Looped Sheathing Aids for Heart Valve Alignment
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Solution Overview
Problem
Current cardiovascular treatments, particularly for heart valve issues, are often invasive, leading to significant discomfort and long recovery times, and there is a need for less invasive methods to align valves with the native annulus effectively.
Innovation Solution
The design and manufacturing of valve delivery devices that include an outer shaft with an inner shaft and looped sheathing aids to facilitate coaxial alignment of the valve with the native annulus, using materials like stainless steel and nickel-titanium alloys, and shape memory materials to ensure precise engagement and deployment of the implantable heart valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional invasive surgical methods are used for heart valve replacement, then reliable valve implantation is achieved, but patient discomfort and recovery time significantly increase
Solution Approach 1:
The patent employs a flexible delivery catheter with a distal balloon that can be inflated and deflated to guide and deploy the heart valve. The flexible nature of the catheter allows percutaneous access through blood vessels, avoiding open surgery while maintaining reliable valve implantation through controlled balloon expansion at the target site
Solution Approach 2:
The delivery catheter system acts as an intermediary device that transports the collapsed heart valve through the vasculature to the target annulus, then uses balloon inflation as a mediator to expand and secure the valve in place, replacing the need for direct surgical intervention
2Object-affected harmful factors
If percutaneous delivery methods are used for heart valve implantation, then patient discomfort and recovery time are reduced, but alignment precision with the native annulus becomes more difficult
Solution Approach 1:
The patent replaces manual mechanical alignment methods with imaging-guided positioning systems that use fluoroscopy or other imaging modalities to visualize the delivery catheter's position relative to the native annulus, allowing precise alignment to be achieved through visual feedback rather than tactile mechanical guidance
Solution Approach 2:
The distal balloon serves as an intermediary alignment tool that can be inflated to contact the native annulus structure, providing a reference point for proper valve positioning and ensuring coaxial alignment between the implantable valve and the native annular opening
3Device complexity
If a simple delivery catheter design is used, then device complexity is reduced, but the ability to guide and control valve deployment is insufficient
Solution Approach 1:
The patent incorporates a dynamic balloon that can be inflated and deflated on demand to control valve deployment. The balloon's ability to change volume provides operators with controlled engagement and disengagement capabilities, allowing precise timing and positioning of valve release without requiring complex mechanical locking mechanisms
Solution Approach 2:
The delivery system is segmented into distinct functional components: the catheter body for navigation, the collapsible balloon for deployment control, and the implantable valve for the final function. This segmentation allows each component to be optimized for its specific function while maintaining overall system simplicity
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
These devices enable less invasive delivery and deployment of heart valves, reducing patient discomfort and recovery time by allowing for precise alignment and secure positioning of the valve within the native annulus, thereby improving treatment efficacy and patient outcomes.
Implementation Method 1
Each of the plurality of looped sheathing aids may include a shape memory material
Implementation Method 2
Each of the plurality of looped sheathing aids may include a nickel titanium alloy
Data Source
AI summary
A delivery system for delivering an implantable heart valve includes an outer shaft and an inner shaft that is slidingly disposable within an outer shaft lumen, the inner shaft including a distal end region. A plurality of fingers extend distally relative to the distal end region of the inner shaft and are adapted to releasably engage an implantable heart valve. A plurality of looped sheathing aids extend distally from the distal region of an inner shaft lumen and are adapted to guide the implantable heart valve back into the outer shaft lumen when the implantable heart valve is pulled back into the outer shaft lumen. Each of the plurality of looped sheathing aids include a distal petal adapted to engage tissue adjacent a native valve annulus in order to limit distal advancement of the implantable heart valve during deployment of the implantable heart valve.