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El proyecto NANO-VERTEBRA propone un nuevo tipo de implante vertebral realizado a medida del paciente para facilitar su implantación y asegurar su estabilidad.

Las principales innovaciones que presenta el proyecto son:

  • el uso de implantes a medida para la columna vertebral desarrollados a partir de 3D printing.
  • un nuevo concepto de implante que está pensado para regenerar hueso más que para sustituirlo. Su estructura interna es totalmente porosa (un 90%) para dejar espacio libre que será ocupado por vasos y tejido óseos de nueva formación
  • la técnica quirúrgica utilizada para la realización de la resección en Block de los cuerpos vertebrales ha sido desarrollada en el Instituto Ortopedico Rizzoli por el Dr. Gasbarrini.
  • el nanorecubrimiento superficial que fomenta la integración ósea e inhibe el crecimiento bacteriano es novedosos

Un oportuno nano-recubrimiento de la superficie del implante prevendrá las infecciones y promoverá una más rápida y efectiva integración del implante en el entorno óseo del paciente. La micro-porosidad  (próxima al 90%) del implante es interconectada y deja mucho espacio libre para la regeneración de vasos y nuevo tejido óseo inducido por el nano-tratamiento superficial.

El reemplazo de cuerpos vertebrales sigue siendo un desafío para los cirujanos, presenta una tasa de complicaciones cercanas al 50%. Entre las complicaciones más comunes se encuentran: infecciones de sitio quirúrgico (ISQ), inestabilidad mecánica y regeneración ósea deficiente.

Para reducir las infecciones y aumentar las opciones quirúrgicas de los pacientes después de la resección masiva de la columna, el proyecto desarrollará un dispositivo de vértebra personalizado, mediante la combinación de recubrimientos antibacterianos y osteinductivos nanoestructurados y la optimización simultánea de la arquitectura del implante mediante modelado 3D y tecnologías de fabricación aditiva. Se redefinirá el diseño a las necesidades físico/químicas impuestas por los procesos de recubrimiento antibacteriano.

El consorcio internacional está formado por organizaciones de Italia, España, Rumanía y Taiwán. El Instituto Tecnológico de Canarias (ITC) participa como socio del proyecto a través de su Departamento de Ingeniería Biomédica, cuyas principales líneas de trabajo son la biomecánica y el desarrollo de dispositivos implantables que dan soporte a la reparación y la regeneración de tejido óseo y cartílago. Dentro de las actividades del proyecto, el ITC llevara a cabo el diseño y la fabricación de implantes para la experimentación en modelos animales y para aplicaciones a medida en humanos.

NANO-VERTEBRA (Nueva generación protésica nanoestructurada y personalizada para las reconstrucciones vertebrales, con capacidad antibacteriana y osteoinductora) es un proyecto transnacional sobre nanomedicina, financiado en el marco de la red europea de investigación ERA-NET Cofund EuroNanoMed3 (ENM3) «European Innovative Research & Technological Development Projects in Nanomedicine», a través del Centro para el Desarrollo Tecnológico Industrial (CDTI). 

Este proyecto ha sido cofinanciado por el Fondo Europeo de Desarrollo Regional (FEDER) con el objetivo de promover el desarrollo tecnológico, la innovación y una investigación de calidad.

 

Centro para el Desarrollo Tecnológico Industrial y EuroNanoMed3

NANO-VERTEBRA está alineado con los Objetivos de Desarrollo Sostenible (ODS), siendo de especial interés los siguientes:

 

3. Salud y bienestar 17. Alianzas para lograr los objetivos


 

The Nano-vertebra Project - Youtube

  • Instituto Ortopédico Rizzoli. Italia
  • National lnstitute for Research and Development for Optoelectronics (INOE 2000). Rumanía
  • Instituto Tecnológico de Canarias (ITC). España
  • National Taiwan University (NTU) - Institute of Biomedical Engineering and Department of Orthopaedic Surgery Colleges of Engineering and Medicine. Taiwán

Presupuesto aprobado: 824.440 €

Financiación a través del Programa EuroNanoMed III (76,37%): 629.593 € 

Junio 2019 – Febrero 2021

El proyecto propone el desarrollo de una prótesis personalizada para reemplazar cuerpos vertebrales afectados por tumores óseos o eventos traumáticos importantes, que esté pensada específicamente para prevenir las infecciones y promover una regeneración ósea rápida y efectiva.

Objetivos generales del proyecto:

  • Mejora de nuestros implantes a medida para la reconstrucción y regeneración de segmentos óseos en columna vertebral añadiendo un recubrimiento antibacteriano y osteoinductivo.
  • Ampliación de indicaciones clínicas de nuestros implantes que actualmente se pueden utilizar solo en matástasis o tumores primarios. Con el tratamiento antibacteriano podemos extender el alcance a la reposición de vertebras con infección.
  • Añadir valor a nuestros servicios de implantes a medida gracias a la incorporación de nuevo conocimiento en el área de los recubrimientos superficiales.
  • Consolidación de relaciones con el Instituto Ortopédico Rizzoli, centro de referencia internacional para nuestra tecnología y centro de I+D+i de reconocido prestigio.
  • Expansion del uso de esta tecnlogia de recubrimiento a otros implantes mas frequentes, cadera y rodilla por ejemplo.

Como objetivos técnicos específicos del proyecto se contemplan:

  • Desarrollo de un recubrimiento antibacteriano y puesta a punto de un proceso de deposición que pueda ser utilizado en implantes a medida para pacientes con cuerpos vertebrales infectados.
  • Adaptación de un modelo biomecánico y un entorno computacional para simular, con el método de los elementos finitos, las prestaciones mecánicas de un implante para la sustitución en-block de cuerpos vertebrales.
  • Optimización del diseño de implantes y estructuras trabeculares a medida, utilizando Ia retroalimentación del modelo biomecánico desarrollado en el proyecto.
  • Desarrollo de muestras significativas para ensayos in-vitro e in-vivo

El actividad del ITC en este proyecto se centra en el desarrollo de la parte mecánica del proyecto, todo lo relacionado con diseño y fabricación de elementos protésicos, instrumentales y muestras para ensayos (mecánicos, de proceso, in-vitro, in-vivo)

La tecnología que utilizamos para la fabricación de los implantes porosos es aditiva y funciona por fusión de capas por medio de un haz de electrones (ARCAM EBM S12) utilizando polvo de aleación de Titanio implantable (Ti6Al4V-ELI).

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