Presenting a New Version of the RObotic System for Angioplasty
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Abstract
This paper describes the new version of RObotic System for Angioplasty (ROSA), which was developed from a simplified version of the RObotic System for Endovascular Surgery (ROSES). ROSES itself arose from the original ROSA device and has been tested for clinical use on patients.
The new version of ROSA offers several advantages over the previous versions. First, it allows the measurement of forces used to track catheters during the endovascular procedure. This process only requires standard mechanical disposables, since the measuring system is embedded in a special cart that controls the movement of various robotic actuators. Second, it uses a new hemostasis valve that rotates with the angioplasty disposable, making it easier to guide rotations. Finally, it offers the possibility of positioning the initial catheter using a system that includes two robotic actuators found on the cart. The first of these is simpler and has an internal disposable, whereas the second is new and contains two gear trains, which control five independent parameters (two rotations and three advancements). This makes it possible to control advancement and rotation of the initial catheter, while straightening its curvature using a movable core guidewire. Once the first catheter is correctly positioned, it is possible to perform all procedures without changing the position of the guiding catheter by replacing the disposable for the 0.035" guidewire with movable core with the disposable for angioplasty, which drives both the angioplasty balloons or stents and the 0.016” wire, which instead needs to turn on its axis in order to ease penetration of the small guide wire which has to penetrate the winding path of the coronaries. And this is allowed by the presence of the two independent gear trains of the recent robotic actuator, which can block rotations of the gear train on which the initial catheter is positioned, while allowing all rotations needed for the angioplasty disposable. However, in the near future it will also be possible to change the position of the guiding catheter using a special 6 French catheter with controlled tip curvature, for example, to perform an additional angioplasty on a different coronary artery, should this be required.
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References
2. Carrozza JP. Robotic-assisted percutaneous coronary intervention—Filling an unmet need. J. Cardiovasc. Transl. Res. 2011, 5, 62–66.
3. Britz GW, Panesar SS, Falb P, Tomas J, Desai V, Lumsden A. Neuroendovascular-specific engineering modifications to the CorPath GRX Robotic System. J. Neurosurg. 2019, 133, 1830–1836.
4. Smitson CC, Ang L, Pourdjabbar A, Reeves R, Patel M, Mahmud E. Safety and feasibility of a novel, second-generation robotic-assisted system for percutaneous coronary intervention: First-in-human report. J. Invasive Cardiol. 2018, 30, 152–156.
5. El Naamani K, Abbas R, Sioutas GS, Tjoumakaris SI, Gooch MR, Herial NA, Rosenwasser RH, Jabbour PM. Endovascular Robotic Interventions. Neurosurg. Clin. 2022, 33, 225–231.
6. Beyar R. Transmission for a Remote Catheterization System. European Patent EP1755727B1, 11 January 2012.
7. Durand E. Evolution European Multicenter Study to Evaluate the Safety & Efficacy of the R-Onetm System in Percutaneous Coronary Interventions, Available online: https://www.robocath.com (accessed on 11 Marc 2023)
8. Riga CV, Bicknell CD, Rolls A, Cheshire NJ, Hamady MS. Robot-assisted fenestrated endovascular aneurysm repair (FEVAR) using the Magellan system, J Vasc Interv Radiol. 2013 Feb;24(2):191-6.
9. Mazomenos EB, Chang PL, Rippel RA, Rolls A, Hawkes DJ, Bicknell CD, Desjardins A, Riga CV, Stoyanov D. Catheter manipulation analysis for objective performance and technical skills assessment in transcatheter aortic valve implantation, Int J Comput Assist Radiol Surg. 2016; 11: 1121-1131.
10. Perera AH, Riga CV, Monzon L, Gibbs RG, Bicknell CD, Hamady M. Robotic Arch Catheter Placement Reduces Cerebral Embolization During Thoracic Endovascular Aortic Repair (TEVAR), Eur J Vasc Endovasc Surg. 2017 Mar; 53(3): 362-369.
11. Jones B, Riga C, Bicknell C, Hamady M. Robot-Assisted Carotid Artery Stenting: A Safety and Feasibility Study, Cardiovasc Intervent Radiol, 2021 May; 44(5): 795-800.
12. El-Sayed T, Patel AS, Cho JS, Kelly JA, Ludwinski FE, Saha P, Lyons OT, Smith A, Modarai B. Radiation-Induced DNA Damage in Operators Performing Endovascular Aortic Repair. Circulation. 2017 Dec 19; 136 (25): 2406-2416.
13. Lopez Aventìn D, Gil I, Lopez Gonzalez DM, Pujol RM. Chronic scalp ulceration as a late complication of fluoroscopically guided cerebral aneurysm embolization. Dermatology. 2012;224(3):198-203.
14. Luani B, Zrenner B, Basho M, Genz C, Rauwolf T, Tanev I, Schmeisser A, Braun-Dullaeus RC. Zero-fluoroscopy cryothermal ablation of atrioventricular nodal re-entry tachycardia guided by endovascular and endocardial catheter visualization using intracardiac echocardiography (Ice&ICE Trial). J Cardiovasc Electrophysiol. 2018 Jan; 29(1): 160-166.
15. Li J, De Leon H, Ebato B, Cui J, Todd J, Chronos NA, Robinson KA. Endovascular irradiation impairs vascular functional responses in noninjured pig coronary arteries. Cardiovasc Radiat Med. 2002 Jul-Dec;3(3-4):152-162.
16. Gerber TC, Carr JJ, Arai AE, et al. Ionizing radiation in cardiac imaging. A science advisory from the American Heart Association Committee on Cardiac Imaging of the Council on Clinical Cardiology and Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention. Circulation. 2009; 119: 1056-65.
17. Picano E, Vano E. Radiation exposure as an occupational hazard. EuroIntervention. 2012; 8: 649- 53.
18. Picano E, Andreassi MG, Piccaluga E, et al. Occupational risks of chronic low dose radiation exposure in cardiac catheterisation laboratory: the Italian Healthy Cath Lab study. EMJ Int Cardiol 2013;1:50-8.
19. Monaco MGL, Carta A, Tamhid T, Porru S. Anti-X Apron Wearing and Musculoskeletal Problems Among Healthcare Workers: A Systematic Scoping Review. Int J Environ Res Public Health. 2020 Aug 13;17(16):5877. doi: 10.3390/ijerph17165877. PMID: 32823627; PMCID: PMC7459898.
20. Dixon RG, Khiatani V, Statler JD, Walser EM, Midia M, Miller DL, Bartal G, Collins JD, Gross KA, Stecker MS, et al. Society of Interventional Radiology: Occupational Back and Neck Pain and the Interventional Radiologist. Standards of Practice. J. Vasc. Interv. Radiol. 2017; 28:195–199. doi: 10.1016/j.jvir.2016.10.017
21. Benjamin JL, Meisinger QC. Ergonomics in the Development and Prevention of Musculoskeletal Injury in Interventional Radiologists. Tech. Vasc. Interv. Radiol. 2018; 21:16–20. doi: 10.1053/j.tvir.2017.12.004.
22. Danieli G, Indolfi C, De Rosa S, Battaglia D, De Gaetano G, Fragomeni G., Greco P.F., Larocca G, Perrelli M. Robotic System for Angioplasty and Endoluminal Surgery. PCT/ IT2018/ 050209 printed 91.07.2021, nazionalized USA US20210196412, 17/04/2020, Europe EP18807725.9, 25.05.2020, India E- 1/23927/2020-DEL, 26/05/2020
23. Danieli G. Opto-Haptic System to Measure and Represent Forces Opposing Catheter or Guide Wire Penetration into the Vascular System for Robots for Endovascular Surgery. Italian Patent PCTIT2020050109, 14 March 2022.
24. Danieli G, De Rosa S, Greco PF, Indolfi C, Larocca G, Massetti M, Tinelli G, Tshomba Y, Evolution of ROSES System for Endovascular Surgery. PCT/IT2021/000042, august 31st 2021
25. Danieli G, De Rosa S. New Disposable Components for ROSES Robotic System for Endovascular Surgery. Italian Patent Application 102022000013684, 28 June 2022
26. Danieli G. Small modifications and complementary elements for the disposables of the Robotic System for Endovascular Surgery. Italian Patent Application 1020230000, April 3rd 2023
27. Greco PF, Larocca G, Perrelli M, Danieli G, De Rosa S, Indolfi C ROSA – RObotic System for Angioplasty Mechanisms and Machine Science 2019, 65, pp. 72-81
28. Danieli G, Greco PF, Massetti M, Tinelli G e Tshomba Y, New version of the Robotic Actuator (RA) “Big Mouth” of ROSES (RObotic System for Endovascular Surgery) for TAVI and related disposables. Italian patent application 102020000020746, presented 01/09/2020
29. Tshomba Y, Tinelli G, Mammolito F, Larocca G, La Greca G, Greco PF, Danieli G. Trolley for support and movement of ROSES Robot Actuators in angioplasty and endovascular surgery which allows the measurement of the forces opposed by the body to the advancement of the catheters. Italian patent application 102020000020734, presented 01/09/2020
30. Tshomba Y, Tinelli G, Larocca G, Greco PF, Danieli G. Catheter with curved tip controllable from the Console of the ROSES robot for angioplasty and endovascular surgery, and relative disposable, Italian patent application 102020000020740, presented 01/09/2020
31. Danieli G, Greco PF, Larocca G. Endovascular surgery robot equipped with an opto-haptic system to measure and represent the forces opposing the advancement of a catheter or guidewire within the endovascular system. Italian patent application 102019000006657, presented 08/05/2019, granted 13/04/2021
32. Yang, C., Guo, S., Bao, X. et al. A vascular interventional surgical robot based on surgeon’s operating skills. Med Biol Eng Comput 57, 1999–2010 (2019). https://doi.org/10.1007/s11517-019-02016-8
33. Danieli G, Greco PF, Larocca G, De Rosa S, Indolfi C, Polimeni A, Massetti M, Tinelli G, Tshomba Y, Venturini L. Development of disposables and accessories for ROSES and their in vitro experimentation. Appl. Mech. 2022, 3, 956–973. https://doi.org/10.3390/applmech3030054
34. Danieli G, Gallo R, Greco PF, Larocca G, Maiarota F and Sorbello M. Development of ROSINA (Robotic System for INtubAtion). IJBTT-2021, Volume 11, Issue 3