Interaction of Environmental Conditions: Role in the Reliability of Active Implantable Devices

Author(s):  
Elizabeth S. Drexler ◽  
Andrew J. Slifka ◽  
Nicholas Barbosa ◽  
John W. Drexler

Environmental conditions can have major influence on the lifetimes and reliability of active implantable medical devices (e.g., neurostimulators, cochlear implants, internal cardioverter defibrillators). These environmental conditions can range from those encountered by the device in processing and production to transportation and storage to actual operation. Although one might argue that the environmental conditions found in the first two situations are harsher than those of the third, failures that result from those situations are screened before implantation. If we assume that the active medical device is in perfect operational form at the time it is implanted, it will still experience a host of environmental conditions that can affect reliability. In fact, the ultimate goal of these medical devices is to restore the patient, wherever they may reside, to normal activities. A list of some environmental conditions that may be experienced by a device implanted in a representative patient is found in Table 1.

Sensors ◽  
2020 ◽  
Vol 20 (16) ◽  
pp. 4604
Author(s):  
Bradley D. Nelson ◽  
Salil Sidharthan Karipott ◽  
Yvonne Wang ◽  
Keat Ghee Ong

Wireless technologies are incorporated in implantable devices since at least the 1950s. With remote data collection and control of implantable devices, these wireless technologies help researchers and clinicians to better understand diseases and to improve medical treatments. Today, wireless technologies are still more commonly used for research, with limited applications in a number of clinical implantable devices. Recent development and standardization of wireless technologies present a good opportunity for their wider use in other types of implantable devices, which will significantly improve the outcomes of many diseases or injuries. This review briefly describes some common wireless technologies and modern advancements, as well as their strengths and suitability for use in implantable medical devices. The applications of these wireless technologies in treatments of orthopedic and cardiovascular injuries and disorders are described. This review then concludes with a discussion on the technical challenges and potential solutions of implementing wireless technologies in implantable devices.


Author(s):  
Maria Lund Jensen ◽  
Jayme Coates

Development of implantable medical devices is becoming increasingly interesting for manufacturers, but identifying the right Human Factors Engineering (HFE) approach to ensure safe use and effectiveness is challenging. Most active implantable devices are highly complex; they are built on extremely advanced, compact technology, often comprise systems of several device elements and accessories, and they span various types of user interfaces which must facilitate diverse interaction performed by several different user groups throughout the lifetime of the device. Furthermore, since treatment with implantable devices is often vital and by definition involves surgical procedures, potential risks related to use error can be severe. A systematic mapping of Product System Elements and Life Cycle Stages can help early identification of Use Cases, and for example user groups and high-level use risks, to be accounted for via HFE throughout development to optimize Human Factors processes and patient outcomes. This paper presents a concrete matrix tool which can facilitate an early systematic approach to planning and frontloading of Human Factors Engineering activities in complex medical device development.


2021 ◽  
Vol 23 (12) ◽  
pp. 46-59
Author(s):  
B. Sathyabhama ◽  
◽  
B. Siva Shankari ◽  

Implantable Medical Devices (IMDs) reside within human bodies either temporarily or permanently, for diagnostic, monitoring, or therapeutic purposes. IMDs have a history of outstanding success in the treatment of many diseases, including heart diseases, neurological disorders, and deafness etc.,With the ever-increasing clinical need for implantable devices comes along with the continuous flow of technical challenges. Comparing with the commercial portable products, implantable devices share the same need to reduce size, weight and power. Thus, the need for device integration becomes very much imperative. There are many challenges faced when creating an implantable medical device. While this paper focuses on various techniques adapted to design a reliable device and also focus on the key electronic features of designing an ultra-low power implantable medical circuits for devices and systems.


2020 ◽  
Vol 27 (10) ◽  
pp. 1580-1599 ◽  
Author(s):  
Gabriel Victor Simões Dutra ◽  
Weslany Silvério Neto ◽  
João Paulo Simões Dutra ◽  
Fabricio Machado

Medical devices are important diagnosis and therapy tools for several diseases which include a wide range of products. Technological advances in this area have been proposed to reduce adverse complication incidences. New technologies and manufacturing processes, as well as the development of new materials or medical devices with modified surface and the use of biodegradable polymeric devices such as a substrate for cell culture in the field of tissue engineering, have attracted considerable attention in recent years by the scientific community intended to produce medical devices with superior properties and morphology. This review article focused on implantable devices, addresses the major advances in the biomedical field related to the devices manufacture processes such as 3D printing and hot melting extrusion, and the use of polymer matrices composed of copolymers, blends, nanocomposites or grafted with antiproliferative drugs for manufacturing and/or coating the devices surface.


Author(s):  
N. Sertac Artan ◽  
Reza K. Amineh

Implantable medical devices such as pacemakers, implantable cardioverter defibrillators, deep brain stimulators, retinal and cochlear implants are gaining significant attraction and growth due to their capability to monitor the health condition in real time, diagnose a particular disease, or provide treatment for a particular disease. In order to charge these devices, wireless power transfer technology is considered as a powerful means. This eliminates the need for extra surgery to replace the battery. In this chapter, some of the major implanted medical devices are reviewed. Then, various wireless power transfer configurations are reviewed briefly for charging such devices. The chapter continues with reviewing wireless power transfer configurations based on the multi-layer printed or non-printed planar spiral coils. At the end, some of the recent works related to using multi-layer planar spiral coils for safe and efficient powering of IMDs will be discussed.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Adam Khalifa ◽  
Sunwoo Lee ◽  
Alyosha Christopher Molnar ◽  
Sydney Cash

AbstractIn the past three decades, we have witnessed unprecedented progress in wireless implantable medical devices that can monitor physiological parameters and interface with the nervous system. These devices are beginning to transform healthcare. To provide an even more stable, safe, effective, and distributed interface, a new class of implantable devices is being developed; injectable wireless microdevices. Thanks to recent advances in micro/nanofabrication techniques and powering/communication methodologies, some wireless implantable devices are now on the scale of dust (< 0.5 mm), enabling their full injection with minimal insertion damage. Here we review state-of-the-art fully injectable microdevices, discuss their injection techniques, and address the current challenges and opportunities for future developments.


Author(s):  
N. Sertac Artan ◽  
Reza K. Amineh

Implantable medical devices such as pacemakers, implantable cardioverter defibrillators, deep brain stimulators, retinal and cochlear implants are gaining significant attraction and growth due to their capability to monitor the health condition in real time, diagnose a particular disease, or provide treatment for a particular disease. In order to charge these devices, wireless power transfer technology is considered as a powerful means. This eliminates the need for extra surgery to replace the battery. In this chapter, some of the major implanted medical devices are reviewed. Then, various wireless power transfer configurations are reviewed briefly for charging such devices. The chapter continues with reviewing wireless power transfer configurations based on the multi-layer printed or non-printed planar spiral coils. At the end, some of the recent works related to using multi-layer planar spiral coils for safe and efficient powering of IMDs will be discussed.


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