Research on Biomedical Engineering
http://rbejournal.org/article/doi/10.1590/2446-4740.07517
Research on Biomedical Engineering
Original article

Development of radiofrequency ablation device for surgical hepatocellular carcinoma treatment in agreement with Brazilian standards

Gilvandson Costa Cavalcante, Flávio Ferreira Lima, Murilo Venturin, Ricardo Pezzuol Jacobi, Suélia de Siqueira Rodrigues Fleury Rosa

Abstract

Introduction: Many studies have been carried out on the main causes of hepatocellular carcinoma (HCC) to identify suitable diagnosis methods and treatments to combat the disease. However, high equipment costs and the lack of hepatic-ablation technologies manufactured in Brazil encourage the design and implementation of a solution based on normative principles.

Methods: The analysis and description of equipment features were the first steps in defining the design requirements and constraints. Equipment functionalities were evaluated with three assays set by NBR-IEC 60601-2-2.

Results: The assays of output control adjustment accuracy, output control adjustment monotonicity, and signal quality evaluation using the crest factor (CF) for the equipment showed thresholds superior to the aforementioned standard.

Conclusion: State-of-the-art studies have contributed the equipment construction. The construction process was validated by assays to ensure the equipment functionality with raw materials at acceptable costs. The test results showed the superiority of the equipment in relation to the assays proposed by the standard NBR-IEC 60601-2-2. However, to convert the prototype into a commercial product, other analyses are necessary.

Keywords

Accuracy, Monotonicity, Crest factor, Hepatocellular carcinoma

References

Agência Nacional de Vigilância Sanitária – ANVISA. Consultas [Internet]. Brasília: ANVISA; 2017. [cited 2017 Jul 25]. Available from: https://consultas.anvisa.gov.br.

Alba J, González-Suárez A, Trujillo M, Berjano E. Theoretical and experimental study on RF tumor ablation with internally cooled electrodes: when does the roll-off occur? Conf Proc IEEE Eng Med Biol Soc. 2011; 2011:314-7. https://doi.org/10.1109/IEMBS.2011.6090082. PMID: 22254312.

Alexander C, Sadiku M. Fundamentos de circuitos elétricos. São Paulo: McGraw-Hill Companies Inc.; 2008.

Associação Brasileira de Normas Técnicas – ABNT. NBR-IEC 60601-2-2. Equipamento eletromédico, Parte 2: Requisitos particulares para a segurança básica e desempenho essencial de equipamentos cirúrgicos de alta frequência e acessórios cirúrgicos de alta frequência. Rio de Janeiro; 2013. 80 p.

Audigier C, Mansi T, Delingette H, Rapaka S, Mihalef V, Carnegie D, Boctor E, Choti M, Kamen A, Ayache N, Comaniciu, D. (2015). Efficient lattice boltzmann solver for patient-specific radiofrequency ablation of hepatic tumors. IEEE Transactions on Medical Imaging, 34(7), 1576-1589. http://dx.doi.org/10.1109/TMI.2015.2406575.

Bouza C, López-Cuadrado T, Alcázar R, Saz-Parkinson Z, Amate JM. Meta-analysis of percutaneous radiofrequency ablation versus ethanol injection in hepatocellular carcinoma. BMC Gastroenterol. 2009; 9:31.

Cambridge University Press. Cambridge dictionary [Internet]. Cambridge: Cambridge University Press; 2018. [cited 2018 Feb 25]. Available from: https://dictionary.cambridge.org/pt/dicionario/ingles/ultrasound.

Clavien, P., Lesurtel, M., Bossuyt, P., Gores, G., Langer, B., & Perrier, A. Recommendations for liver transplantation for hepatocellular carcinoma: an international consensus conference report. Lancet Oncol. 2012; 13(1):e11-22. https://doi.org/10.1016/S1470-2045(11)70175-9. PMID: 22047762.

Fairchild Semiconductor. LM78XX [Internet]. California: Fairchild Semiconductor; 2008. [cited 2018 Jan 1]. Available from: www.fairchildsemi.com.

Frenzel LE Jr. Eletrônica moderna, fundamentos, dispositivos, circuitos e sistemas. São Paulo: McGraw Hill; 2015. p. 760-761.

Gomes MA, Priolli DG, Tralhão JG, Botelho MF. (2013). Hepatocellular carcinoma: epidemiology, biology, diagnosis and therapies. Rev Assoc Med Bras. 59(5), 514-24. https://doi.org/10.1016/j.ramb.2013.03.005. PMID: 24041910.

Haemmerich D, Staelin ST, Tungjitkusolmun S, Lee FT Jr, Mahvi DM, Webster JG. Hepatic bipolar radio-frequency ablation between separated multiprong electrodes. IEEE Trans Biomed Eng. 2001; 48(10):1145-52. https://doi.org/10.1109/10.951517. PMID: 11585038.

International Rectifier. IR2110 [Internet]. California: International Rectifier; 2005. [cited 2018 Jan 1]. Available from: www.irf.com.

Kavak, F. A sizing algorithm for non-overlapping. Linköping, Suécia: Institutionen för systemteknik; 2004. p. 581-83.

Kikuchi LOO. (2015). Análise da sobrevida de pacientes com carcinoma hepatocelular atendidos no Instituto do Câncer do Estado de São Paulo [tese]. São Paulo: Universidade de São Paulo.

Linear Technology. LT1014 [Internet]. California: Linear Technology; 1990. [cited 2018 Jan 1]. Available from: www.linear.com.

Nexperia. PCF8591 [Internet]. Nimega: Nexperia; 2013. [cited 2018 Jan 1]. Available from: www.nexperia.com.

Nexperia. 74HC14 [Internet]. Nijmegen: Nexperia; 2017. [cited 2018 Jan 1]. Available from: www.nexperia.com.

On Semiconductor. BC556 [Internet]. Colorado: On Semiconductor; 2007. [cited 2018 Jan 1]. Available from: www.onsemi.com.

Philips Semiconductors. 74HC00 [Internet]. Amesterdã: Philips Semiconductors; 1997. [cited 2018 Jan 1]. Available from: www.semiconductors.philips.com.

Pinheiro MM. Desenvolvimento de um eletrodo expansível de níquel-titânio para ablação hepática por radiofrequência. Brasília: Universidade de Brasília; 2016.

Richman P. Wave factors for rectifiers with capacitor input filters, and other high crest-factor loads. IEEE Trans. Ind. Electron. Control Instrum. 2002; 21(4):235-41.

Schneider B, Bernardi R. Abatti PJ. A faísca eletrocirúrgica como causa da eletroestimulação e da queimadura DC. In: Müller-Karger C, Wong S, La Cruz A, editors. IV Latin American Congress on Biomedical Engineering 2007: Bioengineering Solutions for Latin America Health. IFMBE Proceedings; 2007 Sep 24-8; Berlin, Heidelberg. USA: Springer; 2007. p. 881-85.

Schneider-Junior B, Abatti PL. Desenvolvimento de um equipamento eletrocirúrgico com saída não chaveada. Revista Brasileira de Engenharia Biomédica; 2005; 21(1):15-24.

Texas Instruments. LM317 [Internet]. Dallas: Texas Instruments; 2017a. [cited 2018 Jan 1]. Available from: http://www.ti.com.

Texas Instruments. LM324 [Internet]. Dallas: Texas Instruments; 2017b. [cited 2018 Jan 1]. Available from: http://www.ti.com.

Texas Instruments. ADS1115 [Internet]. Dallas: Texas Instruments; 2018. [cited 2018 Jan 1]. Available from: http://www.ti.com.

Thornton Eletrônica Ltda. Consultas [Internet]. São Paulo: Thornton; 2018. [cited 2018 Apr 5]. Available from: http://www.thornton.com.br/home.htm.

Vernetti JD. Introdução à teoria de redes. Manaus: ULBRA; 2003. p. 97-107.

Vishay Siliconix. IRF540 [Internet]. California: Vishay Siliconix; 2013a. [cited 2018 Jan 1]. Available from: www.vishay.com.

Vishay Siliconix. 1N5408 [Internet]. California: Vishay Siliconix; 2013b. [cited 2018 Jan 1]. Available from: www.vishay.com.

Xiaojing L, Wang Y, Zhu J, Guo Y, Gang L, Chengcheng L. Calculation of capacitance in high-frequency transformer windings. IEEE Transactions on Magnetics; 2016; 52(7):1-4.

Zheng Q, Wu M. Evaluation of therapeutic effect of contrast-enhanced ultrasonography in hepatic carcinoma radiofrequency ablation and comparison with conventional ultrasonography and enhanced computed tomography. Journal of Medical Ultrasound; 2015; 23:76-81.

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