Scoring Balloon Structure for Cutting Lesions and Easy Refolding
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Solution Overview
Problem
Existing balloon catheters struggle to effectively expand stenosed sites, particularly in calcified lesions or in-stent restenosis lesions, due to shifting during expansion and lack of maneuverability, especially when deflated for insertion.
Innovation Solution
A balloon catheter design with protruding portions featuring notches that allow cutting and expanding stenosed sites while deflated, improving maneuverability and rigidity, and facilitating easy folding for insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the height of the scoring element is reduced at both ends of the balloon, then the maneuverability is improved, but the cutting capability at the distal end is insufficient
Solution Approach 1:
The scoring element is designed with non-uniform height distribution: the proximal end has a first height optimized for maneuverability during insertion, while the distal end has a second height greater than the first height to provide enhanced cutting capability where it is most needed during expansion. This local differentiation resolves the contradiction between ease of insertion and effective cutting.
2Reliability
If the height of the protruding portion in the distal-side cone region is made high, then the cutting function is improved, but the maneuverability during insertion is reduced
Solution Approach 1:
The scoring element exhibits spatially varying height characteristics: lower height at the proximal end for smooth insertion through the guiding catheter, and higher height at the distal end for effective cutting during balloon expansion. This gradient design allows the same element to serve both insertion and cutting functions optimally.
3Device complexity
If a general balloon catheter is used to expand a stenosed site with calcification, then the procedure is simple, but the expansion effectiveness is poor
Solution Approach 1:
The scoring element performs preliminary cutting of the calcified stenosed site before the balloon expansion takes place. By pre-fracturing the calcified plaque, the subsequent balloon expansion becomes effective and complete, transforming a simple but ineffective procedure into a two-stage process that ensures reliable expansion.
4Reliability
If the balloon is inflated to expand a stenosed site, then the treatment function is achieved, but the position may shift in ISR lesions
Solution Approach 1:
The scoring element creates initial cuts in the stenosed site before balloon inflation. This preliminary action establishes anchor points that prevent the balloon from shifting position during subsequent expansion, especially critical in ISR lesions with slippery neointima surfaces, thereby maintaining position stability while achieving treatment.
Data Source
AI summary
A balloon for a balloon catheter that, when deflated, can cut a stenosed site and be easily folded to reduce outer diameter and a balloon catheter including the balloon are provided.The balloon includes a balloon main body having an outer surface and an inner surface and a protruding portion protruding outward in a radial direction from the outer surface of the main body and extending in a longitudinal axis direction. The protruding portion in a straight tube portion has an ST-portion notch and the protruding portion in a distal-side tapered portion has a DT-portion notch. A depth of the ST-portion notch and a depth (D4) of the DT-portion notch are each 50 μm or more, and the depth (D3), a height (H3) of the protruding portion in the straight tube portion, the depth (D4), and a height (H4) of the protruding portion in the distal-side tapered portion satisfy D3/H3≤D4/H4.