Flow Controlled Prosthetic Heart Valves

Informazioni relative al progetto

StreamlineValve

ID dell’accordo di sovvenzione: 101157514

DOI

10.3030/101157514

Progetto chiuso

Data della firma CE 5 Febbraio 2024

Data di avvio 1 Marzo 2024

Data di completamento 28 Febbraio 2026

Finanziato da

• European Research Council (ERC)

Costo totale

Nessun dato

Contributo UE

€ 150 000,00

Coordinato da

TECHNION - ISRAEL INSTITUTE OF TECHNOLOGY
Israel

Periodic Reporting for period 1 - StreamlineValve (Flow Controlled Prosthetic Heart Valves)

Periodo di rendicontazione: 2024-03-01 al 2026-02-28

Sintesi del contesto e degli obiettivi generali del progetto

Valvular heart disease affects over 100 million people worldwide and frequently requires prosthetic valve replacement. Current solutions present important limitations: biological valves tend to degrade over time and often require replacement within 10–15 years, while mechanical valves offer durability but require lifelong anticoagulation therapy, increasing the risk of bleeding complications.
The StreamlineValve project aims to address this unmet need by exploring a novel approach based on passive flow control. The objective is to redesign prosthetic heart valves to improve blood flow patterns, with the aim of reducing stagnation zones, turbulence, and elevated shear stress, which are associated with thrombosis and other complications.
The expected impact is the development of improved valve designs that may enhance safety and durability, potentially reducing the need for repeat interventions and long-term medication. The approach is compatible with minimally invasive implantation procedures and could be applied across different types of prosthetic valves, increasing its potential clinical relevance.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

The project combined computational modelling, prototype development, and experimental investigation to explore the feasibility of the concept.
First, computational fluid dynamics (CFD) simulations were performed to design and optimize valve geometries incorporating passive flow-control features. Multiple configurations were developed and assessed based on predicted hemodynamic parameters such as flow patterns, shear stress distribution, and recirculation regions.
Second, initial polymeric valve prototypes were fabricated using 3D printing and molding techniques. In parallel, a custom pulsatile flow system was developed to replicate physiological flow conditions and enable controlled experimental evaluation of valve performance.
Third, experimental studies provided initial indications that the StreamlineValve concept has the potential to reduce clot formation compared to conventional valve designs. Flow visualization studies suggested improved flow patterns, including reduced recirculation zones, consistent with the trends predicted by the computational analysis.
Overall, the project established the feasibility of integrating passive flow-control features into prosthetic valve designs and delivered an initial proof of concept supported by both simulations and experimental observations.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

The project explores a new direction in prosthetic heart valve design by addressing thrombosis through flow control, complementing existing approaches that primarily focus on materials and surface treatments. This represents a novel contribution to the field of cardiovascular device engineering.
The results indicate the potential to improve flow conditions associated with thrombosis, which may translate into improved safety and durability of future valve designs. The approach is flexible and could be integrated into emerging polymeric valves as well as minimally invasive implantation systems such as transcatheter procedures.
Further work is required to advance the technology toward clinical application. This includes continued design optimization, more extensive experimental validation, preclinical and clinical studies, regulatory approval processes, and scaling of manufacturing. In addition, continued development of intellectual property and engagement with industrial partners will be important for successful exploitation.
Overall, the project provides a solid basis for further development of innovative prosthetic heart valves with the potential to address key limitations of current technologies and improve patient outcomes.