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Bioengineering
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Recent Advances of Medical Devices
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Recent Advances of Medical Devices

A special issue of Bioengineering (ISSN 2306-5354). This special issue belongs to the section "Biomedical Engineering and Biomaterials".

Deadline for manuscript submissions: closed (15 November 2022) | Viewed by 29764

Special Issue Editors

Robert M. DiBlasi

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Guest Editor
Department of Respiratory Care, Seattle Children’s Hospital, Seattle, WA 98105, USA
Interests: surfactant therapy; 3D print; airway models; critical care
Dr. Crescenzio Gallo

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Guest Editor
Department of Clinical and Experimental Medicine, Università degli studi di Foggia, 71122 Foggia, FG, Italy
Interests: bioinformatics; artificial intelligence
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Clinicians are constantly at the mercy of the technology at their disposal. Technology with superior design and function can augment clinicians’ ability to provide the best possible care to their patients, while poorly designed technology only hinders their work. Every year, flurries of new devices are released and promoted to care teams throughout the world, but little is actually known about device performance and the effect that this could have for impacting clinical outcomes. Recent advances in MedTech products and the development of novel technologies to support neonatal, pediatric and adult patients within intensive and acute care settings is integral for improving outcomes, especially in a worldwide pandemic such as COVID-19 where respiratory support device resources are stretched thin. There are many gaps in the MedTech market and development pipelines that need to be filled by replacing existing technologies or by developing novel breakthrough innovations that the healthcare industry has not seen before to improve hospital practices. Given the myriad of needs in healthcare and the increasing capability of engineers and designers, the hardest question is not how to solve problems but to determine what clinical problems exist and how new solutions could impact the immediate needs of patients in both well and poorly resourced clinical settings. This Special Issue of Bioengineering will focus on recent advances in medical devices for patients within acute and intensive care settings.

Robert M. DiBlasi
Dr. Crescenzio Gallo
Guest Editors

Manuscript Submission Information

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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.

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14 pages, 3088 KiB  
Article
Computational Modeling of Diffusion-Based Delamination for Active Implantable Medical Devices
by Minh-Hai Nguyen, Adrian Onken, Anika Wulff, Katharina Foremny, Patricia Torgau, Helmut Schütte, Sabine Hild and Theodor Doll
Bioengineering 2023, 10(5), 625; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering10050625 - 22 May 2023
Cited by 1 | Viewed by 1329
Abstract
Delamination at heterogeneous material interfaces is one of the most prominent failure modes in active implantable medical devices (AIMDs). A well-known example of an AIMD is the cochlear implant (CI). In mechanical engineering, a multitude of testing procedures are known whose data can [...] Read more.
Delamination at heterogeneous material interfaces is one of the most prominent failure modes in active implantable medical devices (AIMDs). A well-known example of an AIMD is the cochlear implant (CI). In mechanical engineering, a multitude of testing procedures are known whose data can be used for detailed modeling with respect to digital twins. Detailed, complex models for digital twins are still lacking in bioengineering since body fluid infiltration occurs both into the polymer substrate and along the metal-polymer interfaces. For a newly developed test for an AIMD or CI composed of silicone rubber and metal wiring or electrodes, a mathematical model of these mechanisms is presented. It provides a better understanding of the failure mechanisms in such devices and their validation against real-life data. The implementation utilizes COMSOL Multiphysics®, consisting of a volume diffusion part and models for interface diffusion (and delamination). For a set of experimental data, the necessary diffusion coefficient could be derived. A subsequent comparison of experimental and modeling results showed a good qualitative and functional match. The delamination model follows a mechanical approach. The results of the interface diffusion model, which follows a substance transport-based approach, show a very good approximation to the results of previous experiments. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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10 pages, 574 KiB  
Article
Flat Magnetic Stimulation for Stress Urinary Incontinence: A Prospective Comparison Study
by Matteo Frigerio, Marta Barba, Alice Cola, Giuseppe Marino, Silvia Volontè, Tomaso Melocchi, Desirèe De Vicari and Serena Maruccia
Bioengineering 2023, 10(3), 295; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering10030295 - 26 Feb 2023
Cited by 9 | Viewed by 1826
Abstract
Background: Flat Magnetic Stimulation (FMS) is characterized by a stimulation generated by electromagnetic fields with a homogenous profile. One possible application is the treatment of stress urinary incontinence (SUI). We aimed to compare the objective, subjective, quality of life, and instrumental outcomes in [...] Read more.
Background: Flat Magnetic Stimulation (FMS) is characterized by a stimulation generated by electromagnetic fields with a homogenous profile. One possible application is the treatment of stress urinary incontinence (SUI). We aimed to compare the objective, subjective, quality of life, and instrumental outcomes in women with SUI not eligible for surgery undergoing either FMS or pelvic floor muscle training (PFMT). Methods: This was a prospective interventional study. After proper counseling, patients with isolated SUI were divided according to their treatment of choice into FMS and PFMT groups. At baseline and after treatment, patients completed the International Consultation on Incontinence Questionnaire-Short Form, the Female Sexual Function Index, and the Incontinence Impact Questionnaire, and volumetric measurement of the urethral rhabdosphincter (RS) was performed. The Patient Global Impression of Improvement questionnaire and stress test defined subjective and objective cure rates, respectively. Results: We observed improvements in urinary-related quality of life scores and an increase in RS volume after FMS compared to baseline. All these outcomes were significantly better compared to women who underwent PFMT. Conclusion: Our study demonstrated that FMS is a safe and effective conservative option for SUI management in terms of objective and subjective cure rates. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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12 pages, 3636 KiB  
Article
Inactivation of SARS-CoV-2 on Surfaces by Cold-Plasma-Generated Reactive Species
by Som V. Thomas, Krista Dienger-Stambaugh, Michael Jordan, Yuxin Wang, Jason Hammonds, Paul Spearman and Donglu Shi
Bioengineering 2023, 10(3), 280; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering10030280 - 21 Feb 2023
Cited by 2 | Viewed by 1547
Abstract
A Cold Atmospheric Plasma (CAP) apparatus was designed and developed for SARS-CoV-2 killing as evaluated by pseudotyped viral infectivity assays. The reactive species generated by the plasma system was fully characterized by using Optical Emission Spectroscopy (OES) measurement under given conditions such as [...] Read more.
A Cold Atmospheric Plasma (CAP) apparatus was designed and developed for SARS-CoV-2 killing as evaluated by pseudotyped viral infectivity assays. The reactive species generated by the plasma system was fully characterized by using Optical Emission Spectroscopy (OES) measurement under given conditions such as plasma power, flow rate, and treatment time. A variety of reactive oxygen species (ROS) and reactive nitrogen species (RNS) were identified from plasma plume with energies of 15–72 eV in the frequency range between 500–1000 nm. Systematic virus killing experiments were carried out, and the efficacy of CAP treatment in reducing SARS-CoV-2 viral infectivity was significant following treatment for 8 s, with further enhancement of killing upon longer exposures of 15–120 s. We correlated killing efficacy with the reactive species in terms of type, intensity, energy, and frequency. These experimental results demonstrate effective cold plasma virus killing via ROS and RNS under ambient conditions. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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11 pages, 1241 KiB  
Article
Home Spirometry in Children with Cystic Fibrosis
by Ariel Berlinski, Pamela Leisenring, Lauren Willis and Sandra King
Bioengineering 2023, 10(2), 242; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering10020242 - 11 Feb 2023
Cited by 2 | Viewed by 1844
Abstract
We report the implementation of a pediatric home spirometry program at our institution. A respiratory therapist provided either a virtual or an in-person initiation visit that included a coached spirometry session. Families were instructed to perform daily uncoached spirometry sessions for 5 days. [...] Read more.
We report the implementation of a pediatric home spirometry program at our institution. A respiratory therapist provided either a virtual or an in-person initiation visit that included a coached spirometry session. Families were instructed to perform daily uncoached spirometry sessions for 5 days. The program’s quality assurance component was deemed not to be human research by the local IRB. In total, 52 subjects completed an initiation visit (34 with at least 3 additional uncoached spirometry sessions). The clinic spirometry and coached (same-day) sessions and uncoached (same-week) sessions were completed by 12 and 17 subjects, respectively. The median (99% CI) coefficients of variation for FEV1% of the uncoached maneuvers were 3.5% (2.9–5.9%). The median (IQR) FEV1% and FEV1 (mL) absolute differences between coached and uncoached home spirometry were −2% (−4 and +3%) and −25 mL (−93 and +93 mL), respectively. The median (IQR) absolute differences in FEV1% and FEV1 (mL) between coached or uncoached home spirometry and clinic spirometry were −6% (−10 and −2%) and −155 mL (−275 and −88 mL), and −4% (−10 and +5%), and −110 mL (−280 and +9 mL), respectively. Differences in absolute FEV1 (L) and FEV1% were found among different modalities of spirometry performed by people with cystic fibrosis. Understanding the variability of uncoached home spirometry and the differences among coached and uncoached home spirometry, hospital and coached home spirometry, and hospital and uncoached home spirometry for any given individual is crucial to effectively utilize this tool in clinical care. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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14 pages, 4666 KiB  
Article
Engineering In Situ Weldable Vascular Devices
by Daniel Cohn, Fany Widlan, Matt Zarek, Ziv Peselev and Allan Isaac Bloom
Bioengineering 2023, 10(2), 221; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering10020221 - 07 Feb 2023
Viewed by 1203
Abstract
(1) Background: The minimally invasive implantation of medical devices is largely limited by their insertion profile, and, therefore, minimizing them constitutes a leading trend in the field. (2) Methods: This study introduces the in situ welding strategy, whereby the components of the stent [...] Read more.
(1) Background: The minimally invasive implantation of medical devices is largely limited by their insertion profile, and, therefore, minimizing them constitutes a leading trend in the field. (2) Methods: This study introduces the in situ welding strategy, whereby the components of the stent grafts used to treat abdominal aortic aneurysms were decoupled, deployed sequentially, and welded together at the aneurysmal site, greatly reducing their insertion profile. Polyurethane elastomers were used to produce the graft and to coat the metallic struts of the stent to render it in vivo weldable. Results: The composition of the polyurethanes was fine-tuned, so to minimize the insertion profiles and optimize the welding properties and the clinical performance of the devices assembled. The stent and graft were deployed successively in pigs via a small 8F introducer, in situ welded, and the patency of the bi-component device was confirmed over a three-month post-implantation period. The strength of the stent/graft welded connection was fully retained, with no de-welding observed. Conclusions: The in situ welding strategy resulted in implantations that were easier to perform and markedly less injurious to tissues and organs, largely expanding the applicability of these ultra-minimally invasive procedures to especially frail segments of the population. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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12 pages, 3127 KiB  
Article
Hybrid Therapeutic Device (CUHK-OA-M2) for Relieving Symptoms Induced by Knee Osteoarthritis
by Li Zou, Kisum Chu, Xuan He, Ye Li, Liangbin Zhou, Xiayi Xu, Wei-Hsin Liao and Ling Qin
Bioengineering 2023, 10(1), 95; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering10010095 - 11 Jan 2023
Cited by 2 | Viewed by 2355
Abstract
The symptoms of knee osteoarthritis (KOA) severely affect the life quality of the elderly population. Low-level laser therapy, heat therapy, and massage therapy are widely used as independent treatments for joint disorders. However, there are very limited reports of a combination of these [...] Read more.
The symptoms of knee osteoarthritis (KOA) severely affect the life quality of the elderly population. Low-level laser therapy, heat therapy, and massage therapy are widely used as independent treatments for joint disorders. However, there are very limited reports of a combination of these therapies into an integrated device for KOA so far. This study aims to develop a novel hybrid therapeutic device that can meet various requirements for knee therapy. Our hybrid therapeutic device (CUHK-OA-M2) integrated with low-level laser therapy, heat therapy, and local massage therapy can effectively provide patients with KOA with relief from their clinical symptoms. A pilot test of 50 community-dwelling elderly volunteers with KOA was performed. Finally, 43 volunteers completed two treatment periods (30 days each) and two post-treatment periods (30 days each). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were collected and analyzed after each period. The outputs of the low-level laser, heating, and massage therapies significantly decreased the WOMAC scores in terms of pain, stiffness, function and total WOMAC after two treatment periods (p < 0.05). Although the score increased slightly after the post-treatment period, it was still lower than the baseline, indicating the treatment outcome could last for an extended period. Therefore, our CUHK-OA-M2 device, as an integrated multi-functional hybrid therapeutic device, is therapeutically significant for treating osteoarthritis symptoms on the knee joints of elderly subjects. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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15 pages, 2028 KiB  
Article
Evaluating the Performance of a Nonelectronic, Versatile Oxygenating Perfusion System across Viscosities Representative of Clinical Perfusion Solutions Used for Organ Preservation
by Jose M. Gonzalez, Carorina Villarreal, Anjelyka Fasci, David Di Rocco, Sophia Salazar, Anis Khalil, Brandt Wearden, Jessica Oseghale, Mariana Garcia, Daniel J. Portillo and R. Lyle Hood
Bioengineering 2023, 10(1), 2; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering10010002 - 20 Dec 2022
Viewed by 1228
Abstract
Introduction: On the United States’ Organ Transplantation Waitlist, approximately 17 people die each day waiting for an organ. The situation continues to deteriorate as the discrepancy between harvested organs and the number of patients in need is increasing. Static cold storage is the [...] Read more.
Introduction: On the United States’ Organ Transplantation Waitlist, approximately 17 people die each day waiting for an organ. The situation continues to deteriorate as the discrepancy between harvested organs and the number of patients in need is increasing. Static cold storage is the clinical standard method for preserving a harvested organ but is associated with several drawbacks. Machine perfusion of an organ has been shown to improve preservation quality as well as preservation time over static cold storage. While there are machine perfusion devices clinically available, they are costly and limited to specific organs and preservation solutions. This study presents a versatile oxygenating perfusion system (VOPS) that supplies oxygen and pulsatile perfusion. Materials and Methods: Experiments evaluated the system’s performance with a human kidney mimicking hydraulic analog using multiple compressed oxygen supply pressures and aqueous solutions with viscosities ranging from 1 to 6.5 cP, which simulated viscosities of commonly used organ preservation solutions. Results and Conclusions: The VOPS produced mean flow rates ranging from 0.6 to 28.2 mL/min and perfusion pressures from 4.8 to 96.8 mmHg, which successfully achieved the desired perfusion parameters for human kidneys. This work provides evidence that the VOPS described herein has the versatility to perfuse organs using many of the clinically available preservation solutions. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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8 pages, 1656 KiB  
Article
Smart Flexible 3D Sensor for Monitoring Orthodontics Forces: Prototype Design and Proof of Principle Experiment
by Soobum Lee, Chabum Lee, Jose A. Bosio and Mary Anne S. Melo
Bioengineering 2022, 9(10), 570; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering9100570 - 18 Oct 2022
Cited by 4 | Viewed by 2269
Abstract
There is a critical need for an accurate device for orthodontists to know the magnitude of forces exerted on the tooth by the orthodontic brackets. Here, we propose a new orthodontic force measurement principle to detect the deformation of the elastic semi-sphere sensor. [...] Read more.
There is a critical need for an accurate device for orthodontists to know the magnitude of forces exerted on the tooth by the orthodontic brackets. Here, we propose a new orthodontic force measurement principle to detect the deformation of the elastic semi-sphere sensor. Specifically, we aimed to detail technical issues and the feasibility of the sensor performance attached to the inner surface of the orthodontic aligner or on the tooth surface. Accurate force tracking is important for the optimal decision of aligner replacement and cost reduction. A finite element (FE) model of the semi-sphere sensor was developed, and the relationship between the force and the contact area change was investigated. The prototype was manufactured, and the force detection performance was experimentally verified. In the experiment, the semi-sphere sensor was manufactured using thermoplastic polymer, and a high-precision mold sized 3 mm in diameter. The change in the contact area in the semi-sphere sensor was captured using a portable microscope. Further development is justified, and future implementation of the proposed sensor would be an array of multiple semi-sphere sensors in different locations for directional orthodontic force detection. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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18 pages, 3687 KiB  
Article
Hardware-in-Loop Comparison of Physiological Closed-Loop Controllers for the Autonomous Management of Hypotension
by Eric J. Snider, David Berard, Saul J. Vega, Evan Ross, Zechariah J. Knowlton, Guy Avital and Emily N. Boice
Bioengineering 2022, 9(9), 420; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering9090420 - 27 Aug 2022
Cited by 4 | Viewed by 1508
Abstract
Trauma and hemorrhage are leading causes of death and disability worldwide in both civilian and military contexts. The delivery of life-saving goal-directed fluid resuscitation can be difficult to provide in resource-constrained settings, such as in forward military positions or mass-casualty scenarios. Automated solutions [...] Read more.
Trauma and hemorrhage are leading causes of death and disability worldwide in both civilian and military contexts. The delivery of life-saving goal-directed fluid resuscitation can be difficult to provide in resource-constrained settings, such as in forward military positions or mass-casualty scenarios. Automated solutions for fluid resuscitation could bridge resource gaps in these austere settings. While multiple physiological closed-loop controllers for the management of hypotension have been proposed, to date there is no consensus on controller design. Here, we compare the performance of four controller types—decision table, single-input fuzzy logic, dual-input fuzzy logic, and proportional–integral–derivative using a previously developed hardware-in-loop test platform where a range of hemorrhage scenarios can be programmed. Controllers were compared using traditional controller performance metrics, but conclusions were difficult to draw due to inconsistencies across the metrics. Instead, we propose three aggregate metrics that reflect the target intensity, stability, and resource efficiency of a controller, with the goal of selecting controllers for further development. These aggregate metrics identify a dual-input, fuzzy-logic-based controller as the preferred combination of intensity, stability, and resource efficiency within this use case. Based on these results, the aggressively tuned dual-input fuzzy logic controller should be considered a priority for further development. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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14 pages, 2742 KiB  
Article
Anti-Reflective Zeolite Coating for Implantable Bioelectronic Devices
by Giuseppe Oliva, Maria Giovanna Bianco, Antonino S. Fiorillo and Salvatore A. Pullano
Bioengineering 2022, 9(8), 404; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering9080404 - 20 Aug 2022
Cited by 4 | Viewed by 1486
Abstract
Since sunlight is one of the most easily available and clean energy supplies, solar cell development and the improvement of its conversion efficiency represent a highly interesting topic. Superficial light reflection is one of the limiting factors of the photovoltaic cells (PV) efficiency. [...] Read more.
Since sunlight is one of the most easily available and clean energy supplies, solar cell development and the improvement of its conversion efficiency represent a highly interesting topic. Superficial light reflection is one of the limiting factors of the photovoltaic cells (PV) efficiency. To this end, interfacial layer with anti-reflective properties reduces this phenomenon, improving the energy potentially available for transduction. Nanoporous materials, because of the correlation between the refractive index and the porosity, allow low reflection, improving light transmission through the coating. In this work, anti-reflective coatings (ARCs) deposited on commercial PV cells, which were fabricated using two different Linde Type A (LTA) zeolites (type 3A and 4A), have been investigated. The proposed technique allows an easier deposition of a zeolite-based mixture, avoiding the use of chemicals and elevated temperature calcination processes. Results using radiation in the range 470–610 nm evidenced substantial enhancement of the fill factor, with maximum achieved values of over 40%. At 590 and 610 nm, which are the most interesting bands for implantable devices, FF is improved, with a maximum of 22% and 10%, respectively. ARCs differences are mostly related to the morphology of the zeolite powder used, which resulted in thicker and rougher coatings using zeolite 3A. The proposed approach allows a simple and reliable deposition technique, which can be of interest for implantable medical devices. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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18 pages, 3749 KiB  
Article
An Automated Hardware-in-Loop Testbed for Evaluating Hemorrhagic Shock Resuscitation Controllers
by Eric. J. Snider, David Berard, Saul J. Vega, Sofia I. Hernandez Torres, Guy Avital and Emily N. Boice
Bioengineering 2022, 9(8), 373; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering9080373 - 07 Aug 2022
Cited by 4 | Viewed by 1319
Abstract
Hemorrhage remains a leading cause of death, with early goal-directed fluid resuscitation being a pillar of mortality prevention. While closed-loop resuscitation can potentially benefit this effort, development of these systems is resource-intensive, making it a challenge to compare infusion controllers and respective hardware [...] Read more.
Hemorrhage remains a leading cause of death, with early goal-directed fluid resuscitation being a pillar of mortality prevention. While closed-loop resuscitation can potentially benefit this effort, development of these systems is resource-intensive, making it a challenge to compare infusion controllers and respective hardware within a range of physiologically relevant hemorrhage scenarios. Here, we present a hardware-in-loop automated testbed for resuscitation controllers (HATRC) that provides a simple yet robust methodology to evaluate controllers. HATRC is a flow-loop benchtop system comprised of multiple PhysioVessels which mimic pressure-volume responsiveness for different resuscitation infusates. Subject variability and infusate switching were integrated for more complex testing. Further, HATRC can modulate fluidic resistance to mimic arterial resistance changes after vasopressor administration. Finally, all outflow rates are computer-controlled, with rules to dictate hemorrhage, clotting, and urine rates. Using HATRC, we evaluated a decision-table controller at two sampling rates with different hemorrhage scenarios. HATRC allows quantification of twelve performance metrics for each controller configuration and scenario, producing heterogeneous results and highlighting the need for controller evaluation with multiple hemorrhage scenarios. In conclusion, HATRC can be used to evaluate closed-loop controllers through user-defined hemorrhage scenarios while rating their performance. Extensive controller troubleshooting using HATRC can accelerate product development and subsequent translation. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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11 pages, 8041 KiB  
Article
Development of a New Radiation Shield for the Face and Neck of IVR Physicians
by Toshimitsu Sato, Yoichi Eguchi, Chika Yamazaki, Takanobu Hino, Toshikazu Saida and Koichi Chida
Bioengineering 2022, 9(8), 354; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering9080354 - 29 Jul 2022
Cited by 5 | Viewed by 2616
Abstract
Interventional radiology (IVR) procedures are associated with increased radiation exposure and injury risk. Furthermore, radiation eye injury (i.e., cataract) in IVR staff have also been reported. It is crucial to protect the eyes of IVR physicians from X-ray radiation exposure. Many IVR physicians [...] Read more.
Interventional radiology (IVR) procedures are associated with increased radiation exposure and injury risk. Furthermore, radiation eye injury (i.e., cataract) in IVR staff have also been reported. It is crucial to protect the eyes of IVR physicians from X-ray radiation exposure. Many IVR physicians use protective Pb eyeglasses to reduce occupational eye exposure. However, the shielding effects of Pb eyeglasses are inadequate. We developed a novel shield for the face (including eyes) of IVR physicians. The novel shield consists of a neck and face guard (0.25 mm Pb-equivalent rubber sheet, nonlead protective sheet). The face shield is positioned on the left side of the IVR physician. We assessed the shielding effects of the novel shield using a phantom in the IVR X-ray system; a radiophotoluminescence dosimeter was used to measure the radiation exposure. In this phantom study, the effectiveness of the novel device for protecting against radiation was greater than 80% in almost all measurement situations, including in terms of eye lens exposure. A large amount of scattered radiation reaches the left side of IVR physicians. The novel radiation shield effectively protects the left side of the physician from this scattered radiation. Thus, the device can be used to protect the face and eyes of IVR physicians from occupational radiation exposure. The novel device will be useful for protecting the face (including eyes) of IVR physicians from radiation, and thus could reduce the rate of radiation injury. Based on the positive results of this phantom study, we plan to perform a clinical experiment to further test the utility of this novel radiation shield for IVR physicians. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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14 pages, 2800 KiB  
Article
Development of a Modular Tissue Phantom for Evaluating Vascular Access Devices
by Emily N. Boice, David Berard, Jose M. Gonzalez, Sofia I. Hernandez Torres, Zechariah J. Knowlton, Guy Avital and Eric J. Snider
Bioengineering 2022, 9(7), 319; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering9070319 - 15 Jul 2022
Cited by 4 | Viewed by 2533
Abstract
Central vascular access (CVA) may be critical for trauma care and stabilizing the casualty. However, it requires skilled personnel, often unavailable during remote medical situations and combat casualty care scenarios. Automated CVA medical devices have the potential to make life-saving therapeutics available in [...] Read more.
Central vascular access (CVA) may be critical for trauma care and stabilizing the casualty. However, it requires skilled personnel, often unavailable during remote medical situations and combat casualty care scenarios. Automated CVA medical devices have the potential to make life-saving therapeutics available in these resource-limited scenarios, but they must be properly designed. Unfortunately, currently available tissue phantoms are inadequate for this use, resulting in delayed product development. Here, we present a tissue phantom that is modular in design, allowing for adjustable flow rate, circulating fluid pressure, vessel diameter, and vessel positions. The phantom consists of a gelatin cast using a 3D-printed mold with inserts representing vessels and bone locations. These removable inserts allow for tubing insertion which can mimic normal and hypovolemic flow, as well as pressure and vessel diameters. Trauma to the vessel wall is assessed using quantification of leak rates from the tubing after removal from the model. Lastly, the phantom can be adjusted to swine or human anatomy, including modeling the entire neurovascular bundle. Overall, this model can better recreate severe hypovolemic trauma cases and subject variability than commercial CVA trainers and may potentially accelerate automated CVA device development. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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15 pages, 3132 KiB  
Article
Biomechanical Analysis of the Use of Stems in Revision Total Knee Arthroplasty
by Bernardo Innocenti, Edoardo Bori and Silvia Pianigiani
Bioengineering 2022, 9(6), 259; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering9060259 - 19 Jun 2022
Cited by 9 | Viewed by 2383
Abstract
Adequate fixation is fundamental in revision total knee arthroplasty; consequently, surgeons must determine the correct set-up for each patient, choosing from numerous stem solutions. Several designs are currently available on the market, but there are no evidence-based quantitative biomechanical guideline yet. Therefore, several [...] Read more.
Adequate fixation is fundamental in revision total knee arthroplasty; consequently, surgeons must determine the correct set-up for each patient, choosing from numerous stem solutions. Several designs are currently available on the market, but there are no evidence-based quantitative biomechanical guideline yet. Therefore, several stems were designed and analyzed using a previously-validated finite-element model. The following parameters were studied: stem design characteristics (length and shape), added features (straight/bowed stem), fixation technique, and effect of slots/flutes. Bone stress and Risk of Fracture (RF) were analyzed in different regions of interest during a squat (up to 120°). For the femoral stem, the results indicated that all parameters influenced the bone stress distribution. The maximum von Mises stress and RF were always located near the tip of the stem. The long stems generated stress-shielding in the distal bone. Regarding the tibial stem, cemented stems showed lower micromotions at the bone-tibial tray interface and at the stem tip compared to press-fit stems, reducing the risk of implant loosening. The results demonstrated that anatomical shapes and slots reduce bone stress and risk of fracture, whereas flutes have the opposite effect; no relevant differences were found in this regard when alternating cemented and press-fit stem configurations. Cemented tibial stems reduce antero-posterior micromotions, preventing implant loosening. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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Review

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16 pages, 1185 KiB  
Review
The Evolving Use of Magnets in Surgery: Biomedical Considerations and a Review of Their Current Applications
by William G. Lee, Lauren L. Evans, Sidney M. Johnson and Russell K. Woo
Bioengineering 2023, 10(4), 442; https://0-doi-org.brum.beds.ac.uk/10.3390/bioengineering10040442 - 01 Apr 2023
Cited by 5 | Viewed by 2282
Abstract
The novel use of magnetic force to optimize modern surgical techniques originated in the 1970s. Since then, magnets have been utilized as an adjunct or alternative to a wide array of existing surgical procedures, ranging from gastrointestinal to vascular surgery. As the use [...] Read more.
The novel use of magnetic force to optimize modern surgical techniques originated in the 1970s. Since then, magnets have been utilized as an adjunct or alternative to a wide array of existing surgical procedures, ranging from gastrointestinal to vascular surgery. As the use of magnets in surgery continues to grow, the body of knowledge on magnetic surgical devices from preclinical development to clinical implementation has expanded significantly; however, the current magnetic surgical devices can be organized based on their core function: serving as a guidance system, creating a new connection, recreating a physiologic function, or utilization of an internal–external paired magnet system. The purpose of this article is to discuss the biomedical considerations during magnetic device development and review the current surgical applications of magnetic devices. Full article
(This article belongs to the Special Issue Recent Advances of Medical Devices)
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