U N I V E R S I T À D I P I S A
DIPARTIMENTO DI INGEGNERIA DELL’INFORMAZIONE Dottorato di Ricerca in Ingegneria dell’Informazione
Acitvity Report by the candidate Roberta PIAZZA, cycle XXXII
Tutor: Prof. Vincenzo FERRARI
Supervisors: Dr. Sara CONDINO, Prof. Enzo Pasquale SCILINGO
1. Research Activity
The research activity was carried out at the EndoCAS Research Center (University of Pisa, Italy) and partially at the Robarts Research Institute (London, ON, Canada).
The aim of the PhD thesis was to develop ad-hoc electromagnetic (EM) guided endovascular instru-mentation for the specific in-situ laser fenestration (ISLF) procedure. The ISLF task consists of the intraoperative modification of standard endograft, creating holes in its wall, in order to restore pa-tency after its deployment within an aortic aneurysm which involves the location of the collateral vessels origins.
The proposed endovascular tools are the following: a Guiding Catheter System to easily navigate a
Laser Tool at the correct fenestration site, offering support to perform the 3D computer-guided
antegrade in-situ laser fenestration of a standard endoprosthesis. All the aforementioned tools are equipped with electromagnetic sensors in order to provide a selective fenestration apparatus whose position and orientation can be accurately tracked in real-time within a 3D virtual model of the pa-tient vasculature.
The Laser Tool consisted of a diode laser fiber integrated within a custom-made hollow nitinol guide-wire to selectively perforate, i.e. fenestrate, the stent-graft fabric. As regard its reliability, in vitro tests and a clinical trial were carried out to explore different laser irradiation conditions for a suc-cessful endograft fenestration and to evaluate the harmless effects of diode laser irradiation on human aortic tissue, providing a selective and safe laser fenestration tool. Results from an ex-vivo evaluation of irradiation effects on human aorta samples showed that the laser operative condi-tions, previously evaluated to ensure the fabric fenestration, were harmless for the biological tissue surrounding the endoprosthesis. These experiments suggested that the diode laser can be safely used for the proposed surgical application.
As regards the Guiding Catheter System, different methods were employed to evaluate the desired specifications. Preliminary in vitro test on the first design solutions has been carried out to direct the design process toward an optimal configuration. Mechanical simulations were performed with a design software system for the development of composite tubing for endovascular catheters. Lastly, a revised version of first design project has been tested in vitro in order to perform the EM
of complexity and to technically evaluate the EM catheter system to guide and stabilize the fenes-tration tool. The final prototypes of the Guiding Catheter System consisted of two sensorized endo-vascular catheters:
- Steerable Catheter designed to properly position and orient a fenestration tool toward the target site. It can be easily rotated to properly orient the Laser Tool in the direction of the target site. A single plane articulation (1 DOF) allows the tip bending, which is actuated by a cable system, manually controlled via the catheter handle;
- Stabilizing catheter, consisting of two coaxial tubular structures, respectively connected to the proximal and distal ends of expandable nitinol wires. The expansion of these wires is designed to push the stabilizing catheter against the endograft wall and to offer mechanical support to the steerable catheter, and therefore to the laser tool, during the fenestration procedure at the target site.
Creganna Medical (Galway, Ireland), an international company specialized in endovascular catheter
design and manufacturing, has realized the final prototypes of both catheters.
As regard the use of EM sensor used for the endovascular image guidance systems, the choice to use 5DOF sensors was due to structural dimension restrictions: at the present time, the minimum diameter of 6DOF sensor(0.8 mm) is more than two times than that of 5DOF EM coils (0.3 mm). In particular, the 6DOF coil does not fit with the typical guidewire used in endovascular procedure, which has a J-shape tip (J-tip guidewire). The limitation of using a 5DOF sensor to track the guidewire tip is related to the absence of information regarding the axial rotation about the coil length, and thus the orientation of the J-tip. In addiction, considering that these guidewires have a small bending radius and the structure of the coil itself cannot be bent as a J-tip shape because it would cause its rupture, there are no currently solution for an adequate tracking of J-tip guidewires. Although it is yet impossible to bend the sensor to a J-shape, a study regarding the precision assessment of sen-sors during bending tests has been carried out to demonstrate the feasibility of using a partially bent 5DOF sensor, placed at the level of custom J-tip hollow microtube, together with a second coil in order to infer information regarding the position an orientation of the pre-shaped tip.
The innovative ad hoc design of electromagnetic trackable endovascular instrumentation has the potential to expand indications for endovascular aneurysm repair to patients with unfavorable anat-omy (e.g. short-necked aneurysms), even in the setting of ruptured or symptomatic AAAs which, nowadays, are treated with an open surgical approach. Thus, the potential clinical impact is signifi-cant, since the development of a computer-assisted method and tools for the execution of ante-grade in situ fenestration can allow a minimally invasive endovascular approach to be performed in patients that are currently considered ineligible for an EVAR procedure. Moreover, the proposed approach paves the way to use ISF as a bailout technique for rescuing branched aortic arteries, e.g. renal arteries, after inadvertent coverage during EVAR, avoiding permanent failure of vital organs.
2. Formation Activity
Internal courses:
- Academic writing and academic presentation skills (4 credits)
- Semiconductor trip: from a simple idea to a complex manufacturing (6 credits) - Design of multisensory biomedical integrated circuits (5 credits)
- Finite-element modeling for engineers (4 credits)
- Introduction to estimation algorithms for automation and robotics (5 credits) - Continuous monitoring of health and well-being using wearable sensors (3 credits) - Advanced course in "Academic Writing and Academic Presentation Skills“ (5 credits) - Nanomechanics for intelligent materials (2 credits)
External course:
- 2nd IEEE EMBS International Summer School on Computer Modeling in Medicine.
Theme: Image-based Modeling for Personalized Medical Device Design (June 9–14, 2019, Charleston, SC, USA) (8 credits)
TOTAL COURSES/CREDITS FROM PhD START: 42
3. Research Periods at Qualified Research Institutions
Visiting Graduate Student (research only) at Robarts Research Institute (University of Western On-tario, London, ON, Canada), April 2019 – January 2020.
Publications
International Journals
[J1] Nisar, H., Moore, J., Piazza, R., Maneas, E., Chen, E. C. S., and Peters, T. M., (2020, May). A
Simple, Realistic Walled Phantom for Intravascular and Intracardiac Application. Accepted for
pub-lication in International Journal of Computer Assisted Radiology and Surgery.
[J2] Moglia, A., Piazza, R., Mocellin, D. M., Ferrari, V., Campanelli, G., Ferrari, M. and Berchiolli, R. N. (2020, April). Definition of Proficiency Level by a Virtual Simulator as a First Step towards a
Cur-riculum on Fundamental Skills for Endovascular Aneurysm Repair (EVAR). Accepted for publication
in European Journal of Surgical Education.
[J3] Condino, S., Piazza, R., Viglialoro, R. M., Mocellin, D. M., Turini, G., Berchiolli, R. N., Micheletti, F., Rossi, F., Ferrari, V. and Ferrari, M. (2020, March). Novel EM-Guided Endovascular
Instrumenta-tion for In-Situ Endograft FenestraInstrumenta-tion. IEEE Journal of TranslaInstrumenta-tional Engineering in Health and
Med-icine. (Vol. 8, pp. 1-8). Pamela Bhatti.
[J4] Carbone, M., Piazza, R., Condino, S. (2020, February). Commercially Available Head-Mounted
Displays Are Unsuitable for Augmented Reality Surgical Guidance: A Call for Focused Research for Surgical Applications. Surgical Innovation. Adrian E. Park, Lee Swanstrom.
[J5] Condino, S., Carbone, M., Piazza, R., Ferrari, M., and Ferrari, V. (2020, February). Perceptual
Limits of Optical See-Through Visors for Augmented Reality Guidance of Manual Tasks. IEEE
[J6] Piazza, R., Micheletti, F., Condino, S., Magni, G., Berchiolli, R.N., De Simone, P., Ferrari, V., Fer-rari, M., Pini, R. and Rossi, F. (2019, May). In Situ Diode Laser Fenestration: An Ex-Vivo Evaluation of
Irradiation Effects on Human Aortic Tissue. Journal of Biophotonics. (Vol.12, e201900032). Jürgen
Popp.
[J7] Carbone, M., Ferrari, V., Marconi, M., Piazza, R., Del Corso, A., Lucchesi, Q., Pagni, V. and Ber-chiolli, R. N. (2018, September). A Tele-Ultrasonographic Platform to Collect Specialist Second
Opin-ion in Less Specialized Hospitals. Updates in Surgery. (Vol. 70, pp. 407–413). Francesco Basile, Fulvio
Calise.
[J8] Piazza, R., Condino, S., Alberti, A., Berchiolli, R. N., Coppi, G., Gesi, M., Ferrari, V. and Ferrari, M. (2017, July). Design of Sensorized Guiding Catheter for In-Situ Laser Fenestration of Endovascular
Stent. Computer Assisted Surgery. (Vol. 22, pp. 27-38). International Conferences/Workshops with Peer Review
[C1] Cattari, N., Piazza, R., D’Amato, R., Fida, B., Carbone, M., Condino, S., Cutolo, F., and Ferrari, V. (2020, June). Towards a Wearable Augmented Reality Visor for High-Precision Manual Tasks. 15th Edition of IEEE International Symposium on Medical Measurements and Applications, IEEE MeMeA 2020.
[C2] Nisar, H., Moore, J., Piazza, R., Maneas, E., Chen, E. C. S., and Peters, T. M., (2020, June). A
Simple, Realistic Walled Phantom for Intravascular and Intracardiac Application. Computer Assisted
Radiology and Surgery. CARS 2020.
[C3] Piazza, R., Nisar, H., Moore, J., Condino, S., Ferrari, M., Ferrari, V., Peters, T. M., and Chen, E. C. S. (2020, March). Towards Electromagnetic Tracking of J-Tip Guidewire: Precision Assessment of
Sen-sors During Bending Tests. Proceeding of SPIE, Medical Imaging 2020: Image-Guided Procedures,
Robotic Interventions, and Modeling. (Vol. 11315, 1131506). Baowei Fei, Cristian A. Linte.
[C4] Piazza, R., Micheletti, F., Condino, S., Magni, G., Berchiolli, R. N., De Simone, P., Ferrari, V., Ferrari, M., Pini, R. and Rossi, F. (2019, July). Ex Vivo Efficacy Demonstration of a Laser Fenestration
System for Endovascular Abdominal Aortic Aneurysm Repair (EVAR). Proceeding of SPIE, Medical
Laser Applications and Laser-Tissue Interactions IX. (Vol. 11079, pp. 1107907). Lothar D. Lilge, Car-sten M. Philipp.
[C5] Turini, G., Condino, S., Fontana, U., Piazza, R., Howard, J. E., Celi, S., Positano, V., Ferrari, M. and Ferrari, V. (2019, July). Software Framework for VR-Enabled Transcatheter Valve Implantation
in Unity. 6th International Conference, Augmented Reality, Virtual Reality, and Computer Graphics.
AVR 2019. Lecture Notes in Computer Science. (Vol. 11613, pp. 376-384). Lucio Tommaso De Paolis, Patrick Bourdot.
[C6] Piazza, R., Condino, S., Alberti, A., Giannetti, D., Ferrari, V., Gesi, M. and Ferrari, M. (2017, June).
Using of 3D Virtual Reality Electromagnetic Navigation for Challenging Cannulation in FEVAR Proce-dure. 4th International Conference, Augmented Reality, Virtual Reality, and Computer Graphics.
AVR 2017. Lecture Notes in Computer Science. (Vol. 10325, pp. 221-229). Lucio Tommaso De Paolis, Patrick Bourdot, Antonio Mongelli.
[C7] Micheletti, F., Pini, R., Piazza, R., Ferrari, V., Condino, S. and Rossi, F. (2017, February). In Situ
Laser Fenestration of Endovascular Stent-Graft in Abdominal Aortic Aneurysm Repair (EVAR).
Pro-ceeding of SPIE, Diagnostic and Therapeutic Applications of Light in Cardiology. (Vol. 10042, pp. 100420D). Guillermo J. Tearney, Kenton W. Gregory, Laura Marcu.
Other submissions
[O1] Piazza, R., Condino, S., Sinceri, S., Viglialoro, R. M., Carbone, M., Berchiolli, R. N., Ferrari, M. and Ferrari, V. (2019, October). Realizzazione di Simulatori Fisici per Testing di un Navigatore
Endo-vascolare. III National Congress of Italian Digital Biomanufacturing Network. IDBN 2019. Pending Patent
[P1] Dispositivo di Guida per Guidare Strumenti per Applicazioni Endovascolari. Inventors: Ferrari, M., Berchiolli, R.N., Ferrari, V., Condino, S., Piazza, R. (n°102020000001336, submitted on January 2020).
Pisa, 04/06/2020
The Student
