Steerable Atherectomy Catheter with Sweep Frame for Tortuous Anatomy
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Solution Overview
Problem
Current endovascular procedures for clearing blood vessel obstructions, such as atherosclerosis, face challenges in navigating tortuous anatomy and maintaining vessel patency due to high rates of restenosis and stent failure in the peripheral vasculature, particularly in environments with significant mechanical stress.
Innovation Solution
The development of a steerable atherectomy catheter with a flexible body and a cutting assembly that includes a sweep frame with a weakened section for deflection, allowing controlled navigation and tissue removal in an arcuate path, combined with a torque shaft for rotational movement, and features to prevent radial twisting and maintain column strength, enabling safe and efficient debulking while minimizing collateral damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a stent with high structural integrity is used to supply sufficient radial force to reopen the artery, then the radial force is improved, but the stent fails in the harsh mechanical environment of the peripheral vasculature due to compression, torsion, extension, and bending
Solution Approach 1:
The catheter is divided into multiple functional segments: a steerable distal tip with cutting assembly, a mid-portion with sweep frame for articulation, and a proximal shaft. This segmentation allows each segment to be optimized for its specific function while collectively providing both radial force and mechanical resilience
Solution Approach 2:
The catheter incorporates dynamic features including a rotatable cutting assembly that can rotate to debulk tissue, a sweep frame that can articulate to navigate tortuous anatomy, and a steerable tip that can be directed precisely. These dynamic capabilities allow the device to adapt to varying mechanical conditions in real-time
2Area of stationary object
If balloon angioplasty is used to expand and open the artery by compressing plaque, then the luminal diameter is increased, but barotrauma to the vessel occurs leading to high rates of restenosis
Solution Approach 1:
The cutting assembly physically removes plaque material from the vessel wall through a debulking action, extracting the obstructing tissue rather than merely compressing it. This removal approach opens the lumen without subjecting the vessel to the high pressures that cause barotrauma
Solution Approach 2:
The patent replaces the mechanical compression system of balloon angioplasty with a rotational cutting system. Instead of using high pressure to force plaque aside, a rotating cutter with cutting edges mechanically shaves or grinds plaque away, substituting a controlled mechanical removal process for high-stress compression
3Adaptability or versatility
If a steerable catheter with sweep frame is used to navigate tortuous anatomy, then navigation capability is improved, but device complexity increases
Solution Approach 1:
The sweep frame is nested within the catheter shaft, and the cutting assembly is nested within the sweep frame. This nested configuration allows multiple functional components to be integrated in a compact manner, providing steerable navigation capability while minimizing the overall device profile and complexity
4Productivity
If a rotating cutter is used to remove plaque, then tissue removal efficiency is improved, but risk of vessel wall damage increases
Solution Approach 1:
The cutting assembly is designed to remove only the necessary amount of plaque to restore luminal patency, avoiding excessive removal that could damage the vessel wall. The controlled debulking action targets diseased tissue while preserving healthy tissue
Solution Approach 2:
The housing surrounding the cutting assembly acts as an intermediary protective structure that limits the depth and extent of tissue interaction. This housing confines the cutting action to intended targets and prevents direct contact between the cutter and vulnerable vessel wall structures
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.