LOW COST SPIRAL NEEDLE FOR ENDOSUTURE AND TREATMENT OF THE GREAT SAPHENO VEIN AND OTHER VESSELS.

• Grant number: 24/15642-2
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: July 01, 2025
• End date: March 31, 2026
• Field of knowledge: Engineering - Biomedical Engineering - Medical Engineering
• Principal Investigator: Carlos Hernani Cruz Marmol
• Grantee: Carlos Hernani Cruz Marmol
• Company: DIMENSION CO HEALTH LTDA
• CNAE: Fabricação de instrumentos e materiais para uso médico e odontológico e de artigos ópticos
• Associated researchers: Vinícius Ladeia Semenzim
• Associated scholarship(s): 25/14521-0 - Low cost spiral needle for endosuture and treatment of the great sapheno vein and other vessels, BP.PIPE

Abstract

The project aims to create a commercial product that improves the quality of life of patients with Chronic Venous Insufficiency (CVI). In some cases, when not treated correctly, varicose veins can progress and develop severe complications, such as skin inflammation, dermatitis, thrombosis, bleeding and ulcers. The product, presented in this project, could reduce the number of varicose ulcers, thermal and nerve injuries caused in the lower limbs by current treatment methods for this disease. Technological progress and innovation in health are a secure basis for achieving better living conditions for the population. CVI is a very prevalent condition with high morbidity and high healthcare costs. Surgical treatment for varicose vein resection has level 1A evidence, however, it has been replaced by ablative methods of the great saphenous vein (for example, laser and radiofrequency). Some advantages of ablative methods: quick recovery, less invasive and fewer scars. Disadvantages include stains, burns, neuritis, paresthesia and thrombosis. The devices are manufactured only by multinational companies and involve high financial expenses in their use. In view of the enormous market potential to be explored and the lack of proof of the superiority of the methods currently used, the project aims to develop a simple and cheap suture device from inside the vessel (endosuture).The device - a spiral needle with a suture thread - will be introduced in a minimally invasive way into the great saphenous vein and, with circular and progressive movements, will block the vessel. In this way, the disadvantages of current ablative methods will be reduced. No similar products were available or patented for this purpose. The project aims, therefore, to create a low-cost endosuture device for the treatment of CVI, replacing the traditional ligation of the great saphenous vein in vascular surgeries and the consequences of current ablative methods. The specific objectives of Phase 1 are: 1) construction of the full-scale 3D project based on the illustrative model, 2) research and define suitable materials to create the prototypes that will be made by 3D printing and/or another method that best fits the challenges of this stage, 3) carry out preliminary tests (MVP) on simulators and/or on parts of previously slaughtered animals, 4) evaluate the usability of the product and 5) build an initial proposal for PIPE phase 2. (AU)