Needle-free vascular access port for hemodialysis: Proof-of-concept validation in an experimental animal study.

Vascular access remains a critical challenge in kidney replacement therapy. Although arteriovenous fistulas are the reference standard, they are often compromised by maturation failure, complications, and repeated needling, which causes pain and distress for patients. A needle-free alternative could enhance safety, simplify use, and improve the patient experience, particularly in self-care and home dialysis. We evaluated the Safe Hemodialysis Implantable Vascular Access Technology arteriovenous port, a patented titanium device incorporating a twist-lock system anastomosed to a vascular graft prosthesis. The proof-of-concept study included in vitro testing to assess flow performance, durability, and hemocompatibility, followed by implantation in two sheep to determine surgical feasibility, hemodynamic function, and safety during a sham hemodialysis session. Implantation was successful without complications, the twist-lock system functioned securely, and no blood leakage, arterial bleeding, or air embolism occurred. The device provided adequate blood flow, although refinements are required to achieve clinical targets of 300-400 mL/min. These preliminary findings suggest that the Safe Hemodialysis Implantable Vascular Access Technology port is a feasible and safe needle-free vascular access concept, with potential to reduce needling burden, improve handling, and minimize infection risk in clinical use.