METHODOLOGY FOR RESEARCH AND DEVELOPMENT OF NOVEL MEDICAL DEVICES FOR MINIMALLY INVASIVE INTERVENTIONS

The design of innovative medical device requires extensive and hard efforts to reach good results in terms of safety, efficacy and cost effectiveness. First of all the idea has to be set and a wide search of state of the art, both technological and academic, has to be developed. Then the materials, manufacturing processes and design constraints have to be understood. In this work three examples of innovative surgical devices for minimally invasive surgery and assistance have been presented. The Muneretto Beam catheter is a new device for atrial defibrillation. Starting from a catheter produced by Estech company for the treatment of atrial fibrillation by ablating cardiac tissue during surgery, a system for the magnetic guidance of the same has been implemented. Thanks to finite element analysis of various configurations of magnets and to several in vitro tests, a final configuration which allows a good balance between the sliding of the catheter on the tissues and the magnetic interaction and adhesion to tissues has been found. Further attention has been taken to the development of the cover and the right configuration and method of use of the device. The VideoDrain system is a new catheter for the monitoring of post-operative wound. After critical surgical procedures it is necessary to monitor the status of the surgical wound for avoiding second look surgical interventions. Therefore a new balloon catheter for allowing the vision of the abdominal cavity has been produced. Several in vitro and in vivo trials have been conducted and the device is at the pre-industrial stage. The FloSeal GI cath. is a new device for the gastrointestinal release of an haemostatic substance of the Baxter company: the Floseal thrombin matrix. It consists in a balloon catheter suited for the use in the lower and upper gastrointestinal tract in the occurrence of bleedings during endoscopic procedures. This device has been CE labelled and is now on the market. All the devices described in this work come from ideas of surgeons leader in innovation in the field of minimally invasive interventions. Their collaboration has been fundamental for the several phases of design and tests of the devices. This Ph.D. thesis is divided into five chapters. In the Introduction chapter the process of research and development of innovative MDs for minimally invasive surgery has been illustrated. The second chapter shows the efforts done to find a working configuration for the Muneretto Beam catheter and the subsequent first prototypes developed. The progress in the design of VideoDrain has been explained in the third chapter; the whole process goes from the idea to the animal test on prototypes and a preliminary risk analysis. The development of the Floseal GI Catheter is depicted in the fourth chapter; all the details of the materials used and tests done to ensure a CE mark have been reported. Finally, in the Conclusion chapter I have reported some lessons learned from the work in the field of MDs, as a student, researcher and engineer at close contact with the world of surgery and minimally invasive technologies. Some papers about a preliminary research activity in the field of minimally invasive surgery and robotic interventions have been also enclosed. These works have been very useful to start the understanding of the complex and amazing world of MIS

IX Malta Medical School Conference

Abstracts of papers presented at the 9th Malta Medical School Conference held at the Hilton Malta Hotel, Portomaso, St. Julians between 3rd and 5th December 2015.peer-reviewe

Background Examples of Literature Searches on Topics of Interest

A zip file of various literature searches & some resources related to our work related to exposure after the Chernobyl accident and as we began looking at helping in Semey Kazakhstan----a collection of literature reviews on various topics we were interested in... eg. establishing a registry of those exposed for longterm follow-up, what we knew about certain areas like genetics and some resources like A Guide to Environmental Resources on the Internet by Carol Briggs-Erickson and Toni Murphy which could be found on the Internet and was written to be used by researchers, environmentalists, teachers and any person who is interested in knowing and doing something about the health of our planet. See more at https://archives.library.tmc.edu/dm-ms211-012-0060

Medical-Data-Models.org:A collection of freely available forms (September 2016)

MDM-Portal (Medical Data-Models) is a meta-data repository for creating, analysing, sharing and reusing medical forms, developed by the Institute of Medical Informatics, University of Muenster in Germany. Electronic forms for documentation of patient data are an integral part within the workflow of physicians. A huge amount of data is collected either through routine documentation forms (EHRs) for electronic health records or as case report forms (CRFs) for clinical trials. This raises major scientific challenges for health care, since different health information systems are not necessarily compatible with each other and thus information exchange of structured data is hampered. Software vendors provide a variety of individual documentation forms according to their standard contracts, which function as isolated applications. Furthermore, free availability of those forms is rarely the case. Currently less than 5 % of medical forms are freely accessible. Based on this lack of transparency harmonization of data models in health care is extremely cumbersome, thus work and know-how of completed clinical trials and routine documentation in hospitals are hard to be re-used. The MDM-Portal serves as an infrastructure for academic (non-commercial) medical research to contribute a solution to this problem. It already contains more than 4,000 system-independent forms (CDISC ODM Format, www.cdisc.org, Operational Data Model) with more than 380,000 dataelements. This enables researchers to view, discuss, download and export forms in most common technical formats such as PDF, CSV, Excel, SQL, SPSS, R, etc. A growing user community will lead to a growing database of medical forms. In this matter, we would like to encourage all medical researchers to register and add forms and discuss existing forms

Advances in Ophthalmology

This book focuses on the different aspects of ophthalmology - the medical science of diagnosis and treatment of eye disorders. Ophthalmology is divided into various clinical subspecialties, such as cornea, cataract, glaucoma, uveitis, retina, neuro-ophthalmology, pediatric ophthalmology, oncology, pathology, and oculoplastics. This book incorporates new developments as well as future perspectives in ophthalmology and is a balanced product between covering a wide range of diseases and expedited publication. It is intended to be the appetizer for other books to follow. Ophthalmologists, researchers, specialists, trainees, and general practitioners with an interest in ophthalmology will find this book interesting and useful