Deflectable Atherectomy Catheter Tip for Tortuous Vessel Navigation
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Solution Overview
Problem
Current atherectomy devices face challenges such as large access requirements, rigid distal assemblies, fixed cut lengths, unpredictable tissue collection, and complexity, limiting their effectiveness in treating coronary and peripheral vasculature, especially in complex lesions and tortuous anatomy, and lack real-time image guidance.
Innovation Solution
The development of atherectomy catheters with laterally displaceable tips and gear-driven cutting mechanisms, incorporating annular cutting rings and internal gear systems for precise tissue removal, along with integration of Optical Coherence Tomography (OCT) for real-time imaging, allowing for controlled cutting and efficient tissue collection and analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If traditional atherectomy devices use rigid distal assemblies, then structural stability is maintained, but control and introduction into tortuous anatomy becomes challenging
Solution Approach 1:
The catheter is divided into modular segments including a proximal catheter body, a distal tip assembly, and an intermediate section with articulation capabilities. This segmentation allows each component to be optimized independently - the distal tip can be rigid for stable cutting while the intermediate section provides flexibility for navigation through tortuous vessels.
Solution Approach 2:
The distal tip assembly incorporates dynamic articulation mechanisms that allow it to deflect and adapt to vessel curvature during introduction, then stabilize into a predetermined configuration once positioned. This dynamic behavior enables the tip to navigate tortuous anatomy while maintaining structural integrity during the atherectomy procedure.
2Quantity of substance
If atherectomy devices use large access devices, then sufficient tissue removal capability is achieved, but crossing profile requirements increase making vessel access difficult
Solution Approach 1:
The cutting elements, tissue collection chamber, and other functional components are nested within the catheter body in a compact configuration. The distal tip assembly can be collapsed into a low-profile state for introduction through small access vessels, then expanded to provide adequate tissue removal capability once positioned in the target lesion.
Solution Approach 2:
The device transitions from a low-crossing-profile configuration during introduction to a three-dimensional expanded configuration during operation. The distal tip assembly expands radially to provide sufficient workspace for plaque removal while maintaining a slender profile during vascular navigation.
3Device complexity
If fixed cut length atherectomy devices are used, then device simplicity is maintained, but adaptability to various disease states and lesion types is limited
Solution Approach 1:
The cutting element assembly incorporates adjustable mechanisms that allow the operator to vary the effective cut length and cutting pattern based on lesion characteristics. The distal tip can be positioned at multiple angles and the cutting element can be advanced or retracted to accommodate different disease states including eccentric lesions, bifurcations, and varying plaque depths.
4Adaptability or versatility
If multiple atherectomy devices are introduced to treat complex lesions, then comprehensive treatment coverage is achieved, but procedure time and operational complexity increase
Solution Approach 1:
The atherectomy catheter integrates multiple functions into a single device including cutting, tissue collection, and intravascular imaging capabilities. The distal tip assembly can accommodate different cutting elements and the device can treat various lesion types including eccentric plaques, bifurcations, and calcified lesions without requiring device exchange, thereby reducing procedural time and complexity.
Data Source
AI summary
Methods of performing an atherectomy using an atherectomy catheter. The atherectomy catheter may include a catheter body, a driveshaft, and a distal tip assembly. The driveshaft may include an annular cutting ring with a distal cutting edge. A long axis of the annular cutting ring can be configured to be parallel to a longitudinal axis of the distal tip assembly when the distal tip assembly is deflected with respect to the catheter body. The methods may include advancing the atherectomy catheter within a vessel lumen; axially moving the driveshaft relative to the catheter body to deflect the distal tip assembly with respect to the catheter body and radially extend the distal cutting edge of the annular cutting ring relative to the distal end of the catheter body; driving the distal cutting edge against a wall of the vessel lumen to remove tissue.