BACKGROUND AND OBJECTIVES

Mouth retractors are essential in ensuring efficient yet safe exposure of the oral cavity and oropharynx. However, when applied improperly or haphazardly, retractors can cause tissue injuries and compromise patient safety. In addition, there are gaps in the usability of existing designs. This study aimed to identify the issues encountered by otorhinolaryngology surgeons in the use of commercially available mouth retractors, design and fabricate an improved retractor, and explore the use of additive manufacturing (popularly known as 3D printing) for retractor prototyping.

The study used the United States Food and Drug Administration (US FDA) Design Control as its framework. End-user requirements from otorhinolaryngologists were collected through key informant interviews. Results were organized into a Design Input template which was used to guide the design and development process. Prototype designs were iteratively created using computer-aided design software and 3D printing. Once design specifications were satisfied, a beta prototype was fabricated and given to another cohort of otorhinolaryngologists. The participants assessed the usability of the beta prototype. System Usability Scale (SUS) was used to quantify participant's feedback.

Five designs were created in the course of the study. The final prototype was fabricated using a Stereolithography (SLA) 3D printer. Several features were developed to address user requirements. The primary modification was to make the retractor modular to facilitate easier and shorter mounting and assembly. Gingival injury was addressed with the replacement of the maxillary alveolus hook with support bars. Five participants evaluated the beta prototype which received a mean SUS score of 75, well above the 50th percentile threshold.

This study demonstrates the applicability of the US FDA Design Control Process in the local setting to improve the mouth retractor design. Clinical and ergonomic issues were identified and design solutions were proposed and some have been implemented in a low-fidelity prototype. Results of the small-scale usability test suggest that the present form factor can be the basis for further iterations. Future studies can implement the proposed features to address other clinical and ergonomic needs.

INTRODUCTION: During the coronavirus disease 2019 (COVID-19) pandemic, multiple guidelines have recommended videolaryngoscope (VL) for tracheal intubation. However, there is no evidence that VL reduces time to tracheal intubation, and this is important for COVID-19 patients with respiratory failure. METHODS: To simulate intubation of COVID-19 patients, we randomly assigned 28 elective surgical patients to be intubated with either McGrath™ MAC VL or direct laryngoscope (DL) by specialist anaesthetists who donned 3M™ Jupiter™ powered air-purifying respirators (PAPR) and N95 masks. The primary outcome was time to intubation. RESULTS: The median time to intubation was 61 s (interquartile range [IQR] 37-63 s) and 41.5 s (IQR 37-56 s) in the VL and DL groups, respectively ( P = 0.35). The closest mean distance between the anaesthetist and patient during intubation was 21.6 ± 4.8 cm and 17.6 ± 5.3 cm in the VL and DL groups, respectively ( P = 0.045). There were no significant differences in the median intubation difficulty scale scores, proportion of successful intubations at the first laryngoscopic attempt and proportion of intubations requiring adjuncts. All the patients underwent successful intubation with no adverse event. CONCLUSION There was no significant difference in the time to intubation of elective surgical patients with either McGrath™ VL or DL by specialist anaesthetists who donned PAPR and N95 masks. The distance between the anaesthetist and patient was significantly greater with VL. When resources are limited or disrupted during a pandemic, DL could be a viable alternative to VL for specialist anaesthetists.
Humans ; COVID-19 ; Intubation, Intratracheal ; Laryngoscopes ; Laryngoscopy ; Respiratory Protective Devices ; Video Recording

BACKGROUND: Owing to shortage of surgical and N95 filtering facepiece respirators (FFRs) during the COVID-2019 pandemic, various masks were developed to prevent infection. This study aimed to examine the inward leakage rate (ILR) of sealed face masks and modified surgical masks using a quantitative fit test and compared it with the ILR of unmodified N95 FFRs. METHODS: We conducted paired comparisons of ILRs of bent nose-fit wire masks, double masks, and N95 FFRs from October to December 2021. To measure the protective effectiveness of masks, participants wore masks, and the number of particles outside and inside the mask were measured. The ILR was based on the percentage of particles entering the mask using a fit tester. RESULTS: We enrolled 54 participants (20 men and 34 women) in this study. The median ILR for surgical masks without and with a W-shaped bend in the nose-fit wire were 96.44% and 50.82%, respectively. The nose-fit wire adjustment reduced the ILR of surgical masks by a mean of 28.57%, which was significantly lower than the ILR without adjustment (P < 0.001). For double masks, with surgical or polyurethane masks on top of the W-shaped mask, the ILR did not differ significantly from that of N95. Although the filtration performance of double surgical masks matched that of N95 masks, their ILR was notably higher, indicating that double masks do not provide equivalent protection. CONCLUSIONS Wearing N95 masks alone is effective in many cases. However, surgical mask modifications do not guarantee consistent effectiveness. Properly selected, sealed masks with a good fit overcome leakage, emphasizing their crucial role. Without evidence, mask-wearing may lead to unexpected infections. Education based on quantitative data is crucial for preventing adverse outcomes.
Male ; Humans ; Female ; N95 Respirators ; COVID-19/epidemiology* ; Masks ; Pandemics/prevention & control* ; Respiratory Protective Devices ; Materials Testing ; Equipment Design ; Occupational Exposure/prevention & control*

The number of patients with heart failure in China is large, and the proportion of patients with end-stage heart failure continues to increase. The clinical effect of guideline-directed medications therapy for end-stage heart failure is poor. Heart transplantation is the most effective treatment for end-stage heart failure. But it is faced with many limitations such as the shortage of donors. In recent years, the research and development of artificial heart in China has made great progress. Three devices have been approved by the National Medical Products Administration for marketing, and another one is undergoing pre-marketing clinical trial. Since 2017, more than 200 cases of ventricular assist device implantation have been carried out in more than 34 hospitals in China. Among them, 70 patients in Fuwai Hospital, Chinese Academy of Medical Sciences had a 2-year survival rate of 90%. The first patient has survived more than 5 years with the device. More efforts should be put into the training of standardized technical team and quality control. Further research should be carried out in the aspects of pulsatile blood flow pump, fully implanted cable-free device, and improved biomaterial with better blood compatibility.
Humans ; Heart-Assist Devices ; Heart Failure/surgery* ; Heart, Artificial ; Heart Transplantation ; Pulsatile Flow

Objective: To observe the expansion rule of directional skin and soft tissue expander (hereinafter referred to as expander) in abdominal scar reconstruction. Methods: A prospective self-controlled study was conducted. Twenty patients with abdominal scar who met the inclusion criteria and admitted to Zhengzhou First People's Hospital from January 2018 to December 2020 were selected by random number table method, including 5 males and 15 females, aged 12-51 (31±12) years, with 12 patients of type Ⅰ scar and 8 patients of type Ⅱ scar. In the first stage, two or three expanders with rated capacity of 300-600 mL were placed on both sides of the scar, of which at least one expander had rated capacity of 500 mL (as the follow-up observation object). After the sutures were removed, water injection treatment was started, with the expansion time of 4 to 6 months. After the water injection volume reached 2.0 times of the rated capacity of expander, abdominal scar excision+expander removal+local expanded flap transfer repair was performed in the second stage. The skin surface area at the expansion site was measured respectively when the water injection volume reached 1.0, 1.2, 1.5, 1.8, and 2.0 times of the rated capacity of expander, and the skin expansion rate of the expansion site at corresponding multiples of expansion (1.0, 1.2, 1.5, 1.8, and 2.0 times) and adjacent multiple intervals (1.0-1.2, 1.2-1.5, 1.5-1.8, and 1.8-2.0 times) were calculated. The skin surface area of the repaired site at 0 (immediately), 1, 2, 3, 4, 5, and 6 months after operation, and the skin shrinkage rate of the repaired site at different time points (1, 2, 3, 4, 5, and 6 months after operation) and different time periods (0-1, 1-2, 2-3, 3-4, 4-5, and 5-6 months after operation) were calculated. Data were statistically analyzed with analysis of variance for repeated measurement and least significant difference-t test. Results: Compared with the expansion of 1.0 time ((287.6±2.2) cm² and (47.0±0.7)%), the skin surface area and expansion rate of the expansion site of patients ((315.8±2.1), (356.1±2.8), (384.9±1.6), and (386.2±1.5) cm², (51.7±0.6)%, (57.2±0.6)%, (60.4±0.6)%, and (60.5±0.6)%) were significantly increased when the expansion reached 1.2, 1.5, 1.8, and 2.0 times (with t values of 46.04, 90.38, 150.14, 159.55, 45.11, 87.83, 135.82, and 118.48, respectively, P<0.05). Compared with the expansion of 1.2 times, the skin surface area and expansion rate of the expansion site of patients were significantly increased when the expansion reached 1.5, 1.8, and 2.0 times (with t values of 49.82, 109.64, 122.14, 144.19, 49.51, and 105.85, respectively, P<0.05). Compared with the expansion of 1.5 times, the skin surface area and expansion rate of the expansion site of patients were significantly increased when the expansion reached 1.8 times (with t values of 38.93 and 39.22, respectively, P<0.05) and 2.0 times (with t values of 38.37 and 38.78, respectively, P<0.05). Compared with the expansion of 1.8 times, the skin surface area and expansion rate of the expansion site of patients both had no statistically significant differences when the expansion reached 2.0 times (with t values of 4.71 and 4.72, respectively, P>0.05). Compared with the expansion of 1.0-1.2 times, the skin expansion rate of the expansion site of patient was significantly increased when the expansion reached 1.2-1.5 times (t=6.95, P<0.05), while the skin expansion rate of the expansion site of patient was significantly decreased when the expansion reached 1.5-1.8 and 1.8-2.0 times (with t values of 5.89 and 40.75, respectively, P<0.05). Compared with the expansion of 1.2-1.5 times, the skin expansion rate of the expansion site of patient was significantly decreased when the expansion reached 1.5-1.8 and 1.8-2.0 times (with t values of 10.50 and 41.92, respectively, P<0.05). Compared with the expansion of 1.5-1.8 times, the skin expansion rate of the expansion site of patient was significantly decreased when the expansion reached 1.8-2.0 times (t=32.60, P<0.05). Compared with 0 month after operation, the skin surface area of the repaired site of patient at 1, 2, 3, 4, 5, and 6 months after operation was significantly decreased (with t values of 61.66, 82.70, 96.44, 102.81, 104.51, and 102.21, respectively, P<0.05). Compared with 1 month after operation, the skin surface area of the repaired site of patient was significantly decreased at 2, 3, 4, 5, and 6 months after operation (with t values of 37.37, 64.64, 69.40, 72.46, and 72.62, respectively, P<0.05), while the skin shrinkage rate was significantly increased (with t values of 32.29, 50.00, 52.67, 54.76, and 54.62, respectively, P<0.05). Compared with 2 months after operation, the skin surface area of the repaired site of patient was significantly decreased at 3, 4, 5, and 6 months after operation (with t values of 52.41, 60.41, 70.30, and 65.32, respectively, P<0.05), while the skin shrinkage rate was significantly increased (with t values of 52.97, 59.29, 69.68, and 64.50, respectively, P<0.05). Compared with 3 months after operation, the skin surface area of the repaired site of patient was significantly decreased at 4, 5, and 6 months after operation (with t values of 5.53, 38.00, and 38.52, respectively, P<0.05), while the skin shrinkage rate was significantly increased (with t values of 25.36, 38.59, and 37.47, respectively, P<0.05). Compared with 4 months after operation, the skin surface area (with t values of 41.10 and 50.50, respectively, P>0.05) and skin shrinkage rate (with t values of 48.09 and 50.00, respectively, P>0.05) of the repaired site of patients at 5 and 6 months after operation showed no statistically significant differences. Compared with 5 months after operation, the skin surface area and skin shrinkage rate of the repaired site of patient at 6 months after operation showed no statistically significant differences (with t values of 9.40 and 9.59, respectively, P>0.05). Compared with 0-1 month after operation, the skin shrinkage rate of the repaired site of patient at 1-2, 2-3, 3-4, 4-5, and 5-6 months after operation was significantly decreased (with t values of 13.56, 40.00, 49.21, 53.97, and 57.68, respectively, P<0.05). Compared with 1-2 months after operation, the skin shrinkage rate of the repaired site of patients at 2-3, 3-4, 4-5, and 5-6 months after operation was significantly decreased (with t values of 12.37, 27.72, 30.16, and 31.67, respectively, P<0.05). Compared with 2-3 months after operation, the skin shrinkage rate of the repaired site of patients at 3-4, 4-5, and 5-6 months after operation was significantly decreased (with t values of 33.73, 41.31, and 54.10, respectively, P<0.05). Compared with 3-4 months after operation, the skin shrinkage rate of the repaired site of patient at 4-5 and 5-6 months after operation showed no statistically significant differences (with t values of 10.90 and 23.60, respectively, P>0.05). Compared with 4-5 months after operation, the skin shrinkage rate of the repaired site of patient at 5-6 months after operation showed no statistically significant difference (t=20.90, P>0.05). Conclusions: The expander can effectively expand the abdominal skin, thus repairing the abdominal scar deformity. Maintained expansion for one month after the water injection expansion reaches 1.8 times of the rated capacity of the expander can be set as a phase Ⅱ operation node.
Female ; Male ; Humans ; Cicatrix/surgery* ; Prospective Studies ; Tissue Expansion Devices ; Skin ; Abdominal Wall

Wearable technology, which can continuously and remotely monitor physiological and behavioral parameters by incorporated into clothing or worn as an accessory, introduces a new era for ubiquitous health care. With big data technology, wearable data can be analyzed to help long-term cardiovascular care. This review summarizes the recent developments of wearable technology related to cardiovascular care, highlighting the most common wearable devices and their accuracy. We also examined the application of these devices in cardiovascular healthcare, such as the early detection of arrhythmias, measuring blood pressure, and detecting prevalent diabetes. We provide an overview of the challenges that hinder the widespread application of wearable devices, such as inadequate device accuracy, data redundancy, concerns associated with data security, and lack of meaningful criteria, and offer potential solutions. Finally, the future research direction for cardiovascular care using wearable devices is discussed.
Big Data ; Delivery of Health Care ; Wearable Electronic Devices ; Technology ; Blood Pressure

Intrauterine device use as contraceptionoffers the benefits of being affordable, long- acting, highly effective, and reversible. However, like any foreign body, it can be prone to certain complications, at times, with very serious consequences. Migration is the rarest but most feared complication. This is a report of the case of 72-year old woman with anine-month history of right lower quadrant abdominal pain. Work ups pointed to a migrated intrauterine device.The patient subsequently underwent laparoscopic removal of the foreign body with omental biopsy which laterrevealed metastatic adenocarcinoma from a primary ovarian malignancy.
Intrauterine Devices ; Ovarian Neoplasms ; Adenocarcinoma

Female ; Humans ; Pelvic Inflammatory Disease/diagnosis* ; Intrauterine Devices

Intrauterine device(IUD)migrating to the bladder is rare,especially the migration far away from the uterus into the bladder wall.Due to no obvious clinical symptom in the early stage and being far away from the uterus,the IUD totally embedded in the bladder wall is prone to misdiagnosis and delay in treatment.We reported one case of such migration,aiming to improve the clinical management of the IUD totally embedded in the bladder wall.
Female ; Humans ; Urinary Bladder/surgery* ; Uterus ; Pelvis ; Intrauterine Devices/adverse effects*

Heart failure (HF),a chronic progressive disease,is a global health problem and the leading cause of deaths in the global population.The pathophysiological abnormalities of HF mainly include abnormal cardiac structure (myocardium and valves),disturbance of electrophysiological activities,and weakened myocardial contractility.In addition to drug therapy and heart transplantation,interventional therapies can be employed for advanced-stage HF,including transcatheter interventions and mechanical circulatory assist devices.This article introduces the devices used for advanced HF that have been marketed or certified as innovative or breakthrough devices around the world and summarizes the research status and prospects the trend in this field.As diversified combinations of HF devices are used for the treatment of advanced HF,considerations regarding individualized HF therapy,risk-benefit evaluation on device design,medical insurance payment,post-market supervision system,and protection of intellectual property rights of high-end technology are needed,which will boost the development of the technology and industry and benefit the patients.
Humans ; Heart-Assist Devices ; Heart Failure/therapy* ; Heart Transplantation ; Myocardium ; Chronic Disease