Atherectomy Catheter With OCT Imaging and Hinged Tip
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Solution Overview
Problem
Current atherectomy devices face challenges such as limited applicability, high cost, complexity, and inefficiency in treating complex lesions due to large distal tip assemblies, unpredictable tissue collection, and lack of real-time image guidance, leading to increased risk of vessel trauma and restenosis.
Innovation Solution
The development of atherectomy catheters with on-board optical coherence tomography (OCT) imaging, a hinged distal tip mechanism, and C-shaped balloons to enhance plaque removal precision and minimize vessel injury, along with high-powered flushing jets for material management, and a multi-channeled bushing system for improved cutting edge exposure and tissue collection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If large distal tip assemblies are used in current atherectomy devices, then cutting performance is maintained, but device complexity and risk of vessel trauma increase
Solution Approach 1:
The catheter is divided into functional segments including a separate hinged distal tip assembly that can be independently manipulated. The cutting element is segmented from the main catheter body, allowing independent positioning and operation. This segmentation enables complex cutting functions while maintaining overall device manageability and reducing vessel trauma risk.
Solution Approach 2:
The distal tip assembly incorporates a hinge mechanism that allows dynamic movement between covered and exposed positions. The cutting element can be dynamically positioned against the vessel wall only when needed, transitioning from a protected state during navigation to an active cutting state during plaque removal, thereby reducing unnecessary vessel contact and trauma.
2Ease of operation
If traditional atherectomy devices are used without real-time imaging, then procedural simplicity is maintained, but measurement precision and control are insufficient
Solution Approach 1:
An optical coherence tomography (OCT) imaging system is integrated into the catheter, providing real-time cross-sectional images of the vessel wall and plaque during the procedure. This feedback mechanism allows the operator to visualize lesion characteristics, monitor cutting depth, and assess plaque removal efficacy in real-time, enabling precise control while maintaining procedural simplicity through intuitive imaging guidance.
3Device complexity
If conventional tissue collection methods are used, then device simplicity is maintained, but tissue collection predictability and completeness are insufficient
Solution Approach 1:
A suction mechanism is integrated into the distal tip assembly to actively remove cut plaque material from the vessel lumen during atherectomy. The suction channel creates negative pressure that draws debris into a collection reservoir, providing predictable and complete tissue collection without requiring complex mechanical grasping or retrieval mechanisms, thereby maintaining device simplicity while improving collection reliability.
4Adaptability or versatility
If multiple separate devices are used to treat complex lesions, then versatility is improved, but procedural time and complexity increase
Solution Approach 1:
The catheter integrates multiple functions into a single device including navigation, real-time OCT imaging, plaque cutting with a rotatable blade, debris suction, and tissue collection. This multi-functional design allows treatment of various lesion types and complexities without requiring multiple separate devices, thereby reducing procedural time and complexity while maintaining versatility in treating different arterial pathologies.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
These enhancements enable more precise and efficient plaque removal with reduced vessel trauma, improved image guidance, and enhanced procedural outcomes, including better lumen gain and lower restenosis rates.
Implementation Method 1
an optical coherence tomography (OCT) imaging system integrated into the catheter, providing real-time cross-sectional images
Implementation Method 2
The suction mechanism creates negative pressure that draws debris into a collection reservoir
Data Source
AI summary
An atherectomy catheter includes an elongate flexible catheter body, a cutter near the distal end of the catheter body, a drive shaft connected to the cutter and extending within the catheter body, an imaging element near the distal end of the catheter body.