Sutureless hepatic transection using a new radiofrequency assisted device. Theoretical model, experimental study and clinic trial

Información del artículo

Abstract

The ideal instrument for performing hepatic transection should combine safe and rapid haemostasis in a single tool. We present a new multidisciplinary investigation designed to develop a hepatic transection device assisted by radiofrequency (RF);the investigation included: a computerised theoretical model, and experimental study and a clinical trial of this device. The theoretic modelling was performed by computer, based on the Finite Elements Method (FEM), with the objective of studying the distribution of electrical energy and temperature in the tissue, and to assess the effect of the characteristics of the instrument. The experimental study, based on an in vivo porcine model, suggested that the new instrument would allow the transection velocity of the hepatic parenchyma to be increased with lower bleeding per transection area compared with other techniques extensively used in liver surgery. These data should enable the first phase of clinical trial to be conducted, with preliminary results that suggest that the new device is safe and effective.

Keywords:

Hepatic transection instruments

Radiofrequency

Computer modelling

Experimental study and clinical trial

Resumen

El instrumento ideal para realizar la transección hepática debería aunar en una sola herramienta hemostasia segura y rápida. Presentamos nuestra investigación multidisciplinar encaminada al desarrollo de un dispositivo de transección hepática asistido por radiofrecuencia (RF); la investigación incluye: modelado teórico por computador, estudio experimental y ensayo clínico de este dispositivo. El modelado teórico se realizó por computador basado en el Método de Elementos Finitos (MEF) con objeto de estudiar la distribución de energía eléctrica y temperatura en el tejido y valorar el efecto de las características del instrumento. El estudio experimental basado en un modelo in vivo porcino sugiere que el nuevo instrumento permitiría aumentar la velocidad de transección del parénquima hepático con una menor hemorragia por área de transección al compararlo con otras técnicas ampliamente extendidas en la cirugía hepática. Estos datos permitieron afrontar la realización de la primera fase de un ensayo clínico, cuyos resultados preliminares sugieren que el nuevo instrumento es seguro y eficaz. los derechos reservados.

Palabras clave:

Instrumentos de transección

hepática

Radiofrecuencia

Modelado por computador

Estudio experimental y ensayo clínico

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