Implantable antennas for biomedical applications: a systematic review.

This review presents an in-depth examination of implantable antennas for various biomedical purposes. The development of implantable antennas, including their designs, materials, and operating principles, are introduced at the beginning of the discussion. An overview of the many kinds of implantable antennas utilized in implantable medical devices (IMDs) are presented in this study. The article then discusses the important factors to consider when developing implantable antennas for biomedical purposes, including implant placement, frequency range, and power needs. This investigation additionally examines the challenges and limitations encountered with implantable antennas, including the limited space available within the human body, the requirement for biocompatible materials, the impact of surrounding tissue on antenna performance, tissue attenuation, and signal interference. This review also emphasizes the most recent advances in implanted antenna technology, such as wireless power transmission, multiband operation, and miniaturization. Furthermore, it offers illustrations of several biomedical uses for implantable antennas, including pacemaker, capsule endoscopy, intracranial pressure monitoring, retinal prostheses, and bone implants. This paper concludes with a discussion of the future of implantable antennas and their possible use in bioelectronic medicine and novel medical implants. Overall, this survey offers a thorough analysis of implantable antennas in biomedical applications, emphasizing their importance in the development of implantable medical technology.

Taring the scales: Weight-of-evidence framework for biocompatibility evaluations.

ISO 10993-1:2018 describes evaluating the biocompatibility profile of a medical device from a risk-based approach. This standard details the battery of information that should be considered within the assessment of a device, including raw material composition data, manufacturing processes, and endpoint testing. The ISO 10993/18562 series requires worst-case assumptions and exposure scenarios to be used in the evaluation, which may result in an over-estimation of patient safety risk. Currently, biocompatibility assessments evaluate each data set independently, and the consequence of this individualized assessment of exaggerated inputs is potential false alarms regarding patient safety. To evaluate these safety concerns, the ISO standards indicate that professional judgement should be used to estimate patient risk but does not provide guidance on incorporating a holistic review of the data into the risk assessment. Recalibrating these worst-case data to evaluate them in a weight-of-evidence (WoE) approach may provide a more realistic data set to determine actual patient risk. This proposed WoE framework combines understanding data applicability with a method for gauging the strength of data that can provide additional support for the final safety conclusion. Using a WoE framework will allow risk assessors to contextualize the data and utilize it to comprehensively estimate patient safety.

Pilot Study of Intensive Trismus Intervention Using Restorabite™ During Unilateral Adjuvant Radiation for Head and Neck Cancer.

Trismus commonly arises after surgery for head and neck cancer (HNC) and its severity is potentiated by postoperative radiotherapy. While the benefit of trismus rehabilitation after surgery and radiotherapy is well established, the evidence during radiotherapy is less clear. This may be due to poor adherence to trismus exercises secondary to acute mucositis. This study assessed the feasibility of using a novel trismus device during adjuvant radiotherapy for HNC in patients with acute postoperative trismus. Prospective single-arm cohort feasibility study. Eligible patients had undergone surgery with curative intent for HNC, planned for adjuvant radiotherapy, and were suitable for trismus rehabilitation. Participants completed a 10-week exercise program using a novel jaw stretching device. Study outcomes were adherence, maximal incisal opening (MIO), and trismus-related function and quality of life scores, assessed at baseline, 10 weeks, and 6 months after commencing exercises. Nine patients diagnosed with trismus after primary surgery were recruited. The mean increase in MIO at 10 weeks was 7.8 mm (range -4 to 15 mm, p = 0.03), and at 6 months was 10.6 mm (range 1-26 mm, p = 0.03). Significant improvements were observed in trismus-related quality of life (Gothenburg Trismus Questionnaire; p = 0.04). Adherence to the exercises was 100% in week 1-2, 67% in weeks 3-6, and 100% at 10 weeks (1 month post radiation). This study demonstrates the feasibility of using a novel jaw stretching device during adjuvant radiotherapy. Further evaluation is warranted to assess the effectiveness of early intervention and prevention of trismus during HNC radiotherapy.Level of Evidence: IV.

Customized Silicone Foam Dressing Under Noninvasive Ventilation and Skincare Bundle to Reduce Hospital-Acquired Pressure Injuries in Neonates.

In a sixty-eight-bed level-IV NICU, an increased incidence of hospital-acquired pressure injuries (HAPIs) from noninvasive ventilation (NIV) devices was identified. The aim of this quality improvement project was to decrease HAPIs from NIV by 10%. A literature review and the Plan-Do-Study-Act were implemented. The intervention included a customized silicone foam dressing under NIV, an NIV skincare bundle, and multidisciplinary support. Hospital-acquired pressure injury rates were tracked over 3 years postinterventions. The incidence of HAPIs declined by 20% from 0.2 per 1,000 patient days to 0.05 per 1,000 patient days. Relative risk was 4.6 times greater prior to intervention (p = .04). Continuous positive airway pressure (CPAP) failure was not noted and measured by the percentage of patients on ventilators pre- and postintervention. Customized silicone foam dressings under NIV, NIV skincare bundle, and multidisciplinary team support may decrease HAPIs in neonates without CPAP failure.

[Research Status of Nanomaterial Medical Device and Discussion on Biological Evaluation].

In recent years, China has made great progress in basic nanomedicine, nanotoxicology and nanobiology research. Nanotechnology has been continuously applied in biomaterial and medical device, more and more medical devices applying nanomaterials are developed and manufactured. In order to gain more comprehension and accurate understanding of the research and industrial development in nanobiomaterial medical devices, this study reviewed the common nanomaterial in medical devices and the regulatory situation of nanomaterial medical devices at home and abroad, and discussed the current challenges in biological evaluation of nanomaterial medical devices, with a view to providing ideas for the safety evaluation and research of related products.

[Thoughts on the Biological Evaluation of Biodegradable Cardiovascular Implants].

In recent years, new degradable materials have been applied to cardiovascular implants. Cardiovascular implants with different physicochemical properties and degradation properties have special endpoints for their biological evaluation. In this study, the end points of biological evaluation of degradable cardiovascular implants were reviewed by taking vascular stents and occluders as examples.

[Research on Characterization and Biocompatibility of 3D Printed Ti-6Al-4V Pelvic Prosthesis].

The treatment of bone defects caused by fractures or bone tissue lesions has always been a difficult problem in the field of orthopedics. Implantation of high-performance titanium alloy prosthesis is an effective method to treat bone defects. 3D printing technology can produce low-modulus titanium alloy implants with porous structures, providing a better solution to the above problems. This technology is convenient to design and has a huge advantage in making orthopedic implants. The article used electron beam melting in 3D printing technology to create two samples of Ti-6Al-4V prosthesis, including solid structural pelvic prosthesis and porous structural pelvic prosthesis. The mechanical properties of the prosthesis showed that the yield and tensile strengths of the rod tensile specimen were 894 MPa and 956 MPa, respectively, and the compressive modulus and compressive strength of the porous pelvic prosthesis were 55 GPa and 65.2 MPa, respectively. The results of the L929 cytotoxicity assay and the MC3T3-E1 cell adhesion assay demonstrated good biocompatibility of the prosthetic samples. New Zealand white rabbits were used to prepare the femoral joint cavity defect models and two pelvic prostheses were implanted. A microscopic CT scan 4 weeks after implantation showed that the bone defect caused by the drill had healed and that the porous structure of the pelvic prosthesis formed a new trabecular structure within the hole. In conclusion, the 3D printed Ti-6Al-4V pelvic prosthesis has excellent mechanical properties, biocompatibility, and the ability to promote new bone growth.

Retrospective analysis of failures of ambulatory elastomeric pumps containing 5-FU in a hospital pharmacy unit.

INTRODUCTION: Ambulatory chemotherapy is an important and major advance in clinical oncology practice since it allows the administration of chemotherapy in the comfort of the patient's home without the assistance of a health professional by means of an elastomeric pump. However, these pumps are not without risks and can be the cause of incidents due to technical failures. Our objective is to study the technical failures of elastomeric pumps in the Cytotoxic Preparation Unit and in the patient's home, to evaluate the possible impact of these failures on the patient and on the staff and to propose measures to reduce them. MATERIALS AND METHODS: This is a retrospective study conducted at the pharmacy of the National Institute of Oncology in Rabat. It gathered all the specific reports on elastomeric pumps issued during the period (January 2017-May 2021) by the cytotoxic preparation unit to the materiovigilance cell via a notification form. RESULTS: 205 cases of elastomeric pump materialovigilance were identified during the study period. The main technical failures were: chemotherapy product leakage (44%), flow rate anomalies (30%) and injection difficulties (20%). Following these incidents, certain actions were undertaken such as alerts sent to the supplier and letters sent to the competent health authorities. CONCLUSION: Despite the failures that may have occurred, elastomeric pumps have revolutionized home chemotherapy delivery. They are considered reliable, consistent, easy to use and handle, and are well accepted in the population.

Ambulance referral of more than 2 hours could result in a high prevalence of medical-device-related pressure injuries (MDRPIs) with characteristics different from some inpatient settings: a descriptive observational study.

BACKGROUND: Medical device-related pressure injuries(MDRPI) are prevalent and attracting more attention. During ambulance transfer, the shear force caused by braking and acceleration; extensive medical equipment crowed in a narrow space add external risk factors for MDRPIs. However, there is insufficient research on the relationship between MDRPIs and ambulance transfers. This study aims to clarify the prevalence and characteristics of MDRPI during ambulance transfer. METHOD: A descriptive observational study was conducted with convenience sampling. Before starting the study, six PI specialist nurses certified by the Chinese Nursing Association trained emergency department nurses for three MDRPI and Braden Scale sessions, one hour for each session. Data and images of PIs and MDRPIs are uploaded via the OA system by emergency department nurses and reviewed by these six specialist nurses. The information collection begins on 1 July 2022 and ends on 1 August 2022. Demographic and clinical characteristics and a list of medical devices were collected by emergency nurses using a screening form developed by researchers. RESULTS: One hundred one referrals were eventually included. The mean age of participants was (58.3 ± 11.69) years, predominantly male (67.32%, n = 68), with a mean BMI of 22.48 ± 2.2. The mean referral time among participants was 2.26 ± 0.26 h, the mean BRADEN score was 15.32 ± 2.06, 53.46% (n = 54) of participants were conscious, 73.26% (n = 74) were in the supine position, 23.76% (n = 24) were in the semi-recumbent position, and only 3 (2.9%) were in the lateral position. Eight participants presented with MDRPIs, and all MDRPIs are stage 1. Patients with spinal injuries are most prone to MDRPIs (n = 6). The jaw is the area most prone to MDRPIs, caused by the cervical collar (40%, n = 4), followed by the heel (30%, n = 3) and nose bridge (20%, n = 2) caused by the respiratory devices and spinal board. CONCLUSION: MDRPIs are more prevalent during long ambulance referrals than in some inpatient settings. The characteristics and related high-risk devices are also different. The prevention of MDRPIs during ambulance referrals deserves more research.

Medical Device-Associated Healthcare Infections: Sterilization and the Potential of Novel Biological Approaches to Ensure Patient Safety.

Healthcare-associated infections caused by multi-drug-resistant pathogens are increasing globally, and current antimicrobial options have limited efficacy against these robust species. The WHO details the critically important bacterial and fungal species that are often associated with medical device HAIs. The effective sterilization of medical devices plays a key role in preventing infectious disease morbidity and mortality. A lack of adherence to protocol and limitations associated with each sterilization modality, however, allows for the incidence of disease. Furthermore, issues relating to carcinogenic emissions from ethylene oxide gas (EtO) have motivated the EPA to propose limiting EtO use or seeking alternative sterilization methods for medical devices. The Food and Drug Administration supports the sterilization of healthcare products using low-temperature VH2O2 as an alternative to EtO. With advances in biomaterial and medical devices and the increasing use of combination products, current sterilization modalities are becoming limited. Novel approaches to disinfection and sterilization of medical devices, biomaterials, and therapeutics are warranted to safeguard public health. Bacteriophages, endolysins, and antimicrobial peptides are considered promising options for the prophylactic and meta-phylactic control of infectious diseases. This timely review discusses the application of these biologics as antimicrobial agents against critically important WHO pathogens, including ESKAPE bacterial species.

Determination of medical device-related pressure injury in COVID-19 patients: A prospective descriptive study.

BACKGROUND: COVID-19 patients are at risk for the development of pressure injuries (PI). AIM: The aim of this study was to determine the incidence of medical device-related pressure injury (MDRPI) in patients treated in the COVID-19 Intensive Care Unit (ICU)s. METHODS: The sample of the study consisted of 132 patients, and each with a maximum follow-up of 7 days. Data were collected in the COVID-19 ICU of a university hospital between January and May 2021 by using a Patient Characteristics Form, the MDRPI Follow-up Form, the Braden Pressure Ulcer Risk Assessment Scale, and the Pressure Ulcer Staging Form. RESULTS: Of the patients, 59.1% (n = 78) developed at least one MDRPI. MRDPI was observed in those with a mean age of 65.45 ± 2.462 years who were invasively ventilated (51.3%), enterally fed (46.2%), placed in the prone position (78.2%), and had a Braden score ≤12 (50%). The most common medical devices that caused MDRPIs included endotracheal tube (ET) (31.2% n = 44), non-invasive mechanical ventilation (NIVM) (23.4% n = 33), nasal high-flow (11.3% n = 16), nasogastric tube (10.6% n = 15), the ET connection (8.5% n = 12), respectively. The most common sites for pressure injuries were the nose (28.8% n = 34), mouth (25.8% n = 34), ear (12.9% n = 17), lip (9.1% n = 12), and cheek (8.3% n = 11). The most common gradings of MDRPIs were stage 2 (28.8% n = 38), stage 1 (19.7% n = 26), stage 3 (9.1% n = 12) mucous membrane injuries (12.9% n = 17) and suspected deep tissue injuries (9.1% n = 12), respectively. The time to PI was 3 days (25.7% n = 36). CONCLUSIONS: MDRPI was common among COVID-19 patients. It was found that the most common cause of pressure injury was ventilators, and PI developed in the mouth and lip sites most frequently in patients in prone position, stage 2 and suspected deep tissue damage was the most common grade. It is important to evaluate the skin in contact with medical devices in COVID-19 patients and to take the necessary interventions to prevent PI.

Incidence of medical device-related pressure injuries in the intensive care unit and related risk factors.

AIM: At present, physicians employ medical devices extensively in the treatment of numerous diseases and in the care and follow-up of patients. However, these medical devices are a potential cause of pressure injuries.The study aimed to investigate the incidence and affecting risk factors of medical device-related pressure injuries (MDRPIs) in an adult intensive care unit. MATERIALS AND METHODS: This is a longitudinal descriptive/analytical and cross-sectional study. The researchers conducted this study with 213 intensive care patients between 15.06.2021 and 15.12.2021. The skin and mucosa under and around each medical device were observed once a day for MDRPIs during the stay of patients who had been hospitalized in the intensive care unit for at least 24 h. The data were collected using Patient Information Form developed by the researchers based on the literature, Medical Device-Related Pressure Injury Monitoring Form, the Jackson/Cubbin Pressure Area Risk Calculator (Jackson/Cubbin BARHATr)-Turkish Version, the National Pressure Injury Advisory Panel (NPIAP) Pressure Injury Staging System and the Glasgow Coma Scale. RESULTS: The incidence of MDRPIs was 28.6% (61/213). The study revealed that 48.4% (46/95) of these injuries were caused by medical devices for respiratory system, 26.3% (25/95) by devices for gastrointestinal and genitourinary system. The study also revealed that 70.5% of MDRPIs occurred on the skin and 29.5% on the mucosal membrane, and that 82.1% of the MDRPIs occurring on the skin were at Stage 1. In terms of anatomical location, 21.1% of these injuries developed on the fingers and 13.7% on the mouth/lip. In multivariate analysis, parenteral + enteral (p = 0.006, OR = 0.083, 95%CI = [0.014-0.497]) and oral nutrition (p = 0.037, OR = 0.210, 95%CI = [0.049-0.908]), a higher number of devices (nine or more) (p = 0.002, OR = 5.387, 95%CI = [1.840-15.772]) and the duration of device wear (p < 0.05) were identified as independent risk factors for the occurrence of MDRPIs. CONCLUSIONS: The study showed that the incidence of MDRPIs was relatively high and was associated with various factors. It is critical for intensive care nurses, who encounter MDRPIs more frequently, to consider these factors while caring for their patients and to take appropriate preventive measures to reduce the incidence of these injuries.

A novel treatment based on powder jet deposition technique for dentin hypersensitivity: a randomized controlled trial.

BACKGROUND: This study aimed to evaluate the efficacy and safety of dentin hypersensitivity (DH) treatment using a newly developed device based on a powder jet deposition (PJD) technique that creates a hydroxyapatite (HAP) layer on the dentin surface, thereby alleviating the hypersensitivity. The effect of the PJD treatment was compared with that of conventional treatment using Teethmate Desensitizer (TMD; calcium-phosphate containing material with TTCP (Ca4(PO4)2O) and DCPA (CaHPO4)), which has been used clinically in Japan with well-confirmed effectiveness. MATERIALS AND METHODS: A randomized controlled trial was conducted including 35 patients who had symptoms of DH in two or more quadrants. Two test teeth were selected per patient (70 teeth in total) and randomly assigned to PJD or TMD treatment. The efficacy was evaluated using the improvement rate for air and scratch pain according to the scores obtained via visual analog scale 12 weeks after treatment. The safety assessment was performed focusing on gingival index (GI) and spontaneous pain. The t-test was used to analyze the non-inferiority of PJD treatment compared to TMD treatment. RESULTS: The improvement rate of air pain was 69.0% for PJD and 69.7% for TMD. The improvement rate of scratch pain was 80.8% for PJD and 81.7% for TMD. Non-inferiority with a margin of 10% was not observed for both air and scratch pain. No change was observed in GI from baseline and the improvement rate of spontaneous pain for PJD was higher than that for TMD. CONCLUSION: Non-inferiority of PJD to TMD treatment was not observed in this study; however, it was not statistically demonstrated, and the results were thus interpreted as inconclusive. PJD did improve the DH symptoms, as did TMD. PJD's therapeutic effect was most likely attributable to the deposition of a HAP layer on the tooth surface, which would alleviate hypersensitivity for at least 12 weeks without causing severe adverse events. TRIAL REGISTRATION: UMIN-CTR. ID: UMIN000025022. date: 02/12/2016.

[Progress in Application of Heparin Coating in Blood Contact Medical Devices].

Blood compatibility is the main restriction of blood-contacting medical devices in clinical application, especially long-term blood-contacting medical devices will stimulate the immune defense mechanism of the host, resulting in thrombosis. Heparin anticoagulant coating links heparin molecules to the surface of medical device product materials, improves the compatibility between the material surface interface and the body, and reduces the host immune defense reactions. This study reviews the structure and biological properties of heparin, the market application status of heparin-coated medical products, the insufficiency and improvement of heparin coating, which can provide a reference for the application research of blood contact medical devices.

Evaluation of a novel medical device for pegfilgrastim administration.

Pegfilgrastim, a pegylated form of granulocyte colony-stimulating factor, has reduced the risk of developing febrile neutropenia, which is associated with an increase in severe infection and prolonged hospitalization. However, pegfilgrastim administration requires that patients visit hospital following cancer chemotherapy, thus imposing a burden on patients and those around them. An on-body injector (OBI), which automatically administers pegfilgrastim about 27 hours after chemotherapy, was used in this study. The OBI, which consists of a main pump unit and infusion set, is a drug delivery device designed to be attached to the patient's body, with a timer-controlled dosing function. This study was conducted in breast cancer patients to evaluate the safety of pegfilgrastim administered subcutaneously via the OBI. The study period consisted of screening and treatment observation periods involving four cycles of neoadjuvant or adjuvant chemotherapy with docetaxel plus cyclophosphamide. One 3.6-mg pegfilgrastim dose was administered subcutaneously via OBI during each cycle of chemotherapy. The study enrolled 35 patients, and no serious adverse events or febrile neutropenia occurred. Administration of pegfilgrastim was successfully completed at all times when the OBI was attached to the patient, and no safety concerns associated with OBI function arose. For outpatients requiring pegfilgrastim following cancer chemotherapy, the use of an OBI was considered to be a safe option to reduce the need for outpatient visits that restrict their activities of daily living.

Use of a bilayer biodegradable synthetic dermal matrix for the management of defects arising from necrotising fasciitis.

The aim of this article is to provide a brief overview of necrotising fasciitis, including causative factors, incidence, diagnosis and clinical outcomes. Various surgical treatment options are outlined, including methods of soft tissue reconstruction after wide excision of infected and necrotic tissues. The role of dermal matrices, including a synthetic biodegradable temporising matrix made of polyurethane, are described in terms of wound bed preparation, surgical application and clinical outcomes.

Recent Advances in the Control of Clinically Important Biofilms.

Biofilms are complex structures formed by bacteria, fungi, or even viruses on biotic and abiotic surfaces, and they can be found in almost any part of the human body. The prevalence of biofilm-associated diseases has increased in recent years, mainly because of the frequent use of indwelling medical devices that create opportunities for clinically important bacteria and fungi to form biofilms either on the device or on the neighboring tissues. As a result of their resistance to antibiotics and host immunity factors, biofilms have been associated with the development or persistence of several clinically important diseases. The inability to completely eradicate biofilms drastically increases the burden of disease on both the patient and the healthcare system. Therefore, it is crucial to develop innovative ways to tackle the growth and development of biofilms. This review focuses on dental- and implant-associated biofilm infections, their prevalence in humans, and potential therapeutic intervention strategies, including the recent advances in pharmacology and biomedical engineering. It lists current strategies used to control the formation of clinically important biofilms, including novel antibiotics and their carriers, antiseptics and disinfectants, small molecule anti-biofilm agents, surface treatment strategies, and nanostructure functionalization, as well as multifunctional coatings particularly suitable for providing antibacterial effects to the surface of implants, to treat either dental- or implant-related bacterial infections.

An unusual foreign body in the oral cavity: a case report from a patient safety point of view and literature review.

Accidental foreign bodies (FBs) in the oral cavity, airway, esophagus and breathing circuit associated with anesthetic procedures are rare but can cause serious and life-threatening complications. We here present a case in which an unusual FB in the oral cavity was found after emergence from general anesthesia. The FB was later identified as a melted cap of a felt-tip pen. We investigated the cleaning process for reusable materials and concluded that the FB was accidentally placed in the inner lumen of the reusable bite block during the cleaning process. We then performed a review of the literature on FBs other than those of dental origin which were entrapped in the oral cavity, pharynx, larynx, trachea, esophagus, and anesthetic breathing circuit due to anesthetic procedures. From our case and 53 cases found in the search, we concluded that 1) use of disposable medical devices is recommended, 2) FBs can easily migrate into the oral cavity and airway during anesthesia, 3) delayed FB recognition may be associated with difficult intubation situations, and 4) more attention should be paid to the possibility of any medical or non-medical device becoming an FB during anesthesia.

Evaluation of facial tissue stresses under medical devices post application of a cyanoacrylate liquid skin protectant: An integrated experimental-computational study.

Medical device-related pressure ulcers (PUs) (injuries) are a subclass of PUs, associated with pressure and/or shear applied by a medical device onto the skin. Clinical application of a cyanoacrylate liquid skin protectant (CLSP) under the contours of skin-contacting medical devices to shield an intact skin from the sustained mechanical loads that are applied by medical devices is a preventative option, but no computer modelling work has been reported to assess the biomechanical efficacy of such interventions. Here, we investigated the biomechanical protective effect of a polymerised cyanoacrylate coating using three-dimensional, anatomically realistic finite element models of the ear with oxygen cannula and the mouth with endotracheal attachment device, informed by experimental studies. We have compared tissue stress exposures under the devices at these facial sites between conditions where the cyanoacrylate skin protectant has been applied or where the device was contacting the skin directly, without the shielding of the cyanoacrylate coating. The CLSP considerably reduced the skin stress concentration levels and overall tissue stress exposures under the aforementioned medical devices. This demonstrates strong biomechanical effectiveness of the studied cyanoacrylate-based skin protectant in prevention of facial medical device-related injuries at small, curved and thereby difficult to protect facial sites.

[Recent Advance of Stainless Steel Used In Non-active Surgical Implantable Medical Device and Regulatory Perspective].

Stainless steel has been widely used in non-active surgical implantable medical device of cardiovascular, orthopedics, dental and ophthalmology. In this paper, we mainly focused on development of stainless steel, as well as the material-related standard evolution. We further summarized the recent advancement of stainless steel use in surgical implantable medical device. Insight and regulatory perspective has been further demonstrated.