Heart Valve Loading System with Internal Support Member
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Solution Overview
Problem
The existing methods for loading replacement heart valves into delivery devices face challenges such as uneven collapse and deployment due to complex shapes and components, leading to unbalanced or unexpected results during minimally invasive procedures.
Innovation Solution
A system comprising a base unit, catheters, a mandrel, a hypotube with an internal support member, and a counterbearing is used to facilitate the loading of the heart valve, with a method involving the use of funnels and nosecones to transition the valve from an expanded to a collapsed condition, ensuring uniform collapse and axial positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a replacement heart valve with complex shape and components is collapsed and loaded into a delivery device, then the valve can be delivered via minimally invasive procedure, but the collapse may be unbalanced or unexpected resulting in deployment errors
Solution Approach 1:
An internal support member is positioned within the heart valve frame before the collapsing process begins. This support member pre-establishes a structural framework that guides the collapse sequence, ensuring that the frame collapses uniformly along its entire length rather than unpredictably, thereby improving both ease of operation and reliability of the collapsing process
Solution Approach 2:
The internal support member acts as an intermediary element between the delivery device and the heart valve frame. It mediates the collapsing process by providing a temporary structural framework that distributes collapse forces evenly, preventing localized buckling and ensuring uniform deformation of the frame during loading into the delivery device
2Reliability
If the heart valve is collapsed uniformly using an internal support member, then deployment reliability is improved, but the device complexity increases
Solution Approach 1:
The internal support member is designed to perform multiple functions: it provides structural support during collapse, guides the deformation sequence, and maintains frame geometry throughout the loading process. This multi-functionality reduces the need for additional specialized components, thereby limiting the increase in device complexity while maintaining improved reliability
Solution Approach 2:
The internal support member is constructed from a flexible material that can deform with the frame during collapse but maintains sufficient rigidity to guide the deformation process. This flexibility allows the support member to adapt to the frame's geometry changes without requiring complex mechanical structures, thus improving reliability while minimizing added complexity
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach ensures precise and uniform loading of the heart valve, reducing the complexity of the procedure and minimizing errors, thereby enhancing the reliability of the minimally invasive valve replacement process.
Implementation Method 1
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Data Source
AI summary
A system for heart valve repair includes a collapsible and expandable replacement heart valve and a delivery device for implanting the implanting the valve. The delivery device includes a base unit positioned at a proximal end of the delivery device, an outer catheter extending from the base unit, a first inner catheter positioned within the outer catheter, a second inner catheter positioned within the first inner catheter, a mandrel positioned within the second inner catheter, and a nosecone adapted to be couple to the second inner catheter.