Dilator Flap Design for Body Lumen Protection
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Solution Overview
Problem
Existing medical device delivery systems face challenges in efficiently navigating through body lumens during percutaneous procedures, particularly due to issues like 'fish mouthing' which can cause damage and complications during implantation and removal of medical devices.
Innovation Solution
A medical device delivery system featuring a dilator with a tapering tip and flaps that radially protrude to cover the system when tracking through a body lumen, preventing snagging and facilitating smooth traversal, along with a coupler and method for loading medical devices into a delivery catheter, ensuring secure alignment and protection during advancement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a dilator is tracked through a body lumen during delivery, then the medical device can be delivered to the target site, but the rigid structure of the dilator can cause 'fish mouthing' and damage to the body lumen
Solution Approach 1:
The dilator incorporates flaps that can dynamically change their configuration during tracking through the body lumen. The flaps are positioned to cover the outer surface of the dilator during advancement, creating a smoother profile that reduces damage to the body lumen while maintaining the structural integrity needed for reliable device delivery
Solution Approach 2:
The dilator uses thin flap structures that can flex and adapt to the body lumen geometry. These flaps cover the rigid dilator surface, providing a flexible interface that reduces mechanical damage to the body lumen during tracking while maintaining delivery system rigidity
2Ease of operation
If the dilator tip has a smooth tapered structure for easy tracking, then navigation through body lumen is improved, but secure connection to the coupler and medical device becomes more difficult
Solution Approach 1:
The dilator tip is segmented into distinct functional zones: a smooth tapered outer surface for easy tracking through the body lumen, and an inner connection surface with engagement features for secure coupling. This segmentation allows the tip to simultaneously provide smooth navigation and reliable mechanical connection without requiring complex external mechanisms
3Object-affected harmful factors
If flaps are added to cover the dilator during tracking, then damage to body lumen is reduced, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The flaps are constructed as thin film structures that can be formed using standard medical device manufacturing techniques. The thin film design allows the flaps to be integrated into the dilator assembly without requiring complex multi-component assembly processes, maintaining manufacturing simplicity while providing protection during tracking
Data Source
AI summary
A medical device delivery system can include a dilator including a tip having a taper in a distal direction, a coupler, and a flap that radially protrudes from the tip. The flap can be configured to bend against a body lumen to cover at least a portion of the delivery system when the dilator is tracked through the body lumen. A medical device delivery system can include a dilator including a tip having a lumen and a coupler having a lumen. The coupler can be configured to securely connect to the tip such that the lumen of the tip is aligned with the lumen of the coupler to allow a guide wire to pass therethrough. Methods for loading a medical device into a delivery catheter are also disclosed.