Expert Review of Medical Devices最新文献

Introduction: A key determinant of prosthesis use is the quality of fit of the prosthetic socket. The socket surrounds the residual limb and applies the appropriate force distribution to the soft tissues to maintain suspension, support, and stabilization as well as translate limb movement to prosthesis movement. The challenge in socket fabrication lays in achieving geometry that provides the appropriate force distribution at physiologically appropriate locations; a task dependent on the understanding of interface tissue-mechanics.

Areas covered: In the last 20 years substantial advancements in sensor innovation and computational power have allowed researchers to quantify the socket-residual limb interface; this paper reviews prominent measurement and sensing techniques described in literature over this time frame. Advantages and short comings of each technique are discussed with a focus on translation to clinical environments.

Expert opinion: Prosthetic sockets directly influence comfort, device use, user satisfaction, and tissue health. Advancements in instrumentation technology have unlocked the possibility of sophisticated measurement systems providing quantitative data that may work in tandem with a clinician's heuristic expertise during socket fabrication. If validated, many of the emerging sensing technologies could be implemented into a clinical setting to better characterize how patients interact with their device and help inform prosthesis fabrication and assessment techniques.

Background: For patients with lower pole renal calculi (LPC), preoperative evaluation of infundibulopelvic angles (IPA) is of great significance; however, conventional measuring method is often inconvenient in clinical setting. Here we introduce a rapid novel method using built-in inclinometer in smartphone which is often used in anatomical parameters evaluating to implement the measurement of IPA.

Materials and methods: The randomized, self-controlled study on evaluating inclinometer application measured IPA on urography films collected from enrolled LPC patients. Results of statistical analysis for its validity and reliability compared to conventional PACS system are reported. Predictive performance of postoperative stone-free rates by IPA measured with the novel method was also evaluated in this study.

Results: Bland-Altman plot result shows that there is favorable agreement between IPA values of these two methods. The time required to utilize the PACS was considerably greater than time required to take similar measure using smartphones. The precision-recall curve (PRC) indicates that the new method has similar predictive performance for postoperative clearance rates as PACS.

Conclusions: In summary, measurement of IPA implemented by integrated inclinometer of smartphone is rapid, convenient, accurate and reliable in evaluating renal anatomy parameters of LPC patients.

Introduction: Recent technologies and new devices continue to be developed in vitreoretinal surgeries, and they provide more details, enhance safety, improve surgeons' comfort, and better visual and anatomical outcomes. Some devices have been used for better visualization during surgery, and some help the operation performance. They are divided into the following titles: Intraoperative OCT (including hand-held, probe-integrated, and microscope-integrated OCT), three-dimensional visualization system, virtual reality system, endoscopic vitrectomy (fiber optics and non-fiber optics), wide-angle viewing systems (contact and non-contact lenses), endo-illumination, light filters, chromovitrectomy, the retinal prosthesis (including epiretinal, subretinal, and suprachoroidal devices), robot-assisted vitreoretinal surgery, newer Vitreoretinal instruments, gene and cell therapy.

Areas covered: In this narrative review, we focused on PubMed articles between 2010-2023 with these keywords: 'Optical Coherence Tomography,' 'Three-Dimensional,' 'Virtual System,' 'intraoperative,' 'endoscopic,' 'vitrectomy,' 'lens,' 'illumination,' 'filters,' 'chromovitrectomy,' 'prosthesis,' 'robotic surgery,' 'instrument,' 'gene,' 'cell.'

Expert opinion: The main aim of this review is to update the reader on the latest progression in intraoperative imaging and surgical vision technologies and to provide an understanding of how each has helped improve operation and surgical outcomes. The surgeons should know recent updates to do their best and achieve the most excellent results.

Introduction: At present, the double balloon represented by the COOK Cervix Ripening Balloon and the single balloon represented by the Foley catheter are the commonly used intrauterine balloons. The application of intrauterine balloons in cervical ripening has evolved over 100 years. Although intrauterine balloons have been widely used in cervical ripening, the effect of labor induction in clinical practice does not satisfy all clinicians, especially patients with poor cervical maturity.

Areas covered: The research in this review is about intrauterine balloons and cervical ripening.

Expert opinion: This article reviews the historical evolution and different application methods of intrauterine balloons in cervical ripening, such as application range, placement method and placement duration of intrauterine balloons, volume and temperature of the solution fillings, and whether to apply traction to the catheter. We aim to better understand the principle of intrauterine balloons in cervical ripening and make this method more effective.

Background: The prognosis for heart failure (HF) patients remains poor, with a high mortality rate, and a marked reduction in quality of life (QOL) and functional status. This study aims to explore the ongoing needs of HF management and the epidemiology of patients followed by Italian HF clinics, with a specific focus on cardiac contractility modulation (CCM).

Research design and methods: Data from patients admitted to 14 HF outpatients clinics over 4 weeks were collected and compared to the results of a survey open to physicians involved in HF management operating in Italian centers.

Results: One hundred and five physicians took part in the survey. Despite 94% of patients receive a regular follow-up every 3-6 months, available therapies are considered insufficient in 30% of cases. Physicians reported a lack of treatment options for 23% of symptomatic patients with reduced ejection fraction (EF) and for 66% of those without reduced EF. Approximately 3% of HF population (two patients per month per HF clinic) meets the criteria for immediate CCM treatment, which is considered a useful option by 15% of survey respondents.

Conclusions: Despite this relatively small percentage, considering total HF population, CCM could potentially benefit numerous HF patients, particularly the elderly, by reducing hospitalizations, improving functional capacity and QOL.

Introduction: Bone biopsies have great value for the diagnosis of, amongst others, hematologic diseases. Although the bone biopsy procedure is mostly performed minimally invasive with the use of a slender cannula, the patient may still experience discomfort, especially when the procedure has to be repeated due to an unsuccessful biopsy.

Areas covered: This review presents a comprehensive overview of bone biopsy devices presented in the patent literature. The patents were obtained using a classification search combined with keywords in the Espacenet patent database and were subsequently verified using pre-set eligibility criteria. This resulted in 62 unique patents included in this review.

Expert opinion: The included patents were categorized based on the used strategies for the three steps that can be identified during a bone biopsy (1) biopsy sampling, (2) biopsy severing and (3) biopsy harvesting. Most patents described strategies for multiple steps. Insight into the used strategies and the comprehensive overview may serve as a source of inspiration for the design of novel bone biopsy devices.

Introduction: One-way endobronchial valve treatment improves lung function, exercise capacity, and quality of live in patients with severe emphysema and hyperinflation. Other areas of therapeutic application include treatment of persistent air leak (PAL), giant emphysematous bullae, native lung hyperinflation, hemoptysis, and tuberculosis.

Areas covered: In this review, we will assess the clinical evidence and safety of the different applications of one-way endobronchial valves (EBV).

Expert opinion: There is solid clinical evidence for the use of one-way EBV for lung volume reduction in emphysema. Treatment with one-way EBV can be considered for the treatment of PAL. The application of one-way EBV for giant bullae, post lung transplant native lung hyperinflation, hemoptysis, and tuberculosis is under investigation and more research is required to investigate the efficacy and safety of these applications.

Introduction: Although there has been extensive research on mechanical ventilation for acute respiratory distress syndrome (ARDS), treatment remains mainly supportive. Recent studies and new ventilatory modes have been proposed to manage patients with ARDS; however, the clinical impact of these strategies remains uncertain and not clearly supported by guidelines. The aim of this narrative review is to provide an overview and update on ventilatory management for patients with ARDS.

Areas covered: This article reviews the literature regarding mechanical ventilation in ARDS. A comprehensive overview of the principal settings for the ventilator parameters involved is provided as well as a report on the differences between controlled and assisted ventilation. Additionally, new modes of assisted ventilation are presented and discussed. The evidence concerning rescue strategies, including recruitment maneuvers and extracorporeal membrane oxygenation support, is analyzed. PubMed, EBSCO, and the Cochrane Library were searched up until June 2023, for relevant literature.

Expert opinion: Available evidence for mechanical ventilation in cases of ARDS suggests the use of a personalized mechanical ventilation strategy. Although promising, new modes of assisted mechanical ventilation are still under investigation and guidelines do not recommend rescue strategies as the standard of care. Further research on this topic is required.

Background: Proper maintenance of electro-medical devices is crucial for the quality of care to patients and the economic performance of healthcare organizations. This research aims to identify the interaction between Ultrasound scanners (US) maintenance variables as a function of maintenance indicators: US in service or decommissioned, excessive number of failures, and failure rate. Knowing those interactions, specific maintenance measures will be developed to improve the reliability of the US.

Research design and methods: Multifactor Dimensionality Reduction (MDR) method was eployed to analyze data from 222 US and their four-year maintenance history. Models were developed based on the variables with the greatest influence on maintenance indicators, where US were classified according to the associated risk.

Results: US with more than one major failure or at least one major component replacement had up to 496.4% more failures than the average. Failure rate increased by up to 188.7% over the average for those US with more than three moderate failures, three replacements, or both.

Conclusions: This study identifies and quantifies the causes of risk to establish a specific maintenance plan for US. It helps to better understand the degradation of US to optimize their operation and maintenance.