Cardiac Valve Loading Device Radial Collapse Mechanism
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Solution Overview
Problem
Existing minimally invasive techniques for mitral valve replacement face challenges in efficiently and safely delivering and placing replacement mitral valves due to difficulties in collapsing the valve into a small delivery device.
Innovation Solution
A loading device is designed to radially collapse an expandable medical implant, featuring an operating handle, native and removable sheaths, an actuation rod, and control elements to facilitate the loading of the valve into a delivery system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If minimally invasive techniques are used for mitral valve replacement, then patient trauma and procedural risk are reduced, but the complexity of collapsing and delivering the valve increases
Solution Approach 1:
The patent employs a nested sheath system where an inner collapsible sheath is positioned within an outer delivery sheath. The inner sheath collapses radially to accommodate the valve during delivery, while the outer sheath provides structural support. This nested configuration allows the valve to be compressed into a small delivery profile suitable for minimally invasive access while maintaining control over the collapse process.
Solution Approach 2:
The delivery system is divided into distinct functional segments: an outer delivery sheath, an inner collapsible sheath, and a valve holder assembly. The inner sheath can be independently collapsed and controlled relative to the outer sheath, allowing staged deployment and reducing the complexity of coordinating the entire collapse process simultaneously.
2Length of moving object
If the valve is collapsed into a small delivery device, then minimally invasive delivery is enabled, but the time and difficulty of the collapsing process increase
Solution Approach 1:
The valve is pre-mounted onto a valve holder assembly before being loaded into the delivery system. The holder assembly includes pre-positioned engagement structures that facilitate automatic or semi-automatic engagement with the delivery catheter, eliminating the need for time-consuming manual manipulation during the procedure.
Solution Approach 2:
The patent employs a controlled radial collapse mechanism where the inner sheath is designed to collapse automatically or with minimal actuation force when advanced through the outer sheath. This replaces complex manual compression techniques with a more efficient mechanical system that reduces the time and skill required for valve collapse.
3Adaptability or versatility
If a removable sheath is used in the loading device, then flexibility and adaptability are improved, but the device complexity increases
Solution Approach 1:
The removable inner sheath is designed to be compatible with multiple valve sizes and types while using the same basic holder assembly. The universal design allows a single loading device configuration to accommodate different valve prostheses, reducing the need for multiple specialized devices and offsetting the added complexity through increased versatility.
Data Source
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AI summary
A loading device (200) configured to radially collapse an expandable medical implant (100) may include an operating handle (228) having an opening therein extending along a longitudinal axis, a native sheath (232) coupled to the operating handle and partially extending into the opening, such that the native sheath is configured to translate relative to the operating handle, a removable sheath (213) removably coupled to the native sheath, an actuation rod (217) extending at least partially through the opening, a lumen of the native sheath, and a lumen of the removable sheath, a distal end of the actuation rod being configured to be removably coupled to the expandable medical implant, and a first control element (214) movable relative to the operating handle and coupled to the native sheath, the first control element being configured to translate the native sheath and the removable sheath relative to the operating handle.