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

Abstract

We present 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. The port was developed based on knowledge obtained from long-term experience with implantable hearing devices, which are firmly anchored to the bone behind the ear. This concept of bone anchoring was adapted to the requirements for a vascular access during hemodialysis. The investigational device is comprised of a base plate that is firmly fixed with bone screws to the bone behind the ear (temporal bone). A catheter leads from the base plate valve block through the internal jugular vein and into the right atrium. The valves are opened using a special disposable adapter, without any need to puncture the blood vessels. Between hemodialysis sessions, the port is protected with a disposable cover. Flow rate, leak tightness, and purification were tested on mockups. Preoperative planning and the surgical procedure were verified in 15 anatomical human whole head specimens. Preclinical evaluations demonstrated the technical feasibility and safety of the investigational device. Approximately 1.5 million people are treated with hemodialysis worldwide, and 25% of the overall cost of dialysis therapy results from vascular access problems. New approaches toward enhancing vascular access could potentially reduce the costs and complications of hemodialytic therapy.