Steerable Sheath Disassembly for Reusable Intravascular Devices
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Solution Overview
Problem
There is a need for safe, reliable, and predictable practices to reuse intravascular medical devices, such as ultrasound imaging devices, that have been exposed to bodily fluids, and improved systems for better control and usability of these devices.
Innovation Solution
A method of disassembling and reassembling a medical device system with a steerable sheath and handle assembly, including actuators for deflection and rotation control, and a flexible circuit strip with removable insulation layers to create new electrical contacts, allowing for cleaning and reuse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If a medical device is reused after exposure to bodily fluids, then cost is reduced, but safety and reliability deteriorate due to improper cleaning and handling by inexperienced individuals
Solution Approach 1:
The patent employs a disposable sheath that is discarded after a single use, while the expensive ultrasound probe and handle assembly can be reused. This resolves the contradiction by making the component most prone to contamination (the sheath) disposable, thereby ensuring safety through proper disposal rather than risky reuse, while still reducing overall cost compared to making the entire system disposable.
Solution Approach 2:
The medical device system is segmented into distinct reusable components (ultrasound probe, handle assembly) and a disposable component (sheath). This segmentation allows the expensive, complex components to be reused while the contaminated portion is discarded, balancing cost reduction with safety maintenance.
2Loss of substance
If a medical device is disassembled for cleaning and reuse, then cost is reduced, but device complexity increases and may cause damage
Solution Approach 1:
By making the sheath disposable, the patent eliminates the need to disassemble complex components for cleaning. The simple sheath structure is designed for easy removal and disposal, avoiding the complexity and risk associated with disassembling and reassembling complex medical devices.
3Adaptability or versatility
If the distal portion of the medical tool is designed to extend beyond the sheath, then functionality is improved, but ease of manufacture deteriorates
Solution Approach 1:
The device is segmented into a sheath portion and a tool portion that can be manufactured separately and then assembled. The distal portion of the tool is designed to extend beyond the sheath when assembled, providing the necessary functionality while allowing independent manufacturing of components, thus maintaining ease of manufacture.
Data Source
Figure 1A~1B
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AI summary
Systems, and methods of disassembling systems that includes a medical device, a shaft that is optionally steerable, and a handle assembly. The methods can include providing a system after it has been exposed to a blood environment of a subject, disconnecting a medical device electrical contact from an electrical contact on the printed circuit board, moving the medical distally relative to the sheath and out of the distal end of the sheath, and cleaning at least a portion of the medical device.