Collapsible Vascular Sheath Puncture Locator
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Solution Overview
Problem
Existing vascular insertion devices require a separate puncture locator for proper positioning within a blood vessel, which adds complexity and may lead to mispositioning issues once the locator is removed, and increasing the outer diameter of the insertion sheath to accommodate locating lumens is undesirable as it complicates vessel closure.
Innovation Solution
Incorporating a collapsible puncture-locating lumen within the vascular insertion sheath, reinforced with filaments like stainless steel, carbon fiber, or Kevlar, to provide direct visual indication of the sheath's position through fluid flow without increasing the sheath's outer diameter, allowing for precise placement and detection of mispositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a separate puncture locator is used to indicate insertion sheath position, then the positioning indication is provided, but the device complexity increases and mispositioning may occur after locator removal
Solution Approach 1:
The patent combines the puncture locator functionality directly into the insertion sheath by incorporating locating lumens within the sheath structure. This integration eliminates the need for a separate puncture locator device, thereby reducing device complexity while maintaining continuous position indication capability throughout the procedure.
Solution Approach 2:
The insertion sheath is designed to perform multiple functions: it serves as both the insertion device and the position indicator through its integrated locating lumens. This multi-functionality allows the sheath to provide continuous positioning feedback without requiring additional specialized components.
2Measurement precision
If locating lumens are added to the insertion sheath, then direct position indication is provided, but the outer diameter increases which complicates vessel closure
Solution Approach 1:
The locating lumens are nested within the wall structure of the insertion sheath itself. This nesting approach allows the position indication functionality to be embedded within the existing outer diameter constraints, avoiding the need to increase the sheath size while still providing direct position feedback through the lumens.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The collapsible lumen within the vascular insertion sheath enables direct and precise indication of the sheath's position within the blood vessel, reducing the need for a separate puncture locator and minimizing the risk of mispositioning while maintaining a standard outer diameter, thus facilitating easier vessel closure.
Implementation Method 1
The puncture locator provides a fluid communication path from a distal orifice (where the insertion sheath enters the vessel) to a proximal end, where blood flow can be observed by an operator. As the insertion sheath puncture locator assembly penetrates the vessel wall, blood flows through and out of the puncture locator.
Implementation Method 2
The first flexible lumen comprises a thin, reinforced wall. It is desirable to maintain a thin wall while also adding the precise locating functionality afforded by the puncture locating lumen. Therefore, the first flexible lumen may be reinforced with a coiled, braided, or randomly oriented filaments.
Data Source
AI summary
The present invention provides a vascular insertion sheath with collapsible penetration locators. The collapsible penetration locators provide the insertion sheath with a small outer diameter and the added functionality of precise location indicator. The collapsible penetration locators comprise thin membranes that collapse upon insertion of a sealing device or vascular instrument into the insertion sheath. The insertion sheath includes a reinforced wall according to some embodiments, with a coiled or braided filament for reinforcement.


