3D printing in medicine最新文献

3D printing is revolutionizing the medical device landscape through its ability to rapidly create patient-specific anatomic models, surgical instruments, and implants. Recent advances in 3D printing technology have allowed for the creation of point-of-care (PoC) 3D printing centers. These PoC centers blur the line between healthcare provider, medical center, and device manufacturer, creating regulatory ambiguity. The United States Food & Drug Administration (FDA) currently regulates 3D printed devices through existing medical device regulations. However, the FDA is increasingly interested in developing guidelines and regulations specifically for PoC 3D printing due to its rapid adoption across the healthcare institutions. In this article, we review the regulatory framework that governs medical devices, discuss how PoC 3D printing falls within this framework, and describe a novel conceptual framework that the FDA has proposed. Finally, through analysis of the aforementioned regulations and discussions with industry medical 3D printing regulatory experts, we provide recommendations for PoC medical 3D printing best practices so that institutions are best positioned to utilize this revolutionary technology safely and effectively.

Background: To compare different methods of three-dimensional representations, namely 3D-Print, Virtual Reality (VR)-Glasses and 3D-Display regarding the understanding of the pathology, accuracy of details, quality of the anatomical representation and technical operability and assessment of possible change in treatment in different disciplines and levels of professional experience.

Methods: Interviews were conducted with twenty physicians from the disciplines of cardiology, oral and maxillofacial surgery, orthopedic surgery, and radiology between 2018 and 2020 at the University Hospital of Basel. They were all presented with three different three-dimensional clinical cases derived from CT data from their area of expertise, one case for each method. During this, the physicians were asked for their feedback written down on a pencil and paper questionnaire.

Results: Concerning the understanding of the pathology and quality of the anatomical representation, VR-Glasses were rated best in three out of four disciplines and two out of three levels of professional experience. Regarding the accuracy of details, 3D-Display was rated best in three out of four disciplines and all levels of professional experience. As to operability, 3D-Display was consistently rated best in all levels of professional experience and all disciplines. Possible change in treatment was reported using 3D-Print in 33%, VR-Glasses in 44%, and 3D-Display in 33% of participants. Physicians with a professional experience of more than ten years reported no change in treatment using any method.

Conclusions: 3D-Print, VR-Glasses, and 3D-Displays are very well accepted, and a relevant percentage of participants with less than ten years of professional work experience could imagine a possible change in treatment using any of these three-dimensional methods. Our findings challenge scientists, technicians, and physicians to further develop these methods to improve the three-dimensional understanding of pathologies and to add value to the education of young and inexperienced physicians.

Background: Patients who undergo decompressive craniectomy (DC) are often fitted with a helmet that protects the craniectomy site from injury during rehabilitation. However, conventional "one-size-fits-all" helmets may not be feasible for certain craniectomy defects. We describe the production and use of a custom 3D-printed helmet for a DC patient where a conventional helmet was not feasible due to the craniectomy defect configuration.

Case presentation: A 65-year-old male with ethmoid sinonasal carcinoma underwent cranionasal resection and DC with free vastus lateralis flap reconstruction to treat cerebrospinal fluid leakage. He required an external helmet to protect the craniectomy site, however, the rim of a conventional helmet compressed the craniectomy site, and the straps compressed the vascular pedicle of the muscle flap. Computed topography (CT) scans of the patient's cranium were imported into 3D modelling software and used to fabricate a patient-specific, strapless helmet using fused deposition modelling (FDM). The final helmet fit the patient perfectly and circumvented the compression issues, while also providing better cosmesis than the conventional helmet. Four months postoperatively, the helmet remains intact and in use.

Conclusions: 3D printing can be used to produce low-volume, patient-specific external devices for rehabilitation where standardized adjuncts are not optimal. Once initial start-up costs and training are overcome, these devices can be produced by surgeons themselves to meet a wide range of clinical needs.

Background: The desktop vat polymerization process or stereolithography printing is an ideal approach to develop multifunctional nanocomposites wherein a conventional solid dosage form is used as a reservoir for compliant administration of drug-loaded nanocarriers.

Methods: In this study, a nanocomposite drug delivery system, that is, hydrogel nanoparticles of an approved nutraceutical, berberine entrapped within vat photopolymerized monoliths, was developed for drug delivery applications. For the fabrication of the nanocomposite drug delivery systems/pills, a biocompatible vat photopolymerized resin was selected as an optimum matrix capable of efficiently delivering berberine from stereolithography mediated 3D printed nanocomposite pill.

Results: The obtained data reflected the efficient formation of berberine-loaded hydrogel nanoparticles with a mean particle diameter of 95.05 ± 4.50 nm but low loading. Stereolithography-assisted fabrication of monoliths was achieved with high fidelity (in agreement with computer-aided design), and photo-crosslinking was ascertained through Fourier-transform infrared spectroscopy. The hydrogel nanoparticles were entrapped within the pills during the stereolithography process, as evidenced by electron microscopy. The nanocomposite pills showed a higher swelling in an acidic environment and consequently faster berberine release of 50.39 ± 3.44% after 4 h. The overall results suggested maximal release within the gastrointestinal transit duration and excretion of the exhausted pills.

Conclusions: We intended to demonstrate the feasibility of making 3D printed nanocomposite pills achieved through the desktop vat polymerization process for drug delivery applications.

Background: The global pandemic of novel coronavirus (SARS-CoV-2) has led to global shortages of ventilators and accessories. One solution to this problem is to split ventilators between multiple patients, which poses the difficulty of treating two patients with dissimilar ventilation needs. A proposed solution to this problem is the use of 3D-printed flow splitters and restrictors. There is little data available on the reliability of such devices and how the use of different 3D printing methods might affect their performance.

Methods: We performed flow resistance measurements on 30 different 3D-printed restrictor designs produced using a range of fused deposition modelling and stereolithography printers and materials, from consumer grade printers using polylactic acid filament to professional printers using surgical resin. We compared their performance to novel computational fluid dynamics models driven by empirical ventilator flow rate data. This indicates the ideal performance of a part that matches the computer model.

Results: The 3D-printed restrictors varied considerably between printers and materials to a sufficient degree that would make them unsafe for clinical use without individual testing. This occurs because the interior surface of the restrictor is rough and has a reduced nominal average diameter when compared to the computer model. However, we have also shown that with careful calibration it is possible to tune the end-inspiratory (tidal) volume by titrating the inspiratory time on the ventilator.

Conclusions: Computer simulations of differential multi patient ventilation indicate that the use of 3D-printed flow splitters is viable. However, in situ testing indicates that using 3D printers to produce flow restricting orifices is not recommended, as the flow resistance can deviate significantly from expected values depending on the type of printer used.

Trial registration: Not applicable.

Background: Tissue healthiness could be assessed by evaluating its viscoelastic properties through localized contact reaction force measurements to obtain quantitative time history information. To evaluate these properties for hard to reach and confined areas of the human body, miniature force sensors with size constraints and appropriate load capabilities are needed. This research article reports on the design, fabrication, integration, characterization, and in vivo experimentation of a uniaxial miniature force sensor on a human forearm.

Methods: The strain gauge based sensor components were designed to meet dimensional constraints (diameter ≤3.5mm), safety factor (≥3) and performance specifications (maximum applied load, resolution, sensitivity, and accuracy). The sensing element was fabricated using traditional machining. Inverted vat photopolymerization technology was used to prototype complex components on a Form3 printer; micro-component orientation for fabrication challenges were overcome through experimentation. The sensor performance was characterized using dead weights and a LabVIEW based custom developed data acquisition system. The operational performance was evaluated by in vivo measurements on a human forearm; the relaxation data were used to calculate the Voigt model viscoelastic coefficient.

Results: The three dimensional (3D) printed components exhibited good dimensional accuracy (maximum deviation of 183μm). The assembled sensor exhibited linear behavior (regression coefficient of R²=0.999) and met desired performance specifications of 3.4 safety factor, 1.2N load capacity, 18mN resolution, and 3.13% accuracy. The in vivo experimentally obtained relaxation data were analyzed using the Voigt model yielding a viscoelastic coefficient τ=12.38sec and a curve-fit regression coefficient of R²=0.992.

Conclusions: This research presented the successful design, use of 3D printing for component fabrication, integration, characterization, and analysis of initial in vivo collected measurements with excellent performance for a miniature force sensor for the assessment of tissue viscoelastic properties. Through this research certain limitations were identified, however the initial sensor performance was promising and encouraging to continue the work to improve the sensor. This micro-force sensor could be used to obtain tissue quantitative data to assess tissue healthiness for medical care over extended time periods.

Limited access to key diagnostic tools is detrimental to priority health needs of populations. Ear pain, tenderness, itching, and different degree of hearing loss are common problems which require otoscopy as first diagnostic assessment. Where an otoscope is not available because of budget constraints, a self-fabricated low-cost otoscope might represent a feasible opportunity. In this paper, we share the design and construction process of an open-source, 3D printed, otoscope. The prototype was compared to a commercial solution, demonstrating similar overall quality between the instruments.