Ultra-long-term reliable encapsulation using an atomic layer deposited Hfo2/Al2o3/Hfo2 triple-interlayer for biomedical implants

Long-term packaging of miniaturized, flexible implantable medical devices is essential for the next generation of medical devices. Polymer materials that are biocompatible and flexible have attracted extensive interest for the packaging of implantable medical devices, however realizing these devices with long-term hermeticity up to several years remains a great challenge. Here, polyimide (PI) based hermetic encapsulation was greatly improved by atomic layer deposition (ALD) of a nanoscale-thin, biocompatible sandwich stack of HfO2/Al2O3/HfO2 (ALD-3) between two polyimide layers. A thin copper film covered with a PI/ALD-3/PI barrier maintained excellent electrochemical performance over 1028 days (2.8 years) during acceleration tests at 60 °C in phosphate buffered saline solution (PBS). This stability is equivalent to approximately 14 years at 37 °C. The coatings were monitored in situ through electrochemical impedance spectroscopy (EIS), were inspected by microscope, and were further analyzed using equivalent circuit modeling. The failure mode of ALD Al2O3, ALD-3, and PI soaking in PBS is discussed. Encapsulation using ultrathin ALD-3 combined with PI for the packaging of implantable medical devices is robust at the acceleration temperature condition for more than 2.8 years, showing that it has great potential as reliable packaging for long-term implantable devices

Cybersecurity in implantable medical devices

Mención Internacional en el título de doctorImplantable Medical Devices (IMDs) are electronic devices implanted within the body to treat a medical condition, monitor the state or improve the functioning of some body part, or just to provide the patient with a capability that he did not possess before [86]. Current examples of IMDs include pacemakers and defibrillators to monitor and treat cardiac conditions; neurostimulators for deep brain stimulation in cases such as epilepsy or Parkinson; drug delivery systems in the form of infusion pumps; and a variety of biosensors to acquire and process different biosignals. Some of the newest IMDs have started to incorporate numerous communication and networking functions—usually known as “telemetry”—, as well as increasingly more sophisticated computing capabilities. This has provided implants with more intelligence and patients with more autonomy, as medical personnel can access data and reconfigure the implant remotely (i.e., without the patient being physically present in medical facilities). Apart from a significant cost reduction, telemetry and computing capabilities also allow healthcare providers to constantly monitor the patient’s condition and to develop new diagnostic techniques based on an Intra Body Network (IBN) of medical devices [25, 26, 201]. Evolving from a mere electromechanical IMD to one with more advanced computing and communication capabilities has many benefits but also entails numerous security and privacy risks for the patient. The majority of such risks are relatively well known in classical computing scenarios, though in many respects their repercussions are far more critical in the case of implants. Attacks against an IMD can put at risk the safety of the patient who carries it, with fatal consequences in certain cases. Causing an intentional malfunction of an implant can lead to death and, as recognized by the U.S. Food and Drug Administration (FDA), such deliberate attacks could be far more difficult to detect than accidental ones [61]. Furthermore, these devices store and transmit very sensitive medical information that requires protection, as dictated by European (e.g., Directive 95/46/ECC) and U.S. (e.g., CFR 164.312) Directives [94, 204]. The wireless communication capabilities present in many modern IMDs are a major source of security risks, particularly while the patient is in open (i.e., non-medical) environments. To begin with, the implant becomes no longer “invisible”, as its presence could be remotely detected [48]. Furthermore, it facilitates the access to transmitted data by eavesdroppers who simply listen to the (insecure) channel [83]. This could result in a major privacy breach, as IMDs store sensitive information such as vital signals, diagnosed conditions, therapies, and a variety of personal data (e.g., birth date, name, and other medically relevant identifiers). A vulnerable communication channel also makes it easier to attack the implant in ways similar to those used against more common computing devices [118, 129, 156], i.e., by forging, altering, or replying previously captured messages [82]. This could potentially allow an adversary to monitor and modify the implant without necessarily being close to the victim [164]. In this regard, the concerns of former U.S. vice-president Dick Cheney constitute an excellent example: he had his Implantable Cardioverter Defibrillator (ICD) replaced by another without WiFi capability [219]. While there are still no known real-world incidents, several attacks on IMDs have been successfully demonstrated in the lab [83, 133, 143]. These attacks have shown how an adversary can disable or reprogram therapies on an ICD with wireless connectivity, and even inducing a shock state to the patient [65]. Other attacks deplete the battery and render the device inoperative [91], which often implies that the patient must undergo a surgical procedure to have the IMD replaced. Moreover, in the case of cardiac implants, they have a switch that can be turned off merely by applying a magnetic field [149]. The existence of this mechanism is motivated by the need to shield ICDs to electromagnetic fields, for instance when the patient undergoes cardiac surgery using electrocautery devices [47]. However, this could be easily exploited by an attacker, since activating such a primitive mechanism does not require any kind of authentication. In order to prevent attacks, it is imperative that the new generation of IMDs will be equipped with strong mechanisms guaranteeing basic security properties such as confidentiality, integrity, and availability. For example, mutual authentication between the IMD and medical personnel is essential, as both parties must be confident that the other end is who claims to be. In the case of the IMD, only commands coming from authenticated parties should be considered, while medical personnel should not trust any message claiming to come from the IMD unless sufficient guarantees are given. Preserving the confidentiality of the information stored in and transmitted by the IMD is another mandatory aspect. The device must implement appropriate security policies that restrict what entities can reconfigure the IMD or get access to the information stored in it, ensuring that only authorized operations are executed. Similarly, security mechanisms have to be implemented to protect the content of messages exchanged through an insecure wireless channel. Integrity protection is equally important to ensure that information has not been modified in transit. For example, if the information sent by the implant to the Programmer is altered, the doctor might make a wrong decision. Conversely, if a command sent to the implant is forged, modified, or simply contains errors, its execution could result in a compromise of the patient’s physical integrity. Technical security mechanisms should be incorporated in the design phase and complemented with appropriate legal and administrative measures. Current legislation is rather permissive in this regard, allowing the use of implants like ICDs that do not incorporate any security mechanisms. Regulatory authorities like the FDA in the U.S or the EMA (European Medicines Agency) in Europe should promote metrics and frameworks for assessing the security of IMDs. These assessments should be mandatory by law, requiring an adequate security level for an implant before approving its use. Moreover, both the security measures supported on each IMD and the security assessment results should be made public. Prudent engineering practices well known in the safety and security domains should be followed in the design of IMDs. If hardware errors are detected, it often entails a replacement of the implant, with the associated risks linked to a surgery. One of the main sources of failure when treating or monitoring a patient is precisely malfunctions of the device itself. These failures are known as “recalls” or “advisories”, and it is estimated that they affect around 2.6% of patients carrying an implant. Furthermore, the software running on the device should strictly support the functionalities required to perform the medical and operational tasks for what it was designed, and no more [66, 134, 213]. In Chapter 1, we present a survey of security and privacy issues in IMDs, discuss the most relevant mechanisms proposed to address these challenges, and analyze their suitability, advantages, and main drawbacks. In Chapter 2, we show how the use of highly compressed electrocardiogram (ECG) signals (only 24 coefficients of Hadamard Transform) is enough to unequivocally identify individuals with a high performance (classification accuracy of 97% and with identification system errors in the order of 10−2). In Chapter 3 we introduce a new Continuous Authentication scheme that, contrarily to previous works in this area, considers ECG signals as continuous data streams. The proposed ECG-based CA system is intended for real-time applications and is able to offer an accuracy up to 96%, with an almost perfect system performance (kappa statistic > 80%). In Chapter 4, we propose a distance bounding protocol to manage access control of IMDs: ACIMD. ACIMD combines two features namely identity verification (authentication) and proximity verification (distance checking). The authentication mechanism we developed conforms to the ISO/IEC 9798-2 standard and is performed using the whole ECG signal of a device holder, which is hardly replicable by a distant attacker. We evaluate the performance of ACIMD using ECG signals of 199 individuals over 24 hours, considering three adversary strategies. Results show that an accuracy of 87.07% in authentication can be achieved. Finally, in Chapter 5 we extract some conclusions and summarize the published works (i.e., scientific journals with high impact factor and prestigious international conferences).Los Dispositivos Médicos Implantables (DMIs) son dispositivos electrónicos implantados dentro del cuerpo para tratar una enfermedad, controlar el estado o mejorar el funcionamiento de alguna parte del cuerpo, o simplemente para proporcionar al paciente una capacidad que no poseía antes [86]. Ejemplos actuales de DMI incluyen marcapasos y desfibriladores para monitorear y tratar afecciones cardíacas; neuroestimuladores para la estimulación cerebral profunda en casos como la epilepsia o el Parkinson; sistemas de administración de fármacos en forma de bombas de infusión; y una variedad de biosensores para adquirir y procesar diferentes bioseñales. Los DMIs más modernos han comenzado a incorporar numerosas funciones de comunicación y redes (generalmente conocidas como telemetría) así como capacidades de computación cada vez más sofisticadas. Esto ha propiciado implantes con mayor inteligencia y pacientes con más autonomía, ya que el personal médico puede acceder a los datos y reconfigurar el implante de forma remota (es decir, sin que el paciente esté físicamente presente en las instalaciones médicas). Aparte de una importante reducción de costos, las capacidades de telemetría y cómputo también permiten a los profesionales de la atención médica monitorear constantemente la condición del paciente y desarrollar nuevas técnicas de diagnóstico basadas en una Intra Body Network (IBN) de dispositivos médicos [25, 26, 201]. Evolucionar desde un DMI electromecánico a uno con capacidades de cómputo y de comunicación más avanzadas tiene muchos beneficios pero también conlleva numerosos riesgos de seguridad y privacidad para el paciente. La mayoría de estos riesgos son relativamente bien conocidos en los escenarios clásicos de comunicaciones entre dispositivos, aunque en muchos aspectos sus repercusiones son mucho más críticas en el caso de los implantes. Los ataques contra un DMI pueden poner en riesgo la seguridad del paciente que lo porta, con consecuencias fatales en ciertos casos. Causar un mal funcionamiento intencionado en un implante puede causar la muerte y, tal como lo reconoce la Food and Drug Administration (FDA) de EE.UU, tales ataques deliberados podrían ser mucho más difíciles de detectar que los ataques accidentales [61]. Además, estos dispositivos almacenan y transmiten información médica muy delicada que requiere se protegida, según lo dictado por las directivas europeas (por ejemplo, la Directiva 95/46/ECC) y estadunidenses (por ejemplo, la Directiva CFR 164.312) [94, 204]. Si bien todavía no se conocen incidentes reales, se han demostrado con éxito varios ataques contra DMIs en el laboratorio [83, 133, 143]. Estos ataques han demostrado cómo un adversario puede desactivar o reprogramar terapias en un marcapasos con conectividad inalámbrica e incluso inducir un estado de shock al paciente [65]. Otros ataques agotan la batería y dejan al dispositivo inoperativo [91], lo que a menudo implica que el paciente deba someterse a un procedimiento quirúrgico para reemplazar la batería del DMI. Además, en el caso de los implantes cardíacos, tienen un interruptor cuya posición de desconexión se consigue simplemente aplicando un campo magnético intenso [149]. La existencia de este mecanismo está motivada por la necesidad de proteger a los DMIs frete a posibles campos electromagnéticos, por ejemplo, cuando el paciente se somete a una cirugía cardíaca usando dispositivos de electrocauterización [47]. Sin embargo, esto podría ser explotado fácilmente por un atacante, ya que la activación de dicho mecanismo primitivo no requiere ningún tipo de autenticación. Garantizar la confidencialidad de la información almacenada y transmitida por el DMI es otro aspecto obligatorio. El dispositivo debe implementar políticas de seguridad apropiadas que restrinjan qué entidades pueden reconfigurar el DMI o acceder a la información almacenada en él, asegurando que sólo se ejecuten las operaciones autorizadas. De la misma manera, mecanismos de seguridad deben ser implementados para proteger el contenido de los mensajes intercambiados a través de un canal inalámbrico no seguro. La protección de la integridad es igualmente importante para garantizar que la información no se haya modificado durante el tránsito. Por ejemplo, si la información enviada por el implante al programador se altera, el médico podría tomar una decisión equivocada. Por el contrario, si un comando enviado al implante se falsifica, modifica o simplemente contiene errores, su ejecución podría comprometer la integridad física del paciente. Los mecanismos de seguridad deberían incorporarse en la fase de diseño y complementarse con medidas legales y administrativas apropiadas. La legislación actual es bastante permisiva a este respecto, lo que permite el uso de implantes como marcapasos que no incorporen ningún mecanismo de seguridad. Las autoridades reguladoras como la FDA en los Estados Unidos o la EMA (Agencia Europea de Medicamentos) en Europa deberían promover métricas y marcos para evaluar la seguridad de los DMIs. Estas evaluaciones deberían ser obligatorias por ley, requiriendo un nivel de seguridad adecuado para un implante antes de aprobar su uso. Además, tanto las medidas de seguridad implementadas en cada DMI como los resultados de la evaluación de su seguridad deberían hacerse públicos. Buenas prácticas de ingeniería en los dominios de la protección y la seguridad deberían seguirse en el diseño de los DMIs. Si se detectan errores de hardware, a menudo esto implica un reemplazo del implante, con los riesgos asociados y vinculados a una cirugía. Una de las principales fuentes de fallo al tratar o monitorear a un paciente es precisamente el mal funcionamiento del dispositivo. Estos fallos se conocen como “retiradas”, y se estima que afectan a aproximadamente el 2,6 % de los pacientes que llevan un implante. Además, el software que se ejecuta en el dispositivo debe soportar estrictamente las funcionalidades requeridas para realizar las tareas médicas y operativas para las que fue diseñado, y no más [66, 134, 213]. En el Capítulo 1, presentamos un estado de la cuestión sobre cuestiones de seguridad y privacidad en DMIs, discutimos los mecanismos más relevantes propuestos para abordar estos desafíos y analizamos su idoneidad, ventajas y principales inconvenientes. En el Capítulo 2, mostramos cómo el uso de señales electrocardiográficas (ECGs) altamente comprimidas (sólo 24 coeficientes de la Transformada Hadamard) es suficiente para identificar inequívocamente individuos con un alto rendimiento (precisión de clasificación del 97% y errores del sistema de identificación del orden de 10−2). En el Capítulo 3 presentamos un nuevo esquema de Autenticación Continua (AC) que, contrariamente a los trabajos previos en esta área, considera las señales ECG como flujos de datos continuos. El sistema propuesto de AC basado en señales cardíacas está diseñado para aplicaciones en tiempo real y puede ofrecer una precisión de hasta el 96%, con un rendimiento del sistema casi perfecto (estadístico kappa > 80 %). En el Capítulo 4, proponemos un protocolo de verificación de la distancia para gestionar el control de acceso al DMI: ACIMD. ACIMD combina dos características, verificación de identidad (autenticación) y verificación de la proximidad (comprobación de la distancia). El mecanismo de autenticación es compatible con el estándar ISO/IEC 9798-2 y se realiza utilizando la señal ECG con todas sus ondas, lo cual es difícilmente replicable por un atacante que se encuentre distante. Hemos evaluado el rendimiento de ACIMD usando señales ECG de 199 individuos durante 24 horas, y hemos considerando tres estrategias posibles para el adversario. Los resultados muestran que se puede lograr una precisión del 87.07% en la au tenticación. Finalmente, en el Capítulo 5 extraemos algunas conclusiones y resumimos los trabajos publicados (es decir, revistas científicas con alto factor de impacto y conferencias internacionales prestigiosas).Programa Oficial de Doctorado en Ciencia y Tecnología InformáticaPresidente: Arturo Ribagorda Garnacho.- Secretario: Jorge Blasco Alís.- Vocal: Jesús García López de Lacall

Power Approaches for Implantable Medical Devices.

Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources

Security vulnerabilities on implantable medical devices

Implantable medical devices are used for critical functions like diagnosis, prevention, control, treatment or lifeenhancing patients with chronic diseases, through diagnosing and/or monitoring for better care and quality of patients' lives. Communication between medical devices and healthcare professionals is of utmost importance to treat health data and critical functions without the need for patient surgery. Increasingly, the development, implementation and use of security mechanisms that can provide the availability of information, the integrity of medical devices and the confidentiality of data are needed. Alteration of data, theft, improper access to this information, or even denial of service in a healthcare system can lead to the death of patients on devices such as these essential to life. This paper mainly contribution is a research on implantable medical device vulnerabilities and attack mitigation strategies.5311-8814-F0ED | Sara Maria da Cruz Maia de Oliveira PaivaN/

Security implications of implantable medical devices

The advancement of wireless medical devices in the hospital has created an environment that is unsustainable, unsustainable for security management. I will explain how the development of wireless medical devices has changed the landscape of security in the medical field. How the history of medical devices and organizational issues affected device development. I will look in to the inner workings of pacemakers and pacemaker programmers and how their systems affect security. Who are the stakeholders for protecting the information and function of the medical device and pacemaker? What are the stakeholder\u27s capacities and obstacles, especially if the device is implanted in your body? Once we understand the risk and who has the best ability to mitigate it, how can a system of prioritization of medical devices be used to solve the issues of insecure medical devices and/or pacemakers. How can the process of prioritization bring us back within our risk threshold for medical devices

Integrated Microbatteries for Implantable Medical Devices

Integrated microbatteries have been proposed to satisfy an anticipated need for long-life, low-rate primary batteries, having volumes less than 1 mm3, to power electronic circuitry in implantable medical devices. In one contemplated application, such a battery would be incorporated into a tubular hearing-aid device to be installed against an eardrum. This device is based on existing tube structures that have already been approved by the FDA for use in human ears. As shown in the figure, the battery would comprise a single cell at one end of the implantable tube. A small volume of Li-based primary battery cathode material would be compacted and inserted in the tube near one end, followed by a thin porous separator, followed by a pressed powder of a Li-containing alloy. Current-collecting wires would be inserted, with suitably positioned insulators to prevent a short circuit. The battery would contain a liquid electrolyte consisting of a Li-based salt in an appropriate solvent. Hermetic seals would be created by plugging both ends with a waterproof polymer followed by deposition of parylene

Advances in Microelectronics for Implantable Medical Devices

Implantable medical devices provide therapy to treat numerous health conditions as well as monitoring and diagnosis. Over the years, the development of these devices has seen remarkable progress thanks to tremendous advances in microelectronics, electrode technology, packaging and signal processing techniques. Many of today’s implantable devices use wireless technology to supply power and provide communication. There are many challenges when creating an implantable device. Issues such as reliable and fast bidirectional data communication, efficient power delivery to the implantable circuits, low noise and low power for the recording part of the system, and delivery of safe stimulation to avoid tissue and electrode damage are some of the challenges faced by the microelectronics circuit designer. This paper provides a review of advances in microelectronics over the last decade or so for implantable medical devices and systems. The focus is on neural recording and stimulation circuits suitable for fabrication in modern silicon process technologies and biotelemetry methods for power and data transfer, with particular emphasis on methods employing radio frequency inductive coupling. The paper concludes by highlighting some of the issues that will drive future research in the field

Regenerative Thermoelectric Cooling for Implantable Medical Devices

Implantable Medical Devices (IMDs) are a category of medical devices that include pacemakers, implantable cardiac defibrillators, spinal cord stimulators, and many other devices. Many of these devices are battery-powered such as pacemakers which last an average of 7 years before needing to be replaced via surgery. This research focuses on re-chargeable IMD’s such as spinal cord stimulators. Re-chargeable IMD’s often require daily charging to operate which can be a burden on the patient. Shorter charge times are desired for improved usability. One significant limitation of these re-chargeable IMD’s is that the charging current is reduced from optimal levels to mitigate heat buildup of the device. A high heat generation during charging is not acceptable due to FDA regulations that IMD’s are bound by. This heat is primarily emitted from the charging battery-element within the IMD and can be harmful to human patients. Unfortunately, limiting the current throughput as a solution for the generated heat, results in a longer charging time that affects a patient’s quality of life. This paper serves to document the research performed on the integration of thermoelectric generators (TEGs) in such medical devices. It will present the thermal impacts that a TEG has when operating under similar conditions as an IMD. The TEG serves to harvest the heat energy that is normally wasted by the battery and convert it into electrical energy. The conversion from heat into electrical energy serves as a cooling mechanism for the system that correlates with the resulting charging times of IMD’s. A maximized cooling effect implemented by the TEG will further reduced IMD charging times. The mitigation of heat being introduced to the system will allow for increased charge current to be safely introduced, further increasing the rate of charge. This research will explore how effective thermoelectric devices can be in reducing the charge time for these medical devices. Ultimately, this research aims to increase the quality of life for IMD patients by addressing the thermal obstacle present in these devices