Novel bone-anchored vascular access on the mastoid for hemodialysis: concept and preclinical trials

Stieger, Christof; Arnold, Andreas Michael; Kruse, Anja; Wiedmer, Simona; Widmer, Matthias; Guignard, Jérémie; Schutz, Daniel; Guenat, Jean-Marc; Bachtler, Matthias; Caversaccio, Marco; Uehlinger, Dominik; Frey, Felix; Häusler, Rudolf (2015). Novel bone-anchored vascular access on the mastoid for hemodialysis: concept and preclinical trials. IEEE transactions on bio-medical engineering, 63(5), pp. 984-990. Institute of Electrical and Electronics Engineers 10.1109/TBME.2015.2480241

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GOAL We present the development of a boneanchored port for the painless long-term hemodialytic treatment of patients with renal failure. This port is implanted behind the ear. METHODS 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. RESULTS 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. CONCLUSION Preclinical evaluations demonstrated the technical feasibility and safety of the investigational device. SIGNIFICANCE 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 towards enhancing vascular access could potentially reduce the costs and complications of hemodialytic therapy.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Ear, Nose and Throat Disorders (ENT)
10 Strategic Research Centers > ARTORG Center for Biomedical Engineering Research > ARTORG Center - Image Guided Therapy > ARTORG Center - Artificial Hearing Research
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Unit Childrens Hospital > Forschungsgruppe Nephrologie / Hypertonie
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiovascular Surgery
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Forschungsbereich Pavillon 52 > Forschungsgruppe Audiologie
04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Nephrology and Hypertension

UniBE Contributor:

Stieger, Christof; Arnold, Andreas Michael; Wiedmer, Simona; Widmer, Matthias; Guignard, Jérémie; Bachtler, Matthias; Caversaccio, Marco; Uehlinger, Dominik and Häusler, Rudolf

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1558-2531

Publisher:

Institute of Electrical and Electronics Engineers

Language:

English

Submitter:

Markus Huth

Date Deposited:

11 Feb 2016 10:57

Last Modified:

26 Jun 2016 02:11

Publisher DOI:

10.1109/TBME.2015.2480241

PubMed ID:

26394413

BORIS DOI:

10.7892/boris.76299

URI:

https://boris.unibe.ch/id/eprint/76299

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