Monolithic Introducer Sheath Hub Design for Lumen Alignment
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Solution Overview
Problem
Conventional introducer sheaths are complex assemblies of multiple components, leading to alignment issues during manufacturing, increased costs, and potential damage during overmolding, necessitating a simpler and cost-effective design.
Innovation Solution
A monolithic introducer sheath with an elastically deformable tubular portion and a hub portion formed as a unitary member, featuring a concave valve portion that can move between relaxed and expanded states to align lumens accurately and facilitate sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional introducer sheaths are assembled from multiple components (sheath portion, hub, hemostasis valve), then the device can be manufactured with standardized parts, but the alignment of lumens becomes difficult and manufacturing time increases
Solution Approach 1:
The patent combines the sheath portion and hub into a single unitary component formed by injection molding. This merging eliminates the need for separate assembly of multiple components, thereby ensuring precise lumen alignment while maintaining manufacturing efficiency through standardized injection molding processes.
2Strength
If the hub is overmolded over the elongated sheath portion to produce a stronger sheath, then the structural strength is improved, but the risk of damaging the introducer sheath increases and the entire device must be discarded
Solution Approach 1:
The patent incorporates the hub and sheath portion as a unitary component formed in advance through injection molding, eliminating the need for subsequent overmolding operations. This preliminary formation of the complete structure prevents damage during manufacturing while achieving the required structural strength.
3Adaptability or versatility
If conventional introducer sheaths are assembled from separate components, then manufacturing flexibility is improved, but additional time must be taken during manufacture to ensure alignment leading to increased costs
Solution Approach 1:
The patent merges the hub and sheath portion into a single unitary component formed by injection molding. This eliminates the time-consuming alignment process required for separate components while maintaining manufacturing flexibility through the adaptability of injection molding techniques.
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 design reduces manufacturing complexity and costs, ensures precise alignment of lumens, and minimizes the risk of damage during production, resulting in a more efficient and cost-effective medical device.
Implementation Method 1
The valve portion is substantially non-planar in a relaxed state
Data Source
AI summary
An introducer sheath and methods of making the introducer sheath are described. The introducer sheath may include a hub portion and a tubular portion. The hub portion may include a substantially non-planar valve portion in a relaxed state. The valve portion may include an aperture configured to receive a medical device. A hub portion may be formed using a forming device. An aperture may be formed through a distal surface of the valve portion.