Atherectomy Catheter With Deflectable Tip and OCT Imaging
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Solution Overview
Problem
Current atherectomy catheters face challenges in accurately visualizing tissue during cutting due to the placement of imaging sensors far from the cutter, leading to inefficient procedures and the need for multiple devices to complete a single procedure, especially in minimally invasive treatments for coronary artery disease and peripheral artery disease.
Innovation Solution
The development of atherectomy catheters with a distal tip that can be deflected and a hinged mechanism for improved cutting edge exposure, combined with optical coherence tomography (OCT) imaging for real-time feedback and a C-shaped balloon to enhance cutting efficiency and occlude blood flow, along with high-powered flushing jets for material management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If imaging sensors are placed far from the cutter, then device complexity is reduced, but measurement precision deteriorates
Solution Approach 1:
The imaging sensor is nested within the hollow distal tip, positioned close to the cutter. The distal tip acts as a housing that contains both the cutter and imaging sensor in intimate proximity, allowing the sensor to visualize tissue immediately adjacent to the cutting edge while maintaining a compact overall device structure.
Solution Approach 2:
The imaging sensor is positioned in a different spatial dimension relative to the cutter - specifically, the sensor is placed within the hollow distal tip structure, utilizing the three-dimensional space efficiently. This allows the sensor to be close to the cutter without increasing the device's external dimensions significantly.
2Adaptability or versatility
If multiple devices are used to complete a single procedure, then functional versatility is improved, but device complexity increases
Solution Approach 1:
The atherectomy catheter integrates multiple functions into a single device: the hollow distal tip serves as both a protective sheath and a housing for the imaging sensor; the cutter performs plaque removal; the imaging sensor provides real-time visualization; and the distal tip can be deflected to expose the cutting edge. This multi-functional integration eliminates the need for multiple separate devices.
Solution Approach 2:
The patent combines the cutter, imaging sensor, and distal tip structure into a single integrated assembly. The hollow distal tip merges the functions of protection, sensor housing, and cutting edge exposure mechanism, while the imaging sensor is merged with the cutter assembly to provide co-located visualization and cutting capabilities.
3Productivity
If the distal tip is deflected to expose the cutting edge, then cutting efficiency is improved, but device complexity increases
Solution Approach 1:
The distal tip is designed to be deflectable relative to the longitudinal axis of the catheter shaft, transitioning from a protected retracted position to an exposed cutting position. This dynamic movement allows the cutting edge to be exposed only when needed for cutting, improving efficiency while the tip returns to a protected position during navigation and imaging.
Solution Approach 2:
The hollow distal tip is pre-configured with a hinge mechanism that allows it to be deflected to expose the cutting edge before the actual cutting procedure begins. This preliminary positioning ensures the cutting edge is ready for immediate use when the catheter is deployed, improving cutting efficiency without requiring complex real-time adjustment mechanisms.
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
This configuration allows for precise cutting and improved visualization, reducing the number of devices required per procedure and enhancing the mechanical advantage for effective plaque removal, thereby improving the efficiency and accuracy of atherectomy treatments.
Implementation Method 1
a C-shaped balloon that may be configured to expand to urge the cutting edge against a wall of a vessel
Implementation Method 2
a second (occlusion) balloon that may be configured to expand to occlude blood flow through the vessel
Implementation Method 3
optical coherence tomography (OCT) imaging for real-time feedback
Implementation Method 4
high-powered flushing jets for material management
Data Source
AI summary
Atherectomy catheter devices having a C-shaped balloon opposite a cutting window out of which a rotating cutter may extend and a proximal annular balloon. The C-shaped first balloon may be used to drive the cutter against a vessel and to deploy the cutter by assisting in deflecting a nosecone (distal tip) to expose the distal-facing cutting edge of the cutter. The proximal annular balloon may be used to occlude blood flow. The device may pulled, pushed or rotated in a vessel with the balloons inflated or deflated.