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Special Issue "Medical Devices and Implants"

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A special issue of Bioengineering (ISSN 2306-5354). This special issue belongs to the section "Biofabrication and Biomanufacturing".

Deadline for manuscript submissions: 30 September 2023 | Viewed by 7772

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Special Issue Editors

Dr. Giovanni Francesco Solitro

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Guest Editor

Department of Orthopaedic Surgery, Louisiana State University Health - Shreveport, Shreveport, LA, USA
Interests: imaging; orthopaedic; surgery; dentistry; trauma; experimental testing; point of care diagnostic
Special Issues, Collections and Topics in MDPI journals

Dr. Christina Salas

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Guest Editor

Department of Orthopaedics & Rehabilitation, University of New Mexico, Albuquerque, NM, USA
Interests: orthopaedics; tissue biomechanics; tissue engineering; additive manufacturing; 3D bioprinting; medical device design; finite element modeling

Dr. Francesco Travascio

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Guest Editor

Department of Orthopaedic Surgery, University of Miami, Coral Gables, FL, USA
Interests: fibrocartilage; tissue engineering; computational modeling; injury biomechanics; prosthetics; assistive devices; rehabilitation

Special Issue Information

Dear Colleagues,

We invite contributions for a Special Issue of Bioengineering focused on the design, prototyping, manufacturing, and experimentation of medical devices and implants. Considering the increased demand of these devices and the resultant increased healthcare costs, the clinical deployment of these solutions results in many challenges that need to be overcome. The regulatory compliance, absence of standardized testing procedures, manufacturability, and efficacy of these devices are examples of issues that need to be addressed to launch or maintain a product on the market with satisfactory clinical results. Embedded Artificial Intelligence in diagnostic tools, big-data-driven design processes, wireless communications for real-time monitoring, and finite element modeling for verification and validation are all examples of novel but now well-established technologies that have positively impacted product development. Further, the widespread use of additive manufacturing has boosted patient-specific design and implant development. More recently, bioprinting has been used in medicine to help to study or recreate almost every tissue, cartilage, and organ in the body. The translational role of these solutions is often overlooked, and not much space is given in clinical journals. Therefore, this Special Issue aims to collect studies performed on medical devices and implants strictly related to their development, prototyping, evaluation of efficacy, and safety. Discussion and critical analysis of existing testing methods and standards is welcome, as are original studies on new concepts. We look forward to receiving your groundbreaking contributions.

Dr. Giovanni Francesco Solitro
Dr. Christina Salas
Dr. Francesco Travascio
Guest Editors

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 2000 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.

Keywords

implant
medical devices
prototyping
3D printing
scaffolds
tissue engineering
additive manufacturing

Published Papers (6 papers)

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Research

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Open AccessArticle

‘Distraction Vaginogenesis’: Preliminary Results Using a Novel Method for Vaginal Canal Expansion in Rats

Jonathan Steven Alexander

and

Donald Sorrells

Bioengineering 2023, 10(3), 351; https://doi.org/10.3390/bioengineering10030351 - 12 Mar 2023

Viewed by 870

Abstract

Vaginal atresia is seen in genetic disorders such as Mayer–Rokitansky–Küster–Hauser (MRKH) syndrome, which can cause significant sexual dysfunction. Current treatments include surgical reconstruction or mechanical dilation of the vaginal canal. Mechanical dilation requires patients to be highly motivated and compliant while surgical reconstruction has high rates of complications. This study evaluated a novel vaginal expansion sleeve (VES) method as an alternative treatment for vaginal atresia. The proprietary cylindrical VES is a spring-like device consisting of polyethylene terephthalate helicoid trusses capped at each end with a fixed diameter resin cap for fixation within tissues. Following the development of the VES and mechanical characterization of the force–length relationships within the device, we deployed the VES in Sprague Dawley rat vaginas anchored with nonabsorbable sutures. We measured the VES length–tension relationships and post-implant vaginal canal expansion ex vivo. Vaginal histology was examined before and after implantation of the VES devices. Testing of 30 mm sleeves without caps resulted in an expansion force of 11.7 ± 3.4 N and 2.0 ± 0.1 N at 50% and 40%, respectively. The implanted 20 mm VES resulted in 5.36 mm ± 1.18 expansion of the vaginal canal, a 32.5 ± 23.6% increase (p = 0.004, Student t test). Histological evaluation of the VES implanted tissue showed a significant thinning of the vaginal wall when the VES was implanted. The novel VES device resulted in a significant expansion of the vaginal canal ex vivo. The VES device represents a unique alternative to traditional mechanical dilation therapy in the treatment of vaginal atresia and represents a useful platform for the mechanical distension of hollow compartments, which avoids reconstructive surgeries and progressive dilator approaches. Full article

(This article belongs to the Special Issue Medical Devices and Implants)

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Open AccessArticle

Planar Elliptical Inductor Design for Wireless Implantable Medical Devices

and

Bioengineering 2023, 10(2), 151; https://doi.org/10.3390/bioengineering10020151 - 23 Jan 2023

Cited by 1 | Viewed by 1206

Abstract

Wireless implantable medical devices (WIMDs) have seen unprecedented progress in the past three decades. WIMDs help clinicians in better-understanding diseases and enhance medical treatment by allowing for remote data collection and delivering tailored patient care. The wireless connectivity range between the external reader and the implanted device is considered one of the key design parameters in WIMD technology. One of the common modes of communication in battery-free WIMDs is inductive coupling, where the power and data between the reader and the implanted device are transmitted via magnetically coupled inductors. The design and shape of these inductors depend on the requirements of the application. Several studies have reported models of standard planar inductors such as circular, square, hexagonal, and octagonal in medical applications. However, for applications, constrained by narrow implantable locations, elliptical planar inductors may perform better than standard-shaped planar inductors. The aim of this study is to develop a numerical model for elliptical inductors. This model allows for the calculation of the inductance of the elliptical planar inductor and its parasitic components, which are key design parameters for the development of WIMDs powered by inductive coupling. An area transformation technique is used to transform and derive elliptical inductor formulas from standard circular inductor formulas. The proposed model is validated for various combinations of the number of turns, trace width, trace separation, and different inner and outer diameters of the elliptical planar inductor. For a thorough experimental validation of the proposed numerical model, more than 75 elliptical planar inductors were fabricated, measured, and compared with the numerical output of the proposed model. The mean error between the measured inductor parameters and numerical estimates using the proposed model is <5%, with a standard deviation of <3.18%. The proposed model provides an accurate analytical method for estimating and optimizing elliptical planar inductor parameters using a combination of current sheet expression and area transformation techniques. An elliptical planar inductor integrated with a sensing element can be used as a wireless implant to monitor the physiological signal from narrow implantation sites. Full article

(This article belongs to the Special Issue Medical Devices and Implants)

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Open AccessArticle

An Inductively Powered Implantable System to Study the Gastrointestinal Electrophysiology in Freely Behaving Rodents

and

Amir Javan-Khoshkholgh

Bioengineering 2022, 9(10), 530; https://doi.org/10.3390/bioengineering9100530 - 06 Oct 2022

Viewed by 860

Abstract

Chronic studies in the fasting and fed states of conscious subjects are fundamental for understanding the pathophysiological significance of functional gastrointestinal (GI) disorders and motility dysfunctions. To study the electrophysiology of the GI tract in the long term, the development of gastric implants is essential. This paper presents the development of an implantable system capable of monitoring the bioelectrical activity of the gastric system and modulating the activity in freely behaving rodents. The system consists of a miniature-sized implantable unit (IU), a stationary unit (SU) that communicates with the IU over a 2.4 GHz far-field radio frequency (RF) bidirectional link, and a charging unit (CU) that establishes an inductive 13.56 MHz near-field communication (NFC) with the IU, implementing an adaptive wireless power transfer (WPT). The CU can generate an adjustable power between +20 dBm and +30 dBm, and, in the presence of body movements and stomach motility, can deliver a constant rectified voltage to the IU. The live subject’s exposure to the electromagnetic WPT in the developed system complies with the RF energy absorption restrictions for health and safety concerns. The system can be utilized to investigate the relationship between functional GI disorders and dysrhythmias in the gastric bioelectrical activity and study the potential of electroceutical therapies for motility dysfunctions in clinical settings. Full article

(This article belongs to the Special Issue Medical Devices and Implants)

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Review

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Open AccessReview

A Review of Barbed Sutures—Evolution, Applications and Clinical Significance

Karuna Nambi Gowri

and

Martin W. King

Bioengineering 2023, 10(4), 419; https://doi.org/10.3390/bioengineering10040419 - 27 Mar 2023

Viewed by 975

Abstract

Surgical ligatures are a critical component of any surgical procedure since they are the device that provides immediate post-surgical tissue apposition. There have been several studies to improve the design and use of these wound closure devices for different surgical procedures. Yet, there is no standardized technique or device that can be used for any specific application. Over the last two decades, there has been an increased focus on the innovative surgical sutures known as knotless or barbed sutures, along with studies focusing on their advantages and disadvantages in clinical environments. Barbed sutures were invented to reduce the localized stress on the approximated tissues as well as facilitating the surgical technique and improving the clinical outcome for the patient. This review article discusses how barbed sutures evolved from the first patent published in 1964 and how these barbed sutures influence the surgical outcomes in different procedures ranging from cosmetic surgery to orthopedic surgery performed on both human patients and animals. Full article

(This article belongs to the Special Issue Medical Devices and Implants)

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Open AccessReview

The Safety and Effectiveness of Early, Progressive Weight Bearing and Implant Choice after Traumatic Lower Extremity Fracture: A Systematic Review

and

Bioengineering 2022, 9(12), 750; https://doi.org/10.3390/bioengineering9120750 - 01 Dec 2022

Viewed by 1172

Abstract

The goal of this systematic review was to examine existing evidence on the effectiveness of early, progressive weight bearing on patients after traumatic lower extremity fractures and relate these findings to device/implant choice. A search of the literature in PubMed/Medline, Embase, Web of Science, and the Cochrane Library was performed through January 2022. Randomized controlled trials and non-randomized, prospective longitudinal investigations of early, progressive weight bearing in skeletally mature adults after traumatic lower extremity fracture were included in the search, with 21 publications included in the final analysis. A summary of the loading progressions used in each study, along with the primary and additional outcomes, is provided. The progression of weight bearing was variable, dependent on fracture location and hardware fixation; however, overall outcomes were good with few complications. Most studies scored “high” on the bias tools and were predominately performed without physical therapist investigators. Few studies have investigated early, progressive weight bearing in patients after traumatic lower extremity fractures. The available clinical evidence provides variable progression guidelines. Relatively few complications and improved patient function were observed in this review. More research is needed from a rehabilitation perspective to obtain graded progression recommendations, informed by basic science concepts and tissue loading principles. Full article

(This article belongs to the Special Issue Medical Devices and Implants)

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Other

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Open AccessSystematic Review

Biodegradable Bone Implants as a New Hope to Reduce Device-Associated Infections—A Systematic Review

José C. C. Paiva

Luís Oliveira

Maria Fátima Vaz

and

Sofia Costa-de-Oliveira

Bioengineering 2022, 9(8), 409; https://doi.org/10.3390/bioengineering9080409 - 22 Aug 2022

Cited by 2 | Viewed by 1600

Abstract

Bone fractures often require fixation devices that frequently need to be surgically removed. These temporary implants and procedures leave the patient more prone to developing medical device-associated infections, and osteomyelitis associated with trauma is a challenging complication for orthopedists. In recent years, biodegradable materials have gained great importance as temporary medical implant devices, avoiding removal surgery. The purpose of this systematic review was to revise the literature regarding the use of biodegradable bone implants in fracture healing and its impact on the reduction of implant-associated infections. The systematic review followed the PRISMA guidelines and was conducted by searching published studies regarding the in vivo use of biodegradable bone fixation implants and its antibacterial activity. From a total of 667 references, 23 studies were included based on inclusion and exclusion criteria. Biodegradable orthopedic implants of Mg-Cu, Mg-Zn, and Zn-Ag have shown antibacterial activity, especially in reducing infection burden by MRSA strains in vivo osteomyelitis models. Their ability to prevent and tackle implant-associated infections and to gradually degrade inside the body reduces the need for a second surgery for implant removal, with expectable gains regarding patients’ comfort. Further in vivo studies are mandatory to evaluate the efficiency of these antibacterial biodegradable materials. Full article

(This article belongs to the Special Issue Medical Devices and Implants)

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