Balloon Catheter Cutting Elements for Hardened Lesion Dilation
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Solution Overview
Problem
Conventional balloon catheters face challenges in effectively dilating hardened stenotic regions and preventing acute occlusion and restenosis during angioplasty procedures, with issues such as abrupt closure and re-narrowing of arteries due to elastic recoil, arterial dissection, and thrombosis.
Innovation Solution
A balloon catheter with an expandable balloon and a cutting device featuring at least one cutting element, where a bioactive is applied directly to the vessel wall during dilation, either on the cutting element, within the balloon, or on its surface, to facilitate precise delivery and reduce unnecessary bioactive application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional balloon catheters are used to dilate hardened stenotic regions, then the procedure is simple and non-invasive, but the dilation effectiveness is insufficient due to resistance from hardened plaque
Solution Approach 1:
The patent combines a cutting device with a balloon catheter into a single integrated device. The cutting elements are mounted on the balloon surface, allowing simultaneous plaque disruption and vessel dilation in one procedure, thereby improving dilation effectiveness without requiring multiple separate interventions
Solution Approach 2:
The cutting device is segmented into multiple discrete cutting elements distributed across the balloon surface. This segmentation allows targeted disruption of hardened plaque at specific locations while maintaining the ability to dilate the entire vessel segment, resolving the contradiction between effectiveness and complexity
2Reliability
If bioactive is applied broadly to the vessel wall, then coverage is comprehensive, but the amount of bioactive required increases and unnecessary application occurs
Solution Approach 1:
The patent applies bioactive substances locally at the cutting sites rather than uniformly across the entire balloon surface. The bioactive is concentrated at specific locations where plaque disruption occurs, providing targeted prevention of abrupt closure and restenosis while minimizing the total quantity of bioactive required
Solution Approach 2:
The bioactive is pre-applied to the cutting elements before the procedure. When the cutting elements contact the vessel wall during dilation, the bioactive is immediately delivered to the treatment site, ensuring timely prevention of complications without requiring broad application
3Reliability
If cutting elements are added to the balloon catheter, then the ability to treat hardened lesions is improved, but the device complexity and potential for arterial dissection increase
Solution Approach 1:
The cutting and dilation functions are merged into a single simultaneous action. The balloon inflation that expands the vessel also presses the cutting elements against the plaque, ensuring that cutting occurs only when the vessel is properly supported and diluted, thereby reducing the risk of arterial dissection while effectively treating hardened lesions
Data Source
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AI summary
A balloon catheter is provided that may be used to dilate hardened regions of a stenosis on a vessel wall. The balloon catheter is provided with cutting elements that extend along a surface of a balloon. At least one bioactive is present, either on the cutting element, within the interior of the balloon, within the material of the balloon or on an outside surface of the balloon. The bioactive is delivered to the vessel wall upon dilation of the balloon.