Distal Tip Flareable Funnel Sheath Fish-Mouthing
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Solution Overview
Problem
Delivery catheters experience 'fish-mouthing' and discontinuities between the distal edge of the retaining sheath and the distal tip, leading to difficulties in tracking and potential damage during transcatheter valve replacement procedures, especially when recapturing the prosthetic heart valve.
Innovation Solution
The use of a distal tip configured with a flareable funnel segment and a secure attachment mechanism to maintain engagement with the sheath component, preventing separation and ensuring complete closure, even after deformation, to facilitate safer tracking and recapture of the prosthetic heart valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the delivery catheter is tracked through tortuous anatomy, then the delivery catheter can reach the treatment site within the heart, but the distal edge of the retaining sheath may flex and separate from the distal tip causing fishmouthing
Solution Approach 1:
The distal tip is pre-configured with a flareable funnel segment that can be expanded before deployment to preemptively seal the distal opening of the retaining sheath, preventing fishmouthing from occurring during tracking through tortuous anatomy
Solution Approach 2:
The distal tip transitions from a compressed delivery configuration to an expanded deployed configuration, changing its physical state to maintain engagement with the distal opening and prevent separation during catheter tracking
2Adaptability or versatility
If the distal edge of the retaining sheath separates from the distal tip, then the delivery catheter can navigate tortuous anatomy, but the leading distal edge may catch on and damage vessel walls
Solution Approach 1:
The distal tip acts as an intermediary component between the retaining sheath and the vessel wall, maintaining engagement with the distal opening to prevent the sheath edge from directly contacting and damaging the vessel wall during navigation
Solution Approach 2:
The distal tip is positioned and expanded in advance to create a sealing barrier that prevents the retaining sheath edge from separating and potentially damaging vessel walls during subsequent catheter tracking
3Adaptability or versatility
If the distal edge of the retaining sheath experiences permanent deformation during recapture, then the prosthetic heart valve can be repositioned, but a gap may occur between the distal edge and distal tip reducing tracking capability
Solution Approach 1:
The distal tip is pre-expanded to a larger diameter that can accommodate the deformed distal edge of the retaining sheath after recapture, preemptively preventing gap formation and maintaining tracking capability
Solution Approach 2:
The distal tip maintains an expanded configuration with increased diameter to compensate for the permanent deformation of the retaining sheath edge, ensuring continuous engagement and preserved tracking capability after recapture operations
Data Source
AI summary
Distal tips for use with delivery catheters are disclosed that are configured to maintain complete engagement between the distal tip and a distal opening of a sheath component of the delivery catheter so as to prevent separation therebetween and/or to prevent fish-mouthing of a distal leading edge of the sheath component during in vivo use. Distal tips so configured realize one or more of the objectives of safer tracking of the delivery catheter through the vasculature, safe crossing of the delivery catheter through structural components of the vasculature and heart, such as through native valves, and safe removal of the delivery catheter post deployment.