Atherectomy Drive and Advancer Split for Sterile Reuse
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Solution Overview
Problem
Existing medical devices for atherectomy procedures are limited by the need for single-use components that increase costs and waste, while reusable components may not be efficiently integrated with single-use parts, leading to inefficiencies and potential contamination risks.
Innovation Solution
Atherectomy systems are designed with a reusable drive assembly and single-use advancer assembly, featuring a rotatable and releasable connection, allowing for cost-effective reuse of expensive components and minimizing contamination through sterile separation of reusable and single-use parts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If single-use components are used for atherectomy procedures, then contamination risks are reduced, but costs increase and waste is generated
Solution Approach 1:
The atherectomy system is divided into two distinct segments: a reusable drive assembly containing the drive motor and controller, and a single-use advancer assembly containing the burr catheter and gearing. This segmentation allows the expensive, complex drive components to be reused while only the sterile, single-use components are disposed of after one procedure, reducing both waste and contamination risks.
Solution Approach 2:
The drive motor and controller are extracted from the single-use portion and placed in a separate reusable drive assembly. This extraction allows the expensive electromagnetic components to be removed from the sterile field, enabling cost-effective reuse while maintaining sterility in the advancer assembly that actually contacts the patient.
2Loss of substance
If reusable components are used, then costs are reduced, but contamination risks increase
Solution Approach 1:
The system separates reusable and single-use components into distinct assemblies. The drive assembly with motor and controller is reusable and remains outside the sterile field, while the advancer assembly with burr catheter is single-use and maintains sterility, thus reducing costs without compromising contamination control.
Solution Approach 2:
A flexible drive cable acts as an intermediary connection between the reusable drive assembly and the single-use advancer assembly. This cable transmits rotational force while maintaining the boundary between reusable and single-use portions, allowing the expensive drive components to be reused without compromising the sterility of the components that contact the patient.
3Productivity
If reusable and single-use parts are integrated, then operational efficiency may improve, but integration complexity increases
Solution Approach 1:
The system is segmented into modular assemblies with clearly defined interfaces. The drive assembly and advancer assembly are separate but can be easily connected through the flexible drive cable, allowing efficient operation without complex integration. Each assembly can be independently prepared, sterilized, and replaced as needed.
Solution Approach 2:
The reusable drive assembly serves as a universal platform that can work with multiple different single-use advancer assemblies. The standardized interface through the flexible drive cable allows the same drive assembly to operate with various burr catheters and advancer configurations, simplifying the overall system while maintaining operational efficiency.
Data Source
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.