Prótese óculopalpebral com captação de movimento palpebral: proposta de dispositivo mecânico / Oculopalpebral prosthesis with eyelid motion capture: mechanical appliance proposition

Introdução: A reconstrução de grandes defeitos da face nem sempre é passível de correção cirúrgica, podendo ser restaurados com as próteses faciais. Apesar da prótese óculopalpebral apresentar uma aparência natural, ela é facilmente notada, pois não apresenta os movimentos palpebrais de abertura e fechamento sincronizadas com o olho contralateral, tornando assim a reconstrução protética um grande desafio. Objetivos: Planejar, desenhar, viabilizar e construir um protótipo com recurso mecânico/elétrico possibilitando sincronia dos movimentos palpebrais com o olho sadio para utilização em prótese óculopalpebral. Material e Métodos: Confecção de uma prótese óculopalpebral com um dispositivo de pálpebra móvel em silicone médico capaz de conectar-se a um sistema mecânico-elétrico responsável por realizar movimentos de abertura e fechamento da pálpebra móvel da prótese. Resultados e Discussão: Foi confeccionada uma prótese óculo-palpebral em resina acrílica termicamente ativada, criando-se um nicho para a acomodação de um sistema elétrico e possibilitar a livre movimentação de uma fina pálpebra em silicone interligada ao dispositivo tornando possível a conexão desse sistema com um sensor que capta o movimento palpebral de um olho saudável. Conclusão: No presente estudo um protótipo mecânico - elétrico foi planejado, desenhado e desenvolvido acoplado a uma prótese óculopalpebral estabelecendo e sincronizando seus movimentos palpebrais com o olho sadio.

Introduction: Surgical reconstruction of large facial defects may not be always possible. Extraoral maxillofacial prosthesis are a good restorative option. Even though when the oculopalpebral prosthesis presents a natural appearance, it can be easily noticed because its eyelids do not move. It is desirable for the eyelids to open and close synchronously with contralateral eye. Thus, prosthetic reconstruction of oculopalpebral region is a great challenge. Objectives: To plan, design, enable and build a oculopalpebral prosthesis prototype with mechanical and electric features allowing eyelid motion with synchronization with the sound eye. Material and method: Fabrication of an oculopalpebral prosthesis with a medical grade silicone movable eyelid which has the capability to connect itself to an mechanical-eletrical system responsible to make opening and closing movements on prosthesis movable eyelid. Results and discussion: An oculopalpebral prosthesis was made in thermoactivated acrylic resin. A gap was created to accomodate an electrical system and also allow free motion of a thin silicone eyelid attached to the dispositive. This system can be connected to a sensor which captured the eyelid motion of a sound eye. Conclusion: A mechanical-electrical prototype was planned, designed and developed attached to an oculopalpebral prosthesis stablishing and synchronizing its eyelid movements with the sound eye.

[Total artificial heart]. / Das komplett künstliche Herz.

BACKGROUND: To date the CardioWest™ total artificial heart is the only clinically available implantable biventricular mechanical replacement for irreversible cardiac failure. OBJECTIVES: This article presents the indications, contraindications, implantation procedere and postoperative treatment. MATERIAL AND METHODS: In addition to a overview of the applications of the total artificial heart this article gives a brief presentation of the two patients treated in our department with the CardioWest™. RESULTS: The clinical course, postoperative rehabilitation, device-related complications and control mechanisms are presented. CONCLUSION: The total artificial heart is a reliable implant for treating critically ill patients with irreversible cardiogenic shock. A bridge to transplantation is feasible with excellent results.

Scientific evaluation of spinal implants: an ethical necessity.

The clinical introduction of novel medical devices often occurs without evidence of good methodological quality and with relatively little oversight and regulation. As a consequence, the safety, efficacy, and long-term effects of devices are frequently insufficiently known upon device approval. Recent controversies surrounding the Poly Implant Prothèse (PIP) breast implants, metal-on-metal hip implants, and interspinous implants underscore the need to reconsider how innovation in medical devices can adhere to sound ethical standards without inhibiting surgical research and development. In this article, the introduction of spinal implants is taken as an example to firstly discuss the scientific and ethical challenges of developing, testing, and introducing novel medical devices and to secondly identify avenues for improving the existing regulatory frameworks for such innovation. Two measures for improvement are most feasible in the short term: demanding prospective studies before device introduction and developing registries to monitor and evaluate new medical devices. Level of evidence: 5.