RESUMEN
Implantable patient-specific devices are the next frontier of personalized medicine, positioned to improve the quality of care across multiple clinical disciplines. Translation of patient-specific devices requires time- and cost-effective processes to design, verify and validate in adherence to FDA guidance for medical device manufacture. In this study, we present a generalized strategy for selective laser sintering (SLS) of patient-specific medical devices following the prescribed guidance for additive manufacturing of medical devices issued by the FDA in 2018. We contextualize this process for manufacturing an Airway Support Device, a life-saving tracheal and bronchial implant restoring airway patency for pediatric patients diagnosed with tracheobronchomalacia and exhibiting partial or complete airway collapse. The process covers image-based modeling, design inputs, design verification, material inputs and verification, device verification, and device validation, including clinical results. We demonstrate how design and material assessment lead to verified Airway Support Devices that achieve desired airway patency and reduction in required Positive End-Expiratory Pressure (PEEP) after patient implantation. We propose this process as a template for general quality control of patient-specific, 3D printed implants.
Asunto(s)
Bronquios , Tráquea , Niño , Humanos , Impresión TridimensionalRESUMEN
Recording from the human brain at the spatiotemporal resolution of action potentials provides critical insight into mechanisms of higher cognitive functions and neuropsychiatric disease that is challenging to derive from animal models. Here, organic materials and conformable electronics are employed to create an integrated neural interface device compatible with minimally invasive neurosurgical procedures and geared toward chronic implantation on the surface of the human brain. Data generated with these devices enable identification and characterization of individual, spatially distribute human cortical neurons in the absence of any tissue penetration (n = 229 single units). Putative single-units are effectively clustered, and found to possess features characteristic of pyramidal cells and interneurons, as well as identifiable microcircuit interactions. Human neurons exhibit consistent phase modulation by oscillatory activity and a variety of population coupling responses. The parameters are furthermore established to optimize the yield and quality of single-unit activity from the cortical surface, enhancing the ability to investigate human neural network mechanisms without breaching the tissue interface and increasing the information that can be safely derived from neurophysiological monitoring.