Orthogonal Clip for Single-Operator Heart Valve Loading
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Solution Overview
Problem
Conventional delivery devices for self-expanding collapsible prosthetic heart valves require two operators to load the valve due to the length of the delivery system, making the process cumbersome and inefficient.
Innovation Solution
A delivery device with a catheter assembly and an operating handle, where an outer shaft is coupled to a clip that fixes the catheter assembly at a specific distance from the handle, allowing for easier loading of the prosthetic heart valve, and includes a clip system that holds an intermediate portion of the outer shaft in a fixed relationship to the handle, reducing the overall length and facilitating single-operator loading.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the delivery device uses a long outer shaft to accommodate the catheter assembly, then the catheter assembly can be positioned at the implant site, but the device becomes too long requiring two operators to load
Solution Approach 1:
The catheter assembly is nested within or alongside the outer shaft in a compact configuration during storage and loading. The clip mechanism enables the catheter assembly to be positioned close to the operating handle during loading, effectively nesting the functional components in a space-efficient manner that reduces the operational length of the delivery device.
Solution Approach 2:
The clip provides a dynamic adjustment mechanism that allows the catheter assembly to be repositioned along the outer shaft. During loading, the clip holds the catheter assembly at a reduced distance from the handle, but during delivery, the catheter assembly can be extended to the full length needed to reach the implant site, thus adapting the device length to the operational requirements.
2Productivity
If the delivery device allows single-operator loading, then the loading process becomes more efficient, but the device structure becomes more complex
Solution Approach 1:
The clip acts as an intermediary component that mediates between the operator and the catheter assembly. By providing a simple clipping mechanism that can be easily engaged and disengaged, it enables single-operator loading without requiring complex automation systems or multiple operators, thus achieving high productivity with minimal structural complexity.
Solution Approach 2:
The delivery device is segmented into distinct functional modules: the outer shaft, the catheter assembly, and the clip mechanism. This segmentation allows each component to be independently optimized and assembled, enabling single-operator loading through modular assembly while keeping the overall device structure manageable and not excessively complex.
Data Source
AI summary
A clip for use during the loading of a prosthetic heart valve into a delivery device having an operating handle, a catheter assembly having a compartment for receiving the prosthetic heart valve, and an outer shaft joining the catheter assembly to the operating handle. The clip includes a first receiver coupleable to the operating handle of the delivery device and a second receiver coupleable to the outer shaft of the delivery device. The first and second receivers may be arranged orthogonally to one another so that in use the clip orients the catheter assembly substantially orthogonally to the operating handle.