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

Area of Science:

• Vascular Surgery
• Medical Device Engineering
• Interventional Radiology

Background:

• Peripheral artery disease interventions face high failure rates due to device limitations.
• Conventional catheters exhibit poor controllability, limited pushability, and inadequate anatomical feedback during procedures.
• Current imaging modalities like 2D X-ray fluoroscopy lack precise device localization.

Purpose of the Study:

• To quantitatively assess and compare the performance of conventional non-steerable (NS) and steerable (S) catheters.
• To evaluate catheter-based intervention limitations in terms of navigation, workspace, and force delivery.
• To establish a performance benchmark for future peripheral intervention device development.

Main Methods:

• Phantom and ex vivo experiments were conducted using a 10 mm diameter, 30 cm long artery model.
• Four operators evaluated target access success rate, crossing time, accessible workspace, and delivered force for both NS and S catheters.
• Ex vivo chronic total occlusions (fixed and fresh lesions) were used to assess crossing success and time.

Main Results:

• Steerable catheters achieved a 69% target access success rate versus 31% for non-steerable catheters.
• Operators accessed 68% of the cross-sectional area with steerable catheters compared to 45% with non-steerable ones.
• Mean force delivered was 14.2 g for steerable and 10.2 g for non-steerable catheters; 0% of fixed lesions were crossed with NS catheters.

Conclusions:

• Conventional catheters possess significant limitations in navigation, workspace, and pushability for peripheral interventions.
• Steerable catheters demonstrate superior performance in target access, workspace utilization, and force delivery.
• This quantitative analysis provides a critical baseline for evaluating novel devices in peripheral interventions.