Peel-Away Introducer Sheath With Pitched Peel Lines
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Solution Overview
Problem
Existing vascular introducer sheaths with straight score lines do not evenly distribute shearing forces during peeling, leading to operational difficulties and malfunctions, and slitting devices are expensive and require high manual dexterity.
Innovation Solution
A vascular introducer with diametrically opposed peel lines having an axially extending pitch between 5° and 45°, formed by regions of reduced wall thickness with concave inner and outer surfaces, and a method of extrusion using a rotating die to create these pitch lines, facilitating even force distribution and easy separation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If straight score lines are used in peelable sheaths, then the sheath can be easily manufactured, but the shearing forces during peeling are not evenly distributed causing operational difficulties and malfunction
Solution Approach 1:
The patent applies curvature to the peel lines by forming them as arcs rather than straight lines. The peel lines are defined as arcs having a radius of curvature that is a predetermined percentage of the introducer sheath radius, causing the sheath to peel back in a curved manner that evenly distributes shearing forces along the peel path, preventing concentration of forces at any single point.
2Reliability
If slitting devices are used to cut the sheath, then complete separation can be achieved, but the device complexity and manual dexterity requirements increase significantly
Solution Approach 1:
The patent incorporates pre-formed peel lines directly into the sheath structure during manufacturing. These peel lines are created as regions of reduced wall thickness through the extrusion process, forming weak points that guide separation. This preliminary preparation eliminates the need for separate slitting devices during the procedure, as the sheath is designed to separate along these pre-defined paths.
3Ease of manufacture
If straight score lines are used, then fabrication is simple, but uneven separation and partial peeling occur during operation
Solution Approach 1:
The patent applies curvature to the peel lines by forming them as arcs rather than straight lines. The peel lines are defined as arcs having a radius of curvature that is a predetermined percentage of the introducer sheath radius, causing the sheath to peel back in a curved manner that evenly distributes shearing forces along the peel path, preventing concentration of forces at any single point.
Solution Approach 2:
The patent creates regions of locally reduced wall thickness along the peel lines. These regions are formed during extrusion by varying the die geometry to create thinner wall sections that define the peel paths. This local modification of wall thickness ensures that separation occurs uniformly along the curved peel lines while maintaining the overall structural integrity of the sheath.
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 solution ensures even distribution of shearing forces, simplifies the peeling process, reduces fabrication costs, and enhances user efficiency by preventing tearing and ensuring complete separation of the sheath.
Implementation Method 1
The block copolymer material is fed through a unique die while an extruding machine imparts a controlled rotation to the material. This rotation causes a gradual pitch of the peel lines.
Implementation Method 2
The tubular introducer sheath is formed from a polymeric material in an extrusion process. The block copolymer material is fed through a unique die while an extruding machine imparts a controlled rotation to the material.
Data Source
AI summary
A percutaneous peel-away vascular introducer that includes an elongated tubular sheath having opposed proximal and distal ends, and a pair of diametrically opposed peel lines that extend along the length of the sheath from the proximal end thereof to the distal end thereof, wherein the diametrically opposed peel lines have an axially extending pitch. The introducer further includes a pair of spreadable handles associated with the proximal end of the sheath for splitting the sheath along the peel lines.