process. Medical experts can then import
the model onto 3D Systems’ EXT 220 MED open fi lament 3D printer to print the implant. Formerly known as Kumovis R1, the printer is equipped with a global laminar air fl ow which allows users to heat the build chamber homogenously up to 250°C. The additional local airfl ow helps users improve the mechanical properties of the device. The platform is also designed to control temperature during production. “High-performance polymers such
as PEEK need to be processed at extremely high temperatures, as we have to ensure that each layer shows a good bonding to the next layer ,” Leonhardt explains. “The layer bonding is determining the mechanical properties of the fi nal part. Our proprietary temperature management system ensures that we are processing PEEK at optimal conditions to produce printed parts that show mechanical properties comparable to machined implants.” The EXT 220 MED printer includes
a fi lter system which creates a clean- room environment inside the build chamber. Particle measurements show that an environment equal to an ISO class 7 cleanroom can be achieved. “This fi ltration system ensures that there’s no contaminations
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