Steerable Atherectomy Catheter with Rotating 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 long procedure times, 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, where the housing and cutter can rotate relative to each other, allowing for controlled tissue removal and navigation through tortuous vessels, and features such as a sweep frame that enables bending and steering while maintaining a straight configuration when not in use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rotating cylindrical shaver or fluted cutter is used to remove plaque, then tissue removal capability is improved, but procedure time increases and embolic debris is generated
Solution Approach 1:
The cutter assembly is designed to rotate relative to the housing, enabling dynamic cutting action that efficiently removes plaque. The rotation capability allows the cutter to engage and disengage from tissue, improving removal efficiency while reducing procedure time compared to static cutting mechanisms.
Solution Approach 2:
The cutting assembly can be extracted or retracted into the housing when not in use, and deployed when cutting is needed. This selective deployment reduces unnecessary tissue interaction and minimizes embolic debris generation while maintaining effective tissue removal capability when activated.
2Adaptability or versatility
If the catheter is made flexible to navigate tortuous vessels, then navigability is improved, but structural stability deteriorates
Solution Approach 1:
The catheter is divided into multiple segments including a flexible body portion and a more rigid cutter assembly portion. This segmentation allows the distal end to navigate tortuous vessels while the proximal end maintains structural stability for controlled manipulation and cutting operations.
Solution Approach 2:
Different portions of the catheter have different flexibility characteristics - the distal end is more flexible to navigate tortuous anatomy, while the proximal end and cutter assembly maintain greater rigidity for stable positioning and effective cutting. This local variation in mechanical properties resolves the contradiction between navigability and structural stability.
3Manufacturing precision
If the cutter housing rotates relative to the catheter body, then cutting precision is improved, but device complexity increases
Solution Approach 1:
The housing rotation mechanism is integrated with the existing catheter structure, combining the rotational degrees of freedom with the flexible body design. This merging allows precise angular positioning of the cutter relative to the vessel wall without requiring separate complex control systems, thus improving cutting precision while limiting overall device complexity.
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.