Notched Introducer Housing Separation Force Reduction
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Solution Overview
Problem
Existing introducer devices require high forces to separate the sheath housing, which can be challenging for care providers and may result in unintentional device movement or dislodgement, and they are difficult to manufacture consistently due to thin wall thickness and added ergonomic features.
Innovation Solution
A notched housing design that concentrates separation force at a specific area, reducing the required force for separation and incorporating a retainer ring to prevent fluid flow, along with a dilator subassembly for secure fit and easy removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If the housing wall thickness is reduced to promote crack initiation and propagation, then the separation force is reduced, but the housing becomes more difficult to manufacture consistently and harder to produce with repeatable separation force
Solution Approach 1:
The patent applies preliminary action by pre-forming notches in the housing wall before use. These notches are created during manufacturing as controlled features that concentrate stress and initiate crack propagation at predictable locations. This preliminary structural modification allows the housing to separate with reduced force while maintaining manufacturing consistency, as the notches provide predetermined failure points that ensure repeatable separation behavior despite variations in wall thickness or ergonomic features.
2Ease of operation
If ergonomic and aesthetic features are added to the housing, then the housing functionality is improved, but the wall thickness and complexity increase, thereby increasing the force needed to separate the housing
Solution Approach 1:
The patent applies local quality by concentrating structural modifications at specific locations rather than uniformly throughout the housing. The notches are placed at predetermined locations where they will initiate crack propagation, while the rest of the housing can incorporate ergonomic and aesthetic features without uniformly increasing wall thickness. This localized approach allows ergonomic features to be added in non-critical areas while maintaining the separation force reduction achieved through the notched regions.
3Ease of operation
If high force is applied to initiate housing separation, then the housing can be separated, but the device may unintentionally move or dislodge within the vasculature
Solution Approach 1:
The notches serve as pre-prepared failure points that require minimal force to initiate separation. By having the crack initiation sites prepared in advance during manufacturing, the actual separation action during use requires only small forces to propagate the crack from these predetermined locations. This eliminates the need for high separation forces that could cause device dislodgement, while still achieving complete housing separation for sheath removal.
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 notched housing design reduces the separation force needed and ensures consistent separation, improving manufacturability and user safety by focusing the force at a specific point, while the retainer ring enhances sealing and fluid management.
Implementation Method 1
A score-line residing within a portion of the thickness of the exterior surface of the housing extends from the housing body proximal end to the housing body distal end. Positioned at the proximal end of the housing body is a notch that extends at least part way through the thickness of the sidewall and extends from the proximal end of the housing body. This notch, which can comprise a multitude of geometric shapes, is design to concentrate application of the separation force to a specific area or point thus reducing the force required to initiate and propagate the separation crack through the sidewall of the housing body
Data Source
AI summary
An improved splittable medical device introducer designed to introduce a medical device such as a lead or catheter, into a patient's vasculature without loss of blood or introduction of air is described. The introducer assembly is designed with a notch provided at the proximal end of the introducer housing. The notch, which may comprise a multitude of cross-sectional geometries, is designed to reduce the force required to separate the housing and the introducer sheath, thereby minimizing the possibility of unintentional dislodgement during separation. The notch also increases the repeatability and consistency of the amount of force required to separate the introducer housing and sheath.