Flexible Cutting Balloon Catheter Navigating Tortuous Vasculature
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Solution Overview
Problem
Existing cutting elements in angioplasty balloon catheters are rigid, limiting their flexibility and ability to navigate tortuous vasculature, which can lead to re-stenosis and trauma to both the treatment site and adjacent healthy tissue.
Innovation Solution
The development of cutting balloon catheters with cutting members featuring enhanced flexibility designs, such as T-shaped slots, undulating patterns, and discrete regions of flexibility, which are securely mounted to the balloon using polymeric adhesive pads to reduce strain concentrations and improve navigation through complex vascular anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If rigid cutting elements are used in angioplasty balloon catheters, then cutting effectiveness is improved, but flexibility and ability to navigate tortuous vasculature deteriorates
Solution Approach 1:
The cutting element is divided into multiple segments or struts connected by hinges, allowing each segment to flex independently while maintaining the overall cutting structure. This segmentation enables the cutting element to adapt to tortuous vasculature while preserving cutting effectiveness at the lesion site.
Solution Approach 2:
The cutting element transitions from a static rigid structure to a dynamic flexible structure with moving joints. The hinges or flex points allow the cutting element to change its configuration dynamically, conforming to the vascular anatomy while maintaining cutting capability when deployed.
2Manufacturing precision
If rigid cutting elements are mounted to the balloon, then cutting precision is improved, but conformance to balloon expansion characteristics deteriorates
Solution Approach 1:
The cutting element incorporates flexible components such as thin-walled struts or membrane-like structures that can expand and conform with the balloon while maintaining their cutting function. These flexible structures allow the cutting element to follow the balloon's expansion pattern closely.
Solution Approach 2:
The cutting element's physical parameters such as thickness, material properties, or structural configuration are changed to allow flexibility during balloon expansion. The element is designed to be flexible during inflation but maintains sufficient rigidity to perform cutting when the balloon is fully expanded.
3Adaptability or versatility
If flexible cutting elements are used, then navigation through tortuous anatomy is improved, but cutting effectiveness deteriorates
Solution Approach 1:
The cutting element is segmented into multiple rigid or semi-rigid sections connected by flexible joints. Each segment maintains cutting capability while the connections between segments provide the necessary flexibility for navigation through tortuous vasculature.
Solution Approach 2:
The cutting element uses composite material construction combining rigid materials for cutting surfaces with flexible materials for the structural framework or connections. This composite approach allows the element to be both flexible enough for navigation and rigid enough for effective cutting.
Data Source
AI summary
A cutting balloon catheter including a balloon mounted on a distal portion of a catheter shaft. The balloon includes a cutting member mounted on an exterior surface of the balloon which includes one or more features for providing the cutting member with enhanced flexibility for navigating tortuous anatomy and more closely conforms to the expansion characteristics of the balloon to which the cutting member is mounted.