Modular Introducer Sheath Assembly for Manufacturing Yield
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Solution Overview
Problem
Conventional introducer sheaths are prone to manufacturing defects, leading to high costs and low yields due to their unitary design, which requires discarding the entire device if a portion is damaged, and struggle with material changes and quality control during manufacturing.
Innovation Solution
The introducer sheath is designed as multiple components that can be assembled using resilient connections, including a hub, retaining member, and elongated tubular member with a flared portion, allowing for secure attachment and easy assembly while accommodating manufacturing variations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If introducer sheaths are formed as unitary design, then manufacturing process is simplified, but manufacturing costs increase and quality control decreases due to discarding entire device when portion is damaged
Solution Approach 1:
The introducer sheath is divided into multiple separate components including a hub portion, an elongated tubular member, and a strain relief member. These components can be manufactured independently and assembled together, allowing defective parts to be replaced without discarding the entire device, thereby improving manufacturing yield and reducing costs.
2Strength
If multiple components are assembled using molding process, then attachment strength is improved, but risk of damaging components during manufacturing increases
Solution Approach 1:
The hub portion includes a distal end that is pre-formed with a recess or groove structure designed to receive the elongated tubular member. This pre-prepared receiving structure allows for controlled assembly without requiring high-force molding operations that could damage components, while still achieving strong attachment.
3Device complexity
If unitary design is used, then device structure is simplified, but adaptability to manufacturing variations and material changes decreases
Solution Approach 1:
By segmenting the introducer sheath into separate components, each component can be manufactured using different materials and processes optimized for its specific function. This allows greater flexibility in material selection and manufacturing methods while maintaining overall device functionality.
Solution Approach 2:
The hub portion serves multiple functions: it provides a connection interface for the elongated tubular member, houses the hemostasis valve, and provides structural support. This multi-functional design allows for standardized hub components that can be paired with different tubular members, enhancing manufacturing flexibility.
4Ease of manufacture
If overmolded process is used for unitary design, then all portions are subjected to heat, but this results in uncontrolled geometry changes and quality decrease
Solution Approach 1:
Separating the manufacturing process into distinct steps for different components avoids subjecting all portions to high heat simultaneously. Each component can be manufactured and cured independently, preserving geometric precision while achieving strong final assembly through controlled bonding processes.
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
This modular design reduces manufacturing costs, enhances quality control, and provides improved kink resistance and splitting properties, allowing for efficient assembly and use in minimally invasive medical procedures.
Implementation Method 1
The distal end of the retaining member contacts the flared portion of the tubular member when the distal end of the retaining member is disposed in the groove such that the tubular member is retained within the lumen of the hub
Data Source
AI summary
In accordance with the present invention there is provided exemplary embodiments of an introducer sheath in accordance with the present invention, wherein the introducer sheath of the present invention is formed of multiple components which are resiliently assembled to form a single introducer sheath. One embodiment of the introducer sheath includes a hub, a retaining member and an elongated tubular member. The hub has a lumen that has a groove. The elongated tubular member has a proximal end that includes a flared portion. The distal end of the retaining member is configured to be received in the groove formed in the lumen of the hub. The distal end of the retaining member contacts the flared portion of the tubular member when distal end of the retaining member is disposed in the groove such that the tubular member is retained within the lumen of the hub in a sealed engagement.