Scoring Device for Controlled Vessel Lesion Dissection
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Solution Overview
Problem
Current balloon dilation methods for treating stenotic vessels are inadequate for extended lesions, large vessel diameters, heart valves, and bifurcations, as they fail to provide effective and sustained relief, leading to vessel re-occlusion.
Innovation Solution
A scoring device with multiple longitudinally arranged wires, which can be configured to expand radially with a balloon catheter, is used to perform controlled longitudinal incisions within the vessel, allowing for enhanced maneuverability and treatment options, including cutting, scoring, fracturing, or pulverizing lesions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional balloon dilation is used to treat stenotic vessels, then the luminal dimensions are temporarily increased, but the plaque and vessel walls redistribute to an unfavorable configuration leading to re-occlusion
Solution Approach 1:
The scoring device divides the vessel wall into multiple segments by creating multiple longitudinal scores at different locations around the circumference. This segmentation prevents plaque redistribution by creating discrete, controlled injuries that stabilize the vessel wall configuration, thereby maintaining luminal patency longer than conventional single-site balloon dilation
Solution Approach 2:
The device applies localized scoring actions at specific locations around the vessel circumference rather than uniform dilation. The scoring elements create controlled injuries at predetermined positions, concentrating the mechanical action to stabilize plaque and vessel wall configuration locally, which prevents re-occlusion while maintaining overall vessel patency
2Adaptability or versatility
If scoring elements are added to angioplasty balloons to address extended lesions, then cutting capability is improved, but the device complexity increases
Solution Approach 1:
The scoring device integrates multiple functions into a single apparatus: the balloon provides dilation while the scoring elements provide controlled cutting and scoring. This multi-functional design allows the device to treat extended lesions through combined dilation and scoring actions, improving adaptability without requiring multiple separate devices
Solution Approach 2:
The scoring elements are nested within the balloon structure, with the scoring elements positioned inside or integrated with the balloon membrane. This nested configuration allows the cutting and scoring functionality to be contained within the existing balloon framework, minimizing additional complexity while adding the capability to treat extended lesions
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
The device provides improved vessel treatment by allowing for localized, controlled scoring of lesions, maintaining vessel patency and reducing the likelihood of re-occlusion, and can be adapted for use with various balloon catheter sizes and configurations.
Implementation Method 1
the balloon is inflated which causes radial pressure to be applied to the inner wall of the vessel
Implementation Method 2
manipulating the scoring device to score the material inside the body lumen
Data Source
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AI summary
Systems, devices and methods for treating a stenosed vessel or heart valve are disclosed. In some embodiments, a cutting/scoring assembly/device for treating a stenosed vessel/heart valve is provided and includes a main, elongated element (e.g., wires) with multiple longitude wires arranged at a distal end. A distal end of the elongated element is proximal to the multiple longitude wires which, when used in conjunction with a balloon catheter, is used to for, according to some embodiments, localized controlled longitudinal vessel incision.