Rotating Atherectomy Tip with Auger Aspiration for Plaque Removal
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Solution Overview
Problem
Current minimally invasive vascular surgical methods, such as balloon angioplasty and atherectomy, face challenges in effectively removing plaque and improving blood flow due to limitations in device design and invasiveness, particularly in handling hard occlusions and calcified lesions, which can lead to restenosis and complications.
Innovation Solution
An atherectomy device with a rotatable tip and shaft designed for high-speed rotation, featuring a unique geometry and material composition to enhance plaque removal, including scalloped sections and an auger mechanism for efficient debris aspiration, allowing for larger plaque removal areas and reduced introducer sheath size, facilitating insertion through smaller incisions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If balloon angioplasty is used to treat vessel occlusion, then the procedure is minimally invasive, but the plaque is only stretched or cracked and not removed, leading to frequent restenosis
Solution Approach 1:
The atherectomy device extracts and removes plaque material from the vessel wall through mechanical cutting or ablation, rather than merely compressing it as in balloon angioplasty. The cutting elements physically remove the obstructive material, which is then evacuated through the device, addressing the restenosis problem by eliminating the plaque rather than just displacing it.
Solution Approach 2:
The invention replaces the purely mechanical compression mechanism of balloon angioplasty with a combined mechanical cutting and suction system. The atherectomy device uses rotating cutting elements to mechanically remove plaque while simultaneously using suction to evacuate debris, providing a more effective and durable solution to vessel occlusion.
2Productivity
If atherectomy device with larger cutting tip is used to remove more plaque, then plaque removal area increases, but device size increases requiring larger introducer sheath and larger incision
Solution Approach 1:
The atherectomy device employs a nested structure where the cutting elements and plaque removal mechanisms are housed within a compact catheter that can pass through a relatively small introducer sheath. The device components are arranged concentrically and telescoping, allowing the functional elements to be contained within a minimal external profile during insertion, then deployed at the target site to perform extensive plaque removal.
Solution Approach 2:
The device utilizes three-dimensional deployment of cutting elements that can extend radially outward from the catheter axis to engage plaque over a larger surface area, while maintaining a small axial profile for introduction. The cutting elements may be arranged in multiple planes or layers, allowing extensive plaque contact and removal without proportionally increasing the device's introduction size.
3Productivity
If high-speed rotation is used to cut through hard occlusion and calcified lesions, then plaque removal effectiveness increases, but device complexity and risk of complications increase
Solution Approach 1:
The atherectomy device integrates multiple functions into a single platform: high-speed rotation for cutting hard and calcified plaque, low-speed rotation for softer plaque, and suction for debris evacuation. The device can adapt its rotational speed and cutting element configuration to handle different plaque types, providing a universal solution that reduces the need for multiple specialized devices while managing complexity through integrated control.
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 effectively breaks up and removes plaque, widening the blood passageway with reduced trauma and recovery time, improving blood flow while minimizing the risk of restenosis and complications associated with traditional surgical methods.
Implementation Method 1
a rotatable tip having a proximal end and a distal end, the proximal end of the rotatable tip positioned distally of a distalmost edge of the outer member to create a gap providing a fixed spacing between the proximal end of the rotatable tip and the distalmost edge of the outer member for the aspiration of particles
Implementation Method 2
an auger mechanism for efficient debris aspiration
Implementation Method 3
create a gap providing a fixed spacing between the proximal end of the rotatable tip and the distalmost edge of the outer member for the aspiration of particles
Data Source
Figure 1~3A
Figure 4~8
Figure 9~10B
AI summary
An atherectomy device for removing deposits such as plaque from an interior of a vessel including an outer member (24, 47, 80, 80', 100, 120) and a rotatable shaft (20, 42, 70, 70', 94, 114, 138) positioned for rotational movement within the outer member. The outer member is fixed axially. A rotatable tip (12, 45, 50, 60, 92, 112) is mounted to the distal region of the rotatable shaft for rotation about its longitudinal axis upon rotation of the shaft. The rotatable shaft includes a guidewire lumen (25) for receiving a guidewire (G) to enable over the wire insertion of the device.