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. 2020 Mar 4:8:1900208.
doi: 10.1109/JTEHM.2020.2973973. eCollection 2020.

Novel EM Guided Endovascular Instrumentation for In Situ Endograft Fenestration

S Condino  1   2 , R Piazza  1   2 , R M Viglialoro  2 , D M Mocellin  3 , G Turini  2   4 , R N Berchiolli  2   3 , F Micheletti  5 , F Rossi  5 , R Pini  5 , V Ferrari  1   2 , M Ferrari  2   3
Affiliations

Novel EM Guided Endovascular Instrumentation for In Situ Endograft Fenestration

S Condino et al. IEEE J Transl Eng Health Med. .

Abstract

Objective: This work aims at providing novel endovascular instrumentation to overcome current technical limitations of in situ endograft fenestration including challenges in targeting the fenestration site under fluoroscopic control and supplying mechanical support during endograft perforation. Technology: Novel electromagnetically trackable instruments were developed to facilitate the navigation of the fenestration device and its stabilization at the target site. In vitro trials were performed to preliminary evaluate the proposed instrumentation for the antegrade in situ fenestration of an aortic endograft, using a laser guidewire designed ad hoc and the sharp end of a commercial endovascular guidewire. Results: In situ fenestration was successfully performed in 22 trials. A total of two laser tools were employed since an over bending of laser guidewire tip, due to its manufacturing, caused the damage of the sensor in the first device used. Conclusions: Preliminary in vitro trials demonstrate the feasibility of the proposed instrumentation which could widespread the procedure for in situ fenestration. The results obtained should be validated performing animal studies. Clinical Impact: The proposed instrumentation has the potential to expand indications for standard endovascular aneurysm repair to cases of acute syndromes.

Keywords: EVAR; Electromagnetic guidance; endovascular instrumentation; in situ fenestration; laser fenestration.

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Figures

FIGURE 1.
FIGURE 1.
Diagram of the endovascular navigator: the software (in cyan) and the hardware (in grey) modules, the surgeon/user (in red), the developed instrumentation (in green), testing in vitro setups (in yellow). Physical interactions and data transfers are represented with directional lines.
FIGURE 2.
FIGURE 2.
Overview of developed sensorized laser guidewire. The EM coil and the laser fiber are both integrated within the nitinol hollow strand, as shown in the zoomed detail.
FIGURE 3.
FIGURE 3.
Overview of stabilizer (a): from navigation configuration (b) the nitinol components are expanded in working configuration (c) by pulling (yellow direction) the slidable handle (white arrowhead).
FIGURE 4.
FIGURE 4.
Overview of steerable catheter (a): the straight distal part of the tip (b) can be bent (c) by turning the cog (white arrowhead) of the handle.
FIGURE 5.
FIGURE 5.
In vitro testing setups: Setup A, a non-anthropomorphic phantom (a); and Setup B, a phantom of a short-necked aneurysm (b).
FIGURE 6.
FIGURE 6.
EM-guided mechanical ISF: the navigator scene (a) allows the user to position the stabilizer (white arrowhead) and orient the steerable catheter (asterisk) at the target site (visible also in the endoscopic view). A successful mechanical ISF is shown in the real scene (b), where the sharp-end of the guidewire perforated the endograft wall.
FIGURE 7.
FIGURE 7.
Overview of Setup B for laser ISF (a): the navigator scene (b) allows the user to position the stabilizer (green) and orient the steerable catheter (blue) at the target site (visible also in the endoscopic view). A successful laser ISF is shown in the real scene (c), where the sensorized laser guidewire perforated the endograft wall at left renal level.
See this image and copyright information in PMC

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