From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind.

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Development of Implantable Medical Devices: From an Engineering Perspective

The application of microfabrication to the development of biomedical implants has produced a new generation of miniaturized technology for assisting treatment and research. Microfabricated implantable devices (μID) are an increasingly important tool, and the development of new μIDs is a rapidly growing field that requires new microtechnologies able to safely and accurately function in vivo. Here, we present a review of μID research that examines the critical role of material choice in design and fabrication. Materials commonly used for μID production are identified and presented along with their relevant physical properties and a survey of the state-of-the-art in μID development. The consequence of material choice as it pertains to microfabrication and biocompatibility is discussed in detail with a particular focus on the divide between hard, rigid materials and soft, pliable polymers.

Materials for microfabricated implantable devices: a review

Corrosion is a prime concern for active implantable devices. In this paper we review the principles underlying the concepts of hermetic packages and encapsulation, used to protect implanted electronics, some of which remain widely overlooked. We discuss how technological advances have created a need to update the way we evaluate the suitability of both protection methods. We demonstrate how lifetime predictability is lost for very small hermetic packages and introduce a single parameter to compare different packages, with an equation to calculate the minimum sensitivity required from a test method to guarantee a given lifetime. In the second part of this paper, we review the literature on the corrosion of encapsulated integrated circuits (ICs) and, following a new analysis of published data, we propose an equation for the pre-corrosion lifetime of implanted ICs, and discuss the influence of the temperature, relative humidity, encapsulation and field-strength. As any new protection will be tested under accelerated conditions, we demonstrate the sensitivity of acceleration factors to some inaccurately known parameters. These results are relevant for any application of electronics working in a moist environment. Our comparison of encapsulation and hermetic packages suggests that both concepts may be suitable for future implants.

/pdf/corrosion-of-silicon-integrated-circuits-and-lifetime-3nt6bmx1uz.pdf

Corrosion of silicon integrated circuits and lifetime predictions in implantable electronic devices

Lead zirconate titanate (PZT) thin films stand for a prominent technological brick in the field of microsystems. The recent improvements of their manufacturability combined with excellent piezoelectric properties have enabled their introduction in industrial clean rooms all around the world. These films require annealing temperatures beyond 600 °C to crystallize in the desired perovskite phase, which exhibits outstanding piezoelectric coefficients. This temperature requirement forbids large application fields such as flexible electronics, smart glass but also system-on-chip approaches. Decreasing the annealing temperature of PZT films would therefore spread further their potential usage to other applications. The purpose of this paper is to provide the reader with a comprehensive review of the different techniques available in the literature to process piezoelectric PZT thin films at temperatures compatible with semiconductors (450 °C), smart glass (400 °C), or flexible electronics (350 °C). We first present the typical ferroelectric and piezoelectric properties of PZT films. The different deposition techniques and growth mechanisms of these films are then reviewed with a focus on thermodynamics. Then, all the low temperature processes are detailed, such as seeding effects, the modification of deposition parameters in vapor-phase deposition, special annealing technologies assisted with UV, lasers, flash lamps, microwave radiations or high-pressure, a focus on the hydrothermal method, and finally what is called solution chemistry design with notably combustion synthesis. Transfer processing is also detailed, as an alternative way to this low temperature approach. An outlook of future applications enabled by these innovative techniques is finally provided.

Toward low-temperature processing of lead zirconate titanate thin films: Advances, strategies, and applications

Future brain-computer-interfaces (BCIs) for severely impaired patients are implanted to electrically contact the brain tissue. Avoiding percutaneous cables requires amplifier and telemetry electronics to be implanted too. We developed a hermetic package that protects the electronic circuitry of a BCI from body moisture while permitting infrared communication through the package wall made from alumina ceramic. The ceramic package is casted in medical grade silicone adhesive, for which we identified MED2-4013 as a promising candidate.

Hermetic electronic packaging of an implantable brain-machine-interface with transcutaneous optical data communication

A fabrication technology for small hermetic implant packages with large numbers of electrical feedthroughs is presented. First prototypes were fabricated on a ceramic substrate of 25·25 mm area, having a metal cup of 5 mm height soldered to it. These prototypes provide 360 feedthroughs. The electrical properties of the feedthroughs are characterized and the leakage rate of the packages is determined using helium fine leak tests. The amount of water sealed inside the packages is investigated. Based on maximum allowable water vapour concentrations inside hermetic packages reported in literature and applying a commonly accepted mathematical model, we predicted a minimum lifetime to water-induced failure of a few hundred years.

Fabrication and test of a hermetic miniature implant package with 360 electrical feedthroughs

The electronic circuitry of active implantable devices is commonly protected against the risk of water-induced corrosion by using gas-tight (hermetic) packages, preventing moisture from the host body to reach the electronics. However, when closing the package, one has to ensure that the packaged components do not contain moisture that could rise humidity inside the package to critical levels by outgassing. For our miniature metal/ceramic packages, we found a drying procedure of 120°C at 180 mbar absolute pressure for one hour, followed by a dry helium purge sufficient to keep the relative humidity below 2.5% over a time span of 300 days at 80°C, corresponding to over 15 years at 37°C. The additional integration of a desiccant inside the package permits to keep the relative humidity below 0.1%, the detection limit of the integrated sensor. This sensor was selected based on an evaluation of 17 commercially available humidity sensors.

Ensuring minimal humidity levels in hermetic implant housings

Towards low-temperature deposition of piezoelectric Pb(Zr,Ti)O 3 : Influence of pressure and temperature on the properties of pulsed laser deposited Pb(Zr,Ti)O 3

Integration of lead zirconate titanate (Pb[Zrx,Ti1-x]O3 – PZT) thin films on complementary metal-oxide semiconductor substrates (CMOS) is difficult due to the usually high crystallization temperature of the piezoelectric perovskite PZT phase, which harms the CMOS circuits. In this work, a wafer-scale pulsed laser deposition tool was used to grow 1 μm thick PZT thin films on 150 mm diameter silicon wafers. Three different routes towards a post-CMOS compatible deposition process were investigated, maintaining a post-CMOS compatible thermal budget limit of 445 °C for 1 h (or 420 °C for 6 h). By crystallizing the perovskite LaNiO3 seed layer at 445 °C, the PZT deposition temperature can be lowered to below 400 °C, yielding a transverse piezoelectric coefficient e31,f of −9.3 C/m2. With the same procedure, applying a slightly higher PZT deposition temperature of 420 °C, an e31,f of −10.3 C/m2 can be reached. The low leakage current density of below 3 × 10−6 A/cm2 at 200 kV/cm allows for application of the post-CMOS compatible PZT thin films in low power micro-electro-mechanical-systems actuators.

Pulsed laser deposition of piezoelectric lead zirconate titanate thin films maintaining a post-CMOS compatible thermal budget

Controlling the growth of piezoelectric lead zirconate titanate (Pb[Zr x Ti 1−x ]O 3 - PZT) thin-films is a key issue for their application in sensor and actuator devices. The pulsed laser deposition (PLD) process which is used in this work to grow PZT on platinized 150 mm silicon wafers can be easily modified by changing deposition parameters as the deposition pressure, deposition temperature, laser spot area on the target or laser pulse energy. In order to investigate the influence of these PLD parameters on the deposition rate and properties of the PZT thin-film as the leakage current density or the transverse piezoelectric coefficient e 31,ƒ , statistical Design of Experiment methods were applied. Empirical models could be derived, describing the thin-film properties as function of the deposition parameters. It is observed that not only the PZT deposition parameters but also the parameters which are modified for the deposition of the LaNiO 3 (LNO) template need to be controlled carefully. The parameters with the highest effect on the e 31,ƒ are shown to be the combination of deposition pressure and deposition temperature of the PZT layer, where either both high or low values lead to good PZT properties.

/pdf/application-of-doe-methods-to-establish-a-model-for-the-4rxsvfd0b4.pdf

Application of DoE methods to establish a model for the pulsed laser deposition of PZT thin-films

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