ABSTRACT

Figure 7.2 Metallised PVDF film. Piezotech S.A. (www.piezotech.fr). As an aid to the development work for medical devices integrating these materials as sensors, we will show a detailed case study concerning the development of an intraoral device for measuring pressure. With the help of this case study different basic issues are explained that are connected with modelling, simulation, design, processing, material and device characterisation, in vitro and in vivo tests and pre-commercial validation. We hope the methodology shown will be of interest to researchers working on these issues. The references included at the end of the chapter provide very detailed information on the different aspects of the development process set out. The characteristics

sheets provided by the suppliers mentioned in the chapter and the annexes to the handbook must be very carefully borne in mind when comparing alternatives and selecting candidate materials for a specific application. The following section begins with a review of the main applications of these polymers as sensors in medical or health-oriented devices, many of which have passed the in vivo test stage and have reached the pre-marketing stage or are already on the market. 7.2  Potential for BiodevicesBiomedical applications of these kinds of materials are mainly related to their being used as pressure/force sensors. Below are explained some specific proposals for developing medical devices based on the use of electroactive polymers (normally piezoelectric polymers) as sensors, most of which have undergone in vitro laboratory testing. After undergoing in vitro and animal in vivo testing and meeting the requirements for official approval, in some cases their commercialisation is subject to their attaining the goals described at the end of this chapter. Pressure sensors for dentistryAs part of the “FEMAB” project of Madrid Polytechnic University, a pressure sensor has been developed with applications in dentistry for diagnosing and treating bruxism (Lafont Morgado and Díaz Lantada, 2008, 2009), based on the use of PVDF piezoelectric film. This film is marketed with the electrodes already in position, usually Au or Pt, by companies like “Piezotech S.A.” or “KTech Corp.”.