K Pump–mackenzie: desenvolvimento e validação em bancada de um dispositivo de assistência ventricular totalmente implantável com telemetria 5G no Brasil

Luiz Fernando Kubrusly; Osvaldo Malafaia; Benedito Guimarães Aguiar-Neto; Paulo Batista Lopes; Roberto Coutinho; Cristiano Akamine; Pollyana Coelho da Silva Notargiacomo; Elesandro Antonio Baptista; Licia M. D'arezzo Maestrelli; Douglas Mesadri Gewehr; Cris Rangel de Abreu; Fernando Bermudez Kubrusly

doi:10.1590/SciELOPreprints.15302

##article.authors##

Luiz Fernando Kubrusly Federal University of Paraná https://orcid.org/0000-0002-6546-9841
- Project Administration
Osvaldo Malafaia Federal University of Paraná https://orcid.org/0000-0002-1829-7071
- Writing – Review & Editing
Benedito Guimarães Aguiar-Neto Mackenzie Presbyterian University https://orcid.org/0000-0002-8928-2256
- Supervision
Paulo Batista Lopes Mackenzie Presbyterian University https://orcid.org/0000-0002-8070-1688
- Supervision
Roberto Coutinho Mackenzie Presbyterian University https://orcid.org/0000-0003-1039-9185
- Supervision
Cristiano Akamine Mackenzie Presbyterian University https://orcid.org/0000-0002-3161-4668
- Software
Pollyana Coelho da Silva Notargiacomo Mackenzie Presbyterian University https://orcid.org/0000-0001-8292-1644
- Validation
Elesandro Antonio Baptista Mackenzie Presbyterian University https://orcid.org/0000-0002-0414-4656
- Validation
Licia M. D'arezzo Maestrelli Mackenzie Presbyterian University https://orcid.org/0000-0002-0432-2694
- Validation
Douglas Mesadri Gewehr Evangelical Mackenzie College of Paraná, Curitiba, PR, Brazil https://orcid.org/0000-0001-9393-2445
- Conceptualization
Cris Rangel de Abreu Evangelical Mackenzie College of Paraná, Curitiba, PR, Brazil https://orcid.org/0000-0002-6546-6704
- Methodology
Fernando Bermudez Kubrusly Evangelical Mackenzie College of Paraná, Curitiba, PR, Brazil https://orcid.org/0000-0002-5045-9237
- Formal Analysis

DOI:

https://doi.org/10.1590/SciELOPreprints.15302

Keywords:

Ventricular assist device, Mechanical circulatory support, Artificial heart, Implantable medical device, Medical telemetry, 5G technology, Preclinical device validation

Abstract

Introduction: Advanced heart failure is an important cause of mortality in Brazil. Limited access to heart transplantation and the high cost of imported devices reinforce the need for national technological solutions. The KPump-Mackenzie project proposes the development of a fully implantable Mechanical Circulatory Assist Device (MCS), integrated with 5G telemetry, with potential application in the Unified Health System of Brazil (SUS).

Methods: A centrifugal prototype rotor, real-time control system and integrated flow and pressure sensors was developed. The device was submitted to laboratory tests to evaluate mechanical performance, operational stability, structural integrity and connectivity via 5G network. The preclinical protocol in the sheep model was designed and approved by the Ethics Committee on the Use of Animals (CEUA), from the Faculdade Evangelic Mackezie do Parana (FEMPAR), in accordance with CONCEA guidelines.

Results: In bench tests, the device showed controlled rotation of up to 10,000 rpm, adjustable flow between 2 and 6 L/min and average latency of less than 20 ms in data transmission. Continuous operational stability was observed for up to 72 hours, with adequate functioning of the monitoring and safety systems.

Conclusion: KPump-Mackenzie demonstrated technical feasibility and satisfactory performance in initial bench validation. The planned preclinical stage will be fundamental to evaluate safety and biological performance, constituting a necessary step for future clinical application and will take place in 2026