Development of more assertive and accessible electrostimulators for the anorrectal malformations correction surgery

• Grant number: 17/01038-2
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: November 01, 2017
• End date: October 31, 2020
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Henrique de Souza Nery
• Grantee: Henrique de Souza Nery
• Company: BGE Médica Indústria e Comércio Ltda
• City: São Paulo
• Pesquisadores principais: Humberto Salgado Filho
• Associated researchers: Jose Carlos Correa Borges ; Walter Campos Junior
• Associated scholarship(s): 19/02794-0 - User interface development for the muscle stimulator visualization system for Posterior Sagittal Anorectoplasty procedure, BP.TT; 18/15875-6 - Development of an electronic board for a muscle stimulator for Posterior Sagittal Anorectoplasty procedure, BP.TT; 18/14494-9 - Implementation of Microscopy of Movement in the Identification of the Sphincter in the Procedure of Posterior Sagittal Anorectoplasty., BP.TT

Abstract

According to data provided by the UNICEF, the Ecology Communication Group and by the NGO PullThrough, an average of 100 children are born, per day, with some kind of anorectal anomaly, an malformation of the digestive system, of which a large number are born with imperforate anus - a condition in which the anus misses altogether, causing the rectum to move to other structures or completely unabling its depletion - a situation that, if not treated, results in the dead of the affected newborn by the build of feces in the bowels or by infections at other structures. The single treatment available, the anorectal anomalies correction procedure - improved by Doctor A. Peña in the 80s through a procedure called PSARP (Posterior Sagittal Anorectoplasty), now the standard - needs the use of an specific muscular electrostimulator in order to identify the anal muscular structures. The inaccurate identification or even the unidentification of said structures may cause severe complications, such as fecal incontinence through the patient whole life. Nowadays, there's just one company which produces the electrostimulator that, besides not being significantly updated since it's creation, has a price tag which is prohibitive for most markets, resulting in the shortage of suited equipment by surgeons and hospitals worldwide. This project aims to supply these needy markets by re-launching a financially viable electro-stimulator, now, with a new functionality called movement microscopy that increases precision in the identification of the sphincter, decreasing the chance of postoperative complications. The technology to be developed in this project is unprecedented in medicine, and may be internationally patented. The proof of concept - related to phase 1 of PIPE - has already been successfully carried out by BGE Médica - the proposing company - without any funding from FAPESP. The team consists of physicians specialized in the treatment of anorectal anomalies, engineers with experience in electrostimulators, and competent business managers. The research will be based at BGE Médica, a company incubated at CIETEC, which in the past sold the electro-stimulator in question but had to discontinue it because of an update at ANVISA. The company was the dent of two patents in the area. The project methodology will adopt pioneering innovation and product design techniques whose goal is to maximize the product-market fit. To achieve this, the design of the solution will come from continuous observations of the interaction between physicians and prototypes during various surgeries. The former electro-stimulator, despite meeting medical needs, was discontinued for regulatory reasons. Now, with a team motivated to break down technological barriers, BGE is proposing a way to replenish the market with an innovative product. (AU)