Introducer Sheath with Dynamic Plug Expansion for Vessel Access
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Solution Overview
Problem
Conventional methods of accessing a vessel, such as a femoral artery, for introducing a delivery apparatus require multiple dilators or sheaths that progressively increase in diameter, increasing procedure time and risk of vessel damage.
Innovation Solution
A sheath with an integrated expandable introducer plug that expands transiently upon withdrawal, allowing for the introduction of a delivery apparatus without requiring multiple dilators or progressively larger sheaths.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple dilators or sheaths that progressively increase in diameter are used to access a vessel, then the delivery apparatus can be introduced into the vasculature, but the procedure time increases and the risk of damage to the vessel increases
Solution Approach 1:
The sheath is designed with dynamic expandability, transitioning from a compressed low-profile state for insertion to an expanded state for delivery apparatus introduction. This dynamic structural change eliminates the need for multiple progressive dilators, reducing both procedure time and vessel manipulation steps.
Solution Approach 2:
The sheath is pre-configured with expandable structures (such as expandable supports or self-expanding membranes) that are activated after insertion but before delivery apparatus introduction. This preliminary expansion prepares the sheath to accommodate larger delivery apparatus without requiring additional dilators during the procedure.
2Ease of operation
If multiple dilators or sheaths that progressively increase in diameter are used to access a vessel, then the delivery apparatus can be introduced into the vasculature, but the complexity of the procedure increases
Solution Approach 1:
The invention combines multiple functions into a single sheath structure: the sheath simultaneously provides vessel access, self-dilates through its expandable structure, and prepares the pathway for delivery apparatus introduction. This merging of functions eliminates the need for multiple separate dilators and sheaths, simplifying the overall procedure.
Solution Approach 2:
The sheath is designed as a multi-functional device that performs vessel access, self-expansion, and delivery apparatus accommodation. This universal design replaces the traditional sequence of multiple specialized tools (different sized sheaths and dilators) with a single versatile device.
3Volume of moving object
If a plug is expanded to a large diameter to expand the sheath, then the sheath can accommodate the delivery apparatus, but the pulling force required increases and the risk of the plug getting stuck increases
Solution Approach 1:
The sheath and plug are designed with dynamic expandability, allowing the plug to expand the sheath to the necessary diameter only when needed for delivery apparatus introduction. After the delivery apparatus is introduced, the sheath can be collapsed back to a smaller diameter, reducing the pulling force required for removal and minimizing the risk of the plug getting stuck.
Solution Approach 2:
The sheath's physical parameters (diameter, cross-sectional area) are changed dynamically during the procedure. The sheath expands to a larger diameter during delivery apparatus introduction and then collapses to a smaller diameter for easier removal, optimizing the balance between accommodating the delivery apparatus and minimizing removal resistance.
Data Source
AI summary
A system for introducing a delivery apparatus into a patient's vasculature. The system may include a sheath having a lumen and configured to be inserted into the patient's vasculature. An introducer has a channel for receiving a guide wire and is configured to be positioned within the lumen of the sheath. A plug is coupled to the introducer and is configured to move from a first position in which the plug has a first diameter to a second position in which the plug has a second diameter that is greater than the first diameter and greater than the interior diameter of the sheath, the plug being configured to slide within the lumen in a direction from the distal end of the sheath towards the proximal end of the sheath to expand the sheath in the direction radially outward from the lumen.