Fabrication Of Patient-specific Implants Research Articles

Patient-specific implants made of 3D printed bioresorbable polymers at the point-of-care: material, technology, and scope of surgical application

BackgroundBioresorbable patient-specific additive-manufactured bone grafts, meshes, and plates are emerging as a promising alternative that can overcome the challenges associated with conventional off-the-shelf implants. The fabrication of patient-specific implants (PSIs) directly at the point-of-care (POC), such as hospitals, clinics, and surgical centers, allows for more flexible, faster, and more efficient processes, reducing the need for outsourcing to external manufacturers. We want to emphasize the potential advantages of producing bioresorbable polymer implants for cranio-maxillofacial surgery at the POC by highlighting its surgical applications, benefits, and limitations.MethodsThis study describes the workflow of designing and fabricating degradable polymeric PSIs using three-dimensional (3D) printing technology. The cortical bone was segmented from the patient’s computed tomography data using Materialise Mimics software, and the PSIs were designed created using Geomagic Freeform and nTopology software. The implants were finally printed via Arburg Plastic Freeforming (APF) of medical-grade poly (L-lactide-co-D, L-lactide) with 30% β-tricalcium phosphate and evaluated for fit.Results3D printed implants using APF technology showed surfaces with highly uniform and well-connected droplets with minimal gap formation between the printed paths. For the plates and meshes, a wall thickness down to 0.8 mm could be achieved. In this study, we successfully printed plates for osteosynthesis, implants for orbital floor fractures, meshes for alveolar bone regeneration, and bone scaffolds with interconnected channels.ConclusionsThis study shows the feasibility of using 3D printing to create degradable polymeric PSIs seamlessly integrated into virtual surgical planning workflows. Implementing POC 3D printing of biodegradable PSI can potentially improve therapeutic outcomes, but regulatory compliance must be addressed.

Investigation of Patient-Specific Maxillofacial Implant Prototype Development by Metal Fused Filament Fabrication (MF3) of Ti-6Al-4V.

Additive manufacturing (AM) and related digital technologies have enabled several advanced solutions in medicine and dentistry, in particular, the design and fabrication of patient-specific implants. In this study, the feasibility of metal fused filament fabrication (MF3) to manufacture patient-specific maxillofacial implants is investigated. Here, the design and fabrication of a maxillofacial implant prototype in Ti-6Al-4V using MF3 is reported for the first time. The cone-beam computed tomography (CBCT) image data of the patient’s oral anatomy was digitally processed to design a 3D CAD model of the hard tissue and fabricate a physical model by stereolithography (SLA). Using the digital and physical models, bone loss condition was analyzed, and a maxillofacial implant initial design was identified. Three-dimensional (3D) CAD models of the implant prototypes were designed that match the patient’s anatomy and dental implant requirement. In this preliminary stage, the CAD models of the prototypes were designed in a simplified form. MF3 printing of the prototypes was simulated to investigate potential deformation and residual stresses. The patient-specific implant prototypes were fabricated by MF3 printing followed by debinding and sintering using a support structure for the first time. MF3 printed green part dimensions fairly matched with simulation prediction. Sintered parts were characterized for surface integrity after cutting the support structures off. An overall 18 ± 2% shrinkage was observed in the sintered parts relative to the green parts. A relative density of 81 ± 4% indicated 19% total porosity including 11% open interconnected porosity in the sintered parts, which would favor bone healing and high osteointegration in the metallic implants. The surface roughness of Ra: 18 ± 5 µm and a Rockwell hardness of 6.5 ± 0.8 HRC were observed. The outcome of the work can be leveraged to further investigate the potential of MF3 to manufacture patient-specific custom implants out of Ti-6Al-4V.

Suturable regenerated silk fibroin scaffold reinforced with 3D-printed polycaprolactone mesh: biomechanical performance and subcutaneous implantation.

The menisci have crucial roles in the knee, chondroprotection being the primary. Meniscus repair or substitution is favored in the clinical management of the meniscus lesions with given indications. The outstanding challenges with the meniscal scaffolds include the required biomechanical behavior and features. Suturability is one of the prerequisites for both implantation and implant survival. Therefore, we proposed herein a novel highly interconnected suturable porous scaffolds from regenerated silk fibroin that is reinforced with 3D-printed polycaprolactone (PCL) mesh in the middle, on the transverse plane to enhance the suture-holding capacity. Results showed that the reinforcement of the silk fibroin scaffolds with the PCL mesh increased the suture retention strength up to 400%, with a decrease in the mean porosity and an increase in crystallinity from 51.9 to 55.6%. The wet compression modulus values were significantly different for silk fibroin, and silk fibroin + PCL mesh by being 0.16 ± 0.02, and 0.40 ± 0.06 MPa, respectively. Both scaffolds had excellent interconnectivity (>99%), and a high water uptake feature (>500%). The tissue's infiltration and formation of new blood vessels were assessed by means of performing an in vivo subcutaneous implantation of the silk fibroin + PCL mesh scaffolds that were seeded with primary human meniscocytes or stem cells. Regarding suturability and in vivo biocompatibility, the findings of this study indicate that the silk fibroin + PCL mesh scaffolds are suitable for further studies to be carried out for meniscus tissue engineering applications such as the studies involving orthotopic meniscal models and fabrication of patient-specific implants.

Clinical applications of three-dimensional printing in otolaryngology-head and neck surgery: A systematic review.

Medical three-dimensional (3D) printing, the fabrication of handheld models from medical images, has the potential to become an integral part of otolaryngology-head and neck surgery (Oto-HNS) with broad impact across its subspecialties. We review the basic principles of this technology and provide a comprehensive summary of reported clinical applications in the field. Standard bibliographic databases (MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and The Cochrane Central Registry for Randomized Trials) were searched from their inception to May 2018 for the terms: "3D printing," "three-dimensional printing," "rapid prototyping," "additive manufacturing," "computer-aided design," "bioprinting," and "biofabrication" in various combinations with the terms: "ptolaryngology," "head and neck surgery," and "otology." Additional articles were identified from the references of retrieved articles. Only studies describing clinical applications of 3D printing were included. Of 5,532 records identified through database searching, 87 articles were included for qualitative synthesis. Widespread implementation of 3D printing in Oto-HNS is still at its infancy. Nonetheless, it is increasingly being utilized across all subspecialties from preoperative planning to design and fabrication of patient-specific implants and surgical guides. An emerging application considered highly valuable is its use as a teaching tool for medical education and surgical training. As technology and training standards evolve and as healthcare moves toward personalized medicine, 3D printing is emerging as a key technology in patient care in Oto-HNS. Treating physicians and surgeons who wish to stay abreast of these developments will benefit from a fundamental understanding of the principles and applications of this technology. Laryngoscope, 129:2045-2052, 2019.

Patient-Specific Surgical Implants Made of 3D Printed PEEK: Material, Technology, and Scope of Surgical Application.

Additive manufacturing (AM) is rapidly gaining acceptance in the healthcare sector. Three-dimensional (3D) virtual surgical planning, fabrication of anatomical models, and patient-specific implants (PSI) are well-established processes in the surgical fields. Polyetheretherketone (PEEK) has been used, mainly in the reconstructive surgeries as a reliable alternative to other alloplastic materials for the fabrication of PSI. Recently, it has become possible to fabricate PEEK PSI with Fused Filament Fabrication (FFF) technology. 3D printing of PEEK using FFF allows construction of almost any complex design geometry, which cannot be manufactured using other technologies. In this study, we fabricated various PEEK PSI by FFF 3D printer in an effort to check the feasibility of manufacturing PEEK with 3D printing. Based on these preliminary results, PEEK can be successfully used as an appropriate biomaterial to reconstruct the surgical defects in a “biomimetic” design.

Patient-Specific Polyetheretherketone Facial Implants in a Computer-Aided Planning Workflow

In the present study, we report an innovative workflow using polyetheretherketone (PEEK) patient-specific implants for esthetic corrections in the facial region through onlay grafting. The planning includes implant design according to virtual osteotomy and generation of a subtraction volume. The implant design was refined by stepwise changing the implant geometry according to soft tissue simulations. One patient was scanned using computed tomography. PEEK implants were interactively designed and manufactured using rapid prototyping techniques. Positioning intraoperatively was assisted by computer-aided navigation. Two months after surgery, a 3-dimensional surface model of the patient's face was generated using photogrammetry. Finally, the Hausdorff distance calculation was used to quantify the overall error, encompassing the failures in soft tissue simulation and implantation. The implant positioning process during surgery was satisfactory. The simulated soft tissue surface and the photogrammetry scan of the patient showed a high correspondence, especially where the skin covered the implants. The mean total error (Hausdorff distance) was 0.81 ± 1.00 mm (median 0.48, interquartile range 1.11). The spatial deviation remained less than 0.7 mm for the vast majority of points. The proposed workflow provides a complete computer-aided design, computer-aided manufacturing, and computer-aided surgery chain for implant design, allowing for soft tissue simulation, fabrication of patient-specific implants, and image-guided surgery to position the implants. Much of the surgical complexity resulting from osteotomies of the zygoma, chin, or mandibular angle might be transferred into the planning phase of patient-specific implants.

Fatigue behavior of thin-walled grade 2 titanium samples processed by selective laser melting. Application to life prediction of porous titanium implants

Because of its biocompatibility and high mechanical properties, the commercially pure grade 2 titanium (CPG2Ti) is largely used for fabrication of patient specific implants or hard tissue substitutes with complex shape. To avoid the stress-shielding and help their colonization by bone, prostheses with a controlled porosity are designed. The selective laser melting (SLM) is well adapted to manufacture such geometrically complicated structures constituted by struts with rough surfaces and relatively small diameters. Few studies were dedicated to characterize the fatigue properties of SLM processed samples and bulk parts. They followed conventional or standard protocols. The fatigue behavior of standard samples is very different from the one of porous raw structures. In this study, the SLM made “as built” (AB) and “heat treated” (HT) tubular samples were tested in fatigue. Wöhler curves were determined in both cases. The obtained endurance limits were equal to σDAB=74.5MPa and σDHT=65.7MPa, respectively. The heat treatment worsened the endurance limit by relaxation of negative residual stresses measured on the external surface of the samples. Modified Goodman diagram was established for raw specimens. Porous samples, based on the pattern developed by Barbas et al. (2012), were manufactured by SLM. Fatigue tests and finite element simulations performed on these samples enabled the determination of a simple rule of fatigue assessment. The method based on the stress gradient appeared as the best approach to take into account the notch influence on the fatigue life of CPG2Ti structures with a controlled porosity. The direction dependent apparent fatigue strength was found. A criterion based on the effective, or global, nominal stress was proposed taking into account the anisotropy of the porous structures. Thanks to this criterion, the usual calculation methods can be used to design bone substitutes, without a precise modelling of their internal fine porosity.