Multi-Element Atherectomy Cutter for Total Occlusion Debulking
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Solution Overview
Problem
Existing atherectomy devices struggle to effectively treat total occlusions due to structural and performance limitations, particularly in removing plaque from arteries without causing damage to the arterial wall.
Innovation Solution
An atherectomy device with a cutter assembly featuring a proximal and distal cutting element, each with multiple cutting features or blades, rotatable relative to a housing, and a drive shaft, designed to mechanically remove plaque while minimizing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If balloon angioplasty is performed to reopen narrowed arteries, then blood flow is improved, but the artery is stretched and scar tissue formation occurs leading to restenosis
Solution Approach 1:
The atherectomy device extracts and removes the plaque material from the artery before performing angioplasty. The cutter assembly mechanically debulks the occlusive material, separating the harmful plaque from the arterial wall, which prevents the plaque from causing restenosis while allowing the artery to be reopened with minimal scar tissue formation.
Solution Approach 2:
The atherectomy procedure is performed as a preliminary action before balloon angioplasty. By removing the plaque first, the subsequent angioplasty operates on a cleaner arterial wall, reducing the damage and scar tissue formation that would otherwise occur when inflating the balloon against plaque-laden walls.
2Reliability
If stent placement is performed to prevent re-narrowing of the artery, then arterial patency is maintained, but arterial tissue is cut and scar tissue formation occurs
Solution Approach 1:
The atherectomy device extracts and removes the plaque material from the artery before performing angioplasty. The cutter assembly mechanically debulks the occlusive material, separating the harmful plaque from the arterial wall, which prevents the plaque from causing restenosis while allowing the artery to be reopened with minimal scar tissue formation.
3Productivity
If conventional atherectomy devices are used to remove plaque, then some plaque debulking is achieved, but total occlusions cannot be adequately treated
Solution Approach 1:
The cutter assembly is segmented into multiple cutting elements arranged along the length of the catheter. This segmentation allows different portions of the occlusive material to be addressed by different cutting elements, enabling the device to effectively treat total occlusions that extend along the artery rather than being limited to a single localized site.
Solution Approach 2:
The cutting elements are arranged in a three-dimensional configuration along the catheter length, allowing the device to engage and cut plaque at multiple positions simultaneously or sequentially. This spatial arrangement provides the versatility needed to treat total occlusions that conventional single-point cutting devices cannot adequately address.
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 efficiently debulks occlusive material, including calcified plaque, with reduced risk of arterial wall injury, enhancing luminal gain and reducing restenosis.
Implementation Method 1
A proximal cutting element is rotatably carried by the housing... A distal cutting element is carried by the cutting stem and is rotatable with the proximal cutting element relative to the housing
Data Source
Figure 1
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Figure 2B
AI summary
An atherectomy device including a handle configured to be manipulated by a user. The device further includes a catheter comprising an outer sheath and a drive shaft carried within and rotatable relative to the outer sheath. A cutter assembly is coupled to and extends distally relative to the outer sheath. The cutter assembly includes a housing coupled to and extending distally from the outer sheath. A proximal cutting element is rotatably carried by the housing, and the proximal cutting element is coupled to and extends distally from the drive shaft. The proximal cutting element includes a cutting stem having at least one cutting feature and at least one cutting blade coupled to the cutting stem. A distal cutting element is carried by the cutting stem and is rotatable with the proximal cutting element relative to the housing. The distal cutting element includes at least one cutting blade.