PROJECT TITLE :

Novel Bone-Anchored Vascular Access on the Mastoid for Hemodialysis: Concept and Preclinical Trials

ABSTRACT:

Goal: We tend to gift the development of a bone-anchored port for the painless long-term hemodialytic treatment of patients with renal failure. This port is implanted behind the ear. Ways: The port was developed based mostly on knowledge obtained from long-term expertise with implantable hearing devices, that are firmly anchored to the bone behind the ear. This concept of bone anchoring was custom-made to the wants for a vascular access throughout hemodialysis. The investigational device is comprised of a base plate that's firmly fixed with bone screws to the bone behind the ear (temporal bone). A catheter leads from the bottom plate valve block through the internal jugular vein and into the correct atrium. The valves are opened using a special disposable adapter, while not any would like to puncture the blood vessels. Between hemodialysis sessions, the port is protected with a disposable cover. Results: Flow rate, leak tightness, and purification were tested on mockups. Preoperative designing and therefore the surgical procedure were verified in fifteen anatomical human whole head specimens. Conclusion: Preclinical evaluations demonstrated the technical feasibility and safety of the investigational device. Significance: Approximately 1.5 million individuals are treated with hemodialysis worldwide, and 25% of the general value of dialysis therapy results from vascular access problems. New approaches toward enhancing vascular access could probably scale back the costs and complications of hemodialytic therapy.