The measurement and calculation of the mechanical properties of silicone rubber used for the manufacture of a prosthesis for the auricle of patients based on dental CAD/CAM systems, using a hybrid technology that includes traditional and digital methods of manufacturing medical devices were performed. Mechanical tensile tests were carried out in a climatic chamber at various temperatures: -20; 0; 25; 40 °C. All mechanical characteristics of silicone rubber lay in a very limited range of values and monotonically decreased with increasing test temperature from -20 to + 45°C. At the same time, the elastic characteristics (elastic modulus) decreased by 1.55, deformation (fracture deformation) - by 1.98, strength (tensile strength) - by 2.37 times. The average values of tensile strength were 6.54 MPa, fracture deformation - 1480.61%, modulus of elasticity - 0.53 MPa, and temperature gradient: 0.08 MPa/deg, 14.8%/deg and 0.004 MPa/deg, respectively. In the framework of the Mooney - Rivlin hyperelastic model, the coefficients of the model C 01 and C 10 are determined, which can be used as parameters when performing simulation modeling of the stress-strain state of prostheses. Based on the data obtained, an assessment was made of the cross-linked density of the silicone rubber material as a synthetic polymer. It turned out to be equal to 0.49.
Objective. To develop the bionic ear prosthesis design and a method for its manufacture based on intellectual and medical 3D technologies.
Materials and methods. Taking into account the analysis of data from domestic and foreign literature, a bionic ear prosthesis and a device for its manufacture have been developed. During the implementation of the project, digital equipment and software were used.
The developed design of a bionic ear prosthesis consists of several components, including an auricle prosthesis and a sound processor inserted into it. This provides the functionality of remote control, configuration and wireless charging. The system is based on the principle of bone conduction. The auricle prosthesis is an external attachment device with high aesthetic characteristics, made of biocompatible materials using modern digital technologies. Built-in hearing aid, includes a microphone; a sound processor based on a digital signal component with built-in analog-to-digital and digital-to-analog converters; Bluetooth radio channel module for communication with the settings control device (Android smartphone); and an emitter of sound vibrations.
Results. The expected positive effect is to increase the effectiveness of treatment, rehabilitation and socialization of deaf and hard of hearing patients by reducing the volume of surgical intervention; prevention of postoperative complications; the use of a rational aesthetic design of the auricle epithesis made of biologically compatible materials, with an inclinated highly functional electronic hearing aid integrated with the patient's auditory environment.
Conclusions. The combination of these factors can provide a significant reduction in the terms of medical and social rehabilitation of patients of different ages. In addition to the above, a significant advantage of the developed design of a bionic prosthesis and the method of its manufacture is ease of use and economic availability.
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