Rotating Atherectomy Device with Debris Management
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Solution Overview
Problem
Current endovascular procedures for clearing occlusions in body lumens, such as atherosclerosis, face challenges in efficiently and safely removing plaque while maintaining vessel patency due to high restenosis rates and mechanical stress on stents, particularly in the peripheral vasculature.
Innovation Solution
The development of advanced atherectomy devices with a flexible catheter body and rotating cutter assembly, featuring a deflecting member and conveying members, allows for controlled and safe removal of occlusive materials, including the use of a burr for grinding calcified lesions, and articulation to navigate tortuous anatomy, combined with features for debris removal and stent deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If balloon angioplasty is used to expand and open the artery by compressing plaque, then luminal diameter is increased, but barotrauma to the vessel wall occurs leading to high restenosis rates
Solution Approach 1:
The patent replaces the high-pressure mechanical compression system of balloon angioplasty with a rotational cutting system. The atherectomy device uses a rotating cutter or burr to mechanically shave or grind plaque away, converting the compression-based mechanism into a removal-based mechanism that avoids barotrauma to the vessel wall.
Solution Approach 2:
The patent extracts the plaque material from the vessel wall through rotational cutting or grinding. The cutter or burr removes plaque particles that are then evacuated through the catheter, physically taking out the obstructing material rather than compressing it, thereby avoiding damage to the underlying vessel wall.
2Force
If a stent with high structural integrity is used to supply sufficient radial force to reopen the artery, then vessel patency is maintained, but the stent fails under mechanical stress in the peripheral vasculature
Solution Approach 1:
The patent changes the mechanical parameters of the treatment approach by removing plaque through atherectomy before stent deployment. This reduces the amount of plaque burden and allows for the use of stents with lower radial force requirements, making them more resistant to mechanical failure in the peripheral vasculature while still achieving adequate vessel patency.
3Productivity
If a rotating cutter is used to remove plaque, then occlusive material is efficiently removed, but debris may embolize downstream vessels
Solution Approach 1:
The patent introduces an intermediary debris management system consisting of a filter positioned downstream of the cutter and an aspiration mechanism. The filter captures plaque particles generated by the rotating cutter, and the aspiration system actively removes debris from the treatment site, preventing embolization while maintaining efficient plaque removal.
Solution Approach 2:
The patent extracts debris from the treatment zone through a combination of filtration and aspiration. The filter physically traps plaque particles, and the aspiration system actively pulls debris away from the cutting zone and downstream vessels, removing the harmful factor generated by the efficient plaque removal process.
4Manufacturing precision
If the cutter assembly is made rigid to maintain cutting precision, then cutting accuracy is improved, but the device cannot navigate tortuous anatomy
Solution Approach 1:
The patent segments the catheter structure into flexible and rigid zones. The proximal catheter body is flexible to navigate tortuous anatomy, while the distal cutter assembly maintains sufficient rigidity for precise cutting. This segmentation allows each portion to perform its optimal function without compromising the other.
Solution Approach 2:
The patent employs flexible catheter materials and thin-walled construction in the proximal portion to enable navigation through tortuous vasculature. The flexibility allows the catheter to conform to vessel curvature while the cutter assembly at the distal end maintains enough structural integrity to perform precise plaque removal.
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
These devices enable efficient and controlled removal of occlusive materials, reducing restenosis and stent failure by maintaining vessel patency and allowing for precise navigation and debris management, improving long-term vessel integrity.
Implementation Method 1
In atherectomy, plaque is cut away, or excised. Various configurations are used including a rotating cylindrical shaver or a fluted cutter.
Implementation Method 2
In some cases a burr may be used instead of a cutter, particularly to grind heavily calcified lesions into very small particle sizes.
Implementation Method 3
Aspiration may also be used with a burr-type atherectomy device.
Data Source
AI summary
The devices and methods generally relate to treatment of occluded body lumens. In particular, the present devices and method relate to removal of the occluding material from the blood vessels as well as other body lumens.