Diseño y desarrollo de una metodología de estandarización para prótesis personalizadas en el control local del efluvio intestinal por fístula enteroatmosférica

Las fístulas enteroatmosféricas son entidades no frecuentes enmarcadas dentro del campo de la cirugía abdominal que pueden surgir como consecuencia de complicaciones en un proceso postquirúrgico, siendo su tasa de mortalidad cercana al 40%. Presenta una gran variabilidad en función del número, forma y tamaño de los orificios fistulosos, del débito de los mismos y de las dimensiones de la herida. Uno de los grandes retos que se presenta para el cirujano es conseguir un buen control local de la misma. Actualmente, existen varios métodos descritos acerca del uso de dispositivos artesanales y comercializados para conseguirlo y dada la importante diversidad de estas fístulas, a día de hoy los adaptadores estándares de mercado no son válidos o efectivos al 100 % para todo tipo de pacientes. Tras estudios iniciales sobre la situación actual, se plantea una alternativa innovadora que podría dar solución a la problemática a través de la ingeniería y la cirugía, mediante la creación de estructuras tridimensionales con tecnología de fabricación aditiva que cubran las carencias que a día de hoy siguen existiendo durante el proceso de cura. La presente tesis aborda la definición y el desarrollo de un modelo metodológico de estandarización basado en sistemas CAD (Computer Aied Design), Bioescaneado e impresión 3D de biomateriales, de manera que permita diseñar y fabricar prótesis totalmente personalizadas y dar solución al problema de tallaje que hoy día experimentan los pacientes que sufren de fístula enteroatmosférica. Esta metodología, a su vez, asentará las bases de un modelo de producción propio en el diseño y fabricación de prótesis 3D dentro del campo de la cirugía abdominal. Su aplicación práctica se llevará a cabo durante procesos reales de cura de fístula enteroatmosférica, de manera que puedan obtenerse resultados que demuestren la viabilidad de la tesis.Enteroatmospheric fistulas are infrequent entities framed within the field of abdominal surgery that can arise as a consequence of complications in a postsurgical process, their mortality rate being close to 40%. It presents great variability depending on the number, shape and size of the fistulous orifices, as well as their debit and the size of the wound. One of the great challenges that arise for the surgeon is to get a good local control of it. Currently, there are several methods described about the use of handcrafted and marketed devices to achieve this and given the important diversity of these fistulas, market standard adapters nowdays are not valid or 100% effective for all types of patients. After initial studies on the current situation, an innovative alternative is proposed that could solve the problem through engineering and surgery, by creating tridimensional structures with additive manufacturing technology that cover the continous gaps to exist nowdays during the healing process. This thesis approachs the definition and development of a methodological model of standardization based on CAD (Computer Aied Design), Bioscanning and 3D printing of biomaterials. In such a way that it allows to design and manufacture fully customized prostheses to solve the problem of carving that today undergoes patients suffering from enteroatmospheric fistula. This methodology, in turn, will lay the foundations of a model of own production in the design and manufacture of 3D prostheses within the field of abdominal surgery. It is practical application will be carried out during real enteroatmospheric fistula healing processes, so that results can be obtained that demonstrate the feasibility of the thesi

Personalized additive manufacturing of devices for the management of enteroatmospheric fistulas

This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.Additive manufacturing techniques allow the customized design of medical devices according to the patient's requirements. Enteroatmospheric fistula is a pathology that benefits from this personalization due to its extensive clinical variability since the size and morphology of the wound differ extensively among patients. Standard prosthetics do not achieve proper isolation of the wound, leading to a higher risk of infections. Currently, no effective personalized technique to isolate it has been described. In this work, we present the workflow for the design and manufacture of customized devices adapted to the fistula characteristics as it evolves and changes during the treatment with Negative Pressure Wound Therapy (NPWT). For each case, a device was designed with dimensions and morphology depending on each patient's requirements using white light scanning, CAD design, and additive manufacturing. The design and manufacture of the devices were performed in 230.50 min (184.00– 304.75). After the placement of the device, the wound was successfully isolated from the intestinal content for 48–72 h. The therapy was applied for 27.71 ± 13.74 days, and the device was redesigned to adapt to the wound when geometrical evolutionary changes occur during the therapy. It was observed a decrease in weekly cures from 23.63 ± 10.54 to 2.69 ± 0.65 (p = 0.001). The fistulose size was reduced longitudinal and transversally by 3.25 ± 2.56 cm and 6.06 ± 3.14 cm, respectively. The wound depth also decreased by 1.94 ± 1.08 cm. In conclusion, customization through additive manufacturing is feasible and offers promising results in the generation of personalized devices for the treatment of enteroatmospheric fistula.Instituto de Salud Carlos III PI19/0182

Using a bio-scanner and 3D printing to create an innovative custom made approach for the management of complex entero-atmospheric fistulas.

Enteroatmospheric fistulae are challenging clinical conditions that require surgical expertise and that can result in chronic debilitating conditions placing the patient in a vicious cycle characterized by non healing wounds and malnutrition. They are a complex entity that presents great variability depending on the number, shape, and size of the fistulous orifices, their debit, and the dimensions of the wound. This means that, at present, there is no device that adapts to the anatomical characteristics of each patient and manages to control the spillage of intestinal effluvium from the wound. The aim of this study is to describe the manufacturing technique and to assess the preliminary results of a custom device designed through bioscanner imaging and manufactured using 3D printing for use with negative pressure wound therapy (NPWT) in the management of enteroatmospheric fistula. A proof of concept is given, and the design of the device is presented for the first time. After obtaining images of each fistula with a bioscanner, a personalised device was designed for each patient by 3D printing shape of a prism and a hollow base, taking into account the dimensions of the fistulous area in order to perform a floating ostomy to isolate the wound from the debit enteric. The polycaprolactone (PCL) device was placed including inside the fistulous surface and surrounding it with the NPWT system in order to accelerate wound healing