Balloon Catheter Abrasive Distal Tip for Occlusion Crossing
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Solution Overview
Problem
Conventional balloon catheters face difficulties in crossing and treating high-grade stenoses and chronic total occlusions without damaging the vessel wall, especially when encountering calcified plaque.
Innovation Solution
A catheter system with an expandable balloon and an abrasive distal tip, featuring a sharpened or beveled tip and abrasive material, is used to manually abrade and penetrate occlusive material, allowing for safe passage creation and dilation of lesions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If motorized atherectomy devices are used to cross and open chronic total occlusions, then the ability to penetrate calcified plaque is improved, but the risk of damaging the intimal layers of the vessel wall increases
Solution Approach 1:
The catheter is divided into distinct functional segments: a collapsible balloon section for dilation and a separate abrasive distal tip section for plaque modification. This segmentation allows each component to perform its specific function independently - the abrasive tip penetrates calcified plaque while the balloon provides controlled dilation without excessive force that could damage the vessel wall
Solution Approach 2:
The distal tip is specifically designed with abrasive material (such as diamond grit) applied only to its outer surface, creating a localized abrasive region. This local quality enables the tip to effectively abrade and penetrate calcified occlusive material while the rest of the catheter body remains smooth and compliant, minimizing damage to the surrounding vessel wall during navigation and deployment
2Device complexity
If conventional balloon catheters are used for treating high-grade stenoses, then the simplicity of the device is maintained, but the ability to cross and treat chronic total occlusions is insufficient
Solution Approach 1:
The invention merges two previously separate functions into a single integrated catheter device: the plaque modification function (via the abrasive distal tip) and the balloon dilation function. This combination allows the device to both cross chronic total occlusions by abrading the plaque and subsequently dilate the lesion, eliminating the need for multiple separate devices while maintaining operational simplicity
Solution Approach 2:
The catheter is designed with multi-functionality, serving both as a navigation tool through the use of the abrasive distal tip for crossing occlusions and as a treatment device through balloon dilation. This universal design enables a single device to handle both the crossing and treatment phases of interventional procedures, improving reliability without significantly increasing complexity
3Reliability
If an abrasive distal tip is added to the catheter, then the ability to abrade occlusive material is improved, but the device complexity increases
Solution Approach 1:
The abrasive material is pre-applied to the outer surface of the distal tip during manufacturing, creating a ready-to-use abrasive surface before the device enters the patient's body. This preliminary preparation eliminates the need for complex mechanisms to apply or activate abrasive material during the procedure, reducing operational complexity while maintaining effective plaque abration capability
Solution Approach 2:
The abrasive distal tip is designed as a disposable component that is replaced after a single use. This approach simplifies the overall device design by eliminating the need for complex mechanisms to maintain, clean, or replace abrasive elements, as the entire tip is discarded after use. The simplicity of a single-use component offsets the added complexity of incorporating abrasive functionality into the catheter
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
Facilitates the crossing and dilation of high-grade stenoses and chronic total occlusions with minimal risk of damaging the vessel wall, providing a safe and effective treatment for occlusive lesions.
Implementation Method 1
an abrasive distal tip extending distally beyond the expandable member. The distal tip may terminate in a sharpened tip for penetrating occlusive material, e.g., a beveled tip, and/or may include abrasive material on an outer surface thereof, e.g., for abrading occlusive material adjacent the distal tip
Data Source
AI summary
Apparatus and methods are provided for treating a lesion within a body lumen using a catheter including a balloon on its distal end and an abrasive distal tip extending distally beyond the balloon. The distal tip may terminate in a sharpened tip for penetrating occlusive material, e.g., a beveled tip, and includes abrasive material on an outer surface thereof, e.g., abrasive grit, cutting elements, and the like, for abrading occlusive material adjacent the distal tip. The abrasive material may be arranged in a predetermined pattern, e.g., an axial, circumferential, or helical pattern, to facilitate abrading occlusive material. The distal tip may have a substantially uniform diameter or tapered shape along its length.