Segmented Vascular Dilator with Adjustable Shoulders
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Solution Overview
Problem
Conventional vascular dilators and introducer sheaths have a mismatched crossing profile, leading to vessel tears and damage during insertion due to the excess width and rigidity of the sheath, which complicates smooth advancement and increases the risk of injury to the vessel wall and sheath.
Innovation Solution
The design of segmented vascular dilators with adjustable circumferential shoulders and internal recesses allows for a reduced transition between the dilator and the introducer sheath, enabling sequential retraction of segments to minimize damage, with features like radially adjustable mandrels and biasing mechanisms to control shoulder positioning and facilitate smooth entry and withdrawal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the introducer sheath is made thicker and more rigid for structural heart interventions, then the strength and stability of the sheath is improved, but the smooth advancement into the vessel deteriorates and vessel tearing increases
Solution Approach 1:
The dilator is divided into multiple segments that can be retracted sequentially through the sheath. The first segment has a larger crossing profile for initial insertion, while the second segment has a smaller profile for withdrawal, allowing the rigid sheath to advance smoothly without tearing.
Solution Approach 2:
The dilator segments are designed with dynamic retraction capability, where the second segment can be pulled back through the sheath lumen before the first segment is withdrawn. This dynamic sequence allows the sheath to maintain its rigid structure during insertion while avoiding damage during withdrawal.
2Ease of operation
If the dilator crossing profile is made larger to match the sheath, then the retraction through the sheath is improved, but the vessel wall damage during insertion deteriorates
Solution Approach 1:
The dilator is segmented into a first segment with a larger crossing profile for insertion and a second segment with a smaller profile for retraction. This segmentation allows the dilator to match the sheath size during insertion for smooth advancement, while the smaller second segment enables easy retraction through the sheath without damaging the vessel wall.
Solution Approach 2:
Different segments of the dilator have different crossing profiles tailored to specific functions. The first segment has a larger profile for sheath matching during insertion, while the second segment has a reduced profile for minimizing vessel wall contact during retraction, optimizing both insertion and withdrawal.
3Ease of manufacture
If the dilator is designed as a single piece, then the manufacturing simplicity is improved, but the sequential retraction control deteriorates
Solution Approach 1:
The dilator is divided into multiple segments that can be manufactured separately and then assembled, allowing for simpler manufacturing of each individual component while enabling complex sequential retraction control through the sheath. The segmentation allows independent optimization of each segment's properties.
Solution Approach 2:
The second segment is designed to be nested within the first segment during retraction. The smaller second segment can be pulled back through the sheath lumen while the first segment remains in place, creating a nested configuration that enables controlled sequential withdrawal of the dilator components.
Data Source
AI summary
Technology disclosed herein provides a reduced transition between the edge of a rigid vascular dilator and the distal edge of the accompanying introducer sheath. Disclosed dilators can be segmented into two or more primarily longitudinally extending parts, can have rigid circumferential or semi-circumferential leading shoulders to minimize the transition between the dilator and the sheath edge, and can contain internal recesses to allow sequential retraction of segments once the introducer sheath is delivered to a target chamber. With this technology, vascular introducer sheaths can be introduced percutaneously into a broad range of diseased target vessels and chambers with reduced damage to the wall of the vessel or chamber, and with reduced damage to the distal end of the introducer sheath.