The CathEye: A Forward-Looking Ultrasound Catheter for Image-Guided Cardiovascular Procedures.

Catheter based procedures are typically guided by X-Ray, which suffers from low soft tissue contrast and only provides 2D projection images of a 3D volume. Intravascular ultrasound (IVUS) can serve as a complementary imaging technique. Forward viewing catheters are useful for visualizing obstructions along the path of the catheter. The CathEye system mechanically steers a single-element transducer to generate a forward-looking surface reconstruction from an irregularly spaced 2-D scan pattern. The steerable catheter leverages an expandable frame with cables to manipulate the distal end independently of vessel tortuosity. The tip position is estimated by measuring the cable displacements and used to create surface reconstructions of the imaging workspace with the single-element transducer. CathEye's imaging capabilities were tested with an agar phantom and an ex vivo chronic total occlusion (CTO) sample while the catheter was confined to various tortuous paths. The CathEye maintained similar scan patterns regardless of path tortuosity and was able to recreate major features of the imaging targets, such as holes and extrusions. The feasibility of forward-looking IVUS with the CathEye is demonstrated in this study. The CathEye mechanism can be applied to other imaging modalities with field-of-view (FOV) limitations and represents the basis for an interventional device fully integrated with image guidance.

The CathCam: A Novel Angioscopic Solution for Endovascular Interventions.

Peripheral arterial diseases are commonly managed with endovascular procedures, which often face limitations in device control and visualization under X-ray fluoroscopy guidance. In response, we developed the CathCam, an angioscope integrated into an expandable cable-driven parallel mechanism to enhance real-time visualization, precise device positioning and catheter support for successful plaque crossing. The primary objective of this study was to assess and compare the performance of the novel CathCam with respect to conventional catheters and the CathPilot (i.e., CathCam without the angioscope), for applications in crossing chronic total occlusions (CTO). We first assessed the system in 3D-printed phantom models, followed by an ex vivo evaluation with CTO samples from a patient's superficial femoral artery. We measured and compared success rates, crossing times, and fluoroscopy times in both experiments. The CathCam demonstrated a 100% success rate in phantom experiments and a 75% success rate in ex vivo experiments with CTO samples, compared to conventional catheters, with 35% and 25% success rates, respectively. The average crossing times for the CathCam and the conventional catheter were 31 s and 502 s for the phantom experiments and 210 s and 511 s for the actual CTO lesions. The Cathcam also showed to be a reliable endovascular imaging approach in an in vivo experiment. Compared to conventional catheters, the CathCam significantly increased the success rate and reduced crossing and fluoroscopy times in both phantom and ex vivo setups. CathCam can potentially improve clinical outcomes for minimally invasive endovascular interventions by offering high-resolution real-time imaging alongside accurate device control.

The CathPilot: Performance Validation and Preclinical Safety and Feasibility Assessment.

OBJECTIVES: Peripheral endovascular revascularization procedures often fail due to technical limitations of guidewire support, steering, and visualization. The novel CathPilot catheter aims to address these challenges. This study assesses the safety and feasibility of the CathPilot and compares its performance to conventional catheters for peripheral vascular interventions. METHODS: The study compared the CathPilot to non-steerable and steerable catheters. The success rates and access times for a relevant target inside a tortuous vessel phantom model were assessed. The reachable workspace within the vessel and the guidewire's force delivery capabilities were also evaluated. To validate the technology, chronic total occlusion tissue samples were used ex vivo to compare crossing success rates with conventional catheters. Finally, in vivo experiments in a porcine aorta were conducted to evaluate safety and feasibility. RESULTS: The success rates for reaching the set targets were 31%, 69%, and 100% with the non-steerable catheter, the steerable catheter, and the CathPilot, respectively. CathPilot had a significantly larger reachable workspace, and allowed for up to four times higher force delivery and pushability. In crossing of chronic total occlusion samples, the CathPilot achieved a success rate of 83% and 100%, for fresh and fixed lesions respectively, which was also significantly higher than conventional catheters. The device was fully functional in the in vivo study, and there were no signs of coagulation or damage to the vessel wall. CONCLUSION: This study shows the safety and feasibility of the CathPilot system and its potential to reduce failure and complication rates in peripheral vascular interventions. The novel catheter outperformed conventional catheters in all defined metrics. This technology can potentially improve the success rate and outcome of peripheral endovascular revascularization procedures.

Quantification of Mechanical Characteristics of Conventional Steerable Ablation Catheters for Treatment of Atrial Fibrillation Using a Heart Phantom.

PURPOSE: Accurate and reliable catheter navigation is important in formation of adequate lesions during radiofrequency cardiac catheter ablation. To inform future device design efforts and to characterize the limitations of conventional devices, the focus of this study is to assess and quantify the mechanical performance of manual ablation catheters for pulmonary vein isolation procedures within a phantom heart model. METHODS: We measured three important metrics: accuracy of catheter tip navigation to target anatomical landmarks at the pulmonary veins (PVs), orientation of the catheter relative to the tissue at the targets, and the delivered force values and their stability and variations at those targets. A stereovision system was used for navigational guidance and to measure the catheter's tip position and orientation relative to the targets. To measure force, piezoelectric sensors were used which were integrated at the targets, whereby operators were instructed to stabilize the catheter to achieve a chosen reference force value. RESULTS: An overall positioning accuracy of 1.57 ± 1.71 mm was achieved for all targets. No statistical significance was observed in position accuracy between the right and left PVs (p = 0.5138). The orientation of the catheter relative to tissue surface was 41° ± 21° with no statistical significance between targets. The overall force stability was 41 ± 6 g with higher difficulty in force stabilization in the right compared to the left PV (40 ± 8 vs. 43 ± 2 g, p < 0.0001). CONCLUSION: Based on our results, future improvements to manual catheter navigation for ablation should focus on improving device performance in orientation control and improved force stability.

Experimental Protocol and Phantom Design and Development for Performance Characterization of Conventional Devices for Peripheral Vascular Interventions.

Conventional catheter-based interventions for treating peripheral artery disease suffer high failure and complication rates. The mechanical interactions with the anatomy constrain catheter controllability, while their length and flexibility limit their pushability. Also, the 2D X-ray fluoroscopy guiding these procedures fails to provide sufficient feedback about the device location relative to the anatomy. Our study aims to quantify the performance of conventional non-steerable (NS) and steerable (S) catheters in phantom and ex vivo experiments. In a 10 mm diameter, 30 cm long artery phantom model, with four operators, we evaluated the success rate and crossing time in accessing 1.25 mm target channels, the accessible workspace, and the force delivered through each catheter. For clinical relevance, we evaluated the success rate and crossing time in crossing ex vivo chronic total occlusions. For the S and NS catheters, respectively, users successfully accessed 69 and 31% of the targets, 68 and 45% of the cross-sectional area, and could deliver 14.2 and 10.2 g of mean force. Using a NS catheter, users crossed 0.0 and 9.5% of the fixed and fresh lesions, respectively. Overall, we quantified the limitations of conventional catheters (navigation, reachable workspace, and pushability) for peripheral interventions; this can serve as a basis for comparison with other devices.