Evaluation of the laser cutting process for biological membranes used in the manufacture of cardiovascular implants

• Grant number: 18/00489-3
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: February 01, 2019
• End date: October 31, 2019
• Field of knowledge: Engineering - Biomedical Engineering - Bioengineering
• Principal Investigator: Guilherme Agreli
• Grantee: Guilherme Agreli
• Company: Products and Features Brasil Pesquisa e Desenvolvimento Ltda
• CNAE: Fabricação de artefatos de material plástico não especificados anteriormente ; Fabricação de produtos de metal não especificados anteriormente ; Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: São José do Rio Preto

Abstract

The development of new devices for the treatment of cardiac structural diseases, especially transcatheter heart valves, rapidly altered the treatment paradigm in patients of advanced age and with a high-risk profile or inoperable to be treated by conventional surgical techniques. The advancement of these minimally invasive techniques of heart valve implantation to treat patients with lower age or with a lower surgical risk profile, therefore with a longer life expectancy, requires that the implants have a proven long duration without suffering structural degeneration or deterioration in their characteristics functional. Currently, the transcatheter treatment of aortic valve diseases is well established with the technique called TAVI or TAVR from Transcatheter Aortic Valve Implantation or Transcatheter Aortic Valve Replacement, and new devices are being tested for pulmonary, mitral and tricuspid valves. All these devices in use and in development have in common the use of biological membranes of bovine or porcine pericardium for the formation of the valve mechanism. These leaflets are cut, sutured and molded into metal support structures called stents, which can be self-expanding or balloon expandable. The process of cutting the bovine pericardium biological membranes used by Products and Features Brazil (PFBr) is performed with the use of scalpel blades and scissors, and requires extensive operator experience in addition to extensive microscopic evaluation to check for defects or damages along the entire length of the cuts that form the profile of the leaflet, because failures of this process can cause the early fracture of the leaflets. The developed valves shall be considered during the test phases to be subjected to accelerated fatigue tests which reproduce from two to four hundred million cycles of opening and closing at a rate of at least 600 cycles per minute and that when implanted in patients should operate continuously for more than 10 years without presenting failures that could compromise the patient's life. The use of laser cutting in the bovine pericardium membranes aims to reduce faults and ensure that there are no fragilities along the cutting section that can cause structural failure or accelerated degeneration, in addition to increasing the degree of complexity in the design of the components cut. In this project we propose the study of the laser cutting process with low-cost equipment for tissue cutting, using a CO2 laser of up to 40W power and cutting speed up to 50mm / second. (AU)