The Pentaport
Designing a safe gateway for complex endovascular aortic repair
T. Brenninkmeyer (TU Delft - Industrial Design Engineering)
R.J.H.G. van Heur – Mentor (TU Delft - Human Factors)
Magda Chmarra – Coach (TU Delft - Medical Instruments & Bio-Inspired Technology)
J. Van Schaik – Coach (Leiden University Medical Center)
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Abstract
“A ruptured AAA [Abdominal Aortic Aneurysm]
is the 15th leading cause of death in the country, and the 10th leading cause
of death in men older than 55” in the United States, states Singh (n.d.),
in the Society for Vascular Surgeons. Such Abdominal Aortic Aneurysms (AAA, see
Figure 2.2) are increasingly treated by endovascular surgery, during which
stent grafts are placed in the ballooned vessel through access sites such as
the femoral (thigh) arteries, a procedure called Endo Vascular Aneurysm Repair
(EVAR). 10% of patients has an aneurysm near significant arteries (Mayo Clinic,
2019), called a complex AAA, requiring stent grafts fitted with fenestrations
(FEVAR, see Figure 2.1) or side branches (BEVAR). After puncture of the femoral artery, an introducer sheath is
placed in the vessel, functioning as a re-usable access point to the arterial
system. The sheath prevents blood from flowing out of the artery and enables
entrance of tools such as guide wires, catheters and smaller sheaths into the
arteries. However, treatment of complex AAA requires introduction of multiple
tools (up to 5) through the sheath simultaneously, compared to just one or two
during EVAR. With every additional tool being introduced, the valve’s
capability of adequate closure is reduced even more. This results in leakage
that can lead to significant blood loss for the patient. The Pentaport is a new, safe gateway for complex endovascular
aortic repair (Figure 2.3). It functions as an add-on for commonly used sheath
models. A leakproof ‘plug & screw’ connection facilitates safe and easy
fastening to large-bore introducer sheaths. The Pentaport minimises blood
leakage. Preventing severe blood losses of 2L or even more during one
surgery, spares a heavy attack on the patient’s condition and eliminates the
need for costly consequences, such as cell-saving or blood transfusion. In
addition, it prevents the need for lengthy recatheterisation efforts (up
to 60 minutes) and possible harm to the patient’s arteries. The design was
evaluated and proof of concept was achieved, through functionality tests in
simulated environments and usability tests with medical specialists.