Reusable Atherectomy Drive With Single-Use Advancer Coupling
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Solution Overview
Problem
Existing atherectomy systems face challenges in efficiently and cost-effectively removing occlusive material from body lumens, particularly due to the need for single-use components that cannot be reused and the complexity of integrating reusable and single-use assemblies.
Innovation Solution
Atherectomy systems are designed with a reusable drive assembly and a single-use advancer assembly, featuring a rotatable connection and a mechanism for advancing and retracting the atherectomy burr, allowing for the separation of reusable and disposable parts to enhance cost-effectiveness and operational flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single-use advancer assembly is used, then sterility and contamination risk are improved, but device complexity and cost increase
Solution Approach 1:
The atherectomy system is divided into two distinct segments: a reusable drive assembly and a single-use advancer assembly. This segmentation allows the sterility-critical components to be disposable while the expensive drive mechanism can be reused, resolving the contradiction between sterility requirements and device complexity
Solution Approach 2:
A coupling mechanism serves as an intermediary between the reusable drive assembly and the single-use advancer assembly. This intermediary enables reliable connection and disconnection while maintaining sterility barriers, allowing the system to achieve both sterility and reusability without excessive complexity
2Reliability
If expensive components are made single-use, then sterility is improved, but cost efficiency deteriorates
Solution Approach 1:
The system segments components based on their reusability characteristics, making only the necessary sterile portions (advancer assembly) disposable while keeping expensive reusable components (drive assembly) intact for multiple uses, thereby improving cost efficiency while maintaining sterility
Solution Approach 2:
The advancer assembly is designed as a disposable component that is relatively inexpensive compared to the drive assembly, allowing it to be discarded after single use to maintain sterility without significant cost penalty, while the expensive drive assembly is preserved for reuse
3Adaptability or versatility
If reusable and single-use assemblies are integrated, then operational flexibility is improved, but ease of operation deteriorates
Solution Approach 1:
A specially designed coupling mechanism acts as an intermediary that simplifies the connection and disconnection operations between reusable and single-use assemblies. This intermediary provides intuitive engagement features and clear operational cues, making the complex integration easy to operate while maintaining operational flexibility
Data Source
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AI summary
An atherectomy system includes a drive assembly and an advancer assembly. The drive assembly, which may be reusable, includes a drive motor having an output shaft and a first coupler segment that is secured relative to the output shaft. A controller may be adapted to regulate operation of the drive motor. The advancer assembly, which may be single use, includes a flexible drive cable that is adapted to be releasably securable to the first coupler segment. The advancer assembly includes gearing that is secured within the advancer assembly and is operably coupled with the flexible drive cable. A burr catheter is coupled with and extends distally of the gearing. The advancer assembly is adapted to enable relative translation of the burr catheter in order to advance and withdraw an atherectomy burr rotatably secured to a distal end of the burr catheter.