Research and Development Trend of Medical Oxygen Production Equipment / 中国医疗器械杂志

Oxygen therapy is an effective clinical method for the treatment of respiratory disorders, oxygen concentrator as a necessary medical auxiliary equipment in hospitals, its research and development has been a hot spot. The study reviewed the development history of the ventilator, introduced the two preparation technique of the oxygen generator pressure swing absorption (PSA) and vacuum pressure swing adsorption (VPSA), and analyzed the core technology development of the oxygen generator. In addition, the study compared some major brands of oxygen concentrators on the market and prospected the development trend of oxygen concentrators.

Adaptation and acceptability testing of the Expector® vibration vest in horses / Adaptação e teste de aceitabilidade do colete de vibração Expector® em equinos

The project is based on a test of a thoracic vibration vest prototype, adapted to equines by the Expector® vest's company, on healthy animals. Ten (10) equines were used in the project, male or female, adults, healthy, belonging to FMVZ-USP or private owners. Each animal went through two phases: A and B. Phase A consisted of the placement of the vest without turning on the vibrators, evaluating the animal's acceptability, facility, adaptation to the animal's body, and discomfort due to the vest's use. Phase B included the placement of the vest and turning on the vibrators, evaluating the animal's acceptability, reaction to the vibrators, and, if present, to which velocity/type of vibration, and the presence of adverse effects. Both phases were done three times on separate days. The behavioral parameters: "placement facility" and "adaptation to the animal's body" were observed. In phase B, the response to the vibration was classified from 0 to 5. The answer was evaluated on low and high intensities for the four vibration types. The heart rate (HR) and respiratory rate (RR) were also evaluated at the beginning and end of each repetition. The animals' HR was kept on normal, except for one animal on one day of the test. Concerning the RR, most animals presented moments of tachypnea. On the experiment's first day, 100% of grade Great to "facility of placement" and "adaptation to the animal's body" was obtained, but on days 2 and 3 this value dropped to 90% due to alterations in one animal's responses. Regarding vibration's responses, 77.3% were evaluated as no discomfort (grade 0), 17.1% little discomfort (grade 1), 3.3% medium discomfort (grade 2), 0.4% great discomfort (grade 3), 0.21% extreme discomfort (grade 4), and 1.6% non-acceptance of the vest (grade 5). Some possible changes on the prototype were also verified to be suggested to the manufacturer, such as the change of the buckle and the use of wireless control. Vest use appears promising for equine respiratory physiotherapy, considering the acceptability was good, and its efficiency on the expectoration of diseased animals must be tested.

O projeto consistiu no teste de um protótipo de colete de vibração torácica, adaptado aos equinos pela empresa do colete Expector®, em animais saudáveis. Foram utilizados 10 equinos, machos ou fêmeas, adultos, saudáveis, pertencentes à FMVZ-USP e a proprietários particulares. Cada animal passou por duas fases: A e B. A Fase A consistiu na colocação do colete sem ligar os vibradores, avaliando-se a aceitabilidade do animal; facilidade; adaptação ao corpo do animal e incômodo do mesmo à sua presença. Já a Fase B contava com a colocação do colete e funcionamento dos vibradores, avaliando-se a aceitabilidade do animal; reação aos vibradores e, se presente, a qual velocidade/tipo de vibração; presença de reações ou efeitos adversos. As duas fases foram realizadas em triplicata em dias separados. Foram observados os parâmetros comportamentais "facilidade de colocação" e "adaptação ao corpo do animal". Na fase B, a resposta à vibração foi classificada de 0 a 5. A resposta foi avaliada nas intensidades baixa e alta para os quatro diferentes tipos de vibração. Foram avaliadas também as frequências cardíaca (FC) e respiratória (FR) no início e final de cada repetição. A FC dos animais se manteve dentro do intervalo de normalidade, com exceção de um animal em um dia de avaliação. Em relação à FR, a maioria apresentou momentos de taquipneia. No primeiro dia de experimento obteve-se 100% de avaliação Ótima para "facilidade de colocação" e "adaptação ao corpo do animal", mas nos dias 2 e 3 esse valor caiu para 90% devido à alteração na resposta de um animal. Em relação à resposta à vibração, 77,3% das respostas foram avaliadas como nenhum incômodo (nota 0), 17,1% pouco incômodo (nota 1), 3,3% médio incômodo (nota 2), 0,4% muito incômodo (nota 3), 0,21% incômodo extremo (nota 4) e 1,6% não aceitação do colete (nota 5). Foram também verificadas algumas possíveis mudanças no protótipo a serem sugeridas ao fabricante, como mudança do tipo de fivela e uso de controle sem fio. A utilização do colete parece ser muito promissora para a fisioterapia respiratória em equinos, visto que a aceitabilidade foi muito boa, devendo-se agora realizar a avaliação de sua eficácia na expectoração de animais enfermos.(AU)

Evolution and development: engine-driven endodontic rotary nickel-titanium instruments / 国际口腔科学杂志·英文版

Various engine-driven NiTi endodontic files have been indispensable and efficient tools in cleaning and shaping of root canals for practitioners. In this review, we introduce the relative terms and conceptions of NiTi file, including crystal phase composition, the design of the cutting part, types of separation. This review also analysis the main improvement and evolution of different generations of engine-driven nickel-titanium instruments in the past 20 years in the geometric design, manufacturing surface treatment such as electropolishing, thermal treatment, metallurgy. And the variety of motion modes of NiTi files to improve resistance to torsional failure were also discussed. Continuous advancements by the designers, provide better balance between shaping efficiency and resistance to of NiTi systems. In clinical practice an appropriate system should be selected based on the anatomy of the root canal, instrument characteristics, and operators' experience.

An Integrated Digital Magnetic Resonance Imaging Spectrometer / 中国医疗器械杂志

An integrated digital magnetic resonance imaging spectrometer was proposed in this study. By using the FPGA chip Artix7 200T, timing control, data processing, digital frequency conversion and phase control were implemented into a single-chip, thus effectively improved timing accuracy and phase accuracy, while avoided the structural design complexity caused by multi-board connection and improved system integration and imaging quality.

Realization and Clinical Study of Robotic Technology in Cardiovascular Interventional Surgery / 中国医疗器械杂志

The high incidence of cardiovascular diseases is a serious threat to human health, and endovascular surgery has become the standard treatment for most interventional cardiovascular diseases. The robotassisted endovascular surgery system further enhances surgeons' ability to perform minimally invasive endovascular procedures in interventional cardiology. This study presents a new robotic technique for coronary intervention from the perspective of clinical application. Aiming at clinical application scenarios, this scheme proposed an intuitive guide wire catheter mechanism design, which accurately and perfectly simulates the doctor's hand movements, realizes the positive and negative direction translation of the guide wire catheter, accurate torque control of the guide wire rotation and locking. The results of animal test showed that the R-OneTM has a high degree of dexterity, accuracy and stability,and meets the clinical needs.

Discussion on Testing and Standard of Blood Pressure Sensor at the Tip of Catheter / 中国医疗器械杂志

With the implementation of the new policy for coronary stent centralized volume purchasing in China, the blood pressure sensor at the tip of the catheter, as one of the essential medical instruments for the diagnosis and treatment of coronary artery disease, will meet the new development opportunity of the industry, a number of medical device companies will actively participate in the development and registration of the catheter tip blood pressure sensor. As an invasive blood pressure sensor, the catheter tip blood pressure sensor should meet the current effective industry standard YY 0781-2010, however, there are many problems when using YY 0781-2010 as a blood pressure sensor because of the difference of product structure and working mode. In this paper, the problems about "Operation Manual", "electrical performance" and "safety requirement" in the course of carrying out YY 0781- 2010 with the blood pressure sensor on the tip of catheter are discussed and analyzed in detail, hope to provide some inspiration for more research and development enterprises of blood pressure sensors on the tip of catheters and inspectors of medical device testing institutions, also hope to be able to contribute to the high-quality development of blood pressure sensor industry at the tip of the Catheter.

Design and Experimental Research of Portable Extracorporeal Circulation Pipeline Performance Testing System / 中国医疗器械杂志

Aiming at the current situation of performance testing of hemodialysis extracorporeal circulation tubing, which has slow efficiency, inaccurate measurement, and inconvenient testing, a portable detection system for testing the performance of hemodialysis extracorporeal circulation tubing is designed. The system mainly includes a hardware system and a software system. The hardware system uses STM32F407 single-chip microcomputer as the core to design the driving control of the roller pump; the software system uses the C++ real-time operating system, and the flow detection data is transmitted to the upper computer through RS485 communication and displayed. Experimental showed that the system detects the accuracy and the stability of the flow rate. It has the characteristics of stability and high precision. The relative error of the experimental measurement is within the range of ±10%. The weight of the whole machine is 2 kg, which improves the efficiency by 50% compared with the traditional detection method.

Portable Monitoring Device for Motor Rehabilitation Equipment with Rotor Shaft / 中国医疗器械杂志

A novel and portable device is proposed to monitor motor rehabilitation equipment, which can be mounted on most equipment with rotor shaft. The software of the device, whose main functions include equipment configuration, monitoring and statistical computation, is developed based on available sensor. The data collected by the device serve both department managers to learn the efficiency of the equipment, and physicians and therapists to understand the physical conditions of the patients who perform training exercises with the monitored rehabilitation equipment. About 2000 hours' monitoring has been carried out, and the experimental result indicates that the monitoring device is applicable to many types of motor rehabilitation equipment and achieves good monitoring accuracy. The data aggregated by the device can be used to evaluate the motor functions of the patients and make rehabilitation training plan. Besides, it is agreed by physicians and therapists that the device is easy-to-use, robust and has good real-time performance. The monitoring device thus holds the promise of boosting the development of digitalized rehabilitation medicine.

Evaluation on Surgical Robotic Pose Repeatability Based on Laser Tracking Measurement / 中国医疗器械杂志

To provide accurate information for registration and safety evaluation of surgical robot, the pose repeatability measurement method was proposed. According to the terminal instrument of the master-slave surgical robot (such as high-frequency electric knife, ultrasonic knife), a suitable target ball fixture was designed. The node data at 10%, 50% and 100% rated speed were measured respectively. Through data analysis, the pose repeatability property of the tested samples at different speeds was obtained. It has high applicability and repeatability, and can meet the requirements of data traceability and registration testing.

Research and Implementation of 433 MHz-based Wireless Implantable Pacing System / 中国医疗器械杂志

In order to solve the problem of communication interference and communication distance caused by the rapid pacing system when establishing the rapid atrial fibrillation model, a low-power implantable pacing system based on 433 MHz communication frequency to form a star network is designed. The system includes an implantable pacemaker, a programmer head, and programmer software. The pacemaker is composed of a wireless communication module, a pacing module, an ECG monitoring module, and a power management module. The programmer head acts as an intermediate node in the star network and is controlled by PC programmer software to program each pacemaker. This article introduces the hardware design and software flow of each part of the system, and describes the results of in vivo simulation and in vivo animal models of the system. The results show that the designed system and application method are effective and feasible for the rapid atrial pacing atrial fibrillation model. 433 MHz wireless communication, implantable, pacemaker system, low-power, ECG monitoring.

Research on real-time detection system of catheter delivering force in vascular interventional robots / 生物医学工程学杂志

In existing vascular interventional surgical robots, it is difficult to accurately detect the delivery force of the catheter/guidewire at the slave side. Aiming to solve this problem, a real-time force detection system was designed for vascular interventional surgical (VIS) robots based on catheter push force. Firstly, the transfer process of catheter operating forces in the slave end of the interventional robot was analyzed and modeled, and the design principle of the catheter operating force detection system was obtained. Secondly, based on the principle of stress and strain, a torque sensor was designed and integrated into the internal transmission shaft of the slave end of the interventional robot, and a data acquisition and processing system was established. Thirdly, an ATI high-precision torque sensor was used to build the experimental platform, and the designed sensor was tested and calibrated. Finally, sensor test experiments under ideal static/dynamic conditions and simulated catheter delivery tests based on actual human computed tomography (CT) data and vascular model were carried out. The results showed that the average relative detection error of the designed sensor system was 1.26% under ideal static conditions and 1.38% under ideal dynamic stability conditions. The system can detect on-line catheter operation force at high precision, which is of great significance towards improving patient safety in interventional robotic surgery.

Structural design and performance analysis of an auxiliary dining robot / 生物医学工程学杂志

An auxiliary dining robot is designed in this paper, which implements the humanoid feeding function with theory of inventive problem solving (TRIZ) theory and aims at the demand of special auxiliary nursing equipment. Firstly, this robot simulated the motion function of human arm by using the tandem joints of the manipulator. The end-effector used a motor-driven spoon to simulate the feeding actions of human hand. Meanwhile, the eye in hand installation style was adopted to instead the human vision to realize its automatic feeding action. Moreover, the feeding and drinking actions of the dining robot were considered comprehensively with the flexibility of spatial movement under the lowest degree of freedom (DOF) configuration. The structure of the dining robot was confirmed by analyzing its stresses and discussing the specific application scenarios under this condition. Finally, the simulation results demonstrate high-flexibility of the dining robot in the workspace with lowest DOF configuration.

Design, simulation and application of multichannel microfluidic chip for cell migration / 生物医学工程学杂志

Cell migration is defined as the directional movement of cells toward a specific chemical concentration gradient, which plays a crucial role in embryo development, wound healing and tumor metastasis. However, current research methods showed low flux and are only suitable for single-factor assessment, and it was difficult to comprehensively consider the effects of other parameters such as different concentration gradients on cell migration behavior. In this paper, a four-channel microfluidic chip was designed. Its characteristics were as follows: it relied on laminar flow and diffusion mechanisms to establish and maintain a concentration gradient; it was suitable for observation of cell migration in different concentration gradient environment under a single microscope field; four cell isolation zones (20 μm width) were integrated into the microfluidic device to calibrate the initial cell position, which ensured the accuracy of the experimental results. In particular, we used COMSOL Multiphysics software to simulate the structure of the chip, which demonstrated the necessity of designing S-shaped microchannel and horizontal pressure balance channel to maintain concentration gradient. Finally, neutrophils were incubated with advanced glycation end products (AGEs, 0, 0.2, 0.5, 1.0 μmol·L -1), which were closely related to diabetes mellitus and its complications. The migration behavior of incubated neutrophils was studied in the 100 nmol·L -1 of chemokine (N-formylmethionyl-leucyl-phenyl-alanine) concentration gradient. The results prove the reliability and practicability of the microfluidic chip.

Development of Nasal Continuum Minimally Invasive Surgical Robot System / 中国医疗器械杂志

In order to improve the operation difficulties in the narrow space of the nasal maxillary sinus, the nasal continuum minimally invasive surgical robot system is designed. The ball-and-socket joints and NiTiNol tubes are used as the main body of the continuum structure to improve the degree of freedom. The hardware systems and software systems are designed. The security control policies are planned. Finally, the robot confirmed prototype experiments are conducted and the feasibility of continuum robot confirmed through master-slave control experiment and animal experiment.

Correspondência entre alvo e saída da prótese auditiva segundo as regras prescritivas NAL-NL1 e NAL-NL2 / Correspondência entre alvo e saída da prótese auditiva segundo as regras prescritivas NAL-NL1 e NAL-NL2

RESUMO Objetivo Analisar comparativamente os alvos prescritos pelas regras NAL (National Acoustic Laboratories) não lineares com a resposta da prótese auditiva obtida por meio das mensurações com microfone-sonda no ajuste de uso efetivo, de acordo com o grau da perda auditiva. Método Participaram do estudo 67 usuários experientes de próteses auditivas. Todos foram reavaliados quando compareceram às sessões de acompanhamento periódico. Nesse momento, realizou-se avaliação audiológica, registrando-se as horas de uso do dispositivo e realizando-se a resposta com prótese auditiva (REAR - Real Ear Aided Response). Resultados Observou-se que 80% das próteses auditivas de todos os grupos atingiram a faixa analisada, com exceção do grupo de perda moderada. Também foi realizada a análise da porcentagem de orelhas cuja resposta com prótese auditiva estivesse em ±5 dB para as frequências baixas e ±8 dB nas altas frequências e observou-se que menos de 80% dos ajustes atingiram esta faixa. Intervalos de confiança foram construídos para verificar a faixa de adaptação de preferência dos usuários experientes. Conclusão A faixa de ±10 dB demonstra ser a de preferência dos usuários. Porém, para usuários experientes, sugere-se que a faixa de adaptação encontre-se na faixa de ±3 nas frequências baixas e médias e ±7 na região de altas frequências.

ABSTRACT Purpose To compare the targets prescribed by the non-linear NAL with the real ear aided response - REAR obtained through probe microphone in the setting of effective use according to the degree of hearing loss. Methods 67 experienced hearing aid users participated in the study. All were reassessed when attending follow-up sessions. At that moment, they were asked whether they had any complaints with respect to the amplification. An audiological evaluation was performed, the hours of use of the device were recorded and the new probe microphone measurement was taken. Results The percentage of ears with REAR within ± 10dB of the prescriptive target was verified. It was observed that 80% of the hearing aids of all groups reached the analyzed range, with the exception of the moderate hearing loss group. We also performed the analysis of the percentage of ears whose hearing aid response was within ± 5 dB for the low frequencies and ± 8 dB for the high frequencies, and it was observed that less than 80% of the adjustments reached this range. Confidence intervals were constructed to verify the preference fit to target of experienced users. Conclusion The range of ±10dB proves to be the users' preference. For experienced users, it is suggested that the adaptation phase be found in the range of ±3 in the low and medium frequencies and ±7 in the high frequency region

Comparison of automated breast ultrasound and hand-held breast ultrasound in the screening of dense breasts / Comparação entre a ultrassonografia automatizada e a ultrassonografia convencional no rastreio de mamas densas

Abstract Objective To compare hand-held breast ultrasound (HHBUS) and automated breast ultrasound (ABUS) as screening tool for cancer. Methods A cross-sectional study in patients with mammographically dense breasts was conducted, and both HHBUS and ABUS were performed. Hand-held breast ultrasound was acquired by radiologists and ABUS by mammography technicians and analyzed by breast radiologists. We evaluated the Breast Imaging Reporting and Data System (BI-RADS) classification of the exam and of the lesion, as well as the amount of time required to perform and read each exam. The statistical analysis employed was measures of central tendency and dispersion, frequencies, Student t test, and a univariate logistic regression, through the odds ratio and its respective 95% confidence interval, and with p<0.05 considered of statistical significance. Results Atotal of 440 patientswere evaluated. Regarding lesions,HHBUS detected 15 (7.7%) BI-RADS 2, 175 (89.3%) BI-RADS 3, and 6 (3%) BI-RADS 4, with 3 being confirmed by biopsy as invasive ductal carcinomas (IDCs), and 3 false-positives. Automated breast ultrasound identified 12 (12.9%) BI-RADS 2, 75 (80.7%) BI-RADS 3, and 6 (6.4%) BI-RADS 4, including 3 lesions detected by HHBUS and confirmed as IDCs, in addition to 1 invasive lobular carcinoma and 2 high-risk lesions not detected by HHBUS. The amount of time required for the radiologist to read the ABUS was statistically inferior compared with the time required to read the HHBUS (p<0.001). The overall concordance was 80.9%. A total of 219 lesions were detected, from those 70 lesions by both methods, 126 only by HHBUS (84.9% not suspicious by ABUS) and 23 only by ABUS. Conclusion Compared with HHBUS, ABUS allowed adequate sonographic study in supplemental screening for breast cancer in heterogeneously dense and extremely dense breasts.

Resumo Objetivo Comparar a ultrassonografia convencional das mamas (US) com a ultrassonografia automatizada das mamas (ABUS) no rastreio do câncer. Métodos Realizamos um estudo transversal com pacientes com mamas mamograficamente densas, sendo avaliadas pela US e pela ABUS. A US foi realizada por radiologistas e a ABUS por técnicos de mamografia e analisada por radiologistas especializados em mama. A classificação Breast Imaging Reporting and Data System (BIRADS) do exame e das lesões o tempo de leitura e de aquisição foram avaliados. A análise estatística foi realizada através de medidas de tendência central, dispersão e frequências, teste t de Student e regressão logística univariada, através do odds ratio, com intervalo de confiança de 95%, e com p<0,05 sendo considerado estatisticamente significante. Resultados Foram avaliadas 440 pacientes. Em relação às lesões, a US detectou 15 (7,7%) BI-RADS 2, 175 (89,3%) BI-RADS 3 e 6 (3%) BI-RADS 4, das quais 3 foram confirmadas, por biópsia, como carcinomas ductais invasivos e 3 falso-positivos. A ABUS identificou 12 (12,9%) BI-RADS 2, 75 (80,7%) BI-RADS 3 e 6 (6,4%) BI-RADS 4, incluindo 3 lesões detectadas pela US e confirmadas como carcinomas ductais invasivos, além de 1 carcinoma lobular invasivo e 2 lesões de alto risco não detectadas pela US. O tempo de leitura dos exames da ABUS foi estatisticamente inferior ao tempo do radiologista para realizar a US (p<0,001). A concordância foi de 80,9%. Um total de 219 lesões foram detectadas, das quais 70 por ambos os métodos, 126 observadas apenas pela US (84,9% não eram lesões suspeitas no ABUS) e 23 apenas pela ABUS. Conclusão Comparado à US, a ABUS permitiu adequado estudo complementar no rastreio do câncer de mamas heterogeneamente densas e extremamente densas.