Rotating Catheter Tip with OCT Imaging for Occlusion Crossing
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Solution Overview
Problem
Current atherectomy devices for treating peripheral artery disease face challenges such as complex operation, unpredictable tissue removal, limited applicability, and lack of real-time image guidance, leading to inefficiencies and potential vessel damage during occlusion crossing and plaque removal.
Innovation Solution
Development of catheters with a rotating distal tip equipped with an OCT imaging sensor and tissue dissecting elements, allowing for precise navigation and imaging within the vessel while minimizing static friction and avoiding adventitial damage, along with a guidewire lumen for safe occlusion crossing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional atherectomy devices are used for occlusion crossing and plaque removal, then the procedure can be performed, but the operation becomes complex and tissue removal becomes unpredictable
Solution Approach 1:
The catheter is divided into distinct functional segments: a rotatable distal tip for occlusion crossing, a mid-portion with OCT imaging sensor for real-time visualization, and a proximal control portion. This segmentation allows each component to perform its specific function independently, simplifying the overall operation while maintaining comprehensive functionality.
Solution Approach 2:
The catheter integrates multiple functions into a single device: occlusion crossing capability through the rotatable tip, real-time imaging through the OCT sensor, and guided plaque removal. This multi-functionality eliminates the need for multiple separate devices, reducing procedural complexity while maintaining ease of operation.
2Manufacturing precision
If traditional atherectomy devices are used, then plaque removal can be performed, but tissue removal becomes unpredictable and vessel damage may occur
Solution Approach 1:
The OCT imaging sensor provides real-time feedback on the position of the catheter tip and the characteristics of the vessel wall and plaque. This feedback allows the operator to precisely control the depth and location of tissue removal, ensuring accurate plaque excision while avoiding damage to the healthy vessel wall.
Solution Approach 2:
The rotatable distal tip performs preliminary action by safely crossing the occlusion and positioning the catheter before plaque removal begins. The real-time OCT imaging also performs preliminary assessment of the plaque composition and vessel wall integrity, allowing for planned and precise intervention that minimizes vessel damage.
3Measurement precision
If real-time imaging is added to guide the procedure, then navigation precision improves, but device complexity increases
Solution Approach 1:
The OCT imaging sensor is merged with the catheter structure itself, positioned in the mid-portion to provide real-time imaging during the procedure. This integration combines the imaging function with the delivery catheter, improving navigation precision without requiring separate imaging devices and procedures.
Solution Approach 2:
The OCT imaging sensor acts as an intermediary between the operator and the target tissue, providing real-time visual information that bridges the gap between catheter position and tissue characteristics. This intermediary function enhances navigation precision while the automated imaging reduces the operational burden on the user.
4Adaptability or versatility
If the distal tip is made rotatable for better occlusion crossing, then crossing capability improves, but friction and potential tissue damage increase
Solution Approach 1:
The distal tip is designed to be rotatable, allowing it to dynamically adapt to the geometry of the occlusion and vessel path. This rotational capability enables the tip to navigate complex occlusions more effectively while the controlled rotation minimizes friction and reduces the risk of vessel trauma through smooth, predictable motion.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The catheters enable safer and more precise occlusion crossing and plaque removal, reducing vessel trauma and improving procedural outcomes by providing real-time imaging and controlled tissue dissection, thus enhancing treatment efficacy and reducing restenosis rates.
Implementation Method 1
an optical fiber that is configured to wind and unwind within the catheter as the OCT imaging sensor at the distal end rotates
Data Source
AI summary
A catheter device for crossing occlusions includes an elongate body, a central lumen extending within the elongate body from the proximal end to the distal end, a rotatable tip at the distal end of the elongate body, and an OCT imaging sensor. The rotatable tip is configured to rotate relative to the elongate body. The OCT imaging sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. A distal end of the elongate body includes one or more markers configured to occlude the OCT imaging sensor as it rotates. A fixed jog in the elongate body proximal to the distal end of the catheter positions the distal end of the catheter at an angle relative to the region of the catheter proximal to the fixed jog and is aligned with the one or more markers on the elongate body.