Angioplasty Balloon Tapered Cutting Edge
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Solution Overview
Problem
Current angioplasty balloon catheters face challenges in effectively treating long lesions and hardened or calcified lesions due to re-stenosis and trauma to healthy tissue, as they often cannot expand these lesions adequately without causing trauma.
Innovation Solution
The development of angioplasty balloon catheters equipped with cutting blades that taper from the distal end to the proximal end, allowing for a tapered cutting edge that can be pulled through lesions to crack, cut, or score them, reducing re-stenosis and trauma while accommodating lesions longer than the blade length.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a standard angioplasty balloon catheter is used to treat long or hardened lesions, then the procedure is simpler, but the lesion cannot be adequately expanded and re-stenosis occurs
Solution Approach 1:
The patent combines an angioplasty balloon with cutting blades to create a hybrid device that performs both angioplasty and lesion cutting in one procedure. The blade is integrated into the balloon structure, allowing simultaneous expansion and cutting action to effectively treat hardened and long lesions without requiring multiple separate procedures.
Solution Approach 2:
The catheter device performs multiple functions: it can inflate the balloon for angioplasty, deploy the blade for cutting hardened lesions, and score the vessel wall to prevent re-stenosis. This multi-functional design addresses various lesion types (hardened, long, and standard) with a single device, improving reliability across different clinical scenarios.
2Reliability
If a cutting blade is added to the angioplasty balloon, then re-stenosis is reduced, but trauma to healthy tissue increases
Solution Approach 1:
The cutting blade is designed with varying thickness along its length, with the thinnest section positioned to contact the vessel wall at the target site. This localized thinning concentrates the cutting action precisely where needed, while the thicker portions of the blade remain retracted or less aggressive, minimizing trauma to surrounding healthy tissue.
Solution Approach 2:
The blade is designed to be deployable and retractable, allowing it to extend only when needed for cutting and retracting when not in use. This dynamic configuration enables precise control over when and where the cutting action occurs, reducing unnecessary contact with healthy tissue while maintaining effective cutting capability at the lesion site.
3Length of moving object
If the cutting blade is made longer to treat longer lesions, then coverage is improved, but delivery through tortuous vasculature becomes difficult
Solution Approach 1:
The cutting blade is designed with a segmented or articulated structure that allows it to flex and conform to tortuous vessel paths during delivery. The blade may consist of multiple sections that can bend relative to each other, enabling navigation through complex vasculature while maintaining sufficient length to cover long lesions once deployed.
Solution Approach 2:
The blade's physical parameters (such as flexibility, cross-sectional shape, or material properties) are optimized to allow easy delivery through tortuous vasculature in the compressed or deflated state, while maintaining sufficient structural integrity and cutting capability when deployed and inflated. The blade may transition from a flexible delivery configuration to a rigid cutting configuration.
Data Source
AI summary
A medical device includes a catheter shaft including a distal region and an inflatable balloon that is secured to the distal region of the catheter shaft. The inflatable balloon has an outer surface and defines a centerline when inflated. A blade extends over and is secured to the outer surface, the blade having a cutting edge extending from a distal end of the blade to a proximal end of the blade, when the inflatable balloon is inflated, the cutting edge extends to a maximum distance measured relative to the centerline of the inflatable balloon at the distal end of the blade and a minimum distance measured relative to the centerline of the inflatable balloon of the medical device at the proximal end of the blade.