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1.
Radiology ; 306(1): 20-31, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36346314

RESUMEN

Adequate clinical evaluation of artificial intelligence (AI) algorithms before adoption in practice is critical. Clinical evaluation aims to confirm acceptable AI performance through adequate external testing and confirm the benefits of AI-assisted care compared with conventional care through appropriately designed and conducted studies, for which prospective studies are desirable. This article explains some of the fundamental methodological points that should be considered when designing and appraising the clinical evaluation of AI algorithms for medical diagnosis. The specific topics addressed include the following: (a) the importance of external testing of AI algorithms and strategies for conducting the external testing effectively, (b) the various metrics and graphical methods for evaluating the AI performance as well as essential methodological points to note in using and interpreting them, (c) paired study designs primarily for comparative performance evaluation of conventional and AI-assisted diagnoses, (d) parallel study designs primarily for evaluating the effect of AI intervention with an emphasis on randomized clinical trials, and (e) up-to-date guidelines for reporting clinical studies on AI, with an emphasis on guidelines registered in the EQUATOR Network library. Sound methodological knowledge of these topics will aid the design, execution, reporting, and appraisal of clinical evaluation of AI.


Asunto(s)
Algoritmos , Inteligencia Artificial , Humanos , Estudios Prospectivos , Proyectos de Investigación , Ensayos Clínicos Controlados Aleatorios como Asunto
2.
Sensors (Basel) ; 20(16)2020 Aug 09.
Artículo en Inglés | MEDLINE | ID: mdl-32784914

RESUMEN

Sarcopenia is defined as muscle mass and strength loss with aging. As places, such as South Korea, Japan, and Europe have entered an aged society, sarcopenia is attracting global attention with elderly health. However, only few developed devices can quantify sarcopenia diagnosis modalities. Thus, the authors developed a sarcopenia detection system with 4 degrees of freedom to scan the human thigh with ultrasound probe and determine whether he/she has sarcopenia by inspecting the length of muscle thickness in the thigh by ultrasound image. To accurately measure the muscle thickness, the ultrasound probe attached to the sarcopenia detection system, must be moved angularly along the convex surface of the thigh with predefined pressure maintained. Therefore, the authors proposed an angular thigh scanning method for the aforementioned reason. The method first curve-fits the angular surface of the subject's thigh with piecewise arcs using D information from a fixed RGB-D camera. Then, it incorporates a Jacobian-based ultrasound probe moving method to move the ultrasound probe along the curve-fitted arc and maintains radial interface force between the probe and the surface by force feedback control. The proposed method was validated by in-vitro test with a human thigh mimicked ham-gelatin phantom. The result showed the ham tissue thickness was maintained within approximately 26.01 ± 1.0 mm during 82° scanning with a 2.5 N radial force setting and the radial force between probe and surface of the phantom was maintained within 2.50 ± 0.1 N.


Asunto(s)
Sarcopenia , Ultrasonografía , Anciano , Europa (Continente) , Femenino , Humanos , Japón , Masculino , Músculo Esquelético/diagnóstico por imagen , República de Corea , Sarcopenia/diagnóstico por imagen , Ultrasonografía/instrumentación
3.
Biotechnol Bioeng ; 116(11): 3041-3052, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31294818

RESUMEN

The purpose of this study was to demonstrate self-organizing in vitro multicellular tumor spheroid (MCTS) formation in a microfluidic system and to observe the behavior of MCTSs under controlled microenvironment. The employed microfluidic system was designed for simple and effective formation of MCTSs by generating nutrient and oxygen gradients. The MCTSs were composed of cancer cells, vascular endothelial cells, and type I collagen matrix to mimic the in vivo tumor microenvironment (TME). Cell culture medium was perfused to the microfluidic device loaded with MCTSs by a passive fluidic pump at a constant flow rate. The dose response to an MMPs inhibitor was investigated to demonstrate the effects of biochemical substances. The result of long-term stability of MCTSs revealed that continuous perfusion of cell culture medium is one of the major factors for the successful MCTS formation. A continuous flow of cell culture medium in the in vitro TME greatly affected both the proliferation of cancer cells in the micro-wells and the sustainability of the endothelial cell-layer integrity in the lumen of microfluidic channels. Addition of MMP inhibitor to the cell culture medium improved the stability of the collagen matrix by preventing the detachment and shrinkage of the collagen matrix surrounding the MCTSs. In summary, the present constant flow assisted microfluidic system is highly advantageous for long-term observation of the MCTS generation, tumorous tissue formation process and drug responses. MCTS formation in a microfluidic system may serve as a potent tool for studying drug screening, tumorigenesis and metastasis.


Asunto(s)
Técnicas de Cultivo de Célula , Dispositivos Laboratorio en un Chip , Neoplasias Pulmonares/metabolismo , Técnicas Analíticas Microfluídicas , Esferoides Celulares/metabolismo , Microambiente Tumoral , Células A549 , Humanos , Neoplasias Pulmonares/patología , Esferoides Celulares/patología
4.
Sci Rep ; 14(1): 14649, 2024 06 25.
Artículo en Inglés | MEDLINE | ID: mdl-38918552

RESUMEN

Cognitive impairment (CI) is prevalent in central nervous system demyelinating diseases, such as multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMOSD). We developed a novel tablet-based modified digital Symbol Digit Modalities Test (MD-SDMT) with adjustable protocols that feature alternating symbol-digit combinations in each trial, lasting one or two minutes. We assessed 144 patients (99 with MS and 45 with NMOSD) using both MD-SDMT protocols and the traditional paper-based SDMT. We also gathered participants' feedback through a questionnaire regarding their preferences and perceived reliability. The results showed strong correlations between MD-SDMT and paper-based SDMT scores (Pearsons correlation: 0.88 for 2 min; 0.85 for 1 min, both p < 0.001). Among the 120 respondents, the majority preferred the digitalized SDMT (55% for the 2 min, 39% for the 1 min) over the paper-based version (6%), with the 2 min MD-SDMT reported as the most reliable test. Notably, patients with NMOSD and older individuals exhibited a preference for the paper-based test, as compared to those with MS and younger patients. In summary, even with short test durations, the digitalized SDMT effectively evaluates cognitive function in MS and NMOSD patients, and is generally preferred over the paper-based method, although preferences may vary with patient characteristics.


Asunto(s)
Esclerosis Múltiple , Neuromielitis Óptica , Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Esclerosis Múltiple/psicología , Esclerosis Múltiple/fisiopatología , Neuromielitis Óptica/fisiopatología , Pruebas Neuropsicológicas , Disfunción Cognitiva/diagnóstico , Reproducibilidad de los Resultados , Anciano , Enfermedades Desmielinizantes , Encuestas y Cuestionarios , Adulto Joven , Computadoras de Mano
5.
Artif Organs ; 37(1): 107-12, 2013 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-23043484

RESUMEN

Robot-assisted minimally invasive surgery is effective for operations in limited space. Enhancing safety based on automatic tracking of surgical instrument position to prevent inadvertent harmful events such as tissue perforation or instrument collisions could be a meaningful augmentation to current robotic surgical systems. A vision-based instrument tracking scheme as a core algorithm to implement such functions was developed in this study. An automatic tracking scheme is proposed as a chain of computer vision techniques, including classification of metallic properties using k-means clustering and instrument movement tracking using similarity measures, Euclidean distance calculations, and a Kalman filter algorithm. The implemented system showed satisfactory performance in tests using actual robot-assisted surgery videos. Trajectory comparisons of automatically detected data and ground truth data obtained by manually locating the center of mass of each instrument were used to quantitatively validate the system. Instruments and collisions could be well tracked through the proposed methods. The developed collision warning system could provide valuable information to clinicians for safer procedures.


Asunto(s)
Algoritmos , Endoscopía/métodos , Robótica/instrumentación , Cirugía Asistida por Computador/instrumentación , Instrumentos Quirúrgicos , Humanos , Aumento de la Imagen/métodos , Procedimientos Quirúrgicos Mínimamente Invasivos/instrumentación , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Cirugía Asistida por Computador/métodos , Grabación en Video
6.
Artif Organs ; 37(4): 368-79, 2013 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-23461583

RESUMEN

This study seeks to improve the mechanical performance of stents by conducting reliability performance testing and finite element method (FEM)-based simulations for coronary stents. Three commercially available stent designs and our own new design were tested to measure the factors affecting performance, specifically foreshortening, recoil, radial force, and flexibility. The stents used in the present experiments were 3 mm in working diameter and 18 mm of working length. The results of the experiments indicate that the foreshortening of stents A, B, C, and our new design, D, was equivalent to 2.25, 0.67, 0.46, and 0.41%, respectively. The recoil of stents A, B, C, and D was 6.00, 4.35, 3.50, and 4.36%, respectively. Parallel plate radial force measurements were A, 3.72 ± 0.28 N; B, 3.81 ± 0.32 N; C, 4.35 ± 0.18 N; and D, 4.02 ± 0.24 N. Radial forces determined by applying uniform pressure in the circumferential direction were A, 28.749 ± 0.81 N; B, 32.231 ± 1.80 N; C, 34.522 ± 3.06 N; and D, 42.183 ± 2.84 N. The maximum force of crimped stent at 2.2-mm deflection was 1.01 ± 0.08 N, 0.82 ± 0.08 N, 0.92 ± 0.12 N, and 0.68 ± 0.07 N for each of stents A, B, C and D. The results of this study enabled us to identify several factors to enhance the performance of stents. In comparing these stents, we found that our design, stent D, which was designed by a collaborative team from seven universities, performed better than the commercial stents across all parameter of foreshortening, recoil, radial force, and flexibility.


Asunto(s)
Stents , Análisis de Elementos Finitos , Humanos , Docilidad , Diseño de Prótesis , Reproducibilidad de los Resultados , Estrés Mecánico
7.
Sci Rep ; 13(1): 10817, 2023 Jul 04.
Artículo en Inglés | MEDLINE | ID: mdl-37402750

RESUMEN

A mini basket type mapping catheter consists of thin film flexible sensors and is applied in the medical field to measure the electrocardiography (ECG) signals in order to localize and quantize the physiological condition/status of heart. The flexible nature of the thin film changes the configuration with respect to the contact boundary conditions when it contacts a target surface. Therefore, to accurately localize the flexible sensor, the thin film flexible sensor's configuration must be determined accurately in an on-line fashion. As a study of localizing the thin film flexible sensor, this study proposes an on-line thin film buckling configuration determination method using parametric optimization and interpolation technique. With the specific modulus of elasticity and dimensions of the thin film flexible sensor of the mapping catheter prototype, the buckling configuration with two point boundary condition under axial load can be calculated in desktop environment. The proposed calculation method is validated by mapping catheter sensor prototype test. The calculation/test results showed that the maximum overall length L, x[Formula: see text], and y[Formula: see text] value error between the calculation and experiment are approximately 0.16 mm, - 0.12 mm. - 0.10 mm in 50 ms calculation time. The calculation result of the proposed method is also compared with that of the numerical simulation by FEM, which has approximately 0.44 mm y[Formula: see text] value error compared with that of the experiment.

8.
Adv Mater ; 35(43): e2204938, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-35917488

RESUMEN

Hydroxyapatite (HAP) is a green catalyst that has a wide range of applications in catalysis due to its high flexibility and multifunctionality. These properties allow HAP to accommodate a large number of catalyst modifications that can selectively improve the catalytic performance in target reactions. To date, many studies have been conducted to elucidate the effect of HAP modification on the catalytic activities for various reactions. However, systematic design strategies for HAP catalysts are not established yet due to an incomplete understanding of underlying structure-activity relationships. In this review, tuning methods of HAP for improving the catalytic performance are discussed: 1) ionic composition change, 2) morphology control, 3) incorporation of other metal species, and 4) catalytic support engineering. Detailed mechanisms and effects of structural modulations on the catalytic performances for attaining the design insights of HAP catalysts are investigated. In addition, computational studies to understand catalytic reactions on HAP materials are also introduced. Finally, important areas for future research are highlighted.

9.
Minim Invasive Ther Allied Technol ; 21(3): 188-94, 2012 May.
Artículo en Inglés | MEDLINE | ID: mdl-21745135

RESUMEN

The applications of robotic minimally invasive surgery (MIS) have widened, providing new advantages such as augmented dexterity and telesurgery. However, current commercial robotic laparoscopic surgical systems still have aspects to be improved such as heavy and bulky systems not suitable for agile operations, large rotational radii of robot manipulator arms, limited remote control capacity, and absence of force feedback. We have developed a robotic laparoscopic surgical system that features compact slave manipulators. The system can simultaneously operate one laparoscope arm and up to four instrument arms. The slave robot is controlled remotely through an Ethernet network and is ready for telesurgery. The developed surgical robot has sufficient workspace to perform general MIS and has been shown to provide acceptable motion tracking control performance.


Asunto(s)
Procedimientos Quirúrgicos Mínimamente Invasivos/instrumentación , Robótica , Cirugía Asistida por Computador/instrumentación , Telemedicina/instrumentación , Redes de Comunicación de Computadores/instrumentación , Estudios de Factibilidad , Humanos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Cirugía Asistida por Computador/métodos
10.
Tissue Eng Regen Med ; 19(2): 363-375, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-34870799

RESUMEN

BACKGROUND: In vitro generation of three-dimensional vessel network is crucial to investigate and possibly improve vascularization after implantation in vivo. This work has the purpose of engineering complex tissue regeneration of a vascular network including multiple cell-type, an extracellular matrix, and perfusability for clinical application. METHODS: The two electrospun membranes bonded with the vascular network shape are cultured with endothelial cells and medium flow through the engineered vascular network. The flexible membranes are bonded by amine-epoxy reaction and examined the perfusability with fluorescent beads. Also, the perfusion culture for 7 days of the endothelial cells is compared with static culture on the engineered vascular network membrane. RESULTS: The engineered membranes are showed perfusability through the vascular network, and the perfused network resulted in more cell proliferation and variation of the shear stress-related genes expression compared to the static culture. Also, for the generation of the complex vascularized network, pericytes are co-cultured with the engineered vascular network, which results in the Collagen I is expressed on the outer surface of the engineered structure. CONCLUSION: This study is showing the perfusable in vitro engineered vascular network with electrospun membrane. In further, the 3D vascularized network module can be expected as a platform for drug screening and regenerative medicine.


Asunto(s)
Células Endoteliales , Ingeniería de Tejidos , Técnicas de Cocultivo , Matriz Extracelular , Medicina Regenerativa/métodos , Ingeniería de Tejidos/métodos
11.
Medicine (Baltimore) ; 101(9): e28890, 2022 Mar 04.
Artículo en Inglés | MEDLINE | ID: mdl-35244042

RESUMEN

ABSTRACT: The aim of this study was to determine which of 4 laryngoscopes, including A-LRYNGO, a newly developed channel-type video-laryngoscope with an embedded artificial intelligence-based glottis guidance system, is appropriate for tracheal intubation training in novice medical students wearing personal protective equipment (PPE).Thirty healthy senior medical school student volunteers were recruited. The participants underwent 2 tests with 4 laryngoscopes: Macintosh, McGrath, Pentax Airway-Scope and A-LRYNGO. The first test was conducted just after a lecture without any hands-on workshop. The second test was conducted after a one-on-one hands-on workshop. In each test, we measured the time required for tracheal intubation, intubation success rate, etc, and asked all participants to complete a short questionnaire.The time to completely insert the endotracheal tube with the Macintosh laryngoscope did not change significantly (P = .177), but the remaining outcomes significantly improved after the hands-on workshop (all P < .05). Despite being novice practitioners with no intubation experience and wearing PPE, the, 2 channel-type video-laryngoscopes were associated with good intubation-related performance before the hands-on workshop (all P < .001). A-LRYNGO's artificial intelligence-based glottis guidance system showed 93.1% accuracy, but 20.7% of trials were guided by the vocal folds.To prepare to manage the airway of critically ill patients during the coronavirus disease 2019 pandemic, a channel-type video-laryngoscope is appropriate for tracheal intubation training for novice practitioners wearing PPE.


Asunto(s)
COVID-19/prevención & control , Intubación Intratraqueal/instrumentación , Laringoscopios , Laringoscopía/instrumentación , Equipo de Protección Personal/efectos adversos , Adulto , Inteligencia Artificial , Diseño de Equipo , Femenino , Glotis , Humanos , Masculino , Maniquíes , SARS-CoV-2 , Estudiantes de Medicina
12.
Artif Organs ; 35(11): 1127-31, 2011 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-22023171

RESUMEN

In manual or robot-assisted catheter intervention, excessive manipulation force may cause tissue perforation. Using images acquired by an imaging device routinely used for catheter interventions such as X-ray fluoroscopy, the structure and size of blood vessels and the relative position of the catheter tip inside the vessel can be obtained. To prevent collision of the catheter tip and the vessel wall, vision-assisted control methods using forbidden-region virtual fixture (FRVF) technique can be utilized and an experimental implementation has been performed in this study. A master-slave configured robotic platform for cardiac catheter was used for this study. The robotic master handle can provide haptic rendering to the user. A vessel phantom model mimicking human vasculature for the inner radii was fabricated for simulated intervention experiments. A digital optical camera was used for image acquisition. After the vessel phantom and the catheter tip were segmented, distance between the vessel centerline and the catheter tip was calculated and the forbidden region that the catheter tip should keep away from was set for the safe catheter manipulation. Virtual force generation algorithm was implemented for feeding the signal indicating the catheter tip penetrating into the forbidden region back to the user in the robotic master handle. To validate the suggested method, in vitro experiments were conducted. Through a chain of image filtering procedures including edge detection, the catheter tip and the vessel wall were able to be well segmented. The virtual force generator worked appropriately. The developed FRVF technique could provide helpful auxiliary information to clinicians for safer manipulation of catheters in cardiac catheterization procedures.


Asunto(s)
Cateterismo Cardíaco/métodos , Catéteres , Cirugía Asistida por Computador/métodos , Humanos , Robótica/métodos
13.
Artif Organs ; 35(11): 1082-94, 2011 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-22097983

RESUMEN

A magnetic bearing system is a crucial component in a third-generation blood pump, particularly when we consider aspects such as system durability and blood compatibility. Many factors such as efficiency, occupying volume, hemodynamic stability in the flow path, mechanical stability, and stiffness need to be considered for the use of a magnetic bearing system in a third-generation blood pump, and a number of studies have been conducted to develop novel magnetic bearing design for better handling of these factors. In this study, we developed and evaluated a new magnetic bearing system having a motor for a new third-generation blood pump. This magnetic bearing system consists of a magnetic levitation compartment and a brushless direct current (BLDC) motor compartment. The active-control degree of freedom is one; this control is used for controlling the levitation in the axial direction. The levitation in the radial direction has a passive magnetic levitation structure. In order to improve the system efficiency, we separated the magnetic circuit for axial levitation by using a magnetic circuit for motor drive. Each magnetic circuit in the bearing system was designed to have a minimum gap by placing mechanical parts, such as the impeller blades, outside the circuit. A custom-designed noncontact gap sensor was used for minimizing the system volume. We fabricated an experimental prototype of the proposed magnetic bearing system and evaluated its performance by a control system using the Matlab xPC Target system. The noncontact gap sensor was an eddy current gap sensor with an outer diameter of 2.38 mm, thickness of 0.88 mm, and resolution of 5 µm. The BLDC motor compartment was designed to have an outer diameter of 20 mm, length of 28.75 mm, and power of 4.5 W. It exhibited a torque of 8.6 mNm at 5000 rpm. The entire bearing system, including the motor and the sensor, had an outer diameter of 22 mm and a length of 97 mm. The prototype exhibited sufficient levitation performance in the stop state and the rotation state with a gap of 0.2 mm between the rotor and the stator. The system had a steady position error of 0.01 µm in the stop state and a position error of 0.02 µm at a rotational speed of 5000 rpm; the current consumption rates were 0.15 A and 0.17 A in the stop state and the rotation state, respectively. In summary, we developed and evaluated a unique magnetic bearing system with an integrated motor. We believe that our design will be an important basis for the further development of the design of an entire third-generation blood pump system.


Asunto(s)
Corazón Auxiliar , Magnetismo/instrumentación , Simulación por Computador , Campos Electromagnéticos , Diseño de Equipo , Humanos , Modelos Químicos
14.
Artif Organs ; 35(11): 1132-6, 2011 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-22097985

RESUMEN

Bioprinting is a technology for constructing bioartificial tissue or organs of complex three-dimensional (3-D) structure with high-precision spatial shape forming ability in larger scale than conventional tissue engineering methods and simultaneous multiple components composition ability. It utilizes computer-controlled 3-D printer mechanism or solid free-form fabrication technologies. In this study, sodium alginate hydrogel that can be utilized for large-dimension tissue fabrication with its fast gelation property was studied regarding material-specific printing technique and printing parameters using a multinozzle bioprinting system developed by the authors. A sodium alginate solution was prepared with a concentration of 1% (wt/vol), and 1% CaCl(2) solution was used as cross-linker for the gelation. The two materials were loaded in each of two nozzles in the multinozzle bioprinting system that has a total of four nozzles of which the injection speed can be independently controlled. A 3-D alginate structure was fabricated through layer-by-layer printing. Each layer was formed through two phases of printing, the first phase with the sodium alginate solution and the second phase with the calcium chloride solution, in identical printing pattern and speed condition. The target patterns were lattice shaped with 2-mm spacing and two different line widths. The nozzle moving speed was 6.67 mm/s, and the injection head speed was 10 µm/s. For the two different line widths, two injection needles with inner diameters of 260 and 410 µm were used. The number of layers accumulated was five in this experiment. By varying the nozzle moving speed and the injection speed, various pattern widths could be achieved. The feasibility of sodium alginate hydrogel free-form formation by alternate printing of alginate solution and sodium chloride solution was confirmed in the developed multinozzle bioprinting system.


Asunto(s)
Alginatos/química , Órganos Bioartificiales , Hidrogel de Polietilenoglicol-Dimetacrilato/química , Ingeniería de Tejidos/instrumentación , Andamios del Tejido/química , Materiales Biocompatibles/química , Diseño de Equipo , Ácido Glucurónico/química , Ácidos Hexurónicos/química , Ingeniería de Tejidos/métodos
15.
Artif Organs ; 35(11): 1123-6, 2011 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-21954946

RESUMEN

Blood viscosity during operation of ventricular assist device (VAD) can be changed by various conditions such as anemia. It is known generally that the blood viscosity can affect vascular resistance and lead to change of blood flow. In this study, the effect of fluid viscosity variation on hemodynamic energy was evaluated with a pulsatile blood pump in a mock system. Six solutions were used for experiments, which were composed of water and glycerin and had different viscosities of 2, 2.5, 3, 3.5, 4, and 4.5 cP. The hemodynamic energy at the outlet cannula was measured. Experimental results showed that mean pressure was increased in accordance with the viscosity increase. When the viscosity increased, the mean pressure was also increased. However, the flow was decreased according to the viscosity increase. Energy equivalent pressure value was increased according to the viscosity-induced pressure rise; however, surplus hemodynamic energy value did not show any apparent changing trend. The hemodynamic energy made by the pulsatile VAD was affected by the viscosity of the circulating fluid.


Asunto(s)
Viscosidad Sanguínea , Corazón Auxiliar , Flujo Pulsátil , Velocidad del Flujo Sanguíneo , Diseño de Equipo , Hemodinámica , Humanos
16.
Artif Organs ; 35(6): 614-24, 2011 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-21535444

RESUMEN

In 2002, the paracorporeal pulsatile electro-mechanical pneumatic ventricular assist device (VAD) began to be developed by the Korea Artificial Organ Center at Korea University under a Health & Medical Technology Research and Development program which finished in 2008. In vitro durability testing was conducted on the paracorporeal pulsatile pneumatic VAD to determine device durability and to evaluate device failures. The 1- and 2-year reliability of the paracorporeal pulsatile pneumatic VAD was shown to be 91.2% and 54.9%, respectively, with an 80% confidence level. Failure modes were analyzed using fault tree analysis, with customized software continuously acquiring data during the test period. After this period, 21 in vivo animal tests were done, with 14 cases of left atrium to left ventricle (LV) inflow cannulation (36Fr)/outflow grafting to descending aorta, and seven cases of apex cannulation of LV to descending aorta (12 mm). The longest postoperative day (182 days) in Korea was recently recorded in in vivo animal testing (bovine, 90 kg, male, 3.5-4.0 L/min flow rate, and 55 bpm).


Asunto(s)
Corazón Auxiliar , Animales , Bovinos , Diseño de Equipo , Corea (Geográfico) , Falla de Prótesis , Flujo Pulsátil
17.
Korean J Radiol ; 22(3): 442-453, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33629545

RESUMEN

Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and prediction. Discrimination accuracy of AI algorithms is often evaluated with the Dice similarity coefficient, sensitivity, specificity, and traditional or free-response receiver operating characteristic curves. Calibration accuracy should also be assessed, especially for algorithms that provide probabilities to users. As current AI algorithms have limited generalizability to real-world practice, clinical validation of AI should put it to proper external testing and assisting roles. External testing could adopt diagnostic case-control or diagnostic cohort designs. A diagnostic case-control study evaluates the technical validity/accuracy of AI while the latter tests the clinical validity/accuracy of AI in samples representing target patients in real-world clinical scenarios. Ultimate clinical validation of AI requires evaluations of its impact on patient outcomes, referred to as clinical utility, and for which randomized clinical trials are ideal. Device approval of AI is typically granted with proof of technical validity/accuracy and thus does not intend to directly indicate if AI is beneficial for patient care or if it improves patient outcomes. Neither can it categorically address the issue of limited generalizability of AI. After achieving device approval, it is up to medical professionals to determine if the approved AI algorithms are beneficial for real-world patient care. Insurance coverage decisions generally require a demonstration of clinical utility that the use of AI has improved patient outcomes.


Asunto(s)
Inteligencia Artificial , Aprobación de Recursos , Cobertura del Seguro , Área Bajo la Curva , Estudios de Casos y Controles , Toma de Decisiones , Atención a la Salud , Humanos , Neoplasias Pulmonares/diagnóstico , Curva ROC
18.
Biosensors (Basel) ; 11(9)2021 Sep 10.
Artículo en Inglés | MEDLINE | ID: mdl-34562918

RESUMEN

Conventional vascular intervention procedures present issues including X-ray exposure during operation, and an experience-dependent success rate and clinical outcome. This paper presents a novel robotic system using modularized bi-motional roller cartridge assemblies for robotic vascular interventions, specifically percutaneous coronary interventions (PCIs). The patient-side robot manipulates instruments such as the guiding catheter, guidewire, balloon/stent catheter, and diagnostic sensor catheter via commands from the user interface device, which is controlled by the physician. The proposed roller cartridge assembly can accommodate instruments of various sizes with an active clamping mechanism, and implements simultaneous translation and rotation motions. It also implements force feedback in the physician-side system, to effectively monitor the patient-side system's status. The positioning accuracy and precision in using the robotic system showed satisfactory performance in a phantom-based test. It was also confirmed, through animal experiments and a pilot clinical trial, that the system demonstrates feasibility for clinical use.


Asunto(s)
Cateterismo/métodos , Diseño de Equipo , Retroalimentación , Humanos , Fenómenos Mecánicos , Movimiento (Física) , Procedimientos Quirúrgicos Robotizados
19.
Biosensors (Basel) ; 11(7)2021 Jul 16.
Artículo en Inglés | MEDLINE | ID: mdl-34356714

RESUMEN

Skeletal muscle mass deficiency and quality degradation constitute sarcopenia for elderly people. Sarcopenia can result in musculoskeletal damage and accompany various metabolic problems, which make early sarcopenia diagnosis important. Various modalities, such as computed tomography (CT) and magnetic resonance imaging (MRI), have been developed for screening sarcopenia. Recently, ultrasound scanning was suggested for screening sarcopenia because of its safety, usability, and cost effectiveness. However, there has been no standardized assessment methodology for screening sarcopenia with ultrasound scanning. Therefore, prior to this study, we developed a four-degrees-of-freedom (DOF) sarcopenia detection system using an RGB-D camera and an ultrasound probe to automatically scan the human thigh without operator dependency. However, due to the eye-to-hand approach with the RGB-D camera, the system has limited usability for clinical trials. Therefore, in this study we modified the system such that it became eye-in-hand by attaching the RGB-D camera to the upper part of the system with an enhanced arc fitting algorithm. The modified system and enhanced algorithm were verified by an in-vitro test with bean curd-gelatin phantom. The results showed that the thickness of bean curd in the gelatin phantom was maintained at approximately 12.7 ± 0.35 mm over the 71.5∘ scanning range with 2.49 ± 0.15 N radial force at various thickness measuring points.


Asunto(s)
Sarcopenia/diagnóstico por imagen , Ultrasonografía/métodos , Anciano , Humanos , Imagen por Resonancia Magnética , Músculo Esquelético/diagnóstico por imagen , Sarcopenia/patología , Muslo/diagnóstico por imagen , Tomografía Computarizada por Rayos X
20.
Artif Organs ; 34(11): 1034-9, 2010 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-21092046

RESUMEN

Electrophysiological catheters are used for both diagnostics and clinical intervention. To facilitate more accurate and precise catheter navigation, robotic cardiac catheter navigation systems have been developed and commercialized. The authors have developed a novel force-reflecting robotic catheter navigation system. The system is a network-based master-slave configuration having a 3-degree of freedom robotic manipulator for operation with a conventional cardiac ablation catheter. The master manipulator implements a haptic user interface device with force feedback using a force or torque signal either measured with a sensor or estimated from the motor current signal in the slave manipulator. The slave manipulator is a robotic motion control platform on which the cardiac ablation catheter is mounted. The catheter motions-forward and backward movements, rolling, and catheter tip bending-are controlled by electromechanical actuators located in the slave manipulator. The control software runs on a real-time operating system-based workstation and implements the master/slave motion synchronization control of the robot system. The master/slave motion synchronization response was assessed with step, sinusoidal, and arbitrarily varying motion commands, and showed satisfactory performance with insignificant steady-state motion error. The current system successfully implemented the motion control function and will undergo safety and performance evaluation by means of animal experiments. Further studies on the force feedback control algorithm and on an active motion catheter with an embedded actuation mechanism are underway.


Asunto(s)
Ablación por Catéter/instrumentación , Robótica/instrumentación , Cirugía Asistida por Computador/instrumentación , Algoritmos , Ablación por Catéter/métodos , Retroalimentación , Ensayo de Materiales , Diseño de Software , Factores de Tiempo , Torque , Interfaz Usuario-Computador
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