Implantable Medical Devices

A special issue of Bioengineering (ISSN 2306-5354).

Deadline for manuscript submissions: closed (1 February 2019) | Viewed by 64705

Special Issue Editor


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Guest Editor
Department of Mechanical Engineering, University of Kansas, Lawrence, KS 66045, USA
Interests: orthopaedic biomechanics; biomaterials; medical devices; technology entrepreneurship; mechanical testing
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Research that will lead to the eventual development of implantable medical devices must be of the highest scientific standards in order to help ensure patient safety. However, those of us who specialize in this research also understand that other considerations must often be made when designing these projects. Future regulatory and reimbursement considerations must be made when setting up research on implantable medical devices. In this way, the probability that the research will be applied to and useful for a commercially viable device is enhanced.  

In order to highlight this type of research, the MDPI journal, Bioengineering, is offering this Special Issue dedicated to research on implantable medical devices. The goal of this issue is to highlight cutting-edge research that has a high probability of leading to either improvements in or development of medical implants. The research presented can range from basic science studies to biomechanics and biomaterials work to testing in large animals. This issue will include a broad range of novel research related to medical devices across all sectors.

Topics include, but are not limited to, research on development and evaluation of implants in the areas of:

  • Orthopaedic and spine
  • Cardiovascular
  • Pulmonary
  • Neural
  • Drug delivery

Prof. Dr. Elizabeth A Friis
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Bioengineering is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Published Papers (7 papers)

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Research

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16 pages, 3880 KiB  
Article
Synergistic Model of Cardiac Function with a Heart Assist Device
by Eun-jin Kim and Massimo Capoccia
Bioengineering 2020, 7(1), 1; https://doi.org/10.3390/bioengineering7010001 - 19 Dec 2019
Cited by 9 | Viewed by 5236
Abstract
The breakdown of cardiac self-organization leads to heart diseases and failure, the number one cause of death worldwide. The left ventricular pressure–volume relation plays a key role in the diagnosis and treatment of heart diseases. Lumped-parameter models combined with pressure–volume loop analysis are [...] Read more.
The breakdown of cardiac self-organization leads to heart diseases and failure, the number one cause of death worldwide. The left ventricular pressure–volume relation plays a key role in the diagnosis and treatment of heart diseases. Lumped-parameter models combined with pressure–volume loop analysis are very effective in simulating clinical scenarios with a view to treatment optimization and outcome prediction. Unfortunately, often invoked in this analysis is the traditional, time-varying elastance concept, in which the ratio of the ventricular pressure to its volume is prescribed by a periodic function of time, instead of being calculated consistently according to the change in feedback mechanisms (e.g., the lack or breakdown of self-organization) in heart diseases. Therefore, the application of the time-varying elastance for the analysis of left ventricular assist device (LVAD)–heart interactions has been questioned. We propose a paradigm shift from the time-varying elastance concept to a synergistic model of cardiac function by integrating the mechanical, electric, and chemical activity on microscale sarcomere and macroscale heart levels and investigating the effect of an axial rotary pump on a failing heart. We show that our synergistic model works better than the time-varying elastance model in reproducing LVAD–heart interactions with sufficient accuracy to describe the left ventricular pressure–volume relation. Full article
(This article belongs to the Special Issue Implantable Medical Devices)
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16 pages, 3801 KiB  
Article
A Proof of Concept Study of Using Machine-Learning in Artificial Aortic Valve Design: From Leaflet Design to Stress Analysis
by Liang Liang and Bill Sun
Bioengineering 2019, 6(4), 104; https://doi.org/10.3390/bioengineering6040104 - 8 Nov 2019
Cited by 8 | Viewed by 8631
Abstract
Artificial heart valves, used to replace diseased human heart valves, are life-saving medical devices. Currently, at the device development stage, new artificial valves are primarily assessed through time-consuming and expensive benchtop tests or animal implantation studies. Computational stress analysis using the finite element [...] Read more.
Artificial heart valves, used to replace diseased human heart valves, are life-saving medical devices. Currently, at the device development stage, new artificial valves are primarily assessed through time-consuming and expensive benchtop tests or animal implantation studies. Computational stress analysis using the finite element (FE) method presents an attractive alternative to physical testing. However, FE computational analysis requires a complex process of numeric modeling and simulation, as well as in-depth engineering expertise. In this proof of concept study, our objective was to develop machine learning (ML) techniques that can estimate the stress and deformation of a transcatheter aortic valve (TAV) from a given set of TAV leaflet design parameters. Two deep neural networks were developed and compared: the autoencoder-based ML-models and the direct ML-models. The ML-models were evaluated through Monte Carlo cross validation. From the results, both proposed deep neural networks could accurately estimate the deformed geometry of the TAV leaflets and the associated stress distributions within a second, with the direct ML-models (ML-model-d) having slightly larger errors. In conclusion, although this is a proof-of-concept study, the proposed ML approaches have demonstrated great potential to serve as a fast and reliable tool for future TAV design. Full article
(This article belongs to the Special Issue Implantable Medical Devices)
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15 pages, 4928 KiB  
Article
Finite Element Driven Design Domain Identification of a Beating Left Ventricular Simulator
by Utku Gulbulak and Atila Ertas
Bioengineering 2019, 6(3), 83; https://doi.org/10.3390/bioengineering6030083 - 13 Sep 2019
Cited by 5 | Viewed by 5624
Abstract
Almost ten percent of the American population have heart diseases. Since the number of available heart donors is not promising, left ventricular assist devices are implemented as bridge therapies. Development of the assist devices benefits from both in-vivo animal and in-vitro mock circulation [...] Read more.
Almost ten percent of the American population have heart diseases. Since the number of available heart donors is not promising, left ventricular assist devices are implemented as bridge therapies. Development of the assist devices benefits from both in-vivo animal and in-vitro mock circulation studies. Representation of the heart is a crucial part of the mock circulation setups. Recently, a beating left ventricular simulator with latex rubber and helically oriented McKibben actuators has been proposed. The simulator was able to mimic heart wall motion, however, flow rate was reported to be limited to 2 liters per minute. This study offers a finite element driven design domain identification to identify the combination of wall thickness, number of actuators, and the orientation angle that results in better deformation. A nonlinear finite element model of the simulator was developed and validated. Design domain was constructed with 150 finite element models, each with varying wall thickness and number of actuators with varying orientation angles. Results showed that the combination of 4 mm wall thickness and 8 actuators with 90 degrees orientation performed best in the design domain. Full article
(This article belongs to the Special Issue Implantable Medical Devices)
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8 pages, 2151 KiB  
Article
The Impact of a New “Inverted Arch” Prosthetic Annuloplasty Ring on the Mitral Valve’s 3-D Motion: An Experimental Ex-Vivo Study
by Philippe Caimmi, Emmanouil Kapetanakis, Carla Beggino, Giovanni Vacca, Elena Grossini, Florian Stratica, Roberto Sacco and Andrea Capponi
Bioengineering 2019, 6(2), 31; https://doi.org/10.3390/bioengineering6020031 - 8 Apr 2019
Viewed by 5975
Abstract
This experimental study aimed to evaluate the ex-vivo three-dimensional (3-D) motion of the Inverted Arch Ring (IAR), an innovative new design concept for a flexible incomplete annuloplasty prosthesis with an incorporated stabilizing rigid arch that can be used in correcting mitral valve regurgitation. [...] Read more.
This experimental study aimed to evaluate the ex-vivo three-dimensional (3-D) motion of the Inverted Arch Ring (IAR), an innovative new design concept for a flexible incomplete annuloplasty prosthesis with an incorporated stabilizing rigid arch that can be used in correcting mitral valve regurgitation. Twenty explanted porcine hearts were placed in a circulation simulation system. Ultrasonometry transducers implanted in the mitral annulus were used to measure the 3-D valvular motion during a simulated cardiac cycle. Annular distance measurements were recorded and compared in each heart before and after the implantation of the IAR prosthesis at pressures corresponding to mid-systole and mid-diastole. Distances measured in mid-systole and mid-diastole demonstrated no significant differences in annular motion or in valve areas either prior to or after IAR implantation. Therefore, the results of this study confirm the minimal effects exerted by the IAR prosthesis on the mitral valve’s 3-D motion during a simulated cardiac cycle. Full article
(This article belongs to the Special Issue Implantable Medical Devices)
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12 pages, 1783 KiB  
Article
Stacked PZT Discs Generate Necessary Power for Bone Healing through Electrical Stimulation in a Composite Spinal Fusion Implant
by Eileen S. Cadel, Ember D. Krech, Paul M. Arnold and Elizabeth A. Friis
Bioengineering 2018, 5(4), 90; https://doi.org/10.3390/bioengineering5040090 - 23 Oct 2018
Cited by 3 | Viewed by 5526
Abstract
Electrical stimulation devices can be used as adjunct therapy to lumbar spinal fusion to promote bone healing, but their adoption has been hindered by the large battery packs necessary to provide power. Piezoelectric composite materials within a spinal interbody cage to produce power [...] Read more.
Electrical stimulation devices can be used as adjunct therapy to lumbar spinal fusion to promote bone healing, but their adoption has been hindered by the large battery packs necessary to provide power. Piezoelectric composite materials within a spinal interbody cage to produce power in response to physiological lumbar loads have recently been investigated. A piezoelectric macro-fiber composite spinal interbody generated sufficient power to stimulate bone growth in a pilot ovine study, despite fabrication challenges. The objective of the present study was to electromechanically evaluate three new piezoelectric disc composites, 15-disc insert, seven-disc insert, and seven-disc Compliant Layer Adaptive Composite Stack (CLACS) insert, within a spinal interbody, and validate their use for electrical stimulation and promoting bone growth. All implants were electromechanically assessed under cyclic loads of 1000 N at 2 Hz, representing physiological lumbar loading. All three configurations produced at least as much power as the piezoelectric macro-fiber composites, validating the use of piezoelectric discs for this application. Future work is needed to characterize the electromechanical performance of commercially manufactured piezoelectric stacks under physiological lumbar loads, and mechanically assess the composite implants according to FDA guidelines for lumbar interbody fusion devices. Full article
(This article belongs to the Special Issue Implantable Medical Devices)
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Review

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26 pages, 6516 KiB  
Review
Cardiac Assist Devices: Early Concepts, Current Technologies, and Future Innovations
by Jooli Han and Dennis R. Trumble
Bioengineering 2019, 6(1), 18; https://doi.org/10.3390/bioengineering6010018 - 15 Feb 2019
Cited by 53 | Viewed by 25583
Abstract
Congestive heart failure (CHF) is a debilitating condition that afflicts tens of millions of people worldwide and is responsible for more deaths each year than all cancers combined. Because donor hearts for transplantation are in short supply, a safe and durable means of [...] Read more.
Congestive heart failure (CHF) is a debilitating condition that afflicts tens of millions of people worldwide and is responsible for more deaths each year than all cancers combined. Because donor hearts for transplantation are in short supply, a safe and durable means of mechanical circulatory support could extend the lives and reduce the suffering of millions. But while the profusion of blood pumps available to clinicians in 2019 tend to work extremely well in the short term (hours to weeks/months), every long-term cardiac assist device on the market today is limited by the same two problems: infections caused by percutaneous drivelines and thrombotic events associated with the use of blood-contacting surfaces. A fundamental change in device design is needed to address both these problems and ultimately make a device that can support the heart indefinitely. Toward that end, several groups are currently developing devices without blood-contacting surfaces and/or extracorporeal power sources with the aim of providing a safe, tether-free means to support the failing heart over extended periods of time. Full article
(This article belongs to the Special Issue Implantable Medical Devices)
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Other

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10 pages, 4731 KiB  
Perspective
Data Integration and Interoperability for Patient-Centered Remote Monitoring of Cardiovascular Implantable Electronic Devices
by Carly Daley, Tammy Toscos and Michael Mirro
Bioengineering 2019, 6(1), 25; https://doi.org/10.3390/bioengineering6010025 - 17 Mar 2019
Cited by 11 | Viewed by 7256
Abstract
The prevalence of cardiovascular implantable electronic devices with remote monitoring capabilities continues to grow, resulting in increased volume and complexity of biomedical data. These data can provide diagnostic information for timely intervention and maintenance of implanted devices, improving quality of care. Current remote [...] Read more.
The prevalence of cardiovascular implantable electronic devices with remote monitoring capabilities continues to grow, resulting in increased volume and complexity of biomedical data. These data can provide diagnostic information for timely intervention and maintenance of implanted devices, improving quality of care. Current remote monitoring procedures do not utilize device diagnostics to their potential, due to the lack of interoperability and data integration among proprietary systems and electronic medical record platforms. However, the development of a technical framework that standardizes the data and improves interoperability shows promise for improving remote monitoring. Along with encouraging the implementation of this framework, we challenge the current paradigm and propose leveraging the framework to provide patients with their remote monitoring data. Patient-centered remote monitoring may empower patients and improve collaboration and care with health care providers. In this paper, we describe the implementation of technology to deliver remote monitoring data to patients in two recent studies. Our body of work explains the potential for developing a patent-facing information display that affords the meaningful use of implantable device data and enhances interactions with providers. This paradigm shift in remote monitoring—empowering the patient with data—is critical to using the vast amount of complex and clinically relevant biomedical data captured and transmitted by implantable devices to full potential. Full article
(This article belongs to the Special Issue Implantable Medical Devices)
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