• 대한의용생체공학회:의공학회지
• /
• 제40권5호
• /
• pp.197-205
• /
• 2019

The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

• Journal of Chest Surgery
• /
• 제27권12호
• /
• pp.977-983
• /
• 1994

From April 1989 to December 1993, total 39 patients who were unable to be weaned off CPB or expected fatal immediate postoperiatively, were treated with ventricular assist device [VAD] or extracorporeal membrane oxygenator[ECMO] at the Royal Children`s Hospital, Melbourne. Ages ranged from 3 day to 19.4 year old and body weights from 2.0Kg to 70Kg. Twenty-seven[69.2%] of 39 patients were weaned to be decannulated successfully and sixteen[41.0%] survived to hospital discharge and late survival rate was twelve[30.8%] of 39 patients. The total follow-up period was 4 to 56 months [32.92$\pm$20.77months] and most of the late survivals showed good myocardial recovery state. From the viewpoint of the assist modality, 29 patients were treated with VAD and among them, 23 were weaned from assist successfully, but among the 8 ECMO patients, only 3 could be weaned, and both modalities were performed to the 2 patients with one weaned. The total duration of assist was from 8 to 428 hours and there was a significant difference between hospital discharged group and hospital death group, which were 83.13$\pm$31.29 hours vs 147.52$\pm$112.03 hours[P=0.032]. Conclusively, at the critical postcardiotomy situation of the paediatrtic patients including various congenital complex disease and procedures, we can choose this VAD or ECMO treatment strategy as the reasonable life saving way except transplantation.

• Journal of Chest Surgery
• /
• 제47권4호
• /
• pp.409-412
• /
• 2014

Percutaneous extracorporeal life support (P-ECLS) is a useful modality for the management of refractory cardiac or pulmonary failure. However, venoarterial P-ECLS may result in a complication of left ventricular distension. In this case report, we discuss a patient with drug-induced dilated cardiomyopathy managed with venoarterial P-ECLS and a left atrial vent catheter. The venoarterial P-ECLS was modified to a paracorporeal left ventricular assist device (LVAD) by removing the femoral venous cannula. After 28 days of hospitalization, the patient was successfully weaned from the paracorporeal LVAD and discharged home from the hospital.

• 한국정밀공학회지
• /
• 제15권4호
• /
• pp.83-90
• /
• 1998

In this paper, we present neural network for control of Left Ventricular Assist Device(LVAD) system with a pneumatically driven mock circulation system. Beat rate(BR), Systole-Diastole Rate(SDR) and flow rate are collected as the main variables of the LVAD system. System modeling is completed using the neural network with input variables(BR, SBR, their derivatives, actual flow) and output variable(actual flow). It is necessary to apply high perfomance control techniques, since the LVAD system represent nonlinear and time-varing characteristics. Fortunately. the neural network can be applied to control of a nonlinear dynamic system by learning capability In this study, we identify the LVAD system with neural network and control the LVAD system by PID controller and neural network feedforward controller. The ability and effectiveness of controlling the LVAD system using the proposed algorithm will be demonstrated by experiment.

• 한국정밀공학회:학술대회논문집
• /
• 한국정밀공학회 1997년도 춘계학술대회 논문집
• /
• pp.150-155
• /
• 1997

In this paper,we present neural network for control of Left Ventricular Assist Device(LVAD)system with a pneumatically driven mock cirulation system. It is necessary to apply high perfomance control techniques, since the LVAD system represent nonlinear and time-varing characteristics. Fortunately, the neural network can be applied to control of a nonliner dynamic system by learning capability. In this study,we identify the LVAD system with neural network and control the LVAD system by PID controller and neural network feedforward controller. The ability and effectiveness of controlling the LVAD system using the proposed algorithm will be demonstrated by computer simulation and experiment.

• 한국정밀공학회:학술대회논문집
• /
• 한국정밀공학회 1996년도 추계학술대회 논문집
• /
• pp.260-266
• /
• 1996

In this paper, we presents neural network identification and control of highly complicated nonlinear Left Ventricular Assist Device(LVAD) system with a pneumatically driven mock circulation system. Generally the LVAD system need to compensate nonlinearities. Hence, it is necessary to apply high performance control techniques. Fortunately, the neural network can be applied to control of a nonlinear dynamic system by learning capability. In this study, we identify the LVAD system with Neural Network Identification. Once the NNI has learned the dynamic model of LVAD system, the other network, called Neural Network Controller(NNC), is designed for control of a LVAD system. The ability and effectiveness of identifying and controlling a LVAD system using the proposed algorithm will be demonstrated by computer simulation.

• 제어로봇시스템학회논문지
• /
• 제4권3호
• /
• pp.315-320
• /
• 1998

In this paper, we present the PID control method for the controlling flow rate of highly complicated nonlinear Left Ventricular Assist Device(LVAD) with pneumatically driven mock circulatory system. Beat Rate (BR), Systole-Diastole Rate (SDR) and flow rate are used as the main variables of the LVAD system. System modeling is completed using the neural network with input variables (BR, SDR, their derivatives, actual flow) and an output valiable(actual flow). Then, as the basis of this model, we perform the simulation of PID control to predict the performance and tendency of the system and control the flow rate of LVAD system using the PID controller. The ability and effectiveness of identifying and controlling a LVAD system using the proposed algorithm will be demonstrated through computer simulation and experiments.

• Journal of Chest Surgery
• /
• 제57권3호
• /
• pp.312-314
• /
• 2024

A 3-year-old boy with Glenn physiology exhibited refractory heart failure with reduced ejection fraction. To improve the patient's oxygen saturation, he underwent ventricular assist device (VAD) implantation with concomitant Fontan completion. The extracardiac conduit Fontan operation was performed with a 4-mm fenestration. For VAD implantation, Berlin Heart cannulas were positioned at the left ventricular apex and the neo-aorta. Following weaning from cardiopulmonary bypass, a temporary continuous-flow VAD, equipped with an oxygenator, was utilized for support. After a stabilization period of 1 week, the continuous-flow VAD was replaced with a durable pulsatile-flow device. Following 3 months of support, the patient underwent transplantation without complications. The completion of the Fontan procedure at the time of VAD implantation, along with the use of a temporary continuous-flow device with an oxygenator, may aid in stabilizing postoperative hemodynamics. This approach could contribute to a safe transition to a durable pulsatile VAD in patients with Glenn physiology.

• 대한방사선기술학회지:방사선기술과학
• /
• 제46권2호
• /
• pp.151-157
• /
• 2023

The purpose of this study was to develop an assist device that could correct and support patient position during biopsy on computed tomography (CT) using 3D printing technology. The development method was conducted in the order of 3D design, 3D output, intermediate evaluation for product, final assist device evaluation. The 3D design method was conducted in the order of prior research data survey, measurement, primary modeling, 3D printing, output evaluation, and supplementary modeling. The 3D output was the 3D printer (3DWOX 2X, Sindoh, Korea) with additive manufacturing technology and the polylactic acid (PLA) materials. At this time, the optimal strength was evaluated to infill degree of product as the 3D printing factors into 20%, 40%, 60%, and 80%. The intermediate evaluation and supplementation was measured noise in the region of interest (ROI) around the beam hardening artifact on the CT images. We used 128-channel MDCT (Discovery 75 HD, GE, USA) to scan with a slice thickness of 100 kVp, 150 mA, and 2.5 mm on the 3D printing product. We compared the surrounding noise of the final 3D printing product with the beginning of it. and then the strength of it according to the degree of infill was evaluated. As a result, the surrounding noise of the final and the early devices were measured at an average of 3.3 ± 0.5 HU and 7.1 ± 0.1 HU, respectively, which significantly reduced the noise of the final 3D printing product (p<0.001). We found that the percentage of infill according to the optimal strength was found to be 60%. Finally, development of assist devices for CT biopsy will be able to minimize artifacts and provide convenience to medical staff and patients.

• Journal of Chest Surgery
• /
• 제57권2호
• /
• pp.184-194
• /
• 2024

Background: Left ventricular assist devices (LVADs) are widely employed as a therapeutic option for end-stage heart failure. We evaluated the outcomes associated with centrifugal-flow LVAD implantation, comparing 2 device models: the Heartmate 3 (HM3) and the Heartware Ventricular Assist Device (HVAD). Methods: Data were collected from patients who underwent LVAD implantation between June 1, 2015 and December 31, 2022. We analyzed overall survival, first rehospitalization, and early, late, and LVAD-related complications. Results: In total, 74 patients underwent LVAD implantation, with 42 receiving the HM3 and 32 the HVAD. A mild Interagency Registry for Mechanically Assisted Circulatory Support score was more common among HM3 than HVAD recipients (p=0.006), and patients receiving the HM3 exhibited lower rates of preoperative ventilator use (p=0.010) and extracorporeal membrane oxygenation (p=0.039). The overall early mortality rate was 5.4% (4 of 74 patients), with no significant difference between groups. Regarding early right ventricular (RV) failure, HM3 implantation was associated with a lower rate (13 of 42 [31.0%]) than HVAD implantation (18 of 32 [56.2%], p=0.051). The median rehospitalization-free period was longer for HM3 recipients (16.9 months) than HVAD recipients (5.3 months, p=0.013). Furthermore, HM3 recipients displayed a lower incidence of late hemorrhagic stroke (p=0.016). In the multivariable analysis, preoperative use of continuous renal replacement therapy (odds ratio, 22.31; p=0.002) was the only significant predictor of postoperative RV failure. Conclusion: The LVAD models (HM3 and HVAD) demonstrated comparable overall survival rates. However, the HM3 was associated with a lower risk of late hemorrhagic stroke.