Steerable Atherectomy Catheter with Deflectable Cutter Housing
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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 due to limitations in existing atherectomy devices and methods.
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 tortuous vessels, remove occlusive materials, and prevent accidental cutting of the vessel wall, while maintaining a straight configuration when not in use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a traditional atherectomy device is used to remove plaque from blood vessels, then plaque removal is achieved, but the procedure time is prolonged and embolic debris is generated
Solution Approach 1:
The atherectomy device is divided into multiple functional segments: a rotatable cutter head with cutting blades for plaque removal, a housing that shields the cutter, and an aspiration system with separate lumen for debris evacuation. This segmentation allows each component to perform its function optimally, improving overall plaque removal efficiency while reducing procedure time
Solution Approach 2:
An aspiration system acts as an intermediary between the cutting action and the bloodstream. The aspiration lumen creates negative pressure that actively draws embolic debris away from the treatment site during plaque removal, preventing embolization while maintaining continuous cutting operation and reducing procedure time
2Productivity
If a cutting assembly is used to remove occlusive materials, then plaque removal is effective, but accidental cutting of the vessel wall may occur
Solution Approach 1:
A housing structure is provided beforehand to shield and contain the rotatable cutter head. The housing acts as a protective barrier that limits the cutter's radial excursions, ensuring that even if the cutter encounters resistance or slips, it cannot easily contact and injure the vessel wall while maintaining effective plaque removal
Solution Approach 2:
The housing serves as an intermediary protective layer between the cutting blades and the vessel wall. It absorbs and redirects forces that might otherwise cause vessel injury, allowing aggressive plaque removal while preventing harmful contact with healthy tissue
3Adaptability or versatility
If a steerable catheter system is used to navigate tortuous vessels, then navigation capability is improved, but device complexity increases
Solution Approach 1:
The catheter incorporates a dynamic sweep frame structure that can be actively deflected and repositioned during the procedure. This allows the catheter to adapt to tortuous vessel anatomy and reach difficult-to-access lesions while maintaining a relatively simple overall device architecture through controlled flexibility rather than complex multi-component steering mechanisms
Data Source
AI summary
The devices and methods generally relate to treatment of occluded body lumens. In particular, the present devices and methods relate to removal of the occluding material from the blood vessels as well as other body lumens. In some variations, the methods comprise providing a vascular device comprising a catheter body, a cutter assembly, a drive mechanism, a torque shaft, and a deflecting mechanism. The methods may further comprise operating the drive mechanism to cut occlusive material, operating the deflecting mechanism to deflect the cutter assembly, and rotating the distal end of the catheter body to sweep the cutter assembly.