Balloon Protector Tapered Sleeve Profile Reduction
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Solution Overview
Problem
Existing balloon protectors for catheters are difficult to apply and remove without damaging the balloon or its coating, and they do not effectively reduce the profile to improve trackability and flexibility.
Innovation Solution
A balloon protector comprising an inner sleeve with a tapered outer surface and an outer sleeve with a tapered inner surface, allowing easy application and removal without damaging the balloon, and reducing the profile by moving between expanded and contracted configurations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a balloon is used to maintain the expanded state of a self-expanding scaffold, then the scaffold can be delivered in a compressed state, but the balloon may rupture due to high radial forces during expansion
Solution Approach 1:
The balloon is divided into multiple segments or sections that can independently withstand the radial forces. Each segment is designed to handle a portion of the total expansion force, reducing the risk of rupture while maintaining the overall structural integrity needed for scaffold expansion.
Solution Approach 2:
The balloon is pre-treated with a protective coating or pre-inflated to a predetermined pressure before deployment. This beforehand cushioning creates a protective barrier that prevents rupture during the high-stress expansion phase, allowing the scaffold to achieve full expansion without balloon failure.
2Ease of operation
If a balloon is used to maintain the expanded state of a self-expanding scaffold, then the scaffold can be delivered in a compressed state, but the balloon may be misplaced or remain in the vessel after scaffold deployment
Solution Approach 1:
The balloon is designed with a detachable or extractable feature that allows it to be easily removed from the vessel after serving its purpose. The balloon can be deflated and withdrawn through the catheter, preventing misplacement while ensuring complete removal after scaffold expansion is achieved.
Solution Approach 2:
A guide wire or stylet is used as an intermediary tool to control and position the balloon during deployment. The guide wire provides a stable reference that prevents balloon misplacement, while the balloon itself can be easily manipulated and removed along the guide wire after scaffold expansion.
3Strength
If a self-expanding scaffold is used, then the scaffold can expand without external support, but the scaffold may collapse or deform during delivery
Solution Approach 1:
The scaffold is pre-formed and pre-stabilized in a compressed state within the delivery catheter before deployment. The delivery catheter provides a protective sheath that maintains the scaffold's structural integrity during delivery, preventing collapse or deformation while allowing the scaffold to expand autonomously upon release.
4Manufacturing precision
If a balloon is used for scaffold deployment, then the scaffold can be expanded to the desired diameter, but the balloon may not be able to maintain the expanded state due to vessel compliance
Solution Approach 1:
The balloon is designed with adjustable pressure parameters and variable wall thickness to compensate for vessel compliance. By changing the pressure distribution and structural parameters of the balloon, it can maintain sufficient expansion force even when the vessel walls deform during scaffold deployment.
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3A~3B
AI summary
A balloon protector for a balloon catheter. the balloon protector comprising an inner sleeve having an interior for receiving a balloon and a tapered outer surface. The balloon protector further comprising an outer sleeve having a tapered inner surface. The interior of the inner sleeve has an expanded configuration and a contracted configuration. The tapered outer surface of the inner sleeve engages the tapered inner surface of the outer sleeve such that pushing the inner sleeve and the outer sleeve together will move the interior of the inner sleeve from the expanded configuration to the contracted configuration.