Expandable Balloon Sheaths With Splitting Element
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Solution Overview
Problem
Existing expandable balloon sheaths are fragile and prone to damage during insertion, and their coatings, such as drug coatings, can be damaged or lost during handling and navigation.
Innovation Solution
A tubular sheath designed to enclose and protect the expandable balloon, featuring a longitudinal splitting element or a gripping portion with poor cohesive strength, allowing for easy removal and minimizing contact that could damage the balloon or its coating.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the expandable balloon is made fragile to allow easy expansion, then the balloon can be inflated at the target site, but it becomes prone to damage during insertion and handling
Solution Approach 1:
The system is divided into two distinct components: a fragile expandable balloon for the target site and a robust tubular sheath for protection during insertion. The sheath acts as a separate protective segment that encloses the balloon during handling and navigation, allowing the balloon to remain fragile yet protected. This segmentation resolves the contradiction by spatially separating the fragile component from the protective structure.
Solution Approach 2:
The tubular sheath provides preliminary protection to the expandable balloon before insertion into the patient's body. By pre-enclosing the fragile balloon in a protective sheath during handling and navigation, the system prevents damage that would otherwise occur. The sheath is then removed at the target site, allowing the balloon to be inflated safely.
2Reliability
If the tubular sheath is designed to enclose the expandable balloon through the entire insertion process, then the balloon is protected from damage, but the sheath must be removable without damaging the balloon or its coating
Solution Approach 1:
The tubular sheath incorporates localized features with different properties: a gripping portion with relatively poor cohesive strength that facilitates easy removal. This local quality change allows the sheath to provide robust protection during insertion while enabling simple removal by applying force to the specific gripping portion. The gripping portion's weakened cohesive strength creates a controlled failure point that prevents damage to the balloon during sheath removal.
Solution Approach 2:
The gripping portion is designed as a removable component or feature that can be extracted or separated from the main body of the sheath. By providing a specific gripping portion with poor cohesive strength, the system allows the operator to easily remove or split the sheath by applying force to this extracted portion, thereby facilitating sheath removal without damaging the enclosed balloon or its coating.
3Adaptability or versatility
If the expandable balloon includes drug coatings for treatment, then the balloon provides therapeutic benefit, but the coatings are damaged or lost during insertion and handling
Solution Approach 1:
The tubular sheath provides beforehand cushioning and protection to the drug-coated balloon during insertion and handling. By enclosing the coated balloon within the smooth-walled sheath, the system prevents mechanical damage, abrasion, and loss of the delicate drug coating. The sheath acts as a protective cushion that shields the coated surface from external forces until the balloon reaches the target site.
Solution Approach 2:
The tubular sheath functions as a flexible protective shell that encloses the drug-coated balloon. This flexible shell provides a smooth, protective interface that prevents damage to the coating while allowing the balloon to be navigated through the vasculature. The sheath's flexible nature accommodates the balloon's shape while maintaining protection of the therapeutic coating.
Data Source
AI summary
A tubular sheath for enclosing an expandable balloon attached to the distal portion of a catheter encloses and protects the expandable balloon. The tubular sheath is configured to be slidable and removable from the catheter. The tubular sheath may include a longitudinal splitting element that is removable as a result of a force applied to the longitudinal splitting element. The longitudinal splitting element is configured to split the wall of the tubular sheath in response to the force. Alternatively, the tubular sheath may include a gripping portion that has relatively poor cohesive strength to adjacent portions of the tubular sheath. The tubular sheath is configured to be removable in response to a force applied to the gripping portion.