Time to consider blunt needles for implant surgery? A systematic review and meta-analysis shows that blunt suture needles reduce glove perforation.

BACKGROUND: Despite a recent Cochrane Review demonstrating blunt suture needles are safer for surgeons, the use of blunt suture needles has not become widely adopted. In the 'Implant Era', with the value of medical implant companies to surpass $145 billion by 2027, should we re-examine the use of blunt suture needles, especially to reduce infection in implant surgery? We performed a systematic review and meta-analysis of randomised controlled trials (RCTs) assessing whether blunt suture needles reduce risks to surgeons and patients. METHODS: A systematic review and meta-analysis was performed per PRISMA guidelines. PubMed, Cochrane and EMBASE databases were searched for RCTs. Dichotomous variables were pooled as risk ratios (RR) and associated 95% confidence intervals (CI) using the MH method. Random or fixed effects modelling use was based on statistical heterogeneity (I2). RESULTS: 14 RCTs were identified with 2488 patients. The RCTs included laparotomies, caesarean sections, episiotomies, and orthopaedic surgeries. Blunt suture needles when compared with sharp needles resulted in a significant reduction in glove perforation; RR: 0.47, 95% CI [0.37 to 0.60] and needlestick injuries, RR: 0.50, 95% CI [0.26 to 0.97]. Sharp needles caused more wound infections, but the result was not statistically significant; RR: 2.73, 95% CI [0.54 to 13.76], p 0.22. Surgeon's satisfaction decreased with blunt needles compared with sharp (RR: 1.22, 95% CI [1.09 to 1.37]). CONCLUSION: Blunt suture needles are safer than sharp needles for surgeons and likely reduce risks to patients. This, however, comes at the cost of decreased ease of use. The authors recommend the routine use of blunt suture needles, especially in implant surgery.

Reduced Cell Adhesion on LightPLAS-Coated Implant Surfaces in a Three-Dimensional Bioreactor System.

Most implants used in trauma surgery are made of steel and remain inside the body only temporarily. The strong tissue interaction of such implants sometimes creates problems with their explantation. Modified implant surfaces, which decrease tissue attachment, might allow an easier removal and therefore a better outcome. Such a modification must retain the implant function, and needs to be biocompatible and cost-effective. Here, we used a novel VUV-light (Vacuum-Ultraviolett)-based coating technology (LightPLAS) to generate coated stainless-steel plates. The tested LightPLAS coating only had an average thickness of around 335 nm, making it unlikely to interfere with implant function. The coated plates showed good biocompatibility according to ISO 10993-5 and ISO 10993-12, and reduced cell adhesion after four different time points in a 2D cell culture system with osteoblast-like MG-63 cells. Furthermore, we could show decreased cell adhesion in our 3D cell culture system, which mimics the fluid flow above the implant materials as commonly present in the in vivo environment. This new method of surface coating could offer extended options to design implant surfaces for trauma surgery to reduce cell adhesion and implant ingrowth. This may allow for a faster removal time, resulting in shorter overall operation times, thereby reducing costs and complication rates and increasing patient wellbeing.

What is the best technic to dislodge Staphylococcus epidermidis biofilm on medical implants?

BACKGROUND: Bacterial biofilm can occur on all medical implanted devices and lead to infection and/or dysfunction of the device. In this study, artificial biofilm was formed on four different medical implants (silicone, piccline, peripheral venous catheter and endotracheal tube) of interest for our daily clinical and/or research practice. We investigated the best conventional technic to dislodge the biofilm on the implants and quantified the number of bacteria. Staphylococcus epidermidis previously isolated from a breast implant capsular contracture on a patient in the university hospital of Dijon was selected for its ability to produce biofilm on the implants. Different technics (sonication, Digest-EUR®, mechanized bead mill, combination of sonication plus Digest-EUR®) were tested and compared to detach the biofilm before quantifying viable bacteria by colony counting. RESULTS: For all treatments, the optical and scanning electron microscope images showed substantial less biofilm biomass remaining on the silicone implant compared to non-treated implant. This study demonstrated that the US procedure was statistically superior to the other physical treatment: beads, Digest-EUR® alone and Digest-EUR® + US (p < 0.001) for the flexible materials (picc-line, PIV, and silicone). The number of bacteria released by the US is significantly higher with a difference of 1 log on each material. The result for a rigid endotracheal tube were different with superiority for the chemical treatment dithiothreitol: Digest-EUR®. Surprisingly the combination of the US plus Digest-EUR® treatment was consistently inferior for the four materials. CONCLUSIONS: Depending on the materials used, the biofilm dislodging technique must be adapted. The US procedure was the best technic to dislodge S. epidermidis biofilm on silicone, piccline, peripheral venous catheter but not endotracheal tube. This suggested that scientists should compare themselves different methods before designing a protocol of biofilm study on a given material.

Use of Miniature Step Gauges to Assess the Performance of 3D Optical Scanners and to Evaluate the Accuracy of a Novel Additive Manufacture Process.

In this work, we show how miniature step gauges featuring unidirectional and bidirectional lengths can be used to assess the performance of 3D optical scanners as well as the accuracy of novel Additive Manufacturing (AM) processes. A miniature step gauge made of black polyphenylene sulfide (PPS) was used for the performance verification of three different optical scanners: a structured light scanner (SLS), a laser line scanner (LLS), and a photogrammetry-based scanner (PSSRT), having comparable resolutions and working volumes. Results have shown a good agreement between the involved scanners, with errors below 5 µm and expanded uncertainties below 10 µm. The step gauge geometry due to the bidirectional lengths, highlights that there is a different interaction between the optical properties of the step gauge under measurement and each optical instrument involved and this aspect has to be considered in the uncertainty budget. The same geometry, due to its great significance in the detection of systematic errors, was used, as a novelty, to evaluate the accuracy of Lithography-based Ceramics Manufacturing (LCM), a proprietary additive manufacturing technology used for the fabrication of medical implants. In particular, two miniature step gauges made of Tricalcium Phosphate (TCP) were produced. Measurements conducted with the SLS scanner were characterized by a negligible error and by an uncertainty of about 5 µm. Deviations of the manufactured step gauges with respect to the Computer Aided Designed (CAD) model were comprised between ±50 µm, with positive deviations in the order of 100 µm on vertical sides. Differences in the order of 50 µm between the two step gauges were registered.

Framing the failure of medical implants: Media representations of the ASR hip replacements in the UK.

BACKGROUND: During the twentieth century, hip replacement became one of the most popular and successful operations. In the 1990s, a new type of hip replacement namely the metal-on-metal hip resurfacing was developed. This paper draws on one of the available implants, namely the DePuy Orthopaedics' Articular Surface Replacement (ASR) hip system which was withdrawn from the market because of higher than expected rates of failure. It examines media representations on the failure of the ASR metal-on-metal hip replacement device and its subsequent withdrawal from the market. METHODS: Drawing on content analysis this paper explores how systemic failure of the medical implant was framed and performed by press media in the UK. RESULTS: Two narratives were particularly important in framing press media coverage of the ASR case: the role of patients as passive recipients of care and a distinction between health and disability identities as related to how individuals' narratives about the past shaped their sense of present and future. In all cases, the voice of the orthopaedic surgeons responsible for the selection and implantation of the ASR devices remains silent. CONCLUSIONS: Press media coverage of medically induced harm in the UK is significantly less common than coverage of any other patient safety issues and public health debates. This study aims to contribute to the evidence base on how public discourse on medically induced harm becomes framed through the reported experiences of individuals in press media and also how this process influences the legitimacy of various solutions to medical errors or unanticipated outcomes.

AMPs as Anti-biofilm Agents for Human Therapy and Prophylaxis.

Microbial cells show a strong natural tendency to adhere to surfaces and to colonize them by forming complex communities called biofilms. In this growth mode, biofilm-forming cells encase themselves inside a dense matrix which efficiently protects them against antimicrobial agents and effectors of the immune system. Moreover, at the physiological level, biofilms contain a very heterogeneous cell population including metabolically inactive organisms and persisters, which are highly tolerant to antibiotics. The majority of human infectious diseases are caused by biofilm-forming microorganisms which are responsible for pathologies such as cystic fibrosis, infective endocarditis, pneumonia, wound infections, dental caries, infections of indwelling devices, etc. AMPs are well suited to combat biofilms because of their potent bactericidal activity of broad spectrum (including resting cells and persisters) and their ability to first penetrate and then to disorganize these structures. In addition, AMPs frequently synergize with antimicrobial compounds and were recently reported to repress the molecular pathways leading to biofilm formation. Finally, there is a very active research to develop AMP-containing coatings that can prevent biofilm formation by killing microbial cells on contact or by locally releasing their active principle. In this chapter we will describe these strategies and discuss the perspectives of the use of AMPs as anti-biofilm agents for human therapy and prophylaxis.

Local SAR near deep brain stimulation (DBS) electrodes at 64 and 127 MHz: A simulation study of the effect of extracranial loops.

PURPOSE: MRI may cause brain tissue around deep brain stimulation (DBS) electrodes to become excessively hot, causing lesions. The presence of extracranial loops in the DBS lead trajectory has been shown to affect the specific absorption rate (SAR) of the radiofrequency energy at the electrode tip, but experimental studies have reported controversial results. The goal of this study was to perform a systematic numerical study to provide a better understanding of the effects of extracranial loops in DBS leads on the local SAR during MRI at 64 and 127 MHz. METHODS: A total of 160 numerical simulations were performed on patient-derived data, in which relevant factors including lead length and trajectory, loop location and topology, and frequency of MRI radiofrequency (RF) transmitter were assessed. RESULTS: Overall, the presence of extracranial loops reduced the local SAR in the tissue around the DBS tip compared with straight trajectories with the same length. SAR reduction was significantly larger at 127 MHz compared with 64 MHz. SAR reduction was significantly more sensitive to variable loop parameters (eg, topology and location) at 127 MHz compared with 64 MHz. CONCLUSION: Lead management strategies could exist that significantly reduce the risks of 3 Tesla (T) MRI for DBS patients. Magn Reson Med 78:1558-1565, 2017. © 2016 International Society for Magnetic Resonance in Medicine.

Wireless induction coils embedded in diamond for power transfer in medical implants.

Wireless power and data transfer to medical implants is a research area where improvements in current state-of-the-art technologies are needed owing to the continuing efforts for miniaturization. At present, lithographical patterning of evaporated metals is widely used for miniature coil fabrication. This method produces coils that are limited to low micron or nanometer thicknesses leading to high impedance values and thus limiting their potential quality. In the present work we describe a novel technique, whereby trenches were milled into a diamond substrate and filled with silver active braze alloy, enabling the manufacture of small, high cross-section, low impedance microcoils capable of transferring up to 10 mW of power up to a distance of 6 mm. As a substitute for a metallic braze line used for hermetic sealing, a continuous metal loop when placed parallel and close to the coil surface reduced power transfer efficiency by 43%, but not significantly, when placed perpendicular to the microcoil surface. Encapsulation of the coil by growth of a further layer of diamond reduced the quality factor by an average of 38%, which can be largely avoided by prior oxygen plasma treatment. Furthermore, an accelerated ageing test after encapsulation showed that these coils are long lasting. Our results thus collectively highlight the feasibility of fabricating a high-cross section, biocompatible and long lasting miniaturized microcoil that could be used in either a neural recording or neuromuscular stimulation device.

Evolutionary trends and innovations in cardiovascular intervention.

Cardiovascular diseases remain a global health challenge, prompting continuous innovation in medical technology, particularly in Cardiovascular MedTech. This article provides a comprehensive exploration of the transformative landscape of Cardiovascular MedTech in the 21st century, focusing on interventions. The escalating prevalence of cardiovascular diseases and the demand for personalized care drive the evolving landscape, with technologies like wearables and AI reshaping patient-centric healthcare. Wearable devices offer real-time monitoring, enhancing procedural precision and patient outcomes. AI facilitates risk assessment and personalized treatment strategies, revolutionizing intervention precision. Minimally invasive procedures, aided by robotics and novel materials, minimize patient impact and improve outcomes. 3D printing enables patient-specific implants, while regenerative medicine promises cardiac regeneration. Augmented reality headsets empower surgeons during procedures, enhancing precision and awareness. Novel materials and radiation reduction techniques further optimize interventions, prioritizing patient safety. Data security measures ensure patient privacy in the era of connected healthcare. Modern technologies enhance traditional surgeries, refining outcomes. The integration of these innovations promises to shape a healthier future for cardiovascular procedures, emphasizing collaboration and research to maximize their transformative potential.

Integrated microscopy techniques for comprehensive pathology evaluation of an implantable left atrial pressure sensor.

The safety and efficacy of an implantable left atrial pressure (LAP) monitoring system is being evaluated in a clinical trial setting. Because the number of available specimens from the clinical trial for histopathology analysis is limited, it is beneficial to maximize the usage of each available specimen by relying on integrated microscopy techniques. The aim of this study is to demonstrate how a comprehensive pathology analysis of a single specimen may be reliably achieved using integrated microscopy techniques. Integrated microscopy techniques consisting of high-resolution gross digital photography followed by micro-computed tomography (micro-CT) scanning, low-vacuum scanning electron microscopy (LVSEM), and microground histology with special stains were applied to the same specimen. Integrated microscopy techniques were applied to eight human specimens. Micro-CT evaluation was beneficial for pinpointing the location and position of the device within the tissue, and for identifying any areas of interest or structural flaws that required additional examination. Usage of LVSEM was reliable in analyzing surface topography and cell type without destroying the integrity of the specimen. Following LVSEM, the specimen remained suitable for embedding in plastic and sectioning for light microscopy, using the positional data gathered from the micro-CT to intersect areas of interest in the slide. Finally, hematoxylin and eosin (H&E) and methylene blue staining was deployed on the slides with high-resolution results. The integration of multiple techniques on a single specimen maximized the usage of the limited number of available specimens from the clinical trial setting. Additionally, this integrated microscopic evaluation approach was found to have the added benefit of providing greater assurance of the derived conclusions because it was possible to cross-validate the results from multiple tests on the same specimen.

Tetrapodal ZnO-Based Composite Stents for Minimally Invasive Glaucoma Surgery.

The glaucoma burden increases continuously and is estimated to affect more than 100 million people by 2040. As there is currently no cure to restore the optic nerve damage caused by glaucoma, the only controllable parameter is the intraocular pressure (IOP). In recent years, minimally invasive glaucoma surgery (MIGS) has emerged as an alternative to traditional treatments. It uses micro-sized drainage stents that are inserted through a small incision, minimizing the trauma to the tissue and reducing surgical and postoperative recovery time. However, a major challenge for MIGS devices is foreign body reaction and fibrosis, which can lead to a complete failure of the device. In this work, the antifibrotic potential of tetrapodal ZnO (t-ZnO) microparticles used as an additive is elucidated by using rat embryonic fibroblasts as a model. A simple, direct solvent-free process for the fabrication of stents with an outer diameter of 200-400 µm is presented, in which a high amount of t-ZnO particles (45-75 wt %) is mixed into polydimethylsiloxane (PDMS) and a highly viscous polymer/particle mixture is extruded. The fabricated stents possess increased elastic modulus compared to pure PDMS while remaining flexible to adapt to the curvature of an eye. In vitro experiments showed that the fibroblast cell viability was inhibited to 43 ± 3% when stents with 75 wt % t-ZnO were used. The results indicate that cell inhibiting properties can be attributed to an increased amount of protruding t-ZnO particles on the stent surface, leading to an increase in local contacts with cells and a disruption of the cell membrane. As a secondary mechanism, the released Zn ions could also contribute to the cell-inhibiting properties in the close vicinity of the stent surface. Overall, the fabrication method and the antifibrotic and mechanical properties of developed stents make them promising for application in MIGS.

Design and Modeling of Ultra-Compact Wideband Implantable Antenna for Wireless ISM Band.

This paper proposes a wideband ultra-compact implantable antenna for a wireless body area network (WBAN). The proposed patch antenna works in the industrial, scientific, and medical (ISM) bands. The proposed patch antenna with an ultra-compact size (5 × 5 × 0.26 mm3) was designed with 29% wide bandwidth (about 670 MHz). This wide bandwidth makes the antenna unaffected by implantation in different human body parts. The miniaturization process passed many steps by adding many slots with different shapes in the radiating element as well as in the ground plane. A 50 Ω coaxial feeding excites the antenna to maintain matching and low power loss. The specific absorption rate (SAR) was calculated for health considerations. The result was within the standard limits of IEEE organizations and the International Commission on Non-Ionizing Radiation Protection (ICNRP). The antenna was tested in tissues with multiple layers (up to seven layers) and at various depths (up to 29 mm). The link margin was calculated, and the proposed antenna enables 100 Kbps of data to be transferred over a distance of 20 m and approximately 1 Mbps over a distance of 7 m. The proposed antenna was fabricated and tested. The measured S11 parameters and the simulated results using the Computer Simulation Technology (CST Studio) simulator were in good agreement.

Localized, on-demand, sustained drug delivery from biopolymer-based materials.

INTRODUCTION: Local drug delivery facilitiates higher concentrations of drug molecules at or near the treatment site to enhance treatment efficiency and reduce drug toxicity and other systemic side effects. However, local drug delivery systems face challenges in terms of encapsulation, delivery, and controlled release of therapeutics. AREAS COVERED: We provide an overview of naturally derived biopolymer-based drug delivery systems for localized, sustained, and on-demand treatment. We introduce the advantages and limitations of these systems for drug encapsulation, delivery, and local release, as well as recent applications. EXPERT OPINION: Naturally derived biopolymers like cellulose, silk fibroin, chitosan, alginate, hyaluronic acid, and gelatin are good candidates for localized drug delivery because they are readily chemically modified, biocompatible, biodegradable (with the generation of metabolically compatible degradation products), and can be processed in aqueous and ambient environments to maintain the bioactivity of various therapeutics. The tradeoff between the effective treatment dosage and the response by local healthy tissue should be balanced during the design of these delivery systems. Future directions will be focused on strategies to design tunable and controlled biodegradation rates, as well as to explore commercial utility in substituting biopolymer-based systems for currently utilized synthetic polymers for implants for drug delivery.

Local delivery and controlled release of miR-34a loaded in hydroxyapatite/mesoporous organosilica nanoparticles composite-coated implant wire to accelerate bone fracture healing.

Immediate mechanical stability is a prerequisite for fracture healing. In addition to bringing immediate mechanical stability in fracture site, implants with bioactive coating can release active substance to accelerate bone-fracture healing. However, limited drug-loading capacity of established coatings weakens their biological functions, which urges the engineering of more effective coating biomaterials for accelerating fracture healing. Herein, mesoporous organosilica nanoparticles (MONs), as miR-34a delivers, are loaded onto hydroxyapatite (HA)-coated Kirschner wire to engineer a HA/MONs@miR-34a composite coating. The composite coating can effectively deliver miR-34a into osteoclasts, generate gene dose-dependent inhibiting effect on differentiation and resorptive activity of osteoclasts by regulating multiple downstream gene expression at the early stage of fracture healing, which additionally exhibits decent bone regeneration potentials as evidenced in rat tibial fracture model. In particular, differentially expressed genes regulated by miR-34a are identified using RNA-seq followed by bioinformatics analysis. Functional enrichment analysis reveals that genes with altered expression mainly distribute in mainly distribute in DNA replication and cell cycle, which are associated with the development of osteoclasts. This work not only demonstrates the high clinical translation potential of HA/MONs@miR-34a to accelerate fracture healing, but also reveals the underlying molecular mechanism of regulating physiological functions of osteoclasts based on analysis of singlecell RNA sequencing.

Exposure Optimization Trial for Patients With Medical Implants During MRI Exposure: Balance Between the Completeness and Efficiency.

Elongated conductors, such as pacemaker leads, can couple to the MRI radio-frequency (RF) field during MRI scan and cause dangerous tissue heating. By selecting proper RF exposure conditions, the RF-induced power deposition can be suppressed. As the RF-induced power deposition is a complex function of multiple clinical factors, the problem remains how to perform the exposure selection in a comprehensive and efficient way. The purpose of this work is to demonstrate an exposure optimization trail that allows a comprehensive optimization in an efficient and traceable manner. The proposed workflow is demonstrated with a generic 40 cm long cardio pacemaker, major components of the clinical factors are decoupled from the redundant data set using principle component analysis, the optimized exposure condition can not only reduce the in vivo power deposition but also maintain good image quality.

Niobium Carbide MXene Augmented Medical Implant Elicits Bacterial Infection Elimination and Tissue Regeneration.

Incurable bacterial infections, impenetrable microbial biofilm, and irreversible antibiotic resistance are among the most dangerous threats for humans. With few effective strategies available in antimicrobial and antibiofilm development, innovative methodologies inspired by the advances in other fields such as nanomedicine are becoming more and more attractive to realize innovative antibacterial agents. Herein, a 2D niobium carbide (Nb2C) MXene titanium plate (Nb2C@TP)-based clinical implant with practical multimodal anti-infection functions was developed. Such emerging modes are capable of destroying biofilms for direct bacteria elimination through down-regulating bacterial energy metabolism pathways, suppressing biofilm formation, and enhancing as-formed biofilm detachment via an activating accessory gene regulator. Another intriguing feature of this nanomedicine is the sensitization ability toward bacteria via photothermal transduction, which reduces the temperature necessary for bacteria eradication and mitigates possible normal tissue damage. Moreover, the Nb2C@TP medical implant is able to alleviate proinflammatory responses by scavenging excessive reactive oxygen species in infectious microenvironments, benefiting angiogenesis and tissue remodeling.

Potential of subdermal solar energy harvesting for medical device applications based on worldwide meteorological data.

SIGNIFICANCE: Active implants require batteries as power supply. Their lifetime is limited and may require a second surgical intervention for replacement. Intracorporal energy harvesting techniques generate power within the body and supply the implant. Solar cells below the skin can be used to harvest energy from light. AIM: To investigate the potential of subdermal solar energy harvesting. APPROACH: We evaluated global radiation data for defined time slots and calculated the output power of a subdermal solar module based on skin and solar cell characteristics. We assumed solar exposure profiles based on daily habits for an implanted solar cell. The output power was calculated for skin types VI and I/II. RESULTS: We show that the yearly mean power in most locations on Earth is sufficient to power modern cardiac pacemakers if 10 min midday solar irradiation is assumed. All skin types are suitable for solar harvesting. Moreover, we provide a software tool to predict patient-specific output power. CONCLUSIONS: Subdermal solar energy harvesting is a viable alternative to primary batteries. The comparison to a human case study showed a good agreement of the results. The developed code is available open source to enable researchers to investigate further applications of subdermal solar harvesting.

Polysiloxane Nanofilaments Infused with Silicone Oil Prevent Bacterial Adhesion and Suppress Thrombosis on Intranasal Splints.

Like all biofluid-contacting medical devices, intranasal splints are highly prone to bacterial adhesion and clot formation. Despite their widespread use and the numerous complications associated with infected splints, limited success has been achieved in advancing their safety and surface biocompatibility, and, to date, no surface-coating strategy has been proposed to simultaneously enhance the antithrombogenicity and bacterial repellency of intranasal splints. Herein, we report an efficient, highly stable lubricant-infused coating for intranasal splints to render their surfaces antithrombogenic and repellent toward bacterial cells. Lubricant-infused intranasal splints were prepared by creating superhydrophobic polysiloxane nanofilament (PSnF) coatings using surface-initiated polymerization of n-propyltrichlorosilane (n-PTCS) and further infiltrating them with a silicone oil lubricant. Compared with commercially available intranasal splints, lubricant-infused, PSnF-coated splints significantly attenuated plasma and blood clot formation and prevented bacterial adhesion and biofilm formation for up to 7 days, the typical duration for which intranasal splints are kept. We further demonstrated that the performance of our engineered biointerface is independent of the underlying substrate and could be used to enhance the hemocompatibility and repellency properties of other medical implants such as medical-grade catheters.

[Research progress on antibacterial properties of porous medical implant materials].

OBJECTIVE: The antibacterial properties of porous medical implant materials were reviewed to provide guidance for further improvement of new medical implant materials. METHODS: The literature related to the antibacterial properties of porous medical implant materials in recent years was consulted, and the classification, characteristics and applications, and antibacterial methods of porous medical implant materials were reviewed. RESULTS: Porous medical implant materials can be classified according to surface pore size, preparation process, degree of degradation in vivo, and material source. It is widely used in the medical field due to its good biocompatibility and biomechanical properties. Nevertheless, the antibacterial properties of porous medical implant materials themselves are not obvious, and their antibacterial properties need to be improved through structural modification, overall modification, and coating modification. CONCLUSION: At present, coating modification as the mainstream modification method for improving the antibacterial properties of porous medical materials is still a research hotspot. The introduction of new antibacterial substances provides a new perspective for the development of new coated porous medical implant materials, so that the porous medical implant materials have a more reliable antibacterial effect while taking into account biocompatibility.

Selective Laser Melting of Patient Individualized Osteosynthesis Plates-Digital to Physical Process Chain.

We report on the exemplified realization of a digital to physical process chain for a patient individualized osteosynthesis plate for the tarsal bone area. Anonymized patient-specific data of the right feet were captured by computer tomography, which were then digitally processed to generate a surface file format (standard tessellation language, STL) ready for additive manufacturing. Physical realization by selective laser melting in titanium using optimized parameter settings and post-processing by stress relief annealing results in a customized osteosynthesis plate with superior properties fulfilling medical demands. High fitting accuracy was demonstrated by applying the osteosynthesis plate to an equally good 3D printed bone model, which likewise was generated using the patient-specific computer tomography (CT) data employing selective laser sintering and polyamid 12. Proper fixation has been achieved without any further manipulation of the plate using standard screws, proving that based on CT data, individualized implants well adapted to the anatomical conditions can be accomplished without the need for additional steps, such as bending, cutting and shape trimming of precast bone plates during the surgical intervention. Beyond parameter optimization for selective laser melting, this exemplified digital to physical process chain highlights the potential of additive manufacturing for individualized osteosynthesis.