Development Of Medical Devices Research Articles

Collagen Networks under Indentation and Compression Behave Like Cellular Solids.

Simple synthetic and natural hydrogels can be formulated to have elastic moduli that match biological tissues, leading to their widespread application as model systems for tissue engineering, medical device development, and drug delivery vehicles. However, two different hydrogels having the same elastic modulus but differing in microstructure or nanostructure can exhibit drastically different mechanical responses, including their poroelasticity, lubricity, and load bearing capabilities. Here, we investigate the mechanical response of collagen-1 networks to local and bulk compressive loads. We compare these results to the behavior of polyacrylamide, a fundamentally different class of hydrogel network consisting of flexible polymer chains. We find that the high bending rigidity of collagen fibers, which suppresses entropic bending fluctuations and osmotic pressure, facilitates the bulk compression of collagen networks under infinitesimal applied stress. These results are fundamentally different from the behavior of flexible polymer networks in which the entropic thermal fluctuations of the polymer chains result in an osmotic pressure that must first be overcome before bulk compression can occur. Furthermore, we observe minimal transverse strain during the axial loading of collagen networks, a behavior reminiscent of open-celled cellular solids. Inspired by these results, we applied mechanical models of cellular solids to predict the elastic moduli of the collagen networks and found agreement with the moduli values measured through contact indentation. Collectively, these results suggest that unlike flexible polymer networks that are often considered incompressible, collagen hydrogels behave like rigid porous solids that volumetrically compress and expel water rather than spreading laterally under applied normal loads.

Open-source design of medical devices

Open-source design of medical devices

Translating patient needs into medical device development: co-design of a photoprotection visor for Xeroderma Pigmentosum using qualitative interviews

IntroductionPeople with Xeroderma Pigmentosum (XP) have a heightened sensitivity to ultraviolet radiation (UVR) and are advised to wear photoprotective clothing including a visor covering the face and neck. Photoprotective visors are homemade and predominately worn by children with decreasing frequency as age increases. To improve upon the current design and efficacy we were tasked with developing a prototype visor to meet patients’ needs.MethodsAdopting a codesign methodology, patients’ experiences of wearing a visor and patient and carer views of emerging prototypes were explored during interviews. A thematic analysis was conducted in parallel with data collection and themes were interpreted into design cues; desirable attributes of a visor that would counteract the negative user experiences and meet the requirements described by patients and carers. The design cues guided the iterative development of prototypes by academic engineers.ResultsTwenty-four interviews were conducted with patients and carers. Thematic analysis resulted in the following five themes: Being safe from UVR exposure; self-consciousness; temperature effects; acoustic difficulties; and material properties. The following design cues were developed from the themes respectively; materials and design with high UVR protection; ability to customise with own headwear; ventilation to reduce steaming up; acoustic functionality to enable hearing and speech; foldable, portable, and easy to put on and take off.ConclusionsIt is important to understand people’s experiences of using medical devices to improve their safety, efficiency and user satisfaction. The user experience themes and design cues, informed the iterative development of low fidelity visor prototypes as part of a codesign process. These design cues and responses to the prototypes are guiding commercial manufacturing and regulatory approval. The visor can then be prescribed to patients, providing an equitable service of care.

Sustainability across the Medical Device Lifecycle: A Scoping Review

Medical devices are instrumental in servicing the healthcare sector and promoting well-being in modern societies. However, their production and use contribute significantly to greenhouse gas emissions, thus causing indirect harm to global health. With a share of approximately 4.4% of global emissions, the healthcare sector exhales CO2 throughout its value chain; sources of this range from direct electricity consumption and water heating in healthcare facilities to the supply chains delivering healthcare services and products. Within this context, the environmental impact of medical devices is present across their production, distribution, usage, and eventual disposal. Each step in the lifecycle of medical devices consumes energy and natural resources, and the end product, after its often single use, is discarded, generating plastic or electronic waste. This study aims to present the key findings from a scoping review of academic research on the topic, which focuses on reducing the environmental impact of medical devices and equipment. The review, conducted according to the PRISMA checklist for scoping reviews, examined 41 studies and categorised them based on the lifecycle stages of medical devices (design and development, manufacturing, usage, and end of life) and the sustainability aspects (economic, environmental, and social) discussed by the authors. The findings suggest that while efforts have been made to enhance economic and environmental sustainability throughout the design, development, and usage of medical devices, there is still room for improvement in mitigating their ecological impact at the end of their lifecycle and maximising their social impact by design.

Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms.

Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting and structuring patient-generated data for regulators to use in approval decisions alongside traditional clinical outcomes. Although a growing body of evidence has documented increasing use of DHTs in clinical trials overall, the use of DHTs in clinical trials supporting medical product development is unclear; here, we quantify the use of DHTs in clinical trials sponsored by pharmaceutical and medical device firms. Despite interest from pharmaceutical and medical device manufacturers in DHTs, we find tepid uptake of DHTs in trials by these sponsor types over time. Further, to date, these sponsors have most frequently used conventional, hardware-based technologies that have been available for many years (e.g., Holter monitors and glucose meters) rather than newer activity monitors, mobile apps, and other online-based tools that are frequently used by non-industry sponsors. Considering the recent and evolving nature of regulatory guidance around DHT use in clinical trials, our findings suggest that organizations pursuing product development still appear hesitant to incorporate DHTs in trials that provide the most critical evidence for regulatory review and impact how new products are used. This suggests there are likely additional opportunities for sponsors of regulated trials to incorporate (more) DHTs and patient-centric endpoints into product development clinical trials. However, additional regulatory clarity and efforts to reduce operational barriers may be needed in order to more fully capture these opportunities.

Proof of concept testing of a positive reference material for in vivo and in vitro sensitization testing of medical devices.

In vivo skin sensitization tests are required to evaluate the biological safety of medical devices in contact with living organisms to provide safe medical care to patients. Negative and positive reference materials have been developed for biological tests of cytotoxicity, implantation, hemolysis, and in vitro skin irritation. However, skin sensitization tests are lacking. In this study, polyurethane sheets containing 1 wt/wt % 2,4-dinitrochlorobenzene (DNCB-PU) were developed and evaluated as a positive reference material for skin sensitization tests. DNCB-PU sheet extracts prepared with sesame oil elicited positive sensitization responses for in vivo sensitization potential in the guinea pig maximization test and the local lymph node assay. Furthermore, DNCB-PU sheet extracts prepared with water and acetonitrile, 10% fetal bovine serum-containing medium, or sesame oil elicited positive sensitization responses as alternatives to animal testing based on the amino acid derivative reactivity assay, human cell line activation test, and epidermal sensitization assay, respectively. These data suggest that the DNCB-PU sheet is an effective extractable positive reference material for in vivo and in vitro skin sensitization testing in medical devices. The formulation of this reference material will lead to the development of safer medical devices that contribute to patient safety.

Mechanical, structural, and physiologic differences between above and below-knee human arteries

Peripheral Artery Disease (PAD) affects the lower extremities and frequently results in poor clinical outcomes, especially in the vessels below the knee. Understanding the biomechanical and structural characteristics of these arteries is important for improving treatment efficacy, but mechanical and structural data on tibial vessels remain limited. We compared the superficial femoral (SFA) and popliteal (PA) arteries that comprise the above-knee femoropopliteal (FPA) segment to the infrapopliteal (IPA) anterior tibial (AT), posterior tibial (PT), and fibular (FA) arteries from the same 15 human subjects (average age 52, range 42–67 years, 87 % male). Vessels were imaged using μCT, evaluated with biaxial mechanical testing and constitutive modeling, and assessed for elastin, collagen, smooth muscle cells (SMCs), and glycosaminoglycans (GAGs). IPAs were more often diseased or calcified compared to the FPAs. They were also twice smaller, 53 % thinner, and significantly stiffer than the FPA longitudinally, but not circumferentially. IPAs experienced 48 % higher physiologic longitudinal stresses (62 kPa) but 27 % lower circumferential stresses (24 kPa) and similar cardiac cycle stretch of <1.02 compared to the FPA. IPAs had lower longitudinal pre-stretch (1.12) than the FPAs (1.29), but there were no differences in the stored elastic energy during pulsation. The physiologic circumferential stiffness was similar in the above and below-knee arteries (718 kPa vs 754 kPa). Structurally, IPAs had less elastin, collagen, and GAGs than the FPA, but maintained similar SMC content. Our findings contribute to a better understanding of segment-specific human lower extremity artery biomechanics and may inform the development of better medical devices for PAD treatment. Statement of significancePeripheral Artery Disease (PAD) in the lower extremity arteries exhibits distinct characteristics and results in different clinical outcomes when treating arteries above and below the knee. However, their mechanical, structural, and physiologic differences are poorly understood. Our study compared above- and below-knee arteries from the same middle-aged human subjects and demonstrated distinct differences in size, structure, and mechanical properties, leading to variations in their physiological behavior. These insights could pave the way for creating location-specific medical devices and treatments for PAD, offering a more effective approach to its management. Our findings provide new, important perspectives for clinicians, researchers, and medical device developers interested in treating PAD in both above- and below-knee locations.

Digital marketing innovation: New business models for pharmaceutical and medical device product marketing.

Within the rapidly evolving healthcare landscape in Japan, digital marketing innovations are transforming pharmaceutical and medical device marketing. This study explores the emergence of new business models in the digital marketing, highlighting a transition from traditional methods to more dynamic, data-driven strategies. InsighTCROSS® is a business model that qualitatively and quantitatively examines three steps based on stratified persona images: (1) verifying the effectiveness of product marketing promotions, (2) identifying competitors from the users' perspective, and (3) developing marketing strategies to counter competition. To demonstrate the effectiveness of this model, a case study was conducted focusing on the current anticoagulant drugs, including apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin. Rivaroxaban, the only drug prescribed for the prevention of thrombus and embolism formation in patients with peripheral artery disease after lower limb revascularization, garnered the most interest from interventional cardiologists performing peripheral vascular interventions, as determined by InsighTCROSS® factor analysis, confirming that the manufacturer's marketing activities have effectively penetrated the market. A survey conducted between 20 September 2023 and 3 October 2023, among members of a cardiology website, identified edoxaban as the market leader with a 39.1% share, followed by apixaban (32.7%) and rivaroxaban (16.8%). The main competitor of edoxaban was warfarin, whereas that of rivaroxaban was apixaban. Decision tree analysis was conducted using InsighTCROSS®, highlighting the strengths and weaknesses of each anticoagulant, providing strategic approaches to exploit competitive weaknesses. For edoxaban, increased use was driven by elderly and poorly adherent patients; for apixaban, high-volume percutaneous coronary intervention centers; and for rivaroxaban, the influence of medical representative detailing. It is recommended to avoid markets where these drugs have a strong presence and to focus marketing activities on leveraging their specific strengths. The findings suggest that digital marketing enhances product visibility and patient engagement, providing valuable insights into market behavior and consumer preferences.

Nzubechukwu Chukwudum Ohalete

This paper delves into the critical role of Navier-Stokes equations in biomedical engineering, with a specific focus on their application in the development of medical devices across the United States and Africa. The study aims to elucidate the integration of fluid dynamics principles in medical device innovation, assess the influence of cultural and economic factors on device design, and explore the regulatory landscape shaping this domain. Employing a methodical approach, the study analyzes Navier-Stokes applications in diverse geographical contexts, utilizing case studies to underscore the relevance and methodological rigor in biomedical engineering. The findings reveal that Navier-Stokes equations are pivotal in modeling biological fluid flows, essential for the design and analysis of cardiovascular and respiratory devices. The advancement of computational fluid dynamics (CFD) has significantly enhanced these applications, enabling more precise and patient-specific analyses. However, challenges in computational resources and simulating physiological conditions are identified as key limitations. The study highlights the profound impact of cultural and economic considerations on medical device design and functionality. It emphasizes the necessity of creating devices that are not only innovative and effective but also culturally appropriate and economically viable. Additionally, the evolving regulatory frameworks, particularly in the wake of global health crises, are examined for their impact on device safety and efficacy. In conclusion, the study recommends continued research and development to address the identified challenges and limitations, advocating for a multidisciplinary approach that integrates engineering, computational modeling, and medical expertise. It also calls for the consideration of cultural, economic, and regulatory factors in the design and development of medical devices, ensuring their global applicability and effectiveness in improving healthcare outcomes.

Innovative Approaches to 3D Printing of PA12 Forearm Orthoses: A Comprehensive Analysis of Mechanical Properties and Production Efficiency.

This research paper aims to explore the mechanical characteristics of polyamide PA12 (PA12) as a 3D material printed utilizing Selective Laser Sintering (SLS) and HP MultiJet Fusion (HP MJF) technologies in order to design and manufacture forearm orthoses. The study assessed the flowability of the materials used and compared the mechanical performance of PA12 with each other using tensile, flexure, and impact tests in five different fabrication orientations: X, Y, Z, tilted 45° XZ, and tilted 45° YZ. The results of the study provide, firstly-the data for testing the quality of the applied polyamide powder blend and, secondly-the data for the design of the orthosis geometry from the aspect of its strength parameters and the safety of construction. The mechanical parameters of SLS specimens had less variation than MJF specimens in a given orientation. The difference in tensile strength between the 3D printing technologies tested was 1.8%, and flexural strength was 4.7%. A process analysis of the forearm orthoses revealed that the HP MJF 5200 system had a higher weekly production capacity than the EOS P396 in a production variance based on obtaining maximum strength parameters and a variance based on maximizing economic efficiency. The results suggest that medical device manufacturers can use additive manufacturing technologies to produce prototypes and small-batch parts for medical applications. This paper pioneers using 3D printing technology with Powder Bed Fusion (PBF) methods in designing and manufacturing forearm orthoses as a low- to medium-volume product. The applied solution addresses the problem of medical device manufacturers with regard to the analysis of production costs and mechanical properties when using 3D printing for certified medical devices.

Design and evaluation of smart blood pressure monitor oriented to user needs

This study aims to address the caregiving needs and medical challenges of EPCD through the design and evaluation of a smart blood pressure monitor. Firstly, the user requirements of EPCD are obtained through on-site investigations, user interviews, and questionnaires. To accommodate the fuzziness of user needs, a Fuzzy KANO (FKANO) model questionnaire is constructed to accurately classify and filter user demands. Subsequently, based on the categorised user demands, an evaluation system is developed, and three smart blood pressure monitors are designed. Additionally, the weights of each evaluation criterion are calculated using the Coefficient of Variation (CV) method, aiming to mitigate subjectivity in the decision-making process. Finally, the three existing blood pressure monitors on the market and the three smart blood pressure monitors designed in this study were introduced to participate in the decision-making process. Grey Relational Analysis (GRA) is employed to calculate the degree of correlation in the data of alternative designs, ultimately determining the optimal design proposal. This study established a comprehensive evaluation system that combines FKANO, CV method, and GRA method to effectively reflect user needs, provide valuable insights for the design team, and guide the development of medical devices that better meet user needs.

Piezoelectric polymer based acoustic energy harvester for implantable medical devices

Wireless implantable devices (WIDs) have the potential to revolutionize biomedical sensing, but their power supplies face significant challenges. Traditional energy transfer methods such as inductive and RF have limitations due to associated tissue losses. This work demonstrates a promising approach to this problem, using a flexible implantable ultrasound energy harvester (IUEH) made of biocompatible Poly (vinylidene fluoride-co-trifluoro ethylene) (P(VDF-TrFe)) free-standing film. Unlike commonly used piezoceramic devices, IUEH can be fabricated using economical solution processing methods such as spin coating. In addition, the PVDF-TrFE Ultrasound energy harvesters are rarely reported in the literature. The device performance of the polymer IUEH was investigated in air, water, and animal meat tissue, and the results show that it can generate a power output of 1.1 mW cm−2 in meat, and 1.4 mW cm−2 in water at 80 kHz. The device fabricated using a free-standing piezoelectric thin film, offers an optimum output that is comparable to other P(VDF-TrFe) based high-frequency devices. Additionally, its flexible design, lower costs, and biocompatibility make it a promising alternative to lead-based devices; thus, offering safety, affordability, and quick customization, while promoting minimally invasive procedures and driving innovation in medical device development.

Streamlining Randomized Clinical Trials for Device Therapies in Heart Failure: Bayesian Borrowing of External Data.

The Breakthrough Devices Program of the US Food and Drug Administration has accelerated the development and evaluation of medical devices for patients with heart failure. One such device is the Optimizer Smart System, which the US Food and Drug Administration approved in 2019. The Optimizer device was evaluated in a pivotal randomized clinical trial (FIX-HF-5C [Confirmatory Randomized Trial Evaluating the Optimizer System]) that leveraged Bayesian borrowing of external data to reduce the sample size and determine therapeutic device benefit versus continued medical therapy. Bayesian borrowing is explained in the context of the FIX-HF-5C trial, including an overview of the statistical methodologies, regulatory considerations, and interpretations of trial results. The US Food and Drug Administration Breakthrough Devices Program and novel Bayesian statistical methodology accelerated the path to regulatory approval and patient access to a potentially lifesaving device and may serve as a model for future clinical trials.

Fibroblasts and osteoblasts behavior after contact with different titanium surfaces used as implant abutment: An in vitro experimental study

BackgroundThe goal of this in vitro study was to compare three different surfaces: two types of implant surfaces commercially available ([a] smooth/machined and [b] acid-treated surface) versus (c) anodized surface. Discs were manufactured with commercially pure titanium (CP) grade IV, which were subsequently analyzed by scanning microscopy and fibroblastic and osteoblastic cell cultures. MethodsNinety-nine discs (5 × 2 mm) were manufactured in titanium grade IV and received different surface treatments: (i) Mach group: machined; (ii) AA group: double acid etch; and (iii) AN group: anodizing treatment. Three discs from each group were analyzed by Scanning Electron Microscopy (SEM) to obtain surface topography images and qualitatively analyzed by EDS. Balb/c 3T3 fibroblasts and pre-osteoblastic cells (MC3T3-E1 lineage) were used to investigate each group's biological response (n = 10/cellular type). The data were compared statistically using the ANOVA one-way test, considered as a statistically significant difference p < 0.05. ResultsThe AA group had numerous micropores with diameters between 5 and 10 μm, while nanopores between 1 and 5 nm were measured in the AN group. The EDX spectrum showed a high titanium concentration in all the analyzed samples. The contact angle and wetting tension were higher in the AA, whereas similar results were observed for the other groups. A lower result was observed for base width in the AA, which was higher in the other two groups. The AN showed the best values in the fibroblast cells, followed by Mach and AA; whereas, in the culture of the MC3T3 cells, the result was precisely the opposite (AA > Mach > AN). There was similar behavior for cell adhesion for the test groups (Mach and AN), with greater adhesion of Balb/c 3T3 fibroblasts compared to MC3T3 cells; in the AA group, there was greater adherence for MC3T3 cells compared to Balb/c 3T3 fibroblasts. ConclusionsThe findings suggest that different surface characteristics can produce different biological responses, possibly cell-line dependent. These findings have important implications for the design of implantable medical devices, where the surface characteristics can significantly impact its biocompatibility.

Effects of post-processing curing parameters and gamma irradiation on the mechanical properties of medical graded vat photopolymerization parts

Purpose This paper aims to investigate the influence of post-curing temperature, post-curing time and gamma ray irradiation dose upon the tensile and compressive mechanical properties of the medical graded vat photopolymerization parts. Design/methodology/approach Medical graded vat photopolymerization specimens, made from photopolymer resin, were fabricated using bottom-up vat photopolymerization machine. Tensile and compressive tests were conducted to assess the mechanical properties. The specimens were categorized into uncured and post-curing groups. Temperature post-processing and/or gamma irradiation exposure were for post-curing specimens. The post-curing parameters considered included temperature levels of 50°C, 60°C and 70°C, with 1, 2, 3 and 4 h periods. For the gamma irradiation, the exposure doses were 25, 50, 75 and 100 kGy. Findings Post-curing improved the mechanical properties of medical graded vat photopolymerization parts for both tensile and compressive specimens. Post-curing temperature greater than 50°C or a prolonged post-curing period of more than 1 h made insignificant changes or deterioration in mechanical properties. The optimal post-curing condition was therefore a 50°C post-curing temperature with 1 h post-curing time. Exposure to gamma ray improved the compressive mechanical properties, but deteriorated tensile mechanical properties. Higher gamma irradiation doses could decrease the mechanical properties and also make the part more brittle, especially for doses more than 25 kGy. Originality/value The obtained results would be beneficial to the medical device manufacturer who fabricated the invasive temporary contact personalized surgical instruments by vat photopolymerization technique. In addition, it also raised awareness in excessive gamma sterilization in the medical graded vat photopolymerization parts.

Upconversion 3D Bioprinting for Noninvasive In Vivo Molding.

Tissue engineered bracket materials provide essential support for the physiological protection and therapeutics of patients. Unfortunately, the implantation process of such devices poses the risk of surgical complications and infection. In this study, an upconversion nanoparticles (UCNPs)-assisted 3D bioprinting approach is developed to realize in vivo molding that is free from invasive surgery. Reasonably designed UCNPs, which convert near-infrared (NIR) photons that penetrate skin tissues into blue-violet emission (300-500 nm), induce a monomer polymerization curing procedure in vivo. Using a fused deposition modeling coordination framework, a precisely predetermined trajectory of the NIR laser enables the manufacture of implantable medical devices with tailored shapes. A proof of the 3D bioprinting of a noninvasive fracture fixation scaffold is achieved successfully, thus demonstrating an entirely new method of in vivo molding for biomedical treatment.

Journey of medical device development from the bench to the bedside—four real-life examples of commercial biomaterials development

Translating biomaterials research into clinical products is a multidisciplinary yet rewarding journey. It should primarily aim to improve patient treatment and clinical outcomes by addressing unmet clinical needs. Four examples of commercial development of biomaterial implants illustrate the diversity of paths, starting from academic research work (AlchiMedics, TISSIUM, Cousin Surgery) or corporate initiatives to develop new products (Medtronic-Sofradim Production). They have been selected from the Translational Research session of the 2022 Conference of the European Society for Biomaterials (ESB) in Bordeaux (France). Commitment, agility, and perseverance were among the key common skills to successfully meet challenges, especially the most unexpected ones. All dimensions of translation projects must be integrated from the start, including the regulatory strategy.

From Body Monitoring to Biomolecular Sensing: Current Progress and Future Perspectives of Triboelectric Nanogenerators in Point-of-Care Diagnostics.

In the constantly evolving field of medical diagnostics, triboelectric nanogenerators (TENGs) stand out as a groundbreaking innovation for simultaneously harnessing mechanical energy from micromovements and sensing stimuli from both the human body and the ambient environment. This advancement diminishes the dependence of biosensors on external power sources and paves the way for the application of TENGs in self-powered medical devices, especially in the realm of point-of-care diagnostics. In this review, we delve into the functionality of TENGs in point-of-care diagnostics. First, from the basic principle of how TENGs effectively transform subtle physical movements into electrical energy, thereby promoting the development of self-powered biosensors and medical devices that are particularly advantageous for real-time biological monitoring. Then, the adaptable design of TENGs that facilitate customization to meet individual patient needs is introduced, with a focus on their biocompatibility and safety in medical applications. Our in-depth analysis also covers TENG-based biosensor designs moving toward exceptional sensitivity and specificity in biomarker detection, for accurate and efficient diagnoses. Challenges and future prospects such as the integration of TENGs into wearable and implantable devices are also discussed. We aim for this review to illuminate the burgeoning field of TENG-based intelligent devices for continuous, real-time health monitoring; and to inspire further innovation in this captivating area of research that is in line with patient-centered healthcare.

Antibacterial and osteogenic thin films on Ti-6Al-4V surface formed by passivation process in copper hydroxide solution

ABSTRACT Implant-associated infections are threatening and devastating complications that lead to bone destruction and loss. As a smooth surface is suitable for inhibiting bacterial adhesion, endowing antibacterial activity to the Ti surface without any structural changes in the surface topography is an effective strategy for preventing infection. The thin film on the Ti-6Al-4 V surface was functionalized to endow antibacterial activity by immersion in a Cu(OH)2 solution. The resulting surface maintains the surface topography with a surface roughness of 0.03 μm even after the immersion in the Cu(OH)2 solution. Moreover, Cu was detected at approximately 10 atom% from the surface and was present up to a depth of 30 nm of thin film. In vitro experiments revealed that the resulting surface exhibited antibacterial activity against methicillin-resistant Staphylococcus aureus and allowed the cellular proliferation, differentiation, and calcification of MC3T3-E1 cells. Furthermore, in vivo experiments determined that the presence of Cu in the thin film on the Ti-6Al-4 V surface led to no inflammatory reactions, including bone resorption. Thus, immersion in a Cu(OH)2 solution incorporates and immobilizes Cu into the thin film on the Ti-6Al-4 V surface without any structural alternations in the surface topography, and the resulting smooth surface exhibits antibacterial activity and osteogenic cell compatibility without cytotoxicity or inflammatory reactions. Our findings provide fundamental insights into the surface design of Ti-based medical devices, to achieve bone reconstruction and infection prevention.

A novel discrete linkage-type electrode for radiofrequency-induced intestinal anastomosis

Introduction For decades, radiofrequency (RF)-induced tissue fusion has garnered great attention due to its potential to replace sutures and staples for anastomosis of tissue reconstruction. However, the complexities of achieving high bonding strength and reducing excessive thermal damage present substantial limitations of existing fusion devices. Materials and methods This study proposed a discrete linkage-type electrode to carry out ex vivo RF-induced intestinal anastomosis experiments. The anastomotic strength was examined by burst pressure and shear strength test. The degree of thermal damage was monitored through an infrared thermal imager. And the anastomotic stoma fused by the electrode was further investigated through histopathological and ultrastructural observation. Results The burst pressure and shear strength of anastomotic tissue can reach 62.2 ± 3.08 mmHg and 8.73 ± 1.11N, respectively, when the pressure, power and duration are 995 kPa, 160 W and 13 s, and the thermal damage can be controlled within limits. Histopathological and ultrastructural observation indicate that an intact and fully fused stomas with collagenic crosslink can be formed. Conclusion The discrete linkage-type electrode presents favorable efficiency and security in RF-induced tissue fusion, and these results are informative to the design of electrosurgical medical devices with controllable pressure and energy delivery.