Reusable Clip Sizing Tool for Left Atrial Appendage Occlusion
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Solution Overview
Problem
Current single-use clip sizing tools for left atrial appendage closure procedures are expensive, contribute to medical waste, and cannot be recycled due to biohazard concerns, leading to economic and environmental issues.
Innovation Solution
A reusable clip sizing tool made from malleable annealed stainless steel with indicator markers for sizing left atrial appendage clips, designed for autoclave sterilization and featuring atraumatic construction and contrasting marker patterns for enhanced visibility, allowing multiple sterilization cycles and reduced waste.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If single-use clip sizing tools are used, then sterility and safety are ensured, but cost and medical waste increase
Solution Approach 1:
The patent changes the key parameter of the tool from single-use to reusable by modifying its material composition to annealed stainless steel, which can withstand autoclave sterilization. This allows the tool to be sterilized and reused multiple times, reducing medical waste while maintaining sterility assurance through controlled sterilization processes.
Solution Approach 2:
The patent employs composite material construction combining annealed stainless steel for structural components with specialized coatings or treatments on the indicator markers to ensure they withstand sterilization. This composite approach enables the tool to maintain both structural integrity and functional visibility after repeated sterilization cycles.
2Loss of substance
If reusable tools are used, then cost and waste are reduced, but sterilization durability must be maintained
Solution Approach 1:
The patent specifies annealed stainless steel as the material, which has been heat-treated to achieve optimal balance between flexibility and sterilization resistance. The annealing process modifies the material parameters to resist deterioration from autoclave and chemical sterilization while maintaining bendability after repeated use.
Solution Approach 2:
The patent designs the indicator markers with inherent durability features, using methods like laser engraving, chemical etching, or stamping that create permanent markings resistant to sterilization. This beforehand cushioning ensures the markers maintain visibility and accuracy through multiple sterilization cycles without degrading.
3Measurement precision
If indicator markers are made visible with high contrast, then sizing accuracy is improved, but marker durability through sterilization becomes challenging
Solution Approach 1:
The patent uses contrasting inverted background patterns between adjacent sizes with alternating contrast levels to enhance visibility. These patterns are applied through durable methods such as laser engraving, chemical etching, stamping, or pad printing, which ensure the markers withstand multiple sterilization cycles while maintaining their contrasting appearance for accurate sizing.
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 reusable tool reduces costs and waste by allowing sterilization and reuse, maintaining functionality and accuracy through multiple cycles while minimizing environmental impact.
Implementation Method 1
The malleable material can comprise annealed stainless steel configured to resist deterioration from autoclave and chemical sterilization and to maintain bendability after use.
Implementation Method 2
The plurality of indicator markers are made by laser engraving, chemical etching, stamping, or pad printing.
Data Source
AI summary
Disclosed herein are devices and methods for a reusable clip sizing tool to select a clip for use with a left atrial appendage. The clip can comprise a handle portion having a proximal end and a distal end, a base portion distal to the handle portion, a plurality of indicator markers on the base portion, wherein the plurality of indicator markers comprise numbers corresponding to a size of a left atrial appendage when a distal end of the base portion is aligned with the left atrial appendage. The plurality of indicator markers can comprise alternating contrast levels. The handle portion and the base portion can comprise a malleable material.