Unveiling the prospects of point-of-care 3D printing of Polyetheretherketone (PEEK) patient-specific implants

Additive manufacturing (AM) or three-dimensional (3D) printing is rapidly gaining acceptance in the healthcare sector. With the availability of low-cost desktop 3D printers and inexpensive materials, in-hospital or point-of-care (POC) manufacturing has gained considerable attention in personalized medicine. Material extrusion-based [Fused Filament Fabrication (FFF)] 3D printing of low-temperature thermoplastic polymer is the most commonly used 3D printing technology in hospitals due to its ease of operability and availability of low-cost machines. However, this technology has been limited to the production of anatomical biomodels, surgical guides, and prosthetic aids and has not yet been adopted into the mainstream production of patient-specific or customized implants.
Polyetheretherketone (PEEK), a high-performance thermoplastic polymer, has been used mainly in reconstructive surgeries as a reliable alternative to other alloplastic materials to fabricate customized implants. With advancements in AM systems, prospects for customized 3D printed surgical implants have emerged, increasing attention for POC manufacturing. A customized implant may be manufactured within few hours using 3D printing, allowing hospitals to become manufacturers. However, manufacturing customized implants in a hospital environment is challenging due to the number of actions necessary to design and fabricate the implants.
The focus of this thesis relies on material extrusion-based 3D printing of PEEK patient-specific implants (PSIs). The ambitious challenge was to bridge the performance gap between 3D printing of PEEK PSIs for reconstructive surgery and the clinical applicability at the POC by taking advantage of recent developments in AM systems.
The main reached milestones of this project include:
(i) assessment of the fabrication feasibility of PEEK surgical implants using material extrusion-based 3D printing technology,
(ii) incorporation of a digital clinical workflow for POC manufacturing,
(iii) assessment of the clinical applicability of the POC manufactured patient-specific PEEK scaphoid prosthesis,
(iv) visualization and quantification of the clinical reliability of the POC manufactured patient-specific PEEK cranial implants, and
(v) assessment of the clinical performance of the POC manufactured porous patient-specific PEEK orbital implants.
During this research work, under the first study, we could demonstrate the prospects of FFF 3D printing technology for POC PEEK implant manufacturing. It was established that FFF 3D printing of PEEK allows the construction of complex anatomical geometries which cannot be manufactured using other technologies. With a clinical digital workflow implementation at the POC, we could further illustrate a smoother integration and faster implant production (within two hours) potential for a complex-shaped, patented PEEK patient-specific scaphoid prosthesis.
Our results revealed some key challenges during the FFF printing process, exploring the applicability of POC manufactured FFF 3D printed PEEK customized implants in craniofacial reconstructions. It was demonstrated that optimal heat distribution around the cranial implants and heat management during the printing process are essential parameters that affect crystallinity, and thus the quality of the FFF 3D printed PEEK cranial implants. At this stage of the investigation, it was observed that the root mean square (RMS) values for dimensional accuracy revealed higher deviations in large-sized cranial prostheses with “horizontal lines” characteristics.
Further optimization of the 3D printer, a layer-by-layer increment in the airflow temperature was done, which improved the performance of the FFF PEEK printing process for large-sized cranial implants. We then evaluated the potential clinical reliability of the POC manufactured 3D printed PEEK PSIs for cranial reconstruction by quantitative assessment of geometric, morphological, and biomechanical characteristics. It was noticed that the 3D printed customized cranial implants had high dimensional accuracy and repeatability, displaying clinically acceptable morphologic similarity concerning fit and contours continuity. However, the tested cranial implants had variable peak load values with discrete fracture patterns from a biomechanical standpoint. The implants with the highest peak load had a strong bonding with uniform PEEK fusion and interlayer connectivity, while air gaps and infill fusion lines were observed in implants with the lowest strength. The results of this preclinical study were in line with the clinical applicability of cranial implants; however, the biomechanical attribute can be further improved.
It was noticed that each patient-specific reconstructive implant required a different set of manufacturing parameters. This was ascertained by manufacturing a porous PEEK patient-specific orbital implant. We evaluated the FFF 3D printed PEEK orbital mesh customized implants with a metric considering the design variants, biomechanical, and morphological parameters. We then studied the performance of the implants as a function of varying thicknesses and porous design constructs through a finite element (FE) based computational model and a decision matrix based statistical approach. The maximum stress values achieved in our results predicted the high durability of the implants. In all the implant profile configurations, the maximum deformation values were under one-tenth of a millimeter (mm) domain. The circular patterned design variant implant revealed the best performance score. The study further demonstrated that compounding multi-design computational analysis with 3D printing can be beneficial for the optimal restoration of the orbital floor.
In the framework of the current thesis, the potential clinical application of material extrusion-based 3D printing for PEEK customized implants at the POC was demonstrated. We implemented clinical experience and engineering principles to generate a technical roadmap from preoperative medical imaging datasets to virtual surgical planning, computer-aided design models of various reconstructive implant variants, to the fabrication of PEEK PSIs using FFF 3D printing technology. The integration of 3D printing PEEK implants at the POC entails numerous benefits, including a collaborative team approach, quicker turnaround time of customized implants, support in pre-surgical and intraoperative planning, improved patient outcomes, and decreased overall healthcare cost. We believe that FFF 3D printing of customized PEEK implants could become an integral part of the hospitals and holds potential for various reconstructive surgery applications.