Self-Expanding Scaffold Scoring Assembly for Stenotic Regions
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Solution Overview
Problem
Current angioplasty procedures for treating stenotic regions in vessels often result in restenosis and vessel damage due to the inability to effectively score or cut the stenotic material, leading to incomplete dilation and potential cardiac arrest, stroke, or tissue necrosis.
Innovation Solution
A medical assembly comprising a self-expanding scaffold with a scoring member and a deployment member that allows for selective expansion and scoring of stenotic regions, enabling concurrent dilation and scoring to prevent restenosis and minimize vessel trauma by using a scoring member that can receive various-sized dilatation balloons.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a dilatation balloon is used to dilate the stenotic region, then the vessel lumen is enlarged, but the stenotic material cannot be effectively scored or cut, leading to restenosis and vessel damage
Solution Approach 1:
The patent combines the scoring function and dilation function into a single integrated assembly. The scoring member with cutting edges is positioned on the exterior surface of the dilatation balloon, allowing simultaneous scoring of the stenotic material and dilation of the vessel lumen in one procedure, thereby achieving complete dilation and preventing restenosis
Solution Approach 2:
The scoring member scores or cuts the stenotic material before the dilatation balloon inflates to dilate the vessel. This preliminary action of scoring the calcified or fibrotic plaque makes the stenotic region more susceptible to dilation and reduces the risk of vessel damage during the dilation process
2Manufacturing precision
If high balloon pressure is applied to dilate the stenotic region, then the vessel lumen is enlarged, but vascular trauma increases
Solution Approach 1:
The scoring member scores the stenotic material before dilation, creating controlled incisions in the calcified or fibrotic plaque. This preliminary scoring reduces the resistance to dilation, allowing the dilatation balloon to achieve effective lumen enlargement with lower pressure, thereby minimizing vascular trauma
3Ease of operation
If conventional angioplasty is performed without scoring, then the procedure is simpler, but treatment efficacy is reduced
Solution Approach 1:
The scoring member and dilatation balloon are integrated into a single assembly that is delivered through a catheter over a guidewire. This combined design allows the physician to perform both scoring and dilation in one straightforward procedure without requiring separate steps or devices, maintaining procedural simplicity while enhancing treatment efficacy
Solution Approach 2:
The scoring member automatically scores the stenotic material as the assembly is advanced to the target site, before the dilatation balloon is inflated. This preliminary scoring action is performed seamlessly as part of the delivery process, maintaining ease of operation while significantly improving treatment efficacy by enabling effective dilation of calcified or fibrotic plaque
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 solution enhances treatment efficacy by maintaining the enlarged opening in stenotic regions, reducing the likelihood of restenosis, and minimizing vascular trauma during angioplasty, allowing for effective blood flow restoration with lower balloon pressure.
Implementation Method 1
the self-expanding scaffold can be movable between a downsized configuration, when receiving axial tension from the deployment member, and an expanded configuration, in the absence of axial tension
Data Source
AI summary
Assemblies and methods for scoring a stenotic region within a vessel of a patient are disclosed. An assembly can comprise a scoring member and a deployment member. The scoring member can include an elongate push structure and a tubular, self-expanding scaffold. The elongate push structure can be positioned proximal of the self-expanding scaffold and, at its distal end portion, eccentrically coupled with a proximal end portion of the self-expanding scaffold. The deployment member can be removably positioned within a central lumen of the self-expanding scaffold and detachably engageable with a portion of the self-expanding scaffold. The self-expanding scaffold can be movable between a downsized configuration, when receiving axial tension from the deployment member, and an expanded configuration, in the absence of axial tension. The assembly can further comprise means for detachably engaging the deployment member and the self-expanding scaffold and means for detachably engaging the deployment member and the elongate push structure.