Abstract
BackgroundBlood-contacting devices have contributed to improving the treatment of patients. However, thrombus formation at the interface between a connector and tube is still a potential source of thrombus-related complications that induce stroke or myocardial infarction. We aimed to develop a non-blood-contacting real-time method for visualizing thrombus formation, and to experimentally investigate the time-dependent phenomenon of thrombus formation at the interface between a connector and a tube in a medical device.Methods and findingsAn optical coherence tomography device with a center wavelength of 1330 nm was used to visualize thrombus formation during porcine blood circulation for 50 min in a closed 50-mL circulation system isolated from ambient air. The thrombus formation sites at the interface between a tube and connector were visualized. The area of the thrombus formation at the interface between the inlet of the connector and the tube was found to be 0.012 ± 0.011 mm2. Conversely, at the interface between the outlet of the connector and the tube, the area was found to be 0.637 ± 0.306 mm2. Thus, significantly larger amounts of thrombus were formed at the outlet interface (p < 0.01). The thrombus formation area at the outlet interface increased over time. Conversely, the area of thrombus formation showed repeated increasing and decreasing behavior at the inlet interface. Flow visualization with particle image velocimetry showed the presence of a flow separated area in the minimal flow phase at the inlet interface and a large recirculating slow flow region at the outlet interface in the minimal flow phase. These data suggested that the recirculating stagnant flow region contributed to thrombus growth.ConclusionsThe method presented here was effective in quantitatively assessing time-dependent phenomena of thrombus formation at the connector-tube interface. The method may contribute to the assessment of thrombogenicity of a novel design of connector.
Highlights
Blood-contacting medical devices, such as extracorporeal membrane oxygenation for longterm support of respiratory as well as cardiac functions and continuous hemofiltration devices for renal failure patients, are commonly used in various patient treatment procedures [1,2]
An optical coherence tomography device with a center wavelength of 1330 nm was used to visualize thrombus formation during porcine blood circulation for 50 min in a closed 50-mL circulation system isolated from ambient air
The thrombus formation area at the outlet interface increased over time
Summary
Blood-contacting medical devices, such as extracorporeal membrane oxygenation for longterm support of respiratory as well as cardiac functions and continuous hemofiltration devices for renal failure patients, are commonly used in various patient treatment procedures [1,2]. The spatial resolution of intravascular ultrasound ranges from 0.1 to 0.2 mm, whereas that of magnetic resonance imaging is approximately 0.8 mm Neither of these techniques is sensitive enough to detect the initiation of thrombus formation [6]. The spatial resolutions of angioscopy and intravascular OCT are higher, ranging from 0.01 to 0.05 mm Both these methods require the removal of some blood components and filling with saline in the vicinity of the observation region, which limit their applicability for continuous monitoring of the thrombus formation process [6]. We aimed to develop a non-blood-contacting real-time method for visualizing thrombus formation, and to experimentally investigate the time-dependent phenomenon of thrombus formation at the interface between a connector and a tube in a medical device
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