Segmented Cutting Device for Coronary Plaque Removal
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Solution Overview
Problem
Existing medical devices for cutting substances in body lumens, such as stenosed sites in coronary arteries, face challenges with calcified plaque and bifurcated sites, risking tissue damage and device malfunction due to expandable and contractible bars contacting blood vessels and getting caught in gaps.
Innovation Solution
A medical device with a rotatable tubular drive shaft, a treatment member connected to a distal side, an elongated tube, and a bearing member, featuring a strut with a central portion that expands radially outward and a support portion with multiple gaps, allowing for precise cutting and reduced tissue damage by tilting inward during rotation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If expandable and contractible bars are used to cut stenosis substance, then the device can be delivered into the body lumen and expand to perform cutting, but the edges of the bars contact the blood vessel causing tissue damage and the bars get caught in gaps between themselves causing device damage
Solution Approach 1:
The cutting unit is divided into multiple struts that can be independently configured. Each strut has a blade portion positioned radially outward, and the struts are arranged with gaps between them. This segmentation allows the cutting function to be distributed while reducing the harmful effects of individual bar edges contacting tissue and bars getting caught in gaps.
Solution Approach 2:
The struts are configured with different properties at different locations: the blade portions are positioned radially outward for cutting, while the central portions can be made flexible or collapsible. The gaps between struts are positioned and sized to prevent bar entanglement. This local differentiation of properties allows the device to achieve cutting effectiveness while minimizing tissue damage and device malfunction.
2Productivity
If the bars are made rigid to ensure cutting effectiveness, then the cutting performance improves, but the risk of device damage when bars get caught in gaps increases
Solution Approach 1:
The struts are designed with dynamic characteristics - they can be rigid at the blade portions for effective cutting, while the central portions can be flexible or collapsible. This dynamic design allows the struts to maintain cutting effectiveness while being able to flex or collapse to avoid getting caught in gaps, thereby improving device reliability and preventing damage.
3Area of stationary object
If the treatment member is expanded to ensure proper cutting range, then the cutting coverage is sufficient, but the contact with biological tissues increases causing more tissue damage
Solution Approach 1:
The cutting unit is segmented into multiple struts with blades positioned radially outward. This segmentation allows the device to achieve sufficient cutting coverage when expanded, while the segmented structure with gaps between struts reduces the continuous contact area with the blood vessel wall, thereby minimizing tissue damage compared to a solid expandable structure.
Data Source
AI summary
A treatment method and medical device are disclosed for cutting a substance inside a body lumen. The medical device for cutting substances inside a body lumen, the medical device including a rotatable tubular drive shaft; a treatment member connected to a distal side of the drive shaft; an elongated tube extending through the drive shaft; and a bearing member connecting a distal side of the treatment member and the elongated tube.