Loop-Shaped Lesion Crossing Tip for Calcified Occlusions
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Solution Overview
Problem
There is a need to improve the passability of medical devices through lesions, particularly in highly calcified lesions such as chronic completely occlusions.
Innovation Solution
A medical device with an elongated main body and a leading portion that includes a loop shape at its distal end, where the outer edge has specific geometric configurations to enhance entry and passage through lesions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional medical device with a simple distal end structure is used, then the device structure is simple, but the passability through highly calcified lesions is insufficient
Solution Approach 1:
The leading portion is designed with a loop shape having specific curvature characteristics. The outer edge includes a convex portion that curves toward the distal end, allowing the device to better conform to and penetrate highly calcified lesion structures. This curvature enables the leading portion to effectively engage with the lesion wall while maintaining structural integrity during advancement.
Solution Approach 2:
The outer edge of the loop-shaped leading portion features asymmetric geometry with a convex portion on one side and a straight portion on the other. This asymmetric design allows the device to interact differently with the lesion wall during rotation, creating effective drilling motion while maintaining a relatively simple overall structure. The asymmetric shape provides directional engagement with the calcified tissue.
2Reliability
If the leading portion has a loop shape with specific outer edge configuration, then the passability through lesions is improved, but the manufacturing precision requirements increase
Solution Approach 1:
The loop shape with controlled curvature provides a balanced design that achieves effective lesion penetration while maintaining manufacturability. The curvature radius and convex portion dimensions are specified within practical ranges that can be achieved through conventional medical device manufacturing processes, avoiding excessively tight tolerances.
Solution Approach 2:
The asymmetric outer edge configuration concentrates the geometric complexity only at the critical leading edge contact points with the lesion, while the rest of the device maintains simpler geometry. This localized complexity approach focuses manufacturing precision requirements only where they are most needed for lesion engagement, rather than requiring high precision throughout the entire device.
Data Source
AI summary
A medical device includes an elongated main body part and a leading portion connected to a distal end of the main body part and enters a lesion. When viewed from a first direction orthogonal to an axial direction of the main body part, an outer edge of the leading portion satisfies at least one of (1) a first condition that the outer edge has a first end portion located at a distal end of the leading portion and a second end portion located on a side opposite to the first end portion across a center axis of the main body part in a second direction orthogonal to both an axial direction of the main body part and the first direction, the second end portion being convex toward the distal end side, and (2) a second condition that the outer edge has a straight portion extending in the second direction.