Sheathed Scoring Elements for Tortuous Vessel Navigation
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Solution Overview
Problem
Existing angioplasty balloons with rigid cutting blades face challenges in navigating tortuous vessels and cause inadvertent tissue damage due to their fixed structure, limiting flexibility and increasing the risk of vessel dissection.
Innovation Solution
A sheathed scoring element system comprising a separate scoring member and sheath, where the sheath moves relative to the scoring member between delivery and scoring conditions, allowing for improved navigation and reduced tissue damage by providing a larger quantity of flexible scoring members that can be deployed at the target site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If rigid cutting blades are used on angioplasty balloons, then cutting effectiveness is improved, but flexibility and ability to navigate tortuous vessels deteriorates
Solution Approach 1:
The cutting element is divided into multiple discrete scoring members (at least two separate elements) rather than a single rigid blade structure. Each scoring member can independently flex and score the vessel wall, allowing the assembly to navigate tortuous vessels while maintaining cutting capability through distributed scoring actions.
Solution Approach 2:
The scoring members are designed to be dynamically flexible rather than rigid, allowing them to bend and conform to the vessel geometry during navigation. The scoring members can flex radially and longitudinally to navigate tortuous vessels while still delivering effective scores to the atherosclerotic plaque when the balloon is inflated.
2Strength
If fixed blades permanently attached to balloon surface are used, then cutting capability is improved, but risk of inadvertent tissue contact and entanglement increases
Solution Approach 1:
The scoring members are designed to be dynamically flexible rather than rigid, allowing them to bend and conform to the vessel geometry during navigation. This flexibility prevents inadvertent contact with non-target tissues while maintaining cutting capability when properly positioned at the target site.
Solution Approach 2:
The scoring members act as intermediaries between the balloon and the vessel wall, providing a controlled mechanism for scoring. The flexible scoring members can be positioned precisely at the target site and will only contact the vessel wall when the balloon is inflated and positioned correctly, reducing the risk of inadvertent tissue damage during navigation.
3Strength
If atherotomes several millimeters in length are used, then scoring effectiveness is improved, but ability to navigate along vasculatures deteriorates
Solution Approach 1:
The scoring members are designed to be dynamically flexible rather than rigid, allowing them to bend and conform to the vessel geometry during navigation. This flexibility enables the relatively long scoring members (several millimeters in length) to navigate along tortuous vasculatures without causing inadvertent tissue contact or entanglement.
Solution Approach 2:
The scoring members are constructed as flexible elements that can bend and flex radially and longitudinally. This flexibility allows the scoring members to conform to the curvature of tortuous vessels during navigation while maintaining their scoring capability when positioned at the target site.
Data Source
AI summary
An example system for treatment of a vessel lesion, the system comprising a catheter shaft; a balloon having an exterior surface, where the balloon is configured to move between a deflated condition and an inflated condition; and a sheathed scoring element that is separate from the balloon and includes: a scoring member having a proximal end region, a distal end region, and a body portion therebetween; and a sheath including a channel, where the sheath is configured to move relative to the scoring member between: a delivery condition where at least a portion of the scoring member is located in the channel; and a scoring condition where the portion of the scoring member is located distal to a distal end of the channel and is configured to contact a target site.