Swaging Die Flexure Gap for Cleanroom Catheter Marker Bands
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Solution Overview
Problem
Existing swaging machines are not well-suited for swaging cylindrical marker bands onto polymer tubes used in balloon catheter assemblies due to contamination concerns, size limitations of cleanrooms, and noise, making them unsuitable for medical applications.
Innovation Solution
A compact, quiet, and contamination-free swager machine and die with a swaging die that features an elongated gap separating it into flexure portions, allowing for precise movement and actuation without externally lubricated components, enabling efficient swaging of marker bands on catheters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional swaging machines are used, then swaging function is achieved, but contamination is introduced and cleanroom requirements are violated
Solution Approach 1:
The patent removes all externally lubricated components and contaminants from the swaging system. The die is designed to operate without external lubrication, extracting the harmful element (contamination) from the system while maintaining swaging functionality.
Solution Approach 2:
The die structure incorporates self-lubricating features through its internal geometry and material properties. The elongated gap design allows the die to self-regulate friction and wear without external lubricants, making the system self-sufficient and contamination-free.
2Ease of manufacture
If large swaging machines are used, then swaging capability is achieved, but cleanroom size and cost increase
Solution Approach 1:
The die is segmented into two separate flexure portions connected by an elongated gap. This segmentation allows the die to flex and close properly while maintaining a compact overall structure, reducing machine size without compromising swaging capability.
Solution Approach 2:
The die incorporates flexible portions that dynamically close during operation. The elastic flexure portions bend to bring the die cavity portions together, enabling the machine to achieve full swaging capability in a compact, dynamic configuration rather than requiring a large static structure.
3Ease of manufacture
If traditional swaging machines are used, then swaging function is achieved, but excessive noise is generated
Solution Approach 1:
The patent replaces traditional mechanical actuation systems with a hub assembly that rotates to actuate the die. This substitution creates a smoother, quieter operation by eliminating the impact and friction associated with conventional mechanical swaging mechanisms.
4Strength
If the die cavity is continuous, then structural strength is maintained, but actuation precision is reduced
Solution Approach 1:
The die cavity is divided into two separate portions by the elongated gap. This segmentation enables precise actuation control as each flexure portion can be independently controlled by the hub assembly, improving manufacturing precision while the overall die structure maintains sufficient strength.
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 allows for efficient, contamination-free swaging of marker bands on catheters, reducing the size and noise of the swaging machine, making it suitable for use in cleanrooms and medical facilities, while maintaining consistent swage force across higher frequencies.
Implementation Method 1
An elongated gap is defined in the swaging die and separates the swaging die into a first flexure portion and a second flexure portion
Data Source
AI summary
A swager machine and die includes a base with a product holder assembly mounted thereon for linear reciprocating movement between a start and a finished position along an axis of movement. A disc is rotatably mounted on the base and has a swaging die mounted thereon. The swaging die defines a die cavity having an open and a closed position. The die cavity has a longitudinal axis coaxial with an axis of rotation of the disc and coaxial with the axis of movement of the product holder assembly. A hub assembly is rotatably mounted on the disc for relative rotation between the hub assembly and the disc. The hub assembly includes actuating apparatus positioned to engage a portion of the swaging die and move the swaging die from the open to the closed position during relative rotation of the hub assembly and the disc.


