Steerable Atherectomy Catheter with Segmented Cutter
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Solution Overview
Problem
Current treatments for Peripheral Arterial Disease (PAD) face challenges in effectively navigating tortuous anatomy and efficiently removing plaque from blood vessels, leading to prolonged procedures, embolic debris, and high rates of restenosis, especially in the peripheral vasculature where mechanical stresses are high.
Innovation Solution
Development of a steerable atherectomy catheter system with a flexible body and a cutting assembly that includes a housing and cutter, allowing for controlled deflection and rotation to navigate through tortuous vessels while minimizing damage to the vessel wall, and featuring a sweep frame that prevents undesirable bending and enhances cutting efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a rotating cylindrical shaver or fluted cutter is used to remove plaque, then plaque removal capability is improved, but the risk of vessel wall damage and embolic debris increases
Solution Approach 1:
The cutting assembly is segmented into multiple discrete cutting elements (cutting edges) distributed around the circumference of the cutter, allowing controlled plaque removal while reducing concentrated stress on the vessel wall. The cutter body itself is segmented into flutes that guide debris removal
Solution Approach 2:
A housing structure serves as an intermediary between the rotating cutter and the vessel wall, providing a controlled interface that limits the depth and direction of cutting. The housing acts as a mediator to prevent direct uncontrolled contact between the cutter and vessel wall, reducing damage risk
2Adaptability or versatility
If the catheter is made flexible to navigate tortuous vessels, then navigability is improved, but control precision and stability during cutting deteriorate
Solution Approach 1:
The catheter incorporates dynamic flexibility with controlled stiffness characteristics that allow it to adapt to tortuous vessel geometry while maintaining sufficient stability for precise cutting operations. The flexibility is dynamically adjusted through the structural design to balance navigability and control
Solution Approach 2:
Different sections of the catheter have different mechanical properties - the distal portion is more flexible for navigation, while the proximal portion maintains greater stiffness for control. The cutting assembly section has localized structural reinforcement to ensure stability during the cutting operation
3Productivity
If the cutter is allowed to rotate freely to remove plaque efficiently, then plaque removal speed is improved, but the risk of uncontrolled cutting into the vessel wall increases
Solution Approach 1:
The housing is positioned and oriented before the cutter rotation begins, establishing predetermined safe boundaries for the cutting operation. The housing configuration is pre-established to limit the cutter's effective cutting depth and direction, preventing uncontrolled vessel wall injury
Solution Approach 2:
The housing structure provides continuous geometric feedback to the rotating cutter, constraining its motion within safe boundaries. The physical presence of the housing walls creates inherent feedback that prevents the cutter from rotating beyond safe cutting depths, ensuring controlled operation
Data Source
AI summary
The devices and methods generally relate to treatment of occluded body lumens. In particular, the present devices and method relate to removal of the occluding material from the blood vessels as well as other body lumens.